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					                         Table of Contents
Part VIII   DESCRIPTIONS/DISCLOSURES AND UTILITY

A.    INTRODUCTION                                          469
B.    THE PATENT APPLICATION                                469
C.    WRITTEN DESCRIPTION                                   473
      University of Rochester v. G.D. Searle & Co.          474
      FALKO-GUNTER FALKNER, v. STEPHEN C. INGLIS            484
      LG ELECTRONICS, INC., v. BIZCOM ELECTRONICS, INC.     492
      In Re Joyce A. CORTRIGHT                              495
D.    CLAIMS                                                501
      SOLOMON v. KIMBERLY-CLARK CORP.                       502
      BEACHCOMBERS v. WILDEWOOD CREATIVE PRODUCTS           507
      TRONZO v. BIOMET, INC.                                509
E.    UTILITY AND ENABLING DISCLOSURE                       513
      1.     Utility                                        513
      2.     Enabling Disclosure                            514
      3.     Chemical and Pharmacological Compounds         515
      In Re Donald R. MILLIGAN                              516
      CROSS v. IIZUKA                                       517
E.    “BEST MODE” DISCLOSURE                                524
      TRANSCO PRODUCTS v. PERFORMANCE CONTRACTING           527
      UNITED STATES GYPSUM v. NATIONAL GYPSUM               535
      ROBOTIC VISION SYSTEMS v. VIEW ENGINEERING            541
G.    INEQUITABLE CONDUCT - FRAUD ON THE PATENT OFFICE      547
      APTIX CORPORATION v. QUICKTURN DESIGN SYSTEMS, INC.   551
      CRITIKON, INC. v. BECTON DICKINSON VASCULAR ACCESS    559
      B.F. GOODRICH v. AIRCRAFT BRAKING SYSTEMS             563
      DESTRON/IDI v. ELECTRONIC IDENTIFICATION DEVICES      567
      ALLIED COLLOIDS INC. v. AMERICAN CYANAMID             573
      Life Techs., Inc. v. Clontech Lab., Inc.              575
      ATD CORPORATION v. LYDALL, INC.                       580
      MARLOW INDUSTRIES, INC. v. IGLOO PRODUCTS             581
      BRISTOL-MYERS SQUIBB v. RHONE-POULENC RORER           586
      PURDUE PHARMA L.P. v. ENDO PHARMACEUTICALS INC.       598
Part VIII Descriptions/Disclosures and Utility

A.      Introduction
         This Part includes three topics which are not usually combined in Patent Law casebooks -
patent disclosures, utility, and ―fraud on the Patent Office.‖ Utility is generally covered in
conjunction with novelty and non-obviousness as it is one of the three - or four, if ―patentable
subject matter‖ is included - basic requirements for a patent. However, as a practical matter,
utility is rarely an issue and when it is an issue, it is often combined with a failure to ―enable.‖
Hence, in these materials, utility is combined with ―enabling disclosure,‖ one of the requirements
for a validly issued patent. Furthermore, a complete disclosure should be regarded as a
fundamental requirement for a patent monopoly - the quid pro quo for the government granted
exclusive right or license. ―Fraud on the Patent Office,‖ a/k/a ―inequitable conduct,‖ is included
here since it represents an attempt by the applicant to obtain ―something for nothing‖ - a 20 year
monopoly in exchange for an ―invention‖ which is either not new or is obvious to someone
skilled in the area.

        As was true for anticipation and obviousness, disclosure issues frequently reach the
Federal Circuit in an appeal from a final decision of a U.S. District Court in an infringement suit.
It should be recalled that an issued patent is presumed valid and all challenges – including an
allegation of fraud on the Patent Office - must be proven by ―clear and convincing evidence.*
The Federal Circuit continues to try to explain this presumption in a way that all can understand
and apply it:

         The presumption of validity and the placement of the burden of proof remain ―static,
     never-changing.‖ The purpose of the presumption of validity, codified at 35 U.S.C. §
     282, is to contribute stability to the grant of patent rights. The presumption operates by
     placing the burden of proving invalidity on the person attacking the patent, who must
     prove invalidity by clear and convincing evidence. The presumption does not dissolve
     and the burden of proof does not change during the trial; rather, the evidence presented
     by the challenger must be of such quality and weight as to establish invalidity despite the
     presumption.

MAGNIVISION, INC. v. The BONNEAU COMPANY, 115 F.3d 956, 42 U.S.P.Q.2d 1925
(Federal Circuit, 1997)


B. The Patent Application

       A patent application is said to be ―one of the most difficult legal instruments to draw with
accuracy.‖1 Unlike most applications, which lose their importance once the application has been

*
         The proposed Patent Reform Act would make major changes in how - and where – inequitable conduct would
be raised. The Bill can be found on the course website.
1
        Harmon, Patents and the Federal Circuit, 2nd Edition, p. 115.


                                                     469
granted,1 the patent application, when granted, becomes the issued patent – what you get is what
you asked for! However, in addition to a formal patent application (FPA) there are two methods for
filing pre-applications – the Provisional Patent Application (PPA) and the Inventor Disclosure
Statement (IDS). The advantages and disadvantages of Provisional Patent Application are
discussed in the following article.

Advantages and Disadvantages of a Provisional Patent Application, N. Paul
Friederichs, Patent Café, Wednesday, March 10, 1999

    Provisional Patent Applications (PPAs) were devised to hold costs down, while an inventor
    explores the marketability of an invention. The PPA shifts costs, but does not necessarily
    reduce costs.

    1. Initial cost - Some commentators suggest that the initial cost of a PPA is slightly lower.
    Formal patent applications (FPAs) have typically been about $3000-$5000 for preparation
    and filing of a simple mechanical patent. A PPA covering the same invention would be
    between $1000 and $1200.

    2. Higher overall cost - The overall cost of a patent can be higher if one files a PPA. The
    PPA is a cost shifting tool. It allows one to market the invention, while enjoying a patent
    pending status. The marketing information is used to determine whether a formal patent
    application should be pursued. The overall cost will be higher, assuming the marketing is
    positive and one files an FPA. Of course, the business should justify the cost before filing
    the FPA. Should the invention prove not salable, the loss will be minimized, since there is
    no requirement to file an FPA. Note: The cost of a subsequently filed FPA should be
    reduced over standard rates due to the overlap in effort between a PPA and an FPA.

    3. Delaying Examination Costs - This is the primary benefit of filing a PPA and is the reason
    for creating this form of protection. This one year delay should be used to gather
    information on the market viability of the invention. Viable inventions justify further
    expenditures, while unworthy inventions are dropped before overspending occurs.

    …

    5. Risk of Inadequate Disclosure - This is a serious risk depending upon whether the PPA is
    prepared with a cavalier attitude. The PPA should contain the full and complete disclosure
    of the invention equivalent to the quality level found in an FPA. This means the PPA
    should be written as the Detailed Description and further include the drawings that will be
    used in an FPA. Prepared in this manner, there is no more risk of an inadequate disclosure
    than there is with the preparation and filing of an FPA. Too often, however, inventors


1
        An impressive law school application may get the applicant into a good law school, but it wouldn‘t
necessarily result in graduation and bar passage.

         The main difference between a PPA and a FPA is that the former does not include claims.


                                                   470
  believe they can prepare and file their own PPA and in the process provide an incomplete
  disclosure, which can lead to a variety of problems include complete and total loss of rights.

  6. Foreign Recognition - Under the Patent Cooperation Treaty each country is free to
  determine whether it will recognize the priority dates of other countries. Nobody knows for
  certain how each country will treat the PPA foreign filing date. However, international
  politics would suggest that each country will respect priority dates granted by the United
  States government.

  The usefulness of a PPA is readily appreciated in some situations and not in others, thus the
  mixed reactions. Commentators have identified the key times for pursuing a PPA to be when
  time is short and/or when financial resources are low. Most independent inventors fall
  squarely in this second category - low funds. In this situation, the primary risk to be avoided
  is an inadequate disclosure. A properly prepared professional application should not suffer
  from this problem.



       An ―inventor disclosure‖ is not a formal application but can establish important dates,
both for priority and novelty/non-obviousness purposes. Such disclosures can be submitted to
the PTO:

                            Disclosure Document Program
   A paper disclosing an invention (called a Disclosure Document) and signed by the
   inventor or inventors may be forwarded to the USPTO by the inventor (or by any one of
   the inventors when there are joint inventors), by the owner of the invention, or by the
   attorney or agent of the inventor(s) or owner. The Disclosure Document will be retained
   for two years, and then be destroyed unless it is referred to in a separate letter in a related
   nonprovisional patent application filed within those two years.

   THE DISCLOSURE DOCUMENT IS NOT A PATENT APPLICATION. THE DATE
   OF ITS RECEIPT IN THE USPTO WILL NOT BECOME THE EFFECTIVE FILING
   DATE OF ANY PATENT APPLICATION SUBSEQUENTLY FILED.

   These documents will be kept in confidence by the Patent and Trademark Office without
   publication in accordance with 35 U.S.C. 122(b) effective November 29, 2000.

   This program does not diminish the value of the conventional, witnessed, permanently
   bound, and page-numbered laboratory notebook or notarized records as evidence of
   conception of an invention, but it should provide a more credible form of evidence than
   that provided by the mailing of a disclosure to oneself or another person by registered
   mail.

   Content of the Disclosure Document



                                                471
   The benefits afforded by the Disclosure Document will depend directly upon the
   adequacy of the disclosure. It is strongly recommended that the document contain a clear
   and complete explanation of the manner and process of making and using the invention in
   sufficient detail to enable a person having ordinary knowledge in the field of the
   invention to make and use the invention. When the nature of the invention permits, a
   drawing or sketch should be included. The use or utility of the invention should be
   described, especially in chemical inventions.

   Preparation of the Disclosure Document

   A standard format for the Disclosure Document is required to facilitate the USPTO's
   electronic data capture and storage. ….

   Other Enclosures

   The Disclosure Document must be accompanied by a separate cover letter signed by the
   inventor stating that he or she is the inventor and requesting that the material be received
   under the Disclosure Document Program.

   A notice with an identifying number and date of receipt in the USPTO will be mailed to
   the customer, indicating that the Disclosure Document may be relied upon only as
   evidence and that a patent application should be diligently filed if patent protection is
   desired. The USPTO prefers that applicants send two copies of the cover letter or
   Disclosure Document Deposit Request form and one copy of the Disclosure Document,
   along with a self-addressed stamped envelope. The second copy of the cover letter or
   form will be returned with the notice. It is not necessary to submit more than one copy of
   the document in order for it to be accepted under the Disclosure Document Program.

   WARNINGS to Inventors

   The two-year retention period is not a "grace period" during which the inventor can wait
   to file his or her patent application without possible loss of benefits. It must be
   recognized that, in establishing priority of invention, an affidavit or testimony referring to
   a Disclosure Document must usually also establish diligence in completing the invention
   or in filing the patent application after the filing of the Disclosure Document.
Source: USPTO

        The application process can be time consuming. Some patents are granted (or denied)
within two years but many take much, much longer. The following article describes a technique
which can be used in certain cases to expedite the process.

―Make Special‖ For Faster Patent Processing, Michael Gallagher, Patent Café
Wednesday, February 27, 2002

  With patent examination routinely taking more than a year, a little known PTO procedure
  offers the prospect of saving considerable time. Congress and the PTO has recognized that


                                                472
  public interest in certain inventions, and certain inventors, deserves expedited handling.
  Under certain conditions, an inventor can petition for an application to be ―made special,‖
  and advanced out of turn on the PTO calendar. Generally, the conditions governing making
  special fall into two general categories, those that relate to particular areas of invention, or to
  some special status of the inventor.

  Within the particular areas of invention, some command a more preferred status than others.
  For example, PTO guidelines state that articles ready for manufacture, inventions already
  under active infringement, biotechnology inventions by small entities, and certain
  applications directed to a single invention, ―may‖ be made special on petition to the PTO.
  Others inventions have an even more preferred status, namely those relating to
  environmental quality, energy, recombinant DNA, superconductivity, HIV/AIDS, and
  counter-terrorism inventions, which ―will‖ be accorded special status. This last provision is
  coming into greater interest with the rise in the number of security related applications since
  last September‘s terrorist attacks. The counter terrorism invention category is particularly
  broad, covering inventions designed to counter international terrorism is nearly all forms,
  including ―violent acts or acts dangerous to human life‖ that would be a violation of any
  federal or state criminal law.

  Certain inventors qualify for special status. The guidelines provide for special status upon
  petition by an applicant who is 65 years or more old, or one whose state of health is such as
  to threaten an orderly prosecution through regular channels.

  Good news for the inventor is that ―make special‖ applications based on the age or health of
  the inventor carry no extra filing fees. Those applications based on the nature of the
  invention, unfortunately, do not have a consistent fee structure. Certain inventions, such as
  those relating to environmental quality, energy, and superconductivity are currently
  processed without fee. On the other hand, those relating to the other areas discussed above
  currently carry an additional fee.

  Applications to make special are granted only on petition, and must be in writing and
  identify the application by application number and filing date. The Special Program
  Examiner of the patent examining group for the application in question decides those ―make
  special‖ petitions where the PTO has discretion to grant or not grant the petition.


C. Written Description
        The purpose of §112 ¶1 is to ensure that the scope of the right to exclude, as set forth in
the claims, does not overreach the scope of the inventor's contribution to the field of art as
described in the patent specification. See In re Gosteli, 872 F.2d 1008, 1012, 10 U.S.P.Q.2D
(BNA) 1614, 1618 (Fed. Cir. 1989) ("The description must clearly allow persons of ordinary
skill in the art to recognize that [the inventor] invented what is claimed."); see also Vas-Cath,
Inc. v. Mahurkar, 935 F.2d 1555, 1561, 19 U.S.P.Q.2D (BNA) 1111, 1115 (Fed. Cir. 1991)
("Adequate description of the invention guards against the inventor's overreaching by insisting



                                                 473
that he recount his invention in such detail that his future claims can be determined to be
encompassed within his original creation.")

       Compliance with the written description requirement requires that the specifications of
these patents describe the inventions claimed in these patents. Thus, an application considered as
a whole must convey to one of ordinary skill in the art, either explicitly or inherently, that the
applicant invented the subject matter claimed in the patent.

       The standard for determining whether the written description requirement has been met
has been stated as follows:

         Although [the applicant] does not have to describe exactly the subject matter claimed,
    ... the description must clearly allow persons of ordinary skill in the art to recognize that
    [he or she] invented what is claimed.... The test for sufficiency of support in a parent
    application is whether the disclosure of the application relied upon reasonably conveys to
    the artisan that the inventor had possession at that time of the later claimed subject matter.

Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed.Cir.1991). Whether the written
description requirement has been met is a question of fact. Thus, the Federal Circuit ―must
determine whether substantial evidence supports the verdict that the written description
requirement was met.‖ WANG LABORATORIES, INC. v. TOSHIBA CORPORATION, 993
F.2d 858, 26 U.S.P.Q.2d 1767 (Federal Circuit 1993).


      Section 112 ¶1 has recently created a major controversy within the Federal Circuit, one
which might eventually have to be resolved by the Supreme Court or Congress:

                   University of Rochester v. G.D. Searle & Co.
                      United States Court of Appeals, Federal Circuit (2004)

    ON PETITION FOR REHEARING EN BANC
    A petition for rehearing en banc was filed by the Appellant, and a response thereto was
invited by the court and filed by the Appellees. … A poll was requested, taken, and failed.*
    Upon consideration thereof,
    IT IS ORDERED THAT:
    (1) The petition for rehearing is denied.
    (2) The petition for rehearing en banc is denied.

LINN, Circuit Judge, with whom RADER and GAJARSA, Circuit Judges, join, dissenting from
the court's decision not to hear the case en banc.#

*
   Circuit Judges Newman, Rader, Bryson, Gajarsa, and Linn voted in favor of en banc reconsideration.
Chief Judge Mayer and Circuit Judges Michel, Lourie, Clevenger, Schall, Dyk, and Prost voted against en
banc reconsideration.


                                                 474
    The panel opinion in this case perpetuates the confusion our precedent has engendered in
establishing "written description" as a separate requirement of 35 U.S.C. § 112, paragraph 1, on
which a patent may be held invalid. That precedent should be overturned. Accordingly, I
respectfully dissent from the court's decision not to hear this case en banc.
     Section 112 of Title 35 of the United States Code requires a written description of the
invention, but the measure of the sufficiency of that written description in meeting the conditions
of patentability in paragraph 1 of that statute depends solely on whether it enables any person
skilled in the art to which the invention pertains to make and use the claimed invention and sets
forth the best mode of carrying out the invention. The question presented by 35 U.S.C. § 112,
paragraph 1, is not, "Does the written description disclose what the invention is?" The question
is, "Does the written description describe the invention recited in the claims - themselves part of
the specification - in terms that are sufficient to enable one of skill in the art to make and use the
claimed invention and practice the best mode contemplated by the inventor?" That is the
mandate of the statute and is all our precedent demanded prior to Regents of the University of
California v. Eli Lilly & Co. (Fed. Cir. 1997).
    Reading into paragraph 1 of section 112 an independent written description requirement,
divorced from enablement, sets up an inevitable clash between the claims and the written
description as the focus of the scope of coverage. This is ill-advised. Surely there is no principle
more firmly established in patent law than the primacy of the claims in establishing the bounds
of the right to exclude. [Citations omitted] The statute itself makes clear that Congress intended
the claims to define the scope of coverage. 35 U.S.C. § 112 ¶2, ("The specification shall
conclude with one or more claims particularly pointing out and distinctly claiming the subject
matter which the applicant regards as his invention.").
    The primary role of the written description is to support the claims, assuring that persons
skilled in the art can make and use the claimed invention. §112 ¶1 ("The specification shall
contain a written description of the invention, and of the manner and process of making and
using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to
which it pertains, or with which it is most nearly connected, to make and use the same.").
     Construing section 112 to contain a separate written description requirement beyond
enablement and best mode creates confusion as to where the public and the courts should look to
determine the scope of the patentee's right to exclude. Under the panel's analysis, a court looks to
the written description to determine the parameters of the patentee's invention - under guidelines
yet to be articulated and then determines if the claims, as properly construed, exceed those
parameters. ("While it is true that this court and its predecessor have repeatedly held that claimed
subject matter 'need not be described in haec verba' in the specification to satisfy the written
description requirement, it is also true that the requirement must still be met in some way so as
to 'describe the claimed invention so that one skilled in the art can recognize what is claimed.'")
There is simply no reason to interpret section 112 to require applicants for patent to set forth the
metes and bounds of the claimed invention in two separate places in the application. That is the
exclusive function of the claims.



#
   The separate opinions are reproduced in an order different from the original in an attempt to better present
the issues. Ed.


                                                     475
    The burden of Lilly and Enzo has fallen on the biotech industry disproportionately, but, as
this decision makes clear, the new-found written description requirement will affect all fields of
emerging technology. When patent attorneys set out to write patent applications, they do so for
an educated audience--those skilled in the art--and attempt to describe the invention in a way that
enables those of ordinary skill to make and use the invention as claimed. Before the decision in
Lilly, the practicing bar had accepted and found workable the notion elucidated in our precedent
that § 112 requires a written description sufficient to enable one of ordinary skill in the art to
make and use the claimed invention - i.e., enablement. Lilly changed the landscape and set in
motion the debate the panel opinion in this case perpetuates.
    As I commented in my dissent from the court's decision not to hear the Enzo case en banc,
"Some have praised Lilly for maintaining the integrity of patent disclosures and for curbing
patent filings for inventions that have not yet been made but are just nascent ideas. Others have
been sharply critical of Lilly." That debate continues to leave uncertain how inventions are
protected, how the United States Patent and Trademark Office discharges its responsibilities, and
how business is conducted in emerging fields of law. These uncertainties will remain unless
resolved by this court en banc or by the Supreme Court. The issue is important, is ripe for
consideration, and deserves to be clarified, one way or the other. For these reasons, I respectfully
dissent from the court's refusal to consider this case en banc.

RADER, Circuit Judge, dissenting from the court's decision not to hear the case en banc, with
whom Circuit Judges GAJARSA and LINN, join.
    By a narrow margin, this court has declined to take this case en banc. Thus, this court avoids
the opportunity to clarify and correct its confusing jurisprudence on the new written description
invalidity doctrine.
    In 1997, this court for the first time applied the written description language of 35 U.S.C. §
112 ¶1 as a general disclosure requirement in place of enablement, rather than in its traditional
role as a doctrine to prevent applicants from adding new inventions to an older disclosure. In
simple terms, contrary to logic and the statute itself, Eli Lilly requires one part of the
specification (the written description) to provide "adequate support" for another part of the
specification (the claims). Neither Eli Lilly nor this case has explained either the legal basis for
this new validity requirement or the standard for "adequate support." Because this new judge-
made doctrine has created enormous confusion which this court declines to resolve, I respectfully
dissent.

      Confusion in This New Validity Doctrine
    A recent case illustrates well the confusion engendered by this new doctrine. In Enzo
Biochem, Inc. v. Gen Probe, Inc. (Fed. Cir. 2002), this court struggled over the scope of the
written description invalidity doctrine first created in 1997. In its original Enzo opinion, this
court invalidated claims to polypeptides that detect the gonorrhea bacteria. The inventor of these
DNA probes specifically disclosed them and deposited three polypeptides at the American Type
Culture Collection. Even for claims limited in scope to the deposited material, this court
invalidated the patent for insufficient disclosure of the invention. (concluding that "a deposit is
not a substitute for a written description of the claimed invention." This decision correctly
applied the 1997 Eli Lilly doctrine which requires a nucleotide-by-nucleotide recitation of the



                                                476
structure of a biotechnological invention. Accordingly, the mere deposit of material did not
satisfy that reading of §112 ¶1

     That Enzo opinion caused an immediate firestorm. Within a few months, this court vacated
its original opinion and reversed the result. This flip-flop shows the problem.
   Following issuance, withdrawal, and reissuance of Enzo, this court engaged in lengthy debate
over the new disclosure validity doctrine. That debate continued in this court's subsequent cases.
    Indeed a brief survey of the literature on this topic, an astounding amount in a few short
years, shows 31 articles criticizing the Eli Lilly doctrine, 7 articles defending the doctrine, and 16
neutrally commenting on the state of this evolving case law. In its brief requesting en banc
reconsideration in Enzo Biochem, the United States issued a call for clarity, which this court has
yet to address:

      Although this Court has addressed the "written description" requirement of section
      112 on a number of occasions, its decisions have not taken a clear and uniform
      position regarding the purpose and meaning of the requirement. . . . A review of the
      plain text of section 112, and the case law of this Court, reveals at least three
      different possible tests for an adequate "written description." . . . En banc
      consideration of the written description provision is appropriate so that the court can
      provide inventors, the public, and the USPTO with an authoritative interpretation of
      the provision.

Brief of Amicus Curiae United States.
    In sum, by any measure, the Eli Lilly doctrine has engendered confusion. After all, Eli Lilly
created a new validity doctrine under §112 ¶1 separate from enablement and yet described it as
"analogous to enablement.". Unfortunately, this court has passed up another opportunity to
resolve the confusion.
Supreme Court's Role in the Eli Lilly Doctrine
    In an effort to supply some coherent basis for its new validity doctrine, this court in
Rochester refers to an 1822 Supreme Court case that discusses the written description language
of the Patent Act. Univ. of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 924 (Fed. Cir.
2004). An examination of Rochester's references to the Supreme Court in their proper historical
context impeaches, rather than supports, the modern written description validity doctrine.
    In 1793, the Patent Act, 1 Stat. 318, required an inventor to describe the scope of the
invention in the body of the specification; the Act did not require any claims. Instead the Act
required the inventor to provide "a written description of his invention, and of the manner of
using, or process of compounding the same, in such full, clear, and exact terms, as to distinguish
the same from all other things before known, and to enable any person skilled in the art or
science . . . to make, compound, and use the same. . . ." In re Barker (CCPA 1977). Without
citing this statutory language, Rochester recounts the Supreme Court's explanation that this
provision contained two requirements:
         The specification, then, has two objects: one is to make known the manner of
      constructing the machine (if the invention is of a machine) so as to enable artizans to



                                                 477
       make and use it, and thus to give the public the full benefit of the discovery after the
       expiration of the patent. . . . The other object of the specification is, to put the public
       in possession of what the party claims as his own invention, so as to ascertain if he
       claim anything that is in common use, or is already known, and to guard against
       prejudice or injury from the use of an invention which the party may otherwise
       innocently suppose not to be patented.

Evans v. Eaton, 20 U.S. 356, 433-34 (1822). For obvious reasons, Rochester undertakes no
further explanation of the Supreme Court's language. In simple terms, the Supreme Court could
not have meant that the written description portion of the specification must provide adequate
support for the claims as this court's law presently requires. Patents did not even contain claims
in 1822.
    In fact, even the Supreme Court's allusion to "two objects," the reason for the Rochester cite,
takes on a different meaning under careful legal analysis. The Supreme Court clearly linked its
"other object" of the specification disclosure to the portion of the statute requiring the inventor
"to distinguish the same from all things before known." Significantly, that language no longer
appears in §112. Later in 1870, the Patent Act first articulated the requirement that applicants
define their exclusive right in a distinctly drafted claim. Only one logical conclusion flows from
this history. When the Patent Act assigned the notice function to claims rather than the written
description, enablement became the sole §112 ¶1 standard for adequate disclosure of an
invention. 1 . This observation about the meaning §112 ¶1 has been axiomatic patent law for
decades. In a decision of the Court of Customs and Patent Appeals that is binding on this court,
Judge Rich interpreted §112 ¶1 to have only two requirements - not enablement and the Eli Lilly
written description doctrine, but enablement and best mode! In re Gay (CCPA 1962). In sum, the
Eli Lilly written description doctrine has no basis in this court's legal precedent. Thus, Rochester
cannot explain the missing 1793 statutory language, the advent of the claim requirement that
replaced the 1822 description doctrine, the inapplicability of the Evans quote to a new 1997
invalidity doctrine, or the apparent conflict with binding CCPA interpretations of §112 ¶1.

    The Rochester reference to the 1822 Supreme Court language does, however, reveal some
insights into the reasons that the Eli Lilly doctrine engenders confusion. As the 1822 Supreme
Court reference explains, the original statute required a written description to warn "an innocent
purchaser or other person using a machine, of his infringement." In other words, the statute
incorporated a written description requirement to define the scope of the invention for
infringement and for distinguishing the invention from prior art. Eli Lilly and its progeny convert
that original infringement doctrine into a new challenge to validity. Suddenly, all the difficulty
and imprecision of defining an invention in legal language becomes a validity doctrine.
    In sum, a careful legal analysis of the language and history of §112 ¶1 shows that the Eli
Lilly doctrine has no basis in the written description language of the original Patent Act.
Moreover, as this court's binding CCPA precedent shows, the statutory language of 35 U.S.C. §

1
  Indeed the United States notes that the current statute requires "a written description of the invention, and
of the manner and process of making and using it, in such full clear, concise, and exact terms as to enable
[the invention]." 35 U.S.C. § 112, P 1. As the United States noted, "A straightforward reading of the text of
section 112 suggests that the test for an adequate written description is whether it provides enough written
information for others to make and use the invention." Brief of Amicus Curiae United States.


                                                     478
112, P 1 has not changed in any way that justifies "discovery" of a vast new validity doctrine
over two hundred years after the 1793 Act. To the contrary, the changes in the statutory language
of §112 ¶1 since 1793 impeach the reasoning of Rochester and Eli Lilly.
    A careful analysis of the Supreme Court's passing recitations of patent requirements does not
support the Eli Lilly doctrine. … The Supreme Court is entirely correct to acknowledge the
requirement of full "disclosure" at the time of invention that prevents updating the patent
document with later inventions. Beginning in 1967, this court and its predecessor applied the
written description language to achieve this vital purpose of the Patent Act - tying disclosure to
the time of invention. In the words of Judge Rich, the first judge to use the description
requirement to police priority, "The function of the description requirement is to ensure that the
inventor had possession, as of the filing date of the application relied on, of the specific subject
matter later claimed by him." In re Wertheim (CCPA 1976). In fact, every application of the
written description doctrine before Eli Lilly in 1997 applied the written description doctrine for
this important purpose and only for this important purpose. Thus, the Festo listing does not
endorse the Eli Lilly innovation, but properly invokes the necessity of tying disclosure to the
time of invention.
    In sum, the Supreme Court offers no comfort to the Eli Lilly doctrine. Rather, in proper
historical and legal context, the Supreme Court's allusions to the description requirement
impeach both Rochester and Eli Lilly.

The Hypothetical Policy Analysis
    Rochester refers to a situation where a patent can enable an invention that is not described by
the specification. In the words of the opinion, "such can occur when enablement of a closely
related invention A that is both described and enabled would similarly enable an invention B if B
were described." This hypothetical seems to suggest that the 1997 doctrinal creation closes a
major gap in patent law. To the contrary, this court only created the Eli Lilly requirement in
1997; the patent system had succeeded quite well for over two hundred years without it.
Moreover no other patent system in the world has the Eli Lilly requirement to this day. The
world's patent systems work quite well without it.
    The hypothetical actually facilitates a policy analysis that explains the reasons that the new
1997 requirement is both superfluous and dangerous. In the first place, the hypothetical rarely, if
ever, happens. No actual case presents the hypothetical. In both Eli Lilly and Rochester, for
instance, the invention A (rat insulin in Eli Lilly; an assay for Cox 1 and 2 in Rochester) was
enabled and described, but the invention B (human insulin in Eli Lilly; a Cox 2 inhibitor in
Rochester) was not enabled.
    In understandable terms, the hypothetical says that an inventor invents the radio, but his
invention solves a problem that enables those of ordinary skill in the art to know how to make
and use both a radio and a TV. His patent disclosure only describes a radio but he claims broadly
an "electrical receiver." Thus, his claims seem to encompass the TV which his specification does
not describe but would enable if it were described. In that context, the reason the hypothetical
does not occur becomes obvious. If everyone of ordinary skill in the art knows from the
disclosure how to make and use the TV, the exceptionally talented inventor will also. To avoid
any risk of losing the TV invention, the inventor will fully disclose it and claim it, probably in a
separate application. For this very practical reason, no case has ever presented the hypothetical.


                                                479
Inventors know when they have made an invention and realize that they must properly disclose it
or risk losing it entirely.
    Carrying the genuinely "hypothetical" hypothetical forward, however, what happens if the
radio inventor for some unfathomable reason does not grasp that he has enabled a TV and later
asserts the radio patent against a TV maker? In simple terms, a court would properly interpret the
claim as limited to the radio. The TV maker would not infringe a claim that covers only the
radio. On the other hand, the Eli Lilly doctrine would instead invalidate the radio patent. Is that
the best result? After all, the inventor did invent the radio. Should he lose everything because he
did not disclose the TV?
    The facts of Eli Lilly itself illustrate the real problems in this area of patent interpretation and
enforcement. In simple terms, the inventor in that case invented and disclosed rat insulin but not
human insulin. In fact, at the dawn of the biotechnological age in 1977, the inventor could not
make human insulin. Biotechnology was in its infancy; it would have taken months, if not years,
of experimentation to make human insulin. Nonetheless the inventor claimed the rat insulin
invention broadly and later asserted it against human insulin. In this setting, U.S. patent law (and
world patent law in general) has two complementary ways to prevent any injustice - enablement
and traditional (not Eli Lilly) written description (enforcing the actual time of invention). If the
inventor has not enabled human insulin in the specification, the inventor has not enabled the full
scope of the claim. By the way, as noted earlier, if the rat insulin inventor had invented human
insulin as well, he surely would have disclosed it. In other words, a lack of disclosure is a dead
give-away for enablement problems. Alternatively, or likely in conjunction, the traditional
written description requirement as applied by this court and its predecessor beginning in 1967
will prohibit any addition of new matter to the patent document to "update" the claims to cover
human insulin.
    In sum, our patent law (and the world's patent law) has worked well for 200 years because
the law already possesses ample remedies for the Rochester hypothetical, which, as a practical
matter, never occurs. Neither Eli Lilly nor Rochester explains the legal policy that supports the
new doctrine.
The Practical Problems
    This new 1997 rule changes the established rules of claiming and disclosing inventions.
Many biotechnological inventions predate Eli Lilly. Before the 1997 change, no inventor could
have foreseen that the Federal Circuit would make a new disclosure rule. Without any way to
redraft issued patents to accommodate the new rule, many patents in the field of biotechnology
face serious and unavoidable validity challenges simply because the patent drafter may not have
included the lengthy nucleotide sequences. After all, the sequences are often routinely available
(albeit at some cost) to those of ordinary skill in this art.
    The Eli Lilly doctrine also seems to impose some illogical requirements on patent drafters
today. Must a software patent disclose every potential coding variation that performs a claimed
function? Must a biotechnological invention list every amino acid variation for a particular
protein or protein function - a task conceivably as impractical as the software disclosure
requirement? Must a university or small biotech company expend scarce resources to produce
every potential nucleotide sequence that exhibits their inventive functions? Perhaps more
important for overall patent policy, must inventors spend their valuable time and resources
fleshing out all the obvious variants of their last invention instead of pursuing their next


                                                  480
significant advance in the useful arts? Again Eli Lilly and Rochester appear to have given little
thought to these unintended consequences.
    This court, however, is not even the only judicial institution that must deal with the
unintended consequences of the 1997 doctrine. Under this new disclosure test, every case where
the written description does not specifically disclose some feature of the claimed invention will
give rise to a validity challenge. Thus, trial courts will have to empanel juries to inquire whether
one of skill in the art would have known that the inventor "possessed" the full invention. In a
sense, the Eli Lilly doctrine converts this court's confusing case law about the role of the
specification in defining the invention into a validity question. Thus, trial courts as well must
struggle to discern the standard for sufficient disclosure of an invention.
     Rochester emphasizes that this new disclosure doctrine is different from enablement. Thus, a
trial court, as in this case, must first ask its jury whether the specification provides sufficient
information to enable one of ordinary skill in the art to make and use the invention. Then the trial
court must ask the jury again to look at the same specification for information that an inventor of
extraordinary skill "possessed" the invention. Under this court's law, a patent disclosure could
apparently enable one of ordinary skill to make and practice the entire invention, but still not
inform that same artisan that the inventor was in possession of the invention. Moreover, the trial
court must give separate instructions and entertain separate witnesses on these inseparable patent
rules to ensure adequate disclosure. Viewed in the practical terms of trial procedure and jury
understanding, this 1997 doctrine unnecessarily complicates and prolongs patent enforcement. In
sum, Rochester does not resolve any of the confusion or provide a sound legal basis for the Eli
Lilly doctrine. For these reasons, this court should have reviewed this case en banc.

LOURIE, Circuit Judge, concurring (in the decision of the court not to rehear this case en banc).
    I concur … because this case was properly decided based on one of the grounds relied on by
the district court in invalidating the Rochester patent, the analysis of which will not be repeated
here.
    Contrary to the assertions of the appellant, certain amici, and some of the dissenters, there is
and always has been a separate written description requirement in the patent law. The
requirement to describe one's invention is basic to the patent law, and every patent draftsman
knows that he or she must describe a client's invention independently of the need to enable one
skilled in the relevant art to make and use the invention. The specification then must also
describe how to make and use the invention (i.e., enable it), but that is a different task.
    The requirements of the statute cannot be swept away by claiming that it relates only to
priority issues or that the prohibition on introduction of new matter takes care of the need for a
written description. The statute does not contain a limitation that it pertains only to priority
issues. Moreover, the prohibition on introduction of new matter (35 U.S.C. § 132) is not a
substitute for the written description requirement. Section 282 of the Patent Act lists as a defense
to an infringement action invalidity arising from a failure to comply with a requirement of
section 112 of the Act, which includes written description. In contrast, the new matter provision,
section 132, appears in a provision entitled "Notice of rejection; reexamination." Failure to
comply with that section is not expressly listed in the statute as an invalidity defense to
infringement, although we have held that the unsupported claims are invalid. See, e.g., Quantum




                                                481
Corp. v. Rodime, PLC (Fed. Cir. 1995) (invalidating claims that were broadened in scope during
reexamination in violation of 35 U.S.C. § 305, which is analogous to section 132).
    The separate written description requirement poses no conflict with the role of the claims. It
is well established that the specification teaches an invention, whereas the claims define the right
to exclude. While claims must be supported by the written description, the latter contains much
material that is not in the claims. The written description contains an elucidation of various
aspects of an invention as well as material that is necessary for enablement. Moreover, the
written description often contains material that an applicant intended to claim that has been
rejected in examination. Thus, the written description and the claims do not duplicate each other.
    The fact, if it is a fact, that written description has only been relied upon in recent years as a
ground of invalidity does not remove that requirement from the statute. Legal holdings arise
when they do because litigants raise them and courts have to decide them. Contrary to what has
been asserted, the interpretation of the statute as containing a separate written description
requirement did not originate with Lilly. It has always been there. And if a particular scope of
claim has not been sustained by the courts for failure to comply with the written description
requirement, it is because the applicant did not describe, and presumably did not invent, the
subject matter of the scope sought.
     Moreover, it is not correct, as has been asserted, that our decisions, particularly Regents of
the Univ. of Cal. v. Eli Lilly & Co. (Fed. Cir. 1997), have created a "heightened" written
description requirement for biotechnology inventions. We have applied the written description
requirement to cases that are not in the fields of chemistry or biotechnology. See, e.g., In re
Curtis (Fed. Cir. 2004) (dental floss) and … Gentry Gallery, Inc. v. Berkline Corp., (Fed. Cir.
1998) (sectional sofas). The statute is the same for all types of inventions, although it may be
applied differently, based on the technology and what is known by one of ordinary skill in the art
at the time an invention was made..
    It has been noted that genes can be described by their informational function, not just by
structure or physical or chemical properties, and that a lesser written description may be
adequate than is required for other types of inventions. Maybe so. Technology progresses, and
what one skilled in the art would read from a particular disclosure may change. The PTO has
now provided guidelines that help to guide applicants in preparing their patent applications.
    It is obviously correct that genes convey information (e.g., to make other nucleic acids or to
encode particular proteins). That fact does not serve to deny the existence of a written description
requirement in the law. It only goes to whether, under the facts of a particular case, the written
description requirement has been met. A fact-finder may have to decide whether claiming a
material solely by its information-conveying character results in a "single means claim"
purporting to claim everything that works, a dubious fulfillment of the requirement to "distinctly
claim the subject matter" of the invention. 35 U.S.C. § 112. In any event, it is fact-intensive. But,
once again, these matters go to whether the written description requirement has been met, not
whether it exists.
    As for the proposition that an original claim is part of the written description, that is clear.
See However, the issue may still remain in a given case, especially with regard to generic claims,
whether an original claim conveys that one has possession of and thus has invented species
sufficient to constitute the genus. Thus, the fact that a statement of an invention is in an original
claim does not necessarily end all inquiry as to the satisfaction of the written description


                                                 482
requirement. See Enzo, 323 F.3d at 968-69 ("Regardless whether the claim appears in the
original specification and is thus supported by the specification as of the filing date, § 112, ¶1 is
not necessarily met. . . . If a purported description of an invention does not meet the requirements
of the statute, the fact that it appears as an original claim or in the specification does not save it.
A claim does not become more descriptive by its repetition, or its longevity.").

DYK, Circuit Judge, concurring in the court's decision not to hear the case en banc.
    In my view the question of whether 35 U.S.C. § 112 contains a written description
requirement (separate from the enablement requirement) does not merit en banc review. For the
reasons set forth in the panel opinion and in Judge Lourie's opinion concurring in the denial of en
banc review, I think it is clear that the statute contains such a requirement - applicable both in the
context of priority and validity disputes. In this particular case the failure to satisfy that
requirement was not even a close case. The appellant simply did not invent, much less describe,
what was claimed.
    My vote to deny en banc review, however, should not be taken as an endorsement of our
existing written description jurisprudence. In my view we have yet to articulate satisfactory
standards that can be applied to all technologies. Future panel opinions may provide the
necessary clarity. If not, there may be a time when en banc consideration of the proper written
description standards will be appropriate. But this is neither the right time, nor the right case, in
which to consider those difficult questions.

NEWMAN, Circuit Judge, dissenting from the denial of rehearing en banc.
    I respectfully dissent from the court's decision not to resolve en banc the burgeoning conflict
in pronouncements of this court concerning the written description and enablement requirements
of the Patent Act. This question has been promoted from simple semantics into a fundamental
conflict concerning patent scope and the support needed to claim biological products. The
appropriate forum is now the en banc tribunal, not continuing debate in panel opinions applying
divergent law.
    I fully share Judge Lourie's understanding of the law. The continuing attack on well-
established and heretofore unchallenged decisions … is not only unwarranted, but is disruptive
of the stability with which this court is charged. If precedent has become obsolete or
inapplicable, we should resolve the matter as a court and again speak with one voice.
    The new biology has indeed raised new and important questions, with implications for policy
as well as law. However, the answer is not the simplistic one espoused by some commentators; it
is simply incorrect to say that there is not now and never has been a "written description"
requirement in the patent law. It has always been necessary to disclose and describe what is
patented. It has never been the law that one can claim what is not made known and set forth in
the patent.
   Various past decisions have been offered to support the exotic proposition that it is not
necessary for the inventor to describe the patented invention, but that enablement alone suffices
under the statute. These cases concern traditional issues of generic disclosures and specific
examples, and questions of support and predictability for scientific concepts and their
embodiments. Such traditional law was applied in Regents of the University of California v. Eli



                                                 483
Lilly & Co. (Fed. Cir. 1997), a case that is misdescribed in this debate, for Lilly does not depart
from precedent in its holding that the written description requirement can be fulfilled by "a
precise definition, such as by structure, formula, chemical name, or physical properties."
    If the nature of the subject matter is not amenable to precise description, some alternative
mode of disclosure is required, such as deposit in a public depository. However, the public
purpose of patents is seriously disserved by eliminating the description requirement entirely.
Federal Circuit law of written description has become encumbered with inconsistent
pronouncements, leading me to remark that "claims to an invention that is not described in the
specification are an anachronism." Housey Pharms., Inc. v. Astrazeneca UK Ltd. (Fed. Cir.
2004) (Newman, J., dissenting). If the majority of this court is nonetheless sympathetic to that
position, there should be careful consideration of the implications of precedent, for the law is that
"Section 112 requires that the application describe, enable, and set forth the best mode of
carrying out the invention." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S.
722, 724 (2002).
    The issue of whether patent law contains a separate written description requirement has
percolated through various panels of this court, on a variety of facts. The differences of opinion
among the judges of the Federal Circuit, are, in microcosm, the "percolation" that scholars feared
would be lost by a national court at the circuit level. Percolation is the great justifier of conflict
among the regional circuits. … This question has percolated enough; it is ripe for en banc
resolution.


          FALKO-GUNTER FALKNER, v. STEPHEN C. INGLIS
            U. S. COURT OF APPEALS FOR THE FEDERAL CIRCUIT
                   2006 U.S. App. LEXIS 13127 (May 26, 2006)

Before GAJARSA, Circuit Judge, ARCHER, Senior Circuit Judge and DYK, Circuit Judge.

GAJARSA, Circuit Judge.
    This is an appeal from a decision of the Board of Patent Appeals and Interferences ("Board")
in Interference No. 105,187, declared on December 24, 2003, between Falkner et al., U.S. Patent
No. 5,770,212 ("the Falkner '212 patent") and Inglis et al., U.S. Application Serial No.
08/459,040 ("the Inglis '040 application"). The Administrative Patent Judge (APJ) designated
Inglis as the senior party. On December 29, 2004, the Board issued a final decision, holding that
Falkner could not antedate Inglis' September 25, 1990 priority date, and entered judgment
against Falkner on the sole count of the interference. It ordered that Falkner was not entitled to
claims 1-19 of the Falkner '212 patent. It further ordered that Inglis was entitled to claims 9, 10,
29 and 30 of the '040 application. Falkner filed a timely notice of appeal. For the reasons
discussed below, we affirm the judgment of the Board.
   I. BACKGROUND
   A. The Invention
    Some vaccines against a virus (the "target virus") incorporate harmless fragments of the
target virus's genetic material into a second virus, called a "viral vector." When a person is



                                                 484
vaccinated, the viral vector produces harmless fragments of the target virus, ultimately
conferring immunity against it. To prevent the viral vector from itself causing a harmful
infection in the inoculee, it must be attenuated. Attenuation is achieved by deleting or
inactivating one or more genes responsible for the vector's growth and infectiousness. However,
because the vaccine is produced by essentially "growing" the vector virus (accompanied by its
inserted target virus gene), attenuation makes it difficult to manufacture the vaccine. The
traditional solution to this problem has been to inactivate genes known as "inessential" genes.
With inessential genes inactivated, the viral vector is substantially less pathogenic. At the same
time, because the vector virus can still fully reproduce itself, albeit more slowly, the vaccine can
be produced in commercial quantities. However, the traditional approach carried a disadvantage,
namely the risk that the vector virus, though attenuated, could still cause a harmful infection in
the inoculee.
    The inventors discovered a way of making vaccines safer by deleting or inactivating an
essential, rather than an inessential, gene from the viral vector's genome, while at the same time
solving the production problem by growing the vaccines in cells that were complementarily
modified to produce the absent essential viral gene product "on behalf of" the vector virus. Thus,
the modified vector virus could be readily grown in these complementarily-modified cells, but
not in other cells, such as those of an inoculee.
    This approach is applicable to many different kinds of vector viruses, e.g., adenoviruses,
herpesviruses, poxviruses and retroviruses. The subject matter of this interference, however, is
directed specifically to vaccines in which the vector [*4] virus is a poxvirus. For many vector
viruses, there is a risk that vectors that have been attenuated in essential genes can "swap" genes
with the host cell genome, thereby reacquiring their deleted genes and reverting to wild-type
virus. This risk can be minimized through the use of viruses that are "cytoplasmic", meaning that
they are unlikely to enter the cell nucleus. Because a cell's genes are located in the nucleus,
cytoplasmic viruses such as poxvirus cannot swap genes with the cell genome and possibly
revert to a virulent wild-type virus.
   B. Defining the Count and Assigning Priority
    The sole count of the interference was either "[a] vaccine according to Claim 1 of Falkner's
5,770,212 patent or a vaccine according to Claim 29 of Inglis' 08/459,040 application." Claim 29
of the Inglis '040 application reads:

      A vaccine comprising a pharmaceutically acceptable excipient and an effective
      immunizing amount of a mutant virus, wherein said mutant virus is a mutant
      poxvirus and has a genome which has an inactivating mutation in a viral gene, said
      viral gene being essential for the production of infectious new virus particles,
      wherein said mutant virus is able to cause production of infectious new virus
      particles in a complementing host cell gene expressing a gene which complements
      said essential viral gene, but is unable to cause production of infectious new virus
      particles when said mutant virus infects a host cell other than a complementing host
      cell; for prophylactic or therapeutic use in generating an immune response in a
      subject.

Claim 1 of the Falkner '212 patent reads:



                                                485
      A vaccine comprising (a) a defective poxvirus that lacks a function imparted by an
      essential region of its parental poxvirus, wherein (i) said defective poxvirus
      comprises a DNA polynucleotide encoding an antigen and said DNA polynucleotide
      is under transcriptional control of a promoter, and (ii) the function can be
      complemented by a complementing source; and (b) a pharmaceutically acceptable
      carrier.

 The Administrative Patent Judge (APJ) designated claims 1-19 of the Falkner '212 patent and
claims 9,10, 29, and 30 of the Inglis '040 application as corresponding to the interference count.
Both parties sought the benefit of earlier-filed applications to establish dates of constructive
reduction to practice. The ALJ accorded the Inglis '040 application (filed June 2, 1995) the
benefit of several earlier-filed applications, dating back to September 25, 1990.3 Likewise, the
APJ accorded the Falkner '212 patent (issued June 23, 1998 from an application filed February
21, 1997) the benefit of earlier-filed applications, but these dated back only to April 29, 1994.4
Consequently, the APJ designated Inglis as the senior party.

    C. Board Decision
    The specifications of all of Inglis' earlier applications were similar. Although they focused on
herpesvirus vectors, they contained several passages related to poxvirus-based vaccines. Because
Falkner believed that these passages did not adequately describe and enable the poxvirus
invention, he challenged both Inglis' entitlement to priority as to the count and the patentability
of Inglis' corresponding claims. Falkner brought these challenges in three closely-related
preliminary motions before the Board. In each, as the moving party, Falkner carried the burden
of proof by a preponderance of the evidence.
    Falkner brought his first preliminary motion … arguing that the claims in Inglis's involved
('040) application that corresponded to the count were unpatentable because they failed to meet
the written description requirement of 35 U.S.C. § 112. In support of his argument, he stated,
inter alia, that (1) the specification of Inglis's '040 application did not identify any essential genes
in poxvirus or describe the inactivation of such genes, (2) vaccines based on vaccinia (a type of
poxvirus) had not yet been produced, and (3) the bulk of the Inglis specification was directed not
to poxviruses but to herpesviruses. The Board denied Falkner's motion, based in part on his
failure to address the perceived shortcomings of the '040 claims in light of the specification.


3
         The Inglis priority applications were U.S. Application Serial No. 08/384,963 ("the Inglis '963
application"), filed February 7, 1995; U.S. Application Serial No. 08/030,073 ("the Inglis '073
application"), filed May 20, 1993; WO/92/05263, PCT/GB91/01632 ("the Inglis PCT application"), filed
September 23, 1991, published in English on April 2, 1992; GB 9104903.1 ("the Inglis 1991 British
application"), filed March 8, 1991; and GB 9020799.4 ("the Inglis 1990 British application"), filed
September 25, 1990. The Inglis '040 application is a continuation in part of the '963 application, which
was in turn a continuation of the Inglis '073 application. The '073 application corresponded to the Inglis
PCT application. The Inglis PCT application claimed priority to, and was essentially identical to, the
Inglis 1990 and 1991 British applications.
4
         The Falkner priority applications were U.S. Application Serial No. 08/616,313 ("the Falkner '313
application") filed March 14, 1996; and U.S. application Serial No. 08/235,392 ("the Faulkner '392
application"), filed April 29, 1994.


                                                  486
    Second, Falkner moved … to deny Inglis the priority benefit of his earlier applications,
arguing that they did not sufficiently describe and enable the claims in question.6 Falkner argued
that without the benefit of these applications Inglis would be unable to establish constructive
reduction to practice earlier than Falkner. Falkner would win priority as to the count, and Inglis'
corresponding claims would be unpatentable. In support of his motion, Falkner alleged
deficiencies in Inglis' benefit specifications similar to those raised in his first motion. The Board
carefully articulated the legal standard, correctly explaining that "benefit with respect to priority
in an interference is granted with respect to counts not claims" and that "[a]ll that is necessary for
a party to be entitled to benefit of an earlier filed application for priority purposes is compliance
with §112 with respect to at least one embodiment within the scope of the count." After careful
review of the record, the Board held that Falkner had failed to meet his burden of proof.
    Third, Falkner moved for judgment [asserting] that the claims in Inglis' involved ('040)
application that corresponded to the count were anticipated and therefore unpatentable. He
argued that because Inglis' earlier applications had failed to adequately describe and enable the
full scope of his current claims, the current claims could not be accorded the benefit of §120 for
the purpose of antedating patent-defeating prior art.7 The Board explained that §§119 & 120
require benefit applications to comply with §112, first paragraph, with respect to the full scope of
what a party now claims, rather than with respect to merely one embodiment within the scope of
the interference count. After carefully considering the written description and enablement issues,
the Board denied the motion. As a result of the denial of Falkner's several motions, Inglis
remained the senior party, and the Board ordered judgment as to the subject matter of the count
in favor of Inglis.

    D. Issue and Standard of Review
    On appeal, Falkner essentially reiterates the arguments that he made before the Board. While
we recognize that each of these three arguments is distinct, they are nonetheless all related, and
under the facts of this particular case, we need only to resolve the following common issue:
whether the Inglis benefit applications adequately describe and enable a poxvirus-based vaccine.
Falkner also argues that the Board committed other errors, such as initially designating Inglis as
the senior party and failing to afford Falkner an opportunity for briefing prior to making this
designation. These arguments lack merit, and we shall not further discuss them. We turn,
therefore, to the central issues in this case: written description and enablement.
    Written description is a question of fact, judged from the perspective of one of ordinary skill
in the art as of the relevant filing date. Enablement is a question of law involving underlying
factual inquiries (holding that whether undue experimentation is required is a "conclusion
reached by weighing many factual considerations. . . . includ[ing] (1) the quantity of
experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or
absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the
relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the
breadth of the claims.").
6
         Falkner did not argue lack of enablement with respect to the Inglis '963 patent because he believed
that the teachings of the Falkner '392 patent, filed in 1994, would have enabled the subsequent '963 patent.
7
        Here, Falkner points to his own U.S. Pat. No. 5,766,882 ("the '882 patent'), issued in March 1995,
as the patent-defeating prior art.


                                                    487
    This court applies the standards of the Administrative Procedure Act ("APA") in reviewing
decisions of the Board. See Dickinson v. Zurko. Accordingly, we will set aside actions of the
Board if they are arbitrary, capricious, an abuse of discretion, or otherwise not in accordance
with law, and we set aside factual findings that are unsupported by substantial evidence. We
review questions of law de novo.
    Substantial evidence is defined as that which a reasonable person might accept as adequate to
support a conclusion. It requires an examination of the record as a whole, taking into account
both the evidence that justifies and detracts from an agency's opinion. An agency decision can
be supported by substantial evidence, even where the record will support several reasonable but
contradictory conclusions.
    II. DISCUSSION
    A. Contents of the Inglis Priority Applications
    The claims that correspond to the count of the interference are directed to a novel type of
vaccine that is comprised of a "vector virus" in the poxvirus family. Conceptually, poxviruses are
a "subgenus" of viruses that includes the "species" vaccinia. All of the prior Falkner applications
described poxvirus vaccine vectors in detail, and to the exclusion of other types of vaccine
vectors (e.g., herpesvirus vaccine vectors). These applications provided five detailed working
examples regarding the preparation and use of vaccines from defective poxviruses. They also
described the use of a particular species of poxvirus vaccine vector, namely vaccinia virus.
    In contrast, the Inglis applications described vaccine vectors in general, and then focused on
the subgenus of herpesviruses, for which they provided a detailed example. Nevertheless, at least
three passages discussed the poxvirus invention and specifically mentioned "vaccinia virus." For
example, after introducing the concept of vaccine vectors, the specification states that
"[t]ypically members of the pox virus family, e.g. vaccinia virus, are used as vaccine vectors."9
The specification later discusses the deletion of essential genes from vaccine vector genomes,
noting that the "invention can be applied to any virus where one or more essential gene(s) can be
identified and deleted from or inactivated within the virus genome" (emphasis added). Moreover,
it provides that "the virus may comprise an orthopox virus, for example, vaccinia virus, which
may comprise a heterologous sequence encoding an immunogen derived from a pathogen."
Finally, it reads:

       For example vaccinia virus, a poxvirus, can carry and express genes from various
       pathogens, and it has been demonstrated that these form effective vaccines when
       used in animal experimental systems. The potential for use in humans is vast, but
       because of the known side effects associated with the widespread use of vaccinia as
       a vaccine against smallpox, there is reluctance to use an unmodified vaccine in
       humans. There have been attempts to attenuate vaccinia virus by deleting non-
       essential genes such as the vaccinia growth factor gene. . . However, such
       attenuated viruses can still replicate in vivo, albeit at a reduced level. No vaccinia
       virus with a deletion in an essential gene has yet been produced, but such a virus,


9
         Because of the substantial similarity in the specifications of all of the Inglis benefit applications, we
shall refer in this opinion to representative passages from the earliest of the applications, the Inglis 1990
British application.


                                                       488
      deleted in an essential gene as described above, with its complementing cell for
      growth, would provide a safer version of this vaccine.

    The application provides a detailed example of an embodiment that comprised not a
poxvirus, but a herpesvirus, including the identity of the deleted essential sequences therein.
Nevertheless, for the reasons discussed below, we find no error in the Board's determinations on
the adequacy of written description and enablement in the various Inglis disclosures.
   B. Enablement
    Because the adequacy of the disclosure is judged from the perspective of one of ordinary
skill in the art, we start our review of the Board's decision by noting that the parties stipulated to
a high level of skill in the art. They defined the skilled artisan as having 5-10 years experience
creating recombinant poxvirus, as being familiar with the poxvirus literature, the use of poxvirus
as a vector for the expression of heterologous genes, and having the "needed technical skill to
practice the experimentation described in the scientific literature relating to recombinant virus,
including poxvirus." The Board agreed with the parties' stipulation as to level of skill.
    The Board did not err in finding Inglis' claims to be enabled as a matter of law, in light of its
articulated underlying factual findings. In support of its conclusion, it noted that "there is
extensive disclosure of the selection of an essential gene, its deletion or inactivation and the
production of a mutated virus with said deleted or inactivated gene, albeit for herpesvirus."
Moreover, because the differences between the herpesviruses and poxviruses were well known,
this would have aided the person of ordinary skill in the art in her application of the lessons of
the herpesvirus example in the construction of poxvirus vaccines. The Board observed that "the
mere fact that the experimentation may have been difficult and time consuming does not
mandate a conclusion that such experimentation would have been considered to be 'undue' in this
art. Indeed, great expenditures of time and effort were ordinary in the field of vaccine
preparation." Thus, the Board found the Inglis applications to be enabling.
    Reviewing the Board's legal conclusion of enablement, as based on its underlying findings of
fact, we cannot say that the Board erred. With respect to a skilled artisan's ability to identify
"essential" poxvirus genes, as discussed below we note that there was undisputed testimony that
as of the time of filing of the earliest Inglis application publications in professional journals had
disclosed the DNA sequence of the poxvirus genome along with the locations of the "essential
regions." The person of ordinary skill in the art would clearly have possessed such knowledge,
and given the ready accessibility of the journals, the absence of incorporation by reference is not
problematic. Indeed, "[a] patent need not teach, and preferably omits, what is well known in the
art." Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 1534 (Fed. Cir. 1987).
   C. Written Description
    On appeal to this court, Falkner essentially reargues the positions on written description that
he took before the Board. Although the Board erred in its articulation of the written description
standard, that error is harmless. The Board held that "an actual possession standard is not
required." But our precedent clearly establishes that "[t]he applicant must . . . convey to those
skilled in the art that, as of the filing date sought, he or she was in possession of the invention."
Vas-Cath, Inc. v. Mahurkar, (Fed. Cir. 1991). Nonetheless, we conclude there is no need for
remand because the undisputed testimony supports the Board's ultimate conclusion.



                                                 489
    As noted above, the Board found several passages in the Inglis '040 application (and in the
benefit applications) that were directed to poxvirus. No length requirement exists for a disclosure
to adequately describe an invention. Furthermore, the testimony of Falkner's expert, Dr.
Boursnell, established that the articles describing essential genes for poxvirus were well-known
in the art. Dr. Boursnell testified that "the skilled person would have been readily able to choose
an essential vaccinia gene" based on references that have been publicly available since 1990. The
testimony of Inglis' expert, Dr. Carroll, did not refute this claim.
    The parties also dispute several aspects of our law of written description, which we now
address. We conclude that the Board applied correct law. Specifically, we hold, in accordance
with our prior case law, that (1) examples are not necessary to support the adequacy of a written
description (2) the written description standard may be met (as it is here) even where actual
reduction to practice of an invention is absent; and (3) there is no per se rule that an adequate
written description of an invention that involves a biological macromolecule must contain a
recitation of known structure.
     1. Examples Are Not Required
   First, it is clear that the absence of examples involving poxviruses in the Inglis applications
does not render the written description inadequate. As we explained in LizardTech, Inc. v. Earth
Resource Mapping, PTY, Inc.:

       A claim will not be invalidated on section 112 grounds simply because the
      embodiments of the specification do not contain examples explicitly covering the
      full scope of the claim language. That is because the patent specification is written
      for a person of skill in the art, and such a person comes to the patent with the
      knowledge of what has come before. Placed in that context, it is unnecessary to spell
      out every detail of the invention in the specification; only enough must be included
      to convince a person of skill in the art that the inventor possessed the invention and
      to enable such a person to make and use the invention without undue
      experimentation.
(Fed. Cir. 2005)
     2. Actual Reduction to Practice Is Not Required
    As we explained in Capon v. Eshhar, "[t]he 'written description' requirement implements the
principle that a patent must describe the technology that is sought to be patented; the requirement
serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which
the patent is based, and to demonstrate that the patentee was in possession of the invention that is
claimed." (Fed. Cir. 2005). The Board was correct, however, not to view as dispositive that
Inglis had not actually produced a poxvirus vaccine,10 because an actual reduction to practice is
not required for written description.11 In the context of interpreting 35 U.S.C. § 102(b), the
Court held that "[t]he word 'invention' must refer to a concept that is complete, rather than

10
         The Inglis specifications stated that "[n]o vaccinia virus with a deletion in an essential gene has yet
been produced, but such a virus, deleted in an essential gene as described above, with its complementing
cell for growth, would provide a safer version of this vaccine."
11
         The Board believed that Falkner's expert, Dr. Carroll, had premised his opinions on the
misunderstanding that actual reduction to practice was required to prove written description, and it
discredited his expert opinion.


                                                      490
merely one that is 'substantially complete.'" Pfaff v. Wells Elecs., (1998). It then proceeded to
make clear that although "reduction to practice ordinarily provides the best evidence that an
invention is complete. . . . it does not follow that proof of reduction to practice is necessary in
every case."12 Thus, to the extent that written description requires a showing of "possession of the
invention," Pfaff makes clear that an invention can be "complete" even where an actual reduction
to practice is absent.13 The logical predicate of "possession" is, of course, "completeness."
     3. Recitation of Known Structure Is Not Required
     Falkner argues, inter alia, that the Inglis specifications do not adequately describe the
poxvirus invention, in light of Eli Lilly, because they do not describe the "essential regions" of
any poxvirus. We note, in addition, that Inglis did not attempt to incorporate by reference any
literature that described the DNA sequence of the poxvirus genome and the locations of the
"essential regions." However, it is the binding precedent of this court that Eli Lilly does not set
forth a per se rule that whenever a claim limitation is directed to a macromolecular sequence, the
specification must always recite the gene or sequence, regardless of whether it is known in the
prior art. Thus, "[w]hen the prior art includes the nucleotide information, precedent does not set
a per se rule that the information must be determined afresh." Rather, we explained that:

       The descriptive text needed to meet these requirements varies with the nature and
       scope of the invention at issue, and with the scientific and technologic knowledge
       already in existence. The law must be applied to each invention that enters the patent
       process, for each patented advance is novel in relation to the state of the science.
       Since the law is applied to each invention in view of the state of relevant knowledge,
       its application will vary with differences in the state of knowledge in the field and
       differences in the predictability of the science.
    Indeed, a requirement that patentees recite known DNA structures, if one existed, would
serve no goal of the written description requirement. It would neither enforce the quid pro quo
between the patentee and the public by forcing the disclosure of new information, nor would it
be necessary to demonstrate to a person of ordinary skill in the art that the patentee was in
possession of the claimed invention. As we stated in Capon, "[t]he 'written description'
requirement states that the patentee must describe the invention; it does not state that every
invention must be described in the same way. As each field evolves, the balance also evolves
between what is known and what is added by each inventive contribution." Indeed, the forced
recitation of known sequences in patent disclosures would only add unnecessary bulk to the
specification. Accordingly we hold that where, as in this case, accessible literature sources
clearly provided, as of the relevant date, genes and their nucleotide sequences (here "essential
genes"), satisfaction of the written description requirement does not require either the recitation
or incorporation by reference (where permitted) of such genes and sequences.



12
         Similarly, this court has carefully explained the relationship between written description and
possession, explaining that a showing of possession is not necessarily sufficient to demonstrate the adequacy
of written description.
13
         In contrast to reduction to practice, conception is a prerequisite to an adequate written description.
See Fiers v. Sugano, 984 F.2d 1164, 1171 (Fed. Cir. 1993) ("[O]ne cannot describe what one has not
conceived.").


                                                     491
    In conclusion, having reviewed the decision of the Board, we can discern no error in its
conclusion that the disclosures relied upon by Inglis for priority purposes adequately described
and enabled the invention directed to poxvirus, there being substantial evidence to support these
findings. Consequently, we hold that the Board's award of priority to Inglis was proper.
   AFFIRMED


      LG ELECTRONICS, INC., v. BIZCOM ELECTRONICS, INC.
   U. S. COURT OF APPEALS FOR THE FEDERAL CIRCUIT (July 7, 2006)
                     2006 U.S. App. LEXIS 16916

Before MICHEL, Chief Judge, NEWMAN, and MAYER, Circuit Judges.

MAYER, Circuit Judge.
   LG Electronics, Inc. ("LGE") appeals from the final judgment of the District Court for the
Northern District of California, which granted summary judgment of noninfringement of [five]
U.S. Patents in favor of Bizcom Electronics, Inc. et al. (collectively "defendants").
   Background
    LGE is the owner of patents relating to personal computers, including U.S. Patents Nos.
4,918,645 (disclosing systems and methods that increase the band width efficiency of a
computer's system bus)…. LGE sued defendants alleging infringement of these patents.
    Defendants purchase microprocessors and chipsets from Intel or its authorized distributors
and install them in computers. Intel is authorized to sell these products to defendants under an
agreement with LGE. However, pursuant to this agreement, Intel notified defendants that,
although it was licensed to sell the products to them, they were not authorized under that
agreement to combine the products with non-Intel products. LGE brought suit against
defendants, asserting that the combination of microprocessors or chipsets with other computer
components infringes LGE's patents covering those combinations. LGE did not assert patent
rights in the microprocessors or chipsets themselves.
   After construing the patent claims, the trial court granted summary judgment of
noninfringement of each patent. … We have jurisdiction under 28 U.S.C. §1295(a)(1).
   Discussion
   We review claim construction de novo. Cybor Corp. v. FAS Techs., Inc., (Fed. Cir. 1998) (en
banc).

***

IV. '645 patent
    The '645 patent discloses a digital computer system that has devices called agents that are
inter-connected by a system bus. The claimed system and corresponding method require one
agent, the requesting agent, to request access to a memory stored on another agent, called the
replying agent. The requested data is organized as a matrix of memory cells, having column and


                                              492
row coordinates. The "memory controller" of the replying agent processes the request from the
requesting agent by asserting a plurality of memory address control signals, including at least
one row address strobe ("RAS") signal and one column address strobe ("CAS") signal. This
"page mode memory access" operates by the assertion of an entire row of data followed by the
assertion and deassertion of multiplecolumn addresses. By the RAS signal accessing an entire
row followed by the assertion and deassertion of particular column addresses, this page mode
memory access differs from the conventional memory access, which separately accessed each
memory cell by asserting its individual row address and column address. In the claimed
invention, after the data is accessed, it is then transferred to the requesting agent over the system
bus.
     LGE alleged infringement of system claims 1-4 and 6 and method claims 12-15 and 17. The
trial court granted summary judgment of noninfringement of all asserted claims, concluding that
the RAS/CAS signals in defendants' devices did not travel over the system bus. However, the
'645 patent claims do not contain a limitation requiring that the strobe signals travel over the
system bus. Moreover, the specification does not suggest that the strobe signals must travel over
the system bus. To the contrary, Figure 5 shows an embodiment of the invention in which the
strobe signals travel only internally within the replying agent, not across the system bus.
    In an attempt to impose this limitation on the claims, defendants rely on the prosecution
history. While the prosecution history is relevant to claim construction, "it often lacks the clarity
of the specification and thus is less useful for claim construction purposes." Phillips Here,
defendants point to statements in the prosecution history that the prior art does not teach "a page
mode type of access over a system bus from a requesting agent to a replying agent." While we
agree that this and other statements in the prosecution history lack ideal clarity, we do not find
that they rise to the level of disclaiming or limiting the scope of the express claim language.
Therefore, the trial court erred in construing the '645 claims to require the RAS and CAS signals
to travel over the system bus. In addition, there is a genuine issue of material fact as to whether
the accused devices and methods utilize strobe signals. LGE's expert submitted an affidavit that
the accused devices employ strobe signals, which precludes summary judgment.
    In the alternative, defendants contend that LGE failed to present evidence of an "end of
access signal." This signal, which is required by the claims, is generated by the requesting agent
and received by a detecting means coupled to the memory address control signal asserting
means. When the detection means receives this end of access signal, the operation is halted.
Defendants contend that LGE failed to establish the existence of a genuine issue of material fact
as to whether the accused devices contain this limitation. However, the trial court did not
consider this argument, and we will not address this factual issue in the first instance. LGE also
argues that the trial court's construction of the "requesting agent" claim limitation was in error.
The court construed this term as "a device coupled to the system bus that requests access to a
memory located on a replying agent." LGE contends that an industry standard, which was
incorporated into the specification by reference, provides the proper claim construction of this
term.3 The incorporated standard explicitly defines the term "requesting agent" as "an agent that


          3
                The specification provides:
                  Although the method and apparatus of the invention will be described
              herein in the context of a Multibus II environment, it should be appreciated


                                                493
has entered into the arbitration function for bus access." Defendants contend, however, that the
patentee did not act as its own lexicographer by incorporating this industry standard by
reference. The trial court did not accept LGE's proposed construction, concluding that it was a
preferred embodiment and did not limit the claimed invention. The difference in the two
constructions is temporal: LGE's proposed construction defines an agent as a requesting agent
only when it is engaged in arbitration for bus access, whereas the trial court's construction
defines a requesting agent regardless of whether it is actively engaged in arbitration.
    We have recognized that the "[i]nterpretation of descriptive statements in a patent's written
description is a difficult task, as an inherent tension exists as to whether a statement is a clear
lexicographic definition or a description of a preferred embodiment." E-Pass Techs., Inc. v. 3
COM Corp. (Fed. Cir. 2003). "Thus in determining whether a statement by a patentee was
intended to be lexicographic, it is important to determine whether the statement was designed to
define the claim term or to describe a preferred embodiment." Id. We agree with the trial court
and defendants that the patentee did not act as its own lexicographer here. Instead, the industry
standard was incorporated as a preferred embodiment. The specification makes this clear by
explaining that "although the method and apparatus of the invention will be described herein in
the context of a Multibus II environment, it should be appreciated that the invention may be
practiced in many digital computer systems having a bus for transferring data between at least
two agents interconnected upon the bus."
    Chimie v. PPG Industries, Inc., 402 F.3d 1371 (Fed. Cir. 2005), does not compel a different
result. In Chimie, we were confronted with the claim terms "dust-free and non-dusting." After
concluding that these terms were relative and could only be understood by comparison with the
prior art, we concluded that only one standard was disclosed in the specification for making such
a comparison. We limited these claim terms to the disclosed standard. Here, however, there is no
relative term that cannot be understood without reference to an industry standard.
    But, this does not end our inquiry. The proper claim construction is "the ordinary and
customary meaning . . . that the term would have to a person of ordinary skill in the art in
question at the time of the invention, i.e., as of the effective filing date of the patent application."
Phillips, 415 F.3d at 1313 (citations omitted). "When prior art that sheds light on the meaning of
a term is cited by the patentee, it can have particular value as a guide to the proper construction
of the term, because it may indicate not only the meaning of the term to persons skilled in the art,
but also that the patentee intended to adopt that meaning." Arthur A. Collins, Inc. v. N. Telecom
Ltd. (Fed. Cir. 2000). Although we have concluded that the patentee did not expressly adopt the
definition of "requesting agent" in the incorporated industry standard, that standard remains
relevant in determining the meaning of the claim term to one of ordinary skill in the art at the
time the patent application was filed, and it is treated as intrinsic evidence for claim construction
purposes, see V-Formation, Inc. v. Benetton Group SpA (Fed. Cir. 2005) ("This court has


            that the invention may be practiced in many digital computer systems having a
            bus for transferring data between at least two agents interconnected upon the
            bus.
The operating characteristics of the Multibus II are described in a document entitled "High
Performance 32-Bit Bus Standard P1296" which was produced by the IEEE microprocessor
standards committee P1296 working group, Jun. 20, 1986, draft 2.0, the disclosure of which is
incorporated herein in its entirety.


                                                  494
established that 'prior art cited in a patent or cited in the prosecution history of the patent
constitutes intrinsic evidence.'")
    Here, the trial court erred by failing to give proper weight to the incorporated industry
standard; it failed to consider the standard as intrinsic evidence of the meaning to one of ordinary
skill in the art as of the filing date. After considering the standard, in addition to the patent claims
and specification, we conclude that LGE's proffered definition based on the standard is correct.
Thus, we construe "requesting agent" as "an agent that has entered into the arbitration function
for bus access." This construction is entirely consistent with the specification, which provides
that "at one time in the operation of the system . . . the requesting agent 12 may be a replying
agent, and that the replying agent 16 may at that time be a requesting agent." This language
makes clear that the classification of an agent depends upon the function the agent is performing
at any given time, i.e., whether it is engaged in arbitration at a given moment.


Indefiniteness due to the use of ―about‖
        BJ Services Company owned a patent directed to a method of fracturing subterranean
formations to stimulate oil and gas wells by injecting a fluid into a drilling at a sufficient
pressure to induce a crack in the formation. The patent claim called for a ―C* value of about
0.06 percent by weight.‖ Appellant argued that the claim lacked definiteness because ―about
0.06‖ was not defined in the claim and a person of ordinary skill in the art could not make and
use the invention. Based on testimony of experts as well as excerpts from textbooks, BJ Services
established that a person of ordinary skill in the art would know how to measure C*. Therefore,
the question is whether one of skill in the art, having done the experiments to calculate C*,
would have known if the result that he reached was ―about 0.06.‖ The court found that the jury
had substantial evidence to conclude that a person would have known if a result was ―about
0.06.‖ The United States Court of Appeals affirmed the judgment of the district court finding the
claim did not fail due to indefiniteness; merely because claim language is not precise does not
automatically render a claim invalid. BJ Services Company v. Halliburton Energy Services, Inc.,
338 F.3d 1368 (CAFC 2003)


                              In Re Joyce A. CORTRIGHT
                  United States Court of Appeals, Federal Circuit, 1999
                                     165 F.3d 1353

Before MAYER, Chief Judge, NEWMAN, and RADER, Circuit Judges.

MAYER, Chief Judge.

 Joyce A. Cortright appeals the September 23 and November 28, 1997, decisions of the United
States Board of Patent Appeals and Interferences sustaining the rejection of claims 1 and 15 of
patent application Serial No. 07/849,191 under 35 U.S.C. § 112, ¶ 1 (1994). Because the board
erred with respect to claim 1 but not claim 15, we affirm-in-part, reverse-in-part, and remand.



                                                 495
                                            Background

 Cortright's patent application, filed in 1992, concerns a method of treating baldness by applying
Bag Balm, a commercially available product used to soften cow udders, to human scalp.
Claims 1 and 15 are the only claims on appeal. Claim 1 recites a method of "treating scalp
baldness with an antimicrobial to restore hair growth, which comprises rubbing into the scalp the
ointment wherein the active ingredient 8-hydroxy-quinoline sulfate 0.3% is carried in a
petrolatum and lanolin base." Claim 15 recites a method of "offsetting the effects of lower levels
of a male hormone being supplied by arteries to the papilla of scalp hair follicles with the active
agent 8- hydroxy-quinoline sulfate to cause hair to grow again on the scalp, comprising rubbing
into the scalp the ointment having the active agent 8-hydroxy-quinoline sulfate 0.3% carriedin a
petrolatum and lanolin base so that the active agent reaches the papilla."

 The examiner rejected the claims under section 101 as lacking utility. According to the
examiner, Cortright's statements of utility, namely, her claims of treating baldness, are suspect
because "baldness is generally accepted in the art as being incurable...." The examiner, therefore,
required clinical evidence to establish the claimed utility, which Cortright did not supply.
Furthermore, with respect to claim 15's recitation of offsetting the effects of lower levels of a
male hormone, Cortright "offered no proof that such an off-set occurs and has disclosed that this
is only speculation." The examiner also rejected the claims under 35 U.S.C. § 102(a) (1994),
arguing that the admitted prior art anticipates the claims because the written description discloses
that Bag Balm® has been applied to human skin and the "scalp is the skin of the head."
Cortright appealed these rejections to the Board of Patent Appeals and Interferences.

 In its September 23, 1997, decision, the board reversed the section 101 rejection because the
examiner did not set out sufficient reasons for finding Cortright's statements of utility incredible.
It noted that "there is no per se requirement for clinical evidence to establish the utility of any
invention" and the examples in Cortright's application are objective evidence. The board also
reversed the section 102(a) rejection because although the prior art discloses the application of
Bag Balm to human skin, it does not disclose applying it to bald, human scalp.

 Despite these reversals, Cortright did not prevail because the board found a new ground for
rejecting the claims: that they are based on a non-enabling disclosure in violation of 35 U.S.C. §
112, ¶ 1. The board found that Cortright's written description does not teach those of ordinary
skill in the art how to make and use the claimed invention without undue experimentation
because it "fails to provide any teachings as to the administration of Bag Balm in a manner
which (i) restore[s] hair growth (claim 1), or (ii) 'offset[s] the effects of lower levels of male
hormone being supplied by arteries to the papilla of scalp hair follicles' (claim 15)." The board
explained that Example 1 does not show that applying a teaspoon of Bag Balm to the scalp
daily for about one month "restored hair growth" and that Examples 2 and 3 do not disclose the
amount of Bag Balm to apply or how to restore hair growth. With respect to claim 15, the
board found that the written description "merely surmis[es] that the active ingredient, 8-hydroxy-
quinoline sulfate, even reaches the papilla," which would not enable one of ordinary skill to use
the claimed method. Finally, the board observed that the breadth of the claims and the
unpredictable nature of the art of hair growth aggravated its finding that those of ordinary skill in
the art would not be able to practice the invention without undue experimentation.


                                                496
 Cortright requested reconsideration, which the board denied in a November 28, 1997, opinion.
The board explained that claim 1 is not enabled because it claims "restor[ing] hair growth,"
which the board interpreted as requiring the user's hair "to return to its original state," that is, a
full head of hair. Thus, the board's rejection was not based on complete non-enablement, as the
original decision had implied, but on the claim not being commensurate with the scope of the
disclosure. With respect to claim 15, the board maintained its general non-enablement rejection,
adding that "there is no evidence of record that the resultant hair growth is due to (i) the
stimulation of the papilla, and (ii) the offsetting [of] the effects of lower male hormone which is
supplied by arteries to the papilla, and not due to some other mechanism(s)." Cortright appeals.

                                             Discussion

       "Whether making and using an invention would have required undue experimentation,
and thus whether a disclosure is enabling under 35 U.S.C. § 112, ¶ 1 (1994), is a legal
conclusion based upon underlying factual inquiries." Johns Hopkins Univ. v. Cellpro, Inc.
Fed.Cir.1998). Utility is a factual issue, which we review for clear error.

       A lack of enablement rejection under section 112, ¶ 1 is appropriate where the written
description fails to teach those in the art to make and use the invention as broadly as it is claimed
without undue experimentation.

        This rejection takes several forms. The PTO will make a scope of enablement rejection
where the written description enables something within the scope of the claims, but the claims
are not limited to that scope. This type of rejection is marked by language stating that the
specification does not enable one of ordinary skill to use the invention commensurate with the
scope of the claims. On the other hand, if the written description does not enable any subject
matter within the scope of the claims, the PTO will make a general enablement rejection, stating
that the specification does not teach how to make or use the invention.

        If the written description fails to illuminate a credible utility, the PTO will make both a
section 112, ¶ 1 rejection for failure to teach how to use the invention and a section 101 rejection
for lack of utility. See M.P.E.P. § 706.03(a), form ¶ 7.05.04. This dual rejection occurs because
"[t]he how to use prong of section 112 incorporates as a matter of law the requirement of 35
U.S.C. § 101 that the specification disclose as a matter of fact a practical utility for the invention.
Thus, an applicant's failure to disclose how to use an invention may support a rejection under
either section 112, ¶ 1 for lack of enablement as a result of "the specification's ... failure to
disclose adequately to one ordinarily skilled in the art 'how to use' the invention without undue
experimentation," or section 101 for lack of utility "when there is a complete absence of data
supporting the statements which set forth the desired results of the claimed invention."

        The PTO cannot make this type of rejection, however, unless it has reason to doubt the
objective truth of the statements contained in the written description. See Brana, ("[T]he PTO
has the initial burden of challenging a presumptively correct assertion of utility in the disclosure.
Only after the PTO provides evidence showing that one of ordinary skill in the art would
reasonably doubt the asserted utility does the burden shift to the applicant to provide rebuttal



                                                 497
evidence sufficient to convince such a person of the invention's asserted utility."); In re
Marzocchi (CCPA 1971) ("[A] specification disclosure which contains a teaching of the manner
and process of making and using the invention in terms which correspond in scope to those used
in describing and defining the subject matter sought to be patented must be taken as in
compliance with the enabling requirement of the first paragraph of § 112 unless there is reason to
doubt the objective truth of the statements contained therein which must be relied on for enabling
support."). The PTO may establish a reason to doubt an invention's asserted utility when the
written description "suggest[s] an inherently unbelievable undertaking or involve[s] implausible
scientific principles." Brana, Treating baldness was once considered an inherently unbelievable
undertaking.

        Since then, however, treatments for baldness have gained acceptance. Rogaine
(minoxidil) and Propecia (R) are recognized as effective in treating baldness. In addition, the
PTO has granted approximately one hundred patents on methods of treating baldness. Some of
these patents disclose applying an electric current to the scalp, see, e.g., U.S. Pat. No. 5,800,477,
whereas others teach ingesting substances orally or applying a salve of some kind to the scalp,
see, e.g., U.S. Pat. No. 5,777,134. Some patents disclose the active ingredient in chemical terms.
See, e.g., U.S. Pat. No. 5,777,134 (5 alpha-reductase inhibitor); U.S. Pat. No. 5,767,152
(cyanocarboxylic acid derivatives); U.S. Pat. No. 4,139,619 (formula for minoxidil). Other
patents, however, disclose baldness remedies made from more mundane materials, such as Dead
Sea mud (U.S.Pat. No. 5,679,378); emu oil (U.S.Pat. No. 5,744,128); potato peelings and
lantana leaves (U.S.Pat. No. 5,665,342); and vitamin D3 and aloe (U.S.Pat. No. 5,597,575).

Claim 1

With respect to claim 1, the examiner made a lack of utility rejection under section 101 arguing
that the asserted statements of utility were incredible in light of Cortright's failure to prove utility
with clinical evidence. The board first appeared to make a generic enablement rejection under
section 112, ¶ 1, focusing on "the lack of any teachings or guidance as to how to perform the
claimed methods and the unpredictable nature of the art of restoring hair growth." Upon
reconsideration, however, the board clarified that its rejection pertained to scope. It took the
position that the broadest interpretation of "restore hair growth" requires the application of Bag
Balm to "return" the user's hair "to its original state," that is, a full head of hair. Because
Cortright's written description discloses results of only "three times as much hair growth as two
months earlier," "filling-in some," and "fuzz," the board reasoned, it does not support the breadth
of the claims.

        Although the PTO must give claims their broadest reasonable interpretation, this
interpretation must be consistent with the one that those skilled in the art would reach. Prior art
references may be "indicative of what all those skilled in the art generally believe a certain term
means ... [and] can often help to demonstrate how a disputed term is used by those skilled in the
art." Vitronics Corp. v. Conceptronic, Inc., (Fed.Cir.1996).             Accordingly, the PTO's
interpretation of claim terms should not be so broad that it conflicts with the meaning given to
identical terms in other patents from analogous art.

The PTO's construction of "restore hair growth" in the present case is inconsistent with its


                                                  498
previous definitions. U.S. Pat. Nos. 5,695,748 ("the '748 patent"), 5,679,378 ("the '378 patent"),
and 5,578,599 ("the ' 599 patent"), for example, each recite a method of restoring hair growth.
The '748 patent recites:

    A process ... for restoring hair growth which comprises the steps of:
    (a) applying a cleansing mixture of sage, aloe and nettles to the hair and scalp in an
    amount and for a period of time sufficient to effect cleansing and then removing same;
    (b) applying a treatment mixture of castor oil, shea butter, wheat germ oil and white
    iodine to the hair and scalp in an amount and for a period of time effective to treat the
    hair and scalp; and
    (c) heating the treatment mixture on the hair and scalp for a period of time sufficient to
    promote penetration of the treatment mixture into the hair and scalp and then removing
    the treatment mixture.

The accompanying disclosure reveals five examples in which women and men practiced the
claimed method. One "subject's hair began to fill-in in the previously balding and thinning areas
and the subject ... achieved a significant degree of improvement...." (Example 3). For another
subject, "there [was] a partial filling-in and restoration of the bald spot on the top of the subject's
head." (Example 4). A third subject noticed that he had "fifty percent more hair in both the
frontal and middle sections of his scalp." (Example 6).

The '378 patent recites:
   The method for the restoration of hair growth ... which comprises the steps of:
   applying a finite layer of Dead Sea mud to the body surface area to be treated for the
   restoration of hair growth ...;
   allowing said layer to be undisturbed for a finite time; and
   rinsing said layer from said surface area.

The accompanying disclosure reveals an example in which a man noticed "[m]any sprouts of ...
new hair" after practicing the method for six weeks and ultimately "approximately 25% regrowth
over the entire previously bald scalp." (Example 1). Another example discloses the results of a
five-month study of men who practiced the invention. In this study, the participants noticed an
increase in the number of new hairs on their scalp per month, which varied from 0 to 22.
Although some participants reported significant growth of hair, there was no evidence that the
claimed method resulted in full heads of hair. See (Example 3).

The '599 patent recites:
    A method for increasing or restoring hair growth over the sole administration of a
    topical minoxidil treatment comprising the concomitant administration of:
    a topical preparation of minoxidil in an amount sufficient to promote hair growth,
    applied to an area of skin where hair growth is to be increased or restored; and
    an oral administration of 17 beta-(N-tert-butylcarbamoyl)-4-aza-5-alpha- androst-1-en-
    3-one in an amount from about 0.05 to about 0.03 mg/Kg to promote hair growth such
    that hair growth is increased over the administration of minoxidil alone.

The examples disclosed by the patent show that subjects practicing this method experienced



                                                 499
increased growth of hair compared to those using minoxidil alone. Nevertheless, the patent does
not show that this method completely cured baldness by producing a full head of hair.

 In light of these disclosures, one of ordinary skill would not construe "restoring hair growth" to
mean "returning the user's hair to its original state," as the board required. To the contrary,
consistent with Cortright's disclosure and that of other references, one of ordinary skill would
construe this phrase as meaning that the claimed method increases the amount of hair grown on
the scalp but does not necessarily produce a full head of hair. Properly construed, claim 1 is
amply supported by the written description because Example 1 discloses the amount of Bag
Balm to apply (about one teaspoon daily) and the amount of time (about one month) in which
to expect results. These dosing instructions enable one of ordinary skill to practice the claimed
invention without the need for any experimentation. Therefore, we reverse the board's rejection
of claim 1.

Claim 15

        With respect to claim 15, the examiner made a lack of utility rejection under section 101
because Cortright "offered no proof that such an off-set occurs and has disclosed that this is only
speculation." Although the board purported to reject the examiner's section 101 rejection of
claim 15, its new rejection under section 112, ¶ 1 suggests that it did not disagree with the
examiner entirely. The board stated that because the written description "merely 'surmises' " that
the active ingredient, 8-hydroxy- quinoline sulfate reaches the papilla and offsets the lower levels
of male hormone, it did not teach how to use the method of claim 15. It observed further that the
written description fails to provide a working example of the subject matter of claim 15 or any
evidence that "the effects of lower male hormone levels have been offset [by the claimed
method], or even if Bag Balm has reached the papilla." The board also faulted Cortright for
not producing evidence that "the resultant hair growth is due to (i) the stimulation of the papilla,
and (ii) the offsetting [of] the effects of lower male hormone which is supplied by arteries to the
papilla, and not due to some other mechanism(s)." Moreover, it found that the written
description indicates that "the underlying basis for the observed physiological phenomenon can
not [sic] be predicted from the results obtained," and that this type of unpredictability alone may
"provide a reasonable doubt as to the accuracy of broad statements made in support of the
enablement of a claim."

       "[I]t is not a requirement of patentability that an inventor correctly set forth, or even
know, how or why the invention works." Newman v. Quigg (Fed.Cir.1989); see also Fromson v.
Advance Offset Plate, Inc. (Fed.Cir.1983) ("[I]t is axiomatic that an inventor need not
comprehend the scientific principles on which the practical effectiveness of his invention rests.").

        Furthermore, statements that a physiological phenomenon was observed are not
inherently suspect simply because the underlying basis for the observation cannot be predicted or
explained. Therefore, the board erred in suggesting that Cortright was required to prove the cause
of the resultant hair growth.

       Statements relating to observations that salves applied to the scalp penetrate the skin and
reach the papilla or that chemicals affect hormones do not run counter to generally accepted


                                                500
scientific norms. Therefore, a disclosure that the active agent, 8-hydroxy-quinoline sulfate,
reached the papilla and offset lower levels of male hormones is not inherently suspect.
Nevertheless, we must affirm the rejection of claim 15 because the written description fails to
disclose that the active ingredient reaches the papilla or that offsetting occurs. See In re Bundy
(CCPA 1981) ("What is necessary to satisfy the how-to-use requirement of §112 is the disclosure
of some activity coupled with knowledge as to the use of this activity."). Here, although the
written description states that people observed hair growth after applying Bag Balm (R) to the
scalp, it does not disclose that anyone observed the active ingredient reach the papilla and offset
the effects of lower levels of male hormones. It states, rather, that "[i]t is believed that the
rubbed-in ointment offsets the effects of lower levels of male hormones in the papilla and/or
provides an antimicrobial effect on infection," and that "Applicant surmises that the active
antimicrobial agent, 8-hydro[x]y-quinoline sulfate, reaches the papilla, and is effective to off-set
the male hormones such as testosterone and/or androsterone, and/or kill or seriously weaken any
bacteria about or in the papilla ...." (emphasis added). These statements reflect no actual
observations. Moreover, we have not been shown that one of ordinary skill would necessarily
conclude from the information expressly disclosed by the written description that the active
ingredient reaches the papilla or that off-setting occurs. See Tronzo v. Biomet, Inc.
(Fed.Cir.1998) ("In order for a disclosure to be inherent ... the missing descriptive matter must
necessarily be present in the ... application's specification such that one skilled in the art would
recognize such a disclosure."); see also In re Oelrich (CCPA 1981) ("Inherency ... may not be
established by probabilities or possibilities. The mere fact that a certain thing may result from a
given set of circumstances is not sufficient."). Therefore, claim 15 does not satisfy the how to
use requirement of section 112, ¶ 1.


D. Claims
        A patent can be challenged for being indefinite under § 112 ¶ 2. The ―distinctly claiming‖
requirement of § 112 ¶ 2 means that the claims must have a clear and definite meaning when
construed in the light of the complete patent document. Section 112 thus ensures definiteness of
claim language.




                                                501
      Under § 112 ¶ 2, a specification shall include claims ―particularly pointing out and distinctly
claiming the subject matter which the applicant regards as his invention.‖ Determining whether a
claim is indefinite requires an analysis of ―whether one skilled in the art would understand the
bounds of the claim when read in light of the specification.... If the claims read in light of the
specification reasonably apprise those skilled in the art of the scope of the invention, [section] 112
demands no more.‖ Miles Lab., Inc. v. Shandon Inc., 997 F.2d 870, 875 (Fed.Cir.1993). The
degree of precision necessary for adequate claims is a function of the nature of the subject matter.

       Drawings included in the application may aid in the interpretation of claim language. Indeed,
―drawings alone may provide a ‗written description‘ of an invention as required by § 112.‖
Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1565 (Fed.Cir.1991). Similarly, drawings may be used
like the written specification to provide evidence relevant to claim interpretation. See Autogiro Co.
of America v. United States, 384 F.2d 391, 398 (Ct.Cl. 1967) (―[I]n those instances where a visual
representation can flesh out words, drawings may be used in the same manner and with the same
limitations as the specification.‖ The Federal Circuit has instructed the PTO to give the claims their
broadest reasonable interpretation consistent with the drawings as well as the specification, and the
―claim language should be read in light of the specification as it would be interpreted by one of
ordinary skill in the art,‖ In re Bond, 910 F.2d 831, 833 (Fed.Cir. 1990).




                   SOLOMON v. KIMBERLY-CLARK CORP.
          UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT
                      2000 U.S. App. LEXIS 15317 (June 30, 2000)

Before LOURIE, CLEVENGER, and BRYSON, Circuit Judges.

LOURIE, Circuit Judge.
    Sandra Solomon appeals from the decision of the District Court for the District of Arizona
granting Kimberly-Clark Corporation's motion for summary judgment that the claims of U.S.
Patent 4,560,381 are invalid as indefinite under 35 U.S.C. § 112, ¶ 2. Because the district court
erred in holding the claims invalid under that provision of the statute, we reverse.
   BACKGROUND

A. The Claimed Invention
    Sandra Southwell (now Sandra Solomon) is the named inventor on the '381 patent, which is
directed to disposable panties and panty liners for use during a woman's menstrual cycle.
Independent claim 1, which is representative of the claims at issue, reads as follows:

    1. A disposable woman's protective menstrual panty for holding a feminine napkin
    comprising:
    a relatively thick layer of disposable absorbent material; and
    a depression means in said relatively thick layer of disposable absorbent material, said


                                                 502
    depression means including a substantially thinner layer of disposable absorbent
    material operably disposed longitudially [sic] in the crotch area of said panty and
    extending at least partially upward thereof in both front and rear areas, said depression
    means being dimensioned for receiving said feminine napkin therein for positioning
    same during use.

     The panty is divided into [a] body portion, [a] waist portion, [a] crotch portion and leg
portions. The body portion is itself divided into [a] top portion and [a] bottom portion. The top
portion is preferably made of lightweight open mesh-type material or fabric, and the outer
surface of [the] bottom portion may be made of the same or different material, e.g., a woven,
hydrophobic material. The inner surface of [the] bottom portion, however, is composed of a
highly absorbent, thick layer. The crotch portion of [the] lower portion contains an elongated,
oval-shaped depression that is bounded on both sides by [a] thick layer and contains a relatively
thin layer of absorbent material at its base. The depression functions to receive and to hold a
commercially available feminine napkin or pad.

B. Procedural History
    Solomon sued Kimberly-Clark, alleging that its Personals® panty infringed all fifty-nine
claims of the '381 patent. … Kimberly-Clark moved for summary judgment, alleging that the
patent was invalid under … 35 U.S.C. 112, ¶2, because Solomon failed to claim the subject
matter that she regarded as her invention. Kimberly-Clark based its allegations in part on
Solomon's deposition testimony, in which she allegedly stated on several occasions that the
depression limitation in the claimed invention was made of material having a uniform, rather
than varying, thickness. Kimberly-Clark contended that those statements were contrary to what
was claimed in the patent, apparently based on our (and the district court's) construction of
"depression" to mean a portion of the panty "formed by surrounding a region of substantially
thinner material with a region of thicker material." Kimberly-Clark also based its arguments on
Solomon's DX13 prototype of the claimed invention, which depicts an area of uniform thickness
in the region where the depression is located.
    The district court concluded that Solomon's deposition testimony revealed that "her patent
does not accurately depict her invention" and thus held that there was no genuine issue of
material fact that the patent was invalid under section 112, paragraph 2, for failure to claim "the
subject matter which the applicant regards as his invention." While acknowledging that this case
did not involve a "typical" validity challenge under section 112, paragraph 2, the district court
noted that it could "see little reason to ignore the mandate of § 112 in such a case." The court
also held that Solomon's affidavit attesting to her inventorship was insufficient to prevent
summary judgment on that issue.
   Solomon appealed the district court's invalidity ruling to this court.

   DISCUSSION

A. Standard of Review
    The determination whether a claim recites "the subject matter which the applicant regards as
his invention," like a determination whether a claim is sufficiently definite, "is a legal conclusion
that is drawn from the court's performance of its duty as the construer of patent claims." Thus, as


                                                503
with claim construction, a determination under either portion of section 112, paragraph 2, is a
question of law that we review de novo.

B. Invalidity under Section 112, Paragraph 2
    Solomon argues that the district court erred in invalidating the claims of the '381 patent under
section 112, paragraph 2, asserting that a court evaluates compliance with that provision by
comparing the claims to the disclosure in the specification, not by comparing the claims to an
inventor's deposition testimony. Solomon alternatively contends that even if the testimony and
other evidence are considered, Kimberly-Clark has still failed to prove invalidity by clear and
convincing evidence. Solomon also asserts that Kimberly-Clark's evidence and arguments really
relate to inventorship, not definiteness, and such a challenge should have been raised under
section 102(f). Kimberly-Clark responds that the language of section 112, paragraph 2, plainly
states that patent claims must specify what "the applicant regards as his invention," and that
therefore claims may be invalid if inventor testimony conflicts with the recitations of the claims.
Kimberly-Clark further contends that based on the evidence it presented, it did succeed in
proving that the claims of the '381 patent are invalid under section 112, paragraph 2.
    We agree with Solomon that the district court erred in invalidating the claims of the '381
patent under section 112, paragraph 2, based on Solomon's deposition testimony. As an initial
matter, we note that for a claim to comply with section 112, paragraph 2, it must satisfy two
requirements: first, it must set forth what "the applicant regards as his invention," and second, it
must do so with sufficient particularity and distinctness, i.e., the claim must be sufficiently
"definite."
    During the prosecution of a patent application, a claim's compliance with both portions of
section 112, paragraph 2, may be analyzed by consideration of evidence beyond the patent
specification, including an inventor's statements to the Patent and Trademark Office ("PTO").
See In re Conley, 490 F.2d 972, 976, 180 U.S.P.Q. (BNA) 454, 456-57 (CCPA 1974) (noting that
the phrase "which the applicant regards as his invention" in the second portion of section 112,
paragraph 2, "has been relied upon in cases where some material submitted by applicant, other
than his specification, shows that a claim does not correspond in scope with what he regards as
his invention."); In re Moore, 58 C.C.P.A. 1042, 439 F.2d 1232, 1235, 169 U.S.P.Q. (BNA) 236,
238 (CCPA 1971) ("The definiteness of the language employed must be analyzed--not in a
vacuum, but always in light of the teachings of the prior art and of the particular application
disclosure as it would be interpreted by one possessing the ordinary level of skill in the pertinent
art.").
    It is not inappropriate for the PTO or a reviewing tribunal to consider such evidence extrinsic
to the patent application in light of the goals of the examination process and the fact that pending
claims can be freely amended to comport with those goals. As we explained in In re Zletz:

    During patent examination the pending claims must be interpreted as broadly as their
    terms reasonably allow. When the applicant states the meaning that the claim terms are
    intended to have, the claims are examined with that meaning, in order to achieve a
    complete exploration of the applicant's invention and its relation to the prior art. The
    reason is simply that during patent prosecution when claims can be amended,
    ambiguities should be recognized, scope and breadth of language explored, and


                                                504
     clarification imposed. . . . An essential purpose of patent examination is to fashion
     claims that are precise, clear, correct, and unambiguous. Only in this way can
     uncertainties of claim scope be removed, as much as possible, during the administrative
     process.

 In re Zletz, 893 F.2d 319, 321-22, 13 U.S.P.Q.2D (BNA) 1320, 1322 (Fed. Cir. 1989) (citation
omitted). Thus, in the more fluid environment of patent examination, an inventor's statements
are relevant to determining compliance with the statute.
    On the other hand, when a court analyzes whether issued claims comply with section 112,
paragraph 2, the evidence considered in that analysis should be more limited. As for the
"definiteness" portion of section 112, paragraph 2, our precedent is well-settled that a court will
typically limit its inquiry to the way one of skill in the art would interpret the claims in view of
the written description portion of the specification. As we stated in Personalized Media:
     Determining whether a claim is definite requires an analysis of whether one skilled in
     the art would understand the bounds of the claim when read in light of the specification.
     If the claims read in light of the specification reasonably apprise those skilled in the art
     of the scope of the invention, § 112 demands no more.
 Personalized Media, 161 F.3d at 705, 48 U.S.P.Q.2D (BNA) at 1888 (internal quotation marks
omitted); see Atmel, 198 F.3d at 1378, 53 U.S.P.Q.2D (BNA) at 1227-28 ("As a general matter, it
is well-established that the determination whether a claim is invalid as indefinite depends on
whether those skilled in the art would understand the scope of the claim when the claim is read in
light of the specification." (internal quotation marks omitted)).4 Although we have not
specifically addressed the types of evidence that may be considered in analyzing whether a claim
complies with the "which the applicant regards as his invention" portion of that statute, we see
no reason for a different standard to apply, as the rationale for reviewing a limited range of
evidence under either portion of the statute is the same.

    A more limited range of evidence should be considered in evaluating validity as opposed to
patentability under either portion of section 112, paragraph 2, because the language of issued
claims is generally fixed (subject to the limited possibilities of reissue and reexamination), the
claims are no longer construed as broadly as is reasonably possible, and what the patentee
subjectively intended his claims to mean is largely irrelevant to the claim's objective meaning
and scope, see Markman v. Westview Instruments, Inc., 52 F.3d 967, 985-86 (Fed. Cir.1995) (en
banc), aff'd, 517 U.S. 370 (1996). As has been noted in the context of definiteness, the inquiry
under section 112, paragraph 2, now focuses on whether the claims, as interpreted in view of the
written description, adequately perform their function of notifying the public of the patentee's
right to exclude. See United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 233, 55 U.S.P.Q.
(BNA) 381, 384, 87 L. Ed. 232, 63 S. Ct. 165 (1942) ("To sustain claims so indefinite as not to
give the notice required by the statute would be in direct contravention of the public interest

4
         Despite this general rule, in some circumstances evidence beyond the claims and written description
may be reviewed. See e.g., Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1217-18 (Fed. Cir.1991);
Texas Instruments Inc. v. ITC, 871 F.2d 1054, 1063 (Fed. Cir.1989). Moreover, we note that the
determination of the perspective of one of skill in the art may involve reference to evidence extrinsic to the
patent, such as prior art and witness testimony.


                                                    505
which Congress therein recognized and sought to protect."); see also 3 Chisum, supra, § 8.03, at
8-14 ("The primary purpose of this requirement of definiteness in claims is to provide clear
warning to others as to what constitutes infringement of the patent.").
     It is particularly inappropriate to consider inventor testimony obtained in the context of
litigation in assessing validity under section 112, paragraph 2, in view of the absence of
probative value of such testimony. In Markman, we addressed the closely related issue of
litigation-derived inventor testimony in the context of claim construction, and concluded that
such testimony is entitled to little, if any, probative value. See Markman, 52 F.3d at 985, 34
U.S.P.Q.2D (BNA) at 1332-33 (holding that inventor testimony as to "the subjective intent of the
inventor when he used a particular term is of little or no probative weight in determining the
scope of a claim (except as documented in the prosecution history)."). We reasoned that an
inventor is not competent to construe patent claims for the following reasons:
     Commonly the claims are drafted by the inventor's patent solicitor and they may even
     be drafted by the patent examiner in an examiner's amendment (subject to the approval
     of the inventor's solicitor). While presumably the inventor has approved any changes to
     the claim scope that have occurred via amendment during the prosecution process, it is
     not unusual for there to be a significant difference between what an inventor thinks his
     patented invention is and what the ultimate scope of the claims is after allowance by the
     PTO.

 Markman, 52 F.3d at 985, 34 U.S.P.Q.2D (BNA) at 1335 (citation omitted). We find this
analysis equally compelling in the present context, as the determination whether a claim
complies with section 112, paragraph 2, is "drawn from the court's performance of its duty as the
construer of patent claims." Personalized Media, 161 F.3d at 705, 48 U.S.P.Q.2D (BNA) 1888.
Although we recognize that "which the applicant regards as his invention" is subjective
language, once the patent issues, the claims and written description must be viewed objectively,
from the standpoint of a person of skill in the art.
     For the foregoing reasons, we conclude that inventor testimony, obtained in the context of
litigation, should not be used to invalidate issued claims under section 112, paragraph 2.5
Accordingly, we agree with Solomon that the district court erred in using her deposition
testimony to invalidate the claims of the '381 patent under that provision of the statute.



                       BEACHCOMBERS, INTERN‘AL, INC.
                                   v.
                     WILDEWOOD CREATIVE PRODUCTS, INC.
                         United States Court of Appeals, Federal Circuit, 1994
                                          1994 WL 398257

5
        While Kimberly-Clark cites cases such as In re Cormany, 476 F.2d 998, 177 U.S.P.Q. (BNA) 450
(CCPA 1973), for the proposition that inventor testimony obtained in the context of litigation can be used to
invalidate a claim, as we have explained above, those cases address the use of inventor testimony in the
context of patent prosecution.


                                                    506
         Before PLAGER, Circuit Judge, and COWEN, Senior Circuit Judge, and SCHALL, Circuit
Judge.

         PLAGER, CIRCUIT JUDGE.

         This is a patent infringement case involving an improved kaleidoscope as described and
claimed in the patent-in-suit, U.S. Patent No. 4,740,046 (the ‗046 patent). A jury found in favor of
the accused infringer (WildeWood), finding that the asserted claims of the ‗046 patent were invalid
and were not infringed by the accused ILLUSION kaleidoscope. The trial court entered judgment
for defendant [and subsequently] denied plaintiffs‘ motion for judgment as a matter of law (JMOL)
or, in the alternative, a new trial. Plaintiffs appeal.

                                          BACKGROUND

        Plaintiff Patrick MacCarthy is the inventor of the liquid kaleidoscope disclosed and claimed
in the ‗046 patent. Plaintiff Beachcombers is the exclusive licensee of MacCarthy under the patent.
Kaleidoscopes are well known in the art, the invention of which is attributed to Sir David Brewster,
a Scot, who patented his in 1816, and for whom the Brewster Society, an organization of designers,
collectors, and lovers of kaleidoscopes is named. Defendant WildeWood sells a kaleidoscope,
known as the ILLUSION, which is the accused device.

         MacCarthy‘s invention, an improvement in a crowded field, involves changing the object
cell of the typical kaleidoscope into one that is ―comprised of one or more channels through which
liquid can flow as the kaleidoscope is rotated.‖ At the proximal end of the barrel of the
kaleidoscope is an opaque barrier containing an eye-piece. Contained within the barrel and fixably
attached to it are two mirrors. These mirrors are aligned along the longitudinal axis of the barrel, and
are displaced at an angle relative to one another.

         At the distal end of the barrel is rotatable container. Within that container is a chamber
which is bounded by the container in conjunction with transparent window and translucent/frosted
window. Contained within that chamber is closed loop receptacle which is positioned along axis so
that it lies in plane. The closed loop receptacle is partially filled with a liquid, and is configured
with a reservoir bulb. It is this closed loop receptacle that is the ―object cell‖ in the context of
MacCarthy‘s invention.

         Plaintiffs brought a patent infringement action against defendant alleging infringement of
the ‗046 patent by defendant‘s making and selling the ILLUSION kaleidoscope. Defendant denied
infringement and sought a declaratory judgment that the patent was invalid. The case then went to
trial before a jury. The jury returned 22 special verdicts, finding that the claims at issue were not
infringed, and were invalid as anticipated, obvious, and indefinite. Judgment was entered
accordingly.

                                            DISCUSSION

                                                   1.



                                                 507
       Claim 1 of the ‗046 patent - the only independent claim at issue - reads:

   1. In a kaleidoscope comprising plural reflecting surfaces joined along one edge, a viewing
   means proximal to one end of said surfaces and an object cell proximal to the other end of
   said surfaces, the improvement comprising an object cell comprising at least one channel
   containing liquid. The remaining dependent claims read: 6. A kaleidoscope as in [claim] 1 ...
   wherein the design changes as a function of the angle at which the kaleidoscope is held with
   respect to the horizontal.

        We first consider plaintiffs‘ assertion that the trial court erred in denying the motion for
JMOL in relation to the jury‘s conclusion of indefiniteness.... Plaintiffs‘ point is that one skilled in
the art would understand that the phrase ―object cell‖ recited in the body of the ‗046 claims is broad
enough to encompass a liquid-filled tube extending through the end of the barrel, such as that of the
accused device, and would not be confused so as to surmise, as defendants assert, that the phrase is
limited to the chamber situated at the end of the barrel through which the liquid-filled tube extends.

         Plaintiffs are correct. Section 112 ¶ 2 requires that the claims ―particularly [point] out and
distinctly [claim] the subject matter which the applicant regards as his invention.‖ The operative
standard for determining whether this requirement has been met is ―whether those skilled in the art
would understand what is claimed when the claim is read in light of the specification.‖

        The background section of the ‗046 specification begins with the conventional definition of
the phrase ―object cell‖: the chamber at the end of the kaleidoscope barrel opposite to the end
containing the eyepiece containing movable objects such as pieces of colored glass or the like.
However, the remainder of the specification clarifies that MacCarthy intended the phrase to mean
something different in the context of his invention. That is perfectly acceptable. As we have
repeatedly said, a patentee can be his own lexicographer provided the patentee‘s definition, to the
extent it differs from the conventional definition, is clearly set forth in the specification.

        Closed-loop, liquid-filled channels are illustrated [in the drawings] which extend through or
are situated within the chamber conventionally known as the ―object cell‖. The specification
expressly identifies these channels as object cells. Then, liquid-filled tubes, both linear and
nonlinear, are illustrated which extend through what is conventionally known as the ―object cell‖.
Again, the specification expressly identifies these tubes as object cells. Thus, it is clear from the
specification that a meaning other than the conventional one and broad enough to encompass the
liquid-filled channels or tubes illustrated in the figures was intended. Accordingly, the district court
erred in denying the motion for JMOL in relation to the indefiniteness question.



                               TRONZO v. BIOMET, INC.
                      United States Court of Appeals, Federal Circuit, 1998.
                                  --- F.3d ----, 1998 WL 546978




                                                 508
Before RICH, NEWMAN, Circuit Judges, and ARCHER, Senior Circuit Judge.

ARCHER, Senior Circuit Judge.

    Biomet, Inc. appeals the judgment of the District Court for the Southern District of Florida
holding Biomet liable for infringement of U.S. Patent No. 4,743,262 (‗262 patent)…. The court
determined that claims 1, 2, 9, and 10 of the ‗262 patent were not invalid…. Because claims 1
and 9 are not entitled to the filing date of the ‗262 patent‘s parent application and are anticipated
by intervening prior art, we reverse the district court‘s judgment that these claims are not invalid.

                                         BACKGROUND

 The patent and technology in this case relate to artificial hip sockets that include cup implants
adapted for insertion into an acetabular, or hip, bone.




The claims of the ‗262 patent at issue read:

    1. An acetabular cup prothesis [sic] comprising a body extending generally
    longitudinally and terminating into front and rear surfaces, said front surface extending
    substantially transversely to said body; and at least one fin for securing said cup to a
    prepared acetabulum cavity, said fin having a length extending generally longitudinally


                                                509
    from said front surface toward said rear surface continuously along said body
    throughout the entire length of said fin, and said fin being configured so as to extend
    radially outwardly beyond the perimeter of said front surface and said body so as to
    engage with the cavity thereby securing said cup.

    2. An implant of claim 1, wherein the body has a generally conical outer surface.

    9. An acetabular prosthesis consisting essentially of (1) a body extending generally
    longitudinally and terminating into front and rear surfaces extending substantially
    transversely to said body; and (2) at least one fin for securing said cup to a prepared
    acetabulum cavity, said fin having a length extending generally longitudinally from said
    front surface toward said rear surface continuously along said body throughout the
    entire length of said fin, and said fin being configured so as to extend radially outwardly
    beyond the perimeter of said front surface and said body so as to engage with the cavity
    thereby securing said cup.

    10. A prosthesis of claim 9, wherein the body has a generally conical outer surface.

  On March 24, 1987, Tronzo filed the application that yielded the ‗262 patent as a
continuation-in-part of an application filed on June 1, 1984, which issued as U.S. Patent No.
4,681,589 (‗589 patent). The ‗262 patent issued to Tronzo on May 10, 1988. Subsequently, the
‗262 patent was twice reexamined at the Patent and Trademark Office, resulting in the
confirmation of the patentability of the original claims and the addition of claims 9, 10, and 11.

        Tronzo sued Biomet on April 25, 1991 for patent infringement…. By special verdict, the
jury found that the patent was entitled to the filing date of the ‗589 patent‘s application (the
parent application), was not invalid, and was willfully infringed….

                                           DISCUSSION

                                                  I.

  For a claim in a later-filed application to be entitled to the filing date of an earlier application
under 35 U.S.C. § 120, the earlier application must comply with the written description
requirement of 35 U.S.C. § 112, ¶ 1. Section 112, paragraph 1 requires that the specification
―contain a written description of the invention, and of the manner and process of making and
using it .‖ To meet this requirement, the disclosure of the earlier application, the parent, must
reasonably convey to one of skill in the art that the inventor possessed the later-claimed subject
matter at the time the parent application was filed. A disclosure in a parent application that
merely renders the later-claimed invention obvious is not sufficient to meet the written
description requirement; the disclosure must describe the claimed invention with all its
limitations. Because the issue of whether the written description requirement has been satisfied
is a question of fact, we must determine whether substantial evidence supports the jury‘s verdict
that the requirement has been met.




                                                 510
 Biomet asserts that claims 1 and 9 of the ‗262 patent are not entitled to the filing date of the
parent application and consequently that intervening prior art anticipates these claims.1
Specifically, Biomet argues that the ‗589 patent‘s specification describes only one cup - a conical
cup - and thus does not provide sufficient support for claims 1 and 9, which are generic as to the
shape of the cup. Thus, Biomet contends that claims 1 and 9 are not entitled to the benefit of the
parent application‘s earlier filing date and are anticipated under § 102(b) by intervening prior art,
including Tronzo‘s British application which was published on December 4, 1985, more than
one year before the filing of the CIP application resulting in the ‗262 patent, and which was the
counterpart to his U.S. application that yielded the ‗589 patent.

 Tronzo responds that claims 1 and 9 are generic claims as to the shape of the cup and that the
‗589 patent‘s specification need only describe a sufficient number of species of cups to support
the generic claim. Tronzo asserts that the ‗589 patent discloses six species of acetabular cup
implants, which is sufficient support.

 The patentee has conceded that intervening prior art would anticipate claims 1 and 9.3 Thus, the
only issue is whether claims 1 and 9 are entitled to the earlier filing date of the parent
application. We conclude that substantial evidence does not support the conclusion that the ‗589
patent specification meets the written description requirement relative to claims 1 and 9 of the ‗
262 patent. Accordingly, these claims are not entitled to the parent application‘s filing date.

  The ‗589 patent describes the invention as a ―trapezoid,‖ a ―truncated cone,‖ or a cup of
―conical shape.‖ A reading of the specification demonstrates that these labels describe the same
cup, and not three different species as asserted by Tronzo. Indeed, contrary to Tronzo‘s
assertions, the ‗589 patent discloses only two species of cups: an ―eccentric cup,‖ which has a
top lip shorter than the bottom lip, and a ―true‖ cup, with all sides being equal.

 Moreover, the only reference in the ‗589 patent‘s specification to different shapes is a recitation
of the prior art. Instead of suggesting that the ‗589 patent encompasses additional shapes, the
specification specifically distinguishes the prior art as inferior and touts the advantages of the
conical shape of the ‗589 cup. (―Another extremely important aspect of the present device
resides in the configuration of the acetabular cup as a trapezoid or a portion of a truncated
cone.‖). Such statements make clear that the ‗589 patent discloses only conical shaped cups and
nothing broader. The disclosure in the ‗ 589 specification, therefore, does not support the
later-claimed, generic subject matter in claims 1 and 9 of the ‗262 patent.

 The expert testimony offered at trial does not require a contrary conclusion. Tronzo‘s expert, Dr.
Catanzaro, testified that hemispherical cups are disclosed in the ‗589 patent‘s specification,
identifying two sections in the ‗589 patent supposedly making such a disclosure. As recognized
by the district court, however, the first section referred to by Dr. Catanzaro as a sufficient
disclosure served the narrow purpose of reviewing the prior art and did not describe the
invention. The second section identified by Dr. Catanzaro described ―hemispheroidal‖ position

1
        Biomet concedes that claims 2 and 10 are adequately supported by the specification of the ‗589
patent and thus are entitled to the earlier filing date.
3
        Although the basis of the patentee‘s concession of intervening prior art is not evident from the
record, we note that the CIP application disclosed for the first time generically-shaped implant bodies.


                                                 511
maintaining devices, but Dr. Catanzaro later conceded that this section did not refer to the shape
of the patented cup.

 Indeed, the district court recognized that ―the written description in the parent ‗589 does not
attempt to identify other, equally functional shapes or talk in terms of a range of shapes....‖ The
court concluded that ―the narrow language of the ‗589 application cannot be said to disclose
expressly either the particular hemispherical shape of the ‗262 claims or the entire genus of cups
within which the conical cup of the ‗589 claims and the hemispherical cup of the ‗262 claims
belong.‖ The district court nevertheless determined that the jury‘s conclusion could be supported
because the ‗589 patent‘s specification inherently contained a disclosure sufficient to meet the
written description requirement of § 112, ¶ 1.

  The only evidence claimed as supporting an inherent disclosure, however, is the testimony of
Norman Torchin, another Tronzo expert. Torchin testified that when the inventor stated that
―[a]propos of this, the present concept or invention differs completely from the blades as shown,
for example, in prior U.S. Pat. No. 3,840,904‖ the inventor meant that ―the difference is in the
blade as opposed to the structure of the cup, although [the inventor] does prefer the conical cup.‖

 In order for a disclosure to be inherent, however, the missing descriptive matter must necessarily
be present in the parent application‘s specification such that one skilled in the art would
recognize such a disclosure. There is nothing in the ‗589 specification to suggest that shapes
other than conical are necessarily a part of the disclosure. Indeed, as discussed above, the
specification clearly suggests the contrary by asserting advantages of the conical shape over prior
art shapes. The rationale of Tronzo‘s expert claimed to support inherency is not sufficient to
support the generic claims in the ‗262 patent. See In re MacLean, 59 C.C.P.A. 799, 454 F.2d
756, 759, 172 USPQ 494, 497 (CCPA 1972) (―Certainly the single exemplary disclosure of using
93% by weight water in the liquid phase provides no support or description of the recited range
‗preponderantly water,‘ i.e. anything above 50% by weight.‖). Torchin‘s testimony does not
explain why a broader supporting disclosure is necessarily part of the ‗589 patent. We also agree
that the district court properly rejected Torchin‘s reliance on an incorporation by reference of a
prior Tronzo patent as supporting inherency.

 Finally, relevant expert testimony of Biomet‘s witness, Dr. Hill, who testified that in his view as
an orthopedic surgeon the ‗589 patent disclosed only a trapezoidal cup and nothing more is
consistent with the express language in the ‗589 specification.

 Accordingly, because the specification of the ‗589 patent fails to meet the written description
necessary to support claims 1 and 9 of the ‗262 patent, these claims are not entitled to the filing
date of the parent application and are invalid as anticipated by the intervening prior art.




                                                512
E.      Utility and Enabling Disclosure

1.      Utility
        The utility requirement has its origin in article I, section 8 of the Constitution, which
indicates that the purpose of empowering Congress to authorize the granting of patents is ―to
promote progress of ... useful arts.‖ U.S. Const. Art. I, § 8, cl. 8. [Emphasis added.] Indeed, ―the
basic quid pro quo contemplated by the Constitution and the Congress for granting a patent
monopoly is the benefit derived by the public from an invention with substantial utility.‖
Brenner v. Manson, 383 U.S. 519, 534 (1966) (emphasis added). The Court in Brenner noted that
―a simple, everyday word ―useful,‖ as found in Section 101 can be pregnant with ambiguity when
applied to the facts of life.‖ While noting that ―one of the purposes of the patent system is to
encourage dissemination of information concerning discoveries and inventions,‖ the Court found
that a more compelling consideration in the determination of whether a patent should be granted ―is
the benefit derived by the public from an invention with substantial utility. Unless and until a
process is refined and developed to this point - where specific benefit exists in currently available
form - there is insufficient justification for permitting an applicant to engross what may prove to be
a broad field.‖ Brenner provides broad guidelines which are helpful in ascertaining what constitutes
practical utility for compounds having a pharmacological effect.

        The current Patent Act provides that patents may be granted only for ―new and useful ―
inventions, 35 U.S.C. section 101. Consequently, it is well established that a patent may not be
granted to an invention unless substantial or practical utility for the invention has been
discovered and disclosed. Section 101 has also been interpreted to exclude inventions deemed to
be immoral, such as (until 1977) gambling machines, or devices deemed to be scientifically
impossible, such as perpetual motion machines.

        Notwithstanding the above, the utility requirement is not a rigorous one in most cases:

     All that the law requires is that the invention should not be frivolous, or injurious to the
     well-being, good policy, or good morals of society. The word useful therefore is
     incorporated into the act in contradistinction to mischievous or immoral.

In re Nelson, 280 F.2d 172, 178-79 (CCPA 1960) (citing Lowell v. Lewis, 15 Fed.Cas. 1018, No.
8568 (C.C.Mass.1817) (Story, J.)).

        To meet the utility requirement, the Supreme Court has held that a new product or process
must be shown to be ―operable‖ - that is, it must be ―capable of being used to effect the object
proposed.‖ Mitchell v. Tilghman, 86 U.S. (19 Wall.) 287, 396 (1873). The Federal Circuit has not
interpreted this language to mean that a patented device must accomplish all objectives stated in the
specification. On the contrary, ―[w]hen a properly claimed invention meets at least one stated
objective, utility under § 101 is clearly shown.‖ Raytheon Co. v. Roper Corp., 724 F.2d 951, 958
(Fed.Cir.1983). The utility requirement, though an essential requisite of patentability, has other
limits. An invention need not be the best or the only way to accomplish a certain result, and it need
only be useful to some extent and in certain applications: ―[T]he fact that an invention has only
limited utility and is only operable in certain applications is not grounds for finding lack of utility.‖


                                                  513
Envirotech Corp. v. Al George, Inc., 730 F.2d 753, 762 (Fed.Cir.1984). Whether an invention
claimed in a patent lacks utility is a question of fact, which the Court of Appeals reviews for clear
error.

2.      Enabling Disclosure
        The first paragraph of 35 USC 112 requires that the specification of a patent contain a
written description of the claimed invention and the manner and process of making and using that
invention in such full, clear, concise, and exact terms as to enable any person skilled in the art to
which that invention pertains, or with which it is most nearly connected, to make and use that
invention. As a statutory requirement, enablement is a question of law that the Federal Circuit
reviews de novo, while reviewing for clear error any underlying facts found by the Board in
rendering its enablement determination.

        Although not explicitly stated in section 112, to be enabling, the specification of a patent
must teach those skilled in the art how to make and use the full scope of the claimed invention
without ―undue experimentation.‖ Nothing more than objective enablement is required, and
therefore it is irrelevant whether this teaching is provided through broad terminology or illustrative
examples.

         When rejecting a claim under the enablement requirement of section 112, the PTO bears an
initial burden of setting forth a reasonable explanation as to why it believes that the scope of
protection provided by that claim is not adequately enabled by the description of the invention
provided in the specification of the application; this includes, of course, providing sufficient reasons
for doubting any assertions in the specification as to the scope of enablement. If the PTO meets this
burden, the burden then shifts to the applicant to provide suitable proofs indicating that the
specification is indeed enabling.

         In the relatively few non-pharmaceutical reported cases involving utility, the analysis of
utility is often combined with an analysis of enablement, as an invention which lacks utility can not
be enabled - you can‘t teach how something works, if it doesn’t work. Conversely,

     A correct finding of infringement of otherwise valid claims mandates as a matter of law a
     finding of utility under § 101. The rule is … but a common sense approach to the law. If a
     party has made, sold, or used a properly claimed device, and has thus infringed, proof of
     that device‘s utility is thereby established. People rarely, if ever, appropriate useless
     inventions.

RAYTHEON COMPANY v. ROPER CORPORATION, 724 F.2d 951, 220 U.S.P.Q. 592
(Federal Circuit 1993) [Emphasis added.]


3. Chemical and Pharmacological Compounds




                                                 514
        In pharmaceutical cases, the issues of utility and enablement are often combined with an
analysis of whether there has been an actual reduction to practice, since one may not know if a
pharmaceutical invention will, in fact, work until it has been tested either in vitro or in vivo.

        The Federal Circuit has held that practical utility may be shown by adequate evidence of
any pharmacological activity. Such activity constitutes a practical utility because ―[i]t is
inherently faster and easier to combat illnesses and alleviate symptoms when the medical
profession is armed with an arsenal of chemicals having known pharmacological activities.
Since it is crucial to provide researchers with an incentive to disclose pharmacological activities
in as many compounds as possible, we conclude that adequate proof of any such activity
constitutes a showing of practical utility.‖ Nelson, 626 F.2d at 856, 206 USPQ at 883.

        It may be difficult to predict, however, whether a novel compound will exhibit
pharmacological activity, even when the behavior of analogous compounds is known to those
skilled in the art. Consequently, testing is often required to establish practical utility. But the
test results need not absolutely prove that the compound is pharmacologically active. All that is
required is that the tests be ―reasonably indicative of the desired [pharmacological] response.‖
Nelson, 626 F.2d at 856. In other words, there must be a sufficient correlation between the tests
and an asserted pharmacological activity so as to convince those skilled in the art, to a reasonable
probability, that the novel compound will exhibit the asserted pharmacological behavior.

        The CCPA in Rey-Bellet v. Englehardt, 493 F.2d 1380, 1383, (1974), stated that where a
count contains no limitation related to utility, evidence establishing a substantial utility for any
purpose is sufficient to show a reduction to practice. The court held that three in vivo tests
conducted in the United States prior to the filing of Englehardt‘s U.S. application failed to establish
an actual reduction to practice. The court proceeded, however, to find sufficient evidence in the
record to establish that Englehardt had conceived a utility for his compound prior to the filing date
of his U.S. application. The evidence the court found to be sufficient was testimony by the inventor
that he believed his compound would exhibit a particular pharmacological activity because of its
structural similarity to another compound which was known to possess the particular
pharmacological activity. The court found that the testimonial evidence of Englehardt was
corroborated by two exhibits entered into evidence. The court further noted that this was a
completed conception of utility because it appeared that nothing beyond the exercise of routine skill
would have been required to demonstrate that Englehardt‘s compound possessed the particular
pharmacological utility.

        The CCPA has held that nebulous expressions, such as ―biological activity‖ or ―biological
properties,‖ disclosed in a specification convey little explicit indication regarding the utility of a
compound. In re Kirk, 376 F.2d 936, 941 (CCPA 1967). But, while agreeing with the Board that
the specification failed to disclose a specific allegation of utility for any compound within the scope
of the claims, and that reference in the specification to biological properties of the claimed
compound was so general and vague as to be meaningless, the court implied that a disclosure in the
specification that the requisite properties of the claimed compounds are similar to those of a natural
or synthetic hormone of known activity may, in appropriate circumstances, rectify an inadequate
disclosure relating to the practical utility for the compound.




                                                 515
                               In Re Donald R. MILLIGAN
                      United States Court of Appeals, Federal Circuit, 1997
                          1997 WL 168316 (Unpublished Disposition)

       Before SCHALL, Circuit Judge, COWEN, and SKELTON, Senior Circuit Judges.

       PER CURIAM.

         Donald R. Milligan appeals the February 22, 1996 decision of the Board of Patent
Appeals and Interferences … [which] affirmed the examiner‘s final rejection of all pending
claims under … the first paragraph of 35 U.S.C. § 112 for lack of utility…. We affirm for lack
of utility.

                                           DISCUSSION

       The ‗664 application is a divisional application of the ‗361 application, which related to
processes for treating different disease conditions using lactic acid in composition with water.
The examiner required a restriction of the ‗361 application to several inventions, where each
invention asserted a method of curing a different disease. In In re Milligan, 101 F.3d 715
(Fed.Cir.1996) (Table), a nonprecedential decision, we affirmed the Board‘s rejection of the ‗361
application for lacking credible utility. The ‗361 application, after the restriction, claimed a cure
for both the symptoms and the cause of arthritis by using formulas of lactic acid. The ‗664
application claims the identical compositions of lactic acid in water and methods of applying this
formula to relieve pain and heal damaged tissue. Independent claim 1 is representative of the
seven pending claims in the application. It states as follows:

    This aqueous solution of only lactic acid and water will activate the bodies [sic.] neural
    systems to relieve symptoms of neuralgia pain and damage: of angina pectoris, of neural
    degeneration in the facial, in the hallucinatory, or the neuritis of the muscles and joint
    damaged functional nerve systems almost immediately and induces tissue repair to
    remove these symptoms in a manner that has not been a recognized medical procedure.

         In affirming the rejections under 35 U.S.C. § 101 and the first paragraph of 35 U.S.C. §
112, the Board found claims 1-7 properly rejected ―for being drawn to an incredible utility which
is unsupported by any evidence and lack of enablement to practice that utility.‖ The Board
incorporated by reference its earlier decisions concerning related applications for its reasoning on
the utility issue. In particular, the Board noted that Milligan asserted in the specification at issue
that the application of a few drops of lactic acid solution acts as a ―neurostimulator‖ which can
immediately cure debilitating diseases. The Board concluded that the asserted utility lacked
credibility and ―can hardly be said to be enabled by the two page descriptive portion of the
specification.‖ We find no error in the Board‘s decision that Milligan has failed to prove that the
mere act of placing a solution of lactic acid and water on one‘s skin will have the beneficial
effects claimed in the ‗664 application.

                                         Notes & Questions


                                                 516
    1. Would an application claiming that drinking soy milk a couple of times a day will
       prevent the development of certain kinds of cancers of the mouth be rejected on the
       grounds that is is drawn to ―an incredible utility?‘

    2. What‘s the harm in giving an inventor a patent monopoly on something that doesn‘t
       work?



                                         CROSS v. IIZUKA
                         United States Court of Appeals, Federal Circuit (1985)
                                   753 F.2d 1040, 224 U.S.P.Q. 739

        Before KASHIWA, BENNETT and BISSELL, Circuit Judges.

        KASHIWA, Circuit Judge.

        This appeal is from the decision of the United States Patent and Trademark Office Board of
Patent Interferences awarding priority on the single phantom count to Iizuka, the senior party.*

                                                   Background

       Interference No. 100,650 was declared on 20 April 1981 between application serial No.
68,365, for ―Imidazole Derivatives,‖ filed by Iizuka on 21 August 1979 and application serial No.
95,755, for ―N-Phenoxyalkyl) Imidazoles as Selective Inhibitors of the Thromboxane Synthetase
Enzyme and Pharmaceutical Compositions Thereof,‖ filed by Cross, et al. The single phantom
count of the interference is directed to imidazole derivative compounds ....

        The applications of Cross and Iizuka both disclose inventions directed to imidazole
derivative compounds which inhibit the synthesis of thromboxane synthetase, an enzyme which
leads to the formation of thromboxane A sub2 (TXA sub2 ), a highly unstable, biologically active
compound which is converted to stable thromboxane B sub2 by the addition of water.
Thromboxane A sub2 , as of the time period during which the applications were filed, was
postulated to be a causal factor in platelet aggregation.1 Platelet aggregation is associated with

*
         Although this is technically a priority case, Iizuka‘s priority turns on whether his Japanese patent
disclosed any ―practical utility.‖
1
         Iizuka‘s position is that, as of the ―critical date‖ of his application, TXA sub2 was widely accepted in
the art as causing platelet aggregation. Cross‘ position is that, as of the ―critical date,‖ platelet aggregation
was believed to be nonspecific, i.e., platelet aggregation may occur in the presence of thromboxane
synthetase, but thromboxane synthetase is not necessary for platelet aggregation. We note in retrospect that
THE MERCK INDEX 1345-46 (10th ed. 1983) describes TXA sub2 as inducing irreversible platelet
aggregation. More to the point, however, this court has noted that it is axiomatic that an inventor need not
comprehend the scientific principles on which the practical effectiveness of his invention rests, nor is the
inventor‘s theory or belief as to how his invention works a necessary element in the specification to satisfy
the enablement requirement of Section 112.


                                                      517
several deleterious conditions in mammalia, including humans, such as platelet thrombosis,
pulmonary vasoconstriction or vasospasm, inflammation, hypertension, and collagen-induced
thrombosis.

        Each party moved to be accorded the benefit of a foreign priority application under Section
119, Cross claiming priority based upon a British application filed 13 December 1978, and Iizuka
claiming priority based upon a Japanese application filed 21 August 1978. Each party opposed the
motion of the other party, each party contending that the other party‘s foreign priority application
did not comply with the disclosure requirements of Section 112.

        The primary examiner granted each party‘s motion, noting that the utility alleged in each
application was of a pharmacological nature, i.e., the inhibition of thromboxane synthetase, and that
inasmuch as the single phantom count of the interference was directed to a compound, it was not
necessary that utility be established by tests and dosages with respect to human beings. The
examiner found that one of ordinary skill in the art would know how to use the imidazole
derivatives, i.e., be able to determine specific dosages, for biological purposes. Based upon the
filing dates of the foreign priority applications,1 Iizuka was declared the senior party and a show
cause order was issued against Cross.

                                              Decision of the Board

        The Board noted that the sole issue before it was whether Iizuka was entitled to the benefit
of his Japanese priority application. Relying on In re Bundy, 642 F.2d 430 (CCPA 1981), and
Nelson v. Bowler, 626 F.2d 853 (CCPA 1980), the Board held that tests evidencing
pharmacological activity may manifest a practical utility even though they may not establish a
specific therapeutic use. The Board found that the Japanese priority application disclosed
pharmacological activity in the similar activity of the imidazole derivatives of the count to
imidazole and 1-methylimidazole, which possess an inhibitory action for thromboxane synthetase,
and that practical utility was disclosed in the strong inhibitory action for thromboxane synthetase
from human or bovine platelet microsomes, i.e., an in vitro utility.2

        The Board further found that the Japanese priority application disclosed ―how-to-use‖
knowledge directed to the practical utility in a microsome system, and that microsome assays were
admittedly known in the art. A skilled worker could determine the relative strength of the imidazole
compounds of the count vis-a- vis the known parent imidazole and 1-methylimidazole compounds
for use in the microsome assay milieu. Knowledge of the pharmacological activities of compounds
is beneficial to the medical profession, and requiring Iizuka to have disclosed in vivo dosages in the
Japanese priority application would delay and frustrate researchers by failing to provide an incentive
for early public disclosure of such compounds, thereby failing to further the public interest.

1
          Each party relies on the filing date of its foreign priority application to establish a constructive
reduction to practice, the earliest date of invention to which each party is entitled under the patent laws of the
United States.
2
          Generally, in vitro refers to an environment outside of a living organism, usually an artificial
environment such as a test tube or culture. In contradistinction, in vivo generally refers to an environment
within a living organism, such as a plant or animal, or it may refer to a particular portion of an organ external
to the living organism, e.g., rat aortic loop.


                                                      518
       Accordingly, the Board held that the Japanese priority application contained an adequate
how-to-use disclosure for the practical utility stated therein.

                                                       Issues

        Whether the Board erred in finding that the utility disclosed in the Japanese priority
application is sufficient to meet the practical utility requirement of 35 U.S.C. Section 101.

        Whether the Board erred in finding that the Japanese priority application contained
sufficient disclosure to satisfy the enablement, i.e., how-to-use, requirement of Section 112.

                                                     OPINION

         Proper resolution of the issues before this court necessitates that we address, seriatim, the
following questions: (1) What utility is disclosed by the Japanese priority application? (2) Does
this stated utility comply with the ―practical utility‖ requirement of Section 101, as delimited by
prior decisions of the judiciary? 1 (3) Does the Japanese priority application contain sufficient
disclosure to meet the how-to-use requirement of Section 112 with respect to the stated utility?

        It is axiomatic that an invention cannot be considered ―useful‖, in the sense that a patent can
be granted on it, unless substantial or practical utility for the invention has been discovered and
disclosed where such utility would not be obvious. Brenner v. Manson, 383 U.S. 519 (1966).
Where a constructive reduction to practice is involved, as contrasted to an actual reduction to
practice, a practical utility for the invention is determined by reference to, and a factual analysis of,
the disclosures of the application.

                                      1. Japanese Priority Application

        The Board factually analyzed the Japanese priority application and found that the only
effective disclosure relating to a stated utility for the imidazole derivative compounds of the
phantom count was the following:

    [The compounds disclosed] are useful for treatment of inflammation, thrombus,
    hypertension, cerebral apoplexy, asthma, etc. Up to this time, it is a known fact that
    imidazole and 1-methylimidazole possess an inhibitory action for thromboxane synthetase
    and inhibit a biosynthesis of thromboxane A sub2. However, since their inhibitory effect is
    not satisfactory one, these compounds have not been put to practical use yet as therapeutical
    medicines for diseases caused by thromboxane A sub2, such as inflammation, hypertension,
    thrombus, cerebral apoplexy, asthma, etc. To develop some compounds possessing a strong

1
          While questions one and two are closely connected, a thorough analysis of the utility issue requires
first, a determination as to what utility is disclosed, i.e., the stated utility, for the invention claimed in the
application. Only after the stated utility has been determined, can a proper analysis be undertaken to
determine if the stated utility complies with the ―practical utility‖ requirement of Section 101. As noted
above, these questions regarding utility are factual in nature, and are to be determined in the first instance by
the PTO, the agency with the expertise in this regard.


                                                      519
    inhibitory action for biosynthesis of thromboxane A sub2, the present inventors devoted
    themselves to study for various imidazole derivatives, and as a result, found that the
    compounds [of this invention] possess a strong inhibitory action for thromboxane synthetase
    from human or bovine platelet microsomes and are extremely useful as therapeutically
    active agents for diseases caused by thromboxane A sub2, for example, inflammation,
    hypertension, thrombus, cerebral apoplexy, asthma, etc., and thus we proposed this
    invention based upon those findings.

                                                      ***

        The imidazole derivatives ... of this invention are novel compounds which are not
    described in literature, and which possess a strong inhibitory action for thromboxane
    synthetase from human or bovine platelet microsomes, and which exhibit a strong inhibitory
    action for biosynthesis of thromboxane A sub2 in mammalia including human. In general, a
    satisfactory inhibitory effect is found at a level of molar concentrations of 2.5 x 10 –8, for
    example, 2-[p-(1- imidazolylmethyl) phenoxy]-acetic acid hydrochloride produce the about
    50% inhibitory effect at the molar concentrations of 2.5 x 10 –8. Accordingly, the imidazole
    derivatives of this invention are extremely useful as therapeutical medicines for diseases
    caused by thromboxane A sub2, such as inflammation, hypertension, thrombus, cerebral
    apoplexy, asthma, etc.

        The Board found that these pertinent sections of the Japanese priority application disclosed
some activity or utility, namely that the imidazole derivative compounds of the count possess a
strong inhibitory action for thromboxane synthetase in human or bovine platelet microsomes.
Cross‘ position is that the stated purpose or sole contemplated utility of the invention of Iizuka is to
provide a novel class of compounds which provide ―practical use‖ as ―therapeutical medicines for
diseases caused by thromboxane A sub2,‖ and therefore the Board erred in its finding as to the
stated utility of the Japanese priority application.

         While recognizing that Kawai constrains an applicant to entitlement to the benefit of only
what is disclosed in the foreign priority application and no more, we also recognize that foreign
priority applications, as subsequently filed in the PTO, typically have a style and format dissimilar
to the arrangement of application elements suggested by 37 C.F.R. Section 1.77. In part this arises
because of differences in filing requirements in foreign patent offices, and in part because of the
awkwardness resulting from direct literal translations from a foreign language to English. Thus,
while the factual determination of the stated utility in an application prepared in the United States
may be relatively straightforward,1 the factual analysis of a foreign priority application to determine
the utility disclosed therein may be more laborious and open to varying interpretations.

       The weakness of Cross‘ position is that a fair reading of the pertinent sections of the
Japanese priority application, as set forth above, discloses utility for the imidazole derivative
compounds of the phantom count both as an inhibiting agent for thromboxane synthetase in human
or bovine platelet microsomes, as found by the Board, and as therapeutically active agents

1
         In applications prepared in the United States by experienced patent drafters, the drafter of the
application typically sets forth objectives for the invention in the ―Summary of the Invention‖ section of the
application. These objectives will normally be consonant with the utility disclosed for the invention.


                                                    520
preventing the biosynthesis of thromboxane A sub2, thereby functioning as a medicine preventing
deleterious conditions caused by thromboxane A sub2, as contended by Cross.

        Evidence of any utility is sufficient when the count does not recite any particular utility.
Here the Board, which is charged with the factual determination of utility, has found that the
specification of the Japanese priority application disclosed a utility for the imidazole derivative
compounds of the phantom count in the inhibition of thromboxane synthetase in human or bovine
platelet microsomes. Inasmuch as the Board is charged with making this factual determination
when the issue is raised, inasmuch as they have so done in the instant case, and inasmuch as there is
credible evidence to support this factual determination, we are not prepared to say that the Board
erred in its finding as to the stated utility disclosed in the Japanese priority application.

                                              2. Practical Utility

         As noted in the preceding part of this opinion, Cross has contended that the Board erred in
its finding as to the utility disclosed in the Japanese priority application. This argument may be
viewed in a different perspective, we believe, which is that the stated utility in the Japanese priority
application, as found by the Board - the inhibition of thromboxane synthetase in human or bovine
platelet microsomes - is not sufficiently correlated to a pharmacological activity1 to be a practical
utility. In other words, Cross may be arguing that the minimum acceptable level of utility disclosed
in an application claiming a compound having pharmacological activity must be directed to an in
vivo utility in order to comply with the practical utility requirement of Section 101.

                                                     ***

        Every utility question arising in an interference, in the final analysis, must be decided on the
basis of its own unique factual circumstances. Relevant evidence must be judged as a whole for its
persuasiveness in determining whether the suggested use for the compound of the count is a
practical utility.

         The Board has found that the Japanese priority application of Iizuka disclosed a practical
utility for the compounds of the phantom count in the inhibition of thromboxane synthetase in
human or bovine platelet microsomes, i.e., an in vitro utility. Clearly, this stated utility as found by
the Board has been delimited with sufficient specificity to satisfy the threshold requirements of
Kawai and Kirk. The stated utility of the Japanese priority application is directed to a specific
pharmacological activity possessed by the imidazole derivatives of the phantom count--the
inhibition of thromboxane synthetase in vitro. Thus, this court on review is not presented with a
general allegation of ―biological activity‖ or ―biological properties‖ as was the CCPA in Kirk, nor is
reliance on prior art required to ascertain what specific pharmacological activity the compound of
the count possesses, the factual situation confronting the court in Kawai.

         The Japanese priority application, moreover, disclosed that it was generally known in the
art, as of the critical date, that the parent imidazole and 1-methylimidazole compounds possessed an
inhibitory action for thromboxane synthetase. Reliance on this disclosure in the specification of the
1
         Generally, pharmacological activity refers to the properties and reactions of drugs, especially with
relation to their therapeutic value.


                                                    521
pharmacological property of the parent imidazole and 1-methylimidazole compounds, as going
towards proof of the pharmacological activity of the imidazole derivatives of the phantom count, is
particularly relevant in the instant case, we believe, because Iizuka is not relying on this inference to
supplement an inadequate disclosure in the Japanese priority application regarding the
pharmacological activity of the compound of the phantom count, but rather is relying on this
inference as cumulative probative evidence showing an adequately disclosed practical utility in the
Japanese priority application.

        This court, in Rey-Bellet and Kawai, has implied that a particular pharmacological activity
identified with prior art compounds may have probative value as to the fact that the compound of
the count possesses this particular pharmacological activity where there is a structural similarity
between the prior art compounds and the compound of the count. Cross has failed to proffer
sufficient evidence or present any persuasive arguments going to the question of significant
structural dissimilarities between the parent imidazole and 1-methylimidazole compounds and the
imidazole derivatives of the phantom count.

        The expert of Iizuka, Dr. Ramwell, testified that, as of the critical date, there was an
awareness on the part of those skilled in the art that the parent imidazole compound exhibited an
inhibitory activity for thromboxane synthetase, in both in vitro and in vivo environments. Dr.
Ramwell further testified that there was an awareness by those skilled in the art of a correlation
between thromboxane A sub2 and platelet aggregation, namely that thromboxane A sub2 was a
mediator in platelet aggregation. Several exhibits proferred by Iizuka corroborated Dr. Ramwell‘s
testimony as to the general knowledge in the art with respect to the inhibitory effect of the parent
imidazole compound for thromboxane synthetase. Accordingly, the similar pharmacological
activity of the parent imidazole and 1-methylimidazole compounds have probative value in the
factual determination of practical utility for the compounds of the phantom count inasmuch as Cross
has not met the burden of proof to establish structural dissimilarities between the parent imidazole
and 1-methylimidazole compounds and the imidazole derivatives of the phantom count.

         The Board found that there was adequate proof that the Japanese priority application
disclosed a pharmacological activity for the compounds of the phantom count in inhibiting the
action of thromboxane synthetase, similar to the pharmacological activity of the parent imidazole
and 1-methylimidazole compounds which were found to possess an inhibitory action for
thromboxane synthetase, this disclosed knowledge of the inhibitory action of the prior art
compounds having been corroborated by testimony and documentary evidence. During the
proceedings before the Board, the burden of proof rested upon Cross to show that the Japanese
priority application was deficient. On review, Cross bears the burden of proof to show that the
Board erred in finding that the Japanese priority application had adequately disclosed a practical
utility. Reviewing the relevant evidence presented to the Board as a whole, we are not persuaded
that Cross has met this burden of proof.

        The final question we must address is whether the inhibitory activity for thromboxane
synthetase in human or bovine platelet microsomes, i.e., an in vitro utility, is sufficient to comply
with the practical utility requirement of § 101. Based upon the facts of this case, we are not
persuaded that the Board erred in finding that the in vitro utility disclosed in the Japanese priority
application for the compounds of the count is sufficient to establish a practical utility.



                                                  522
        Our predecessor court has noted that adequate proof of any pharmacological activity
constitutes a showing of practical utility. (Citations omitted) Dr. Ramwell testified that initial
testing of compounds for a particular pharmacological activity is typically done in vitro. In vitro
testing permits an investigator to establish the rank order of compounds with respect to the
particular pharmacological activity, i.e., to determine the relative potency of the compounds.
Compounds having the highest ranking or potency are then selected for further testing in vivo.
Presumably this is the accepted practice in the pharmaceutical industry inasmuch as Cross has not
proffered any evidence refuting this testimony of Dr. Ramwell, and we note that this practice has an
inherent logical persuasiveness. In vitro testing, in general, is relatively less complex, less time
consuming, and less expensive than in vivo testing. Moreover, in vitro results with respect to the
particular pharmacological activity are generally predictive of in vivo test results, i.e., there is a
reasonable correlation therebetween. Were this not so, the testing procedures of the pharmaceutical
industry would not be as they are. Iizuka has not urged, and rightly so, that there is an invariable
exact correlation between in vitro test results and in vivo test results. Rather, Iizuka‘s position is
that successful in vitro testing for a particular pharmacological activity establishes a significant
probability that in vivo testing for this particular pharmacological activity will be successful.

        As discussed above, Dr. Ramwell testified that the parent imidazole and 1-methylimidazole
compounds had been subjected to both in vitro and in vivo testing as of the critical date, this
corroborated by documentary evidence, and found to possess an inhibitory effect for thromboxane
synthetase. Based upon this, Dr. Ramwell further testified that he would expect that in vivo testing
of the imidazole derivatives of the phantom count would show that these compounds also possessed
an inhibitory action for thromboxane synthetase, i.e., there would be a reasonable correlation
between in vitro test results and in vivo test results. This evidence was found sufficient by the
Board as proof that the Japanese priority application had disclosed a completed practical utility for
the imidazole derivatives of the phantom count in inhibiting thromboxane synthetase in human or
bovine platelet microsomes.

        Cross argues that the in vitro utility disclosed by the Japanese priority application is not per
se useful, and that more sophisticated in vitro tests, using intact cells, or in vivo tests are necessary
to establish a practical utility. Cross is arguing that there must be a rigorous correlation of
pharmacological activity between the disclosed in vitro utility and an in vivo utility to establish a
practical utility. We, however, find ourselves in agreement with the Board that, based upon the
relevant evidence as a whole, there is a reasonable correlation between the disclosed in vitro utility
and an in vivo activity, and therefore a rigorous correlation is not necessary where the disclosure of
pharmacological activity is reasonable based upon the probative evidence.

        Our predecessor court has accepted evidence of in vivo utility as sufficient to establish a
practical utility ... (and has) recognized the fact that pharmacological testing of animals is a
screening procedure for testing new drugs for practical utility. (Citations omitted) This in vivo
testing is but an intermediate link in a screening chain which may eventually lead to the use of the
drug as a therapeutic agent in humans. We perceive no insurmountable difficulty, under appropriate
circumstances, in finding that the first link in the screening chain, in vitro testing, may establish a
practical utility for the compound in question. Successful in vitro testing will marshal resources and
direct the expenditure of effort to further in vivo testing of the most potent compounds, thereby



                                                  523
providing an immediate benefit to the public, analogous to the benefit provided by the showing of
an in vivo utility.

         Today, under the circumstances of the instant case, where the Japanese priority application
discloses an in vitro utility, i.e., the inhibition of thromboxane synthetase in human or bovine
platelet microsomes, and where the disclosed in vitro utility is supplemented by the similar in vitro
and in vivo pharmacological activity of structurally similar compounds, i.e., the parent imidazole
and 1-methylimidazole compounds, we agree with the Board that this in vitro utility is sufficient to
comply with the practical utility requirement of Section 101.


E.      ―Best Mode‖ Disclosure*
Introduction
        Section 112 requires that a patent application ―set forth the best mode contemplated by the
inventor of carrying out his invention.‖ A patent applicant is expected to disclose information
sufficient to enable another person skilled in the art to practice the best mode. This requirement
―ensures that the public, in exchange for the rights given the inventor under the patent laws, obtains
from the inventor a full disclosure of the preferred embodiment of the invention.‖ Dana Corp. v.
IPC Ltd. Partnership, 860 F.2d 415, 418 (Fed.Cir. 1988). The purpose underlying the best mode
requirement is to keep inventors from obtaining the protection of the patent system while keeping
secret the ―preferred embodiment‖ of their inventions. By requiring the inventor to disclose the best
mode for practicing his invention, the statute permits others skilled in the art to practice the patented
invention most efficiently once the patent‘s monopoly expires. The best mode requirement is thus
aimed at ensuring that a patent applicant plays ―fair and square‖ with the patent system. If the best
mode contemplated by the inventor is not submitted in the patent application, the patent is invalid.

         In Chemcast Corp. v. Arco Industries Corp., 913 F.2d 923, 927-28 (FedCir.1990), the
Federal Circuit explained that a ―proper best mode analysis‖ has two components. The first is
whether, at the time the inventor filed his patent application, he knew of a mode of practicing his
claimed invention that he considered to be better than any other. This part of the inquiry is wholly
subjective, and resolves whether the inventor must disclose any facts in addition to those sufficient
for enablement. If the inventor in fact contemplated such a preferred mode, the second part of the
analysis compares what he knew with what he disclosed - is the disclosure adequate to enable one
skilled in the art to practice the best mode or, in other words, has the inventor ―concealed‖ his
preferred mode from the ―public‖? Assessing the adequacy of the disclosure, as opposed to its
necessity, is largely an objective inquiry that depends upon the scope of the claimed invention and
the level of skill in the art. Thus, a court ―must look at the scope of the invention, the skill in the art,
the evidence as to the inventor‘s belief, and all of the circumstances in order to evaluate whether the
inventor‘s failure to disclose particulars of manufacture gives rise to an inference that he concealed
information which one of ordinary skill in the art would not know.‖ Wahl Instruments, 950 F.2d at
1580. Where a person skilled in the art ―simply could not divine‖ the most advantageous way to


*
        This requirement would be eliminated under the proposed Patent Reforma Act of 2005.


                                                     524
use an invention, the best mode requirement is not met. Defendant must prove that the patent
applicant failed to comply with the ―best mode‖ requirement by clear and convincing evidence.

        The best mode requirement has been interpreted to require the disclosure of the best mode
subjectively contemplated by the inventor, not the objective best mode. The requirement is
subjective in that it requires a finding of the inventor‘s subjective knowledge at the time of the
patent application. The inventor need not disclose every detail as long as the best means of
achieving the inventive results are disclosed. It may be found that the inventor did not contemplate
any best mode and thus there could be no duty to disclose a best mode. Noncompliance with the
best mode requirement will be found only if the patent applicant has concealed, either knowingly or
accidentally, ―his or her preferred embodiment of the claimed invention.‖

        While there is a presumption that the commercial version of the invention being sold at the
time of the filing date is the best mode, patent law does not require the patentee to disclose specific
data on how to mass-produce the invented product, nor to list the dimensions, tolerances, drawings,
and other parameters of mass production not necessary to enable one skilled in the art to practice the
invention.

       The failure to disclose the best mode for practicing an invention can result in summary
judgment against the patentee. Pursuant to 35 U.S.C. § 282, defendants have the burden of proving
by clear and convincing evidence that the inventors of the ‗989 patent failed to disclose what they
contemplated to be the best mode for carrying out their invention, notwithstanding the fact that the
Examiner will never be in a position to know whether the inventor has disclosed the ―best mode.‖


Albert L. Jacobs, Jr., THE BEST MODE REQUIREMENT: WHAT THE LAW IS AND WHAT
IT SHOULD BE, 16 Hous. J. Int‘l L. 533 (Spring 1994) [Most of the footnotes and citations, as
well as much of the text, has been omitted]

        Our patent laws promote inventions by giving inventors the exclusive right to exploit
   their inventions for a limited time. In return for this protection, inventors must fully
   describe the invention, including the ―best mode‖ of carrying out the invention.

        The best mode requirement is one consideration exacted for the fixed term of
   monopoly rights granted to the inventor. The best mode requirement is independent of,
   and should not be confused with, the enablement provision which requires disclosure of
   the creation and use of the invention. The best mode requirement ―restrain(s) inventors
   from applying for a patent while at the same time concealing from the public preferred
   embodiments of their inventions which they have in fact conceived.‖ It is also intended
   ―to ensure that a patent applicant plays ‗fair and square‘ with the patent system,‖ and ―to
   allow the public to compete fairly with the patentee following the expiration of the
   patents.‖

   Modes Known to Subsidiary Organizations




                                                 525
         In Hewlett- Packard Co. v. Bausch & Lomb Inc.,1 an inventor at Hewlett-Packard had
    been assigned the task of developing a system whereby paper could be moved precisely for
    use by an ―x-y plotter‖ printer. The system designed by the inventor utilized a system of
    ―grit wheels,‖ or rollers wrapped in sandpaper, to move the paper. Although the inventor
    had experimented with the idea of affixing ―grit kernels‖ directly to the rollers with epoxy,
    he concluded that sandpaper performed this task better than directly-adhered grit and on
    his patent application identified sandpaper as the best mode for carrying out his invention.

         Before the inventor filed the application, however, Hewlett-Packard assigned the task
    of refining the grit wheel system for commercial production to others within the company.
    During the course of refinement, Hewlett-Packard‘s San Diego division determined
    directly-adhered grit to be the superior mode of production and implemented its production
    accordingly. In subsequent litigation over infringement of the patent, the question arose
    whether the inventor had disclosed the ―best mode‖ of production as required by § 112. In
    determining that the patent was valid, the court noted that the San Diego division‘s
    preference for directly-adhered grit was irrelevant. Rather, the court observed, the only
    issue relevant to the validity of the application was the inventor‘s opinion at the time he
    filed the application. Upon finding that the inventor had disclosed the best mode
    contemplated by him at the time he filed his application, the court held that the inventor‘s
    patent met the best mode requirement of § 112.

    A foreign priority application need only disclose the ―best mode‖ known at the time the
    application was filed in the foreign jurisdiction.

         A domestic application, in order to obtain priority under a foreign filing date, need not
    disclose a best mode developed since the foreign filing. In Tyler Refrigeration Corp. v.
    Kysor Indus. Corp., the original application filed in Japan disclosed the best mode at the
    time it was filed. However, between the priority date of the Japanese application and the
    filing of the U.S. application a better mode was discovered. The district court specifically
    found that as long as the priority application disclosed the best mode as of its foreign filing
    date, the U.S. application was valid under § 112, and there was no requirement for the
    applicants to ―update‖ the application.

         In Standard Oil Co. v. Montedison, S.P.A., the plaintiffs attempted to invalidate
    Montedison‘s claim of priority to the invention of solid crystalline polypropylene. 2
    Although Montedison‘s application for the invention was not filed in the United States
    until June 8, 1955, Montedison sought the benefit of its June 8, 1954 application for the
    same product in Italy pursuant to § 119. Although the Italian application disclosed the best
    mode known at its filing date, Montedison had discovered a better catalyst when it filed its
    American patent application. The plaintiffs asserted that the U.S. application did not
    disclose the best mode as required by § 112. The court rejected the plaintiffs‘ argument
    since Montedison‘s U.S. application reflected what Montedison believed to be the best
    mode at the time of its Italian filing.


1
        722 F. Supp. 595 (N.D. Cal. 1989), aff‘d, 909 F.2d 1464 (Fed. Cir. 1990).
2
        494 F. Supp. 370, 373 (D. Del. 1980), aff‘d, 664 F.2d 356 (3d Cir. 1981).


                                                   526
                         TRANSCO PRODUCTS INC.
                                   v.
                     PERFORMANCE CONTRACTING, INC.
                     United States Court of Appeals, Federal Circuit, 1994.
                                ---F.3d----, 32 U.S.P.Q.2d 1077


       Before RICH, PLAGER, and SCHALL, Circuit Judges.

       RICH, Circuit Judge

        Performance Contracting, Inc. appeals the decision of the District Court for the Northern
District of Illinois holding by summary judgment claims 1-4 of U.S. Patent No. 4,009,735
(Pinsky patent) invalid on the basis of three violations of the best mode requirement of section
112. The district court based two of these violations on Pinsky‘s failure to update his best mode
disclosure upon filing a continuation application pursuant to 37 CFR § 1.60 (Rule 60). The
district court based the third violation on Pinsky‘s failure to provide supplier/trade name
information for a material recited in the claims and described in the specification.

        Because the district court erred as a matter of law in holding that an applicant must
update the best mode disclosure upon the filing of a continuing application containing no new
matter, the district court‘s holding regarding the first two violations is reversed. In addition,
because the district court improperly resolved a genuine issue of material fact on summary
judgment to find the third violation, that part of the district court‘s holding is vacated and
remanded for further proceedings in accordance with our discussion herein.

                                       BACKGROUND

       I. The Pinsky Patent

       The Pinsky patent issued from a Rule 60 continuation application filed on October 2,
1974, which application claimed priority pursuant to section 120 based on a parent application
filed October 24, 1973. The Pinsky patent is directed generally to thermal insulation for vessels
and piping within nuclear power plants.

       Claim 1, the only independent claim in the Pinsky patent, reads as follows:

        Readily removable and replaceable rewettable thermal insulation for use on vessels and
       piping within reactor containment areas of nuclear power plants comprising high
       temperature resistant mineral fiber or glass fiber encapsulated within rewettable, high
       temperature resistant, asbestos free glass cloth held in place with a plurality of spaced
       quick release and engage fasteners, wherein the glass cloth can withstand repeated
       wettings from spray systems within the reactor containment areas of nuclear power plants
       and wherein the fasteners are two woven nylon, hook and loop mating strips, wherein the


                                              527
       glass cloth has a finish of a leachable, organic silicate carried in a fatty and mineral oil
       vehicle.

       II. District Court Proceedings

        The district court, sua sponte, instructed the parties, however, to brief the issue of
whether claims 1-4 of the Pinsky patent should be held invalid by summary judgment on the
basis that the Pinsky patent fails to disclose the best mode of practicing the claimed invention.
Following briefing, the district court issued the appealed decision holding the Pinsky patent
invalid in view of three violations of the best mode requirement.

        The district court based the first two best mode violations on knowledge Pinsky allegedly
had at the time of filing his continuation application, but did not have at the time of filing the
corresponding parent application. The district court found that Pinsky knew at the time of filing
his continuation application that the use of stainless steel hooks for the fasteners (6), as opposed
to the disclosed nylon-type hooks, constituted the best mode for carrying out the claimed
invention. The district court also found that Pinsky knew at the time of filing his continuation
application that the claimed fasteners should be placed longitudinally on the insulation with
respect to the pipe, as opposed to circumferentially.

        Of particular relevance to our disposition of this case, the district court found, and
Transco does not dispute, that Pinsky did not consider either of the foregoing to be the best mode
of practicing the claimed invention as of the filing date of the parent application. The district
court stated, however, that the filing date of Pinsky‘s continuation application controlled,
because, according to the district court, an applicant must update the best mode disclosure upon
each filing of a continuing application. Accordingly, the district court held that Pinsky‘s failure
to disclose this information in his continuation application was a violation of the best mode
requirement.

       Regarding the third violation, the district court found that Pinsky violated the best mode
requirement by failing to disclose the commercial designation for a material that he described in
the specification for use as the finished glass cloth (14). The district court found that Pinsky‘s
description of the cloth was deficient and that Pinsky should have disclosed that the use of
Burlington Industries‘ commercial 603A finished glass cloth constituted the best mode, since he
knew this supplier/trade name information at the time of filing the parent application.

                                           ANALYSIS

       II. Continuing Applications and the Best Mode Requirement

       A. Continuing Applications

        Prior to analyzing the particulars of this issue, we believe it necessary to recognize that
there are various types of ―continuing‖ applications that one may file at the PTO. An applicant
may file a continuation, divisional, or continuation-in-part (CIP) application of a prior
application, all of which the PTO characterizes as ―continuing‖ applications. In general, a



                                                528
continuing application is one filed during the pendency of another application which contains at
least part of the disclosure of the other application and names at least one inventor in common
with that application.

        ―Continuation‖ and ―divisional‖ applications are alike in that they are both continuing
applications based on the same disclosure as an earlier application. They differ, however, in
what they claim. A ―continuation‖ application claims the same invention claimed in an earlier
application, although there may be some variation in the scope of the subject matter claimed. A
―divisional‖ application, on the other hand, is one carved out of an earlier application which
disclosed and claimed more than one independent invention, the result being that the divisional
application claims only one or more, but not all, of the independent inventions of the earlier
application. A ―CIP‖ application is a continuing application containing a portion or all of the
disclosure of an earlier application together with added matter not present in that earlier
application. The term ―parent‖ is often used to refer to the immediately preceeding application
upon which a continuing application claims priority; the term ―original‖ is used to refer to the
first application in a chain of continuing applications.

        The PTO has noted that the expressions ―continuation,‖ ―divisional,‖ and
―continuation-in-part‖ are merely terms used for administrative convenience. As explained more
fully in section II.B. below, the bottom line is that, no matter what term is used to describe a
continuing application, that application is entitled to the benefit of the filing date of an earlier
application only as to common subject matter.

       B. Interplay of Section 120 and Section 112

         The district court held that an applicant must update the best mode disclosure upon filing
any continuing application. … On its face, section 112 does not distinguish between a parent
application and continuing applications thereof. However, section 112 must be read in light of
the other parts of Title 35, namely section 120, which governs the manner in which continuing
applications are to be treated. In essence, ―having the same effect‖ means having the benefit of
the filing date of the earlier filed application.

        When statutory interpretation is at issue, the plain and unambiguous meaning of a statute
prevails in the absence of clearly expressed legislative intent to the contrary. The plain and
unambiguous meaning of section 120 is that any application fulfilling the requirements therein
―shall have the same effect‖ as if filed on the date of the application upon which it claims
priority. The courts have repeatedly recognized this principle.

       C. Best Mode Requirement

        By use of the language ―in the manner provided by the first paragraph of section 112,‖
section 120 speaks of the first paragraph of section 112 as a whole. Indeed, the CCPA has stated
that: symmetry in the law, and evenness of its application, require that § 120 be held applicable
to all bases for rejection, that its words ―same effect‖ be given their full meaning and intent.




                                                529
        Section 120 thus does not exempt the best mode requirement from its reach, and therefore
this court must accept the plain and precise language of section 120 as encompassing the same.
Accordingly, the date for evaluating a best mode disclosure in a continuing application is the
date of the earlier application with respect to common subject matter.6

        We note by analogy the manner in which the best mode requirement has been examined
in other contexts. It has been held that the appropriate date for determining compliance with the
best mode requirement for a reissue application is the filing date of the original application and
not that of the reissue application. In a similar vein, it has been held that, in the context of a
priority claim under 35 U.S.C. § 119, one looks to the foreign application and its filing date to
determine the adequacy of the best mode disclosure and not to the filing date of the
corresponding U.S. application.7 We see no reason for treating the best mode issue any
differently under section 120.

        Contrary to Transco‘s assertions, public policy does not demand that the public receive a
new best mode disclosure in all continuing applications. Such a rule would subvert the patent
system‘s goal of promoting the useful arts through encouraging early disclosure. An inventor‘s
motivation to file early and then continue to test and improve upon his invention would be stifled
by the knowledge that any progress that he made could preclude him from enjoying the
procedural benefits available through continuing application practice. If he later developed
better modes for practicing an invention adequately disclosed in an earlier filed application, he
would nonetheless have to redraft his disclosure to add these later-developments upon filing a
continuing application.

         The district court‘s comments regarding continuing application practice and new matter
illustrate a misunderstanding of patent law and patent office practice. The subject matter that the
district court believes Pinsky should have disclosed in his continuation application would clearly
have constituted ―new matter‖ pursuant to 35 U.S.C. § 132. It must be understood that the
introduction of a new best mode disclosure would constitute the injection of ―new matter‖ into
the application and automatically deprive the applicant of the benefit of the earlier filing date of
the parent or original application for any claim whose validity rests on the new best mode
disclosure.

        Moreover, imagine the practical implications if an applicant were forced to update the
best mode disclosure upon each filing of a continuing application. Under current practice, the
filing of many, if not most, continuing applications is merely a matter of form not requiring any
input from the inventor. The best mode requirement, however, focuses on what the inventor
knows. Thus, under the district court‘s holding, an attorney would necessarily be forced to
discuss with an inventor any progress that has been made regarding the invention each time that

6
         However, as mentioned earlier, a continuing application is entitled to rely on the filing date of an
earlier application only with respect to subject matter common to both applications.
7
         In IN RE GOSTELI, this court stated: Section 119 provides that a foreign application ―shall have the
same effect‖ as if it had been filed in the United States. Accordingly, if the effective filing date of what is
claimed in a United States application is at issue, to preserve symmetry of treatment between sections 120
and 119, the foreign priority application must be examined to ascertain if it supports, within the meaning of
section 112, ¶ 1, what is claimed in the United States application.


                                                     530
a continuing application is filed, even when it is being filed merely for administrative
convenience. This result would be completely contrary to current continuing application
practice.

        Furthermore, given that much of continuing application practice stems from actions taken
by the PTO, it would be unfair to impose upon applicants an additional best mode burden. For
example, when confronted with an application claiming more than one independent and distinct
invention, an examiner often will impose a restriction requirement pursuant to 35 U.S.C. § 121 to
ease the burden of examining that subject matter, thus forcing an applicant to file one or more
divisional applications. In addition, an examiner also will often issue a final rejection and
indicate that, if certain amendments are made to the claims in a continuation application filed
pursuant to the streamlined procedures set forth in Rule 62, the examiner will allow those claims
and pass them to issuance. Actions such as these, taken by the PTO primarily for administrative
convenience, should not increase the burdens on an applicant regarding his ability to obtain
patent protection.

        Indeed, in this case, Pinsky filed his continuation application merely for the purpose of
having the examiner consider an amendment to the claims proposed after final rejection in the
parent application, but which was not entered in the parent application on the basis that it did not
meet the procedural requirements of 37 CFR § 1.116. This is not an atypical chain of events. To
impose upon an applicant the burden of updating the best mode disclosure under this type of
circumstance would be unreasonable.9

        In conclusion, because the relevant date for evaluating a best mode disclosure is the date
of the parent application, and because there is no dispute that Pinsky did not believe that the use
of steel hooks and longitudinal fasteners constituted the best mode for practicing the claimed
invention at the time Pinsky filed his parent application, reversal of these two best mode holdings
is necessitated.

        III. Cloth Finish

        A. Background

       The district court also found that Pinsky violated the best mode requirement by failing to
provide supplier/trade name information for the finished glass cloth used in the preferred
embodiment of his invention at the time he filed his parent application. The Pinsky patent
provides the following description of the cloth:

       The finish employed in this invention can vary widely. Generally, the finish is a
    leachable, organic silicate carried in a fatty and mineral oil vehicle. The finished fabric
    meets the requirements of U.S. Navy specification Mil-I-24244 with regard to chemical
    analysis and chemical resistance of materials used in the insulation of stainless steel, as

9
        We view the fact that there have been relatively few cases to date addressing whether the best mode
disclosure must be updated in a continuing application, as to common subject matter, as evidencing how
widely accepted it is that there is no such requirement, not that this is an unclear or unresolved issue as
Transco and the district court suggest.


                                                   531
     well as the requirements of Coast Guard specification CFL-164.009 relating to
     incombustible materials. The glass cloth of this invention can withstand repeated
     wettings from spray systems within reactor containment areas of nuclear power plants
     and can withstand temperatures of 700F for at least 40 years.

         The district court found the foregoing description of the finished glass cloth deficient in
that Pinsky did not additionally disclose that the preferred cloth was Burlington Industries‘ 603A
cloth, which was supplier/trade name information that Pinsky knew at the time of filing his
parent application.10 For the reasons set forth below, we hold that the district court committed
legal error when it resolved in this case, on summary judgment, a dispute as to a genuine issue of
material fact, namely the adequacy of Pinsky‘s disclosure. We therefore vacate this part of the
district court‘s decision and remand this issue to the district court for trial.

        B. Best Mode Requirement

        The best mode requirement does not require an inventor to disclose production details so
long as the means to carry out the invention are disclosed. This includes providing supplier/trade
name information where it is not needed, i.e., where such information would be ―mere
surplusage - an addition to the generic description.‖ Such supplier/trade name information must
be provided only when a skilled artisan could not practice the best mode of the claimed invention
absent this information. See Chemcast, 913 F.2d 923, 16 USPQ2d 1033 (patentee failed to
disclose specific composition of preferred material or fact that it possessed a specific hardness,
instead merely supplying a very general description of the material and a broad hardness range,
thus effectively concealing the best mode).

        C. Analysis

        Performance does not dispute that Pinsky believed at the time that he filed the parent
application that the use of a finished glass cloth like Burlington‘s 603A cloth constituted the best
mode of practicing the claimed invention. The first part of Chemcast‘s two-step analysis
therefore has been satisfied. Thus, the pertinent part of the Chemcast analysis at issue in this case
is the second part dealing with the adequacy of Pinsky‘s disclosure. As will be illustrated below,
there clearly existed before the district court a dispute as to the adequacy of Pinsky‘s disclosure,
and the district court improperly resolved this issue on summary judgment.

        We note at the outset that the district court concluded that ―Transco‘s motion for
summary judgment must be denied to the extent that it asserts a failure to disclose the best mode
due to an inaccurate description of the invention.‖ The district court was of the opinion that the
evidence of record, viewed in the light most favorable to Performance, adequately supported
Performance‘s position that the description of the finished glass cloth provided in the
specification would have apprised one of ordinary skill in the art at the time of filing the parent
application of the composition and the pertinent properties required for the finished glass cloth
according to the best mode of the claimed invention.

10
         As a practical matter, we note that Examiners often require that a generic description be inserted in
place of, or in addition to, a trade name, on the basis that trade names may, over time, come to represent
different things. The arguments here appear to assume that the opposite is the case.


                                                    532
         The district court concluded, however, that it was not sufficient in this particular case that
one of ordinary skill in the art would have understood the description and known what was
needed to practice the best mode. The district court reasoned that the availability to the public of
Burlington‘s 603A cloth prevented Pinsky‘s description from rising to the level of an adequate
disclosure of the best mode. In particular, the district court stated: the problem confronting
Performance Contracting is that although the skilled artisan could presumably have practiced the
art if he or she were actually furnished a product that had the characteristics set out in the generic
description, there is no showing that the mere statement of those characteristics would enable the
skilled person to replicate the fabric. Hence Pinsky‘s nondisclosure of the source for the best
mode material is the equivalent of concealment if that source was not otherwise known. The
district court believed that Chemcast and Wahl require that both a generic description and
supplier/trade name information be provided in a case such as this.

        Performance argues that the court effectively held there to be a per se rule that
supplier/trade name information be provided, when available, for a disclosure to be adequate for
purposes of the best mode requirement. We disagree. The district court correctly noted that
there is no such per se rule. Contrary to Performance‘s assertions, the district court merely held
that it believed supplier/trade name information should have been disclosed in this particular
case. Even so, the district court erred in finding on summary judgment that such commercial
information should have been provided in this particular case for Pinsky‘s disclosure to satisfy
the adequacy prong of Chemcast ‗s two-part test, as this was a fact issue highly disputed. The
record evidence before the district court included a July 24, 1992, affidavit by a Mr. Vaughn, the
director of research and development of Clark-Schwebel Fiber Glass Corp., one of the three
major suppliers of finished glass cloth in the country. Vaughn‘s affidavit states, in particular,
that ―the description ‗glass cloth having a finish of a leachable, organic silicate carried in a fatty
and mineral oil vehicle‘ that is known to meet Mil-I-24244 and CFL-164.009 is an accurate
description of glass cloth with a 603A finish‖ and is one ―that one of ordinary skill in the art of
finishes for glass cloth now, and in 1973, would understand to be a generic description of a 603A
finish.‖ (emphasis added). Vaughn‘s affidavit also states that the 603A finish ―became a
production finish on 10/13/72,‖ which is corroborated by a September 12, 1983, letter from a
Burlington attorney to Owens-Corning.

       Also of record is a February 23, 1993, affidavit by Pinsky stating in pertinent part:

    One of ordinary skill in the fiberglass cloth art in 1973 and 1974 would know that the
    generic terminology used in my patent application applied to the Burlington 603A
    finished cloth, and its equivalents. In 1973 and 1974 there were only a handful of
    significant fiberglass cloth manufacturers; the only three of any size were Burlington,
    J.P. Stevens, and Clark-Schwebel, and all three of these were well known to those
    seeking to purchase glass cloth for industrial applications.

Pinsky also testified in this affidavit, as well as in one dated July 24, 1992, that the only reason
he considered use of the 603A cloth to be the best mode of practicing his invention was because
this cloth possessed the necessary properties to comply with government specifications. Pinsky
further testified by deposition on September 12, 1991, that Burlington‘s 603A product was



                                                 533
―commercially available in 1973. You could issue a purchase order and they would sell it to
you.‖

         Rebuttal evidence included an affidavit of a Mr. Avery, the President of Transco, stating
that ―[i]n 1971-1974, I was someone skilled in the art of insulation‖ and that ―[i]n the 1971-1974
time period and continuing to this day, I, and everyone I know in this industry, save Mr. Pinsky,
have no idea (1) what a glass fabric is that has a finish of a leachable organic silicate carried in a
fatty and mineral oil vehicle and that meets U.S. Navy Specification Mil-I-24244 and
CFL-164.009 and (2) who makes and sells such a glass fabric.‖ Avery‘s affidavit also takes
specific issue with Vaughn‘s testimony. Performance counters that Avery is not technically
qualified in the art and knows nothing about finishes.

         Performance contends that, at the very least, the evidence it presented before the district
court was sufficient to preclude summary judgment. We agree. The evidence outlined above
illustrates that the district court was faced with a dispute as to a genuine issue of a material fact,
namely, the adequacy of Pinsky‘s disclosure. As discussed previously, there must be no such
disputes for summary judgment to be appropriate. Therefore, the district court committed legal
error by resolving this issue on summary judgment.

        Notwithstanding the foregoing, we feel compelled to comment on the district court‘s
concerns about the availability of the Burlington 603A cloth. The district court has imposed on
Performance not only the burden of establishing that a skilled artisan would have understood
what was needed to practice the best mode, but also the burden of establishing that the skilled
artisan could actually have replicated or obtained the material needed to practice the best mode.
Although there may be factual scenarios in which the latter burden would be reasonable, caution
should be exercised in imposing such a burden. Otherwise, such a burden ultimately evolves into
a per se rule that supplier/trade name information must be disclosed or that an application
become a production specification, a result clearly contrary to law.

        An ―inventor‘s manufacturing materials or sources or techniques used to make a device
may vary from wholly irrelevant to critical.‖ Even so, if Pinsky‘s generic description in this case
is indeed sufficient to have apprised a skilled artisan of what was needed to practice the best
mode of the invention during the relevant time period, and, if there were indeed a limited number
of sources of industrial products of the type required at that time, then it is an entirely defensible
position, if not an ultimately convincing one, that a skilled artisan could easily have procured the
necessary material to practice the invention. For the above reasons, the decision of the district
court on this issue is vacated and the case remanded for further proceedings consistent herewith.




                                                 534
                     UNITED STATES GYPSUM COMPANY
                                    v.
                       NATIONAL GYPSUM COMPANY
                       United States Court of Appeals, Federal Circuit (1996)
                                    --- F.3d ---, 1996 WL 10916

        Before LOURIE, CLEVENGER, and SCHALL, Circuit Judges.

        LOURIE, Circuit Judge.

        United States Gypsum Company (―USG‖) appeals from the decision of the United States
District Court for the Northern District of Illinois granting summary judgment of patent
invalidity in favor of National Gypsum Company.

                                           BACKGROUND

        Joint compounds are adhesives used in the construction of building walls and ceilings to
fill and coat the joints between adjacent gypsum wallboards. The patent in suit, U.S. Patent
4,454,267, assigned to USG, is directed to a lightweight joint compound.

        In 1978, Terrance L. Williams, a USG employee, conceived the idea of making a
lightweight joint compound containing silicone-treated expanded perlite.2 He began his research
efforts by preparing a joint compound containing a silicone-treated expanded perlite which had
been made by a fellow USG employee, Michael L. Bolind. The joint compound made with
Bolind‘s perlite ―worked satisfactorily‖; however, it was somewhat heavier than desired and
exhibited cracking when applied to a surface. In 1981, Williams experimented with a type of
silicone-treated expanded perlite sold by Silbrico Corporation under the name Sil-32. However,
Sil-32 perlite contained grit, which required screening to prevent ―scratching‖ on the surface of a
joint compound. Williams also investigated combinations of perlites with a lightweight filler
known as Q-Cel microspheres. The resulting joint compounds had unacceptable properties.

        A breakthrough in Williams‘ research efforts occurred in early 1982 when Silbrico
Corporation sent Williams a sample of silicone-treated expanded perlite designated as Sil-42.
Williams did not know the chemical composition of Sil-42 perlite or its method of manufacture
because Silbrico viewed that information as proprietary. He discovered, however, that because
Sil-42 perlite was made almost entirely (99%) of particles -100 mesh in size or smaller, it did not
have to be screened before use in a joint compound.3 That was a major advantage over the
Sil-32 perlite with which Williams had previously experimented. In addition, Williams found
that Sil-42 perlite eliminated the coarse look of other lightweight fillers, resisted breakdown
under vacuum treatment, and yielded a joint compound that was lightweight, easy to sand, and

2
        Perlite is a volcanic ore that contains water; when the ore is pulverized and heated it expands to
form porous, lightweight particles known as expanded perlite. According to the ‗267 patent, treating
expanded perlite with silicone renders the material water-insensitive.
3
        A fineness of 99%-100 mesh meant that 99% of the particles would pass through a 100 mesh (150
micron) screen.


                                                  535
exhibited good non-cracking and adhesion properties. He tested various grades of Sil-42 perlites
supplied to him by Silbrico and ultimately selected a particular grade of the material.4

        When it became apparent to USG that Williams had developed a lightweight joint
compound having good application properties without the need to screen the perlite, USG
decided to sell a joint compound containing Sil-42 perlite. Concurrently, USG‘s patent attorney
began preparing a patent application covering the invention. He asked Williams to forward a
description of his best formulation for inclusion in the application; all the formulations that
Williams sent to the attorney listed Sil-42 perlite as a component. Sometime before the patent
application was filed, however, a USG executive instructed the attorney to omit from the
application any reference to Sil-42 or Silbrico Corporation. Subsequently, when the application
was filed on December 20, 1982, it did not refer to Sil-42 either by chemical formula, method of
manufacture, trade name, or supplier. The ‗267 patent issued in June 1984.

         USG sued National for infringement of the ‗267 patent. National denied the allegation of
infringement and moved for summary judgment, arguing that the patent was invalid for failure to
disclose the best mode of practicing the claimed invention. The district court determined, first,
that there was no genuine dispute that Williams had a best mode of practicing the invention. In
particular, the court determined that at the time the patent application was filed Williams
preferred Sil-42 silicone-treated expanded perlite because it did not have to be screened before
use and it improved the joint compound‘s quality and performance characteristics. The court
further determined that the ‗267 specification did not inform those of ordinary skill in the art how
to make (or otherwise obtain) Sil-42 perlite, an essential component of Williams‘ preferred
formulation. Accordingly, the court granted summary judgment that the patent was invalid for
failure to satisfy the best mode requirement of 35 U.S.C. § 112 (1988). This appeal followed.

                                           DISCUSSION

       Validity - Best Mode

        On appeal, USG contends that Williams believed that any of three silicone-treated
expanded perlites (Bolind‘s perlite, Sil-32, and Sil-42) would perform equally well in a joint
compound and thus that Williams did not have a best mode of practicing the invention. National
responds that the district court correctly concluded that there was no genuine dispute that
Williams believed that Sil-42 perlite represented a substantially better material than the other
silicone-treated expanded perlites with which he had experimented. We agree with National.
National brought forward clear and convincing evidence that Williams believed that Sil-42
perlite was the best material for use in the invention. To begin with, Williams knew that Sil-42
perlite did not have to be screened before use in a joint compound and that this was a significant
advantage over other silicone-treated expanded perlites. Moreover, the record shows that
Williams believed that Sil-42 perlite eliminated the coarse look of other lightweight fillers,
resisted breakdown under vacuum better than Sil-32, and yielded a lightweight joint compound
having improved application properties.

4
        For purposes of this appeal, there were no meaningful differences between the various grades of
Sil-42 perlites. Silbrico Corporation and USG also referred to the Sil-42 perlites as ―USG-42.‖ For
simplicity we shall refer only to ―Sil-42 perlite.‖


                                                 536
        Williams‘ testimony before the district court fully supported the court‘s conclusion that
Williams had a best mode of practicing the claimed invention. Williams admitted, during
multiple depositions, that he considered Sil-42 perlite to be the best material for use in the
invention. Similarly, he stated in an affidavit that ―[a]t the time the application was filed, I
considered a perlite supplied by Silbrico under the name Sil-42 or USG 42 to be the best
commercially available perlite for use in the [claimed] lightweight joint compounds.‖ His
affidavit did not suggest, as USG contends, that Williams equally preferred Sil-32, Bolind‘s
perlite, and Sil-42. On the contrary, the affidavit stated that ―the joint compound made with
[unscreened] Sil-32 was not acceptable.‖ Likewise, the affidavit stated that Bolind‘s perlite
yielded a joint compound that ―worked satisfactorily‖; it did not state that Bolind‘s perlite
worked as well as Sil-42 perlite.

       USG argues, alternatively, that Williams did prefer Sil-42 perlite, but only for purposes
of developing a commercial product, and that Williams selected Sil-42 perlite only because it
was available in large quantities. Thus, USG contends that Sil-42 perlite was not part of the best
mode of practicing the claimed invention. In support, USG cites the following passage from
Wahl Instruments, Inc. v. Acvious, Inc., 950 F.2d 1575, 1581 (Fed.Cir.1991):

        Any process of manufacture requires the selection of specific steps and materials
    over others. The best mode does not necessarily cover each of these selections. To so
    hold would turn a patent specification into a detailed production schedule, which is not
    its function. Moreover, a requirement for routine details to be disclosed because they
    were selected as the ―best‖ for manufacturing or fabrication would lay a trap for
    patentees whenever a device has been made prior to filing for the patent.... A step or
    material or source or technique considered ―best‖ in a manufacturing circumstance may
    have been selected for a non‖best mode‖ reason, such as the manufacturing equipment
    was on hand, certain materials were available, prior relationship with supplier was
    satisfactory, or other reasons having nothing to do with development of the invention.

        We acknowledge this statement of the law. However, we cannot accept USG‘s argument
because Williams‘ selection of Sil-42 perlite was not ―a routine manufacturing choice‖ made
―because of expected volume of production‖ or ―reasons of cost.‖ Wahl Instruments, 950 F.2d at
1581. Rather, it was not genuinely disputed that Williams selected Sil-42 perlite because it did
not require screening and because it significantly improved the physical properties of the joint
compound, not just because it was available in large quantities. In short, Williams believed that
Sil-42 perlite was essential to improving the invention; the material was not selected as a matter
of commercial expediency. Disclosure concerning the best mode of practicing an invention must
be distinguished for best mode purposes from disclosure for optimum commercial production.
The former is required; the latter is not. Transco Prods., 38 F.3d at 560 (―[T]he best mode
requirement does not require an inventor to disclose production details so long as the means to
carry out the invention are disclosed.‖). Thus, we find no error in the court‘s determination that
there was no genuine issue of material fact that Williams had a best mode of practicing the
invention, namely, use of Sil-42 perlite in the claimed joint compound.




                                               537
       The question remains whether the ‗267 specification discloses Williams‘ best mode in a
way that would enable those having ordinary skill in the art to practice it. ―Assessing the
adequacy of the disclosure, as opposed to its necessity, is largely an objective inquiry that
depends upon the scope of the claimed invention and the level of skill in the art.‖ Chemcast
Corp., 913 F.2d at 928 Applying this standard, the district court held that there was no genuine
dispute that Williams did not disclose his best mode, because the ‗267 specification does not
disclose the chemical composition of Sil-42 perlite, its method of manufacture, or supplier/trade
name information.

        We agree that there was no genuine dispute that the ‗267 patent specification does not
disclose Williams‘ best mode. The specification does not provide a chemical description of
Sil-42 perlite or its method of manufacture for the simple reason that neither Williams nor
anyone else at USG knew the chemical composition or method of manufacture of Sil-42 perlite,
which were trade secrets of Silbrico Corporation. Williams cannot claim that he disclosed what
he did not know. Thus, while the specification defines perlite as a rock that ―generally contains
65-75% SiO2, 10-20% Al2O3, 2-5% H2O, and smaller amounts of soda, potash, and lime,‖ that
is not a description of Sil-42 silicone-treated expanded perlite, which consists of a proprietary
blend of perlite ores coated with an unknown silicone compound. The specification‘s use of the
term ―Silicone Treated Expanded Perlite‖ does not indicate the chemical composition of Sil-42
perlite. The specification also fails to mention Williams‘ preference that the particle
distribution/size of the silicone- treated expanded perlite be 99% -100 mesh. In addition, USG
concedes that the specification only discloses a method of making Bolind‘s perlite, not Sil-42
perlite. Disclosing a non-preferred embodiment of the invention obviously does not satisfy the
best mode requirement. That the composition and method of manufacture of Sil-42 perlite were
trade secrets and thus were unknown to Williams does not excuse compliance with the best mode
requirement. See Chemcast Corp., 913 F.2d at 930 (―Whatever the scope of Reynosol‘s asserted
trade secret, to the extent it includes information known by Rubright that he considered part of
his preferred mode, section 112 requires that he divulge it.‖).

        The specification also does not identify Sil-42 perlite by supplier or trade name. Of
course, ―supplier/trade name information must be provided only when a skilled artisan could not
practice the best mode of the claimed invention absent this information.‖ Transco Prods., 38
F.3d at 560. Here, because Williams did not know the composition or method of manufacture of
Sil-42 perlite, he was required, at a minimum, to provide supplier/trade name information in
order to satisfy the best mode requirement. See Chemcast Corp., 913 F.2d at 929 (―Because
Chemcast used only R-4467, because certain characteristics of the grommet material were
claimed elements of the ‗879 invention, and because Rubright himself did not know the formula,
composition, or method of manufacture of R-4467, section 112 obligated Rubright to disclose
the specific supplier and trade name of his preferred material.‖). Without such information,
those skilled in the art would remain ignorant of Williams‘ best mode of practicing the claimed
invention. The ‗267 specification, however, omits this information.6

6
         As a practical matter, however, even if the ‗267 specification had disclosed ―Sil-42 perlite from
Silbrico Corporation‖ the PTO may have required additional technical information. ―Examiners often
require that a generic description be inserted in place of, or in addition to, a trade name, on the basis that
trade names may, over time, come to represent different things.‖ Transco Prods. Inc. v. Performance
Contracting, Inc., 38 F.3d 551, 559 n. 10 (Fed.Cir.1994). The PTO permits a trade name to be used in a


                                                    538
         USG contends, nonetheless, that those of ordinary skill in the art would have known how
to obtain -100 mesh silicone-treated expanded perlite because Sil-42 perlite was commercially
available. The evidence indicates, however, that the material was not well-known in the art in
December 1982. For instance, William Forte, a former manager in National‘s joint treatment
group, testified that at the time of his retirement in 1983 he knew of no source of -100 mesh
perlite. USG brought forth no contrary evidence. Moreover, there were qualities of Sil-42 apart
from its fineness that led Williams to consider it his best mode. Sil-42 perlite resisted breakdown
under vacuum treatment and yielded a joint compound that was lightweight, easy to sand, and
which exhibited good non- cracking and adhesion properties.

        More fundamentally, even though Sil-42 perlite was sold commercially, the ‗267
specification does not disclose it and, at the time the ‗267 application was filed, no one in the art
except Williams and USG knew that Sil-42 perlite should be used in a joint compound. Section
112 requires that the specification ―set forth the best mode,‖ if one exists at the time a patent
application is filed, so that those having ordinary skill in the art may practice that best mode.
Williams had to inform the public of his best mode of practicing the invention in order to obtain
valid patent claims. He failed to do so.

        USG further argues that those skilled in the art could have identified the nature of
Williams‘ best mode embodiment by examining USG‘s commercial product. We reject this
argument. USG cannot cure its failure to disclose the best mode of practicing the invention at
the time the application was filed by later selling a commercial product embodying the invention.
Compliance with § 112 cannot depend on whether a patentee later commercializes the invention.
Moreover, those skilled in the art should not have to reverse-engineer USG‘s product; the ‗267
specification should have informed them of Williams‘ best mode of practicing the claimed
invention.

         Finally, USG argues that there can be no best mode violation absent an intent to conceal,
and that Williams had no such intent. This argument is unpersuasive. Although it has been said
that ―[i]nvalidity for violation of the best mode requires intentional concealment of a better mode
than was disclosed,‖ the rule is not so limited. A best mode violation may occur if the disclosure
of the best mode is so objectively inadequate as to effectively conceal the best mode from the
public.

       The ―concealment‖ language of our case law originated in In re Gay, 309 F.2d 769
(CCPA 1962). In Gay, the Court of Customs and Patent Appeals (CCPA) explained that ―the
sole purpose of [the best mode] requirement is to restrain inventors from applying for patents
while at the same time concealing from the public preferred embodiments of their inventions
which they have in fact conceived.‖ Subsequently, the CCPA clarified that ―only evidence of
concealment (whether accidental or intentional) is to be considered. That evidence, in order to

patent specification only if (1) the specification also contains a generic definition of the trade name, i.e., one
that is ―sufficiently precise and definite to be made a part of a claim,‖ or (2) the trade name‘s meaning is
well-known and defined in the literature. Manual of Patent Examining Procedure § 608.01(v). Because the
composition of Sil-42 perlite was not defined in the literature (it was a trade secret) or disclosed in the ‗267
specification, supplier/trade name information alone may not have satisfied the PTO‘s guidelines.


                                                      539
result in affirmance of a best mode rejection, must tend to show that the quality of an applicant‘s
best mode disclosure is so poor as to effectively result in concealment.‖ In re Sherwood, 613
F.2d 809, 816 (CCPA 1980). We consider Sherwood to be binding precedent, and that, by its
reference to ―accidental‖ concealment, it holds that failure to find intentional concealment does
not preclude a finding that the best mode requirement has been violated. We also note that the
second inquiry concerning best mode compliance is an objective one, relating to whether the
inventor effectively enabled his best mode of practicing the claimed invention. Inquiry into an
intent to conceal, being subjective, is inconsistent with the objective nature of the second aspect
of best mode compliance. It is not part of that analysis.8

        Thus, the district court did not need to determine that Williams intentionally concealed
his best mode of practicing the claimed invention. Rather, it was sufficient that the court held
that there was no genuine dispute that the ‗267 specification did not adequately disclose
Williams‘ best mode in a way that would allow those of ordinary skill in the art to practice it.
The court determined that the best mode had been effectively concealed. This analysis was
consistent with our precedent.

        The district court held that when the evidence was viewed in the light most favorable to
USG, as required on summary judgment, the evidence pointed in only one direction: Williams
had a best mode of practicing the claimed invention, use of Sil-42 perlite, which was not
adequately disclosed in the ‗267 specification. Having carefully reviewed the record and the
parties‘ arguments, we fully agree with the court‘s conclusion. We therefore hold that the court
did not err in determining that there was no genuine issue of material fact precluding summary
judgment that all claims of the ‗267 patent are invalid.




8
       In addition, we note that intentional concealment of a best mode coupled with disclosure of a false
mode of practicing an invention may constitute inequitable conduct rendering a patent unenforceable.


                                                  540
                         ROBOTIC VISION SYSTEMS, INC.
                                      v.
                           VIEW ENGINEERING, INC.
                      United States Court of Appeals, Federal Circuit, 1997
                              112 F.3d 1163) 42 U.S.P.Q.2d 1619


       Before LOURIE, CLEVENGER, and RADER, Circuit Judges.

       LOURIE, Circuit Judge.

        Robotic Vision Systems, Inc. appeals from the summary judgment of the United States
District Court for the Central District of California holding that U.S. Patent 5,463,227 is invalid
on the grounds of failure to disclose the best mode of carrying out the invention and violation of
the on-sale bar. Because the district court erred in holding that the patent is invalid on the
grounds of failure to comply with the best mode requirement ... we reverse-in-part,
vacate-in-part, and remand.
                                           DISCUSSION

       A. Best Mode

        Robotic argues that summary judgment was inappropriate because there were genuine
issues of material fact concerning whether the specific software program used by Robotic was
necessary for successfully carrying out the invention and therefore had to have been disclosed.
Robotic argues that the court erred in concluding that software was the best mode known to the
inventors of carrying out the invention. View responds that the inventors had a best mode, the
nature of which they failed to disclose, and that that best mode included software. Robotic also
argues that, since software is not part of the claims, it need not have disclosed software to satisfy
the best mode requirement. In any event, Robotic argues that the specification is adequate to
lead one of ordinary skill in the art to use software in the invention. View responds that no
amount of skill in the art can overcome the lack of disclosure.

        We conclude that there is no genuine issue of material fact regarding the best mode and
that the specification is not deficient concerning the disclosure of the best mode. As noted, the
requirement to disclose the best mode of carrying out one‘s invention is statutory and one does
not usually meet a statutory requirement for disclosure with silence. While a disclosure
necessary to meet a statutory requirement is to be understood from the standpoint of one skilled
in the relevant art, a certain basic disclosure is needed of the best mode. Cf. Genentech, Inc. v.
Novo Nordisk, A/S, 108 F.3d 1361, 1366-67 (Fed.Cir.1997) (stating that the knowledge of one
skilled in the art may supplement a disclosure for purposes of satisfying the enablement
requirement, but it is ―not a substitute for a basic enabling disclosure‖). Even an only mode must
be disclosed, expressly or implicitly. Moreover, the fact that the use of software or a computer is
not mentioned in the claims of the Robotic patent does not, contrary to Robotic‘s argument,
exempt such use from the requirements of a best mode disclosure, since carrying out the
invention usually involves more than what is expressly claimed.



                                                541
        On the other hand, the inventors in this case disclosed a device for carrying out their
method, and it is plainly apparent that a computer, operating under software control, is to be
interfaced to the device for controlling the movement of the sensor. Something must be
connected to the device for providing control signals to the motors and for receiving information
from the linear encoders concerning a position of the sensor, and there is no dispute that that
something is a computer.

        The facts support the conclusion that software is to be used. William Yonescu, one of the
named inventors, averred in an affidavit that, as of the filing date of the patent, he and the other
inventors knew of no mode other than what was described in the specification. View cites a
different portion of the same affidavit, in which Yonescu averred that, other than the software
code developed to implement the invention, he and the other inventors ―did not know of any
other software program, code, or other mode which existed as of June 24, 1992, that was useful
to carry out the mode disclosed in the specification of the ‗227 patent.‖ View interprets this
statement as an admission that at least two modes existed, the mode disclosed in the patent and
the mode consisting of software, but we do not consider that this statement raises a genuine issue
of fact. It is not an admission. It simply states that a software program was the only means
contemplated of carrying out the invention. From the record before us, it is clear that a software
program was involved in the carrying out of the invention and that no other mode existed.

        Moreover, as asserted by Robotic, it would have been apparent to one skilled in the art,
knowing that software was used in the prior art system, to use software for implementing the
improved scanning method claimed in the patent. Yonescu averred that: ―A person of ordinary
skill in the art to which the ‗227 patent pertains would know and understand that software is
needed to perform the patented method. The details of such software would also be within the
skill of a person of ordinary skill in the art to which the ‗227 patent pertains.‖ View has not
provided a basis for concluding that Yonescu‘s assertions are not correct. Thus, one cannot
conclude that a person skilled in the art would not have known that software was the best mode
of carrying out the invention and how to implement it. The patent cannot be held to fail to
comply with the best mode requirement for lack of the word ―software,‖ the use of which was
plainly apparent to one skilled in the art. Such a disclosure was implicit in the specification.

        Finally, it has not been shown that there is a genuine issue as to whether one skilled in the
art would have known how to create specific source code for this purpose. We have previously
held in Hayes and in Fonar (after the district court decided this case) that when disclosure of
software is required, it is generally sufficient if the functions of the software are disclosed, it
usually being the case that creation of the specific source code is within the skill of the art. The
functions that a software program would instruct the computer to perform for controlling the
machine are readily apparent from the specification of the patent at issue here, which describes
the scan paths and parameters for full-tray scanning. View has not presented any evidence to
controvert Robotic‘s assertion that one skilled in the art could generate the necessary software
program to implement the disclosed functions. We therefore must conclude that the district court
erred in granting summary judgment to View that the ‗227 patent is invalid for failure to disclose
the best mode.




                                                542
Jerry R. Selinger, IN DEFENSE OF ―BEST MODE‖: PRESERVING THE BENEFIT OF THE
BARGAIN FOR THE PUBLIC, 43 Cath. U. L. Rev. 1071, (Summer, 1994) [Most footnotes and
substantial portions of the text have been omitted.]

         Recently, several groups have attacked the best mode concept. One of the more
    influential critics is the 1990 Advisory Commission on Patent Law Reform to the Secretary
    of Commerce (Advisory Commission).1 The Advisory Commission issued its report in
    August 1992 (1992 Report), recommending, inter alia, that best mode be eliminated,
    ostensibly to reduce the cost and complexity of patent enforcement. Enablement alone, it
    suggests, can sufficiently educate the public by providing complete and honest disclosure
    of the patented invention.2

                                                    ***

         Clearly, if the statutory best mode obligation is repealed, the public will no longer
    receive the benefit of the additional disclosure compelled by best mode. There are several
    cases in which patentees have satisfied the enabling obligation, while still concealing
    relevant information. Even with the present statutory best mode disclosure requirement,
    applicants sometimes withhold important technical details to which the public is entitled.
    Inventors realistically will not disclose more than they are absolutely required to divulge.
    Without a best mode obligation, enablement will establish both the upper and lower
    boundaries of disclosure. The Advisory Commission‘s reasons for eliminating best mode
    and the supposed benefits to be derived therefrom must be weighed against the definable,
    if not quantifiable, loss of information that the public will suffer.

    A. Voodoo Economics?

         The Advisory Commission Report proceeds from the premise that ―challenges to
    patent validity which create a disproportionate effect on costs and delays during patent
    litigation without providing a corresponding public benefit‖ should be eliminated. Best
    mode, it argues, creates such undue cost and delay and should therefore be eliminated. The
    Advisory Commission ostensibly uses a cost-benefit analysis, which balances the
    availability of certain infringement defenses against additional litigation costs and
    increased uncertainty in patent rights. Yet the Advisory Commission concedes ―that the

1
         The American Bar Association Section of Patent, Trademark and Copyright Law also criticized best
mode, proposing that the statutory provision be limited to require only disclosure of the best mode of what is
actually claimed. The following year, the American Bar Association Section on Intellectual Property Law
passed a resolution at the 1992 annual meeting, which states that the section opposes in principle the
elimination of the best mode requirement.
2
         The Advisory Commission compares the United States‘ requirements with disclosure obligations in
Japan and Germany, which do not require disclosure of best mode. ―Despite the absence of a ‗best mode‘
requirement,‖ it argues, ―there are no general concerns over the quality of the German or Japanese patent
disclosures.‖ But see J. Philip Anderegg, The Best Mode Requirement of 35 U.S.C. Section 112, 1978 Am.
Patent L. Ass‘n Q.J. 219, 219 (contending that best mode will become more significant internationally as
developing countries complain that foreign companies are providing insufficient disclosure in exchange for
patent protection).


                                                    543
right to challenge a patent on the grounds that it was improperly granted is a basic element
of the patent system.‖

     The Advisory Commission‘s economic attack on best mode begins with the accurate
premise that during patent examinations, some patentability requirements are never
considered. The Patent and Trademark Office independently evaluates only a few
statutory obligations. It accepts the appearance of satisfactory compliance with certain
important obligations without additional inquiry.

     Failure to comply with best mode is not something an examiner normally can evaluate
when reviewing the application and that failure (or concealment) is not under any
circumstance easily detected.

     Hypothetically, an applicant who wishes to protect information as a trade secret could
inform the examiner that a specific formulation is being withheld as a trade secret but that
the applicant seeks to satisfy the best mode obligation by disclosing a generic formula.
The patent examiner possibly could determine whether the applicant has complied with the
best mode obligation. The Advisory Commission correctly recognizes that, in reality, this
simply does not occur. Best mode is not normally examined during the patent solicitation
process; compliance is presumed.

     The Advisory Commission‘s conclusion that best mode should be abolished because it
is not considered during examination, however, is not logically derived. If the Patent
Office is not adequately equipped to determine best mode compliance, then it does not
follow that best mode should be eliminated. Instead, courts must be empowered to review
patents for compliance. The alternative solution suggested by the Advisory Commission
Report - eliminating the disclosure obligation - does not sufficiently account for the
consequences to the public.

      The Advisory Commission suggests that because best mode is not reviewed by the
Patent Office, the parties often use ―extensive efforts and uncontrolled discovery‖ before
trial. While patent litigation is usually expensive, no evidence indicates that litigation
costs are materially increased by disputes over best mode. Analysis of best mode
compliance is based on the inventor‘s state of mind at the time the patent application is
filed. This analysis is initially a subjective question. The inventor‘s state of mind,
however, will be relevant during discovery regardless of whether best mode compliance is
contested. Parties almost invariably depose inventors in patent litigation. The inventor‘s
development efforts are scrutinized for numerous reasons. These reasons typically include:
to determine whether the invention may have been derived from another; to identify
whether there has been an error in inventorship; to test assertions that the claimed subject
matter has achieved commercial success; to identify any difficulties a patentee may have
experienced in commercializing the claimed invention, which may bear on the issue of
enabling disclosure; and to gather relevant information about whether the claimed subject
matter was unobvious.




                                            544
         Even in the absence of a best mode dispute, routine discovery in patent litigation will
    almost inevitably encompass facts pertinent to best mode analysis. Therefore, if best mode
    is repealed, no material cost saving will be achieved during discovery. The degree of
    evidentiary overlap among various commonly disputed patent issues at trial removes any
    realistic possibility that trials could be shortened by eliminating best mode.

        B. The Postulated Countervailing Policy Considerations

        The Advisory Commission also speculates as to whether the best mode requirement
    actually achieves its intended purpose of promoting full and fair disclosure. Even
    assuming that best mode does achieve this goal, through its cost-benefit analysis, the
    Advisory Commission cautions that ―it is questionable whether the costs of the best mode
    requirement outweigh any benefit gained from the additional disclosure.‖

         The costs on which the Advisory Commission focuses, however, are illusory. It
    considers associated costs that arise whenever a patent is held invalid. Yet the public also
    receives the concomitant benefit of the right to make, use and sell without fear of suit when
    an improvidently-granted patent is declared invalid. The Advisory Commission apparently
    ignores this public benefit. More significantly, the Advisory Commission also ignores the
    issue of basic fairness. If it is fair to invalidate patents for reasons such as obviousness or
    prior invention by another where both the applicant and the Patent Office have acted open
    and honestly, is it any less fair to reward those who conceal best mode by eliminating that
    statutory obligation?

         It is clear that patents may be declared invalid because of the existence of prior art that
    is ―better‖ than that which the Patent Office examined during its limited ex parte review.
    In that situation, both the government and the patentee have acted in good faith.
    Nevertheless, when the patent is issued, the public learns about subject matter that might
    otherwise have been maintained as a trade secret. The patentee ultimately receives nothing
    once the patent is held to be invalid. Conversely, when an inventor intentionally conceals
    the best mode of his invention, the public does not receive the full benefit of its bargain.
    The patentee nevertheless enjoys exclusionary rights over the patented invention even
    though he has not acted in good faith. Accordingly, it is less costly to the public and no
    more costly to a patent owner if a patent is invalidated because of best mode
    noncompliance than if a patent is held invalid on some other ground.1

        The Advisory Commission also postulates that best mode is not necessary to ensure
    the full and fair disclosure of patented inventions. This conclusion is belied by two
    hundred years of legislative and judicial pronouncements. Clear, strong policy reasons

1
          The Advisory Commission suggests that the best mode obligation is discriminatory against United
States inventors, finding no cases in which a foreign patent has been invalidated for failure to comply with
best mode. This, perhaps, is due to the difficulty in obtaining disclosure from foreign inventors because of
restrictions on discovery outside of the United States. Discovery abroad, however, is not completely
unobtainable. See Hague Convention on the Taking of Evidence Abroad in Civil or Commercial Matters.
More significantly, United States courts require that foreign inventors be made available for reasonable
discovery when their employer asserts a United States patent in a United States court.


                                                   545
    exist as to why our country requires both enabling disclosure and disclosure of an
    inventor‘s best mode. Seeking to justify its premise, the Advisory Commission suggests
    that ―there are substantive deterrents to concealment of useful or material information in
    patent documents.‖ One such deterrent is said to be the doctrine of inequitable conduct.1
    Inequitable conduct relates to how the inventor and patent counsel conduct themselves
    during negotiations with the Patent Office, normally after the application has been filed. A
    finding of inequitable conduct requires a misrepresentation that is material to the
    examination process. While a material misrepresentation is an essential element of
    inequitable conduct, the essence of non-compliance with best mode is concealment rather
    than overt misrepresentation. Inequitable conduct would not inhibit an inventor from
    disclosing a second-best mode. Consequently, reliance on inequitable conduct has
    not - and will not- protect the important public policies embodied in the best mode
    requirement.2

         Enablement also differs from best mode in that compliance with enablement
    inherently does not compel disclosure of the best mode. For an enablement analysis, a
    court makes an objective determination as to whether a hypothetical person skilled in the
    art could practice the invention. A factfinder need not consider whether the inventor
    intended to deceive or mislead, so long as the patent specification is enabling. Invalidity
    for failure to provide an enabling disclosure is not an effective alternative either.

         The Advisory Commission concludes that best mode ―does not effectively compel
    higher quality disclosures.‖ To the contrary, the fear of having a patent invalidated for
    failure to comply with this obligation effectively compels higher quality disclosures. 3
    Prudent inventors and patent counsel are obviously taking the best mode obligation
    seriously. Eliminating the best mode disclosure obligation would actively discourage full
    and forthright patent application disclosures.

IS "BEST MODE" AN IMPOTENT REQUIREMENT?

       All countries outside the US allow enablement of "the best mode contemplated for
    carrying out the invention" to be kept secret and not required to be disclosed in
    patents. Thus, for example the questionable Australian patent may disclose and claim
    broadly the recipe, but omit and keep secret e.g. critical concentrations of
    ingredients. The shame is that examination of US applications do not extend to

1
         Interestingly, the Advisory Commission proposes that the inequitable conduct defense be curtailed.
2
         The Advisory Commission also suggests that concealment places a patent applicant at risk from
later innovators who discover and then patent the superior method. In fact, the concealed mode usually is
marketed, even though it is not disclosed in the patent.
3
         The Commission‘s recognition that the number of best mode challenges has risen over the past 20
years supports this conclusion.
         The Advisory Commission justifies the repeal of best mode because, in its current form, it is only a
recent disclosure obligation. It explains that the pre-1952 requirement was far more restricted in
application. Id. However, without repeating the detailed discussion provided earlier in this Article, it is
apparent that best mode has long been a statutory obligation. Whatever the reasons for the relatively few
reported litigation cases involving a best mode defense prior to 1960, such reasons hardly justify termination
of that important disclosure obligation.


                                                    546
    examiners querying disclosures which obviously omit disclosure of the best
    mode. Therefore, many invalid U.S. patents issue with the "best mode" disclosure
    missing. Among these are many foreign originated patents that are invalid, because they
    were not modified to include the best mode in the foreign application which did not include
    it.

       It is too bad that the CAFC eroded the best mode requirement, with its ill considered,
    arbitrary decisions, such as the one which dispensed with the inclusion of the best mode
    that was "contemplated" at the US filing date, thus eliminated the need to update foreign
    applications with the best mode at the US filing date, and in its notorious Glaxo decision in
    which it dispensed with the need to include the best mode when in an industrial entity the
    patent details were developed not by the inventor, but another department in the same
    company in which the inventor was also present. Even worse, our US Patent Office in its
    subservient mode agreed in writing with foreign interests that want to keep their
    inventions' best mode secret, to strive for the elimination of the US statute that now
    requires inclusion of the best mode. 1



G.      Inequitable Conduct - Fraud on the Patent Office
Introduction#
         Applicants for patents - and their attorneys - owe the Patent Office a duty of candor, good
faith, and honesty which necessitates a fair and full disclosure of material information relating to the
patentability of the invention in question. A violation of this duty is both a breach of the
attorney’s professional responsibility and a basis for baring enforcement of an otherwise valid
patent. Inequitable conduct may consist of an affirmative misrepresentation, a misleading
statement, or an omission of material information. To be guilty of a breach of the duty of candor,
the patent applicant must have had some culpable state of mind with respect to a misrepresentation
or omission. A good faith mistake does not constitute fraud or inequitable conduct. Breach of the
duty of candor through fraudulent conduct renders the patent unenforceable and may subject the
patent owner to other liabilities.

         The party making the charge of fraud or inequitable conduct in the procurement of a patent
bears the burden of proof. To prevail in a claim of inequitable conduct, a party must prove by clear
and convincing evidence both that the prior art withheld from the PTO was material and that
plaintiffs and/or their patent counsel manifested a deceptive intent to withhold such matter. Issues
relating to fraud and inequitable conduct are questions of fact.

        A culpable act of fraud or inequitable conduct in the procurement of a patent may consist of
a misrepresentation, a misleading statement, or even an omission. The areas of particular concern
are: (1) the statutory oath of inventorship, particularly as it relates to the question of prior public use
by the inventor or his assignee; (2) the citation of the known relevant prior art; (3) the use of

1
       Comment from Australian patent attorney. Source: PATNEWS (on line) 7/16/2003
2
       Based in part on STRYKER CORPORATION V. INTERMEDICS ORTHOPEDICS, INC., 148 F.R.D. 493
(E.D.N.Y. 1993)(Orenstein, U.S. Magistrate).


                                                   547
affidavits concerning the date of invention; and (4) the use of affidavits presenting factual evidence
on patentability. ―[I]f an applicant withholds material information from the PTO with the intent to
affect the allowance of claims, the applicant may be found guilty of inequitable conduct.‖
LaBounty Mfg., Inc., 958 F.2d at 1070. ―An equitable judgment must be made that, in light of all
the particular circumstances, the conduct of the patentee is so culpable that its patent should not be
enforced.‖ Id.

       The C.A.F.C. has cautioned that

    inequitable conduct‘ is not, or should not be, a magic incantation to be asserted against
    every patentee. Nor is that allegation established upon a mere showing that art or
    information having some degree of materiality was not disclosed. To be guilty of
    inequitable conduct, one must have intended to act inequitably. Thus, one who alleges a
    ‗failure to disclose‘ form of inequitable conduct must offer clear and convincing proof of:
    (1) prior art or information that is material; (2) knowledge chargeable to applicant of that
    prior art or information and of its materiality; and (3) failure of the applicant to disclose
    the [prior] art or information resulting from an intent to mislead the PTO. That proof may
    be rebutted by a showing that: (a) the prior art or information was not material (e.g.,
    because it is less pertinent than or merely cumulative with prior art or information cited to
    or by the PTO); (b) if the prior art or information was material, a showing that applicant
    did not know of that art or information; (c) if applicant did know of that art or information,
    a showing that applicant did not know of its materiality; (d) a showing that applicant‘s
    failure to disclose art or information did not result from an intent to mislead the PTO.
    Thus, a balancing of overlapping considerations is involved in determining, in view of all
    the circumstances, the presence or absence of inequitable conduct. The level of materiality
    may be high or low. Applicant must be chargeable with knowledge of the existence of the
    prior art or information, for it is impossible to disclose the unknown [citations omitted].
    Similarly, an applicant must be chargeable with knowledge of the materiality of the art or
    information ... [or] it may be found that the applicant ‗should have known‘ of that
    materiality.

FMC Corp. v. Manitowoc Co., 835 F.2d 1411, 1415 (Fed.Cir. 1987)

        A determination of ―inequitable conduct‖ requires a two-step analysis. The trial court must
first determine if the alleged non-disclosure or false information has a threshold degree of
materiality. The court then must determine whether there was an intent to deceive or gross
negligence. However, a finding of gross negligence, by itself, does not justify an inference of intent
to deceive; ―the involved conduct, viewed in light of all the evidence, including evidence indicative
of good faith, must indicate sufficient culpability to require a finding of intent to deceive.‖
Kingsdown Medical Consultants v. Hollister, Inc., 863 F.2d 867, 876 (Fed.Cir.1988). The
defendant has the burden of proving both elements by a clear and convincing standard.

Materiality




                                                 548
         Former Patent Office rule 56 1 defined information as being material ―where there is a
substantial likelihood that a reasonable examiner would consider it important in deciding whether to
allow the application to issue as a patent.‖ The Federal Circuit noted that the PTO Rule was ―an
appropriate starting point for any discussion of materiality, for it appears to be the broadest ... and
because that materiality boundary most closely aligns with how one ought to conduct business with
the PTO.‖ American Hoist & Derrick Co. v. Sowa & Sons Inc., 725 F.2d 1350, 1363 (Fed.Cir.
1984). The ―Old Rule‖ provided that information was material if ―there is a substantial likelihood
that a reasonable examiner would consider it important in deciding whether to allow the application
to issue as a patent.‖ Under this standard, an applicant need not disclose all relevant prior art. The
applicant need not disclose prior art which is less material, or merely cumulative to that considered
by the examiner. To be material, a misrepresentation need not be relied on by the examiner in
deciding to allow the patent.

The current Rule# – not binding on the courts – seems less rigorous as it requires that the non-
disclosed information to would have created a prima facie case of nonpatentability.

1
         Old Rule 56(a) provided that applicants and their attorneys must ―disclose to the [PTO] information
they are aware of which is material to the examination of the application.‖ This duty has been held to be
equally applicable to foreign practioners who represent claims in the PTO through local firms. Gemveto
Jewelry Co. v. Lamber Bros., Inc. 542 F.Supp. 933, 943 (S.D.N.Y. 1982). A revised Rule 56 became
effective on March 16, 1992.
#
     37 CFR § 1.56
Rule 56 Duty to disclose information material to patentability.
 (a) A patent by its very nature is affected with a public interest. The public interest is best served, and
the most effective patent examination occurs when, at the time an application is being examined, the
Office is aware of and evaluates the teachings of all information material to patentability. Each individual
associated with the filing and prosecution of a patent application has a duty of candor and good faith in
dealing with the Office, which includes a duty to disclose to the Office all information known to that
individual to be material to patentability as defined in this section. The duty to disclose information
exists with respect to each pending claim until the claim is cancelled or withdrawn from consideration, or
the application becomes abandoned. Information material to the patentability of a claim that is cancelled
or withdrawn from consideration need not be submitted if the information is not material to the
patentability of any claim remaining under consideration in the application. There is no duty to submit
information which is not material to the patentability of any existing claim. The duty to disclose all
information known to be material to patentability is deemed to be satisfied if all information known to be
material to patentability of any claim issued in a patent was cited by the Office or submitted to the Office
in the manner prescribed by §§ 1.97(b)-(d) and 1.98. However, no patent will be granted on an
application in connection with which fraud on the Office was practiced or attempted or the duty of
disclosure was violated through bad faith or intentional misconduct. The Office encourages applicants to
carefully examine:
 (1) prior art cited in search reports of a foreign patent office in a counterpart application, and
 (2) the closest information over which individuals associated with the filing or prosecution of a patent
application believe any pending claim patentably defines, to make sure that any material information
contained therein is disclosed to the Office.

 (b) Under this section, information is material to patentability when it is not cumulative to information
already of record or being made of record in the application, and
 (1) It establishes, by itself or in combination with other information, a prima facie case of unpatentability
of a claim; or


                                                    549
Intent to Deceive
        ―An applicant‘s conduct in its entirety must ‗manifests a sufficiently culpable state of mind
to warrant a determination that it was inequitable.‘‖ Halliburton Co. v. Schlumberger Technology
Corp., 925 F.2d 1435, 1443 (Fed.Cir.1991). ―Direct proof of wrongful intent is rarely available but
may be inferred from clear and convincing evidence of the surrounding circumstances.‖ LaBounty,
958 F.2d at 1076; see Klein v. Peterson, 866 F.2d 412, 415 (Fed.Cir. 1989) (―circumstantial
evidence may permit an inference of intent‖). Intent is most often proven by ‗a showing of acts the
natural consequences of which are presumably intended by the actor. However, knowledge alone of
the prior art is not culpable intent, nor does a finding of gross negligence alone justify an inference
of intent to deceive. Instead, the Court must view the conduct in light of the totality of the
circumstances, ―including the nature and level of culpability of the conduct and the absence or
presence of affirmative evidence of good faith.‖ Kingsdown Medical Consultants, Ltd. v. Hollister,
Inc., 863 F.2d 867, 876 (Fed.Cir.1988) (in banc). Because direct evidence of an intent to deceive
rarely exists, the Court may rely on circumstantial evidence leading to an inference of intent to
mislead as the basis for a finding of inequitable conduct.

        An applicant may breach the duty of candor by failing to disclose a specific item of prior art
which the applicant knows to be more relevant than the prior art cited and considered by the patent
examiner. Yet, even under the broadest view of the duty to disclose prior art, the applicant does not
commit inequitable conduct by failing to cite art of which the applicant has no knowledge or which
the applicant believes in good faith to be less relevant than that expressly considered by the PTO.


(2) It refutes, or is inconsistent with, a position the applicant takes in:
(i) Opposing an argument of unpatentability relied on by the Office, or
(ii) Asserting an argument of patentability.

A prima facie case of unpatentability is established when the information compels a conclusion that a
claim is unpatentable under the preponderance of evidence, burden-of-proof standard, giving each term in
the claim its broadest reasonable construction consistent with the specification, and before any
consideration is given to evidence which may be submitted in an attempt to establish a contrary
conclusion of patentability.

 (c) Individuals associated with the filing or prosecution of a patent application within the meaning of this
section are:
 (1) Each inventor named in the application;
 (2) Each attorney or agent who prepares or prosecutes the application; and
 (3) Every other person who is substantively involved in the preparation or prosecution of the application
and who is associated with the inventor, with the assignee or with anyone to whom there is an obligation
to assign the application.
 (d) Individuals other than the attorney, agent or inventor may comply with this section by disclosing
information to the attorney, agent, or inventor.
 (e) In any continuation-in-part application, the duty under this section includes the duty to disclose to the
Office all information known to the person to be material to patentability, as defined in paragraph (b) of
this section, which became available between the filing date of the prior application and the national or
PCT international filing date of the continuation-in-part application.



                                                     550
        Once the thresholds of materiality and intent are established, the Court must balance them to
determine whether the equities in the case warrant a conclusion that inequitable conduct occurred:
materiality and intent are inversely related - ―the more material the omission, the less culpable the
intent required, and vice versa.‖ Halliburton Co. v. Schlumberger Technology Corp., 925 F.2d
1435 (Fed.Cir.1991).


Right to a Jury Trial on Inequitable Conduct
        While conceding that ―a number of Supreme Court cases‖ seem to suggest that inequitable
conduct is an issue to be resolved by a jury, see, e.g., Poller v. Columbia Broadcasting Sys. Inc., 368
U.S. 464, 473 (1962) and White Motor Co. v. United States, 372 U.S. 253, 259 (1963), the Federal
Circuit concluded, without any elaboration or explanation, that ―on closer analysis‖ the Supreme
Court decisions ―have no applicability in the context of an equitable defense.‖ The Federal Circuit
held that as inequitable conduct in a patent suit is ―entirely equitable in nature,‖ is not an issue for a
jury to decide:

    As this court held upon extensive analysis in Gardco Mfg., Inc, v. Herst Lighting Co, 820
    F.2d 1209, 1211-13 (Fed. Cir.1987), the decision respecting inequitable conduct is a
    discretionary decision to be made by the judge on his or her own factual findings. Thus, a
    disputed finding of intent to mislead or to deceive is one for the judge to resolve, not the
    jury, albeit not on summary judgment if there is a genuine dispute. A patentee has no right
    to a jury trial respecting the factual element of culpable intent as part of the defense of
    inequitable conduct.
Paragon Podiatry Laboratory, Inc. v. KLM Laboratories, Inc., 25 U.S.P.Q.2D 1561 (Fed. Cir. 1993).


 APTIX CORPORATION v. QUICKTURN DESIGN SYSTEMS, INC.
                    United States Court of Appeals for the Federal Circuit 2001
                                          269 F.3d 1369


Before MAYER, Chief Judge, RADER, and LINN, Circuit Judges.

RADER, Circuit Judge.

 On June 14, 2000, the United States District Court for the Northern District of California
dismissed the patent infringement complaint of Aptix Corporation and Meta Systems, Inc., after
ruling that Aptix's United States Patent No. 5,544,069 ('069 patent) is unenforceable. The trial
court refused to enforce the '069 patent because Aptix submitted falsified engineering notebooks
to the court.

                                                    I.




                                                  551
 Dr. Amr Mohsen, the founder, chairman, and chief executive officer of Aptix, is the sole
inventor of the '069 patent. The '069 patent discloses and claims "field programmable" circuit
boards that permit computer programmers to reconfigure the electronic components of an
integrated circuit. Dr. Mohsen filed a patent application on September 20, 1989. The United
Stated Patent Office issued the '069 patent on August 6, 1996.

 Aptix licensed the '069 patent to Meta and Mentor Graphics Corporation, granting Meta the
right to sue to enforce the patent in San Jose, California, where Quickturn Design Systems, Inc.
is located. Under the agreement, Mentor agreed to advance Aptix the cost of enforcing the '069
patent against Quickturn. On February 26, 1998, Aptix and Meta jointly sued Quickturn for
infringement of the '069 patent. Quickturn asserted counterclaims and added Mentor as a
counterclaim defendant.

 The local rules for the Northern District of California require patentees to disclose a date of
conception for each asserted claim. N.D. Cal. Civ. L.R. 16- 7(b)(3) (1998). On April 13, 1998,
Aptix submitted to the court seventeen pages of Dr. Mohsen's alleged 1989 notebook as an initial
proffer of a conception date. On April 18, 1998, Dr. Mohsen advised Aptix's counsel that he
found another of his engineering notebooks, allegedly started in 1988. Relying on the 1988
notebook, Aptix and Meta listed July 31, 1988, as the date of conception for all asserted claims.
Without this earlier notebook, Aptix later conceded, it would "have a hard row to hoe to avoid
invalidating prior art." Aptix Corp. v. Quickturn Design Sys., No. 98-00762, 2000 WL 852813,
at *23 (N.D.Cal. June 14, 2000).

 During discovery, Quickturn obtained a copy of a number of pages from a 1989 notebook that
Dr. Mohsen had provided to Skjerven, Morrill, MacPherson, Franklin & Friel, patent counsel
during prosecution of the '069 patent. Quickturn noticed substantial differences between this
copy and the purported 1989 notebook Dr. Mohsen first supplied the court. The submission to
the court contained extensive text and diagram additions not found in the version of the 1989
notebook obtained from Skjerven. When asked about these discrepancies in his deposition, Dr.
Mohsen conceded that he added material to his notebooks after they had been signed.

 During discovery, Aptix produced still another notebook, the "Ink On Photocopy" version of the
1989 notebook. This version of the 1989 notebook contained Dr. Mohsen's handwritten
additions to the photocopied entries of an earlier version of the 1989 notebook. The trial court
determined that the Ink- On-Photocopy version was a "dry run" for Dr. Mohsen's fabrications.
Once Dr. Mohsen had inked new material onto the rudimentary photocopied version, according
to the district court, he inserted pages of the Ink-On-Photocopy version underneath the
corresponding pages of the 1989 notebook to assist as a copying template. Forensic evidence
showed that the Ink On Photocopy version retained the impressions of Dr. Mohsen's pen as he
copied the newly inked material into the evolving 1989 notebook. The Ink-On-Photocopy
version was the source for the seventeen-page production to the court.

 Thus, the record before the district court included four different notebook submissions: the
seventeen pages originally submitted to the court from Mohsen's purported 1989 notebook,
another notebook allegedly started in 1988, an original copy of the 1989 notebook that was used
to prosecute the '069 patent (containing discrepancies from the seventeen-page submission), and



                                              552
the Ink On Photocopy version of the 1989 notebook, which apparently served as the template for
Dr. Mohsen's elaborations.

 On November 24, 1998, Quickturn moved to compel production of the original notebooks for
forensic testing. Dr. Mohsen had been insistent upon personally keeping the notebooks, locking
them in a safe in his house. However, on December 14, 1998, Dr. Mohsen took the notebooks to
work and left them in his car the entire day. That night, he purportedly found his car window
broken and the notebooks gone. The trial court found that the "circumstances of the 'theft'
strongly suggest that Amr Mohsen staged the incident."

 After the disappearance of the notebooks, Dr. Mohsen produced additional evidence to
corroborate his asserted conception date. His 1989 Daytimer, for example, included various
entries referring to the engineering notebooks. However, forensic evidence showed that these
entries were written with an ink that was not manufactured until 1994, five years after the
supposed entries.

 Shortly before the scheduled date of an evidentiary hearing on spoliation of the notebooks (at
which time Aptix would have had to demonstrate under Fed.R.Evid. 1004 that the original
notebooks were not destroyed in bad faith), Dr. Mohsen purportedly received a priority mail
package containing fragments of the missing notebooks. The package, which bore Dr. Mohsen's
correct mailing address, had no return address but contained an anonymous note from "FL"
stating: "These were discovered lately in our backyard. These look like important documents
for you." The package contained invoices with Dr. Mohsen's address, which apparently provided
the basis for "FL" to address the envelope. Significantly, however, those invoices had either the
wrong zip code, or no zip code at all, even though the address on the package from "FL"
included the proper zip code. The trial court found that "[i]t seems plain that Amr Mohsen
addressed the envelope, or instructed someone else to address it, and simply slipped up in using
the correct zip code."

 Referring to the 1988 notebook, the trial court noted that in five instances, Dr. Mohsen had first
written "1998," and then overwritten the date to read "1988." Moreover, although Dr. Mohsen's
brother, Aly Mohsen, had witnessed many pages of the notebook by writing "read and
understood," the court noted that many of these pages were blank with nothing but a large "X,"
suggesting that Aly had witnessed a blank notebook, and that his brother later filled in text and
diagrams. Indeed, all of Aly's signatures were written in the same ink, despite their purported
dates on occasions 22 days apart. Furthermore, the court noted that none of Dr. Mohsen's
colleagues, including his trial attorneys, patent prosecutors, and fellow executives, knew about
the 1988 notebook until 1998. The trial court concluded that the 1988 notebook was a "complete
fraud from bark to core, a notebook without a single genuine entry."

 On May 9-10, 2000, the trial court held an evidentiary hearing concerning the authenticity of the
notebooks. Dr. Mohsen took the stand and asserted his Fifth Amendment privilege against self-
incrimination in response to all questions. Thereafter, the trial court concluded that Aptix had
attempted "to defraud the Court and to strengthen its patent through a premeditated and sustained
campaign of lies and forgery." The trial court determined that the '069 patent was unenforceable
and dismissed the complaint, invoking the unclean hands doctrine as set forth in Keystone Driller



                                               553
Co. v. General Excavator Co., 290 U.S. 240 (1933) ("Keystone I "). After finding this case
exceptional under 35 U.S.C. § 285 (1994), the trial court ordered Aptix to pay Quickturn's
reasonable attorney fees and costs.

                                                II.

 The record amply supports the district court's finding that Dr. Mohsen submitted the seventeen
pages of his 1989 notebook to the court after adding new material to the signed and dated pages.
Indeed, the Ink On Photocopy version retained the impressions of his pen as he added material to
his purported 1989 notebook. Moreover, after Dr. Mohsen invoked his Fifth Amendment
privilege and refused to testify about the forgery, disappearance, and reappearance of the
notebooks, the trial court was free to make adverse inferences against him. Baxter v.
Palmigiano, 425 U.S. 308, 318 (1976) ("[T]he Fifth Amendment does not forbid adverse
inferences against parties to civil actions when they refuse to testify in response to probative
evidence offered against them."). Even Aptix does not seem to dispute that the only straight-
faced explanation for the theft of the notebooks and their subsequent mysterious return is that Dr.
Mohsen himself staged the incidents--an inference that the trial court was free to draw.

 Aptix nonetheless urges that the evidence of falsification of the 1988 notebook (its primary
evidence to corroborate its asserted conception date) is not so utterly compelling as with the
1989 notebook. Therefore, Aptix seeks a determination that the trial court lacked clear and
convincing evidence to find unclean hands. Contrary to Aptix's assertions, however, rarely, if
ever, will litigation misconduct be so thoroughly documented. The record clearly and
convincingly supports the district court's conclusion of extreme litigation misconduct.

 The district court's finding of litigation misconduct fully justified its decision to invoke the
unclean hands doctrine and dismiss Aptix from suit. This case is reminiscent of Keystone I, in
which the Supreme Court affirmed the dismissal of a patentee that engaged in fraud during
litigation. In Keystone I, the patentee, in a prior proceeding, had purchased the silence of
another inventor whose testimony would have provided grounds to invalidate the asserted
patents. After successfully suppressing this testimony and obtaining an injunction in the earlier
action, the patentee relied on its earlier victory in support of another suit against General
Excavator. In this later litigation, the earlier fraud emerged. By invoking against General
Excavator a decree obtained by fraud, the patentee came to the court with unclean hands.
Therefore, the Supreme Court denied all relief. As in Keystone I, the district court in the present
case had wide discretion to find Aptix remediless, and to dismiss its claim for want of equity.

 Moreover, the district court possessed ample discretion to award Quickturn attorney fees and
costs. Without question, fraud and misconduct make this case exceptional under 35 U.S.C. §
285 (1994) and warrant a full compensation of Quickturn's reasonable attorney fees and costs.

 Upon dismissal of Aptix, Meta lost standing to sue in its own right. Only a patentee may bring
an action for patent infringement. Unless it holds "all substantial rights" under the patent, a
licensee may not enforce a patent without the patentee. Meta is a non-exclusive licensee with
only limited rights under the patent. Therefore, it lacks standing to sue without Aptix. The
district court correctly dismissed Meta's complaint upon dismissal of Aptix.



                                               554
                                                 III.

  As further relief, the trial court declared the '069 patent unenforceable. Litigation misconduct,
while serving as a basis to dismiss the wrongful litigant, does not infect, or even affect, the
original grant of the property right. The doctrine of unclean hands does not reach out to
extinguish a property right based on misconduct during litigation to enforce the right. Indeed
neither the Supreme Court nor this court has ever declared a patent unenforceable due to
litigation misbehavior. The Supreme Court's decision in Keystone I, upon which the district
court primarily relied, illustrates that litigation misconduct does not affect the viability of the
property right itself: "The governing principle is 'that whenever a party who, as actor, seeks to
set the judicial machinery in motion and obtain some remedy, has violated conscience, or good
faith, or other equitable principle, in his prior conduct, then the doors of the court will be shut
against him in limine; the court will refuse to interfere on his behalf, to acknowledge his right,
or to award him any remedy.' " Leaving the patent right intact, the Supreme Court repeatedly
stressed that litigation misconduct bars the litigant. Again in Hazel-Atlas Glass Co. v. Hartford-
Empire Co., 322 U.S. 238 (1944), another instance of extreme litigation misconduct, the
Supreme Court "require[d] that Hartford be denied relief," but left the patent right intact. Thus,
the remedies for litigation misconduct bar the malfeasant who committed the misconduct. The
property right itself remains independent of the conduct of a litigant.

 This court's doctrines of inequitable conduct render the patent itself unenforceable to prevent
"the enforcement of patents secured by fraud." Inequitable conduct in the process of procuring a
patent taints the property right itself. Thus, inequitable conduct furthers the "paramount interest"
of ensuring that patents issue from "backgrounds free from fraud or other inequitable conduct."
Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806, 816 (1945). The
process creating the patent right "demands that all facts relevant to [patentability] ... be submitted
formally or informally to the Patent Office, which can then pass upon the sufficiency of the
evidence." Upon a showing of inequitable conduct during acquisition of the patent, courts
declare the patent unenforceable because the property right is tainted ab initio.

 Thus, the remedies for litigation misconduct differ from the remedies for misconduct in
acquisition of a property right. While inequitable conduct before the PTO renders the patent
unenforceable by any party, the unclean hands doctrine bars only the offending party. Moreover,
a finding of unclean hands generally does not prejudice the offending party in subsequent cases,
but only provides a bar to relief in the case at hand.

                                                ***

                                                 IV.

 For reasons discussed above, if Aptix had procured its patent by inequitable conduct before the
PTO, the trial court would have full discretion to declare the '069 patent unenforceable. Even
presumably innocent licensees like Meta and Mentor would be properly barred from enforcing
the patent, had the rights thereunder accrued through inequitable conduct.




                                                 555
 In the present case, however, the record discloses no misconduct in acquisition of the patent
right. Moreover, Meta and Mentor licensed the ' 069 patent from Aptix before the present
litigation. The record does not show that either company participated in any wrongful conduct
during litigation or before the PTO. Indeed, the trial court noted: "Meta may be a victim."

 In the absence of any showing of misconduct before the PTO, the '069 patent remains a
presumptively valid grant of personal property. See 35 U.S.C. § 261 (1994) ("Subject to the
provisions of this title, patents shall have the attributes of personal property."). No case law from
the Supreme Court or this court provides a basis for nullifying property rights granted by the
United States when such property rights did not themselves accrue through inequitable conduct.

 Despite this lack of authority, however, the trial court declared the '069 patent unenforceable as
a form of relief. The court called this relief a "penalty," necessary for deterring Aptix and other
parties from engaging in future misconduct. The court based its decision on Keystone I and the
doctrine of unclean hands. As discussed above, however, the trial court's reliance on Keystone I
was not fully justified, as the Supreme Court did not declare Keystone's patents unenforceable -
to the contrary, it resolved yet another suit by Keystone on several of the same patents on the
merits only two years later. Keystone II, Nor does the doctrine of unclean hands provide a
suitable basis for the trial court's judgment, as this equitable doctrine is not a source of power to
punish. In declaring the '069 patent unenforceable based solely on misconduct during litigation,
the trial court clearly exceeded the bounds of Keystone I and the doctrine of unclean hands.

                                                 V.

  Within the limits discussed above, courts are free to sanction bad faith conduct that arises
during the course of litigation. These "inherent powers" to punish bad faith conduct during
litigation are "necessarily vested in courts to manage their own affairs so as to achieve the
orderly and expeditious disposition of cases." Chambers v. NASCO, Inc., 501 U.S. 32, 44,
(1991). "The power to punish for contempts is inherent in all courts." Although a particularly
severe sanction, outright dismissal of a lawsuit is within the court's discretion. And, the " 'less
severe sanction' of an assessment of attorney's fees is undoubtedly within a court's inherent
power as well." Thus, the trial court did not abuse its discretion by denying relief to Aptix, or by
ordering Aptix to pay attorney fees and costs.


MAYER, Chief Judge, dissenting-in-part.

 Because a fraud upon the court is no less grave than a fraud on the Patent and Trademark Office,
I would affirm the district court's holding that the '069 patent is unenforceable.

 The maxim of unclean hands is applied broadly, giving substantial discretion to the officer of
the court in its application. It is "not bound by formula or restrained by any limitation that tends
to trammel the free and just exercise of discretion." ("Keystone I "). The maxim itself is
predicated upon the need to protect the integrity of the judicial system. "[The] doctrine is rooted
in the historical concept of court of equity as a vehicle for affirmatively enforcing the
requirements of conscience and good faith. This presupposes a refusal on its part to be 'the



                                                556
abettor of iniquity.' " Precision Instrument, 324 U.S. at 814.

 Had Mohsen's deception occurred in the Patent and Trademark Office ("PTO") rather than
before the court, everyone agrees that the '069 patent would be unenforceable. There is no
reason to reach a different result here. The duty of candor to the court is entitled to at least as
much honor as that to the PTO. The courts have no greater resources to uncover fraud than the
PTO. Although patent prosecutions are ex parte and judicial proceedings are adversarial, the
PTO has the benefit of hundreds of experts in the relevant arts to make independent inquiries.
The rationale of Hazel-Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238, 246 (1944),
applies: "[T]ampering with the administration of justice in the manner indisputably shown here
involves far more than an injury to a single litigant. It is a wrong against the institutions set up to
protect and safeguard the public, institutions in which fraud cannot complacently be tolerated ...
The public welfare demands that the agencies of public justice be not so impotent that they must
always be mute and helpless victims of deception and fraud."

 There is no limit inherent in the doctrine of unclean hands that prevents declaring a patent
unenforceable based on the post-issuance conduct of the party seeking relief. The governing
principle of the doctrine is that " 'whenever a party who, as actor, seeks to set the judicial
machinery in motion and obtain some remedy, has violated conscience, or good faith, or other
equitable principle, in his prior conduct, then the doors of the court will be shut against him in
limine; the court will refuse to interfere on his behalf, to acknowledge his right, or to award him
any remedy.'" Keystone I.         Rendering the patent unenforceable for Mohsen's forgery of
engineering notebooks purporting to establish the conception and reduction to practice of his
invention is entirely consistent with this language. The district court properly refused to "
'acknowledge [the patentee's] right' " in that patent.

 Indeed, the unclean hands doctrine is the source of our ability to declare a patent unenforceable,
for the well-recognized defense of inequitable conduct in the PTO.

                                                ***

 Here, the district court held that the only way to protect the judicial proceedings from Mohsen's
deceptions was to declare the '069 patent unenforceable. His forgery was pervasive, long-
standing, and wanton. It was committed in the context of a series of inter-related patent
litigations among the parties concerning related technology in courts in many jurisdictions, as
well as an antitrust action and a takeover attempt. Closing the door to one courtroom would
merely lead to prompt refiling in another, and would be of little deterrence to subsequent
attempts to undermine the integrity of the judicial process.

 That Mohsen's forged documents infected the evidence of the conception and reduction to
practice of the invention bolsters the conclusion that the patent should not be enforced. Although
the record does not fully develop the issue, it appears that he was seeking to avoid potentially
invalidating prior art with his forgery, intending to swear behind the date of his patent
application. Thus, the fraud concerns the validity of an issued patent, a matter of public concern.

Had Mohsen succeeded, he might unjustly have retained or enlarged the scope of his property



                                                 557
right, avoided a finding of obviousness or anticipation, and thus remained the owner of valid
patent claims where he should have none. As the district court observed, the patent would be
strengthened through its testing in litigation and in reliance upon the fraudulent documentation
and testimony. Aptix would likely be able to command a higher price for it (in license or
assignment), and would more readily be able to obtain settlements from potential infringers than
if it had not survived a challenge to its validity. This strengthened patent could be helpful in
obtaining infringement verdicts in subsequent litigation, resulting in a chain of judgments based
on the same fraud. See Donald S. Chisum, Chisum on Patents, § 19.02[2][a] at 19-51 (2000)
("A prior judgment of validity cannot bind non-parties to a suit. Nevertheless, under the doctrine
of comity, a court will give some weight to prior adjudications ... based on the same evidence.").
Permitting the possibility of such a chain of judgments tainted with deception is precisely what
the Supreme Court sought to avoid in Keystone I, Hazel-Atlas, and Precision Instrument.

 This type of deception taints the patent itself. The documentary record of the invention has been
permanently blotched. The forgery is sufficiently pervasive that it is difficult to tell if any of the
purported engineering notebooks and supporting documents are authentic. Thus, the effects of
Mohsen's conduct before the court would not necessarily be eradicated inan action brought by
another party. If the patent is not held unenforceable, a subsequent owner may attempt in
litigation to establish a date of conception and reasonable diligence in reduction to practice
before the date of the patent's application. To permit this possibility is to countenance the
continued involvement of the courts in sorting through the muddy morass of Mohsen's forgeries
and dishonest testimony. The unclean hands doctrine does not permit this boon to the forger and
stain on the courts. Therefore, we do not exceed the limits of equity in refusing to enforce the
patent.

 In other contexts, we have not been so quick to confine the consequences of a patentee's fraud.
For example, even if inequitable conduct in a patent's prosecution only directly concerns one of
the claims, we hold that it is fatal to the entire patent. See Kingsdown Med. Consultants, 863
F.2d at 877, 9 USPQ2d at 1392 (en banc) ("When a court has finally determined that inequitable
conduct occurred in relation to one or more claims during prosecution of the patent application,
the entire patent is rendered unenforceable."). There is no reason to become parsimonious with
equity here.

 With respect to Meta, as the patent's licensee, it derives its rights in the ' 069 patent entirely
through Aptix and has no standing to sue in its own right. To the extent that Meta would be
harmed by our refusal to recognize Aptix's right to the patent, its action is against Aptix. Had
Aptix's deception initially been before the PTO, the patent would be unenforceable, and Meta
would lose all its rights in the patent even if it had no knowledge of the misconduct. Besides, as
the driving force behind the Aptix patent litigation, Meta had ample notice of the alleged fraud
and ample opportunity to require the testing of the veracity of the documents that it and Aptix
continued to rely on. The district court made no findings about whether Meta itself had clean
hands. However, willful blindness to another's wrongful acts and continued reliance upon them
could rise to the level of intentional or unconscionable conduct.


 CRITIKON, INC. v. BECTON DICKINSON VASCULAR ACCESS, INC.


                                                 558
                       United States Court of Appeals, Federal Circuit, 1997


Before ARCHER, Chief Judge, RICH, and MAYER, Circuit Judges.

RICH, Circuit Judge.

 Becton Dickinson appeals from the judgment of the District Court for the District of Delaware,
issuing a permanent injunction enjoining Becton Dickinson from making, using, selling or
offering to sell its infringing safety catheter products in the United States based on U.S. Patent
Nos. 4,952,207, reissued as RE34,416, and 4,978,344 (the patents). Following a bench trial, the
district court held that … Critikon did not engage in inequitable conduct.

                                         BACKGROUND

 The patents and relevant claims in suit are claims 8, 21, and 56 of U.S. Patent No. RE34,416
(Lemieux reissue patent) and U.S. Patent No. 4,952,207, (original Lemieux patent) and claims 18
and 19 of U.S. Patent No. 4,978,344, (Dombrowski patent). These patents are in the field of
intravenous (IV) catheters. IV catheters are thin tubes that are inserted into a vein for the
administration of fluids and the like. A needle is used to insert the tube into the vein and then the
needle is withdrawn, leaving the tube in the vein. The patents are specifically directed to safety
IV catheters, designed to protect health care workers from accidental needle sticks. They feature
a needle guard that automatically moves into position over the tip of the needle as the needle is
withdrawn from the IV catheter. For ease of reference, we will refer to the reissue and original
Lemieux patents collectively as the ―Lemieux patents.‖ Claims were added by the reissue.

Through a series of amended complaints, Critikon filed an infringement action against Becton
Dickinson based on the Lemieux patents and the Dombrowski patent.

                                          DISCUSSION

2. Inequitable Conduct

    On appeal, Becton Dickinson argues that Critikon‘s failure to disclose U.S. Patent No.
4,834,718 (the McDonald patent) during both the prosecution of the original Lemieux patent and
the Lemieux reissue patent constituted inequitable conduct. Becton Dickinson argues that the
district court‘s failure to find intent is contrary to the weight of the evidence. We agree. We
hold that the McDonald patent was material to patentability and Critikon should have disclosed it
to the Patent and Trademark Office (PTO). But, more importantly, during the reissue
proceedings, Critikon should have disclosed that the original Lemieux patent was concurrently
involved in the present litigation and that claims of invalidity and inequitable conduct were
asserted against the patent. Failure to disclose the McDonald patent and the fact that the
Lemieux patent was in litigation was done with an intent to mislead or deceive and rises to the
level of inequitable conduct.




                                                559
   A patent applicant‘s duty to disclose material information to the PTO arises under the general
duty of candor, good faith, and honesty embodied in 37 C.F.R. § 1.56(a) (1996). Specifically,
applicants have a duty to disclose to the PTO information of which they are aware which is
material to the examination of the application. This duty is also applicable to reissue
proceedings.

A. Intent

    Becton Dickinson argues that the district court ignored the weight of the evidence in holding
that Becton Dickinson failed to establish by clear and convincing evidence that the Lemieux
patents were unenforceable due to inequitable conduct. Our review of the record leads us to
conclude that Critikon failed to cite the McDonald patent and to disclose the ongoing litigation to
the PTO with intent to mislead or deceive. Direct evidence of intent or proof of deliberate
scheming is rarely available in instances of inequitable conduct, but intent may be inferred from
the surrounding circumstances. For example, intent may be inferred where a patent applicant
knew, or should have known, that withheld information would be material to the PTO‘s
consideration of the patent application.

    A relatively high degree of intent may be inferred under the facts of this case. Critikon was
aware of the McDonald Patent. It was aware that the ―retaining means‖ was a point of novelty
the examiner relied upon during the course of prosecution. It knew or should have known that
the ―retaining means‖ disclosed in the McDonald patent was relevant to a point of novelty in the
Lemieux proceedings. And, despite this, it did not disclose the patent or provide a good faith
explanation for not disclosing the patent. Furthermore, despite the clear materiality of the
ongoing litigation to the reissue proceedings, Critikon never disclosed its existence to the PTO.

    Critikon was intimately familiar with the McDonald patent. Both of Critikon‘s patent
counsel who were involved in the prosecution of the Lemieux patents, Mr. Colletti and Mr.
York, had reviewed the McDonald patent in detail. On appeal, Critikon argues that Mr. Colletti
believed that the reference was not material and that Mr. York had no recollection of the patent.
However, at one point Mr. York reviewed the McDonald patent and in handwritten annotations
opined that all the claims, except those including the ―retaining means,‖ were invalid. Further,
there is evidence that he passed these notes on to Mr. Colletti, who cited the McDonald patent to
the PTO in several other patent proceedings. If that were not sufficient to infer intent to mislead
or deceive, the record indicates that Critikon‘s counsel was repeatedly confronted with the
McDonald patent and its significance over the course of the litigation, which substantially
overlapped the Lemieux reissue proceedings.

    Critikon knew that the examiner considered the retaining means a point of novelty of the
Lemieux patent. The examiner was in direct communication with Critikon and reiterated on at
least two occasions the importance of the ―retaining means‖ as a point of novelty in the
application. During the course of prosecution of the original Lemieux patent, the examiner twice
rejected the application‘s independent claims that did not call for a means for retaining the
needle guard together with the catheter hub. Both times, the examiner stated that those claims
―lack the structure at the point of novelty to achieve the intended result and are therefore
incomplete,‖ and suggested that they be amended to include retaining means for holding the



                                               560
needle guard within the catheter hub until the needle guard was engaged in place over the needle
tip. Critikon was aware of the PTO procedures in effect at that time, which required examiners
to construe means-plus-function claim limitations broadly to encompass any means for
performing the function recited in the means clause.

    Contrary to the district court‘s conclusion and Critikon‘s argument, Critikon‘s counsel made
no effort to offer a good faith explanation of why McDonald was never cited, but merely offered
conclusory statements that the reference was cumulative. The court stated that it ―weighed the
testimony of both Mr. Yorks and Mr. Colletti and determined that their explanations for not
disclosing the McDonald ‗718 patent were credible under the totality of the circumstances.‖
However, the court does not identify the testimony it relied upon. Our review of the record does
not reveal a single instance where Mr. Yorks or Mr. Colletti provided a good faith explanation
for the exclusion.

    Further, the district court did not address Critikon‘s failure to disclose the ongoing litigation
to the PTO. As evidenced by their participation in depositions, the patent counsel who were
handling the reissue proceedings were keenly aware of the litigation and the issues involved prior
to the resolution of the reissue proceedings. However, there is no evidence in the record that
anyone reported the ongoing litigation to the PTO. Nor is there any evidence as to a good faith
explanation as to why it was never reported.

    It is axiomatic that ―[c]lose cases should be resolved by disclosure, not unilaterally by
applicant.‖ LaBounty Mfg., Inc. v. United States Int‘l Trade Comm‘n, 958 F.2d 1066, 1076
(Fed.Cir.1992). This sentiment is also repeatedly reflected in the Manual of Patent Examining
Procedure (MPEP), which, although it does not have the force of law, is well known to those
registered to practice in the PTO and reflects the presumptions under which the PTO operates.

       Presumably, applicants will continue to submit information for consideration by the
    Office in applications rather than making and relying on their own determinations of
    materiality. An incentive remains to submit the information to the Office because it
    will result in a strengthened patent and will avoid later questions of materiality and
    intent to deceive.

MPEP 2001.04 (1994).

  No single factor or combination of factors can be said always to require an inference of intent
to mislead; yet a patentee facing a high level of materiality and clear proof that it knew or
should have known of that materiality, can expect to find it difficult to establish ―subjective good
faith‖ sufficient to prevent the drawing of an inference of intent to mislead. A mere denial of
intent to mislead (which would defeat every effort to establish inequitable conduct) will not
suffice in such circumstances.

B. Materiality

  Information must be disclosed when it is material to patentability. The starting point in
determining materiality is the definition of the PTO, which recites, in part, as follows:



                                                561
―information is material to patentability when it is not cumulative to information already of
record or being made of record in the application, and ... [i]t refutes, or is inconsistent with, a
position the applicant takes in: ... [a]sserting an argument of patentability.‖ 37 C.F.R.
1.56(b)(2)(ii).

  The district court found the McDonald patent was not material because it was substantially
different from the claimed invention. The court was ―persuaded by the testimony of both expert
witnesses that the McDonald [ ] patent teaches a device that is substantially different than that
contemplated by the Lemieux patents.‖ However, the court did not explicitly outline the
evidence that it relied upon in drawing this conclusion nor did it address Critikon‘s failure to
disclose the ongoing litigation during the Lemieux reissue proceedings.

  The court apparently failed to recognize that although overall the Lemieux device may be
substantially different from McDonald, the McDonald patent teaches two features, which the
examiner considered central in the prosecution of the Lemieux patents. Briefly, the protective
housing of the McDonald device is designed to automatically cover the needle tip for the purpose
of preventing accidental needle sticks. The housing is comprised of a long barrel and a guard
hub. As the needle is withdrawn from the catheter, the proximal end of the housing engages with
a groove on the handle and automatically releases the needle guard that sheaths the needle.
Specifically, it teaches a ―retaining means‖ and an automatically, albeit passively, engaged
protective housing.

  As noted above, the examiner specifically relied on the ―retaining means‖ as a point of novelty.
The use of the ―retaining means‖ to achieve automatic positioning is disclosed only in the
uncited McDonald patent; it is not disclosed in any other prior art considered by the examiner.
Furthermore, there was testimony from Mr. Fischell, Becton Dickinson‘s expert, to the effect
that the McDonald patent is the most relevant art to the ―retaining means‖ limitation.

  Specifically, Mr. Fischell indicated that the retaining means were integral to the automatic
positioning. In addition, Mr. Fischell indicated that the key features of McDonald were the
automatic positioning and the ―retaining means.‖ Mr. Colletti reflected this position, and
Critikon‘s knowledge thereof, when he testified that he could not recall any prior art considered
by the examiner who allowed the original Lemieux patent that describes a catheter device with
the ―retaining means‖. And yet Mr. Colletti relied on the novelty of the ―retaining means‖ and
the automatic positioning of the protective housing in his arguments to gain allowance of the
patent application. It would appear that the ―retaining means‖ and the automatic positioning
aspects of McDonald would have been material to a reasonable patent examiner under the PTO
standard.

  Critikon argues that the McDonald device is significantly different for three primary reasons:
(1) the McDonald device operates differently; (2) the McDonald device does not feature
automatic positioning; and (3) the McDonald device requires a two step procedure while the
Lemieux patent requires the protective housing to function without intervention. The first reason
is of no moment. A device that operates differently, assuming the McDonald patent operates
differently, may nonetheless have relevant features. With regard to the second and third reasons,
there is unrefuted testimony that the catheter may be inserted with one hand and, furthermore,



                                               562
the Lemieux patent only requires that the catheter function without intervention in its preferred
embodiment. Thus, we find Critikon‘s arguments without merit.

  The district court did not consider whether the litigation relating to the Lemieux patents was
material to the Lemieux reissue proceedings. A patent applicant‘s duty to disclose is not limited
to disclosing prior art. A patent applicant must disclose any material information to the PTO. 37
C.F.R. § 1.56(a) (1996). There seems little doubt that the litigation involving the patent in
question would be relevant to its reissue proceeding. According to the Manual of Patent
Examining Procedure, relevant litigation includes the defenses raised against validity of the
patent, or charges of fraud or inequitable conduct in litigation, which would normally be material
to the reissue application. MPEP 2001.06(c) (1994).

        Where the patent for which reissue is being sought is, or has been, involved in
    litigation which raised a question material to patentability of the reissue application,
    such as the validity of the patent, or any allegations of ―fraud‖, ―inequitable conduct‖,
    or ―violation of duty of disclosure‖, the existence of such litigation must be brought to
    the attention of the Office by the applicant.... [T]he defenses raised against validity of
    the patent, or charges of ―fraud‖ or ―inequitable conduct‖ in the litigation, would
    normally be ―material to patentability‖ of the reissue application.... As a minimum, the
    applicant should call the attention of the Office to the litigation, the existence and the
    nature of any allegations relating to validity and /or ―fraud‖, or ―inequitable conduct‖
    relating to the original patent, and the nature of the litigation materials relating to these
    issues.

 MPEP 2001.06(c) (1994); see also, MPEP 1442.04 (1994). In the interests of consistent claim
interpretation, it may be appropriate to suspend such proceedings until such litigation is resolved.

  In summary, Critikon failed to disclose the McDonald patent, which it should have known was
material, but, more importantly, it failed to disclose the ongoing litigation in the reissue
proceedings. Given the materiality and the failure at any point to offer a good faith explanation
of the pattern of nondisclosure, an intent to mislead may be inferred. We reverse the district
court‘s finding with regard to inequitable conduct and hold the original Lemieux patent and the
Lemieux reissue patent unenforceable.


                  The B.F. GOODRICH COMPANY
                               v.
            AIRCRAFT BRAKING SYSTEMS CORPORATION
                      United States Court of Appeals, Federal Circuit, 1996
                               72 F.3d 1577, 37 U.S.P.Q.2d 1314


       Before ARCHER, Chief Judge, NEWMAN, and LOURIE, Circuit Judges.

       LOURIE, Circuit Judge.



                                                563
        During prosecution of the patents, the PTO was apparently not aware of, and hence did
not consider, a published paper by employees of Dunlop Ltd. This paper, entitled The Economic
and Safety Aspects of Commercial Aircraft Carbon Brakes [hereinafter Dunlop], was presented
at the International Federation of Airworthiness Annual Conference in Long Beach, California,
in April 1982. Although several individuals at BFG had copies of Dunlop in their files, BFG did
not cite it to the PTO during prosecution of the patent applications. Relevant portions of Dunlop
describe what is referred to as a 2 for 1 refurbishment scheme in which two worn disks are
machined to smoothness and then clipped together to form one ―new‖ disk. Dunlop describes
how these thicker 2 for 1 disks can be used with new disks:

       Following brake chassis inspection the heat stack can either be put back into the
       brake for the remainder of its life, or some of the half worn discs can be
       assembled with re-furbished discs from other brakes.             Because of this
       arrangement it is possible to use reclaimed discs which are thicker than new discs.
       In other words, during the machining for reclaim [sic] the minimum amount of
       carbon has been machined off in order not to waste any of this expensive material.
       Individually these extra thick discs have a life potential well in excess of 3,000
       landings. By the use of this half life inspection routine, and by using extra thick
       discs mixed with part worn discs the cost per brake landing can be reduced
       significantly.

Dunlop also teaches obtaining maximum use of the carbon disks by building up the heat stack to
fill the space available for the disks by using a combination of new and refurbished disks.

        In addition, Dunlop describes brake overhaul schedules using the 2 for 1 refurbishment
technique. A chart in Dunlop illustrates the overhaul schedules. Aircraft are listed on the left
side of the chart, and the months from October 1984 through June 1988 are listed across the top
of the chart. The chart contains boxes representing a particular overhaul for the corresponding
aircraft and month. The chart also contains a description of several overhaul routines, the most
relevant of which are referred to as overhaul combinations 3 and 5. The description for
combination 3 states: ―New stators, pressure and thrust stators, half worn rotors.‖ That for
combination 5 states: ―New rotors, half worn stators, pressure and thrust stators.‖ Combinations
3 and 5, therefore, together describe an overhaul scheme involving a thick/thin aircraft brake
assembly.

       BFG also failed to submit to the PTO other prior art that it was aware of during its
prosecution of the patents. This prior art included a Concorde manual, which describes a brake
overhaul method used on the Concorde, which was the first commercial aircraft to use carbon
disk brakes. According to this method, new or partially worn disks were placed in the brake
assembly during overhaul. Thus, after use in this manner, the carbon disks in the Concorde
brake had varying thicknesses.

       Other prior art also included U.S. Patent 3,480,115, which describes a brake assembly
having steel disks arranged in descending order of thickness. BFG had itself used brake
assemblies with steel rotors of different wear thicknesses.



                                              564
        BFG also failed to notify the PTO of certain of its own activities which may have
implicated the on-sale bar under 35 U.S.C. § 102(b). BFG made a presentation in France to
Airbus Industries, which has customers in the United States, concerning the brake assembly in
January 1983. Later, BFG met with representatives of Boeing on March 24, 1983 in Seattle,
Washington, in order to discuss BFG‘s carbon brakes. This meeting was part of an ongoing
effort by BFG to interest Boeing in its thick/thin carbon aircraft brake assemblies. Even though
these activities occurred before the critical date, BFG failed to disclose them to the PTO during
prosecution of the ‗017 and ‗895 patents. Moreover, the inventor, Lowell D. Bok, stated in his
invention record, which he submitted to a BFG in-house attorney, that the BFG thick/thin brake
assemblies had been ―proposed for the 757-200, A310-300 and 767-300 Aircraft[.]‖

        A determination of inequitable conduct is committed to the district court‘s discretion.
Accordingly, we review the district court‘s judgment under the abuse of discretion standard. To
overturn such a discretionary ruling of a district court, ―the appellant must establish that the
ruling is based on clearly erroneous findings of fact or on a misapplication or misinterpretation
of applicable law, or evidences a clear error of judgment on the part of the district court.‖
Molins PLC v. Textron, Inc., 48 F.3d 1172, 1178 (Fed.Cir.1995).

        ABS and Allied-Signal allege inequitable conduct with respect to several pieces of prior
art. In particular, they allege that BFG engaged in inequitable conduct in its failure to disclose to
the PTO Dunlop, the Concorde manual, U.S. Patent 3,480,115 showing an example of the steel
brake art, BFG‘s own steel brake prior art, and BFG‘s activities with Boeing and Airbus. They
also allege that the statements in the Perry affidavit provide evidence of an intent to mislead.

        BFG argues that there was no intent by the inventor, Bok, or his attorneys to mislead the
PTO. BFG asserts that there is no evidence that Bok or his attorneys knew of Dunlop during
prosecution. While they of course knew of the Boeing and Airbus activities, BFG argues that it
had a reasonable belief that these activities did not violate the on-sale bar. BFG also argues that
the Perry affidavit does not show an intent to mislead the PTO, because all the statements in the
affidavit were true.

         Inequitable conduct consists of an ―affirmative misrepresentation of a material fact,
failure to disclose material information, or submission of false material information, coupled
with an intent to deceive.‖ Molins, 48 F.3d at 1178. One alleging inequitable conduct must
prove the threshold elements of materiality and intent by clear and convincing evidence. The
district court must then weigh the threshold findings of materiality and intent in light of all the
circumstances to determine whether the equities warrant a conclusion that inequitable conduct
occurred.

         Much of the prior art involved here certainly was material. Dunlop was directly relevant
to the problem addressed by the ‗017 and ‗895 patents; it discloses techniques for increased
carbon utilization in aircraft brakes, as well as a thick/thin aircraft brake assembly. BFG‘s sales
activities were also material, because they were potential statutory bars under § 102(b). The
steel brake art included brakes having steel disks of varying thickness, and the Concorde manual




                                                565
disclosed carbon brakes with disks of varying thickness. All of this prior art was thus arguably
material.

        The focus of the inequitable conduct issue in this case must thus be on intent, which is a
question of fact. We must affirm the district court on this issue unless its finding was clearly
erroneous. The district court was troubled by BFG‘s conduct, but essentially gave it the benefit
of the doubt because determinations of obviousness and the applicability of the on-sale bar are
often close and subject to varying reasonable interpretations. In particular, the district court
stated that ―[t]he application of the on-sale bar in § 102(b) and the factors determining
obviousness under § 103 is by no means a certain enterprise, and the fact that the Court has
found the patents invalid on these grounds does not mean that BFG‘s failure to submit this art
and information in connection with its patent applications was intentionally misleading.‖

         We too are troubled by BFG‘s conduct, but conclude that the district court did not clearly
err in its findings or abuse its discretion in determining that BFG did not engage in inequitable
conduct. ―[A] finding that particular conduct amounts to ‗gross negligence‘ does not of itself
justify an inference of intent to deceive; the involved conduct, viewed in light of all the
evidence, including evidence indicative of good faith, must indicate sufficient culpability to
require a finding of intent to deceive.‖ Kingsdown, 863 F.2d at 876.

        There was a basis for the patent attorney prosecuting the applications to conclude that
BFG‘s meeting with Boeing did not trigger the on-sale bar on the ground that it was a technical,
not a sales, meeting, and thus that it need not have been disclosed to the PTO. Prudence would
have dictated otherwise, but the requisite evidence of intent to deceive is lacking. In addition,
the Airbus activity seemingly occurred outside the United States, and its nondisclosure does not
reveal an intent to deceive. Even though Dunlop was in the files of several BFG employees, it is
not clear that Bok and his attorney possessed it. The evidence tends to show that Bok only
became aware of Dunlop after the ‗017 and ‗895 patents issued, and the patent attorney was not
on the circulation list to receive the publication. There is also a letter of record from BFG to a
foreign attorney indicating after the patents issued that BFG had just recently become aware of
Dunlop. The other alleged prior art is similarly not associated with evidence of an intent to
deceive.

        The Perry affidavit is more troubling, but also falls short of providing an inference of an
intent to mislead the PTO. While the statements in the affidavit are true, as BFG asserts, this
alone does not negate a finding of inequitable conduct, since truthful statements can be crafted in
a misleading manner through intentional omission of particular relevant facts. However, there is
no evidence of intentional omission of relevant facts in the affidavit and, in particular, no
evidence that Perry in fact knew of Dunlop. While Perry was not called as a witness at trial due
to an agreement between the parties, relevant portions of his deposition transcript are of record.
In Perry‘s deposition, he testified that he ―may have seen it [Dunlop] before,‖ but did not
―specifically remember seeing it.‖ He also testified that he did not recall seeing the copy of
Dunlop on which his name was handwritten as part of a circulation list. The district court‘s
conclusion that evidence of intent to deceive is lacking cannot be said to be clearly erroneous.




                                               566
        We have considered whether the totality of the actions here lead to an inference of an
intent to deceive even though the individual instances do not. We arrive at the same conclusion,
lack of evidence of intent. It is not surprising that those who are careless exhibit those qualities
more than once. It still does not demonstrate, without more, an intent to deceive. Accordingly,
we conclude that the district court did not clearly err in its finding of lack of intent to deceive or
abuse its discretion in finding that BFG did not engage in inequitable conduct. In the absence of
an intent to deceive, courts cannot find inequitable conduct merely because patents are held
invalid over the relevant prior art. Having affirmed the district court‘s conclusion that there was
no inequitable conduct, we also affirm its conclusion that this case was not exceptional and
hence its denial of attorney fees.

        Our conclusion does not mean, however, that we condone BFG‘s conduct in prosecuting
the ‗017 and ‗895 patents. Barely dodging a bullet based on our deference to a trial court‘s
decision on the factual question of intent and on a matter of equity does not merit approval or
justify complacency. BFG‘s conduct shows a pattern of careless patent prosecution. It has led to
the grant of a patent which is invalid over a withheld reference. While we have not reviewed the
holding of invalidity based upon the on-sale bar, there certainly was a close question concerning
that uncited event. The Perry affidavit evidences questionable conduct, considering that Perry‘s
name was on a circulation list for Dunlop and that he stated in his affidavit that he was
responsible for knowing the literature on aircraft brakes and that he had never seen a brake
assembly as described and shown in the ‗017 and ‗895 patents. Submission of careless
statements under oath deserves criticism, but, as noted above, we are not able to conclude that
the district court erred in failing to find intent to deceive from these actions.



                         DESTRON/IDI, INC.
                                 v.
               ELECTRONIC IDENTIFICATION DEVICES, INC.
                      United States Court of Appeals, Federal Circuit, 1997
                          1997 WL 414646 (Unpublished Disposition)


       Before RICH, MICHEL, Circuit Judges, COWEN, Senior Circuit Judge.

       MICHEL, CIRCUIT JUDGE.

        Electronic Identification Devices, Inc., Infopet Identification Systems, Inc., Edward
Pechacek, and Trovan, Ltd. (collectively, ―Infopet‖) appeal judgments of the District Court for
the District of Colorado holding that the asserted claims of the patent-in-suit were willfully
infringed, were ... not unenforceable for inequitable conduct.... Because the district court clearly
erred in finding that the information withheld by Destron/IDI from the Patent and Trademark
Office (―PTO‖) was not material, but did not reversibly err in any of its other determinations, we
affirm-in-part, vacate-in-part and remand.

                                         BACKGROUND


                                                 567
       Destron/IDI and Hughes are joint owners of United States Patent No. 5,211,129 (―the
‗129 patent‖), which resulted from an application filed in 1986. The patent claims a syringe
implantable identification transponder about the size of a grain of rice that can be injected into
animals for identification purposes.

        It is uncontroverted that, prior to the critical date in 1985, Destron/IDI sold such
transponders for implantation into animals. Indeed, Destron/IDI concedes that it began
marketing a transponder as early as 1981, and its pre-critical date business plan stated it was
developing an injectable, glass-encased silicon chip and antenna that would likely cost between
$8-$15. Infopet asserts, and Destron/IDI does not dispute, that prior to the critical date more
than 6000 transponders were sold to 14 customers. Moreover, there is evidence that these sales
included a one year warranty. It is also undisputed that the sales do not fall within the
―experimental use‖ exception to the on-sale bar of 35 U.S.C. § 102(b). Even Destron/IDI‘s own
attorney stated in a letter that he had ―no doubt‖ that a judicial fact-finder would conclude that
there had been non-experimental offers for sale in light of ―a flood of letters from what was
apparently anybody having anything to do with IDI sales at the time ... all assuring prospective
customers that the IDI transponders would handle their jobs and including brochures and price
lists.‖ The parties do dispute, however, whether these transponders were encapsulated in glass or
plastic and whether they worked properly over the intended period of time.

        Also of importance to this case is the prosecution history of the ‗129 patent. Destron/IDI
filed its first application on February 25, 1986. A continuation application was filed on
December 24, 1987. Destron/IDI did not disclose any sales activity in these first two
applications. A second continuation application was filed on October 26, 1988 and, on October
31, 1990, after the notice of allowance had been issued, Destron/IDI attempted to submit a
supplementary Information Disclosure Statement (―IDS‖) and affidavit of John Bradin, Director
of Research and Development at Destron/IDI, disclosing that there had been a small number of
pre-critical date sales to four entities and arguing that the sales were experimental. The PTO
would not consider the supplemental filing.

        Therefore, a third continuation application was filed on January 25, 1991. In the IDS
submitted with that application, Destron/IDI told the Examiner to assume that sales or offers for
sale were made prior to the critical date, but that transponders so sold were not sufficiently
encapsulated for sealing against leakage of host fluids over a plurality of months. The IDS was
supported by affidavits from John Bradin and Earl Prentice, an employee of the National Marine
Fisheries Service. Destron/IDI also amended the specification to clarify that the transponder had
to survive in the host and remain sealed against leakage for at least a plurality of months.
Destron/IDI eventually amended the claims to require that the transponder be encased in glass or
an equivalent material and argued to the PTO that the pre-critical date sales did not bar the
claims because those transponders did not work properly and it was not until Destron/IDI
decided to try glass encapsulation that the failure rate became acceptable. Additionally,
Destron/IDI‘s counsel submitted a letter stating:

    The undersigned has not become aware of any case on all fours with the present fact
    situation wherein a party sold a product alleging it was reduced to practice when, in



                                               568
    fact, the product was not successfully reduced to practice until later. However, in
    Section 11 (entitled Uncompleted Article) of 25 A.L.R. Fed. 486, it is stated that
    reduction to practice is ―a condition precedent to application of ‗on sale‘ bar of 102(b)‖
    (citing Imi-Tech Corp. v. Gagliani (1986), SD Cal) 692 F.Supp. 214, 6 U.S.P.Q.2d
    1241.

The patent ultimately issued on May 18, 1993.

        Infopet stipulated at trial that Infopet‘s manufacture, use and sale of its transponder
infringe the claims at issue. The jury advised that Destron/IDI had not committed inequitable
conduct because it had not withheld material information, concluded that the claims at issue had
not been proven invalid, found that Infopet willfully infringed the patent, and found that
Destron/IDI was entitled to $371,557.00 in damages. The district court, treating the inequitable
conduct finding as advisory, entered judgment on the jury verdict on January 31, 1996.

                                          DISCUSSION

                                                  I

        Infopet argues that Destron/IDI, and therefore Hughes, committed inequitable conduct:
(1) by failing to disclose material information, including all of the pre-critical date sales; (2) by
arguing that those sales were experimental; and (3) for improperly citing the Imi-Tech case. We
agree that Destron/IDI failed to disclose material information.

        Although Destron/IDI disclosed to the PTO during the third continuation application that
it could ―assume that offers for sale and sales prior to February 25, 1985 occurred for
transponders substantially along the lines of those shown in this application,‖ Destron/IDI
nowhere disclosed the true extent of those sales. In fact, it appears to have affirmatively
misrepresented the extent of the sales. An affidavit of John Bradin provides that arrangements
were entered into with ―selected organizations who received the below listed quantities of
transponders‖ and discloses the names of four organizations that received a total of 1350
transponders. Thus, while the declaration strongly suggests that only 1350 transponders were
sold to 4 customers, the true facts are that over 6000 transponders were sold to 14 customers.
This is especially troubling in light of the assertions of Destron/IDI‘s attorney in the IDS filed
with the third application that ―the quantities shipped were unquestionably small for the
ultimately intended product usage‖ and his argument that these sales were therefore
experimental.

        Destron/IDI also misrepresented the success of the transponders it sold before the critical
date. Destron/IDI improperly emphasized only the 50% failure rate experienced by one
researcher, Neal Campbell, to support its argument that the transponders did not work for the
required plurality of months. Destron/IDI failed to disclose, however, evidence of other tests
with much lower failure rates. For example, Ralph Knowles implanted transponders in horses
and experienced only a 7% failure rate over 4 or 5 months. Additionally, of the transponders
tested by Earl Prentice, between 84% and 99% were operational after 127 days and, in another
test, 86.7% functioned after 341 days. Thus, the PTO was improperly led to believe that a 50%



                                                569
failure rate was the norm, when it appears in fact that Destron/IDI knew that the failure rate was
actually much lower. This is troubling in light of the fact that one of Destron/IDI‘s arguments
was that the transponders had not been successfully reduced to practice. While a 50% failure
rate would seem to support Destron/IDI‘s position given the specific facts and circumstances of
this case, success rates between 84% and 99% strongly suggest that the transponder was
successfully reduced to practice, at least for some purposes, again given the facts of this
particular case.

        Destron/IDI also represented to the PTO that it never made a successful transponder until
after the critical date and the use of glass to encapsulate the transponder was the critical
innovation that made the invention work. However, Destron/IDI failed to inform the PTO that it
had conceived of glass as an encapsulent well before the critical date and even took steps to use
glass encapsulation. Specifically, in a 1983 business plan distributed to venture capitalists and
potential investors, Destron/IDI stated that it was developing a glass-encased silicone chip and
antenna, strongly suggesting that Destron/IDI had long-ago conceived of the notion of using
glass to encapsulate the transponder and suggesting that changing from plastic to glass would
have been obvious. Additionally, the evidence shows that in 1983 Destron/IDI offered for sale
glass-encapsulated transponders to the American Dental Association for implantation in
dentures. Destron/IDI also sent letters to several veterinarians in 1983 enclosing a piece of metal
encased in glass and asking them whether it would work. None of this was disclosed to the PTO.

         We conclude that the PTO Examiner would have considered this evidence, in whole or in
part, important in deciding whether to allow the application to issue as a patent. The information
was relevant to determining both whether the patented transponders were on sale before the
critical date and whether they were obvious over what was on sale prior to the critical date, and
the fact that the jury did not find this evidence sufficient to invalidate the patent does not mean
that the evidence was not material. At trial, Infopet was faced with overcoming the presumption
of validity and proving its case by clear and convincing evidence; no such presumption exits
during prosecution. The information was also contrary to the arguments made by Destron/IDI
that any sales prior to the critical date were experimental and that the patented transponder had
not yet been reduced to practice. Moreover, the fact that Destron/IDI disclosed some of its
pre-critical date sales is not sufficient. Applicants have a ―duty to disclose all information,
including uses and sales of [their] invention more than one year before [they] filed [their]
application, if such information would be deemed ‗material.‘ ― Manville Sales Corp. v.
Paramount Sys. Inc., 917 F.2d 544, 552, 16 USPQ2d 1587, 1593 (Fed.Cir.1990). In light of
Destron/IDI‘s repeated arguments that the sales were experimental and the sold products did not
work, we believe a reasonable examiner would have found it important that buyers actually
purchased several thousand more devices than Destron/IDI admitted and that many worked
substantially better than Destron/IDI claimed.

        Although we conclude as a matter of law that the withheld information was material, we
cannot decide by the same standard on this record whether the material withholding was done
with the requisite intent to deceive. The jury, unfortunately, was instructed that if it determined
that the withheld information was immaterial, it was not to answer the question of whether
Infopet had proven by clear and convincing evidence that Destron/IDI withheld that information
from the PTO with the intent to deceive the PTO. The trial court likewise did not itself make any



                                               570
finding on the issue of deceptive intent. Therefore, there are no findings for us to review. Nor
should an appellate court generally make such fact findings in the first instance. Were the record
clear that, as a matter of law, Destron/IDI did not have an intent to deceive the PTO, we could
affirm the district court‘s holding that the patent was not unenforceable in spite of its clear error
on the issue of materiality. Such a record, however, is not presented here. Rather, there is
sufficient evidence of intent to deceive that we must remand this case to the district court for a
finding on deceptive intent.

        We are particularly troubled by Destron/IDI‘s repeated assertions that the pre-critical date
sales were all experimental, even though its attorney stated that a fact-finder would not so find.
Specifically, in the supplementary IDS filed with the third application, Destron/IDI‘s attorney
stated ―it is submitted that the sales and use of transponders as set forth in the accompanying
Affidavit was [sic] experimental in nature and not a bar to the validity of any patent issuing from
the original grandparent of the present application.‖ Destron/IDI now concedes that these sales
were not experimental and argues instead that they were not sales of the patented transponder.
We are also troubled that the IDS filed with the third continuation application, which was
supposed to cure previous misinformation, contained its own inaccuracies. This IDS, while
asserting that sales had occurred, likewise represents that the sales were for experimental
purposes. Specifically, it states that ―[i]mplantation in a significant number of subjects over a
substantial length of time was needed but the financial status of the original assignee at that time
barred any such extensive experimental testing.‖ It also states ―the evidence shows that Mr.
Bradin and the engineering personnel of the assignee engaged in conduct consistent with an
experimental use in conjunction with the sales with that use terminating in a much later reduction
to practice.‖ Furthermore, Destron/IDI‘s mis-citation to the Imi-Tech case gives us pause.
Destron, relying on Imi-Tech, represented that reduction to practice is a condition precedent to
the on-sale bar, even though our case law held that reduction to practice was not required. UMC
Electronics v. United States, 816 F.2d 647, 656, 2 USPQ2d 1465, 1471 (Fed.Cir.1987) (―Implicit
in the operation of a sections 102(b)/103 bar is the absence of reduction to practice of the
claimed invention as a requirement for the bar to operate.‖ and ―In view of all of the above
considerations, we conclude that reduction to practice of the claimed invention has not been and
should not be made an absolute requirement of the on-sale bar.‖).

       We therefore must remand for further proceedings at which the district judge must find
whether Destron/IDI intended to deceive the PTO. If the trial court finds that Infopet has proven
such intent by clear and convincing evidence, it must then weigh together the evidence of
materiality and intent to determine whether Destron/IDI engaged in inequitable conduct.


                                             NOTES
        In Paragon Podiatry Laboratory, Inc. v. KLM Laboratories, Inc., 25 U.S.P.Q.2d 1561 (Fed
Cir. 1993), the court upheld the district court‘s finding that the patent was unenforceable by reason
of the applicant‘s inequitable conduct before the Patent and Trademark Office. The district court
based its holding on both the applicant‘s failure to disclose to the patent examiner the previously
discussed sales of the Omniflex orthotic and (2) its submission of deceptive affidavits in response to



                                                 571
the patent examiner‘s request for affidavits from a ―disinterested third party‖ under 37 C.F.R. §
1.132 (1991).7

         Tho submission of deceptive Rule 132 affidavits with intent to mislead is supported by
     the following evidence. At the conclusion of a personal interview with Paragon‘s counsel
     to discuss an obviousness rejection, the examiner placed a summary of the interview in the
     official PTO file which states, ―No agreement as to whether or not this is unobvious in
     view of all relevant facts. Applicant will provide a [Rule] 132 affidavit from a disinterested
     third party on this point and the overall lowprofile--re prior art. Determination of
     obviousness to be made after considering affidavit.‖ Three affidavits were submitted by
     the applicant from professionals in the field who attested to the advantages of the invention
     over prior art devices. It is now admitted that each of the affiants held stock in Paragon
     and one of them or all three had been consultants for which they received remuneration.
     These facts were not disclosed to the examiner. Further, there was not merely omission of
     the information of these interests. Each affiant averred with what now conveys the
     impression of deliberate artfulness in light of their ownership interest in the patent that: I
     have not been in the past employed by nor do I intend in the future to become employed by
     Paragon Podiatry Laboratories, a corporation which I understand is the assignee of the
     interest in the above captioned patent application. We conclude, as did the district court,
     that the inference of an intent to deceive the PTO is strongly supported by the submission
     of these deceptive affidavits. The materiality of these submissions in securing allowance
     of the claims is not disputed.

        Mr. Grumbine‘s affidavit in this case states that he selected the affiants because ―it
     would be unrealistic for [him] to expect [he] could obtain a statement from a competitor
     complimentary of Paragon‘s product,‖ that although the affiants held stock and/or received
     discounts on devices ―in return for making themselves available for consultation,‖ he ―did
     not consider them interested parties in the sense that their opinions should not be given full
     weight‖ because they were not ―employed by Paragon.‖ His attorney averred that he
     drafted the Rule 132 affidavits and that he understood the three affiants‘ opinions were
     given ―without remuneration for the statements made.‖

        We need not quibble about whether a ―consultant‖ is or is not ―employed‖ by a
     company. The representation to the PTO that the affiants were not employed presents a
     classic example of a half truth, and the explanation that the attorney understood no
     remuneration was paid for their statements is nonresponsive. None was a ―disinterested‖
     party in any recognized sense of the word. Further tho gratuitous averment that each
     ―understood‖ Paragon was an assignee of the patent also implies they had no connection
     with their own company. That averment serves no other purpose.

       The court also found that the patentee‘s failure to disclose to the examiner the pre-critical
date commercial sales of the patented device.


7
         Section 1.132 states: ―When any claim of an application ... is rejected on reference to a domestic
patent which substantially shows or describes but does not claim the invention .... affidavits or declarations
traversing these references or objections may be received.‖


                                                    572
                           ALLIED COLLOIDS INC.
                                    v.
                       AMERICAN CYANAMID COMPANY
                      United States Court of Appeals, Federal Circuit, 1995
                               64 F.3d 1570, 35 U.S.P.Q.2d 1840


       Before ARCHER, Chief Judge, NEWMAN and LOURIE, Circuit Judges.

       NEWMAN, Circuit Judge.

        In this patent infringement action tried to a jury, the district court directed the grant of
judgment as a matter of law in favor of the defendant American Cyanamid Company
(―Cyanamid‖), upon completion of the case in chief presented by the plaintiffs Allied Colloids
Inc. and Allied Colloids Ltd. (collectively ―Colloids‖). The court held that a reasonable jury
could reach only the verdict that the patents in suit, United States Patents Nos. 4,720,346 and
4,943,378, were invalid based on the public use bar of 35 U.S.C. § 102(b). An additional issue is
the correctness of the district court‘s ruling that Colloids‘ patents are unenforceable for
inequitable conduct because Colloids did not tell the Patent and Trademark Office about this
public use.

                                               ***

                                                 II

                                  INEQUITABLE CONDUCT

       The district court held the patents in suit permanently unenforceable for inequitable
conduct. The court ruled that Colloids had the obligation to tell the PTO of its testing activities
in Detroit on April 16-17, 1985. This ruling was based on the letter written by Colloids‘ British
patent attorney in March 1985, advising that a patent application should be filed before
―commercial sampling‖ in Detroit ―the end of April.‖ Cyanamid‘s motion for judgment as a
matter of law was granted on this issue, at the close of the plaintiff‘s case in chief.

                                                 A

       The issue of inequitable conduct was not the subject of testimony in Colloids‘ case in
chief. It appears to have been raised on quite short notice, in connection with Cyanamid‘s Rule
50(a)(1) motion. Cyanamid does not appear to dispute this point, confirming in its brief that
Colloids had been served with ―Cyanamid‘s motion papers, which thoroughly briefed the issue
of inequitable conduct, on the previous evening.‖

       The district court stated from the bench that ―I didn‘t rest my decision on the duty to
bring [the April 1985 tests] to the attention of the Patent Office.‖ However, in the court‘s


                                                573
subsequent written Order this was the only reason given for the ruling of inequitable conduct.
The court‘s Order referred to the British patent attorney‘s letter of March 29, 1985, about which
he had testified in connection with the issue of experimental use and his understanding of the
forthcoming ―commercial sampling.‖ The district court apparently concluded (the Order does
not explain) that if Colloids‘ British patent attorney believed that there was a public use bar
under United States law, he should have told the PTO.

         The British patent attorney was not asked about his statement during cross-examination.
For example, he was not asked why he did not file a patent application as the letter proposed.
Colloids correctly points out that it was not required to foresee and respond to an issue that had
not been raised. Rule 50(a) authorizes a directed verdict against a party only if the party has
been fully heard on the issue. The notes to Rule 50(a)(1) states: In no event, however, should the
court enter judgment against a party who has not been apprised of the materiality of the
dispositive fact and been afforded an opportunity to present any available evidence bearing on
that fact. Fed.R.Civ.P. Rule 50 advisory committee‘s note (1991 Amendment). It is apparent that
this criterion was not met.

                                                   B

       To establish unenforceability based on inequitable conduct the challenger must prove, by
clear and convincing evidence, that material information was intentionally withheld for the
purpose of misleading or deceiving the patent examiner.

        It was to mitigate the ―plague‖ whereby every patentee‘s imperfections were promoted to
―inequitable conduct‖ that this court reaffirmed that both materiality and culpable intent must be
established. As stated in Kingsdown, ―all of the evidence, including evidence indicative of good
faith, must indicate sufficient culpability to require a finding of intent to deceive.‖ 863 F.2d at
876, 9 USPQ2d at 1392. Colloids had no opportunity to present evidence concerning either
materiality or intent. The patentee can not be deprived of the right to rebut an inequitable
conduct charge by showing lack of materiality, or good faith and the absence of intent to mislead
or deceive the patent examiner.

         In view of our holding that a public use bar is not supportable on the evidence that was
adduced, the failure to tell the examiner about this purported bar can not be deemed material and
culpable in terms of the requirements of Rule 50(a)(1). It is not inequitable conduct to omit
telling the patent examiner information that the applicant in good faith believes is not material to
patentability. Whatever might be established upon trial of the issue is not before us; but the
predicate facts of materiality and intent can not be inferred in the circumstances that here existed.
The judgment of invalidity or unenforceability based on inequitable conduct must be vacated.


                       Life Techs., Inc. v. Clontech Lab., Inc.*
      UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT (2000)
                     224 F.3d 1320; 56 U.S.P.Q.2D (BNA) 1186

*
       This case was used as an exam question in Fall 2000.


                                                 574
Before MICHEL, BRYSON, and GAJARSA, Circuit Judges.

GAJARSA, Circuit Judge.
    Life Technologies, Inc. ("LTI") appeals the judgment of the United States District Court for
the District of Maryland, entered after a bench trial, in which the court held that LTI's U.S.
Patents Nos. 5,244,797 ("the '797 patent") and 5,668,005 ("the '005 patent") were unenforceable
on the ground of inequitable conduct.
   BACKGROUND
    Reverse transcriptase ("RT") is a naturally occurring enzyme that exhibits DNA polymerase
activity. DNA polymerase activity enables the RT enzyme to utilize a messenger RNA
("mRNA") molecule as a template to synthesize a complementary strand of DNA ("cDNA").
This reaction results in a DNA/RNA hybrid molecule. In addition to DNA polymerase activity,
naturally occurring RT, known as "wild-type" RT, also exhibits RNase H activity. RNase H
activity degrades the original mRNA template as the cDNA molecule is made. RNase H activity
is undesirable because this degradation of the mRNA template negatively affects the ability and
efficiency of the RT to make cDNA.
   Beginning in the early 1980's, the inventors of the '797 and '005 patents, Drs. Michael
Kotewicz and Gary Gerard, sought to develop a genetically engineered RT enzyme that exhibited
DNA polymerase activity but did not substantially exhibit RNase H activity. Kotewicz and
Gerard faced several difficulties in developing this enzyme. First, it was unknown at the time
where on the RT molecule the DNA polymerase and RNase H activities resided. Further, it was
unknown whether the RNase H activity could be selectively removed to produce an improved
mutant RT enzyme that retained DNA polymerase activity. The inventors spent several years
unsuccessfully attempting to locate and delete the RNase H activity from the RT molecule.
     The breakthrough for the inventors came in 1986 with the publication of M. S. Johnson et al.,
Computer Analysis of Retroviral Pol Genes: Assignment of Enzymatic Functions to Specific
Sequences and Homologies with Nonviral Enzymes, 83 Proceedings of the Nat'l. Acad. of Sci.
7648 (1986) ("the Johnson article"). The Johnson article reported comparisons made between
amino sequences of certain RT molecules and the sequence of the ribonuclease enzyme from E.
coli, which exhibits RNase H activity but not DNA polymerase activity. The findings of Johnson
suggested to the inventors that the RNase H activity of the RT enzyme resided at the carboxyl
terminal end of the molecule. The inventors, however, were skeptical of Johnson's results
because the literature existing at the time suggested that the location of the RNase H activity was
at the front end of the RT molecule. Additionally, the Johnson article was suspect because it
utilized computer comparisons of amino acid sequences, rather than experimental data. Such
computer comparisons were fairly new in the art at the time. Thus, in order to "exclude the
possibility" that Johnson was correct, Kotewicz and Gerard decided to conduct experiments at
the carboxyl terminal end of the RT enzyme. Contrary to expectations, these experiments were
successful and, by December 1986, the inventors had created a mutant RT enzyme that lacked
RNase H activity but retained DNA polymerase activity.
    A few months after confirming their discovery, Kotewicz and Gerard learned that another
researcher, Dr. Stephen Goff, was working to develop an engineered RT enzyme. On April 15,
1987, Kotewicz spoke on the telephone with Goff, a researcher at Columbia University. During


                                               575
this conversation, Goff stated that he had developed "oligonucleotide insertion mutations that
reduce RNase H in cloned [RT]." However, there is no indication in the record that Goff
revealed any further details concerning his work to Kotewicz during this conversation.
Additionally, during the summer of 1987, Gerard learned that Goff had presented his RT
research at Stanford University. Although neither Gerard nor Kotewicz attended this
presentation, they surmised, based on conversations with colleagues, that Goff demonstrated
"similar results" as the inventors. Based on this information, Kotewicz and Gerard urged LTI to
allow them to publish their results as quickly as possible, under the assumption that Goff would
soon publish similar work. They also submitted forms to management at LTI that initiated the
process for preparing a patent application for their engineered RT enzyme.
    In January 1988, Kotewicz and Gerard filed the parent application from which the '797 and
'005 patents ultimately issued. In general, the application claimed an engineered RT enzyme that
exhibited DNA polymerase activity but did not exhibit substantial RNase H activity. As part of
the duty of disclosure under 37 C.F.R. § 1.56, the inventors disclosed to the Patent and
Trademark Office ("PTO") numerous prior art references, including the Johnson article.
However, the inventors did not reveal their knowledge of Goff's work because their patent
attorney indicated that such limited and incomplete information would not be material.
    During the prosecution leading to the '797 patent, the Johnson article took on particular
importance for the Examiner. Several times, the Examiner rejected the inventors' claims as
obvious over Johnson, often in combination with other prior art that described the RT gene
sequence. According to the Examiner, because Johnson taught that the RNase H activity was
located at the carboxyl terminal end, and because there was a strong motivation in the art to
eliminate such activity, the claimed invention would have been obvious. In response to these
rejections, the inventors argued that, at the time of the invention, there would have been no
reasonable expectation that the application of Johnson's results would successfully lead to the
deletion of RNase H activity. This was because the teachings of Johnson were contrary to
teachings in the prior art which suggested that "something more was necessary" than a deletion at
the carboxyl terminal end to eliminate RNase H activity. Thus, the inventors contended that the
claimed invention would not have been obvious over Johnson. The Examiner was persuaded by
these arguments, and the '797 patent issued on September 19, 1993. At no time during this
prosecution did the inventors reveal to the Examiner that the Johnson article played a key role in
their development [**7] of the claimed invention.
    Shortly after the issuance of the '797 patent, the inventors filed the continuation application
that eventually resulted in the issuance of the '005 patent. During the prosecution of this
application, the inventors revealed their knowledge of Goff's work. The Examiner allowed the
application to issue over the newly revealed information regarding Goff, stating that the new
information had "no bearing on . . . the instant application."
    In December 1996, LTI sued Clontech Laboratories, Inc. ("Clontech") for infringement of the
'797 and '005 patents. In response, Clontech asserted various affirmative defenses, including an
allegation that the patents should be held unenforceable due to inequitable conduct. A bench trial
on the inequitable conduct issue ensued. After the trial, the court found that the inventors
withheld material information regarding the motivations that they derived from the Johnson
article and their reliance on it in reaching their invention. The court also found that the inventors
made affirmative material misrepresentations during prosecution regarding the Johnson article.
Further, the court found that the inventors' knowledge of Goff's work was material and should


                                                576
have been revealed to the PTO during the prosecution of the '797 patent. Finally, the court
determined that these actions were done with the intent to deceive the PTO. As a result, the court
held that both the '797 and '005 patent were unenforceable on the ground of inequitable conduct.
This appeal followed.

                                         DISCUSSION
    The district court determined that the inventors committed inequitable conduct based on three
actions during the prosecution of the '797 patent--withholding information regarding their
"reliance" on the Johnson article, making material misrepresentations regarding the Johnson
article, and withholding information regarding Goff's work. We will address each of these
actions in turn.
   1. Withholding Information Regarding the Johnson Article
     As described above, the Johnson article was extremely influential in leading the inventors to
their engineered RT enzymes. Realizing its materiality to the patentability of the claimed
invention, the inventors revealed the Johnson article to the PTO during prosecution and even
discussed it in the written description section of the patent application. The district court,
however, determined that merely disclosing the reference itself was insufficient to comply with
the duty of candor. Relying heavily on the testimony of former PTO Commissioner Harry
Manbeck, the court found that the inventors should have also disclosed their "reliance" on
Johnson, and how it motivated them to conduct the experiments that eventually led to the
invention. Thus, the district court determined that the manner in which the inventors used a
disclosed prior art reference is material information and must be revealed to the PTO. Because
this factual finding was premised upon a misapprehension of the legal standards of patentability,
it is clearly erroneous.
    Information is material when there is a substantial likelihood that a reasonable Examiner
would have considered the information important in deciding whether to allow the application to
issue as a patent.. Because patentability is assessed from the perspective of the hypothetical
person of ordinary skill in the art, information regarding the subjective motivations of inventors
is not material. See Standard Oil Co. v. American Cyanamid Co., 774 F.2d 448, 454, 227
U.S.P.Q. (BNA) 293, 297 (Fed. Cir. 1985) (noting that the person of ordinary skill in the art is an
objective legal construct presumed to think along conventional lines without undertaking to
innovate, whether by systematic research or by extraordinary insights). As stated by this court in
Standard Oil:

    Inventors, as a class, according to the concepts underlying the Constitution and the
    statutes that have created the patent system, possess something--call it what you will--
    which sets them apart from the workers of ordinary skill, and one should not go about
    determining obviousness under § 103 by inquiring into what patentees . . . would have
    known or would likely have done, faced with the revelations of references.

    Furthermore, the path that leads an inventor to the invention is expressly made irrelevant to
patentability by statute. See 35 U.S.C. § 103(a) ("Patentability shall not be negatived by the
manner in which the invention was made."). Thus, the inventors' reliance on the Johnson article
and the motivations that they derived from it have no bearing on the issue of patentability. It does


                                                577
not matter whether the inventors reached their invention after an exhaustive study of the prior art,
or developed their RT enzymes in complete isolation. The only inquiry is whether the teachings
of the Johnson article, in combination with other relevant prior art, would have rendered the
claimed invention obvious to one of ordinary skill in the art; this inquiry, as a matter of law, is
independent of the motivations that led the inventors to the claimed invention. Therefore, the
district court clearly erred by finding that the inventors' reliance on Johnson was material.
   2. Material Misrepresentations Regarding the Johnson Article
    The district court also found that the inventors made affirmative misrepresentations regarding
the Johnson article. During the prosecution of the '797 patent, the inventors were faced with
rejections based on Johnson, which taught the location of the RNase H activity, in combination
with other prior art references that described the RT enzyme itself. In response to these
rejections, the inventors argued that this combination did not render the claimed invention
obvious because at the time the invention was made, one of ordinary skill in the art would have
thought that "something more was necessary" than a deletion at the carboxyl terminal end to
eliminate RNase H activity. Thus, they argued, there would have been no reasonable expectation
of success in applying Johnson's teachings. The court               determined that this was a
misrepresentation because the inventors later admitted that the Johnson article correctly taught
the location of RNase H activity and led them directly to the claimed invention. In effect, the
court determined that inventors could not truthfully argue lack of reasonable expectation of
success as a basis for non-obviousness when they successfully used the prior art reference at
issue. The court clearly erred in this determination.
    It is axiomatic that a claimed invention is not obvious solely because it is composed of
elements that are all individually found in the prior art. Thus, even though the location of the
RNase H activity is taught in the Johnson article, the claimed invention of the '797 patent is not
per se obvious. For the Johnson article to render the claimed invention obvious, there must have
been, at the time the invention was made, a reasonable expectation of success in applying
Johnson's teachings. Because the Johnson article was contrary to established teachings and was
based on a relatively new technique, the inventors argued that a reasonable expectation of
success was lacking. This argument is simply not a misrepresentation.
    First, in making the argument, the inventors merely advocated a particular interpretation of
the teachings of the Johnson article and the level of skill in the art, which the Examiner was free
to accept or reject. This argument did not contain any factual assertions that could give rise to a
finding of misrepresentation. See, e.g., Akzo N.V. v. United States Int'l Trade Comm'n (Fed. Cir.
1986) (holding that an argument for distinguishing prior art, even though favorable to the
applicant's position, was not a material misrepresentation because the Examiner could reach
his/her own conclusions regarding the prior art). Furthermore, the inventors' argument is not
contradicted by the fact that they successfully used the Johnson article to achieve the desired
result. Reasonable expectation of success is assessed from the perspective of the person of
ordinary skill in the art. That the inventors were ultimately successful is irrelevant to whether
one of ordinary skill in the art, at the time the invention was made, would have reasonably
expected success. The court's finding to the contrary represents impermissible use of hindsight--
using the inventors' success as evidence that the success would have been expected. See In re
Kotzab (Fed. Cir. 2000) (noting the importance of casting the mind back to the time of the
invention to avoid the "insidious effect of a hindsight syndrome wherein that which only the
invention taught is used against its teacher"). In short, the inventors' non-obviousness arguments


                                                578
were not affirmative misrepresentations and cannot give rise to a determination of inequitable
conduct. Thus, the district court committed clear error.
   3. Withholding Knowledge of Goff's Work
    Finally, the district court determined that the inventors had withheld material information
regarding Goff's work. Specifically, the court found that the inventors should have revealed that
Goff claimed to have developed "oligonucleotide insertion mutations that reduced RNase H in
cloned [RT]," and had presented these results at a conference during the summer of 1987. The
court clearly erred in finding that this information was material.
    As described above, information is material when there is a substantial likelihood that a
reasonable Examiner would have considered the information important in deciding whether to
allow the application to issue as a patent. The inventors were in possession of only very limited
information regarding Goff's work. At most, the inventors could have disclosed to the PTO that a
rival researcher claimed to have reduced RNase H activity in cloned RT and had presented his
results at a conference, which neither of the inventors attended. Clontech contends that this
information was material because it indicated that Goff was a prior inventor. However, this
information lacks the specificity and definiteness required to support a patentability rejection
under section 102(g).
    To establish prior inventorship, one must show either a prior reduction to practice of the
invention or a prior conception followed by reasonable diligence in reducing the invention to
practice. While the inventors knew that Goff had potentially achieved a reduction in RNase H
activity in RT enzymes, the inventors were unaware of when these results were achieved, how
they were achieved, the degree to which the RNase H activity was reduced, or whether DNA
polymerase activity was retained. Knowledge of these details would have been required for the
Examiner to consider whether Goff was a prior inventor. Because the inventors lacked such
crucial information, the incomplete knowledge that they did have regarding Goff would not have
been material to a reasonable Examiner. See Hartness Int'l, Inc. v. Simplimatic Eng'g Co. (Fed.
Cir. 1987) (holding that inequitable conduct had not been established when the patentee had only
"heard of" a third-party usage). This conclusion is supported by the fact that when the substance
of the Goff telephone conversation was revealed to the Examiner during the prosecution of the
'005 patent, the Examiner stated that the information had "no bearing on the patents issued or the
instant application." Such a strong statement regarding the Goff information is highly probative
of its immateriality. See Molins ("The result of a PTO proceeding that assesses patentability in
light of information not originally disclosed can be of strong probative value in determining
whether the undisclosed information was material.").
    Moreover, the inventors did not obtain any material information regarding Goff's work based
on his presentation at Stanford. The inventors neither attended this presentation, nor were
provided with an abstract of the presentation. They had heard from colleagues that Goff
presented results similar to theirs, but the record does not show that the inventors learned any
additional details regarding Goff's work. Thus, the inventors could not have revealed anything to
the Examiner regarding this presentation beyond conjecture and a vague report that "similar
results" were presented. Such incomplete information would be singularly unhelpful to the
Examiner in determining whether the invention was patentable, and consequently, would not be
material.




                                               579
                    ATD CORPORATION v. LYDALL, INC.
                  United States Court of Appeals, Federal Circuit, Oct. 6, 1998.
                                 --- F.3d ----, 1998 WL 690811


Before RICH, NEWMAN, and CLEVENGER, Circuit Judges.

PAULINE NEWMAN, Circuit Judge.

   ATD Corporation appeals the final judgment of the District Court for the Eastern District of
Michigan, holding the claims in suit invalid.…

                                        BACKGROUND

 The ‗743 patent relates to a flexible insulating pad that includes heat sink and thermal insulation
areas. It is described as particularly useful for providing ―hot spot‖ insulation, and is used
primarily in automotive underbodies. It achieved prompt commercial acceptance, as an
economical and efficient structure for dissipating heat.

 Upon ATD‘s suit for patent infringement, Lydall raised the defenses of non- infringement,
invalidity, and unenforceability. … The district court also granted ATD‘s motion that there was
not inequitable conduct in the prosecution of the patents.

                                               ***

                                           IV
                                  INEQUITABLE CONDUCT

 The district court ruled on summary judgment that the ‗743 and ‗577 patents were not
unenforceable for inequitable conduct. Lydall appeals this ruling, stating that there were disputed
facts as to whether certain information was material to patentability, and therefore that the issue
was not amenable to summary disposition. Although the premises of inequitable conduct require
findings based on all the evidence, a procedure that may preclude summary determination, a
motion for summary judgment may be granted when, drawing all reasonable factual inferences in
favor of the non-movant, the evidence is such that the non-movant can not prevail.

 Lydall argued that during prosecution of the ‗577 divisional application ATD withheld U.S.
Patent No. 2,212,481 to Sendzimir, as well as a PCT search report and prosecution records
applying Sendzimir to the corresponding PCT application. Lydall argues that this inequitable
conduct in prosecuting the ‗ 577 patent ―infects‖ the ‗743 parent patent, and that both patents
should be held unenforceable.

 The Sendzimir patent was cited in the prosecution of the ‗743 patent. Thus the district court
found that ATD‘s failure to provide the Sendzimir information during the prosecution of the ‗577


                                                580
divisional patent was not clear and convincing evidence of intent to deceive, observing that in
accordance with M.P.E.P. § 609 a reference is not required to be resubmitted in prosecuting a
divisional application:

    § 609 .... the patent examiner will consider information cited or submitted to the Office
    in a parent application when examining a continuing application, and a list of the
    information need not be submitted in the continuing application unless applicant desires
    the information to be printed on the patent.

In view of § 609 it can not be inequitable conduct for an applicant not to resubmit, in the divisional
application, the information that was cited or submitted in the parent application. Nor was ATD
required to submit the documents relating to Sendzimir in the record of the PCT application, when
Sendzimir was already of record in the United States parent application. Although international
search reports may contain information material to patentability if they contain closer prior art than
that which was before the United States examiner, it is the reference itself, not the information
generated in prosecuting foreign counterparts, that is material to prosecution in the United States.
The details of foreign prosecution are not an additional category of material information.

 We discern no clear error in the district court‘s ruling that because the Sendzimir reference was
of record in the parent ‗743 application, and because M.P.E.P. § 609 states that the information
need not be resubmitted, there was not clear and convincing evidence of material withholding
with intent to deceive. The summary judgment of no inequitable conduct is affirmed.


                            MARLOW INDUSTRIES, INC.
                                      v.
                             IGLOO PRODUCTS CORP.
                   United States Court of Appeals, Federal Circuit, May 23, 2003.
                              65 Fed.Appx. 313, 2003 WL 21212626
                 [This case was not selected for publication in the Federal Reporter.]



   Before LOURIE, LINN, and PROST, Circuit Judges.

    PROST, Circuit Judge.

     Marlow Industries, Inc. ("Marlow") appeals from the decision of the United States District
Court for the Northern District of Texas granting summary judgment to Igloo Products Corp. and
holding Marlow's United States Patent No. 4,726,193 ("the '193 patent"), as amended by
Reexamination Certificate B1 4,726,193 ("the first reexamination") and Reexamination
Certificate U.S. 4,726,193 C2 ("the final reexamination") unenforceable due to Marlow's
inequitable conduct before the United States Patent and Trademark Office ("PTO"). Because the
district court did not commit error in granting Igloo's motion for summary judgment, we affirm
the judgment.



                                                 581
                                                   I

     The '193 patent covers picnic boxes. Independent claim 1 reads in pertinent part "[a]
refrigerator/food warmer picnic box apparatus or the like comprising ... means ... for selectively
heating and cooling and circulating the air in the food compartment picnic box ...." (emphasis
added). Marlow filed an infringement action against Igloo in September 1996 and cross-moved
for partial summary judgment on September 29, 1997, claiming that, as a matter of law, several
of the contested picnic boxes infringed the patent.

     In an opinion dated April 3, 1998, the district court concluded, "it is obvious that the plain
meaning of Claim 1 requires that the picnic box be capable of both 'heating and cooling.' " Both
parties moved the court to reconsider its April 3 order. On September 1, 1998, the district court
entered an order denying Marlow's motion for reconsideration, but granting Igloo's motion in
part by vacating its prior ruling that some of the accused picnic boxes literally infringed the '193
patent, concluding rather that none of the accused products literally infringed the patent. The
court left open several issues regarding infringement under the doctrine of equivalents.

     In June 1998, Igloo requested the PTO to reexamine the '193 patent to consider prior art that
was not previously considered. Marlow subsequently moved to stay further action in the district
court until completion of the reexamination proceedings. Igloo's request for the final
reexamination brought to the examiner's attention the pending infringement litigation in the
district court between Marlow and Igloo, and included a copy of Marlow's brief in support of its
September 29, 1997, motion for partial summary judgment. During the reexamination, Marlow
attempted to amend the patent by adding claims 4 and 5. These claims included language that
covers a picnic box, which "cools or heats" (independent claim 4) and which "only cools" (claim
5, depending from claim 4). The examiner rejected these claims pursuant to 35 U.S.C. § 305,
which prohibits expanding the scope of the claimed invention during a reexamination.

     Marlow then attempted for a second time to amend the patent by adding claims 6 and 7.
These claims, both depending from claim 1, included language covering a picnic box, which
"heats and circulates only warm air" (claim 6) and which "cools and only circulates cooled air"
(claim 7). The examiner again rejected these claims as an attempt to impermissibly broaden the
scope of the original patent. Marlow appealed the examiner's rejection of its claims, including
the rejection of its four proposed amendments, to the Board of Patent Appeals and Interferences
("Board"). The Board affirmed the examiner's rejection of proposed claims 5-7. However, the
Board reversed the examiner's rejection of claim 4 on the basis that it, like preexisting claim 1,
includes the "selectively heating and cooling" language and, thus, cannot be construed as
enlarging the scope of the claimed invention.

     In August 2001, Igloo moved for summary judgment in the district court, in which the
infringement action was pending, alleging that Marlow had committed inequitable conduct by
failing to disclose to the examiner during the final reexamination of the '193 patent the court's
prior claim construction of that patent. The district court determined that Marlow had failed
during the reexamination to provide the examiner with the court's April 3 and September 1, 1998
orders, that these orders were material to the reexamination proceeding, and that Marlow knew
or should have known that a patent examiner would have found such information material. The



                                                582
district court also found that Marlow failed to submit to the examiner its motion for
reconsideration of the court's April 3 order, but the court did not analyze Marlow's inequitable
conduct with regard to its failure to submit this document. Based upon these findings, the court
concluded that Marlow engaged in inequitable conduct before the PTO. The district court
therefore granted Igloo's motion for summary judgment and declared all claims of the '193 patent
unenforceable.

                                                   II

                                                 ***

    On appeal, Marlow maintains that the district court erred in granting summary judgment to
Igloo because it raised genuine issues of material fact. According to Marlow, the district court
impermissibly weighed the evidence regarding its failure to disclose information to the PTO, the
materiality of the allegedly withheld information, and Marlow's intent to deceive the PTO. Igloo
counters that Marlow has no additional evidence to offer that would warrant changing the district
court's determination or that would otherwise merit further proceedings. After drawing all
justifiable inferences in favor of Marlow, we conclude that there are no genuine issues of
material fact with regard to Marlow's inequitable conduct and Igloo is entitled to judgment as a
matter of law.

                                                   A

    Marlow first argues that a genuine issue of material fact exists with regard to whether it
withheld any information relating to the district court action from the PTO during the final
reexamination. In this regard, Marlow notes that it advised the examiner that the '193 patent was
the subject of an infringement action pending before the district court, the examiner was
provided with copies of the particular documents relating to those proceedings which Igloo
believed relevant to the final reexamination, and the entire record was made available to the
examiner by Marlow's and Igloo's disclosures.

     Igloo maintains that Marlow never once apprised the examiner of the substance of the
district court's claim construction of the '193 patent or even of the fact that the court had
construed the patent. Igloo specifically contends that the district court correctly found that
Marlow failed to submit the three disputed documents to the examiner.

    The district court did not err in concluding that there was no genuine issue of material fact
with respect to Marlow's failure to submit copies of the disputed documents to the examiner
during the final reexamination. In its responses to Igloo's Requests for Admission Nos. 92-94,
Marlow admitted that at the time of the issuance of the final reexamination, the file wrapper did
not include copies of these documents. We reject Marlow's argument that a genuine issue of
material fact exists as to whether it withheld any information relating to the infringement action
from the PTO. Informing the examiner of the pending infringement action is not commensurate
with bringing to the examiner's attention the district court's prior claim construction of the patent
or disclosing the court orders embodying this construction. See Rohm & Haas Co. v. Crystal
Chem. Co. (Fed.Cir.1983) (concluding that a presumption that an examiner was able to find, with


                                                583
his expertise and adequate time, the critical data when he was presented with a "mountain of
largely irrelevant data" ignores the real world conditions under which examiners work).
Moreover, the only document from the infringement litigation submitted to the examiner was
Marlow's motion for partial summary judgment filed on September 25, 1997, which was
included as an exhibit to Igloo's request for reexamination. This document, however, was filed
in the district court more than six months prior to the court's initial construction of the '193 patent
and, thus, had no bearing on the scope of the claims at issue during the reexamination
proceedings.

                                                    B

    Marlow next argues that a genuine issue of material fact exists with regard to the materiality
of the district court's claim construction orders. "Materiality is not limited to prior art but
embraces any information that a reasonable examiner would be substantially likely to consider
important in deciding whether to allow an application to issue as a patent."

     Marlow contends that in reaching its finding that its previous orders were material to the
examiner's final reexamination of the '193 patent, the district court erroneously assumed that: (1)
the construction of claim 1, and thus claim 4, applied by the Board was in conflict with the
district court's construction of claim 1; and (2) Marlow was attempting during the reexamination
to avoid the district court's requirement that to infringe the '193 patent an accused device had to
be capable of both heating and cooling. According to Marlow, it argued to the examiner that
claim 1 could not require both "simultaneous" heating and cooling because that would be
physically impossible, which is not inconsistent with the district court's interpretation of the
claim.

   Igloo responds that the district court correctly concluded that the disputed documents were
material to the final reexamination because: (1) they bore directly on the scope of the claims that
Marlow attempted to amend; and (2) Marlow's interpretation of the patent asserted before the
examiner was inconsistent with the district court's construction of the patent and Marlow's
acquiescence to that construction.

     The district court did not err in concluding that there was no genuine issue of material fact
with respect to the materiality of the April 3 and September 1, 1998, orders to the final
reexamination from the standpoint of a reasonable examiner reviewing Marlow's proposed
amendments. Faced with Marlow's attempts to amend claim language in the '193 patent, the
examiner had to first construe the scope of the claims, including the specific language covering
picnic boxes that are capable of both "heating and cooling," to determine whether the proposed
"cools or heats" language would impermissibly enlarge the scope of the patent. In addition, the
district court's two previous orders construing the '193 patent and concluding that picnic boxes
that only cooled did not infringe the patent were binding on the examiner under the doctrine of
issue preclusion. See In re Freeman (Fed.Cir.1994) (concluding that the Board was bound by the
district court's prior interpretation of the reissue claims under the doctrine of issue preclusion).
Thus, a reasonable examiner would have been substantially likely to consider these two orders
important in deciding whether to allow the amendments to issue.




                                                 584
     Moreover, contrary to Marlow's assertion, whether or not the Board, applying the same
construction of claim 1 as the district court, found claim 4 equivalent in scope to claim 1 is
irrelevant to the materiality inquiry. This court has articulated the materiality criterion as
follows:

        [T]he standard to be applied in determining whether a reference is "material" is not
    whether the particular examiner of the application at issue considered the reference to
    be important; rather, it is that of a "reasonable examiner." Nor is a reference immaterial
    simply because the claims are eventually deemed by an examiner to be patentable
    thereover.

      Molins; Perseptive Biosystems, Inc. v. Pharmacia Biotech, Inc. (Fed.Cir.2000) (stating that
a patent may be valid and yet be rendered unenforceable due to inequitable conduct). Thus, that
the Board's interpretation of the '193 patent may have been consistent with the district court's
previous construction does not eviscerate the materiality of the previous orders from the
viewpoint of a reasonable examiner in the first instance. Here, a reasonable examiner reviewing
Marlow's proposed amendments would have considered the district court's prior construction of
that patent important.

                                                  C

    Lastly, Marlow argues that a genuine issue of material fact exists with regard to Marlow's
intent to deceive the PTO. Intent to mislead does not require direct evidence, and is typically
inferred from the facts. Intent may be inferred when a patent applicant knew, or should have
known, that withheld information could be material to the PTO's consideration of the patent
application.

    Marlow argues that a factual dispute exists with regard to its alleged intent to deceive the
PTO. According to Marlow, the district court found intent by incorrectly assuming that claim 4 is
broader than claim 1 and by disregarding the affidavit of Marlow's attorney denying an intent to
deceive.

     Igloo argues that the district court correctly concluded that Marlow acted with intent to
deceive the PTO. According to Igloo, Marlow knew, or should have known that the examiner
would have considered the district court's claim construction of the '193 patent (specifically its
holding that cool only or heat only devices cannot infringe the '193 patent) material to Marlow's
attempts to add claims directed to cool only or heat only devices. Igloo further contends that the
affidavit of Marlow's counsel does not create a genuine issue of fact as to Marlow's intent
because it consists of mere denials of an intent to deceive.

     The district court did not err in concluding that there was no genuine issue of material fact
with respect to Marlow's intent to deceive the PTO by failing to submit the district court's prior
orders construing the claims of the '193 patent when it proposed amended language during the
final reexamination. The same attorney represented Marlow before the district court in this case
and before the PTO during the final reexamination proceedings. See Critikon, (noting that the
patent counsel who were handling the reissue proceedings were keenly aware of the ongoing


                                               585
district court litigation and the issues involved prior to the resolution of the reissue proceedings).
Yet, despite the district court's prior holding that a picnic box had to both heat and cool to
infringe the ' 193 patent, Marlow proposed claims using the disjunctive language of "cools or
heats." See In re Freeman (stating that "given the interpretation of the district court during the
infringement litigation, it is clear that the amendments to the independent claims during
reexamination attempt[ed] an end run around the [district court's] interpretation"). Under these
circumstances and in light of the binding nature of the district court's prior claim construction,
Marlow's failure to submit the April 3 and September 1, 1998, orders leads to a finding that
Marlow intended to deceive the PTO. As the district court recognized when considering Igloo's
inequitable conduct motion, Marlow should have known that a patent examiner would have
found the two prior court orders considering the construction of the '193 patent material to the
reexamination. Indeed, during the pendency of the reexamination, Igloo's counsel twice
reminded Marlow by letter of its duty to disclose the district court's claim construction to the
examiner. The only evidence Marlow offers to negate a finding of an intent to deceive is an
affidavit from its counsel denying such deceitful intent. However, a mere denial of an intent to
deceive is not sufficient where a patentee faces a high level of materiality and proof that it knows
or should have known of that materiality.



                     BRISTOL-MYERS SQUIBB COMPANY
                                   v.
                       RHONE-POULENC RORER, INC.,
                 United States Court of Appeals, Federal Circuit.(2003)
                          326 F.3d 1226, 66 U.S.P.Q.2d 1481

    Before CLEVENGER, SCHALL, and PROST, Circuit Judges.

    PROST, Circuit Judge.

     Rhone-Poulenc Rorer Inc., Rhone-Poulenc Rorer, S.A., and Centre National De La
Recherche Scientifique (collectively "RPR") appeal from the judgments of the United States
District Court for the Southern District of New York: (1) holding that RPR obtained United
States Patent No. 4,924,011 ("the '011 patent") and United States Patent RE 34,277 ("the '277
patent") by inequitable conduct and, thus, that its '277 patent is unenforceable…. Because the
district court's holding that RPR committed inequitable conduct is not an abuse of discretion, we
affirm.

                                                    I

    The patents at issue claim a semi-synthesis of taxol, a cancer chemotherapeutic agent. The
inventors' method involves modifying 10- deacetylbaccatin III ("10-DAB") with an acetyl group
and adding a (2R, 3S) 3- phenylisoserine side chain ("the side chain") through an esterification
reaction. Several hydroxyl groups, located on both the 10-DAB and side chain molecules,
readily react to form other unwanted products. To overcome this problem, the inventors devised


                                                 586
a method of utilizing "protecting groups" to prevent particular hydroxyl groups on the 10-DAB
core and side chain molecules from reacting in side reactions and thereby preventing the
formation of taxol. First, starting with 10-DAB, a hydroxy-protecting group is introduced at the
C- 7 hydroxyl position on the 10-DAB molecule to form the C-7 protected intermediate.
Second, an acetyl group replaces the hydrogen atom that is bonded to the oxygen atom at the
C-10 position on the 10-DAB molecule, forming protected Baccatin III. Third, the side chain is
protected by a hydroxy-protecting group at its C-2' position and then esterified (or coupled) with
the protected Baccatin III at its C-13 position. Lastly, the hydroxy- protecting groups at the C-7
position of the Bacacatin III core and the C-2' position of the side chain are deprotected
(removed) to form taxol. Of particular significance in this appeal is that the subject patents
stemmed from a scientific article, written by the named inventors of the patents, entitled "A
Highly Efficient, Practical Approach to Natural Taxol," which was eventually published in the
Journal of the American Chemical Society ("the JACS article").2

     On approximately November 3, 1987, the inventors submitted a draft of what became the
published JACS article to Jacques Pilard, a patent agent in the employ of RPR in France. The
draft JACS article, written in English, stated that the conversion of 10-DAB to taxol "could be
successfully achieved only with specific protecting groups and under unique reaction
conditions."3 It also explained the limitations of several protecting groups as follows:

     "A methoxymethyl [ ("MOM") ] protecting group at C-2' could not be removed
     following esterification" (footnote 16 of the JACS article).

     "The trimethylsilyl [ ("TMS") ] group could also be selectively introduced at C-7, but it
     proved unstable to the subsequent esterification conditions" (footnote 13 of the JACS
     article).

     "The tert-butyldimethylsilyl [("TBDMS")] group could not be cleanly introduced" at
     C-7 (footnote 13 of the JACS article).

     On approximately November 17, 1987, Mr. Pilard recommended to one of the inventors that
the draft publication should or could be the subject of a patent application. In a letter sent to Mr.
Pilard dated January 29, 1988, P.E. Simon of RPR's Grants and Licenses Department suggested
that a patent application covering the inventors' semi-synthesis of taxol be filed in consideration
of an exclusive license to RPR. On or about March 7, 1988, two of the inventors provided Mr.
Pilard their resumes and an invention disclosure, entitled "Modes Operatoires," which described
their semi-synthesis of taxol in detail. Consistent with the draft JACS article, the Modes
Operatoires also explained the limitations of several protecting groups. Specifically, it stated the
following:



2
         Four of the six authors of the JACS article were named inventors on the '011 patent application.
Aside from the difference in the listed authors of the draft and published JACS articles, the substance of the
draft and the published JACS articles is the same.
3
         The published version of the JACS article changed "under unique reaction conditions" to "under
specially developed reaction conditions, as described below."


                                                    587
       The regioselective protection of the hydroxyl at C-7 of 10-DAB was also obtained
    with TMS. "However, this [TMS] group proved too fragile in the esterifying reaction
    with the protected side chain."

        "The protecting reaction does not go forward with the [TBDM] chloride."

   (English translation of French original)

     Moreover, the Modes Operatoires stated the hydroxyl function of the side chain was
protected with a wide variety of protective groups, such as the MOM group, but it did not state
that MOM could be removed.

     On March 10, 1988, Mr. Pilard began drafting a French patent application for the
semi-synthesis of taxol. In claim 1 of the draft patent application, Mr. Pilard claimed the process
as one "in which R2 is a hydroxy-protecting group ... [and] in which R3 is a hydroxy-protecting
group," without specifying any limitation as to the hydroxy-protecting groups that could be used
in the process. In claim 2 of the draft application, Mr. Pilard claimed the process according to
claim 1 "in which R2 is chosen from [MOM and other compounds] ... and R3 is chosen from
trialkylsilyl groups in which each alkyl portion contains one to three carbon atoms." (The '011
patent application is an English translation of the French application.) Not only did Mr. Pilard
specify that MOM and TMS were permissible hydroxy-protecting groups in claim 2, but he also
stated in the specification of the draft patent application that "R2 denotes, more especially, a
[MOM and other compounds] ... radical" and that "[p]referably, R3 is a[TMS] ... radical."

    On approximately March 18, 1988, Mr. Pilard sent his draft of the French patent application
to two of the inventors asking them to carefully review it and add all the complements and
modifications they deemed necessary. They made no substantive changes to either the
specification or the claims. Mr. Pilard filed the French patent application on April 6, 1988. The
Journal of the American Chemical Society received the draft article on April 20, 1988, and it was
published on August 17, 1988.

     In March 1989, Mr. Pilard sent a copy of the French application and a search report dated
November 24, 1988, generated by the French National Institute of Industrial Property, to J.A.
Kemp & Company for translation into English and forwarding to Mr. Ellsworth H. Mosher,
RPR's United States patent attorney. The search report did not list the JACS article and Mr.
Pilard did not send a copy of the JACS article, the Modes Operatoires, or any of the inventors'
test results to J.A. Kemp & Company or Mr. Mosher.

     On April 3, 1989, Mr. Mosher filed the '011 patent application with the United States Patent
and Trademark Office ("PTO"). The filed patent application, except for the abstract, is an
English translation of the French patent application previously prepared and filed by Mr. Pilard.
Mr. Mosher, who never received a copy of the JACS article from Mr. Pilard, did not disclose it
to the PTO.

    At some point during the prosecution of the '011 patent, the Examiner assigned to the '011
patent application asked the PTO Scientific Library to perform a computer search of chemical


                                               588
abstracts using the chemical structure of claim 1 as the subject matter to be searched. The
generated search report listed the JACS article as "Answer 1 of 11" and identified, among other
attributes, its year of publication, 1988. The search report also listed another article, authored by
two of the inventors of the '011 patent and published in 1987, as "Answer 5 of 11." The
Examiner listed the 1987 article on a "Notice of References Cited." However, the Examiner did
not place his initials next to either of the listed articles on the search report. He placed the search
report in the file history. On May 8, 1990, the PTO issued the '011 patent.

    On approximately January 31, 1991, Mr. Pilard wrote to the European patent office and
withdrew the claims previously drawn in the counterpart European patent application. He
replaced those claims with a single claim (similar to claims 2-7 of the '011 patent) for the
inventors' semi-synthesis process.

     On June 11, 1991, Mr. Pilard sent Mr. Frederick F. Calvetti, a United States patent attorney
in a different law firm than the one employing Mr. Mosher, a letter by fax and post about filing a
reissue patent application with additional claims directed to the disclosed but unclaimed
intermediates of formulas IV and V of the '011 patent.5 Mr. Pilard's letter attached a copy of the
'011 patent and the JACS article with footnote 16 circled, although it is unclear who circled the
footnote. On June 13, 1991, Mr. Calvetti replied to Mr. Pilard's letter stating that the JACS
article would not affect the grant of the original '011 patent because the journal publication was
filed less than one year prior to the filing of the '011 patent application in compliance with 35
U.S.C. § 119, and that a reissue patent application could be filed.

     On approximately June 24, 1991, Mr. Calvetti wrote Mr. Pilard's supervisor at RPR stating
that the intermediate of formula V was likely patentable, but expressed reservations about the
patentability of the intermediate of formula IV because it was derived from modifying a naturally
occurring compound, which "may not be considered nonobvious." Mr. Pilard's response to Mr.
Calvetti attached a document that discussed the reasons he believed the intermediates were
patentable and included a draft of the proposed additional claims. The relevant portion of Mr.
Pilard's letter stated:

        The protecting group at C-7 has to be stable under the acetylating conditions and to
    the subsequent esterifying conditions. Furthermore, the elimination of the protecting
    groups has to be made under conditions which do not conduct to an epimerisation at the
    C-13 or at the C-2': ... Even if protecting groups are known, it is difficult to select an
    appropriate protecting group without undue experimentation.

     On November 1, 1991, Mr. Calvetti filed the '277 reissue patent application. In addition to
all the claims in the '011 patent, the reissue application claimed three intermediates in the prior
patent. Mr. Calvetti did not disclose the JACS article to the PTO upon filing the reissue
application. During prosecution of the reissue application, the Examiner assigned to review the '
277 patent application, the same Examiner who had reviewed the '011 patent application,
requested a computer search of the newly claimed intermediates. That search result identified the



5
       Formula IV is protected Baccatin III and formula V is protected taxol.


                                                  589
JACS article. Mr. Calvetti, however, did not disclose the JACS article to the PTO during any of
his interactions or communications with the agency at this point in time.

     On approximately July 17, 1992, Mr. Pilard sent a letter to Mr. Calvetti identifying prior art
and references published between the filing dates of the original patent application and the
reissue patent applications. With regard to the latter category, Mr. Pilard identified seven
documents, including the JACS article, and stated "[a]ccording to our evaluation, these
references are irrelevant." On October 20, 1992, Mr. Calvetti interviewed with the Examiner
regarding the reissue application. On or around December 14, 1992, Mr. Calvetti filed a
response to an Official Action by the Examiner, but did not submit the JACS article to the PTO.

     By letter dated December 15, 1992, Mr. Calvetti filed an information disclosure statement
with the PTO citing and providing a copy of the JACS article, pursuant to Mr. Pilard's
instructions. A receipt stamp of the PTO on the information disclosure statement bears the date
January 14, 1993. In February 1993, subsequent to indicating that the reissue application would
be allowed, the Examiner reviewed the information disclosure statement that listed the JACS
article as a reference. On June 8, 1993, the PTO issued the '277 patent.

     In October 1995, Bristol filed suit against RPR in the United States District Court for the
Southern District of New York seeking a declaratory judgment that it does not infringe the '277
reissue patent and that the patent is invalid and unenforceable. RPR subsequently filed suit
against Bristol in the United States District Court for the District of Delaware asserting
infringement. The suit was transferred and consolidated with Bristol's New York case. In March
2001, the district court held a two-day evidentiary hearing on claim construction and
interpretation of the JACS article.1 The court issued an opinion finding by clear and convincing
evidence that the inventors failed to provide material information by not providing the PTO with
the JACS article during the prosecution of the '011 patent and that the Examiner did not review
the article prior to issuing the '011 patent. Thereafter, in November 2001, the court held a
four-day bench trial on the issue of RPR's intent. The court found by clear and convincing
evidence that RPR procured the '011 and '277 patents by inequitable conduct by intentionally
withholding material information from the PTO with intent to mislead and, therefore, held that
the '277 patent is unenforceable. The court … subsequently declared the case exceptional and
awarded Bristol costs and reasonable attorney fees to be determined by the court.

                                                      II

    To establish RPR's inequitable conduct, Bristol must show by "clear and convincing
evidence" that RPR failed to disclose material information with an intent to mislead the PTO.
Once the materiality of the information and RPR's intent to mislead have been established, the
court must "weigh them to determine whether the equities warrant a conclusion that inequitable
conduct occurred." Moreover, when balanced against high materiality, the showing of intent can
be proportionally less. Both materiality and intent to mislead are questions of fact reviewed for


1
       The district court referred several matters to a Special Master,   including the "interpretation of
the JACS article" relating to materiality of the JACS article. The Special Master filed a Report and
Recommendation with his findings, which the district court fully adopted.


                                                  590
clear error. We review the ultimate determination of inequitable conduct under an abuse of
discretion standard.

                                                    A

    We first review the district court's materiality finding. "Materiality is not limited to prior art
but embraces any information that a reasonable examiner would be substantially likely to
consider important in deciding whether to allow an application to issue as a patent." The district
court found by clear and convincing evidence that the inventors failed to provide material
information by not providing the JACS article to the PTO during the prosecution of the '011
patent and that the Examiner did not review the article prior to issuing the '011 patent.

     We conclude that the district court's finding that the JACS article was material to the
prosecution of the '011 patent from the standpoint of a reasonable patent examiner is not clearly
erroneous considering the examiner's obligation to review the application for enablement under
35 U.S.C. § 112. The legal question of enablement involves an assessment of whether a patent
disclosure would have enabled one of ordinary skill in the art at the time the application was
filed to make and use the claimed invention without undue experimentation. The patents
specifically recommend using the TMS and MOM hydroxy-protecting groups in the
esterification process, but the JACS article, from which the '011 patent application stemmed,
reports that the TMS group was unstable in the esterification process and that the MOM group
could not be removed after esterification. Moreover, the evidence supports the district court's
finding that a reasonable patent examiner reviewing the subject patent application would have
expected the use of TMS and MOM groups to yield more than trace amounts of taxol, but that a
review of the JACS article would have raised doubts that the use of TMS and MOM would
produce taxol in more than trace amounts. The '011 patent application emphasizes the
importance of taxol and states, "[t]his process may be used to produce taxol in good yield."
However, the JACS article declares limitations with regard to the use of TMS and MOM in
producing taxol from 10-DAB. Footnote 13 of the JACS article, which relates the difficulties
associated with using TMS, was consistent with testimony at the hearing that TMS historically
was known not to be very useful. In addition, Bristol's expert, Dr. Elias J. Corey, testified that a
person of ordinary skill in the art would understand footnote 16 of the article to mean that the
inventors had unsuccessfully examined MOM as a possible protecting group. Moreover, one of
the inventors testified that using MOM would result in something between a very bad yield and
zero. No expert witness testified that a person of ordinary skill in the art would see the TMS or
MOM failures reported in the article as related to just one experiment or that such a person
would know that TMS or MOM could be made to work under other experimental conditions. In
addition, there was no testimony by any of the inventors suggesting how further experimentation
with TMS or MOM could be carried out or how a person of ordinary skill in the art would know
what to do to make these protecting groups work efficiently. Under the circumstances, a
reasonable Examiner would have wanted to know whether the unsuccessful use of MOM and
TMS discussed in the JACS article affected the ability of a person of ordinary skill in the art to
practice the invention, which specifically taught the use of MOM and TMS, without undue
experimentation. Therefore, the district court did not clearly err in concluding that the limiting
statements in the JACS article with regard to the unsuccessful use of TMS and MOM in
producing taxol would have raised an important issue in a reasonable examiner's mind as to



                                                 591
whether the inventors had broadened the patent beyond that legally permissible based on the
examiner's review of the application for enablement.

    In affirming the district court's decision, we reject the four arguments raised by RPR on
appeal challenging the finding of materiality. RPR essentially asks this court to substitute its
view of the evidence and credibility of the witnesses for the district court's careful and thorough
fact finding. We cannot provide such relief because our task as a reviewing court is not to make
factual determinations in the first instance, but to review the district court's factual findings for
clear error. RPR first argues that the Examiner must have determined the JACS article was
immaterial because he "likely considered" the article during the '011 patent prosecution and still
allowed the patent. [FN8] According to RPR, applying the statutorily mandated presumption of
patent validity assumes that the Examiner performed his job properly or regularly and leads to
the conclusion that the Examiner must have read all the references on the search report requested
by him. See Am. Hoist & Derrick Co. v. Sowa & Sons, Inc., 725 F.2d 1350, 1359, 220 USPQ
763, 770 (Fed.Cir.1984) (noting that imposition of presumption of validity standard is related to
presumption that PTO does its job properly). The Examiner did not initial any of the items on
the search report, which listed the JACS article as "Answer 1 of 11," but the Examiner listed
"Answer 5 of 11" from the report on a form PTO-892. RPR contends that the lack of the
examiner's initials on the '011 computer search report is consistent with his "regular" practice and
does not rebut the presumption of validity/regularity or the logical conclusion that the Examiner
in fact considered every listing on the search report, including the JACS article, to determine
what to list on the form PTO- 892.

     We uphold the district court's finding that the Examiner did not review the JACS article
during the '011 patent prosecution because the MPEP and the record evidence belie RPR's
insistence that the lack of the Examiner's initials next to the listing of the article on the search
report supports a finding that he reviewed the article. The MPEP § 717.05 (5th ed. Rev. 6 Oct.
1987) states that an examiner "should indicate which publications [on a search printout] were
reviewed by initialing and dating the copy of the printout in the left margin adjacent to each
reviewed publication." Thus, had the Examiner been performing his duties "regularly," he would
have initialed and dated "Answer 5 of 11" on the search report and the JACS article if he read it.
Those are not the facts presented. Rather, the file history does not contain a copy of the JACS
article and the Examiner did not initial and date the listing of the article on the search report, a
copy of which he placed in the file history. Moreover, the district court did not find convincing
or credible the opinion of RPR's expert that the Examiner had reviewed the article despite the
provisions of the MPEP because he had the discretion to initial and date listings on the search
report. See Refac Int'l, Ltd. v. Lotus Dev. Corp. (Fed.Cir.1996) (stating that the district court is
best suited to make credibility determinations and we accord such determinations deference).
The lack of any objective evidence that the Examiner reviewed the article in connection with his
review of the '011 patent application supports the court's finding that the JACS article was not
before the PTO in its review of the '011 patent application. See Rohm & Haas Co. v. Crystal
Chem. Co. 302 (Fed.Cir.1983) (concluding that a presumption that an examiner was able to find,
with his expertise and adequate time, the critical data when he was presented with a "mountain of
largely irrelevant data" ignores the real world conditions under which examiners work).




                                                592
     RPR next argues that materiality is lacking because it is undisputed that the Examiner
considered the JACS article during the '277 reissue prosecution, but did not reject any claims
because of it. In support of its argument, RPR notes this court's statement in an opinion on
RPR's petition for a writ of mandamus in an earlier phase of this case that "it is by no means
clear that Bristol-Myers will ultimately prevail in making a showing of fraud sufficient to render
the patents unenforceable.... To be sure, the fact that the JACS article was disclosed to the
examiner in the reissue prosecution but did not lead the examiner to reject the application is
relevant evidence favoring RPR with regard to the issue of materiality."

     We conclude, however, that the district court did not clearly err in finding that the JACS
article was material notwithstanding the Examiner's decision to issue the '277 reissue patent after
RPR disclosed the JACS article to the PTO. First, RPR's reliance on this court's previous
mandamus order is misplaced because the court was not deciding the issue of materiality
favorably to RPR on the limited record then before it. Indeed, this court also recognized that the
district court had made explicit findings adverse to RPR on the issues of materiality and this
court was not persuaded that those findings were clearly wrong. Second, although the
examiner's allowance of the reissue patent after considering the JACS article is probative
evidence, that does not end the materiality inquiry. Molins, (stating that "the result of a PTO
proceeding that assesses patentability in light of information not originally disclosed can be of
strong probative value in determining whether the undisclosed information was material"). This
court has articulated the materiality criterion as follows:

        [T]he standard to be applied in determining whether a reference is "material" is not
    whether the particular examiner of the application at issue considered the reference to
    be important; rather, it is that of a "reasonable examiner." Nor is a reference immaterial
    simply because the claims are eventually deemed by an examiner to be patentable
    thereover.

    PerSeptive Biosystems, Inc. v. Pharmacia Biotech, Inc. (Fed.Cir.2000) (stating that a patent
may be valid and yet be rendered unenforceable due to inequitable conduct). Indeed, in Molins,
the court affirmed a finding of inequitable conduct, notwithstanding that the withheld reference
was later cited in a reexamination and the claims were allowed to issue.

        We recognize that [the withheld references] were cited eventually to the PTO and
    that the examiner initialed them and passed the reexamination application to issue
    thereafter. However, the references were not cited when they should have been.

    RPR further contends that the record contains other evidence that weighs against a finding of
materiality. Specifically, RPR relies on Mr. Pilard's characterization of the article in 1992 as
"irrelevant," and Mr. Calvetti's statement in 1991 that the article did not "affect" the patent. RPR
further argues that the inventors understood that TMS and MOM would work in their claimed
process and were justified in describing TMS and MOM as preferred. RPR contends that the
JACS article reports results under "specially developed reaction conditions," which are not
required by the patent claims, and further notes that the article's footnotes do not state that TMS
and MOM would never work. According to RPR, the inventors understood, and a person of
ordinary skill in the art reviewing the subject patent would have understood, that under



                                                593
conditions other than those in the JACS article, TMS and MOM would work. In support, RPR
notes that in a footnote of the district court's opinion the court stated, "[t]he inventors may have
had a basis to think that MOM could be used to produce taxol" and that an inventor testified that
TMS and "TES" (with which successful results were reported in the JACS article) are very
similar molecules.

     Having considered the evidence relied upon by RPR to support its argument that the JACS
article is immaterial, we conclude that the district court did not clearly err in finding that the
JACS article was material for three reasons. First, the district court did not find Mr. Pilard's 1992
statement, that the article is "irrelevant," persuasive or credible. Rather, the district court found
that given Mr. Pilard's extensive chemical engineering background, he would have known that a
person of ordinary skill in the art would read the statements in the JACS article either to apply to
TMS and MOM at any yield or, at the very least, to be unclear. Specifically, the district court
could not reconcile Mr. Pilard's knowledge that "the protecting group at C-7 has to be stable ... to
the subsequent esterifying conditions" with his position that the statement in the JACS article,
TMS "proved unstable to the subsequent esterification conditions," was not adverse. Likewise,
the district court was unable to reconcile Mr. Pilard's statement that "the elimination of the
protecting groups has to be made under conditions which do not conduct to an epimerisation at
the ... C-2'" with his position that the statement, "[a MOM] protecting group at the C-2' could not
be removed following esterification," was not adverse. Also, Mr. Calvetti's assessment of the
article was limited to whether or not he thought the JACS article was prior art.

     Second, it is the explicit statements in the JACS article that made the article material to the
prosecution of the subject patents, not the information that could have been included in the
article. In the same footnote referred to by RPR above, the district court stated that although one
of the inventors successfully deprotected MOM, albeit in poor yield, from deacetyl taxol, the
inventors did not claim the results in the article. Rather, the article stated that the authors were
unsuccessful at using TMS or MOM to yield taxol in anything other than poor yield. Indeed, as
discussed above, no expert testified that a person of ordinary skill in the art would see the TMS
or MOM failures in the article as related to just one experiment or that such a person would
know how to make TMS or MOM work as protecting groups under other experimental
conditions.

    Third, materiality is determined from the viewpoint of a reasonable patent examiner and not
the subjective beliefs of the patentee. To the extent that the opinion of the inventors as to how a
reasonable examiner would have viewed the article sheds light on materiality, the district court
did not find the testimony persuasive because it was "the self-serving testimony of an interested
witness" and was supported by neither objective evidence nor by the testimony of any
independent expert. The court instead found persuasive what the inventors explicitly stated in
the article as compared to what was claimed in the subject patent and stated in the specification.

    Lastly, RPR argues that the district court's holding on inequitable conduct is contradictory to
its holding denying Bristol's motion for summary judgment for lack of enablement pursuant to
35 U.S.C. § 112. Specifically, RPR contends that the district court's finding that the JACS article
is material to enablement because a person of ordinary skill in the art would read the article to
mean that TMS and MOM were unsuitable to produce taxol is directly contradicted by the



                                                594
declaration of Bristol's expert, Dr. Corey, that the use of TMS and MOM was known and
obvious.

    We conclude, however, that the district court's holding on inequitable conduct is not
contradictory to its holding on enablement. The issue of whether a reference would be
considered important by a reasonable examiner in determining whether a patent application is
allowable, including whether the invention is enabled, is a separate issue from whether the
invention is actually enabled. Dr. Corey testified that based on the explicit statements made by
the inventors in the article, a person of ordinary skill in the art in 1998 reading the article,
specifically footnotes 13 and 16, would have concluded that TMS and MOM were unsuitable or
unsatisfactory protecting groups to use in the described process for producing taxol. That
testimony illuminates how such a person would interpret the JACS article, but does not expound
upon whether the subject invention is in fact enabled. The district court denied Bristol's
summary judgment motion for lack of enablement because it failed to show by clear and
convincing evidence that a person of ordinary skill in the art would be required to engage in
undue experimentation to practice the full scope of the claimed invention. In so doing, it relied
partly on Dr. Corey's declaration that certain claims in the '277 patent were obvious. As the
district court later explained, it rejected Bristol's counsel's argument that Dr. Corey's affidavit
should be construed more narrowly in view of his earlier testimony in the trial proceedings
because Bristol was relying on counsel's argument rather than providing an affidavit from Dr.
Corey to that effect. Thus, to the extent an inconsistency existed, it was with regard to Bristol's
position that the '277 patent was obvious and its position that the '277 patent was not enabled, not
in the district court's holdings on materiality and enablement.

     In sum, we conclude that the district court did not clearly err in finding that the JACS article
was material to the prosecution of the '011 patent. We next review the district court's intent
finding.

                                                   B

    Intent to mislead does not require direct evidence, and is typically inferred from the facts.
GFI, 265 F.3d at 1274, 60 USPQ2d at 1144; Brasseler, 267 F.3d at 1375-76, 60 USPQ2d at
1484 (stating that intent may be inferred when a patent applicant knew, or should have known,
that withheld information could be material to the PTO's consideration of the patent application);
Merck & Co. v. Danbury Pharmacal, Inc. (Fed.Cir.1989) (stating that intent is most often proven
by a showing of acts the natural consequences of which are presumably intended by the actor).
Further, where withheld information is material and the patentee knew or should have know of
that materiality, he or she can expect to have great difficulty in establishing subjective good faith
sufficient to overcome an inference of intent to mislead.

    The district court found by clear and convincing evidence that: (1) Mr. Pilard intentionally
drew the '011 patent more broadly than warranted by the information he possessed; (2) he was
aware of the JACS article at the time he drafted the patent application and at the time he
provided Mr. Mosher materials for filing the '011 patent; (3) he was aware of the PTO duty of
disclosure; and (4) his attempted justifications for not disclosing the JACS article were




                                                595
insufficient grounds for not supplying it to the PTO Examiner and were not credible.10 These
findings led the court to conclude that Mr. Pilard intentionally withheld the JACS article from
Mr. Mosher and the PTO with an intent to mislead the Examiner and that this inequitable
conduct was not cured during the prosecution of the '277 reissue application.

     We conclude that the district court's finding that Mr. Pilard intentionally withheld the JACS
article in an attempt to mislead the PTO in connection with the prosecution of the '011 patent is
not clearly erroneous. The evidence established that Mr. Pilard prepared the French patent
application based on the invention disclosure, Modes Operatoires, provided by the inventors,
which included the information in footnotes 13 and 16. The evidence also established that he
read the draft JACS article and had it in his possession at the time he drafted the application.
Although these two documents explicitly asserted the limitations of using TMS as a C-7/R3
protecting group and MOM as a C-2'/R2 protecting group, the patent application did not disclose
these limitations.11 None of the inventors testified that they recalled any communication with
Mr. Pilard informing him that R2 and R3 could be defined as any hydroxy-protecting group, that
R2 was preferably MOM, or that R3 was preferably TMS. Moreover, at his deposition, Mr.
Pilard could not recall any support whatsoever for having claimed in the application that TMS or
MOM could be used to produce taxol or for stating that they were the preferred protecting
groups. Mr. Pilard was responsible on behalf of RPR for providing Mr. Mosher all information
relevant to the filing of the '011 patent application, and there is no dispute that he understood the
PTO duty of disclosure. Yet, despite being aware of the information in the JACS article from
which the ' 011 patent application stemmed, he did not provide Mr. Mosher, RPR's U.S. patent
attorney, a copy of the JACS article. He provided Mr. Mosher only with a copy of the French
patent application that he had filed and a copy of the French search report generated by the
National Institute of Industrial Research, which did not list the JACS article. In a case such as
this, where Mr. Pilard was intimately familiar with the article because the inventors with whom
he worked wrote it, he approved the article for publication, and the article was in his possession
while he was drafting the French patent application, the determination that Mr. Pilard knew of
the significance of the JACS article in combination with the finding that he knew of the duty to
disclose is sufficient to establish intent.

    In affirming the district court's decision, we reject the four arguments raised by RPR on
appeal challenging the finding of intent to deceive. In making these arguments, RPR again asks
us to substitute our view of the evidence and credibility of the witnesses for that of the district
court's finding of intent to deceive. RPR first argues that contemporaneous documents establish
that those prosecuting the patents were acting in good faith, which is inconsistent with an intent

10
         Mr. Pilard did not appear at the hearing on intent, and thus, the district court had to rely on the
portions of his videotaped depositions submitted by the parties and a transcript of his depositions to assess
his credibility. The district court found Mr. Pilard to be lacking in credibility because in light of the fact that
he had been prepared for three days prior to his initial deposition, his responses at that deposition were less
than candid. We accord the district court's credibility determination substantial deference.
11
         Specifically, the draft JACS article stated that only "specific protecting groups" and "unique
reactions conditions" were successful in producing taxol, that TMS was "unstable" during the esterification
process, that MOM could not be removed following esterification, and that TBDMS "could not be clearly
introduced." The invention disclosure stated that TMS was "too fragile," but did not say that MOM could
be removed following esterification, and that a reaction with TBDMS "does not go forward."


                                                       596
to mislead. In support of its good faith argument, RPR notes that Mr. Pilard approved
publication of the JACS article in a widely circulated journal without requesting that the
inventors omit or somehow qualify the footnotes. RPR also relies on the fact that Mr. Pilard
forwarded the article to Mr. Calvetti and that in response to Mr. Pilard's instructions, Mr. Calvetti
disclosed the article to the PTO.

    We conclude, however, that the district court did not clearly err in finding an intent to
deceive after considering the evidence relied upon by RPR to support its good faith argument. In
our view, RPR's argument misses the mark because RPR's duty of disclosure was to the PTO and
publishing the article did not amount to RPR disclosing the article to the PTO. The article's
appearance on a computer search report requested by the Examiner during the prosecution of the
'011 patent was not the result of an affirmative action taken by RPR to disclose the article to the
PTO. Furthermore, the issue is RPR's intent during the prosecution of the original application.
Thus, RPR's disclosure during reissue is irrelevant to the inquiry of whether RPR acquired the
'011 patent by engaging in inequitable conduct.

     RPR next argues that those prosecuting the '011 patent believed the JACS article was
immaterial. According to RPR, Mr. Pilard's assessment in 1992 that the JACS article was
"irrelevant" is contemporaneous evidence that he did not believe the JACS article was material
negating a finding of intent to mislead. We conclude, however, that the district court did not
clearly err in rejecting RPR's argument that intent to mislead the PTO was lacking on this
ground. Mr. Pilard's assessment occurred after the issuance of the '011 patent and, thus, does not
shed light on Mr. Pilard's intent with regard to the prosecution of the '011 patent application. In
addition, as discussed above, the district court did not find this evidence persuasive or credible.

    RPR further argues that the evidence establishes that the inventors had a reasonable basis to
think that TMS and MOM could work without undue experimentation to produce taxol at the
time the application was filed, which demonstrates a lack of intent to mislead. RPR also makes a
similar argument that the inventors' approval of the application undercuts a finding of intent to
deceive because by doing so the inventors communicated their beliefs that TMS and MOM
would work in their process to Mr. Pilard.

     We conclude, however, that the district court did not clearly err in finding an intent to
deceive after considering the evidence of the inventors' purported beliefs for three reasons. First,
even assuming the inventors fostered a belief that TMS and MOM would work in the patented
process, the JACS article drafted by the inventors did not assert such a belief or explain its
foundation.12 Second, it is RPR's intent with regard to not disclosing the article to the PTO that is
relevant, not whether the inventors' beliefs supported a finding of enablement. Third, none of the
inventors could recall any communication with Mr. Pilard informing him that R2 and R3 could
be defined as any hydroxy- protecting group, that R2 was preferably MOM, or that R3 was
preferably TMS.


12
         Because we assume the credibility of the inventors' beliefs, we do not address the district court's
finding that the inventors could not have provided Mr. Pilard with any reasonable scientific basis for
believing that that the patented process could work with any hydroxy-protecting group or that the testimony
on this subject was not credible


                                                   597
    Lastly, RPR argues that the January 29, 1988, letter from Mr. Simon to Mr. Pilard urging him
to seek a broad patent did not provide Mr. Pilard with any improper motive because it was not
improper for RPR to seek broad patent rights. RPR's argument misses the mark because the
district court did not find that RPR's motivation to seek a broad patent rights was an "improper"
motive. Rather, the district court found that seeking broad patents was a motive held by Mr.
Pilard and more importantly concluded that Mr. Pilard drew the patent application more broadly
than warranted in light of the limiting statements in the JACS article and the Modes Operatoires
and having done so had a reason to not submit these documents to the PTO. These findings are
not clearly erroneous.

     We have considered RPR's remaining arguments challenging the district court's findings
with regard to intent to deceive, as well as materiality, and conclude that they lack merit as well.
Therefore, we agree with the district court that Mr. Pilard failed to disclose the JACS article with
intent to mislead the patent office in connection with the prosecution of the '011 and '277 patents.


    PURDUE PHARMA L.P. v. ENDO PHARMACEUTICALS INC.
               United States Court of Appeals for the Federal Circuit, June 7, 2005

Before GAJARSA, Circuit Judge, PLAGER, Senior Circuit Judge, and LINN, Circuit Judge.

PLAGER, Senior Circuit Judge.

        This is a patent infringement case in which the patents were held unenforceable by the
trial judge due to inequitable conduct during prosecution before the United States Patent and
Trademark Office. Purdue Pharma filed an infringement suit against Endo Pharmaceuticals in the
United States District Court for the Southern District of New York. Plaintiffs alleged that Endo‘s
proposed generic versions of OxyContin®, Purdue‘s controlled release oxycodone product,
would infringe three Purdue patents.

        After a bench trial, the district court found that Endo would infringe Purdue‘s patents, but
determined the patents were unenforceable due to the inequitable conduct that occurred during
prosecution. Purdue appeals the inequitable conduct judgment; Endo cross-appeals the
infringement judgment. Because the trial court did not err in its inequitable conduct
determination, we affirm the court‘s judgment on that issue. We do not reach the issues raised in
Endo‘s cross-appeal.

                                        BACKGROUND

        The three patents asserted by Purdue against Endo are directed to controlled release
oxycodone medications for the treatment of moderate to severe pain. The patents are related:
U.S. Patents No. 5,656,295 (the ―‘295 patent‖) and No. 5,508,042 (the ―‘042 patent‖) are,
respectively, a continuation-in-part and a divisional of U.S. Patent No. 5,549,912 (the ―‘912
patent‖). The ‘912 patent itself is a continuation-in-part of U.S. Patent No. 5,266,331 (the ―‘331
patent‖), which Purdue has not asserted against Endo. The ‘331 patent is the parent patent, and
for ease of reference will be identified as such from time to time.


                                                598
        The written descriptions of the ‘912, ‘295 and ‘042 patents are virtually identical. The
asserted claims include composition claims (claims 1-4 of the ‘912 patent and claims 1-4 and 6-7
of the ‘295 patent) and method claims (claims 8-10 of the ‘295 patent and claims 1 and 2 of the
‘042 patent). Claim 1 of the ‘912 patent is representative of the composition claims and reads:
        A controlled release oxycodone formulation for oral administration to human
        patients, comprising from about 10 to about 40 mg oxycodone or a salt thereof,
        said formulation providing a mean maximum plasma concentration of oxycodone
        from about 6 to about 60 ng/ml from a mean of about 2 to about 4.5 hours after
        administration, and a mean minimum plasma concentration from about 3 to about
        30 ng/ml from a mean of about 10 to about 14 hours after repeated administration
        every 12 hours through steady-state conditions.

Claim 1 of the ‘042 patent is representative of the method claims and reads:
       A method for reducing the range in daily dosages required to control pain in
       human patients, comprising administering an oral controlled release dosage
       formulation comprising from about 10 to about 40 mg oxycodone or a salt thereof
       which provides a mean maximum plasma concentration of oxycodone from about
       6 to about 60 ng/ml from a mean of about 2 to about 4.5 hours after
       administration, and a mean minimum plasma concentration from about 3 to about
       30 ng/ml from a mean of about 10 to about 14 hours after repeated administration
       every 12 hours through steady-state conditions.

       The ―Detailed Description‖ section of the written description in each asserted patent
opens with the following statement, which played a prominent role in the trial court‘s inequitable
conduct determination:
       It has now been surprisingly discovered that the presently claimed controlled
       release oxycodone formulations acceptably control pain over a substantially
       narrower, approximately four-fold [range] (10 to 40 mg every 12 hours—around-
       the-clock dosing) in approximately 90% of patients. This is in sharp contrast to
       the approximately eight-fold range required for approximately 90% of patients for
       opioid analgesics in general.

‘912 patent, col. 3, ll. 34-41 (emphasis added).
        The thrust of this language is that the invented oxycodone formulation using a four-fold
range of dosages (e.g., between 10 mg and 40 mg) achieves the same clinical results as the prior
art opioid formulations using an eight-fold range of dosages (e.g., between 10 mg and 80 mg).
The written description later explains that the ―clinical significance‖ of the four-fold dosage
range of the oxycodone formulations of the present invention, as compared to other opioid
analgesics, such as morphine, requiring twice the dosage range, is a more efficient titration
process, which is the process of adjusting a patient‘s dosage to provide acceptable pain relief
without unacceptable side effects.

In December 1995, after obtaining FDA approval, Purdue introduced its controlled release
oxycodone product under the name OxyContin. In September 2000, pursuant to the procedures
of the Hatch-Waxman Act, 21 U.S.C. § 355(j), Endo filed an Abbreviated New Drug Application



                                               599
(―ANDA‖) with the FDA seeking approval to make and sell a generic version of Purdue‘s
OxyContin formulation. The patents-in-suit had issued by this time, and Purdue had listed them
in the Orange Book.3 as covering OxyConti. Endo notified Purdue it had filed a paragraph IV
certification asserting that Purdue‘s patents either would not be infringed by Endo‘s generic drug
or were invalid. In October 2000 Purdue initiated a patent infringement suit under 35 U.S.C. §
271(e)(2) on the basis of Endo‘s ANDA filing, alleging that Endo‘s generic drug would infringe
the ‘912, ‘295, and ‘042 patents. Endo subsequently twice amended its ANDA to seek approval
for additional dosage strengths. Purdue filed two additional infringement suits, which the trial
court consolidated with the original action.

        Endo filed counterclaims seeking a declaratory judgment that Purdue‘s patents were
invalid, unenforceable, and not infringed. Endo also filed counterclaims under federal antitrust
and New York unfair trade practice laws. The trial court bifurcated the patent claims from the
antitrust and unfair trade claims and in June 2003 held an 11-day bench trial on the patent issues.
In an extensive and thorough opinion, the trial court found that Purdue had shown by a
preponderance of the evidence that Endo‘s proposed generic drug products would infringe
Purdue‘s patents.. The trial court also concluded, however, that Endo had shown by clear and
convincing evidence that Purdue‘s patents were ―invalid‖ due to Purdue‘s inequitable conduct
during prosecution of the patents before the PTO. The court based its inequitable conduct
determination on underlying findings of materiality and intent. First, the court found that in view
of Purdue‘s repeated statements to the PTO that it had discovered an oxycodone formulation for
controlling pain over a four-fold range of dosages for 90% of patients, compared to an eight-fold
range for other opioids, Purdue failed to disclose material information because it did not inform
the PTO that the ―discovery‖ was based on ―insight‖ without ―scientific proof.‖ Id. at *23.
Second, the trial court found the record as a whole reflected a ―clear pattern of intentional
misrepresentation.‖

       As a result of its inequitable conduct determination, the trial court enjoined Purdue from
enforcing the ‘912, ‘295, and ‘042 patents….

                                          DISCUSSION

                                           1. Materiality

        In evaluating materiality, this court has consistently referred to the standard set forth in
PTO Rule 56. Bruno Indep. Living Aids, Inc. v. Acorn Mobility Servs., Ltd., 394 F.3d 1348,
1352 (Fed. Cir. 2005). Because all of the patent applications at issue in this case were pending on
or filed after March 16, 1992, we look to the current version of Rule 56, rather than the pre-1992
version of the rule. See id. at 1352-53. Under the current rule, information is material to
patentability when:
        [I]t is not cumulative to information already of record or being made of record in
        the application, and

3
      Patents covering approved drugs or uses thereof are listed in a book entitled ―Approved
Drug Products with Therapeutic Equivalence Evaluations,‖ commonly referred to as the ―Orange
Book‖ based on the color of its cover.


                                                600
           (1) It establishes, by itself or in combination with other information, a prima
       facie case of unpatentability of a claim; or
           (2) It refutes, or is inconsistent with, a position the applicant takes in:
               (i) Opposing an argument of unpatentability relied on by the Office, or
               (ii) Asserting an argument of patentability.
37 C.F.R. § 1.56(b) (2004).5 In applying this version of the rule, ―we give deference to the
PTO‘s formulation at the time an application is being prosecuted before an examiner of the
standard of conduct it expects to be followed in proceedings in the Office.‖ Bruno, 394 F.3d at
1353.

        The trial court in this case based its materiality finding on Purdue‘s repeated and
convincing representations to the PTO that it had discovered its controlled release oxycodone
formulations controlled pain over a four-fold range of dosages for 90% of patients, compared to
an eight-fold range for other opioids. Purdue had no clinical evidence supporting its claim at the
time it was made or at any time before the patents issued. During prosecution of the patents, the
examiner repeatedly rejected the applications on the grounds that the invention was obvious in
light of prior art. Eventually, however, in response to the applicants‘ further explanations, the
examiner allowed the claims.

        The trial court found that the lack of scientific proof of a four-fold dosage range for
oxycodone was a material fact inconsistent with statements made by Purdue to obtain allowance
of the patent claims over the examiner‘s rejections. In the trial court‘s view, by representing to
the PTO that it had ―discovered‖ that oxycodone acceptably controlled pain over a four-fold
dosage range, while withholding from the PTO the fact that the discovery was based on insight
without scientific proof, Purdue failed to disclose material information.

        Purdue does not dispute the absence of clinical evidence during the relevant timeframe to
support its claim of a four-fold dosage range for oxycodone. Indeed, Dr. Kaiko testified at trial
that it was ―insight‖ that led to discovery of the reduced range. He asserted that, based on his
knowledge of the pharmacological properties of opioids and the differences between oxycodone
and other opioids such as morphine, he ―envisioned‖ a controlled release oxycodone product that
would control pain over a four-fold dosage range in 90% of patients.

        Purdue, however, contends it is irrelevant that it lacked scientific proof of the four-fold
dosage range for oxycodone because the inventors never stated during prosecution of the patents
that the discovery had been clinically tested, and thus did not expressly misrepresent a material
fact. But that was not the basis for the trial court‘s materiality finding. The trial court found
Purdue had relied on its discovery of a four-fold dosage range throughout prosecution of the ‘331
parent patent and the related patents-in-suit as ―a prominent, and at times, the only, argument in
favor of patentability before the PTO, resulting in allowance of the claims.‖ In the trial court‘s
view, by failing to explain to the PTO that Dr. Kaiko‘s ―insight‖ provided the only support for its
―discovery,‖ Purdue failed to disclose material information that was inconsistent with its
arguments for patentability.


5
       This new standard was not intended to constitute a significant substantive break with the pre-1992 standard.
Hoffman-La Roche, Inc. v. Promega Corp., 323 F.3d 1354, 1368 n.2 (Fed. Cir. 2003).


                                                        601
        Purdue first told the PTO it had ―surprisingly discovered‖ the four-fold dosage range for
controlled release oxycodone, compared to the eight-fold range for other opioids, during
prosecution of the ‘331 parent patent in October 1992, prior to the filing date of the ‘912 patent.
In response to an obviousness rejection, under headings containing the phrases ―Surprisingly
Improved Results‖ and ―Results Obtained,‖ Purdue distinguished its oxycodone formulations
from other opioids based on the ―surprising result‖ of the four-fold dosage range and its ―clinical
significance‖—a more efficient titration process. Purdue presented this argument even though
neither the written description nor the pending claims of the ‘331 patent application made
reference to the four-fold dosage range. Purdue‘s response contained language identical to that
which was soon to appear in the written description of the ‘912 patent application.

         Purdue continued to rely on oxycodone‘s four-fold dosage range and more efficient
titration process to support its patentability arguments throughout prosecution of the ‘331 patent.
After another obviousness rejection and an interview between the examiner and Purdue‘s
attorney, Purdue submitted a response accompanied by the declaration of Dr. Robert Kaiko
(named as an inventor on the ‘912, ‘295, and ‘042 patents, but not on the ‘331 patent). The Kaiko
declaration emphasized the difficulty of predicting the pharmacological characteristics of opioids
and cautioned that ―the most meaningful therapeutic conclusions‖ should be based on ―the
results of the most adequate and well-controlled therapeutic evaluations.‖ This statement
referenced an attachment, which appears to be an invention disclosure prepared by Dr. Kaiko. In
that attachment, under the heading ―INVENTION,‖ Dr. Kaiko asserted that controlled release
oxycodone acceptably controls pain over a four-fold dosage range for 90% of patients. The
attachment then described clinical studies that compared the resulting in vivo plasma
concentrations of controlled release oxycodone with those of immediate release oxycodone. The
Kaiko attachment concluded by stating that the ―CLINICAL SIGNIFICANCE‖ of the four-fold
dosage range compared to other opioids requiring twice the dosage range was ―the most efficient
and humane method of managing pain requiring repeated dosing,‖ i.e., an improved titration
process.

        By the time Purdue submitted the Kaiko declaration to the PTO, the application that
resulted in the ‘912 patent had been filed as a continuation-in-part of the ‘331 patent. The written
description of the ‘912 patent contains several paragraphs of text not in the written description of
the ‘331 patent, including the statements that the four-fold dosage range had been ―surprisingly
discovered‖ and that the clinical significance of the discovery was a more efficient titration
process. During prosecution of the ‘912 patent, Purdue again found it necessary to distinguish its
controlled release oxycodone formulations over prior art directed to a different opioid analgesic
by emphasizing its ―surprising discovery‖ of oxycodone‘s four-fold dosage range and more
efficient titration process. Purdue further stated that the in vivo parameters set forth in the claims
―are specifically related to the surprising results obtained by the invention,‖ thereby directly
linking the features of the claimed invention to the newly discovered four-fold dosage range.

       In light of Purdue‘s consistent representations of the four-fold dosage range for controlled
release oxycodone as a ―surprising discovery‖ and the context in which that statement was
repeatedly made, we cannot say the trial court‘s finding that Purdue failed to disclose material
information was clearly erroneous. While Purdue never expressly stated that the discovery of the




                                                 602
four-fold dosage range was based on the results of clinical studies, that conclusion was clearly to
be inferred from the language used by Purdue in both the patents and prosecution history.

        For example, Purdue a number of times during prosecution referred to the four-fold
dosage range as a ―result,‖ implying that clinical results had been obtained. Purdue also
frequently noted the ―clinical significance‖ of its discovery, sometimes, as in the Kaiko
attachment, in close proximity to a description of the clinical studies performed by Purdue, again
suggesting the discovery was supported by experimental results. In addition, Purdue continually
compared the dosage range of controlled release oxycodone to that of other opioid analgesics in
concise, quantitative terms (e.g., four-fold vs. eight-fold for approximately 90% of patients). In
the absence of any statements indicating the true origin of its ―surprising discovery,‖ Purdue‘s
arguments to the PTO provide enough of a suggestion that clinical trials had been performed that
failure to tell the PTO the discovery was based on Dr. Kaiko‘s insight and not scientific proof
was a failure to disclose material information.

        Purdue contends it did not make material misrepresentations or fail to disclose material
information to the PTO because the examiner did not rely on its assertion of a four-fold dosage
range for oxycodone. According to Purdue, the examiner could have allowed the claims based on
other arguments it made to distinguish the oxycodone claims over the prior art. Even if the
examiner did not necessarily rely on Purdue‘s discovery of a four-fold dosage range, however,
that would not be inconsistent with a finding of materiality. See Hoffman-La Roche, 323 F.3d at
1368 (citing Merck & Co. v. Danbury Pharmacal, Inc., 873 F.2d 1418, 1421 (Fed. Cir. 1989)
(rejecting a ―but for‖ standard of materiality)). A review of the prosecution history of the patents-
in-suit and the parent ‘331 patent leaves no doubt that Purdue disclosed its ―surprising
discovery‖ of oxycodone‘s four-fold dosage range to support one of its central patentability
arguments and to oppose the examiner‘s argument that Purdue‘s claims were unpatentable in
view of the prior art. Information that Purdue‘s assertion of a four-fold dosage range was based
only on Dr. Kaiko‘s insight and not on experimental results was material because it was
inconsistent with Purdue‘s statements suggesting otherwise.

        Purdue also argues that the trial court‘s materiality finding was unduly influenced by the
court‘s allegedly erroneous conclusion that the claims of the patents-in-suit must be construed to
include the four-fold dosage range as a limitation. Purdue‘s argument is without merit for two
reasons. First, the trial court stated it would have reached the same result even if the claims were
not so limited. Second, materiality ―is not limited to matters reflected in the claims of a patent.‖
Hoffman-La Roche, 323 F.3d at 1367. Under the PTO‘s current materiality standard, information
may be material if it refutes or is inconsistent with the applicant‘s patentability arguments, which
may be independent of the claims.

         We are also unpersuaded by Purdue‘s argument that the four-fold dosage range is simply
a benefit of the claimed invention and therefore not material because the examiner would have
given it little weight. Purdue relies on this court‘s decision in CFMT, Inc. v. Yieldup
International Corp. (Fed. Cir. 2003), which reversed the trial court‘s materiality finding based on
a list of advantages of the claimed invention identified by the applicants during prosecution. In
that case, however, this court found that the applicants‘ ―advantages advocacy recited only the
natural, expected results of a closed system [for cleaning semiconductor wafers].‖ At most the



                                                603
applicants had overemphasized the benefits of the invention. Purdue‘s assertion of a four-fold
dosage range for oxycodone and more efficient titration process compared to other opioids was
much more than ―advantages advocacy‖; it was one of the key arguments Purdue made
consistently and repeatedly during prosecution to overcome prior art cited by the examiner in an
obviousness rejection. Purdue did not present the four-fold dosage range as a general benefit of
the claimed oxycodone formulations, but instead relied on the four-fold dosage range to
distinguish its invention over other opioid analgesics in precise, quantitative terms.

        Finally, Purdue and the supporting amicus curiae brief of Guilford Pharmaceuticals argue
that the trial court erred by requiring a patent application for a pharmaceutical discovery to be
supported by clinical results. This argument misconstrues the trial court‘s ruling. The law
recognizes that a discovery can be made by insight or experiment, and that alone does not affect
patentability. See 35 U.S.C. § 103(a) (―Patentability shall not be negatived by the manner in
which the invention was made.‖).

        Purdue‘s position presumes that the trial court found materiality only because Purdue
described the four-fold dosage range in its patents as a ―surprising discovery‖ without providing
any scientific proof. That is not the case. The trial court examined the entire record and found
materiality because Purdue repeatedly argued to the PTO that the four-fold dosage range
distinguished the invention over prior art and, while using language that implied, if not
suggested, experimental results had been obtained, failed to tell the PTO its discovery was based
only on Dr. Kaiko‘s insight.

        In this respect the case is similar to Hoffman-La Roche. In that case, the patentees had
erroneously stated in the written description that a procedure had been performed and presented
―results‖ of that procedure. Hoffman-La Roche, 323 F.3d at 1363. This court affirmed the trial
court‘s finding of materiality, not on the ground that experimental results were required for
patentability, but on the ground that the patentees misrepresented the results and made reference
to them during prosecution in responding to a PTO office action. Id. at 1367-68. Similarly, the
trial court‘s finding in this case was not based on Purdue‘s failure to provide scientific proof of
its ―surprising discovery,‖ but on its claim to have made a surprising medical discovery without
disclosing the evidentiary basis for it, i.e., that the alleged ―discovery‖ under these circumstances
was based on insight and was without an empirical basis.

                                               2. Intent

        ―Intent [to deceive or mislead the PTO] need not be proven by direct evidence. Indeed,
‗[d]irect proof of wrongful intent is rarely available but may be inferred from clear and
convincing evidence of the surrounding circumstances.‘ When balanced against high materiality,
the showing of intent can be proportionately less. When determining whether intent has been
shown, a court must weigh all evidence, including evidence of good faith. However, ―a patentee
facing a high level of materiality and clear proof that it knew or should have known of that
materiality, can expect to find it difficult to establish ‗subjective good faith‘ sufficient to prevent
the drawing of an inference of intent to mislead.‖ Critikon, Inc. v. Becton Dickinson




                                                 604
        The trial court began its intent analysis by focusing on Purdue‘s claim that it believed in
good faith that the statements regarding the four-fold dosage range and more efficient titration
process were true. After citing trial testimony from Purdue witnesses (Dr. Kaiko and his
supervisor Dr. Goldenheim) and quoting a number of internal Purdue memoranda, the trial court
concluded that any such good faith belief was undercut by Purdue‘s admitted inability to prove
scientifically the accuracy of the statements.

        The documents and testimony relied on by the trial court relate primarily to Purdue‘s
attempt to gain FDA approval for its proposed labeling claim that OxyContinwas ―the most
efficiently titratable analgesic‖ rather than its attempt to obtain allowance of its patent claims.
We agree with Purdue that its internal discussions regarding the difficulty in proving the titration
claim for FDA approval purposes are not inconsistent with Purdue‘s asserted belief that it had
discovered its oxycodone formulations were effective over a four-fold dosage range, compared
to an eight-fold dosage range for other opioids. And we agree that the quantum of proof
necessary for FDA approval is significantly higher than that required by the PTO.

        The question, however, is not whether Purdue believed the assertions of a four-fold
dosage range and more efficient titration process to be true, or even whether in fact they were
true. The relevant question is whether Purdue intentionally withheld material information as to
the source of its ―surprising discovery,‖ information that would be relevant to, and the absence of
which might mislead, the examiner in his or her determinations regarding patentability. See
Hoffman-La Roche, 323 F.3d at 1367 (―[T]he district court‘s finding that the inventors had a
good faith belief in the novelty of their invention is not incompatible with a finding of deceptive
intent.‖).

        In this case, intent to mislead the PTO can be inferred from Purdue‘s statements and the
context in which they were made. Purdue‘s carefully chosen language suggests that it had
obtained clinical results, and that suggestion was left unclarified by any disclosure that discovery
of the four-fold dosage range for oxycodone was based on insight. The trial court‘s ruling did not
hinge on a single statement in the patents, as Purdue suggests, but instead was based on a clear
pattern of misdirection throughout prosecution of Purdue‘s controlled release oxycodone patents.
Purdue had several opportunities to inform the PTO it had no scientific proof of a reduced
dosage range, yet Purdue continued to describe its discovery in terms of ―results,‖ using precise,
quantitative, and comparative language. The consistent and repetitive nature of Purdue‘s
communications with the PTO fully supports the trial court‘s conclusion that Purdue made a
deliberate decision to withhold and thus misrepresent the origin of its ―discovery‖ to the PTO.
Based on our review of the record, we discern no clear error in the trial court‘s finding that
Purdue acted with intent to mislead the PTO.

       Accordingly, we conclude that the trial court‘s findings on materiality and intent were
well-founded, and thus not clearly erroneous. Weighing materiality and intent is a matter of
judgment. On the record before us we cannot say that the trial court abused its discretion in
weighing these findings to conclude that the patents-in-suit are unenforceable due to Purdue‘s
inequitable conduct.

                                         CONCLUSION



                                                605
        The trial court‘s judgment that the patents-in–suit are unenforceable due to inequitable
conduct is affirmed. Because we affirm the trial court‘s judgment on inequitable conduct, we do
not reach Endo‘s cross-appeal of the infringement judgment.

                                      Notes & Questions

1. In Purdue Pharma L.P. v. Endo Pharmaceuticals Inc., __ F.3d __ (Fed. Cir. 2006), a panel on
rehearing, in a very unusual move,vacated its earlier opinion, and sent the case back to the trial
court to reconsider the level of materiality of what it continued to consider Purdue's
misrepresentation to the PTO, and also matters of scienter.

2. Does the composition of the panel make a difference in ―inequitable conduct‖ cases? How
much more likely is it that a panel including Judge Prost will uphold a lower court finding of
inequitable conduct than one including Judge Newman? Why?

3. Do you think the fact that a finding of inequitable conduct carries a ―mandatory death penalty‖
[e.g. total unenforceability of the patent] makes some judges somewhat reluctant to find
inequitable conduct in the absence of a ―smoking gun?‖ If so, what solution would you propose?




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