The Lab to Market Series:
Building Sound Patent Practices
NYS Science & Technology
Law Center
May 16-17, 2005
George R. McGuire, Esq.
When is an invention
complete?
Every invention contains two elements:
a mental element, and
a physical one
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Conception
Mental element defined:
Conception (formation) of definite idea in
mind of inventor of complete and operative
invention
Complete performance of the mental part with
the only thing left to do is manifest in physical
form (reduce it to practice)
Capable of being understood, constructed by,
and operated by those skilled in the art
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Reduction to Practice
Reduction to practice must be carried out
personally by the inventor or through
someone under the inventor's direction,
but it can be:
Actual,or
Constructive
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When is an invention
complete?
3 classes
So simple and of obvious efficacy
No need to build and test machine
Mechanically imperfect machine
Sufficient if all essential elements of invention are
present and practical utility demonstrated
Complex machine
The particular use for which it is intended must be
given special consideration, and requires
satisfactory operation in actual execution of the
object
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Actual Reduction
Building working invention
Experimental machine that does not complete
utility is insufficient
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Constructive Reduction
Filingof patent application
Describing the invention in detail which will
enable one skilled in the art to make and use
that which is disclosed
Telephone cases (1888): A. G. Bell had not
been able to transmit telegraphically spoken
words, but description was so precise and
accurate that one skilled in the art could build
working telephone, thus demonstrating
reduction to practice
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Critical dates for invention?
Conception
Reduction to Practice
Diligence between those two dates
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Diligence
Reasonable effort directed toward embodiment of an
invention
Fact specific – no bright line rule
To prove, the first to conceive must show diligence during
the ―critical period from just before his opponent entered the
field up to the time he filed his own patent application.‖
Not necessary to devote all time to invention or give up
livelihood
Where inventor assigns control over invention to another
(e.g., for testing), conduct of assignee is controlling on
question of diligence (assignee behavior is transferred to
inventor)
Inventor’s testimony on diligence must be corroborated!!!
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Delay
Excusable or Not?
Legitimacy of delay governed by facts of each
case
Possible Legitimate Delay Examples
Testing an invention (awaiting results)
Awaiting materials held up in shipment
Compliance with Administrative Agency’s rules
(e.g., PTO rules)
Funds – but generally in and of itself insufficient
unless extreme circumstance
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Priority of invention?
Priority goes to first to conceive and diligently
reduce invention to practice (U.S. rule)
102(g): A person shall be entitled to a patent unless
before such person’s invention thereof, the invention
was made in this country by another inventor who
had not abandoned, suppressed, or concealed it. In
determining priority of invention under this
subsection, there shall be considered not only the
respective dates of conception and reduction to
practice of the invention, but also the reasonable
diligence of one who was first to conceive and last to
reduce to practice, from a time prior to conception by
the other.
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Who is an inventor?
The claims of the patent are the standard
for determining inventorship and who
conceived of the claimed invention is the
critical question
a sole inventor must have conceived the
ideas in all of the patent's claims;
a co-inventor must have conceived the idea in
at least one of the patent's claims.
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Who is an inventor?
―To constitute a man an inventor, it is not
necessary for him to have skill enough to
embody the invention in a working
machine, or in a model, or even in a
drawing‖ (suggestions by the inventor to
one of mechanical skill to make machine is
still inventorship).
But it is not a sole invention to conceive a
result and then employ another to produce
that result.
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What are rights of
co-inventors
Each inventor owns an undivided interest
in the whole (absent an agreement to the
contrary) 35 U.S.C. §262
No need to account to other co-owners
No need to get approval from other co-
owners for exploitation
Compare to Copyright Law
Each co-owner can exploit without consent of
other co-owners, but must make an accounting
(prevents opportunistic exploitation of copyrighted
14 work)
Who are co-inventors
Standards for determining joint inventors:
inventive contribution versus suggestion
A later participant’s contribution is not co-
invention unless it forms a definite conception
of at least some identifiable part of the
invention
Same standard as conception for purposes of priority
Must be so detailed that one skilled in the art be able
to incorporate the improvement into working example
of invention without exercising undue experimentation
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Who are co-inventors
If this idea had not been contributed,
would the claimed invention exist?
Ifthe answer is no, then that person is
probably a co-inventor
Be aware that inventorship can change as
application is prosecuted
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Who are co-inventors
divide co-workers into three groups:
Those who contribute ideas that result in the
development of an invention as claimed. Members of
this group should be considered inventors;
Those who contribute labor, supervision, or routine
techniques and other non-mental contributions.
Members of this group should not be considered
inventors; and
Those who contribute ideas while an invention is
being developed, but whose ideas don't contribute
directly to the claimed invention. This group also
should not be considered as inventors
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The Lab to Market Series:
Building Sound Patent Practices
NYS Science & Technology
Law Center
May 16-17, 2005
George R. McGuire, Esq.
PANEL DISCUSSION
Richard Newman
Vice President, New Produce Development, Medical Division,
Welch Allyn
Developing laboratory notebook protocols
Lisa Dolak
Professor of Law, Syracuse University College of Law
Use of electronic records in labs and in administrative/judicial proceedings
Varda Main
Director, Technology Licensing Office,
Rochester Institute of Technology
Managing co-invention involving multiple institutions
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LAB NOTEBOOKS
Inventorship
1. USA –
• Official inventor is the first to invent.
• Essential that you keep good records.
2. Foreign –
• Inventor is first to file the patent.
• Lab notebook entries are immaterial.
3. Convention Priority –
• You have 12 months from the US
filing date to file foreign equivalent patents.
• Priority date is same as original country.
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LAB NOTEBOOKS
What should be kept in a Lab Notebook?
•Concepts and ideas.
•Experimental data: materials (including
suppliers, catalog numbers, lot numbers,
concentrations, etc.)
•Instruments used (make, model, serial
number, settings, calibration data,
software versions.)
Copyright Syracuse University 2005 NYSTARbuffalo.ppt
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LAB NOTEBOOKS
What should be kept in a Lab Notebook?
•Procedures/protocols + raw data = results
(favorable and unfavorable).
•Formulas and calculations.
•Content/date of outside collaborations, plus
identities of
collaborators.
•Results of brainstorming sessions, identify
novel contributors.
Copyright Syracuse University 2005 NYSTARbuffalo.ppt
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LAB NOTEBOOKS
How should research records be kept?
•Traditional bound notebook with sequentially
numbered pages.
•Record in ink. May be in colors for clarity.
•State the need, teach solution, and explain
what you feel is novel.
•Date each entry.
•Use pages sequentially. Use line out and date
spaces.
•Cross out, don’t erase, mistakes or date
changes.
Copyright Syracuse University 2005 NYSTARbuffalo.ppt
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LAB NOTEBOOKS
How should research records be kept?
Cross reference by notebook and page number
related works,
including other notebook entries, physical
samples,
computer printouts stored outside the
notebook.
•Securely affix inserts (data printouts,
photographs, napkins) with
signature and date across one side and
either the top or bottom.
Copyright Syracuse University 2005 NYSTARbuffalo.ppt
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LAB NOTEBOOKS
How should research records be kept?
•Sign and date entries, changes, and
corrections at the end of
Each work day. All inventors must sign
each page.
•Have entries, changes, and corrections
witnessed and dated by
at least two non-inventors, but who
understand the work.
Copyright Syracuse University 2005 NYSTARbuffalo.ppt
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LAB NOTEBOOKS
Security
•Inventor keeps notebook until full.
•Lock notebooks at night.
•When filled, file the notebooks in Legal
Department in safe location.
•If notebook becomes subject of suit, then Legal
keeps it.
•Be sure notebooks are not exposed to fire and
sprinkler systems.
Copyright Syracuse University 2005 NYSTARbuffalo.ppt
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LAB NOTEBOOKS
Related Procedures
•In the US, a patent is barred if there is a
publication, public use, sale, or offer to sell more
than one year before filing.
•In foreign countries, a patent is barred if there is a
publication public use, sale, or offer for sale
occurring before the filing of either the US or
foreign application.
Copyright Syracuse University 2005 NYSTARbuffalo.ppt
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LAB NOTEBOOKS
Related Procedures
•Do not offer for sale before filing patent
application (provisional?).
•Make out a marketing report to prove that it was a
market survey, not an offer for sale.
•Likewise, create a clinical results report to prove
that is was a clinical evaluation, not an offer for
sale.
•Do not disclose/receive information to/from
outsiders (suppliers, customers, joint ventures
without a signed NDA.
Copyright Syracuse University 2005 NYSTARbuffalo.ppt
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LAB NOTEBOOKS
Overall Comments
•Do not discount your work, it might be
patentable.
•What might seem obvious to you, is not
necessarily ―obvious to one with
ordinary skill in the art‖.
•Write it in your lab notebook, and
•Let Legal decide later if it is patentable.
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Lab Notebooks
Developing lab notebook protocols.
Good practices, include:
Bound and numbered pages
Dates when an idea was formed and work begun and
completed recorded
Initial statements of objectives prior to experiments (always
written in ink)
Full citations of standard protocols
Test results attached to notebook, signed and dated across
added page and underlying notebook page.
Conclusions and evaluation of results
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Lab Notebooks
Every page signed and dated by inventor and a witness (who is
not free to disclose publicly the contents of the notebook, and
who understands the invention should also sign and date the
notebook periodically (e.g., weekly))
State reasons for not working on a project for any period of time
Avoid gaps between entries and draw a line between sequential
entries
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Lab Notebooks
Each experiment should include the following sections:
a) Purpose. Begin with a short explanation of why you did the
experiment.
b) Protocol. Include a detailed description of what you actually
did. Provide sufficient detail so someone could repeat the
experiment exactly the way you did it. Indicate how each
solution was made. All procedures obtained from other
sources (e.g. lab manuals, lab protocols or research
articles) should be included as a permanent part of your
notebook the first time they are used. It is OK to cross-
reference previous experiments, but you should specify any
changes or differences in the experiments. Do not count on
your memory -- write all observations in your notebook
while you are doing the experiment.
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Lab Notebooks
c) Results. Include the actual raw data in your notebook as
well as any plots or calculations. Show any equations used
for your calculations.
d) Discussion. Include a brief summary of the conclusions. Did
the control work? What do the results mean?
Errors should be crossed out with a single line so
they remain readable. Do not erase or scratch
out errors or tear pages out of your notebook.
When an error is made, include a comment on
what went wrong and whether the experiment
was repeated. This will allow you to figure out
what actually happened even a long time after
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you did the experiment.
Electronic Records
Electronic records in labs and litigation/admin.
procedures
Substantive legal issues relating to evidence of
inventions for the purposes of proving priority of
invention (first to invent) for U.S. patents. The law
respecting how to prove priority of invention is a well
defined body of law. Its application to electronic
record keeping merely requires an application of that
law to e-records. Thus, it is the legal principles that
are paramount, not the technology, per se, of record
keeping.
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Electronic Records
Corroboration
Evidence of what was invented and when that invention came
into existence is generally NOT admissible in the United States
Patent and Trademark Office and U.S. courts for the purpose of
invalidating claims to the same invention made by another
UNLESS it is corroborated by someone other than the inventor.
Here, "inventor" means the person or persons who are named
on the patent/application. Corroboration therefore requires a
non-inventor to have reviewed and understood the inventors'
work. It is the date of that corroborator's review that defines
provable evidence of a date of invention. Thus, a co-worker,
technician, manager, or secretary, for instance, can corroborate.
It is, however, less likely that a non-technically trained person
will understand what they were asked to corroborate, and
therefore, it would be harder to prove a right to a date of
invention based upon a non technical person's knowledge.
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Electronic Records
Chain of Custody
Evidence in legal proceedings in the U.S. is
only admissible if it meets the admissibility
requirements of the Federal Rules of
Evidence (FREs). The FREs provide that
documents and things relied upon as
evidence may be challenged for lack of a
"chain of custody", i.e., proof that they were in
the possession and control of a person or
entity that would not tamper with them.
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Electronic Records
Authentications
Inall evidentiary proceedings, most
documents and things held out as evidence
do not "speak for themselves"; they must be
brought into evidence by testimony of a
person explaining what they are and where
they came from. Exceptions to this rule are
self authenticating records, such as patents,
publications, certain notarized documents,
and the like
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Electronic Records
Guidelines for e-records
Generally speaking, a document
management system should incorporate
technology and security that facilitates
meeting the evidentiary requirements
noted above.
Establish an official procedure for
electronic record keeping
This procedure should be provided in written
form to each employee.
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Electronic Records
Generate permanent electronic records
Back up and write protect electronic data
Reference this data in a signed and dated
handwritten notebook
Store electronic records in a safe repository
retained by custodians who could vouch for
their authenticity
Electronic or digital signature software may
be employed to enhance the credibility of the
electronic records
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Electronic Records
Use hardware or software that prevents
the ability to edit original research
descriptions
Create records that show the development of
the research
Ensure security to prevent unauthorized
access to the system
Password protect the system and data
Limit system access to authorized personnel
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Joint Research Management
Managing co-inventors at multiple
institutions
• keeping records of who are considered
inventors and authors
• maintaining current addresses of inventors
and authors – e.g. when students graduate
• determination of royalty-sharing between
inventors/authors
• managing IP terms in sub-contracts and use
of consultants
• incorporation of third party IP
• export control issues
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Joint Research Management
CREATE ACT Safe Harbor (amendment to
35 U.S.C. 103(c)(2),(3)), in relevant part:
(2) For purposes of this subsection, subject
matter developed by another person and a
claimed invention shall be deemed to have been
owned by the same person or subject to an
obligation of assignment to the same person if —
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Joint Research Management
• (A) the claimed invention was made by or on
behalf of parties to a joint research
agreement that was in effect on or before
the date the claimed invention was made;
• (B) the claimed invention was made as a
result of activities undertaken within the
scope of the joint research agreement;
and
• (C) the application for patent for the claimed
invention discloses or is amended to
disclose the names of the parties to the
joint research agreement.
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PANEL DISCUSSION
(3) For purposes of paragraph (2), the term ―joint
research agreement‖ means a written contract,
grant, or cooperative agreement entered into by
two or more persons or entities for the
performance of experimental, developmental,
or research work in the field of the claimed
invention.
• using a project IP management plan
• coordination of invention disclosures
• coordination of patent application filing
• understanding IP ownership policies at each
institution (e.g. ownership of student IP,
44 adjunct faculty, visiting scientists)
PANEL DISCUSSION
Richard Newman
Vice President, New Produce Development, Medical Division,
Welch Allyn
Lisa Dolak
Professor of Law, Syracuse University College of Law
Varda Main
Director, Technology Licensing Office,
Rochester Institute of Technology
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