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DOCKET NO,:
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APPLICANT(S):
0 TRADEMARK OFFICE STAMP HEREON A&KNOWLEDGES RECEIPT OF THE FOLLOWING PARERS: MONT UCTENSION OF TIME ( TRANSMITXAL LETTER MISSING PARTS RESPONSE WITH. RECL AMENDMENT a SUPPLEMENTAL J-J PREUMINARY REPLY TO OFFICE ACTION RESTRIC710N/ELECTION REPLY q WtTH DISK SEQUENCE LISTING CPA REQUEST TRANSM1TTAL NOTICE OF APPEAL APPEAL BRIEF (TRIPLICATE)
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MAXOrj MSCLOSURE f-J FORM 1449 & PRIORITY DOCUMENT(S) NO. DECLARATION UNPER 8 LE-T-I-ER DRAFTSMAN TO SliEffS OF RRAWtNGS f3 ISSUE FEE TRANSMl.lXAL FORM
IN THE UN4TED STATES PATENT AND TRADEMARK In Re Application of: Vet-mud REDDY et al Dffiie
OFFtCE of the Deputy Assistant a?$ Qb@ Commissioner for Patent Fotciy
Patent No.: 4,840,896 Issued: June 20,1989 For: HETEROPOLYMERIC PROTEIN
:
Atty.% Docket: REDDY=BEXT Date: November 20,200tl
THE COMMISSIONER OF PATENTS Washington, D.C. 20231 Sir: Transmitted [ [ m ] ] herewith is Apolication application. Applicant(s)
AND TRADEMARKS
%%ZCElVE
for Extension of Patent Term and Exhibi claim small entity status. See 37 C.F.R. §1,27.
in the above-identified
Small Entity Status:
No additional fee is required. The fee has been calculated as shown below:
OR
ADDITICINAL FEE -rOTAt. If the entry in Cal. 1 is less than the entry in Cot. 2, write “0’ in Col. 3. If the “Highest Number Previously Paid for” IN THIS SPACE is Jess than 20, write “20’ in this gaca. If the “Highest Number Previously Paid for” IN THIS SPACE is less than 3, write “3” in this space. The “Highest Number Previously Paid For” (total or independent) number of claims originally filed. Conditional Petition for Extension of Time requests that this be considered with 37 CFR 1.136(a}.
$
gR
TOTAL
1 $
I
is the highest number found from t&e equivalent box in bol. 1 of a prior amendment
of the
if any extension of time for a response is required, applicant It is hereby petitioned for an extension of time in accordance Small Enthy Response r I Filed Within First Second Third Fourth $ 55.00 $ 196.00 $445.00 $635.00
a petition therefor. fee required by 37 CFR 1 .I7 is catculated as shown below:
The appropriate
Other Than Small Entity Response Filed Within I r f I 1 I First Second Third Faurth f 0 $ 110.00 890.00 Set $ 390.00 $139O*M)
I 1 I 1 I 1
[ ]
Month After Time Period Set Less fees ($ ) alreadypaid for _ month(s) extension of time on
I I Month After Time,Period
Fee under 37 C.F.R. $Y.20@(1) for receiving and acting upon application Please charge my Deposit Account No. 02-4036 in the amount of $ Credit Card Payment Form, PTO-2038, is attached, authorizing
for extension:
%t.l20.00
payment in the amount of $1.120.01) which may be required ia o&rneotion,with this application or credit any limited to paymentof alJfeesaseootated~with thiscommunication, including intended to indude alt fees fog the presentation of extra claims under 37 CFR of the case. Thfs blanket authorization does f& tncfude patent issue fees
The Commissioner is hereby autho&ed and requested to charge any additional fees overpayment to Deposit Account No. 02-4036. This authorization and request is not any Extension of Time fee, not covered by check or specific authorization, but is also $1 .I6 and all patent processing fees under 37 CFR §Y .17 throughout the prosecution under 37 CFR Bl.18.
t3ROWDY AND NEtMARK
Facsimile: Telephone:
(202) 737-3526 (202) 628-5197
.
PTO-2038 (02-2000) Approved fbruse tlmagh W3fI2003. OMB 0651-0043 Uidted StatdsPatentamI Trademark Mice; U.s; DEPARTMENT OF COMMERCE Undq the Paperwork Reduction Act of 1995,no personsare required to respmd to a collection oftiomation unless it displays a valid OMB control number.
1:
Credit %ard Payment Form
Credit Card Account #:
3727-X26626-01094 08/03
Roger
Credit Card Expiration Date: Neme as it Appears on Credit Card: Payment Amount $(US Dollars):
f,.
Browdy
requasted, and will not not& the payar of such’ amaunts (37 CFR 1.26). Retind of a fee p&d by credit card v&f be.via @edit to the credit card account, Service Charge: There is a 50.00 service charge for procassfng each payment refused (inc&d&t a check returned “unpaid”) or charged
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re United States Pate& & Tradenrark Offie willnot be iiabIe in the eve@t&at t&s creditclvdnumbler becwtqpElblic knowledge.
IN THE UNITED STATES E'ATEWX'AND BEG
OFFICE
In re Application RJ&DY et al Patent-No.: Issued: For:
of:
1 ,'
Office of the Deputy Assistant Commissioner for Patent 'Policy and Projects Washington, D.C.
4,840,896 June 20, 1989
; 1 J )
November 20, 2000 Atty.Docket: REDDY==2EXT
HETEROPOLYMERIC PROTEIN
APPLICATION
i?OR EXTENSICTN OF PATENT TERM
Honorable Commissioner for Washington, D.C. 20.231 Sir: In accordance Corporation, extension through with
Patents
35 USC 156, patentee, attorney,
Genzyme for
the undersigned
hereby applies patent. -Following
of the term of the above-identified required by 37 C.F.R. product,is
is the information
(a) (1)
51.740. chorlogonadotropin gonadotropin glycoprotein - designated cx (r-
The approved
alfa hCG).
also
known.as. recombinant alfa
human chorionic
Choriogonadotropin
is a wate‘ soluble r linked subunits
consisting
of two non-covalently
and j'3 - consisting respectively, Asn-'78 Ser-132 with
of 92 and 145 amino acid carbohydrate moieties
residues, to Asn-52 and Se.+121, Ser-127;
linked
(on the CY. subunit) and Ser-138
and Asn-23,
Asn-30,
(on the p subunit),
The full.
amino acid
In re of
Patent
ru3. 4,840,896
sequences as follows: (x subunit:
of
the
01 and p subunits
of
choriogonadotropin
alfa
are
10
Ala Pro Asp Val Gln Asp Cys Pro Glu Cys 30 Pro Gly Ala Pro Ile Leu Gin Cys Met Gly 50 Leu Arg Ser Lys Lys Thr Met Leu Val Gln 70 Val Ala Ala Lys Ser Cys Tyr Sex Asn Arg VaZ Thr Tyr Val 90 Cys His His Met Lys Gly 92 Ser Gly Phe Lys Val Glu Asn His Lys Asn Val Ths Ser Glu Ser Thr Cys Cys Cys Phe Ser Arg Ala Tyr Pro Thr Thr 'Leu Gla Glu Asn Pro Phe Phe Ser
20 Gln 40 Pro 60 Cys 80 Thr
Thr Cys Tyr
B-subunit
10
20 Pro Ile Asn Ala Thr Leu Ala Val Glu Lys 40 Thr Thr Ile.Cys, Ala Gly Tyr Cys Pro Thr 60 Ala Leu Pro Gin Va$ Val Cys Asn,,Tyr Arg 80 Gly Cys Pro Arg Gly Val Am Pro Val Val 100 Leu Cy5 Arg $rg Ser Thr Thr Asp Cys 120 Asp Pro Arg Phe GLn Asp Ser SeL- Ser 140 Pro Ser Axg I+u Pro Gly Pro Sex Asp Thr
Ser
Lys
Glu
Pro
Leu
Arg
Pro
Arg
Cys Axg 30
Glu
Gly
Cys
Pro
Val
Cys
Ile
Thr
Val
Asn 50
Met
Thr
Arg
Val
Leu
Gln
Gly
Val
Leu
Pro 70
Asp
Val
Arg
Phe Glu
Ser
Ile
Arg
Leu
Pro 90
Ser
Tyr
Ala
Val
Ala
Leu
Ser
Cys
Gin
Cys Ala 110
Gly
Gly
Pro
Lys
Asp
His
Pro
Leu
Thr
Cys Asp 130
Ser .. Pro
Lys
Ala
Pro
Pro 145
Pro
Ser
lieu
Pro
Ser
Ile
Leu
Pro
Gln O-glycosylation site
Asn:
N-glycosylation (a) (2)
site
Ser:
The pro‘ duct Food, Drug
was approved Act
under
Section
505(b)
of
the
Federal
and Cosmetic -2-
(21 USC 355(b)).
In re of Patentk
. 4,840,s;;
fa) (3) commercial marketing
The product
received Section
permission 505(b)
fbr of the Federal
or u&e under
Food, Drug and Cosmetic (a) (4) product Federal Act),
Act on September product
20, 200.0. is a human biological terms are used in the Health Service
As the present
and not a drug product Food, Drug and Cosmetic 37 C.F.R. W (5) §1.740fa)
(as those
Act and the Public
(4) is not applicable, application for that is being submission submitted pursuant be to
The present day period It
within
the sixty
permittbd
37 C.F.R. filed letter
§1.72O(f). sixty
is required
the application
,within
days following
the date of the FDA approval day period is expires on
of September
20, ZQOO. The sixty As November 19, 2000, could
November 19, 2000, date on which
a Sunday,
the last
the application
be filed
is November 20, 2000
(37 C.F.R.
§i1.7(a)). Ia)
(6)
The patent 4,840,896
for
which an extension the inventors
is being are
sought Vermuri
is U.S. patent
of which
B. Reddy, Nancy Hsiung, The date of issue
Anton K. Beck,
and Edward G. of
Bernstine. expiration
was June 20, 19'89,, and the.date
is June 20, 2006,. (a) (7) A copy of patent the entire 4,840,896 specification &s attached (including hereto
as Exhibit claims
A, including
and drawings).
-3-
In re of Patent
LUO. 4,840,896
(a) (8)
Attached
hereto
as Exhibit with
3 is‘ a respect
copy of the to this of
Certificate patent. receipts Also
of Correction attached
which hereto
has issued
as Exhibits
C and D are copies that
of maintenance
fee payments
establishing paid with
the first to this
and second maintenance patent.
(4 (9)
fees were timely
respect
Th.e patent Attached
claims hereto
a me2;hod‘ manufacturing of as Exhibit E is a copy of from the process. Exhibit
the approved a portion original E includes manufacturing manufacturing scope of claim Exhibit July
product.
of Section NDA submitted
C, "Method of~Manufacture", during the FDA approval
pages numbered 032-049. process process of 'the approved of the approved
These documents product, product This falls
show the
within hereto
the as
17 of the
'896 patent,
Also attached
F are sections 26, 2000, Exhibit showing relating
l-3.2
of a submission
to the FDA dated for the drug The this product. claim
to bioassay
specification
product. following reads Patent
F includes
pages numbered 002-014. manner in which the approved Approved Product
demonstrates.the
on the method of manufacturing Claims
1. A method for producing biologically active hCG comprising
See Figure CM&-5 on page 049 of Exhibit E. It shows that the final product of the purification process of the culture medium ~from the bioreactor is "r-hCG DRUG SU%STAHCE". Exhibit F shows the biological activity of the r-hCG
In re
of
Patent
,.a.
4,840,896
drug product, Note the last paragraph on page 004 which shows that the. mean specific activity was 26,400 IU per mg rhCG . Thus, as the hCG can be measured in international units, biologically active hCG is produced by the method. culturing host mammalian cells See pages 046 and 047 of Exhibit E which indicates that the r-hCG is produced from CHO cells. See also page 034 in the section "Mode of introduction into the production s@ain" which indicates that the production strain is a CHO cell line. CHO is Chinese hamster ovary cells. Hamster cells are mammalian cells. af The section at the bottom of page 034 of Exhibit E, entitled into the "M0de of introduction production strain", states that cells were c&transfected with uncut pHcxDHFR containing the cx hCG and pHLHPODC containing the P-hCG gene, The construction of the cx hCG gene,expression vector is discussed at pages 032 and 033. Accordingly, it is clear that the (x and p subunits are introduced in separate vectors. Thus, the inammalian cells comprise a. first expression vector encoding the cx subunit of hCG. ' The construct.icm of the @ hCG gemi expression vector is discussed on pages 033 alid 034 o‘ Exhibit f E. As discussed above, the pa,ragraph at the bottom of page 34 indicates that the a and fi gene vectors are introduced separately. Thus, the mammalian cells also -5-
comprising a first expression vector encoding the cx subunit said hCG and
a second encoding hCG.
expression vector the p subunit of
said
In re of
Patent
HO. 4,840,896
comprise a second expression vector encoding the p subunit hCG. (4 (10) (i) New Drug IND number submitted 149. (IND) The effective ddte 2, of the Investigational and was assigned
of
application
was October
1995,
48934.
The New Drug Application 23, 1999,
was initially NDA,number 21-
on November
and was assigned 20, 2000.
The NDA was approved ia) (11)
on September is
The following undertaken review period:
a brief
description
of
significant during the
activities applicable
by the
marketing
applicant
IND submitted IND received by FDA
September October October November February April 2, IO;
29,
1995
1995 1994 1995 1996
FDA Action Letter and Acknowledgement of Receipt Study Approval 7927 submitted for to IND
28, 1,
7927 to commence Date
7927 Completion NDA submitted NDA received FDA letter
1998 23, 24, 30, 23, 1999 1999 1999 2000
November November acknowledging receipt November February March
USAN name adopted Correction to USAN information
2.2, .2000
Submission of 120-day safety report and additional clinical and bioequivalents reports -6-
April
7, 2000
In re of
Patent
NO. 4,840,896
Submission of information package CMC for diluent Submission financial of additional disclosure information for the drug
June 16, June 28,
2000 2000; July 5,,2OOO
Bioassay specification drug substance and the product Withdrawal mcg doses Withdrawal manufactured of of
July
August
26,
1,
2000
2000
500 mcg and 250 alternate diluent by Pharma Hameln for August August 7, 2000 29, 2UaOO 6, 2000 20, 2000. patent Applicant will extend was periods the
August
3,
2000
Response to CMC request information Addition for drug Withdrawal packaging NDA approval (a) 4,840,896 claims patent is
of microplasma testing substance release of alternate facility
September September
(12)
Applicant for..patent extension 2009, using
is
of term
the
opinion.that
eligible of
extension.
a length through
of
1054 days which
May 9,
The length the rS1.775: following
of extension dates
determined as set (c) (1) (cl (c)
(2)
as follows in
and time
forth
37 C.F.R.
lo/IO/1995 11/24/1999
through through
11/24/1999 09/20/2000
1506 301 1807
(c) (I)+ Ic) (2)
-7-
In re of Patent
DO. 4,840,896
td) (1) (il
none not known f (cl (U-(d) (c)-(d((l)(i)-(d) 06/20/2006 09/20/2000 earliest 06/20/2006 earliest W (5) 0-i)
(a) (13)
0 0 (I) (i) )42 (l)(ii)-(d) f Id) (1) (1) (iii) 753 1054 05/09/2009 09/20/2014 05,'09/2009 06/20/2011 05/09/2009 05/09/2009 acknowledges and Trademarks or the Secretary a duty to disclose to of any
Cd) (1) (ii) (d) (1) (iii)
(d) (1) Cd)
(2)
(d) (3)
+ 14 years
.'
(d.1 (4) Cd) (5) (i) (d) (5) C4 tdl
of
fd) (2) and Cd) (3) + 5 years ' and W (5) 0-1
of
(d)(4)
Applicant of Patents
the Commissioner Health
and the Secretary of Agriculture
and Human Services which
information
is material. sought. Attached
to the determination
of entitlement
to the extension (a) (14)
hereto payment
is PTO Form 20-38, Credit in the amount af $1,120.00 for receiving
Card in
Payment Form, authorizing accordance with 37 C.F.R, for
$$1.2O(j)(I) extension.
and acting
upon the application (4 (15) person present
The name, address
and telephone relating
number of the to the
to whom inquiries application
and correspondence
are to be directed
is as follows
-8-
In re of
Patent
iuo', 4,840,896
Roger L. Browdy BROWDYAND NEIMARK, P.L.L.C. 624 Ninth Street, N.W. Suite 300 Washington, D.C. 20001~-5303 Telephone: Facsimile: (a) is a duplicate
(16)
202-628-5197 202-737-3528. certifies application Roger attorney Office owner relating the that attached papers. hereby to general 4,840,896 hereto
The undersigned all I, that the of the the present
of
Ia) 117) declare practice authority to act and state before from on their
undersigned
L.,Browdy, authorized
I am a patent
Patent
and Trademark the matters
and have of patent
Genzyme Corporation, behalf in patent
to patent contents to to of the
4‘ 840,896. foregoing §1.740. pursuant claimed, the
I have application I believe to §1.710. to
reviewed being that the
and understand submitted patent that is
pursuant subject
3'7 C.F.R. extension of the length by
I believe any reduction
an extension caused
subject
by a determination under with 35 USC
Secretary (2)(B)
of Health that
and Human Services did not act
156(d) justified believe meets forth
applicant
due diligence, regulations. is of being a patent
is I sought as set i
under that the in the
35 USC 156 and the patent for §1.720. for which
applicable the of extension the term
conditions 37 C.F.R.
extension
-9-
In re of
Patent
~0.
4,840,896
I declare own knowledge information these are
further true
that
all all
statements statements to be true; knowledge
made herein made on and further that willful or the
of my
and that
and belief
are believed the
that false
statements
were made with like
statements imprisonment, United jeopardize
and the
so made are punishable under Section such willful the patent. Respectfully
by fine
or both,
1001 o:f Title false
18 of
States the
Code and that validity of
statements
may
submitted, P.L.L.C. Owner
BROWDY AND NEIH&RK, Attorneys for-Patent
Registration RLB:al:rd 624 Ninth Washington Telephone Facsimile Street, N.W, D.C. 20001-5303 No.: (202) 628-5197 No.: (202) 737-3528
No.
25,616
F:\,S\S,erl\Reddy2Ext\PatentTermExt.doc
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