`
`3.
`
`On January 18, 2011, Carter filed a notice of cross-appeal of the
`
`Board's adverse decision denying Carter's motion that Adair's claim 24 was
`
`unpatentable under 35 U.S.C. § 112, first paragraph, for lack of written description.
`
`4.
`
`Adair requested and was granted a twenty-five day extension of time
`
`extending the time to file its principal brief from April 18, 2011, to May 13, 20 11.
`
`Adair filed its principal brief on May 13, 2011.
`
`5.
`
`On March 24, 201 1, this Court issued a precedential order in Aventis
`
`Phanna S.A. v. Hospira, Nos. 2011-1018,-1047 (Fed. Cir. March 24, 2011). In
`
`that order, the Court held that Apotex's additional claims for invalidity and claims
`
`of non-infringement to the same claims did not expand the scope of the judgment
`
`in Apotex's favor and thus were improper grounds for cross-appeal. Slip op. at 4-
`
`5. The Court did go on to note, however, that Apotex could "consistent with our
`
`practice and precedent, raise these arguments in its appellees' brief if it so
`
`chooses." !d. at 5.
`
`6.
`
`The Aventis order does not address the specific circumstance wherein
`
`a claim has been held to be barred under 35 U.S.C. § 135(b) but a motion asserting
`
`the unpatentability of the same claim under 35 U.S.C. § 112, first paragraph, has
`
`been denied. Neverthe1ess, in view of the Court's concern expressed in Aventis as
`
`to whether an issue on cross-appeal would expand the scope of the judgment,
`
`Carter withdraws its cross-appeal relating to the issue of whether Adair's claim 24
`
`2
`
`PFIZER EX. 1595
`Page 1752
`
`
`
`
`
`
`
`
`
`
`
`UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT
`
`20 11 -1212,-1213
`(Interference No. 105,744)
`
`JOHN ROBERT ADAIR, DILJEET SINGH ATHWAL,
`and JOHN SPENCER EMTAGE,
`Appellants,
`
`v .
`
`PAUL J. CARTER and LEONARD G. PRESTA,
`Cross Appellants.
`
`Appeals from the United States Patent and Trademark Office, Board of
`Patent Appeals and Interferences
`
`UNOPPOSED MOTION OF CROSS APPELLANTS, PAUL J. CARTER
`AND LEONARD G. PRESTA, FOR A THIRTY-DAY EXTENSION OF
`TIME TO FILE ITS OPENING BRIEF
`
`Oliver R. Ashe, Jr.
`ASHE, P.C.
`11440 Isaac Newton Square North, # 210
`Reston, VA 20 l 90
`(703) 467-9001
`
`Jeffrey P. Kushan
`Rachel H. Townsend
`SIDLEY A US TIN LLP
`1501 KStreet,N.W.
`Washington, DC 20005
`(202) 736-8000
`
`Attorneys fo r Cross-Appellants, Carteret al.
`
`, .
`. . -
`c :
`
`-
`
`( . ,.
`
`June 1 5, 20 1 1
`
`PFIZER EX. 1595
`Page 1757
`
`
`
`CERTIFICATE OF INTEREST
`
`Counsel for the Cross-Appellants certifies the following:
`
`l .
`
`T he full name of every paity or amicus represented by me is:
`
`PAUL J. CARTER and LEONARD G. PRESTA
`
`2.
`
`The name of the real party in interest represented by me is:
`
`GENENT ECH, INC.
`
`3.
`
`All parent corporations and any publicly held companies that O\Vn 10 percent
`
`or more of the stock of the patty or amicus curiae represented by me are:
`
`ROCHE HOLDINGS, INC.
`
`4.
`
`The names of all law fi rms and the pattners or associates that appeared for
`
`the paity or amicus now represented by me in the trial court or agency or are
`
`expected to appear in this court are:
`
`Oliver R . Ashe, Jr. of ASHE, P .C.
`Jeffrey P. Kushan and Rachel H. Townsend of SIDLEY AUSTIN, LLP
`
`Dated: June 15, 201 1
`
`o~· Ra "f.
`Oliver R. Ashe, J~
`
`PFIZER EX. 1595
`Page 1758
`
`
`
`UNOPPOSED lVIOTION OF CROSS APPELLANTS, PAUL J. CARTER ·
`AND LEONARD G. PRESTA, FOR A THIRTY-DAY EXTENSION OF
`Tll\-IE TO FILE ITS OPENING BRIEF
`
`Pursuant to Fed. R. App. P. 26(b), Cross-Appellants PAUL J. CARTER
`
`AND LEONARD G. PRESTA ("Carter") respectfully requests that this Court
`
`grant a thirty (30) day extension of time to and including July 27, 20 11 , within
`
`which to file its opening brief in the above-identified case.
`
`The date that Catier' s opening brief is cunently due is June 27, 2011. Carter
`
`has not previously sought any extension of time in this appeal and is filing this
`
`motion at least seven days before the brief clue date. Counsel for JOHN ROBERT
`
`ADAIR, DILJEET SINGH ATHWAL, and JOHN SPENCER EMTAGE has
`
`represented that it does not oppose this motion.
`
`There is good cause for this motion as explained below. Cmt er's lead
`
`attorney on this appeal, Oliver R. Ashe, Jr., is lead and backup lead counsel on five
`
`interference proceedings presently before the Board of Patent Appeals and
`
`Interferencf?S ("the Board"). Two of these interference proceedings are in fully
`
`active motions phases and the schedules are not amenable to significant alterations.
`
`Mr. Ashe is responsible for preparing a number of motions to be filed at the Board,
`
`including motions due on \Vednesday, June 15,2011 , in Interference No. 105,792,
`
`motions due on June 24, 20 II, in Interference No. 105,77 1, and responsive
`
`motions due on July 15,2011, in Interference No. 105,77 1. In addition, due to
`
`1
`
`PFIZER EX. 1595
`Page 1759
`
`
`
`longstanding plans for a family vacation, Mr. Ashe will be away from the office
`
`from June 25, 20 ll , through July 10, 2011.
`
`Additionally, one of Catier's other appellate counsel, Jeffery P. Kushan, has
`
`a variety of professional commitments that has limited and will continue to limit
`
`the time that he is able to devote to the assistance of the preparation and review of
`
`Carter's brief. Mr. Kushan is one of the attorneys responsible for preparing and
`
`filing expert reports on July 1, 2011 in a case docketed in the District of Delaware.
`
`In addition, Mr. Kushan has a longstanding speaking engagement on June 21. And
`
`due to a longstanding professional commitment and planned vacation, Mr. Kushan
`
`w ill be away from the office from June 22 th rough June 28.
`
`Accordingly, Carter needs additional time to prepare its brief. For the
`
`purposes of Fed. Cir. R. 27(a)(8), it is not believed that any of the above facts are
`
`subject to dispute. However, for the purposes of Fed. Cir. R. 26(b )( 5), Carter
`
`hereby submits declarations of counsel showing good cause for the extension.
`
`For the reasons set forth herein, it is respectfully requested that Carter's
`
`unopposed motion to extend the due date for its brief in the above appeal by thirty
`
`(30) days to and including July 27, 201 1, be granted.
`
`2
`
`PFIZER EX. 1595
`Page 1760
`
`
`
`
`
`
`
`UNITED STATES COURT OF APPEALS .FOR THE FEDERAL CIRCUIT
`
`20 11- 1212, -12 13
`(Interference No. 1 05,744)
`
`JOHN ROBERT ADAIR, DILJEET SINGH ATHWAL,
`and JOHN SPENCER EMT AGE,
`
`Appellants,
`
`v.
`
`PAUL J. CARTER and LEONARD G. PRESTA,
`Cross Appellants.
`
`Appeals from the United States Patent and Trademark Office, Board of
`Patent Appeals and Interferences
`
`ORDER
`
`Upon consideration of the Unopposed Motion for Extension of Time filed by
`Cross-Appellants PAUL J. CARTER and LEONARD G. PREST A,
`
`IT IS ORDERED THAT:
`
`1)
`The unopposed motion be GRANTED, and the Clerk of the Court
`note this extension on the docket.
`
`2)
`The principal brief of Cross-Appellants PAUL J. CARTER and
`LEONARD G. PRESTA shall be due on July 27,2011 .
`
`FOR THE COURT:
`
`Date: - -- --
`
`PFIZER EX. 1595
`Page 1763
`
`
`
`. '
`
`Ser vice List:
`
`Oliver R. Ashe, Jr.
`ASHE, P.C.
`1 1440 Isaac Newton Square No rth
`Suite2 10
`Reston, VA 20 190
`Tel.: (703) 467-9001
`Counsel fo r Cross Appellants, Carter et a!.
`
`Doreen Yatko Trujillo, Esq.
`Kyle Vos Strache, Esq.
`Cozen O 'Connor P.C.
`l900 Market Street, 7'11 Floor
`Philadelphia, P A 19 103
`T el. : 2 15-665-5593
`Counsel fo r Appellees, Adair et al.
`
`The Board of Patent Appeals and Interferences
`M adison Building East, 9111 Floor
`600 Dula ny Street
`A lexandria, VA 223 14
`Tel.: 571 -272-9797
`
`PFIZER EX. 1595
`Page 1764
`
`
`
`
`
`3:
`
`I am lead and backup lead counsel on five inte rfe rence proceedings
`
`present ly before the Board of Patent Appeals and Interferences (" the Board" ).
`
`Two of these interference proceedings are in fully acti ve motions phases and the
`
`schedules are not amenable to significant alterations. I am responsible for
`
`preparing a number of motions to be filed at the Board, including motions due on
`
`Wednesday, June 15, 20 11, in Interference No . 105,792, and motions due on June
`
`24, 2011 , in Interference No. 105,771 , and responsive motions due on July 15,
`
`20 11 , in Interference No. 105,77 1. In addition, due to longstanding plans for a
`
`family vacation, I will be away from the office from Ju ne 25, 2011 , through July
`
`l 0, 20 I I.
`
`4. While signiftcant efforts have been made to avoid having to seek an
`
`extension in this case, it has now been determined that an extension of time of -
`
`thirty (30) days to and including July 27,20 11 , would allow adequate time for me
`
`to coordinate the drafting, reviewing and fil ing of Carter's brief.
`
`Pursuant to 29 U.S.C. § 1746, I declare under
`penalty of petjury that the foregoing is true
`and correct.
`
`Ju ne 15,2011
`
`Oliver R. Ashe, Jr.
`
`{/
`
`PFIZER EX. 1595
`Page 1766
`
`
`
`UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT
`
`2011-1212,-1213
`(Interference No. 105,744)
`
`JOHN ROBERT ADAIR, DILJEET SINGH ATHWAL,
`and JOHN SPENCER EMT AGE,
`Appellants,
`
`v.
`
`\ .. · PAUL J. CARTER and LEONARD G. PRESTA,
`Cross-Appellants.
`
`Declaration of Jeffrey P. Kushan
`
`. . ~ .
`··-··
`., .....
`. '
`... _ ... '
`
`! •
`
`.;; ......
`Cr.::
`
`-·
`
`~
`('J
`
`1.
`
`I am~o-counsel for Cross-Appellants PAUL J. CARTER AND LEONARD
`
`G. PRESTA ("Carter'}
`
`2.
`
`This appeal was docketed in this Court on February 15, 2011, which made
`
`Appellants JOHN ROBERT ADAIR, DILJEET SINGH ATHWAL, and JOHN
`
`SPENCER EMT AGE ("Adair") opening brief due on April 18, 2011. Adair
`
`requested and was granted an extension of time in which to file its opening brief.
`
`Adair filed that brief on May 13, 2011. Based on the May 13 filing of Adair's
`
`brief, Carter's brief is due on June 27,2011.
`
`3.
`
`Various professional commitments have limited and will continue to limit
`
`the time that I am able to devote to the assistance of the preparation and review of
`
`PFIZER EX. 1595
`Page 1767
`
`
`
`
`
`NOTE: This order is nonprecedential.
`
`\Mniteb $->tate1) <!ourt of £lppeals
`for tbe jf eberal <!trcutt
`
`JOHN ROBERT ADAIR, DILJEET SINGH ATHWAL,
`.<\ND JOHN SPENCER EMTAGE,
`Appellants,
`v.
`PAUL J. CARTER AND LEONARD G. PRESTA,
`Appellees.
`
`2011-1212
`(Interference No. 105,744)
`
`Appeal from the United States Patent & Trademark
`Office, Board of Patent Appeals and Interferences.
`
`JOHN ROBERT ADAIR, DILJEET SINGH ATHWAL,
`AND JOHN SPENCER EMTAGE,
`Appellees,
`v.
`PAUL J . CARTER AND LEONARD G. PRESTA,
`Appellants.
`
`2011-1213
`(Interference No. 105,7 44)
`
`PFIZER EX. 1595
`Page 1769
`
`
`
`ADAIR v. CARTER
`
`2
`
`Appeal from the United States Patent & Trademark
`Office, Board of Patent Appeals and Interferences.
`
`ORDER
`Upon consideration of the cross-appellants' unopposed
`motion for voluntary dismissal of cross-appeal, 2011-1213,
`pursuant to Fed. R. App. P. 42(b),
`IT Is ORDERED THAT:
`The motion is granted. The revised caption in 2011-
`1212 is reflected above.
`(2) Each side shall bear its own costs in 2011-1213.
`
`FOR T HE COURT
`
`Is/ J an Horbaly
`Jan Horbaly
`Clerk
`
`JIJl 6 2011
`Date
`
`cc: Doreen Yatko Trujillo, Esq.
`Oliver R. Ashe, Jr., Esq.
`s24
`
`ISSUED AS A MANDATE (as to 2011-1213 only): JUl 6 2011
`
`FSLED
`ti.S. COURT OF APPEALS FOR
`THE FEDER.b.l CIRCUIT
`JUL 0 6 2011
`
`c:;~r!!=':::~ c:~
`I HEREBY CER' 1F'I' THIS DOCUMENT
`IS A :P.VS I'.N!) 0C:i~SCT COPY
`OF THE ORIGINAL ON FILE.
`
`JAN HCR8ALV
`ClEf*(
`
`UNITE!) ST:\T~S C0~~T CF 1\PPeAI.S
`FOR THE FEDERAL CIRCUIT
`~1J1?1ifflru~ate: ~«/;'
`
`PFIZER EX. 1595
`Page 1770
`
`
`
`2011-1212
`(Interference No. 105,744)
`
`UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT
`
`JOHN ROBERT ADAIR, DILJEET SINGH ATHWAL,
`and JOHN SPENCER EMTAGE,
`
`Appellants,
`
`V.
`
`PAUL J. CARTER and LEONARD G. PRESTA,
`
`Cross Appellants.
`
`Appeals from the United States Patent and Trademark Office, Board
`of Patent Appeals and Interferences.
`
`REPLY BRIEF OF THE APPELLANTS
`JOHN ROBERT ADAIR, DILJEET SINGH ATHWAL,
`and JOHN SPENCER EMTAGE
`
`Doreen Yatko Trujillo
`(Counsel of Record)
`Kyle Vos Strache
`Cozen O'Connor, P .C.
`1900 Market St.
`Philadelphia, P A 19103
`215-665-2000
`
`Attorneys for Appellants
`John Robert Adair, Diljeet Singh Athwal,
`And John Spencer Emtage
`
`Dated: August 15, 2011
`
`PFIZER EX. 1595
`Page 1771
`
`
`
`
`
`TABLE OF CONTENTS
`
`CERTIFICATE OF INTEREST ...................................................................... .
`
`TABLE OF AUTHORITIES.............................................................................
`
`INTRODUC"fiON . . . . . . . . . . . . .. .. . . . .. . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . .. . . .. . . . .
`
`I.
`
`II.
`
`The Basis For This Appeal......................................................................
`35 U.S.C. § 135(b) Does Not Require An Additional Comparison
`Between Pre- And Post-Critical Date Claims Without Reference To
`The Patent Claims Being Copied For Interference.................................
`
`III. Even If An Additional Comparison Under§ 135(b) Is Required,
`Adair Claim 24 Satisfies It......................................................................
`
`IV. No Precedent Requires Patentability of Pre-Critical Date Claims
`Under§ 135(b) ........................................................................................
`
`V.
`
`The Board Cannot Create Substantive Law........................................ ....
`
`VI. The Board Improperly Shifted The Burden Of Production To Adair....
`
`CONCLUSION AND STATEMENT OF RELIEF SOUGHT. ........................
`
`Page
`
`w
`
`1
`
`2
`
`3
`
`9
`
`12
`
`13
`
`14
`
`i 5
`
`11
`
`PFIZER EX. 1595
`Page 1773
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases:
`
`Corbett v. Chisholm,
`568 F.2d 759 (CCPA 1977) ................................................................. passim
`
`In re Berger,
`279 F.3d 975 (Fed. Cir. 2002) .............................................................. passim
`
`Merck & Co., Inc. v. Kessler,
`80 F.3d 1543 (Fed. Cir. 1996).................................................................
`
`Novo Nordisk of North America, Inc. v. Genentech, Inc.,
`77 F.3d 1364 (Fed. Cir. 1996).................................................................
`
`14
`
`12
`
`Regents of the Univ. of Cal. v. Univ. of Iowa Res. Found. ,
`455 F.3d 1371 (Fed. Cir. 2006), reh 'g en bane denied,
`2006 U.S. Appl. Lexis 27583 (Fed. Cir. Oct. 16, 2006) ...................... passim
`
`Stalego v. Heymes,
`263 F.2d 334 (CCPA 1959) ....................................................................
`
`Univ. of Iowa Res. Found. v. Regents ofthe Univ. ofCal., Interf. No.
`105, 171 (B.P.A.l. March 10, 2005) (Board Decision).................. .........
`
`4
`
`6
`
`Statutes & Other Authorities:
`
`35 U.S.C. § 6(a).................................................................................................
`
`14
`
`35 U.S.C. § 112 .................................................................................................
`
`35 U.S.C. § 120 .................................................................................................
`
`7
`
`7
`
`35 U.S.C. § 135(b) .......................................................................................... passim
`
`35 U.S.C. § 135(b)(1)........................................................................................
`
`37C.F.R.§l.601...............................................................................................
`
`37 C.F.R. § 41.125(c)(3) ...................................................................................
`
`37 C.F.R. § 4 1.208(b)...... ..................................................................................
`
`15
`
`8
`
`11
`
`14
`
`lll
`
`PFIZER EX. 1595
`Page 1774
`
`
`
`INTRODUCTION
`
`Carter dedicated over seven pages of its 57-page brief (twice as long as
`
`Adair's principal brief) arguing, essentially, that Adair's claims should be limited
`
`by its specification, and that the specification requires multiple framework residues
`
`to be changed to donor, i.e., to be non-human (Red Br. 11-18). Adair is unsure
`
`why Carter dedicated such a major portion of its brief to an argument not relevant
`
`to the issues on appeal. Nonetheless, Carter is misrepresenting Adair's
`
`specification. Adair's specification is not as limiting as Carter alleges - the
`
`specification does not require multiple framework residues to be changed (A565).
`
`Carter is relying upon what is clearly delineated as a "preferred" protocol in
`
`arguing that the specification is so limited (Red Br. 12; A576). Further, In re
`
`Berger, 279 F.3d 975 (Fed. Cir. 2002) disapproves of focusing upon the
`
`specification for satisfying§ 135(b) . !d., at 983.
`
`Citing an irrelevant patent issued to Adair, Carter also advances the
`
`disingenuous argument that changing multiple residues to donor was necessary for
`
`Adair to overcome the prior art (Red Br. 18). But Carter's claims do not recite
`
`changing multiple residues (A91-3). If the recitation of multiple residues was not
`
`necessary for Carter's claims to overcome the prior art, then it is difficult to see
`
`how it would be necessary for Adair claim 24.
`
`Neither of the foregoing arguments is relevant to the basis for this appeal.
`
`1
`
`PFIZER EX. 1595
`Page 1775
`
`
`
`I. The Basis For This Appeal
`
`The basis for this appeal is the correct interpretation of35 U.S.C. § 135(b).
`
`Specifically, does§ 135(b) require applicants to show, in an interference based
`
`upon a claim that was submitted post-critical date, not only that the claim has pre-
`
`critical date support for its post-critical date identity with a claim of the patent, but
`
`also an additional requirement, as Carter and the Board allege, that the claim does
`
`not differ from the pre-critical date claim in virtually any respect? By presuming
`
`that any change to pre-critical date claims is material and suggesting (repeatedly)
`
`that Adair could have moved to add claims identical to pre-critical date claims in
`
`the involved application, the Board is essentially requiring a showing that the post-
`
`critical date claim does not differ from the pre-critical date claim in any respect,
`
`thereby setting forth a standard that is not only inconsistent with legal precedent,
`
`but is also impossible for applicants to meet.
`
`As anyone who has prosecuted an application before the USPT0 1 knows,
`
`particularly in the field of biotechnology, originally-filed claims are rarely, if ever,
`
`allowed. Indeed, if they are, applicants are concerned that they did not claim
`
`broadly enough. Thus, the fact that an applicant chooses to amend the claims upon
`
`rejection, or even cancel them in favor of different claims, is not a concession of
`
`unpatentability per se, particularly for applications filed after June 7, 1995, but
`
`1 Unless otherwise indicated, the same abbreviations as were used in the principal
`brief are used here.
`
`2
`
`PFIZER EX. 1595
`Page 1776
`
`
`
`more a reflection of a desire to get allowable claims in a reasonable time frame .
`
`An appeal of a rejection can take years to be resolved, particularly if the appeal has
`
`to be taken to this Court.
`
`II. 35 U.S.C. § 135(b) Does Not Require An Additional Comparison Between
`Pre- And Post-Critical Date Claims Without Reference To The Patent Claims
`Being Copied For Interference
`
`Adair contends that this Court did not impose an additional requirement in
`
`Regents ofthe Univ. of Cal. v. Univ. of iowa Res. Found., 455 F.3d 1371 (Fed. Cir.
`
`2006), reh 'g en bane denied, 2006 U.S. Appl. Lexis 27583 (Fed. Cir., Oct. 16,
`
`2006) that pre- and post-critical date claims do not differ from each other in any
`
`respect, irrespective of whether or not both contain all material limitations of the
`
`patent claim. In Regents, this Court stated that§ 135(b) prohibits unsupported
`
`post-critical date identity with a patent claim, that one must show pre-critical date
`
`support for the post-critical date identity between the post-critical date claim in
`
`interference and a patent claim, and that this demonstration entails a comparison
`
`between the pre- and post-critical date claims. !d., at 1375, emphasis added.
`
`Accordingly, the pre-critical date claim must have all material limitations of the
`
`post-critical date claim, with materiality being assessed in view of the patent claim.
`
`This analysis is all that the precedent cited throughout Regents, i.e., Berger, 279
`
`F.3d 975 and Corbett v. Chisholm, 568 F.2d 759 (CCPA 1977), required. In
`
`Berger, a limitation added by the patentee was considered material.
`
`3
`
`PFIZER EX. 1595
`Page 1777
`
`
`
`The Board found the "circumferential groove" limitation
`to be material because it was added by Muller [the
`patentee] during prosecution to avoid prior art. We agree
`with the Board's determination of materiality.
`
`Berger, 279 F.3d at 982. Similarly, in Chisholm, materiality was assessed in view
`
`of the patent claim.
`
`Turning to a comparison of Chisholm patent claim 1 and
`claims 24-27, we agree with the conclusion of the board
`that these claims, even considered as a group, do not
`recite Chisholm's claimed squeezing step (b). Corbett
`does not seriously contend that this is not a material
`limitation, that is, necessary to patentability ... There
`being a material limitation ofthe copied claim not
`present in Corbett's claims 24-27, they cannot be said to
`be directed to substantially the same invention.
`
`Corbett, 568 F.2d at 765-66. The pre-critical date claim does not need to have all
`
`limitations of the post-critical date claim, then, just those limitations that were
`
`material to the patented claim.
`
`Indeed, every express limitation is not material under§ 135(b). Stalego v.
`
`Heymes, 263 F.2d 334, 339 (CCPA 1959). A review of Berger reveals that the
`
`"circumferential groove" was not the only difference between the post-critical date
`
`claim that was copied from the Muller patent and the pre-critical date claim. The
`
`pre-critical date claim also did not contain a recitation of a pull tab. Berger, 279
`
`F.3d 977-78.
`
`When the post-critical date claim contains all material limitations of the
`
`patented claim the comparison becomes, in essence, a comparison between the pre-
`
`4
`
`PFIZER EX. 1595
`Page 1778
`
`
`
`critical date claims and the patent claims. See Berger, 279 F.3d at 982-83 and
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`Corbett, 568 F.2d at 763,765-66. The Court in Regents also stated, however, that
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`there is a distinction between comparing pre- and post-critical date claims with one
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`another and comparing pre-critical date claims with the patented claims. Regents,
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`455 F.3d at 1375. The Board, and Carter, has interpreted this statement in Regents
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`to mean that there is an additional requirement that the pre-critical date claims
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`contain, essentially, all the limitations of the post-critical date claims, and vice
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`versa, irrespective of whether both contain all material limitations of the patent
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`claims. Adair, however, cannot reconcile this interpretation with the purpose of§
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`135(b}, nor the Court's statements in Regents regarding the purpose of§ 135(b),
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`i.e., prohibiting unsupported post-critical date identity with the patent claim, nor
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`the Court's repeated references to Berger and Corbett. Regents, 455 F .3d 1374-75.
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`An alternative interpretation proffered by Adair in this interference is that if,
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`after prosecution, the applicant's allowed post-critical date claims lack material
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`limitations from the pre-critical date claims, i.e., limitations that were necessary to
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`the patentability of the patent claims, the applicant should not be allowed in the
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`interference, as the claims are no longer to substantially the same invention (Br.
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`14). Under such circumstances, it would not be sufficient to compare the pre(cid:173)
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`critical date claims to the patent claims alone. Consistent with this view, the Court
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`distinguished cases in which the post-critical date claims were the ones copied
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`5
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`PFIZER EX. 1595
`Page 1779
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`
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`from the patent. Regents, 455 F.3d at 1375.
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`This interpretation seems to be the most consistent with the whole of the
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`Court's decision but, unfortunately, it is not consistent with the underlying facts as
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`Adair interprets them. A review of the underlying decision of the Board in Regents
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`suggests that the post-critical date claim had all the material limitations of the
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`patented claim. Univ. of Iowa Res. Found. v. Regents of the Univ. of Cal., Interf.
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`No. 105,171, slip op. at 3 and 6 (B.P.A.I. March 10, 2005) (Board Decision)
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`Perhaps, however, the Court took the appellant in Regents at its word that there
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`were material differences between the post- and pre-critical date claims, and
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`assumed that the post-critical date claims were no longer to the same invention as
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`the patent claims.
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`Assuming Adair's alternative interpretation is correct, Regents is not
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`applicable to the current facts. Adair first requested this interference post-critical
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`date. Even if applicable, Adair maintains that Regents did not create an additional
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`test for materiality completely divorced from the patent claims for purposes of
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`compliance with§ 135(b).
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`Carter argues, incredulously, that this Court found the limitations of the
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`patent claims to be irrelevant in Regents because "the relevant question for the
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`issue of repose is whether the later claim is entitled to the effective date of the
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`earlier claim . .. which is essential to establishing that the same interference could
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`6
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`PFIZER EX. 1595
`Page 1780
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`
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`have been declared earlier" (Red Br. 43, emphasis in original). Adair questions
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`how the limitations of the patent claims can ever be irrelevant under a statute that
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`requires that a claim that is to substantially the same subject matter as a claim of an
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`issued patent be submitted within a specified time frame. 35 U.S.C. § 135(b ).
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`Further,§ 135(b) does not require that the same interference could have been
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`declared earlier, just that an interference could have been declared earlier.
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`Adair contends that both Carter and the Board are confounding the analysis
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`for determining effective filing date for purposes of35 U.S.C. § 120 with the
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`analysis for determining effective filing date for purposes of 35 U.S.C. § 135(b).
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`But these sections of the Patent Statute serve distinct purposes and have very
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`different requirements. This distinction was recognized in Berger which refers to
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`"the earlier effective filing date of those prior claims for purposes of satisfying 35
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`U.S.C. § 135(b)." Berger, 279 F.3d at 982 (emphasis added). For example,§ 120
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`allows an application for patent to rely upon the filing date of an earlier filed
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`application if the invention is disclosed in the earlier application in the manner
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`provided by the first paragraph of35 U.S.C. § 112. 35 U.S.C. § 120. Accordingly,
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`under§ 120, one must show, inter alia, written descriptive support for the
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`recitations in the claims in earlier applications, and one can look to the
`
`specification for such support. Contrastingly, §J 35{b) makes no reference to the
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`first paragraph of35 U.S.C. § 112, nor to the benefit of a filing date, and focuses
`
`7
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`PFIZER EX. 1595
`Page 1781
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`
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`upon the claims alone. All that§ 135(b) requires is that a claim that is to
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`substantially the same subject matter, not exactly the same subject matter, as a
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`claim of the patent be made prior to one year from the date the patent was granted.
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`35 U.S.C. § 135(b ). The Board and Carter, however, are requiring applicants to
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`show, allegedly under§ 1 35{b), written descriptive support for all recitations in the
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`post-critical date claims in the pre-critical date claims themselves.
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`One source of the confusion may be the apparent discrepancy in the various
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`reported versions of a statement in Berger, 279 F.3d at 982. The Lexis® and
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`Westlaw® electronic databases report the statement as the following:
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`This is a distinctly different question from whether
`claims made for purposes of interference by different
`parties are directed to interfering subject matter.
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`Other electronic databases, as well as the book version of the reporter, report the
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`statement as the following:
`
`This is a distinctly different question from whether
`claims made for purposes of interference by different
`parties are directed to the same or substantially the
`same subject matter.
`
`The differences between the two are highlighted in bold. Notably, the immediately
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`preceding sentence in Berger sets forth what must be shown under§ 135{b). !d.,
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`279 F.3d at 981-2. As discussed above,§ J35(b) recites the language "the same or
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`substantially the same subject matter." 35 U.S.C. § 135(b). Adair contends that
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`the correct version is the first one because interfering subject matter under (prior)
`
`8
`
`PFIZER EX. 1595
`Page 1782
`
`
`
`37 C.F.R. § 1.601 was being distinguished from the requirements under§ 135(b) in
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`Berger. !d. Under the latter version, showing that claims are to the same or
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`substantially the same subject matter is being distinguished from showing that
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`claims are to the same or substantially the same subject matter.
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`III. Even If An Additional Comparison Under §135(b) Is Required, Adair
`Claim 24 Satisfies It
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`As the Board, and Carter, repeatedly asserted, a limitation that is necessary
`
`to patentability is material (see, for example, Red Br. 36). Adair claim 24, having
`
`been indicated as allowable, is presumptively patentable (Red Br. 26). If Adair
`
`claim 24 is lacking limitations from the earlier claims, then, those limitations could
`
`not have been material. Regardless, as Adair argued in its request for rehearing,
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`claim 2 of the PCT application recites all the residues recited as alternatives in
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`Adair claim 24 (Hr. 14; A431, A435). As shown in the appendix to Adair's
`
`request for rehearing, claim 16 of the PCT application, as depending from claim 2
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`of the PCT application, thus, contains all material limitations of Adair claim 24,
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`and vice versa? The Board declined to consider claim 2 of the PCT application,
`
`2 Carter also argues that the Board noted that Adair did not make a sufficient
`comparison to show that claim 2 is materially the same as the copied claim,
`evidently in reference to claim 66 of the Carter patent (Red Br. 24). In its initial
`decision, however, the Board argued that Adair was not to compare its pre-critical
`date claims to the patent claims under Regents (A9). Regardless, if Adair claim 24
`contains all material limitations of claim 66 of the Carter patent, which neither the
`Board nor Carter has argued to the contrary, and claim 16 of the PCT application,
`as depending from claim 2, contains all material limitations of Adair claim 24,
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`9
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`PFIZER EX. 1595
`Page 1783
`
`
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`however, citing a rule related to ex parte appeals, not interferences (A26).
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`In defense of the Board's declination, Carter asserts that Adair has been
`
`prosecuting this portfolio for over 14 years and had ample opportunity to explain
`
`why claim 2 provided the requisite pre critical date support under§ 135(b) (Red
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`Br. 51). Carter's assertion is flawed. Adair had only been trying to provoke an
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`interference with the Carter patent since November 21, 2005 (Br. 2-3). Adair
`
`would have had no reason to raise the issue before then. Further, as Adair has
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`repeatedly pointed out, the rules do not require Adair to show compliance with
`
`§ 135(b) to provoke an interference (Br. 4-5). Carter keeps faulting Adair for not
`
`raising an issue that Adair was not required to raise. Notably, nothing prevented
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`the USPTO from raising §135(b) as a basis for rejection during that five-year
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`period. See Berger, 279 F.3d at 981.
`
`Carter also asserts the Adair's submission of arguments regarding claim 2 of
`
`the PCT application were belated (Red Br. 52-3). Carter notes that the Board's
`
`Standing Order explains that the Board will not consider evidence presented
`
`belatedly in a reply (Red Br. 52). Carter is completely disregarding that the burden
`
`was on Carter, as the movant, to make out a prima facie case, not on Adair. All
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`Adair needed to do in its opposition was address the arguments raised by Carter.
`
`Carter did not cite Regents in its motion to support its arguments that Adair claim
`
`claim 16 of the PCT application, as depending from claim 2, must contain all
`material limitations of claim 66 of the Carter patent.
`
`10
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`PFIZER EX. 1595
`Page 1784
`
`
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`24 differed materially from Adair's non-original, pre-critical date claims (A308).
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`In its opposition, then, Adair focused upon arguing that Carter was applying the
`
`incorrect materiality test (372). Regents was first raised by the Board in its
`
`decision (A6). Adair's first chance to address the Board's int