CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES
`
`Control Nos.:
`
`Confirmation Nos.:
`
`90/ 007,542
`90/ 007,859
`
`7585 (’542)
`6447 (’859)
`
`Filed:
`
`13 May 2005
`23 December 2005
`
`(’542)
`(’859)
`
`Patent Owner:
`
`Genentech, Inc. and
`
`City of Hope
`
`Group Art Unit:
`
`3991
`
`Examiner:
`
`P. Ponnaluri
`
`For:
`
`Merged Reexaminations of U.S. Patent No. 6,331,415 (Cabilly Ll.)
`
`Mail Stop Ex Parte Reexam
`Commissioner for Patents
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`APPEAL BRIEF
`
`Further to the Notice of Appeal under 37 C.F.R. § 41.31 filed in this merged
`
`reexamination proceeding on 22 August 2008, Owners file this appeal brief in compliance with
`
`§ 41.37. On 17 October 2008, the Office granted a request to extend the time for filing a brief to
`
`10 December 2008. Accordingly, this brief is timely filed.
`
`Owners request that the Director debit the fee for filing an appeal brief, $540
`
`(§ 41.20(b)(2)), as well as any other fees required to make this or any other paper submitted in
`
`support of this appeal timely or proper, from our Deposit Account No. 18-1260.
`
`Sections (1) to (7) below correspond to the requirements of § 41 .37(c)(1)(i)-(Vii),
`
`respectively. The sections required under § 41 .37(c)(1)(Viii)-(x) appear as appendices to this
`
`brief.
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE 1
`
`Sanofi/Regeneron Ex. 1024, pg 711
`
`Mylan Ex. 1024, pg 711
`
`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`Table of Contents
`
`(1) Real Party in Interest........................................................................................................ .. 10
`
`(2) Related Appeals, Interferences, and Judicial Proceedings ........................................... .. 11
`
`(3) Status of Claims ................................................................................................................. .. 13
`
`(4) Status of Amendments ...................................................................................................... .. 14
`
`(5) Summary of Claimed Subject Matter ............................................................................. .. 15
`
`(6) Grounds of Rejection to be Reviewed on Appeal ........................................................... .. 18
`
`(7) Argument ........................................................................................................................... .. 19
`
`(a) The ’415 Invention Was Made a Quarter Century Ago During the
`Infancy of the Biotechnology Industry........................................................................19
`
`(b) The Separate and Very Different Cabilly Inventions .............................................. ..22
`
`(i)
`
`The Cabillyl Patented Invention (the ’567 Patent) ............................................. ..22
`
`(ii) The C abilly II Patented Invention (the ’4l5 Patent) ............................................ ..22
`
`(c) Four Distinct Reasons Mandate Reversal of the Rejections .....................................24
`
`(i)
`
`The Prior Art Does Not Disclose or Suggest All of the Elements Required
`by the ’4l 5 Claimed Invention ............................................................................ ..25
`
`(ii) The Prior Art Leads Away from the ’4l5 Claimed Approach of Producing
`a Multimeric lmmunoglobulin Structure ............................................................. ..26
`
`(iii) The ’567 Claims and the Cited References Do Not Show that the ’4l5
`Claimed Invention Could Have Been Predictably Achieved in April 1983 ........ .28
`
`(iv) The Strong Evidence of Secondary Considerations Negates the Asserted
`Obviousness of the ’4l5 Claims .......................................................................... ..29
`
`(d) The Examiner’s Rejection Must Be Reversed as Unsupported by the
`Evidence and the Controlling Law ............................................................................ ..29
`
`(i) Applicable Law .................................................................................................... ..29
`
`(ii) The Final Rejection and the Underlying Record of Examination........................ ..3l
`
`(iii) The Patentably Distinct Inventions of the ’4l5 and ’567 Patents ........................ ..32
`
`A. Three Important Differences Between the Claimed Inventions .................... ..32
`
`B. The Examiner Fails to Properly Identify and Appreciate the
`Differences Between the Host Cells Required by the ’4l5 and ’567
`Claimed Inventions ........................................................................................ ..34
`
`C. The ’415 Invention Requires a Substantially Different Product Made
`by a Substantially Different Process .............................................................. ..37
`
`D. The Examiner Mistakenly Relies on Geneva Pharmaceuticals ............... ..39
`
`(iv) The Examiner Does Not Establish a Prima Facie Case of Obviousness-
`Type Double Patenting, But Instead Rests on a Hindsight Reconstruction
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE 2
`
`Sanofi/Regeneron Ex. 1024, pg 712
`
`Mylan Ex. 1024, pg 712
`
`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`of the ’4l5 Claimed Invention Using a Scientifically Incorrect Portrayal of
`the Prior Art ......................................................................................................... ..40
`
`A. The Examiner Improperly Employed a Hindsight-Driven, Rather than
`Objective, Analysis of the Claims and Prior Art Teachings .......................... ..40
`
`B. The Examiner Ignored the “Collective” Teachings of the Cited
`References and the General Knowledge in the Field of the Invention in
`April 1983 ...................................................................................................... ..41
`
`C. Axel Does Not Teach or Suggest the Type of Expression Required by
`the ’4l5 Patent Claims ................................................................................... ..44
`
`I. Axel Proposes the Same “One Polypeptide in a Host Cell” Strategy
`Shared by the ’567 Claims ....................................................................... ..45
`
`II. Axel Produced No “Functional” Desired Polypeptides ........................... ..47
`
`III. Axel Did Not Show Successful “Co-Expression” of Two Foreign
`DNA Sequences ....................................................................................... ..49
`
`IV. Axel Does Not Teach or Suggest Expressing Multiple DNA
`Sequences Encoding Different “Desired” Polypeptides in One Host
`Cell ........................................................................................................... ..51
`
`V. Axel Does Not Show or Suggest Production of “Intact
`(Assembled)” Antibodies by Producing Heavy and Light
`Immunoglobulin Chains in One Host Cell ............................................... ..52
`
`D. Rice Expressed a Single Recombinant Light Chain Gene and Reported
`Unpredictable Results .................................................................................... ..55
`
`I. Rice Does Not Describe or Suggest the ’4l5 Claimed Invention ............ ..55
`
`II. The Examiner Improperly Equates the ’415 Claimed Invention to
`the Actual Rice Experiments ................................................................... ..58
`
`III. The Examiner Improperly Dismissed the Relevant Testimony of
`Qualified Experts ..................................................................................... ..59
`
`IV. The Examiner Improperly Relies on a Third-Party Declaration
`About a Hypothetical Experiment Not Disclosed or Suggested in
`Rice .......................................................................................................... ..63
`
`E. Kaplan and Moore Direct the Person of Ordinary Skill Down a
`Different Path Than What is Required by the ’4 l 5 Invention ....................... ..66
`
`I. The “Road Map” in Kaplan Leads Away from the ’415 Claimed
`Invention .................................................................................................. ..67
`
`II. Moore Also Leads Away from the ’415 Claimed Approach of
`Producing an Immuno globulin Multimer ................................................ ..68
`F. Dallas Would Have Been Considered Irrelevant to Production and
`
`Recovery of Multimerie Eukaryotie Proteins in April 1983 .......................... ..69
`
`I. The Dallas Method of Making a Whole—Cell E. coli Vaccine
`Would Not Have Made Producing a Multimerie Immunoglobulin
`Obvious .................................................................................................... ..69
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE 3
`
`Sanofi/Regeneron Ex. 1024, pg 713
`
`Mylan Ex. 1024, pg 713
`
`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`II. The Examiner Distorts the Relevance of Dallas with Hindsight ............. ..74
`
`G. Ochi Demonstrates Unpredictability in a Far Simpler Experiment than
`What Is Required by the ’415 Claims ............................................................ ..76
`
`H. Experimental Work in Frog Oocytes Would Not Have Set
`Expectations for Recombinant Host Cells ..................................................... ..78
`
`I. The Frog Oocyte Experiments Do Not Foretell Results in DNA
`Transformed Host Cells ........................................................................... ..79
`
`II. The Examincr’s View that Differences Between mRNA and DNA
`are “Not Substantive” is Incorrect ........................................................... ..80
`
`I. Accolla and Builder Add Nothing to the Examincr’s Rationale ....................... ..83
`
`J. The Cited References Refilte, Rather than Support, the Examincr’s
`Essential Findings Allegedly Supporting his Conclusion of
`Obviousness ................................................................................................... ..83
`
`(V)
`
`Substantial Evidence of Secondary Considerations Supports the
`Conclusion that the ’4 1 5 Patent Claims Are Not Obvious, and Must Be
`
`Accorded Proper Weight ...................................................................................... ..84
`
`(vi) The Examiner Either Ignored or Improperly Dismissed the Testimony of
`Qualified Experts in the § 1.132 Declarations ..................................................... ..85
`
`(vii) The Board Should Give Weight to the Numerous Past PTO
`Determinations, Including Those of the Board, Finding the Approach
`Required by the ’4l5 Claims Patentably Distinct from that Required by
`the ’567 Claims .................................................................................................... ..87
`
`(viii) The Examiner Erred as a Matter of Law in Repeatedly Treating the ’567
`Patent Disclosure as Prior Art .............................................................................. ..89
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE 4
`
`Sanofi/Regeneron Ex. 1024, pg 714
`
`Mylan Ex. 1024, pg 714
`
`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`TABLE OF AUTHORITIES
`
`CASES
`
`
`Arkie Lures Inc. V. Gene Larew Tackle Inc.,
`
`119 F.3d 953, 43 U.S.P.Q.2d 1294 (Fed. Cir. 1997) ................................................. ..84
`
`Bausch & Lomb, Inc. V. Bames—Hind/Hydrocurve, Inc.,
`796 F.2d 443, 230 U.S.P.Q. 416 (Fed. Cir. 1986) ..................................................... ..31
`
`Eisai Co. Ltd. V. Dr. Reddy’s Labs, Ltd.,
`533 F.3d 1353, 87 U.S.P.Q. 1452 (Fed. Cir. 2008) ................................................... ..27
`
`Environmental Designs, Ltd. V. Union Oil Co. of Cal.,
`713 F.2d 693, 218 U.S.P.Q. 865 (Fed. Cir. 1983) ............................................... ..65, 66
`
`EX 12arte Clap13,
`227 U.S.P.Q. 972 (Bd. Pat. App. & Intcrf. 1985) ...................................................... ..30
`
`Ex parte Honsberg-Riedl,
`2007 WL 3827797 (Bd. Pat. App. & Interf. 2007) .................................................... ..31
`
`Ex partc Kimbcll,
`226 U.S.P.Q. 688 (Bd. Pat. App. & Interf. 1985) ...................................................... ..82
`
`Ex parte McGaughey,
`6 U.S.P.Q.2d 1334 (Bd. Pat. App. & Interf. 1988) .................................................... ..82
`
`Ex parte Seiko Koko Kabushiki Kaisha Co.,
`225 U.S.P.Q. 1260 (Bd. Pat. App. & Interf. 1984) .................................................... ..82
`
`General Foods Corp. V. Studiengesellschaft Kohle mbH,
`972 F.2d 1272, 23 U.S.P.Q.2d 1839 (Fed. Cir. 1992) ....................... ..25, 30, 38, 89, 90
`
`Geneva Pharmaceuticals Inc. V. GlaXoSmithKline PLC,
`
`349 F.3d 1373, 68 U.S.P.Q.2d 1865 (Fed. Cir. 2003) ............................................... ..39
`
`Graham V. John Deere Co.,
`
`383 U.S. 1, 148 U.S.P.Q. 459 (1966) ................................................. ..29, 33, 40, 74, 84
`
`Hybritech Inc. V. Abbott Laboratories,
`4 U.S.P.Q.2d 1001 (C.D. Cal. 1987) .......................................................................... ..66
`
`In re Aldrich,
`
`398 F.2d 855,158 U.S.P.Q. 311 (C.C.P.A. 1968) ............................................... ..90, 91
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE 5
`
`Sanofi/Regeneron Ex. 1024, pg 715
`
`Mylan Ex. 1024, pg 715
`
`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`In re Buchner,
`929 F.2d 660, 18 U.S.P.Q.2d 1331 (Fed. Cir. 1991) ................................................. ..66
`
`In re Carroll,
`
`601 F.2d1184, 202 U.S.P.Q. 571 (C.C.P.A. 1979) ................................................... ..42
`
`In re Eli Lilly & C0.,
`902 F.2d 943, 14 U.S.P.Q.2d 1741 (Fed. Cir. 1990) ................................................. ..85
`
`In re Fax,
`347 F.2d 597, 146 U.S.P.Q. 47 (C.C.P.A. 1965) ....................................................... ..86
`
`In re Fine,
`
`837 F.2d 1071, 5 U.S.P.Q.2d 1596 (Fed. Cir. 1988) ................................................. ..31
`
`In Re Gordon,
`
`733 F.2d 900,221 U.S.P.Q. 1125 (Fed. Cir. 1984) ............................................. ..50, 70
`
`
`In re ICON Health and Fitness Inc.,
`496 F.3d 1374, 83 U.S.P.Q.2d 1746 (Fed. Cir. 2007) ......................................... ..27, 28
`
`In re Kaplan,
`789 F.2d 1574, 229 U.S.P.Q. 678 (Fed. Cir. 1986) ................................................... ..89
`
`In re Katzschrnann,
`347 F.2d 620, 146 U.S.P.Q. 66 (C.C.P.A. 1965) ....................................................... ..86
`
`In re Keller,
`
`642 F.2d 413, 208 U.S.P.Q. 871 (C.C.P.A. 1981) ..................................................... ..42
`
`In re McKenna,
`
`203 F.2d 717, 97 U.S.P.Q. 348 (C.C.P.A. 1953) ....................................................... ..86
`
`
`In re Merck & C0.
`
`800 F.2d 1091, 231 U.S.P.Q. 375 (Fed. Cir. 1986) ................................................... ..42
`
`In re Noniiya,
`509 F.2d 566, 184 U.S.P.Q. 607 (C.C.P.A. 1975) ..................................................... ..82
`
` ,
`
`745 F.2d 1468, 223 U.S.P.Q. 785 (Fed. Cir. 1984) ................................................... ..85
`
`In re Rinehart,
`531 F.2d 1048, 189 USPQ 143 (C.C.P.A. 1976) ....................................................... ..85
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE 6
`
`Sanofi/Regeneron Ex. 1024, pg 716
`
`Mylan Ex. 1024, pg 716
`
`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`In re Rouffet,
`149 F.3d 1350, 47 U.S.P.Q.2d 1453 (Fed. Cir. 1998) ................................... ..24, 41, 87
`
`In re Sarett,
`
`327 F.2d 855, 158 U.S.P.Q. 311 (C.C.P.A. 1968) ..................................................... ..90
`
`In re Schulpen,
`390 F.2d 1009, 157 U.S.P.Q. 52 (C.C.P.A. 1968) ..................................................... ..50
`
`In re Sullivan,
`
`498 F.3d 1345, 84 U.S.P.Q.2d 1034 (Fed. Cir. 2007) ............................................... ..87
`
`In re Vogel,
`422 F.2d 438, 164 U.S.P.Q. 619 (C.C.P.A. 1970) ..................................................... ..89
`
`In re Wesslau,
`
`353 F.2d 238, 147 U.S.P.Q. 391 (C.C.P.A. 1965) ..................................................... ..31
`
`In re Zeidler,
`682 F.2d 961, 215 U.S.P.Q. 490 (C.C.P.A. 1982) ..................................................... ..86
`
`Interconnect V. Feil,
`
`774 F.2d1132, 227 U.S.P.Q. 543 (Fed. Cir. 1985) ................................................... ..86
`
`
`KSR International Co. V. Teleflex Inc.
`
`127 S. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007) ..................................................... ..passin1
`
`
`Medhnmune Inc. V. Genentech Inc.,
`
`427 F.3d 958, 76 U.S.P.Q.2d 1914 (Fed. Cir. 2005), rev’d and remanded, 549
`U.S. 118, 81 U.S.P.Q.2d 1225 (2007) ........................................................................ ..11
`
`Ortho-McNeil Phannaceuticals, Inc. V. Mylan Laboratories, Inc.,
`520 F.3d 1358, 86 U.S.P.Q.2d 1196 (Fed. Cir. 2008) ......................................... ..28, 84
`
`Phillips V. AWH Corp,
`415 F.3d 1303, 75 U.S.P.Q.2d 1321 (Fed. Cir. 2005) ............................................... ..54
`
`Ruiz V. A.B. Chance Co.,
`357 F.3d 1270, 69 U.S.P.Q.2d 1686 (Fed. Cir. 2004) ................................................ .30
`
`Schenck V. Nortron Corp,
`713 F.2d 782, 218 U.S.P.Q. 698 (Fed. Cir. 1983) ................................... ..25, 30, 33, 38
`
`Stratoflex, Inc. V. Aeroguip Corp,
`713 F.2d 1530, 218 U.S.P.Q. 871 (Fed. Cir. 1983) ................................................... ..84
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE 7
`
`Sanofi/Regeneron Ex. 1024, pg 717
`
`Mylan Ex. 1024, pg 717
`
`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`Studiengesellschaft Kohle mbH V. Dart Industries, Inc.,
`549 F. Supp. 716, 216 U.S.P.Q. 381 (D. Del. 1982) .................................................. ..66
`
`United States V. Adams,
`
`383 U.S. 39, 148 U.S.P.Q. 479 (1966) ...................................................................... ..33
`
`W.L. Gore & Associates, Inc. V. Garlock, Inc.,
`
`721 F.2d 1540, 220 U.S.P.Q. 303 (Fed. Cir. 1983) ................................................... ..30
`
`WMS Gaming, Inc. v. lntemational Game Technology,
`184 F.3d 1339, 51 U.S.P.Q.2d 1385 (Fed. Cir. 1999) ............................................... ..84
`
`STATUTES
`
`35 U.S.C. § 103 ......................................................................................................... ..29, 33
`
`35 U.S.C. § 146 .................................................................................................... ..15, 23, 88
`
`35 U.S.C. § 282 .......................................................................................................... ..53, 54
`
`35 U.S.C. § 302 ................................................................................................................ ..82
`
`37 C.F.R.§ 1.116 ............................................................................................................. ..14
`
`37 C.F.R. § 1.132 ........................................................................................... ..14, 84, 86, 87
`
`37 C.F.R. § 1.510 ............................................................................................................. ..82
`
`37 C.F.R. § 41.31 ............................................................................................................... ..1
`
`37 C.F.R. § 41.37 ............................................................................................................... ..1
`
`MISCELLANEOUS
`
`Chisum, M, § 9.03[1][a] (2005) ............................................................................... ..89
`
`Harvard J.L. & Tech. 17(2):583—61 8 (Spring 2004) ........................................................ ..54
`
`Manual Of Patent Examination Procedure (“M.P.E.P.”) § 716.01 .................................. ..86
`
`Manual Of Patent Examination Procedure (“M.P.E.P.”) § 804(II)(B)(1) ................. ..29, 84
`
`Manual Of Patcnt Examination Proccdurc (“M.P.E.P.”) § 2124 ..................................... ..66
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE 8
`
`Sanofi/Regeneron Ex. 1024, pg 718
`
`Mylan Ex. 1024, pg 718
`
`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`Manual Of Patent Examination Procedure (“M.P.E.P.”) § 2143.03 ................................ ..25
`
`Manual Of Patent Examination Procedure (“M.P.E.P.”) § 2164.05 ................................ ..66
`
`Manual Of Patent Examination Procedure (“M.P.E.P.”) § 2258(l)(E) ............................ ..65
`
`Manual Of Patent Examination Procedure (“M.P.E.P.”) § 2258(I)(F) ............................ ..82
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE 9
`
`Sanofi/Regeneron Ex. 1024, pg 719
`
`Mylan Ex. 1024, pg 719
`
`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`(1)
`
`Real Party in Interest
`
`The real parties in interest are Genentech, Inc., a corporation organized under the laws of
`
`the State of Delaware, and City of Hope, a corporation organized under the laws of the State of
`
`California.
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE 10
`
`Sanofi/Regeneron Ex. 1024, pg 720
`
`Mylan Ex. 1024, pg 720
`
`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`(2)
`
`Related Appeals, Interferences, and Judicial Proceedings
`
`No prior or pending appeals related to this proceeding within the meaning of 37 C .F.R.
`
`§ 41 .37(c)(1)(ii) are known to appellants or counsel.
`
`The patent under reexamination, U.S. Patent No. 6,331,415 [App. B49-72] (“the ’415
`
`patent”), has been involved in the proceedings noted below. The listed decisions from those
`
`proceedings appear in the Related Proceedings Appendix at the page numbers noted in brackets.
`
`—
`
`—
`
`-
`
`—
`
`Cabilly V. Boss, Interference No. 102,572, involving the application on which the
`patent under reexamination was granted, serial no. 07/205,419, and U.S. Patent
`No. 4,816,397 to Boss GL1 After entry of an initial adverse judgment, priority
`was eventually awarded to Cabilly ell. following judgment in an action under 35
`U.S.C. § 146.
`
`-
`
`-
`
`Final Decision, 55 U.S.P.Q.2d 1238 (Bd. Pat. App. & Interf., 13 August
`1988) [App. C1—58]
`
`Final Order after District Court Judgment, 60 U.S.P.Q.2d 1752 (Bd. Pat.
`App. & Interf., 26 July 2001) [App C59—73]
`
`Genentech, Inc. v. Celltech Therapeutics, Ltd., Civil Action No. C98—3926 MMC
`(WDB) (N.D. Cal.) (§ 146 action seeking review ofjudgment in Interference No.
`102,572)
`
`-
`
`Judgment (16 March 2001) [App. C74-77]
`
`
`Medlmmune Inc. v. Genentech Inc., Civil Action No. CV03-02567 MRP (CTx)
`(C.D. Cal.) (settled)
`
`-
`
`—
`
`—
`
`—
`
`Amended Memorandum of Decision Re: Defendant Celltech’s Motion for
`
`Judgment on the Pleadings and Defendant Genenteeh’s Motion for
`Summary Judgment (CD. Cal., 14 January 2004) [App. C78—l 03]
`
`427 F.3d 958, 76 U.S.P.Q.2d 1914 (Fed. Cir. 2005) [App. C104—120]
`
`549 U.S. 118, 81 U.S.P.Q.2d 1225 (2007) [App. C121—142]
`
`Claim Construction Order (C.D. Cal., 16 August 2007) [App. C143—169]
`
`
`Centoeor Inc. V. Genentech Inc., Civil Action No. CV08—03573 PA (AGRX)
`(W.D. Cal.) (pending)
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE 11
`
`Sanofi/Regeneron Ex. 1024, pg 721
`
`Mylan Ex. 1024, pg 721
`
`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`Applications related to the patent under reexamination have been involved in the
`
`proceedings noted below. The listed decision appears in the Related Proceedings Appendix at
`
`the page numbers noted in brackets.
`
`—
`
`—
`
`Cabilly V. Glaxo Wellcome Inc., Interference No. 104,532, involving application
`serial no. 08/909,611, which claimed priority to the patent under rccxamination
`(terminated)
`
`-
`
`-
`
`Order Denying Glaxo Wellcome Miscellaneous Motion 1, 56 U.S.P.Q.2d
`1983, Bd. Pat. App. & Interf., 26 October 2000) [App. C170-172]
`
`Decision on Priority and Other Motions and Final Judgment (Bd. Pat.
`App. & Interf., 4 September 2002) [App. Cl73—230]
`
`Cabilly v. Boss, Interference No. 105,531, involving application serial no.
`08/422,187, which claims priority to the patent under reexamination (pending)
`
`—
`
`-
`
`-
`
`-
`
`Memorandum Opinion and Order (Decision on C abilly Motion 1 —
`cstoppcl) (Bd. Pat. App. & Interf., 4 June 2008) [App. C231-263]
`
`Memorandum Opinion and Order (Decision on C abilly Motion 2 —
`patentability) (Bd. Pat. App & Interf, 8 December 2008) [App. C264-284]
`
`Memorandum Opinion and Order (Decision on Cabilly Motion 5 —
`priority) (Bd. Pat. App & Interf, 8 December 2008) [App C285-312]
`
`Judgment (Bd. Pat. App & Interf., 8 December 2008) [App C313-316].
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE 12
`
`Sanofi/Regeneron Ex. 1024, pg 722
`
`Mylan Ex. 1024, pg 722
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`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`(3)
`
`Status of Claims
`
`Claims 1-36 were granted in the ’4l5 patent and have not been amended in this
`
`proceeding.
`
`Claims 1-36 stand finally rejected and are involved in this appeal.
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE 13
`
`Sanofi/Regeneron Ex. 1024, pg 723
`
`Mylan Ex. 1024, pg 723
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`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`(4)
`
`Status of Amendments
`
`A reply under 37 C.F.R. § 1.1 16 was filed on June 6, 2008, together with two
`
`declarations under § 1.132. The reply did not include amendments to the claims. In an advisory
`
`action mailed on July 19, 2008, the Examiner indicated that the reply and declarations would be
`
`entered.
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE l4
`
`Sanofi/Regeneron Ex. 1024, pg 724
`
`Mylan Ex. 1024, pg 724
`
`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`(5)
`
`Summary of Claimed Subject Matter
`
`The invention relates generally to methods for recombinantly producing immunoglobulin
`
`molecules or immunologically functional immunoglobulin fragments (collectively
`
`“immunoglobulin multimers” or “multimeric immunoglobulin structures”).1 The methods of the
`
`invention require the immunoglobulin multimer to be made from immunoglobulin heavy and
`
`light chains produced in a single recombinantly transformed host cell. In particular, the claims
`
`require transforming a single host cell with DNA sequences encoding the heavy chain and light
`
`chain, and independently cxprcssing both sequences such that the heavy chain and light chain
`
`polypeptides are both produced as separate molecules in the same host cell.
`
`Claims 1-18 of the ’415 patent were copied (with minor variations appropriate to the
`
`disclosure of the application filcd by Cabilly ct al.) from U.S. Patent No. 4,816,397 to Boss L1.
`
`The Office declared an interference (Interference No. 102,572), designating claim 1 of the ’4l5
`
`patent as the Count. Priority of invention was awarded to Cabilly following an action under 35
`
`U.S.C. § 146. E section (2) above and the Related Proceedings appendix to this brief.
`
`The specific text of various limitations of the independent claims finds support at least in
`
`the passages of the ’4l5 patent and the claims of the original application (Q, serial no.
`
`07/205,419 (“the ’419 application”)) as indicated below.
`
`1.
`
`A process for producing an immunoglobulin
`molecule or an immunologically functional
`immunoglobulin fragment comprising at
`least the variable domains of the
`
`Col. 3, line 42 — col. 4, line 5;
`col. 4, line 5l - col. 5, line 39;
`col. 6, lines 3-1 1;
`col. 7, lines 35-39, 47-59;
`
`immunoglobulin heavy and light chains, in a
`single host cell, comprising the steps of:
`
`col. 12, lines 17-22, 26-30, 50-56;
`col. 16, lines 6-10;
`col. 23, lines 5-10.
`
`Immuno globulin molecules and immunologically functional immunoglobulin fragments are
`“multimeric” protein complexes made up of multiple discrete immunoglobulin polypeptides.
`The multimeric immunoglobulin complex is formed through disulfide bonds and non-
`covalent associations between the discrete polypeptides. E ’4l5 patent, col. 3. lines 16-40.
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE 15
`
`Sanofi/Regeneron Ex. 1024, pg 725
`
`Mylan Ex. 1024, pg 725
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`

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`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`(i)
`
`(ii)
`
`transforming said single host cell
`with a first DNA sequence encoding
`at least the variable domain of the
`
`immunoglobulin heavy chain and a
`second DNA sequence encoding at
`least the variable domain of the
`
`immunoglobulin light chain, and
`
`Col. 3, lines 42-45;
`col. 8, lines 26-32;
`col. 12, lines 17-30;
`
`col. 23, lines 5-10.
`
`Col. 4, lines 24-29;
`independently expressing said first
`DNA sequence and said second DNA col. 12, lines 17-22, 31-33, 50-56;
`sequence so that said
`col. 23, lines 16-33;
`immunoglobulin heavy and light
`col. 24, line 18.
`chains are produced as separate
`molecules in said transformed single
`host cell.
`
`15.
`
`18.
`
`A vector comprising a first DNA sequence
`encoding at least a variable domain of an
`immunoglobulin heavy chain and a second
`DNA sequence encoding at least a variable
`domain of an immunoglobulin light chain
`wherein said first DNA sequence and said
`second DNA sequence are located in said
`vector at different insertion sites.
`
`A transformed host cell comprising at least
`two vectors, at least one of said vectors
`comprising a DNA sequence encoding at
`least a variable domain of an
`
`immunoglobulin heavy chain and at least
`another one of said vectors comprising a
`DNA sequence encoding at least the variable
`domain of an immunoglobulin light chain.
`
`21. A method comprising
`
`preparing a DNA sequence consisting
`essentially of DNA encoding an
`immunoglobulin consisting of an
`immunoglobulin heavy chain and
`light chain or Fab region, said
`immuno globulin having specificity
`for a particular known antigen;
`
`a)
`
`b)
`
`Col. 12, lines 9-22.
`
`Col. 12, lines 23-27.
`
`Col. 3, lines 42-50;
`col. 4, lines 33-37;
`col. 6, lines 3-4;
`col. 14, lines 45-50.
`
`inserting the DNA sequence of step a) C01. 8, lines 3-6, 16-25;
`into a replicable expression vector
`col. 8, line 57 - col. 10, line 18.
`operably linked to a suitable
`promoter;
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE 16
`
`Sanofi/Regeneron Ex. 1024, pg 726
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`Mylan Ex. 1024, pg 726
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`

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`CONTROL NOS. 90/007,542 AND 90/007,859
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`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
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`c)
`
`transforming a prokaryotic or
`eukaryotic microbial host cell culture
`with the vector of step b);
`
`Col. 8, lines 33-36, 41-43.
`
`d)
`
`culturing the host cell; and
`
`Col. 12, lines 31-32.
`
`e)
`
`recovering the immuno globulin from Col. 12, lines 36-39.
`the host cell culture, said
`
`immunoglobulin being capable of
`binding to a known antigen.
`
`33. A process for producing an immunoglobulin
`molecule or an immunologically functional
`immunoglobulin fragment comprising at least
`the variable domains of the immunoglobulin
`heavy and light chains, in a single host cell,
`comprising:
`
`Col. 4, line 51 - col. 5, line 39;
`col. 7, lines 35-39, 47-59;
`col. 12, lines l7—22, 27-30, 50-56;
`col. 16, lines 5-l0;
`col. 23, lines 5-l0.
`
`independently expressing a first DNA
`sequence encoding at least the variable
`domain of the immunoglobulin heavy chain
`and a second DNA sequence encoding at
`least the variable domain of the
`
`immunoglobulin light chain so that said
`immunoglobulin heavy and light chains are
`produced as separate molecules in said
`single host cell transformed with said first
`and second DNA sequences.
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE 17
`
`Sanofi/Regeneron Ex. 1024, pg 727
`
`Mylan Ex. 1024, pg 727
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`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`(6)
`
`Grounds of Rejection to be Reviewed on Appeal
`
`Claims 1-36 have been rejected under the nonstatutory doctrine of obviousness-type
`
`double patenting over claims 1-7 of U.S. Patent No. 4,816,567, [App. B49-72], (“the ’567
`
`patent”) in View ofthe following references, as indicated at page l0 ofthe final Office action,
`
`[App. Bl588—1637]:
`
`—
`
`-
`
`—
`
`—
`
`-
`
`—
`
`-
`
`—
`
`—
`
`U.S. Patent No. 4,399,216 (“Axel”), [App. 1373-100]
`
`Rice, D.A.,L1l. (1982) Proc. Nat’l Acad. Sci. USA 79: 7862-65 (“Rice”), [App.
`B101-104]
`
`EP 0 044 722 (“Kaplan”), [App. 13105-122]
`
`U.S. Patent No. 4,511,502 (“Builder”), [App. B174-196]
`
`Accolla, R.S. 11. (1980) Proc. Nat’l Acad. Sci. USA 77: 563-66 (“Accolla”),
`[App. Bl70—l73]
`
`W0 82/ 03088 (“Dallas”), [App. 3137-151]
`
`Deacon, N.J., L1. (1976) Biochem. Soc. Trans. 4: 818-20 (“Deacon”), [App.
`B160—162]
`
`Valle, G., et al. (l98l)Nature 291: 338-40 (“Valle l98l”), [App. Bl63—l65]
`
`Ochi, A., et al. (1983) Nature 302: 340-42 (“Ochi”), [App. Bl52—l54] alone, or
`further in View ofU.S. Patent No. 5,840,545 (“Moore”), [App. B123-136]
`
`APPEAL BRIEF
`
`9 DECEMBER 2008 — PAGE 18
`
`Sanofi/Regeneron Ex. 1024, pg 728
`
`Mylan Ex. 1024, pg 728
`
`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`ATTORNEY DOCKET NOS. 2233 8-10230 AND -10231
`
`(7)
`
`Argument
`
`The Board should reverse the Examiner’s rejection of the claims of the second Cabilly
`
`patent (the ’415 patent) for obviousness-type double patenting over the claims of the first Cabilly
`
`patent (the ’567 patent). Owners provided extensive evi