UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
`Petitioner,
`v.
`
`GENENTECH, INC.
`Patent Owner.
`
`
`
`IPR2017-02032
`Patent No. 6,407,213
`
`Title: METHOD FOR MAKING HUMANIZED ANTIBODIES
`
`
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 6,407,213 B1
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`

`

`TABLE OF CONTENTS
`
`Page
`
`I.
`
`INTRODUCTION ........................................................................................... 1
`
`II. MANDATORY NOTICES ............................................................................. 1
`
`A.
`
`B.
`
`C.
`
`Real Parties-In-Interest .......................................................................... 1
`
`Related Matters ...................................................................................... 2
`
`Identification of Counsel and Service Information ............................... 2
`
`III. GROUNDS FOR STANDING AND PROCEDURAL STATEMENT ......... 3
`
`IV.
`
`IDENTIFICATION OF CHALLENGE AND STATEMENT OF THE
`PRECISE RELIEF REQUESTED .................................................................. 3
`
`V.
`
`STATEMENT OF REASONS FOR THE RELIEF REQUESTED ............... 4
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`Summary of the Argument .................................................................... 5
`
`Background of the ’213 Patent ............................................................10
`
`1.
`
`2.
`
`The ’213 Patent .........................................................................10
`
`Brief Overview of the ’213 Patent’s Prosecution History and
`Related PTO Proceedings .........................................................12
`
`Level of Ordinary Skill in the Art .......................................................14
`
`Claim Construction..............................................................................15
`
`Patents and Printed Publications Relied On In This Petition ..............19
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`Queen 1989 [Ex._1034] ............................................................19
`
`Queen 1990 [Ex._1050] ............................................................20
`
`U.S. Patent No. 5,530,101 .........................................................23
`
`Protein Data Bank (PDB) Database ..........................................23
`
`Tramontano [Ex._1051] ............................................................25
`
`Kabat 1987 [Ex._1052] .............................................................26
`
`F.
`
`The Prior Art Renders the Challenged Claims Obvious .....................27
`
`1.
`
`Detailed Instructions for Humanizing Antibodies Were Widely
`Available Before the ‘213 Patent Filing ...................................27
`
`G. Grounds 1 and 2: Claims 1;2;4;25;29;62-64;66-67;71-73;75-78; and
`80-81 Are Unpatentable as Obvious Over Queen 1989 or Queen 1990,
`in View of the PDB Database .............................................................28
`
`i
`
`

`

`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`Ground 1: Claim 1 is Obvious Over Queen 1989, in View of the
`PDB Database ...........................................................................29
`
`Ground 2: Claim 1 is Obvious over Queen 1990, in view of the
`PDB Database ...........................................................................34
`
`Grounds 1 and 2: Dependent Claims 2, 25 and 29 Are Obvious
`Over Queen 1989 and the PDB Database or Queen 1990 and
`the PDB Database .....................................................................37
`
`Ground 2: Dependent Claim 4 Is Obvious in View of Queen
`1990 and PDB Database ...........................................................38
`
`Grounds 1, 2: Independent Claims 62-64 and 66 Are Obvious
`Over Queen 1989 or Queen 1990 and PDB Database ..............39
`
`Grounds 1, 2: Dependent Claims 67, 71-73 and 78 Are Obvious
`Given Queen 1989 or Queen 1990 and PDB Database ............43
`
`Grounds 1, 2: Dependent Claims 75-77 Are Obvious in View of
`Queen 1989 or Queen 1990 and PDB Database .......................45
`
`Grounds 1, 2: Independent Claim 80 and Dependent Claim 81
`Are Obvious in View of Queen 1989 or Queen 1990 and PDB
`Database ....................................................................................49
`
`H. Grounds 3 and 4: Claims 75-77 Are Unpatentable As Obvious over
`Queen 1989 or Queen 1990 and PDB Database and Further in View of
`Tramontano. ........................................................................................50
`
`I.
`
`J.
`
`Ground 5: Claims 4;62;64 and 69 are obvious in view of Queen 1989
`and the PDB database, and further in view of Kabat 1987 .................51
`
`Ground 6: Claims 1;2;4;25;29;62-64;66;67;69;71;73;75-78, and 80-81
`are anticipated by the ’101 patent .......................................................52
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`Independent Claim 1 is Anticipated by the ’101 patent ...........52
`
`The ’101 patent Anticipates Dependent Claims 2, 4, 25 and 29
` ...................................................................................................55
`
`Independent Claim 62 is Anticipated by the ’101 patent .........57
`
`Independent Claim 63 is Anticipated by the ’101 patent .........57
`
`Independent Claim 64 is Anticipated by the ’101 patent .........57
`
`Independent Claim 66 and Dependent Claims 67, 69, 71, 73,
`and 75-78 are Anticipated by the ’101 patent ...........................58
`
`ii
`
`

`

`7.
`
`Independent Claim 80 and Dependent Claim 81 Are
`Anticipated by the ’101 patent ..................................................60
`
`K.
`
`Secondary Considerations Cannot Overcome Obviousness. ..............60
`
`1.
`
`2.
`
`3.
`
`The Methods Recited in the ’213 Patent Produced No Relevant
`Unexpected Results. ..................................................................61
`
`The ’213 Patent Satisfied No Long-Felt But Unmet Need. ......63
`
`No nexus/commercial success with respect to Herceptin. ........64
`
`
`
`
`
`
`
`iii
`
`

`

`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`
`Atlas Powder Co. v. Ireco Inc.,
`190 F.3d 1342 (Fed. Cir. 1999) .......................................................................... 40
`
`Bristol-Myers Squibb Co. v. BenVenue Labs, Inc.,
`246 F.3d 1368 (Fed. Cir. 2001) .......................................................................... 39
`
`In re Clarke,
`356 F.2d 987 (C.C.P.A. 1966) ............................................................................ 13
`
`Cuozzo Speed Techs. LLC v. Lee,
`136 S. Ct. 2131 (2016) ........................................................................................ 15
`
`Ecolochem, Inc. v. Southern California Edison Co.,
`91 F.3d 169 (Fed. Cir. 1996) .............................................................................. 16
`
`In re Hall,
`781 F.2d 897 (Fed. Cir. 1986) ............................................................................ 24
`
`Merck & Co. v. Teva Pharms. USA,
`395 F.3d 1364 (Fed. Cir. 2005) .......................................................................... 61
`
`Norgren Inc. v. ITC,
`699 F.3d 1317 (Fed. Cir. 2012) .......................................................................... 63
`
`In re PepperBall Techs., Inc.,
`469 F. App’x 8783 (Fed. Cir. 2012) ................................................................... 64
`
`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2007) .......................................................................... 61
`
`Purdue Pharma L.P. v. Epic Pharma, LLC,
`811 F.3d 1345 (Fed. Cir. 2016) ................................................................ 9, 53, 54
`
`Ex Parte Takeshi Shimono,
`2015 WL 1952506 .............................................................................................. 62
`
`Ex Parte Takeshi Shimono,
`Appeal 2013-003410 (PTAB Apr. 29, 2015) ..................................................... 61
`
`iv
`
`

`

`In re Thorpe,
`777 F.2d 695 (Fed.Cir.1985) .......................................................................... 9, 54
`
`In re Wyer,
`655 F.2d 221 (C.C.P.A. 1981) ............................................................................ 24
`
`Statutes
`
`35 U.S.C. § 102(b) ................................................................................................... 24
`
`35 U.S.C. § 103 .......................................................................................................... 3
`
`35 U.S.C. § 112 ........................................................................................................ 15
`
`35 U.S.C. § 135(b)(1)............................................................................................... 14
`
`35 U.S.C. §§ 311-319................................................................................................. 1
`
`35 U.S.C. § 314(a) ..................................................................................................... 5
`
`Other Authorities
`
`37 C.F.R. § 42 ............................................................................................................ 1
`
`37 C.F.R. §§ 42.6(e) and 42.105 .............................................................................. 67
`
`37 C.F.R. §42.24(a)(1) ............................................................................................. 66
`
`37 C.F.R. § 42.100(b) .............................................................................................. 15
`
`37 C.F.R. § 42.104(a) ................................................................................................. 3
`
`
`
`v
`
`

`

`LIST OF EXHIBITS
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`1002
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`1003B
`
`1003C
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`U.S. Patent No. 6,407,213, Method for making humanized
`antibodies (filed Jul. 17, 1993) (issued June 18, 2002)
`
`File History for U.S. Patent No. 6,407,213 (9 volumes)
`
`Declaration of Dr. Geoffrey Hale, Ph.D. in Support of Petition for
`Inter Partes Review of Patent No. 6,407,213
`
`Curriculum Vitae of Dr. Geoffrey Hale, Ph.D.
`
`Materials Reviewed by Dr. Geoffrey Hale, Ph.D.
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`Exhibits A-R of Dr. Geoffrey Hale, Ph.D.
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