UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`CELLTRION, INC.
`Petitioner,
`v.
`
`GENENTECH, INC.
`Patent Owner.
`
`
`IPR2017-01374
`U.S. 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
`
`V.
`
`INTRODUCTION ........................................................................................... 1
`I.
`II. MANDATORY NOTICES ............................................................................. 1
`A.
`Real Parties-In-Interest (37 C.F.R. § 42.8(b)(1)) ................................. 1
`B.
`Related Matters (37 C.F.R. § 42.8(b)(2)) ............................................. 2
`C.
`Identification of Counsel (37 C.F.R. § 42.8(b)(3)) and Service
`Information (37 C.F.R. § 42.8(b)(4)) ................................................... 2
`III. GROUNDS FOR STANDING AND PROCEDURAL STATEMENT ......... 2
`IV.
`IDENTIFICATION OF CHALLENGE AND STATEMENT OF THE
`PRECISE RELIEF REQUESTED .................................................................. 3
`STATEMENT OF REASONS FOR THE RELIEF REQUESTED ............... 5
`A.
`Summary of the Argument .................................................................... 5
`B.
`’213 Patent—Background ..................................................................... 8
`1.
`The ’213 Patent ........................................................................... 8
`2.
`Brief Overview of the ’213 Patent’s Prosecution History and
`Related PTO Proceedings ......................................................... 11
`Level of Ordinary Skill in the Art ....................................................... 12
`Claim Construction ............................................................................. 13
`Patents and Printed Publications Relied On In This Petition .............. 15
`1.
`EP 0403156 (“Kurrle”) [Ex. 1071] ........................................... 16
`2.
`Queen 1990 [Ex. 1050] ............................................................. 17
`3.
`Furey [Ex. 1125] ....................................................................... 20
`4.
`Chothia & Lesk [Ex. 1062] ....................................................... 21
`5.
`Chothia 1985 [Ex. 1063] ........................................................... 22
`6.
`Hudziak [Ex. 1021] ................................................................... 23
`The Prior Art Renders the Challenged Claims Obvious ..................... 24
`1.
`Detailed Instructions for Humanizing Antibodies Were Widely
`Available Before the ’213 Patent Filing ................................... 24
`
`C.
`D.
`E.
`
`F.
`
`
`
`- i -
`
`

`

`
`
`
`
`
`
`TABLE OF CONTENTS
`(Continued)
`
`Page
`
`5.
`
`G. Ground 1: Claims 1, 2, 25, 29, 63, 66, 71, 75, 76, 78, 80 and 81 Are
`Unpatentable as Anticipated by Kurrle ............................................... 25
`1.
`Independent Claim 1 is Anticipated by Kurrle ......................... 25
`2.
`Kurrle Anticipates Dependent Claims 2, 25 and 29 ................. 27
`3.
`Independent Claim 63 is Anticipated by Kurrle ....................... 28
`4.
`Independent Claim 66 and Dependent Claims 71, 72, 75 and 76
`are Anticipated by Kurrle .......................................................... 29
`Independent Claim 80 and Dependent Claim 81 Are
`Anticipated by Kurrle ............................................................... 30
`H. Ground 2: Claims 1, 2, 4, 29, 62, 63, 64, 80 and 81 are Anticipated by
`Queen 1990 .......................................................................................... 31
`1.
`Independent Claim 1 is Anticipated by Queen 1990 ................ 31
`2.
`Queen 1990 Anticipates Dependent Claims 2, 4 and 29 .......... 33
`3.
`Independent Claim 62 is Anticipated by Queen 1990 .............. 34
`4.
`Independent Claim 63 is Anticipated by Queen 1990 .............. 35
`5.
`Independent Claim 64 is Anticipated by Queen 1990 .............. 36
`6.
`Claims 80 and 81 are Anticipated by Queen 1990 ................... 37
`Ground 3: Claims 1, 2, 4, 25, 29, 62–64, 66–67, 69, 80 and 81 Are
`Unpatentable As Obvious over Queen 1990 and Kurrle ..................... 38
`1.
`Claim 1 is Obvious Over Queen 1990 and Kurrle .................... 38
`2.
`Claims 2, 25 and 29 are Obvious Over Queen 1990 and Kurrle41
`3.
`Claim 4 is Obvious Over Queen 1990 and Kurrle .................... 42
`4.
`Claim 62 is Obvious Over Queen 1990 and Kurrle .................. 43
`5.
`Claim 63 is Obvious Over Queen 1990 and Kurrle .................. 43
`6.
`Claim 64 is Obvious Over Queen 1990 and Kurrle .................. 44
`7.
`Claim 66 is Obvious Over Queen 1990 and Kurrle .................. 45
`8.
`Claims 67, 71, 72, 75, 76 and 78 are Obvious Over Queen 1990
`and Kurrle ................................................................................. 46
`Claim 69 is Obvious Over Queen 1990 and Kurrle .................. 47
`9.
`10. Claims 80 and 81 are Obvious Over Queen 1990 and Kurrle .. 47
`
`I.
`
`ii
`
`

`

`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`(Continued)
`
`Page
`
`J.
`
`L.
`
`Ground 4: Claim 12 Is Obvious Over Queen 1990 and Kurrle, in View
`of Furey ............................................................................................... 49
`K. Ground 5: Claims 73, 74, 77, 79, and 65 are Obvious Over Queen
`1990 and Kurrle, In View of Chothia & Lesk and Chothia 1985 ....... 50
`Ground 6: Claims 30, 31 and 33 Are Obvious Over Queen 1990 in
`View of Hudziak ................................................................................. 54
`M. Ground 7: Claim 42 is Obvious Over Queen 1990 in view of Furey
`and Hudziak ......................................................................................... 59
`N. Ground 8: Claim 60 is Obvious Over Queen 1990 In view of Chothia
`& Lesk and Hudziak ............................................................................ 59
`Secondary Considerations Cannot Preclude Obviousness. ................. 60
`1.
`The Methods Recited in the ’213 Patent Produced No Relevant
`Unexpected Results. .................................................................. 61
`The ’213 Patent Satisfied No Long-Felt But Unmet Need. ...... 62
`No nexus/commercial success to Herceptin. ............................ 63
`
`O.
`
`2.
`3.
`
`iii
`
`

`

`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Adair v. Carter,
`101 U.S.P.Q.2d 1625 (Fed. Cir. 2012) ............................................................... 12
`
`Atlas Powder Co. v. Ireco Inc.,
`190 F.3d 1342 (Fed. Cir. 1999) ........................................................ 28, 30, 35, 48
`
`Bristol-Myers Squibb Co. v. BenVenue Labs, Inc.,
`246 F.3d 1368 (Fed. Cir. 2001) ........................................................ 28, 35, 43, 53
`
`Cuozzo Speed Techs. LLC v. Lee,
`136 S. Ct. 2131 (2016) ........................................................................................ 13
`
`Ecolochem, Inc. v. Southern California Edison Co.,
`91 F.3d 169 (Fed. Cir. 1996) .............................................................................. 14
`
`Merck & Co. v. Teva Pharms. USA,
`395 F.3d 1364 (Fed. Cir. 2005) .......................................................................... 60
`
`Norgren Inc. v. ITC,
`699 F.3d 1317 (Fed. Cir. 2012) .......................................................................... 62
`
`In re PepperBall Techs., Inc.,
`469 F. App’x 878 (Fed. Cir. 2012) ..................................................................... 62
`
`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2007) .......................................................................... 60
`
`Ex Parte Takeshi Shimono,
`Appeal 2013-003410 (P.T.A.B. Apr. 29, 2015) ................................................. 60
`
`Statutes
`
`35 U.S.C. § 102 .......................................................................................................... 3
`
`35 U.S.C. § 103 .......................................................................................................... 3
`
`35 U.S.C. § 112 ........................................................................................................ 13
`
`
`
`- iv -
`
`

`

`
`
`35 U.S.C. § 135(b)(1)............................................................................................... 11
`35 U.S.C. § 135(b)(1) ............................................................................................. ..11
`
`35 U.S.C. §§ 311-319 ................................................................................................ 1
`35 U.S.C. §§311-319 .............................................................................................. ..1
`
`35 U.S.C. § 314(a) ..................................................................................................... 5
`35 U.S.C. § 314(a) ................................................................................................... ..5
`
`Other Authorities
`
`Other Authorities
`
`37 C.F.R. § 42 ............................................................................................................ 1
`37 C.F.R. § 42 .......................................................................................................... ..1
`
`37 C.F.R. § 42.6(c) ..................................................................................................... 3
`37 C.F.R. §42.6(c) ................................................................................................... ..3
`
`37 C.F.R. § 42.8(b)(1) ................................................................................................ 1
`37 C.F.R. § 42.8(b)(1) .............................................................................................. ..1
`
`37 C.F.R. § 42.8(b)(2) ................................................................................................ 2
`37 C.F.R. § 42.8(b)(2) .............................................................................................. ..2
`
`37 C.F.R. § 42.8(b)(3) ................................................................................................ 2
`37 C.F.R. § 42.8(b)(3) .............................................................................................. ..2
`
`37 C.F.R. § 42.8(b)(4) ................................................................................................ 2
`37 C.F.R. § 42.8(b)(4) .............................................................................................. ..2
`
`37 C.F.R. § 42.10(b) .................................................................................................. 1
`37 C.F.R. §42.10(b) ................................................................................................ ..1
`
`37 C.F.R. § 42.100(b) .............................................................................................. 13
`37 C.F.R. § 42.100(b) ............................................................................................ ..13
`
`37 C.F.R. § 42.103 ..................................................................................................... 1
`37 C.F.R. § 42.103 ................................................................................................... ..1
`
`37 C.F.R. § 42.104(a) ................................................................................................. 2
`37 C.F.R. §42.104(a) ............................................................................................... ..2
`
`
`
`
`
`
`
`
`v
`
`

`

`
`
`LIST OF EXHIBITS
`
`EXHIBIT NO.
`
`DESCRIPTION
`
`1001
`
`U.S. Patent No. 6,407,213, Method for making humanized
`antibodies (filed Jul. 17, 1993) (issued June 18, 2002)
`
`1002 Part I
`
`File History for U.S. Patent No. 6,407,213 Part I
`
`1002 Part II
`
`File History for U.S. Patent No. 6,407,213 Part II
`
`1003
`
`1003A
`
`1003B
`
`1003C
`
`1004
`
`1004A
`
`1004B
`
`1005
`
`1006
`
`1007
`
`
`
`Declaration of Dr. Lutz Riechmann, Ph.D. in Support of Petition
`for Inter Partes Review of Patent No. 6,407,213
`
`Curriculum Vitae of Dr. Lutz Riechmann, Ph.D.
`
`Materials Reviewed by Dr. Lutz Riechmann, Ph.D.
`
`Exhibits A-O of Dr. Lutz Riechmann, Ph.D.
`
`Declaration of Dr. Robert Charles Fredrick Leonard, M.D. in
`Support of Petition for Inter Partes Review of Patent No.
`6,407,213
`
`Curriculum Vitae of Dr. Robert Charles Fredrick Leonard, M.D.
`
`Materials Reviewed by Dr. Robert Charles Fredrick Leonard,
`M.D.
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`- vi -
`
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`Treat Relapse of Malignancy after Allogeneic Hematopoietic Cell
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`
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`and monoclonal antibody 22 can specifically induce FcgammaRI
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`small cell carcinoma of the lung cells. Clin. Can. Res. 1:425–34
`(April 1995)
`
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`lysis of SCCL by a bispecific molecule comprised of Lys3-BN and
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`
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`xii
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