`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In the Inter Partes Review of:
`
`Trial Number: To Be Assigned
`
`
`
`U.S. Patent No. 6,407,213
`
`Filed: November 17, 1993
`
`Issued: June 18, 2002
`
`Inventor(s): Paul J. Carter; Leonard G. Presta
`
`Assignee: Genentech, Inc.
`
`
`
`
`
`
`
`
`
`
`
`Title: METHOD FOR MAKING HUMANIZED
`ANTIBODIES
`
`Panel: To Be Assigned
`
`Mail Stop Inter Partes Review
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`DECLARATION OF AMANDA HOLLIS
`
`1
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`PFIZER EX. 1187
`Page 1
`
`
`
`
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`I, Amanda Hollis, declare under penalty of perjury as follows:
`
`1.
`
`2.
`
`I am an attorney and Partner of the law firm Kirkland & Ellis, LLP.
`
`I make this Declaration in support of the petition for inter partes
`
`review of U.S. Patent No. 6,407,213 before the United States Patent and
`
`Trademark Office. I make this Declaration of my own personal knowledge.
`
`3.
`
`4.
`
`Exhibit 1001 is a true and correct copy of U.S. Patent No. 6,407,213.
`
`Exhibit 1002 Vols. 1–10 is a true and correct copy of File History for
`
`U.S. Patent No. 6,407,213.
`
`5.
`
`Exhibit 1021 is a true and correct copy of Hudziak et al., pl85HER2
`
`Monoclonal Antibody Has Antiproliferative Effects In Vitro and Sensitizes Human
`
`Breast Tumor Cells to Tumor Necrosis Factor, 9(3) MOLECULAR CELLULAR
`
`BIOLOLGY 1165–72 (1989).
`
`6.
`
`Exhibit 1022 is a true and correct copy of Köhler et al., Continuous
`
`Cultures of Fused Cells Secreting Antibody of Predefined Specificity, 256 (5517)
`
`Nature 495-97 (1975).
`
`7.
`
`Exhibit 1023 is a true and correct copy of Prabakaran, The Quest for a
`
`Magic Bullet 349(6246) SCIENCE 389 (2015).
`
`8.
`
`Exhibit 1024 is a true and correct copy of Marks, The Story of Cesar
`
`Milstein and Monoclonal Antibodies: A Healthcare Revolution in the Making at
`
`
`
`2
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`PFIZER EX. 1187
`Page 2
`
`
`
`
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`http://www.whatisbiotechnology.org/exhibitions/milstein (last accessed April 13,
`
`2017).
`
`9.
`
`Exhibit 1025 is a true and correct copy of Cosimi et al., Treatment of
`
`Acute Renal Allograft Rejection with OKT3 Monoclonal Antibody, 32(6)
`
`TRANSPLANTATION 535−39 (1981).
`
`10. Exhibit 1026 is a true and correct copy of Ortho Multicenter
`
`Transplant Study Group, A Randomized Clinical Trial of OKT3 Monoclonal
`
`Antibody for Acute Rejection of Cadaveric Renal Transplants. 313(6) N. Engl. J.
`
`Med. 337-42 (1985).
`
`11. Exhibit 1027 is a true and correct copy of Jaffers et al., Monoclonal
`
`Antibody Therapy: Anti-Idiotypic and Non-Anti-Idiotypic Antibodies to OKT3
`
`Arising Despite Intense Immunosuppression, 41(5) TRANSPLANTATION 572–78
`
`(1986).
`
`12. Exhibit 1028 is a true and correct copy of Sears et al., Phase-I
`
`Clinical Trial of Monoclonal Antibody in Treatment of Gastrointestinal Tumours, 1
`
`LANCET 762–65 (1982).
`
`13. Exhibit 1029 is a true and correct copy of Sikora, Monoclonal
`
`Antibodies in Oncology, 35(4) J. CLINICAL PATHOLOGY 369-75 (1982).
`
`
`
`3
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`PFIZER EX. 1187
`Page 3
`
`
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`
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`14. Exhibit 1030 is a true and correct copy of “Protein Data Bank -
`
`Chronology” at https://www.nsf.sov/news summ.isp?cntn id=l00689 (last visited
`
`April 12, 2017).
`
`15. Exhibit 1031 is a true and correct copy of Morrison et al., Chimeric
`
`Human Antibody Molecules: Mouse Antigen-Binding Domains with Human
`
`Constant Region Domains, 81(21) PROC. NAT’L ACAD. SCI. USA 6851–55 (1984).
`
`16. Exhibit 1032 is a true and correct copy of Liu et al., Chimeric
`
`MouseHuman IgGl Antibody that can Mediate Lysis of Cancer Cells, 84(10) PROC.
`
`NAT’L ACAD. SCI. USA 3439–43 (1987).
`
`17. Exhibit 1033 is a true and correct copy of Jones et al., Replacing the
`
`Complementarity-Determining Regions in a Human Antibody With Those From a
`
`Mouse, 321(6069) NATURE 522–25 (1986).
`
`18. Exhibit 1034 is a true and correct copy of Queen et al., A Humanized
`
`Antibody that Binds to the Interleukin 2 Receptor, 86(24) PROC. NAT’L ACAD. SCI.
`
`USA 10029–33 (1989).
`
`19. Exhibit 1035 is a true and correct copy of Kirkman et al., Early
`
`Experience with Anti-Tac
`
`in Clinical Renal Transplantation. 21(1)
`
`TRANSPLANTATION PROC. 1766–68 (1989).
`
`20. Exhibit 1036 is a true and correct copy of Waldmann et al., The
`
`Interleukin-2 Receptor: A Target for Monoclonal Antibody Treatment of Human T-
`
`
`
`4
`
`PFIZER EX. 1187
`Page 4
`
`
`
`
`
`Cell Lymphotrophic Virus I-Induced Adult T-Cell Leukemia, 82(6) BLOOD 1701–
`
`12 (1993).
`
`21. Exhibit 1037 is a true and correct copy of Hakimi et al., Reduced
`
`Immunogenicity and Improved Pharmacokinetics of Humanized Anti-Tac in
`
`Cynomolgus Monkeys, 147(4) J. IMMUNOLOGY 1352–59 (1991).
`
`22. Exhibit 1038 is a true and correct copy of Vincenti et al., Interleukin
`
`2-Receptor Blockade with Daclizumab to Prevent Acute Rejection in Renal
`
`Transplantation. 338(3) NEW ENG. J. MED. 161–65 (1998).
`
`23. Exhibit 1039 is a true and correct copy of SEER Stat Fact Sheets:
`
`Breast
`
`Cancer,
`
`National
`
`Cancer
`
`Institute,
`
`at
`
`http://seer.cancer.gov/statfacts/html/breast.html (last accessed March 17, 2017).
`
`24. Exhibit 1040 is a true and correct copy of Harris, et al., Medical
`
`Progress: Breast Cancer, 327(5) NEW ENG. J. MED. 319–28 (1992).
`
`25. Exhibit 1041 is a true and correct copy of King et al., Amplification of
`
`a Novel v-erbB-Related Gene in a Human Mammary Carcinoma, 229(4717)
`
`SCIENCE 974–76 (1985).
`
`26. Exhibit 1042 is a true and correct copy of Semba et al., A v-erbB-
`
`Related Protooncogene, c-erbB-2, is Distinct From the c-erbB-1 Epidermal
`
`Growth Factor-Receptor Gene and is Amplified in a Human Salivary Gland
`
`Adenocarcinoma, 82(19) PROC. NAT’L ACAD. SCI. USA 6497–01 (1985).
`
`
`
`5
`
`PFIZER EX. 1187
`Page 5
`
`
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`
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`27. Exhibit 1043 is a true and correct copy of Coussens et al., Tyrosine
`
`Kinase Receptor with Extensive Homology to EGF Receptor Shares Chromosomal
`
`Location with neu Oncogene. 230(4730) SCIENCE 1132–39 (1985).
`
`28. Exhibit 1044 is a true and correct copy of Fukushige et al.,
`
`Localization of a Novel v-erbB-Related Gene, c-erbB-2, on Human Chromosome
`
`17 and its Amplification in a Gastric Cancer Cell Line. 6(3) MOLECULAR
`
`CELLULAR BIOLOGY 955–58 (1986)).
`
`29. Exhibit 1045 is a true and correct copy of Slamon et al., Human
`
`Breast Cancer Correlation of Relapse and Survival with Amplification of the HER-
`
`2/neu Oncogene, 235(4785) SCIENCE 177–82 (1987).
`
`30. Exhibit 1046
`
`is a
`
`true and correct copy of Kraus et al.,
`
`Overexpression of the EGF Receptor-Related Proto-Oncogene erbB-2 in Human
`
`Mammary Tumor Cell Lines by Different Molecular Mechanisms, 6(3)The EMBO
`
`J. 605-10 (1987).
`
`31. Exhibit 1047 is a true and correct copy of Hudziak et al., Increased
`
`Expression of
`
`the Putative Growth Factor Receptor pl85HER2 Causes
`
`Transformation and Tumorigenesis of NIH 3T3 Cells, 84 (20) 84 PROC. NAT’L
`
`ACAD. SCI. USA 7159–163 (1987).
`
`
`
`6
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`PFIZER EX. 1187
`Page 6
`
`
`
`
`
`32. Exhibit 1048 is a true and correct copy of Shepard et al., Monoclonal
`
`Antibody Therapy of Human Cancer: Taking the HER2 Protooncogene to the
`
`Clinic, 11(3) J. CLINICAL IMMUNOLOGY, 117–27 (1991).
`
`33. Exhibit 1049 is a true and correct copy of Chothia et al.,
`
`Conformations of Immunoglobulin Hypervariable Regions, 342(21) NATURE 877–
`
`83 (1989).
`
`34. Exhibit 1050 is a true and correct copy of Queen, Cary L.:
`
`International Publication No. WO 1990/07861 (published July 26, 1990).
`
`35. Exhibit 1051 is a true and correct copy of Tramontano et al.,
`
`Framework Residue 71 is a Major Determinant of the Position and Conformation
`
`of the Second Hypervariable Region in the VH Domains of Immunoglobulins 215
`
`(1) J. MOLECULAR BIOLOGY 175–82 (1990).
`
`36. Exhibit 1052 is a true and correct copy of Kabat et al., SEQUENCES OF
`
`PROTEINS OF IMMUNOLOGICAL INTEREST: TABULATION AND ANALYSIS OF AMINO
`
`ACID AND NUCLEIC ACID SEQUENCES OF PRECURSORS, V-REGIONS, C-REGIONS, J-
`
`CHAIN, T-CELL RECEPTOR FOR ANTIGEN, T-CELL SURFACE ANTIGENS, β2-
`
`MICROGLUBINS, MAJOR HISTOCOMPATIBILITY ANTIGENS, THY-1 COMPLEMENT, C-
`
`REACTIVE PROTEIN, THYMOPOIETIN, POST-GAMMA GLOBULIN, AND α2-
`
`MACROGLOBULIN 41–175 (4th ed. 1987).
`
`
`
`7
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`PFIZER EX. 1187
`Page 7
`
`
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`
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`37. Exhibit 1055 is a true and correct copy of Kabat et al., 1 SEQUENCES
`
`OF PROTEINS OF IMMUNOLOGICAL INTEREST: TABULATION AND ANALYSIS OF AMINO
`
`ACID AND NUCLEIC ACID SEQUENCES OF PRECURSORS, V-REGIONS, C-REGIONS, J-
`
`CHAIN, T-CELL RECEPTOR FOR ANTIGEN, T-CELL SURFACE ANTIGENS, β2-
`
`MICROGLUBINS, MAJOR HISTOCOMPATIBILITY ANTIGENS, THY-1 COMPLEMENT, C-
`
`REACTIVE
`
`PROTEIN,
`
`THYMOPOIETIN,
`
`POST-GAMMA
`
`GLOBULIN,
`
`α2-
`
`MACROGLOBULINS, AND OTHER RELATED PROTEINS 103–338 (5th ed. 1991).
`
`38. Exhibit 1058 is a true and correct copy of Davies & Metzger,
`
`Structural Basics of Antibody Function, 1 ANN. REV. IMMUNOLOGY 87–117 (1983).
`
`39. Exhibit 1059 is a true and correct copy of Amit et al., Three-
`
`Dimensional Structure of an Antigen-Antibody Complex at 2.8 A Resolution,
`
`233(4765) SCIENCE 747–53 (1986).
`
`40. Exhibit 1062 is a true and correct copy of Chothia & Lesk, Canonical
`
`Structures
`
`for
`
`the Hypervariable Regions of Immunoglobulins, 196(4) J.
`
`MOLECULAR BIOLOGY 901–17 (1987).
`
`41. Exhibit 1063 is a true and correct copy of Chothia et al., Domain
`
`Association in Immunoglobulin Molecules: The Packing of Variable Domains,
`
`186(3) J. MOLECULAR BIOLOGY 651–63 (1985).
`
`
`
`8
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`PFIZER EX. 1187
`Page 8
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`
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`42. Exhibit 1068 is a true and correct copy of Verhoeyen et al., Reshaping
`
`Human Antibodies: Grafting an Antilysozyme Activity, 239(4847) SCIENCE 1534–
`
`36 (1988).
`
`43. Exhibit 1069 is a true and correct copy of Riechmann et al.,
`
`Reshaping Human Antibodies for Therapy, 332(6162) NATURE 323–27 (1988).
`
`44. Exhibit 1071 is a true and correct copy of Kurrle et al., EP Publication
`
`Number 0403156, Improved Monoclonal Antibodies Against the Human Alphabeta
`
`T-Cell Receptor, Their Production and Use (Published December 19, 1990).
`
`45. Exhibit 1073 is a true and correct copy of Winter et al., EP
`
`Publication Number 0239400, Recombinant Antibodies and Methods for Their
`
`Productions (Published September 30, 1987).
`
`46. Exhibit 1079 is a true and correct copy of Kabat et al., SEQUENCES OF
`
`PROTEINS OF IMMUNOLOGICAL INTEREST: TABULATION AND ANALYSIS OF AMINO
`
`ACID AND NUCLEIC ACID SEQUENCES OF PRECURSORS, V-REGIONS, C-REGIONS, J-
`
`CHAIN, β2 MICROGLOBULINS, MAJOR HISTOCOMPATIBILITY ANTIGENS, THY-1,
`
`COMPLEMENT, C-REACTIVE PROTEIN, THYMOPOIETIN, POST-GAMMA GLOBULIN,
`
`AND α2-MACROGLOBULIN (1983) .
`
`47. Exhibit 1080 is a true and correct copy of Bernstein et al., The Protein
`
`Data Bank: A Computer-Based Archival File for Macromolecular Structures,
`
`112(3) J. MOLECULAR BIOLOGY 535–42 (1977).
`
`
`
`9
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`PFIZER EX. 1187
`Page 9
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`
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`
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`48. Exhibit 1081 is a true and correct copy of Sheriff et al. Three-
`
`Dimensional Structure of an Antibody-Antigen Complex, 84(22) PROC. NAT’L
`
`ACAD. SCI. USA. 8075-79 (1987).
`
`49. Exhibit 1082 is a true and correct copy of Marquart et al., The Three-
`
`Dimensional Structure of Antibodies, 3(6) IMMUNOLOGY TODAY 160–66 (1982).
`
`50. Exhibit 1083 is a true and correct copy of Saul et al., Preliminary
`
`Refinement and Structural Analysis of
`
`the FAB Fragment
`
`from Human
`
`Immunoglobulin NEW at 2.0 Å Resolution *, 253(2) J. BIOLOGICAL CHEMISTRY
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`585-95 (1978).
`
`51. Exhibit 1085
`
`is a
`
`true and correct copy of Satow et al.,
`
`Phosphocholine Binding Immunogloubulin Fab McPC306 An X-ray Diffraction
`
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`
`52. Exhibit 1086 is a true and correct copy of Herron et al., Three-
`
`Dimensional Structure of a Fluorescein-Fab Complex Crystallized in 2-Methyl-
`
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`
`53. Exhibit 1087 is a true and correct copy of Padlan et al., Structure of
`
`an Antibody-Antigen Complex: Crystal Structure of the HyHEL-10 FAB-Lysozyme
`
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`
`54. Exhibit 1088 is a true and correct copy of Kumar et al., Regulation of
`
`Phosphorylation of the c-erbB- 2 HER2 Gene Product by Monoclonal Antibody
`
`
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`10
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`PFIZER EX. 1187
`Page 10
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`
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`and Serum Growth Factor(s) in Human Mammary Carcinoma Cells, 11(2)
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`MOLECULAR CELLULAR BIOLOGY 979–86 (1991).
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`55. Exhibit 1089 is a true and correct copy of Soomro et al., C-erbB-2
`
`Expression in Different Histological Types of Invasive Breast Carcinoma, 44(3) J.
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`CLINICAL PATHOLOGY 211–14 (1991).
`
`56. Exhibit 1090 is a true and correct copy of Wilson & Goulding, A
`
`BIOLOGIST’S GUIDE TO PRINCIPLES AND TECHNIQUES OF PRACTICAL
`
`BIOCHEMISTRY, §Protein Sequencing, 170-173 (3rd ed., 1986).
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`57. Exhibit 1091 is a true and correct copy of Edelman et al., The
`
`Covalent Structure of an Entire γG Immunoglobulin Molecule*, 63(1) PROC.
`
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`
`58. Exhibit 1092 is a true and correct copy of Capra, & Kehoe, Variable
`
`Region Sequences of Five Human Immunoglobulin Heavy Chains of the VHIII
`
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`
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`
`59. Exhibit 1093 is a true and correct copy of Morin, From Oncogene to
`
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`
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`
`60. Exhibit 1095 Vols. 1–15 is a true and correct copy of File History for
`
`Patent Interference No. 105,744 (Senior party Application No. 11/284,261,
`
`
`
`11
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`PFIZER EX. 1187
`Page 11
`
`
`
`
`
`Inventors John Robert Adair et al. Junior Party, U.S. Patent 6,407,213, Inventors
`
`Paul J. Carter and Leonard G. Presta).
`
`61. Exhibit 1096 is a true and correct copy of U.S. Patent No. 5,677,171
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`Monoclonal Antibodies Directed to the HER2 Receptor, (Filed August 5, 1994)
`
`(Issued October 14, 1997).
`
`62. Exhibit 1097 is a true and correct copy of Sambrook et al., Molecular
`
`Cloning, A Laboratory Manual (Cold Spring Harbor Laboratory Press, 2d ed.
`
`1989).
`
`63. Exhibit 1100 is a true and correct copy of Colman et al., Three-
`
`Dimensional Structure of a Complex of Antibody with Influenza Virus
`
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`
`64. Exhibit 1102 is a true and correct copy of Bender et al.,
`
`Immunogenicity, Efficacy and Adverse Events of Adalimumab in RA Patients,
`
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`65. Exhibit 1103 is a true and correct copy of Brient & Nisonoff,
`
`Quantitative Investigations of Idiotypic Antibodies. IV. Inhibition by Specific
`
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`
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`
`66. Exhibit 1104 is a true and correct copy of Koprowski et al., Human
`
`Anti-Idiotype Antibodies in Cancer Patients: is the Modulation of the Immune
`
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`
`67. Exhibit 1105 is a true and correct copy of Chanh et al., Monoclonal
`
`Anti-Idiotypic Antibody Mimics
`
`the CD4 Receptor and Binds Human
`
`Immunodeficiency Virus, 84 PROC. NAT’L. ACAD. SCI. USA 3891-95 (1987).
`
`68. Exhibit 1106 is a true and correct copy of Schroff et al., Human Anti-
`
`Murine Immunoglobulin Responses in Patients Receiving Monoclonal Antibody
`
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`
`69. Exhibit 1107 is a true and correct copy of Abdou et al., Network
`
`Theory in Autoimmunity. In Vitro Suppression of serum anti-DNA by Anti-Idiotypic
`
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`
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`
`70. Exhibit 1113 is a true and correct copy of Epp et al., The Molecular
`
`Structure of a Dimer Composed of the Variable Portions of the Bence-Jones
`
`Protein REI Refined at 2.0-Å Resolution, 14(22) BIOCHEMISTRY 4943-52 (1975).
`
`71. Exhibit 1114 is a true and correct copy of Mian, Structure, Function
`
`and Properties of Antibody Binding Sites, 217(1) J. MOLECULAR BIOLOGY 133–51
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`(1991).
`
`72. Exhibit 1115 is a true and correct copy of Poljak et al., The Three-
`
`Dimensional Structure of
`
`the Fab Fragment of A Human Myeloma
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`
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`PFIZER EX. 1187
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`
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`44 (1974).
`
`73. Exhibit 1116 is a true and correct copy of Padlan et al., Model
`
`Building Studies of Antigen-binding Sites: the Hapten Binding Site of MOPC-315,
`
`41 COLD SPRING HARBOR SYMP. QUANTITATIVE BIOLOGY 627–37 (1977).
`
`74. Exhibit 1121 is a true and correct copy of Suh et al., The Galactan-
`
`Binding Immunoglobulin Fab J539: An X-Ray Diffraction Study at 2.6-Å
`
`Resolution, 1(1) PROTEINS 74-80 (1986).
`
`75. Exhibit 1125 is a true and correct copy of Furey et al., Structure of A
`
`Novel Bence-Jones Protein (Rhe) Fragment at 1.6Å Resolution, 167(3) J.
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`MOLECULAR BIOLOGY 661–92 (1983).
`
`76. Exhibit 1126 is a true and correct copy of Segal et al., The Three-
`
`Dimensional Structure of a Phosphorylcholine-Binding Mouse Immunoglobulin
`
`Fab and the Nature of the Antigen Binding Site, 71(11) PROC. NAT’L ACAD. SCI.
`
`USA 4298 (1974).
`
`77. Exhibit 1127 is a true and correct copy of Jones, Diffraction Methods
`
`for Biological Macromolecules. Interactive Computer Graphics: FRODO, 115
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`METHODS ENZYMOLOGY 157–71 (1985).
`
`
`
`14
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`PFIZER EX. 1187
`Page 14
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`
`
`
`
`78. Exhibit 1128 is a true and correct copy of Co et al., Humanized
`
`Antibodies for Antiviral Therapy, 88(7) PROC. NAT’L ACAD. SCI. USA 2869–73
`
`(1991).
`
`79. Exhibit 1129 is a true and correct copy of History of Microsoft Excel
`
`1978-2013, http://www.exceltrick.com/others/history-of-excel/ (Accessed April
`
`13, 2017).
`
`80. Exhibit 1130 is a true and correct copy of U.S. Patent No. 4,891,762
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`Method and Apparatus for Tracking, Mapping and Recognition of Spatial Patterns
`
`(Filed February 9, 1988) (Issued January 2, 1990).
`
`81. Exhibit 1131 is a true and correct copy of Wallick et al.,
`
`Glycosylation of a VH Residue of a Monoclonal Antibody Against α (l-6) Dextran
`
`Increases its Affinity for Antigen, 168(3) J. EXPERIMENTAL MED. 1099–109 (1988).
`
`82. Exhibit 1182 is a true and correct copy of Bodmer, International
`
`Publication No. WO 1989/01783 (Published March 9, 1989).
`
`83. Exhibit 1183 is a true and correct copy of Gorman, International
`
`Publication No. WO 1992/05274 (Published April 2, 1992).
`
`84. Exhibit 1185 is a true and correct copy of Miller, To Build a Better
`
`Mousetrap, Use Human Parts, 90(1) J. NAT’L CANCER INST. 1416 (1998).
`
`85.
`
`I declare under penalty of perjury under the laws of the United States
`
`of America that all statements made herein of my own knowledge are true and that
`
`
`
`15
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`PFIZER EX. 1187
`Page 15
`
`
`
`
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`all statements made on information and belief are believed to be true; and further
`
`that these statements were made with the knowledge that willful false statements
`
`and the like so made are punishable by fine or imprisonment, or both, under
`
`Section 1001 of the Title 18 of the United States Code.
`
`
`
`Executed on May 24, 2017, in Chicago, Illinois.
`
` /Amanda Hollis/
`Amanda Hollis
`
`
`
`16
`
`PFIZER EX. 1187
`Page 16
`
`
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