UNITED STATES PATENT AND TRADEMARK OFFICE
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner
`v.
`
`
`GENENTECH, INC.,
`Patent Owner
`
`————————————————
`
`Case IPR2016-01694
`Patent 6,407,213
`————————————————
`
`
`
`PETITIONER’S UPDATED EXHIBIT LIST
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`
`
`
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`
`
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`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner
`v.
`
`
`GENENTECH, INC.,
`Patent Owner
`
`————————————————
`
`Case IPR2016-01694
`Patent 6,407,213
`————————————————
`
`
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`
`Exhibit No.
`
`1001
`
`Description
`
`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
`
`1008
`
`Declaration of Dr. Eduardo A. Padlan in Support of Petition for
`Inter Partes Review of Patent No. 6,407,213
`
`Curriculum Vitae of Dr. Eduardo A. Padlan
`
`Materials Reviewed by Dr. Eduardo A. Padlan
`
`Exhibits A-M of Dr. Eduardo A. Padlan
`
`Declaration of Professor Edward Ball, M.D. in Support of
`Petition for Inter Partes Review of Patent No. 6,407,213
`
`Curriculum Vitae of Professor Edward Ball, M.D.
`
`Materials Reviewed by Professor Edward Ball, M.D.
`
`Ball E.D., et al. Studies on the ability of monoclonal antibodies to
`selectively mediate complement-dependent cytotoxicity of human
`myelogenous leukemia blast cells. J. Immunol. 128(3):1476-81
`(March 1982)
`
`Ball, E.D., et al. Monoclonal antibodies reactive with small cell
`carcinoma of the lung. J. Nat’l Cancer Inst. 72(3):593-598
`(March 1984)
`
`Magnani, J.L., Ball, E.D., et al. Monoclonal antibodies PMN 6,
`PMN 29 and PM-81 bind differently to glycolipids containing a
`sugar sequence occurring in lacto-N-fucopentaose III, Arch.
`Biochem. Biophys. 233(2):501-506 (September 1984)
`
`Memoli, V.A., Jordan, A.G., and Ball, E.D. A novel monoclonal
`antibody, SCCL 175, with specificity for small cell
`neuroendocrine carcinoma of the lung. Cancer Res. 48:7319-
`
`- 2 -
`
`
`
`Exhibit No.
`
`Description
`7322 ( December 15, 1988)
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`Ball E.D., et al. Monoclonal antibodies to myeloid differentiation
`antigens: in vivo studies of three patients with acute
`myelogenous leukemia. Blood 62(6):1203-1210 (December
`1983)
`
`Ball E.D., et al. Phase I clinical trial of serotherapy in patients
`with acute myeloid leukemia with an immunoglobulin M
`monoclonal antibody to CD15. Clin Cancer Res 1:965-972
`(September 1995)
`
`Bashey A., Ball E.D., et al. CTLA4 Blockade with Ipilimumab to
`Treat Relapse of Malignancy after Allogeneic Hematopoietic Cell
`Transplantation. Blood 113(7):1581-1588 (2009)
`
`Armand P., Ball E.D., et al. Disabling Immune Tolerance by
`Programmed Death-1 Blockade with Pidilizumab after
`Autologous Hematopoietic Stem-Cell Transplantation for Diffuse
`Large B-Cell Lymphoma: Results of an International Phase II
`Trial. J. Clin. Oncol. 31(33):4199-4206 (November 20, 2013)
`
`Ball E.D., et al. Initial trial of bispecific antibody-mediated
`immunotherapy of CD15-bearing tumors: cytotoxicity of human
`tumor cells using a bispecific antibody comprised of anti-CD15
`(MoAb PM81) and anti-CD64/Fc gamma RI (MoAb 32). J.
`Hematotherapy 1:85-94 (1992)
`
`Chen J, Zhou J.H., Ball E.D. Monocyte-mediated lysis of acute
`myeloid leukemia cells in the presence of the bispecific antibody
`251 x 22 (anti-CD33 x anti-CD64). Clin. Can. Res. 1:1319-
`1325(November 1995)
`
`Balaian, L. and Ball, E.D. Direct effect of bispecific anti-CD33 x
`anti-CD64 antibody on proliferation and signaling in myeloid
`cells. Leukemia Res. 25:1115-1125 (2001)
`
`Chen J., Ball, E.D., et al. An immunoconjugate of Lys3-bombesin
`and monoclonal antibody 22 can specifically induce FcgammaRI
`(CD64)-dependent monocyte- and neutrophil-mediated lysis of
`
`- 3 -
`
`
`
`Exhibit No.
`
`Description
`small cell carcinoma of the lung cells. Clin. Can. Res. 1:425-434
`(April 1995)
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`Chen J., Ball, E.D., et al. Monocyte- and neutrophil-mediated
`lysis of SCCL by a bispecific molecule comprised of Lys3-BN and
`mAb22. Peptides 1994. 819-820(1995)
`
`Zhou J.H., Ball E.D., et al. Immunotherapy of a human small cell
`lung carcinoma (SCLC) xenograft model by the bispecific
`molecule (BsMol) mAb22xLys3-Bombesin (M22xL-BN). Peptides
`1996, 935-936 (1998)
`
`Ball, E.D. and Balaian, L. Cytotoxic activity of gemtuzumab
`ozogamicin (Mylotarg) in acute myeloid leukemia correlates with
`the expression of protein kinase Syk. Leukemia, 20:2093-2101
`(2006)
`
`Ball E.D., et al. Update of a phase I/II trial of 5-azacytidine
`prior to gemtuzumab ozogamicin (GO) for patients with relapsed
`acute myeloid leukemia with correlative biomarker studies
`[abstract]. Blood (ASH Annual Meeting Abstracts) 116:
`Abstract 3286 (2010)
`
`Hudziak et al. p185HER2 Monoclonal Antibody Has
`Antiproliferative Effects In Vitro and Sensitizes Human Breast
`Tumor Cells to Tumor Necrosis Factor. Mol. Cell Biol.
`9(3):1165-1172 (March 1989)
`
`Köhler and Milstein, Continuous Cultures of Fused Cells
`Secreting Antibody of Predefined Specificity. Nature
`256(5517):495-497 (August 7, 1975)
`
`Prabakaran, S. The Quest for a Magic Bullet Science,
`349(6246):389 (July 24, 2015)
`
`Marks, L. The story of Cesar Milstein and Monoclonal
`Antibodies: A Healthcare Revolution in the Making at
`http://www.whatisbiotechnology.org/exhibitions/milstein (last
`accessed September 08, 2015)
`
`- 4 -
`
`
`
`Exhibit No.
`
`Description
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`Cosimi et al., Treatment of Acute Renal Allograft Rejection with
`OKT3 Monoclonal Antibody. Transplantation 32:535-539 (1981)
`
`Ortho Multicenter Transplant Study Group, A Randomized
`Clinical Trial of OKT3 Monoclonal Antibody for Acute Rejection
`of Cadveric Renal Transplants. N. Engl. J. Med. 313(6):337-342
`(August 8, 1985)
`
`Jaffers et al. Monoclonal Antibody Therapy. Anti-idiotypic and
`Non-anti-idiotypic antibodies to OKT3 Arising Despite Intense
`Immunosuppression. Transplantation 41(5):572-578 (1986)
`
`Sears et al. Phase-I clinical trial of monoclonal antibody in
`treatment of gastrointestinal tumours. The Lancet 762-765
`(April 3, 1982)
`
`Sikora Monoclonal antibodies in oncology. J. Clin. Pathol.
`35:369-375 (1982)
`
`“Protein Data Bank – Chronology” at
`https://www.nsf.gov/news_summ.jsp?cntn_id=100689 (accessed
`August 29, 2016)
`
`Morrison et al., Chimeric Human Antibody Molecules: Mouse
`Antigen-Binding Domains with Human Constant Region
`Domains. Pro. Nat’l Acad. Sci. 81:6851-6855 (November 1984).
`
`Liu et al., Chimeric Mouse-human IgG1 Antibody that can
`Mediate Lysis of Cancer cells. Pro. Nat’l Acad. Sci. 84:3439-
`3443 (May 1987).
`
`Jones et al. Replacing the Complementarity-Determining Regions
`in a Human Antibody with those from a Mouse. Nature 321:522-
`525 (1986)
`
`Queen et al. A Humanized Antibody that Binds to the Interleukin
`2 Receptor. Pro. Nat’l Acad. Sci. 86:10029-10033 (1989)
`
`Kirkman et al., Early Experience with anti-Tac in Clinical Renal
`
`- 5 -
`
`
`
`Exhibit No.
`
`Description
`Transplantation. Transplant. Proc. 21:1766-1768 (1989)
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`Waldmann et al. The Interleukin-2 Receptor: A Target for
`Monoclonal Antibody Treatment of Human T-Cell
`Lymphotrophic Virus I-Induced Adult T-Cell Leukemias. Blood
`72:1705-1716 (1988)
`
`Hakimi et al. Reduced Immunogenicity and Improved
`Pharmacokinetics of Humanized anti-Tac in Cynomolgus
`Monkeys. J. Immunol. 147:1352-1359 (August 15, 1991)
`
`Vincenti et al., Interleukin 2-Receptor Blockade with Daclizumab
`to Prevent Acute Rejection in Renal Transplantation. N. Engl. J.
`Med. 338(3):161-165 (January 15, 1998)
`
`SEER Stat Fact Sheets: Breast Cancer at
`http://seer.cancer.gov/statfacts/html/breast.html (last accessed
`September 08, 2015)
`
`Harris, J.R., et al. Medical Progress: Breast Cancer. N. Engl. J.
`Med. 327(5):319-328 (1992)
`
`King C.R., Kraus M.H., and Aaronson, S.A. Amplification of a
`Novel v- erbB-Related Gene in a Human Mammary Carcinoma.
`Science 229:974-976 (1985)
`
`Semba K., 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. Pro.
`Nat’l Acad. Sci. 82:6497-6501 (1985)
`
`Coussens L., et al. Tyrosine kinase receptor with extensive
`homology to EGF receptor shares chromosomal location with
`neu oncogene. Science 230:1132-1139 (December 6, 1985)
`
`Fukushige S., 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. Mol. Cell. Biol. 6:955-958 (1986)
`
`Slamon, D.J. et al. Human Breast Cancer Correlation of Relapse
`
`- 6 -
`
`
`
`Exhibit No.
`
`Description
`and Survival with Amplification of the HER-2/neu Oncogene.
`Science 235:177-182 (1987)
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`
`Kraus, M.H., et al. Overexpression of the EGF receptor-related
`proto-oncogene erbB-2 in human mammary tumor cell lines by
`different molecular mechanisms. The EMBO Journal 6(3):605-
`610 (1987)
`
`Hudziak, R. M., et al. Increased expression of the putative
`growth factor receptor p185HER2 causes transformation and
`tumorigenesis of NIH 3T3 cells. Pro. Nat’l Acad. Sci. 84:7159-
`7163 (1987)
`
`Shepard, H. M. et al. Monoclonal Antibody Therapy of Human
`Cancer: Taking the HER2 Protooncogene to the clinic. Journal
`of Clinical Immunology, 11(3):117-127 (1991).
`
`Chothia, C. et al. Conformations of immunoglobulin
`hypervariable regions. Nature 342(21):877-883 (December
`1989).
`
`Queen, Cary L.: International Publication No. WO 1990/07861
`(published July 26, 1990)
`
`Tramontano, A. 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, J.
`Mol. Biol. 215:175-182 (1990)
`Kabat, et al. Sequences of Proteins of Immunological Interest 4th
`Ed., 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 (National
`Institutes of Health, Bethesda, Md.) (1987)
`
`Wu and Kabat, An analysis of the sequences of the variable
`regions of Bence Jones proteins and myeloma light chains and
`their implications for antibody complementarity. J. Exp. Med.
`132:211-250 (1970)
`
`- 7 -
`
`
`
`Exhibit No.
`
`Description
`
`1054
`
`1055
`
`1056
`
`1057
`
`1058
`
`1059
`
`1060
`
`1061
`
`1062
`
`1063
`
`1064
`
`Kieber-Emmons et al. Perspectives on Antigenicity and Idiotypy.
`Intern. Rev. Immunol. 2:339-356 (1987)
`Kabat, et al. Sequences of Proteins of Immunological Interest 5th
`Ed., 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 (National
`Institutes of Health, Bethesda, Md.) (1991)
`
`Milstein, et al. The Wellcome Foundation Lecture 1980,
`Monoclonal Antibodies from Hybrid Myelomas. Proc. Royal
`Soc. London 211:393-412 (March 27, 1981)
`
`Johnson and Wu The Kabat database and a bioinformatics
`example, Methods in Molecular Biology 248:11-25 (December
`2003)
`
`Davies & Metzger, Structural Basics of Antibody Function,
`Annu. Rev. Immunol. 1:87-117 (1983)
`
`Amit et al. Three-Dimensional Structure of an Antigen-Antibody
`Complex at 2.8 A Resolution Science 233:747-53 (1986)
`
`Lascombe et al. Three-dimensional Structure of Fab R19.9, a
`Monoclonal Murine Antibody Specific for the p-
`azobenzenearsonate group. Pro. Nat’l Acad. Sci. 86:607-611
`(January 1989)
`
`Novotný et al. Molecular Anatomy of the Antibody Binding Site.
`J. Biol. Chem. 258(23):14433-14437 (December 10, 1983)
`
`Chothia and Lesk, Canonical structures for the hypervariable
`regions of immunoglobulins. J. Mol. Biol. 196:901-917 (1987)
`
`Chothia et al. Domain Association in Immunoglobulin
`Molecules: The Packing of Variable Domains. J. Mol. Biol.
`186:651-63 (1985)
`
`Van Kroonenburgh & Pauwels Human Immunological Response
`to Mouse Monoclonal Antibody Treatment or Diagnosis of
`
`- 8 -
`
`
`
`Exhibit No.
`
`Description
`Malignant Diseases. Nucl. Med. Commun. 9:919-30 (1988)
`
`1065
`
`1066
`
`1067
`
`1068
`
`1069
`
`1070
`
`1071
`
`1072
`
`1073
`
`1074
`
`Tjandra et al. Development of human anti-murine antibody
`(HAMA) response in patients. Immunol. Cell. Biol. 68:367-76
`(1990)
`
`Lind, et al. Development of human antimouse antibodies
`(HAMA) after single and repeated diagnostic application of
`intact murine monoclonal antibodies. Antibod. Immunoconj.
`Radiopharm. 4(4):811-818 (1991)
`
`Mountain and Adair, Engineering Antibodies for Therapy.
`Biotech. Genet. Eng. Rev. 10:1-142 (1992)
`
`Verhoeyen, Milstein & Winter et al. Reshaping Human
`Antibodies: Grafting an Antilysozyme Activity. Science
`239:1534- 1536 (March 25, 1988)
`
`Riechmann, et al. Reshaping human antibodies for therapy.
`Nature 332:323-327 (March 24, 1988)
`
`Tempest, et al. Reshaping a human monoclonal antibody to
`inhibit human respiratory syncytial virus infection in vivo.
`BioTechnology 9:266-271 (March 1991)
`
`Kurrle, et al. Improved monoclonal antibodies against the human
`alphabeta T-Cell receptor, their production and use. EP0403156.
`(1990)
`
`Shearman, et al. Construction, expression and characterization of
`humanized antibodies directed against the human a/b T cell
`receptor. J. Immunol. 147(12):4366-4373, (December 15, 1991)
`
`Winter, Gregory Paul et al. EP Publication Number 0239400,
`Recombinant antibodies and methods for their productions.
`Published September 30, 1987.
`
`Accelrys Inc. (http://accelrys.com/micro/insight/insight.html)
`(Last accessed October 16, 2015)
`
`- 9 -
`
`
`
`Exhibit No.
`
`Description
`
`1075
`
`1076
`
`1077
`
`1078
`
`1079
`
`1080
`
`1081
`
`1082
`
`1083
`
`1084
`
`Dayringer et al., Interactive program for visualization and
`modelling of proteins, nucleic acids and small molecules. J. Mol.
`Graphics 4(2):82-87 (1986)
`
`Loew, G. et al. Engergy-Conformational Studies of B-Endorphis:
`Identification of Plausible Folded Conformers. Int. J. Quant.
`Chem. Quant. Biol. 15:55-66 (1988)
`
`Bruccoleri et al. Structure of antibody hpervariable loops
`reproduced by a conformational search algorithm. Nature
`335(6):564-568 (1988)
`
`Chothia et al. The Predicted Structure of Immunoglobulin D1.3
`and its Comparison with the Crystal Structure. Science New
`Series, 233(4765):755-758 (August 15, 1986)
`
`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 (National
`Institutes of Health, Bethesda, Md.) (1983).
`
`Bernstein et al. The Protein Data Bank: A Computer-based
`Archival File for Macromolecular Structures. J. Mol. Biol.
`112:535-542 (1977)
`
`Sheriff et al. Three-Dimensional Structure of an Antibody-
`Antigen Complex, Proc. Nat’l Acad. Sci. U.S.A. 84:8075 (1987)
`
`Marquart et al. The three-dimensional structure of antibodies.
`Immun. Today 3(6):160-166 (1982)
`
`Saul et al. Preliminary Refinement and Structural Analysis of the
`FAB Fragment from Human Immunoglobulin NEW at 2.0
`Angstroms Resolution. J. Biol. Chem. 253:585 (1978)
`
`Navia et al. Crystal structure of galactan-binding mouse
`immunoglobulin J539 FAB at 4.5 Angstroms resolution. Proc.
`Natl. Acad. Sci. 76(8):4071-4074 (August 1979)
`
`- 10 -
`
`
`
`Exhibit No.
`
`Description
`
`1085
`
`1086
`
`1087
`
`1088
`
`1089
`
`1090
`
`1091
`
`1092
`
`1093
`
`1094
`
`Satow et al. Phosphocholine Binding Immunogloubulin Fab
`McPC306 An X-ray Diffraction Study at 2•Å. J. Mol. Biol.
`190:593-604 (1986)
`
`Herron et al. Three-Dimensional Structure of a Flourescein-Fab
`Complex Crystallized in 2-Methyl-2,4-pentanediol. Proteins
`5:271-280 (1989)
`
`Padlan et al. Structure of an antibody-antigen complex: crystal
`structure of the HYHEL-10 FAB-lysozyme complex. Proc. Nat’l
`Acad. Sci. 86:5938-5942 (August 1989)
`
`Kumar et al. Regulation of phosphorylation of the c-erbB-
`2/HER2 gene product by monoclonal antibody and serum growth
`factor(s) in human mammary carcinoma cells. Mol. Cell. Biol.
`11(2):979-986 (February 1991)
`
`Soomro et al. C-erbB-2 expression in different histological types
`of invasive breast carcinoma. J. Clin. Pathol. 44:211-14 (1991)
`
`Keith Wilson & Kenneth H. Goulding, A Biologist’s Guide to
`Principles and Techniques of Practical Biochemistry, §Protein
`sequencing, 170-173 (3rd ed., 1986)
`
`Edelman et al. The Covalent Structure of an Entire γG
`Immunoglobulin Molecule. Proc. Nat’l Acad. Sci 63:78-85
`(1969)
`
`Capra, J. Donald and Kehoe, K. Michael Variable Region
`Sequences of Five Human Immunoglobulin Heavy Chains of the
`VHIII Subgroup: Definitive Identification of Four Heavy Chain
`Hypervariable Regions. Proc. Nat’l Acad. Sci. 71:845-8 (1974)
`
`Morin, Michael J. From Oncogene to Drug: Development of
`Small Molecule Tyrosine Kinase Inhibitors as Anti-tumor and
`Anti-angiogenic agents. Oncogene 19:6574- 6583 (2000)
`
`File History for U.S. Patent Application No. 07/715,272
`Immunoglobulin Variants (filed June 14, 1991).
`
`- 11 -
`
`
`
`Exhibit No.
`
`Description
`
`1095
`
`1096
`
`1097
`
`1098
`
`1099
`
`1100
`
`1101
`
`1102
`
`1103
`
`1104
`
`File History for Patent Interference No. 105,744 (Senior party
`Application No. 11/284,261, Inventors John Robert Adair et al.
`Junior Party, U.S. Patent 6,407,213, Inventors Paul J. Carter and
`Leonard G. Presta)
`
`US Patent No. 5,677,171 Monoclonal antibodies directed to the
`HER2 receptor. (filed August 5, 1994) (Issued October 14,
`1997).
`
`Sambrook et al., Molecular Cloning (2d ed., Cold Spring Harbor
`Laboratory Press) (1989)
`
`Daugherty et al., Polymerase chain reaction facilitates the
`cloning, CDR-grafting and rapid expression of a murine
`monoclonal antibody directed against the CD18 component of
`leukocyte integrins. Nucl. Acids Res. 19(9):2471-2476 (May
`1991).
`
`Padlan and Kabat, Modeling of Antibody Combining Sites Meth.
`Enzymol. 203:3 (1991).
`
`Colman et al., Three-dimensional structure of a complex of
`antibody with influenza virus neuraminidase, Nature 326:358
`(1987)
`
`Tulip et al., Crystal structures of neuraminidase-antibody
`complexes, Cold Spring Harbor Symp. Quant. Biol. 4:257 (1989)
`
`Bender et al., Immunogenicity, efficacy and adverse events of
`adalimumab in RA patients. Rheumatol. Int. 27:269-74 (2007)
`
`Brient, Bruce W. and Nisonoff, Alfred Quantitative
`investigations of idiotypic antibodies. IV. Inhibition by specific
`haptens of the reaction of anti-hapten antibody with its anti-
`idiotypic antibody, J Exp Med. 132:951-62 (1970)
`
`Koprowski et al., Human anti-idiotype antibodies in cancer
`patients: Is the modulation of the immune response beneficial for
`the patient? Proc. Nat’l. Acad. Sci. U.S.A. 81:216 (1984)
`
`- 12 -
`
`
`
`Exhibit No.
`
`Description
`
`1105
`
`1106
`
`1107
`
`1108
`
`1109
`
`1110
`
`1111
`
`1112
`
`1113
`
`1114
`
`1115
`
`Chanh et al., Monoclonal anti-idiotypic antibody mimics the CD4
`receptor and binds human immunodeficiency virus, Proc. Nat’l.
`Acad. Sci. U.S.A. 84:3891 (1987)
`
`Schroff et al., Human Anti-Murine Immunoglobulin Responses in
`Patients Receiving Monoclonal Antibody Therapy, Cancer Res.
`45:879 (1985)
`
`Abdou et al., Network Theory in Autoimmunity. In vitro
`suppression of serum anti-DNA by anti-idiotypic antibody in
`systemic lupus erythematosus, J. Clin. Invest. 67:1297 (1981)
`
`Harris, L.J. et al. The three-dimensional structure of an intact
`monoclonal antibody for canine lymphoma, Nature 360:369-72
`(1992)
`
`Janeway, C.A. et al., IMMUNOBIOLOGY: THE IMMUNE SYSTEM IN
`HEALTH & DISEASE (4th ed., Garland Science Publishing, NY,
`(1999)
`
`Potter, M. Immunoglobulin-producing tumors and myeloma
`proteins of mice, Physiol. Rev. 52:631-719 (1972)
`
`Kabat K.A. and Wu, T.T. Attempts to locate complementarity-
`determining residues in the variable positions of light and heavy
`chains Ann. NY Acad. Sci. 190:382-93 (1971)
`
`D.R. Davies et al. Antibody-antigen complexes, Ann. Rev.
`Biochem. 59:439-73 (1990)
`
`Epp et al., The molecular structure of a dimer composed of the
`variable portions of the Bence Jones protein REI refined at 2.0Å
`resolution, Biochem. 14:4943 (1975)
`Mian, I.S. Structure, function and properties of antibody binding
`sites, J. Mol. Biol. 217:133-51 (1991)
`
`Poljak et al. The three-dimensional structure of the fab fragment
`of a human myeloma immunoglobulin at 2.0-angstrom resolution,
`
`- 13 -
`
`
`
`Exhibit No.
`
`Description
`Proc. Nat’l Acad. Sci. U.S.A. 71:3440-4 (1974)
`
`1116
`
`1117
`
`1118
`
`1119
`
`1120
`
`1121
`
`1122
`
`1123
`
`1124
`
`Padlan et al. Model building studies of antigen binding sites: The
`hapten binding site of MOPC315 Cold Spring Harbor Symp.
`Quant. Biol. 41:627-37 (1977))
`
`Boulianne et al. Production of functional chimaeric
`mouse/human antibody, Nature 312:643-6 (1984)
`
`Padlan, E.A. A possible procedure for reducing the
`immunogenicity of antibody variable domains while preserving
`their ligand-binding properties, Mol. Immunol. 28:489-98 (1991)
`
`U.S. Patent No. 6,797,492 Method for Reducing the
`Immunogenicity of Antibody Variable Domains (veneering of
`CD18 monoclonal antibodies) (Filed March 16, 2001)(Issued
`September 28, 2004)
`
`Padlan, Eduardo A., Choosing The Best Framework To Use In
`The ‘Humanization’ Of An Antibody by CDR-Grafting:
`Suggestions From 3-D Structural Data. The 2nd Annual IBC
`International Conference on Antibody Engineering. Omni San
`Diego Hotel, San Diego, CA. (December 16-18, 1991)
`
`Suh et al., The galactan-binding immunoglobulin Fab J539: an
`X-ray diffraction study at 2.6-Å resolution, Proteins 1:74 (1986)
`
`U.S. Patent No. 5,792,852 Polynucleotides Encoding Modified
`Antibodies with Human Milk Fat Globule Specificity
`(humanization of monoclonal antibodies binding to human milk
`fat globule antigen) (Filed November 16, 1992) (Issued August
`11, 1998)
`
`U.S. Patent No. 5,889,157 Humanized B3 Antibody Fragments,
`Fusion Proteins, and Uses Thereof (humanization of monoclonal
`antibodies to Lewisϒ-related carbohydrate antigen) (Filed
`October 28, 1994) (Issued March 30, 1999)
`
`US Patent No. 5,795,965 Reshaped human antibody to human
`interleukin-6 receptor (claiming priority to April 25, 1991)
`
`- 14 -
`
`
`
`Exhibit No.
`
`Description
`
`(Issued August 18, 1998)
`
`1125
`
`1126
`
`1127
`
`1128
`
`1129
`
`1130
`
`1131
`
`1132
`
`Furey et al. Structure of a novel Bence-Jones protein (Rhe)
`fragment at 1.6 Å resolution, J. Mol. Biol. 167:661-92 (1983)
`
`Segal et al. The Three-Dimensional Structure of a
`Phosphorylcholine-Binding Mouse Immunoglobulin Fab and the
`Nature of the Antigen Binding Site, Proc. Nat’l Acad. Sci. U.S.A.
`71:4298 (1974)
`
`Jones, TA Diffraction methods for biological macromolecules.
`Interactive computer graphics: FRODO, Meth. Enzymol.
`115:157-71 (1985)
`
`Co, M. et al. Humanized antibodies for antiviral therapy, Proc.
`Nat’l Acad. Sci. U.S.A. 88:2869-73 (1991)
`
`History of Microsoft Excel 1978-2013
`http://www.exceltrick.com/others/history-of-excel/ (accessed
`August 29, 2016)
`
`U.S. Patent No. 4,891,762 Method and Apparatus for Tracking,
`Mapping and Recognition of Spatial Patterns (Filed February 9,
`1988) (Issued January 2, 1990)
`
`Wallick, S. et al. Glycosylation of a VH residue of a monoclonal
`antibody against α(1-6) dextran increases its affinity for antigen,
`J. Exp. Med. 168:1099-109 (1988)
`
`Settlement Agreement between Petitioner Mylan
`Pharmaceuticals Inc. and Patent Owner Genentech, Inc.
`
`- 15 -
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on March 7, 2017, the
`
`foregoing document is being served by E-mail by agreement of the parties to the
`
`following counsel of record for the Patent Owner:
`
`David L. Cavanaugh
`Reg. No. 36,476
`WILMER CUTLER PICKERING HALE
` AND DORR LLP
`1875 Pennsylvania Avenue NW
`Washington, DC 20006
`David.Cavanaugh@wilmerhale.com
`Telephone: 202-663-6025
`Facsimile: 202-663-6363
`
`
`
`
`
`Dated: March 7, 2017
`
`
`
`
`
`
`
`
`
`
`
`Robert J. Gunther, Jr.
`Pro hac vice
`robert.gunther@wilmerhale.com
`Adam R. Brausa
`Reg. No. 60,287
`abrausa@durietangri.com
`Owen K. Allen
`Reg. No. 71,118
`owen.allen@wilmerhale.com
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
` /Deanne M. Mazzochi/
`Deanne M. Mazzochi (Reg. No. 50,158)
`dmazzochi@rmmslegal.com
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Telephone: (312) 222-6305
`Facsimile: (312) 222-6325
`
`
`
`- 16 -
`
`
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