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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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`SAMSUNG BIOEPIS CO., LTD., Petitioner,
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`v.
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`GENENTECH, INC., Patent Owner.
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`________________
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`United States Patent No. 6,407,213
`Title: Method for Making Humanized Antibodies
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`Case No.: IPR2017-02140
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`________________
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`DECLARATION OF SCOTT T. WEINGAERTNER
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`BIOEPIS EX. 1184
`Page 1
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`Scott T. Weingaertner, an attorney duly admitted to practice before the
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`United States Patent and Trademark Office, hereby affirms under the penalty of
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`perjury:
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`1.
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`2.
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`I am a partner at the law firm of White & Case LLP.
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`I make this Declaration in support of the petition for inter
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`partes review of U.S. Patent No. 6,407,213 before the United States Patent &
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`Trademark Office. I make this Declaration of my own personal knowledge. The
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`exhibits filed in support of this inter partes review are substantively identical to
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`those submitted by Pfizer Inc. (“Pfizer”) in support of IPR2017-01489.
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`3.
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`Exhibit 1001 is a true and correct copy of U.S. Patent No.
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`6,407,213, as filed in IPR2017-01489.
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`4.
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`Exhibit 1002 is a true and correct copy of File History for U.S.
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`Patent No. 6,407,213, as filed in IPR2017-01489.
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`5.
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`Exhibit 1021 is a true and correct copy of Hudziak, et al.,
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`pl85HER2
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` Monoclonal Antibody Has Antiproliferative Effects In Vitro and Sensitizes
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`Human Breast Tumor Cells to Tumor Necrosis Factor, 9(3) MOLECULAR
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`CELLULAR BIOLOGY 1165–72 (1989), as filed in IPR2017-01489.
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`6.
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`Exhibit 1022 is a true and correct copy of Köhler, et al.,
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`Continuous Cultures of Fused Cells Secreting Antibody of Predefined Specificity,
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`256 (5517) Nature 495-97 (1975), as filed in IPR2017-01489.
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`1
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`BIOEPIS EX. 1184
`Page 2
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`7.
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`Exhibit 1023 is a true and correct copy of Prabakaran, The
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`Quest for a Magic Bullet 349(6246) SCIENCE 389 (2015), as filed in IPR2017-
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`01489.
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`8.
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`Exhibit 1024 is a true and correct copy of Marks, The Story of
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`Cesar Milstein and Monoclonal Antibodies: A Healthcare Revolution in the
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`Making at http://www.whatisbiotechnology.org/exhibitions/milstein, as filed in
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`IPR2017-01489.
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`9.
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`Exhibit 1025 is a true and correct copy of Cosimi, et al.,
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`Treatment of Acute Renal Allograft Rejection with OKT3 Monoclonal Antibody,
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`32(6) TRANSPLANTATION 53539 (1981), as filed in IPR2017-01489.
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`10. Exhibit 1026 is a true and correct copy of Ortho Multicenter
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`Transplant Study Group, A Randomized Clinical Trial of OKT3 Monoclonal
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`Antibody for Acute Rejection of Cadaveric Renal Transplants. 313(6) N. Engl. J.
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`Med. 337-42 (1985), as filed in IPR2017-01489.
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`11. Exhibit 1027 is a true and correct copy of Jaffers, et al.,
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`Monoclonal Antibody Therapy: Anti-Idiotypic and Non-Anti-Idiotypic Antibodies
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`to OKT3 Arising Despite Intense Immunosuppression, 41(5) TRANSPLANTATION
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`572–78 (1986), as filed in IPR2017-01489.
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`2
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`BIOEPIS EX. 1184
`Page 3
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`12. Exhibit 1028 is a true and correct copy of Sears, et al., Phase-I
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`Clinical Trial of Monoclonal Antibody in Treatment of Gastrointestinal Tumours, 1
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`LANCET 762–65 (1982), as filed in IPR2017-01489.
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`13. Exhibit 1029 is a true and correct copy of Sikora, Monoclonal
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`Antibodies in Oncology, 35(4) J. CLINICAL PATHOLOGY 369-75 (1982), as filed in
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`IPR2017-01489.
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`14. Exhibit 1030 is a true and correct copy of “Protein Data Bank -
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`Chronology” at https://www.nsf.sov/news summ.isp?cntn id=l00689, as filed in
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`IPR2017-01489.
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`15. Exhibit 1031 is a true and correct copy of Morrison, et al.,
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`Chimeric Human Antibody Molecules: Mouse Antigen-Binding Domains with
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`Human Constant Region Domains, 81(21) PROC. NAT’L ACAD. SCI. USA 6851–55
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`(1984), as filed in IPR2017-01489.
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`16. Exhibit 1032 is a true and correct copy of Liu, et al., Chimeric
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`Mouse Human IgGl Antibody that can Mediate Lysis of Cancer Cells, 84(10)
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`PROC. NAT’L ACAD. SCI. USA 3439–43 (1987), as filed in IPR2017-01489.
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`17. Exhibit 1033 is a true and correct copy of Jones et al.,
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`Replacing the Complementarity-Determining Regions in a Human Antibody With
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`Those From a Mouse, 321(6069) NATURE 522–25 (1986), as filed in IPR2017-
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`01489.
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`3
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`BIOEPIS EX. 1184
`Page 4
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`18. Exhibit 1034 is a true and correct copy of Queen, et al., A
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`Humanized Antibody that Binds to the Interleukin 2 Receptor, 86(24) PROC. NAT’L
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`ACAD. SCI. USA 10029–33 (1989), as filed in IPR2017-01489.
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`19. Exhibit 1035 is a true and correct copy of Kirkman et al., Early
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`Experience with Anti-Tac
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`in Clinical Renal Transplantation. 21(1)
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`TRANSPLANTATION PROC. 1766–68 (1989), as filed in IPR2017-01489.
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`20. Exhibit 1036 is a true and correct copy of Waldmann, et al.,
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`The Interleukin-2 Receptor: A Target for Monoclonal Antibody Treatment of
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`Human T-Cell Lymphotrophic Virus I-Induced Adult T-Cell Leukemia, 82(6)
`
`BLOOD 1701–12 (1993), as filed in IPR2017-01489.
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`21. Exhibit 1037 is a true and correct copy of Hakimi, et al.,
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`Reduced Immunogenicity and Improved Pharmacokinetics of Humanized Anti-Tac
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`in Cynomolgus Monkeys, 147(4) J. IMMUNOLOGY 1352–59 (1991), as filed in
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`IPR2017-01489.
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`22. Exhibit 1038 is a true and correct copy of Vincenti, et al.,
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`Interleukin 2-Receptor Blockade with Daclizumab to Prevent Acute Rejection in
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`Renal Transplantation. 338(3) NEW ENG. J.MED. 161–65 (1998), as filed in
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`IPR2017-01489.
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`4
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`BIOEPIS EX. 1184
`Page 5
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`23. Exhibit 1039 is a true and correct copy of SEER Stat Fact
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`Sheets:
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`Breast
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`Cancer,
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`National
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`Cancer
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`Institute,
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`at
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`http://seer.cancer.gov/statfacts/html/breast.html, as filed in IPR2017-01489.
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`24. Exhibit 1040 is a true and correct copy of Harris, et al., Medical
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`Progress: Breast Cancer, 327(5) NEW ENG. J.MED. 319–28 (1992), as filed in
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`IPR2017-01489.
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`25. Exhibit 1041 is a true and correct copy of King, et al.,
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`Amplification of a Novel v-erbB-Related Gene in a Human Mammary Carcinoma,
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`229(4717) SCIENCE 974–76 (1985), as filed in IPR2017-01489.
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`26. Exhibit 1042 is a true and correct copy of Semba, et al., A v-
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`erbB Related Protooncogene, c-erbB-2, is Distinct From the c-erbB-1 Epidermal
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`Growth Factor-Receptor Gene and is Amplified in a Human Salivary Gland
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`Adenocarcinoma, 82(19) PROC. NAT’L ACAD. SCI. USA 6497–01 (1985), as filed
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`in IPR2017-01489.
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`27. Exhibit 1043 is a true and correct copy of Coussens, et al.,
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`Tyrosine Kinase Receptor with Extensive Homology to EGF Receptor Shares
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`Chromosomal Location with neu Oncogene. 230(4730) SCIENCE 1132–39 (1985),
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`as filed in IPR2017-01489.
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`28. Exhibit 1044 is a true and correct copy of Fukushige, et al.,
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`Localization of a Novel v-erbB-Related Gene, c-erbB-2, on Human Chromosome
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`5
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`BIOEPIS EX. 1184
`Page 6
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`17 and its Amplification in a Gastric Cancer Cell Line. 6(3) MOLECULAR
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`CELLULAR BIOLOGY 955–58 (1986)), as filed in IPR2017-01489.
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`29. Exhibit 1045 is a true and correct copy of Slamon, et al.,
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`Human Breast Cancer Correlation of Relapse and Survival with Amplification of
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`the HER- 2/neu Oncogene, 235(4785) SCIENCE 177–82 (1987), as filed in
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`IPR2017-01489.
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`30. Exhibit 1046 is a true and correct copy of Kraus, et al.,
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`Overexpression of the EGF Receptor-Related Proto-Oncogene erbB-2 in Human
`
`Mammary Tumor Cell Lines by Different Molecular Mechanisms, 6(3)The EMBO
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`J. 605-10 (1987), as filed in IPR2017-01489.
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`31. Exhibit 1047 is a true and correct copy of Hudziak, et al.,
`
`
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`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)], as filed in IPR2017-01489.
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`32. Exhibit 1048 is a true and correct copy of Shepard, et al.,
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`Monoclonal Antibody Therapy of Human Cancer: Taking
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`the HER2
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`Protooncogene to the Clinic, 11(3) J. CLINICAL IMMUNOLOGY, 117–27 (1991), as
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`filed in IPR2017-01489.
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`6
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`BIOEPIS EX. 1184
`Page 7
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`33. Exhibit 1049 is a true and correct copy of Chothia, et al.,
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`Conformations of Immunoglobulin Hypervariable Regions, 342(21) NATURE 877–
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`83 (1989), as filed in IPR2017-01489.
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`34. Exhibit 1050 is a true and correct copy of Queen, Cary L.:
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`International Publication No. WO 1990/07861 (published July 26, 1990), as filed
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`in IPR2017-01489.
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`35. Exhibit 1051 is a true and correct copy of Tramontano, et al.,
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`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)
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`J.MOLECULAR BIOLOGY 175–82 (1990), as filed in IPR2017-01489.
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`36. Exhibit 1052 is a true and correct copy of Kabat, et al.,
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`SEQUENCES OF PROTEINS OF IMMUNOLOGICAL INTEREST: TABULATION AND
`
`ANALYSIS OF AMINO ACID AND NUCLEIC ACID SEQUENCES OF PRECURSORS, V-
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`REGIONS, C-REGIONS, J-CHAIN, T-CELL RECEPTOR FOR ANTIGEN, T-CELL SURFACE
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`ANTIGENS, β2-MICROGLUBINS, MAJOR HISTOCOMPATIBILITY ANTIGENS, THY-1
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`COMPLEMENT, C-REACTIVE PROTEIN, THYMOPOIETIN, POST-GAMMA GLOBULIN,
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`AND α2-MACROGLOBULIN 41–175 (4th ed. 1987), as filed in IPR2017-01489.
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`37. Exhibit 1055 is a true and correct copy of Kabat, et al., 1
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`SEQUENCES OF PROTEINS OF IMMUNOLOGICAL INTEREST: TABULATION AND
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`ANALYSIS OF AMINO ACID AND NUCLEIC ACID SEQUENCES OF PRECURSORS, V-
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`7
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`BIOEPIS EX. 1184
`Page 8
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`REGIONS, C-REGIONS, J-CHAIN, T-CELL RECEPTOR FOR ANTIGEN, T-CELL SURFACE
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`ANTIGENS, β 2-MICROGLUBINS, MAJOR HISTOCOMPATIBILITY ANTIGENS, THY-1
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`COMPLEMENT, C-REACTIVE PROTEIN, THYMOPOIETIN, POST-GAMMA GLOBULIN, α
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`2-MACROGLOBULINS, AND OTHER RELATED PROTEINS 103–338 (5th ed. 1991), as
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`filed in IPR2017-01489.
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`38. Exhibit 1058 is a true and correct copy of Davies & Metzger,
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`Structural Basics of Antibody Function, 1 ANN. REV. IMMUNOLOGY 87–117
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`(1983), as filed in IPR2017-01489.
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`39. Exhibit 1059 is a true and correct copy of Amit et al., Three-
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`Dimensional Structure of an Antigen-Antibody Complex at 2.8 A Resolution,
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`233(4765) SCIENCE 747–53 (1986), as filed in IPR2017-01489.
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`40. Exhibit 1062 is a true and correct copy of Chothia & Lesk,
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`Canonical Structures for the Hypervariable Regions of Immunoglobulins, 196(4) J.
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`MOLECULAR BIOLOGY 901–17 (1987), as filed in IPR2017-01489.
`
`41. Exhibit 1063 is a true and correct copy of Chothia, et al.,
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`Domain Association in Immunoglobulin Molecules: The Packing of Variable
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`Domains, 186(3) J.MOLECULAR BIOLOGY 651–63 (1985), as filed in IPR2017-
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`01489.
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`8
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`BIOEPIS EX. 1184
`Page 9
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`42. Exhibit 1068 is a true and correct copy of Verhoeyen, et al.,
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`Reshaping Human Antibodies: Grafting an Antilysozyme Activity, 239(4847)
`
`SCIENCE 1534–36 (1988), as filed in IPR2017-01489.
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`43. Exhibit 1069 is a true and correct copy of Riechmann, et al.,
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`Reshaping Human Antibodies for Therapy, 332(6162) NATURE 323–27 (1988), as
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`filed in IPR2017-01489.
`
`44. Exhibit 1071 is a true and correct copy of Kurrle, et al., EP
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`Publication Number 0403156, Improved Monoclonal Antibodies Against the
`
`Human Alphabeta T-Cell Receptor, Their Production and Use (Published
`
`December 19, 1990), as filed in IPR2017-01489.
`
`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), as filed in IPR2017-01489.
`
`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-
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`GAMMA GLOBULIN, AND α2-MACROGLOBULIN (1983), as filed in IPR2017-01489.
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`9
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`BIOEPIS EX. 1184
`Page 10
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`47. Exhibit 1080 is a true and correct copy of Bernstein, et al., The
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`Protein Data Bank: A Computer-Based Archival File for Macromolecular
`
`Structures, 112(3) J. MOLECULAR BIOLOGY 535–42 (1977), as filed in IPR2017-
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`01489.
`
`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), as filed in IPR2017-01489.
`
`49. Exhibit 1082 is a true and correct copy of Marquart, et al., The
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`Three-Dimensional Structure of Antibodies, 3(6) IMMUNOLOGY TODAY 160–66
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`(1982), as filed in IPR2017-01489.
`
`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
`
`585-95 (1978), as filed in IPR2017-01489.
`
`51. Exhibit 1085 is a true and correct copy of Satow, et al.,
`
`Phosphocholine Binding Immunoglobulin Fab McPC306 An X-ray Diffraction
`
`Study at 2•7 Å, J. MOLECULAR BIOLOGY 593–604 (1986), as filed in IPR2017-
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`01489.
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`10
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`BIOEPIS EX. 1184
`Page 11
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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-
`
`2,4-Pentanediol, 5(4) PROTEINS 271–80 (1989), as filed in IPR2017-01489.
`
`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 Complex, 86(15) PROC. NAT’L ACAD. SCI. USA 5938–42 (1989),
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`as filed in IPR2017-01489.
`
`54. Exhibit 1088 is a true and correct copy of Kumar, et al.,
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`Regulation of Phosphorylation of the c-erbB- 2 HER2 Gene Product by
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`Monoclonal Antibody and Serum Growth Factor(s) in Human Mammary
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`Carcinoma Cells, 11(2) MOLECULAR CELLULAR BIOLOGY 979–86 (1991), as filed
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`in IPR2017-01489.
`
`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,
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`44(3) J. CLINICAL PATHOLOGY 211–14 (1991), as filed in IPR2017-01489.
`
`56. Exhibit 1090 is a true and correct copy of Wilson & Goulding,
`
`A BIOLOGIST’S GUIDE TO PRINCIPLES AND TECHNIQUES OF PRACTICAL
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`BIOCHEMISTRY, Protein Sequencing, 170-173 (3rd ed., 1986), as filed in
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`IPR2017-01489.
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`11
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`BIOEPIS EX. 1184
`Page 12
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`57. Exhibit 1091 is a true and correct copy of Edelman, et al., The
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`Covalent Structure of an Entire G Immunoglobulin Molecule*, 63(1) PROC.
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`NAT’L ACAD. SCI. USA 78–85 (1969), as filed in IPR2017-01489.
`
`58. Exhibit 1092 is a true and correct copy of Capra, & Kehoe,
`
`Variable Region Sequences of Five Human Immunoglobulin Heavy Chains of the
`
`VHIII Subgroup: Definitive Identification of Four Heavy Chain Hypervariable
`
`Regions, 71(3) PROC. NAT’L ACAD. SCI. USA 845–48 (1974), as filed in IPR2017-
`
`01489.
`
`59. Exhibit 1093 is a true and correct copy of Morin, From
`
`Oncogene to Drug: Development of Small Molecule Tyrosine Kinase Inhibitors as
`
`Anti-Tumor and Anti-Angiogenic Agent, 19(56) ONCOGENE 6574– 83 (2000), as
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`filed in IPR2017-01489.
`
`60. Exhibit 1095 is a true and correct copy of 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), as filed in IPR2017-01489.
`
`61. Exhibit 1096 is a true and correct copy of U.S. Patent No.
`
`5,677,171 Monoclonal Antibodies Directed to the HER2 Receptor, (Filed August
`
`5, 1994) (Issued October 14, 1997), as filed in IPR2017-01489.
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`12
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`BIOEPIS EX. 1184
`Page 13
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`62. Exhibit 1097 is a true and correct copy of Sambrook, et al.,
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`Molecular Cloning, A Laboratory Manual (Cold Spring Harbor Laboratory Press,
`
`2d ed. 1989), as filed in IPR2017-01489.
`
`63. Exhibit 1100 is a true and correct copy of Colman, et al., Three-
`
`Dimensional Structure of a Complex of Antibody with Influenza Virus
`
`Neuraminidase, 326 NATURE 358-63 (1987), as filed in IPR2017-01489.
`
`64. Exhibit 1102 is a true and correct copy of Bender, et al.,
`
`Immunogenicity, Efficacy and Adverse Events of Adalimumab in RA Patients,
`
`27(3) RHEUMATOLOGY INT’L 269–74 (2007), as filed in IPR2017-01489.
`
`65. Exhibit 1103 is a true and correct copy of Brient & Nisonoff,
`
`Quantitative Investigations of Idiotypic Antibodies. IV. Inhibition by Specific
`
`Haptens of the Reaction of Anti-Haptens Antibody with its Anti- Idiotypic
`
`Antibody, 132 J. EXPERIMENTAL MED. 951–61 (1970), as filed in IPR2017-01489.
`
`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 Response Beneficial for the Patient?, 81(1) PROC. NAT’L. ACAD. SCI.
`
`USA 216-19 (1984), as filed in IPR2017-01489.
`
`67. Exhibit 1105 is a true and correct copy of Chanh, et al.,
`
`Monoclonal Anti-Idiotypic Antibody Mimics the CD4 Receptor and Binds Human
`
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`
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`13
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`BIOEPIS EX. 1184
`Page 14
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`Immunodeficiency Virus, 84 PROC. NAT’L. ACAD. SCI. USA 3891-95 (1987), as
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`filed in IPR2017-01489.
`
`68. Exhibit 1106 is a true and correct copy of Schroff, et al.,
`
`Human Anti-Murine Immunoglobulin Responses in Patients Receiving Monoclonal
`
`Antibody Therapy, 45(2) CANCER RES. 879-85 (1985), as filed in IPR2017-01489.
`
`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 Antibody in Systemic Lupus Erythematosus, 67(5) J. CLINICAL
`
`INVESTIGATION 1297-1304 (1981), as filed in IPR2017-01489.
`
`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), as filed in IPR2017-01489.
`
`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 (1991), as filed in IPR2017-01489.
`
`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
`
`Immunoglobulin at 2.0-Å Resolution, 71(9) PROC. NAT’L ACAD. SCI. USA. 3440–
`
`44 (1974), as filed in IPR2017-01489.
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`14
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`BIOEPIS EX. 1184
`Page 15
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`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), as filed
`
`in IPR2017-01489.
`
`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), as filed in IPR2017-01489.
`
`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. MOLECULAR BIOLOGY 661–92 (1983), as filed in IPR2017-01489.
`
`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), as filed in IPR2017-01489.
`
`77. Exhibit 1127 is a true and correct copy of Jones, Diffraction
`
`Methods
`
`for Biological Macromolecules. Interactive Computer Graphics:
`
`FRODO, 115 METHODS ENZYMOLOGY 157–71 (1985), as filed in IPR2017-01489.
`
`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), as filed in IPR2017-01489.
`
`
`
`
`15
`
`
`
`
`
`BIOEPIS EX. 1184
`Page 16
`
`
`
`
`
`79. Exhibit 1129 is a true and correct copy of History of Microsoft
`
`Excel 1978-2013, http://www.exceltrick.com/others/history-of-excel/, as filed in
`
`IPR2017-01489.
`
`80. Exhibit 1130 is a true and correct copy of 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), as filed in
`
`IPR2017-01489.
`
`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),
`
`as filed in IPR2017-01489.
`
`82. Exhibit 1182 is a true and correct copy of Bodmer, International
`
`Publication No. WO 1989/01783 (Published March 9, 1989), as filed in IPR2017-
`
`01489.
`
`83. Exhibit 1183
`
`is a
`
`true and correct copy of Gorman,
`
`International Publication No. WO 1992/05274 (Published April 2, 1992), as filed
`
`in IPR2017-01489.
`
`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), as
`
`filed in IPR2017-01489.
`
`
`
`
`16
`
`
`
`
`
`BIOEPIS EX. 1184
`Page 17
`
`
`
`
`
`5,859,205.
`
`85. Exhibit 1189 is a true and correct copy of U.S. Patent No.
`
`86. Exhibit 1192 is a true and correct copy of S. Roberts, et al.,
`
`Generation of an antibody with enhanced affinity and specificity for its antigen by
`
`protein engineering, 328 NATURE 731-34 (Aug. 1987)
`
`87. The following Protein Data Bank (“PDB”) entries are
`
`substantially identical to those submitted by Pfizer in support of IPR2017-01489,
`
`which are available at the PDB webpage: http:///www.rcsb.org.
`
`88. Exhibits 1003F and 1190F are true and correct copies of the
`
`PDB entry for PDB ID 2HFL, as submitted by Pfizer in support of IPR2017-
`
`01489.
`
`89. Exhibit 1184A is a true and correct copy of the PDB webpage
`
`http://www.rcsb.org/pdb/explore/obsolete.do?obsoleteId=2HFL, as submitted by
`
`Pfizer in support of IPR2017-01489. Exhibit 1184A is a report showing that entry
`
`2HFL was first deposited in the PDB August 17, 1987 and released October 16,
`
`1987.
`
`90. Exhibits 1003G and 1190G are true and correct copies of the
`
`PDB entry for PDB ID 1FB4, as submitted by Pfizer in support of IPR2017-01489.
`
`91. Exhibit 1184B is a true and correct copy of the PDB webpage
`
`http://www.rcsb.org/pdb/explore/obsolete.do?obsoleteId=1FB4, as submitted by
`
`
`
`
`17
`
`
`
`
`
`BIOEPIS EX. 1184
`Page 18
`
`
`
`
`
`Pfizer in support of IPR2017-01489. Exhibit 1184B is a report showing that entry
`
`1FB4 was first deposited in the PDB May 9, 1983 and released July 28, 1983.
`
`92. Exhibits 1003H and 1190H are true and correct copies of the
`
`PDB entry for PDB ID 3FAB, as submitted by Pfizer in support of IPR2017-
`
`01489.
`
`93. Exhibit 1184C is a true and correct copy of the PDB webpage
`
`http://www.rcsb.org/pdb/explore/obsolete.do?obsoleteId=3FAB, as submitted by
`
`Pfizer in support of IPR2017-01489. Exhibit 1184C is a report showing that entry
`
`3FAB was first deposited September 29, 1981 and released December 8, 1981.
`
`94. Exhibits 1003I and 1190I are true and correct copies of the
`
`PDB entry for PDB ID 2FBJ, as submitted by Pfizer in support of IPR2017-01489.
`
`95. Exhibit 1184D is a true and correct copy of the PDB webpage
`
`http://www.rcsb.org/pdb/explore/explore.do?structureId=2FBJ, as submitted by
`
`Pfizer in support of IPR2017-01489. Exhibit 1184D is a report showing that entry
`
`2FBJ was first deposited August 18, 1989 and released July 15, 1990.
`
`96. Exhibits 1003J and 1190J are true and correct copies of the
`
`PDB entry for PDB ID 1MCP, as submitted by Pfizer in support of IPR2017-
`
`01489.
`
`97. Exhibit 1184E is a true and correct copy of the PDB webpage
`
`http://www.rcsb.org/pdb/explore/explore.do?structureId=1MCP , as submitted by
`
`
`
`
`18
`
`
`
`
`
`BIOEPIS EX. 1184
`Page 19
`
`
`
`
`
`Pfizer in support of IPR2017-01489. Exhibit 1184E is a report showing that entry
`
`1MCP was first deposited July 9, 1984 and released January 2, 1985.
`
`98. Exhibits 1003K and 1190K are true and correct copies of the
`
`PDB entry for PDB ID 4FAB, as submitted by Pfizer in support of IPR2017-
`
`01489.
`
`99. Exhibit 1184F is a true and correct copy of the PDB webpage
`
`http://www.rcsb.org/pdb/explore/explore.do?structureId=4FAB , as submitted by
`
`Pfizer in support of IPR2017-01489. Exhibit 1184F is a report showing that entry
`
`4FAB was first deposited April 10, 1989 and released July 15, 1990.
`
`100. Exhibits 1003L and 1190L are true and correct copies of the
`
`PDB entry for PDB ID 3HFM, as submitted by Pfizer in support of IPR2017-
`
`01489.
`
`101. Exhibit 1184G is a true and correct copy of the PDB webpage
`
`http://www.rcsb.org/pdb/explore/explore.do?structureId=3HFM, as submitted by
`
`Pfizer in support of IPR2017-01489. Exhibit 1184G is a report showing that entry
`
`3HFM was first deposited August 11, 1988 and released July 12, 1989.
`
`102. Exhibits 1003M and 1190M are true and correct copies of the
`
`PDB entry for PDB ID 1REI, as submitted by Pfizer in support of IPR2017-01489.
`
`103. Exhibit 1184H is a true and correct copy of the PDB webpage
`
`http://www.rcsb.org/pdb/explore/explore.do?structureId=1REI, as submitted by
`
`
`
`
`19
`
`
`
`
`
`BIOEPIS EX. 1184
`Page 20
`
`
`
`
`
`Pfizer in support of IPR2017-01489. Exhibit 1184H is a report showing that entry
`
`1REI was first deposited March 17, 1976 and released May 19, 1976.
`
`104. Exhibits 1003N and 1190N are true and correct copies of the
`
`PDB entry for PDB ID 2RHE, as submitted by Pfizer in support of IPR2017-
`
`01489.
`
`105. Exhibit 1184I is a true and correct copy of the PDB webpage
`
`http://www.rcsb.org/pdb/explore/explore.do?structureId=2RHE , as submitted by
`
`Pfizer in support of IPR2017-01489. Exhibit 1184I is a report showing that entry
`
`2RHE was first deposited June 13, 1983 and released September 15, 1983.
`
`
`
`Dated:
`
`
`
`
`
`September 29, 2017
`New York, New York
`
`
`
`
`
`By:
`
`
`
`/s/ Scott T. Weingaertner /
`Scott T. Weingaertner
`USPTO Reg. No. 37,756
`
`
`
`
`20
`
`
`
`
`
`BIOEPIS EX. 1184
`Page 21
`
`
`
`
`
`
`
`
`
`
`
`Exhibit A
`
`Exhibit A
`
`BIOEPIS EX. 1184
`
`Page 22
`
`BIOEPIS EX. 1184
`Page 22
`
`
`
`RCSB PDB
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`
`
`THREE-DIMENSIONAL STRUCTURE OF AN ANTIBODY-ANTIGEN COMPLEX
`
`Obsolete Structure Summary Page
`
`2HFL
`
`
`
`
`
` Display Files
` Download Files
` Share this Page
`
`
`
`2HFL was obsoleted on 1995-07-31 and superseded by 3HFL
`
`Image of 2HFL
`
`1972-01-01
`
`2017-04-25
`
`Archive of Obsolete PDB Structures
`
`2HFL
`3HFL
`1YQV
`
`Note: Mouse over colored bars for date info, mouse over PDB IDs for file download or Structure Explorer link.
`
`
`Title
`
`Authors
`
`2HFL
`THREE-DIMENSIONAL STRUCTURE
`OF AN ANTIBODY-ANTIGEN
`COMPLEX
`Sheriff, S., Davies, D.R.
`
`Textual Comparison
`3HFL
`THE REFINED STRUCTURE OF THE MONOCLONAL ANTIBODY
`HY(SLASH)HEL-5 WITH ITS ANTIGEN HEN EGG WHITE
`LYSOZYME
`Cohen, G.H., Sheriff, S., Davies, D.R.
`
`
`
`1YQV
`The crystal structure of the antibody Fab
`HyHEL5 complex with lysozyme at 1.7A
`resolution
`Cohen, G.H., Silverton, E.W., Padlan, E.A.,
`Dyda, F., Wibbenmeyer, J.A., Wilson, R.C.,
`Davies, D.R.
`
`BIOEPIS EX. 1184
`Page 23
`
`
`
`Residues per chain
`Number of Atoms
`Non-polymer entities
`Source
`
`B: 213, A: 212, C: 129
`4227
`PCA
`Polymer 1: n/a, Polymer 2: n/a,
`Polymer 3: n/a
`X-RAY DIFFRACTION
`54.79 74.82 78.95
`90.00 101.82 90.00
`
`Exp. Method
`Unit cell
` Length [Å]: a b c
` Angle: alpha beta gamma
`Space Group
`P 2
`1
`Resolution
`n/a
`R-value
`n/a
`Deposited
`1987-08-17
`Released
`1987-10-16
`Obsoleted
`1995-07-31
`Replaced by
`3HFL
`Replaces
`
`Details
`n/a
`Note: Mouse over table elements for additional info
`
`B: 215, A: 212, C: 129
`4251
`PCA
`Polymer 1: n/a, Polymer 2: n/a, Polymer 3: n/a
`
`X-RAY DIFFRACTION
`54.79 74.82 78.95
`90.00 101.82 90.00
`
`P 2
`1
`2.65
`0.196 (obs.)
`1995-05-02
`1995-07-31
`2005-04-26
`1YQV
`2HFL
`n/a
`
`B: 215, A: 211, C: 129
`4273
`none
`Polymer 1: Mus musculus, Polymer 2: Mus
`musculus, Polymer 3: Gallus gallus
`X-RAY DIFFRACTION
`54.46 74.26 78.26
`90.00 101.65 90.00
`
`P 2
`1
`1.70
`0.195 (work)
`2005-02-02
`2005-04-26
`
`
`3HFL
`
`
`About
` About Us Citing Us Publications Team Careers Usage & Privacy
`Help Contact Us Help Topics Website FAQ Browser Test
` Glossary
`RCSB Partners Nucleic Acid Database Structural Biology Knowledgebase
`
`RCSB PDB (citation) is managed by two members of the
`
`Research Collaboratory for Structural Bioinformatics:
`
`Rutgers and UCSD/SDSC
`
`RCSB PDB is a member of the
`
`
`
`The RCSB PDB is funded by a grant (DBI-1338415) from the National Science Foundation, the National Institutes of Health, and the US Department of Energy.
`
`BIOEPIS EX. 1184
`Page 24
`
`
`
`
`Exhibit B
`
`Exhibit B
`
`
`
`
`
`BIOEPIS EX. 1184
`
`Page 25
`
`BIOEPIS EX. 1184
`Page 25
`
`
`
`RCSB PDB
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`Advanced Search | Browse by Annotations
`
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`
`
`
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`
`
`
`
`
` Go
`
`
`
`THE THREE-DIMENSIONAL STRUCTURE OF ANTIBODIES
`
`Obsolete Structure Summary Page
`
`1FB4
`
`
`
`
`
` Display Files
` Download Files
` Share this Page
`
`
`
`1FB4 was obsoleted on 1989-07-12 and superseded by 2FB4
`
`Image of 1FB4
`
`1972-01-01
`
`2017-04-25
`
`Archive of Obsolete PDB Structures
`
`1FB4
`2FB4
`
`Note: Mouse over colored bars for date info, mouse over PDB IDs for file download or Structure Explorer link.
`
`Textual Comparison
`
`
`
`
`Title
`
`Authors
`Residues per chain
`Number of Atoms
`
`1FB4
`THE THREE-DIMENSIONAL
`STRUCTURE OF ANTIBODIES
`Marquart, M., Huber, R.
`B: 229, A: 216
`3317
`
`2FB4
`DIR PRIMAERSTRUKTUR DES KRISTALLISIERBAREN MONOKLONALEN IMMUNOGLOBULINS IGG1 KOL. II.
`AMINOSAEURESEQUENZ DER L-KETTE, LAMBDA-TYP, SUBGRUPPE I (GERMAN)
`Marquart, M., Huber, R.
`B: 229, A: 216
`3312
`
`BIOEPIS EX. 1184
`Page 26
`
`
`
`none
`Polymer 1: n/a, Polymer 2: n/a
`X-RAY DIFFRACTION
`78.30 138.90 40.00
`90.00 90.00 90.00
`
`Non-polymer entities
`Source
`Exp. Method
`Unit cell
` Length [Å]: a b c
` Angle: alpha beta gamma
`Space Group
`P 2 2 2
`1 1 1
`Resolution
`n/a
`R-value
`n/a
`Deposited
`1983-05-09
`Released
`1983-07-28
`Obsoleted
`1989-07-12
`Replaced by
`2FB4
`Replaces
`
`Details
`n/a
`Note: Mouse over table elements for additional info
`
`none
`Polymer 1: Homo sapiens, Polymer 2: Homo sapiens
`X-RAY DIFFRACTION
`78.30 138.90 40.00
`90.00 90.00 90.00
`
`P 2 2 2
`1 1 1
`1.90
`0.189 (work)
`1989-04-18
`1989-07-12
`
`
`1FB4
`
`
`About
` About Us Citing Us Publications Team Careers Usage & Privacy
`Help Contact Us Help Topics Website FAQ Browser Test
` Glossary
`RCSB Partners Nucleic Acid Database Structural Biology Knowledgebase
`
`RCSB PDB (citation) is managed by two members of the
`
`Research Collaboratory for Structural Bioinformatics:
`
`Rutgers and UCSD/SDSC
`
`RCSB PDB is a member of the
`
`
`
`The RCSB PDB is funded by a grant (DBI-1338415) from the National Science Foundation, the National Institutes of Health, and the US Department of Energy.
`
`BIOEPIS EX. 1184
`Page 27
`
`
`
`
`Exhibit C
`
`Exhibit C
`
`
`
`
`
`BIOEPIS EX. 1184
`
`Page 28
`
`BIOEPIS EX. 1184
`Page 28
`
`
`
`RCSB PDB
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`Advanced Search | Browse by Annotations
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` Go
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`
`
`PRELIMINARY REFINEMENT AND STRUCTURAL ANALYSIS OF THE FAB
`FRAGMENT FROM HUMAN IMMUNOGLOBULIN NEW AT 2.0 ANGSTROMS
`RESOLUTION
`
`Obsolete Structure Summary Page
`
`3FAB
`
`
`
`
`
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`
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`
`3FAB was obsoleted on 1994-01-31 and superseded by 7FAB
`
`Image of 3FAB
`
`1972-01-01
`
`2017-04-25
`
`Archive of Obsolete PDB Structures
`
`1FAB
`2FAB
`3FAB
`7FAB
`
`Note: Mouse over colored bars for date info, mouse over PDB IDs for file download or Structure Explorer link.
`
`
`Title
`
`1FAB
`PRELIMINARY REFINEMENT AND
`STRUCTURAL ANALYSIS OF THE FAB
`FRAGMENT FROM HUMAN
`IMMUNOGLOBULIN NEW AT 2.0
`
`Textual Comparison
`2FAB
`PRELIMINARY REFINEMENT AND
`STRUCTURAL ANALYSIS OF THE FAB
`FRAGMENT FROM HUMAN
`IMMUNOGLOBULIN NEW AT 2.0
`
`3FAB
`PRELIMINARY REFINEMENT AND
`STRUCTURAL ANALYSIS OF THE FAB
`FRAGMENT FROM HUMAN
`IMMUNOGLOBULIN NEW AT 2.0
`
`7FAB
`CRYSTAL STRUCTURE OF
`HUMAN IMMUNOGLOBULIN
`FRAGMENT FAB NEW
`REFINED AT 2.0
`
`
`
`BIOEPIS EX. 1184
`Page 29
`
`
`
`Authors
`
`Residues per chain
`Number of Atoms
`Non-polymer entities
`Source
`
`ANGSTROMS RESOLUTION
`Poljak, R.J., Amzel, L.M., Chen, B.L.,
`Phizackerley, R.P., Saul, F.
`B: 220, A: 208
`3187
`PCA
`Polymer 1: n/a, Polymer 2: n/a
`
`ANGSTROMS RESOLUTION
`Poljak, R.J., Amzel, L.M., Chen, B.L.,
`Phizackerley, R.P., Saul, F.
`B: 220, A: 208
`3184
`PCA
`Polymer 1: n/a, Polymer 2: n/a
`
`ANGSTROMS RESOLUTION
`Poljak, R.J., Amzel, L.M., Chen, B.L.,
`Phizackerley, R.P., Saul, F.
`B: 220, A: 208
`3189
`PCA
`Polymer 1: n/a,
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