`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`Celltrion, Inc.
`Petitioner,
`
`v.
`
`Genentech, Inc.
`Patent Owner
`
`Patent No. 6,407,213
`
`
`
`
`
`
`
`Inter Partes Review No. IPR2017-01374
`
`
`
`
`
`
`
`
`
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`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
`
`1008
`
`
`
`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.
`
`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):593–98 (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):501–06 (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. 48:7319–22 (December 15, 1988)
`
`2
`
`
`
`EXHIBIT
`NO.
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`DESCRIPTION
`
`1009
`
`1010
`
`1011
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`1012
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`1013
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`1014
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`1015
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`1016
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`Ball E.D., et al. Monoclonal antibodies to myeloid differentiation
`antigens: in vivo studies of three patients with acute myelogenous
`leukemia. Blood 62(6):1203–10 (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 1:965–72 (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):1581–88 (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. 1:1319–25(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. 25:1115–25 (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 small cell
`carcinoma of the lung cells. Clin. Can. Res. 1:425–34 (April 1995)
`
`Chen J., Ball, E.D., et al. Monocyte- and neutrophil-mediated lysis of
`SCCL by a bispecific molecule comprised of Lys3-BN and mAb22.
`
`3
`
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`Peptides 1994. 819–20(1995)
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
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`1024
`
`1025
`
`1026
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`1027
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`
`
`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, 935–36
`(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 of5-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):1165–72 (March 1989)
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`Kohler and Milstein, Continuous Cultures of Fused Cells Secreting
`Antibody of Predefined Specificity. Nature 256(5517):495–97 (August
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`Prabakaran, S. The Quest for a Magic Bullet Science, 349(6246):389
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`Marks, L. The story of Cesar Milstein and Monoclonal Antibodies: A
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`Cosimi et al., Treatment of Acute Renal Allograft Rejection with
`OKT3 Monoclonal Antibody. Transplantation 32:535–39 (1981)
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`Trial of OKT3 Monoclonal Antibody for Acute Rejection of Cadveric
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`Jaffers et al. Monoclonal Antibody Therapy. Anti-idiotypic and Non-
`anti-idiotypic antibodies to OKT3 Arising Despite Intense
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`4
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`EXHIBIT
`NO.
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`1028
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`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
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`1036
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`1037
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`1038
`
`
`
`DESCRIPTION
`Immunosuppression. Transplantation 41(5):572–78 (1986)
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`Sears et al. Phase-I clinical trial of monoclonal antibody in treatment
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`Morrison et al., Chimeric Human Antibody Molecules: Mouse
`Antigen-Binding Domains with Human Constant Region Domains.
`Pro. Nat’l Acad. Sci. 81:6851–55 (November 1984).
`
`Liu et al., Chimeric Mouse-human IgG1 Antibody that can Mediate
`Lysis of Cancer cells. Pro. Nat’l Acad. Sci. 84:3439–43 (May 1987).
`
`Jones et al. Replacing the Complementarity-Determining Regions in a
`Human Antibody with those from a Mouse. Nature 321:522–25 (1986)
`
`Queen et al. A Humanized Antibody that Binds to the Interleukin 2
`Receptor. Pro. Nat’l Acad. Sci. 86:10029–33 (1989)
`
`Kirkman et al., Early Experience with anti-Tac in Clinical Renal
`Transplantation. Transplant. Proc. 21:1766–68 (1989)
`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 72:1705–16 (1988)
`
`Hakimi et al. Reduced Immunogenicity and Improved
`Pharmacokinetics of Humanized anti-Tac in Cynomolgus Monkeys. J.
`Immunol. 147:1352–59 (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):161–65 (January 15, 1998)
`
`5
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`
`
`EXHIBIT
`NO.
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`
`
`DESCRIPTION
`SEER Stat Fact Sheets: Breast Cancer at
`http://seer.cancer.gov/statfacts/html/breast.html (last accessed
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`Harris, J.R., et al. Medical Progress: Breast Cancer. N. Engl. J. Med.
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`229:974–76 (1985)
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`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)
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`to EGF receptor shares chromosomal location with neu oncogene.
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`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
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`Slamon, D.J. et al. Human Breast Cancer Correlation of Relapse and
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`proto-oncogene erbB-2 in human mammary tumor cell lines by
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`factor receptor p185HER2 causes transformation and tumorigenesis
`of NIH 3T3 cells. Pro. Nat’l Acad. Sci. 84:7159–63 (1987)
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`Shepard, H. M. et al. Monoclonal Antibody Therapy of Human
`Cancer: Taking the HER2 Protooncogene to the clinic. Journal of
`Clinical Immunology, 11(3):117–27 (1991).
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`6
`
`
`
`EXHIBIT
`NO.
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`DESCRIPTION
`
`1049
`
`1050
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`1051
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`1052
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`1053
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`1054
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`1055
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`Queen, Cary L.: International Publication No. WO 1990/07861
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`Tramontano, A. et al. Framework Residue 71 is a Major Determinant
`of the Position and Conformation of the Second Hypervariable
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`of Precursors, V-Regions, C-Regions, J-Chain, T-Cell Receptor for
`Antigen, T-Cell Surface Antigens (National Institutes of Health,
`Bethesda, Md.) (1987)
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`Wu and Kabat, An analysis of the sequences of the variable regions of
`Bence Jones proteins and myeloma light chains and their implications
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`of Precursors, V-Regions, C-Regions, J-Chain, T-Cell Receptor for
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`7
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`1059
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`1060
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`1061
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`1062
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`Lascombe et al. Three-dimensional Structure of Fab R19.9, a
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`9:266–71 (March 1991)
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`receptor and binds human immunodeficiency virus, Proc. Nat’l. Acad.
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`DESCRIPTION
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`1119
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`1120
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`1121
`
`1122
`
`1123
`
`
`
`Mian, I.S. Structure, function and properties of antibody binding
`sites, J. Mol. Biol. 217:133–51 (1991)
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`Poljak et al. The three-dimensional structure of the fab fragment of a
`human myeloma immunoglobulin at 2.0-angstrom resolution, Proc.
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`Padlan et al. Model building studies of antigen binding sites: The
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`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-A 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 HumanizedB3 Antibody Fragments, Fusion
`Proteins, and Uses Thereof (humanization of monoclonal antibodies
`to Lewis -related carbohydrate antigen) (Filed October 28, 1994)
`
`13
`
`
`
`EXHIBIT
`NO.
`
`(Issued March 30, 1999)
`
`DESCRIPTION
`
`1124
`
`1125
`
`1126
`
`1127
`
`1128
`
`1129
`
`1130
`
`1131
`
`1132
`
`1133
`
`1134
`
`
`
`US Patent No. 5,795,965 Reshaped human antibody to human
`interleukin-6 receptor (claiming priority to April 25, 1991) (Issued
`August 18, 1998)
`
`Furey et al. Structure of a novel Bence-Jones protein (Rhe) fragment
`at 1.6 A 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 a(1-6) dextran increases its affinity for antigen, J.
`Exp. Med. 168:1099–109 (1988)
`
`Hale, G. et al. Remission Induction in Non-Hodgkin Lymphoma
`with Reshaped Human Monoclonal Antibody Campath-1H,
`Lancet, Vol. 2, 1394-1399 (1988).
`
`Declaration of Matthew Miner, PH.D.
`
`“Protein Data Bank - Chronology” at
`https://www.nsf.gov/news_summ_jsp?cntn_id=100689 (accessed
`
`14
`
`
`
`EXHIBIT
`NO.
`
`December 28, 2017)
`
`DESCRIPTION
`
`1135
`
`1136
`
`1137
`
`1138
`
`1139
`
`1140
`
`1141
`
`1142
`
`1143
`
`1144
`
`1145
`
`1146
`to
`
`
`
`SEER Stat Fact Sheets: Breast Cancer, as archived at
`https://web.archive.org/web/20150907161940/http://seer.cancer.gov/s
`tatfacts/html/breast.html (accessed December 28, 2017)
`
`History of Microsoft Excel 1978-2013
`http://www.exceltrick.com/others/history-of-excel/ (accessed
`December 28, 2017)
`
`Declaration of Robert V. Cerwinski in Support of Motion for Pro Hac
`Vice Admission
`
`Deposition Transcript of Ian A. Wilson (Apr. 21, 2018)
`
`Deposition Transcript of John Barney Ridgway Brady (Apr. 27, 2018)
`PROTECTIVE ORDER MATERIAL
`
`Deposition Transcript of Paul J. Carter (Apr. 27, 2018)
`PROTECTIVE ORDER MATERIAL
`
`Deposition Transcript of Irene Loeffler (May 1, 2018)
`PROTECTIVE ORDER MATERIAL
`
`Deposition Transcript of Leonard George Presta (May 1, 2018)
`PROTECTIVE ORDER MATERIAL
`
`Second Declaration of Dr. Lutz Riechmann, Ph.D. PROTECTIVE
`ORDER MATERIAL
`
`U.S. Patent 5,821,337
`
`Pauling, The Nature of Chemical Bond and the Structure of Molecules
`and Crystals: An Introduction to Modern Structure Chemistry,
`Cornell University Press (3rd Ed. 1960).
`
`Intentionally Omitted
`
`15
`
`
`
`EXHIBIT
`NO.
`1192
`
`1193
`
`1194
`
`1195
`
`1196
`
`
`
`DESCRIPTION
`
`Foote, Humanized Antibodies, 61 Nova Acta Leopoldine, 269, 103-
`110 (1989) [Carter Deposition Ex. 1193].
`
`Kolbinger et al., Humanization of a Mouse Anti-Human IgE
`Antibody: A Potential Therapeutic for IgE-Mediated Allergies, 6
`Protein Engineering, 8, 971-980 (1993) [Wilson Deposition Ex.
`1194].
`
`David J. King, Applications and Engineering of Monoclonal
`Antibodies (1998) [Wilson Deposition Ex. 1195].
`
`Presta, Humanized Monoclonal Antibodies, 29 Annual Reports in
`Medicinal Chemistry, 32, 317-324 (1994) [Presta Deposition Ex.
`1196].
`
`
`
`
`
`16
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on May 25,
`
`2018, I caused copies of the foregoing PETITIONER’S UPDATED EXHIBIT
`
`LIST to be served via email on the following counsel for Patent Owners:
`
`David Cavanaugh (David.Cavanaugh@wilmerhale.com)
`
`Lauren V. Blakely (Laurren.Blakely@wilmerhale.com)
`
`Adam Brausa (abrausa@durietangri.com)
`
`Robert Gunther (Robert.Gunther@wilmerhale.com)
`
`Daralyn Durie (ddurie@durietangri.com)
`
`Lisa Pirozzolo (Lisa.Pirozzolo@wilmerhale.com)
`
`Kevin Prussia (Kevin.Prussia@wilmerhale.com)
`
`
`
`Andrew Danford (Andrew.Danford@wilmerhale.com)
`
`
`/Cynthia Lambert Hardman/
`Cynthia Lambert Hardman
`(Reg. No. 53,179)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`(212) 813-8800 (telephone)
`(212) 355-3333 (facsimile)
`
`
`
`
`
`
`
`
`
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