`
`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
`
`
`
`
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`
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`
`
`DECLARATION OF CHRISTOPHER LOWDEN
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`
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`1
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`PFIZER EX. 1188
`Page 1
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`I, Christopher Lowden, declare under penalty of perjury as follows:
`
`I.
`
`INTRODUCTION
`1.
`
`I am an Electronic Services Librarian at Kirkland & Ellis LLP.
`
`2.
`
`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.
`
`II. QUALIFICATIONS
`3.
`I obtained a Masters in Library Science from the University of
`
`Pittsburgh in 1994. In connection with that degree, I took three courses in
`
`cataloging: a general cataloging course, and advanced courses in bibliographic
`
`description and subject analysis.
`
`4.
`
`From 1995 to 1998, I worked as a cataloger at New York University
`
`Library. As part of my job duties at New York University, I created and
`
`maintained bibliographic records for books and electronic resources at the library.
`
`From 1998 to 2001, I was a research analyst for Goodrich & Sherwood. From 2002
`
`to 2005, I worked as a research librarian at Wachtell, Lipton, Rosen & Katz,
`
`performing research for attorneys. From 2005 to 2012, I worked as a research
`
`librarian at Dewey & Leboeuf, performing research for attorneys.
`
`
`
`2
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`PFIZER EX. 1188
`Page 2
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`5.
`
`From 2012 to today, I have been an Electronic Services Librarian at
`
`Kirkland & Ellis LLP, and I am currently employed by Kirkland & Ellis LLP. I
`
`manage the firm's commercial database and news subscriptions, and am personally
`
`involved in maintaining the catalog for the Kirkland & Ellis LLP library.
`
`6.
`
`Through my education and experience described above, I have
`
`interacted with and become personally familiar with the Library of Congress and
`
`its cataloging records. The Library of Congress is a research library for the United
`
`States Congress. Based on my knowledge and experience, it is the national library
`
`of the United States and the most authoritative resource in the United States for
`
`library cataloging records. I have used and am familiar with the Library of
`
`Congress's online catalog, including through performing searches on the online
`
`catalog to find information about the availability of books and other references.
`
`The Library of Congress also maintains the United States Copyright Office
`
`catalog, which records the registration of copyrighted material.
`
`III. EXHIBITS
`7.
`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). Exhibit 1141 is a true and correct copy of the
`
`Library of Congress Copyright Record for Transplantation, a record which I
`
`obtained
`
`from
`
`the Library of Congress online
`
`catalog
`
`located
`
`at
`
`
`
`3
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`PFIZER EX. 1188
`Page 3
`
`
`
`
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`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
`
`Volume 32, Number 6 is December 7, 1981.
`
`8.
`
`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 Cadveric Renal Transplants, 313(6) NEW ENG. J.
`
`MED. 337–42 (1985). Exhibit 1142 is a true and correct copy of the Library of
`
`Congress Copyright Record for The New England Journal of Medicine, a record
`
`which I obtained from the Library of Congress online catalog located at
`
`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
`
`Volume 313, Number 6 is August 8, 1985.
`
`9.
`
`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). Exhibit 1143 is a true and correct copy of the Library of Congress
`
`Copyright Record for Transplantation, a record which I obtained from the Library
`
`of Congress online catalog located at http://catalog.loc.gov on March 12, 2017. In
`
`that record, the publication date of Volume 41, Number 5 is May 16, 1986.
`
`10. 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).
`
`
`
`4
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`PFIZER EX. 1188
`Page 4
`
`
`
`
`
`Exhibit 1144 is a true and correct copy of the Library of Congress Copyright
`
`Record for The Proceedings of the National Academy of Sciences of the U.S.A., a
`
`record which I obtained from the Library of Congress online catalog located at
`
`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
`
`Volume 81, Number 21 is November 13, 1984.
`
`11. Exhibit 1032 is a true and correct copy of Liu et al., Liu et al.,
`
`Chimeric Mouse-Human Igg1 Antibody That Can Mediate Lysis of Cancer Cells,
`
`84(10) PROC. NAT’L ACAD. SCI. USA 3439– 43 (1987). Exhibit 1145 is a true and
`
`correct copy of the Library of Congress Copyright Record for The Proceedings of
`
`the National Academy of Sciences of the U.S.A., a record which I obtained from
`
`the Library of Congress online catalog located at http://catalog.loc.gov on March
`
`12, 2017. In that record, the publication date of Volume 84, Number 10 is May 15,
`
`1987.
`
`12. 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). Exhibit 1146 is a true and correct copy
`
`of the Library of Congress Copyright Record for Nature, a record which I obtained
`
`from the Library of Congress online catalog located at http://catalog.loc.gov on
`
`March 12, 2017. In that record, the publication date of Volume 321, Number 6069
`
`is May 29, 1986.
`
`
`
`5
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`PFIZER EX. 1188
`Page 5
`
`
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`
`
`13. 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). Exhibit 1147 is a true and correct copy of the Library of
`
`Congress Copyright Record for The Proceedings of the National Academy of
`
`Sciences of the U.S.A., a record which I obtained from the Library of Congress
`
`online catalog located at http://catalog.loc.gov on March 12, 2017. In that record,
`
`the publication date of Volume 86, Number 24 is December 20, 1989.
`
`14. 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). Exhibit 1148 is a true and correct copy
`
`of the Library of Congress Copyright Record for Transplantation Proceedings, a
`
`record which I obtained from the Library of Congress online catalog located at
`
`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
`
`Volume 21, Number 1 is March 10, 1989.
`
`15. 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-
`
`Cell Lymphotrophic Virus I-Induced Adult T-Cell Leukemia, 82(6) BLOOD 1701–
`
`12 (1993). Exhibit 1149 is a true and correct copy of the Library of Congress
`
`Copyright Record for Blood, a record which I obtained from the Library of
`
`
`
`6
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`PFIZER EX. 1188
`Page 6
`
`
`
`
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`Congress online catalog located at http://catalog.loc.gov on April 13, 2017. In that
`
`record, the publication date of Volume 82, Number 6 is September 15, 1993.
`
`16. 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). Exhibit 1150 is a
`
`true and correct copy of the Library of Congress Copyright Record for The Journal
`
`of Immunology, a record which I obtained from the Library of Congress online
`
`catalog located at http://catalog.loc.gov on March 12, 2017. In that record, the
`
`publication date of Volume 147, Number 4 is August 14, 1991.
`
`17. 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). Exhibit 1151 is a true
`
`and correct copy of the Library of Congress Copyright Record for The New
`
`England Journal of Medicine, a record which I obtained from the Library of
`
`Congress online catalog located at http://catalog.loc.gov on March 12, 2017. In that
`
`record, the publication date of Volume 338, Number 3 is January 15, 1998.
`
`18. 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). Exhibit 1152
`
`is a true and correct copy of the Library of Congress Copyright Record for The
`
`New England Journal of Medicine, a record which I obtained from the Library of
`
`
`
`7
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`PFIZER EX. 1188
`Page 7
`
`
`
`
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`Congress online catalog located at http://catalog.loc.gov on March 12, 2017. In that
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`record, the publication date of Volume 327, Number 5 is July 30, 1992.
`
`19. 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). Exhibit 1153 is a true and correct copy of the Library of
`
`Congress Copyright Record for Science, a record which I obtained from the
`
`Library of Congress online catalog located at http://catalog.loc.gov on March 12,
`
`2017. In that record, the publication date of Volume 229, Number 4717 is August
`
`29, 1985.
`
`20. 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). Exhibit
`
`1154 is a true and correct copy of the Library of Congress Copyright Record for
`
`The Proceedings of the National Academy of Sciences of the U.S.A., a record
`
`which I obtained from the Library of Congress online catalog located at
`
`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
`
`Volume 82, Number 19 is September 30, 1985.
`
`21. Exhibit 1043 is a true and correct copy of Coussens et al., Tyrosine
`
`Kinase Receptor with Extensive Homology to EGF Receptor Shares Chromosomal
`
`
`
`8
`
`PFIZER EX. 1188
`Page 8
`
`
`
`
`
`Location with neu Oncogene, 230(4730) SCIENCE 1132–39 (1985). Exhibit 1155 is
`
`a true and correct copy of the Library of Congress Copyright Record for Science, a
`
`record which I obtained from the Library of Congress online catalog located at
`
`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
`
`Volume 230, Number 4730 is November 29, 1985.
`
`22. 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). Exhibit 1156 is a true
`
`and correct copy of the Library of Congress Copyright Record for Science, a
`
`record which I obtained from the Library of Congress online catalog located at
`
`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
`
`Volume 235, Number 4785 is January 8, 1987.
`
`23. Exhibit 1047 is a true and correct copy of Hudziak et al., Increased
`
`Expression of
`
`the Putative Growth Factor Receptor p185HER2 Causes
`
`Transformation and Tumorigenesis of NIH 3T3 cells. 84(20) PROC. NAT’L ACAD.
`
`SCI. USA 7159– 163 (1987). Exhibit 1157 is a true and correct copy of the Library
`
`of Congress Copyright Record for The Proceedings of the National Academy of
`
`Sciences of the U.S.A., a record which I obtained from the Library of Congress
`
`online catalog located at http://catalog.loc.gov on March 12, 2017. In that record,
`
`the publication date of Volume 84, Number 20 is October 15, 1987.
`
`
`
`9
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`PFIZER EX. 1188
`Page 9
`
`
`
`
`
`24. Exhibit 1049 is a true and correct copy of Chothia et al.,
`
`Conformations of Immunoglobulin Hypervariable Regions, 342(21) NATURE 877–
`
`83 (1989). Exhibit 1158 is a true and correct copy of the Library of Congress
`
`Copyright Record for Nature, a record which I obtained from the Library of
`
`Congress online catalog located at http://catalog.loc.gov on March 12, 2017. In that
`
`record, the publication date of Volume 342, Number 21 is December 14, 1989.
`
`25. Exhibit 1058 is a true and correct copy of Davies & Metzger,
`
`Structural Basics of Antibody Function, 1 ANN. REV. IMMUNOLOGY. 87–117
`
`(1983). Exhibit 1159 is a true and correct copy of the Library of Congress
`
`Copyright Record for the Annual Review of Immunology, a record which I
`
`obtained
`
`from
`
`the Library of Congress online
`
`catalog
`
`located
`
`at
`
`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
`
`Volume 1 is April 15, 1983.
`
`26. Exhibit 1059 is a true and correct copy of Amit et al., Three-
`
`Dimensional Structure of an Antigen-Antibody Complex at 2.8 Å Resolution,
`
`233(4765) SCIENCE 747–53 (1986). Exhibit 1160 is a true and correct copy of the
`
`Library of Congress Copyright Record for Science, a record which I obtained from
`
`the Library of Congress online catalog located at http://catalog.loc.gov on March
`
`12, 2017. In that record, the publication date of Volume 233, Number 4765 is
`
`August 7, 1986.
`
`
`
`10
`
`PFIZER EX. 1188
`Page 10
`
`
`
`
`
`27. 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). Exhibit 1163 is a true and correct copy of the Library of Congress
`
`Copyright Record for Science, a record which I obtained from the Library of
`
`Congress online catalog located at http://catalog.loc.gov on March 12, 2017. In that
`
`record, the publication date of Volume 239, Number 4847 is March 24, 1988.
`
`28. Exhibit 1069 is a true and correct copy of Riechmann et al.,
`
`Reshaping Human Antibodies for Therapy, 332(6162) NATURE 323–27 (1988).
`
`Exhibit 1164 is a true and correct copy of the Library of Congress Copyright
`
`Record for Nature, a record which I obtained from the Library of Congress online
`
`catalog located at http://catalog.loc.gov on March 12, 2017. In that record, the
`
`publication date of Volume 332, Number 6162 is March 24, 1988.
`
`29. 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). Exhibit 1167 is a true and correct copy of the
`
`Library of Congress Copyright Record for The Proceedings of the National
`
`Academy of Sciences of the U.S.A., a record which I obtained from the Library of
`
`Congress online catalog located at http://catalog.loc.gov on March 12, 2017. In that
`
`record, the publication date of Volume 84, Number 22 is November 17, 1987.
`
`
`
`11
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`PFIZER EX. 1188
`Page 11
`
`
`
`
`
`30. 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). Exhibit 1168 is a true and correct copy of the Library of Congress
`
`Copyright Record for The Journal of Biological Chemistry, a record which I
`
`obtained
`
`from
`
`the Library of Congress online
`
`catalog
`
`located
`
`at
`
`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
`
`Volume 253, Number 2 is January 27, 1978.
`
`31. 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). Exhibit 1170 is a
`
`true and correct copy of the Library of Congress Copyright Record for The
`
`Proceedings of the National Academy of Sciences of the U.S.A., a record which I
`
`obtained
`
`from
`
`the Library of Congress online
`
`catalog
`
`located
`
`at
`
`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
`
`Volume 86, Number 15 is August 1, 1989.
`
`32. 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(6111) NATURE 358 (1987). Exhibit 1171 is a true and correct
`
`copy of the Library of Congress Copyright Record for Nature, a record which I
`
`
`
`12
`
`PFIZER EX. 1188
`Page 12
`
`
`
`
`
`obtained
`
`from
`
`the Library of Congress online
`
`catalog
`
`located
`
`at
`
`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
`
`Volume 326, Number 6111 is April 1, 1987.
`
`33. 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). Exhibit 1172 is a true and correct copy of the Library of Congress
`
`Copyright Record for The Proceedings of the National Academy of Sciences of the
`
`U.S.A., a record which I obtained from the Library of Congress online catalog
`
`located at http://catalog.loc.gov on March 12, 2017. In that record, the publication
`
`date of Volume 81, Number 1 is January 20, 1984.
`
`34. 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(11) PROC. NAT’L. ACAD. SCI. USA 3891–95 (1987).
`
`Exhibit 1173 is a true and correct copy of the Library of Congress Copyright
`
`Record for The Proceedings of the National Academy of Sciences of the U.S.A., a
`
`record which I obtained from the Library of Congress online catalog located at
`
`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
`
`Volume 84, Number 11 is June 2, 1987.
`
`
`
`13
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`PFIZER EX. 1188
`Page 13
`
`
`
`
`
`35. 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). Exhibit 1174 is a true and correct
`
`copy of the Library of Congress Copyright Record for Cancer Research, a record
`
`which I obtained from the Library of Congress online catalog located at
`
`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
`
`Volume 45, Number 2 is January 29, 1985.
`
`36. 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). Exhibit 1178 is a true and correct copy of
`
`the Library of Congress Copyright Record for Proteins, a record which I obtained
`
`from the Library of Congress online catalog located at http://catalog.loc.gov on
`
`March 12, 2017. In that record, the publication date of Volume 1, Number 1 is
`
`August 28, 1986.
`
`37. 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). Exhibit 1179 is a true and correct copy of
`
`the Library of Congress Copyright Record for the Methods in Enzymology, a
`
`record which I obtained from the Library of Congress online catalog located at
`
`
`
`14
`
`PFIZER EX. 1188
`Page 14
`
`
`
`
`
`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
`
`Volume 115 is November 8, 1985.
`
`38. 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). Exhibit 1180 is a true and correct copy of the Library of Congress
`
`Copyright Record for The Proceedings of the National Academy of Sciences of the
`
`U.S.A., a record which I obtained from the Library of Congress online catalog
`
`located at http://catalog.loc.gov on March 12, 2017. In that record, the publication
`
`date of Volume 88, Number 7 is April 1, 1991.
`
`39. 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).
`
`Exhibit 1181 is a true and correct copy of the Library of Congress Copyright
`
`Record for Journal of Experimental Medicine, a record which I obtained from the
`
`Library of Congress online catalog located at http://catalog.loc.gov on March 12,
`
`2017. In that record, the publication date of Volume 168, Number 3 is October 6,
`
`1988.
`
`40. 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). Exhibit
`
`1186 is a true and correct copy of the Library of Congress Copyright Record for
`
`
`
`15
`
`PFIZER EX. 1188
`Page 15
`
`
`
`Journal of National Cancer Institute, a record which I obtained from the Library of
`
`Congress online catalog located at http://catalog.loc.gov on April 27, 2017. In that
`
`record, the publication date of Volume 90, Number 1 is January 5, 1998.
`
`IV. CONCLUSION
`
`41.
`
`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
`
`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 23, 2017, in New York, New York.
`
`
`
`
`
`Christopher Lowden
`
`16
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`PFIZER EX. 1188
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`Page 16
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`PFIZER EX. 1188
`Page 16
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`
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