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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`In the Inter Partes Review of:
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`Trial Number: To Be Assigned
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`U.S. Patent No. 6,407,213
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`Filed: November 17, 1993
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`Issued: June 18, 2002
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`Inventor(s): Paul J. Carter, Leonard G. Presta
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`Assignee: Genentech, Inc.
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`Title: Method for making humanized antibodies Panel: To Be Assigned
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`Mail Stop Inter Partes Review
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`DECLARATION OF CHRISTOPHER LOWDEN
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`1
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`BIOEPIS EX. 1188
`Page 1
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`I, Christopher Lowden, declare under penalty of perjury as follows:
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`I.
`
`INTRODUCTION
`1.
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`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
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`Trademark Office. I make this declaration of my own personal knowledge.
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`II. QUALIFICATIONS
`3.
`I obtained a Masters in Library Science from the University of
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`Pittsburgh in 1994. In connection with that degree, I took three courses in
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`cataloging: a general cataloging course, and advanced courses in bibliographic
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`description and subject analysis.
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`4.
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`From 1995 to 1998, I worked as a cataloger at New York University
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`Library. As part of my job duties at New York University, I created and
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`maintained bibliographic records for books and electronic resources at the library.
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`From 1998 to 2001, I was a research analyst for Goodrich & Sherwood. From 2002
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`to 2005, I worked as a research librarian at Wachtell, Lipton, Rosen & Katz,
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`performing research for attorneys. From 2005 to 2012, I worked as a research
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`librarian at Dewey & Leboeuf, performing research for attorneys.
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`2
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`BIOEPIS EX. 1188
`Page 2
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`5.
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`From 2012 to today, I have been an Electronic Services Librarian at
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`Kirkland & Ellis LLP, and I am currently employed by Kirkland & Ellis LLP. I
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`manage the firm's commercial database and news subscriptions, and am personally
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`involved in maintaining the catalog for the Kirkland & Ellis LLP library.
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`6.
`
`Through my education and experience described above, I have
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`interacted with and become personally familiar with the Library of Congress and
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`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
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`of the United States and the most authoritative resource in the United States for
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`library cataloging records. I have used and am familiar with the Library of
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`Congress's online catalog, including through performing searches on the online
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`catalog to find information about the availability of books and other references.
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`The Library of Congress also maintains the United States Copyright Office
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`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
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`Acute Renal Allograft Rejection with OKT3 Monoclonal Antibody, 32(6)
`
`TRANSPLANTATION 535−39 (1981). Exhibit 1141 is a true and correct copy of the
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`Library of Congress Copyright Record for Transplantation, a record which I
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`obtained
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`from
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`the Library of Congress online
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`catalog
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`located
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`at
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`3
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`BIOEPIS EX. 1188
`Page 3
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`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
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`Volume 32, Number 6 is December 7, 1981.
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`8.
`
`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 Cadveric Renal Transplants, 313(6) NEW ENG. J.
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`MED. 337–42 (1985). Exhibit 1142 is a true and correct copy of the Library of
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`Congress Copyright Record for The New England Journal of Medicine, a record
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`which I obtained from the Library of Congress online catalog located at
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`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
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`Volume 313, Number 6 is August 8, 1985.
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`9.
`
`Exhibit 1027 is a true and correct copy of Jaffers et al., Monoclonal
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`Antibody Therapy: Anti-Idiotypic and Non-Anti-Idiotypic Antibodies to OKT3
`
`Arising Despite Intense Immunosuppression, 41(5) TRANSPLANTATION 572–78
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`(1986). Exhibit 1143 is a true and correct copy of the Library of Congress
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`Copyright Record for Transplantation, a record which I obtained from the Library
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`of Congress online catalog located at http://catalog.loc.gov on March 12, 2017. In
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`that record, the publication date of Volume 41, Number 5 is May 16, 1986.
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`10. Exhibit 1031 is a true and correct copy of Morrison et al., Chimeric
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`Human Antibody Molecules: Mouse Antigen-Binding Domains with Human
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`Constant Region Domains, 81(21) PROC. NAT’L ACAD. SCI. USA 6851–55 (1984).
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`4
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`BIOEPIS EX. 1188
`Page 4
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`Exhibit 1144 is a true and correct copy of the Library of Congress Copyright
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`Record for The Proceedings of the National Academy of Sciences of the U.S.A., a
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`record which I obtained from the Library of Congress online catalog located at
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`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
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`Volume 81, Number 21 is November 13, 1984.
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`11. Exhibit 1032 is a true and correct copy of Liu et al., Liu et al.,
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`Chimeric Mouse-Human Igg1 Antibody That Can Mediate Lysis of Cancer Cells,
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`84(10) PROC. NAT’L ACAD. SCI. USA 3439– 43 (1987). Exhibit 1145 is a true and
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`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
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`the Library of Congress online catalog located at http://catalog.loc.gov on March
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`12, 2017. In that record, the publication date of Volume 84, Number 10 is May 15,
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`1987.
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`12. Exhibit 1033 is a true and correct copy of Jones et al., Replacing The
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`Complementarity-Determining Regions In a Human Antibody with Those From a
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`Mouse, 321(6069) NATURE 522– 25 (1986). Exhibit 1146 is a true and correct copy
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`of the Library of Congress Copyright Record for Nature, a record which I obtained
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`from the Library of Congress online catalog located at http://catalog.loc.gov on
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`March 12, 2017. In that record, the publication date of Volume 321, Number 6069
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`is May 29, 1986.
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`5
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`BIOEPIS EX. 1188
`Page 5
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`13. Exhibit 1034 is a true and correct copy of Queen et al., A Humanized
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`Antibody that Binds to The Interleukin 2 Receptor, 86(24) PROC. NAT’L ACAD. SCI.
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`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,
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`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
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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). Exhibit 1148 is a true and correct copy
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`of the Library of Congress Copyright Record for Transplantation Proceedings, a
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`record which I obtained from the Library of Congress online catalog located at
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`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
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`Volume 21, Number 1 is March 10, 1989.
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`15. Exhibit 1036 is a true and correct copy of Waldmann et al., The
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`Interleukin-2 Receptor: A Target for Monoclonal Antibody Treatment of Human T-
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`Cell Lymphotrophic Virus I-Induced Adult T-Cell Leukemia, 82(6) BLOOD 1701–
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`12 (1993). Exhibit 1149 is a true and correct copy of the Library of Congress
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`Copyright Record for Blood, a record which I obtained from the Library of
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`6
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`BIOEPIS EX. 1188
`Page 6
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`Congress online catalog located at http://catalog.loc.gov on April 13, 2017. In that
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`record, the publication date of Volume 82, Number 6 is September 15, 1993.
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`16. Exhibit 1037 is a true and correct copy of Hakimi et al., Reduced
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`Immunogenicity and Improved Pharmacokinetics of Humanized ANTI-Tac in
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`Cynomolgus Monkeys, 147(4) J. IMMUNOLOGY 1352–59 (1991). Exhibit 1150 is a
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`true and correct copy of the Library of Congress Copyright Record for The Journal
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`of Immunology, a record which I obtained from the Library of Congress online
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`catalog located at http://catalog.loc.gov on March 12, 2017. In that record, the
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`publication date of Volume 147, Number 4 is August 14, 1991.
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`17. Exhibit 1038 is a true and correct copy of Vincenti et al., Interleukin
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`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
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`and correct copy of the Library of Congress Copyright Record for The New
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`England Journal of Medicine, a record which I obtained from the Library of
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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 338, Number 3 is January 15, 1998.
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`18. 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). Exhibit 1152
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`is a true and correct copy of the Library of Congress Copyright Record for The
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`New England Journal of Medicine, a record which I obtained from the Library of
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`7
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`BIOEPIS 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.
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`19. Exhibit 1041 is a true and correct copy of King et al., Amplification of
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`a Novel v-erbB-Related Gene in a Human Mammary Carcinoma, 229(4717)
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`SCIENCE 974–76 (1985). Exhibit 1153 is a true and correct copy of the Library of
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`Congress Copyright Record for Science, a record which I obtained from the
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`Library of Congress online catalog located at http://catalog.loc.gov on March 12,
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`2017. In that record, the publication date of Volume 229, Number 4717 is August
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`29, 1985.
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`20. Exhibit 1042 is a true and correct copy of Semba et al., A V-Erbb-
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`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). Exhibit
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`1154 is a true and correct copy of the Library of Congress Copyright Record for
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`The Proceedings of the National Academy of Sciences of the U.S.A., a record
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`which I obtained from the Library of Congress online catalog located at
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`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
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`Volume 82, Number 19 is September 30, 1985.
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`21. Exhibit 1043 is a true and correct copy of Coussens et al., Tyrosine
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`Kinase Receptor with Extensive Homology to EGF Receptor Shares Chromosomal
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`8
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`BIOEPIS EX. 1188
`Page 8
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`Location with neu Oncogene, 230(4730) SCIENCE 1132–39 (1985). Exhibit 1155 is
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`a true and correct copy of the Library of Congress Copyright Record for Science, a
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`record which I obtained from the Library of Congress online catalog located at
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`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
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`Volume 230, Number 4730 is November 29, 1985.
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`22. Exhibit 1045 is a true and correct copy of Slamon et al., Human
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`Breast Cancer: Correlation of Relapse and Survival with Amplification of the
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`HER-2/neu Oncogene, 235(4785) SCIENCE 177–82 (1987). Exhibit 1156 is a true
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`and correct copy of the Library of Congress Copyright Record for Science, a
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`record which I obtained from the Library of Congress online catalog located at
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`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
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`Volume 235, Number 4785 is January 8, 1987.
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`23. Exhibit 1047 is a true and correct copy of Hudziak et al., Increased
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`Expression of
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`the Putative Growth Factor Receptor p185HER2 Causes
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`Transformation and Tumorigenesis of NIH 3T3 cells. 84(20) PROC. NAT’L ACAD.
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`SCI. USA 7159– 163 (1987). Exhibit 1157 is a true and correct copy of the Library
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`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
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`online catalog located at http://catalog.loc.gov on March 12, 2017. In that record,
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`the publication date of Volume 84, Number 20 is October 15, 1987.
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`9
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`BIOEPIS EX. 1188
`Page 9
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`24. 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). Exhibit 1158 is a true and correct copy of the Library of Congress
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`Copyright Record for Nature, a record which I obtained from the Library of
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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 342, Number 21 is December 14, 1989.
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`25. 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). Exhibit 1159 is a true and correct copy of the Library of Congress
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`Copyright Record for the Annual Review of Immunology, a record which I
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`obtained
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`from
`
`the Library of Congress online
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`catalog
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`located
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`at
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`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
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`Volume 1 is April 15, 1983.
`
`26. 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 Å Resolution,
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`233(4765) SCIENCE 747–53 (1986). Exhibit 1160 is a true and correct copy of the
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`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
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`12, 2017. In that record, the publication date of Volume 233, Number 4765 is
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`August 7, 1986.
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`10
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`Page 10
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`27. Exhibit 1068 is a true and correct copy of Verhoeyen et al., Reshaping
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`Human Antibodies: Grafting an Antilysozyme Activity, 239(4847) SCIENCE 1534–
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`36 (1988). Exhibit 1163 is a true and correct copy of the Library of Congress
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`Copyright Record for Science, a record which I obtained from the Library of
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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 239, Number 4847 is March 24, 1988.
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`28. 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).
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`Exhibit 1164 is a true and correct copy of the Library of Congress Copyright
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`Record for Nature, a record which I obtained from the Library of Congress online
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`catalog located at http://catalog.loc.gov on March 12, 2017. In that record, the
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`publication date of Volume 332, Number 6162 is March 24, 1988.
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`29. Exhibit 1081 is a true and correct copy of Sheriff et al., Three-
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`Dimensional Structure of an Antibody-Antigen Complex, 84(22) PROC. NAT’L
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`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
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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 84, Number 22 is November 17, 1987.
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`
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`11
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`BIOEPIS EX. 1188
`Page 11
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`30. Exhibit 1083 is a true and correct copy of Saul et al., Preliminary
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`Refinement and Structural Analysis of
`
`the Fab Fragment
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`from Human
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`Immunoglobulin New at 2.0 Å Resolution*, 253(2) J. BIOLOGICAL CHEMISTRY 585–
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`95 (1978). Exhibit 1168 is a true and correct copy of the Library of Congress
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`Copyright Record for The Journal of Biological Chemistry, a record which I
`
`obtained
`
`from
`
`the Library of Congress online
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`catalog
`
`located
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`at
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`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
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`Volume 253, Number 2 is January 27, 1978.
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`31. Exhibit 1087 is a true and correct copy of Padlan et al., Structure of
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`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
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`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
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`catalog
`
`located
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`at
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`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
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`Volume 86, Number 15 is August 1, 1989.
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`32. Exhibit 1100 is a true and correct copy of Colman et al., Three-
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`Dimensional Structure of a Complex of Antibody with Influenza Virus
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`Neuraminidase, 326(6111) NATURE 358 (1987). Exhibit 1171 is a true and correct
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`copy of the Library of Congress Copyright Record for Nature, a record which I
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`12
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`BIOEPIS EX. 1188
`Page 12
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`
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`obtained
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`from
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`the Library of Congress online
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`catalog
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`located
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`at
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`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
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`Volume 326, Number 6111 is April 1, 1987.
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`33. Exhibit 1104 is a true and correct copy of Koprowski et al., Human
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`Anti-idiotype Antibodies in Cancer Patients: Is the Modulation of the Immune
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`Response Beneficial for the Patient?, 81(1) PROC. NAT’L. ACAD. SCI. USA 216–19
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`(1984). Exhibit 1172 is a true and correct copy of the Library of Congress
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`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
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`located at http://catalog.loc.gov on March 12, 2017. In that record, the publication
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`date of Volume 81, Number 1 is January 20, 1984.
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`34. Exhibit 1105 is a true and correct copy of Chanh et al., Monoclonal
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`Anti-idiotypic Antibody Mimics
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`the CD4 Receptor and Binds Human
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`Immunodeficiency Virus, 84(11) PROC. NAT’L. ACAD. SCI. USA 3891–95 (1987).
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`Exhibit 1173 is a true and correct copy of the Library of Congress Copyright
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`Record for The Proceedings of the National Academy of Sciences of the U.S.A., a
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`record which I obtained from the Library of Congress online catalog located at
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`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
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`Volume 84, Number 11 is June 2, 1987.
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`Page 13
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`35. Exhibit 1106 is a true and correct copy of Schroff et al., Human Anti-
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`Murine Immunoglobulin Responses in Patients Receiving Monoclonal Antibody
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`Therapy, 45(2) CANCER RES. 879–85 (1985). Exhibit 1174 is a true and correct
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`copy of the Library of Congress Copyright Record for Cancer Research, a record
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`which I obtained from the Library of Congress online catalog located at
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`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
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`Volume 45, Number 2 is January 29, 1985.
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`36. Exhibit 1121 is a true and correct copy of Suh et al., The Galactan-
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`Binding Immunoglobulin Fab J539: An X-Ray Diffraction Study at 2.6-Å
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`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
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`from the Library of Congress online catalog located at http://catalog.loc.gov on
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`March 12, 2017. In that record, the publication date of Volume 1, Number 1 is
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`August 28, 1986.
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`37. Exhibit 1127 is a true and correct copy of Jones, Diffraction Methods
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`for Biological Macromolecules. Interactive Computer Graphics: FRODO, 115
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`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
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`record which I obtained from the Library of Congress online catalog located at
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`
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`14
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`BIOEPIS EX. 1188
`Page 14
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`
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`http://catalog.loc.gov on March 12, 2017. In that record, the publication date of
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`Volume 115 is November 8, 1985.
`
`38. Exhibit 1128 is a true and correct copy of Co et al., Humanized
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`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
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`date of Volume 88, Number 7 is April 1, 1991.
`
`39. Exhibit 1131 is a true and correct copy of Wallick et al.,
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`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
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`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
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`Mousetrap, Use Human Parts, 90(1) J. NAT’L CANCER INST. 1416 (1998). Exhibit
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`1186 is a true and correct copy of the Library of Congress Copyright Record for
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`
`
`15
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`BIOEPIS EX. 1188
`Page 15
`
`
`
`Journal of National Cancer Institute, a record which I obtained from the Library of
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`Congress online catalog located at http://catalog.loc.gov on April 27, 2017. In that
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`record, the publication date of Volume 90, Number 1 is January 5, 1998.
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`IV. CONCLUSION
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`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
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`all statements made on information and belief are believed to be true; and further
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`that these statements were made with the knowledge that willful false statements
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`and the like so made are punishable by fine or imprisonment, or both, under
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`Section 1001 of the Title 18 of the United States Code.
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`Executed on May 23, 2017, in New York, New York.
`
`
`Christopher Lowden
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`BIOEPIS EX. 1188
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