IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In the Inter Partes Review of:
`
`Trial Number: To Be Assigned
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`U.S. Patent No. 7,892,549
`
`Filed: February 3, 2003
`
`Issued: February 22, 2011
`
`Inventor(s): Virginia E. Paton, Steven Shak,
`Susan D. Hellmann
`
`Assignee: Genentech, Inc.
`
`Title: Treatment with Anti-ErbB2 Antibodies
`
`Panel: To Be Assigned
`
`Mail Stop Inter Partes Review
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`DECLARATION OF CHRISTOPHER LOWDEN
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`1
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`HOSPIRA EX. 1112
`Page 1
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`
`
`In the Inter Partes Review of:
`
`Trial Number: To Be Assigned
`
`U.S. Patent No. 7,892,549
`
`Filed: February 3, 2003
`
`Issued: February 22, 2011
`
`Inventor(s): Virginia E. Paton, Steven Shak,
`Susan D. Hellmann
`
`Assignee: Genentech, Inc.
`
`Title: Treatment with Anti-ErbB2 Antibodies
`
`Panel: To Be Assigned
`
`Mail Stop Inter Partes Review
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`DECLARATION OF CHRISTOPHER LOWDEN
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`1
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`HOSPIRA EX. 1112
`Page 1
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`
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`I, Christopher Lowden, declare under penalty of perjury as follows:
`
`I.
`
`INTRODUCTION
`
`1.
`
`2.
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`I am an Electronic Services Librarian at Kirkland & Ellis LLP.
`
`I make this declaration in support of the petition for inter partes
`
`review of U.S. Patent No. 7,892,549 before the United States Patent and
`
`Trademark Office. I make this declaration of my own personal knowledge.
`
`II. QUALIFICATIONS
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`3.
`
`I obtained a Masters m Library Science from the University of
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`Pittsburgh m 1994. In connection with that degree, I took three courses m
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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.
`
`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
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`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
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`librarian at Dewey & Leboeuf, performing research for attorneys.
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`1
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`HOSPIRA EX. 1112
`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
`
`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.
`
`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
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`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
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`Congress's online catalog, including through performing searches on the online
`
`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 1105 is a true and correct copy of Baselga et al., Phase II
`
`Study of Weekly Intravenous Recombinant Humanized Anti-p185HER2 Monoclonal
`
`Antibody in Patients with HER2/neu-Overexpressing Metastatic Breast Cancer,
`
`14(3) J. CLIN. ONCOL. 737-44 (1996). Exhibit 1055 is a true and correct copy of
`
`the Library of Congress Copyright Record for the Journal of Clinical Oncology, a
`
`2
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`HOSPIRA EX. 1112
`Page 3
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`
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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 November 28, 2016. In that record, the publication date of
`
`Volume 14, Number 3 is February 28, 1996.
`
`8.
`
`Exhibit 1107 is a true and correct copy of Baselga et al., HER2
`
`Overexpression and Paclitaxel Sensitivity
`
`in Breast Cancer: Therapeutic
`
`Implications, 11(3) (Suppl. 2) ONCOLOGY 43--48 (1997). Exhibit 1156 is a true and
`
`correct copy of the Library of Congress Copyright Record for Oncology, a record
`
`which I obtained from the Library of Congress online catalog located at
`
`http://catalog.loc.gov on November 29, 2016. In that record, the publication date of
`
`the Supplement to Volume 11, Number 3 is March 15, 1997.
`
`9.
`
`Exhibit 1115 is a true and correct copy of Hudziak et al., pl85HER2
`
`Monoclonal Antibody has Antiproliferative Effects in Vitro and Sensitizes Human
`
`Breast Tumor Cells to Tumor Necrosis Factor, 9(3) MOLECULAR AND CELLULAR
`
`BIOLOGY 1165-172, (1989). Exhibit 1157 is a true and correct copy of the Library
`
`of Congress Copyright Record for the Journal of Molecular and Cellular Biology, a
`
`record which I obtained from the Library of Congress online catalog located at
`
`http://catalog.loc.gov on November 29, 2016. In that record, the publication date of
`
`Volume 9, Number 3 is February 27, 1989.
`
`10. Exhibit 1116 is a true and correct copy of Carter et al., Humanization
`
`of an anti-pl85HER2 antibody for human cancer therapy, 89(10) PROC. NATL.
`
`3
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`HOSPIRA EX. 1112
`Page 4
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`
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`ACAD. Sci. USA 4285-89 (1992). Exhibit 1158 is a true and correct copy of the
`
`Library of Congress Copyright Record for The Proceedings of the National
`
`Academy of Sciences of the United States of America, a record which I obtained
`
`from the Library of Congress online catalog located at http://catalog.loc.gov on
`
`November 29, 2016. In that record, the publication date of the Volume 89, Number
`
`10 is May 15, 1992.
`
`11. Exhibit 1118 is a true and correct copy of Pegram et al., Phase II
`
`Study of Receptor-Enhanced Chemosensitivity Using Recombinant Humanized
`
`Anti-pl85HER2
`!neu Monoclonal Antibody Plus Cisplatin in Patients with HER2/neu(cid:173)
`
`Overexpressing Metastatic Breast Cancer Refractory to Chemotherapy Treatment,
`
`16(8) J. CLIN. ONCOL. 2659-71 (1998). Exhibit 1168 is a true and correct copy of
`
`the Library of Congress Copyright Record for the Journal of Clinical Oncology, a
`
`record which I obtained from the Library of Congress online catalog located at
`
`http://catalog.loc.gov on November 28, 2016. In that record, the publication date of
`
`Volume 16, Number 8 is July 31, 1998.
`
`12. Exhibit 1125 is a true and correct copy of Gelmon et al., Phase !III
`
`Trial of Biweekly Paclitaxel and Cisplatin in the Treatment of Metastatic Breast
`
`Cancer, 14(4) J. CLIN. ONCOL. 1185-91 (1996). Exhibit 1159 is a true and correct
`
`copy of the Library of Congress Copyright Record for the J oumal of Clinical
`
`Oncology, a record which I obtained from the Library of Congress online catalog
`
`4
`
`HOSPIRA EX. 1112
`Page 5
`
`
`
`located at http://catalog.loc.gov on November 29, 2016. In that record, the
`
`publication date of Volume 14, Number 4 is March 28, 1996.
`
`13.
`
`Exhibit 1133 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 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 November 29, 2016. In that record, the publication date of
`
`Volume 235, Number 4785 is January 8, 1987.
`
`14.
`
`Exhibit 1134 is a true and correct copy of Slamon et al., Studies of the
`
`HER-2/neu Proto-Oncogene in Human Breast and Ovarian Cancer, 244(4905)
`
`SCIENCE 707-12 (1989). Exhibit 1161 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 November
`
`29, 2016. In that record, the publication date of Volume 244, Number 4905 is May
`
`11,1989.
`
`15.
`
`Exhibit 1136 is a true and correct copy of Nicolaou et al., Taxoids:
`
`New Weapons against Cancer, 27 4( 6) SCIENTIFIC AMERICAN 94-98 (1996). Exhibit
`
`1162 is a true and correct copy of the Library of Congress Copyright Record for
`
`Scientific American, a record which I obtained from the Library of Congress
`
`5
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`HOSPIRA EX. 1112
`Page 6
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`
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`online catalog located at http://catalog.loc.gov on November 29, 2016. In that
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`record, the publication date ofVolume 274, Number 6 is May 6, 1996.
`
`16.
`
`Exhibit 1140 is a true and correct copy of Pegram et al., Monoclonal
`
`Antibody to HER-2/neu Gene Product Potentiates Cytotoxicity of Carboplatin and
`
`Doxorubicin in Human Breast Tumor Cells, 33 PROCEEDINGS OF THE AMERICAN
`
`ASSOCIATION FOR CANCER RESEARCH, 442 (Abstract. 2639) (1992) ("Pegram '92").
`
`Exhibit 1163 is a true and correct copy of the Library of Congress Copyright
`
`Record for Proceedings of the American Association for Cancer Research, a record
`
`which I obtained from the Library of Congress online catalog located at
`
`http://catalog.loc.gov on November 29, 2016. In that record, the publication date of
`
`Volume 33 is April 15, 1992.
`
`17.
`
`Exhibit 1142 is a true and correct copy of Shan et al., Anthracycline-
`
`Induced Cardiotoxicity, 125(1) ANN. INTERN. MED. 47-58, (1996). Exhibit 1164 is
`
`a true and correct copy of the Library of Congress Copyright Record for Annals of
`
`Internal Medicine, a record which I obtained from the Library of Congress online
`
`catalog located at http://catalog.loc.gov on November 29, 2016. In that record, the
`
`publication date ofVolume 125, Number 1 is June 18, 1996.
`
`18.
`
`Exhibit 1143 is a true and correct copy of Mendelsohn et al.,
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`Epidermal Growth Factor Receptor Family and Chemosensitization, 89(5) J.
`
`NATL. CANCER INSTITUTE 341--43 ( 1997). Exhibit 1165 is a true and correct copy
`
`6
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`HOSPIRA EX. 1112
`Page 7
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`
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`of the Library of Congress Copyright Record for the Journal of the National
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`Cancer Institute, a record which I obtained from the Library of Congress online
`
`catalog located at http://catalog.loc.gov on November 29, 2016. In that record, the
`
`publication date of Volume 89, Number 5 is March 1, 1997.
`
`19. Exhibit 1145 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 1166 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
`
`November 29, 2016. In that record, the publication date of Volume 321, Number
`
`6069 is May 29, 1986.
`
`20. Exhibit 1154 is a true and correct copy of Pegram et al., Results of
`
`Two Open-Label, Multicenter Phase II Studies of Docetaxel, Platinum Salts, and
`
`Trastuzumab in HER2-Positive Advanced Breast Cancer, 96 (10) J. NATL. CANCER
`
`INST. 759-69 (2004). Exhibit 1167 is a true and correct copy of the Library of
`
`Congress Copyright Record for Journal of National Cancer Institute, a record
`
`which I obtained from the Library of Congress online catalog located at
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`http://catalog.loc.gov on December 20, 2016. In that record, the publication date of
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`Volume 96, Number 10 is May 4, 2004.
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`7
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`HOSPIRA EX. 1112
`Page 8
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`
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`IV. CONCLUSION
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`21.
`
`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
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`Section 1001 of the Title 18 of the United States Code.
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`Executed on January 18,2017, in New York, New York.
`
`0k4~ LvwdJA~
`
`Christopher Lowden
`
`8
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`HOSPIRA EX. 1112
`Page 9
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`
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