Petition for Inter Partes Review
`of U.S. Patent No. 9,540,445
`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MILTENYI BIOMEDICINE GmbH and MILTENYI BIOTEC INC.
`Petitioner
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`v.
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`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
`Patent Owner
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`IPR Trial No. IPR2022 -
`U.S. Patent No. 9,540,445
`Issue Date: January 10, 2017
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`Title: Compositions and Methods for Treatment of Cancer
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`DECLARATION OF MONICA M. ARNOLD
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`of U.S. Patent No. 9,540,445
`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MILTENYI BIOMEDICINE GmbH and MILTENYI BIOTEC INC.
`Petitioner
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`v.
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`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
`Patent Owner
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`IPR Trial No. IPR2022 -
`U.S. Patent No. 9,540,445
`Issue Date: January 10, 2017
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`Title: Compositions and Methods for Treatment of Cancer
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`DECLARATION OF MONICA M. ARNOLD
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`- 1 -
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,540,445
`I, Monica M. Arnold, make the following Declaration pursuant to 28 U.S.C. § 1746:
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`1. I am an associate at the law firm of Milbank LLP, attorneys for Petitioner
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`Miltenyi Biomedicine GmbH and Miltenyi Biotec Inc. I am a member of the
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`bar of the State of California and registered to practice in front of the United
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`States Patent and Trademark Office.
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`2. I submit this Declaration in connection with the above-identified Petition for
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`Inter Partes Review proceeding of U.S. Patent No. 9,540,445 that is being
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`requested at the U.S. Patent and Trademark Office under 35 U.S.C §§ 311-
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`319, 37 C.F.R. § 42.
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`3. Exhibit 1001 is a true and correct certified copy of U.S. Patent No. 9,540,445
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`to Carl H. June, Bruce L. Levine, David L. Porter, Michael D. Kalos, and
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`Michael C. Milone, issued January 10, 2017 (“the ’445 patent”), which was
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`retrieved pursuant to my instructions from the United States Patent and
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`Trademark Office. An exhibit label and page number have been added to the
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`bottom right corner of this document, but no other alterations have been made.
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`4. Exhibit 1002 is a true and correct copy of the Expert Declaration of Richard
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`Paul Junghans (Dated April 8, 2022). An exhibit label and page number have
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`been added to the bottom right corner of this document, but no other
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`alterations have been made.
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`- 2 -
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,540,445
`5. Exhibit 1003 is a true and correct certified copy of U.S. Patent Application
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`Publication No. 2005/0113564 to Dario Campana and Chihaya Imai,
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`published May 26, 2005 (“Campana”), which was retrieved pursuant to my
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`instructions from the United States Patent and Trademark Office. An exhibit
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`label and page number have been added to the bottom right corner of this
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`document, but no other alterations have been made.
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`1. Exhibit 1004 is a true and correct copy of Ian C. Nicholson et al.,
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`Construction and Characterisation of a Functional CD19 Specific Single
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`Chain Fv Fragment for Immunotherapy of B Lineage Leukaemia and
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`Lymphoma, 34 Molecular Immunology 1157 (1997) (“Nicholson”), which is
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`a scan from the original journal article retrieved pursuant to my instructions.
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`An exhibit label and page number have been added to the bottom right
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`corner of this document, but no other alterations have been made.
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`2. Exhibit 1005 is a true and correct certified copy of U.S. Patent No. 4,844,893
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`to Cyril J. Honsik and Ralph A. Reisfeld, issued July 4, 1989 (“Honsik”),
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`which was retrieved pursuant to my instructions from the United States Patent
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`and Trademark Office. An exhibit label and page number have been added to
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`the bottom right corner of this document, but no other alterations have been
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`made.
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`- 3 -
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,540,445
`3. Exhibit 1006 is a true and correct copy of the Duncan Hall Decl. for Pilot
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`Study for Patients With Chemotherapy Resistant or Refractory CD19
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`Leukemia
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`and
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`Lymphoma
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`(CART-19),
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`ClinicalTrials.gov,
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`https:/clinicaltrials.gov/ct2/show/NCT00891215
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`[https://web.archive.org/web/
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`20090507184629/
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`https:/
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`clinicaltrials.gov/ct2/show/NCT00891215 (May 07, 2009)] (“CART-19
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`ClinicalTrials.gov”), which was retrieved pursuant to my instructions from
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`the Internet Archive. An exhibit label and page number have been added to
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`the bottom right corner of this document, but no other alterations have been
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`made.
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`4. Exhibit 1007 is a true and correct certified copy of U.S. Patent Application
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`Publication No. 2004/0126363 to Michael C. Jensen, Stephen Forman, and
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`Andrew Raubitschek, published July 1, 2004 (“Jensen”), which was
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`retrieved pursuant to my instructions from the United States Patent and
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`Trademark Office. An exhibit label and page number have been added to the
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`bottom right corner of this document, but no other alterations have been
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`made.
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`5. Exhibit 1008 is a true and correct copy of Michael C. Milone et al., Chimeric
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`Receptor Containing CD137 Signal Transduction Domains Mediate
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`Enhanced Survival of T Cells and Increased Antileukemic Efficacy In Vivo,
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`- 4 -
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,540,445
`17 Molecular Therapy 1453 (2009) (“Milone”), which is a scan from the
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`original journal article retrieved pursuant to my instructions. An exhibit label
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`and page number have been added to the bottom right corner of this
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`document, but no other alterations have been made.
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`6. Exhibit 1009 is a true and correct copy of Dan R. Littman et al., The
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`Isolation and Sequence of the Gene Encoding T8: A Molecule Defining
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`Functional Classes of T Lymphocytes, 40 Cell 237 (1985) (“Littman”),
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`which is a scan from the original journal article retrieved pursuant to my
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`instructions. An exhibit label and page number have been added to the
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`bottom right corner of this document, but no other alterations have been
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`made.
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`6. Exhibit 1010 is a true and correct certified copy of U.S. Patent Application
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`Publication No. 2004/0043401 to Michel Sadelain, Renier Brentjens, and
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`John Maher, published March 4, 2004 (“Sadelain”), which was which was
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`retrieved pursuant to my instructions from the United States Patent and
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`Trademark Office. An exhibit label and page number have been added to the
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`bottom right corner of this document, but no other alterations have been made.
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`7. Exhibit 1011 is a true and correct certified copy of U.S. Patent Application
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`Publication No. 2008/0121415 to Stanley R. Riddell, Carolina Berger, and
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`Michael C. Jensen, published June 5, 2005 (“Riddell”), which was which was
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`- 5 -
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,540,445
`retrieved pursuant to my instructions from the United States Patent and
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`Trademark Office. An exhibit label and page number have been added to the
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`bottom right corner of this document, but no other alterations have been made.
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`7. Exhibit 1012 is a true and correct copy of David L. Porter et al., Chimeric
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`Antigen Receptor–Modified T Cells in Chronic Lymphoid Leukemia, 365 N.
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`ENGL J. MED. 725 (2011), (“Porter”), which is a scan from the original
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`journal article retrieved pursuant to my instructions. An exhibit label and
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`page number have been added to the bottom right corner of this document,
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`but no other alterations have been made.
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`8. Exhibit 1013 is a true and correct copy of the Protocol for David L. Porter et
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`al., Chimeric Antigen Receptor–Modified T Cells in Chronic Lymphoid
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`Leukemia, 365 N. Engl J. Med. 725 (2011), which I downloaded from
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`NEJM.org on or about January 8, 2022. An exhibit label and page number
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`have been added to the bottom right corner of this document, but no other
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`alterations have been made.
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`9. Exhibit 1014 is reserved.
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`10. Exhibit 1015 is reserved.
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`11. Exhibit 1016 is reserved.
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`12. Exhibit 1017 is reserved.
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,540,445
`13. Exhibit 1018 is a true and correct certified copy of excerpts from the certified
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`File History of PCT/US2011/064191, filed December 9, 2011, which was
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`retrieved pursuant to my instructions the World Intellectual Property
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`Organization. An exhibit label and page number have been added to the
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`bottom right corner of this document, but no other alterations have been made.
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`14. Exhibit 1019 is a true and correct certified copy of the File History of U.S.
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`Provisional Application 61/502,649, filed June 29, 2011 (“the ’649
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`application”), which was retrieved pursuant to my instructions from the
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`United States Patent and Trademark Office. An exhibit label and page number
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`have been added to the bottom right corner of this document, but no other
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`alterations have been made.
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`15. Exhibit 1020 is a true and correct certified copy of the File History of U.S.
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`Provisional Application 61/421,470, filed December 9, 2010 (“the ’470
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`application”), which was retrieved pursuant to my instructions from the
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`United States Patent and Trademark Office. An exhibit label and page number
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`have been added to the bottom right corner of this document, but no other
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`alterations have been made.
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`16. Exhibit 1021 is a true and correct copy of excerpts from the certified File
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`History of the ’445 patent, which was retrieved pursuant to my instructions
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`from the United States Patent and Trademark Office. An exhibit label and
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`- 7 -
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,540,445
`page number have been added to the bottom right corner of this document, but
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`no other alterations have been made.
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`17. Exhibit 1022 is a true and correct copy of C. Imai & D. Campana, Chimeric
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`Receptors with 4-1BB Signaling Capacity Provoke Potent Cytotoxicity
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`Against Acute Lymphoblastic Leukemia, 18 LEUKEMIA 676 (2004) (“Imai”),
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`which is a scan from the original journal article retrieved pursuant to my
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`instructions. An exhibit label and page number have been added to the bottom
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`right corner of this document, but no other alterations have been made.
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`18. Exhibit 1023 is a true and correct copy of Ng and Henikoff, SIFT: Predicting
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`Amino Acid Changes That Affect Protein Function, 31 NUCLEIC ACIDS RSCH.
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`3812 (2003) (“Ng”), which is a scan from the original journal article retrieved
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`pursuant to my instructions. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`19. Exhibit 1024 is a true and correct copy of the Nathaniel E. Frank-White Decl.
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`for
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`Sorting
`
`Intolerant From Tolerant, N. Engl.
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`J. Med.,
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`http://blocks.fhcrc.org/blocks/
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`[https://web.archive.org/web/20130728182255/http://blocks.fhcrc.org/blocks
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`/ (Nov. 18, 2008)], which was retrieved pursuant to my instructions from the
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`- 8 -
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,540,445
`Internet Archive. An exhibit label and page number have been added to the
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`bottom right corner of this document, but no other alterations have been made.
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`20. Exhibit 1025 is a true and correct copy of Salvatore J. Turco, Intravaneous
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`Admixtures, in 18 Remington’s Pharmaceutical Sciences 1570 (Alfonso R.
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`Gennaro ed., 1990) (“Turco”), scan from the original textbook retrieved
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`pursuant to my instructions. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`21. Exhibit 1026 is a true and correct copy of Stanley J. Dudrick et al., Parenteral
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`Nutrition Techniques in Cancer Patients, 37 CANCER RSCH. 2240 (1977)
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`(“Dudrick”), which is a scan from the original journal article retrieved
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`pursuant to my instructions. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`22. Exhibit 1027 is a true and correct copy of the correction issued for Porter (Ex.
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`1012), which is a scan from the original journal article retrieved pursuant to
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`my instructions. An exhibit label and page number have been added to the
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`bottom right corner of this document, but no other alterations have been made.
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`23. Exhibit 1028 is a true and correct copy of excerpts from the certified File
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`History of U.S. Patent Application No. 15/353,899 (“the ’899 application”),
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`- 9 -
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,540,445
`which was retrieved pursuant to my instructions from the United States Patent
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`and Trademark Office. An exhibit label and page number have been added to
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`the bottom right corner of this document, but no other alterations have been
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`made.
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`24. Exhibit 1029 is a true and correct copy of excerpts from Kenneth Murphy et
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`al., Janeway’s Immunobiology (7th ed. 2008) (“Immunobiology”), which is a
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`scan from the original textbook retrieved pursuant to my instructions. An
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`exhibit label and page number have been added to the bottom right corner of
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`this document, but no other alterations have been made.
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`25. Exhibit 1030 is a true and correct copy of excerpts from BRUCE ALBERTS ET.
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`AL., MOLECULAR BIOLOGY OF THE CELL (4th ed. 2002) (“Molecular
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`Biology”), which is a scan from the original textbook retrieved from my
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`personal library. An exhibit label and page number have been added to the
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`bottom right corner of this document, but no other alterations have been made.
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`26. Exhibit 1031 is a true and correct copy of Bipulendu Jena et al., Redirecting
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`T-cell Specificity by Introducing a Tumor-Specific Chimeric Antigen
`
`Receptor, 116 Blood 1035 (2010) (“Jena”), which is a scan from the original
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`journal article retrieved pursuant to my instructions. An exhibit label and page
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`number have been added to the bottom right corner of this document, but no
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`other alterations have been made.
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`- 10 -
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,540,445
`27. Exhibit 1032 is a true and correct copy of Christopher A. Klebanoff et al.,
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`Sinks, Suppressors and Antigen Presenters: How Lymphodepletion Enhances
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`T Cell Mediated Tumor Immunotherapy, 26 Trends Immunol. 111 (2005)
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`(“Klebanoff”), which is a scan from the original journal article retrieved
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`pursuant to my instructions. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`28. Exhibit 1033 is a true and correct copy of James S. Huston et al., Protein
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`Engineering of Antibody Binding Sites: Recovery of Specific Activity in an
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`Anti-Digoxin Single-Chain Fv Analogue Produced in Escherichia coli, 85
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`Proc. Nat’l Acad. Sci. 5879 (1988) (“Huston”), which is a scan from the
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`original journal article retrieved pursuant to my instructions. An exhibit label
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`and page number have been added to the bottom right corner of this document,
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`but no other alterations have been made.
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`29. Exhibit 1034 is a true and correct copy of R.D. Mosteller, Simplified
`
`Calculation of Body-surface Area, 317 N. Engl. J. Med. 1098 (1987)
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`(“Mosteller”), which is a scan from the original journal article retrieved
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`pursuant to my instructions. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`- 11 -
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,540,445
`30. Exhibit 1035 is a true and correct copy of Margaret A. McDowell et al., Nat’l
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`Ctr. For Health Stat., Anthropometric Reference Data for Children and
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`Adults: United States, 2003–2006, NAT’L HEALTH STAT. REPS., October 22,
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`2008 (“McDowell”), which is a scan from the original journal article retrieved
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`pursuant to my instructions. An exhibit label and page number have been
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`added to the bottom right corner of this document, but no other alterations
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`have been made.
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`31. Exhibit 1036 is a true and correct copy of Exhibit 1036 is a true and correct
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`copy of Jean Philippe Boursier et al., Evidence for an Extended Structure of
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`the T-cell Co-receptor CD8a as Deduced from the Hydrodynamic Properties
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`of Soluble Forms of the Extracellular Region, 268 J. Biological Chemistry
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`2013 (1993) (“Boursier”), which is a scan from the original journal article
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`retrieved pursuant to my instructions. An exhibit label and page number have
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`been added to the bottom right corner of this document, but no other
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`alterations have been made.
`
`32. Exhibit 1037 is a true and correct copy of Vikas P. Sukhatme, The T Cell
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`Differentiation Antigen Leu-2/T8 Is Homologous to lmmunoglobulin and T
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`Cell Receptor Variable Regions, 40 CELL 591 (1985) (“Sukhatme”), which
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`is a scan from the original journal article retrieved pursuant to my instructions.
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,540,445
`An exhibit label and page number have been added to the bottom right corner
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`of this document, but no other alterations have been made.
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`33. Exhibit 1038 is a true and correct copy of CART19 to Treat B-Cell Leukemia
`
`or Lymphoma That Are Resistant or Refractory
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`to Chemotherapy,
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`ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT01029366
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`(last
`
`visited April 2022), I downloaded from Clinicaltrials.gov. An exhibit label
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`and page number have been added to the bottom right corner of this document,
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`but no other alterations have been made.
`
`34. Exhibit 1039 is a true and correct copy of the Nathaniel E. Frank-White Decl.
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`for David L. Porter et al., Chimeric Antigen Receptor-Modified T Cells in
`
`Chronic Lymphoid Leukemia, N. Engl. J. Med. (Aug. 25, 2011),
`
`https://www.nejm.org/doi/full/10.1056/NEJMoa1103849
`
`[https://web.archive.org/web/20110924175244/http://www.nejm.org/doi/full
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`/10.1056/NEJMoa1103849 (Sept. 24, 2011)], which was retrieved pursuant to
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`my instructions from the Internet Archive. An exhibit label and page number
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`have been added to the bottom right corner of this document, but no other
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`alterations have been made.
`
`35. Exhibit 1040 is a true and correct copy of the Nathaniel E. Frank-White Decl.
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`for David L. Porter et al., Chimeric Antigen Receptor-Modified T Cells in
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`Chronic Lymphoid Leukemia, N. Engl. J. Med. (Aug. 25, 2011),
`
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,540,445
`https://www.nejm.org/doi/full/10.1056/NEJMoa1103849
`
`[https://web.archive.org/web/20120422111453/http://www.nejm.org:80/doi/
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`full/10.1056/NEJMoa1103849 (April 22, 2012)], which was retrieved
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`pursuant to my instructions from the Internet Archive. An exhibit label and
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`page number have been added to the bottom right corner of this document, but
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`no other alterations have been made.
`
`36. Exhibit 1041 is a true and correct copy of excerpts from the certified Excerpts
`
`from File History of U.S. Patent No. 8,911,993, which was retrieved pursuant
`
`to my instructions from the United States Patent and Trademark Office. An
`
`exhibit label and page number have been added to the bottom right corner of
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`this document, but no other alterations have been made.
`
`37. Exhibit 1042 is a true and correct copy of Ulrich Schneider et al.,
`
`Characterization of EBV-genome negative "null" and "T" cell lines derived
`
`from children with acute lymphoblastic leukemia and leukemic transformed
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`non-Hodgkin lymphoma, 19 Int. J. Cancer 621 (1977) (“Schneider”), which is
`
`a scan from the original journal article retrieved pursuant to my instructions.
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`An exhibit label and page number have been added to the bottom right corner
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`of this document, but no other alterations have been made.
`
`38. Exhibit 1043 is a true and correct copy of Yangbing Zhao et al., Multiple
`
`Injections of Electroporated Autologous T Cells Expressing a Chimeric
`
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`- 14 -
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,540,445
`Antigen Receptor Mediate Regression of Human Disseminated Tumor, 70
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`CANCER RSCH. 9053 (2010) (“Zhao”), which is a scan from the original
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`journal article retrieved pursuant to my instructions. An exhibit label and page
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`number have been added to the bottom right corner of this document, but no
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`other alterations have been made.
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`39. Exhibit 1044 is reserved.
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`40. Exhibit 1045 is a true and correct copy of James N. Kochenderfer et al.,
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`Eradication of B-lineage cells and regression of lymphoma in a patient
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`treated with autologous T cells genetically engineered to recognize CD19,
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`116 Blood 4099 (“Kochenderfer 2010”), which I downloaded from
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`ashpublications.org. An exhibit label and page number have been added to the
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`bottom right corner of this document, but no other alterations have been made.
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`41. Exhibit 1046 is a true and correct copy of excerpts from Renier J. Brentjens
`
`et al., Phase I Trial for the Treatment of Chemo-Refractory Chronic
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`Lymphocytic Leukemia with CD19-Targeted Autologous T Cells, 16
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`MOLECULAR THERAPY S15 (2008) (“Brentjens”), which I downloaded
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`from cell.com. An exhibit label and page number have been added to the
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`bottom right corner of this document, but no other alterations have been made.
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`42. Exhibit 1047 is a true and correct copy of Marco L. Davila et al., B Cell
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`Aplasia In a Patient with Relapsed B Cell Acute Lymphoblastic Leukemia
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,540,445
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`Following Re-Induction and Consolidation with Autologous T Cells
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`Genetically Targeted to the CD19 Antigen, 116 Blood Abstract 3268 (2010)
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`(“Davila”), which I downloaded from ashpublations.org. An exhibit label and
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`page number have been added to the bottom right corner of this document, but
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`no other alterations have been made.
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`43. Exhibit 1048 is a true and correct copy of James N. Kochenderfer,
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`Construction and Pre-clinical Evaluation of an Anti-CD19 Chimeric Antigen
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`Receptor, 32 J. IMMUNOTHERAPY 689 (2009) (“Kochenderfer 2009”),
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`which is a scan from the original journal article retrieved pursuant to my
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`instructions. An exhibit label and page number have been added to the bottom
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`right corner of this document, but no other alterations have been made.
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`44. Exhibit 1049 is reserved.
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`45. Exhibit 1050 is a true and correct copy of David Mead et al., Recombinant
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`Human Albumin: Applications as a Biopharmaceutical Excipient, 22
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`Innovations Pharm. Tech. 42 (2007) (“Mead 2007), which I downloaded from
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`iptonline.com. An exhibit label and page number have been added to the
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`bottom right corner of this document, but no other alterations have been made.
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`
`Petition for Inter Partes Review
`of U.S. Patent No. 9,540,445
`I declare under penalty of perjury under the law of the United States of
`
`America that the foregoing is true and correct.
`
`
`
`
`
`
`
`Dated: April 11, 2022
`
`
`
`\s\ Monica M. Arnold
`Monica M. Arnold
`Reg. No. 77,262
`
`- 17 -
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`
`
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