Petition for Inter Partes Review
`of U.S. Patent No. 9,464,140
`
`Exhibit
`No.
`
`1001
`
`1004
`
`Reference
`U.S. Patent No. 9,464,140 to Carl H. June, Bruce L. Levine, David L.
`Porter, Michael D. Kalos, and Michael C. Milone, issued October 11,
`2016 (“the ’140 patent”)
`1002 Expert Declaration of Richard Paul Junghans (Dated April 8, 2022)
`1003 U.S. Patent Application Publication No. 2005/0113564 to Dario
`Campana and Chihaya Imai, published May 26, 2005 (“Campana”)
`Ian C. Nicholson et al., Construction and Characterisation of a
`Functional CD19 Specific Single Chain Fv Fragment for
`Immunotherapy of B Lineage Leukaemia and Lymphoma, 34
`MOLECULAR IMMUNOLOGY 1157 (1997) (“Nicholson”)
`1005 U.S. Patent No. 4,844,893 to Cyril J. Honsik and Ralph A. Reisfeld,
`issued July 4, 1989 (“Honsik”)
`Duncan Hall Decl. for Pilot Study for Patients With Chemotherapy
`Resistant or Refractory CD19 Leukemia and Lymphoma (CART-19),
`CLINICALTRIALS.GOV,
`https:/clinicaltrials.gov/ct2/show/NCT00891215
`[https://web.archive.org/web/20090507184629/https:/clinicaltrials.gov
`/ct2/show/NCT00891215 (May 07, 2009)] (“CART-19
`ClinicalTrials.gov”)
`U.S. Patent Application Publication No. 2004/0126363 to Michael C.
`Jensen, Stephen Forman, and Andrew Raubitschek, published July 1,
`2004 (“Jensen”)
`Michael C. Milone et al., Chimeric Receptor Containing CD137
`Signal Transduction Domains Mediate Enhanced Survival of T Cells
`and Increased Antileukemic Efficacy In Vivo, 17 MOLECULAR
`THERAPY 1453 (2009) (“Milone”)
`Dan R. Littman et al., The Isolation and Sequence of the Gene
`Encoding T8: A Molecule Defining Functional Classes of T
`Lymphocytes, 40 CELL 237 (1985) (“Littman”)
`1010 U.S. Patent Application No. 2004/0043401 to Michel Sadelain, Renier
`Brentjens, and John Maher, published March 4, 2004 (“Sadelain”)
`1011 Reserved
`David L. Porter et al., Chimeric Antigen Receptor–Modified T Cells in
`Chronic Lymphoid Leukemia, 365 N. ENGL J. MED. 725 (2011), and
`Protocol for Porter et al. (“Porter”)
`
`1006
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`1007
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`1008
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`1009
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`1012
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,464,140
`
`Exhibit
`No.
`
`1013
`
`1019
`
`1022
`
`Reference
`Protocol for David L. Porter et al., Chimeric Antigen Receptor–
`Modified T Cells in Chronic Lymphoid Leukemia, 365 N. ENGL J.
`MED. 725 (2011)
`1014 Reserved
`1015 Reserved
`1016 Reserved
`1017 Reserved
`1018 Excerpts from File History of PCT/US2011/064191, filed December 9,
`2011
`File History of U.S. Provisional Application 61/502,649, filed June 29,
`2011 (“the ’649 application”)
`File History of U.S. Provisional Application 61/421,470, filed
`1020
`December 9, 2010 (“the ’470 application”)
`1021 Excerpts from File History of the ’140 patent
`C. Imai & D. Campana, Chimeric Receptors with 4-1BB Signaling
`Capacity Provoke Potent Cytotoxicity Against Acute Lymphoblastic
`Leukemia, 18 LEUKEMIA 676 (2004) (“Imai”)
`1023 Ng and Henikoff, SIFT: Predicting Amino Acid Changes That Affect
`Protein Function, 31 NUCLEIC ACIDS RSCH. 3812 (2003) (“Ng”)
`Nathaniel E. Frank-White Decl. for Sorting Intolerant From Tolerant,
`N. ENGL. J. MED., http://blocks.fhcrc.org/blocks/
`[https://web.archive.org/web/20130728182255/http://blocks.fhcrc.org/
`blocks/ (Nov. 18, 2008)]
`Salvatore J. Turco, Intravaneous Admixtures, in 18 REMINGTON’S
`PHARMACEUTICAL SCIENCES 1570 (Alfonso R. Gennaro ed., 1990)
`(“Turco”)
`1026 Reserved
`1027 Corrections, 374 N. ENGL J. MED. 998 (2016)
`1028 Excerpts from File History of U.S. Patent Application No. 15/353,899
`(“the ’899 application”)
`1029 Excerpts from KENNETH MURPHY ET AL., JANEWAY’S
`IMMUNOBIOLOGY (7th ed. 2008) (“Immunobiology”)
`1030 Excerpts from BRUCE ALBERTS ET. AL., MOLECULAR BIOLOGY OF THE
`CELL (4th ed. 2002) (“Molecular Biology”)
`Bipulendu Jena et al., Redirecting T-cell Specificity by Introducing a
`Tumor-Specific Chimeric Antigen Receptor, 116 BLOOD 1035 (2010)
`(“Jena”)
`
`1024
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`1025
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`1031
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,464,140
`
`Exhibit
`No.
`
`1032
`
`1033
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`Reference
`Christopher A. Klebanoff et al., Sinks, Suppressors and Antigen
`Presenters: How Lymphodepletion Enhances T Cell Mediated Tumor
`Immunotherapy, 26 TRENDS IMMUNOL. 111 (2005) (“Klebanoff”)
`James S. Huston et al., Protein Engineering of Antibody Binding Sites:
`Recovery of Specific Activity in an Anti-Digoxin Single-Chain Fv
`Analogue Produced in Escherichia coli, 85 PROC. NAT’L ACAD. SCI.
`5879 (1988) (“Huston”)
`1034 R.D. Mosteller, Simplified Calculation of Body-surface Area, 317 N.
`ENGL. J. MED. 1098 (1987) (“Mosteller”)
`Margaret A. McDowell et al., Nat’l Ctr. For Health Stat.,
`Anthropometric Reference Data for Children and Adults: United
`States, 2003–2006, NAT’L HEALTH STAT. REPS., October 22, 2008
`(“McDowell”)
`Jean Philippe Boursier et al., Evidence for an Extended Structure of
`the T-cell Co-receptor CD8a as Deduced from the Hydrodynamic
`Properties of Soluble Forms of the Extracellular Region, 268 J.
`BIOLOGICAL CHEMISTRY 2013 (1993) (“Boursier”)
`Vikas P. Sukhatme, The T Cell Differentiation Antigen Leu-2/T8 Is
`Homologous to lmmunoglobulin and T Cell Receptor Variable
`Regions, 40 CELL 591 (1985) (“Sukhatme”)
`CART19 to Treat B-Cell Leukemia or Lymphoma That Are Resistant
`or Refractory to Chemotherapy, CLINICALTRIALS.GOV,
`https://clinicaltrials.gov/ct2/show/NCT01029366 (last visited April
`2022)
`Nathaniel E. Frank-White Decl. 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/d
`oi/full/10.1056/NEJMoa1103849 (Sept. 24, 2011)]
`Nathaniel E. Frank-White Decl. 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/20120422111453/http://www.nejm.org:8
`0/doi/full/10.1056/NEJMoa1103849 (April 22, 2012)]
`1041 Excerpts from File History of U.S. Patent No. 8,911,993
`
`1040
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`

`Petition for Inter Partes Review
`of U.S. Patent No. 9,464,140
`
`Exhibit
`No.
`
`1042
`
`1043
`
`1045
`
`Reference
`Ulrich Schneider et al., Characterization of EBV-genome negative
`"null" and "T" cell lines derived from children with acute
`lymphoblastic leukemia and leukemic transformed non-Hodgkin
`lymphoma, 19 INT. J. CANCER 621 (1977) (“Schneider”)
`Yangbing Zhao et al., Multiple Injections of Electroporated
`Autologous T Cells Expressing a Chimeric Antigen Receptor Mediate
`Regression of Human Disseminated Tumor, 70 CANCER RSCH. 9053
`(2010) (“Zhao”)
`1044 Reserved
`James N. Kochenderfer et al., Eradication of B-lineage cells and
`regression of lymphoma in a patient treated with autologous T cells
`genetically engineered to recognize CD19, 116 BLOOD 4099
`(“Kochenderfer 2010”)
`Renier J. Brentjens et al., Phase I Trial for the Treatment of Chemo-
`Refractory Chronic Lymphocytic Leukemia with CD19-Targeted
`Autologous T Cells, 16 MOLECULAR THERAPY S15 (2008)
`(“Brentjens”)
`Marco L. Davila et al., B Cell Aplasia In a Patient with Relapsed B
`Cell Acute Lymphoblastic Leukemia Following Re-Induction and
`Consolidation with Autologous T Cells Genetically Targeted to the
`CD19 Antigen, 116 BLOOD Abstract 3268 (2010) (“Davila”).
`James N. Kochenderfer, Construction and Pre-clinical Evaluation of
`an Anti-CD19 Chimeric Antigen Receptor, 32 J. IMMUNOTHERAPY 689
`(2009) (“Kochenderfer 2009”)
`1049 Reserved
`David Mead et al., Recombinant Human Albumin: Applications as a
`Biopharmaceutical Excipient, 22 INNOVATIONS PHARM. TECH. 42
`(2007) (“Mead 2007)
`1051 Reserved
`1052 Attorney Declaration of Monica M. Arnold
`
`
`
`
`
`1046
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`1047
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`1048
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`1050
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`Petition for Inter Partes Review
`of U.S. Patent No. 9,464,140
`
`Certificate
`
`I hereby certify, pursuant to 37 C.F.R. Sections 42.6 and 42.105, that a
`complete copy of the attached Exhibit List, including related documents, are being
`served via Priority Mail Express on the eleventh day of April, the same day as the
`filing of the above-identified document in the United States Patent and Trademark
`Office/Patent Trial and Appeal Board, upon the patent owner by serving the
`correspondence address of record with the USPTO as follows:
`
`Kathryn Doyle & Patent Docket Clerk
`Saul Ewing Arnstein & Lehr LLP
`Centre Square West
`1500 Market Street, 38th Floor
`Philadelphia PA 19102-2186).
`
`DATED: April 11, 2022
`
`
`/
`
`/Yite John Lu
`Yite John Lu
`Reg. No. 63158
`Milbank LLP
`2029 Century Park East, 33rd Floor
`Los Angeles, CA 91167
`Tel. (424) 386-4318
`Fax. (213) 629-5063
`jlu@milbank.com
`
`Counsel for Petitioner
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