Petition for Inter Partes Review
`
`of U.S. Patent 9,987,308
`
`1005
`
`Reference
`
`Exhibit
`No.
`1001 U.S. Patent No. 9,987,308 to Stanley R. Riddell and Michael Hudecek,
`issued June 5, 2018 (the “’308 patent”)
`1002 Expert Declaration of Jonathan Bramson, Ph.D. (Dated March 22,
`2023) (“Bramson”)
`1003 Harjeet Singh et al., Redirecting Specificity of T-cell Populations for
`CD19 Using the Sleeping Beauty System, 68 CANCER RES. 2961-71
`(2008) (“Singh”)
`1004 Ronald T. Mitsuyasu et al., Prolonged Survival and Tissue Trafficking
`Following Adoptive Transfer of CD4ζ Gene-modified Autologous
`CD4+ and CD8+ T Cells in Human Immunodeficiency Virus-infected
`Subjects, 96 BLOOD 785-93 (2000) (“Mitsuyasu”)
`International Application No. PCT/US2012/030388, filed Mar. 23,
`2012 (the “’388 application”)
`1006 U.S. Provisional Patent Application No. 61/466,552, filed Mar. 23,
`2011 (the “’552 application”)
`1007 Carolina Berger et al., Adoptive Transfer of Virus-Specific and Tumor-
`Specific T Cell Immunity, 21 CURR. OPIN. IN IMMUNOL. 224-32 (2009)
`(“Berger”)
`1008 Excerpts from File History of the ’308 patent
`1009 Claudia M. Kowolik et al., CD28 Costimulation Provided Through a
`CD19-Specific Chimeric Antigen Receptor Enhances In Vivo
`Persistence and Antitumor Efficacy of Adoptively Transferred T Cells,
`66 CANCER RES. 10995-11004 (2006) (“Kowolik”)
`1010 Laurence J.N. Cooper et al., Chimeric Antigen Receptor on T Cells, in
`ENCYCLOPEDIA OF CANCER, 644-48 (Manfred Schwab 2nd ed. 2008)
`(“Cooper”)
`1011 Michael Hudecek et al., Adoptive T-cell Therapy for B-cell
`Malignancies, 2 EXPERT REV. HEMATOL. 517-32 (2009) (“Hudecek I”)
`1012 Michael Hudecek et al., CD8+ T Cells Engineered to Express a ROR1-
`Specific Chimeric Antigen Receptor Specifically Recognize ROR1
`Positive B Cell Tumors, 114 BLOOD 930 (2009) (“Hudecek II”)
`1013 Hinrich Abken, Chimeric T Cell Receptors, in ENCYCLOPEDIA OF
`CANCER, 649-52 (Manfred Schwab 2nd ed. 2008) (“Abken”)
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`Petition for Inter Partes Review
`
`of U.S. Patent 9,987,308
`
`Reference
`
`Exhibit
`No.
`1014 Karen Reckamp et al., CE7 Epitope of L1CAM is a Potential Target
`for Tumor Specific T Cell Therapy in Lung Cancer, 68 CANCER RES.
`(9 Supplement) 4620 (2008) (“Reckamp”)
`1015 Carmine Carpenito et al., Control of Large, Established Tumor
`Xenografts with Genetically Retargeted Human T Cells Containing
`CD28 and CD137 Domains, 106 PROC. NAT’L ACAD. SCI. 3360-65
`(2009) (“Carpenito”)
`1016 Maria Moeller et al., Adoptive Transfer of Gene-engineered CD4+
`Helper T Cells Induces Potent Primary and Secondary Tumor
`Rejection, 106 BLOOD 2995-3003 (2005) (“Moeller”)
`1017 Xiuli Wang et al., The CD19 Chimeric Antigen Receptor Re-directs
`CMV Specific T Cells Derived from Central Memory T Cells (Bi-
`specific T Cells) Against Human Acute Lymphoid Leukemia (ALL),
`31 J. IMMUNOTHER. 926-27 (2008) (“Wang”)
`1018 U.S. Patent Application Publication No. 2004/0126363 A1 to Michael
`C. Jensen, Stephen Forman, and Andrew Raubitschek, published
`July 1, 2004 (“Jensen”)
`1019 Hirotomo Shibaguchi et al., A Fully Human Chimeric Immune
`Receptor for Retargeting T-Cells to CEA-Expressing Tumor Cells,
`26 ANTICANCER RES. 4067-72 (2006) (“Shibaguchi”)
`1020 Mhairi Cavers et al., Differential Expression of β1 and β2 Integrins
`and L-Selectin on CD4+ and CD8+ T Lymphocytes in Human Blood:
`Comparative Analysis Between Isolated Cells, Whole Blood Samples
`and Cryopreserved Preparations, 127 CLIN. EXP. IMMUNOL. 60-65
`(2002) (“Cavers”)
`1021 Ryan P. McGuinness et al., Anti-tumor activity of human T cells
`expressing the CC49-zeta chimeric immune receptor, 10 HUMAN GENE
`THER. 165-73 (1999) (“McGuinness”)
`1022 Challenged Claim Listing for the ’308 patent
`1023 Attorney Declaration of Yite John Lu
`1024 CD19-specific T Cell Infusion in Patients with B-Lineage Lymphoid
`Malignancies After Autologous Hematopoietic Stem Cell
`Transplantation, CLINICALTRIALS.GOV,
`https://clinicaltrials.gov/ct2/history/NCT00968760?V_1=View#Study
`PageTop (last visited Mar. 6, 2023) (“ClinicalTrials.gov”)
`James N. Kochenderfer et al., Eradication of B-lineage Cells and
`Regression of Lymphoma in a Patient Treated with Autologous T Cells
`
`1025
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`Exhibit
`No.
`
`Reference
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`Petition for Inter Partes Review
`
`of U.S. Patent 9,987,308
`
`1026
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`1027
`
`Genetically Engineered to Recognize CD19, 116 BLOOD 4099-102
`(2010) (“Kochenderfer”)
`Partow Kebriaei et al., Infusing CD19-Directed T Cells to Augment
`Disease Control in Patients Undergoing Autologous Hematopoietic
`Stem-Cell Transplantation for Advanced B-Lymphoid Malignancies,
`23 HUMAN GENE THER. 444-50 (2012) (“Kebriaei”)
`Shicheng Yang et al., In Vitro Generated Anti-tumor T Lymphocytes
`Exhibit Distinct Subsets Mimicking In Vivo Antigen-Experienced
`Cells, 60 CANCER IMMUNOL. IMMUNOTHER. 739-49 (2011) (“Yang I”)
`Shicheng Yang et al., TCR Engineered and In Vitro Expanded T
`Lymphocytes Recapitulate the Properties of Central Memory T Cells,
`18 (Suppl. 1) MOLECULAR THER. S184 (2010) (“Yang II”)
`Federica Sallusto et al., Two Subsets of Memory T Lymphocytes with
`Distinct Homing Potentials and Effector Functions, 401 NATURE 708-
`12 (1999) (“Sallusto”)
`1030 Warren N. D’Souza et al., IL-2 Is Not Required for the Initiation of
`CD8 T Cell Cycling but Sustains Expansion, 171 J. IMMUNOL. 5727-35
`(2003) (“D’Souza”)
`Simone C. Zimmerli et al., HIV-1-specific IFN-γ/IL-2-secreting CD8 T
`cells support CD4-independent proliferation of HIV-1-specific CD8 T
`cells, 102 PNAS 7239-44 (2005) (“Zimmerli”)
`1032 Yue Sun et al., Dysfunction of Simian Immunodeficiency Virus/Simian
`Human Immunodeficiency Virus-Induced IL-2 Expression by Central
`Memory CD4+ T Lymphocytes, 174 J. IMMUNOL. 4753-60 (2005)
`(“Sun”)
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`1028
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`1029
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`1031
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`Petition for Inter Partes Review
`
`of U.S. Patent 9,987,308
`
`Certificate of Service
`
`I hereby certify, pursuant to 37 C.F.R. §§ 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 twenty-second day of March, 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:
`
`
`
`
`
`
`
`
`
`David Carlson & Patent Docket Clerk
`
`Seed Intellectual Property Law Group LLP
`
`701 Fifth Ave, Suite 5400
`
`Seattle, WA 98104
`
`DATED: March 22, 2023
`
`/Yite John Lu /
`
`
`
`Yite John Lu
`Reg. No. 63158
`Orrick Herrington & Sutcliffe LLP
`355 S. Grand Ave., Ste. 2700
`Los Angeles, CA 90071
`Tel. (213) 612-2374
`Fax. (213) 612-2499
`jlu@orrick.com
`
`
`Counsel for Petitioner
`
`4
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