Petition for Inter Partes Review
`
`of U.S. Patent No. 9,987,308
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`______________________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`______________________
`
`
`
`MILTENYI BIOMEDICINE GmbH and MILTENYI BIOTEC INC.
`
`Petitioner
`
`v.
`
`FRED HUTCHINSON CANCER CENTER
`
`Patent Owner
`
`
`
`______________________
`
`
`
`IPR Trial No. IPR2023-
`
`U.S. Patent No. 9,987,308
`
`Issue Date: June 5, 2018
`
`Title: Method and Compositions for Cellular Immunotherapy
`
`
`
`______________________
`
`DECLARATION OF YITE JOHN LU
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`
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`Miltenyi Ex. 1023 Page 1
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`
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`of U.S. Patent No. 9,987,308
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`______________________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`______________________
`
`
`
`MILTENYI BIOMEDICINE GmbH and MILTENYI BIOTEC INC.
`
`Petitioner
`
`v.
`
`FRED HUTCHINSON CANCER CENTER
`
`Patent Owner
`
`
`
`______________________
`
`
`
`IPR Trial No. IPR2023-
`
`U.S. Patent No. 9,987,308
`
`Issue Date: June 5, 2018
`
`Title: Method and Compositions for Cellular Immunotherapy
`
`
`
`______________________
`
`DECLARATION OF YITE JOHN LU
`
`
`
`
`
`
`
`
`
`Miltenyi Ex. 1023 Page 1
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`
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`I, Yite John Lu, make the following Declaration pursuant to 28 U.S.C.
`
`Petition for Inter Partes Review
`
`of U.S. Patent No. 9,987,308
`
`§ 1746:
`
`1.
`
`I am a partner at the law firm of Orrick, Herrington & Sutcliffe LLP,
`
`attorneys for Petitioner Miltenyi Biomedicine GmbH and Miltenyi Biotec Inc. I am
`
`a member of the bar of the State of California and registered to practice in front of
`
`the United States Patent and Trademark Office.
`
`2.
`
`I submit this Declaration in connection with the above-identified
`
`Petition for Inter Partes Review proceeding of U.S. Patent No. 9,987,308 that is
`
`being requested at the U.S. Patent and Trademark Office under 35 U.S.C. §§ 311-
`
`319, 37 C.F.R. § 42.
`
`3.
`
`Exhibit 1001 is a true and correct certified copy of U.S. Patent
`
`No. 9,987,308 to Stanley R. Riddell and Michael Hudecek, issued June 5, 2018 (the
`
`“’308 patent”), which was 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, but
`
`no other alterations have been made.
`
`4.
`
`Exhibit 1002 is a true and correct copy of the Expert Declaration of
`
`Jonathan Bramson, Ph.D. (Dated March 22, 2023). An exhibit label and page
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`number 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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`1
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`Miltenyi Ex. 1023 Page 2
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`
`
`Petition for Inter Partes Review
`
`of U.S. Patent No. 9,987,308
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`5.
`
`Exhibit 1003 is a true and correct copy of Harjeet Singh et al.,
`
`Redirecting Specificity of T-cell Populations for CD19 Using the Sleeping Beauty
`
`System, 68 CANCER RES. 2961-71 (2008) (“Singh”), which is a scan retrieved
`
`pursuant to my instructions. An exhibit label and page number have been added to
`
`the bottom right corner of this document, but no other alterations have been made.
`
`6.
`
`Exhibit 1004 is a true and correct copy of 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”), which is a scan
`
`retrieved pursuant to my instructions. An exhibit label and page number have been
`
`added to the bottom right corner of this document, but no other alterations have been
`
`made.
`
`7.
`
`Exhibit 1005 is a true and correct certified copy of International
`
`Application No. PCT/US2012/030388, filed Mar. 23, 2012 (the “’388 application”),
`
`which was retrieved pursuant to my instructions. An exhibit label and page number
`
`have been added to the bottom right corner of this document, but no other alterations
`
`have been made.
`
`8.
`
`Exhibit 1006 is a true and correct certified copy of U.S. Provisional
`
`Patent Application No. 61/466,552, filed Mar. 23, 2011 (the “’552 application”),
`
`
`
`2
`
`Miltenyi Ex. 1023 Page 3
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`
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`which was retrieved pursuant to my instructions. An exhibit label and page number
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`have been added to the bottom right corner of this document, but no other alterations
`
`Petition for Inter Partes Review
`
`of U.S. Patent No. 9,987,308
`
`have been made.
`
`9.
`
`Exhibit 1007 is a true and correct copy of Carolina Berger et al.,
`
`Adoptive Transfer of Virus-Specific and Tumor-Specific T Cell Immunity, 21 CURR.
`
`OPIN. IN IMMUNOL. 224-32 (2009) (“Berger”), which is a scan retrieved pursuant to
`
`my instructions. An exhibit label and page number have been added to the bottom
`
`right corner of this document, but no other alterations have been made.
`
`10.
`
`Exhibit 1008 is a true and correct certified copy of excerpts from the
`
`certified File History of the ’308 patent, which was retrieved pursuant to my
`
`instructions. 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.
`
`11.
`
`Exhibit 1009 is a true and correct copy of 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”), which is a
`
`scan retrieved pursuant to my instructions. An exhibit label and page number have
`
`been added to the bottom right corner of this document, but no other alterations have
`
`been made.
`
`
`
`3
`
`Miltenyi Ex. 1023 Page 4
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`
`
`Petition for Inter Partes Review
`
`of U.S. Patent No. 9,987,308
`
`12.
`
`Exhibit 1010 is a true and correct copy of Laurence J.N. Cooper et al.,
`
`Chimeric Antigen Receptor on T Cells, in ENCYCLOPEDIA OF CANCER, 644-48
`
`(Manfred Schwab 2nd ed. 2008) (“Cooper”), which is a scan retrieved pursuant to
`
`my instructions. An exhibit label and page number have been added to the bottom
`
`right corner of this document, but no other alterations have been made.
`
`13.
`
`Exhibit 1011 is a true and correct copy of Michael Hudecek et al.,
`
`Adoptive T-cell Therapy for B-cell Malignancies, 2 EXPERT REV. HEMATOL. 517-32
`
`(2009) (“Hudecek I”), which is a scan retrieved pursuant to my instructions. An
`
`exhibit label and page number have been added to the bottom right corner of this
`
`document, but no other alterations have been made.
`
`14.
`
`Exhibit 1012 is a true and correct copy of 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”), which is a scan retrieved pursuant to my instructions. An exhibit
`
`label and page number have been added to the bottom right corner of this document,
`
`but no other alterations have been made.
`
`15.
`
`Exhibit 1013 is a true and correct copy of Hinrich Abken, Chimeric T
`
`Cell Receptors, in ENCYCLOPEDIA OF CANCER, 649-52 (Manfred Schwab 2nd ed.
`
`2008) (“Abken”), which is a scan retrieved pursuant to my instructions. An exhibit
`
`
`
`4
`
`Miltenyi Ex. 1023 Page 5
`
`
`
`Petition for Inter Partes Review
`
`of U.S. Patent No. 9,987,308
`
`label and page number have been added to the bottom right corner of this document,
`
`but no other alterations have been made.
`
`16.
`
`Exhibit 1014 is a true and correct copy of 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”), which is a scan
`
`retrieved pursuant to my instructions. An exhibit label and page number have been
`
`added to the bottom right corner of this document, but no other alterations have been
`
`made.
`
`17.
`
`Exhibit 1015 is a true and correct copy of 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”), which is a scan retrieved pursuant to my
`
`instructions. 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.
`
`18.
`
`Exhibit 1016 is a true and correct copy of 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”), which is a
`
`scan retrieved pursuant to my instructions. An exhibit label and page number have
`
`
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`5
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`Miltenyi Ex. 1023 Page 6
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`
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`been added to the bottom right corner of this document, but no other alterations have
`
`Petition for Inter Partes Review
`
`of U.S. Patent No. 9,987,308
`
`been made.
`
`19.
`
`Exhibit 1017 is a true and correct copy of 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”), which is a scan retrieved
`
`pursuant to my instructions. An exhibit label and page number have been added to
`
`the bottom right corner of this document, but no other alterations have been made.
`
`20.
`
`Exhibit 1018 is a true and correct certified copy of U.S. Patent
`
`Application Publication No. 2004/0126363 A1 to Michael C. Jensen, Stephen
`
`Forman, and Andrew Raubitschek, published July 1, 2004 (“Jensen”), which was
`
`retrieved pursuant to my instructions. An exhibit label and page number have been
`
`added to the bottom right corner of this document, but no other alterations have been
`
`made.
`
`21.
`
`Exhibit 1019 is a true and correct copy of 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”),
`
`which is a scan retrieved pursuant to my instructions. An exhibit label and page
`
`
`
`6
`
`Miltenyi Ex. 1023 Page 7
`
`
`
`number have been added to the bottom right corner of this document, but no other
`
`Petition for Inter Partes Review
`
`of U.S. Patent No. 9,987,308
`
`alterations have been made.
`
`22.
`
`Exhibit 1020 is a true and correct copy of 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”), which is a scan retrieved pursuant to my instructions. An
`
`exhibit label and page number have been added to the bottom right corner of this
`
`document, but no other alterations have been made.
`
`23.
`
`Exhibit 1021 is a true and correct copy of Ryan P. McGuinness et al.,
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`Anti-tumor activity of human T cells expressing the CC49-zeta chimeric immune
`
`receptor, 10 HUMAN GENE THERAPY 165-73 (1999) (“McGuinness”), which is a
`
`scan retrieved pursuant to my instructions. An exhibit label and page number have
`
`been added to the bottom right corner of this document, but no other alterations have
`
`been made.
`
`24.
`
`Exhibit 1022 is a true and correct copy of the list of the claims
`
`challenged in the above-identified Petition for Inter Partes Review proceeding of
`
`U.S. Patent No. 9,987,308 that is being requested at the U.S. Patent and Trademark
`
`Office.
`
`
`
`7
`
`Miltenyi Ex. 1023 Page 8
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`
`
`Petition for Inter Partes Review
`
`of U.S. Patent No. 9,987,308
`
`25.
`
`Exhibit 1024 is a true and correct copy of 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#StudyPageTop
`
`(last visited Mar. 6, 2023) (“ClinicalTrials.gov”), that was retrieved pursuant to my
`
`instructions. An exhibit label and page number have been added to the bottom right
`
`corner of this document, but no other alterations have been made.
`
`26.
`
`Exhibit 1025 is a true and correct copy of 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
`
`4099-102 (2010) (“Kochenderfer”), which is a scan retrieved pursuant to my
`
`instructions. An exhibit label and page number have been added to the bottom right
`
`corner of this document, but no other alterations have been made.
`
`27.
`
`Exhibit 1026 is a true and correct copy of Partow Kebriaei et al.,
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`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 THERAPY 444-50 (2012) (“Kebriaei”),
`
`which is a scan retrieved pursuant to my instructions. An exhibit label and page
`
`
`
`8
`
`Miltenyi Ex. 1023 Page 9
`
`
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`number have been added to the bottom right corner of this document, but no other
`
`Petition for Inter Partes Review
`
`of U.S. Patent No. 9,987,308
`
`alterations have been made.
`
`28.
`
`Exhibit 1027 is a true and correct copy of 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”), which is a scan retrieved pursuant to my instructions. An exhibit label
`
`and page number have been added to the bottom right corner of this document, but
`
`no other alterations have been made.
`
`29.
`
`Exhibit 1028 is a true and correct copy of 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”),
`
`which is a scan retrieved pursuant to my instructions. An exhibit label and page
`
`number have been added to the bottom right corner of this document, but no other
`
`alterations have been made.
`
`30.
`
`Exhibit 1029 is a true and correct copy of Federica Sallusto et al., Two
`
`Subsets of Memory T Lymphocytes with Distinct Homing Potentials and Effector
`
`Functions, 401 NATURE 708-12 (1999) (“Sallusto”), which is a scan retrieved
`
`pursuant to my instructions. An exhibit label and page number have been added to
`
`the bottom right corner of this document, but no other alterations have been made.
`
`
`
`9
`
`Miltenyi Ex. 1023 Page 10
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`
`
`Petition for Inter Partes Review
`
`of U.S. Patent No. 9,987,308
`
`31.
`
`Exhibit 1030 is a true and correct copy of 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”), which is a scan retrieved pursuant to
`
`my instructions. An exhibit label and page number have been added to the bottom
`
`right corner of this document, but no other alterations have been made.
`
`32.
`
`Exhibit 1031 is a true and correct copy of Simone C. Zimmerli et al.,
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`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”), which is a scan retrieved pursuant to my instructions. An exhibit label
`
`and page number have been added to the bottom right corner of this document, but
`
`no other alterations have been made.
`
`33.
`
`Exhibit 1032 is a true and correct copy of 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”) , which is a scan retrieved pursuant to my instructions. An exhibit
`
`label and page number have been added to the bottom right corner of this document,
`
`but no other alterations have been made.
`
`I declare under penalty of perjury under the law of the United States of
`
`America that the foregoing is true and correct.
`
`
`
`10
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`Miltenyi Ex. 1023 Page 11
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`
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`DATED: March 22, 2023
`
`
`Petition for Inter Partes Review
`
`of U.S. Patent No. 9,987,308
`
`/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
`
`11
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`Miltenyi Ex. 1023 Page 12
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