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`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
`
`v.
`
`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
`Patent Owner
`
`
`
`
`
`
`IPR Trial No. IPR2022-00855
`U.S. Patent No. 9,540,445
`
`
`
`
`
`
`JOINT MOTION TO KEEP CONFIDENTIAL AND SEPARATE UNDER
`35 U.S.C. § 327(b) AND 37 C.F.R. § 42.74(c)
`
`41591362.1
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`PATENT OWNER’S EXHIBIT LIST
`
`Reference
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`Denise Grady, In Girl’s Last Hope, Altered Immune Cells Beat
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`leukemia-using-altered-t-cells.html.
`Denise Grady, F.D.A. Approves First Gene-Altering Leukemia
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`transferred autologous CD19-targeted T cells in patients with relapsed
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`James N. Kochenderfer et al., B-cell depletion and remissions of
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`2709 (2012).
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`World, PENN MEDICINE (Apr. 26, 2018),
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`100-most-influential-people-world.
`
`41591362.1
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`2022
`
`Holly Auer, Penn Medicine Immunotherapy Pioneer Carl June, MD,
`Awarded 2015 Paul Ehrlich and Ludwig Darmstaedter Prize, PENN
`TODAY (Mar. 11, 2015), https://penntoday.upenn.edu/news/penn-
`medicine-immunotherapy-pioneer-carl-june-md-awarded-2015-paul-
`ehrlich-and-ludwig-darmstaed.
`Andrew Pollock, Setting the Body’s ‘Serial Killers’ Loose on Cancer,
`N.Y. TIMES (Aug. 1, 2016),
`https://www.nytimes.com/2016/08/02/health/cancer-cell-therapy-
`immune-system.html.
`2015 Watanabe Award Winner Carl H. June, IND. CLINICAL AND
`TRANSLATIONAL SCIS. INST., https://indianactsi.org/awards/watanabe-
`award-winners/2015-watanabe-award-winner-carl-h-june/ (last visited
`July 12, 2022).
`Agilent Presents Thought Leader Award to Drs. Carl H. June and
`Michael Milone, AGILENT TECHS. INC. (Nov. 17, 2020),
`https://www.agilent.com/about/newsroom/presrel/2020/17nov-
`ca20030.html.
`Information Disclosure Statement Initialed by Examiner (Apr. 18,
`2016), U.S. Patent Application No. 14,997,136.
`Information Disclosure Statement Initialed by Examiner (Apr. 18,
`2027
`2016), U.S. Patent Application No. 14,997,136.
`2028 World Intell. Prop. Org. Patent Application No. WO 02/077029 A2.
`Pilot Study for Patients with Chemotherapy Resistant or Refractory
`CD19 Leukemia and Lymphoma (CART-19), CLINICALTRIALS.GOV
`(April 29, 2009),
`[http://web.archive.org/web/20090903002304/http://clinicaltrials.gov/c
`t2/show/NCT00891215].
`2030 Amendments to the Claims (Nov. 13, 2018), U.S. Patent Application
`No. 15,353,899.
`Steven A. Rosenberg et al., Use of Tumor-Infiltrating Lymphocytes and
`Interleukin-2 in the Immunotherapy of Patients with Metastatic
`Melanoma, 319 NEW ENG. J. MED. 1676 (1988).
`Michael C. Jensen et al., Antitransgene Rejection Responses Contribute
`to Attenuated Persistence of Adoptively Transferred CD20/CD19-
`Specific Chimeric Antigen Receptor Redirected T Cells in Humans, 16
`BIOLOGY BLOOD AND MARROW TRANSPLANTATION 1245 (2010).
`
`2023
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`2024
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`2025
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`2026
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`2029
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`2031
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`2032
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`2033
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`2034
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`2035
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`2036
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`2038
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`2039
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`2040
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`2041
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`Richard A. Morgan et al., Case Report of a Serious Adverse Event
`Following the Administration of T Cells Transduced With a Chimeric
`Antigen Receptor Recognizing ERBB2, 18 MOLECULAR THERAPY 843
`(2010).
`David L. Porter et al., A phase 1 trial of donor lymphocyte infusions
`expanded and activated ex vivo via CD3/CD28 costimulation, 107
`BLOOD 1325 (2006).
`Grazyna Lipowska-Bhalla, Targeted immunotherapy of cancer with
`CAR T cells: achievements and challenges, 61 CANCER IMMUNOLOGY,
`IMMUNOTHERAPY 953 (2012).
`Latest paper from the father of CAR-T: CAR-T really completely cured
`cancer, MEDICALTREND.ORG,
`https://medicaltrend.org/2022/02/03/latest-paper-from-the-father-of-
`car-t-car-t-really-completely-cured-cancer/ (last visited July 13, 2022).
`2037 Bipulendu Jena et al., Redirecting T-cell specificity by introducing a
`tumor-specific chimeric antigen receptor, 116 BLOOD 1035 (2010).
`Michael H. Kershaw et al., A Phase I Study on Adoptive
`Immunotherapy Using Gene-Modified T Cells for Ovarian Cancer, 12
`CLINICAL CANCER RSCH. 6106 (2006).
`Cor H.J. Lamers et al., Treatment of Metastatic Renal Cell Carcinoma
`With Autologous T-Lymphocytes Genetically Retargeted Against
`Carbonic Anhydrase IX: First Clinical Experience, 24 J. CLINICAL
`ONCOLOGY e20 (2006).
`ASH honors Bruce R. Blazar, M.D., and Carl H. June, M.D., with 2012
`Ernest Beutler Lecture and Prize, SCIENCEX (Aug. 27, 2012),
`https://sciencex.com/wire-news/107531358/ash-honors-bruce-r-blazar-
`md-and-carl-h-june-md-with-2012-ernest.html.
`Renier J. Brentjens et al., Genetically Targeted T Cells Eradicate
`Systemic Acute Lymphoblastic Leukemia Xenografts, 13 CLINICAL
`CANCER RSCH. 5426 (2007).
`2042 U.S. Patent No. 7,402,431.
`Cancer treatment myths: Any truth to these common beliefs?, MAYO
`CLINIC (March 22, 2022), https://www.mayoclinic.org/diseases-
`conditions/cancer/in-depth/cancer/art-20046762.
`2044 Adam Bagg Aff., July 19, 2022.
`SITC Smalley Award 2013 Recipient, SOC’Y FOR IMMUNOTHERAPY OF
`CANCER, https://www.sitcancer.org/funding/named-funds-and-
`awards2/smalley/2013 (last visited July 19, 2022).
`
`2043
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`2045
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`2046
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`2050
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`2051
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`2054
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`2056
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`2057
`
`AAI-Steinman Award for Human Immunology Research Past
`Recipients, AM. ASS’N OF IMMUNOLOGISTS,
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`for-Human-Immunology-Research/Past-Recipients.aspx (last visited
`July 19, 2022).
`2048 Decl. of Thomas S. Fletcher, Nov. 8, 2022.
`2049
`Search Results of Clinical Trials Associated with Dr. Richard P.
`Junghans, CLINICALTRIALS.GOV (Jan. 12, 2023),
`https://beta.clinicaltrials.gov/search?distance=SO&term=Richard
`Junghans.
`Recombinant DNA Advisory Committee Minutes of Meeting, US DEP’T
`OF HEALTH & HUM. SERVS., (Feb. 10, 2003).
`Recombinant DNA Advisory Committee Minutes of Meeting, US DEP’T
`OF HEALTH & HUM. SERVS., (Mar. 16, 2005).
`2052 Hildegund C.J. Ertl et al., Considerations for the Clinical Application
`of Chimeric Antigen Receptor (CAR) T Cells: Observations from a
`Recombinant DNA Advisory Committee (RAC) Symposium June 15,
`2010, 71 CANCER RES. 1 (2011).
`2053 Augusto C. Ochoa et al., Immune Defects in T Cells
`From Cancer Patients: Parallels in Infectious Diseases, in CURRENT
`CLINICAL ONCOLOGY: CANCER IMMUNOTHERAPY AT THE CROSSROADS:
`HOW TUMORS EVADE IMMUNITY AND WHAT CAN BE DONE 35 (J. H.
`Finke & R. M. Bukowski eds., 2004).
`Peter S. Kim et al., Features of responding T cells in cancer and
`chronic infection, 22 CURRENT OPINION IN IMMUNOLOGY 223 (2010).
`2055 Marta Czesnikiewicz-Guzik et al., T cell subset-specific susceptibility
`to aging, 127 CLINICAL IMMUNOLOGY 107 (2008).
`Jonathan E. Benjamin et al., Biology and clinical effects of natural
`killer cells in allogeneic transplantation, 22 CURRENT OPINION IN
`ONCOLOGY 130 (2010).
`Elisabeth Ersvaer et al., Intensive chemotherapy for acute myeloid
`leukemia differentially affects circulating TC1, TH1, TH17 and TREG
`cells, 11 BMC IMMUNOLOGY 1 (2010).
`2058 Miroslaw J. Szczepanski, Increased Frequency and Suppression by
`Regulatory T Cells in Patients with Acute Myelogenous Leukemia, 15
`CLINICAL CANCER RSCH. 3325 (2009).
`Sabine Mumprecht et al., Programmed death 1 signaling on chronic
`myeloid leukemia–specific T cells results in T-cell exhaustion and
`disease progression, 114 BLOOD 1528 (2009).
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`2064
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`2060 Gideon Gross et al., Expression of immunoglobulin-T-cell receptor
`chimeric molecules as functional receptors with antibody-type
`specificity, 86 IMMUNOLOGY 10024 (1989).
`2061 Anna Kruschinski et al., Engineering antigen-specific primary human
`NK cells against HER-2 positive carcinomas, 105 PROC. OF THE NAT’L
`ACAD. OF THE SCIS. 17481 (2008).
`2062 Olan Dolezal et al., ScFv multimers of the anti-neuraminidase antibody
`NC10: shortening of the linker in single-chain Fv fragment assembled
`in VL to VH orientation drives the formation of dimers, trimers,
`tetramers and higher molecular mass multimers, 13 PROTEIN ENG’G
`565 (2000).
`2063 Michael C. Milone et al., Chimeric Receptor Containing CD137 Signal
`Transduction Domains Mediate Enhanced Survival of T Cells and
`Increased Antileukemic Efficacy In Vivo: Supplementary Materials and
`Methods, 17 MOLECULAR THERAPY 1453 (2009).
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`current insights and future prospects, 266 J. INTERNAL MED. 154
`(2009).
`2065 Chihaya Imai et al., Genetic modification of primary natural killer cells
`overcomes inhibitory signals and induces specific killing of leukemic
`cells, 106 BLOOD 376 (2005).
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`NK Cells Can Specifically Inhibit Tumor Progression In Vivo, 181 THE
`J. IMMUNOLOGY 3449 (2008).
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`alloreactivity in mismatched hematopoietic transplants, 295 SCI. 2097
`(2002).
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`changes in gene expression of CD4 and CD8 T cells, 115 J. CLINICAL
`INVESTIGATION 1797 (2005).
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`2023).
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`2072
`John Carroll, Novartis may still be grappling with Kymriah sales, but
`historic CAR-T promise still shines through 5-year data,
`ENDPOINTSNEWS (June 13, 2022), https://endpts.com/novartis-may-
`still-be-grappling-with-kymriah-sales-but-historic-car-t-promise-still-
`shines-through-5-year-data/.
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`Immunoconjugate for the Treatment of B-Cell Malignancies, 17
`CLINICAL CANCER RSCH. 6448 (2011).
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`T-cell receptor signalling paradigm, 4 NATURE REVS. IMMUNOLOGY
`301 (2004).
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`Proximal Signaling and Downstream Functions in Immortalized
`and Primary T Cells, 4 PLOS ONE 1 (2009).
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`Expression During Activation of Human Peripheral Blood T Cells
`and Leukemic Jurkat T Cells, 83 LAB’Y INVESTIGATION 765 (2003).
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`the Jurkat cell line, 19 BMC GENOMICS 1 (2018).
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`Containing CD137 Signal Transduction Domains Mediate Enhanced
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`MOLECULAR THERAPY 1278 (2015).
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`CORP. (May 2022).
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`Looking Forward, 22 MOLECULAR THERAPY 1564 (2014).
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`study of intra-arterial chimeric antigen receptor modified T cell
`therapy for CEA+ liver metastases, 21 CLINICAL CANCER RSCH. 1
`(2015).
`2082 University of Pennsylvania’s Policy on Privacy in the Electronic
`Environment
`Settlement and Licensing Agreement
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`2076
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`2077
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`2080
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`2081
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`2083
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`Pursuant to 35 U.S.C. § 327(b) and 37 C.F.R. § 42.74(c), Petitioners Miltenyi
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`Biomedicine GmbH and Miltenyi Biotec Inc. and Patent Owner The Trustees of the
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`University of Pennsylvania (collectively, “Parties”) jointly move for authorization
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`to file their Settlement and License Agreement (“Agreement”) and its respective
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`exhibit, Confidential Exhibit 2083—as referenced in the concurrently filed Joint
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`Motion to Terminate Proceeding, Paper No. 28—as business confidential
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`information, which shall be kept separate from the file of the involved patent, and
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`made available only to Federal Government agencies on written request, or to any
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`person on a showing of good cause. The terms of the Agreement (submitted as
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`Confidential Exhibit 2083) require the Parties to treat the Agreement as confidential
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`information and prohibits disclosure to third parties, and the terms of the Agreement
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`reflect sensitive and proprietary information of both Parties. In view of the terms of
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`the Agreement, and the Parties’ joint request to file it confidentially, the Settlement
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`and License Agreement has been filed for access by the “Board and Parties Only.”
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`The Parties further request that should such a petition be filed, the Parties be given
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`the opportunity to comment on the request before a decision is made with respect to
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`whether it should be granted or denied.
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`CONCLUSION
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`For the foregoing reasons, the Parties respectfully request that the Board treat
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`the Agreement as business confidential information and make it available only
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`41591362.1
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`where required by statute or regulation. See 35 U.S.C. § 327(b); 37 C.F.R.
`
`§ 42.72(c).
`
`Dated: May 16, 2023
`
`Respectfully submitted,
`
`By:
`
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`
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`Jessamyn S. Berniker (Reg. No.
`72,328)
`David M. Krinsky (Reg. No. 72,339)
`Thomas S. Fletcher (Reg. No.
`72,383)
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue SW
`Washington, DC 20024
`Tel: (202) 434-5000
`jberniker@wc.com
`dkrinsky@wc.com
`tfletcher@wc.com
`
`
`Backup Counsel for Real Party in
`Interest and Licensee Novartis
`Pharma AG
`
`
`
`
`
`By:
`
`/Brian R. Landry/
`Brian Landry (Reg. No. 62,074)
`SAUL EWING LLP
`131 Dartmouth Street, Suite 501
`Boston, MA 02116
`Tel: (617) 912-0969
`brian.landry@saul.com
`Counsel for Patent Owner
`
`Kathryn Doyle (Reg. No. 36,317)
`SAUL EWING LLP
`Centre Square West
`1500 Market Street, 38th Floor
`Philadelphia, PA 19102
`Tel: (215) 972-7734
`kathryn.doyle@saul.com
`
`Alireza Behrooz (Reg. No. 60,882)
`SAUL EWING LLP
`1919 Pennsylvania Avenue, N.W.,
`Suite 550
`Washington, DC 20006-3434
`Tel: (202) 295-6687
`alireza.behrooz@saul.com
`Backup Counsel for Patent Owner
`
`
`
`
`
`
`/Yite John Lu/
`Yite John Lu (Reg. No. 63,158)
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`41591362.1
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`ORRICK HERRINGTON &
`SUTCLIFFE LLP
`355 S. Grand Ave., Ste. 2700
`Los Angeles, CA 90071
`Tel: (213) 612-2374
`Fax: (213) 612-2499
`PTABDocketL2Y7@orrick.com
`
`Gary N. Frischling (Reg. No. 35,515)
`ORRICK HERRINGTON &
`SUTCLIFFE LLP
`355 South Grand Avenue, Suite 2700
`Los Angeles, CA 90071
`Tel: (213) 629-2020
`Fax: (213) 612-2499
`PTABDocketG2F1@orrick.com
`Counsel for Petitioners
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`41591362.1
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`Certification of Service Under 37 C.F.R. § 42.6(e)(4)
`
`The undersigned hereby certifies that the Joint Motion to Keep Confidential
`
`and Separate was served in its entirety by filing through the Patent Trial and Appeal
`
`Case Tracking System (P-TACTS), as well as providing a courtesy copy via e-mail
`
`to the following attorneys of record for Petitioners listed below:
`
`PTABDocketL2Y7@orrick.com
`
`PTABDocketG2F1@orrick.com
`
`
`
`
`
`By: /Brian R. Landry/
`Reg. No. 62,074
`
`Yite John Lu
`
`Gary N. Frischling
`
`
`
`Date: May 16, 2023
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