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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 TERMINATE PROCEEDING
`PURSUANT TO 35 U.S.C. § 327(a) AND 37 C.F.R. § 42.74
`
`41591247.1
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`PATENT OWNER’S EXHIBIT LIST
`
`Reference
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`1
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`100-most-influential-people-world.
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`41591247.1
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`2022
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`Holly Auer, Penn Medicine Immunotherapy Pioneer Carl June, MD,
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`medicine-immunotherapy-pioneer-carl-june-md-awarded-2015-paul-
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`Andrew Pollock, Setting the Body’s ‘Serial Killers’ Loose on Cancer,
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`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
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`Agilent Presents Thought Leader Award to Drs. Carl H. June and
`Michael Milone, AGILENT TECHS. INC. (Nov. 17, 2020),
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`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.
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`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.
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`Interleukin-2 in the Immunotherapy of Patients with Metastatic
`Melanoma, 319 NEW ENG. J. MED. 1676 (1988).
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`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).
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`2034
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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).
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`2043
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`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.
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`Junghans.
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`OF HEALTH & HUM. SERVS., (Feb. 10, 2003).
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`2052 Hildegund C.J. Ertl et al., Considerations for the Clinical Application
`of Chimeric Antigen Receptor (CAR) T Cells: Observations from a
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`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:
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`Finke & R. M. Bukowski eds., 2004).
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`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).
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`killer cells in allogeneic transplantation, 22 CURRENT OPINION IN
`ONCOLOGY 130 (2010).
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`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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`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).
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`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).
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`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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`NK Cells Can Specifically Inhibit Tumor Progression In Vivo, 181 THE
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`INVESTIGATION 1797 (2005).
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`shines-through-5-year-data/.
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`T-cell receptor signalling paradigm, 4 NATURE REVS. IMMUNOLOGY
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`2082 University of Pennsylvania’s Policy on Privacy in the Electronic
`Environment
`Settlement and Licensing Agreement
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`Pursuant to 35 U.S.C. § 327(a) and 37 C.F.R. § 42.74, 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, “the Parties”) jointly move for dismissal
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`and termination of the Inter Partes Review of U.S. Patent No. 9,540,445 (“the ’445
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`Patent”), Case No. IPR2022-00855 (“the IPR Proceeding”).
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`The Parties respectfully submit that termination of the IPR Proceeding is
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`appropriate at this stage because the Parties have reached an agreement resolving the
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`dispute involving the patent at issue in the IPR Proceeding. See Confidential
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`Exhibit 2083.
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`On April 11, 2022, Petitioner filed a Petition for Inter Partes Review seeking
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`to cancel claims 1-17, 19-24, and 26 of the ’123 Patent. See Paper No. 1. Patent
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`Owner filed a preliminary response on July 19, 2022 (see Paper No. 7), and the
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`Board instituted Inter Partes Review on October 11, 2022 (see Paper No. 9). Patent
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`Owner filed a response on February 13, 2023. See Paper No. 18. To date, Petitioner
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`has not yet filed a reply to the Patent Owner’s response.
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`On May 12, 2023, Petitioner and Patent Owner executed a confidential
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`Settlement and License Agreement to resolve all present disputes and to avoid any
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`additional disputes regarding the ’123 Patent. As required under 35 U.S.C. § 327(b)
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`and 37 C.F.R. 42.74(b), filed herewith is a true and accurate copy of the confidential
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`41591247.1
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`Settlement and License Agreement resolving the dispute in the IPR proceeding.
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`That Confidential Settlement and License Agreement also resolves the dispute in co-
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`pending IPR2022-00852, regarding U.S. Patent 9,518,123, which the parties are
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`concurrently moving to terminate. As of the signing of the confidential Settlement
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`and License Agreement, there are no other related proceedings before the Board, nor
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`any related proceedings between the parties regarding the ’445 Patent. Accordingly,
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`termination is appropriate because all disputes between the parties regarding the
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`’123 Patent have been resolved.
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`Pursuant to 37 C.F.R. § 42.5 and 42.72, the Board may terminate a trial
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`without rendering a final written decision where appropriate, including pursuant to
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`a joint request under 35 U.S.C. § 327(a). See, e.g., Winplus N. Am., Inc. v. Pilot,
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`Inc., IPR2018-00488, Paper 13 (P.T.A.B. Oct. 24, 2018). A dismissal of this IPR
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`Proceeding would promote efficiency and minimize unnecessary costs. This
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`proceeding is still in its preliminary stages. While the Board issued its institution
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`decision in October of 2022 and Patent Owner filed its response in February of 2023,
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`Petitioner has not yet filed a reply. Oral argument is not scheduled until July 13,
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`2023. Thus, the Board has not conducted an oral hearing, decided the merits of this
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`proceeding, or issued a final written decision.
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`The Parties also respectfully submit that termination of the IPR Proceeding is
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`appropriate as both Congress and federal courts have expressed a strong interest in
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`41591247.1
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`encouraging settlement in litigation. See, e.g., Delta Air Lines, Inc. v. August, 450
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`U.S. 346, 352 (1981) (“The purpose of [Fed. R. Civ. P.] 68 is to encourage the
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`settlement of litigation.”); Bergh v. Dept. of Transp., 794 F.2d 1575, 1577 (Fed. Cir.
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`1986) (“The law favors settlement of cases.”), cert. denied, 479 U.S. 950 (1986).
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`The Federal Circuit places a particularly significant emphasis on settlement. See
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`Cheyenne River Sioux Tribe v. U.S., 806 F.2d 1046, 1050 (Fed. Cir. 1986) (noting
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`that the law favors settlement to reduce antagonism and hostility between parties).
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`Ending this IPR Proceeding further promotes the Congressional goal of establishing
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`a more efficient patent system by limiting unnecessary and counterproductive costs.
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`See Changes to Implement Inter Partes Review Proceedings, Post-Grant Review
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`Proceedings, and Transitional Program for Covered Business Method Patents, 77
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`Fed. Reg. 48,680 (Aug. 14, 2012).
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`In agreement with Congress and the federal courts, the Board’s Trial Practice
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`Guide stresses that “[t]here are strong public policy reasons to favor settlement
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`between the parties to a proceeding. The Board expects that a proceeding will
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`terminate after the filing of a settlement agreement, unless the Board has already
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`decided the merits of the proceeding. 35 U.S.C. 317(a), as amended, and 35 U.S.C.
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`327.” Office Patent Trial Practice Guide; 77 Fed. Reg. 48,756, 46,768 (Aug. 14,
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`2012).
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`The Parties have submitted a true and correct copy of their confidential
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`Settlement and License Agreement as Confidential Exhibit 2083. In accordance
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`with 35 U.S.C. § 327(b) and 37 C.F.R. § 42.74(c), the parties have also concurrently
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`submitted herewith a Joint Motion to Keep Confidential and Separate, Paper No. 28,
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`requesting that the confidential Settlement and License Agreement be treated as
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`business confidential information, be kept separate from the file of the involved
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`patent, and be made available only to Federal Government agencies on written
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`request, or to any person on showing of good cause.
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`Petitioner and Patent Owner certify that there are no other agreements, oral or
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`written, between the Parties made in connection with, or in contemplation of, the
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`termination of the proceeding. Both Petitioner and Patent Owner support
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`termination of the IPR Proceeding.
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`CONCLUSION
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`For the foregoing reasons, Petitioner and Patent Owner jointly request that the
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`Board dismiss this IPR Proceeding in its entirety.
`
`Dated: May 16, 2023
`
`Respectfully submitted,
`
`
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`
`
`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
`
`41591247.1
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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:
`
`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
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`
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`/Yite John Lu/
`Yite John Lu (Reg. No. 63,158)
`ORRICK HERRINGTON &
`SUTCLIFFE LLP
`355 S. Grand Ave., Ste. 2700
`Los Angeles, CA 90071
`Tel: (213) 612-2374
`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
`PTABDocketG2F1@orrick.com
`Counsel for Petitioners
`
`
`
`
`41591247.1
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`12
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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 Terminate
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`Proceeding was served in its entirety by filing through the Patent Trial and Appeal
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`Case Tracking System (P-TACTS), as well as providing a courtesy copy via e-mail
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`to the following attorneys of record for Petitioners listed below:
`
`Yite John Lu
`
`Gary N. Frischling
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`
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`Date: May 16, 2023
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`PTABDocketL2Y7@orrick.com
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`PTABDocketG2F1@orrick.com
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`
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`By: /Brian R. Landry/
`Reg. No. 62,074
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`41591247.1
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`13
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