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IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`GENOME & COMPANY,
`Petitioner,
`
`v.
`
`THE UNIVERSITY OF CHICAGO,
`Patent Owner.
`
`Case No. PGR2019-00002
`Patent No. 9,855,302
`
`PATENT OWNER’S SECOND UPDATED EXHIBIT LIST
`
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`

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`PGR2019-00002
`Patent 9,855,302 B2
`
`Patent Owner’s Second Updated Exhibit List
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`2008
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`2009
`
`2010
`
`2011
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`2012
`
`2013
`
`Exhibit Description
`2001
`Kim et al., “Proteomic Analysis of Bifidobacterium longum subsp.
`infantis Reveals the Metabolic Insight on Consumption of Prebiotics
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`Bifidobacterium longum subsp. infantis isolates,” 33 Food
`Microbiol. 262-70 (2013).
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`Bifidobacterium sp. Strains Isolated from Infants,” 74(3) Appl.
`Environ. Microbiol. 660-66 (2008).
`Sivan et al., “Commensal Bifodobacterium promotes antitumor
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`Declaration of Sridhar Mani, M.D.
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`anti-KIR receptor therapeutic antibody that augments natural killer-
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`Metabolic Activation of the Colon Carcinogen Azoxymethane in
`Mice, Clin. Res. Toxicol. 27:656-662 (2014).
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`activity of natural killer cells as monotherapy and in combination with
`anti-CD20 antibodies, Blood123:678–686 (2014).
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`Synergistically Regulate T-cell Function to Promote Tumoral Immune
`Escape, Cancer Res 72:917–927 (2012).
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`Study of IMP321, a Novel MHC Class II Agonist, in Patients with
`Advanced Renal Cell Carcinoma, Clin. Cancer Res. 15:6225–6231
`(2009).
`
`
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`1
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`

`

`Patent Owner’s Second Updated Exhibit List
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`PGR2019-00002
`Patent 9,855,302 B2
`2014
`Le Mercier et al., VISTA Regulates the Development of Protective
`Antitumor Immunity, Cancer Res. 74:1933–1944 (2014).
`Sakuishi et al., Targeting Tim-3 and PD-1 pathways to reverse T cell
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`2194 (2010).
`Beavis et al., Blockade of A2A receptors potently suppresses the
`metastasis of CD73+ tumors, PNAS 110:14711-14716 (2013).
`Derré et al., BTLA mediates inhibition of tumor-specific CD8⁺ T cells
`that can be partially reversed by vaccination, J. Clin. Investig.
`120(1):157–167 (2010)
`Loo et al., Development of an Fc-enhanced anti-B7-H3 monoclonal
`antibody with potent antitumor activity, Clin. Cancer Res.
`18(14):3834–45 (2012).
`Curran et al., PD-1 and CTLA-4 combination blockade expands
`infiltrating T cells and reduces regulatory T and myeloid cells within
`B16 melanoma tumors, PNAS 107:4275–4280 (2010).
`Wolchok et al., Nivolumab plus Ipilimumab in Advanced Melanoma,
`N. Engl. J. Med. 369:122–133 (2013).
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`to distinct immunologic changes in-vivo, J Immunol. 194:950–959
`(2015) .
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`Patients With Metastatic Pancreatic Ductal Adenocarcinoma: A Phase
`2 Randomized Clinal Trial, JAMA Oncol., abstr. 2019.1588 (2019).
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`stereotactic body radiotherapy for metastatic head and neck
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`Immunology, Infection, and Immunity, Pier. G.B., Lyczak, J.B., and
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`Coulie et al., Tumour antigens recognized by T lymphocytes: at the
`core of cancer immunotherapy, Nature Reviews Cancer 14: 135–146
`(2014).
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`Rev. Cancer 12:307–313 (2013).
`
`2028
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`2023
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`2024
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`2025
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`2026
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`2027
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`Patent Owner’s Second Updated Exhibit List
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`2030
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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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`2037
`
`PGR2019-00002
`Patent 9,855,302 B2
`2029
`Alexandrov et al., Signatures of mutational processes in human
`cancer, Nature 500:415–421 (2013).
`Schumacher and Schreiber, Neoantigens in cancer immunotherapy,
`Science 348:69–74 (2015) .
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`and implications to cancer immunotherapy, Ann. N .Y. Acad. Sci.
`1284:1–5 (2013).
`Brown et al., Neo-antigens predicted by tumor genome meta-analysis
`correlate with increased patient survival, Genome Res. 24:743–750
`(2014).
`Transcript of Deposition of Jonathan Braun, M.D., Ph.D. (June 19,
`2019).
`Shih et al., Clinical Impact of Checkpoint Inhibitors as Novel Cancer
`Therapies, Drugs 74:1993–2013 (2014).
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`348: 56–61 (2015).
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`480:480–489 (2011).
`Berger et al., Phase I Safety and Pharmacokinetic Study of CT-011, a
`Humanized Antibody Interacting with PD-1, in Patients with
`Advanced Hematologic Malignancies, Clin. Cancer Res. 14:3044–
`3051 (2008).
`Sampson et al., Preliminary safety and activity of nivolumab and its
`combination with ipilimumab in recurrent glioblastoma (GBM):
`CHECKMATE-143, J. Clin. Oncol. 33(15S):150s, abstr. 3011 (May
`20, 2015).
`Schaff et al., Ipilimumab for recurrent glioblastoma (GBM), J. Clin.
`Oncol. 32 (suppl.; abstr. e13026) (2014).
`Le et al., Evaluation of Ipilimumab in combination with allogeneic
`pancreatic tumor cells transfected with a GM-CSF gene in previously
`treated pancreatic cancer, J. Immunother. 36:382-389 (2013).
`Lesokhin et al., Preliminary Results of a Phase I Study of Nivolumab
`(BMS-936558) in Patients with Relapsed or Refractory Lymphoid
`Malignancies, Blood 124:291 (2014).
`Slovin et al., Ipilimumab alone or in combination with radiotherapy in
`metastatic castration-resistant prostate cancer: results from an open-
`label, multicenter phase I/II study, Annals of Oncology 24:1813–1821
`(2013).
`
`2040
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`2038
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`2039
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`2041
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`2042
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`3
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`

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`Patent Owner’s Second Updated Exhibit List
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`2045
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`2046
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`2044
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`PGR2019-00002
`Patent 9,855,302 B2
`2043
`Hamanishi et al., Efficacy and Safety of Anti-PD-1 Antibody
`(Nivolumab: BMS-936558, ONO-4538) in Patients with Platinum-
`Resistant Ovarian Cancer, J. Clin. Oncol. 32:353s (suppl.; abstr.
`5511) (2014).
`El-Khoueiry et al., Phase I/II Safety and Antitumor Activity of
`Nivolumab in Patients with Advanced Hepatocellular Carcinoma, J
`Clin Oncol 33:5s (suppl.; abstr. LBA101) (2015).
`Seiwert et al., Antitumor Activity of the Anti-PD-1 Antibody
`Pembrolizumab in Biomarker-Unselected Patients with R/M Head
`and Neck Cancer: Preliminary Results from KEYNOTE-012
`Expansion Cohort, J. Clin Oncol 33 (suppl.; abstr. LBA6008) (2015).
`Segal 2015, Safety and efficacy of MEDI4736, an anti-PD-L1
`antibody, in patients from a squamous cell carcinoma of the head and
`neck (SCCHN) expansion cohort, J. Clin. Oncol. 33(15S):150s, abstr.
`3011 (May 20, 2015).
`Supplemental Data Table S3 to Exhibit 1031 (D. T. Le et al., PD-1
`Blockade in Tumors with Mismatch-Repair Deficiency, N. Engl. J.
`Med. (2015)).
`Antonia et al., Phase I/II study of nivolumab with or without
`ipilimumab for treatment of recurrent small cell lung cancer, (SCLC):
`CA2019-032 (Oral Abst. Presented May 30, 2015)
`Powles et al., MPDL3280A (anti-PD-L1) treatment leads to clinical
`activity in metastatic bladder cancer, Nature 515:558–562 (2014).
`Antonia, Association of tumor PD-L1 expression and immune
`biomarkers with clinical activity in patients with non-small cell lung
`cancer (NSCLC) treated with nivolumab (Anti-PD-1; BMS-936558;
`ONO-4538), J. Thoracic Oncol. 8(Suppl. 2):S907-S908 (2013).
`Garon et al., Safety and clinical activity of MK-3475 in previously
`treated patients (pts) with non-small cell lung cancer (NSCLC), J.
`Clin. Oncol. 32(5s):511s (abstr. 8020) (2014).
`Hodi et al., Improved Survival with Ipilimumab in Patients with
`Metastatic Melanoma, N. Engl. J. Med.363:713–723 (2010).
`Hamid et al., Safety and Tumor Responses with Lambrolizumab
`(Anti-PD-1) in Melanoma, N. Engl. J. Med. 369:134–144 (2013).
`Kefford et al., Clinical Efficacy and Correlation With Tumor PD-L1
`Expression in Patients With Melanoma Treated With the Anti-PD-1
`Monoclonal Antibody Pembrolizumab (MK-3475), J. Clin Oncol
`32(5s):180s (abstr. 3005) (2014).
`
`2047
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`2048
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`2049
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`2050
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`2051
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`2052
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`2053
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`2054
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`4
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`

`

`Patent Owner’s Second Updated Exhibit List
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`2056
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`2057
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`2058
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`2059
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`2060
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`2061
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`2062
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`2063
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`2064
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`2065
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`PGR2019-00002
`Patent 9,855,302 B2
`2055
`Ansell et al., PD-1 Blockade with Nivolumab in Relapsed or
`Refractory Hodgkin’s Lymphoma, N. Engl. J. Med. 372:311–319
`(2015).
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`1 cancer trials, Eur. J. Cancer 47(10):1490-7 (2011).
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`Re-induction Therapy with an Anti-PD-1 Antibody, Clin. Cancer Res.
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`melanoma patients surviving more than 2 years following treatment in
`a phase III trial (MDX010-20), Ann. Oncol. 24:2694–2698 (2013).
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`
`2068
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`2066
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`2067
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`Patent Owner’s Second Updated Exhibit List
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`2070
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`2071
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`2072
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`2073
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`2074
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`2077
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`2078
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`PGR2019-00002
`Patent 9,855,302 B2
`2069
`Perše et al., Morphological and Molecular Alterations in 1,2
`Dimethylhydrazine and Azoxymethane Induced Colon
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`(Nov. 21, 2019).
`
`2075
`2076
`
`Dated: December 17, 2019
`
`
`Respectfully submitted,
`
` /Scott E. Kamholz/
`Scott E. Kamholz, Reg. No. 48,543
`Covington & Burling LLP
`One CityCenter
`850 Tenth Street, NW
`Washington, DC 20001
`Phone: (202) 662-5339
`Fax: (202) 778-5339
`
`
`6
`
`

`

`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6, I certify that on the date listed below, a copy of
`
`this paper and every exhibit filed with this paper (if any) was served on the Petitioner
`
`by electronic mail to the following counsel of record for Petitioner:
`
`John A. Bauer (john.bauer@nelsonmullins.com)
`Kongsik Kim (kongsik.kim@nelsonmullins.com)
`Jane Remillard (jane.remillard@nelsonmullins.com)
`Amy Mandragouras (amy.mandragouras@nelsonmullins.com)
`
`
`
`Dated: December 17, 2019
`
`
`
`
` /Scott E. Kamholz/
`Scott E. Kamholz, Reg. No. 48,543
`
`
`
`
`
`

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