UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________
`
`
`
`EVERGREEN THERAGNOSTICS, INC.
`
`Petitioner
`
`– vs. –
`
`ADVANCED ACCELERATOR APPLICATIONS SA
`
`Patent Owner
`
`____________________
`
`CASE NO. PGR2021-00003
`
`
`
`PETITIONER EVERGREEN THERAGNOSTICS, INC.’S
`UPDATED LIST OF EXHIBITS
`
`
`
`
`
`
`
`
`
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________
`
`
`
`EVERGREEN THERAGNOSTICS, INC.
`
`Petitioner
`
`– vs. –
`
`ADVANCED ACCELERATOR APPLICATIONS SA
`
`Patent Owner
`
`____________________
`
`CASE NO. PGR2021-00003
`
`
`
`PETITIONER EVERGREEN THERAGNOSTICS, INC.’S
`UPDATED LIST OF EXHIBITS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`LIST OF EXHIBITS
`
`Exhibit
`1001
`
`Description
`U.S. Patent No. 10,596,276 (“the ’276 patent”)
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`Number Not Used
`
`Prosecution History of U.S. Patent No. 10,596,276 (Application
`Serial No. 16/175,261) (“the ’261 application”)
`
`Number Not Used
`
`Declaration of Stephan Maus Under 37 C.F.R. § 1.68 in Support of
`Petition for Post Grand Review of U.S. Patent No. 10,596,276 (All
`Claims)
`
`Number Not Used
`
`Number Not Used
`
`Expert Declaration of Ingrid Hsieh-Yee, Ph.D. Under 37 C.F.R.
`§ 1.68 (“Hsieh-Yee Declaration”)
`
`S. Maus, et al., Aspects on radiolabeling of 177Lu-DOTA-TATE: After
`C18 purification re-addition of ascorbic acid is required to maintain
`radiochemical purity, Int. J. Diagnostic Imaging, 1(1):5-12, 2014
`(“the Maus article”)
`
`D. Kwekkeboom et al., [177Lu-DOTA0,Tyr3]octreotate: comparison
`with [111In-DTPA0]octreotide in patients, Eur. J. Nucl. Med.,
`28(9):1319-1325, Sept. 2001 ( “Kwekkeboom”)
`
`J. Strosberg et al., Phase 3 Trial of 177Lu-Dotatate for Midgut
`Neuroendocrine Tumors, N. Engl. J. Med., 376(2):125–135, Jan. 12,
`2017 (“Strosberg”)
`
`1012
`
`Protocol associated with Strosberg (Ex. 1011) providing the protocol
`used in the clinical study reported in Strosberg (“Protocol”)
`
`2
`
`
`
`
`
`
`
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`U.S. Patent No. 6,261,536 (“the ’536 patent”)
`
`L. De León-Rodríguez et al., The Synthesis and Chelation Chemistry
`of DOTA−Peptide Conjugates, Bioconjugate Chem., 19(2):391-402,
`Feb. 2008 (“De León-Rodríguez”)
`
`P. Scott et al., Studies into Radiolytic Decomposition of Fluorine-18
`Labeled Radiopharmaceuticals for Positron Emission Tomography,
`Appl. Radiat. Isot., 67(1): 88-94 Jan. 2009 (“Scott”)
`
`S. Banerjee et al., Lutetium-177 Therapeutic Radiopharmaceuticals:
`Linking Chemistry, Radiochemistry, and Practical Applications,
`Chem. Rev., 115:2934−2974, 2015 (“Banerjee”)
`
`E. de Blois et al., Application of single-vial ready-for-use formulation
`of 111In- or 177Lu-labelled somatostatin analogs, Applied Radiation
`and Isotopes, 85:28-33, 2014 (“de Blois”)
`
`United States Security and Exchange Commission Form F-1 for
`Advanced Accelerator Applications S.A., 2014 (“SEC Statement”)
`
`U.S. Published Patent Application No. US 2012/0065365 (“the ’365
`publication”)
`
`1020 W. Breeman et al., Optimising conditions for radiolabelling of
`DOTA-peptides with 90Y, 111In and 177Lu at high specific activities,
`Eur. J, Nuc. Med. and Molecular Imaging, 30(6):917-920, June 2003
`(“Breeman 2003”)
`
`1021
`
`1022
`
`T. Das et al., Formulation of Patient Dose of 177Lu-DOTA-TATE in
`Hospital Radiopharmacy in India: Preparation Using In Situ
`Methodology Vis-a-Vis Freeze-Dried Kit, Cancer Biotherapy and
`Radiopharmaceuticals, 29(7):301-302, 2014 (“Das 1”)
`
`T. Das et al., Preparation of DOTA-TATE and DOTA-NOC freeze-
`dried kits for formulation of patient doses of 177Lu-labeled agents and
`their comparison for peptide receptor radionuclide therapy
`application, J. Radioanal. Nucl. Chem., 299:1389-1398, 2014 (“Das
`2”)
`
`3
`
`
`
`
`
`1023
`
`S. Liu et al., Stabilization of 90Y-Labeled DOTA-Biomolecule
`Conjugates Using Gentisic Acid and Ascorbic Acid, Bioconjugate
`Chem., 12:554-558, 2001 (“Liu”)
`
`1024
`
`Lutetium 177 – LuMark® Lu-177 Chloride product page,
`https://www.idb-holland.com/our-products/lutetium-177-lumark/
`
`1025 M. Luna-Gutiérrez et al., Freeze-dried multi-dose kits for the fast
`preparation of 177Lu-Tyr3-octreotide and 177Lu-PSMA(inhibitor)
`under GMP conditions, J. Radioanal. Nucl. Chem., pp. 2181-2188,
`published on-line Nov. 2, 2017 (“Luna-Gutierrez”)
`
`1026
`
`J. Sosabowski et al., Conjugation of DOTA-like chelating agents to
`peptides and radiolabeling with trivalent metallic isotopes, Nature
`Protocols, 1(2):972-976, 2006 (“Sosabowski”)
`
`1027 W. Breeman et al., Overview of Development and Formulation of
`177Lu-DOTA-TATE for PRRT, Current Radiopharmaceuticals, 9:8-18,
`2016 (“Breeman 2016”)
`
`1028
`
`1029
`
`1030
`
`1031
`
`A. Filice et al., Radiolabeled Somatostatin Analogues Therapy in
`Advanced Neuroendocrine Tumors: A Single Centre Experience, J.
`Oncology, 2012:1-10, Aug. 9, 2012 (“Filice”)
`
`J. Chen et al., Synthesis, stabilization and formulation of [177Lu]Lu-
`AMBA, a systemic radiotherapeutic agent for Gastrin Releasing
`Peptide receptor positive tumors, Applied Radiation and Isotopes,
`66(4):497–505, Apr. 2008 (“Chen”)
`
`Guidance for Industry, Q1A(R2) Stability Testing of New Drug
`Substances and Products, U.S. Department of Health and Human
`Services, Food and Drug Administration, Center for Drug Evaluation
`and Research (CDER), Center for Biologics Evaluation and Research
`(CBER), Nov. 2003 (“FDA Guidance”)
`
`T. Das et al., On the preparation of a therapeutic dose of 177Lu-
`labeled DOTA–TATE using indigenously produced 177Lu in medium
`flux reactor, Applied Radiation and Isotopes, 65:301-308, 2007 (“Das
`3”)
`
`
`
`
`4
`
`
`
`
`
`
`
`
`
`
`
`1032
`
`A. Aslani et al., Lutetium-177 DOTATATE Production with an
`Automated Radio-pharmaceutical Synthesis System, Asia Oceania J.
`Nucl. Med. Biol., 3(2):107-115, 2015 (“Aslani”)
`
`1033
`
`1034
`
`Number Not Used
`
`Number Not Used
`
`1035 W. Breeman et al., The addition of DTPA to [177Lu-DOTA0,
`Tyr3]octreotate prior to administration reduces rat skeleton uptake of
`radioactivity, Eur. J. Nucl. Med. Mol. Imaging, 30(2):312-315, Feb.
`2003 (“Breeman 2003B”)
`
`1036
`
`A. Frilling et al., Treatment with 90Y- and 177Lu-DOTATOC in
`patients with metastatic neuroendocrine tumors, Surgery,140(6):968-
`977, 2006 (“Frilling”)
`
`1037
`
`Declaration of Paul E. Dietz, Ph.D., Esq. in Support of Reply to
`Patent Owner’s Preliminary Response, with Exhibits A, B, and C
`
`5
`
`
`
`
`
`CERTIFICATE OF SERVICE
`This is to certify that I caused to be served a true and correct copy of the
`
`foregoing Petitioner Evergreen Theragnostics, Inc.’s Updated List of Exhibits by
`
`email on this 22nd day of February, 2021 on the following attorneys of record:
`
`Jane M. Love, Ph.D.
`GIBSON, DUNN & CRUTCHER LLP
`200 Park Avenue
`New York, NY 10166
`jlove@gibsondunn.com
`
`Kyanna Sabanoglu
`GIBSON, DUNN & CRUTCHER LLP
`200 Park Ave
`New York, NY 10166
`ksabanoglu@gibsondunn.com
`
`
`
`Respectfully submitted,
`
`February 22, 2021
`
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`
`
`/C. Kyle Musgrove/
`C. Kyle Musgrove
`Registration No. 40,742
`Attorney for Evergreen Theragnostics, Inc.
`
`
`
`
`
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