Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and ROBERT A.
`POLLOCK, Administrative Patent Judges.
`
`
`PETITIONER’S AMENDED EXHIBIT LIST
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ROXANE LABORATORIES, INC.
`Petitioner
`
`
`
`v.
`
`
`
`NOVARTIS AG
`Patent Owner
`
`
`
`Case IPR2016-01102
`U.S. Patent No. 5,665,772
`
`
`POLLOCK, Administrative Patent Judges.
`
`
`PETITIONER’S AMENDED EXHIBIT LIST
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ROXANE LABORATORIES, INC.
`Petitioner
`
`
`
`v.
`
`
`
`NOVARTIS AG
`Patent Owner
`
`
`
`Case IPR2016-01102
`U.S. Patent No. 5,665,772
`
`
`
`
`
`Case IPR2016-01102
`U.S. Patent No. 5,665,772
`
`
`Pursuant to 37 C.F.R. § 42.63(e), Petitioner Roxane Laboratories, Inc.
`
`respectfully submits the following amended exhibit list.
`
`Exhibit
`Number Description
`1001
`U.S. Patent No. 5,665,772 (“the ’772 Patent”)
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`File History for the ’772 Patent
`
`Declaration of William L. Jorgensen, Ph.D. in Support of Petition for
`Inter Partes Review of U.S. Patent No. 5,665,772
`
`Curriculum Vitae of William L. Jorgensen
`
`Randall Ellis Morris, Rapamycins: Antifungal, Antitumor,
`Antiproliferative, and Immunosuppressive Macrolides, 6
`TRANSPLANTATION REVIEWS 39 (1992) (“Morris”)
`
`Gregory D. Van Duyne et al., Atomic Structure of the Rapamycin
`Human Immunophilin FKBP-12 Complex, 113 J. AM. CHEMICAL
`SOC’Y 7433 (1991) (“Van Duyne”)
`
`Samuel H. Yalkowsky, Estimation of Entropies of Fusion of Organic
`Compounds, 18 INDUS. & ENG’G CHEMISTRY FUNDAMENTALS
`108 (1979) (“Yalkowsky”)
`
`Thomas L. Lemke, Chapter 16: Predicting Water Solubility, REVIEW
`OF ORGANIC FUNCTIONAL GROUPS 113 (2d ed. 1988)
`
`U.S. Patent No. 5,233,036 (“Hughes”)
`
`U.S. Patent No. 4,650,803 (“Stella”)
`
`U.S. Patent No. 5,100,883 (“Schiehser”)
`
`Stuart L. Schreiber, Chemistry and Biology of the Immunophilins and
`Their Immunosuppressive Ligands, 251 SCI. 283 (1991) (“Schreiber”)
`
`1
`
`
`
`
`
`Case IPR2016-01102
`U.S. Patent No. 5,665,772
`
`
`Exhibit
`Number Description
`1013
`Joseph B. Moon & W. Jeffrey Howe, Computer Design of Bioactive
`Molecules: A Method for Receptor-Based de Novo Ligand Design, 11
`PROTEINS: STRUCTURE, FUNCTION, & GENETICS 314 (1991)
`(“Moon”)
`Hans-Joachim Böhm, LUDI: rule-based automatic design of new
`substituents for enzyme inhibitor leads, 6 J. COMPUTER-AIDED
`MOLECULAR DESIGN 593 (1992) (“Böhm”)
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`Silverman, Chapter 2: Drug Discovery, Design, and Development, THE
`ORGANIC CHEMISTRY OF DRUG DESIGN & ACTION 4 (1992)
`(“Silverman”)
`Julianto Pranata & William L. Jorgensen, Computational Studies on
`FK506: Conformational Search and Molecular Dynamics Simulation in
`Water, 113 J. AM. CHEMICAL SOC’Y 9483 (1991)
`
`William L. Jorgensen, Rusting of the Lock and Key Model for Protein-
`Ligand Binding, 254 SCI. 954 (1991)
`
`Modesto Orozco et al., Mechanism for the Rotamase Activity of FK506
`Binding Protein from Molecular Dynamics Simulations, 32
`BIOCHEMISTRY 12864 (1993)
`
`Michelle L. Lamb & William L. Jorgensen, Investigations of
`Neurotrophic Inhibitors of FK506 Binding Protein via Monte Carlo
`Simulations, 41 J. MED. CHEMISTRY 3928 (1998)
`
`Michelle L. Lamb et al., Estimation of Binding Affinities of FKBP12
`Inhibitors Using a Linear Response Method, 7 BIOORGANIC &
`MEDICINAL CHEMISTRY 851 (1999)
`
`Thomas W. Bell, Construction of a Soluble Heptacyclic Terpyridine, 51
`J. ORGANIC CHEMISTRY 764 (1986) (“Bell”)
`
`M. Ballauff, Phase Equilibria in Rodlike Systems with Flexible Side
`Chains, 19 MACROMOLECULES 1366 (1986) (“Ballauff”)
`
`2
`
`
`
`
`
`Case IPR2016-01102
`U.S. Patent No. 5,665,772
`
`
`Exhibit
`Number Description
`1023
`R. Stern et al., Rigid rod polymers with flexible side chains, 32
`POLYMER 2096 (1991) (“Stern”)
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`Michael G. Rossmann et al., Three-Dimensional Coordinates from
`Stereodiagrams of Molecular Structures, B36 ACTA
`CRYSTALLOGRAPHICA 819 (1980) (“Rossmann”)
`
`William L. Jorgensen & Julian Tirado-Rives, The OPLS Potential
`Functions for Proteins. Energy Minimizations for Crystals of Cyclic
`Peptides and Crambin, 110 J. AM. CHEMICAL SOC’Y 1657 (1988)
`
`Julian Tirado-Rives & William L. Jorgensen, Molecular Dynamics of
`Proteins with the OPLS Potential Functions. Simulation of the Third
`Domain of Silver Pheasant Ovomucoid in Water, 112 J. AM.
`CHEMICAL SOC’Y 2773 (1990)
`
`Michael L. Connolly, Solvent-Accessible Surfaces of Proteins and
`Nucleic Acids, 221 SCI. 709 (1983)
`
`Yoshihiko Nisibata et al., Automatic Creation of Drug Candidate
`Structures Based on Receptor Structure. Starting Point for Artificial
`Lead Generation., 47 TETRAHEDRON 8985 (1991)
`
`Stephen W. Michnick et al., Solution Structure of FKBP, a Rotamase
`Enzyme and Receptor for FK506 and Rapamycin, 252 SCI. 836 (1991)
`
`1030
`
`Certificate of Correction for U.S. Patent No. 5,665,772
`
`1031
`
`Transcript of June 1, 2016 Conference Call
`
`3
`
`
`
`
`
`
`
`Respectfully submitted,
`
`By: /Keith A. Zullow/
`Keith A. Zullow
`(Reg. No. 37,975)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`Tel: 212-813-8846
`Fax: 646-558-4226
`kzullow@goodwinprocter.com
`
`Counsel for Petitioner Roxane Laboratories,
`Inc.
`
`
`
`4
`
`
`
`Case IPR2016-01102
`U.S. Patent No. 5,665,772
`
`
`
`
`Date: June 8, 2016
`
`
`
`
`
`
`
`
`
`Case IPR2016-01102
`U.S. Patent No. 5,665,772
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that this
`
`“PETITIONER’S AMENDED EXHIBIT LIST” was served by electronic mail in
`
`its entirety on this 8th day of June, 2016 by electronic mail on the Patent Owner’s
`
`lead and backup counsel at the following email address:
`
`Nicholas Kallas (Reg. No. 31,530)
`Raymond R. Mandra (Reg. No. 34,382)
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`NKallas@fchs.com
`RMandra@fchs.com
`ZortressAfinitorIPR@fchs.com
`
`
`
`By: /Keith A. Zullow/
`Keith A. Zullow
`(Reg. No. 37,975)
`
`
`
`
`June 8, 2016
`
`
`
`5
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