`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`ELI LILLY AND COMPANY
`Petitioner
`v.
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH
`Patent Owner
`______________________
`
`Case No. IPR2018-01710
`Patent No. 8,586,045
`______________________
`
`PETITIONER’S UPDATED EXHIBIT LIST AS OF DECEMBER 18, 2019
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`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Further to 37 C.F.R. § 42.63(e), Petitioner Eli Lilly and Company hereby
`
`submits a current listing of Lilly Exhibits.
`
`Exhibit
`
`Description
`
`Ex. 1001
`
`U.S. Patent No. 8,586,045
`
`Served
`Not
`Filed
`
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`Ex. 1002
`
`Reserved
`
`Ex. 1003
`
`Reserved
`
`Ex. 1004
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`Reserved
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`Ex. 1005
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`Reserved
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`Ex. 1006
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`Reserved
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`Ex. 1007
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`Reserved
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`Ex. 1008
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`Reserved
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`Ex. 1009
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`Reserved
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`Ex. 1010
`
`Reserved
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`Ex. 1011
`
`Reserved
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`Ex. 1012
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`Reserved
`
`Ex. 1013
`
`Reserved
`
`Ex. 1014
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`Ex. 1015
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`Declaration of Andrew Charles, M.D. (U.S. Patent No.
`8,586,045)
`
`Declaration of Alain P. Vasserot (U.S. Patent No.
`8,586,045)
`
`Ex. 1016
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`Reserved
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`1
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`Exhibit
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`Ex. 1017
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`Reserved
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`Ex. 1018
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`Reserved
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`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Served
`Not
`Filed
`
`
`Ex. 1019
`
`Teva’s U.S. Provisional Application No. 60/736,623
`
`Ex. 1020
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`Teva’s PCT Application No. WO 2007/054809
`
`Ex. 1021
`
`Ex. 1022
`
`Tan et al., “Demonstration of the Neurotransmitter Role
`of Calcitonin Gene-Related Peptides (CGRP) by
`Immunoblockade with Anti-CGRP Monoclonal
`Antibodies,” Br. J. Pharmacol. (1994) 111: 703-710
`
`Tan et al., “Calcitonin Gene-Related Peptide as an
`Endogenous Vasodilator: Immunoblockade Studies in
`vivo with an Anti-Calcitonin Gene-Related Peptide
`Monoclonal Antibody and Its Fab’ Fragment,” Clinical
`Sci. (1995) 89: 565-573
`
`Ex. 1023
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`Queen et al., U.S. Patent No. 6,180,370
`
`Ex. 1024
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`Ex. 1025
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`Ex. 1026
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`Ex. 1027
`
`Doods et al., “Pharmacological Profile of BIBN4096BS,
`the First Selective Small Molecule CGRP Antagonist,”
`Br. J. Pharmacol. (2000) 129: 420-423
`
`Olesen et al., “Calcitonin Gene-Related Peptide Receptor
`Antagonist BIBN 4096 BS for the Acute Treatment of
`Migraine,” N. Engl. J. Med. (2004) 350: 1104-1110
`
`Sveinsson, International Publication No. WO
`2004/014351
`
`Salmon et al., U.S. Patent Application Publication No.
`2002/0162125
`
`Ex. 1028
`
`De Lacharriere et al., U.S. Patent No. 6,344,438
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`2
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`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`
`
`
`Exhibit
`
`Ex. 1029
`
`Ex. 1030
`
`Ex. 1031
`
`Description
`
`Olesen et al., “S26 CGRP Antagonism as a New
`Therapeutic Principle in Acute Migraine,” Neuropeptides
`(2004) 38: 110-131
`
`Arndt et al., “CGRP Antagonism — A Valid New
`Concept for the Treatment of Migraine Pain,”
`Neuropeptides (2004) 38: 110-131
`
`Arulmani et al., “Calcitonin Gene-Related Peptide and Its
`Role in Migraine Pathophysiology,” Eur. J. Pharmacol.
`(2004) 143: 315-330
`
`Served
`Not
`Filed
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`X
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`X
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`X
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`Ex. 1031A Arulmani et al., “Calcitonin Gene-Related Peptide and Its
`Role in Migraine Pathophysiology,” Eur. J. Pharmacol.
`(2004) 143: 315-330
`
`Ex. 1032
`
`Frobert et al., “A Sensitive Sandwich Enzyme
`Immunoassay for Calcitonin Gene-Related Peptide
`(CGRP): Characterization and Application,” Peptides
`(1999) 20: 275-284
`
`Ex. 1032A Frobert et al., “A Sensitive Sandwich Enzyme
`Immunoassay for Calcitonin Gene-Related Peptide
`(CGRP): Characterization and Application,” Peptides
`(1999) 20: 275-284
`
`Ex. 1033 Wong et al., “Monoclonal Antibody to Rat α-CGRP:
`Production, Characterization, and in vivo
`Immunoneutralization Activity,” Hybridoma (1993) 12:
`93-106
`
`Ex. 1033A Wong et al., “Monoclonal Antibody to Rat α-CGRP:
`Production, Characterization, and in vivo
`Immunoneutralization Activity,” Hybridoma (1993) 12:
`93-106
`
`3
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`Exhibit
`
`Ex. 1034
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`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Rist et al., “From Micromolar to Nanomolar Affinity: A
`Systematic Approach to Identify the Binding Site of
`CGRP at the Human Calcitonin Gene-Related Peptide 1
`Receptor,” J. Med. Chem. (1998) 41: 117-123
`
`Served
`Not
`Filed
`
`
`Ex. 1034A Rist et al., “From Micromolar to Nanomolar Affinity: A
`Systematic Approach to Identify the Binding Site of
`CGRP at the Human Calcitonin Gene-Related Peptide 1
`Receptor,” J. Med. Chem. (1998) 41: 117-123
`
`Ex. 1035
`
`Edvinsson and Hargreaves, The Headaches 289-299 (3rd
`ed. 2006)
`
`Ex. 1035A Edvinsson and Hargreaves, The Headaches 289-299 (3rd
`ed. 2006)
`
`Ex. 1036
`
`Reserved
`
`Ex. 1037
`
`Reserved
`
`Ex. 1038 Mason et al., “Release of the Predicted Calcitonin Gene-
`Related Peptide from Cultured Rat Trigeminal Ganglion
`Cells,” Nature (1984) 308: 653-655
`
`Ex. 1038A Mason et al., “Release of the Predicted Calcitonin Gene-
`Related Peptide from Cultured Rat Trigeminal Ganglion
`Cells,” Nature (1984) 308: 653-655
`
`Ex. 1039
`
`Brain et al., “Calcitonin Gene-Related Peptide is a Potent
`Vasodilator,” Nature (1985) 313: 54-56
`
`Ex. 1039A Brain et al., “Calcitonin Gene-Related Peptide is a Potent
`Vasodilator,” Nature (1985) 313: 54-56
`
`Ex. 1040
`
`Arulmozhi et al., “Migraine: Current Concepts and
`Emerging Therapies,” Vascular Pharmacol. (2005) 43:
`176-187
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`X
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`X
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`X
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`X
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`4
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`Exhibit
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`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Served
`Not
`Filed
`X
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`X
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`X
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`X
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`Ex. 1040A Arulmozhi et al., “Migraine: Current Concepts and
`Emerging Therapies,” Vascular Pharmacol. (2005) 43:
`176-187
`
`Ex. 1041
`
`Durham, “CGRP-Receptor Antagonists — A Fresh
`Approach to Migraine Therapy?” N. Engl. Med. (2004)
`350(11): 1073-1075
`
`Ex. 1041A Durham, “CGRP-Receptor Antagonists — A Fresh
`Approach to Migraine Therapy?” N. Engl. Med. (2004)
`350(11): 1073-1075
`
`Ex. 1042
`
`Ex. 1042A
`
`Iovino et al., “Safety, Tolerability and Pharmacokinetics
`of BIBN 4096 BS, the First Selective Small Molecule
`Calcitonin Gene-Related Peptide Receptor Antagonist,
`Following Single Intravenous Administration in Healthy
`Volunteers,” Cephalalgia (2004) 24: 645-656
`
`Iovino et al., “Safety, Tolerability and Pharmacokinetics
`of BIBN 4096 BS, the First Selective Small Molecule
`Calcitonin Gene-Related Peptide Receptor Antagonist,
`Following Single Intravenous Administration in Healthy
`Volunteers,” Cephalalgia (2004) 24: 645-656
`
`Ex. 1043
`
`Goadsby et al., “Vasoactive Peptide Release in the
`Extracerebral Circulation of Humans During Migraine
`Headache,” Annals of Neurology (1990) 28(2): 183-187
`
`Ex. 1043A Goadsby et al., “Vasoactive Peptide Release in the
`Extracerebral Circulation of Humans During Migraine
`Headache,” Annals of Neurology (1990) 28(2): 183-187
`
`Ex. 1044
`
`Goadsby and Edvinsson, “The Trigeminovascular System
`and Migraine: Studies Characterizing Cerebrovascular
`and Neuropeptide Changes Seen in Humans and Cats,”
`Annals of Neurology (1993) 33(1): 48-56
`
`5
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`Exhibit
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`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Served
`Not
`Filed
`X
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`X
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`X
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`X
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`Ex. 1044A Goadsby and Edvinsson, “The Trigeminovascular System
`and Migraine: Studies Characterizing Cerebrovascular
`and Neuropeptide Changes Seen in Humans and Cats,”
`Annals of Neurology (1993) 33(1): 48-56
`
`Ex. 1045
`
`Ex. 1045A
`
`Ex. 1046
`
`Juhasz et al., “NO-Induced Migraine Attack: Strong
`Increase in Plasma Calcitonin Gene-Related Peptide
`(CGRP) Concentration and Negative Correlation with
`Platelet Serotonin Release,” Pain (2003) 106: 461-470
`
`Juhasz et al., “NO-Induced Migraine Attack: Strong
`Increase in Plasma Calcitonin Gene-Related Peptide
`(CGRP) Concentration and Negative Correlation with
`Platelet Serotonin Release,” Pain (2003) 106: 461-470
`
`Goadsby and Edvinsson, “Human in vivo Evidence for
`Trigeminovascular Activation in Cluster Headache:
`Neuropeptide Changes and Effects of Acute Attacks
`Therapies,” Brain (1994) 117: 427-434
`
`Ex. 1046A Goadsby and Edvinsson, “Human in vivo Evidence for
`Trigeminovascular Activation in Cluster Headache:
`Neuropeptide Changes and Effects of Acute Attacks
`Therapies,” Brain (1994) 117: 427-434
`
`Ex. 1047
`
`Lassen et al., “CGRP May Play a Causative Role in
`Migraine,” Cephalagia (2002) 22: 54-61
`
`Ex. 1047A Lassen et al., “CGRP May Play a Causative Role in
`Migraine,” Cephalagia (2002) 22: 54-61
`
`Ex. 1048
`
`Louis et al., “Antibodies to Calcitonin-Gene Related
`Peptide Reduce Inflammation Induced by Topical
`Mustard Oil But Not that Due to Carrageenin in the Rat,”
`Neuroscience Letters (1989) 102: 257-260
`
`6
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`Exhibit
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`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Served
`Not
`Filed
`X
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`X
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`X
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`X
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`Ex. 1048A Louis et al., “Antibodies to Calcitonin-Gene Related
`Peptide Reduce Inflammation Induced by Topical
`Mustard Oil But Not that Due to Carrageenin in the Rat,”
`Neuroscience Letters (1989) 102: 257-260
`
`Ex. 1049
`
`Dockray et al., “Immunoneutralization Studies with
`Calcitonin Gene-Related Peptide,” Annals of N.Y. Acad.
`Scis. (1992) 258-267
`
`Ex. 1049A Dockray et al., “Immunoneutralization Studies with
`Calcitonin Gene-Related Peptide,” Annals of N.Y. Acad.
`Scis. (1992) 258-267
`
`Ex. 1050
`
`Louis et al., “The Role of Substance P and Calcitonin
`Gene-Related Peptide in Neurogenic Plasma
`Extravasation and Vasodilation in the Rat,” Neuroscience
`(1989) 32(3): 581-586
`
`Ex. 1050A Louis et al., “The Role of Substance P and Calcitonin
`Gene-Related Peptide in Neurogenic Plasma
`Extravasation and Vasodilation in the Rat,” Neuroscience
`(1989) 32(3): 581-586
`
`Ex. 1051
`
`Ex. 1052
`
`Sigma-Aldrich, Biochemicals & Reagents for Life
`Science Research 350-352 (2004)
`
`Escott and Brain, “Effect of a Calcitonin Gene-Related
`Peptide Antagonist (CGRP8-37) on Skin Vasodilatation and
`Oedema Induced by Stimulation of the Rat Saphenous
`Nerve,” Br. J. Pharmacol. (1993) 110: 772-776
`
`Ex. 1052A Escott and Brain, “Effect of a Calcitonin Gene-Related
`Peptide Antagonist (CGRP8-37) on Skin Vasodilatation and
`Oedema Induced by Stimulation of the Rat Saphenous
`Nerve,” Br. J. Pharmacol. (1993) 110: 772-776
`
`7
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`Exhibit
`
`Ex. 1053
`
`Reserved
`
`Ex. 1054
`
`Reserved
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`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Served
`Not
`Filed
`
`
`Ex. 1055
`
`Andrew et al., “Monoclonal Antibodies Distinguishing α
`and β Forms of Calcitonin Gene-Related Peptide,” J.
`Immunol. Methods (1990) 154: 87-94
`
`Ex. 1055A Andrew et al., “Monoclonal Antibodies Distinguishing α
`and β Forms of Calcitonin Gene-Related Peptide,” J.
`Immunol. Methods (1990) 154: 87-94
`
`Ex. 1056
`
`Reichert et al., “Monoclonal Antibody Successes in the
`Clinic,” Nature Biotechnol. (2005) 23: 1073-1078
`
`Ex. 1056A Reichert et al., “Monoclonal Antibody Successes in the
`Clinic,” Nature Biotechnol. (2005) 23: 1073-1078
`
`Ex. 1057
`
`Projan et al., “Small Molecules for Small Minds? The
`Case for Biologic Pharmaceuticals,” Expert Opin. Biol.
`Ther. (2004) 4: 1345-1350
`
`Ex. 1057A Projan et al., “Small Molecules for Small Minds? The
`Case for Biologic Pharmaceuticals,” Expert Opin. Biol.
`Ther. (2004) 4: 1345-1350
`
`Ex. 1058
`
`Janeway et al., Immunobiology 93-122 (5th ed. 2001)
`
`Ex. 1058A
`
`Janeway et al., Immunobiology 93-122 (5th ed. 2001)
`
`Ex. 1059
`
`Janeway et al., Immunobiology 123-154 (5th ed. 2001)
`
`Ex. 1059A
`
`Janeway et al., Immunobiology 123-154 (5th ed. 2001)
`
`Ex. 1060
`
`Janeway et al., Immunobiology 341-380 (5th ed. 2001)
`
`Ex. 1060A
`
`Janeway et al., Immunobiology 341-380 (5th ed. 2001)
`
`8
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`X
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`X
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`X
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`X
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`X
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`X
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`Exhibit
`
`Ex. 1061
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`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Van Valen et al., “Calcitonin Gene-Related Peptide
`(CGRP) Receptors are Linked to Cyclic Adenosine
`Monophosphate Production in SK-N-MC Human
`Neuroblastoma Cells,” Neuroscience Letters (1990) 119:
`195-198
`
`Served
`Not
`Filed
`
`
`Ex. 1061A Van Valen et al., “Calcitonin Gene-Related Peptide
`(CGRP) Receptors are Linked to Cyclic Adenosine
`Monophosphate Production in SK-N-MC Human
`Neuroblastoma Cells,” Neuroscience Letters (1990) 119:
`195-198
`
`Ex. 1062
`
`Kipriyanov and Le Gall, “Generation and Production of
`Engineered Antibodies,” Mol. Biotechnol. (2004) 26: 39-
`60
`
`Ex. 1062A Kipriyanov and Le Gall, “Generation and Production of
`Engineered Antibodies,” Mol. Biotechnol. (2004) 26: 39-
`60
`
`Ex. 1063
`
`Elgert, Immunology: Understanding the Immune System
`58-78 (1st ed. 1996)
`
`Ex. 1064 Wright and Morrison, “Effect of Glycosylation on
`Antibody Function: Implications for Genetic
`Engineering,” Trends Biotechnol. (1997) 15: 26-32
`
`Ex. 1064A Wright and Morrison, “Effect of Glycosylation on
`Antibody Function: Implications for Genetic
`Engineering,” Trends Biotechnol. (1997) 15: 26-32
`
`Ex. 1065
`
`Brüggemann et al., “Comparison of the Effector
`Functions of Human Immunoglobulins Using a Matched
`Set of Chimeric Antibodies,” J. Exp. Med. (1987) 166:
`1351-1361
`
`X
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`X
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`X
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`
`
`9
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`
`Exhibit
`
`
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`
`
`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Served
`Not
`Filed
`X
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`
`
`X
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`
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`X
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`X
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`
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`X
`
`Ex. 1065A Brüggemann et al., “Comparison of the Effector
`Functions of Human Immunoglobulins Using a Matched
`Set of Chimeric Antibodies,” J. Exp. Med. (1987) 166:
`1351-1361
`
`Ex. 1066
`
`Presta, “Selection, Design, and Engineering of
`Therapeutic Antibodies,” J. Allergy Clin. Immunol. (2005)
`116: 731-736
`
`Ex. 1066A Presta, “Selection, Design, and Engineering of
`Therapeutic Antibodies,” J. Allergy Clin. Immunol. (2005)
`116: 731-736
`
`Ex. 1067
`
`Tao and Morrison, “Studies of Aglycosylated Chimeric
`Mouse-Human IgG: Role of Carbohydrate in the Structure
`and Effector Functions Mediated by the Human IgG
`Constant Region,” J. Immunol. (1989) 143: 2595-2601
`
`Ex. 1067A Tao and Morrison, “Studies of Aglycosylated Chimeric
`Mouse-Human IgG: Role of Carbohydrate in the Structure
`and Effector Functions Mediated by the Human IgG
`Constant Region,” J. Immunol. (1989) 143: 2595-2601
`
`Ex. 1068 Maynard and Georgiou, “Antibody Engineering,” Annu.
`Rev. Biomed. Eng. (2000) 2: 339-376
`
`Ex. 1068A Maynard and Georgiou, “Antibody Engineering,” Annu.
`Rev. Biomed. Eng. (2000) 2: 339-376
`
`Ex. 1069
`
`Chester and Hawkins, “Clinical Issues in Antibody
`Design,” Trends Biotechnol. (1995) 13: 294-300
`
`Ex. 1069A Chester and Hawkins, “Clinical Issues in Antibody
`Design,” Trends Biotechnol. (1995) 13: 294-300
`
`10
`
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`
`
`Exhibit
`
`
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`
`
`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Served
`Not
`Filed
`
`
`X
`
`
`
`X
`
`
`
`X
`
`
`
`X
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`
`
`X
`
`Ex. 1070
`
`Kim et al., “Antibody Engineering for the Development of
`Therapeutic Antibodies,” Mol. Cells (2005) 20: 17-29
`
`Ex. 1070A Kim et al., “Antibody Engineering for the Development of
`Therapeutic Antibodies,” Mol. Cells (2005) 20: 17-29
`
`Ex. 1071
`
`Gavilondo and Larrick, “Antibody Engineering at the
`Millennium,” BioTechniques (2000) 29: 128-145
`
`Ex. 1071A Gavilondo and Larrick, “Antibody Engineering at the
`Millennium,” BioTechniques (2000) 29: 128-145
`
`Ex. 1072
`
`Khazaeli et al., “Human Immune Response to Monoclonal
`Antibodies,” J. Immunother. (1994) 15: 42-52
`
`Ex. 1072A Khazaeli et al., “Human Immune Response to Monoclonal
`Antibodies,” J. Immunother. (1994) 15: 42-52
`
`Ex. 1073
`
`Carter, “Improving the Efficacy of Antibody-Based
`Cancer Therapies,” Nature Revs. Cancer (2001) 1: 118-
`129
`
`Ex. 1073A Carter, “Improving the Efficacy of Antibody-Based
`Cancer Therapies,” Nature Revs. Cancer (2001) 1: 118-
`129
`
`Ex. 1074
`
`Kettleborough et al., “Humanization of a Mouse
`Monoclonal Antibody by CDR-Grafting: The Importance
`of Framework Residues on Loop Conformation,” Protein
`Eng. (1991) 4: 773-783
`
`Ex. 1074A Kettleborough et al., “Humanization of a Mouse
`Monoclonal Antibody by CDR-Grafting: The Importance
`of Framework Residues on Loop Conformation,” Protein
`Eng. (1991) 4: 773-783
`
`11
`
`
`
`
`
`
`Exhibit
`
`Ex. 1075
`
`
`
`
`
`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Queen et al., “A Humanized Antibody that Binds to the
`Interleukin 2 Receptor,” Proc. Natl. Acad. Sci. USA
`(1989) 86: 10029-10033
`
`Served
`Not
`Filed
`
`
`Ex. 1075A Queen et al., “A Humanized Antibody that Binds to the
`Interleukin 2 Receptor,” Proc. Natl. Acad. Sci. USA
`(1989) 86: 10029-10033
`
`Ex. 1076
`
`Friend et al., “Phase I Study of an Engineered
`Aglycosylated Humanized CD3 Antibody in Renal
`Transplant Rejection,” Transplantation (1999) 68: 1632-
`1637
`
`Ex. 1076A Friend et al., “Phase I Study of an Engineered
`Aglycosylated Humanized CD3 Antibody in Renal
`Transplant Rejection,” Transplantation (1999) 68: 1632-
`1637
`
`Ex. 1077
`
`Brekke and Sandlie, “Therapeutic Antibodies for Human
`Diseases at the Dawn of the Twenty-First Century,”
`Nature Revs. Drug Discov. (2003) 2: 52-62
`
`Ex. 1077A Brekke and Sandlie, “Therapeutic Antibodies for Human
`Diseases at the Dawn of the Twenty-First Century,”
`Nature Revs. Drug Discov. (2003) 2: 52-62
`
`Ex. 1078
`
`Cole et al., “Human IgG2 Variants of Chimeric Anti-CD3
`are Nonmitogenic to T cells,” J. Immunol. (1997) 159:
`3613-3621
`
`Ex. 1078A Cole et al., “Human IgG2 Variants of Chimeric Anti-CD3
`are Nonmitogenic to T cells,” J. Immunol. (1997) 159:
`3613-3621
`
`X
`
`
`
`X
`
`
`
`X
`
`
`
`X
`
`Ex. 1079
`
`Huse et al., International Publication No. WO 2001/27160
`
`
`
`12
`
`
`
`
`
`
`Exhibit
`
`Ex. 1080
`
`Reserved
`
`Ex. 1081
`
`Reserved
`
`
`
`
`
`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Served
`Not
`Filed
`
`
`Ex. 1082
`
`Vater et al., “Short Bioactive Spiegelmers to Migraine-
`Associated Calcitonin Gene-Related Peptide Rapidly
`Identified by a Novel Approach: Tailored-SELEX,”
`Nucleic Acids Res. (2003) 31: 1-7
`
`Ex. 1082A Vater et al., “Short Bioactive Spiegelmers to Migraine-
`Associated Calcitonin Gene-Related Peptide Rapidly
`Identified by a Novel Approach: Tailored-SELEX,”
`Nucleic Acids Res. (2003) 31: 1-7
`
`Ex. 1083
`
`Djavadi-Ohaniance et al., Antibody Engineering: A
`Practical Approach 77-117 (1st ed. 1996)
`
`Ex. 1083A Djavadi-Ohaniance et al., Antibody Engineering: A
`Practical Approach 77-117 (1st ed. 1996)
`
`Ex. 1084
`
`Van Regenmortal et al., “Improving the Quality of
`BIACORE-Based Affinity Measurements,” Dev. Biol.
`(Basel) (2003) 112: 141-151
`
`Ex. 1084A Van Regenmortal et al., “Improving the Quality of
`BIACORE-Based Affinity Measurements,” Dev. Biol.
`(Basel) (2003) 112: 141-151
`
`Ex. 1085
`
`GE Healthcare, Biacore Sensor Surface Handbook (2005)
`
`Ex. 1086
`
`Kelley, “Thermodynamics of Protein-Protein Interaction
`Studied by Using BIAcore and Single-Site Mutagenesis,”
`Methods (1994) 6: 111-120
`
`Ex. 1086A Kelley, “Thermodynamics of Protein-Protein Interaction
`Studied by Using BIAcore and Single-Site Mutagenesis,”
`Methods (1994) 6: 111-120
`
`13
`
`
`
`
`
`X
`
`
`
`X
`
`
`
`X
`
`
`
`
`
`X
`
`
`
`
`
`
`Exhibit
`
`Ex. 1087
`
`
`
`
`
`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Johnstone et al., “The Effect of Temperature on the
`Binding Kinetics and Equilibrium Constants of
`Monoclonal Antibodies to Cell Surface Antigens,” Mol.
`Immunol. (1990) 27: 327-333
`
`Served
`Not
`Filed
`
`
`Ex. 1088
`
`Carter, “Potent Antibody Therapeutics by Design,”
`Nature Revs. Immunol. (2006) 6: 343-357
`
`Ex. 1088A Carter, “Potent Antibody Therapeutics by Design,”
`Nature Revs. Immunol. (2006) 6: 343-357
`
`Ex. 1089
`
`Goadsby et al., “Migraine — Current Understanding and
`Treatment,” N. Engl. J. Med. (2002) 346: 257-270
`
`Ex. 1089A Goadsby et al., “Migraine — Current Understanding and
`Treatment,” N. Engl. J. Med. (2002) 346: 257-270
`
`Ex. 1090
`
`Petersen et al., “Inhibitory Effect of BIBN4096BS on
`Cephalic Vasodilation Induced by CGRP or Transcranial
`Electrical Stimulation in the Rat,” Br. J. Pharm. (2004)
`143: 697-704
`
`Ex. 1090A Petersen et al., “Inhibitory Effect of BIBN4096BS on
`Cephalic Vasodilation Induced by CGRP or Transcranial
`Electrical Stimulation in the Rat,” Br. J. Pharm. (2004)
`143: 697-704
`
`Ex. 1091
`
`Purves et al., Neuroscience 763-773 (3rd ed. 2004)
`
`Ex. 1092
`
`Reserved
`
`Ex. 1093
`
`Davis et al., Fundamentals of Neurologic Disease 204-207
`(2005)
`
`
`
`X
`
`
`
`X
`
`
`
`X
`
`
`
`
`
`
`
`Ex. 1093A Davis et al., Fundamentals of Neurologic Disease 204-207
`(2005)
`
`X
`
`14
`
`
`
`
`
`
`Exhibit
`
`Ex. 1094
`
`
`
`
`
`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Goadsby et al., “Mechanisms and Management of
`Headache,” J. Royal Coll. Physicians London (1999) 33:
`228-234
`
`Served
`Not
`Filed
`
`
`Ex. 1094A Goadsby et al., “Mechanisms and Management of
`Headache,” J. Royal Coll. Physicians London (1999) 33:
`228-234
`
`Ex. 1095
`
`Conner et al., “Interaction of Calcitonin-Gene-Related
`Peptide with Its Receptors,” Biochemistry Society
`Transactions (2002) 30(4): 451-455
`
`Ex. 1095A Conner et al., “Interaction of Calcitonin-Gene-Related
`Peptide with Its Receptors,” Biochemistry Society
`Transactions (2002) 30(4): 451-455
`
`Ex. 1096 Wimalawansa, “Calcitonin Gene-Related Peptide and Its
`Receptors: Molecular Genetics, Physiology,
`Pathophysiology, and Therapeutic Potentials,” Endocrine
`Revs. (1996) 17(5): 533-585
`
`Ex. 1097 Williamson et al., “Intravital Microscope Studies on the
`Effects of Neurokinin Agonists and Calcitonin Gene-
`Related Peptide on Dural Vessel Diameter in the
`Anaesthetized Rat,” Cephalalgia (1997) 17: 518-524
`
`Ex. 1098
`
`Hong et al., “Pharmacological Coupling and Functional
`Role for CGRP Receptors in the Vasodilation of Rat Pial
`Arterioles,” Am. J. Physiol. (1996) 270: H317-H323
`
`X
`
`
`
`X
`
`
`
`
`
`
`
`Ex. 1098A Hong et al., “Pharmacological Coupling and Functional
`Role for CGRP Receptors in the Vasodilation of Rat Pial
`Arterioles,” Am. J. Physiol. (1996) 270: H317-H323
`
`X
`
`15
`
`
`
`
`
`
`
`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`
`
`
`Exhibit
`
`Ex. 1099
`
`Description
`
`Poyner et al., “International Union of Pharmacology.
`XXXII. The Mammalian Calcitonin Gene-Related
`Peptides, Adrenomedullin, Amylin, and Calcitonin
`Receptors,” Pharamcol. Rev. (2002) 54: 233-246
`
`Served
`Not
`Filed
`
`
`
`
`
`
`X
`
`
`
`
`
`
`
`
`
`
`
`
`
`X
`
`
`
`Ex. 1100
`
`Reserved
`
`Ex. 1101
`
`Jones et al., “Replacing the Complementarity-
`Determining Regions in a Human Antibody with Those
`from a Mouse,” Nature (1986) 321: 522-525
`
`Ex. 1101A
`
`Jones et al., “Replacing the Complementarity-
`Determining Regions in a Human Antibody with Those
`from a Mouse,” Nature (1986) 321: 522-525
`
`Ex. 1102
`
`Reserved
`
`Ex. 1103
`
`Reserved
`
`Ex. 1104
`
`Reserved
`
`Ex. 1105
`
`Reserved
`
`Ex. 1106
`
`Reserved
`
`Ex. 1107
`
`Knight et al., “Pharmacodynamic Enhancement of the
`Anti-Platelet Antibody Fab Abciximab by Site-Specific
`Pegylation,” Platelets (2004) 15: 409-418
`
`Ex. 1107A Knight et al., “Pharmacodynamic Enhancement of the
`Anti-Platelet Antibody Fab Abciximab by Site-Specific
`Pegylation,” Platelets (2004) 15: 409-418
`
`Ex. 1108
`
`RituxanTM (rituximab) Prescribing Information (1997)
`
`16
`
`
`
`
`
`
`Exhibit
`
`Ex. 1109
`
`
`
`
`
`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Reff et al., “Depletion of B Cells in vivo by a Chimeric
`Mouse Human Monoclonal Antibody to CD20,” Blood
`(1994) 83: 435-445
`
`Served
`Not
`Filed
`
`
`Ex. 1109A Reff et al., “Depletion of B Cells in vivo by a Chimeric
`Mouse Human Monoclonal Antibody to CD20,” Blood
`(1994) 83: 435-445
`
`Ex. 1110
`
`Tsurushita et al., “Design of Humanized Antibodies:
`From Anti-Tac to Zenapax,” Methods (2005) 36: 69-83
`
`Ex. 1111
`
`Simulect® (basiliximab) Prescribing Information (1998)
`
`Ex. 1112
`
`Synagis® (palivizumab) EMEA Scientific Discussion
`(2004)
`
`Ex. 1113 Wu et al., “Ultra-Potent Antibodies Against Respiratory
`Syncytial Virus: Effects of Binding Kinetics and Binding
`Valence on Viral Neutralization,” J. Mol. Biol. (2005)
`350: 126-144
`
`Ex. 1113A Wu et al., “Ultra-Potent Antibodies Against Respiratory
`Syncytial Virus: Effects of Binding Kinetics and Binding
`Valence on Viral Neutralization,” J. Mol. Biol. (2005)
`350: 126-144
`
`Ex. 1114 Maini and Feldmann, “How Does Infliximab Work in
`Rheumatoid Arthritis?,” Arthritis Res. (2002) 4: S22-S28
`
`Ex. 1115
`
`Herceptin® (trastuzumab) Prescribing Information (1998)
`
`Ex. 1116
`
`Carter et al., “Humanization of an Anti-p185HER2
`Antibody for Human Cancer Therapy,” Proc. Natl. Acad.
`Sci. USA (1992) 89: 4285-4289
`
`X
`
`
`
`
`
`
`
`
`
`X
`
`
`
`
`
`
`
`17
`
`
`
`
`
`
`Exhibit
`
`
`
`
`
`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Served
`Not
`Filed
`X
`
`
`
`
`
`
`
`X
`
`
`
`X
`
`
`
`Ex. 1116A Carter et al., “Humanization of an Anti-p185HER2
`Antibody for Human Cancer Therapy,” Proc. Natl. Acad.
`Sci. USA (1992) 89: 4285-4289
`
`Ex. 1117 MabCampath® (alemtuzumab) EMEA Scientific
`Discussion (2005)
`
`Ex. 1118
`
`Ex. 1119
`
`ZevalinTM (ibritumomab tiuxetan) Prescribing Information
`(2001)
`
`Santora et al., “Characterization of Noncovalent
`Complexes of Recombinant Human Monoclonal
`Antibody and Antigen Using Cation Exchange, Size
`Exclusion Chromatography, and BIAcore,” Anal.
`Biochem. (2001) 299: 119-129
`
`Ex. 1119A Santora et al., “Characterization of Noncovalent
`Complexes of Recombinant Human Monoclonal
`Antibody and Antigen Using Cation Exchange, Size
`Exclusion Chromatography, and BIAcore,” Anal.
`Biochem. (2001) 299: 119-129
`
`Ex. 1120
`
`Shields et al, “Inhibition of Allergic Reactions with
`Antibodies to IgE,” Int. Arch. Allergy Immunol. (1995)
`107: 308-312
`
`Ex. 1120A Shields et al, “Inhibition of Allergic Reactions with
`Antibodies to IgE,” Int. Arch. Allergy Immunol. (1995)
`107: 308-312
`
`Ex. 1121
`
`Cardarelli et al., “Binding to CD20 by Anti-B1 Antibody
`or F(ab’)2 is Sufficient for Induction of Apoptosis in B-
`Cell Lines,” Cancer Immunol. Immunother. (2002) 51:
`15-24
`
`18
`
`
`
`
`
`
`Exhibit
`
`
`
`
`
`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Served
`Not
`Filed
`X
`
`
`
`X
`
`
`
`X
`
`
`
`
`
`Ex. 1121A Cardarelli et al., “Binding to CD20 by Anti-B1 Antibody
`or F(ab’)2 is Sufficient for Induction of Apoptosis in B-
`Cell Lines,” Cancer Immunol. Immunother. (2002) 51:
`15-24
`
`Ex. 1122 Werther et al., “Humanization of an Anti-lymphocyte
`Function-Associated Antigen (LFA)-l Monoclonal
`Antibody and Reengineering of the Humanized Antibody
`for Binding to Rhesus LFA-1,” J. Immunol. (1996) 157:
`4986-4995
`
`Ex. 1122A Werther et al., “Humanization of an Anti-lymphocyte
`Function-Associated Antigen (LFA)-l Monoclonal
`Antibody and Reengineering of the Humanized Antibody
`for Binding to Rhesus LFA-1,” J. Immunol. (1996) 157:
`4986-4995
`
`Ex. 1123
`
`Goldstein et al., “Biological Efficacy of a Chimeric
`Antibody to the Epidermal Growth Factor Receptor in a
`Human Tumor Xenograft Model,” Clin. Cancer Res.
`(1995) 1: 1311-1318
`
`Ex. 1123A Goldstein et al., “Biological Efficacy of a Chimeric
`Antibody to the Epidermal Growth Factor Receptor in a
`Human Tumor Xenograft Model,” Clin. Cancer Res.
`(1995) 1: 1311-1318
`
`Ex. 1124
`
`Ex. 1125
`
`Avastin® (bevacizumab) EMEA Scientific Discussion
`(2005)
`
`Ferrara et al., “Discovery and Development of
`Bevacizumab, an Anti-VEGF Antibody for Treating
`Cancer,” Nature Revs. Drug Discov. (2004) 3: 391-400
`
`19
`
`
`
`
`
`
`Exhibit
`
`
`
`
`
`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Served
`Not
`Filed
`X
`
`
`
`X
`
`
`
`
`
`
`
`
`
`Ex. 1125A Ferrara et al., “Discovery and Development of
`Bevacizumab, an Anti-VEGF Antibody for Treating
`Cancer,” Nature Revs. Drug Discov. (2004) 3: 391-400
`
`Ex. 1126
`
`Léger et al., “Humanization of a Mouse Antibody against
`Human Alpha-4 Integrin: A Potential Therapeutic for the
`Treatment of Multiple Sclerosis,” Hum. Antibodies (1997)
`8: 3-16
`
`Ex. 1126A Léger et al., “Humanization of a Mouse Antibody against
`Human Alpha-4 Integrin: A Potential Therapeutic for the
`Treatment of Multiple Sclerosis,” Hum. Antibodies (1997)
`8: 3-16
`
`Ex. 1127
`
`Lilly’s U.S. Provisional Application No. 60/753,004
`
`Ex. 1128
`
`U.S. Provisional Application No. 60/711,950
`
`Ex. 1129 Wu et al., “Stepwise in vitro Affinity Maturation of
`Vitaxin, an αvβ3-Specific Humanized mAb,” Proc. Natl.
`Acad. Sci. USA (1998) 95: 6037-6042
`
`Ex. 1130
`
`Janeway et al., Immunobiology 626-627 (5th ed. 2001)
`
`Ex. 1130A
`
`Janeway et al., Immunobiology 626-627 (5th ed. 2001)
`
`X
`
`Ex. 1131
`
`Reserved
`
`Ex. 1132
`
`Reserved
`
`Ex. 1133 Reserved
`
`Ex. 1134
`
`Pisegna et al., U.S. Patent Application Publication No.
`2004/0110170
`
`Ex. 1135
`
`Reserved
`
`
`
`
`
`
`
`
`
`
`
`20
`
`
`
`
`
`
`Exhibit
`
`
`
`
`
`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Served
`Not
`Filed
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Ex. 1136
`
`September 5, 2013 Teva’s Response to Office Action
`(U.S. Patent No. 8,597,649 prosecution history)
`
`Ex. 1137
`
`Reserved
`
`Ex. 1138
`
`Reserved
`
`Ex. 1139
`
`Reserved
`
`Ex. 1140 Reserved
`
`Ex. 1141
`
`Reserved
`
`Ex. 1142 Yang et al., “CDR Walking Mutagenesis for the Affinity
`Maturation of a Potent Human Anti-HIV-1 Antibody into
`the Picomolar Range,” J. Mol. Biol. (1995) 254: 392-403
`
`Ex. 1142A Yang et al., “CDR Walking Mutagenesis for the Affinity
`Maturation of a Potent Human Anti-HIV-1 Antibody into
`the Picomolar Range,” J. Mol. Biol. (1995) 254: 392-403
`
`X
`
`Ex. 1143
`
`June 28, 2013 Amendment (U.S. Patent No. 8,586,045
`prosecution history)
`
`Ex. 1144
`
`Reserved
`
`Ex. 1145
`
`Reserved
`
`Ex. 1146
`
`Reserved
`
`Ex. 1147
`
`Reserved
`
`Ex. 1148
`
`Reserved
`
`Ex. 1149
`
`Reserved
`
`Ex. 1150
`
`Reserved
`
`21
`
`
`
`
`
`
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`
`
`
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`
`
`
`
`
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`
`
`
`
`
`Exhibit
`
`Ex. 1151
`
`Reserved
`
`Ex. 1152
`
`Reserved
`
`Ex. 1153
`
`Reserved
`
`Ex. 1154
`
`Reserved
`
`Ex. 1155
`
`Reserved
`
`Ex. 1156
`
`Reserved
`
`Ex. 1157
`
`Reserved
`
`Ex. 1158
`
`Reserved
`
`Ex. 1159
`
`Reserved
`
`Ex. 1160
`
`Reserved
`
`Ex. 1161
`
`Reserved
`
`Ex. 1162
`
`Reserved
`
`Ex. 1163
`
`Reserved
`
`Ex. 1164
`
`Reserved
`
`Ex. 1165
`
`Reserved
`
`Ex. 1166
`
`Reserved
`
`Ex. 1167
`
`Reserved
`
`Ex. 1168
`
`Reserved
`
`Ex. 1169
`
`Reserved
`
`Ex. 1170
`
`Reserved
`
`
`
`
`
`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Served
`Not
`Filed
`
`
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`22
`
`
`
`
`
`
`Exhibit
`
`Ex. 1171
`
`Reserved
`
`Ex. 1172
`
`Reserved
`
`Ex. 1173
`
`Reserved
`
`Ex. 1174
`
`Reserved
`
`Ex. 1175
`
`Reserved
`
`Ex. 1176
`
`Reserved
`
`Ex. 1177
`
`Reserved
`
`Ex. 1178
`
`Reserved
`
`Ex. 1179
`
`Reserved
`
`Ex. 1180
`
`Reserved
`
`Ex. 1181
`
`Reserved
`
`Ex. 1182
`
`Reserved
`
`Ex. 1183
`
`Reserved
`
`Ex. 1184
`
`Reserved
`
`Ex. 1185
`
`Reserved
`
`Ex. 1186
`
`Reserved
`
`Ex. 1187
`
`Reserved
`
`Ex. 1188
`
`Reserved
`
`Ex. 1189
`
`Reserved
`
`Ex. 1190
`
`Reserved
`
`
`
`
`
`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Served
`Not
`Filed
`
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`
`23
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`
`
`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Served
`Not
`Filed
`
`
`
`
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`
`
`
`
`Exhibit
`
`Ex. 1191
`
`Reserved
`
`Ex. 1192
`
`Reserved
`
`Ex. 1193
`
`Reserved
`
`Ex. 1194
`
`Reserved
`
`Ex. 1195
`
`Reserved
`
`Ex. 1196
`
`Reserved
`
`Ex. 1197
`
`Reserved
`
`Ex. 1198
`
`Reserved
`
`Ex. 1199
`
`Reserved
`
`Ex. 1200
`
`Reserved
`
`Ex. 1201
`
`Reserved
`
`Ex. 1202
`
`Reserved
`
`Ex. 1203
`
`Reserved
`
`Ex. 1204
`
`Reserved
`
`Ex. 1205
`
`Reserved
`
`Ex. 1206
`
`Ex. 1207
`
`Ex. 1208
`
`July 11, 2011 Application Data Sheet (U.S. Patent No.
`8,586,045 prosecution history)
`
`December 20, 2016 Application Data Sheet (U.S. Patent
`No. 8,586,045 prosecution history)
`
`July 11, 2011 Information Disclosure Statement (U.S.
`Patent No. 8,586,045 prosecution history)
`
`24
`
`
`
`
`
`
`Exhibit
`
`
`
`
`
`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Ex. 1209
`
`January 13, 2012 Information Disclosure Statement (U.S.
`Patent No. 8,586,045 prosecution history)
`
`Ex. 1210 May 31, 2012 Information Disclosure Statement (U.S.
`Patent No. 8,586,045 prosecution history)
`
`Ex. 1211
`
`Ex. 1212
`
`February 20, 2013 Information Disclosure Statement
`(U.S. Patent No. 8,586,045 prosecution history)
`
`June 28, 2013 Information Disclosure Statement (U.S.
`Patent No. 8,586,045 prosecution history)
`
`Ex. 1213 March 14, 2013 Non-Final Office Action (U.S. Patent No.
`8,586,045 prosecution history)
`
`Ex. 1214
`
`Reserved
`
`Ex. 1215
`
`Reserved
`
`Ex. 1216
`
`Reserved
`
`Ex. 1217
`
`Reserved
`
`Ex. 1218
`
`Reserved
`
`Ex. 1219
`
`Reserved
`
`Ex. 1220
`
`Reserved
`
`Ex. 1221
`
`Reserved
`
`Ex. 1222
`
`Reserved
`
`Ex. 1223
`
`Reserved
`
`Ex. 1224
`
`Reserved
`
`Ex. 1225
`
`Reserved
`
`25
`
`Served
`Not
`Filed
`
`
`
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`
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`
`
`
`
`
`
`
`
`
`
`
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`
`
`IPR2018-01710
`U.S. Patent No. 8,586,045
`
`Description
`
`Served
`Not
`Filed
`
`
`
`
`
`
`
`
`
`
`
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`
`
`
`
`
`
`
`
`
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`X
`
`
`
`X
`
`
`
`
`Exhibit
`
`Ex. 1226
`
`Reserved
`
`Ex. 1227
`
`Reserved
`
`Ex. 1228
`
`Reserved
`
`Ex. 1229
`
`Reserved
`
`Ex. 1230
`
`Reserved
`
`Ex. 1231
`
`Reserved
`
`Ex. 1232
`
`Reserved
`
`Ex. 1233
`
`Reserved
`
`Ex. 1234
`
`Reserved
`
`Ex. 1235
`
`Reserved
`
`Ex. 1236
`
`Reserved
`
`Ex. 1237
`
`Tepper et al., “Mechanisms of Action of the 5-HT1B/1D
`Receptor Agonists,” Arch. Neurol. (2002) 59: 1084-1088
`
`Ex. 1237A Tepper et al., “M
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