1
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`September 3, 2024
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`PGR2022-00025
`PGR2021-00088
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`Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.
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`1
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`Neurocrine 1048
`Neurocrine v. Spruce
`PGR2021-00088
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`September 3, 2024
`
`PGR2022-00025
`PGR2021-00088
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`Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.
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`1
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`Neurocrine 1048
`Neurocrine v. Spruce
`PGR2021-00088
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`2
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`
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`AONACIASLON-LIGIHX3SAILLVYLSNOWSG
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`NOILONGOUYLNI4
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`INTRODUCTION
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`N
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`2
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`on May 18, 2021
`’908 patent; issued
`continuation of the
`’201 patent filed as
`Oct. 22, 2020
`
`issued on Dec. 1, 2020
`continuation of the PCT;
`’908 patent filed as a
`Apr. 18, 2019
`
`filed
`PCT/US2018/046760
`Aug. 14, 2018
`
`filed
`application 62/545,406
`Spruce’s provisional
`Aug. 14, 2017
`
`2020
`
`2019
`
`2018
`
`2017
`
`2016
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`verucerfont (NBI-77860)
`including crinecerfont &
`antagonists to treat CAH,
`Discloses several CRF1 receptor
`(Ex. 1006)
`US2017/0020877
`Grigoriadis publishes
`Jan. 26, 2017
`
`CAH (Ex. 1008)
`antagonist, to treat
`CRF1 receptor
`study of verucerfont, a
`and published clinical
`Neurocrine completes
`Jan. 11, 2016
`
`Neurocrine’s Work Was Before Spruce’s Patents
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`3
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`pyrimidine
`(1-ethylpropyl)-2,5-dimethylpyrazolo(1,5-a)
`–3-4-Chloro-2-(morpholin-4-yl)thiazol-5-yl)-7-
`–“Compound 1”—tildacerfont
`receptor antagonist
`•Both patents disclose a single CRF1
`specification
`•Both patents share the same
`•PGR2022-00025: U.S. Patent 11,007,201
`•PGR2021-00088: U.S. Patent 10,849,908
`
`’201 patent, Ex. 1001
`’908 patent, Ex. 1001
`
`Spruce’s Patents
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`4
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`5
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`PGR88 Pet. 17-23; Ex. 1002, 308-22, 328-29
`
`CRF1 receptor antagonist
`new claims replacing Compound 1 to a
`canceling all pending claims and adding
`submitted a preliminary amendment
`But when ’908 patent was filed, applicants
`
`sale or solvate thereof
`pharmaceutically acceptable
`Compound 1 (tildacerfont) or a
`limited to administration of
`Provisional and PCT claims were
`
`on May 18, 2021
`’908 patent; issued
`continuation of the
`’201 patent filed as
`Oct. 22, 2020
`
`issued on Dec. 1, 2020
`continuation of the PCT;
`’908 patent filed as a
`Apr. 18, 2019
`
`filed
`PCT/US/2018/046760
`Aug. 14, 2018
`
`filed
`application 62/545,40
`Spruce’s provisional
`Aug. 14, 2017
`
`2020
`
`2019
`
`2018
`
`2017
`
`2016
`
`verucerfont (NBI-77860)
`including crinecerfont &
`antagonists to treat CAH,
`Discloses several CRF1 receptor
`(Ex. 1006)
`US2017/0020877
`Grigoriadis publishes
`Jan. 26, 2017
`
`CAH (Ex. 1008)
`antagonist, to treat
`CRF1 receptor
`study of verucerfont, a
`and published clinical
`Neurocrine completes
`Jan. 11, 2016
`
`’908 and ’201 Patents Claim More Than Spruce Possessed
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`5
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`PGR88, Ex. 1002, 328
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`PGR88, Ex. 1003, 57
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`Spruce Expanded Its Claims Beyond Its Written Description
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`6
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`7
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`AONACIASLON-LIGIHX3SAILLVYLSNOWSG
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`ALIMA@VLNALVdNNAOSGNNOYD4
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`GROUNDS OF UNPATENTABILITY
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`M
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`7
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`8
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`PGR88 Pet. 3-4
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`Lack of enablement under 35 U.S.C. §112
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`Lack of written description under 35 U.S.C. §112
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`Grigoriadis in combination with Romano
`Obviousness under 35 U.S.C. §103 in view of
`
`1-25
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`1-25
`
`Ground 5
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`Ground 4
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`5-6, 15-16
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`Ground 3
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`Grigoriadis and the knowledge of a skilled artisan
`Obviousness under 35 U.S.C. §103 in view of
`
`4, 10, 14, 20-22, 25
`
`Anticipation under 35 U.S.C. §102 by Grigoriadis
`
`1-4, 7-9, 11-14, 17-19, 21-24
`
`Basis for Rejection
`
`’908 Patent Claims
`
`Ground 2
`
`Ground 1
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`Ground
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`PGR2021-00088: Grounds of Unpatentability
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`8
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`9
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`Lack of written description under 35 U.S.C. §112
`the knowledge of the skilled artisan
`Grigoriadis and Turcu in combination with Romano and
`Obviousness under 35 U.S.C. §103 in view of
`artisan
`Grigoriadis and Turcu, and the knowledge of the skilled
`Obviousness under 35 U.S.C. §103 in view of
`knowledge of the skilled artisan
`Grigoriadis in combination with Romano and the
`Obviousness under 35 U.S.C. §103 in view of
`Grigoriadis and the knowledge of a skilled artisan
`Obviousness under 35 U.S.C. §103 in view of
`Anticipation under 35 U.S.C. §102 by Grigoriadis
`
`Basis for Rejection
`
`’201 Patent Claims
`
`PGR2022-00025: Grounds of Unpatentability
`
`PGR25 Pet. 4
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`1-19
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`Ground 6
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`5-6
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`Ground 5
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`1-4, 7-19
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`Ground 4
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`5-6
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`Ground 3
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`10, 16-17, 19
`1-4, 7-9, 11-15, 18
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`Ground 2
`Ground 1
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`Ground
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`9
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`PGR88 Pet. 60 (citing Ex. 1005 ¶ 34); PGR25 Pet. 26-27(citing Ex. 1005 ¶ 34)
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`Spruce does not challenge this definition
`
`CAH or other adrenal disorders.
`conducting research concerning endocrine disorders, including
`ordinary skill would also have at least three years of experience
`employed to treat such disorders. The hypothetical person of
`and disorders, as well as knowledge of the treatment regimens
`endocrinology, and would have knowledge of hormone regulation
`would have a medical degree or a Ph.D. in a field related to
`•A hypothetical person of ordinary skill in the art of the ’908 patent
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`A Person of Ordinary Skill in the Art
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`10
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`11
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`AONACIASLON-LIGIHX3SAILLVYLSNOWSG
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`YO4NOILdIYDSAGNALLIYMALVNOAGV
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`b4dad940SNNASDGAWIVIDAHL
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`SLSINOSVLNVYOldsa90s4
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`RECEPTOR ANTAGONISTS
`THE CLAIMED GENUS OF CRF1
`ADEQUATE WRITTEN DESCRIPTION FOR
`THE ’908 AND ’201 PATENTS LACK
`
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`AIV1SLNALVdL0¢d.GNV806.SHL
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`11
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`12
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`PGR88 Pet. 3-4 & Reply 4; PGR25 Pet. 4 & Reply 4
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`Both PGRs may be decided on lack of written description
`
`because these grounds cover all challenged claims
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`Lack of written description under 35 U.S.C. § 112
`
`Basis for Rejection
`
`’201 Patent Claims
`
`1-19
`
`Ground 6
`Ground
`
`Lack of written description under 35 U.S.C. § 112
`
`1-25
`
`Ground 4
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`Basis for Rejection
`
`’908 Patent Claims
`
`Ground
`
`Grounds for Lack of Written Description
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`12
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`13
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`PGR88 Pet. 70
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`(Fed. Cir. 2010) (en banc)).
`2011) (quotingAriad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351
`Billups-Rothenberg, Inc. v. ARUP Labs., Inc., 642 F.3d 1031, 1036 (Fed. Cir.
`claimed.’”
`recognize that [the inventor] invented what is
`‘allow persons of ordinary skill in the art to
`inventor to disclose the claimed invention so as to
`“The written description requirement requires the
`
`Written Description Must Show Possession
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`13
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`14
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`PGR88 Pet. 73, Ex. 1001, 1:28-55 & claim 1; PGR25 Pet. 76, Ex. 1001, 1:30-58 & claim 1
`
`•Both disclose only a single CRF1 receptor antagonist—
`•The ’908 and ’201 patents share the same specification
`
`Compound 1 (tildacerfont)
`
`•But the claims encompass a genus of CRF1 receptor
`
`antagonists
`
`Genus of CRF1 Receptor Antagonists
`The Patents Disclose Only One Species But Claim an Entire
`
`14
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`PGR25, Ex. 1001 (claim 1)
`PGR88, Ex. 1001 (claims 1 and 11);
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`’201 patent—claim 1
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`’908 patent—claims 1 and 11
`
`Their Functions
`The Genus of CRF1 Receptor Antagonists Are Claimed By
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`15
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`16
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`PGR25 DI (Paper 20), 32
`PGR88 DI (Paper 21), 45;
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`PGR25 DR Dec., 3
`PGR88 DR Dec., 12;
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`CRF1 Receptor Antagonists
`The Director and Board Recognized That the Claims Cover a Genus of
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`16
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`17
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`PGR88 DR Dec.,12
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`Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en banc)
`genus.”
`the art can ‘visualize or recognize’ the members of the
`to the members of the genusso that one of skill in
`scope of the genus, or structural features common
`representative number of speciesfalling within the
`the specification must disclose “either a
`To show sufficient description of the claimed genus,
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`Written Description Legal Test For a Claimed Genus
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`17
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`18
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`the Claimed Functions
`Representative Number of Species that Achieve
`The ’908 and ’201 Patents Fail to Disclose a
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`18
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`19
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`PGR25 DI (Paper 20), 32
`PGR88 DI (Paper 21), 45;
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`PGR25 DR Dec., 3
`PGR88 DR Dec., 12;
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`The Patents Disclose Only One Species—Compound 1
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`19
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`20
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`•Patents’ characterization of Compound 1 as “the Invention”
`
`limited to Compound 1
`is strong evidence that the scope of written description is
`
`•Gentry Gallery Inc. v. Berkline Corp., 134 F.3d 1473, 1478-80
`
`controls
`identified console as only possible location for
`invalid for lack of written description where disclosure
`
`•Claims that did not restrict the location of controls
`
`(Fed. Cir. 1998)
`
`PGR25 Pet. 75-76
`PGR88, Ex. 1001, code (57); PGR88 Pet. 71-72;
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`Invention”
`The Patents Repeatedly Characterize Compound 1 as “The
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`20
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`38, 8:63-67, 9:19-22; 9:46-49
`PGR88, Ex. 1001, 1:30-55, 4:43-64, 8:35-
`PGR88 Pet. 12-14; PGR25 Pet. 12-14;
`
`Each Embodiment Refers to Compound 1
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`21
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`22
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`PGR88 Pet. 14-15; PGR25 Pet. 14-15; PGR88, Ex. 1001, 36:32-41:49, 42:1-43:47; FIGS. 2 & 3
`
`***
`
`for Any Compound Other Than Compound 1
`The Specification Does Not Contain Any Description or Data
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`22
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`23
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`PGR88 Pet. 14-15; PGR25 Pet. 14-15; PGR88, Ex. 1001, 44:7-47:58
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`All Examples Are Limited to Compound 1
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`23
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`24
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`PGR25 Reply 6
`PGR88 Reply 6-7;
`
`deposition transcript at
`
`30:22-31:22
`
`Ex. 1038
`
`One Species
`Spruce’s Expert Concedes the Patents Disclose Only
`
`24
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`25
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`PGR25 DI (Paper 20), 32
`PGR88 DI (Paper 21), 45;
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`PGR25 DR Dec., 3
`PGR88 DR Dec., 13-14;
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`Description Support for the Entire Claimed Genus
`Disclosure of One Species Does Not Provide Adequate Written
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`25
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`26
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`PGR25 POPR (Paper 6), 42-45
`PGR88 POPR (Paper 8), 31-34
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`Director Review Decision at 13:
`
`inherency
`(crinecerfont) cannot be relied on for
`conducted using a different species
`–Argued that the results of a trial study
`
`•POPR:
`
`Unpredictable
`Spruce Admits CRF1 Antagonist Receptor Activity Is
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`26
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`27
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`PGR25 Pet. 23, 78-79
`PGR88 Pet. 21-22, 74-75
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`Ex. 1002, 30-32
`
`Results For Compound 1
`During Prosecution, Spruce Relied on Allegedly Unexpected
`
`27
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`28
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`PGR88 Reply 9; PGR25 Reply 8
`
`deposition transcript at
`
`131:18-132:14
`
`Ex. 1038
`
`Had No Clinical Utility
`Spruce’s Expert Agrees Prior-Art CRF1 Receptor Antagonists
`
`28
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`29
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`PGR25 DI (Paper 20), 32
`PGR88 DI (Paper 21), 45;
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`PGR25 DR Dec., 3
`PGR88 DR Dec., 13-14;
`
`the Art Is A Substitute for Disclosure (POR 64-66)
`The Board and Director Rejected Spruce’s Argument Knowledge in
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`29
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`30
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`Disclose a Structure-Function Relationship
`Neither the ’908 nor the ’201 Patent
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`30
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`AONACIASLON-LIGIHX3SAILLVYLSNOWSG
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`31
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`Le
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`wt
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`'OAANUC
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`patents
`disclosed in the
`chemical structures
`There are no other
`
`
`
`94}UlPesojosip
`
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`
`6L-9-7E
`
`32:6-19
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`oo
`
`Ex. 1001, 1:30-55, 4:43-64, 8:35-38, 8:63-67, 9:19-22; 9:46-49
`PGR88 Reply 5; PGR25 Reply 5;
`
`
`
`jejdugsueduojisodap
`
`deposition transcript at
`
`8E0L‘x7
`
`Ex. 1038
`
`
`
`
`
`
`
`
`
`
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`aulAJUDBSOjOSiqs}jua}eYgJEU]SeeIBYWedxys,eonidse
`
`Structure of Compound 1
`Spruce’s Expert Agrees That Patents Disclose Only the
`
`
`
`JOEAN_ONAAS|YQYRACFsBjAesAT--&8,O70q3BOsNOA
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`op“quejedg06,S843JOTMMODUIDd
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`31
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`32
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`PGR25 Reply 9-10; Ex. 1039, 8
`PGR88 Reply 10; Ex. 1041, 4667;
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`Unique Features
`Spruce’s Own Publication Teaches Compound 1 Has Structurally
`
`32
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`33
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`PGR88 Reply 10; PGR25 Reply 9-10
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`deposition transcript at
`
`52:19-53:13
`
`Ex. 1038
`
`Unique Features
`Spruce’s Expert Agrees That Compound 1 Has Structurally
`
`33
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`34
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`PGR25 DI (Paper 20), 32
`PGR88 DI (Paper 21), 45;
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`PGR25 DR Dec., 3
`PGR88 DR Dec., 12-13;
`
`The Patents Do Not Disclose a Structure-Function Relationship
`
`34
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`35
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`PGR88 Reply 10; PGR25 Reply 9-10
`
`features.
`receptor can have widely diverse structural
`•The compounds that interact with the CRF1
`by a particular structure or structures.
`compounds that inhibit CRF1 receptors, not
`•CRF1 receptor antagonists are defined as
`
`PGR88, Ex. 1044
`
`¶¶ 89-92
`
`Dr. Cutler
`
`CRF1 Receptor Antagonists Are Structurally Diverse
`
`35
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`36
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`Ex. 1029 Williams
`
`•Ex. 2014 ¶ 88
`relationship
`structure-function
`structure as teaching a
`Dr. Dobs points to this
`
`Williams Does Not Disclose a Structure-Function Relationship
`
`36
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`37
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`PGR88 Reply 10-11; Ex. 1044 ¶¶ 95-99
`
`Ex. 1029 Williams
`
`structural features as Figure 2
`same articlethat do not have the same
`•Reports other CRF1 antagonists in the
`OHP/A4)
`claimed results (reducing ACTH/17-
`the chemical structures achieve the
`•Says nothing about which features of
`•Does not even mention CAH
`
`Williams Does Not Disclose a Structure-Function Relationship
`
`37
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`
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`‘Lpaanbiy
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`
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`
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`AONACIASLON-LIGIHX3SAILLVYLSNOWSG
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`OLAIdeYGZHDd“LLAION88HOd‘LL‘9%‘(r‘L)L“SBl4‘6ZOL“XZ
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`8¢
`
`38
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`
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`“sysluoBeque'yy>pe2idAry
`
`
`
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`
`
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`Ex. 1029, Figs. 1 (1, 4), 2, 6, 11; PGR88 Reply 11; PGR25 Reply 10
`
`
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`Structurally Diverse
`Williams Teaches that CRF1 Receptor Antagonists are
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`asJanigAyjeunjons
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`38
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`39
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`PGR88 Reply 11; PGR25 Reply 10
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`Figure 2
`than the structure in
`different structures
`antagonists had
`other CRF1 receptor
`Dr. Dobs admitted that
`
`deposition transcript at
`
`130:13-131:16
`
`Ex. 1038
`
`Spruce’s Expert Admissions About Williams
`
`39
`
`
`
`40
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`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`•Ex. 2014 ¶ 88
`function relationship
`teaching a structure-
`Figure 1 of Fahmy as
`Dr. Dobs also points to
`
`Ex. 1018 Fahmy
`
`Fahmy Does Not Disclose a Structure-Function Relationship
`
`40
`
`
`
`41
`
`Ex. 1044 ¶¶ 100-02
`PGR88 Reply 11; PGR25 Reply 10-11;
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`structural features as Figure 1
`same articlethat do not have the same
`•Reports other CRF1 antagonists in the
`number of compounds
`•General structure encompasses a large
`OHP/A4)
`claimed results (reducing ACTH/17-
`the chemical structures achieve the
`•Says nothing about which features of
`
`Ex. 1018 Fahmy
`
`Fahmy Does Not Disclose a Structure-Function Relationship
`
`41
`
`
`
`42
`
`PGR88 Reply 11; PGR25 Reply 10-11
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
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`structure in Figure 1
`structures than the
`11 and 12 had different
`antagonists of Figures
`the CRF1 receptor
`Dr. Dobs admitted that
`
`deposition transcript at
`
`132:17-134:20
`
`Ex. 1038
`
`Spruce’s Expert Admissions About Fahmy
`
`42
`
`
`
`43
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Description
`Spruce’s Arguments For Written
`
`43
`
`
`
`44
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88 Reply 6-7; PGR25 Reply 5-7
`
`indications (e.g., ’908 patent at 11:57-64)
`–that CRF1 receptor antagonists have been studied for other
`53,10:54-65,11:48-12:26); or
`CRF in hormone regulation (e.g., ’908 patent at 1:14-17,10:47-
`–the differences between CRF receptor subtypes and the role of
`–the use of tildacerfont (e.g., ’908 patent at 12:27-31);
`
`•Spruce’s citations relate to:
`receptor antagonists can achieve the claimed functions
`•Nothing in the patents teaches whether the genus of CRF1
`
`The Patents Do Not Disclose “Class Effects”
`
`44
`
`
`
`45
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88 Reply 8; PGR25 Reply 8
`
`1285, 1301 (Fed. Cir. 2014)
`–AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d
`description
`•A trial-and-error approach does not show adequate written
`
`(Fed. Cir. 1997)
`–Regents of the Univ. of California v. Eli Lilly & Co., 119 F.3d 1559, 1567
`invention.”
`sufficient to satisfy the written description requirement of that
`•“[A] description which renders obvious a claimed invention is not
`oral dosing protocol) to identify effective compounds is irrelevant
`•Spruce’s argument that the patents identify a method (14-day
`
`Spruce Conflates Written Description with Obviousness
`
`45
`
`
`
`46
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88 Sur-Reply 19; PGR25 Sur-Reply 18
`
`–Dr. Cutler’s Deposition, Ex. 2027, 73:3-12
`–Dr. Cutler’s Supplemental Declaration, Ex. 1044 ¶ 23
`
`•Sur-Reply 19, citing:
`depending on dosing
`wide therapeutic efficacy for “any CRF1 receptor antagonist”
`•Spruce argues Dr. Cutler testified to art-recognized class-
`
`Spruce Mischaracterizes Dr. Cutler’s Testimony
`
`46
`
`
`
`47
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25, Ex. 1047 ¶ 23
`PGR88, Ex. 1044 ¶ 23
`Dr. Cutler Declaration,
`
`What Dr. Cutler’s Actually Said
`
`47
`
`
`
`48
`
`PGR88 Reply 11; PGR25 Reply 10-11
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Spruce alleges
`efficacy for ‘any CRF1 receptor antagonist’ depending on dosing” as
`Dr. Cutler says nothing about any “art-recognized class-wide therapeutic
`
`deposition transcript at
`
`73:3-12
`
`Ex. 2027
`
`Dr. Cutler’s Deposition Testimony
`
`48
`
`
`
`49
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88 Sur-Reply 24; PGR25 Sur-Reply 23
`
`Spruce’s Sur-Reply Arguments Ignore the Claims
`
`49
`
`
`
`50
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88 Reply 4-5; PGR25 Reply 4-5
`
`Biotech, Inc., 759 F.3d 1285, 1301 (Fed. Cir. 2014)
`AbbVie Deutschland GmbH & Co., KG v. Janssen
`
`functionally claimed genus.
`genus or to predict what would be coveredby the
`correlation between structure and function for the whole
`are highly unpredictable, where it is difficult to establish a
`description support, especially in technology fields that
`vulnerable to invalidity challenge for lack of written
`Functionally defined genus claims can be inherently
`
`Spruce’s Claims Lack Adequate Written Description Support
`
`50
`
`
`
`51
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Anticipation of the Challenged Claims
`
`51
`
`
`
`52
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88 Pet. 3-4 & Reply 4; PGR25 Pet. 4 & Reply 4
`
`(Ex. 1006) under 35 U.S.C. §102
`Anticipation by disclosure of crinecerfont in Grigoriadis
`
`Basis for Rejection
`
`1-4, 7-9, 11-15, 18
`
`’201 Patent Claims
`
`Ground 1
`
`Ground
`
`in Grigoriadis (Ex. 1006) under 35 U.S.C. §102
`Anticipation by disclosure of crinecerfont and verucerfont
`
`Basis for Rejection
`
`1-4, 7-9, 11-14, 17-19, 21-24
`
`Ground 1
`
`’908 Patent Claims
`
`Ground
`
`Grounds for Anticipation: Grigoriadis’ Disclosure of Crinecerfont
`
`52
`
`
`
`53
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88, Ground 1; PGR25, Grounds 1, 4
`
`(PGR88, Ex. 1037; PGR25, Ex. 1009)
`patent and ’201 patent challenged claims, as shown by Auchus
`
`1.Grigoriadis method re crinecerfontinherently anticipates ’908
`
`–Verucerfont (NBI-77860)
`–Crinecerfont
`receptor antagonists:
`•Grigoriadis discloses method of treating CAH using CRF1
`
`obvious, as shown by Grigoriadis & Turcu (PGR25, Ex. 1008)
`3.Grigoriadis method re verucerfontrenders ’201 patent claims
`
`claims, as shown by data in Grigoriadis (PGR88)
`
`2.Grigoriadis method re verucerfontanticipates ’908 patent
`
`Grigoriadis’ disclosure (Ex. 1006)
`
`53
`
`
`
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`
`Grigoriadis Discloses Crinecerfont & Verucerfont
`
`¢‘LGbbb3e9001“xZ
`
`Ex. 1006 at ¶¶ 51, 54
`
`Grigoriadis,
`
`
`
`9001SNIEDOYNSNL
`
`sIetiostozsniod
`
`guec12er
`
`54
`
`
`
`
`
`(noretoe)orseTeWi
`
`L0UH
`
`
`
`Sayerspayruy
`
`54
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`JUOLIEONIE/
`
`Verucerfont
`
`
`
`JUOLOD9UUD
`
`Crinecerfont
`
`
`
`54
`
`
`
`
`
`
`55
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`’908 Patent, Ex. 1001
`
`’908 Patent Claims
`
`55
`
`
`
`56
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`’201 Patent, Ex. 1001
`
`’201 Patent Claims
`
`56
`
`
`
`57
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Grigoriadis, Ex. 1006
`
`Neurocrine’s Prior Work Anticipates the Independent Claims
`
`57
`
`
`
`58
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25 DI at 24
`
`PGR88 DI at 24-25
`
`Grigoriadis Discloses Administering a CRF1 Receptor Antagonist
`
`58
`
`
`
`59
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Reductions
`Achieves the Claimed Hormone
`Administering Crinecerfont for CAH
`
`59
`
`
`
`60
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25, Ex. 1009 at 6
`
`Auchus, PGR88, Ex. 1037 at 6
`
`Administering Crinecerfont Achieves the Claimed Reductions
`
`60
`
`
`
`61
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25 Pet. 32-33
`PGR88 Pet. 46
`
`Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1329 (Fed. Cir. 2020)
`itself prior art.”
`embodiment even if the extrinsic evidence is not
`what is ‘necessarily present’ in a prior art
`“Extrinsic evidence can be used to demonstrate
`
`Auchus Can be Used to Show Inherency
`
`61
`
`
`
`62
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25, Ex. 1009 at 7
`
`Auchus, PGR88, Ex. 1037 at 7
`
`Administering Crinecerfont Achieves the Claimed Reductions
`
`62
`
`
`
`63
`
`PGR25, Ex. 1047 ¶ 35
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88, Ex. 1044 ¶ 34
`
`PGR25, Ex. 1047 ¶ 35
`PGR88, Ex. 1044 ¶ 34
`Dr. Cutler Declaration,
`
`Administering Crinecerfont Achieves the Claimed Reductions
`
`63
`
`
`
`64
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25, Ex. 1009 at 7,10
`
`Auchus, PGR88, Ex. 1037 at 7,10
`
`Administering Crinecerfont Achieves the Claimed Reductions
`
`64
`
`
`
`65
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25, Ex. 1009 at 10
`
`Auchus, PGR88, Ex. 1037 at 10
`
`Crinecerfont Achieves the Claimed Reductions in Individual Patients
`
`65
`
`
`
`66
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25, Ex. 1047 ¶ 36
`
`PGR88, Ex. 1044 ¶ 35
`
`PGR25, Ex. 1047 ¶ 36
`PGR88, Ex. 1044 ¶ 35
`Dr. Cutler Declaration,
`
`Crinecerfont Achieves the Claimed Reductions in Individual Patients
`
`66
`
`
`
`67
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PG88 DI at 26
`
`Administering Crinecerfont Achieves the Claimed Reductions
`
`67
`
`
`
`68
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PG25 DI at 26
`
`Administering Crinecerfont Achieves the Claimed Reductions
`
`68
`
`
`
`69
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25 DR Dec., 3
`PGR88 DR Dec., 9-10;
`
`Administering Crinecerfont Achieves the Claimed Reductions
`
`69
`
`
`
`70
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25, Ex. 1009 at 3, 5
`
`Auchus, PGR88, Ex. 1037 at 3, 5
`
`Auchus Demonstrates Claimed Reductions “From Baseline”
`
`70
`
`
`
`71
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`deposition transcript at
`Dr. Dobs, Ex. 1038
`
`81:18-82:20
`
`Auchus Demonstrates Claimed Reductions “From Baseline”
`
`71
`
`
`
`72
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25, Ex. 1009 at 5
`
`Auchus, PGR88, Ex. 1037 at 5
`
`Auchus Demonstrates Reductions Maintained “Post 24 Hours”
`
`72
`
`
`
`73
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Spruce’s Arguments For Anticipation
`
`73
`
`
`
`74
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88 POR (Paper 29), 33-41
`
`Spruce: Auchus Does Not “Follow the Method of Grigoriadis”
`
`74
`
`
`
`75
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88 DR Dec., 10
`
`Differences in Methods Are Not Recited in the Claims
`
`75
`
`
`
`76
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`deposition transcript at
`
`Dr. Dobs, Ex. 1038
`
`25:8-29:14
`
`Differences in Methods Are Not Recited in the Claims
`
`76
`
`
`
`77
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25 POR, 41
`PGR88 POR, 42
`
`Spruce: Claims Require Reductions in AllHumans
`
`77
`
`
`
`78
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`201 Patent
`
`908 Patent
`
`Claims Require Reduction in “A Human” Not AllHumans
`
`78
`
`
`
`79
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88, Ex. 1001, 3, 26
`
`Patent Data Shows Reduction in Some, Not All, Humans
`
`79
`
`
`
`80
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR 88, Ex. 1001, 43:53-65
`
`Patent Data Shows Reduction in Some, Not All, Humans
`
`80
`
`
`
`81
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`deposition transcript at
`Dr. Dobs, Ex. 1038
`
`20:8-22:2
`
`Patent Data Shows Reduction in Some, Not All, Humans
`
`81
`
`
`
`82
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Ex. 1044 ¶ 38
`
`PGR88
`
`Claims Require Reduction in “A Human” Not AllHumans
`
`82
`
`
`
`83
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88 Reply 16, 19; PGR25 Reply 15, 18
`
`In re Montgomery, 677 F.3d 1375, 1381, 1384 (Fed. Cir. 2012)
`
`prior art reference.”
`must have necessarily resulted from the practice of a
`“For anticipation by inherency, a later-claimed invention
`inevitably flows from the prior art disclosure….”
`out the claim steps.… [A] result is only inherent if it
`an efficacy requirement, efficacy is inherent in carrying
`“[W]e agree with the Board that even if the claim includes
`
`Limitations
`Administration of Crinecerfont Inherently Meets Claimed
`
`83
`
`
`
`84
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88 POR, 46
`
`Spruce: Statistical Significance Required to Show Claimed Reductions
`
`84
`
`
`
`85
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88, Ex. 1037, Fig.
`
`Ex. 1044 ¶¶ 44-45
`
`4
`
`Statistical Significance Not Required, but Shown by Auchus Results
`
`85
`
`
`
`86
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Ex. 1047 ¶ 45
`
`PGR25
`
`Statistical Significance Not Required, but Shown by Auchus Results
`
`86
`
`
`
`87
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Ex. 1044 ¶ 24
`
`PGR88
`
`Dr. Cutler: All Dose Cohorts Meet Claim Limitations
`
`87
`
`
`
`88
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88
`
`Adopted Ex. 1036 ¶ 16
`
`Ex. 1005 ¶ 85
`
`•Spruce does not dispute anticipation of claims 3-4, 7-9, 11-14, 17-19,
`
`and 23 other than its arguments for the independent claims
`
`Grigoriadis’ Disclosure Anticipates the ’908 Patent Dependent Claims
`
`88
`
`
`
`89
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88
`
`Adopted Ex. 1036 ¶ 16
`
`Ex. 1005 ¶ 92
`
`Grigoriadis’ Disclosure Anticipates the ’908 Patent Dependent Claims
`
`89
`
`
`
`90
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88 DI, 35-37
`
`Grigoriadis’ Disclosure Anticipates the ’908 Patent Dependent Claims
`
`90
`
`
`
`91
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88 Pet. 3-4 & Reply 4
`
`(Ex. 1006) under 35 U.S.C. §102
`Anticipation by disclosure of verucerfont in Grigoriadis
`
`Basis for Rejection
`
`1-4, 7-9, 11-14, 17-19, 21-24
`
`Ground 1
`
`’908 Patent Claims
`
`Ground
`
`Grounds for Anticipation: Grigoriadis’ Disclosure of Verucerfont
`
`91
`
`
`
`92
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Grigoriadis, Ex. 1006, ¶¶ 90, 93
`
`Grigoriadis’ Disclosure of Verucerfont Anticipates the Claims
`
`92
`
`
`
`93
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Grigoriadis, Ex. 1006, Fig. 5
`
`Grigoriadis’ Disclosure of Verucerfont Anticipates the Claims
`
`93
`
`
`
`94
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88
`
`Adopted Ex. 1036 ¶ 16
`
`Ex. 1005 ¶ 65
`
`Grigoriadis’ Disclosure of Verucerfont Anticipates the Claims
`
`94
`
`
`
`95
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Grigoriadis, Ex. 1006, Fig. 6
`
`Grigoriadis’ Disclosure of Verucerfont Anticipates the Claims
`
`95
`
`
`
`96
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88
`
`Adopted Ex. 1036 ¶ 16
`
`Ex. 1005 ¶ 66
`
`Grigoriadis’ Disclosure of Verucerfont Anticipates the Claims
`
`96
`
`
`
`97
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25 DI at 11
`
`PGR88 DI at 11
`
`Verucerfont ACTH, 17-OHP, A4 Reductions are “from baseline”
`
`97
`
`
`
`98
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Grigoriadis, Ex. 1006, Fig. 4
`
`Placebo Administered Prior to Administration of the Drug (Verucerfont)
`
`98
`
`
`
`99
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Ex. 1044 ¶ 67
`
`PGR88
`
`Grigoriadis’ Disclosure of Verucerfont Anticipates the Claims
`
`99
`
`
`
`100
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`deposition transcript at
`
`24:11-17
`
`Ex. 1038
`
`Spruce’s Expert Did Not Consider Board’s Construction
`
`100
`
`
`
`101
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Ex. 1044 ¶ 69
`
`PGR88
`
`A Placebo Baseline is Appropriate
`
`101
`
`
`
`102
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Ex. 1044 ¶ 70
`
`PGR88
`
`A Placebo Baseline is Appropriate
`
`102
`
`
`
`103
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25 POR, 52-53
`
`Inter-Patient Variability Irrelevant to Anticipation in “A Human”
`
`103
`
`
`
`104
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Obviousness of the Challenged Claims
`
`104
`
`
`
`105
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25 Pet. 4 & Reply 4
`
`U.S.C. §103
`Grigoriadis (Ex. 1006) and Turcu(Ex. 1008) under 35
`Obvious in view of disclosure of verucerfont in
`
`1-4, 7-19
`
`Basis for Rejection
`
`’201 Patent Claims
`
`Ground 4
`
`Ground
`
`Verucerfont
`Grounds for Obviousness: Grigoriadis & Turcu Disclosure of
`
`105
`
`
`
`106
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Turcu, Ex. 1008
`
`Grigoriadis, Ex. 1006
`
`Grigoriadis & Turcu Disclose Results of Same Study
`
`106
`
`
`
`107
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`Turcu, Ex. 1008, Table 3
`
`Administering Verucerfont Achieves A4 Reductions
`
`107
`
`
`
`108
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25
`
`Adopted Ex. 1036 ¶ 16
`
`Ex. 1005 ¶ 58
`
`Administering Verucerfont Achieves A4 Reductions
`
`108
`
`
`
`109
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25
`
`Adopted Ex. 1036 ¶ 16
`
`Ex. 1005 ¶ 61
`
`Obvious that A4 Reductions Would be Maintained with Repeat Dosing
`
`109
`
`
`
`110
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88 Pet. 3-4 & Reply 4; PGR25 Pet. 4 & Reply 4;
`
`and Romano (Ex. 1007) under 35 U.S.C. §103
`Obvious in view of disclosures in Grigoriadis (Ex. 1006)
`and knowledge of a skilled artisan under 35 U.S.C. §103
`Obvious in view of disclosures in Grigoriadis (Ex. 1006)
`
`Basis for Rejection
`
`5-6
`
`Grounds 3, 5
`
`10, 16-17, 19
`
`’201 Patent Claims
`
`Ground 2
`
`Ground
`
`and Romano (Ex. 1007) under 35 U.S.C. §103
`Obvious in view of disclosures in Grigoriadis (Ex. 1006)
`and knowledge of a skilled artisan under 35 U.S.C. §103
`Obvious in view of disclosures in Grigoriadis (Ex. 1006)
`
`Basis for Rejection
`
`5-6, 15-16
`
`Ground 3
`
`4, 10, 14, 20-22, 25
`
`’908 Patent Claims
`
`Ground 2
`
`Ground
`
`Grounds for Obviousness: Dependent Claims
`
`110
`
`
`
`111
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88 Pet. 58-59
`
`other than stated for Ground 1
`•Ground 3: Spruce does not dispute obviousness for reasons
`
`other than stated for Ground 1
`•Ground 2: Spruce does not dispute obviousness for reasons
`PGR88, ’908 Patent: Obviousness of Dependent Claims
`
`111
`
`
`
`112
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25
`
`Adopted Ex. 1036 ¶ 16
`
`Ex. 1005 ¶¶ 87-88
`
`Obvious that A4 Reductions Would be Maintained Post 4 or 6 Weeks
`
`112
`
`
`
`113
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25
`
`Adopted Ex. 1036 ¶ 16
`
`Ex. 1005 ¶¶ 87-88
`
`Obvious that A4 Reductions Would be Maintained Post 4 or 6 Weeks
`
`113
`
`
`
`114
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25
`
`Adopted Ex. 1036 ¶ 16
`
`Ex. 1005 ¶¶ 91-95
`
`Grigoriadis’ Disclosure of Verucerfont Renders Claim 19 Obvious
`
`114
`
`
`
`115
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR25 Pet. 47, 65-66
`
`other than stated for Ground 4
`•Ground 5: Spruce does not dispute obviousness for reasons
`
`reasons other than stated for Ground 1
`•Grounds 3: Spruce does not dispute obviousness for
`PGR25, ’201 Patent: Obviousness of Dependent Claims
`
`115
`
`
`
`
`
`ObL
`
`116
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
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`
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`Claim Construction
`
`
`
`Ex. 1001, ’908 Patent
`
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`
`116
`
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`
`116
`
`
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`
`117
`
`DEMONSTRATIVE EXHIBIT -NOT EVIDENCE
`
`PGR88 Pet. 23-28, DI at 11; PGR25 Pet. 27-30, DI at 11
`
`release of ACTH
`“Administered 4 hours prior to sleeping”(’908 patent claim 24): administered 4 hours prior to the circadian
`
`“Maintained at a reduced level post
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