Neurocrine Biosciences, Inc. vs Spruce Biosciences, Inc.

Order Denying Director Review of Final Written Decision

Patent Owner's Request for Director Review

Final Written Decision: original

Petitioner's Opposition to Patent Owner's Additional Briefing on Claim Construction

Patent Owner's Opposition to Petitioner's Additional Briefing on Claim Construction

Petitioner's Additional Briefing on Claim Construction

Patent Owner's Additional Briefing on Claim Construction

Other: Hearing transcript

ORDER Conduct of the Proceeding Authorizing Additional Briefing on Claim Construction 37 C.F.R. §§ 42.5, 42.20(d)

Petitioner's Statement of Objections to Patent Owner's Demonstrative Evidence

Petitioner's Updated Exhibit List

Petitioner's Demonstratives

Patent Owner's Opposition to Petitioner's Motion to Strike

Patent Owner's Updated Exhibit List

Patent Owner's Demonstrative Exhibits

Patent Owner's Reply in Support of Motion to Exclude

Petitioner Reply in Support of Motion to Exclude Evidence

Petitioner's Motion to Strike

EX1047 Board Authorization Aug-15-2024

Petitioner's Opposition to Patent Owner's Motion to Exclude

Board's Authorization to Submit Supplemental Information dated December 28, 2023

Patent Owner's Opposition to Petitioner's Motion to Exclude

Petitioner's Objections to Evidence

Petitioner's Motion to Exclude Evidence

Patent Owner's Motion to Exclude Evidence

Inventors’ Oaths for PCT/US2021/036668

US Patent App. No. 18/009,537 Filing Receipt

US Patent App. No. 18/009,537 Information Disclosure Statement dated December 7, 2023

US Patent App. No. 18/009,537 Preliminary Amendment dated August 11, 2023

US Patent App. No. 17/311,310 Filing Receipt

US Patent App. No. 17/311,310 Information Disclosure Statement dated December 15, 2021

US Patent App. No. 17/311,310 Reply to Restriction Requirement dated April 16, 2024

Transcript of July 25, 2024, Deposition of Dr. Gordon B. Cutler, Jr. regarding PGR2021-00088 and PGR2022-00025

Patent Owner's Sur-Reply

Petitioner's Updated Mandatory Notices

Petitioner's Power of Attorney

Third Joint Stipulation to Modify the Scheduling Order

Patent Owner's Updated Mandatory Notices

Conditionally Granting Petitioner’s Motions for Admission Pro Hac Vice of Juanita Brooks 37 C.F.R. § 42.10

Order: Setting Oral Argument

Patent Owner's Request for Oral Argument

Second Joint Stipulation to Modify the Scheduling Order

Motion for Pro Hac Vice Admission of Juanita Brooks

Declaration of Juanita Brooks in Support of PHV Admission

Notice of Second Deposition of Dr. Cutler

Petitioner's Request for Oral Hearing

Patent Owner's Objections to Evidence

PETITIONER'S REPLY TO PATENT OWNER'S RESPONSE

Deposition Transcript for Adrian Saundra Dobs

December 14, 2023 Email from Counsel Regarding Dr. Carey's health status

Sarafoglou et al, Tildacerfont in Adults With Classic Congenital Adrenal Hyperplasia

Recto et al, Comparison of the Efficacy and Tolerability of Sirnvastatin and Atorvastatin in the Treatment of Hypercholesterolemia

Auchus et al, Phase 3 Trial of Crinecerfont in Adult Congenital Adrenal Hyperplasia

Reply Declaration of Gordon B. Cutler, Jr., M.D.

Spierling & Zorrilla 2017

Petitioner's Notice of Deposition

Petitioner's Objections to Evidence

Patent Owner Response

Transcript of Cutler Deposition

Yanovski, J.A. et al. 1996

Mercado-Asis, L.B., et al. (1997)

Declaration of A. Dobs.

Dobs CV

Leadership - Neurocrine Biosciences

Lee, D.K. et al. (2015)

Sullivan, L. et al., InterQuartile Range (IQR)

Habibzadeh, F., ôStatistical Data Editing (2017)

Exhibit 3002

Notice of Deposition of Dr. Cutler

Joint Stipulation to Modify the Scheduling Order

Declaration of Gordon B. Cutler, JR., M.D.

Auchus

Petitioner's Updated Exhibit List

Patent Owner's Objections to Evidence

Revised Joint Scheduling Order

Panel Change Order

Order: Joint Scheduling Order

Institution Decision: Grant

Petitioner's Updated Mandatory Notices

ORDER Granting Petitioner’s Motion for Withdrawal and Substitution of Lead Counsel 37 C.F.R. secs 42.10, 42.20 b

Petitioner's Motion to Substitute Lead Counsel

ORDER Conduct of the Proceeding 37 C.F.R. sec 42.5

DECISION Vacating the Decision Denying Institution and Remanding to the Patent Trial and Appeal Board Panel for Further Proceedings

Order Granting Sua Sponte Director Review

Order: Order Dismissing POP Request

Exhibit 3001

Notice: notice of receipt of POP request

Petitioner's Request for Rehearing

Denying Institution of Post-Grant Review 35 U.S.C. § 324

Patent Owner's Preliminary Response

Patent Owner's Notice Regarding Redacted Filing

EX2001 - Anthenelli

EX2002 - Hamilton

EX2003 - Rose M. Rose, Plasma Cortisol and Growth Hormone Responses to Intravenous Catheterization, J. HUM. STRESS 22 (March 1975).

EX2004 - Stefan Koelsch, The Impact of Acute Stress on Hormones and Cytokines, and How Their Recovery is Affected by Music-Evoked Positive Mood, 6 SCI. REPS. 23008, 1 (March 2016).

EX2005 - Fabrizio Benedetti, The Biochemical and Neuroendocrine Bases of the Hyperalgesic Nocebo Effect, 26 (46) J. NEUROSCIENCE, 12014 (Nov. 15, 2006).

EX2006 - Andrew J. Vickers, Why Use Placebos in Clinical Trials? A Narrative Review of the Methodological Literature, 53 J. CLINICAL EPIDEMIOLOGY, 157 (2000).

EX2007 - Ali Iranmanesh, Glucose Ingestion Selectively Amplifies ACTH and Cortisol Secretory-Burst Mass and Enhances Their Joint Synchrony in Healthy Men, 96 (9) J. CLINICAL ENDOCRINOLOGY & METABOLISM, 2882 (Sept. 2011)

EX2008 - Baseline, Medical Dictionary, THE FREE DICTIONARY (Nov. 7, 2016), https://web.archive.org/web/20161107132345/https://medical-dictionary.thefreedictionary.com/baseline

CONFIDENTIAL - Patent Owner's Preliminary Response

Patent Owner's Mandatory Notices

Patent Owner's Power of Attorney

Notice of Accord Filing Date

U.S. Patent No. 10,849,908 to Alexis Howerton, et al

U.S. Prosecution History of the 908 Patent

Application No. PCTUS2018046760

U.S. Provisional Application Serial No. 62545406

U.S. Patent Application Publication No. 20170020877 to Grigoriadis et al

U.S. Patent Application Publication No. 20050209250 to Romano

Turcu et al., Single Dose Study of a Corticotropin Releasing Factor Receptor 1 Antagonist in Women With 21 Hydroxylase Deficiency

Auchus et al

U.S. Patent Application Publication No. 20060078623 to Dhoot et al

Spruce Biosciences Presents Phase 1 and 2 Data for Tildacerfont in Adults with Congenital Adrenal Hyperplasia from Endocrine Society's 2021 Annual Meeting

U.S. Patent No. 8,030,304 to Chen et al

Speiser et al., Congenital Adrenal Hyperplasia Due to Steroid 21 Hydroxylase Deficiency

Turcu, The Next 150 Years of Congenital Adrenal Hyperplasia

El Maouche et al., Congenital Adrenal Hyperplasia

Merke Congenital Adrenal Hyperplasia

Speiser Congenital Adrenal Hyperplasia Due to Steroid 21 Hydroxylase Deficiency

Fahmy Structure and Function of Small Non Peptide CRF Antagonists and their Potential Clinical Use

Griebel 4-(2-Chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]5-methyl-N-(2-propynyl)-1,3-thiazol-2-amine Hydrochloride (SSR125543A)

Gully 4-(2-Chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]5-methyl-N-(2-propynyl)-1,3-thiazol-2-amine Hydrochloride (SSR125543A)

Merke New Ideas for Medical Treatment of Congenital Adrenal Hyperplasia

Merke Future Directions in the Study and Management of Congenital Adrenal Hyperplasia due to 21 Hydroxylase Deficiency

Microparticles Formulation as a Targeting Drug Delivery System, J. Nanomed. Res

Merke Congenital Adrenal Hyperplasia Due to 21 Hydroxylase Deficiency

Turcu Novel Treatment Strategies in Congenital Adrenal Hyperplasia

Webb Current and Novel Approaches to Children and Young People with Congenital Adrenal Hyperplasia and Adrenal Insufficiency

Neurocrine Biosciences to Present New Data Analyses for Crinecerfont in Adults with Classical Congenital Adrenal Hyperplasia at ENDO 2021, Neurocrine Biosciences

Neurocrine Biosciences Reports Positive Phase II Data for Crinecerfont in Adults with Congenital Adrenal Hyperplasia at ENDO Online 2020, Neurocrine Biosciences

Williams, Corticotropin Releasing Factor 1 Receptor Antagonists

Zorrilla Progress in Corticotropin-Releasing Factor 1 Antagonist Development

Kehne Therapeutic Utility of Non Peptidic CRF1 Receptor Antagonists in Anxiety, Depression, and Stress Related Disorders: Evidence from Animal Models

Goodman & Gilman's The Pharmacological Basis of Therapeutics

Shargel Applied Biopharmaceutics & Pharmacokinetics

Shargel Applied Biopharmaceutics & Pharmacokinetics

Bale Overview on Therapeutic Applications of Microparticulate Drug Delivery Systems

Petitioner's Power of Attorney

Declaration of Robert M. Carey, M.D.

Declaration of Robert M. Carey, M.D.

Petition for Post Grant Review

Petition for Post Grant Review

Petitioner's Motion to Seal