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 Supporrt of Motion to Exclude

Petitioner Reply in Support of Motion to Exclude Evidence

Petitioner's Motion to Strike

EX1050 Board Authorization Aug-15-2024

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

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

Patent Owner's Sur-Reply

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

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

Transcript of June 5, 2024 Deposition of Dr. Adrian Dobs

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

Spierling & Zorilla 2017

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.

Petitioner's Notice of Deposition

Petitioner's Objections to Evidence

Transcript of Cutler Deposition

Yanovski, J.A. et al. 1996

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

A. Dobs Declaration

Dobs CV

Leadership - Neurocrine Biosciences

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

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

Habibzadeh, F., ôStatistical Data Editing (2017)

Patent Owner Response

Notice of Deposition of Dr. Cutler

Joint Stipulation to Modify the Scheduling Order

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

Petitioner's Updated Exhibit List

Patent Owner's Objections to Evidence

Revised Joint Scheduling 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. §§ 42.10, 42.20 b

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

Petitioner's Motion to Substitute Lead Counsel

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

Ex. 3002 POP Request

Notice: notice of receipt of POP request

Petitioner's Request for Rehearing

Institution Decision: Deny

Patent Owner's Pre-Institution Sur-Reply

Petitioner's Reply to Patent Owner's Preliminary Response

Order Conduct of the Proceeding

Email

Patent Owner's Preliminary Response

EX2001 - Anthenelli

EX2002 - Hamilton

EX2003 - Rose

EX2004 - Koelsch

EX2005 - Benedetti

EX2006 - Vickers

EX2007 - Iranmanesh

EX2008 - Baseline definition by Medical dictionary

EX2009 - PGR2021-00088 Institution Decision

EX2010 - PGR2022-00088 Carey Declaration

Notice: Notice filing date accorded

Patent Owner's Mandatory Notices

Patent Owner's Power of Attorney

U.S. Patent No. 11,007,201 to Alexis Howerton, et al

U.S. Prosecution History of the '201 Patent

Application No. PCT/US2018/046760

U.S. Provisional Application Serial No. 62/545,406

U.S. Patent Application Publication No. 2017/0020877 to Grigoriadis et al

U.S. Patent Application Publication No. 2005/0209250 to Romano

Turcu Single-Dose Study of a Corticotropin-Releasing Factor Receptor-1 Antagonist in Women With 21-Hydroxylase Deficiency

Auchus Crinecerfont Lowers Elevated Hormone Markers in Adults With 21-Hydroxylase Deficiency Congenital Adrenal Hyperplasia

U.S. Patent Application Publication No. 2006/0078623 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 Congenital Adrenal Hyperplasia Due to Steroid 21-Hydroxylase Deficiency: An Endocrine Society Clinical Practice Guideline

Turcu The Next 150 Years of Congenital Adrenal Hyperplasia

El Maouche 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, et al.

Gully et al.

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

Williams, Corticotropin-Releasing Factor 1 Receptor Antagonists A Patent Review

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 (7th ed. 2016)

Shargel Applied Biopharmaceutics & Pharmacokinetics (6th ed. 2012)

Bale Overview on Therapeutic Applications of Microparticulate Drug Delivery Systems

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

U.S. Prosecution History of the '908 Patent

Fuqua Duration of Suppression of Adrenal Steroids after Glucocorticoid Administration

Sarafoglou Tildacerfont in Adults with Classic Congenital Adrenal Hyperplasia Results from Two Phase 2 Studies

Reif Mechanisms Involved in Placebo and Nocebo Responses and Implications for Drug Trials

Declaration of Robert M. Carey

Petitioner's Power of Attorney

Petition for Post Grant Review