Neurocrine Biosciences, Inc. vs. Spruce Biosciences, Inc.

Explore the PTAB proceeding PGR2025-00032 filed by Neurocrine Biosciences, Inc. on 2025-02-10. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Proceeding Overview

Proceeding Number

PGR2025-00032

Filing Date

2025-02-10

Accorded Filing Date

2025-02-10

Institution Decision Date

2025-10-03

Last Modified Date

2025-11-07

Proceeding Type

PGR

Termination Date

2025-10-03

Trial Status

Institution Denied

Parties & Counsel

Petitioner

Neurocrine Biosciences, Inc.

Represented By

Sawert, Kristiet al

Patent Owner / Respondent

Spruce Biosciences, Inc.

Represented By

Rosato, Michaelet al

Tribunal & Venue

Tribunal

Patent Trial and Appeal Board (USPTO)

Technology Center

TC 1600 - Biotechnology & Organic Chemistry

Patent Information

1 Patent Involved

Respondent Application Number 18307718

Respondent Patent Number 12115166

External Links

Espacenet

Google Patents

Respondent Inventor Alexis HOWERTON et al

Respondent Tech Center TC 1600 - Biotechnology & Organic Chemistry

Address and Attorney/Agent Information

184 Registered Practitioners

Power of Attorney & Correspondence

Firm / Entity Name WILSON SONSINI GOODRICH & ROSATI

Customer Number 21971

Address 650 PAGE MILL ROAD, PALO ALTO, CA, 94304-1050, UNITED STATES

Attorney / Agent Information

Reg #	Name	Phone
32483	Vernon Norviel	650-320-4704
34448	Richard Torczon Jr	202-973-8811
39666	Um Ping Eng	650-493-9300
42296	William Barrett	650-771-9816
44409	Karen Wong	650-493-9300
47664	Michael Hostetler	858-350-2306
52182	Michael Rosato	206-883-2529
52353	Lorelei Westin	858-350-2225
52505	Maya Skubatch	650-849-3330
53333	Gregory Mitchell	858-350-2335
54152	Ingo Hardt	858-350-2352
54196	Megan Jamroz	(651) 736-7586
57243	Esther Kepplinger	202-973-8800
57613	Elaine Lee	650-845-5064
59502	David Clark	858-350-2300
60302	Louis Lieto	202-973-8800
61063	Jeffrey Seidel	202-973-8838
61836	Matthew Argenti	650-493-9300
62407	Darby Chan	650-493-9300
62452	Matthew Bresnahan	858-350-2226
62554	Hin Meng Au	650-849-3064
63876	Lucian Orbai	650-849-3337
65089	Christopher Mcandrew	617-598-7808
65119	Norman Hovijitra	650-493-9300
65256	Craig Kenesky	212-497-7767
65278	Feng Tian	202-973-8921
66650	Laurie Mc Namara	858-350-2369
66747	Kimberly Stopak	415-572-4518
67024	Clark Lin	617-598-7823
67939	James Malecha	858-350-2300
68180	Ali Alemozafar	650-493-9300
68648	Deborah Smith	858-350-2315
68669	Julia Minitti	650-849-3042
68924	Rex Watkins	650-849-3144
70337	Sara Butterfield	858-350-2300
71594	Wesley Derryberry	202-973-8824
71901	Adam Cole	650-849-3298
72136	Ying Chen	617-598-7815
72267	Alicia Umpierre	858-350-2300
72290	Minyoung Shin	858-350-2378
72550	Sara Patak	858-350-2302
72738	Jennifer Floyd	858-350-2267
72875	Celine Bonnefous	858-350-2213
72903	Xue Holdman	617-598-7883
73091	Yingchun Ni	858-350-2390
73101	Matthew Wheeler	858-350-2317
73284	Scott Burkette	858-350-2234
73645	Sanjukta Ghosh	617-901-2589
73674	Derrick Rowe	202-306-3384
73844	Jiarong Lamiquiz	650-849-3125
73914	Rachna Ujwal	212-497-7741
74242	Bruce Kisliuk	301-580-6948
74394	Valentin Zunic	858-350-2211
74578	Eunhee Han	323-210-2908
74595	Wei Huang	212-453-2816
74735	Patrick Medley	206-883-2593
75021	Grant Margulieux	858-350-2356
75424	Sean Reed	858-350-2384
75546	Adrian Barker	415-730-6373
75659	Moonkyoung Um	617-598-7800
75866	Roshni Ghosh	212-453-2860
76067	Mengmeng Zhang	617-598-7814
76153	Tyler Baguley	858-350-2278
76285	Brandon Tavshanjian	415-947-2475
76474	Kelsey Macconaghy	415-471-3946
76486	Jing Wang	650-305-8774
76533	Dawson Wong	202-973-8940
76602	Garrett Potter	206-295-7363
76833	Katerina Otrubova	858-350-2216
76891	Swati Sharma	650-849-3055
76916	Chun Shi Lin	858-350-2300
76971	Payal Vyas	617-598-7842
77124	Brett Zirkle	858-350-2377
77140	Nicholas Calcaterra	415-471-3940
77194	Madeline Elkins	650-849-3301
77260	Koyi Yoon	617-598-7848
77276	Minerva Wong	212-813-8800
77545	Eugene Daneshvar	650-565-3775
77556	Luis Perla	650-849-3351
77626	August Renshaw	858-350-2349
77635	Sung Soo Lee	212-453-2834
77769	Christina Hoong	858-350-2206
77867	Laurence Chen	909-456-4118
77907	Nicholas Tiee	650-849-3327
77926	Maysam Pessian	858-350-2300
78122	Jose Martinez	541-400-0071
78136	Erin Boyle Anderson	858-350-2314
78306	Dylan Kahl	415-947-2479
78329	Karl Hudspith	202-973-8800
78363	Johnson Truong	617-598-7809
78425	Kyle Headrick	858-350-2311
78582	Shu Wang	212-453-2872
78717	Lauren Hodnett	617-598-7834
78775	Charles Schwamb	212-453-2838
78778	Joseph Swabeck	215-568-3439
78849	Weigang Lu	678-908-6667
78875	Vishakha Negi	310-962-8447
79175	Scott May	858-350-2365
79182	David Stanton	304-209-0093
79232	Andrew Heidari	858-350-2367
79324	Cheuk Hei Ho	617-598-7874
79331	Anthony Nastase	415-471-3949
79395	Bridgett Kohno	858-350-2334
79470	Tiara Wong	562-714-8646
79511	Tyler Bird	415-947-2155
79538	Sarah Cohen	614-440-7272
79559	Madeline Hess	641-512-0858
79641	Victoria Cheng	832-605-2488
79642	Phwey Gil	716-597-4874
79700	Hee Min Noh	858-350-2310
79740	Nima Zargari	858-350-2300
79799	Seung Hyeon Ko	202-903-8800
79890	Joseph Lesniewski	202-920-8734
79982	Michael Wormald	202-973-8991
800068	Yijing Chen	917-634-0091
80086	Irene Kasumba	202-920-8749
80285	Stephen Olshemski	570-690-1797
80353	Mitchell Porter	301-775-8661
80382	Shane Crippen	415-947-2019
80412	Matthew Garnica	858-350-2300
80453	Steven Hanna	415-471-3940
80466	Dalton Case	858-350-2386
80595	Evan Bernstein	847-463-0936
80596	Elizabeth Doctorov	650-849-3239
80676	Cassidy Evaristo	858-350-2260
80724	In Young Choi	202-973-8800
80742	Shuobo Boboila	212-453-2893
80848	Kevin Tylock	585-943-6062
80867	Trevor Lyons	203-770-2371
80906	Ting Wei Xiang	212-453-2819
80917	Tingjiao Li	317-373-6676
80962	Bryan Edwards	858-350-2396
80971	Kacey Rajkovich	202-920-8712
80980	Tess Oram	202-257-9186
80991	Trevor Lohrey	415-947-2089
81034	Esther Cynn	212-999-5800
81048	Lisa Nip	617-598-7875
81050	Kaia Parenti	212-453-2852
81075	Uale Taotafa	858-245-3700
81076	Laci Adolfo	303-256-5900
81114	Jacob Daniels	212-999-5800
81152	Nicolette Gregor	781-400-0581
81273	Jamie Gleason-Bremer	714-318-5907
81278	Khailee Marischuk	770-289-4775
81339	James Ryan	917-993-1246
81340	Nicholas Upright	212-453-2841
81365	Daria Lukasz	202-973-8858
81371	Joy Wang	610-844-1301
81388	Michael Rizzuto	203-247-8482
81391	Blake Torrance	617-598-7800
81506	Jane Yang	858-945-6975
81546	Zamin Raza	908-914-7593
81574	Weiwei Dai	202-791-8012
81623	Trevor Butcher	858-350-2300
81679	Nicole Zeinstra	650-461-7386
81691	Eric Ong	415-947-2000
81735	Danya Smart	805-807-1425
81786	Lindsey Lewis	858-239-5375
81877	Julia Kennedy-Darling	503-704-0070
81965	Ali Mohammadabadi	202-973-8927
81977	Longle Ma	617-598-7889
82026	Benjamin Hoar	424-599-5745
82103	Bryan Ellis	303-256-5900
82238	Yijing Chen	917-634-0091
82249	Steven Gore	940-390-2752
82255	Melanie Malinas	775-813-5268
82432	Xiaoyang Tang	617-598-7838
82490	Lucas Batties	650-999-0752
82529	Rachel Wilson	415-947-2119
82557	Xiaomei Yuan	305-804-1855
82641	Gabrielle Kleyner	212-497-7765
82713	Marcos Gonzalez Lopez	858-350-2305
82926	Julian Bieber-Dishart	415-947-2000
83011	Carey Cling	858-350-2300
83023	Amar Sharma	415-867-9739
83025	Claire Storey	704-999-7207
83043	Eric Nealy	650-493-9300
83075	Joleen Cheah	408-594-8945
83290	Carolyn Lorch	765-212-6056
83306	Samuel Riddle	303-256-5900
L1269	Yingjiao Wang	--
L1297	David Williamson	212-497-7729
L1333	Zheng Zeng	650-858-7090
L1361	Shuaimin Liu	650-788-5357

Proceeding Documents

Notice: refund approved NOTICE

2025-11-07 FILING PARTY: BOARD

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Petitioner's Request for Refund OTHER

2025-10-30 FILING PARTY: PETITIONER

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Institution Decision: Deny DECISION

2025-10-03 FILING PARTY: BOARD

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Patent Owner's Preliminary Response POPR

2025-07-08 FILING PARTY: PATENT OWNER

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2001

EX2001 - Statutory Disclaimer filed 05-07-2025 Exhibit

2025-07-08 FILING PARTY: PATENT OWNER

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Neurocrine Biosciences, Inc. vs. Spruce Biosciences, Inc.

Proceeding Overview

Parties & Counsel

Petitioner

Neurocrine Biosciences, Inc.

Represented By

Patent Owner / Respondent

Spruce Biosciences, Inc.

Represented By

Tribunal & Venue

Patent Information

Address and Attorney/Agent Information

Power of Attorney & Correspondence

Attorney / Agent Information

Proceeding Documents

Notice: refund approved NOTICE

Petitioner's Request for Refund OTHER

Institution Decision: Deny DECISION

Patent Owner's Preliminary Response POPR

EX2001 - Statutory Disclaimer filed 05-07-2025 Exhibit

Notice: Referral to Board Panel NOTICE

Notice: Notice filing date accorded NOTICE

Notice: Mandatory Notice NOTICE

Notice: Power of Attorney NOTICE

Director Decision, Paper 16, PGR2021-00088 (Aug. 4, 2023) Exhibit

Kehne & Cain “Therapeutic Utility of Non-Peptidic CRF1" - Kehne & Cain 2010 Exhibit

Petition for Post Grant Review of U.S. Patent No. 11,007,201 Exhibit

Guidance for Industry, Q1A(R2) Stability Testing of New Drug Substances... Exhibit

Mallappa & Merke “Management challenges and therapeutic advances in..." Exhibit

Final Written Decision, Paper 62, PGR2022-00025 (PTAB Nov. 26, 2024). Exhibit

Yamaguchi “Approval success rates of drug candidates based on target..." Exhibit

Auchus “Crinecerfont Lowers Elevated Hormone Markers..." Auchus 2022 Exhibit

U.S. Prosecution History of the ’166 Patent Part 4 of 6 Exhibit

Petition: as filed PETITION

Director Decisions, Paper 15, PGR2022-00025 (Aug. 4, 2023) Exhibit

Declaration of Maya Lodish, M.D. Exhibit

U.S. Prosecution History of the ’166 Patent Part 2 of 6 Exhibit

Zorrilla & Koob 2010 Exhibit

Dec. 13, 2024, Neurocrine Press Release Exhibit

Merke & Cutler “New Ideas for Medical Treatment..."-Merke & Cutler 2001 Exhibit

Spruce March 25, 2019, Press Release Exhibit

Sertkaya “Key cost drivers of pharmaceutical trials in the United States" Exhibit

Notice: Power of Attorney NOTICE

U.S. Patent No. 12,115,166 to Alexis Howerton, et al. (“the ’166 patent”) Exhibit

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

Speiser et al., “Congenital Adrenal Hyperplasia"-Speiser 2010 Exhibit

Spierling & Zorrilla, "Don’t stress about CRF: Assessing..." Exhibit

U.S. Prosecution History of the ’166 Patent Part 5 of 6 Exhibit

Spruce March 13, 2024, Press Release Exhibit

Merke & Bornstein “Congenital Adrenal Hyperplasia,”-Merke & Bornstein 2005 Exhibit

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

El Maouche “Congenital Adrenal Hyperplasia,” - El Maouche 2017 Exhibit

U.S. Prosecution History of the ’166 Patent Part 6 of 6 Exhibit

Pet Reply to POR, Paper 32, PGR2021-00088 (June 20, 2024) Exhibit

Turcu & Auchus, The Next 150 Years of Congenital Adrenal Hyperplasia Exhibit

Sarafoglou “Interpretation of Steroid Biomarkers in 21..." Sarafoglou 2023 Exhibit

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

Webb & Krone “Current and Novel Approaches to Children"-Webb & Krone 2015 Exhibit

Spruce December 10, 2024, Press Release Exhibit

U.S. Patent No. 8,030,304 to Chen et al. (“Chen”) Exhibit

Claahsen-van der Grinten “Congenital Adrenal Hyperplasia..." Exhibit

U.S. Patent No. 11,007,201 B2 to Alexis Howerton, et al. Exhibit

Gully et al., J. Pharmacol. Exp. Ther., Gully 2002 Exhibit

Turcu et al., “Single-Dose Study of a Corticotropin-Releasing"-Turcu 2016 Exhibit

Trapp, “Congenital adrenal hyperplasia: an update in children,” Exhibit

National Center for Biotechnology Information (2025), CID 134694266 Exhibit

U.S. Prosecution History of the ’166 Patent Part 1 of 6 Exhibit

Williams, “Corticotropin-Releasing Factor 1 Receptor ..." Williams 2013 Exhibit

Declaration of David E. Bugay, Ph.D. Exhibit

Final Written Decision, Paper 64, PGR2021-00088 (PTAB Nov. 27, 2024) Exhibit

“Guidance for Industry, Q1E Evaluation of Stability Data,” Exhibit

Speiser "Congenital Adrenal Hyperplasia..."-Speiser 2018 Exhibit

Turcu & Auchus “Adrenal Steroidogenesis and Congenital..." Turcu 2015a Exhibit

Sarafoglou "Phase 3 Trial of Crinecerfont..." Sarafoglou et al. 2024 Exhibit

Fahmy “Structure and Function of Small Non-Peptide CRF..."-Fahmy 2017 Exhibit

Auchus “Phase 3 Trial of Crinecerfont..." Auchus 2024 Exhibit

National Center for Biotechnology Information (2025) Exhibit

Auchus et al., “Crinecerfont Lowers Elevated Hormone Markers"-Auchus 2021 Exhibit

Product Quality Review: CRENESSITY (Crinecerfont) Exhibit

Neurocrine July 1, 2024, Press Release Exhibit