Patent Owner's Preliminary Response | Jul 8, 2025 | PAPER | PATENT OWNER |
EX2001 - Statutory Disclaimer filed 05-07-2025 | Jul 8, 2025 | EXHIBIT | PATENT OWNER |
Notice: Referral to Board Panel | Jun 11, 2025 | PAPER | BOARD |
Notice: Notice filing date accorded | Apr 8, 2025 | PAPER | BOARD |
Notice: Mandatory Notice | Mar 3, 2025 | PAPER | PATENT OWNER |
Notice: Power of Attorney | Mar 3, 2025 | PAPER | PATENT OWNER |
U.S. Patent No. 12,115,166 to Alexis Howerton, et al. (“the ’166 patent”) | Feb 10, 2025 | EXHIBIT | PETITIONER |
U.S. Prosecution History of the ’166 Patent Part 1 of 6 | Feb 10, 2025 | EXHIBIT | PETITIONER |
U.S. Prosecution History of the ’166 Patent Part 2 of 6 | Feb 10, 2025 | EXHIBIT | PETITIONER |
U.S. Prosecution History of the ’166 Patent Part 3 of 6 | Feb 10, 2025 | EXHIBIT | PETITIONER |
U.S. Prosecution History of the ’166 Patent Part 4 of 6 | Feb 10, 2025 | EXHIBIT | PETITIONER |
U.S. Prosecution History of the ’166 Patent Part 5 of 6 | Feb 10, 2025 | EXHIBIT | PETITIONER |
U.S. Prosecution History of the ’166 Patent Part 6 of 6 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Final Written Decision, Paper 64, PGR2021-00088 (PTAB Nov. 27, 2024) | Feb 10, 2025 | EXHIBIT | PETITIONER |
U.S. Patent Application Publication No. 2017/0020877 to Grigoriadis et al. | Feb 10, 2025 | EXHIBIT | PETITIONER |
Final Written Decision, Paper 62, PGR2022-00025 (PTAB Nov. 26, 2024). | Feb 10, 2025 | EXHIBIT | PETITIONER |
Turcu et al., “Single-Dose Study of a Corticotropin-Releasing"-Turcu 2016 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Auchus et al., “Crinecerfont Lowers Elevated Hormone Markers"-Auchus 2021 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Director Decision, Paper 16, PGR2021-00088 (Aug. 4, 2023) | Feb 10, 2025 | EXHIBIT | PETITIONER |
Director Decisions, Paper 15, PGR2022-00025 (Aug. 4, 2023) | Feb 10, 2025 | EXHIBIT | PETITIONER |
U.S. Patent No. 8,030,304 to Chen et al. (“Chen”) | Feb 10, 2025 | EXHIBIT | PETITIONER |
Speiser et al., “Congenital Adrenal Hyperplasia"-Speiser 2010 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Turcu & Auchus, The Next 150 Years of Congenital Adrenal Hyperplasia | Feb 10, 2025 | EXHIBIT | PETITIONER |
El Maouche “Congenital Adrenal Hyperplasia,” - El Maouche 2017 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Merke & Bornstein “Congenital Adrenal Hyperplasia,”-Merke & Bornstein 2005 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Speiser "Congenital Adrenal Hyperplasia..."-Speiser 2018 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Fahmy “Structure and Function of Small Non-Peptide CRF..."-Fahmy 2017 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Griebel et al., J. Pharmacol. Exp. Ther. - Griebel 2002 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Gully et al., J. Pharmacol. Exp. Ther., Gully 2002 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Merke & Cutler “New Ideas for Medical Treatment..."-Merke & Cutler 2001 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Merk “Future Directions in the Study and Management..."-Merke 2002 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Trapp, “Congenital adrenal hyperplasia: an update in children,” | Feb 10, 2025 | EXHIBIT | PETITIONER |
Merke & Auchus “Congenital Adrenal Hyperplasia..." Merke & Auchus 2020 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Turcu & Auchus “Novel Treatment Strategies" Turcu & Auchus 2016 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Webb & Krone “Current and Novel Approaches to Children"-Webb & Krone 2015 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Neurocrine March 20, 2021, Press Release | Feb 10, 2025 | EXHIBIT | PETITIONER |
Nella “A Phase 2 Study of Continuous Subcutaneous Hydrocortisone..." | Feb 10, 2025 | EXHIBIT | PETITIONER |
Williams, “Corticotropin-Releasing Factor 1 Receptor ..." Williams 2013 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Zorrilla & Koob 2010 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Kehne & Cain “Therapeutic Utility of Non-Peptidic CRF1" - Kehne & Cain 2010 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Deore “The Stages of Drug Discovery and Development Process,” | Feb 10, 2025 | EXHIBIT | PETITIONER |
National Center for Biotechnology Information (2025) | Feb 10, 2025 | EXHIBIT | PETITIONER |
U.S. Provisional Application Serial No. 62/545,406 | Feb 10, 2025 | EXHIBIT | PETITIONER |
U.S. Patent No. 10,849,908 to Alexis Howerton, et al. | Feb 10, 2025 | EXHIBIT | PETITIONER |
U.S. Patent No. 11,007,201 B2 to Alexis Howerton, et al. | Feb 10, 2025 | EXHIBIT | PETITIONER |
Yamaguchi “Approval success rates of drug candidates based on target..." | Feb 10, 2025 | EXHIBIT | PETITIONER |
Sarafoglou “Interpretation of Steroid Biomarkers in 21..." Sarafoglou 2023 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Sarafoglou “Tildacerfont in Adults With Classic..." Sarafoglou 2021 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Spruce March 25, 2019, Press Release | Feb 10, 2025 | EXHIBIT | PETITIONER |
Spruce March 13, 2024, Press Release | Feb 10, 2025 | EXHIBIT | PETITIONER |
Spruce December 10, 2024, Press Release | Feb 10, 2025 | EXHIBIT | PETITIONER |
Turcu & Auchus “Adrenal Steroidogenesis and Congenital..." Turcu 2015a | Feb 10, 2025 | EXHIBIT | PETITIONER |
Mallappa & Merke “Management challenges and therapeutic advances in..." | Feb 10, 2025 | EXHIBIT | PETITIONER |
Auchus “Crinecerfont Lowers Elevated Hormone Markers..." Auchus 2022 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Claahsen-van der Grinten “Congenital Adrenal Hyperplasia..." | Feb 10, 2025 | EXHIBIT | PETITIONER |
Guidance for Industry, Q1A(R2) Stability Testing of New Drug Substances... | Feb 10, 2025 | EXHIBIT | PETITIONER |
“Guidance for Industry, Q1E Evaluation of Stability Data,” | Feb 10, 2025 | EXHIBIT | PETITIONER |
Auchus “Phase 3 Trial of Crinecerfont..." Auchus 2024 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Sarafoglou "Phase 3 Trial of Crinecerfont..." Sarafoglou et al. 2024 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Product Quality Review: CRENESSITY (Crinecerfont) | Feb 10, 2025 | EXHIBIT | PETITIONER |
Neurocrine July 1, 2024, Press Release | Feb 10, 2025 | EXHIBIT | PETITIONER |
Dec. 13, 2024, Neurocrine Press Release | Feb 10, 2025 | EXHIBIT | PETITIONER |
National Center for Biotechnology Information (2025), CID 134694266 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Petition for Post Grant Review of U.S. Patent No. 10,849,908 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Pet Reply to POR, Paper 32, PGR2021-00088 (June 20, 2024) | Feb 10, 2025 | EXHIBIT | PETITIONER |
Petition for Post Grant Review of U.S. Patent No. 11,007,201 | Feb 10, 2025 | EXHIBIT | PETITIONER |
Pet Reply to POR, Paper 30, PGR2022-00025 (June 20, 2024). | Feb 10, 2025 | EXHIBIT | PETITIONER |
Sertkaya “Key cost drivers of pharmaceutical trials in the United States" | Feb 10, 2025 | EXHIBIT | PETITIONER |
Spierling & Zorrilla, "Don’t stress about CRF: Assessing..." | Feb 10, 2025 | EXHIBIT | PETITIONER |
Notice: Power of Attorney | Feb 10, 2025 | PAPER | PETITIONER |
Declaration of Maya Lodish, M.D. | Feb 10, 2025 | EXHIBIT | PETITIONER |
Declaration of David E. Bugay, Ph.D. | Feb 10, 2025 | EXHIBIT | PETITIONER |
Petition: as filed | Feb 10, 2025 | PAPER | PETITIONER |