Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see pp. 2-3, filed 04/10/2026, with respect to the restriction requirement have been fully considered and are persuasive. The compound of US 2019/0135805 A1 used to break unity was not the compound dazucorilant as argued. The restriction requirement of 04/10/2026 has been withdrawn. Applicant was contacted via telephone with a new Restriction Requirement which is incorporated below.
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-14, drawn to a method of treating a patient suffering from Huntington's Disease.
Group II, claims 15-22, drawn to a pharmaceutical composition for treating Huntington's Disease.
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
Applicant must elect a single species of a heteroaryl ketone fused azadecalin GRM or an octahydro fused azadecalin GRM, i.e. dazucorilant or zavacorilant.
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: 1-11, 13, 15, 17 and 19-22.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a heteroaryl ketone fused azadecalin GRM or an octahydro fused azadecalin GRM, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Meyer et al. which teaches the compound CORT113176 (dazucorilant) which anticipates the shared technical feature of a heteroaryl ketone fused GRM and is the compound of claims 12 and 16.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
During a telephone conversation with James Fox on 06/24/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-14. Applicant further elected dazucorilant as a species of GRM. Affirmation of this election must be made by applicant in replying to this Office action. Claims 3 and 13-22 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention/species.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/29/2025 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2 and 4-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating a patient suffering from HD, the method comprising administering dazucorilant or zavacorilant, does not reasonably provide enablement for a method of treating a patient suffering from HD, the method comprising administering any heteroaryl ketone fused azadecalin GRM or an octahydro fused azadecalin GRM (claim 1), compounds of the formula of claim 11 or isomers thereof. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The criteria for enablement set out in In re Wands, MPEP 2164.01(a), considers the following factors:
Breadth of the claims—Claim 1 encompasses the use of any heteroaryl ketone fused or octahydro fused azadecalin GRM to treat HD. GRM includes agonists, antagonists etc. Claim 11 includes compounds of the structure
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115
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and isomers thereof.
Level of skill in this art—The level of skill in the art is high. A PHOSITA understands that even minor structural variation can lead to drastic changes in pharmacological properties such as binding affinity and selectivity. A PHOSITA also understands that an agonist would not have the same therapeutic effect as an antagonist or other form of modulator.
State of the prior art—Meyer et al. discloses CORT113176 (dazucorilant) as a high affinity specific glucocorticoid receptor antagonist that attenuates Wobbler neuroinflammation (Highlights, p. 1). Meyer et al. discusses the disease model as “not limited to ALS as other neurodegenerative diseases show hypothalamic-pituitaryadrenal (HPA) axis dysfunction, including Alzheimer, Parkinson and Huntington diseases.” (p. 2, right column, second paragraph).
Working examples—The specification (pp. 28-33) shows assay data for the use of dazucorilant in treating HD.
Direction and Guidance—There is little guidance in the specification as to what compounds may be useful for the claimed use aside from dazucorilant. Zavacorilant is indicated as a GRM lacking cross-reactivity with other steroid receptors (Para. [0102]).
Thus, while the specification has enabled treating a patient suffering from or zavacorilant, the specification has not enabled the use of the breadth of compounds instantly claimed. Not all GRMs, particularly those with different activity such as agonists, could reasonably be expected to be useful for the same purpose. Similarly, the breadth of the compounds of the formula of claim 11 and their isomers would not be reasonably expected to be useful for the same purpose. The specification only shows data indicating that one compound, dazucorilant is useful in treating HD. Zavacorilant is also suggested for use given that it is known to have similar activity. Data for the one compound tested cannot be extrapolated to those with such structural variation as encompassed by the instant claims.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 7 and 10, the phrases "i.e.," and “e.g.,” render the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2 and 4-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer et al."Long-term effects of the glucocorticoid receptor modulator CORT113176 in murine motoneuron degeneration" Brain Research 1727 (2020) 146551.
Meyer et al. discloses CORT113176 (dazucorilant) as a high affinity specific glucocorticoid receptor antagonist that attenuates Wobbler neuroinflammation (Highlights, p. 1). Wobblers are used as a model of ALS and “long-term treatment with CORT113176 attenuated degeneration and inflammation, increased motor performance and decreased paw deformity. Antagonism of the GR may be of potential therapeutic value for neurodegenerative diseases.” (Abstract, p. 1). Meyer et al. discusses the disease model as “not limited to ALS as other neurodegenerative diseases show hypothalamic-pituitaryadrenal (HPA) axis dysfunction, including Alzheimer, Parkinson and Huntington diseases. In addition to HPA axis dysregulation, neuroinflammation and glial reactivity seems a common signature of neurodegenerative disorders. Overall, these data provide support for the hypothesis that chronic glucocorticoid overexposure plays a role in CNS inflammation.” (p. 2, right column, second paragraph).
Meyer et al. does not specifically disclose the use of dazucorilant in treating Huntington’s disease.
Meyer et al. is specifically drawn to the use of dazucorilant in treating ALS. However, Meyer et al. implies usefulness in other neurodegenerative disease and specifically indicates diseases such as “Alzheimer, Parkinson and Huntington diseases” as having etiologies overlapping with ALS that can be targeted with glucocorticoid receptor modulations. Accordingly, a PHOSITA would have found it obvious to administer dazucorilant to a patient suffering from Huntington’s disease because Meyer et al. provides a nexus between using dazucorilant to treat ALS and other neurodegenerative diseases by targeting the same pathologies presented in each. There would have been a reasonable expectation of success because both ALS and HD are shown to exhibit similar symptoms which can be targeted by the same means.
Claims 4-10 recite treatment outcomes. The identical compound (dazucorilant) applied to an identical subject (a patient suffering from Huntington’s Disease) must inherently have the same claimed effect, even if not recognized in the art. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the claimed chemical structure, the properties applicant discloses and/or claims are necessarily present. The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. "The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness." In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983). See MPEP § 2112.01. Consequently, a “a method of treating a patient suffering from Huntington’s Disease (HD), the method comprising administering dazucorilant” of claim 1 would inherently fulfill the limitations regarding treatment outcomes of claims 4-10.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 and 4-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,370,188.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-10 of the issued patent are drawn to unit dosage forms comprising dazucorilant. The unit dosage form is useful for treating Huntington’s Disease (Col. 3, lines 1-5; Col. 18, lines 38-52).
According to MPEP 804(II)(B)(1), “it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context.” In Sun Pharm. v. Lilly, the Court specifically affirms this kind of use of the specification and states,
A ‘claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use,’ extends to any and all such uses disclosed in the specification of the earlier patent. Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 1387 (Fed. Cir. 2010).
In this case, the instantly claimed use of dazucorilant for treating Huntington’s is taught by the reference disclosure. See (Col. 3, lines 1-5; Col. 18, lines 38-52). Therefore, when construed according to the specification, claims 1-10 of the issued patent describe a composition comprising dazucorilant with the same utility as instant claims 1-2 and 4-12. Accordingly, claims 1-2 and 4-12 are rejected on the ground of nonstatutory double patenting as being obvious over claims 1-10 of U.S. Patent No. 12,370,188.
Conclusion
Claims 1-2 and 4-12 are rejected.
Claims 3 and 13-22 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JED A KUCHARCZK/ Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/ Primary Examiner, Art Unit 1621
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