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 .
Claim Objections
Claim 102 is objected to because of the following informalities: claim 102 recited the limitation “McArdle’s syndrome” in which according to applicants’ remarks is exemplified in para. 0124 of the specification. According to applicants’ specification the correct spelling of the syndrome is McCardle’s syndrome. Appropriate correction is required.
Election/Restrictions
Applicant’s election without traverse of Species (I)
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directed to claims 81-98 in the reply filed on 01/05/2026 is acknowledged. However, upon further consideration the application as a whole is now being evaluated in terms of Species I-III. The restriction/election requirement filed 11/03/2025 is withdrawn.
Applicant has added claims 101-102. No new matter was added. Claims 81-102 is pending. Claims 81-102 is now evaluated on its merits.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 81-95 and 97-102 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Winship et al. (WO 2020097266 A1), published 05/14/2020, with a US Priority date of 11/06/2018.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 81-95 and 97-102, Winship teaches a method for treating neuromuscular diseases, such as Duchenne Muscular Dystrophy (DMD) and metabolic myopathy of McCardle’s syndrome (relevant to claims 98 and 101-102) (abstract, para. 0172) comprising administration a pharmaceutical composition of Formula (I)
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or salt thereof
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960
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805
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, Formula (II)
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or salt thereof
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and a pharmaceutically acceptable excipient (relevant to claims 81, 84-95, 97 and 99-100) (para 0007-0008, 0012). The limitations to Formula (I) and (II) of are of the same and overlapping limitations to Formula (I)-(III) of claimed invention. Of particular embodiments Winship teaches
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,
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(relevant to claims 82-83) (para. 0055, 0057) and compounds
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(compound 6),
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(compound 101),
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(compound 4).
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.
Claim 96 is rejected under 35 U.S.C. 103 as being obvious over Winship et al. (WO 2020097266 A1), published 05/14/2020, with a US Priority date of 11/06/2018.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The teachings of Winship of the 102 rejections of claims 81-95 and 97-102 is incorporated herein by reference.
Winship fails to particularly teach the exact compounds of claim 96 of claimed invention, however someone of ordinary skill in the art at the time of filling would have developed all the compounds of claim 96 of claimed invention, in particular compounds
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,
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and
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from the teachings of Winship. One would have been motivated to do so from the teachings of Winship of compounds
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and
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wherein the attachment to the nitrogen atom is a substituted C1-6 alkyl. There is a reasonable expectation of developing the compounds of claim 96 of claimed invention in particular compounds
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,
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and
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from the teachings of Winship.
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 81-90, 95, 97-98 and 100-101 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-11 and 13-30 of U.S. Patent No. 11236065. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-7, 9-11 and 13-30 of US ‘065 are obvious to claims 81-90, 95, 97-98 and 100-101 of claimed invention of
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to treat a neuromuscular condition, wherein R1 and R7 – R8 overlap with the limitations of claimed invention, R25 is H and R2 is a C1-6 alkyl. Claim 1 of claimed invention of R2 of C1-6 alkyl substituted with =O and N(R10)2, wherein one R10 is H and the other is a C1-6 alkyl, C3-10 carbocycle and 3 to 10 membered heterocycle.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKHAIL O'DONNEL ROBINSON whose telephone number is (571)270-0777. The examiner can normally be reached Monday-Friday 7:30am-5:30pm.
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627