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 .
Detailed Action
Applicants’ response, dated 06/29/2026, is acknowledged. Claims 81, 90 and 100 were amended. Claims 81-102 are pending and now evaluated on its merit.
Response to Arguments
Applicants’ arguments, see Page 1, filed 06/29/2026, with respect to the rejection of claims 81-95 and 96-102 under Hunt et al. (WO 2020097266 A1) have been fully considered and are persuasive by applicants’ statement to invoke the prior art exception under 35 U.S.C 102(b)(2)(c). Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hudkins et al. (WO 2008013838 A2).
Applicants’ argument, see page 2, in reference to the double patenting rejection of claims 81-90, 95, 97-98 and 100-101 over U.S. Patent No. 11236065 is rendered moot. Applicant has amended the claims to exclude =O as a substituent of the C1-6 alkyl group to overcome the compounds taught by U.S. ‘065, however the substituent of C(O)R10 wherein R10 is NH2 is taught by U.S. ‘065. Therefore, the double patenting rejection of claims 81-90, 95, 97-98 and 100-101 over U.S. Patent No. 11236065 is maintained.
The teachings of Hudkins of a pharmaceutical composition comprising Formula (I)
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with its embodiments leads to the claimed compounds of claimed invention. Of particular importance are the compounds 117-118, 131 and 171, which embody the structural limitations recited by claimed invention.
Priority
This application is a continuation which claims domestic benefit to U.S. provisional application 63/024,442, dated 05/13/2020.
Information Disclosure Statement
The information disclosure statement (IDS) dated 6/29/2026 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file, and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 81, 84-88, 90-95 and 97 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hudkins et al. (WO 2008013838 A2).
Regarding claims 81, 84-88, 90-95 and 97, Hudkins teaches a pharmaceutical composition comprising a pyridizinone compound of formula (I)
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or a stereoisomeric form, mixture of stereoisomeric forms, or a pharmaceutically acceptable salt forms thereof (Page 3) and a pharmaceutically acceptable carrier (relevant to claim 97) (Page 6, line 16). Of the above formula (I) Hudkins teaches R2 as
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wherein R13 and R14 is selected from a group which consist of H, R12 is C1-C6 alkyl optionally substituted with 1 to 3 R20, wherein each R20 is H, F, Cl, Br, I, NO2, phenyl, C3-C7 cycloalkyl (relevant to claims 90-94) (Pages 3-5). X and Xa are CH or N, Y is selected from a group which consist of O and NH (relevant to claims 84-85), R3 and R4 is selected from a group which consist of H, n is 1-3, m is 1-5 and R1 is selected from NH2 and 4-9 membered heterocycloalkly ring (relevant to claims 86-89) (Pages 3-5).
Of embodiments Hudkins teaches compounds
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,
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and
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(relevant to claim 81).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 82-83 are rejected under 35 U.S.C. 103 as being unpatentable over Hudkins et al. (WO 2008013838 A2).
The teaching of Hudkins for the above 102 rejections of claims 81, 84-88, 90-95 and 97 are incorporated herein by reference.
Hudkins fails to teach an exact example to claims 82-83 of compounds
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and
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, however it would have been obvious for someone of ordinary skill in the art at the time of filing to have developed the above compounds from the teachings of Hudkins. One would have been motivated to do so from the teachings of Hudkins of formula (I)
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wherein X and Xa are CH or N and in particular compound
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wherein the phenyl ring is substituted with one or two Nitrogen atoms for as displayed in compound
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. There is a reasonable expectation of developing compounds
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and
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from the teachings of Hudkins.
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, 97-101 are 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. Claim 81 of claimed invention of R2 of a C1-6 alkyl substituted by C(O)R10 wherein R10 is NH is obvious to the teaching of US’065 of
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wherein R25 is H and R2 is a C1-6 alkyl. The above
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additionally corelates to claim 99 of claimed invention in which R12 is a C2-6 alkyl substituted by C(O)R20 wherein R20 is NH.
Allowable Subject Matter
Claims 96 and 102 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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
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