DETAILED ACTION
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 . Claims 1-19 filed July 23, 2026 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group (I), claims 1-17 in the reply filed on 07/23/2026 is acknowledged.
Claims 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/23/2026.
Secondly, Applicant’s election without traverse of
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in the reply filed on 07/23/2026 is acknowledged.
Species Election
After a careful review of the prior art, Applicant’s elected species is free of the prior art. A claim in independent form directed to Applicant’s elected species would be allowable over the prior art. The examiner has moved on to alternative species within the genus of Formula (I) and subsequent examination is based on this species expansion.
Priority
Acknowledgement is made of the continuation of PCT/US2022/047437 filed 10/21/2022 which claims priority to U.S. Provisional Application 63270933 filed 10/22/2021.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119 (e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63270933 filed 10/22/2021, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The provisional application provides the following broadest generic disclosure ([0004] of the specification and claim 1).
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The provisional application fails to disclose several instantly claimed options including the option for L1 to be
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, L2 to be a 5-6 membered heteroaryl or
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.
The provisional also fails to disclose the instantly claimed options for R¹-R³ to be cyano or hydroxy. Since these differences affect the scope of instant claims 1-19 (where claim 15 encompasses species, for instance, lacking the carbamate moiety required by
the provisional application), the earliest effective filing date of these claims is October 21st, 2022.
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.
Claim(s) 1-2, 4, 6-7, 9-10, 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS REGISTRY DATABASE for entry no 2761387-70-4, indexed on CAS REGISTRY on 03/07/2022. As noted above, the instantly rejected claims have an earliest effective filing date of 10/21/2022.
Registry number 2761387-70-4 is drawn to the following compound, which was supplied by high-throughput screening library Enamine LLC:
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Said compound reads on the following claimed limitations: X is H, L1 is absent as n is 0, L2 is
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each of R1-R3 are independently H, each of R44 and R45 are independently H, and ring A is an indane ring. As shown in paragraph [0036] of the instant specification and claim 12, the indane ring reads on Ring A of the present claims.
Regarding claim 16, Applicant is reminded of MPEP 2131 wherein a reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)). In the present case, one of ordinary skill would at once envisage formulating the art-recognized high-throughput screening library compound above from Enamine LLC with a pharmaceutically acceptable carrier, such as DMSO, in order to validate the efficacy of the high-throughput compound against an array of disorders.
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, 3, 5-10, 12 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-8, and 18 of copending Application No. 18641031 (notice of allowance filed 08/24/2026).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Claims 1-2, 4-8 of copending Application 18641031 embrace wherein ring A is an aryl optionally substituted with one or more R4. As disclosed in paragraph [0061] , the ring system “indane” reads on aryl. Claims 1, 3, 5-10, 12 of the present claims embraces the same m is 1, the same Y of NH, the same L1 of 5-6 heteroaryl, the same n is 1 and the same ring A wherein Ring A is indane. As shown in paragraph [0036] of the instant specification and claim 12, the indane ring reads on Ring A wherein Ring A is C3-12 cycloalkyl. In addition, as disclosed in paragraph [0061] of copending Application 18641031, the ring system “indane” also reads on aryl found in copending claims 1-2, 4-8. In addition the subject matter of a pharmaceutical composition comprising a compound of Formula (I) in combination with a pharmaceutically acceptable carrier present claim 16 overlaps with the subject matter present in claim 18 of copending Application 18641031.
Conclusion
Claims 15 and 17 are allowed. Claims 1-10, 12 and 16 are rejected. Claims 11, 13-14 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
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, CLINTON A BROOKS can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
Prosecution Insights