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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-16) in the reply filed on 23 June 2026 is acknowledged. Applicant further elects the species
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, which has Het substituted with cyclobutyl, variable R1 as branched C5 alkyl, and variables R2 and R3 each as H. This reads on Claims 1, 2, 6, 11, and 13-16. A search was performed for the claimed species with no prior art retrieved. The search was then expanded to all R1, R2, and R3 with R5 through R8 each as H with no prior art retrieved. The search was then expanded to all R4 with R5 through R8 each as H with prior art retrieved. The search was then stopped (See STN Search, Search Notes).
Claims 3-5, 7-10, 12, and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 23 June 2026.
Claims 1, 2, 6, 11, and 13-16, submitted on 23 June 2026, represent all claims currently under consideration.
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.
Priority
This application is a 371 of PCT/US2023/010295, filed 6 January 2023, which claims priority to provisional US 63/297,295, filed 7 January 2022. The effective filing date is 7 January 2022.
Information Disclosure Statement
One Information Disclosure Statement (IDS), submitted on 1 May 2026, is acknowledged and has been considered.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it is fewer than 50 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: Compounds 16-19 in Table 1 are of poor quality and should be replaced with higher quality scans.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: There is an unnecessary “or” prior to “optionally substituted C3-C6 cycloalkyl”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: Three compounds shown below
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are of poor quality and should be replaced with higher quality scans. Appropriate correction is required.
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)(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 1, 6, 11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN RN 2424524-39-8 (Entered STN: 14 June 2020).
STN RN 2424524-39-8
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has variable R1 as branched C6 alkyl, variable R2 as OH, and variable R3 as H.
Claims 1, 6, 11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN RN 2372340-67-3 (Entered STN: 2 September 2019).
STN RN 2372340-67-3
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has variable R1 as branched C-6 alkyl, variable R2 as OH, and variable R3 as H.
Claims 1, 6, 11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN RN 2309877-53-8 (Entered STN: 17 May 2019).
STN RN 2309877-53-8
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has variable R1 as branched C5 alkyl, variable R2 as OH, and variable R3 as H.
Claims 1, 2, 11, 13, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Samajdar (WO 2016/193939; Publication Date: 8 December 2016).
Samajdar discloses compounds useful as selective CDK inhibitors. The present invention also provides preparation of the compounds and pharmaceutical formulations comprising at least one compound of the invention (Abstract). Samajdar discloses the species Compound 91
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(Page 89), which has variable R1 as linear C2 alkyl, variable R2 as H, and variable R3 as phenyl substituted with substituted aryl. Claim 18 claims a pharmaceutical composition comprising a compound of the invention and a pharmaceutically acceptable salt excipient.
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, 11, and 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 11,834,418 (Patent Date: 5 December 2023) (‘418).
Claim 1 of ‘418 is directed towards a compound of formula
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wherein
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. Claim 3 of ‘418 is directed towards a pharmaceutical composition comprising a compound of Claim 1 and a pharmaceutically acceptable excipient.
The claims at issue are not identical, but are not patentably distinct because the compounds of ‘418 are isomers of what is claimed in the examined application, having the ring nitrogen atoms in different locations. The artisan would not expect the compounds of ‘418 and those of the examined application to have significantly different properties due to this close chemical structure (See MPEP § 2144.09 I). The compounds of ‘418 and those of the examined application are activators of the KV7 channel, and the artisan would not expect these two isomers to have significantly different properties with respect to agonizing this receptor. The compounds of ‘418 other than being structural isomers of what is claimed meet the limitations of the compounds claimed in the examined application.
Claims 1, 2, 6, 11, and 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 5 of U.S. Patent No. 11,261,162 (Patent Date: 1 March 2022) (‘162).
Claim 1 of ‘162 is drawn to a compound of formula
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wherein
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. Claim 2 of ‘162 is drawn to specific compounds, such as
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. Claim 5 of ‘162 is directed to a pharmaceutical composition comprising a compound of Claim 1.
The claims at issue are not identical, but are not patentably distinct because the compounds of ‘162 are isomers of what is claimed in the examined application, having the ring nitrogen atoms in different locations. The artisan would not expect the compounds of ‘162 and those of the examined application to have significantly different properties due to this close chemical structure (See MPEP § 2144.09 I). The compounds of ‘162 and those of the examined application are activators of the KV7 channel, and the artisan would not expect these two isomers to have significantly different properties with respect to agonizing this receptor. The compounds of ‘162 other than being structural isomers of what is claimed meet the limitations of the compounds claimed in the examined application.
Regarding Claim 15, claimed compounds such as
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are obvious variations of the compounds of ‘162 as they are isomers, and meet the limitations of what is claimed otherwise.
Claims 1, 2, 6, 11, and 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 12,351,559 (Patent Date: 8 July 2025) (‘559).
Claim 1 of ‘559 is drawn to a compound of formula
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wherein D is isopropyl;
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. Claim 9 of ‘559 is drawn to a compound of formula
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wherein
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.
The claims at issue are not identical, but are not patentably distinct because the compounds of ‘559 are isomers of what is claimed in the examined application, having the ring nitrogen atoms in different locations. The artisan would not expect the compounds of ‘559 and those of the examined application to have significantly different properties due to this close chemical structure (See MPEP § 2144.09 I). The compounds of ‘559 and those of the examined application are activators of the KV7 channel, and the artisan would not expect these two isomers to have significantly different properties with respect to agonizing this receptor. The compounds of ‘559 other than being structural isomers of what is claimed meet the limitations of the compounds claimed in the examined application.
Regarding Claim 16, ‘559 does not specifically claim a pharmaceutical composition comprising these compounds. However, pharmaceutical formulation is standard within the pharmaceutical arts to improve delivery of therapeutic agents to patients in need thereof, and thus, would be obvious to one of ordinary skill in the art.
Claims 1, 2, 6, 11, and 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,914,708 (Patent Date: 13 March 2018) (‘708).
Claim 1 of ‘708 is drawn towards a compound of formula
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or a pharmaceutically acceptable salt thereof, wherein
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.
The claims at issue are not identical, but are not patentably distinct because the compounds of ‘708 are isomers of what is claimed in the examined application, having the ring nitrogen atoms in different locations. The artisan would not expect the compounds of ‘708 and those of the examined application to have significantly different properties due to this close chemical structure (See MPEP § 2144.09 I). The compounds of ‘708 and those of the examined application are activators of the KV7 channel, and the artisan would not expect these two isomers to have significantly different properties with respect to agonizing this receptor. The compounds of ‘708 other than being structural isomers of what is claimed meet the limitations of the compounds claimed in the examined application.
Regarding Claim 16, ‘708 does not specifically claim a pharmaceutical composition comprising these compounds. However, pharmaceutical formulation is standard within the pharmaceutical arts to improve delivery of therapeutic agents to patients in need thereof, and thus, would be obvious to one of ordinary skill in the art.
Claims 1, 2, 6, 11, and 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 10,385,025 (Patent Date: 20 August 2019) (‘025).
Claim 1 of ‘025 is drawn to a compound of formula
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wherein
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. Claim 2 of ‘025 is drawn to a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable excipient.
The claims at issue are not identical, but are not patentably distinct because the compounds of ‘025 are isomers of what is claimed in the examined application, having the ring nitrogen atoms in different locations. The artisan would not expect the compounds of ‘025 and those of the examined application to have significantly different properties due to this close chemical structure (See MPEP § 2144.09 I). The compounds of ‘025 and those of the examined application are activators of the KV7 channel, and the artisan would not expect these two isomers to have significantly different properties with respect to agonizing this receptor. The compounds of ‘025 other than being structural isomers of what is claimed meet the limitations of the compounds claimed in the examined application.
Claims 1, 2, 6, 11, and 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,851,067 (Patent Date: 1 December 2020) (‘067).
Claim 1 of ‘067 claims several specific compounds such as
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. Claim 54 of ‘067 claims a pharmaceutical composition comprising a compound of Claim 1.
The claims at issue are not identical, but are not patentably distinct because the compounds of ‘067 are isomers of what is claimed in the examined application, having the ring nitrogen atoms in different locations. The artisan would not expect the compounds of ‘067 and those of the examined application to have significantly different properties due to this close chemical structure (See MPEP § 2144.09 I). The compounds of ‘067 and those of the examined application are activators of the KV7 channel, and the artisan would not expect these two isomers to have significantly different properties with respect to agonizing this receptor. The compounds of ‘025 other than being structural isomers of what is claimed meet the limitations of the compounds claimed in the examined application.
Claims 1, 2, 6, 11, and 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 17 of U.S. Patent No. 9,481,653 (Patent Date: 1 November 2016) (‘653).
Claim 1 of ‘653 is drawn to a compound of formula
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wherein D is optionally substituted cyclobutyl, optionally substituted phenyl, optionally substituted isoxazolyl, optionally substituted pyridinyl, isopropyl, or t-butyl;
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. Claim 17 of ‘653 claims several specific compounds such as
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.
The claims at issue are not identical, but are not patentably distinct because the compounds of ‘653 are isomers of what is claimed in the examined application, having the ring nitrogen atoms in different locations. The artisan would not expect the compounds of ‘653 and those of the examined application to have significantly different properties due to this close chemical structure (See MPEP § 2144.09 I). The compounds of ‘653 and those of the examined application are activators of the KV7 channel, and the artisan would not expect these two isomers to have significantly different properties with respect to agonizing this receptor. The compounds of ‘653 other than being structural isomers of what is claimed meet the limitations of the compounds claimed in the examined application.
Conclusion
Claims 1, 2, 6, 11, and 13-16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.M.R./ Examiner, Art Unit 1625
/JOHN S KENYON/ Primary Patent Examiner, Art Unit 1625
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