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
Status of the Claims
Applicant’s cancelation of claims 5-8 in the response filed on December 18th 2025 is acknowledged. Claims 1-4 and 9-11 are pending and are examined on their merits.
Information Disclosure Statement
The Information Disclosure Statement filed on December 18th 2025 is acknowledged. It appears that Applicant has uploaded the wrong document. Appropriate correction is required.
Nonstatutory Double Patenting Rejections Necessitated by New Application
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.
Claim 1-4 and 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 9-11 of copending Application No. 19/392,902 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compound genus of the reference application is a broader version of that of the instant application, differing in the scope of the R5 location (reference application, which is a piperazine in the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Nonstatutory Double Patenting Rejections Maintained
Applicant’s response filed on December 18th 2025 is acknowledged. Applicant states, regarding the nonstatutory double patenting rejections, that “Applicant is amenable to filing the appropriate Terminal Disclaimers to overcome these rejections after allowable subject matter has been agreed upon.” It is noted that only the nonstatutory double patenting rejections remain, and the applicant would be put in a state of allowance upon filing of said Terminal Disclaimers. Pending such filing, the nonstatutory double patenting rejections are maintained.
Nonstatutory Double Patenting Rejections Reiterated
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,195,448 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the compound genus of the reference patent is entirely encompassed by that of the instant application. Furthermore, the reference patent teaches a process of preparing the compound (reference patent, claim 7) analogous to that of claim 4, and the treatment of chronic kidney disease with the compound (reference patent, claim 10).
Claim 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-11 and 13 of copending Application No. 17/667,410 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compound genus of the reference application (reference application, claim 10) is entirely encompassed by that of the instant application. Furthermore, the reference application teaches a process of preparing the compound (reference application, claim 7) analogous to that of claim 4, and a composition for the treatment of chronic kidney disease with the compound (reference application, claim 11).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Note that the claims have been allowed, and upon issuance this provisional rejection will convert into a nonstatutory double patenting rejection.
Claim 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/256,647 (reference application) in view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012). Although the claims at issue are not identical, they are not patentably distinct from each other because the compound genus of the reference application (reference application, claim 10) differ from those of the instant application only in the replacement of a hydrogen atom with a fluorine atom. This substitution is known in the art as being one of the most common bioisosteric substitutions (Brown, pg. 17). Furthermore, the reference application teaches a process of preparing the compound (reference application, claim 4) analogous to that of claim 4, and a method the treatment of chronic kidney disease with the compound (reference application, claim 11).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11 and 15-21 of copending Application No. 18/893,545 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compound genus of the reference application (reference application, claim 10) differ from those of the instant application only in the replacement of a hydrogen atom with a fluorine atom. This substitution is known in the art as being one of the most common bioisosteric substitutions (Brown, pg. 17). Furthermore, the reference patent teaches a process of preparing the compound (reference application, claim 4) analogous to that of claim 4, and a method the treatment of chronic kidney disease with the compound (reference application, claim 11).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-3 and 5-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-11 and 13 of copending Application No. 17/667,410 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compound genus of the reference application (reference application, claim 11) is entirely encompassed by that of the instant application. Furthermore, the reference application teaches a composition for the treatment of heart failure with the compound (reference application, claim 11).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
THIS ACTION IS MADE FINAL. 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 Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629