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 .
Response to Amendments
Applicant’s amendments to the claims of May 18, 2026, in response to the Office Action of February 18, 2026, are acknowledged.
Response to Arguments
The § 112 rejections are withdrawn in view of the amendments to the claims.
The DP rejections over 11,046,690, and 10,654,850, are maintained.
The ‘690 patent is directed to treating kidney diseases by administering a compound of Formula (I) that includes the elected species. See at least claims 1 and 5 of the ‘690 patent.
The ‘850 patent is directed to compounds of Formula (I) and the elected species is claimed as part of a pharmaceutical composition (i.e., for a pharmaceutical use). In light of the disclosure, a primary if not sole utility for those claimed compounds and compositions is treating kidney diseases.
Hopkins Corey teaches TRCP5 inhibitors to treat and prevent kidney diseases and protect podocytes. Further, most subjects with FSGS have excess Rac1 in podocytes. Robins teaches prolonged Rac1 activations causes podocyte shedding and proteinuria correlates with degree of Rac1 expression.
Further, Chong teaches TRPC5 inhibition can treat anxiety and pain. Stress, depression, and anxiety are also known to be related/associated with downregulation of Rac1 in chronic long-term stress.
Thus, the claims agents are claimed for use in treating the claimed conditions and the correlation of Rac1 to each of anxiety, depression, and kidney diseases is established.
Status of the Claims
Claims 1, 5, 6, 9-11, 13, and 20-24 are pending and examined.
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, 5, 6, 9-11, 13, and 20-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,046,690, in view of Hopkins Corey (WO2019/051197) (filed September 7, 2018), in view of Robins et al., “Rac1 activation in podocytes induces the spectrum of nephrotic syndrome,” Kidney International (2017) 92, 349–364, as applied above. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘690 patent are directed to method of treating kidney disease with the claimed compounds.
Claims 1, 5, 6, 9-11, 13, and 20-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,654,850, in view of Hopkins Corey (WO2019/051197) (filed September 7, 2018), and in view of Robins et al., “Rac1 activation in podocytes induces the spectrum of nephrotic syndrome,” Kidney International (2017) 92, 349–364, as applied above. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘850 patent are directed to claimed compounds. Further, the use of the claimed compounds are for treating kidney diseases in a subject in need thereof.
As such, no claim is allowed.
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 extension fee 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 JARED D. BARSKY whose telephone number is (571)-272-2795. The examiner can normally be reached on Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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