NON-FINAL REJECTION
This application, filed Apr. 28, 2023, is a CON of 17/687,570, filed Mar. 4, 2022, now USPN 11,642,413; 17/687,570 is a CON of PCT/US2020/060459, filed Nov. 13, 2020, which claims benefit of priority to Provisional Application 62/935,017, filed Nov. 13, 2019.
Claims 58-86, as amended, are pending.
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 .
Priority
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, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on Apr. 28, 2023, May 15, 2023, Jan. 8, 2024, Apr. 17, 2024, Oct. 8, 2024, Nov. 13, 2024, Nov. 18, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
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.
1. Claims 58-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,642,413.
Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims are drawn to methods of using the identical compounds recited by the reference claims.
Specifically, examined claims 58-86 are drawn to methods of aiding in the treatment of tauopathy or treating tauopathy in a subject in need thereof, comprising administering to the subject an effective amount of a compound of Formula I to Formula VI.
As recognized by MPEP § 804 (II)(B)(6), citing Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003), the reference claims are directed to compounds of Formula I to Formula VI, and the written description discloses a single utility of that compound for administration to a human in amounts effective to inhibit tau aggregation (see, e.g., Examples 24-27, which are identical in both the reference disclosure and the examined disclosure). Thus, the examined claims are directed to nothing more than the reference patent’s disclosed utility as a method of using the compound.
See also Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008), holding that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use." Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86; see also Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010).
2. Claims 58-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,377,152. Although the claims at issue are not identical, they are not patentably distinct from each other because both the reference claims and the examined claims are directed to methods of administering overlapping compounds to treat overlapping neurodegenerative diseases.
Specifically, the reference claims would anticipate the examined claims, which are directed to methods of administering compounds of Formula (I) to Formula (VI) to treat a tauopathy or aid in the treatment of a tauopathy; while the reference claims are directed to methods of treating synucleinopathy or reducing α-synuclein aggregation by administering a broad genus of compounds which encompasses many species falling within the scope of formulae (I) through (VI) as recited by the examined claims: e.g., identical compounds 159985, 160275, 160219, 160744, 160939, etc. recited in reference claim 16 and in examined claim 86.
The examined application discloses that tauopathies include, e.g., Parkinson's disease and Alzheimer's disease (para. [0350]); while the reference application discloses that synucleino-pathies include e.g., Parkinson's disease and forms of Alzheimer's disease (col. 1, lines 39-50).
Thus, the compounds and patient populations of both the reference claims and the examined claims substantially overlap in scope.
3. Claims 58-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,291,732. Although the claims at issue are not identical, they are not patentably distinct from each other because both the reference claims and the examined claims are directed to methods of administering overlapping compounds to treat overlapping neurodegenerative diseases.
Specifically, the reference claims would anticipate the examined claims, which are directed to methods of administering compounds of Formula (I) to Formula (VI) to treat a tauopathy or aid in the treatment of a tauopathy; while the reference claims are directed to methods of treating synucleinopathy or reducing α-synuclein aggregation by administering a broad genus of compounds which encompasses many species falling within the scope of formulae (I) through (VI) as recited by the examined claims: e.g., identical compounds 160273, 160313, 160383, 170352, 170357, 170359, 170450, etc. recited in reference claim 14 and in examined claim 86.
The examined application discloses that tauopathies include, e.g., Parkinson's disease and Alzheimer's disease (para. [0350]); while the reference application discloses that synucleino-pathies include e.g., Parkinson's disease and forms of Alzheimer's disease (col. 1, lines 39-50).
Thus, the compounds and patient populations of both the reference claims and the examined claims substantially overlap in scope.
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure: Madak et al. Chem. Eur. J. 23, 13875-13878 (2017), compounds 10 and 11; WO 2018/119441; and WO 2019/126733.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 9:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629