DETAILED ACTION
Claims 1-20, submitted on February 7, 2024, are pending in the application. Claims 12-20 are withdrawn, and claims 1-11 are rejected for the reasons set forth below. No claim is allowed.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. 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.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a compound or a pharmaceu-tical composition thereof, in the reply filed on July 21, 2026 is acknowledged. Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
The requirement for a species election in the communication mailed on March 26, 2026 is hereby withdrawn. Applicant’s election thereof in the response submitted on July 21, 2026 is therefore moot.
Claim Rejections – 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufac-ture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
Claims 1-9 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-9 of prior U.S. Patent No. 10,253,020 B2. Instant claims 1-9 are of identical scope as claims 1-9 of the ‘020 Patent (cited in applicant’s IDS1). This is a statutory double patenting rejection. This rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Non-Statutory 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 possi-ble 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 provi-sions 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 accompa-nied 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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6-7 and of U.S. Patent No. 9,827,237 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘237 Patent (cited in applicant’s IDS2) claims methods of using the same compounds recited in the instant claims. For example, the compound of instant claim 2 is the same as compound “118” recited in claim 6 of the ’237 Patent. Compound “120” in claim 6 of the ‘237 Patent is the same compound of instant claim 3. Similarly, compound “124” in claim 6 of the ‘237 Patent is the same compound of instant claim 4. Other compounds recited in the claims of the ‘237 Patent are also recited in the instant claims. Claim 7 of the ‘237 Patent is drawn to methods of using these compounds in the form of pharmaceutical compositions within the meaning of instant claims 10-11. The instant claims are therefore anticipated by the claims of the ‘237 Patent.
Claims 10-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 10,253,020 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Note that claims 1-9 of the ‘020 Patent are identical to instant claims 1-9, and they are discussed above under § 101. The instant claims are drawn to pharmaceutical compositions comprising a “pharmaceutically acceptable support,” whereas claim 10 of the ‘020 Patent is drawn to a pharmaceutical composition comprising a “pharmaceutically acceptable carrier.” There is no meaningful difference between the “support” referred to in the instant claims and the “carrier” referred to in claim 10 of the ‘020 Patent. The examiner therefore concludes that instant claims 10-11 are prima facie obvious over claim 10 of the ‘020 Patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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, Amy L. Clark can be reached at (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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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
September 24, 2026
1 See the information disclosure statement (IDS) submitted on July 2, 2024.
2 See the IDS submitted on July 2, 2024.