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 .
Current Status of 17/912,341
This Office Action is responsive to the amended claims and Applicant remarks of 10/06/2025. Claims 1-10 have been examined on the merits.
Priority
The instant application is a nation stage entry of PCT/US2021/023442, international filing date 03/22/2021, which claims priority to U.S. Provisional Application No. 63/024,743, filed 05/14/2020, and U.S. Provisional Application No. 62/993,166, filed 03/23/2020.
Response to Applicant Remarks
The arguments presented by Applicants in the reply filed 10/06/2025 have been fully considered and are found to be persuasive. The Examiner acknowledges Applicants’ argument and evidence demonstrating that the claimed combination therapy exhibits greater than expected results in the art. Accordingly, the previous rejection under 35 U.S.C. §103 is withdrawn.
The double patenting rejection in the Non-Final rejection mailed 07/08/2025 parallels the arguments discussed above. Applicants’ arguments are found similarly persuasive as the disclosure supports that the claimed combination therapy exhibits results greater than those expected in the art. The previous double patenting rejection is withdrawn.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14-16, and 20-23 of U.S. Patent No. 12,440,493 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed method is a method comprising administering to a human cancer subject having an IDH mutation a therapeutically effective amount of a compound of the formula:
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wherein the variables R1, R2, and X have the same allowed substituents. Claims 14-16 of the reference discloses that the method is used in the treating acute myeloid leukemia (AML). Claims 20-23 of the reference disclose that the method includes the administration of a second compound, venetoclax. The reference therefore teaches a method of treating AML in a human subject having an IDH mutation through administering the same compound with venetoclax. Although claim 1 of the reference includes (b), the instant claim 1 uses the open-ended term “comprising” and therefore does not exclude the presence of element (b). As such, the claimed method fully encompasses the method of the reference and is not patentably distinct.
Conclusion
Claim 1 is rejected.
Claims 2-10 are objected to for being dependent upon a rejected base claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR KENNEDY ENGLISH whose telephone number is (571)270-0813. The examiner can normally be reached Monday Friday, 8 a.m. 5 p.m. ET..
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/C.K.E./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625