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 . Claims 21-34 filed December 01, 2025 are currently pending.
Response to Amendment
Applicant’s amendments, filed 12/01/2025 are acknowledged. Originally filed claims 1-20 have been canceled in their entirety. New independent claim 21 is directed to the following methodology of treating a subject having thyroid cancer comprising the step of administering a FOS inhibitor to the subject, wherein (i) a C228T and/or C250T TERT promoter mutation and (ii) a BRAF V600E mutation have been detected in the genome of the subject.
In view of Applicant’s amendments, the pending 35 U.S.C 102(a)(1) rejection of claims 1-4 and 11 by Zhao (Oncology Reports Vol. 35 pages 1065-1074 published 2016)., claims 1-4, 11 by Bao (CN102319234 published 01/18/2012; machine translation provided), claim 1 by Vanhoutte (WO2015/155218 published 10/15/2015) and claims 1, 5-6 by Kamide (Cancer Science Vol. 107 pages 666-673 published February 2016) are each withdrawn as neither Zhao, Bao, Vanhoutte, nor Kamide teach each of the present claims, specifically the administration of a FOS inhibitor following detection of a C228T and/or C250T TERT promoter mutation and a BRAF V600E mutation in the thyroid cancer patient.
In addition, the pending 35 U.S.C 103(a) rejection of claims 1, 12, 14-17 over the combination of Xing (WO2015/153808 published 10/8/2015) and Bao (CN102319234 published 01/18/2012; machine translation provided) is also withdrawn as neither Xing nor Bao specifically teach the administration of a FOS inhibitor following detection of a C228T and/or C250T TERT promoter mutation and a BRAF V600E mutation in the thyroid cancer patient.
Applicant's arguments, filed 12/01/2025 have been fully considered. Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and objections presently being applied to the instant application.
Double Patenting-Rejection Maintained
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 21-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,911,356.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following. The subject matter of claims 1-14 of U.S. Patent 11,911,356 overlaps with the subject matter embodied within present claims 21-34 as follows.
Claim 1 of U.S. Patent 11,911,356 is directed to identifying a patient having thyroid cancer comprising the step of detecting a C228T or C250T mutation in the patient and detecting a BRAF V600E mutation in the patient, followed by administering a therapeutically effective amount a c-fos inhibitor to the patient. This is the same patient population (thyroid cancer patient with a detected C228T or C250T TERT mutation and BRAF V600E mutation), the same diagnostic methodology and same therapeutic regimen (Fos inhibitor). Claims 2-8 of U.S. Patent 11,911,356 claim administering the c-fos inhibitors embraced within present claims 22-28. Claim 9-10 of U.S. Patent 11,911,356 claim administering a TERT inhibitor in combination with the c-FOS inhibitor, which reads on the subject matter of instant claims 29-30, while claims 11-14 of U.S. Patent 11,911,356 are directed to further administering a BRAF inhibitor and MEK inhibitor with the c-fos inhibitor regimen, which reads on the subject matter of instant claims 31-34.
Applicant traverses. Applicant asserts that the double patenting rejection of record is now moot in view of the cancelation of original claims 1-17.
Response to Arguments
Applicant’s arguments, filed 12/01/2025 are acknowledged, have been carefully considered and are unpersuasive. As discussed above, the subject matter embodied within newly filed claims 21-34 still overlaps with the subject matter within claim 1-14 of U.S. Patent 11,911,356. As such, the rejection of record is maintained for reasons of record.
Conclusion
In view of the rejection set forth above, no claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621