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 .
CHANGE OF EXAMINER
Please note that this application has been reassigned to Examiner Anthony Seitz.
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 13th 2026 has been entered.
DETAILED ACTION
Status of the Claims
Claims 1-8, 10-12, 14-17, and 21-23 are pending and are examined on their merits.
Information Disclosure Statement
The Information Disclosure Statement filed on September 23rd 2026 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
35 U.S.C. § 103 Rejections Overcome by Amendment
Applicant’s amendments in the response filed on March 23rd 2026 are acknowledged. Applicant has amended the claims to be commensurate in scope with the synergistic combination of vitamin B6 and nicotinamide for increasing muscle mass, wherein the synergy is dependent on the B6: nicotinamide ratio. Applicant’s claim of unexpected results is thereby substantiated and all 103 rejections are withdrawn.
Nonstatutory Double Patenting Rejections Maintained
Applicant’s remarks in the response filed on March 23rd 2026 are acknowledged. Regarding the provisional nonstatutory double patenting rejections over co-pending Application Nos. 18/250,874 (now issued as U.S. Patent No. 12,691,104), 18/250,887 (now issued as U.S. Patent No. 12,691,105), 18/250,891 (claims allowed but yet to be issued), and 18/250,893 (now issued as U.S. Patent No. 12,661,343), applicant states that “terminal disclaimers would be premature at this stage in prosecution because the present claims have not yet been allowed, and thus, the final version of these claims is not yet known.” Applicant accordingly requests that the double patenting rejections be held in abeyance until the claims are otherwise allowable. Consequently, all nonstatutory double patenting rejections are maintained.
The provisional nonstatutory double patenting rejections over co-pending Application No. 18/250,874 have been converted to nonstatutory double patenting rejections over U.S. Patent No. 12,691,104.
The provisional nonstatutory double patenting rejections over co-pending Application No. 18/250,887 have been converted to nonstatutory double patenting rejections over U.S. Patent No. 12,691,105.
The provisional nonstatutory double patenting rejections over co-pending Application No. 18/250,893 have been converted to nonstatutory double patenting rejections over U.S. Patent No. 12,661,343.
The provisional nonstatutory double patenting rejections over co-pending Application No. 18/250,891 have been maintained.
Examiner notes that the nonstatutory double patenting rejections are the only remaining rejections. The grounds of said rejections are reiterated below:
Nonstatutory Double Patenting Rejections Reiterated
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.
(5) Claims 1-8, 11-12 and 16-17, as well as newly added claims 21-23, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8 and 11-12 of U.S. Patent Application No. 18/250,874, already of record, for the reasons of record set forth at p.18-20 of the previous Office Action dated September 10, 2025, of which said reasons are herein incorporated by reference.
Newly amended claim 1 now recites “wherein the administering of the combination of vitamin B6 and nicotinamide promotes recovery from the muscle injury and/or accelerates muscle cell repair, recovery and regeneration after exercise”.
Applicant’s recited “wherein” clause defines a resultant outcome from administering the claimed combination to “an individual with muscle injury”. In the instant case, the ‘874 claims as discussed in the grounds for rejection provide for the execution of this same active step as claimed – specifically, a combination of vitamin B6 with nicotinamide for treating sarcopenia and/or physical frailty, for improving skeletal muscle mass, skeletal muscle lean mass, skeletal muscle strength and/or skeletal muscle function, in an individual with muscle injury. As a result, the resultant effect to “promote[s] recovery from the muscle injury and/or accelerate[s] muscle cell repair, recovery and regeneration after exercise” in this subject that results from executing this same active step must necessarily yield from the ’874 claims as modified in the grounds for rejection because execution of the same active step must yield the same resultant outcomes.
Newly added claim 21 recites that the amount of vitamin B6 administered is 1-7 mg per day.
Claim 2 of the ‘874 application defines the amount of vitamin B6 to be administered as about 1-600 mg per day and, thus, provides for amounts of 1-7 mg per day as required by newly added claim 21.
Newly added claim 22 recites that the amount of nicotinamide administered is about 500-2000 mg per day.
Claim 3 of the ‘874 application defines the amount of nicotinamide to be administered as about 1-3000 mg per day and, thus, provides for amounts of about 500-2000 mg per day as required by newly added claim 22.
Newly added claim 23 recites that the composition is in the form of, e.g., a capsule.
Claim 8 of the ‘874 application provides for the composition of vitamin B6 and nicotinamide to be in the form of a capsule.
(6) Claims 1-5, 7-8, 11-12 and 16-17, as well as newly added claims 21-23, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7 and 12-13 of U.S. Patent Application No. 18/250,887, already of record, for the reasons of record set forth at p.20-22 of the previous Office Action dated September 10, 2025, of which said reasons are herein incorporated by reference.
Newly amended claim 1 now recites “wherein the administering of the combination of vitamin B6 and nicotinamide promotes recovery from the muscle injury and/or accelerates muscle cell repair, recovery and regeneration after exercise”.
Applicant’s recited “wherein” clause defines a resultant outcome from administering the claimed combination to “an individual with muscle injury”. In the instant case, the ‘887 claims as discussed in the grounds for rejection provide for the execution of this same active step as claimed – specifically, a combination of vitamin B6 with nicotinamide for promoting skeletal muscle regeneration, for promoting skeletal muscle mass, skeletal muscle strength and/or skeletal muscle function in an individual with muscle injury. As a result, the resultant effect to “promote[s] recovery from the muscle injury and/or accelerate[s] muscle cell repair, recovery and regeneration after exercise” in this subject that results from executing this same active step must necessarily yield from the ’887 claims as modified in the grounds for rejection because execution of the same active step must yield the same resultant outcomes.
Newly added claim 21 recites that the amount of vitamin B6 administered is 1-7 mg per day.
Claim 2 of the ‘887 application defines the amount of vitamin B6 to be administered as about 1-600 mg per day and, thus, provides for amounts of 1-7 mg per day as required by newly added claim 21.
Newly added claim 22 recites that the amount of nicotinamide administered is about 500-2000 mg per day.
Claim 3 of the ‘887 application defines the amount of nicotinamide to be administered as about 1-3000 mg per day and, thus, provides for amounts of about 500-2000 mg per day as required by newly added claim 22.
Newly added claim 23 recites that the composition is in the form of, e.g., a capsule.
Claim 7 of the ‘887 application provides for the composition of vitamin B6 and nicotinamide to be in the form of a capsule.
(7) Claims 1-12 and 16-17, as well as newly added claims 21-23, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8 and 10 (claims 9 and 11 now being cancelled) of U.S. Patent Application No. 18/250,891, already of record, for the reasons of record set forth at p.22-23 of the previous Office Action dated September 10, 2025, of which said reasons are herein incorporated by reference.
Newly amended claim 1 now recites “wherein the administering of the combination of vitamin B6 and nicotinamide promotes recovery from the muscle injury and/or accelerates muscle cell repair, recovery and regeneration after exercise”.
Applicant’s recited “wherein” clause defines a resultant outcome from administering the claimed combination to “an individual with muscle injury”. In the instant case, the ‘891 claims provide for the execution of this same active step as claimed – specifically, a combination of vitamin B6 with nicotinamide for treating muscle injury, promoting muscle repair, improving skeletal muscle regeneration, maintaining or increasing skeletal muscle function and/or skeletal muscle mass and/or promoting recovery from muscle injury in an individual with muscle injury, thereby meeting the resultant effects of newly amended claim 1.
Newly amended claim 9 now recites that the combination of vitamin B6 and nicotinamide “is administered for promoting recovery from the muscle injury”.
The ‘891 claims provide for the administration of a combination of nicotinamide with vitamin B6 for promoting recovery from muscle injury in a subject with muscle injury, which meets the limitations of amended claim 9.
Newly added claim 21 recites that the amount of vitamin B6 administered is 1-7 mg per day.
Claim 2 of the ‘891 application defines the amount of vitamin B6 to be administered as about 1-600 mg per day and, thus, provides for amounts of 1-7 mg per day as required by newly added claim 21.
Newly added claim 22 recites that the amount of nicotinamide administered is about 500-2000 mg per day.
Claim 3 of the ‘891 application defines the amount of nicotinamide to be administered as about 1-3000 mg per day and, thus, provides for amounts of about 500-2000 mg per day as required by newly added claim 22.
Newly added claim 23 recites that the composition is in the form of, e.g., a capsule.
Claim 8 of the ‘891 application provides for the composition of vitamin B6 and nicotinamide to be in the form of a capsule.
(8) Claims 1-3, 5-8, 11-12 and 16-17, as well as newly added claims 21-23, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 9 (claims 10-11 now being cancelled) of U.S. Patent Application No. 18/250,893, already of record, for the reasons of record set forth at p.23-25 of the previous Office Action dated September 10, 2025, of which said reasons are herein incorporated by reference.
Newly amended claim 1 now recites “wherein the administering of the combination of vitamin B6 and nicotinamide promotes recovery from the muscle injury and/or accelerates muscle cell repair, recovery and regeneration after exercise”.
Applicant’s recited “wherein” clause defines a resultant outcome from administering the claimed combination to “an individual with muscle injury”. In the instant case, the ‘893 claims as discussed in the grounds for rejection provide for the execution of this same active step as claimed – specifically, a combination of vitamin B6 with nicotinamide for promoting skeletal muscle growth and improve skeletal muscle mass and muscle function in an individual with muscle injury. As a result, the resultant effect to “promote[s] recovery from the muscle injury and/or accelerate[s] muscle cell repair, recovery and regeneration after exercise” in this subject that results from executing this same active step must necessarily yield from the ‘893 claims as modified in the grounds for rejection because execution of the same active step must yield the same resultant outcomes.
Newly added claim 21 recites that the amount of vitamin B6 administered is 1-7 mg per day.
Claim 3 of the ‘893 application defines the amount of vitamin B6 to be administered as about 1-200 mg per day and, thus, provides for amounts of 1-7 mg per day as required by newly added claim 21.
Newly added claim 22 recites that the amount of nicotinamide administered is about 500-2000 mg per day.
Claim 4 of the ‘893 application defines the amount of nicotinamide to be administered as about 0.001-2000 mg per day and, thus, provides for amounts of about 500-2000 mg per day as required by newly added claim 22.
Newly added claim 23 recites that the composition is in the form of, e.g., a capsule.
Claim 8 of the ‘893 application provides for the composition of vitamin B6 and nicotinamide to be in the form of a capsule.
Response to Applicant’s Arguments
In reply, Applicant traverses the rejections collectively, stating that “terminal disclaimers would be premature at this stage in prosecution because the present claims have not yet been allowed, and thus, the final version of these claims is not yet known” (Remarks, p.6). Applicant “requests that the double patenting rejections be withdrawn or held in abeyance until claims are otherwise allowable in the present application” (Remarks, p.6).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant’s response requesting that the rejections be withdrawn or held in abeyance fails to comply with the requirements of MPEP §804(I)(B)(1), which states that “[a] complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office Action”. Applicant’s response is technically non-responsive for failing to provide a complete response to the outstanding nonstatutory double patenting rejections as outlined and required by MPEP §804(I)(B)(1).
In any event, the instant claims are not in condition for allowance in view of the pending substantive rejections set forth herein. Because Applicant has not filed a Terminal Disclaimer and/or persuasively distinguished (either through amendment and/or remark) the instant claims over the cited claims of the provisional rejections, the rejections continue to remain proper.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/ANTHONY JOSEPH SEITZ/Examiner, Art Unit 1629
