The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-17 and 21-23 are presented for examination.
Acknowledgement is made of Applicant’s Track 1 Request for Prioritized Examination filed February 14, 2025, which was granted on April 4, 2025.
Applicant’s Amendment filed December 4, 2025 has been received and entered into the present application.
Claims 1-17 and 21-23 are pending. Claims 18-20 are cancelled. Claims 1, 6, 9 and 13 are amended. Claims 21-23 are newly added.
Applicant’s arguments, filed December 4, 2025, have been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Requirement for Restriction/Election
Applicant is reminded of his election without traverse of the invention of Group II (claims 1-17), directed to a method of at least one of (i) treating muscle injury, (ii) promoting muscle repair, (iii) improving skeletal muscle regeneration, or (iv) maintaining or increasing skeletal muscle function and/or skeletal muscle mass in an individual with muscle injury comprising administering a therapeutically effective amount of a combination of vitamin B6 and nicotinamide to the individual, as stated in the reply filed July 1, 2025, which is still in effect over the claims.
In the claim listing filed December 4, 2025, Applicant seeks the addition of new claims 21-23, which further limit the method defined by claims 1 and 8 and, thus, read on the elected invention. Such claims will be included with those presently under examination.
Applicant now cancels previously withdrawn claims 18-20, which were directed to a non-elected invention.
The claims that are, or remain, drawn to the elected invention are claims 1-17 and new claims 21-23 and such claims are herein acted on the merits infra.
Information Disclosure Statement
Applicant’s Information Disclosure Statement filed September 8, 2025 (two pages total) has been received and entered into the present application. As reflected by the attached, completed copy of form PTO/SB/08A, the Examiner has considered the cited references.
Status of Rejections in the September 10, 2025 Non-Final Action
In reply to the rejection of claims 9-10, 13 and 16 under 35 U.S.C. §112(b) (pre-AIA second paragraph), as set forth at p.4-7 of the previous Office Action dated September 10, 2025, Applicant (i) amends claim 9 to remove the limitation “and/or a derivative thereof” and “in an amount effective for” and (ii) amends claim 13 to remove the limitation “in an amount effective for”. Accordingly, the rejections are each hereby withdrawn.
In reply to the rejection of claims 9-10 under 35 U.S.C. §112(d) (pre-AIA fourth paragraph), as set forth at p.7-8 of the previous Office Action dated September 10, 2025, Applicant now amends claims 9 to remove the limitation “and/or a derivative thereof”. Accordingly, the rejection is now hereby withdrawn.
Upon further reconsideration of the claimed subject matter as amended, however, new grounds for rejection are necessitated and set forth infra.
Claim Rejections - 35 USC § 112(d) (Pre-AIA Fourth Paragraph)
(New Grounds of Rejection)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(1) Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 9 recites “[t]he method according to claim 1, wherein the individual has muscle injury, and the combination of (a) vitamin B6 and (b) nicotinamide is administered for promoting recovery from the muscle injury”.
It is unclear in what manner claim 9 further limits parent claim 1. Applicant’s claim 1 already requires the individual to have a “muscle injury”, so claim 9 provides no further limitation on the individual in which the method is practiced. Also, Applicant’s recitation that the combination of vitamin B6 and nicotinamide is “administered for promoting recovery from the muscle injury” appears to identify the intended outcome of the method, but places no further limitation on the active step of the method that would further limit the claim. As a result, claim 9 does not clearly further limit the subject matter of claim 1 in a manner consistent with the requirements of 35 U.S.C. §112(d) (pre-AIA fourth paragraph).
Clarification is required.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
(2) Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 13 recites “[t]he method according to claim 1, wherein the combination of the vitamin B6 and the nicotinamide is administered to accelerate muscle cell repair, recovery and regeneration after exercise”.
It is unclear in what manner claim 13 further limits parent claim 1. Applicant’s recitation that the combination of vitamin B6 and nicotinamide is “administered to accelerate muscle cell repair, recovery and regeneration after exercise” appears to identify the intended outcome of the method, but places no further limitation on the active step of the method that would further limit the claim. As a result, claim 13 does not clearly further limit the subject matter of claim 1 in a manner consistent with the requirements of 35 U.S.C. §112(d) (pre-AIA fourth paragraph).
Clarification is required.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(3) Claims 1, 3, 7-8, 11-12 and 14-17, as well as newly amended claims 9-10 and newly added claims 22-23, are rejected under 35 U.S.C. 103 as being unpatentable over Friedel et al. (WO 2010/142750 A1; 2010) in view of Suidasari et al. (“Dietary Vitamin B6 Modulates the Gene Expression of Myokines, Nrf2-Related Factors, Myogenin and HSP60 in the Skeletal Muscle of Rats”, Experimental and Therapeutic Medicine, 2017; 14:3239-3246, cited by Applicant on the 02/14/25 IDS), each already of record, for the reasons of record set forth at p.8-13 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 prior art teachings of Friedel et al. as modified by Suidasari et al. provide for the execution of this same active step as claimed – specifically, a combination of vitamin B6 with nicotinamide for treating muscle damage, promoting muscle recovery and repair, and to prevent muscle loss due to illness or surgery, in a human subject that exhibits muscle damage or loss of muscle mass due to illness or surgery (thus, “an individual with muscle injury” as broadly recited in claim 1). 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 cited prior art teachings as combined because execution of the same active step must necessarily yield the same outcomes.
Newly amended claim 9 now recites that the combination of vitamin B6 and nicotinamide “is administered for promoting recovery from the muscle injury”.
As established in the grounds for rejection, the prior art teachings of Friedel et al. in view of Suidasari et al. provide for the administration of a combination of nicotinamide with vitamin B6 to treat muscle damage, promote muscle recovery and repair, and to prevent muscle loss due to illness or surgery, in a human subject that exhibits muscle damage or loss of muscle mass due to illness or surgery (thus, “an individual with muscle injury” as broadly recited in claims 1 and 9), which meets the limitations of claim 9 (as well as claim 10, which depends from now rejected claim 9).
Newly added claim 22 recites that “the nicotinamide is administered in an amount of about 500 mg/day to about 2000 mg of the nicotinamide per day”.
As established in the grounds for rejection, Friedel et al. describes the administration of niacinamide (synonymous with nicotinamide) in a daily dose of from 5 mg to 5000 mg per day, more preferably from 10 mg to 3000 mg per day, and even more preferably from 50 mg to 500 mg per day, which overlaps and/or circumscribes Applicant’s instantly claimed range of about 500 to 2000 mg nicotinamide per day.
As stated in MPEP §2144.05, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) …” [A] prior art reference that discloses a range encompassing a somewhat narrower range is sufficient to establish a prima facie case of obviousness.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).”
Newly added claim 23 recites that the composition is in the form of, e.g., a capsule, solution, etc.
As established in the grounds for rejection, the primary teachings to Friedel at al. clearly describe a composition of nicotinamide in the form of a pharmaceutical capsule or solution.
(4) Claims 1-7, 11 and 16-17, as well as newly amended claim 9 and newly added claims 21-22, are rejected under 35 U.S.C. 103 as being unpatentable over Lines et al. (WO 2004/037018 A1; 2004) in view of Friedel et al. (WO 2010/142750 A1; 2010), each already of record, for the reasons of record set forth at p.13-17 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 prior art teachings of Lines et al. as modified by Friedel et al. provide for the execution of this same active step as claimed – specifically, a combination of vitamin B6 with nicotinamide for improving muscle strength, repair and recovery in a subject 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 cited prior art teachings as combined because execution of the same active step must necessarily yield the same outcomes.
Newly amended claim 9 now recites that the combination of vitamin B6 and nicotinamide “is administered for promoting recovery from the muscle injury”.
As established in the grounds for rejection, the prior art teachings of Lines et al. in view of Friedel et al. provide for the administration of a combination of nicotinamide with vitamin B6 to improve muscle strength, repair and recovery in a subject with muscle injury, which meets the limitations of claim 9.
Newly added claim 21 recites that “the vitamin B6 is administered in an amount of 1.0-7.0 mg of the vitamin B6 per day”.
Newly added claim 22 recites that “the nicotinamide is administered in an amount of about 500 mg/day to about 2000 mg of the nicotinamide per day”.
Lines et al. teaches the amount of vitamin B6 in the disclosed composition to be 0.1-200 mg, which clearly circumscribes Applicant’s instantly claimed range of 1-7 mg per day (claim 21). Note that the amounts described by Lines et al. constitute “per day” quantities on any one single day they are administered.
Lines et al. also teaches the amount of vitamin B3 – in this case, the form of niacinamide (synonymous with nicotinamide) described by Friedel et al. – to be 0.1-2000 mg, which clearly circumscribes Applicant’s instantly claimed range of about 500-2000 mg per day (claim 22). Again, the amounts described by Lines et al. constitute “per day” quantities on any one single day they are administered.
As stated in MPEP §2144.05, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) …” [A] prior art reference that discloses a range encompassing a somewhat narrower range is sufficient to establish a prima facie case of obviousness.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).”
Response to Applicant’s Arguments
In reply, Applicant traverses the rejections collectively, stating that “[c]laim 1 has been amended to incorporate the subject matter from dependent [c]laims 9 and 13, which are not included in these obviousness rejections” and, thus, the rejections should be withdrawn” (Remarks, p.6).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant’s amendments to claim 1 are noted, but claim 1 remains properly included in the grounds for rejection for the reasons above.
The subject matter of claims 9 and 13 alleged to be incorporated into claim 1 has been changed fundamentally to circumscribe a resultant outcome of the method – not an undefined amount of the combination that functions in the manner previously recited. Thus, while claims 9 and 13 were not previously subject to rejection, the changes that Applicant has made to such subject matter of claims 9 and 13 now renders such claims newly subject to rejection as a direct result of these claim amendments.
For these reasons supra, rejection of claims 1-12, 14-17 and 21-23 is proper.
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.
(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.
For these reasons supra, rejection of claims 1-12, 16-17 and 21-23 is proper.
Conclusion
Rejection of claims 1-17 and 21-23 is proper.
No claims of the present application are allowed.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
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 Leslie A. Royds Draper whose telephone number is (571)272-6096. The examiner can normally be reached Tuesday to Thursday (08:30 AM to 05:00 PM).
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, Jeffrey 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Leslie A. Royds Draper/Primary Examiner, Art Unit 1629
January 20, 2026
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