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 1-8, 10, 13 and 16-18 are presented for examination.
Applicant’s Amendment filed December 8, 2025 has been received and entered into the present application.
Claims 1-8, 10, 13 and 16-18 are pending and under examination. Claims 16-18 are newly added. Claims 9 and 11-12 are cancelled. Claims 1, 3-6 and 13 are amended.
Applicant’s arguments, filed December 8, 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 Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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.
Status of Objections/Rejections in the September 17, 2025 Non-Final Action
In reply to the objection to claims 1, 3-6 and 11-12 as set forth at p.3 of the previous Office Action dated September 17, 2025, Applicant now cancels claims 11-12 and amends claims 1 and 3-6 to correct the improper capitalization of the term “nicotinamide”. Accordingly, the objection is now hereby withdrawn.
In reply to the rejection of claims 1-13 under 35 U.S.C. §112(b) (pre-AIA second paragraph), as set forth at p.3-6 of the previous Office Action dated September 17, 2025, Applicant now (i) amends claim 1 to clearly recite the administration of a combination of vitamin B6 with nicotinamide, (ii) amends claim 1 to remove the limitation directed to “derivatives”, and (iii) cancels claims 9 and 11. Accordingly, the rejection is now hereby withdrawn.
In reply to the rejection of claim 9 under 35 U.S.C. §112(d) (pre-AIA fourth paragraph), as set forth at p.6-7 of the previous Office Action dated September 17, 2025, Applicant now cancels claim 9. Accordingly, the rejection is now hereby withdrawn.
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.
(1) Claims 1, 3, 7-8, 10 and 13 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 04/27/23 IDS), each already of record, for the reasons of record set forth at p.7-11 of the previous Office Action dated September 17, 2025, of which said reasons are herein incorporated by reference.
Applicant’s cancellation of claims 9 and 11-12 necessitates the removal of such claims from the statement of rejection above.
Applicant’s amendments to claims 1, 3 and 13 are editorial in nature and do not alter the scope of subject matter rejected herein the instant grounds for rejection.
Response to Applicant’s Arguments
In reply, Applicant traverses the rejection, stating that “Friedel is related to niacin, trigonelline or a combination of both niacin and trigonelline for increasing muscle weight during a training period or reducing muscle loss during periods of lesser activity or immobility” (Remarks, p.6).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant takes an unreasonably narrow view of Friedel’s teachings. Here, Friedel et al. teaches a combination of niacin with trigonelline – in which niacin may be any form of niacin suitable for use in a nutraceutical, including niacinamide (also known as nicotinamide) – for preventing muscle loss during illness or after surgery, as well as to support recovery from muscle damage and promote muscle recovery and repair. The teachings of Friedel et al., thus, establish the function of this combination of niacin (including its nicotinamide form, as claimed) with trigonelline in treating muscle damage, promoting muscle recovery and repair and to prevent muscle loss due to illness or surgery (thus, “an individual with muscle injury” as broadly recited in claim 1, particularly “wherein the muscle injury is associated with muscle trauma and/or surgery” as in claim 10). Though Friedel et al. discloses one potential therapeutic use of the disclosed combination for increasing muscle weight during training or to mitigate muscle loss during inactivity, this particular disclosure does not limit Friedel’s broader disclosure, which describes additional benefits and therapeutic applications for the disclosed combination in the treatment of muscle damage, promoting muscle recovery and repair and to prevent muscle loss from surgery, which meets Applicant’s broadly defined therapeutic objectives of claim 1.
Applicant contends that “[o]nly trigonelline is exemplified as having an effect on muscle weight” (Remarks, p.6).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant’s remarks appear to focus exclusively on the working examples proffered in Friedel’s disclosure, in which the effect of trigonelline on muscle weight was observed following administration. MPEP §2123(II) is clear that “[d]isclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments” (citing to In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971)). That Friedel et al. does not explicitly quantify the effect of niacin (or its alternative forms, including nicotinamide) on muscle weight does not vitiate the fact that the combination of niacin with trigonelline is unequivocally disclosed for its beneficial muscle repairing effects. Moreover, Applicant should note that the instantly claimed composition to be employed in the claimed method is defined by the transitional phrase “comprising”, which is open-ended and does not explicitly exclude additional, unrecited elements or method steps – such as, in this case, the trigonelline component of Friedel’s combination. MPEP §2111.03.
Applicant further opines that Suidasari et al. presents experimental evidence that vitamin B6 serves “important roles in skeletal muscles” and the results “suggest that the recommended dietary intake of vitamin B6 upregulates the gene expression of a number of factors that promote the growth and repair of skeletal muscle”, but that “there is no mention of promoting muscle growth or repair in individuals with muscle injury” (Remarks, p.6).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant argues that Suidasari et al. does not explicitly spell out the use of vitamin B6 for identical therapeutic objectives to those instantly claimed. However, such narrow interpretation of Suidasari’s teachings fails to appreciate what Suidasari et al. would have reasonably suggested to the ordinarily skilled artisan before the effective filing date of the claimed invention – namely, that the function of vitamin B6 to promote growth and repair of skeletal muscle would have naturally exerted these same effects to promote muscle growth, recovery and repair following muscle damage or injury. In other words, this shared efficacy of vitamin B6 to promote muscle recovery and repair would have naturally suggested its combination with Friedel’s therapeutic combination to yield this same therapeutic effect following muscle damage or injury, as broadly suggested by Friedel’s disclosure.
Finally, Applicant urges that “the inventors have found that the claimed combination of vitamin B6 and nicotinamide provides a synergistic effect on the treatment of human primary myoblasts”, citing to Ex.1 (Specification, p.16-18) and Fig.3-5 as alleged evidence of “the synergism exhibited between pyridoxine and nicotinamide on treatment of human primary myoblasts”, noting that “[t]he increase in the number of MyoD+ cells after treatment with both pyridoxine and nicotinamide was far higher than the sum of the increases observed on treatment with pyridoxine or nicotinamide” and that “[t]he same synergy was not exhibited between nicotinamide and other vitamins”, such as the B complex vitamin B9 (Remarks, p.8).
The arguments have been fully and carefully considered, but are not found persuasive.
Allegations of unexpected results must be supported by relying upon factual evidence establishing “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance”. MPEP §716.02(b)(I) (quoting Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992)). To establish unexpected results, the claimed subject matter must be compared with the closest prior art to be effective to rebut a prima facie case of obviousness. MPEP §716.02(e) (see also In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979)). To be of probative value, any objective evidence should be supported by actual proof. MPEP §716.01(c). Applicant is reminded that “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” MPEP §716.02(d). Also, it is Applicant, not the Office, that bears the burden of explaining any data provided as evidence of nonobviousness and unexpected results. MPEP §716.02(b). See Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992).
Applicant’s Ex.1 studied the effect of nicotinamide and/or pyridoxine on human primary myoblast cultures to determine their effects on Pax7+ amplifying cells and MyoD+ differentiating cells, noting that specific ratios of vitamin B6 to nicotinamide ranging from 1:2 to 1:80 were tested (p.16, para.5-p.17, para.1).
Applicant’s Fig.1A and Fig.1B associated with Ex.1 of the as-filed specification “demonstrate that [n]icotinamide promotes [m]uscle [s]tem [c]ell function by increasing the proportion of both amplifying (Pax7+) and differentiating (MyoD+) cells in a dose dependent manner” (p.17, para.5).
Applicant’s Fig.2A and Fig.2B associated with Ex.1 of the as-filed specification “demonstrate that [p]yridoxine [vitamin B6] promotes [m]uscle [s]tem [c]ell function by increasing the proportion of differentiating (MyoD+) cells in a dose dependent manner” (p.17, para.6).
Fig.3 presents the effects of nicotinamide and pyridoxine, alone or in combination, on MyoD+ differentiating myoblasts, noting that “the effect of the combination of [n]icotinamide and [p]yridoxine is greater than the sum of the individual effect of [n]icotinamide and [p]yridoxine, indicating a synergistic effect”, which was additionally observed to be statistically significant after applying a linear regression model (p.17, para.7).
While such data supports a synergism of nicotinamide with the pyridoxine form of vitamin B6 in promoting MyoD+ myoblast differentiating cells – an effect that would have reasonably been expected to promote muscular repair, regeneration or growth – over the individual components alone (Fig.3A and Fig.3B), Applicant explicitly acknowledges that “Figure 5 demonstrates that the ratio between [p]yridoxine and [n]icotinamide (ratio Vitamin B6/NAM) has a relevant impact on promoting muscle stem cell function” (p.18, para.1). A closer look at Fig.5 demonstrates that only certain pyridoxine to nicotinamide ratios out of the range of 1:2 to 1:80 tested were statistically significant in this regard – specifically, only the ratios of 1:20, 1:40, 1:60 and 1:80 of pyridoxine to nicotinamide yielded this statistically significant, synergistic effect.
Applicant’s claims, however, do not reflect these specific elements from which this synergism yields. In the instant case, Applicant’s broadest claims permit the use of vitamin B6 in any form (claims 1, 3, 7-8, 10, 13) – not just pyridoxine – and further permit the combination of vitamin B6 with nicotinamide in any ratio (claims 1, 3, 7-8, 10, 13) – not just the 1:20, 1:40, 1:60 and 1:80 range. As a result, the evidence proffered in support of nonobviousness fails to be commensurate in scope with the claims which the evidence is offered to support, as required by MPEP §716.02(d).
Accordingly, the data relied upon by Applicant to support his position of nonobviousness has been fully and carefully considered, but is insufficient to outweigh the evidence in support of prima facie obviousness.
See MPEP §2144(II) (“The weight to be given any objective evidence is made on a case-by-case basis. The mere fact that an applicant has presented evidence does not mean that the evidence is dispositive of the issue of obviousness.”).
For these reasons supra, rejection of claims 1, 3, 7-8, 10 and 13 is proper.
(2) Claims 1-8, 10 and 13, as well as newly added claims 16-18, 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.12-17 of the previous Office Action dated September 17, 2025, of which said reasons are herein incorporated by reference.
Applicant’s cancellation of claims 9 and 11-12 necessitates the removal of such claims from the statement of rejection above.
Newly added claim 16 recites a vitamin B6 to nicotinamide ratio of “from about 1:80 to about 1:20”.
Newly added claim 17 recites a vitamin B6 to nicotinamide ratio of “from about 1:75 to about 1:25”.
Newly added claim 18 recites a vitamin B6 to nicotinamide ratio of “from about 1:60 to about 1:30”.
As established in the grounds for rejection, Lines et al. describes the use of amounts of vitamin B6 in his disclosed composition within the range of 0.1-200 mg, specifically exemplifying 100 mg in his working examples, and further describes the use of amounts of vitamin B3 (to be used in the form of nicotinamide, as established in the grounds for rejection by the teachings to Friedel et al.) in his disclosed composition within the range of 0.1-2000 mg, specifically exemplifying 1000 mg.
A composition containing 100 mg vitamin B6 with 2000 mg nicotinamide would be equivalent to a 1:20 ratio of vitamin B6 to nicotinamide, thereby meeting Applicant’s limitations of new claim 16.
A composition containing 10 mg vitamin B6 with 250 mg nicotinamide would be equivalent to a 1:25 ratio of vitamin B6 to nicotinamide, thereby meeting Applicant’s limitations of new claim 17.
A composition containing 50 mg vitamin B6 with 1500 mg nicotinamide would be equivalent to a 1:30 ratio of vitamin B6 to nicotinamide, thereby meeting Applicant’s limitations of new claim 18.
Applicant’s remaining amendments to claims 1, 3-6 and 13 are editorial in nature and do not alter the scope of subject matter rejected herein the instant grounds for rejection.
Response to Applicant’s Arguments
In reply, Applicant traverses the rejection, stating that “neither reference discloses treating an individual with muscle injury” but that “the Patent Office alleges that the skilled person would have been motivated to use the composition of Lines to treat muscle injury owing to Friedel describing the use of niacin to increase muscle mass during exercise or to reduce muscle loss in a less active or immobile person” (Remarks, p.7).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant mischaracterizes the grounds for rejection. Here, Lines et al. teaches a therapeutic composition that comprises, inter alia, vitamin B3 and vitamin B6, for enhancing physical performance by improving overall strength, balance, fatigue, recovery, intensity of physical exercise and endurance to exercise. Although Lines et al. does not specifically describe nicotinamide as the form of vitamin B3 to be used in the therapeutic composition, Friedel et al. is cited for its teachings documenting that nicotinamide was known in the art before the effective filing date of the claimed invention for use in therapeutic compositions for increasing muscle mass and physical recovery, thereby suggesting its use as the form of vitamin B3 to be used in Lines’ composition for these same therapeutic applications. The teachings of Friedel et al. were not relied upon – as Applicant asserts – to allege the prima facie obviousness of applying Lines’ therapeutic composition to yield these same effects in an individual with muscle injury simply because of the presence of niacin.
The grounds for rejection acknowledge that Lines et al. alone does not explicitly describe administration of his therapeutic composition to a subject with muscle injury as claimed. However, as further stated in the grounds for rejection, the ordinarily skilled artisan would have found it prima facie obvious to administer Lines’ composition (as modified by Friedel et al. to contain nicotinamide as the specific form of vitamin B3 in Lines’ composition) to an individual with muscle injury to yield these same beneficial therapeutic effects of improving muscle strength, recovery and physical endurance. As the ordinarily skilled artisan would have naturally recognized the impact of muscle injury to reduce muscle strength, recovery and physical endurance, this same artisan of ordinary skill would have naturally understood the benefit of administering a composition effective to yield these beneficial effects to a subject with muscle injury to treat such injury by improving muscle strength, repair and recovery in such subject.
Applicant contends that “administration to an individual with muscle injury is not disclosed in Friedel” (Remarks, p.7).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant again fails to consider what Friedel et al. was relied upon to teach. In the instant case, Friedel et al. was cited
for its teachings documenting that nicotinamide was known in the art before the effective filing date of the claimed invention for use in therapeutic compositions for increasing muscle mass and physical recovery, thereby suggesting the use of nicotinamide as the form of vitamin B3 used in Lines’ composition for these same therapeutic applications. The fact that Friedel et al. does not explicitly teach the entirety of Applicant’s invention as claimed is immaterial because Friedel et al. was not applied alone, but rather in combination with the primary reference to Lines et al. Therefore, Applicant must address how the references were combined in the context of the rejection to arrive at the instantly claimed invention – not what each individual reference teaches as if in a vacuum.
Applicant opines that “[e]ven if the uninventive skilled person were to make the leap towards niacin for muscle injury, they would not, based on Lines, also leap to combining niacin with vitamin B6 to treat muscle injury” because “[t]he composition of Lines comprises a very large number of components, and there is no pointer specifically to vitamin B6” (Remarks, p.7). Applicant additionally argues that “the focus of Lines is to enhancing physical performance and endurance to exercise, and the skilled person would not look to such a composition for treating an individual with muscle injury” (Remarks, p.7).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant’s argument that the application of Lines’ composition to the instant claims is inappropriate because it “comprises a very large number of components, and there is no pointer specifically to vitamin B6” is unavailing. Here, Lines et al. teaches a therapeutic composition comprising, inter alia, vitamin B3 and vitamin B6, for enhancing physical performance by improving overall strength, balance, fatigue, recovery, intensity of physical exercise and endurance to exercise. In other words, Lines et al. already provides for a composition that contains both vitamin B3 and vitamin B6. Although Lines et al. does not specifically describe nicotinamide as the form of vitamin B3 to be used in the therapeutic composition, the teachings of Friedel et al. as set forth in the grounds for rejection reconciles the prima facie obviousness of this point. There is no need to specifically highlight, or point to, vitamin B6 as an element of Lines’ composition because Lines’ composition already contains both the vitamin B3 and vitamin B6 components present in Applicant’s instantly claimed composition to be administered.
If it is Applicant’s position that Lines’ composition cannot be applied to the instant claims because it contains additional elements that are not required by Applicant’s composition, then this position would also be unavailing. Applicant’s composition is defined using the open-ended transitional phrase “comprising”, which does not explicitly exclude additional, unrecited elements or method steps – such as, in this case, the additional components of Lines’ composition. MPEP §2111.03.
Finally, Applicant urges that “the inventors have found that the claimed combination of vitamin B6 and nicotinamide provides a synergistic effect on the treatment of human primary myoblasts”, citing to Ex.1 (Specification, p.16-18) and Fig.3-5 as alleged evidence of “the synergism exhibited between pyridoxine and nicotinamide on treatment of human primary myoblasts”, noting that “[t]he increase in the number of MyoD+ cells after treatment with both pyridoxine and nicotinamide was far higher than the sum of the increases observed on treatment with pyridoxine or nicotinamide” and that “[t]he same synergy was not exhibited between nicotinamide and other vitamins”, such as the B complex vitamin B9 (Remarks, p.8).
The arguments have been fully and carefully considered, but are not found persuasive.
Allegations of unexpected results must be supported by relying upon factual evidence establishing “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance”. MPEP §716.02(b)(I) (quoting Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992)). To establish unexpected results, the claimed subject matter must be compared with the closest prior art to be effective to rebut a prima facie case of obviousness. MPEP §716.02(e) (see also In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979)). To be of probative value, any objective evidence should be supported by actual proof. MPEP §716.01(c). Applicant is reminded that “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” MPEP §716.02(d). Also, it is Applicant, not the Office, that bears the burden of explaining any data provided as evidence of nonobviousness and unexpected results. MPEP §716.02(b). See Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992).
Applicant’s Ex.1 studied the effect of nicotinamide and/or pyridoxine on human primary myoblast cultures to determine their effects on Pax7+ amplifying cells and MyoD+ differentiating cells, noting that specific ratios of vitamin B6 to nicotinamide ranging from 1:2 to 1:80 were tested (p.16, para.5-p.17, para.1).
Applicant’s Fig.1A and Fig.1B associated with Ex.1 of the as-filed specification “demonstrate that [n]icotinamide promotes [m]uscle [s]tem [c]ell function by increasing the proportion of both amplifying (Pax7+) and differentiating (MyoD+) cells in a dose dependent manner” (p.17, para.5).
Applicant’s Fig.2A and Fig.2B associated with Ex.1 of the as-filed specification “demonstrate that [p]yridoxine [vitamin B6] promotes [m]uscle [s]tem [c]ell function by increasing the proportion of differentiating (MyoD+) cells in a dose dependent manner” (p.17, para.6).
Fig.3 presents the effects of nicotinamide and pyridoxine, alone or in combination, on MyoD+ differentiating myoblasts, noting that “the effect of the combination of [n]icotinamide and [p]yridoxine is greater than the sum of the individual effect of [n]icotinamide and [p]yridoxine, indicating a synergistic effect”, which was additionally observed to be statistically significant after applying a linear regression model (p.17, para.7).
While such data supports a synergism of nicotinamide with the pyridoxine form of vitamin B6 in promoting MyoD+ myoblast differentiating cells – an effect that would have reasonably expected to promote muscular repair, regeneration or growth – over the individual components alone (Fig.3A and Fig.3B), Applicant explicitly acknowledges that “Figure 5 demonstrates that the ratio between [p]yridoxine and [n]icotinamide (ratio Vitamin B6/NAM) has a relevant impact on promoting muscle stem cell function” (p.18, para.1). A closer look at Fig.5 demonstrates that only certain pyridoxine to nicotinamide ratios out of the range of 1:2 to 1:80 tested were statistically significant in this regard – specifically, only the ratios of 1:20, 1:40, 1:60 and 1:80 of pyridoxine to nicotinamide yielded this statistically significant, synergistic effect.
Applicant’s claims, however, do not reflect these specific elements from which this synergism yields. In the instant case, Applicant’s broadest claims permit the use of vitamin B6 in any form (claims 1-8, 10, 13, 16-18) – not just pyridoxine – and further the combination of vitamin B6 with nicotinamide in any ratio (claims 1-4, 7-8, 10, 13) or in broadly defined ranges of ratios (claims 5-6, 17-18). As a result, the evidence proffered in support of nonobviousness fails to be commensurate in scope with the claims which the evidence is offered to support, as required by MPEP §716.02(d).
Accordingly, the data relied upon by Applicant to support his position of nonobviousness has been fully and carefully considered, but is insufficient to outweigh the evidence in support of prima facie obviousness.
See MPEP §2144(II) (“The weight to be given any objective evidence is made on a case-by-case basis. The mere fact that an applicant has presented evidence does not mean that the evidence is dispositive of the issue of obviousness.”).
For these reasons supra, rejection of claims 1-8, 10, 13 and 16-18 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.
(3) Claims 1-8, 10 and 13, as well as newly added claims 16-18, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 13 (claims 11-12 now being cancelled) of U.S. Patent Application No. 18/250,874, already of record, for the reasons of record set forth at p.18-19 of the previous Office Action dated September 17, 2025, of which said reasons are herein incorporated by reference.
Applicant’s cancellation of claims 9 and 11-12 necessitates the removal of such claims from the statement of rejection above.
Newly added claim 16 recites a vitamin B6 to nicotinamide ratio of “from about 1:80 to about 1:20”.
Newly added claim 17 recites a vitamin B6 to nicotinamide ratio of “from about 1:75 to about 1:25”.
Newly added claim 18 recites a vitamin B6 to nicotinamide ratio of “from about 1:60 to about 1:30”.
Claim 1 of the ‘874 application now recites that the vitamin B6 and nicotinamide are administered in a ratio of “from about 1:80 to about 1:20”, which clearly meets Applicant’s new claim 16.
Claim 5 of the ‘874 application now recites that the vitamin B6 and nicotinamide are administered in a ratio of “from about 1:60 to about 1:30”, which clearly meets Applicant’s new claim 18.
Although the ‘874 claims do not explicitly recite the administration of vitamin B6 and nicotinamide in a ratio of “from about 1:75 to about 1:25” as provided for in Applicant’s new claim 17, the weight ratios explicitly recited in the ‘874 claims circumscribe the range provided for in new claim 17, thereby rendering such range prima facie obvious. MPEP §2144.05.
Applicant’s remaining amendments to claims 1, 3-6 and 13 are editorial in nature and do not alter the scope of subject matter rejected herein the instant grounds for rejection.
(4) Claims 1-8, 10 and 13, as well as newly added claim 16-18, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 14 (claims 11-12 now being cancelled) of U.S. Patent Application No. 18/250,887, already of record, for the reasons of record set forth at p.20-21 of the previous Office Action dated September 17, 2025, of which said reasons are herein incorporated by reference.
Applicant’s cancellation of claims 9 and 11-12 necessitates the removal of such claims from the statement of rejection above.
Newly added claim 16 recites a vitamin B6 to nicotinamide ratio of “from about 1:80 to about 1:20”.
Newly added claim 17 recites a vitamin B6 to nicotinamide ratio of “from about 1:75 to about 1:25”.
Newly added claim 18 recites a vitamin B6 to nicotinamide ratio of “from about 1:60 to about 1:30”.
Claim 1 of the ‘887 application now recites that the vitamin B6 and nicotinamide are administered in a ratio of “from about 1:100 to about 1:30”, which clearly circumscribes the ranges provided for in new claims 16-17, thereby rendering such ranges prima facie obvious. MPEP §2144.05.
Claim 5 of the ‘887 application now recites that the vitamin B6 and nicotinamide are administered in a ratio of “from about 1:60 to about 1:30”, which clearly meets Applicant’s new claim 18.
Applicant’s remaining amendments to claims 1, 3-6 and 13 are editorial in nature and do not alter the scope of subject matter rejected herein the instant grounds for rejection.
(5) Claims 1-8, 10 and 13, as well as newly added claims 16-18, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 12-13 (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.21-23 of the previous Office Action dated September 17, 2025, of which said reasons are herein incorporated by reference.
Applicant’s cancellation of claims 9 and 11-12 necessitates the removal of such claims from the statement of rejection above.
Newly added claim 16 recites a vitamin B6 to nicotinamide ratio of “from about 1:80 to about 1:20”.
Newly added claim 17 recites a vitamin B6 to nicotinamide ratio of “from about 1:75 to about 1:25”.
Newly added claim 18 recites a vitamin B6 to nicotinamide ratio of “from about 1:60 to about 1:30”.
Claims 5-6 of the ‘893 application recites that the vitamin B6 and nicotinamide are administered in a ratio of “from about 1:100 to about 1:9” (claim 5) or “from about 1:45 to about 1:30” (claim 6), which clearly circumscribe the ranges provided for in new claims 16-18, thereby rendering such ranges prima facie obvious. MPEP §2144.05.
Applicant’s remaining amendments to claims 1, 3-6 and 13 are editorial in nature and do not alter the scope of subject matter rejected herein the instant grounds for rejection.
(6) Claims 1-6, 8 and 10, as well as newly added claims 16-18, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-12 and 14-17 (claim 9 now being cancelled) of U.S. Patent Application No. 19/053,861, already of record, for the reasons of record set forth at p.23-25 of the previous Office Action dated September 17, 2025, of which said reasons are herein incorporated by reference.
Applicant’s cancellation of claims 9 and 11-12 necessitates the removal of such claims from the statement of rejection above.
Newly added claim 16 recites a vitamin B6 to nicotinamide ratio of “from about 1:80 to about 1:20”.
Newly added claim 17 recites a vitamin B6 to nicotinamide ratio of “from about 1:75 to about 1:25”.
Newly added claim 18 recites a vitamin B6 to nicotinamide ratio of “from about 1:60 to about 1:30”.
Claim 1 of the ‘861 application now recites that the vitamin B6 and nicotinamide are administered in a ratio of “from about 1:80 to about 1:20”, which clearly meets Applicant’s new claim 16.
Claim 5 of the ‘861 application now recites that the vitamin B6 and nicotinamide are administered in a ratio of “from about 1:75 to about 1:25”, which clearly meets Applicant’s new claim 17.
Claim 6 of the ‘861 application now recites that the vitamin B6 and nicotinamide are administered in a ratio of “from about 1:45 to 1:30”, which meets Applicant’s range recited in new claim 18.
Applicant’s remaining amendments to claims 1, 3-6 and 13 are editorial in nature and do not alter the scope of subject matter rejected herein the instant grounds for rejection.
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.8). Applicant “requests that the double patenting rejections be withdrawn or held in abeyance until claims are otherwise allowable in the present application” (Remarks, p.9).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant’s response requesting that the rejection 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 non-responsive for failing to provide a complete response to the outstanding nonstatutory double patenting rejections as required by MPEP §804(I)(B)(1).
In any event, the instant claims are not in condition for allowance because of the 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 applications, the rejections continue to remain proper.
For these reasons supra, rejection of claims 1-8, 10, 13 and 16-18 is proper.
Conclusion
Rejection of claims 1-8, 10, 13 and 16-18 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).
THIS ACTION IS MADE FINAL. 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
April 30, 2026
Prosecution Insights