DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 31 July 2025, was filed after the mailing date of the non-final Office Action on 6 May 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendments
Status of Claims
The amendment, filed on 6 August 2025, is acknowledged.
Claims 1 and 12 have been amended.
Claims 6 and 9-10 have been cancelled.
Claims 1, 7-8, 11-12, and 14-16 are pending and under consideration in the instant Office Action.
Objections Withdrawn
Objections to Claims
Applicant’s cancellation of claim 6 in the response filed on 6 August 2025, has rendered moot the objection to the claim set forth in the Office Action mailed on 6 May 2025. Accordingly, the relevant objection is withdrawn.
Rejections Withdrawn
Rejections pursuant to 35 U.S.C. § 112
The rejection of claims 9-10 under 35 U.S.C. § 112 is rendered moot by Applicant’s cancellation of the claims in the response filed on 6 August 2025. Accordingly, the relevant rejections are withdrawn.
The rejection of claim 12 under 35 U.S.C. § 112 for reciting a broad range followed by a narrow range is withdrawn in view of Applicant’s amendment to the claim to recite only one limitation.
Rejections pursuant to 35 U.S.C. § 103
The rejections of claims 6 and 9-10 under 35 U.S.C. § 103 have been rendered moot by Applicant’s cancellation of the claims in the response filed on 6 August 2025. Accordingly, the relevant rejections are withdrawn.
The rejection of claims 1, 7-8, 11-12, and 14-16 under 35 U.S.C. § 103 presented in the Office Action mailed on 6 May 2025, are withdrawn in view of Applicant’s amendments and in favor of the new grounds of rejection presented below.
Maintained Rejections
Claim Rejections – 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 is rejected under 35 U.S.C. § 112(b) for including limitations in parentheses because it is unclear whether the unit “w/w” is intended to be a limitation. Applicant may overcome this rejection by removing the parentheses.
New Grounds of Objection
Claim Objections
Amended claim 1 is objected to for reciting “b-nicotinamide mononucleotide” twice in lines 3-4. The claim should be amended to recite the species only once.
Appropriate correction is required.
New Grounds of Rejection
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 7-8, 11, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Bian et al. (Australian Patent Application Publication No. AU 2019/100591 A4, published on 4 July 2019, hereafter referred to as Bian) in view of Mahoney (U.S. Patent Application Publication No. US 2014/0100283 A1, published on 10 April 2014, provided by Applicant in IDS filed on 31 July 2025).
Bian teaches a stable, fast-absorbing sublingual composition, delivered in the form of a hard gel capsule, which can deliver water-soluble drugs, complimentary medicines, and nutrients (Abstract). Traditional administration of complementary medicines, such as vitamin supplements, are taught to be oral administration, but several drawbacks are associated with this administration route including incomplete dissolution in the stomach, excipients that have disadvantageous reactions with other ingredients and/or the user, and widely varying bioavailability impacted by the user’s digestive system (pg. 1, Description, para. 1). To avoid the above drawbacks, Bian teaches administration sublingually, as the region in the oral cavity below the tongue is taught to have a large amount of blood and lymphatic vessels in the region (pg. 3, para. 2). The compositions of Bian’s invention are in the form of hard gel capsules, which allow greater stability, longer storage, and greater variability in size (pg. 3, para. 3).
Glutathione, a tripeptide L-glutathione (GSH) that is also called “reduced glutathione”, is taught to be “a primary intracellular antioxidant capable of preventing cellular damage from reactive oxygen species such as free radicals, peroxides, lipid peroxides, and heavy metals” (pg. 4, penultimate para.). The molecule is taught to be an attractive supplement, but bioavailability following oral consumption is poor and requires effort to improve bioavailability following administration – in the case of the invention of Bian, this is addressed by sublingual administration of a hard gel capsule (pg. 4, final para.).
The composition in the hard gel capsule taught by Bian comprises water-soluble drugs, which in some embodiments may be glutathione, and edible acids, which in some embodiments may be ascorbic acid (vitamin C) (pg. 8, para. 2). The weight ratio of glutathione to edible acid is taught to be from 1:1 to 1:8 (pg. 8, para. 3). In another embodiment, a composition is taught that comprises nicotinamide mononucleotide (NMN) alongside an edible acid, which may be ascorbic acid, in a weight ratio of 1:1 to 1:8 (pg. 9, para. 5-6).
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “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). These guidelines apply to the ratios taught by Bian dictating the ratio of glutathione and NMN to ascorbic acid, which significantly overlap with the ranges of ratios recited in instant claim 1.
Bian does not teach the coenzyme in their composition to be S-acetylglutathione. This deficiency is offset by the teachings of Mahoney.
Mahoney teaches an improved method of delivering glutathione by oral administration of S-acetylglutathione (SAG). Glutathione is taught to be a major intracellular antioxidant in humans and biosynthesized by many cells, and reduced levels of the biomolecule are taught to be associated many diseases and pathologies (para. [0003-0004]). Reduced levels of glutathione are taught to be treated via glutathione augmentation, using intravenous and oral administration of the biomolecule or its precursor (para. [0005-0007]). However, these traditional administration methods are taught to have drawbacks, including poor bioavailability, a requirement for high doses, and insufficient increases in glutathione levels (para. [0007-0008]).
To overcome the above drawbacks, Mahoney teaches administration of S-acetylglutathione orally (para. [0015]). Oral administration of SAG, a “direct precursor” of glutathione, is taught to have the advantages of easier use, convenience, more efficient increases in glutathione levels, lower costs, and fewer unpleasant side-effects (para. [0019]). Mahone teaches these outcomes to be a result of the acetylation of glutathione, as the acetyl group allows the molecule to be “taken up by cells directly” and that the molecule can be “de-acetylated to glutathione to replenish glutathione for mitochondrial action” because “de-acetylation is an ordinary occurrence in cells” (para. [0016]).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, in view of the teachings of Mahoney to substitute glutathione with S-acetylglutathione in the invention of Bian because simple substitution of one known element for another to achieve a known benefit produces predictable results. Bian teaches a solid gel composition for treating the health of a user that may comprise glutathione, NMN, and vitamin C, in ratios that significantly overlap with those recited in instant claim 1. An ordinary artisan would be motivated to substitute glutathione in the invention of Bian with S-acetylglutathione in view of the teachings of Mahoney because Mahoney teaches that increasing bioavailability of glutathione is better addressed not by method of administration, but by chemical modification to the biomolecule. Appending the acetyl group to glutathione imparts multiple benefits, including utilization of natural uptake mechanisms to provide SAG to cells and more efficient increases in glutathione levels, which a person of ordinary skill would recognize as beneficial in the invention of Mahoney. As a result, there is a reasonable expectation of success in arriving at the invention of instant claims 1, 7-8, 11, and 15 in view of the teachings of Bian and Mahoney.
Claims 12, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Bian (Australian Patent Application Publication No. AU 2019/100591 A4, published on 4 July 2019) in view of Mahoney (U.S. Patent Application Publication No. US 2014/0100283 A1, published on 10 April 2014, provided by Applicant in IDS filed on 31 July 2025) as applied to claims 1, 7-8, 11, and 15 above, and further in view of Cazor et al. (U.S. Patent Application Publication No. US 2004/0258634 A1, published on 23 December 2004, hereafter referred to as Cazor).
Bian and Mahoney teach the above.
Bian and Mahoney do not teach the amount of their medications in an oral care composition nor the composition to be in the form of a chewing gum with at least one resin, wax, phospholipid, flavoring agent, and/or elastomer. These deficiencies are offset by the teachings of Cazor.
Cazor teaches a composition for oral hygiene that comprises one or more fluoride-ion vectors and antioxidants, which are described as “active principles”, is in the form of a dentifrice, chewing gum, mouthwash, or spray, and is formulated to prevent and/or combat oral pathologies (Abstract and claim 1). Oral pathologies are taught to occur at a “relatively high frequency” in people with diabetes, due to conditions that cause an inflated level of oxidative stress and inflammation, partly from oxygen free radicals (para. [0004-0005]). One method of treating these oxygen free radicals has been administration of antioxidants to people with diabetes, optionally in the form of a chewing gum or dentifrice, the latter being (para. [0006] and [0058]). The combination of two or more antioxidants in the composition is taught to be capable of providing a synergistic advantage (para. [0054]). Cazor teaches that incorporation of the naturally occurring antioxidant glutathione in its reduced form (GSH) is “difficult to implement industrially, both on account of the instability of this compound at room temperature and on account of its cost”, and therefore does not include it in their compositions (para. [0016]). The total antioxidant content in the composition is taught to be between 5 x 10-4 to 2.0%, which overlaps with the range recited in instant claim 12 (para. [0040] and claim 17).
The form of the composition is taught to be “any form that is suitable for local oral application”, including a dentifrice, a spray, a chewing gum, or a dental gel (para. [0058]). In the form of a dentifrice, which is interpreted as equivalent to the “oral gelling agent” recited in instant claim 14, the composition may be a paste, liquid, gel, or powder (para. [0059]). Finally, Cazor teaches a preferred chewing gum embodiment that comprises xylitol, sorbitol, and flavoring, which are determined to be equivalent to the flavoring agent of instant claim 16, and gum, which is determined to be equivalent to the elastomer of instant claim 16 (para. [0096]).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Cazor with the invention rendered obvious by the teachings of Bian and Mahoney to arrive at the invention of instant claims 12, 14, and 16 because combining prior art elements according to known methods yields predictable results. The teachings of Bian and Mahoney rendered obvious a composition comprising the antioxidants S-acetylglutathione and NMN and vitamin C and its use to improve the health of users. An ordinary artisan would be motivated to modify the invention render obvious above with the teachings of Cazor because Cazor provides a specific user base with a need for antioxidant-containing compositions, which the ordinary artisan would recognize as desirable for their invention. Cazor teaches that antioxidants administered to diabetics are beneficially in a composition in the form of a dentifrice or chewing gum, and when in the form of a chewing gum, also contain a flavoring agent and elastomer.
Cazor further teaches the incorporation of glutathione to be difficult in oral compositions, despite its utility in “preventing and treating gingival symptoms” (Cazor, para. [0014]), and intentionally excludes it. However, the invention rendered obvious by the teachings of Bian and Mahoney utilize SAG to deliver the important antioxidant glutathione to cells and teach that use of SAG provides improved bioavailability at a lower cost. One of ordinary skill would recognize that the use of SAG, rendered obvious by Bian and Mahoney, could fill the gap in compositions that provide glutathione to diabetics following oral administration and the ordinary artisan would subsequently be motivated to combine the composition above with the chewing gum and/or dentifrice taught by Cazor. As a result, there is a reasonable expectation of success in arriving at the invention of claims 12,14, and 16 in view of the teachings of Bian and Mahoney and further in view of the teachings of Cazor.
Response to Arguments
The Applicant’s arguments, filed on 6 August 2025, have been fully considered but are not persuasive.
Applicant argues that the combination of references presented in the Office Action mailed on 6 May 2025, do not teach or suggest every feature in the amended claims (pg. 6, para. 2). This is acknowledged, but rendered moot in view of the new grounds of rejection, necessitated by the amendment to claim 1, presented above.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the feature upon which applicant relies – the high stability of the claimed composition in para. 1 of pg. 7 of the remarks – are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Further, in response to Applicant's argument in para. 1 of pg. 7 that there would not be “any indication that the noted stability and applicability could be achieved” by combining the claimed components, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.J.S./
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619