DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is responsive to Applicant’s preliminary amendment and remarks, filed 02 June 2026, in which claim 12 is canceled and new claims 17-21 are added.
This application is a domestic application, filed 29 Nov 2023; and claims benefit of provisional application 63/385,327, filed 29 Nov 2022.
Claims 1-11 and 13-21 are pending in the current application. Claims 13-16, drawn to non-elected inventions, are withdrawn. Claims 1-11 and 17-21 are examined on the merits herein.
Election/Restrictions
Applicant’s election of Group I, claims 1-11 and new claims 17-21, in the reply filed on 02 June 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 13-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02 June 2026.
Applicant’s election of species of composition comprising the NAD precursor NMN in the reply filed on 02 June 2026 is acknowledged.
As detailed further herein regarding claim 5, the elected species is interpreted to read upon all of claims 1-11 and new claims 17-21.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5-7, 9-11, 17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Lee et al. (US 2022/0184108, published 16 June 2022, filed 11 Dec 2020, provided by Applicant in IDS filed 23 July 2024).
Lee et al. discloses a composition for maximizing NAD enzyme's health benefits. The composition includes adenosine; a vitamin B3, wherein the vitamin B3 is in the form of niacin, niacinamide, nicotinic acid, or nicotinamide including at 0.1 to 10 percent weight of the Vitamin B3; a nicotinamide mononucleotide; and a stilbene derivative (abstract). According to one embodiment of the invention, the composition to maximize NAD enzyme's health benefits are related to formulations comprising both active pharmaceutical molecules, prodrugs, and macro / micro nutrients to enhance NAD levels in a human body (page 2, paragraph 23), addressing the functional properties
of the composition and implying the amounts of the active components are effective amounts, meeting limitations of claim 1. Lee et al. discloses the embodiment of working example X of an elixir containing 0.1 weight percent to 10.0 weight percent of a combination of NAM (Nicotinamide), NA (Nicotinic Acid), NR (Nicotinamide Ribose); 0.1 weight percent to 10.0 weight percent of Nicotinamide Mononucleotide (NMN); 0.1 weight percent to 10.0 weight percent of Ribosyl Phosphate; and 0.1 weight percent to 10.0 weight percent of Adenine (page 7, paragraph 85-86), meeting limitations of claims 1-2 and 9. Lee et al. discloses the embodiment of working example XII of an elixir comprising a vitamin B3 component of 0.1 to 10 percent weight selected from the group consisting of niacin, niacinamide, nicotinic acid and nicotinamide. A nicotinamide
mononucleotide and A stilbene derivatives component of 0.1 to 5 percent weight. Ribose in an amount of between about 5% and 10% by weight (page 7, paragraph 89-90), meeting limitations of claims 1-2, 6-7, 9-11, 17, and 19-20. Lee et al. implies the ribose used in the composition is the naturally-occurring form, D-ribose, as appears in the illustrated NAD 10 shown in figure 1 (page 4, paragraph 44; figure 1).
Regarding claim 5, the claim recites further limitations of the alternative of the NAD compound, however this claim does not require the composition to comprise the NAD compound. Therefore claim 5 is interpreted to encompass the alternative of the composition comprising the NAD precursor Nicotinamide Mononucleotide as disclosed in the cited art.
Claims 1-2 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Livingston et al. (US 10,392,416, issued 27 Aug 2019, cited in PTO-892).
Livingston et al. discloses a crystalline forms of a β-nicotinamide mononucleotide and related pharmaceutical preparations thereof. The invention also relates to preparations suitable for nutraceutical uses (abstract). Diseases, disorders and conditions that are affected by increasing NAD levels are likewise affected by the amount of NMN precursor available for NAD biosynthesis, and thus can be treated by administering the NMN compounds and compositions disclosed herein (column 5, lines 1-60), implying that the NMN compounds and compositions are effective to increase NAD levels in a subject in need thereof. The formulations may conveniently be presented in unit dosage form and may be prepared by any methods well known in the art of pharmacy. The amount of active ingredient that can be combined with a carrier material to produce a single dosage form will generally be that amount of the compound which produces a therapeutic effect. Generally, out of one hundred percent, this amount will range from about 1 percent to about ninety-nine percent of active ingredient, preferably from about 5 percent to about 70 percent (column 25, line 65 to column 26, line 15), meeting limitations of claims 1-2.
Regarding claim 5, the claim recites further limitations of the alternative of the NAD compound, however this claim does not require the composition to comprise the NAD compound. Therefore claim 5 is interpreted to encompass the alternative of the composition comprising the NAD precursor Nicotinamide Mononucleotide as disclosed in the cited art.
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 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Livingston et al. (US 10,392,416, issued 27 Aug 2019, cited in PTO-892).
Livingston et al. discloses as above regarding claims 1-2 and 5.
Livingston et al. does not specifically disclose the composition wherein the NAD precursor is 30-70% of the composition (claim 3) or the NAD precursor is 50% of the composition (claim 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the optimum concentration of the active ingredient NMN in the formulation taught by Livingston et al. through routine experimentation. See MPEP 2144.05 at II.A. providing ““[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” In this case Livingston et al. teaches the range from about 1 percent to about ninety-nine percent of active ingredient, preferably from about 5 percent to about 70 percent, and will generally be that amount of the compound which produces a therapeutic effect, suggesting one of ordinary skill in the art would have been motivated to select the optimum or workable range for the amount of the compound through routine experimentation.
Claims 8, 18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2022/0184108, published 16 June 2022, filed 11 Dec 2020, provided by Applicant in IDS filed 23 July 2024) in view of Horn (US 2018/0071273, published 15 March 2018, cited in PTO-892).
Lee et al. teaches as above regarding claims 1-2, 5-7, 9-11, 17, and 19-20. Lee et al. further teaches NAD enzyme (Nicotinamide adenine dinucleotide) has been demonstrated to improve a large proportion in mitochondrial disease or disorder (page 2, paragraph 23).
Lee et al. does not specifically teach the composition further comprising creatine monohydrate (claims 8 and 18).
Horn teaches nutritional compositions comprising a synergistic effective amount of a NAD-precursor in a combination with an ATP booster, useful to enhance natural energy or treat mitochondrial energy disorders or diseases (abstract). In certain embodiments, the NAD+ precursor comprises at least one of nicotinamide riboside, NAD, nicotinic acid, nicotinamide, nicotinic acid mononucleotide, vitamin B3, nicotinamide mononucleotide or a combination thereof (page 1, paragraph 9). In another aspect, the nutritional composition further comprises an effective amount an ATP cycle enhancer. In certain embodiments, the ATP cycle enhancer comprises creatine monohydrate or D-ribose (page 1, paragraph 15-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Lee et al. in view of Horn in order to modify the composition of Lee et al. by combination with the creatine monohydrate taught by Horn. One of ordinary skill in the art would have been motivated to combine Lee et al. in view of Horn with a reasonable expectation of success because both Lee et al. and Horn are drawn to compositions comprising an NAD-precursor useful to treat mitochondrial energy disorders or diseases, Lee et al. teaches the composition further comprising D-ribose, and Horn teaches creatine monohydrate and D-ribose are equivalents that act as ATP cycle enhancer useful to treat the mitochondrial energy disorders or diseases, suggesting it would have been obvious to one of ordinary skill in the art to combine the creatine monohydrate taught by Horn with the composition of Lee et al. in order to provide a combined composition useful for the same purpose. See MPEP 2144.06 at I., for example providing ““It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)”. Regarding claim 8 reciting the concentration of the creatine monohydrate, one of ordinary skill in the art would look to the concentration of the equivalent D-ribose taught by Lee et al. as a starting point for routine experimentation to determine the optimal or workable concentration.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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