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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/11/2025 has been entered.
Status of Claims
Claims 4-7, 11-14, 16-17 and 20-21 are pending and under examination in this application. Any objections or rejections not repeated below have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4-7, 11-14, 16-17 and 20-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 20 and 21 recite the following, “wherein the dietary supplement is physically stable under ambient conditions.” However, upon further review of the specification it is found that this limitation is never disclosed in the specification. The specification does not discuss the dietary supplement being “physically stable under ambient conditions.” The specification does discuss the pH and how it acts as a preservative and stabilizing mechanism, see [0009]. Thus, the limitation of claims 20-21 is considered new matter since the limitation is not present in the disclosure.
Claims 4-7, 11-14, 16-17 are included in the rejection because they depend from a rejected base claim.
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.
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.
Claims 7, 11-14, 16-17 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Harkins at el. (WO 2020106746) in view of Ruhlmann et al (US 20150147306), Kamcharov et al. (US 20200077682) and Shi et al. (US 20190343155).
Regarding independent claims 20-21 and claims 7 and 11, Harkins teaches a method for synthesis of, or mixing of, a dietary supplement, as required by claims 20 and 21 (all natural biologic enhancing beverage; Abstract, pg. 11 Example 1 L5-11). Harkins teaches providing a nicotinamide adenine dinucleotide, in its reduced form (NADH) component having nicotinamide, as required by claims 20 and 21 (NAD+ precursor such as the reduced form of nicotinamide adenine dinucleotide (NADH); pg. 4 L32-34).
Harkins does not teach the NADH component within the claimed percent range by weight, as required by claims 20 and 21. Harkins does note that any suitable amount of NADH (NAD+ precursor) may be used in the disclosed formulations and that it has been found the presence of NADH, even in relatively high weight percentage, does not cause undesirable effects in taste or side effects (pg. 10 L13-16).
Ruhlmann teaches a liquid supplement (a composition which is a food supplement in a liquid form; [0031]) comprising NADH for treating a circadian rhythm disorder (Abstract, [0001]) where the NADH stimulates or accelerates the production of the body’s “happy hormones” dopamine and noradrenalin and also improves mood, motivation and individual energy potential [0015]. Ruhlmann teaches the composition comprises 30-90 mg of NADH [0034] in 30 ml to 60 ml of water [0036], or in terms of percentage comprises 0.05%-0.3% NADH. This encompasses the claimed amount of 0.3% NADH, required by claim 20, and from about 0.25-0.3%, required by claim 21. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins to incorporate the teachings of Ruhlmann by having the nicotinamide in the amount within the claimed range since NADH stimulates or accelerates the production of the body’s “happy hormones” dopamine and noradrenalin and also improves mood, motivation and individual energy potential, as recognized by Ruhlmann [0015].
Harkins teaches blending the NADH (NAD+ precursor) with water (pg. 6 L3-16, pg. 11 L6-7). Harkins also teaches a supplement component (pg. 11 L5-11). Harkins does not teach the amount of water within the claimed percent range by weight or the supplement component within the claimed percent range by weight, as required by claims 20 and 21.
Kamcharov teaches a method for making a dietary supplement (a beverage comprising a collagen hydrolysate; abstract). Kamcharov teaches several formulations at varying amounts of water and supplement component, one example formulation (pg. 8 Table 3) discloses water is at 82% by weight and the supplement component (ingredients other than water) at 18% by weight [0142]. The amount of water is within the claimed range from about 40-84% by weight, as required by claims 20 and 21. Also, the amount of dietary supplement is within the claimed range from about 13-84% by weight, as required by claims 20 and 21.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins in view of Ruhlmann by incorporate the teachings of Kamcharov by having the supplement component and water within the claimed ranges because Kamcharov teaches varying the amount of water based on the amount of supplement component added to the beverage as seen by Examples 1-9 [0140-0148].
Harkins does not teach collagen as a supplement component. Kamcharov teaches a supplement component of collagen, as required by claims 20 and 21, specifically collagen hydrolysate, as required by claim 11, which is a major protein of human connective tissue and vital importance for muscle function (Abstract, [0003]). Kamcharov discloses that collagen is in the range of about 40 grams per liter or more [0068], which is 4% or more. This encompasses the claimed range of 5-7% collagen, as required by claims 20 and 21. See MPEP 2144.05(I).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins in view of Ruhlmann and Kamcharov to further incorporate the teachings of Kamcharov by providing the supplement component of collagen hydrolysate within the claimed ranges of claims 20 and 21, since collagen is a major protein of human connective tissue and has vital importance for muscle function [0003], as recognized by Kamcharov.
Harkins teaches providing the supplement component of vitamins, as required by claims 20 and 21 (pg. 9 L7-13). Harkins does not teach the vitamin complex within the claimed amount.
Ruhlmann teaches the composition comprises at least one or a plurality of substances from a group consisting of vitamin B3, vitamin B2, vitamin B12 and vitamin C [0017], where these vitamins can be present in the composition in the following amounts: 100-300 mg vitamin B2, 50-150 mg vitamin B3, 500-2000 µg vitamin B12 and 200-500 mg vitamin C (Claim 11) in 30 to 60 ml of water [0036]. Thus, the composition may only comprise one vitamin such as vitamin B3 at 500 µg in 60 ml of water, or may comprise all the vitamins at the upper end of their ranges in 30 ml of water, or in other words the composition may comprise 0.0008% to 3.17% vitamins. This encompasses the claimed range of about 0.12-0.35% vitamins by weight of the dietary supplement, as required by claims 20 and 21. Ruhlmann teaches the B vitamins serve as preliminary stages for coenzymes and vitamin B3 (niacin) and vitamin C helps control the production of L-carnitine which is required for burning fat [0022-0023]. Ruhlmann also states that vitamin C is a radical interceptor and has an antioxidative effect, constitutes an important coenzyme for an enzyme during the biosynthesis of protein collagen and plays other important roles with amino acids [0023].
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins in view of Ruhlmann and Kamcharov to further incorporate the teachings of Ruhlmann by providing the supplement component of vitamins within the claimed ranges of claims 20 and 21, since these vitamins serve as preliminary stages for coenzymes, are a radical interceptor, have antioxidative effect, constitutes an important coenzyme for an enzyme during the biosynthesis of protein collagen and plays other important roles with amino acids [0022-0023], as recognized by Ruhlmann.
Harkins discloses the supplement component comprises minerals, as required by claims 20 and 21 (pg. 9 L 14). Harkins does not teach the amount of minerals within the composition. Shi teaches providing minerals, which are required by living organisms [0789]. Shi discloses the minerals are present from about 25-25,000 ppm, or 0.0025-2.5% [0794]. This overlaps the claimed range of about 0.001-0.021%, as required by claims 20 and 21. See MPEP 2144.05(I).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins in view of Ruhlmann and Kamcharov to incorporate the teachings of Shi by providing the minerals within the claimed ranges of claims 20 and 21 since minerals are required by living organisms [0789], as recognized Shi.
Harkins teaches forming a mixed component by mixing the NADH component with the supplement component at ambient conditions, the mixed component being a liquid at the ambient conditions (pg. 3 L29-30, pg. 11 L5-11), as required by claims 20 and 21.
Harkins discloses the pH is between 2.5-9.5 (pg. 4 L5, Claim 6). This overlaps the claimed pH of about less than 4.0, as required by claims 20 and 21, and a pH of less than 3.8, as required by claim 7. See MPEP 2144.05(I).
Regarding the limitation in claims 20 and 21, “the acidic pH acting as a preservative and stabilizing mechanism for the NADH component and the supplement component,” this limitation is considered a property of the dietary supplement made by the method disclosed above. Since the method of Harkins in view of Ruhlmann, Kamcharov and Shi is a substantially identical method to the claimed method and produces a substantially identical dietary supplement, it is considered to possess the claimed property, absent convincing arguments or evidence to the contrary. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Harkins is silent on subjecting the mixed component to a cold fill production process, as required by claims 20 and 21. Kamcharov discloses subjecting the mixed component (the beverage) to a cold fill production process (clean fill), where the filling of the beverage happens in a sterile environment [0088], which ensures microbial safety of the dietary supplement. It is noted that Kamcharov discusses several filling processes one of them being a clean fill and one being a hot fill [0088-0091]. Since the clean fill occurs after a product is pasteurized and cooled in the pasteurization system, it is considered a cold fill, meaning the product is not hot, or around room temperature during the filling process.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins in view of Ruhlmann, Kamcharov and Shi to further incorporate the teachings of Kamcharov by subjecting the mixed component to a cold fill production process, as required by claims 20 and 21, where the filling of the beverage happens in a sterile environment, as recognized by Kamcharov [0088], ensuring microbial safety of the dietary supplement.
Regarding the limitations in claims 20 and 21, “wherein the dietary supplement is physically stable under ambient conditions” and “oral administration of one serving of the dietary supplement provides an NADH absorption rate of at least about 98%,” these limitation are considered properties of the dietary supplement made by the method disclosed above. Since the method of Harkins in view of Ruhlmann, Kamcharov and Shi is a substantially identical method to the claimed method and produces a substantially identical dietary supplement, it is considered to possess the claimed properties, absent convincing arguments or evidence to the contrary. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Regarding claims 12-14, Harkins teaches providing the supplement component of Coenzyme Q10 (CoQ10) (pg. 3 L27-28; pg. 6 L11-13), but does not teach the claimed ranges required by claims 12-14.
Shi teaches a beverage that has vitamins [0966], where the vitamin is a pseudo-vitamin of Coenzyme Q10, also referred to as a vitamin [0855]. Shi discloses that Coenzyme Q10 is also an antioxidant that inhibits, suppresses or reduces oxidative damage to cells and biomolecules [0828-0829]. Shi teaches the beverage can contain one or more vitamins, and where the Coenzyme Q10 (vitamin) is present in an amount from about 10-10,000 ppm, or 0.001-1% [0854-0857]. This is overlaps the claimed ranges of 1-3%, 1-2% and 1-2.2%, as required by claims 12, 13 and 14, respectively. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins in view of Ruhlmann, Kamcharov and Shi to have further incorporate the teachings of Shi by providing Coenzyme Q10 within the claimed ranges since Coenzyme Q10 is an antioxidant that inhibits, suppresses or reduces oxidative damage to cells and biomolecules [0828-0829].
Regarding claim 16, Harkins teaches providing the supplement component of vitamins, wherein the vitamins are selected from vitamin B1, vitamin B2, vitamin B3, vitamin B12, vitamin E and biotin (pg. 9 L7-13).
Regarding claim 17, Harkins does not teach providing D-ribose. Shi teaches providing D-ribose, a reducing sugar which provides sweetening and flavoring to the composition [0009], [0486].
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins in view of Ruhlmann, Kamcharov and Shi to have further incorporate the teachings of Shi by providing D-ribose since it is a sugar that sweetens and flavors to the composition [0009], [0486].
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Harkins at el. (WO 2020106746) in view of Ruhlmann et al (US 20150147306), Kamcharov et al. (US 20200077682) and Shi et al. (US 20190343155) as applied to claim 20 above, and further in view of Morris (US 20170189447).
Regarding claims 4-6, Harkins does not teach furnishing polysorbate 80. Morris discloses making a composition in liquid dosage form that comprises coenzyme Q10, niacinamide and vitamin and minerals [0005], [0107]. Morris teaches providing a co-surfactant of polysorbate 80, which enhances the solubility of the components of the composition [0114]. Morris discloses the polysorbate 80 are employed at a level from 0.01-2% by weight [0114]. This is within the claimed range of 0.0001-2% as required by claim 4. This range also overlaps the claimed ranges of 0.0001-1.5 and 0.0001-1%, as required by claims 5 and 6 respectively.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harkins in view of Ruhlmann, Kamcharov and Shi to incorporate the teachings of Morris by having polysorbate 80 within the claimed ranges to enhance the solubility of the components of the composition, as recognized by Morris [0114].
Response to Arguments
Applicant's arguments filed 08/11/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to newly narrowed NADH range and vitamin range have been considered but are moot because the new ground of rejection does not rely on any teaching or matter specifically challenged in the argument.
Applicant argues on pg. 9 of their remarks that the collagen at ~5-7% is neither taught nor suggested by the references. The Office disagrees for the following reasons.
As shown in the rejection above, Kamcharov discloses that collagen is in the range of about 40 grams per liter or more [0068], which is 4% or more collagen. This encompasses the claimed range of 5-7% collagen, as required by claims 20 and 21. See MPEP 2144.05(I). It would have been obvious for one of ordinary skill in the art to have modified Harkins to incorporate the teachings of Kamcharov by providing the supplement component of collagen hydrolysate within the claimed ranges, since collagen is a major protein of human connective tissue and has vital importance for muscle function [0003], as recognized by Kamcharov.
Conclusion
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/S.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759