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 .
Status of Claims
Claim 20 is pending and under examination in this application. Any objections or rejections not repeated below have been withdrawn.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.
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.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Harkins at el. (WO 2020106746) in view of Ruhlmann et al (US 20150147306), Prakash (US 20070116838), Kamcharov et al. (US 20200077682), Naidu et al. (US 20060269535), and Shi et al. (US 20190343155).
Regarding claim 20, Harkins teaches a method for synthesis of, or mixing of, a dietary supplement, (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 (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. 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. 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 providing an emulsifier (pg. 4 L6-9, claim 8), but is silent as to the emulsifier being polysorbate 80. Prakash teaches a method for making a dietary supplement (an orally ingestible composition with at least one functional ingredient, such as antioxidants; Abstract, [0002]) with nicotinamide, collagen, coenzyme Q10 and vitamins [0022], [0094], [0099]. Prakash discloses polysorbate 80 as a suitable surfactant additive for the dietary supplement and recognizes it as a sweet taste improving surfactant [0095]. Prakash states the surfactant additive is present in the composition at an amount from about 1 to about 5,000 ppm, or in percentage from about 0.0001% to about 0.5% [0791]. The claimed range and Prakash’s range for polysorbate 80 touch and therefore, the claimed range is obvious per 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 to incorporate the teachings of Prakash by using polysorbate 80 as the emulsifier in the claimed amount because Prakash recognizes polysorbate 80 as a suitable surfactant for a dietary supplement (an orally ingestible composition with at least one functional ingredient), which is able to improve the sweet taste of a composition, and recognizes the claimed amount to be a suitable amount for a surfactant in a dietary supplement (Abstract, [0002], [0095], [0791]).
Harkins discloses 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.
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. Also, the amount of dietary supplement is within the claimed range from about 13-84% by weight.
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 Prakash 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, specifically collagen hydrolysate, 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. 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, Prakash and Kamcharov to further incorporate the teachings of Kamcharov by providing the supplement component of collagen hydrolysate within the claimed range, 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 Coenzyme Q10 (CoQ10) (pg. 3 L27-28; pg. 6 L11-13), but does not teach the claimed amount. Naidu teaches a formulation for the trigger and release of bioenergy, where the formulation is a supplement (Abstract, [0048]. Naidu teaches the formulation includes a coenzyme/vitamin-B complex where the complex includes one or more of coenzyme Q10 and may or may not include other ingredients [0076]. Naidu discloses coenzyme Q10 (coenzyme/vitamin complex) at a range of 0.5-10.0% of the formulation (pg. 9 Table 4, [0103]). This encompasses the claimed range of 2% by weight of the dietary supplement. See MPEP 2144.05(I). Naidu teaches coenzyme Q10 (coenzyme Q) is an essential part of cellular machinery to produce ATP and provides bioenergy for vital cellular functions [0012].
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, Prakash, and Kamcharov to incorporate the teachings of Naidu by providing Coenzyme Q10 within the claimed ranges since Coenzyme Q10 is an essential part of cellular machinery to produce ATP and provides bioenergy for vital cellular functions, as recognized by Naidu [0012].
Harkins does not teach providing D-ribose. Shi teaches a beverage that has vitamins [0966], including a pseudo-vitamin of Coenzyme Q10, also referred to as a vitamin [0855]. 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, Prakash Kamcharov, and Naidu to incorporate the teachings of Shi by providing D-ribose since it is a sugar that sweetens and flavors to the composition [0009], [0486].
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. 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, Prakash, Kamcharov, Naidu, and Shi to further incorporate the teachings of Ruhlmann by providing the supplement component of vitamins within the claimed range, 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 (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%. 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, Prakash, Kamcharov, Naidu, and Shi to further incorporate the teachings of Shi by providing the minerals within the claimed range 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).
Harkins discloses the pH is between 2.5-9.5 (pg. 4 L5, Claim 6). This overlaps the claimed pH of about less than 3.8. See MPEP 2144.05(I).
Regarding the limitation, “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, Prakash, Kamcharov, Naidu, 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. 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 is 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, Prakash, Kamcharov, Naidu, and Shi to further incorporate the teachings of Kamcharov by subjecting the mixed component to a cold fill production process, where the filling of the beverage happens in a sterile environment, as recognized by Kamcharov [0088], ensuring microbial safety of the dietary supplement.
Response to Arguments
Applicant's arguments filed 05/19/2026 have been fully considered but they are not persuasive.
Applicant argues, on pg. 7 of their remarks, that none of the references discloses the claimed formulation. Applicant states the rejection does not identify a non-hindsight reason why a person of ordinary skill would have selected these particular features and amounts from all the cited references above and combined them into the claimed method. However, the Office disagrees for the following reasons.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant argues, on pgs. 7-9, that while Ruhlmann does teach an NADH containing liquid supplement, their composition is not the claimed collagen-hydrolysate dietary supplement and does not teach a pH less than 3.8, cold-fill production, 5-7% collagen hydrolysate and other claimed limitations. Applicant contends that even though Ruhlmann does supply an NADH amount, it does not supply the claimed formulation as a whole. However, the Office disagrees for the following reasons.
The Office agrees that Ruhlmann does not teach each and every claimed limitation in claim 20 and is used for teaching the amount of NADH and vitamin type and amount within the formulation. However, the test for obviousness is not whether the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
As shown above, Ruhlmann does provide motivation to modify Harkins to incorporate the claimed amount of NADH, 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 [0015]. Also, Ruhlmann does provide motivation further modify Harkins to incorporate the claimed type and amount of vitamins since the claimed 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].
Applicant argues, on pg. 8, that Kamcharov is a collagen beverage reference and does not disclose NADH, polysorbate 80 or other claimed limitations. Applicant contends that the Examiner’s reliance on Kamcharov for collagen hydrolysate does not provide a reason to select the claimed 5-7% collagen hydrolysate. Applicant states that Kamcharov’s disclosure described collagen absorption behavior at much lower concentrations than the claimed 5-7%, explaining that Kamcharov’s own teaching does not motivate selection of collagen hydrolysate within the claimed amount and for the use in a separate NADH-based formulation. However, 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. 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. Thus, a person of ordinary skill would have been motivated to add claimed amount of collagen to a dietary supplement formulation because the claimed amount falls within the range taught by the prior art (see MPEP 2144.05(I)) and because of collagen’s vital importance for muscle function and since collagen is a major protein of human connective tissue.
Additionally, Kamcharov may discuss an optimal concentration of collagen for intestinal absorption but they also teach using higher amounts within the claimed range. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See MPEP 2123(I).
Regarding applicant’s argument that Kamcharov has a fundamentally different approach from the present claims, although Kamcharov does not disclose all the features of the present claimed invention, Kamcharov is used as teaching reference to show how adding collagen hydrolysate to a dietary supplement and the amount to be used in a dietary supplement. Therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, namely, collagen hydrolysate and the amount that can be present. Thus, Kamcharov in combination with the other references discloses the presently claimed invention.
Applicant argues, on pg. 9, that Shi does not teach the claimed structural combination of NADH, polysorbate 80 and other claimed limitations, but is only used to teach minerals and D-ribose and is a sweetener and flavor reference. However, the Office disagrees for the following reasons.
Regarding applicant’s argument that Shi has a fundamentally different approach from the present claims, although Shi does not disclose all the features of the present claimed invention, Shi is used as teaching reference to show how adding minerals and D-ribose to a product taken by mouth that contains a dietary ingredient like vitamins and coenzyme Q10 or in other words a dietary supplement. Therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, namely, minerals and D-ribose and the amount that can be present. Thus, Shi in combination with the other references discloses the presently claimed invention.
Applicant argues, on pg. 9, the Morris reference’s teaching of polysorbate 80 and Shi’s teaching for the amount of coenzyme Q10. These arguments 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 pgs. 9-10, impermissible hindsight selection. Applicant contends that while cited references may show that individual nutraceutical ingredients were known, they do not teach or suggest the particular narrowed claimed combination. Applicant states that while KSR permits common-sense combinations supported by an articulated reason, it does not permit reconstruction of Applicant’s claim by picking isolated ingredients and endpoints from unrelated references after viewing the claim. However, the Office disagrees for the following reasons.
In response to applicant's argument that the references are unrelated or are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the references are all considered to be in the same field of the inventor’s endeavor. All of the above references are considered methods of making a product, where the product is taken by mouth and contains a dietary ingredient intended to supplement the diet, or in other words all of the references are considered methods for synthesis of a dietary supplement.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Additionally, as shown by the above rejection, all of the references provide motivation to modify Harkins through common-sense combinations of ingredients that help to improve and supplement the diet and are supported by an articulated reason, as permitted by KSR.
Applicant argues, on pg. 10, the limitation of the acidic pH acting as a preservative and stabilizing mechanism for the NADH component and the supplement component. Applicant contends that the premise for an In re Best presumption is absent because the cited combination is not substantially identical because of the amendments to claim 20 of the amount of polysorbate 80 and coenzyme Q10. However, the Office disagrees for the following reasons.
These arguments regarding modified Harkins not being substantially identical to the claimed invention have been considered but are moot. The new ground of rejection teaches the amount of polysorbate 80 and coenzyme Q10 within the amended claimed range. Thus, the previous reliance on In re Best is still considered relevant. The limitation is considered a property of the dietary supplement made by the method disclosed above. As stated above, since the method of modified Harkins 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)).
Conclusion
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.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759
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