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 .
Summary
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/20/2025 has been entered.
Receipt of Applicant’s Remarks/Arguments and Amendments filed on 06/20/2025 is acknowledged.
Claims 1-17 are pending.
Claims 2, 7, 10, 18-20 are canceled.
Claims 1, 11, 14, 16 and 17 are amended.
Claims 1, 3-6, 8, 9, and 11-17 are pending and under examination in this application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/24/2025, 09/20/2024, 07/23/2024, 03/26/2024, 10/04/2024, 02/24/2023, 08/16/2022, 03/15/2022 and 11/29/2021 are in compliance with the provisions of 37 CFR 1.98. Accordingly, the information disclosure statements has been considered by the examiner. A signed copy of the 3.24.2025 IDS has been attached to this office action.
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.
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, 3-6, 8, 9, and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Grise (US 2011/0217393 A1) in view of Women’s Recovery + Collagen and Coconut Water (hereinafter the reference is referred as Revel) and further in view of Moore et al. (US 8968791 B2) (hereinafter the patent is referred as Moore). All references are cited in IDS filed on 11/29/2021.
Grise teaches a dietary supplement composition directed to reducing fatigue, and/or improving recovery and resistance to fatigue (abstract) comprising collagen hydrolysate in proportion of 0.1% to 25% (w/v or w/w) (¶ 0019) wherein a serving size is from 1-100 grams, and in one regimen of use, a 15 ml or gram serving per day is typically consumed in the morning or before exercising (¶ 0059), glutamine and taurine in concentration of 0.01 % to 15% by weight (¶ 0053).
Regarding claims 1, 5, 6 and 11, as noted above, Grise teaches collagen hydrolysate, glutamine and taurine in the dietary composition, wherein the serving ranges from 1-100 grams overlaps with instant range of 17-23 grams. For example, the glutamine amount of a 38 gram serving of 2.55 % by weight equates to 0.97 grams, wherein the serving of glutamine overlaps with instant range of (0.5-1.5) grams per serving and taurine for example, a 38 gram serving of 0.356 % by weight equates to 0.135 grams, wherein the serving and taurine amount overlaps with instant range of (0.1-0.2) grams per serving. As for the instant requirement of collagen amount in 15-25 grams per serving, Grise teaches collagen hydrolysate in proportion of 0.1% to 25% (w/v or w/w) wherein a serving size is from 1-100 grams (¶s 0019 and 0059), for example, an 80 gram serving size of the composition comprising 25% collagen equates to 20 grams per serving, which overlaps with instant range of 17-23 grams. Additionally, Grise teaches the dietary supplement composition further comprising at least one amino acid can be anyone of the known amino acid in the industry or health, for example lysine, glutamine (¶ 0020) and phenylalanine (¶ 0053). Furthermore, Grise disclose (leucine, lysine, methionine, phenylalanine, tryptophan, valine) are some of the known amino acids in prior art (¶ 0007) and at concentrations of 0.1 to 60 wt % in a composition (¶ 0009). Therefore, the limitation of the above amino acids are taught as well as the total amount of about 6-10 grams or 8 grams per serving in the dietary supplement composition. Grise further teaches at least one additional ingredient thiamine (¶ 0055) as other nutritional components that promote the fatigue recovering effect. Therefore, the limitation and structural features are taught.
Regarding claims 3 and 4, Grise teaches the dietary supplement composition can be in a form of liquid, a powder mixture or the like (¶ 0058).
Regarding claims 9 and 13, Grise teaches the dietary supplement composition further comprises minerals (inorganic salts, for example potassium, sodium, calcium salt etc., vitamins (thiamine, niacin, vitamin C, carotene etc.) (¶ 0055).
Regarding claims 14-16, Grise teaches arginine in the amount of 0.0005 to 0.2 kg (0.5mg – 200 mg) range, glycine 0.01 to 0.4 kg range, lysine 0.01 to 0.4 kg range, glutamine 0.0005 to 0.2 range, collagen hydrolysate 0.005 to 0.5 kg range (Table 1). Therefore, the limitation of at least one of amino acid is taught and a person having ordinary skill in the art would be able to optimize to the desired amount of arginine per serving to equate to 1570 mg and collagen of 20 grams is overlapped in the range 0.005 to 0.5 kg (5 grams to 500 grams) for example. Therefore, the limitation and structural features are taught.
Regarding claim 17, Grise teaches the dietary supplement composition and a method for reducing fatigue, the method comprising orally administering to an individual the food supplement at a rate of at least 1 gram or 1 ml per day, and in an another example at a rate of about from 5 to 25 ml or grams per day (¶ 0022), wherein the oral composition can be mixed into various liquids and soft foods to provide improved fatigue recovery resistance, or endurance enhancer to physical or mental training or stress (¶ 0035). As noted in above rejections, the collagen, glutamine and taurine amounts can be optimized and the additional components of (leucine, lysine, methionine, phenylalanine, tryptophan, valine) are known amino acids taught in prior art (¶ 0007,
¶ 0009) and at concentrations of 0.1 to 60 wt % in a dietary supplement composition, which overlaps of about 6-10 grams per serving.
Grise fails to specifically teach powdered coconut water.
Revel teaches a composition comprising powdered coconut water in an amount of about 10 to 20 wt % of the composition (2000 mg per 13 gram serving, equates to 15 wt%), vitamin D, calcium, potassium, collagen, leucine, isoleucine and valine (page 2, heading-Product Overview).
Regarding claim 8, as noted above, Revel teaches powdered coconut water.
Moore teaches a dietary supplement composition (abstract) comprising collagen, vitamin C, vitamin A, vitamin E, vitamin B12, niacin ( vitamin B3), vitamin B6, folic acid, thiamine (vitamin B1) (column 5, lines 56-65), essential amino acids including glutamine, histidine. isoleucine, leucine, lysine, methionine, phenylalanine,
threonine, tryptophan and valine (column 8, lines 1-6), electrolytes minerals calcium, magnesium, potassium, sodium, zinc (column 6, lines 20-23 and column 13, lines 7-8). Selenium (column 3, line 16 and claims 6, 8, 15 and 18), and the composition may be manufactured in oral dosage form of a reconfigurable powder, liquids, suspensions, emulsions, semisolids or gels, wherein the dietary supplement may be incorporated into a food product or powder for mixing with a liquid (column 13, lines 16-29).
Regarding claim 1, as noted above, Moore teaches dietary supplement composition (abstract) comprising collagen (column 1, line 50), amino acids (alanine, arginine, glutamine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, tryptophan, and valine (column 8, lines 1-7), folic acid (column 5, lines 60-67). Therefore the limitations of collagen, glutamine, amino acids, and at least one additional ingredient (folic acid) is taught.
Regarding claim 9, as noted above, Moore teaches electrolytes sodium, potassium, magnesium, calcium and zinc.
Regarding claim 11, as noted above, Moore teaches the nine essential amino acids.
Regarding claim 12, as noted above, Moore teaches the dietary supplement composition further comprises selenium.
Regarding claim 13, as noted above, Moore teaches vitamins.
Regarding claim 14-16, as noted above, Moore teaches amino acids.
Moore fails to specifically teach dietary supplement composition in powdered coconut water.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the dietary supplement composition of Grise and optimized the composition to provide collagen in the amount of 17-23 grams per serving, in order to achieve a higher amount of collagen in the 38 gram serving size, that would result in a higher concentration of amino acids in order to enhance the effectives of the anti-fatigue formulation. It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have further modified the composition of Grise, in order to have provided powdered coconut water in an amount of 10 to 20 wt % of the composition as taught by Revel, further modified in order to have provided the essential amino acids, leucine and isoleucine, selenium and electrolytes minerals for the enhance nutrient value as taught by Moore.
The combination of Grise, Revel and Moore discloses similar if not exact components in the dietary supplement composition and subject matter, however differs in the collagen, amino acid, and vitamins profile of instant composition, a person having ordinary skill in the art (PHOSITA) would be able to manipulate, optimized and refined the amounts desired in order to reduce fatigue, prevent fatigue and/or provide recovery enhancement or improvement to physical training, exercise or stress.
One of ordinary skill in the art would have been motivated to do this because all references are drawn dietary supplement composition containing collagen, glutamine and taurine directed to reducing fatigue, and/or improving recovery and resistance to fatigue. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to include the components such as collagen, glutamine, taurine, amino acids, vitamins profile and adjust the desired amount per serving size in the dietary supplement composition.
From the combine teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Response to Remarks/Arguments
Applicant’s remarks and arguments (pages 6-10 filed 06/20/2025) regarding the rejections under 35 U.S.C § 101 and 35 U.S.C § 112 has been fully considered and are found persuasive.
The required thiamine chloride, pyridoxine hydrochloride, D-calcium pantothenate, and folic acid in amended claim 1 are not naturally occurring, therefore the rejections under 35 U.S.C § 101 are withdrawn.
The amended claims 14-16 in the form of a list is proper and therefore rejections under 35 U.S.C § 112 is withdrawn.
Rejections under 35 U.S.C § 103
Applicants argue the prior art of record (Grise, Revel and Moore) fail to disclose or suggest the specific combination of ingredients as well as the specific amounts of the ingredients as required in claims 1 and 17, and Grise fails to disclose threonine. Furthermore, combination of Grise, Revel and Moore fail to provide any reason or motivation for the skilled artisan to select the specific ingredients and ingredient amounts to arrive to the claimed invention with a reasonable expectation of success.
Examiner very respectfully disagree.
The combination of Grise, Revel and Moore teach and suggest a dietary supplement composition comprising collagen, the claimed amino acids and vitamins (see rejections above). Motivation to add specific ingredients for such dietary supplement is evidenced in Grise, wherein describes a nutritional composition for enhancing lean muscle stimulus, growth, strength and recovery, supporting endurance, strength, performance, size and stamina in individuals, which may include L-arginine and creatine, L-leucine and L-valine, for example (¶ 0011), and nourishing drinks have been widely used conventionally for recovery from fatigue contain, as main ingredients, various kinds of vitamins, taurine and the like (¶ 0012), and considering the state of the art, it would be highly desirable to be provided with a new composition for reducing fatigue, improving resistance to fatigue, or improving recovery to fatigue (¶ 0014), Therefore, Grise teaches motivation to include collagen, amino acids and certain vitamins in effort for reducing fatigue (¶ 0015-0019), wherein the collagen hydrolysate proportion is 0.1% to 25% (¶ 0019), for example, an 80 gram serving size of the composition comprising 25% collagen equates to 20 grams per serving, which overlaps with instant range of 17-23 grams. Grise further disclose at one amino acid, at least two different amino acids or analogs thereof (¶ 0020), and the composition can be for example, but not limited to , administered at a rate of at least 1 gram or 1 ml per day, or at a rate of about from 5 to 25 ml or grams per day of amino acids (¶ 0022), an to provide improved fatigue recovery or fatigue resistance, or endurance enhancer to physical or mental training or stress, the relatively high concentration of collagen hydrolysate contains approximately twice as many of the amnio acids lysine, glycine and glutamine as the average food protein (¶ 0036). Thus, the amount of glutamine in an amount of about 0.5-1.5 grams is taught in Grise. Furthermore, Grise disclose the concentration of amino acids and their analogs and derivatives in the composition ranges 1 to 2000 ml or mg/70 kg-body weight, 3 to 700 ml or mg/70 kg-body weight, 5 to 500 ml or mg/70 kg-body weight and 10 to 50 ml or mg/70 kg-body weight , and from about 0.01% by weight to about 15.0% by weight, and the amino acids contains about 0.11% by weight to about 11% by weight, and the amino acids includes taurine and glutamine (¶ 0052 - ¶ 0053).
Moore teaches dietary supplement that promote the growth, repair, and maintenance of mammalian bone and joint connective tissue (abstract) comprising selenium and threonine (column 3, lines 16-23).
Revel teaches dietary supplement comprising collagen, amino acids (leucine, valine) and coconut water to support women’s joint health, recovery post-workout.
Therefore, it is obvious to combine prior art reference, all limitations and structural features are taught in prior art of record and there is motivation for the skilled artisan to select the specific ingredients and ingredient amounts to arrive to the claimed invention with a reasonable expectation of success. A prima facie case has been properly established.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDRE MACH whose telephone number is (571)272-2755. The examiner can normally be reached 0800 - 1700 M-F.
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/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615