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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 4, 2026 has been entered.
This action is in response to the papers filed on June 30, 2026. Applicants’ arguments and amendments to the claims filed June 4, 2026 have been entered. Claims 1, 5, 6, 8, 10-12, and 21 have been amended, claims 2-4, 7, 15, 17-20, and 25-26 have been cancelled, and no claims have been newly added. Claims 1, 5, 6, 8-14, 16, and 21-24 are pending and under current examination.
Priority
The instant application is a divisional US application 16/891,178 filed on June 3, 2020 which has matured into patent 11,666,639 which claims priority to the US provisional application 62/856,588 filed on June 3, 2019.
Withdrawn Claim Rejections - 35 USC § 112
Claims 25 and 26 were rejected in the Office Action mailed March 3, 2026 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. Applicant has cancelled clams 25 and 26 rendering the rejection moot. Accordingly, the rejection is hereby withdrawn.
Withdrawn Claim Rejections - 35 USC § 103
Claims 1, 3-6, 8-14, 16 and 21-24 were rejected in the Office Action mailed March 3, 2026 under 35 U.S.C. 103 as being unpatentable over Edward Walker (US20090258833A1, publication date: 10/15/2009, previously cited) (Hereinafter Walker) and Matthew Hesse et al (WO2016112170A1, publication date: 07/14/2016, previously cited) (Hereinafter Hesse) as evidenced by Collagen vs Collagen Peptides: Complete Guide: (Wellbeing Nutrition: Pub. Date: 12-23-2025. https://wellbeingnutrition.com/blogs/skin-beauty/collagen-vs-collagen-peptides-complete-guide?srsltid=AfmBOor4d8px3EjhsMptqpInCHactlfCYetHkKF-e-mbevmZW1XANizI). Applicants’ amendment renders the previous rejection moot. Applicant has narrowed the claim to limit the dietary supplement composition to a powder. The primary reference Walker does not disclose a powder, rather Walker teaches "[t]o enhance solubility of the collagen protein, typically the collagen is hydrolyzed into smaller polypeptides and individual amino acids. This technique not only enhances solubility of the collagen protein, but it also acts as a 'pre-digestion' treatment that helps to facilitate absorption of amino acids in consumers who suffer from compromised digestive processes." Thus, modifying the liquid composition of Walker to a powder form would also render Walker unsatisfactory for its intended purpose and/or change the principle of operation of the primary reference Walker. There is no teaching, suggestion, or motivation to modify the primary reference for a powder composition as required by the instant claims. Accordingly, the rejection for claims 1, 3-6, 8-14, 16 and 21-24 is hereby withdrawn
Claims 1, 9, and 12 were rejected in the Office Action mailed March 3, 2026, under 35 U.S.C. 103 as being unpatentable over Edward Walker (US20090258833A1, publication date: 10/15/2009, previously cited) (Hereinafter Walker), Matthew Hesse et al (WO2016112170A1, publication date: 07/14/2016, previously cited) (Hereinafter Hesse), and Christine L. Clinger et al (US20090162518A1, publication date: 06/25/2009, previously cited) (Hereinafter Clinger). Applicants’ amendment renders the previous rejection moot. Applicant has narrowed the claim to limit the dietary supplement composition to a powder. The primary reference Walker does not disclose a powder, rather Walker teaches "[t]o enhance solubility of the collagen protein, typically the collagen is hydrolyzed into smaller polypeptides and individual amino acids. This technique not only enhances solubility of the collagen protein, but it also acts as a 'pre-digestion' treatment that helps to facilitate absorption of amino acids in consumers who suffer from compromised digestive processes." Thus, modifying the liquid composition of Walker to a powder form would also render Walker unsatisfactory for its intended purpose and/or change the principle of operation of the primary reference Walker. There is no teaching, suggestion, or motivation to modify the primary reference for a powder composition as required by the instant claims. Accordingly, the rejection for claims 1, 3-6, 8-14, 16 and 21-24 is hereby withdrawn
Claims 25 and 26 were rejected in the Office Action mailed March 3, 2026 under 35 U.S.C. 103 as being unpatentable over Edward Walker (US20090258833A1, publication date: 10/15/2009, previously cited) (Hereinafter Walker) and Matthew Hesse et al (WO2016112170A1, publication date: 07/14/2016, previously cited) (Hereinafter Hesse) as applied to claims 1 and 16 above, and further in view of Koitel (Pub No.: WO 2016/113613; Pub. Date July 21, 2016). Applicant has cancelled claims 25 and 26 rendering the rejection moot. Accordingly, the rejection is hereby withdrawn.
Withdrawn Non-Statutory Double Patenting
Claims 1, 3-6, 8-14, and 16 were provisionally rejected in the Office Action mailed March 3, 2026 on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 17/595,874 (reference application) for reasons of record. Although the claims at issue are not identical, they are not patentably distinct from each other. The reference Application was abandoned on April 17, 2026, rendering the rejection moot. Accordingly, the rejection is hereby withdrawn.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 5, 6, 8-14, 16, and 21-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. Claim 1 recites a dietary supplement composition, wherein a serving of the dietary supplement composition is 36-38 grams, and the dietary supplement composition consists of: total sugar in an amount no greater than 4g per serving; about 15-25 grams of the collagen in the serving of the dietary supplement composition, 0.5-1.5 grams of glutamine in the serving of the dietary supplement composition, and about 0.1-0.2 grams of taurine in the serving of the dietary supplement composition; essential amino acids leucine, isoleucine, valine, lysine, phenylalanine, threonine, tryptophan, histidine, and methionine; and optionally at least one additional ingredient selected from the group consisting of carbohydrate, protein, vitamins, electrolytes, minerals, flavors, colors, coconut water powder, malic acid, and fruit extract; wherein the dietary supplement composition is a powder formulated to be mixed with a liquid prior to administration. Claim 16 recites a composition that is a powder formulated to be mixed with a liquid prior to administration, wherein a serving of the composition is 36-38 grams of the composition, wherein the composition consists of: sugar in an amount no greater than 4g per serving; about 15-25 grams of collagen in the serving of the composition, about 0.5-1.5 grams of glutamine in the serving of the composition and about 0.1-0.2 grams of the taurine in the serving of the composition; and optionally at least one additional ingredient selected from the group consisting of carbohydrate, protein, vitamins, electrolytes, minerals, flavors, colors, coconut water powder, malic acid, and fruit extract, the composition having the following amino acid profile:1935 mg per serving of alanine;1570 mg per serving of arginine;1151 mg per serving of aspartic acid;3071 mg per serving of glutamic acid;4728 mg per serving of glycine;138 mg per serving of histidine;40 mg per serving of hydroxylysine;2302 mg per serving of hydroxyproline;1093 mg per serving of isoleucine;2817 mg per serving of leucine;1314 mg per serving of lysine;149 mg per serving of methionine;1053 mg per serving of phenylalanine;2659 mg per serving of proline;661 mg per serving of serine;690 mg per serving of threonine;54 mg per serving of tryptophan;102 mg per serving of tyrosine; and1352 mg per serving of valine.
The following revised flowchart found in MPEP §2106(III), is used when considering whether or not a claimed invention recites eligible subject matter:
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The inventions recited in claims 1, 5, 6, 8-14, 16, and 21-24 are drawn to a composition of matter, a dietary supplement composition, wherein a serving of the dietary supplement composition is 36-38 grams, and the dietary supplement composition consists of: total sugar in an amount no greater than 4g per serving; about 15-25 grams of the collagen in the serving of the dietary supplement composition, 0.5-1.5 grams of glutamine in the serving of the dietary supplement composition, and about 0.1-0.2 grams of taurine in the serving of the dietary supplement composition; essential amino acids leucine, isoleucine, valine, lysine, phenylalanine, threonine, tryptophan, histidine, and methionine; and optionally at least one additional ingredient selected from the group consisting of carbohydrate, protein, vitamins, electrolytes, minerals, flavors, colors, coconut water powder, malic acid, and fruit extract; wherein the dietary supplement composition is a powder formulated to be mixed with a liquid prior to administration. Claim 16 recites a composition that is a powder formulated to be mixed with a liquid prior to administration, wherein a serving of the composition is 36-38 grams of the composition, wherein the composition consists of: sugar in an amount no greater than 4g per serving; about 15-25 grams of collagen in the serving of the composition, about 0.5-1.5 grams of glutamine in the serving of the composition and about 0.1-0.2 grams of the taurine in the serving of the composition; and optionally at least one additional ingredient selected from the group consisting of carbohydrate, protein, vitamins, electrolytes, minerals, flavors, colors, coconut water powder, malic acid, and fruit extract, the composition having the following amino acid profile:1935 mg per serving of alanine;1570 mg per serving of arginine;1151 mg per serving of aspartic acid;3071 mg per serving of glutamic acid;4728 mg per serving of glycine;138 mg per serving of histidine;40 mg per serving of hydroxylysine;2302 mg per serving of hydroxyproline;1093 mg per serving of isoleucine;2817 mg per serving of leucine;1314 mg per serving of lysine;149 mg per serving of methionine;1053 mg per serving of phenylalanine;2659 mg per serving of proline;661 mg per serving of serine;690 mg per serving of threonine;54 mg per serving of tryptophan;102 mg per serving of tyrosine; and 1352 mg per serving of valine.
Accordingly step 1 is satisfied.
Step 2 has now been broken out into a two-prong analysis:
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Step 2A first asks whether or not the claimed invention is directed to a judicial exception such as a natural phenomenon (e.g., product of nature). Here, the answer is yes, since the only compositional requirements set forth in the compositions comprises collagen in an amount of about 15-24 grams per serving, glutamine in an amount of about 0.5-1.5 grams per serving of the composition, taurine in an amount of 0.1-0.2 grams per serving of the composition, no greater than 4g per serving of sugar, leucine, isoleucine, valine, lysine, phenylalanine, threonine, tryptophan, histidine, and methionine. Wherein claim 16 additionally requires the presence of 1151g per serving of aspartic acid, 3071 mg per serving of glutamic acid, 4728 mg per serving of glycine, 40 mg per serving of hydroxylysine, 2302 mg per serving of hydroxyproline, 2659 mg per serving of proline, 661 mg per serving of serine, and 102 mg per serving of tyrosine.
The second leg of the analysis evaluates whether the claim recites additional elements that integrate the established judicial exception into a practical application of the exception. Based on the recitations provided in claims 5, 6, 8-14, and 21-24 the answer is no. There is not a practical application of the law of nature. These claims recite further ingredients that may be naturally occurring (e.g., leucine, isoleucine, valine, lysine, etc.,). For example, electrolytes and the nine essential amino acids are all naturally occurring ingredients. Essential amino acids and vitamins are found in various amounts in animal, plants like fruits, vegetables and nuts.
Lastly, step 2B asks if the claim recites additional elements that amount to “significantly more” than the judicial exception. Asked another way, do the claims recite anything additional demonstrating that the recited composition provides an inventive concept? Here, again, the answer is no because the claims simply do not recite anything else, compositionally or structurally, which provides an inventive concept that departs from a natural product. Reciting the intended use of a natural product (i.e., a method of replacing collagen broken down during physical activity) does not amount to significantly more than the judicial exception. The composition contains naturally occurring ingredients that do not have markedly different characteristics from what occurs in nature. The recitation of the amounts of the ingredients which are naturally occurring (e.g., collagen in an amount of 15-25 grams, glutamine 0.5-1.5 grams and taurine 0.1-0.2 grams) do not arrive at any change in characteristics (structural or functional) that are different from what occurs in nature. Claims 1, 5, 6, 8-14, 16, and 21-25 recites collagen, glutamine, taurine, branched chain amino acids (e.g., leucine, isoleucine, valine, etc.,), electrolytes (e.g., sodium, potassium), and vitamins (e.g., vitamin B1). The claim encompasses combination of naturally occurring ingredients. The recitation of a dietary composition does not add any additional structure to the claim and is also regarded as the intended use of the composition. Even if the claimed subject matter recites specific amounts or ratios, the claims are still patent ineligible because each naturally occurring product would still be structurally identical to what exists in nature. The test is not whether if said ingredients are all found combined together in nature but rather if they are a naturally occurring ingredient.
The composition as claimed is composed of all naturally occurring ingredients. The claims recite ingredients that can be naturally occurring. The claims encompass ingredients that are naturally occurring such as the nine essential amino acids. These are ingredients that are naturally occurring. Recitation of intended use (powder formulated to be mixed with a liquid prior to administration) does not amount to significantly more than the judicial exception as it is an intended use. The composition contains naturally ingredients that do not have markedly different characteristics from the natural components that occurs in nature. The recitation of the amounts of ingredients does not arrive at any change in the characteristics (structural or functional) of the naturally occurring ingredients. The test is not whether if said ingredients are all found combined together in nature but rather if they are the same ingredient that exists in nature. Claims 1 and 16 is a nature-based product (i.e., combination of naturally occurring substances). In the instant case, the claim encompass ingredients that exist in nature thus the composition is formed of naturally occurring ingredients. It does not have markedly different characteristics from any naturally occurring counterpart(s) in their natural state. In the instant case, there is no evidence that the combination has any markedly different characteristics. There is no indication that the claimed ingredients have any characteristics (structure, functional or otherwise) that are different from the naturally occurring ingredients. Another example involves an inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacterial of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific. Here, there is no indication that the claimed mixture of bacteria has any characteristics (structural, functional or otherwise) that are different from the naturally occurring bacteria. Discovery of the fact that certain strains of each species of these bacteria can be mixed without harmful effect to the properties of either is a discovery of their qualities of non-inhibition. The test is not whether the ingredients all occur naturally together in nature. There is no indication that the claimed ingredients have any characteristics (structure, functional or otherwise) that are different from the naturally occurring ingredients.
As such, the instant claims fail to recite subject matter that is patent eligible, and thus the claims do not amount to significantly more than the judicial exception.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA R FALKOWITZ whose telephone number is (571)270-3386. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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