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 .
Amendments Received
Amendments to the claims were received and entered on 01/21/2026.
Election/Restrictions
Newly submitted claim 5 is directed to an invention that lacks unity with the invention originally claimed for the following reasons: Claim 5 is directed to a method comprising steps of determining a collagen amino acid profile and preparing a corresponding vegan amino acid composition, whereas the originally claimed invention is directed to a vegan composition formulated to mimic a human collagen amino acid profile. While both claims relate generally to a composition that mimic a human collagen amino acid profile using vegan or animal-free sources, this shared feature does not constitute a special technical feature that defines a contribution over the prior art. As evidenced by PRNewswire/Geltor (see below), vegan, biomimetic human collagen compositions designed to mimic human collagen types were known in the art, prior to the effective filing date of the claimed invention.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 5 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Status of Claims
Claim 1 is amended and claims 2-6 are newly added.
Claims 1-4 and 6 are under consideration, as claim 5 is withdrawn.
Priority
The present application claims status as a 371 (National Stage) of PCT/IB2021/060415 filed on November 10, 2021 and claims priority to South African application ZA2020/07000, filed on November 11, 2020. Acknowledgment is made of applicant' s claim for foreign priority and papers submitted under 35 U.S.C. 119 (a)-(d). The present application is being examined with an effective filing date of November 11, 2020. In future actions, the effective filing date may change due to amendments or further review of priority documents.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/22/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Withdrawn Objections
In view of Applicant’s amendments to the specification as set forth in the Amendment/Request for Reconsideration and the submission of a replacement drawing sheet, the objections to the Specification and Drawings are hereby withdrawn.
Withdrawn Rejections
In view of Applicant’s amendments, rejection of claim 1 under 35 USC § 102(a)(1) by PRNewswire is hereby withdrawn.
In view of Applicant’s amendments, rejection of claim 1 under 35 USC § 102(a)(2) by Brightman et al. is hereby withdrawn.
In view of Applicant’s amendments and remarks filed on 01/21/2026, rejection of claim 1 under 35 USC § 101 is hereby withdrawn.
In view of Applicant’s amendments, rejection of claim 1 under 35 USC § 112(a) is hereby withdrawn.
In view of Applicant’s amendments, rejection of claim 1 under 35 USC § 112(b) is hereby withdrawn.
Response to Arguments for Prior Art Rejections
In the response filed on 01/21/2026, Applicant’s arguments that the amended claim 1 recites, in part, a specific composition of free amino acids, have been considered and found to be persuasive. Accordingly, rejections of claim 1 under 35 USC 102 by PRNewswire and Geltor have been withdrawn. It is noted, however, that a new rejection under 35 USC 103 is set forth below to address the required limitations directed to the specific amino acid composition recited in claim 1, as taught by Nassa et al.
New Rejections
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 1-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over PRNewswire (Geltor Unveils First Biodesigned Human Collagen for Skincare Market, 2019, https://www.prnewswire.com/news-releases/geltor-unveils-first-biodesigned-human-collagen-for-skincare-market-300819885.html, cited in a previous office action) and Nassa et al. (Analysis of human collagen sequences. Bioinformation. 2012;8(1):26-33, cited in PTO-892), as evidenced by Geltor (HumaColl21, 2019, https://geltor.com/humacoll21-biomimetic-human-collagen, cited in a previous office action).
Claim 1 is directed to a vegan, plant-based, animal-free composition comprising free-form amino acids of vegan origin and/or combinations of vegan protein sources having compatible amino-acid profiles, wherein the composition is specified by recited amino-acid percentages and is intended to mimic a targeted human collagen type. Under the broadest reasonable interpretation, the claim is not limited to a native collagen molecule or an intact triple-helical collagen structure, but encompasses amino-acid mixtures and/or vegan protein sources having compatible amino acid profiles, designed to correspond to a known human collagen amino-acid profile.
Regarding claims 1 and 4, PRNewswire discloses HumaColl21®, “the first ever human collagen created for cosmetics formulations, sustainably produced with zero animal inputs”, specifically human Type 21 collagen. PRNewswire teaches “the sustainable fermentation process of these consumer proteins combines cutting edge advances in biology and computation, and enables production anywhere in the world using only a fraction of the land, water and time required to process animal collagen”. Furthermore, at the effective filing date of the instant application, HumaColl21® was already being used as the “hero ingredient” in AHC’s “Ageless Real Eye Cream for Face”, an anti-aging cream manufactured by Kolmar Korea in Asia, and described by a representative of Kolmar as elevating their products by offering “clean, vegan ingredients” (see whole article). As evidenced by Geltor, HumaColl21® is a “biomimetic human type XXI collagen” that is “expertly biodesigned to mimic the active core of the type XXI protein” and “stimulates core extracellular matrix components, including collagen…” (see screenshot). Thus, PRNewswire/Geltor teaches a vegan, animal‑free, biomimetic human collagen composition for cosmeceutical use; but does not expressly disclose the specific amino-acid percentage profile recited in claim 1.
Nassa et al. teaches that human collagens comprise 28 genetically distinct members comprising alpha-1 chains of human collagens with known amino-acid compositions, noting that collagen is glycine and proline rich (pg. 26-27, Background). Nassa et al. reports the amino acid compositions of the alpha-1 chains of all 28 collagen types as relative percentages, including type I (Supplementary Table 2). For human collagen alpha-1 type I, Nassa et al. discloses the following amino acid composition (percentages): alanine 9.5%, arginine 4.8%, asparagine 1.2%, aspartic acid 4.5%, cysteine 1.2%, glutamine 3.3%, glutamic acid 5.1%, glycine 26.7%, histidine 0.6%, isoleucine 1.6%, leucine 3.3%, lysine 3.9%, methionine 0.9%, phenylalanine 1.8%, proline 19.0%, serine 4.1%, threonine 3.1%, tryptophan 0.4%, tyrosine 0.9%, and valine 3.2%. Thus, Nassa et al. further shows that different human collagen types have distinct but well‑characterized amino‑acid profiles, demonstrating that collagen amino‑acid profiles were known and selectable based on the desired collagen type. Comparison of the Nassa et al. human collagen alpha‑1 type I profile with the recited composition of claim 1 demonstrates close correspondence. Claim 1 recites glycine 27.08% vs. 26.7% in Nassa et al., proline 18.35% vs. 19.0%, alanine 9.48% vs. 9.5%, arginine 4.98% vs. 4.8%, aspartic acid 4.08% vs. 4.5%, serine 4.01% vs. 4.1%, lysine 3.82% vs. 3.9%, leucine 3.66% vs. 3.3%, valine 3.47% vs. 3.2%, threonine 3.07% vs. 3.1%, phenylalanine 1.77% vs. 1.8%, methionine 0.84% vs. 0.9%, histidine 0.77% vs. 0.6%, tryptophan 0.40% vs. 0.4%, and tyrosine 0.98% vs. 0.9%, with similarly small differences for the remaining amino acids. These differences are minor and would have been understood as routine variation and optimization when formulating an amino‑acid mixture to approximate a known collagen amino‑acid profile.
Regarding claims 2-3, as evidenced by Best Korean Skincare (https://bestkoreanskincare.kr/products/ageless-real-eye-cream-for-face), AHC’s “Ageless Real Eye Cream for Face”, the anti-aging cream manufactured by Kolmar Korea disclosed in PRNewswire above, in addition to HumaColl21™ also comprises vitamin C (see screenshot below for partial ingredient list).
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Regarding claim 6, as described above, PRNewswire/Geltor discloses a vegan, animal-free biomimetic human collagen composition (HumaColl21™) used in cosmetic formulations, such as AHC’s “Ageless Real Eye Cream for Face,” and administered to a human subject, including skin, to improve collagen-related properties, including collagen stimulation, improving skin elasticity and reducing the appearance of wrinkles. As further evidenced by Best Korean Skincare (see screenshot above), compositions combining biomimetic collagen ingredients with additional components such as vitamin C were known in the art at the time of the present invention. It is noted that vitamin C is understood by persons of ordinary skill in the art to support collagen production via stimulation of fibroblasts. Nassa et al., as described above, teaches amino acid compositions corresponding to human collagen types, including type I, expressed as relative percentages. Thus, the combination of PRNewswire and Nassa et al. makes obvious the administration of a composition comprising a collagen-mimetic amino acid profile together with an additional component such as vitamin C.
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to combine prior art reference teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, the teachings of PRNewswire, which discloses a vegan, animal‑free biomimetic human collagen composition for cosmetic use, as exemplified by HumaColl21™, and AHC’s “Ageless Real Eye Cream for Face” which further comprises vitamin C (i.e., an “inductor”) which is known in the art to support collagen synthesis and fibroblast activity, combined with the teachings of Nassa et al., that human collagen types, including type I, have known and quantifiable amino‑acid profiles for their alpha‑1 chains, would have led a person of ordinary skill in the art to select a known human collagen type having a desired amino acid composition, such as type I, and to modify the vegan biomimetic collagen composition of PRNewswire/Geltor so as to approximate the known amino‑acid profile of that selected collagen type, as taught by Nassa et al. Furthermore, it would have been obvious to a person of ordinary skill in the art, to administer said composition to a human subject, including topical administration to the skin, for the known purpose of stimulating collagen-related skin benefits. Given PRNewswire/Geltor’s successful demonstration of a vegan, animal-free “biomimetic” human collagen ingredient, optimized for performance in an anti-aging face cream, said practitioner would have a reasonable expectation of success in formulating in a vegan, animal-free composition that mimics a human collagen type, including the amino acid composition recited in claim 1. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claim is in condition for allowance.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAGHMEH NINA MOAZZAMI whose telephone number is (703)756-4770. The examiner can normally be reached Monday-Friday, 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached at 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NAGHMEH NINA MOAZZAMI/Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652