Prosecution Insights
Last updated: May 29, 2026
Application No. 18/297,535

COMPOSITION AND METHODS OF TREATMENT USING TRANSDERMAL SUPPLEMENTATION

Final Rejection §103
Filed
Apr 07, 2023
Examiner
KETCHAM, KAREN A
Art Unit
1614
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Xygenyx Inc.
OA Round
2 (Final)
20%
Grant Probability
At Risk
3-4
OA Rounds
2m
Est. Remaining
56%
With Interview

Examiner Intelligence

Grants only 20% of cases
20%
Career Allowance Rate
9 granted / 46 resolved
-40.4% vs TC avg
Strong +36% interview lift
Without
With
+36.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
34 currently pending
Career history
107
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
84.4%
+44.4% vs TC avg
§102
2.8%
-37.2% vs TC avg
§112
2.1%
-37.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 46 resolved cases

Office Action

§103
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 . Claim Status Claims 1-14 are pending. Claims 7-14 are withdrawn. Claims 1, 4 and 6 are currently amended. Claims 1-7 are currently under consideration. Claims 1-7 are rejected. Acknowledgement of Receipt This Office Action is in response to the Applicants’ amendments and remarks filed 03/02/2026. Withdrawn Objections/Rejections The objections to claims 4 and 6 are withdrawn. Applicants Claim Applicants claim a composition for transdermal supplementation, comprising: an aqueous gel comprising therapeutically effective amounts of: glycerin; polyacrylic acid; a synthetic peptide; aloe vera gel; a cross-linked sodium hyaluronate polymer; carnosine; and at least one tocopherol (claim 1); the synthetic peptide comprises palmitoyl tripeptide-1 (claim 2); palmitoyl tripeptide-7 (claim 3); further comprising an additional therapeutically effective amount of pullulan (claim 4); a microalgae extract (claim 5); Nannochloropsis oculata (claim 6); an extract of the macadamia (claim 7). New Rejections Applicant’s amendments have necessitated the following grounds of rejection: 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 (a) are summarized as follows: Determining the scope and contents of the prior art. Ascertaining the differences between the prior art and the claims at issue. Resolving the level of ordinary skill in the pertinent art. 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. Applicants are 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. Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fuchs et al. (US 2021/0275431 A1, pub. 09/09/2021) in view of Dreher (US 11,331,305 B2, pub. 05/17/2022) and Yao et al. (CN 114642623 A, pub. 06/21/2022) herein referenced Fuchs, Dreher, and Yao. Citations for Yao are taken from the machine translated document. Fuchs discloses a cosmetic composition includes at least one gamma-polyglutamic acid (PGA) composition, at least one plant stem cell extract, at least one additional peptide composition and at least one vitamin composition (abstract). Palmitoyl tripeptide-1 and palmitoyl tripeptide-7 are taught (paragraphs 0014, 0018, 0032, 0036, claims 5 and 9) to read on instant claims 2-3. Fuchs teaches thickeners to include acrylate/C10-30 alkyl acrylate cross polymers (paragraph 0047) to read on the polyacrylic acid of claim 1. Fuchs’ teaches and shows by exemplary composition glycerin, polyacrylic acid, synthetic peptide (tripeptide-1 and tripeptide-7), tocopherol, pullulan, and Nannocloropsis oculate extract (CAS 92128-82-0) (paragraphs 0033, 0045, 0047, 0051, claims 5-6) to read on instant claims 1, and 4-6. Fuchs teaches that the composition is applied for the purpose of provides wrinkle prevention and/or smoothing concomitantly and protect and preserve the human skin stem cells in order to maintain and optionally increase the self-healing properties of the skin (paragraph 0006). Regarding claim 7, Fuchs teaches that macadamia nut oil can be added to provide emollient properties (paragraph 0043). A person of ordinary skill in the art ahead of the effective filing date of the claimed invention would be motivation to add macadamia nut (which reads on macadamia extract) to the composition because its emollient properties would contribute to the composition’s ability to moisturize and further reduce the appearance of wrinkles and/or provide a smoothing effect. Regarding claim 1, Fuchs does not mention aloe vera gel, carnosine, and crosslinked sodium hyaluronate polymer. Dreher discloses compositions for stimulating the formation of one or more extracellular matrix components that contain a lipoamino acid derivative of the tripeptide carnosine such as N-octanoyl carnosine (abstract). Also provided are compositions containing N-octanoyl carnosine in combination with selected tripeptide and/or tetrapeptides as well as pharmaceutical and/or cosmetic compositions containing such compositions (abstract). Dreher’s compositions can have aloe vera in any of its variety of forms (e.g., aloe vera gel) (column 38, line 52). Palmitoyl-GHK (i.e., palmitoyl tripeptide-1) and GEKG (SEQ ID NO:1) can be combined with octanoyl carnosine (column 7, line 8; claims 1, 8). Dreher’s Composition P: Gel (e.g., hydrogel) has 0.01% of the combination of octanolyl carnosine, palmitoyl-GHK and GEKG (column 69, line 12). It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to utilize the aloe vera gel and carnosine taught by Dreher in Fuch’s composition with expected results. Dreher presents aloe vera gel as a skin conditioner (column 38, line 48) which complements well with peptides since Fuchs teaches peptides have a skin conditioning effect (paragraph 0036). Similar to Fuchs, Dreher is focused on anti-wrinkle actives and anti-atrophy actives to include stem cells (column 37, line 45). Dreher’s clinical tests unexpectedly found that octanoyl carnosine, in combination with palmitoyl tri and tetra peptides, have great potential when it comes to cosmetics, dermatology, etc., where extracellular matrix components (including the but not limited to, collagen III) are altered (columns 23, lines 56; 76 line 55; 78, line 11). As such, a person of ordinary skill in the art would be motivated to use the aloe vera gel and carnosine of Dreher because doing so would provide compositions that enhance skin appearance and promote skin resiliency. As mentioned above Fuchs does not teach the cross-linked sodium hyaluronate polymer. Yao discloses a skin anti-bacterial skin repairing function composition comprising a peptide-1, oligopeptide-1, sodium hyaluronate, and aloe vera gel (abstract). Yao teaches that composition may be combined with a fiber fabric function through biological transdermal technology (abstract). Yao teaches that aloe vera gel has an anti-fungal and moisturizing effect on skin (page 4, paragraph 5). Yao teaches that sodium hyaluronate as it is moisturizing it can repair skin damage by promoting the proliferation and differentiation of epidermal cells, removing oxygen free radicals, delaying skin-aging, and can remove wrinkles (page 4, paragraph 4). Yao provides examples (pages 8-9, embodiments 1-3, Tables 1-3) and test results that show restoration of the skin stratum corneum (Fig. 1). Yao discloses that the sodium hyaluronate used in the compositions is divided into the macromolecule, middle molecule and small molecule, according to the different molecular weights for which the action is different (page 4, paragraph 4). Yao discloses macromolecule sodium hyaluronate, with crosslinking function, and the sodium hyaluronate of small molecule, provide anti-wrinkle and anti-aging effects to skin, and improve skin glossiness (page 4, paragraph 4). It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to incorporate the sodium hyaluronate with crosslinking function (i.e., cross-linked sodium hyaluronate polymer) taught by Yao in the composition of Fuchs in view of Dreher with expected results. One would be motivated to do so because Yao provides results that show a synergistic effect of the composition on the function of repairing skin and an anti-bacterial function (page 9, paragraph 1) that would positively contribute to the field of transdermal technology. Response to Arguments Applicants' arguments with respect to claims 1-7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Conclusion All claims under consideration remain rejected; no claims are allowed. 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 extension fee 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 Karen Ketcham whose telephone number is (571)270-5896. The examiner can normally be reached 900-500 ET. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Karen Ketcham/Examiner, Art Unit 1614 /ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
Read full office action

Prosecution Timeline

Apr 07, 2023
Application Filed
Oct 28, 2025
Non-Final Rejection mailed — §103
Mar 02, 2026
Response Filed
May 06, 2026
Final Rejection mailed — §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
20%
Grant Probability
56%
With Interview (+36.1%)
3y 4m (~2m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 46 resolved cases by this examiner. Grant probability derived from career allowance rate.

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