Prosecution Insights
Last updated: May 29, 2026
Application No. 18/299,716

COMPOSITION AND METHODS OF TREATMENT USING TRANSDERMAL SUPPLEMENTATION

Final Rejection §103
Filed
Apr 13, 2023
Examiner
LAZARO, DOMINIC
Art Unit
1611
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Xygenyx Inc.
OA Round
2 (Final)
63%
Grant Probability
Moderate
3-4
OA Rounds
1m
Est. Remaining
94%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allowance Rate
411 granted / 651 resolved
+3.1% vs TC avg
Strong +31% interview lift
Without
With
+31.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
27 currently pending
Career history
691
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
60.2%
+20.2% vs TC avg
§102
6.5%
-33.5% vs TC avg
§112
5.9%
-34.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 651 resolved cases

Office Action

§103
DETAILED ACTION Status of Claims The amendments, and arguments, filed May 13, 2026, are acknowledged and have been fully considered. Claims 1-12 are pending. Claims 1 and 2 have been amended; and claims 7-12 have been withdrawn. Claims 1-6 are currently under consideration. 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 Status of Office Action: Final Withdrawn Claim Rejections The rejection of claims 1-6 under 35 U.S.C. § 103 over HINES (US 2010/0303854 A1), in view of SEINO (CN 101657500 B) (at par. 4-18 of the 09/25/2025 Office action), is withdrawn in light of applicant’s 01/29/2026 amendments (in particular, the amendment to independent claim 1 reciting “a plant extract comprising an extract of at least one of licorice root or marshmallow root”). Applicant’s 01/29/2026 arguments are acknowledged, but are moot in light of the new rejections presented herein. New Claim Rejections – 35 U.S.C. § 103 necessitated by Amendments 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 pre-AIA 35 U.S.C. § 103(a) 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 C.F.R. § 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 1-6 are rejected under 35 U.S.C. § 103 as being unpatentable over HINES (US 2010/0303854 A1, Publ. Dec. 2, 2010; hereinafter, “Hines”; of record), in view of SEINO (CN 101657500 B, Publ. Jun. 13, 2012; as evidenced by English language translation of CN 101657500 B; hereinafter, “Seino”; of record) and KIM (US 5,872,254, Issued Feb. 16, 1999; hereinafter, “Kim”). Page and paragraph numbers for Seino refer to English language translation of CN 101657500 B. Hines is directed to: BOTANCAL ANTI-ACNE FORMULATIONS ABSTRACT Disclosed is a topical skin care composition and corresponding methods for their use comprising Arctium lappa (Burdock) root extract, Epilobium angustifolium (Canadian Willowherb) extract, or Cystoseira amentacea/Caespitosa Brachycarpa extract, or any combination thereof. Hines, title & abstract. In this regard, Hines exemplifies a lotion containing butyl avocadate and botanical extracts: Example 2 Non-Limiting Product Formulations [0102] Non-limiting skin product formulations of the present invention is described in Tables 3-9. The compositions can be made by any known methods in the art. For instance, simple mixing of the ingredients into a container can be used. Further, it is contemplated that additional ingredients can be added to the product formulations, listed ingredients can be replaced, and/or listed ingredients can be removed. The concentration ranges of the ingredients can be modified. […] PNG media_image1.png 200 400 media_image1.png Greyscale PNG media_image2.png 200 400 media_image2.png Greyscale […] Hines, par. [0102], Ex. 2, Table 4. Regarding independent claim 1 and the requirements: 1. ([…]) A composition for transdermal supplementation, comprising: an aqueous gel comprising therapeutically effective amounts of: a plant extract comprising an extract of at least one of licorice root or marshmallow root; a natural plant oil; and a plurality of glycerides. Hines clearly teaches a lotion containing butyl avocadate and botanical extracts (Hines, par. [0102], Ex. 2, Table 4), whereby it is noted that “Butyl Avocadate” relates to a “plant extract” of claims 1 and 3, as well as a “plant extract” furher comprising “butyl avocadate” of claim 3: 3. ([…]) The composition of claim 1, wherein the plant extract [further] comprises butyl avocadate. However, it is noted that: (i) although Hines teaches suitable moisturizing agents (Hines, par. [0072]-[0074]), inter alia: (a) “olive (olea europaea) oil” (Hines, par. [0074]), “apricot (prunus armeniaca) kernel oil” (Hines, par. [0074]) and “grape (vitis vinifera) seed oil” (Hines, par. [0074]), which are encompassed by a “natural plant oil” of claim 1, as well as claim 4: 4. ([…]) The composition of claim 1, wherein the natural plant oil comprises at least one of olive fruit oil, apricot kernel oil, grapeseed oil, or rapeseed oil. Hines DOES NOT EXPRESSLY TEACH an exemplary embodiment thereof, which also contains butyl avocodate; and (b) “caprylic/capric triglyceride” (Hines, par. [0074]) “hydrogenated coco-glycerides” (Hines, par. [0074]) “hydrogenated palm glyceride” (Hines, par. [0074]) and “hydrogenated tallow glyceride” (Hines, par. [0074]), which are encompassed by a “plurality of glycerides” of claim 1, Hines DOES NOT EXPRESSLY TEACH an exemplary embodiment thereof, which also contains butyl avocodate; (ii) although Hines teaches the incorporation of “additional ingredients” that are “known in the art” (Hines, par. [0014]), Hines DOES NOT TEACH “an extract of at least one of licorice root or marshmallow root” as required by claim 1; AND (iii) although Hines teaches suitable “Vehicles,” inter alia, “gels”: E. Vehicles [0064] The compositions of the present invention can be incorporated into all types of vehicles. Non-limiting examples of suitable vehicles include emulsions (e.g., water-in-oil, water-in-oil-in-water, oil-in-water, silicone-in-water, water-in-silicone, oil-in-water-in-oil, oil-in-water-in-silicone emulsions), creams, lotions, solutions (both aqueous and hydro-alcoholic), anhydrous bases (such as lipsticks and powders), gels, and ointments or by other method or any combination of the forgoing as would be known to one of ordinary skill in the art (Remington's, 1990). Variations and other appropriate vehicles will be apparent to the skilled artisan and are appropriate for use in the present invention. In certain aspects, it is important that the concentrations and combinations of the compounds, ingredients, and agents be selected in such a way that the combinations are chemically compatible and do not form complexes which precipitate from the finished product. (Hines, par. [0064]), Hines DOES NOT EXPRESSLY TEACH an “aqueous gel” as required by independent claim 1. Based on the state of the art, an artisan of ordinary skill would have found each of these features obvious. Regarding (i), it is noted that a reference is analyzed using its broadest teachings. MPEP § 2123 [R-5] states: “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to formulate Hines’ lotion containing butyl avocadate and botanical extracts (Hines, par. [0102], Ex. 2, Table 4) per Hines’ broader disclosure to contain the above-noted moisturizers at (i)(a) and (i)(b). Therefore, Hines renders (i) obvious. Regarding (ii) and (iii), Seino, for instance, is directed to: Aqueous Gel, Skin Preparation For External Use And Cosmetic Abstract The purpose of the invention is to provide an aqueous gel, skin external preparation and cosmetic, capable of stably maintaining the aqueous gel, and as a cosmetic ingredient even lower in the presence of the electrolyte lower can display good feeling of use, the skin external preparation and cosmetic can display excellent stability and can obtain good use feeling. The invention claims an aqueous gel, comprising the aqueous gel for skin and cosmetic, comprising the aqueous gel the aqueous gel contains amphoteric ionic amphiphilic polymer compound and the anionic polymer compound complex, said two amphoteric ionic amphiphilic polymer compound is represented by the general formula (1), the weight average molecular weight measured by gel permeation chromatography is 4000-2000000 compound, and the compound is acyl content is 0.1 %-50.0 %. in the formula, n represents an integer more than 10 and n R1 are each independently represents a hydrogen atom or a 8-18 acyl, n R2 each independently represents sodium or hydrogen atom. Seino, title & abstract. In this regard, Seino teaches an “aqueous gel” that “provide[s] an external preparation for skin, the skin can be realized which exhibits excellent stability and/or obtains the good feeling of use effect”: Invention contents [0008] The invention is based on the present invention, the object of the invention is to provide an aqueous gel, the aqueous gel can be realized which is capable of stably maintaining gel formulation and/or as cosmetic components lower in the presence of the electrolyte lower so that the feeling of use of the cosmetic has good effect. In addition, another object of the present invention is to provide an external preparation for skin, the skin can be realized which exhibits excellent stability and/or obtains the good feeling of use effect. Further, another object of the present invention is to provide a cosmetic, the cosmetic can be realized which exhibits excellent stability and/or obtains the good feeling of use effect. (Seino, par. [0008]), which relates to (iii), as noted above. Seino also teaches “licorice extract or licorice flavonoid” as suitable for an “external preparation for skin”: [0043] Furthermore, the external preparation for skin of the invention can also comprise for example with tyrosinase activity inhibition action of whitening effect ingredient, it has whitening function using melanin reducing effect generated by components, activate skin cell of inhibiting skin cell oxidation of anti-aging ingredients, components such as an active ingredient. [0044] with whitening function using tyrosinase activity inhibitory effect generated as the "component", is not particularly limited, can be listed out compound (e.g., polyphenol compound, yellow alkyl compounds, etc.), e.g., contained in the crude extract or plant extract, ellagic acid, arbutin, hydroquinone, higher unsaturated fatty acid kojic acid, linoleic, linolenic acid and the like. is not particularly limited as the crude extract can be listed out e.g., containing light licorice, 7 7 L y or licorice chalcone oil soluble licorice extract or licorice flavonoid. In addition, as the compound contained in the crude extract, in particular, is not particularly limited, can be listed out licorice chalcone, fixed light licorice, Y 7 7 L V, licorice flavonoids. as the plant extract can be listed out, with soybean extract comprising isoflavones-containing plant extract of ferulic acid, plants containing pycnogenol (pycnogenol), Sophora flavescens extract, emblic leaf flower fruit extract, Cortex Mori extract, saxifrage extract, rosemary extract, and rutin, hesperidin or quercetin plant extract of Radix Scutellariae extract. as the compound contained in the plant extract, in particular, is not particularly limited, can be listed out such as isoflavone, ferulic acid, pycnogenol, rutin, hesperidin, quercetin, derived from grape, gold chloris of plant polyphenol and so on. (Seino, par. [0043]-[0044]), which relates to an “extract” of “licorice root” in (ii) as noted above. See also Kim, which is directed to whitening cosmetics containing Ramulus mori extracts (Kim, title & asbtract), and lists extract of “licorice root” among “conventional whitening agent[s]” (Kim, col. 2, ln. 44-49). In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to formulate Hines’ lotion containing butyl avocadate and botanical extracts (Hines, par. [0102], Ex. 2, Table 4), rearranged as discussed above for (i), and to have further: (ii) incorporated “licorice root” per Seino and Kim (Seino, par. [0043]-[0044]; Kim, col. 2, ln. 44-49); and (iii) formulated as an “aqueous gel” per Seino (Seino, abstract). One would have been motivated to do so with a reasonable expectation of success since both Hines and Seino are concerned with similar problems in the art, namely the formulation of compositions for the skin. Hines, abstract; Seino, abstract. Further, it is well within the skill of the ordinary artisan to select a suitable compositional “Vehicle” such as a gel (Hines, par. [0064]) and well as “additional ingredients” that are “known in the art” (Hines, par. [0014]). Doing so amounts to no more than combining prior art elements according to known methods to yield predictable results, namely formulating Hines’ lotion as an “aqueous gel” (Seino, title & abstract) in order to obtain the advantages of: (ii) “licorice extract or licorice flavonoid” (Seino, par. [0043]-[0044]), e.g., extract of “licorice root” as a “conventional whitening agent” (Kim, col. 2, ln. 44-49); and (iii) a compositional form that “provide[s] an external preparation for skin, the skin can be realized which exhibits excellent stability and/or obtains the good feeling of use effect” (Seino, par. [0008]). Therefore, the prior art renders (ii) and (iii) obvious. With regard to claim 1 and the requirement for “therapeutically effective amounts” of the claimed components, Hines teaches: a lotion containing 0.5 wt.% butyl avocadate and 0.1 wt.% botanical extracts (Hines, par. [0102], Ex. 2, Table 4); and moisturizing agents (Hines, par. [0072]-[0074], which include the claimed components noted at (i), above) among “G. Additional Ingredients” (Hines, par. [0067]-[0097]) for which: more than one moisturizer may be incorporated because “the compositions can include any number of combinations of additional ingredients described throughout this specification” (Hines, par. [0067]); and “[t]he concentrations of the any ingredient within the compositions can vary” from “at least about 0.0001%, […], or 99% or any range derivable therein, of at least one of the ingredients that are mentioned throughout the specification and claims” (Hines, par. [0067]). Therefore, Hines appears to reasonably teach the requirement for “therapeutically effective amounts” of the claimed components, absent evidence to the contrary. Thus, the prior art renders claims 1 and 3-4 obvious. Regarding claim 2 and the requirements: 2. ([…]) The composition of claim 1, wherein the plant extract comprises an extract of rice bran. Hines teaches suitable moisturizing agents (Hines, par. [0072]-[0074]), inter alia, “rice (oryza sativa) bran oil” (Hines, par. [0074]), which is an “extract” of “rice bran” of claim 2. See MPEP § 2123 [R-5] regarding the obviousness of rearranging a reference according to the teachings of that same reference. Thus, the prior art renders claim 2 obvious. Regarding claims 5-6 and the requirements: 5. ([…]) The composition of claim 1, wherein the plurality of glycerides comprise esters of at least one of oleic acid, linoleic acid, or stearic acid. 6. ([…]) The composition of claim 5, wherein at least one of the plurality of glycerides is polyglyceryl-3 diisostearate. Hines teaches suitable moisturizing agents (Hines, par. [0072]-[0074]), inter alia, “polyglyceryl-3 diisostearate” (Hines, par. [0074]), which is an “polyglyceryl-3 diisostearate” of claim 6, and an ester of stearic acid of claim 5. See MPEP § 2123 [R-5] regarding the obviousness of rearranging a reference according to the teachings of that same reference. Thus, the prior art renders claim 6 obvious. Summary/Conclusion Claims 1-6 are 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 date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /DOMINIC LAZARO/Primary Examiner, Art Unit 1611
Read full office action

Prosecution Timeline

Apr 13, 2023
Application Filed
Jul 25, 2025
Response after Non-Final Action
Sep 29, 2025
Non-Final Rejection mailed — §103
Jan 29, 2026
Response Filed
May 20, 2026
Final Rejection mailed — §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
63%
Grant Probability
94%
With Interview (+31.3%)
3y 2m (~1m remaining)
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Moderate
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