Prosecution Insights
Last updated: May 29, 2026
Application No. 18/751,708

SKIN TREATMENT METHODS AND COMPOSITIONS FOR TRANSDERMAL DELIVERY OF ACTIVE AGENTS

Non-Final OA §103
Filed
Jun 24, 2024
Priority
Jan 10, 2020 — provisional 62/959,874 +2 more
Examiner
CHANG, KYUNG SOOK
Art Unit
1613
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Topix Pharmaceuticals, Inc.
OA Round
2 (Non-Final)
60%
Grant Probability
Moderate
2-3
OA Rounds
9m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 60% of resolved cases
60%
Career Allowance Rate
476 granted / 789 resolved
At TC average
Strong +41% interview lift
Without
With
+41.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 8m
Avg Prosecution
44 currently pending
Career history
852
Total Applications
across all art units

Statute-Specific Performance

§101
0.1%
-39.9% vs TC avg
§103
59.0%
+19.0% vs TC avg
§102
1.4%
-38.6% vs TC avg
§112
1.2%
-38.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 789 resolved cases

Office Action

§103
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 . DETAILED ACTION Claims 20 and 24-36 are currently pending and amendments to the claims filed on 10/29/2025 is acknowledged. Information Disclosure Statement The information disclosure statement (IDS) submitted on 10/29/2025 was filed before the mailing date of the instant action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith. Withdrawn rejections: Applicant's amendments and arguments filed 10/29/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn. The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application. New Grounds of Rejection --- as necessitated by amendment 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 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 of this title, 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 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. As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Level of Ordinary Skill in the Art (MPEP 2141.03) The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The examiner must ascertain what would have been obvious to one of ordinary skill in the art at the time the invention was made, and not to the inventor, a judge, a layman, those skilled in remote arts, or to geniuses in the art at hand. Environmental Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 218 USPQ 865 (Fed. Cir. 1983), cert. denied, 464 U.S. 1043 (1984). The level of ordinary skill will often predetermine whether an implicit suggestion exists to modify the prior art. Persons of varying degrees of skill not only possess varying bases of knowledge, they also possess varying levels of imagination and ingenuity in the relevant field, particularly with respect to problem-solving abilities. If the level of skill is low, for example that of a mere technician, then it may be rational to assume that such an artisan would not think to combine references absent explicit direction in a prior art reference. If, however, the level of skill is that of a cosmetic research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from cosmetics, pharmacy, physiology and chemistry— without being told to do so. Indeed, MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). This is because “The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the time of the invention.” (MPEP 2141.03(1)) and an artisan must be presumed to know something about the art apart from what the references disclose. See In re Jacoby, 309 F.2d 513, 516 (CCPA 1962). “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418, 82 USPQ2d at 1396. (MPEP 2141.03 (I)). “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07). In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(11)). Claims 20, 24-26, 29, 31, 33 and 34 are rejected under 35 USC 103 as being obvious over Sun et al. (US2015/0272896A1, IDS of 06/24/2024, hereinafter ‘Sun’) in view of Shaffer et al. (US2018/0243196A1, IDS of 06/24/2024, hereinafter ‘Shaffer’). Applicant claims including the below claim 20 filed on 10/29/2025: PNG media_image1.png 278 811 media_image1.png Greyscale Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims; (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143) Sun teaches compositions and methods for enhancing the topical application of an acidic benefit agent (title) for skin care comprising an active agent for topical skin & hair care such as caffeine ([0036]) and tocopheryl acetate ([0153]); glycol such as isopentyldiol and ethoxydiglycol, and mixtures thereof ([0050]); anti-acne agent or anti-aging agent or depigmentation agent such as retinoid or retinol or vitamin A ([0116-0118]); polyol such as dimethyl isosorbide ([0054]); non-ionic surfactant such as polysorbate 20, polysorbate 80 and mixtures thereof; polyglyceryl-4-isostearate ([0081]), phenolic compounds ([0103]); antioxidants such as flavonoids, phenolic compounds, tri-terpenes, sterol, grape seed, green tea that is extracted from Camellia sinensis as supported by the instant publication at [0038], pine bark, propolis, etc. ([0065] and [0103]), and depigmentation agent such as licorice, green tea ([0118]), tocopheryl acetate ([0138]); the composition is applied to skin, hair, mucosa, epithelium or the like ([0019]), nail ([0111]) and scalp ([0115]); and the composition is free of water (claim 1 of prior art); and the topical composition containing the powder may be made into a wide variety of products that include but are not limited to leave-on products (such as lotions, creams, gels, sticks, sprays, and ointments), make-up product, and deodorant and antiperspirant compositions (e.g., [0113]-[0114] and [0140])(instant claim 20, in part). However, Sun does not expressly teach the claimed antioxidant system comprising xanthine and Camellia sinensis polyphenol of instant claim 1; and the method is performed under inert gas of instant claims 1, 20 and 24-25. The deficiency is cured by Shaffer. Shaffer teaches skin treatment formulation for topical administration containing retinoid; as an antioxidant, Camellia sinensis polyphenols and xanthine such as caffeine ([0021]-[0022]), and non-ionic solubilizing agent/emulsifier ([0013]) which reads on the claimed antioxidant system (instant claim 1: antioxidant system); the formulations may be prepared under ambient conditions, and are prepared under an inert atmosphere that is inert gas, such as nitrogen, argon or combinations thereof ([0065]); and the formulation is useful to treat various and diverse dermatological conditions including inflammatory disorders, conditions characterized by increased cell turnover such as psoriasis, photoaging, age spots, skin wrinkles, acne, and skin cancers, improvement in apparent skin age, skin tone, weather-beaten appearance, yellowing, loss of elasticity, redness, dryness, brightness, skin smoothness, radiance, as well as skin pores becoming less noticeable ([0003] and [0026]) (instant claims 1, 20 and 24-25: inert atmosphere). Although Sun discloses xanthine (e.g., caffeine) as an active agent ([0036]) and green tea ([0103]) as an antioxidant agent, it would have been obvious to modify the teachings of Sun with the antioxidant system containing camellia sinensis polyphenol and xanthine of Shaffer in order to enhance the antioxidant activities as taught by Shaffer. Further, it would have been obvious to modify the teachings of Sun with the method using inert gas condition of Shaffer in order to prevent unwanted reaction or oxidation and to protect the cosmetic active ingredients. Although Sun in view of Shaffer does not expressly teach first/second/third/fourth mixtures, Sun discloses retinol and solvent system and Shaffer discloses retinol and antioxidant system, and thus, it would be obvious to apply the divided amount of solvent and antioxidant ingredients at each mixing stage to produce a final formulation. Although Sun in view of Shaffer does not expressly teach the embodiments of antioxidant system containing xanthine and camellia sinensis polyphenol and activation solvent systems containing isopentyldiol, dimethyl isosorbide and a non-ionic surfactant as claimed, one of ordinary skill would be motivated to do this because a reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. Where, as here, the specific combination of features claimed is disclosed within the broad teachings of the reference but the reference of Sun does not disclose the specific combination of variables (for example, the treatment of dermatological condition with active agent and an activator solvent system comprising isopentyldiol, dimethyl isosorbide and a non-ionic surfactant), in a specific embodiment or in a working example, “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). However, "when 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 obvious to one of ordinary skill in the art before the effective filing date of the claimed invention of from the Sun reference, e.g., antioxidant, isopentyldiol, dimethyl isosorbide and non-ionic surfactant to prepare the claimed composition. Such a rearrangement by a person of ordinary skill in the art who is not an automaton to yield the claimed invention is within the purview of the ordinary skilled artisan upon reading the cited reference and would yield predictable results. Although Sun does not expressly teach the claimed method to mix two separate compositions, add third/fourth mixtures and then combine them, such mixing steps in a timely manner would be obvious because all the ingredients should be mixed prior to applying to skin. That is, the order is irrelevant or insignificant absent unexpected results. See MPEP 2144.03 IV: “See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).” (instant claims 26, 29, 31, 33 and 34). In light of the foregoing, instant claims 20, 24-26, 29, 31, 33 and 34 are obvious over Sun in view of Shaffer. Claims 27, 28, 30, 32 and 35 are rejected under 35 USC 103 as being obvious over Sun et al. (US2015/0272896A1, IDS of 2/22/2023, hereinafter Sun) in view of Shaffer et al. (US2018/0243196A1, IDS of 06/24/2024, hereinafter ‘Shaffer’) and further in view of Elliott et al. (US5037850A). However, Sun in view of Shaffer does not expressly teach mixing temperature of retinol of instant claims 27, 28, 30, 32 and 35. The deficiency is cured by Elliott. Elliott discloses retinol-containing composition for topical application comprising non-ionic emulsifier and antioxidant for skin thickening effects wherein retinol mixing temperature of less than 50°C, suitably 35°C (col. 2, lines 43-45, the Examples and claims of prior art) which overlaps the instant range of 37-70C. MPEP 2144.05 states that [I]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). It would have been obvious to modify the temperature of Sun in view of Schaffer with mixing temperature of retinol as taught by Elliot in order to make the ingredients miscible with retinol mixture. Further, although the applied art does not expressly teach mixing time and other mixing temperature, it would be optimized depending on the intended purpose, type of formulation, amounts and properties of ingredients, etc. in the absence of criticality evidence. In this regard, please see MPEP 2144.05 (II)(A): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. In light of the foregoing, instant claims 27, 28, 30, 32 and 35 are obvious over Sun in view of Shaffer and Elliot. Claim 36 is rejected under 35 USC 103 as being obvious over Sun et al. (US2015/0272896A1, IDS of 06/24/2024, hereinafter Sun) in view of Shaffer et al. (US2018/0243196A1, IDS of 06/24/2024, hereinafter ‘Shaffer’) and further in view of Chaudhuri (US2011/0117036A1, IDS of 06/24/2024). However, Sun in view of Shaffer does not expressly teach adding bakuchiol of instant claim 36. The deficiency is cured by Chaudhuri. Chaudhuri teaches skin conditioning composition comprising anti-ageing active such as bakuchiol ([0046]); antioxidant such as retinol, tocopherol, flavonoids, resveratrol, ascorbic acid, Emblica, curcumin ([0056]); surfactant such as polysorbate ([0087] and [0111]); green tea extract ([0023]), aquaporin-stimulating agent such as xanthine and caffeine ([0023]), anti-inflammatory agent such as polyphenol and bisabolol ([0084]), penetration enhancers such as dimethyl isosorbide ([0087]); and humectant such as sorbitol ([0083]) (instant claim 36). It would have been prima facie obvious to one of the skilled in the art before the effective filing date of the claimed invention to further add bakuchiol of Chaudhuri to the composition of Sun in order to enhance the properties, e.g., anti-aging properties of the composition. In light of the foregoing, instant claim 36 is obvious over the applied art in combination. This rejection is based on the well-established proposition of patent law that no invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients, In re Sussman, 1943 C.D. 518. From MPEP 2143 A: “…all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).” In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the 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. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary. Response to Arguments Applicant’s arguments have been fully considered, but are moot in view of new reference of Shaffer. Conclusion 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 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 KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5. 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, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. 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. /KYUNG S CHANG/Primary Examiner, Art Unit 1613
Read full office action

Prosecution Timeline

Jun 24, 2024
Application Filed
Jun 24, 2024
Response after Non-Final Action
Jul 30, 2025
Non-Final Rejection mailed — §103
Oct 29, 2025
Response Filed
Jan 05, 2026
Final Rejection mailed — §103
Mar 05, 2026
Response after Non-Final Action

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Prosecution Projections

2-3
Expected OA Rounds
60%
Grant Probability
99%
With Interview (+41.2%)
2y 8m (~9m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 789 resolved cases by this examiner. Grant probability derived from career allowance rate.

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