Prosecution Insights
Last updated: April 19, 2026
Application No. 18/305,935

PRODUCING A TOPICAL SOLUTION COMPOSITION

Non-Final OA §103§112§DP
Filed
Apr 24, 2023
Examiner
HOFFMAN, SUSAN COE
Art Unit
1655
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Shantel Medical Supply Corp.
OA Round
3 (Non-Final)
54%
Grant Probability
Moderate
3-4
OA Rounds
3y 0m
To Grant
80%
With Interview

Examiner Intelligence

Grants 54% of resolved cases
54%
Career Allow Rate
572 granted / 1058 resolved
-5.9% vs TC avg
Strong +26% interview lift
Without
With
+25.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
67 currently pending
Career history
1125
Total Applications
across all art units

Statute-Specific Performance

§101
9.5%
-30.5% vs TC avg
§103
34.8%
-5.2% vs TC avg
§102
17.4%
-22.6% vs TC avg
§112
26.9%
-13.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1058 resolved cases

Office Action

§103 §112 §DP
DETAILED ACTION 1. The present application is being examined under the pre-AIA first to invent provisions. 2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 28, 2025 has been entered. 3. Claims 38-40, 42-43, 45-48, 50-55, and 62-73 are currently pending. Claim Objections 4. Claim 63 is objected to because of the following informalities: in line 3, “of the of the” should be “of the”. Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 5. Claims 63 and 64 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 63 has been amended to state that the composition comprises “a red wine extract comprising resveratrol present in an amount ranging from 15 to 35 weight percent…”. However, the new limitation that the resveratrol is present in an amount from 15 to 35% introduces new matter into the claims. The specification and claims as originally filed do not discuss the specific concentration of resveratrol in the red wine extract or in the overall composition. Thus, this new limitation lacks literal antecedent basis. The new limitation is also considered to lack inherent antecedent basis because while the specification states that resveratrol is present in the red wine extract, the specification does not discuss the concentration of resveratrol. The specification only states that the concentration of resveratrol is at “high levels” (see paragraph 26). This generic disclosure is not considered to provide support for the specific limitation of 15 to 35% resveratrol. Thus, the new limitation introduces new matter into the disclosure. The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 6. Claim 55 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 55 states “comprises Isoprene Glycol, Xanthan Gum, and Carbomer, or combinations thereof…(emphasis added).” The composition cannot require all three but then state combinations are also allowed. This makes it unclear which ingredients are required or optional. Correction is needed. Claim Rejections - 35 USC § 103 The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. 7. Claims 38, 39, 42-43, 46, 48, 49, 50-55, 63, and 65-73 are rejected under 35 U.S.C. 103(a) as being unpatentable over Liu (US 2006/0078530) in view of Ansmann (US 6,280,712). Liu teaches a topical solution for revitalizing and rejuvenating damaged skin comprising mixing a resveratrol-containing grape/wine extract with a cosmetic system comprising beneficial skin improving ingredients. For example, at [0010], Liu teaches, “In the present invention the resveratrols are extracted from the Grape Botanicals through the well-known process of producing Red (magenta) Wine. Grapes Botanicals are harvested and selected for manufacturing and distillation into wine. The grapes are then squeezed to extract all nutrients and juices. The juices and skins, known in the art as Must, are then stored for fermentation, which may take several weeks. The Must is sanitized in an extraction process that dilutes the water and alcohol from the juices. The remaining portion from the sanitation process, which is mostly sediment, is then mixed with Isoprene Glycol and non-ionic water is re-inserted. Water and any remaining alcohol are again diluted from the solution, and the remaining portion is allowed to sit until dry. Once dry the mixture is granulated several times into a fine powder called resveratrol amalgam. The resveratrol amalgam is further combined with various vitamins and minerals known in the art of cosmetology to protect skin.” Please note that this passage specifically states that alcohol is removed from the red wine extract; thus, the extract would contain less than 2 percent alcohol as required by the claims. In addition, at [0012], Liu teaches that the powdered grape extract can be combined with an ultraviolet inhibitor as described in U.S. Patent 6,280,712 (Ansmann), if a topical lotion that contains a sunscreen is desired. Herein, Liu teaches, “U.S. Patent 6,280,712 describes the process for enhancing the effectiveness of sunscreen lotion containing at least one ultraviolet filter involving solubilizing/dispersing the ultraviolet filter in a dialkyl/alkenyl carbonate.” Liu does not specifically teach that the topical composition contains an emulsifier, a carbomer base, or maintaining the pH between 2.5 to 5.5. However, Liu does suggest that the red wine extract (powder) can be combined with an ultraviolet inhibitor to provide a topical sunscreen solution, as described in the patent of Ansmann (see paragraph [0012]). Thus, it would have been obvious to one of ordinary skill in the art and the ordinary artisan would have been motivated to modify Liu’s composition using the ingredients Ansmann. Ansmann specifically teaches a topical composition in the form of a creams comprising emulsifiers, water, carbomer, and vitamins. For example, in Table 3, Ansmann teaches Composition 8 a water-in-oil sun protection cream comprising Polyglyceryl-2-Dipolyhydroxystearate (synthetic ester of Polyglyceryl-2 and Stearic acid, read herein as an emulsifier); Polyglyceryl-3-Diisostearate (read herein as an emollient or emulsifier); Beeswax; Cocoglycerides (read herein as emollient/emulsifier); Panthenol (alcohol analog of Vitamin B5); Tocopherol/Tocopherol Acetate (Vitamin E); ultraviolet filters; Glycerin (emulsifier); and Water, and Composition 13 an oil-in-water sun protection cream comprising Cetearylglucoside and Cetearyl Alcohol (read herein as emulsifier/emollient); Polyglyceryl-2 Dihydroxystearate (emulsifier) and Lauryl Glucoside (emulsifier) and Glycerin (emulsifier); Cetearyl Alcohol (emulsifier/emulsion stabilizer); PVP/Hexadecene Copolymer; Cocoglycerides (emulsifier) ; Dicaprylyl Carbonate; Oleyl Erucate; Dicaprylyl Ether; Mineral Oil; Panthenol (alcohol analog of Vitamin B5); Bisabolol; Tocopherol/Tocopherol Acetate (Vitamin E); Ultraviolet Filters; Xanthan gum; Carbomer; Preservatives and Water. Also see Examples 14, 16 and 19. In Column 3, lines 15-60, Ansmann teaches using vitamin C, tocopherol and stilbene (read herein as a resveratrol) as secondary sun protection factors of the antioxidant type in the making of the disclosed compositions. In addition, the reference teaches that the composition can contain butylene glycol (see column 6, line 57). The reference does not specifically teach that the composition is in the form of a gel; however, gelled topical composition are well known in the art to be appropriate formulations for topical compositions. Thus, an artisan of ordinary skill would reasonably expect that gelled formulations would also be useful when formulating the composition taught by the combination of the references. Moreover, it would have been obvious to one of ordinary skill in the art at the time the invention was made to add the claim-designated ingredients because it is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art. In re Pinten, 459 F. 2d 1053, 173 USPQ 801 (CCPA 1972); In re Susi, 58 CCPA 1074, 1079-80; 440 F.2d 442, 445; 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21; 279 F.2d 274, 276-277; 126 USPQ 186, 188 (1960). Ansmann specifically teaches including vitamins E and B5 in amounts defined by applicant as sufficient to raise the pH of the red wine extract to between 2.5 and 5.5. Ansmann is considered to teach adding panthenol (vitamin B5) and vitamin E (tocopherol) to the red wine extract of Liu. Formulations 13 and 14 of Ansmann specifically teaches a concentration of 1% panthenol and 3% vitamin E in combination with 0.5 or 0.2% of carbomer in an aqueous base. These concentrations of panthenol and vitamin E are defined by applicant's specification as concentrations of panthenol and vitamin E that would be sufficient to raise the pH of the topical solution to between 2.5 and 8.0 (see paragraph 35). Thus, the topical composition suggested by the combination of Liu and Ansmann would intrinsically have to a pH value within the range claimed by applicant if applicant’s invention functions as claimed. In addition, an artisan of ordinary skill would reasonably expect that the pH of a topical composition would be result effective variable that would be routinely optimized during the formulation of the topical composition taught by the combined references. An artisan of ordinary skill would also reasonably expect that compositions with a pH around that normally found on the surface of the skin would be less likely to cause irritation to the skin of the user during topical application. Applicant’s specification defines the pH of the skin at about 5.5 (see paragraph 49). An artisan would also expect that pH value should be optimized to provide storage stability to the composition. As the references indicate that the various proportions and amounts of the ingredients used in the claimed composition, as well as the experimental parameters for the manufacturing thereof, are result effect variables, they would have been routinely optimized by one of ordinary skill in the art in practicing the invention disclosed by the references. Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary. In regards to claims 69-72, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. 8. Claims 40, 45, 47, and 62 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Liu (US 2006/0078530) in view of Ansmann et al. (US 6,280,712) as applied to claims 38, 39, 42-43, 46, 48, 49, 50-55, 63, and 65-73 above, and further in view of MacNeil (The Wine Bible. Workman Publishing: New York, 2001, Print. Excerpt, pages 30-35) and “Portfolio Winery” website (https://web.archive.org/web/20060324003616/http://www.portfoliowinery.com/winery.html - internet archived version from March 2006). The teachings of Liu and Ansmann are discussed above. While Liu teaches using well-known processes to create the red wine (see paragraph 10), the reference does not specifically teach that the red wine fermentation is performed for seven to 45 days, at a temperature between 35 degrees F and 95 degrees F, and at a humidity between 30 percent and 80 percent as claimed by applicant. However, MacNeil teaches that red wine is produced by fermentation with yeast at a temperature between 60 degrees F and 85 degrees F for several days to a few weeks (see page 33). In addition, the Portfolio winery website teaches that humidity of 70% is useful for wine making. Thus, the parameters claimed by applicant were known in the art at the time of the invention to be useful during the fermentation of red wine. Therefore, an artisan of ordinary skill would have been motivated to utilize these known parameters when producing the red wine in the composition of Liu. The references do not teach that the fermentation will produce cis- and trans-resveratrol. However, according paragraph 29 of applicant’s specification, fermenting under the conditions claimed by applicant, will control the conversion of cis- and trans-piceid into cis- and trans-resveratrol. Thus, the fermentation product suggested by the references would intrinsically have this characteristic. 9. Claim 64 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Liu (US 2006/0078530) in view of Ansmann (US 6,280,712) as applied to claims 38, 39, 42-43, 46, 48, 49, 50-55, 63, and 65-73 above, and further in view of Mathur (US 4,096,240). The teachings of Liu and Ansmann are discussed above. The references are considered to teach combining red wine extract containing resveratrol, water, vitamins, panthenol, and carbomer together to form a sunscreen composition. The references do not specifically teach adding niacinamide to the composition. However, Mathur teaches that niacinamide is useful to combine with sunscreen ingredients (see abstract). These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in compositions that form sunscreens. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art. Based on the disclosure by these references that these substances are used in compositions to form sunscreens, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions to form a sunscreen. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992). The references do not specifically teach adding the ingredients together in the amounts claimed by applicant. However, as discussed in MPEP section 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. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The references teach the use of each of the ingredients in a topical composition. Varying the concentration of ingredients within a topical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before applicant’s claimed invention. Response to Arguments Applicant's arguments filed August 28, 2025 have been fully considered but they are not persuasive. Applicant argues that none of the cited reference teach a red wine extract with the claimed alcohol concentration. However, as discussed above, Liu specifically teaches that alcohol is removed from the red wine extract and that the extract contains resveratrol (see paragraph 10). Thus, Liu is considered to teach the same red wine extract claimed. Applicant also argues that the specification teaches that the pH of the composition is critical for the beneficial result in the reduction of lesions. However, as discussed above, the references teach using vitamins in concentrations which are defined by applicant as being sufficient to control the pH to within the ranges claimed. In addition, MPEP section 716.02(d), states “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960)…”. Applicant’s has not provided any test data which shows results both inside and outside the claimed ranges. Thus, applicant’s argument is not persuasive. Double Patenting 10. Claims 38-40, 42-43, 45-48, 50-55, and 62-73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,654,099 for the reasons set forth in the previous Office action. Applicant argues that the “present amendments to the claims render these rejections moot.” However, this is not persuasive because both sets of claims are drawn to topical compositions comprising red wine extracts with the same ingredients and pH values as claimed. The claims of US ‘099 are of narrower scope than current claims; thus, the claims of US ‘099 anticipate the current claims. In addition, the claims of US ‘099 include the same additional ingredients as claimed by applicant. 11. Claims 38-40, 42-43, 45-48, 50-55, and 62-73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,888,515 for the reasons set forth in the previous Office action. Applicant argues that the “present amendments to the claims render these rejections moot.” However, this is not persuasive because the claims of US ‘515 are directed to making an emulsified topical composition red wine extract and the same additional ingredients as claimed with the same pH values as claimed. Thus, the claims of US ‘515 anticipate the current claims because the claims of US ‘515 result in a composition which is the same as the claimed composition. 12. Claims 38-40, 42-43, 45-48, 50-55, and 62-73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9,770,480 for the reasons set forth in the previous Office action. Applicant argues that the “present amendments to the claims render these rejections moot.” However, this is not persuasive because the claims of US ‘480 are directed to making an emulsified topical composition red wine extract and the same additional ingredients as claimed with the same pH values as claimed. Thus, the claims of US ‘480 anticipate the current claims because the claims of US ‘480 result in a composition which is the same as the claimed composition. 13. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm. 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, Anand Desai can be reached at 571-272-0947. 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. /SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
Read full office action

Prosecution Timeline

Apr 24, 2023
Application Filed
Oct 31, 2023
Response after Non-Final Action
Mar 19, 2024
Non-Final Rejection — §103, §112, §DP
Sep 23, 2024
Response Filed
Sep 23, 2024
Response after Non-Final Action
Feb 11, 2025
Response Filed
May 29, 2025
Final Rejection — §103, §112, §DP
Aug 01, 2025
Response after Non-Final Action
Aug 28, 2025
Request for Continued Examination
Sep 05, 2025
Response after Non-Final Action
Mar 23, 2026
Non-Final Rejection — §103, §112, §DP (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
54%
Grant Probability
80%
With Interview (+25.7%)
3y 0m
Median Time to Grant
High
PTA Risk
Based on 1058 resolved cases by this examiner. Grant probability derived from career allow rate.

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