DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed December 10, 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103 (Maintained)
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.
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 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.
Claims 1, 5, 10, 31, 35-36, 49, 52-53 are rejected under 35 U.S.C. 103 as being as being obvious over Wang (CN 110226975 A) in view of Zech (US 2005/0163741 A1).
Regarding claim 1, Wang discloses a composition (Example A, English translation, pg. 3, paragraph 6) to be used for long-acting skin marking (abstract) comprising, a semi-permanent colorant (genipin), solvent (water), and a film-forming agent (polyvinyl pyrrolidone).
Wang does not disclose the composition includes acrylates copolymer and styrene/acrylates copolymer.
Zech teaches an aqueous-based preparation for application to the skin to be used as a temporary tattoo with an acrylate-based polymer (Abstract) [0012]. Zech discloses the acrylic-based polymer comprises a mixture of acrylates copolymer and styrene/acrylic copolymer (Claim 32). Zech teaches that the acrylic-based polymer provides adhesion of the composition, gloss, and resistance to being rubbed off [0025].
Since Wang generally teaches a composition to be used for long-acting skin marking, it would have been prima facie obvious to one of ordinary skill in the art to include a mixture of acrylates copolymer and styrene/acrylic copolymer, within the teachings of Wang, because Zech teaches these acrylic-based polymers are appropriate to be used in temporary tattoos. An ordinarily skilled artisan would be motived to include acrylic-based polymers, such as a mixture of acrylates copolymer and styrene/acrylic copolymer, because Zech teaches that the acrylic-based polymer provides adhesion of the composition, gloss, and resistance to being rubbed off [0025].
Claim 5 is rendered prima facie obvious because Wang discloses the semi-permanent colorant is genipin (Example A, English translation, pg. 3, paragraph 6).
Claim 10 is rendered prima facie obvious because Wang discloses the solvent comprises a combination of water and ethanol (Example A, English translation, pg. 3, paragraph 6).
Claims 31 and 35-36 are rendered prima facie obvious because Wang discloses the composition comprises the humectant, propylene glycol (Example A, English translation, pg. 3, paragraph 6) (synonym for 1,2- propanediol).
Claim 49 is rendered prima facie obvious because Wang discloses the composition comprises genipin (Example A, English translation, pg. 3, paragraph 6) and genipin is derived from an iridoid glycoside (instant specification [0060]).
Claim 52 is rendered prima facie obvious because Wang discloses the solvent comprises a combination of water and ethanol (Example A, English translation, pg. 3, paragraph 6).
Regarding claim 53, Wang discloses that the long-acting skin marking composition is very suitable for skin coloration with a coloring time of as long as 2-3 weeks and does not easily fade (English translation, pg. 4, paragraph 4). While the composition penetrating one or more layers of the skin or remaining adhered to the skin in an absence of a physical disruption or natural desquamation of the skin is not explicitly disclosed, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because combined teachings of the prior art teach a long-acting skin marking composition with the same components (genipin, water, and the claimed film-forming agents), the properties the applicant discloses and/or claims (penetrating layers of skin and remaining adhered to the skin in an absence of a physical disruption or natural desquamation of the skin) are necessarily present.
Further regarding claim 53, the limitations of “configured to penetrate one or more layers of the skin” and “configured to remain adhered to the skin in an absence of physical disruption or natural desquamation of the skin” are interpreted as product-by-process limitations. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, then the claim is unpatentable even though the prior product was made by a different process. In the instant case, the teachings of Wang of a long-acting skin marking composition containing genipin, solvent, and a film-forming agent (PVP), in view of Zech (teaching acrylates copolymer and styrene/acrylic copolymers) reads on the claimed composition. As such, the patentability of the instant formulation does not depend on its method of production, and the Applicant's limitation regarding the process of configuration to penetrate one or more layers or skin and configuration to remain adhered to the skin is not patentable, in view of Wang and Zech.
Response to Applicant’s Arguments
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive.
Applicants argues at pg. 9 that Wang fails to disclose a film-forming agent being a combination of acrylates copolymer, polyvinylpyrrolidone, and a styrene/acrylates copolymer and Zech fails to cure or otherwise remedy the deficiencies of Wang because a person of ordinary skill in the art, searching to improve the color intensity of a composition comprising a semi-permanent colorant, would not have combined Wang with Zech. Applicants also argue at pg. 10 that there is no motivation for the skilled person to combine PVP (Wang) with only the acrylate polymer of Zech as Zech teaches a combination of polyurethane polymer and acrylate polymer.
The Examiner disagrees. Zech is from the same field of endeavor as Wang because both Wang and Zech teach compositions for application to the skin to be used for skin marking. An ordinarily skilled artisan would be motived to include acrylic-based polymers, such as a mixture of acrylates copolymer and styrene/acrylic copolymers, within the composition of Wang, in addition to the taught PVP, because Zech teaches that the acrylic-based polymer provides adhesion of the composition, gloss, and resistance to being rubbed off [0025]. Furthermore, there is nothing in the instant claims restricting the use of additional polymers within the composition.
Response to Unexpected Results Arguments
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive.
Applicant argues that claim 1, as amended, is commensurate in scope with the showing of unexpected results established by Applicant’s previously submitted response (2/20/2025) and the Exhibit accompanying that response. Accordingly, applicant argues, amended claim 1 is non-obvious in view of the cited art.
The Examiner disagrees. While, as previously noted, the composition according to the application (PVP + acrylates copolymer + styrene/acrylates copolymer) resulting in higher color intensity compared to the comparative composition (PVP) appears to be unexpected over the prior art (if adequately explained), the applicant still has not adequately explained the data presented as being evidence of non-obvious and the claims are still not commensurate in scope with the showing.
As previously noted, in the Declaration, at pg. 4, Table 1, applicant describes “acrylates copolymers” and “styrene/acrylates copolymer” but only gives the trade names as the identifying information. As the composition of tradename polymers is not always publicly available, and even if they are confusion can still arise, the declaration refers to variables that are not adequately described such that the examiner can assess the probative of same. (Applicant might consider describing the specific acrylate copolymers more generically, e.g., by molecular weight and by specifying the comonomers used and their relative amounts).
Furthermore, the Applicant has demonstrated improved skin transferability and color intensity, but this is only shown with the specific combination and amounts of particular acrylates (PVP + acrylates copolymer + styrene/acrylates copolymer – which, as mentioned above, are not adequately defined) and one specific, semi-permanent colorant (genipin). It is unclear that a comparative composition containing these specific components and in these specific percentages would be reasonably representative of compositions containing other classes of polymers (e.g., different molecular weights), other semi-permanent colorants (e.g., different than genipin), etc. and in differing amounts, falling within the broader scope currently claimed.
It is the Examiner’s recommendation that the specific acrylate copolymers be adequately described (e.g., by molecular weight and by specifying the comonomers used), that the specific colorant be defined (genipin), and the specific amounts of the components be defined for claim 1 to be commensurate in scope with the showing.
Claims 2 and 6 are rejected under 35 U.S.C. 103 as being as being obvious over Wang (CN 110226975 A) and Zech (US 2005/0163741 A1) and further in view of Hu (CN 111012686 A).
The 35 U.S.C. 103 rejection over Wang in view of Zech was previously discussed.
Wang further discloses the compositions comprise 1-6% of genipin (abstract).
Wang does not disclose the amount of genipin in terms of w/w of the composition, as recited in claim 2.
Hu discloses a tattoo composition comprising 1-10 wt.% genipin (abstract; English translation, pg. 7, bottom paragraph). Hu teaches that the tattoo composition with this amount of genipin has bright color, is color stable and durable, non-irritating, and cost effective (English translation, pg. 4, (5)).
Since Wang generally teaches a composition to be used for long-acting skin marking with genipin, it would have been prima facie obvious to one of ordinary skill in the art to include 1-10 wt.% genipin, within the teachings of Wang, because Hu teaches this amount of genipin in a tattoo composition. An ordinarily skilled artisan would be motived to include this amount of genipin because Hu teaches that the tattoo cream with this amount of genipin has bright color, is color stable and durable, non-irritating, and cost effective (English translation, pg. 4, (5)).
The instant claim 2 recites, the semi-permanent colorant is present in an amount of about 5% to about 15% w/w of the composition.
Hu taught 1-10% w/w genipin.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 A.
Furthermore, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of genipin (1-6%) are taught by Wang (abstract) and the amount overlapping with that claimed is known in the art (Hu, 1-10 wt.%); as such, it would not have been inventive for the skilled artisan to have discovered the optimum amount of genipin via routine experimentation.
Wang further discloses the composition comprises 60-70% water (Example A, English translation, pg. 3, paragraph 6).
Wang does not disclose the amount of water in terms of w/w of the composition, as recited in claim 6.
Hu discloses a tattoo composition comprising 72-97.2 wt.% water (abstract; English translation, pg. 7, bottom paragraph) to dissolve the components of the tattooing composition uniformly (English translation, pg. 7, paragraph 6; pg. 3, paragraphs 5-9).
Since Wang generally teaches a composition to be used for long-acting skin marking with water, it would have been prima facie obvious to one of ordinary skill in the art to include 72-97.2 wt.% water, within the teachings of Wang, because Hu teaches this amount of water in a tattoo composition. An ordinarily skilled artisan would be motived to include this amount of water because Hu teaches this amount to dissolve the components of the tattooing composition uniformly (English translation, pg. 7, paragraph 6; pg. 3, paragraphs 5-9). A prima facie case of obviousness exists because of overlap, as previously discussed.
Furthermore, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of water (60-70%) are taught by Wang (Example A, English translation, pg. 3, paragraph 6) and the amount overlapping with that claimed is known in the art (Hu, 72-97.2 wt.%; abstract; English translation, pg. 7, bottom paragraph); as such, it would not have been inventive for the skilled artisan to have discovered the optimum amount of water via routine experimentation.
Claims 11, 16, 22, 37, and 46 are rejected under 35 U.S.C. 103 as being as being obvious over Wang (CN 110226975 A) and Zech (US 2005/0163741 A1) and further in view of Bae (EP 3 159 043 A1).
The 35 U.S.C. 103 rejection over Wang in view of Zech was previously discussed.
The combined teachings of the prior art do not disclose water is present in an amount of about 25 to about 35 wt.% as recited in claim 11.
Bae discloses a coloring composition for the skin (abstract) with water in an amount of 15 to 30 wt.% [0027]. Bae teaches when the water content is less than 15 wt.%, there is poor solubility of the different functional components and hence deterioration in the skin feeling after use and when the water content is greater than 30 wt.%, the content of the different functional components is too low in relation to water, so it cannot give a satisfactory effect such as good tinting power with an appropriate amount of the composition applied to the skin [0027].
Since Wang generally teaches a composition to be used for skin marking with water, it would have been prima facie obvious to one of ordinary skill in the art to include 15 to 30 wt.% water, within the teachings of Wang, because Bae teaches this amount of water in a coloring composition for the skin. An ordinarily skilled artisan would be motived to include this amount of water because Bae teaches when the water content is less than 15 wt.% there is poor solubility of the different functional components and hence deterioration in the skin feeling after use and when the water content is greater than 30 wt.%, the content of the different functional components is too low in relation to water, so it cannot give a satisfactory effect such as good tinting power with an appropriate amount of the composition applied to the skin [0027].
Furthermore, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of water are taught by Wang (Example A, English translation, pg. 3, paragraph 6) and the amount overlapping with that claimed is known in the art (Bae 15-30 wt.%); as such, it would not have been inventive for the skilled artisan to have discovered the optimum amount of water via routine experimentation.
Regarding claims 16 and 22, Wang does not disclose the film forming agent (which comprises PVP, acrylates copolymer, and styrene/acrylates copolymer- instant claim 1) is present in an amount of about 5% to about 10% w/w of the composition (claim 16) or about 0.1% to about 10% w/w of the composition (claim 22).
Bae teaches polyvinyl pyrrolidone as a film-forming agent in the coloring composition for the skin in an amount of 2-15 wt.% [0032] [0036]. Bae teaches that when the amount of polyvinyl pyrrolidone (PVP) is less than 2 wt.% the composition dries out and does not remain stable for a long time upon exposure to water or sweat and when the content of PVP is greater than 15 wt.% the composition has too high viscosity to be easily applied, the tinting powder is deteriorated, and the composition decomposes after long term storage [0036].
Since Wang generally teaches a composition to be used for skin marking with PVP, it would have been prima facie obvious to one of ordinary skill in the art to include 2-15 wt.% PVP, within the teachings of Wang, because Bae teaches this amount of PVP in a coloring composition for the skin. An ordinarily skilled artisan would be motived to include this amount of PVP because Bae teaches that when the amount of PVP is less than 2 wt.% the composition dries out and does not remain stable for a long time upon exposure to water or sweat and when the content of PVP is greater than 15 wt.% the composition has too high viscosity to be easily applied, the tinting powder is deteriorated, and the composition decomposes after long term storage [0036].
It would have been prima facie obvious to include an acrylates copolymer, such as a mixture of acrylates copolymer and styrene/acrylic copolymer, within the composition of Wang, as taught by Zech, as previously discussed. Zech discloses the acrylates copolymer is present in an amount of 1-60 wt.% of the composition [0030]. Zech teaches the desired resistance to being rubbed off is not achieved below a proportion of 1 wt.% and when a proportion of more than 60 wt.% is involved there is a reduction in its water resistance, which leads to poor properties of use [0030].
Since Wang generally teaches a composition to be used for long-acting skin marking, it would have been prima facie obvious to one of ordinary skill in the art to include acrylates in the amount taught by Zech, within the teachings of Wang, because Zech teaches the desired resistance to being rubbed off is not achieved below a proportion of 1% and when a proportion of more than 60% is involved there is a reduction in its water resistance, which leads to poor properties of use [0030].
Following the teachings of Wang, Zech, and Bae the ordinarily skilled artisan would arrive at the claimed amount of film-forming agent (which as recited in instant claim 1 comprises PVP, acrylates copolymer, and styrene/acrylates copolymer) as Zech teaches 1-60 wt.% of acrylates copolymer and Bae teaches 2-15 wt.% PVP. A prima facie case of obviousness exists because of overlap, as previously discussed.
Regarding claims 37 and 46, Wang does not disclose the composition comprises the preservative, EDTA.
Bae discloses a coloring composition for the skin (abstract) with EDTA and teaches that the EDTA deactivates trace metal ions in the composition through bonding with them helping to stabilize the composition [0041].
Since Wang generally teaches a composition to be used for skin marking, it would have been prima facie obvious to one of ordinary skill in the art to include EDTA, within the teachings of Wang, because Bae teaches EDTA in a coloring composition for the skin. An ordinarily skilled artisan would be motived to include EDTA because Bae teaches that the EDTA deactivates trace metal ions in the composition through bonding with them helping to stabilize the composition [0041].
Claims 37 and 42-44 are rejected under 35 U.S.C. 103 as being as being obvious over Wang (CN 110226975 A) and Zech (US 2005/0163741 A1) and further in view of Roberts (AU 2019/264607 A1).
The 35 U.S.C. 103 rejection over Wang in view of Zech was previously discussed. Wang discloses that the composition is to be applied to human skin (abstract).
Wang does not disclose that the composition further comprises a preservative (recited in claim 37), wherein the preservative comprises a combination of phenoxyethanol and ethylhexylglycerin (recited in claim 42) present in a ratio of about 9:1 phenoxyethanol:ethylhexylglycerin (claim 43) and the combination of phenoxyethanol and ethylhexylglycerin is present in an amount of about 0.1% to about 2% w/w of the composition (claim 44).
Roberts discloses a composition for human skin (abstract) where the preservatives phenoxyethanol (0.9% w/w) and ethylhexylglycerin (0.1% w/w) are present in the preferred embodiment (pg. 5, line 5, pg. 4, line 12) to help prevent fungal and bacterial growth in the formulation (pg. 6, line 9).
Since Wang generally teaches a composition to be used on human skin, it would have been prima facie obvious to one of ordinary skill in the art to include phenoxyethanol in an amount of 0.9% w/w and ethylhexylglycerin in an amount of 0.1% w/w, within the teachings of Wang, because Roberts teaches these are appropriate preservatives (and amounts) to be used on human skin. An ordinarily skilled artisan would be motived to include these preservatives to help prevent fungal and bacterial growth in the formulation (pg. 6, line 9).
Further regarding claims 43 and 44, a prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 51 is rejected under 35 U.S.C. 103 as being as being obvious over Wang (CN 110226975 A) and Zech (US 2005/0163741 A1) and further in view of Hu (CN 111012686 A) and Bae (EP 3 159 043 A1).
The 35 U.S.C. 103 rejection over Wang in view of Zech was previously discussed.
Wang further discloses the compositions comprise 1-6% of genipin and 60-70% water (abstract).
Wang does not disclose the amount of genipin or water in terms of w/w of the composition or that the film forming agent (which comprises PVP, acrylates copolymer, and styrene/acrylates copolymer - instant claim 1) is present in an amount of about 0.1% to about 10% w/w of the composition, as recited in claim 51.
Hu discloses a tattoo cream comprising 1-10 wt.% genipin (abstract; English translation, pg. 7, bottom paragraph). Hu teaches that the tattoo composition with this amount of genipin has bright color, is color stable and durable, non-irritating, and cost effective (English translation, pg. 4, (5)). Hu also discloses 72-97.2 wt.% water (abstract; English translation, pg. 7, bottom paragraph) to dissolve the components of the tattooing composition uniformly (English translation, pg. 7, paragraph 6; pg. 3, paragraphs 5-9).
It would have been prima facie obvious to include genipin and water, in the amounts taught by Hu, as previously discussed.
Furthermore, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of genipin (1-6 %) and water (60-70 %) are taught by Wang (abstract) and the amounts overlapping with those claimed are known in the art (Hu; 1-10 wt.% genipin; 72-97.2 wt.% water) as such, it would not have been inventive for the skilled artisan to have discovered the optimum amount of genipin or water via routine experimentation.
The combined teachings of the prior art do not disclose that the film forming agent (which comprises PVP, acrylates copolymer, and styrene/acrylates copolymer- instant claim 1) is present in an amount of about 0.1% to about 10% w/w of the composition.
Bae teaches polyvinyl pyrrolidone as a film-forming agent in the coloring composition for the skin in an amount of 2-15 wt.% [0032] [0036]. Bae teaches that when the amount of polyvinyl pyrrolidone (PVP) is less than 2 wt.% the composition dries out and does not remain stable for a long time upon exposure to water or sweat and when the content of PVP is greater than 15 wt.% the composition has too high viscosity to be easily applied, the tinting powder is deteriorated, and the composition decomposes after long term storage [0036].
Zech discloses the acrylates copolymer is present in an amount of 1-60 wt.% of the composition [0030]. Zech teaches the desired resistance to being rubbed off is not achieved below a proportion of 1 wt.% and when a proportion of more than 60 wt.% is involved there is a reduction in its water resistance, which leads to poor properties of use [0030].
It would have been prima facie obvious to include the amount of PVP, taught by Bae, and an acrylates polymer, such as a mixture of acrylates copolymer and styrene/acrylic copolymer, in the amount taught by Zech, within the teachings of Wang, as previously discussed.
Response to Arguments
Applicant argues at the bottom of pg. 10 that all pending dependent claims ultimately depend from claim 1, which is allowable over Wang, alone or in combination with the other cited references.
The Examiner disagrees because claim 1 is not allowable over Wang in view of Zech.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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/ASHLEE E WERTZ/Examiner , Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612