DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-17 are pending and under examination.
Priority
This application is a national stage entry of PCT/US2023/071225 filed on 7/28/2023, which claims priority to US provisional application 63/369,800 filed on 7/29/2022.
Information Disclosure Statement
The information disclosure statements filed on 12/18/2024 and 02/13/2025 have been considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3-5, 8-14 and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a combination of natural products without significantly more. The claim(s) recite(s) at least one organic sunscreen active including a salicylate and pongamia pinnata seed extract with its natural compounds pongamol and karanjin. Note in claim 1, it is provided that there is “at least one sunscreen active including a salicylate”. This use of “including” is in the manner of “comprising” and does not indicate that the salicylate has to be able to have a sunscreen function itself as long as it is included as part of the sunscreen active. Natural plant salicylates include salicylic acid, salicin, and methyl salicylate. As applicant indicates for the pongamia pinnata seed extract, there may be various, different sunscreen/UV protecting agents that occur in plants and their extracts. The claims also include naturally occurring compounds that are metal oxides or cinnamates as well as items such as carriers (e.g. water, natural alcohol or oil), amino acids, natural pigments, pH adjusters (natural acids or bases), and others. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because each of the compounds would be present for a function that it individually provides (natural sunscreen ability, natural action as carrier, natural function to pigment, etc.) rather than one compound providing significantly more via the combination. In regard to claim 17, it is only provided that the composition is in a container, which is routine and conventional storage of a the natural products. This does not provide markedly different characteristics or significantly more to the natural products themselves. The preamble of “sunscreen composition” is read as a composition with the intended use for sun screening.
Claim Rejections - 35 USC § 112(b)
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.
Claims 8-10 and 16 are 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.
Claims 8, 9 and 16 are indefinite for the recitation of “ratio” as it is unclear if ratio is to weight ratio, molar ratio, mass to volume ratio or other such ratios that might exist. Each of these would offer a different meaning to the claim for how ratio is read. For the purpose of compact prosecution, this will be read as weight ratio.
Claim 10 is indefinite for “retinol and its derivatives” as it is unclear what “derivatives” will encompass for the metes and bounds of this limitation since there is no definition provided by applicant to what a retinol derivative is. Additionally, does retinol and its derivatives constitute a mixture of retinol with the derivatives or did applicant mean this recitation to be read as “retinol or its derivatives”. For the purpose of compact prosecution, it will be read as “retinol or its derivatives” and anything that can reasonably be considered a compound derived from retinol or including retinol in the structure will read on the limitation.
Claim Rejections – 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Cocuzza US 20230364005 A1 (effective filing date of 5-16-2022) as evidenced by Ramchandra US20190269594A1.
Cocuzza teaches in at least one aspect the sunscreen comprises: a metal oxide (e.g., zinc oxide) one or more SPF active ingredients (e.g., octinoxate and/or octisalate) and one or more SPF enhancement ingredients (e.g., a photo stabilizer (e.g., butyloctyl salicylate and/or ethylhexyl methoxycrylene) and/or an antioxidant (e.g., a plant extract) (e.g., pongamia pinnata extract) (abstract and paragraph 10). Cocuzza teaches the various options of agents like metal oxides starting in paragraphs 19 and 20 (“may include”). Claim 5 of Cocuzza teaches octisalate and homosalate. Paragraph 36 provides for pongamia pinnata seed extract and amounts of 0.01 to 5wt% and about 0.5wt% (paragraphs 36-37 and paragraph 94). Cocuzza teaches “one or more SPF active ingredients is selected from the group consisting of: octinoxate, octisalate, homosalate, avobenzone, octocrylene, para-aminobenzoic acid, cinoxate, dioxybenzone, menthyl anthranilate, padimate O, ensulizole, sulisobenzone, trolamine salicylate, ecamsule, 4-methylbenzylidene camphor, diethylamino hydroxybenzoyl hexyl benzoate, bis diethylamino hydroxybenzoyl benzoate, disodium phenyl dibenzimidazole tetrasulfonate, Parsol SLX (INCI Polysilicone-15), Butyl Methoxydibenzoylmethane, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Benzophenone-3, Ethylhexyl Dimethyl PAB A, Phenylbenzimidazole Sulfonic Acid, Benzophenone-4, Tris-biphenyl triazine, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Ethylhexyl triazone, Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate, Phenylene Bis-Diphenyltriazine, Isoamyl p-Methoxycinnamate, Benzylidene Camphor Sulfonic Acid, Camphor benzalkonium methosulfate, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Disodium Phenyl Dibenzimidazole Tetrasulfonate, Drometrizole Trisiloxane, PEG-25 PABA, Polyacrylamidomethyl Benzylidene Camphor, Benzophenone-5, benzophenone-8, Diethylhexyl butamido triazone, and combinations thereof.” (paragraph 133). Cocuzza teaches ingredients like antioxidants (paragraph 136) and fragrances, dyes, chelating agents, etc (paragraph 135, also see other claims of Cocuzza). Paragraph 134 teaches octisalate and octinoxate. Cocuzza teaches forms such as emulsions, creams or gels that would be carriers (paragraph 132). Cocuzza provides for lotion, spray, or topical product (paragraph 90) as well as carriers (paragraphs 95-96).
Ramchandra evidences that pongamia pinnata seed extract has pongamol and karanjin. (paragraphs 28-30 of Ramchandra).
Cocuzza exemplifies the combination with using 0.25wt% of the pongamia extract and 4% octisalate (see example 1 that also has vitamins, water, emulsifiers, etc, and also see example 9). This is a 16:1 ratio of octisalate to pongamia extract.
One of ordinary skill in the art before the time of filing would have worked with the ingredients and amounts thereof taught by Cocuzza noting the use of the pongamia pinnata seed extract and salicylates such as octisalate or homosalate along with other common/conventional sun screening agents and cosmetically/pharmaceutically acceptable excipients and actives taught in Cocuzza’s sunscreen formulations to formulate sunscreen formulations of the claims with a reasonable expectation of success in producing such formulations and products. The reasonable expectation is producing another suitable sunscreen composition for a user. Although Cocuzza does not particularly indicate a container, it provides for sprays, sunscreen products and topical products which are routinely known to be stored in containers such as spray containers, tubes or bottles.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ramchandra US20190269594A1.
In claims 11 and 15, the recitation of “sunscreen composition is free of …. isolated pongamol….. or combinations thereof” is met if a composition of the prior art can be free of any one of the items listed from this group of options.
Ramchandra teaches a cosmetic composition comprising: (i) 0.1 to 10 % by weight pongamol; (ii) 0.1 to 10 % by weight karanjin; and, (iii) 0.1 to 40% by weight of a solvent whose Total Hildebrand Parameter (δt) value is 18 to 26 MPa0.5 at 25° C., wherein said composition comprises not more than 2% by weight pongamia oil (abstract) and this composition is photoprotective. Ramchandra teaches a composition with both pongamol and karanjin as a combination, both at 0.1 to 10% by weight of the composition (claim 1 of Ramchandra). This would provide a minimum for both of 0.2% wt. Ramchandra teaches oil soluble UV-B sunscreens from 1 to 10% (high of 10% wt) by weight including octyl salicylate, ethylhexyl salicylate, homosalate and octisalate (paragraphs 62-63). Thus, the ratio of a salicylate UV-B sunscreen agent to the extract could be 100:1 to 1:2. Ramchandra provides hydrophobic zinc oxide, but it is an optional ingredient (paragraph 83). Ramchandra provides for various other UV sunscreens, crosslinked silicone elastomer, emulsifier, humectants, other ingredients such as fatty alcohols and others and skin benefit agents (paragraphs 45-97). Ramchandra provides for vehicles including carriers (paragraphs 51-53). Ramchandra teaches that, whenever present, water is 20 to 80% by weight of the composition, but it may also be anhydrous (paragraph 51). Ramchandra teaches a suitable container for the composition (paragraphs 50 and 99). Paragraph 28 provides for pongamia pinnata and its seed oil as containing ingredients including pongamol and karanjin (paragraphs 28-30). Thus, pongamol and karanjin are compounds of pongamia pinnata seeds that can be extracted. Ramchandra teaches octocrylene as an option (paragraph 63). Paragraph 97 teaches “The CTFA Cosmetic Ingredient Handbook, Second Edition, 1992, which is incorporated by reference herein in its entirety, describes a wide variety of non-limiting cosmetic and pharmaceutical ingredients commonly used in the skin care industry, which are suitable for use in the compositions of the present invention. Examples include antioxidants, binders, biological additives, buffering agents, colorants, astringents, fragrance, opacifying agents, conditioners, exfoliating agents, pH adjusters, natural extracts, essential oils, skin sensates, skin soothing agents and skin healing agents.”
One of ordinary skill in the art before the time of filing would have combined ingredients of applicant’s claims to produce a sunscreen formulation with an extract of pongamia pinnata seed and a sunscreen active including salicylate (e.g. homosalate, octisalate) and combined other ingredients suitable for sunscreen compositions to produce sunscreen compositions and products that will be effective for sun protection with a reasonable expectation of success when using the teachings of Ramchandra. Ramchandra also notes the use of a container for the compositions. One of ordinary skill in the art would work within the ranges of the prior art to produce compositions having such amounts and ratios of applicant’s claims in making other effective sunscreen formulations (MPEP 2114.05).
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Mintel (SPF 50 PA++ Natural Intensive Sun Cream, March 2011, in applicant IDS) and Ramchandra US20190269594A1 with evidence from International Search Report regarding Mintel (Mintel dated 2011 in IDS and provided to application on 12/18/2024, referred to as ISR).
Mintel with evidence of the ISR provides for a sun cream product with pongamia pinnata seed extract and salicylate UVB sunscreen agent(s).
Mintel with evidence of ISR does not provide for the concentrations as provided in applicant’s claims.
Ramchandra teaches a cosmetic composition comprising: (i) 0.1 to 10 % by weight pongamol; (ii) 0.1 to 10 % by weight karanjin; and, (iii) 0.1 to 40% by weight of a solvent whose Total Hildebrand Parameter (δt) value is 18 to 26 MPa0.5 at 25° C., wherein said composition comprises not more than 2% by weight pongamia oil (abstract) and this composition is photoprotective. Ramchandra teaches a composition with both pongamol and karanjin as a combination, both at 0.1 to 10% by weight of the composition (claim 1 of Ramchandra). This would provide a minimum for both of 0.2% wt. Ramchandra teaches oil soluble UV-B sunscreens from 1 to 10% (high of 10% wt) by weight including octyl salicylate, ethylhexyl salicylate, homosalate and octisalate (paragraphs 62-63). Thus, the ratio of a salicylate UV-B sunscreen agent to the extract could be 100:1 to 1:2. Ramchandra provides hydrophobic zinc oxide, but it is an optional ingredient (paragraph 83). Ramchandra provides for various other UV sunscreens, crosslinked silicone elastomer, emulsifier, humectants, other ingredients such as fatty alcohols and others and skin benefit agents (paragraphs 45-97). Ramchandra provides for vehicles including carriers (paragraphs 51-53). Ramchandra teaches that, whenever present, water is 20 to 80% by weight of the composition, but it may also be anhydrous (paragraph 51). Ramchandra teaches a suitable container for the composition (paragraphs 50 and 99). Paragraph 28 provides for pongamia pinnata and its seed oil as containing ingredients including pongamol and karanjin (paragraphs 28-30). Thus, pongamol and karanjin are compounds of pongamia pinnata seeds that can be extracted. Ramchandra teaches octocrylene as an option (paragraph 63). Paragraph 97 teaches “The CTFA Cosmetic Ingredient Handbook, Second Edition, 1992, which is incorporated by reference herein in its entirety, describes a wide variety of non-limiting cosmetic and pharmaceutical ingredients commonly used in the skin care industry, which are suitable for use in the compositions of the present invention. Examples include antioxidants, binders, biological additives, buffering agents, colorants, astringents, fragrance, opacifying agents, conditioners, exfoliating agents, pH adjusters, natural extracts, essential oils, skin sensates, skin soothing agents and skin healing agents.”
One of ordinary skill in the art before the time of filing would have combined ingredients of applicant’s claims to produce a sunscreen formulation with an extract of pongamia pinnata seed and a sunscreen active including salicylate (e.g. homosalate, octisalate) and combined other ingredients suitable for sunscreen compositions to produce sunscreen compositions and products that will be effective for sun protection with a reasonable expectation of success in using the teachings of Mintel and Ramchandra. Ramchandra provides concentrations and also notes the use of a container for the compositions. One of ordinary skill in the art would work within the ranges of the prior art to produce compositions having such amounts and ratios of applicant’s claims in making other effective sunscreen formulations (MPEP 2114.05).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613
