DETAILED ACTION
Status of the Claims
Claims 1-16 are pending in the instant application. Claim 16 has been withdrawn based upon Restriction/Election as discussed below. Claims 1-15 are being examined on the merits in the instant application.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Restriction/Election
Applicant's election without traverse of Group I drawn to compositions of matter, currently claims 1-15, in the reply filed on 03/26/2026 is acknowledged.
Applicants have elected the following species in the reply filed 03/26/2026: (a) a species of a water-soluble UV filter is Phenyl-3H-benzimidazole-5-sulfonic acid (Ensulizole).
The requirement is deemed proper and is therefore made FINAL.
Claims 16 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/26/2026.
Priority
The U.S. effective filing date has been determined to be 01/04/2024, the filing date of the instant application.
Information Disclosure Statement
The information disclosure statements submitted on 02/11/2024, 06/04/2025 and 06/17/2025 were filed before the mailing date of the first office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Specification
The abstract of the disclosure is objected to because the abstract drafted as claims 1 & 16.
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc. In addition, the form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts. Appropriate correction is required.
Claim Objections
Claims 1-15 are objected to because of the following informalities: The claims fail to start with an article such as “A cosmetic composition […]”. Appropriate correction is required.
Claim 14 is objected to because the claim includes a space between the last word and the period. Appropriate correction is required.
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.
Claim 14 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 pre-AIA the applicant regards as the invention.
Claim 14 is rejected as being indefinite because the claim recites “wherein the cosmetic composition is considered water resistance in accordance with the contact angle measurement method” [emphasis added]. The limitation "the contact angle measurement method" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6-8 and 15 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by JANSEN (US 2022/0387281 A1; published December, 2022).
Applicant Claims
Cosmetic composition comprising (i) bemotrizinol (INCI: bis-ethylhexylphenol methoxyphenyl triazine), (ii) a water-soluble organic UV filter or a salt thereof, (iii) at leas one inorganic UV filter, wherein the cosmetic composition is free of the UV filters from the group consisting of hexyl-2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate (INCI diethlamino hydroxybenzeyl hexyl benzoate), 2,2’-Methylenbis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethybutyl)phenol] (bisoctrizole), 3,3,5-Trimethylcyclohexyl 2-hydroxybenzoate (INCI Homosalate), polysilicone-15, and 2-hydroxy-4-methoxybenzophenone (INCI benzophenone-3) (instant claim 1).
Elected Species: Applicants have elected the following species in the reply filed 03/26/2026: (a) a species of a water-soluble UV filter (instant claim 1, (ii)) is Phenyl-3H-benzimidazole-5-sulfonic acid (Ensulizole)(instant claims 6-7 & 11-13).
Claim interpretation: The instant Specification defines “Cosmetic composition” (instant claims 1-15, line 1) as follows: “Cosmetic compositions refer here to topical products. The term "topical product" refers to a product that is applied to the skin and can be a leave-on or rinse-off products.” (instant Specification, p. 5, 3rd paragraph). And defines “free of” (instant claim 1, lines 5-9, instant claims 2, 4 & 5): “As used herein the term ‘does not comprise’ or ‘free of'’ means in the context that the composition of the present invention is free of a specific compound or group of compounds, which may be combined under a collective term, that the composition does not comprise said compound or group of compounds in an amount of more than 0.1 % by weight, based on the total weight of the composition.” (instant Specification, p. 4, 4th paragraph).
Disclosure of the Prior Art
JANSEN discloses sunscreen compositions with low stickiness (title, see whole document), and particularly “a topical preparation comprising a UV filter combination of certain microfine zinc oxide, 2,4-bis{[ 4-(2-ethylhexyloxy)-2-hydroxy ]phenyl}-6-(4-methoxypheny 1)-1,3,5-triazine (INCI: Bis-Ethylhexyloxyphenol methoxyphenyl Triazine), 2-phenylbenzimidazole-5-sulfonic acid and/or one or more salts thereof and 2,4,6-tris[ anilino(p-carbo-2'-ethyl-1 '-hexyloxy)]-1,3,5-triazine (INCI: Ethylhexyl Triazone).” (abstract, [0001]).
JANSEN discloses examples (p. 7, Table 1) including PARSOL® Shield including Bis-ethylhexyloxyphenol methoxyphenyl triazine (instant claim 1, item (i) bemotrizinol), zinc oxide (ZnO-C DS4 or Parsol® ZX)(instant claim 1, item (iii), instant claim 3), and PARSOL® HS including phenylbetzimidazole sulfonic acid (i.e. phenyl-3H-benzimidazole-5-sulfonic acid)(instant claim 1, item (ii); instant claims 6-7), and a neutralizing agent (sodium hydroxide)(instant claim 8). The composition is free of hexyl-2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate (INCI diethlamino hydroxybenzeyl hexyl benzoate), 2,2’-Methylenbis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethybutyl)phenol] (bisoctrizole), 3,3,5-Trimethylcyclohexyl 2-hydroxybenzoate (INCI Homosalate), polysilicone-15, and 2-hydroxy-4-methoxybenzophenone (INCI benzophenone-3) (instant claim 1); 2-ethylhexyl-2-cyano-3,3-diphenylprop-2-enoate (INCI octocrylene)(instant claim 2), and (RS)-2-Ethylhexyl-(2E)-3-(4-methoxyphenyl)prop-2-enoate (octinoxate) (instant claim 4). JANSEN claims the composition of claim 1 including zinc oxide (item a), bemotrizinol (item b) and phenyl-3H-benzimidazole-5-sulfonic acid (item c), and further claims the SPF is at least 20 (claim 13)(instant claim 15).
Claims 1-4 and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by MINTEL_02 (“Day Care Revolution” of record as cited on Applicant’s IDS dated 06/04/2025, NPL citation No. 2).
Disclosure of the Prior Art
MINTEL_02 discloses a skin cosmetic composition including phenylbenzimidazole Sulfonic Acid (instant claim 1, item ii; instant claims 6-7), Bis-ethylhexyloxyphenol Methoxyphenyl Triazine (instant claim 1, item i), silica-coated zinc oxide (instant claim 1, item iii; instant claim 3) while not including UV filters from the group consisting of hexyl-2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate (INCI diethlamino hydroxybenzeyl hexyl benzoate), 2,2’-Methylenbis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethybutyl)phenol] (bisoctrizole), 3,3,5-Trimethylcyclohexyl 2-hydroxybenzoate (INCI Homosalate), polysilicone-15, and 2-hydroxy-4-methoxybenzophenone (INCI benzophenone-3)(instant claim 1), octocrylene (instant claim 2), octinoxate (instant claim 4). And including the neutralizing agent triethanolamine (instant claims 8-9).
Claims 1-4 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by MINTEL_04 (“Sunblock Lotion” of record as cited on Applicant’s IDS dated 06/04/2025, NPL citation No. 4).
Disclosure of the Prior Art
MINTEL_04 discloses a sunblock lotion including titanium dioxide (instant claim 1, item iii; instant claim 3), Bis-ethylhexyloxyphenol Methoxyphenyl Triazine (instant claim 1, item i), and Phenylbenzimidazole Sulfonic Acid (instant claim 1, item ii; instant claims 6-7), while not including UV filters from the group consisting of hexyl-2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate (INCI diethlamino hydroxybenzeyl hexyl benzoate), 2,2’-Methylenbis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethybutyl)phenol] (bisoctrizole), 3,3,5-Trimethylcyclohexyl 2-hydroxybenzoate (INCI Homosalate), polysilicone-15, and 2-hydroxy-4-methoxybenzophenone (INCI benzophenone-3)(instant claim 1), octocrylene (instant claim 2), octinoxate (instant claim 4). And including the neutralizing agent Sodium Hydroxide (instant claims 8).
Claims 1, 3-4 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by MINTEL_06 (“UV Preventer EX” of record as cited on Applicant’s IDS dated 06/04/2025, NPL citation No. 6).
Disclosure of the Prior Art
MINTEL_06 discloses the Ingredients include Phenylbenzimidazole Sulfonic Acid (instant claim 1, item ii; instant claims 6-7); Bis-ethylhexyloxyphenol Methoxyphenyl Triazine (instant claim 1, item i), Titanium Dioxide and Zinc Oxide (instant claim 1, item iii; instant claim 3) while not including UV filters from the group consisting of hexyl-2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate (INCI diethlamino hydroxybenzeyl hexyl benzoate), 2,2’-Methylenbis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethybutyl)phenol] (bisoctrizole), 3,3,5-Trimethylcyclohexyl 2-hydroxybenzoate (INCI Homosalate), polysilicone-15, and 2-hydroxy-4-methoxybenzophenone (INCI benzophenone-3)(instant claim 1), octinoxate (instant claim 4). And including the neutralizing agent Sodium Hydroxide (instant claims 8).
Claims 1-4 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by FOX (Charles, Fox; “DDS Liposomes for Cosmetic Delivery and Other Recent Literature Findings,” 2009, Cosmetics and Toiletries Magazine, Vol. 124, Issue 7, pp. 20-26; of record as cited on Applicant’s IDS dated 06/04/2025, NPL citation No. 7).
Disclosure of the Prior Art
FOX discloses Formula 10 – Stable O/W sunscreen emulsion including Phenylbenzimidazole sulfonic acid (instant claim 1, item ii; instant claims 6-7), Bis-ethylhexyloxyphenol methoxyphenyl triazine (instant claim 1, item i), Titanium dioxide (instant claim 1, item iii; instant claim 3) while not including UV filters from the group consisting of hexyl-2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate (INCI diethlamino hydroxybenzeyl hexyl benzoate), 2,2’-Methylenbis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethybutyl)phenol] (bisoctrizole), 3,3,5-Trimethylcyclohexyl 2-hydroxybenzoate (INCI Homosalate), polysilicone-15, and 2-hydroxy-4-methoxybenzophenone (INCI benzophenone-3)(instant claim 1), octocrylene (instant claim 2), octinoxate (instant claim 4). And including the neutralizing agent Sodium hydroxide (instant claims 8).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 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 1-4, 6-8, 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over JANSEN (US 2022/0387281 A1; published December, 2022).
Applicants Claims
Cosmetic composition comprising (i) bemotrizinol (INCI: bis-ethylhexylphenol methoxyphenyl triazine), (ii) a water-soluble organic UV filter or a salt thereof, (iii) at leas one inorganic UV filter, wherein the cosmetic composition is free of the UV filters from the group consisting of hexyl-2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate (INCI diethlamino hydroxybenzeyl hexyl benzoate), 2,2’-Methylenbis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethybutyl)phenol] (bisoctrizole), 3,3,5-Trimethylcyclohexyl 2-hydroxybenzoate (INCI Homosalate), polysilicone-15, and 2-hydroxy-4-methoxybenzophenone (INCI benzophenone-3) (instant claim 1). Applicant further claims the cosmetic composition comprises a Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (instant claim 10), and has an SPF of more than 15 or more than 30 or more than 50 (instant claim 15).
Determination of the scope
and content of the prior art (MPEP 2141.01)
JANSEN discloses sunscreen compositions with low stickiness, as discussed above and incorporated herein by reference.
JANSEN teaches the inclusion of “Simugel NS (INCI: Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer & Squalane & Polysorbate 60).” ([0094], claim 11)(instant claim 10). JANSEN teaches that: “In another aspect, the composition may have an SPF of at least 20, preferably of at least 30.” ([0079], claim 13)(instant claim 15).
JANSEN teaches “In all embodiments of the present invention, the amount of the micro fine zinc oxide is preferably selected in the range from 0.1 wt.-% to 20 wt.-%, more preferably in the range from 0.5 wt.-% to 15 wt.-%, most preferably in the range from 1 wt.-% to 10 wt.-%, such as in the range from 5 wt.-% to 10 wt.-%, based on the total weight of the topical composition.” ([0026])(instant claims 11-13 amount of zinc oxide). MPEP §2144.05 - In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
JANSEN teaches that: “In all embodiments of the present invention, the amount of the 2,4-bis{[4-(2-ethylhexyloxy)-2-hydroxy]phenyl}-6-(4-methoxyphenyl)-1,3,5-triazine (INCI: Bis-Ethyl hexyloxyphenol methoxyphenyl Triazine) is preferably selected in the range from 0.1 wt.-% to 10 wt.-%, more preferably in the range from 0.5 wt.-% to 7.5 wt.-%, most preferably in the range from 1 wt.-% to 5 wt.-%, based on the total weight of the topical composition.” ([0027])(instant claims 11-13, amount of bemotrizinol). MPEP §2144.05 - In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
JANSEN teaches that: “In all embodiments of the present invention, the amount of the 2-phenylbenzimidazole-5-sulfonic acid and/ or one or more salts thereof is preferably selected in the range from 0.1 wt.-% to 10 wt.-%, more preferably in the range from 0.5 wt.-% to 7.5 wt.-%, most preferably in the range from 1 wt.-% to 5 wt.-%, based on the total weight of the topical composition.” ([0028])(instant claims 11-13, amount of Phenyl-3H-benzimidazole-5-sulfonic acid). MPEP §2144.05 - In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of JANSEN is that JANSEN does not expressly teach a specific embodiment including Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, and an SPF of 30 or more (instant claims 10 & 15). However, JANSEN teaches the copolymer species droxyethyl Acrylate/Sodium Acryloyldimethyl Taurate as suitable for their sunscreen compositions and therefore the inclusion therein would have been prima facie obvious. And the SPF of greater than 30 would have also been prima facie obvious in view of the teaching of JANSEN.
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a cosmetic composition such as a sunscreen comprising bemotrizinol, Phenyl-3H-benzimidazole-5-sulfonic acid, and zinc oxide, and not including specific organic sunscreens that may have been considered harmful to skin and/or the environment on use (e.g. an aquatic toxin), as suggested by JANSEN, in view of the ordinary skill/knowledge in the art pertaining to sunscreens.
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 because it would have required no more than an ordinary level of skill in the art to produce the cosmetic sunscreens in accordance with the teachings of JANSEN. Therefore, the invention as a whole would have been 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.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over JANSEN as applied to claims 1-4, 6-8, 10 and 15 above, and further in view of DWYER (WO 2022/243267 A1; published November, 2022); Sohn et al. (“Performance, Safety and Sustainability – All in Tris-Biphenyl Triazine,” 2021, SOFW Journal, Vol. 147, Issue 7/8, 8-pages) and Jesus et al. (“Recent Trends on UV filters,” 2022, MDPI, Applied Sciences, Vol. 12, Issue 23, Article 12003, pp. 1-12).
Applicants Claims
Cosmetic composition comprising (i) bemotrizinol (INCI: bis-ethylhexylphenol methoxyphenyl triazine), (ii) a water-soluble organic UV filter or a salt thereof, (iii) at leas one inorganic UV filter, as discussed above. And further claims “the cosmetic composition is free of any further organic UV filter.” (instant claim 5).
Determination of the scope
and content of the prior art (MPEP 2141.01)
JANSEN discloses/teaches sunscreen compositions with low stickiness, as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of JANSEN is that JANSEN does not expressly teach “the cosmetic composition is free of any further organic UV filter.” but teaches the inclusion of Ethylhexyl Triazone.
DWYER teaches sunscreen compositions comprising bemotrizinol (title, see whole document), and particularly “The present invention relates to sunscreen compositions containing bis-ethylhexyloxyphenol methoxyphenyl triazine (BEMT) and at least one film forming agent selected from the group consisting of citrate crosspolymers and polyamides in combination with an alkandiol with the proviso that the composition is free of octocrylene, ethylhexyl triazone, diethylamino hydroxybenzoyl hexyl benzoate and ethylhexyl methoxycinnamate. Said compositions exhibit a reduced soaping effect and thus a more appealing skin feel and look.” (p. 1, 1st paragraph). And that: “However sunscreens comprising bis-ethylhexyloxyphenol methoxyphenyl triazine tend to exhibit a soaping effect. To prevent this, consumers tend to use less sunscreen but at the same time they are less protected.” (p. 1, lines 19-21).
Sohn et al. teaches that: “Disrupting changes in the suncare field include the avoidance of Octocrylene (OCR) and Ethylhexyl Methoxycinnamate (EHMC) in new sunscreen developments due to rising concerns regarding their safety profile for humans and for the environment. […] Ethylhexyl Triazone (EHT), Diethylhexyl ButamidoTriazone (DBT) and Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine (BEMT) are very often used as replacement of OCR and EHMC, and create the core of the UVB and broad-spectrum protection. The three belong to the efficient 1,3,5-Triazine filter type, and they are supplied as a powder and require appropriate solubilization. […] Formulating out salicylate-based filters might become an effect of this new final opinion. Other available filters are more effective in absorbing UV rays than salicylate-based UV filters and comprise essentially Phenylbenzimidazole Sulfonic Acid (PBSA), Titanium dioxide (TiO2), […].” (p. 2, §Introduction).
Sohn et al. teaches that: “Concerns of the damaging effects of UV filters on ecosystems gained a high level of awareness in public debates, since they are likely to be directly released into the environment. To meet the demand of eco-conscious consumers, some manufacturers focus their promotion on the biodegradability of their product with a protocol which was developed for the testing of the biodegradability of raw materials and not of finished formulations.” (p. 5, §Eco-friendly sunscreens).
Jesus et al. teaches recent trends on UV filters (title, see whole document). Jesus et al. teaches that: “In the 1940’s, p-aminobenzoic acid (PABA) and its derivatives were studied, with PABA derivatives revealed to be more efficient, namely the mono and dialkyl PABA ester derivatives. Over the years, other methodologies were developed to prove the effectiveness and safety of UV filters. PABA was confirmed to be photounstable and a promotor of allergic reactions [9]. Further research confirmed its low photostability, as well as toxic effects, culminating in its ban in the European Union in 2008.” (p. 2, 1st paragraph). And that: “UV filters are defined in Cosmetic Regulation (EC) n° 1223/2009 as “substances which are exclusively or mainly intended to protect the skin against certain UV radiation by absorbing, reflecting, or scattering UV radiation”. Annex VI of this regulation mentions the list of approved UV filters for cosmetic use, with a total of 28 compounds being listed, including two inorganics (zinc oxide (ZnO) and titanium oxide (TiO2)), which can be present in non-nano or nano forms, and 26 organic UV filters. Of all the 26 organic UV filters, bisoctrizole and trisbiphenyl triazine can also be present in nano forms. One of the controlled parameters is the maximum concentration allowed in the formulation. Over the years, some alterations to the list of European approved UV filters were noted, including both approvals and withdrawals. In 2015, the EU removed 3-benzylidene camphor from the list of approved UV filters because of its toxicity towards marine organisms and endocrine-disruptor potential; in contrast, ZnO was approved in the following year (2016).” (p. 2, 2nd paragraph).
Jesus et al. teaches that: “Avobenzone (BMDBM), octocrylene (OC), and bis-ethylhexyloxyphenol methoxyphenyl triazine (Tinosorb S®) were the three most frequently used UV filters with percentages that varied between 45% and 75%, all belonging to the organic UV filters category (Figure 1).” (p. 3, §3.1, 1st paragraph). And that: “Photostability is critical for the effective photoprotective action of the UV filters Nevertheless, some currently used UV filters have demonstrated low photostability. Avobenzone is photounstable and suffers photoisomerization and/ or photodegradation when exposed to UVR. Phenacyl and benzoyl radicals are the main photodegradation products formed; however, their combination could generate more reactive and toxic species for human beings and the environment, thus losing its photoprotective action. Additionally, octocrylene was recently reported for its transformation through retro-aldol condensation into a phototoxic benzophenone derivative.” (p. 3, §3.1, 2nd paragraph).
Jesus et al. teaches that: “When compared to 2015, the top five UV filters in sunscreens marketed in 2021 remained the same (Figure 6). It is relevant to highlight that avobenzone was the most used organic UV filter in both periods of analysis, with usage frequencies higher than 65%. On the contrary, a change in the usage frequency of bis-ethylhexyloxyphenol methoxyphenyl triazine, ethylhexyl salicylate, and octocrylene was observed. The usage frequency of bis-ethylhexyloxyphenol methoxyphenyl triazine (Tinosorb S®) (2015: 24.6% and 2021: 45.3%) almost doubled in a timespan of six years, probably due to its high photoprotective effectiveness. This triazine UV filter is a broad-spectrum photoprotective agent, and additionally possesses interesting photostable characteristics that make it a good photoprotective and photostabilizing agent of unstable UV filters, which might explain the increased usage. In contrast to what happened to triazine UV filters, the usage of ethylhexyl salicylate (2015: 39.4% and 2021: 36.9%) and octocrylene (2015: 51.7% and 2021: 48.4%) decreased over the analyzed period by around 10%. Ethylhexyl salicylate is a good UVB absorber; however, it tends to suffer from photoisomerization and potentially induces some environmental toxicity. On the other side, octocrylene could be transformed into a benzophenone derivative through a retro-aldol condensation reaction, which increases its phototoxic potential and leads to negative environmental effects. Additionally, this toxic benzophenone derivative possesses chemical similarities to a hydroxylated derivative of benzophenone-type compounds that were already reported as possessing endocrine disrupting activity, evidencing possible cytotoxic effects and its potential to act as an endocrine disrupter agent.” (p. 3, §3.5, 1st paragraph). And that: “Among the available forms of inorganic UV filters, the collected data between 2015 and 2021 showed an increasing tendency towards the use of the inorganic UV filter TiO2, reaching usage frequencies of 24.1% and 10.4% in 2021 for its nano and non-nano forms, respectively. This is particularly evident for non-nano TiO2, whose usage more than doubled in six years (from 4.7% to 10.4%). With respect to ZnO, decreased usage was found for the non-nano form, while nano ZnO was similarly used in both periods of analysis. The reasons for the increased use of TiO2 are not clear but might be explained by its ability to offer broad-spectrum action and higher SPF values, as well as by the toxicity issues that affect other organic filters.” (p. 3, §3.5, 2nd paragraph).
Jesus et al. teaches that: “Recent data on the safety and photostability of UV filters and consumer concerns seem to be, at least partially, being considered in the reformulation of commercial sunscreens, which substantiates the focus of the cosmetic industry on designing safer products.
The use of UV filters in cosmetic formulations is a must-have in order to afford protection against UV radiation. However, the choice of which UV filters should be used is a challenge. There are numerous studies that report some of the drawbacks of the actual UV filters, such as photostability issues, skin sensitization reactions, and human and environmental toxicity, especially towards marine species.” (p. 10, paragraphs 2-3).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a cosmetic composition such as a sunscreen comprising bemotrizinol, Phenyl-3H-benzimidazole-5-sulfonic acid, and zinc oxide, as discussed above and further to exclude ethyl hexyl triazone, as suggested by DWYER, and not including any other organic sunscreens that may have been considered harmful to users skin and/or the environment on use (e.g. an aquatic toxin), as suggested by Sohn et al. and Jesus et al. as recent trends in the art pertaining to sunscreens.
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 because it would have required no more than an ordinary level of skill in the art to produce the cosmetic sunscreens in accordance with the teachings of JANSEN et al. Therefore, the invention as a whole would have been 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.
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.
Claims 9 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over JANSEN as applied to claims 1-4, 6-8, 10 and 15 above, and further in view of ISSACHAR (WO 02/17872 A1) and JOHNCOCK (US 2015/0265510 A1; published September, 2015); and as evidenced by Osterwalder et al. (“The long way towards the ideal sunscreen—where we stand and what still needs to be done”, 2010, RSC; Photochemical & Photobiological Sciences, Vol. 9, pp. 470-481).
Applicants Claims
Cosmetic composition comprising (i) bemotrizinol (INCI: bis-ethylhexylphenol methoxyphenyl triazine), (ii) a water-soluble organic UV filter or a salt thereof, (iii) at leas one inorganic UV filter, as discussed above. And further claims specific neutralizing agents (instant claim 9) as well as combinations of UV-filters bemotrizinol, Ensulizole, zinc oxide, titanium dioxide and the neutralizing agent in range amounts (instant claims 11-13).
Determination of the scope
and content of the prior art (MPEP 2141.01)
JANSEN discloses/teaches sunscreen compositions with low stickiness, as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of JANSEN is that JANSEN does not expressly teach the inclusion of titanium dioxide, or a neutralizing agent such as arginine (instant claims 9 & 11-13).
ISSACHAR teaches sunscreens containing titanium dioxide and triazine derivatives (title, see whole document). ISSACHAR teaches that: “In one aspect, the invention features a composition comprising: (a) titanium dioxide and (b) one or more triazine derivative(s). What is meant by a triazine derivative is a compound comprising one or more triazine group(s) and capable of absorbing radiation in the UV-A range (e.g., from about 290 to about 320 nm). In one embodiment, the triazine derivative is of the formula (I) […].” (p. 2, lines 12-19), and that “In one embodiment, the compound of formula (I) is 2,4-Bis{[4-(2-ethyl-hexyloxy)-2-hydroxy]-phenyl}-6-(4-methoxyphenyl}-(1,3,5)-triazine.” (p. 5, lines 5-7)(instant claims 1, 11-13, bemotrizinol). And that: “In one embodiment, titanium dioxide is present in an amount from about 0.1% to about 20%, by weight, of the composition (e.g., about 1% to about 10%, by weight, of the composition) and the triazine derivative is present in an amount from about 0.1% to about 20%, by weight, of said composition (e.g., about 1% to about 10%, by weight, of the composition).” (p. 5, lines 8-14)(instant claims 11-13, amount of titanium dioxide). MPEP §2144.05 - In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
ISSACHAR teaches Example 1 including 3%(W/W) 2,4-Bis{[4-(2-ethylhexyloxy)-2-hydroxy]-phenyl}-6-(4-methoxyphenyl)-{1,3,5)-triazine ("TS") (Tinosorb S®, Ciba Specialty Chemicals Corporation), Formulation 3 (FORM. 3) contained 3%(W/W) titanium dioxide, and Formulation 2 (FORM. 2) contained both 3%(W/W) TS and 3%(W/W) titanium dioxide.” (pp. 15-16, Example 1, Table 1).
ISSACHAR teaches inclusion of other UV-A and/or UV-B absorbing/reflecting agent(s) including sulfonic acid derivatives such as phenylbenzimidazole sulfonic acid; and zinc oxide, among others (p. 7, lines 20-21, p. 8, lines 2-3, and 7; claims 9-10, 13-14, 17-18).
Specifically regarding the combination of Bemotrizinol, Phenyl-3H-benzimidazole-5-sulfonic acid, zinc oxide and titanium dioxide, Osterwalder et al. discloses the “Cross-reference list of all UV filters used in the BASF sunscreen simulator” in Table 3 (p. 474) indicating that: Bemotrizinol and Zinc oxide are “Broad-spectrum UVA I (340-400 nm)” UV-filters, and Phenylbenzimidazole sulfonic acid (Esulizole) and Titanium dioxide are “UVB (290–320 nm) and UV all (320–340 nm)”. Thus, combination of stable organic UV-filters one UVA (Bemotrizinol) and one UVB (Ensulizole), as well as inorganic UV-filters in the UVA (Zinc oxide) and the UVB (Titanium dioxide) would have been prima facie obvious to provide the best UV protection.
JOHNCOCK teaches sunscreen formulations including Example 4 disclosing that: “At first add the water then add the neutralisation agent Biotive® L-Arginine and the sodium hydroxide solution. Stir until homogeneous.” [emphasis added]([0404])(instant claim 9, neutralizing agent is arginine). JOHNCOCK further teaches in Table 13 the amount of Biotive® L-Arginine is 1% w/w and the sodium hydroxide solution (10% aq.) is 0.30 % w/w ([0414], Table 13, phase B). MPEP §2144.05 - In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
JOHNCOCK further teaches “Neutralization base for acidic components” include AMP, TEA, KOH, NaOH, Arginine, Tromethane (p. 34, Table). The examiner notes that AMP is 2-amino-2-methyl propanol (i.e. aminomethylpropane – instant claim 9), TEA is triethanolamine, KOH is potassium hydroxide, and NaOH is sodium hydroxide.
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a cosmetic composition such as a sunscreen comprising bemotrizinol, Phenyl-3H-benzimidazole-5-sulfonic acid, and zinc oxide, as discussed above and further to include titanium dioxide as an inorganic UVB absorbing agent, as suggested by ISSACHAR, and conventionally used “Neutralization base for acidic components”, as suggested by JOHNCOCK. The examiner further notes that Sohn et al. (cited above) in Table 1 indicates that PBSA requires a pH > 7, which further suggest using a base for neutralizing acidic components for the stability of the PBSA (i.e. Phenyl-3H-benzimidazale-5-sulfonic acid).
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 because it would have required no more than an ordinary level of skill in the art to produce the cosmetic sunscreens in accordance with the teachings of JANSEN et al. Therefore, the invention as a whole would have been 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.
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over JANSEN as applied to claims 1-4, 6-8, 10 and 15 above, and further in view of NGUYEN (US 2010/0322876 A1; published December, 2010) and/or BARRETT (US 2013/0243703 A1; September, 2013).
Applicants Claims
Cosmetic composition comprising (i) bemotrizinol (INCI: bis-ethylhexylphenol methoxyphenyl triazine), (ii) a water-soluble organic UV filter or a salt thereof, (iii) at leas one inorganic UV filter, as discussed above. And further claims specific “wherein the cosmetic composition is considered water resistant in accordance with the contact angle measurement method having a contact angle of more than 30°.” (instant claim 14).
Determination of the scope
and content of the prior art (MPEP 2141.01)
JANSEN discloses/teaches sunscreen compositions with low stickiness, as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of JANSEN is that JANSEN does not expressly teach the contact angle (instant claim 14).
NGUYEN teaches compositions and methods of using the compositions to treat keratinous substrates (title, see whole document), the compositions provide a water resistant and non-transferable protective barrier on the substrate (abstract). NGUYEN teaches sunscreens ([0131]) including a sunscreen formulation ([0182]) having water resistance ([0185] to [0187]), the compositions including a contact angle of at least 66 degrees ([0180], claim 1)(instant claim 14).
BARRETT teaches self adapting polymers for anhydrous sunscreen formulations (title, see whole document), and particularly that: “These polymers then rearrange upon contact with water so that the hydrophobic groups now point to the surface which then increases the water resistance of the formulation.” (abstract). BARRETT teaches that: “The sunscreen compositions described herein include a polymer additive that becomes more hydrophobic upon exposure to water. In accordance with certain aspects of the present invention, the conversion of a relatively hydrophilic polymer to a more hydrophobic one can be determined by measuring the contact angle of formulations containing the polymer. In accordance with certain aspects, the polymer additive is present in an amount sufficient to increase the contact angle of the formulation by at least 5 degrees, more particularly at least about 10 degrees after immersion in water. In accordance with some aspects of the present invention, the final contact angle of the formulation may be 60° or higher to impart water resistance to the formulation.” ([0024])(instant claim 14).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a cosmetic composition such as a sunscreen comprising bemotrizinol, Phenyl-3H-benzimidazole-5-sulfonic acid, and zinc oxide, as discussed above and further to produce the sunscreen formulation as a water-resistant or water-proof sunscreen with a contact angle of greater that about 60°, as taught by NGUYEN and/or BARRETT, in order to improve adherence of the sunscreen composition to the skin while swimming, for example, at a beach.
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 because it would have required no more than an ordinary level of skill in the art to produce the cosmetic sunscreens in accordance with the teachings of JANSEN et al. Therefore, the invention as a whole would have been 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.
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-4, 5-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-16 of copending Application No. 18/797,592 (hereafter, ‘592) in view of JANSEN (US 2022/0387281 A1; published December, 2022); JOHNCOCK (US 2015/0265510 A1; published September, 2015); and NGUYEN (US 2010/0322876 A1; published December, 2010) and/or BARRETT (US 2013/0243703 A1; September, 2013).
Instant claims are discussed above.
Copending ‘592 claim 1 recites Sunscreen or daily care composition comprising (i) bis-ethylhexyloxyphenol methoxyphenyl triazine (bemotrizinol), (ii) 1-(4-(1, 1-dimethylethyl)phenyl)-3-(4-methoxyphenyl)propane-1,3-dione (avobenzone), and (iii) titanium dioxide; wherein the sunscreen or daily care composition is free of UV filters selected from the group consisting of 4,4',4"-(1,3,5-triazine-2,4,6-triyltriimino)tris-benzoic acid-tris(2-ethylhexyl)ester (octyl triazone), hexyl 2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate (INCI diethylamino hydroxybenzoyl hexyl benzoate), 2,2'-Methylenbis[6-(2H-benzotriazol-2-yl)-4-(1, 1,3,3-tetramethylbutyl)phenol] (bisoctrizole), 3,3,5-Trimethylcyclohexyl 2 hydroxybenzoate (INCI Homosalate), (RS)-2-Ethylhexyl (2E)-3-(4-methoxyphenyl)prop-2-enoate (octinoxate), 2-ethylhexyl 2-cyano-3,3-diphenylprop-2-enoate (INCI octocrylene), and 2-hydroxy-4- methoxybenzophenone (oxybenzone). Copending ‘592 claim 2 recites wherein the sunscreen or daily care composition comprises phenylbenzimidazole sulfonic acid (Enzulizole). ‘592 claim 5 recites wherein the sunscreen or daily care composition comprises zinc oxide.
The difference between the instantly rejected claims and the claims of copending ‘592 is that the claim of copending ‘592 do not expressly claim the amount of phenylbenzimidazole sulfonic acid (Enzulizole) or zinc oxide (instant claims 11-13); the inclusion of a neutralizing agent (instant claims 8-9 & 11-13), or Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate copolymer (instant claim 10).
JANSEN discloses/teaches sunscreen compositions with low stickiness, as discussed above and incorporated herein by reference. And particularly teaches the amounts of in the claimed ranges (instant claims 11-13)([0026] & [0028]), the inclusion of a Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate copolymer ([0094]).
JOHNCOCK teaches sunscreen formulations including specific neutralizing agents including amounts, as discussed above and incorporated herein by reference.
NGUYEN teaches compositions and methods of using the compositions to treat keratinous substrates, having a contact angle of at least 66 degrees, as discussed above and incorporated herein by reference.
BARRETT teaches self adapting polymers for anhydrous sunscreen formulations the final contact angle of the formulation may be 60° or higher to impart water resistance to the formulation, as discussed above and incorporated herein by reference.
It would have been prima facie obvious before the effective filing date of the claimed invention that the instantly rejected claims are an obvious variant of the claims of copending ‘592 because it would have been prima facie obvious to select the combination of UV-filters, as now claimed, from the claims of ‘592 for producing a UV-screening cosmetic composition. The skilled artisan would have been motivated to modify the claims of copending ‘592 and produce the instantly rejected claim because the selection of an organic UVA (Bemotrizinol) + UVB (Ensulizole) along with an inorganic UVA (zinc oxide) + UVB (titanium dioxide) would have produced a broad spectrum UV-screening composition. Furthermore, the skilled artisan would have had a reasonable expectation of success in producing the invention of the instantly rejected claims because it would have required no more than an ordinary level of skill to select known sunscreen formulation ingredients and combine them to produce the same.
This is a provisional obviousness-type double patenting rejection.
Citation of Pertinent Art:
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ruiz et al. (“Preliminary clinical pharmacokinetic evaluation of bemotrizinol - A new sunscreen active ingredient being considered for inclusion under FDA’s over-the-counter (OTC) sunscreen monograph”, 2023, ELSEVIER; Regulatory Toxicology and Pharmacology, Vol. 139, Article 105344, pp. 1-8) is cited as teaching regulatory approval of Bemotrizinol (see whole document).
Conclusion
Claims 1-15 are pending and have been examined on the merits. The abstract of the disclosure is objected to, and claims 1-15 are objected to. Claims 1-4, 6-9 and 15 are rejected under 35 U.S.C. 102(a)(1); claims 1-15 are rejected under 35 U.S.C. 103; and claims are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/797,592. No claims allowed at this time.
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/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
Prosecution Insights