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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 3, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 3 and 5 are cancelled.
Claims 1, 2, 4, and 6 – 20 are examined here-in.
Claim Objections
Claims 1, 2, 4, 17, 18, and 20 are objected to because of the following informalities:
Claims 1, 2, 4, 17, and 18 each refer to UVA and UVB, however the presence or absence of a dash in UV-A and UV-B is inconsistent throughout these claims. Either UVA and UVB (the terms without a dash) or UV-A and UV-B (with a dash) should be used consistently throughout these claims.
In claim 17, there are no articles (“and” or “or”) between the listed ingredients. For example, “from 1 to 15 wt% of an oil-soluble UVB sunscreen, wherein the oil-soluble UVB sunscreen is t-butylmethoxy dibenzoylmethane, octyl salicylate, and octocrylene…” or “from 1 to 15 wt% of an oil-soluble UVB sunscreen, wherein the oil-soluble UVB sunscreen is t-butylmethoxy dibenzoylmethane, octyl salicylate, or octocrylene…”. This change should be made for parts i – vii where applicable.
In claim 20 “acrylates copolymer” and “magnesium carbonate” are each capitalized. These terms are not proper nouns and should not be capitalized.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1 – 20 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The term “high” in claims 1 and 17 is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In other words, it is not clear how high the SPF of a composition to be a “high SPF” composition.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 6 – 9, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johncock (EP 2,921,157 B1).
Johncock teaches cosmetic and pharmaceutical compositions for protecting the skin against UV radiation (paragraph 0001).
Johncock’s example 7 includes octocrylene in the amount of 8% w/w, phenylbenzimidazole sulfonic acid in the amount of 1% w/w, xanthan gum in the amount of 0.4% w/w, cetearyl nonanoate in the amount of 1% w/w, 1,2-hexanediol and caprylyl glycol in the amount of 0.5% w/w, and silica-modified dimethicone/vinyl dimethicone crosspolymer in the amount of 0.5% w/w (Table 7), anticipating instant claims 1, 2, 4, 6 – 9, and 11.
Each of the ingredients listed for Johncock’s example 7 above read on the ingredients i – vi recited in claim 1, with the amounts taught by Johncock each falling within the ranges claimed. Specific examples in the prior art that fall within the claimed range are anticipatory according to MPEP 2131.03(ii).
Johncock’s example 7 with octocrylene in the amount of 8% w/w and phenylbenzimidazole sulfonic acid in the amount of 1% w/w (Table 7) is “about” a ratio of 5:1 as recited in instant claim 1. Notably, the instant specification does not define or limit the term “about”, therefore a ratio of 8:1 as taught in Johncock’s example 7 is interpreted to be about a ratio of 5:1 as recited in instant claim 1.
Johncock’s example 7 with octocrylene (also known as 2-ethylhexyl-2-cyano-3,3-diphenyl-2-propenoate) anticipates instant claim 2.
Johncock’s example 7 with octocrylene in the amount of 8% w/w falls within the claimed range of 0.1 to 20 wt%, anticipating instant claim 4.
Johncock’s example 7 includes xanthan gum, anticipating instant claim 6.
Johncock’s example 7 includes 1,2-hexanediol and caprylyl glycol, anticipating instant claim 7.
Johncock’s example 7 includes silica-modified dimethicone/vinyl dimethicone crosspolymer, anticipating instant claim 8.
Johncock’s example 7 includes water in the amount of 40.55% w/w, falling within the range of 10 to 70 wt% as recited in claim 9. Specific examples in the prior art that fall within the claimed range are anticipatory according to MPEP 2131.03(ii).
Johncock’s example 7 has an expected SPF of 30 (paragraph 0186, Table 7), anticipating instant claim 11.
However, in the event that the previous does not have sufficient specificity to rise to anticipation, claims 1, 2, 4, 6 – 9, and 11 are also rejected under 35 U.S.C. 103 below.
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 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 non-obviousness.
Claims 1, 2, 4, and 6 – 18 are rejected under 35 U.S.C. 103 as being unpatentable over Johncock (as cited above).
For the purposes of this ground of rejection only, and purely arguendo, the examiner will take the position that Johncock does not teach a specific embodiment (i.e., preferred embodiment, working example, etc.) having all of the claimed elements arranged as required by claims 1, 2, 4, 6 – 9, and 11 without resorting to some “picking and choosing” within the prior art disclosure. That being said, although Johncock thus would not be anticipatory by this interpretation of the facts, it nevertheless does fairly suggest the claimed invention, as shown below.
Johncock teaches cosmetic and pharmaceutical compositions for protecting the skin against UV radiation (paragraph 0001).
Johncock teaches octisalate (also known as octyl salicylate), octocrylene (also known as 2-ethylhexyl-2-cyano-3,3-diphenyl-2-propenoate), ethylhexyl methoxycinnamate (also known as octyl methoxycinnamate), and phenylbenzimidazole sulfonic acid, among others as UV filters to be included in the composition in an amount of 0.1 to 65 wt. % (paragraphs 0032 – 0033, 0040 – 0044).
Johncock teaches water-soluble phenylbenzimidazole sulfonic acid and salts should be included in an amount of 0.1 to 10.0% of the total formulation (paragraphs 0046 – 0048).
Johncock teaches oil-soluble octocrylene or ethylhexyl methoxycinnamate should be included in an amount of 0.1 to 20.0% of the total formulation (paragraphs 0050 – 0053).
Johncock teaches polymeric thickeners such as hydrophobic silicas, polysaccharides, and other polymers are suitable thickeners for inclusion in the composition (paragraph 0095).
Johncock teaches glycerol, propylene glycol, butylene glycol, and water as liquid carrier materials for the composition (paragraph 01101 – 0112).
Johncock teaches solid carrier materials such as starches, silicon dioxide, and polysaccharide gums including xanthan gum (paragraph 0111).
Johncock teaches phenoxyethanol as a preservative (paragraph 0113).
Johncock teaches the inclusion of niacinamide in an amount of 0.1 to 10% by weight (paragraph 0162).
Johncock teaches the composition may be in the form of a gel and is preferably administered to the skin (paragraphs 0071 – 0072, 0075, 0116).
Claims 1, 2, 4, and 6 - 18 are rendered prima facie obvious over the teachings of Johncock, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results (MPEP 2143(i)(a)). In the instant case, all the claimed elements (e.g., an oil-soluble sunscreen, a water-soluble sunscreen, a water phase thickener, an oil phase thickener, a humectant, and a sensory modifier) were known in the prior art (e.g., cosmetic and pharmaceutic compositions) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (e.g., an SPF composition with the claimed ingredients) to one of ordinary skill in the art.
Johncock’s teaching for oil-soluble sunscreens including octisalate (also known as octyl salicylate), octocrylene (also known as 2-ethylhexyl-2-cyano-3,3-diphenyl-2-propenoate), ethylhexyl methoxycinnamate (also known as octyl methoxycinnamate), and water-soluble sunscreen phenylbenzimidazole sulfonic acid, to be included in a cosmetic composition in an amount of 0.1 to 65 wt. % (paragraphs 0032 – 0033, 0040 – 0044); but specifically oil-soluble octocrylene or ethylhexyl methoxycinnamate in an amount of 0.1 to 20.0% of the total formulation (paragraphs 0050 – 0053) and water-soluble phenylbenzimidazole sulfonic acid in an amount of 0.1 to 10.0% of the total formulation (paragraphs 0046 – 0048) reads on instant claim 1 parts i and ii. Johncock’s taught range of 0.1 to 20.0% oil-soluble octocrylene or ethylhexyl methoxycinnamate (paragraphs 0050 – 0053) and 0.1 to 10.0% water-soluble phenylbenzimidazole sulfonic acid (paragraphs 0046 – 0048) overlap on the instantly claimed ranges of 0.1 to 25 wt. % and 0.1 to 5 wt. % as recited in parts i and ii of claim 1. Further, Johncock’s taught range of 0.1 to 20.0% oil-soluble octocrylene or ethylhexyl methoxycinnamate (paragraphs 0050 – 0053) and 0.1 to 10.0% water-soluble phenylbenzimidazole sulfonic acid (paragraphs 0046 – 0048) produces various ratios, with 20% oil-soluble sunscreen and 4% water-soluble sunscreen producing a ratio of 5:1 as recited in claim 1. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Johncock’s inclusion of xanthan gum in examples 1, 4 – 9, 11 – 13, and 16 – 19 ranges from 0.1 to 0.5% w/w (Tables 1, 4 – 9, 11 – 13, 16 – 19), overlapping on the instantly claimed range of 0.25 to 5 wt. % as recited in part iii of claim 1. Johncock’s inclusion of caprylic/capric triglyceride in examples 2, 10, 12, 14, and 16 – 19 ranges from 0.5 to 10% w/w (Tables 2, 10, 12, 14, 16 – 19), overlapping on the instantly claimed range of 0.5 to 10% of an oil phase thickener as recited in part iv of claim 1.
Johncock’s teaching for glycerol, propylene glycol, and butylene glycol, among others (paragraph 0110 – 0112) with example amounts of propylene glycol ranging from 1 to 5% w/w (Tables 8, 10, 16 – 19) reads on part v of claim 1 which recites 0.5 to 15% of a humectant selected from a glycerol, glycol, or combination thereof.
Johncock’s teaching for dimethicone / vinyl dimethicone crosspolymer silica in amounts ranging from 0.5 to 2% (Tables 5 – 8, 14) reads on part vi of claim 1, which recites 0.5 to 10 wt% of a sensory modifier selected from a modified starch, silica microsphere, a polymer of dimethicone / vinyl dimethicone cross polymer silica or combinations thereof.
Johncock’s teaching for oil-soluble sunscreens including octisalate (also known as octyl salicylate), octocrylene (also known as 2-ethylhexyl-2-cyano-3,3-diphenyl-2-propenoate), and ethylhexyl methoxycinnamate (also known as octyl methoxycinnamate) (paragraphs 0032 – 0033, 0040 – 0044) reads on instant claim 2.
Johncock’s taught range of 0.1 to 20.0% oil-soluble octocrylene or ethylhexyl methoxycinnamate (paragraphs 0050 – 0053), which are both UV-B sunscreens, overlaps on the instantly claimed range of 0.1 to 20 wt. % as recited in claim 4. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Johncock’s teaching for xanthan gum as a polysaccharide gum (paragraph 0095, Tables 1, 4 – 9, 11 – 13, 16 – 19), reads on instant claim 6.
Johncock’s teaching for glycerol, propylene glycol, and butylene glycol, among others (paragraph 0110 – 0112) reads on instant claim 7.
Johncock’s teaching for dimethicone / vinyl dimethicone crosspolymer silica (Tables 5 – 8, 14) reads on instant claim 8.
Johncock teaches the composition contains water in an amount of 5 to 80% by weight (paragraph 0120) overlapping on the instantly claimed range of 10 to 70 wt. % recited in claim 9.
Johncock teaches the composition may contain emulsifiers, but does not require the inclusion of emulsifiers (paragraph 0074). A person of ordinary skill in the art would be motivated to exclude an emulsifier from the composition because additional ingredients have the potential to disrupt the balance of chemicals in the composition thus impacting the form and feel of the composition, reading on instant claim 10.
Johncock’s examples 1, 7, 9, 12 and 13 have expected SPFs of at least 30 (Tables 1, 7, 9, 12, 13), reading on instant claim 11.
Johncock’s teaching that the composition is administered to the skin for protection from UV exposure (paragraphs 0071 – 0072, 0075, 0116, 0176, Figures 2, 3) reads on instant claim 12.
Johncock’s teaching for dimethicone / vinyl dimethicone crosspolymer silica in amounts ranging from 0.5 to 2% (Tables 5 – 8, 14) overlaps on the claimed range of 1 to 3.5 wt. % as recited in claim 13.
Johncock teaches silicone oil is suitable for inclusion in the composition (paragraphs 0085, 0099) with a specific example of cyclopentasiloxane (which is a volatile silicone oil) in examples 1 – 3 and 16 – 18 (Tables 1 – 3, 16 – 18), reading on instant claim 14.
Johncock’s teaching to include niacinamide in the composition (paragraph 0162) reads on instant claim 15.
Johncock’s teaching to include phenoxyethanol as a preservative (paragraph 0113) reads on instant claim 16.
Johncock’s teaching for oil-soluble sunscreens including octisalate (also known as octyl salicylate), octocrylene (also known as 2-ethylhexyl-2-cyano-3,3-diphenyl-2-propenoate), ethylhexyl methoxycinnamate (also known as octyl methoxycinnamate), tret-nutyl-4’-methoxydibenzoylmethane, and water-soluble sunscreen phenylbenzimidazole sulfonic acid, to be included in a cosmetic composition in an amount of 0.1 to 65 wt. % (paragraphs 0032 – 0033, 0040 – 0044, 0050); where the oil-soluble sun protectants are in an amount of 0.1 to 20.0% of the total formulation (paragraphs 0050 – 0053) and water-soluble phenylbenzimidazole sulfonic acid in an amount of 0.1 to 10.0% of the total formulation (paragraphs 0046 – 0048) reads on instant claim 17 parts i – iii. Johncock’s taught range of 0.1 to 20.0% oil-soluble sun protectants (paragraphs 0050 – 0053) and 0.1 to 10.0% water-soluble phenylbenzimidazole sulfonic acid (paragraphs 0046 – 0048) overlap on the instantly claimed ranges of 1 to 15 wt. %, 1 to 4 wt. %, and 1 to 4 wt. % as recited in parts i – iii of claim 17. Further, Johncock’s taught range of 0.1 to 20.0% oil-soluble sun protectant (paragraphs 0050 – 0053) and 0.1 to 10.0% water-soluble phenylbenzimidazole sulfonic acid (paragraphs 0046 – 0048) produces various ratios, with 10% oil-soluble sunscreen and 2% water-soluble sunscreen producing a ratio of 5:1 as recited in claim 17. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Johncock’s inclusion of xanthan gum in examples 1, 4 – 9, 11 – 13, and 16 – 19 ranges from 0.1 to 0.5% w/w (Tables 1, 4 – 9, 11 – 13, 16 – 19), overlapping on the instantly claimed range of 1 to 3 wt. % as recited in part iv of claim 17. Johncock’s inclusion of caprylic/capric triglyceride in examples 2, 10, 12, 14, and 16 – 19 ranges from 0.5 to 10% w/w (Tables 2, 10, 12, 14, 16 – 19), overlapping on the instantly claimed range of 1 to 3% of an oil phase thickener as recited in part v of claim 17.
Johncock’s teaching for glycerol and caprylene glycol (paragraph 0110 – 0112) in ranges of 2 to 9% w/w (Tables 1 – 9, 12, 15 – 19) and 0.3 to 1% w/w (Tables 2, 4 – 8, 10, 12, 13) reads on part vi of claim 17 which recites 1 to 8 wt. % glycerol and caprylyl glycol.
Johncock’s teaching for dimethicone / vinyl dimethicone crosspolymer silica in amounts ranging from 0.5 to 2% (Tables 5 – 8, 14) reads on part vii of claim 17, which recites 1 to 5 wt% of a sensory modifier of silica microsphere, a polymer of dimethicone / vinyl dimethicone cross polymer silica, and optionally a starch.
Although Johncock does not specifically teach a weight ratio of oil-soluble UVB sunscreen to oil-soluble UVA sunscreen is 9:3 to 1, as recited in claim 18, Johncock does teach the total amount of oil-soluble sun protectants are in a range of 0.1 to 20.0% (paragraphs 0050 – 0053). A person of ordinary skill in the art would have the necessary expertise to arrive at such a weight ratio through routine experimentation, which is prima facie obvious according to MPEP 2144.05(ii). For example, a person of ordinary skill in the art would be motivated to start with a simple ratio of 3:1, where each oil-soluble UVB sunscreen is present as 1 (there are three oil-soluble UVB sunscreens), then increase the relative amount of oil-soluble UVB sunscreen as needed. According to MPEP 2144.05(ii)(a) differences in concentration do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Johncock (as cited above) in view of Fuscelli (US 2007/0269389 A1).
Johncock’s teachings are discussed above.
Johncock does not teach the inclusion of a starch that is aluminum starch octenylsuccinate (claim 19) or aluminum starch octenylsuccinate, acrylates copolymer, and magnesium carbonate (claim 20).
Fuscelli teaches the missing element of Johncock.
Fuscelli teaches cosmetic compositions which have a high resistance to water and sweat (abstract). Fuscelli teaches agents that promote the adsorption of oiliness, thus modifying the sensorial capacity of the composition (paragraph 0118). Fuscelli teaches acrylate polymers, magnesium carbonate, and modified starch octenylsuccinate aluminum starch as oiliness absorbing agents (paragraph 0118).
The combination of Johncock and Fuscelli’s teachings renders claims 19 and 20 prima facie obvious as combining prior art elements according to known methods to yield predictable results. A person of ordinary skill in the art would be motivated to include Fuscelli’s oil-adsorbing agents aluminum starch octenylsuccinate, acrylates polymer, and magnesium carbonate in Johncock’s composition to modify the feeling of oiliness the composition has on the skin. Fuscelli’s oil-adsorbing agents are known prior art elements and their combination with Johncock’s composition would yield predictable results (i.e. a composition that feels less oily) which is prima facie obvious according to MPEP 2143(i)(a).
The combination of Johncock’s teachings for a composition with oil-soluble sunscreens, water-soluble sunscreen phenylbenzimidazole sulfonic acid, xanthan gum, caprylic/capric triglyceride, glycerol and caprylene glycol, and dimethicone / vinyl dimethicone crosspolymer silica (paragraphs 0032 – 0033, 0040 – 0044, 0046 – 0048, 0050 – 0053, 0110 – 0112, Tables 1 - 19) with Fuscelli’s teachings for acrylate polymers, magnesium carbonate, and modified starch octenylsuccinate aluminum starch as oiliness absorbing agents (paragraph 0118) reads on instant claim 19 and 20. A person of ordinary skill in the art would be motivated to include Fuscelli’s oil-adsorbing agents in Johncock’s composition to modify the feeling of oiliness the composition has on the skin.
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights