DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ claimed invention, filed 27 June 2024, in the matter of Application N° 18/756,678. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The original claims are at issue; no additions, amendments, or cancellations have been made. The issue of new matter is moot.
Thus, claims 1-20 represent all claims currently under consideration.
Information Disclosure Statement
One Information Disclosure Statement (IDS) filed 5 February 2025 is acknowledged and has been considered.
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.
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 and 12-14 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 8, the phrase “preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP §2173.05(d).
Additionally, regarding claim 8, the phrase “nature-based” renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by “-based”), thereby rendering the scope of the claim unascertainable. See MPEP §2173.05(d), pertaining to “or the like”.
Claim 12 recites the limitation “of amphoteric surfactant…” in the first line of the claim. There is insufficient antecedent basis for this limitation in claims 1 and 2 because the limitation is recited as “the at least one amphoteric surfactant…”.
Claim 13 recites the limitation “of glycolipid…” in the first line of the claim. There is insufficient antecedent basis for this limitation in claims 1 and 3 because the limitation is recited as “at least one glycolipid…”.
Claim 14 recites the limitation “of cationic polymer…” in the first line of the claim. There is insufficient antecedent basis for this limitation in claims 1 and 4 because the limitation is recited as “at least one cationic polymer…”.
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. Applicants are 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Okuda et al. (WO 2024/262649 A1) as further evidenced by Madan et al. (J. Am. Acad. Dermatol.; 2014).
The limitations recited by instant claim 1 are directed to a composition (“coacervate cleansing system”) comprising:
at least one amphoteric surfactant (e.g., hydroxysultaine or coco-betaine);
at least one glycolipid (e.g., rhamnolipids, sophorolipids);
at least one cationic polymer (e.g., chitosan, hyaluronic acid);
at least one acne treatment active; and
at least one cosmetically active solvent;
wherein the composition is essentially free of phenoxyethanol,
wherein the pH of the composition is between 4 and 8 (e.g., 4.5 to 7.5),
wherein the weight ratio of (a) to (b) is from about 0.4:1 to about 4:1, and
wherein the total concentration of (a) and (b) together is from about 10% to about 20% of the total weight of the composition.
Okuda discloses a skin cosmetic composition comprising at least one cationic polymer selected from chitosans, and at least one glycolipid such as rhamnolipids (see e.g., claims 1 and 3). Additional glycolipid species are disclosed and include: glucolipids, sophorolipids, trehalolipids, cellobiose lipids, and mixtures thereof (see e.g., pg. 6, first paragraph).
The concentration of the cationic polymer within the practiced composition is most preferably disclosed as ranging from 0.1% to 5% by weight of the total composition (see e.g., claim 2). Examples 1-5 of Table 1 (see pg. 24) disclose that chitosan is present in an amount of 1 wt%.
The reference also discloses that the composition will comprise at least one amphoteric surfactant in an amount ranging as broadly as 0.01-20% by weight, and most preferably ranging from 1-10% by weight of the total composition (see claims 6 and 7).
The foregoing is considered to teach the limitations for the cationic polymer, the amount of the polymer, the amphoteric surfactant, and the combined amount of both components (a) and (b).
Claim 12 of the reference discloses that the practiced composition will have a pH from 4-8, preferably from 4.5 to 7.5, and most preferably from 5-7.
Claim 5, for instance, discloses that the practiced composition further comprises water (solvent).
The practiced compositions are also taught as comprising such optional ingredients as preservatives such as phenoxyethanol (see pg. 20, lines 21-22). As such an ingredient is disclosed as being optional, it is not required and therefore meets the recited exclusionary limitation in claims 1 and 18.
The foregoing is considered to meet the limitations recited by instant claims 1, 3, 4, 10-12, 14, and 17.
The amphoteric surfactant species recited by instant claims 2 and 9 are disclosed by the reference with cocamidopropyl hydroxysultaine and coco-betaine (cocobetaine) being preferably taught (see pg. 14, lines 7-42, especially lines 33-41).
The glycolipid limitations recited by claim 13 are disclosed by claim 4 of the reference as preferably ranging from about 0.1-10%, and most preferably from 1-5% by weight of the total composition.
The limitations recited by instant claims 7 and 8 are met by the reference’s disclosure of using a mixture of chitosans, whereby they differ on the basis of their molecular weight (see e.g., claim 15).
The limitations of claims 5, 6, 15, and 16 are directed to the acne active agent (e.g., salicylic acid).
The reference discloses that the practiced composition may further comprise at least one monovalent, non-polymeric acid or a salt thereof, with one of two preferred embodiments being salicylic acid (see e.g., claim 10). The non-polymeric acid component is further taught as most preferably being present in an amount ranging from about 0.1-5% by weight of the total composition (see e.g., claim 11).
The Examiner acknowledges that while the reference does teach and suggest the use of salicylic acid in a skin cosmetic composition, it does not expressly brand it as being an “acne treatment active” as instantly claimed.
At the outset, the Examiner advances that the disclosure of salicylic acid meets the compositional definition of the “acne treatment active” as instantly claimed. MPEP §2112.01(I) states that “[p]roducts of identical chemical composition cannot have mutually exclusive properties” and that “[a] chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” Thus, the Examiner submits that Okuda’s disclosure of salicylic acid also discloses its functionality as an acne treatment active agent. Evidence in support of this state-of-the-art knowledge is provided, for instance, by Madan et al. (see e.g., pg 788, left col., third paragraph).
The foregoing is also considered to teach the limitations recited by claim 18, particularly owing to the claim being an amalgamation of the separately recited limitations already addressed.
The limitations of claims 19 and 20 are directed a method for depositing at least one acne treatment active to the skin during cleansing comprising the composition recited by claim 1. Claim 20 recites the added step of wetting the skin prior to application of the composition.
Okuda discloses that its practiced skin cosmetic compositions are preferably used as skin cleansing compositions (see e.g., claim 15), whereby the method for using acknowledges that the skin may be wet prior to application (see e.g., pg. 23, lines 7-10).
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition and arriving at the recited method of treatment. 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, and absent a clear showing of evidence to the contrary.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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