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 1-20 are pending and under current examination.
Priority
Priority has been claimed to US PRO 63/603,902, filed 11/29/2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/27/2024 and 05/16/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the Examiner.
Claim Objections
Claim 12 is objected to because of the following informalities: claim 12 recites “camellia sinensis leaf extract” in line 3 and “tea (camellia sinensis) leaf extract in lines 4-5”; it is suggested that one of these instances be omitted.
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.
Claim 10 is 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.
Claim 10 recites “wherein the polyhydroxy benzoic acid compound is selected from the group consisting of gluconolactone, 2-hydroxy benzoic acid, 3-hydroxy benzoic acid, 4-hydroxy benzoic acid,...”. This is indefinite as gluconolactone is an oxidized glucose derivative which is not known to be a polyhydroxy benzoic acid compound. Further, 2-hydroxy benzoic acid, 3-hydroxy benzoic acid, and 4-hydroxy benzoic acid each comprise only one hydroxy group, and thus are not known as polyhydroxy compounds. It is unclear how the polyhydroxy benzoic acid of claim 9 (from which claim 10 depends) can be selected from gluconolactone, 2-hydroxy benzoic acid, 3-hydroxy benzoic acid, and 4-hydroxy benzoic acid, and the metes and bounds of the claim are uncertain.
For purposes of examination and applying prior art, the polyhydroxy benzoic acid of claim 9 is interpreted to be inclusive of the compounds recited in claim 10.
Claim Interpretation
The “prickly pear” recited in instant claim 1 is interpreted as inclusive of an extract of prickly pear, as exemplified in the instant specification in compositions prepared in accordance with the invention (paragraph [0091]; see also paragraphs [0005], [0052], and [0062]).
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 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 1-14 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al. (US 2017/0189325 A1, published July 6th, 2017), hereafter “Wilson” in view of Moy et al. (US 2022/0362121 A1, published November 17th, 2022), hereafter “Moy”, and Shaffer et al. (WO 1994/27569, published December 8th, 1994; included on IDS submitted 11/27/2024), hereafter “Shaffer”.
Regarding instant claims 1 and 18, Wilson teaches compositions useful to cleanse, exfoliate, smooth, moisturize, hydrate, sooth, soften and/or improve the appearance and/or condition of the skin (see entire document, particularly Abstract and claim 11); the composition comprises prickly pear extract (claim 17). Wilson teaches the inclusion of prickly pear extract from 0.0001 to 1% w/w (paragraph [0012]). Wilson teaches that compositions can include a vitamin in an amount ranging from 0.0001% to 99.9% by weight or ranges between (paragraph [0024]), and vitamins can be e.g., vitamin B (paragraph [0056]). The amounts of prickly pear extract and vitamin B taught by Wilson overlap the ranges of the instant claims; per MPEP 2144.05 I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”. The compositions of Wilson can include exfoliants (paragraph [0056]) and examples of exfoliating agents include glycolic acid, lactic acid, citric acid, alpha hydroxy acids, and beta hydroxy acids (paragraph [0072]). The compositions can be contained in kits into which compositions and desired dispensers are retained (paragraph [0088]).
Regarding instant claim 2, as noted above, Wilson teaches that the composition can comprise exfoliating agents including alpha and beta hydroxy acids (paragraph [0072]).
Regarding instant claim 3, as noted above, Wilson teaches that the composition can comprise exfoliating agents including glycolic acid, lactic acid, and citric acid (paragraph [0072]).
Regarding instant claim 4, as noted above, Wilson teaches that the composition can comprise exfoliating agents including lactic acid (paragraph [0072]).
Regarding instant claims 11-12, Wilson teaches that the compositions are capable of soothing dry skin (claim 11, paragraph [0003]), and can include moisturizing agents such as avocado oil (paragraphs [0059]-[0061]), skin conditioning agents such as allantoin (paragraph [0056]), and botanical extract such as aloe vera (paragraph [0056]). Amounts of ingredients can be varied by a person of ordinary skill in the art in amounts between 0.0001% to 99% by weight or ranges therein (paragraph [0051]).
Regarding instant claims 13-14, Wilson teaches that the composition can comprise a humectant (paragraphs [0020] and [0056]), and the composition is taught to include glycerin (claim 18). In an embodiment, the composition comprises 1 to 10% w/w of glycerin (paragraph [0030], Embodiment 26).
Regarding instant claim 17, as noted above, Wilson teaches that the composition can comprise exfoliating agents including glycolic acid and lactic acid (paragraph [0072]).
Regarding instant claim 20, Wilson teaches that the composition can be in the form of a gel (paragraph [0020]).
Wilson does not explicitly teach that the composition comprises from about 2 to about 23 wt.% of a plurality of hydroxy acids, and does not teach a pad containing the composition (instant claims 1 and 18) or the composition impregnated in the pad (instant claim 19) wherein the pad comprises a gel phase (instant claim 20). Wilson does not teach that the alpha hydroxy acid is present from 1 to about 16 wt.% (instant claim 5), the specific beta hydroxy acids of claims 6-7, or that the beta hydroxy acid is present from about 0.5 to about 10 wt.% (instant claim 8). Wilson does not teach the inclusion of a polyhydroxy benzoic acid, a polyhydroxy benzoic ester, a hydrate thereof, or a combination thereof (instant claim 9) wherein the polyhydroxy benzoic acid compound is selected from those recited in instant claim 10.
Moy teaches personal care compositions for improving the appearance and/or health of the skin comprising an alpha hydroxy acid, a beta hydroxy acid, and a polyhydroxy acid comprising gluconodeltalactone (see entire document, particularly Abstract and claims 35 and 47). The composition comprises alpha hydroxy acids (e.g., citric acid, glycolic acid, mandelic acid, lactic acid, malic acid, tartaric acid, and combinations thereof), in an amount from about 2 to about 22 wt. % or from about 7 to about 15 wt.% (claims 47-49, paragraphs [0056]-[0057], and Table 1 at paragraph [0078]). The composition comprises beta hydroxy acids (e.g., salicylic acid; sodium salicylate; beta hydroxybutanoic acid; tropic acid; trethocanic acid, and combinations thereof) in an amount from about 0.5 to about 10 wt.%, or from about 1.5 to about 3 wt. % (claims 47-48 and 50, paragraphs [0058]-[0059], and Table 1 at paragraph [0078]). The composition comprises poly hydroxy acid(s) (e.g., glucolatone, galactose, and lactobionic acid) in an amount from about 2 to about 20 wt. %, or about 7 to about 20 wt. (claims 47-48 and 51, paragraphs [0060]-[0061], and Table 1 at paragraph [0078]). Using the amounts of hydroxy acids of claim 48, Moy teaches a plurality of hydroxy acids in an amount of 4.5-52% by weight, overlapping the claimed range. Moy teaches that the formulations exfoliate the skin, making it smooth and soft (paragraph [0005]), and teaches that the compositions can comprise humectants and soothing agents (paragraphs [0062]-[0065]). Moy teaches that the formulations may be formulated as a gel and applied with pads (paragraph [0087]), suggesting that the pad contains the formulation as a gel phase prior to administration.
Schaffer teaches a skin care composition for exfoliating and moisturizing which is presaturated (impregnated) into a convenient cosmetic applicator pad; the composition comprises an exfoliating and moisturizing ingredient of at least one alpha hydroxy acid (see entire document, particularly Abstract and claim 22). The pads can have a selected degree of abrasiveness and can be presaturated with a desired quantity of exfoliating agent (pg. 7, lines 29-38). The pad can debride the skin, providing better penetration of the skin layers by alpha hydroxy acids (pg. 10, lines 27-36).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the compositions of Wilson with the specific plurality and amounts of hydroxy acids suggested by Moy. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to achieve a skin care composition that exfoliates the skin, making it smooth and soft, while delivering a low stinging or pain sensation upon application, as suggested by Moy (paragraphs [0005]-[0006]). There is a reasonable expectation of success as the compositions of Wilson useful to cleanse, exfoliate, smooth, moisturize, hydrate, sooth, soften and/or improve the appearance and/or condition of the skin and are taught to include hydroxy acid exfoliants.
It would further have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to contain and impregnate the composition of Wilson in a pad comprising the composition as a gel phase, as suggested by Moy and Shaffer. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to incorporate the composition into an applicator known in the art for the application of exfoliating compositions to the skin, as suggested by Moy, and particularly into an applicator that can deliver a desired quantity of exfoliating agent while debriding the skin and providing better penetration of exfoliating hydroxy acids, as suggested by Shaffer. There is a reasonable as the compositions of Wilson useful to cleanse, exfoliate, smooth, moisturize, hydrate, sooth, soften and/or improve the appearance and/or condition of the skin, are taught to include hydroxy acid exfoliants, can be in the form of a gel, and can be contained in kits into which compositions and desired dispensers are retained.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Moy and Shaffer as applied to claims 1-14 and 17-20 above, and further in view of Soo et al. (KR 20170038581 A, published April 7th, 2017).
The teachings of the modified Wilson are set forth above.
The combination of Wilson, Moy, and Shaffer do not teach that the vitamin B is selected from vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B12, a derivative thereof, and a combination of two or more thereof (instant claim 15) or that the vitamin B is selected from thiamine, riboflavin, niacinamide, pantothenic acid, and combinations thereof (instant claim 16).
Soo teaches a cosmetic composition for keratin softening and whitening comprising alpha hydroxy acids and niacinamide in an amount of 1 to 10 weight percent (see entire document, particularly Abstract and claims 1-2, and 9-10). The alpha hydroxy acid acts as a chemical exfoliating agent (paragraph [0018]). Soo teaches that niacinamide is a physiologically active amide of vitamin B3, and that it is capable of reducing skin pigmentation and having a beneficial effect on skin moisturization (paragraph [0028]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the vitamin B3 active amide of niacinamide suggested by Soo in the compositions of the modified Wilson. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to use a vitamin B3 form that reduces skin pigmentation and provide skin moisturization in skin care compositions comprising exfoliating hydroxy acids. There is a reasonable expectation of success as the compositions of the modified Wilson are taught to exfoliate, smooth, moisturize, hydrate, sooth, soften and/or improve the appearance and/or condition of the skin and are taught to include hydroxy acids and vitamin B; Wilson further teaches that mottled pigmentation is an undesirable visual appearance of the skin that can occur do to skin aging or adverse environmental factors (paragraph [0005]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUDITH M KAMM whose telephone number is (703)756-4575. The examiner can normally be reached M-F 8:00 am-4:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
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