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 .
Formal Matters
Claims 1-12 are pending.
Election/Restriction
Applicant's election with traverse of Group I, claims 1-8 and 11, in the reply filed on 01/20/2026 is acknowledged.
Applicant also elected the following in the reply filed on 01/20/2026:
Ethanol as the species of the monoalcohol(s);
Mandelic acid as the species of the alpha hydroxy acid(s);
Gluconolactone as the species of the polyhydroxy acid(s); and
Glycerin as the species of the at least one humectant.
The traversal of the restriction between groups I, II, and III is on the grounds that sufficient overlap of subject matter exists between the claims of groups I, II, and III such that search and examination for all three groups would not be overly burdensome. The traversal of the election of species requirement is on the grounds that no extra burden related to search and examination of monoalcohol and/or alpha hydroxy acid and/or polyhydroxy acid and/or humectant other than the elected species would exist given the common functionality and properties of non-elected species for these four types of compounds, and searching for disclosure related to one of these compounds would probably result in disclosure of the other non-elected compounds as well, and accordingly, no exhaustive additional search or examination would be required amount these ingredients.
The argument regarding the traversal between groups is not found persuasive because searches for art relevant to a determination of the patentability of one of the independent and distinct inventions claimed would be unlikely to result in the discovery of art permitting a determination of the patentability of the alternative independent and distinct invention claimed, and different searches of the art would therefore be required to determine the patentability of these independent and distinct inventions, per MPEP § 808.02, placing on the examiner an undue search burden. The argument regarding the traversal of the species elections is not found persuasive because the different species of composition have different chemical structures, and therefore have different effects. Further, the generic claims encompass such a multiplicity of species that an unduly extensive and burdensome search would be necessary to search the entire scope of the claims (see MPEP 808.01(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-10 and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim 5 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species (i.e., mandelic acid was elected as the alpha hydroxy acid(s)), there being no allowable generic or linking claim.
Claims 1-4, 6-8, and 11 are under consideration in the instant Office action to the extent of the elected species, i.e., the monoalcohol(s) is ethanol, the alpha hydroxy acid(s) is mandelic acid, the polyhydroxy acid(s) is gluconolactone, and the at least one humectant is glycerin.
Information Disclosure Statement
The information disclosure statements (IDS) filed 08/24/2023 and 01/17/2025 have been considered by the Examiner. A signed copy of each IDS is included with the present Office Action.
Specification
The disclosure is objected to because the entries of the table on Page 15 of the specification should be amended to be consistent with U.S. decimal practice, e.g., “10,00” should be amended to “10.00”.
Appropriate correction is required.
Claim Objections
Claims 6 and 11 are objected to because of the following:
In line 1 of claim 6, “poly hydroxy acid” should be amended to “polyhydroxy acid” in order to improve claim consistency and readability (See claim 1); and
At the end of claim 11, “, [line break] all weights being with respect to the total weight of the composition” should be inserted before the period in order to improve claim consistency and readability (See claim 1).
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.
Claims 2, 4, and 6-7 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, each of claims 2, 4, 6, and 7 recite a broad recitation and also recite at least one narrower statement of the range/limitation using “preferably”. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 1-4, 6-8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Moy et al (US 2022/0362121 A1, published 11/17/2022, cited in IDS dated 08/24/2023).
Moy et al teach personal care formulations for improving the appearance of skin and/or skin health, e.g. a dermatological chemical peel and/or dermatological exfoliating formulation, wherein the inventors discovered that certain combinations of alpha hydroxy acid, beta hydroxy acid, polyhydroxy acid in certain weight ratios provide enhanced benefits to the skin (See entire document, e.g., [0049]). The personal care formulation comprises an alpha hydroxy acid; a beta hydroxy acid; and polyhydroxy acid, wherein the personal care formulation has a weight ratio of alpha hydroxy acid to polyhydroxy acid of about 5:1 to about 1:4, and wherein the personal care formulation has a weight ratio of beta hydroxy acid to polyhydroxy acid of about 1:1 to about 1:11 (e.g., Abstract, [0050]).
The personal care formulation may comprise one or more penetration agent(s) selected from a list including ethanol (e.g., [0054]). The one or more penetration agent(s) are present in an amount of from about 5 to about 99 wt. %, or from about 25 to about 70 wt. %, or from about 45 to about 55 wt. %, relative to the total weight of the personal care formulation, and in some cases, in an amount of from about 5 to about 25 wt. % relative to the total weight of the personal care formulation (e.g., [0055]).
The personal care formulation can include one or more alpha hydroxy acid(s) and/or a salt thereof selected from a list including mandelic acid (e.g., [0056]). The alpha hydroxy acid(s) are present in an amount of from about 2 to about 22 wt. % or from about 7 to about 15 wt. % relative to the total weight of the personal care formulation (e.g., [0057]).
The personal care formulation typically comprises one or more beta hydroxy acid(s) selected from a list including salicylic acid (e.g., [0058]). The one or more beta hydroxy acid(s) are present in an amount of from about 0.5 to about 10 wt. %, or from about 1.5 to about 3 wt. %, relative to the total weight formulation, and in some cases, in an amount of from about 1.5 to about 2 wt. %, based on the total weight of the personal care formulation (e.g., [0059]).
The personal care formulation typically includes one or more polyhydroxy acid(s) selected from a list including gluconolactone (e.g., [0060]). The one or more polyhydroxy acid(s) are present in an amount of from about 2 to about 20 wt. %, about 7 to about 20 wt. %, or from about 10 to about 15 wt. % by weight, relative to the total weight of the personal care formulation, and in some cases, in an amount of from about 2 to about 10 wt. % based on the total weight of the personal care formulation (e.g., [0061]).
The personal care formulation may comprise humectant(s) selected from a list including glycerin (e.g., [0050], [0062]). The humectant(s) are present in an amount of from about 1 to about 20 wt. %, or from about 5 to about 10 wt. %, or from about 10 to about 15 wt. %, relative to the total weight of the personal care formulation (e.g., [0063]).
The personal care formulation may include one or more carrier(s) including water (e.g., [0066]). The one or more carrier(s) are present in an amount of from about 5 to about 90 wt. %, based on the total weight of the personal care formulation, and in some cases, in an amount of from about 5 to about 50 wt. % based on the total weight of the personal care formulation (e.g., [0066]).
The pH of the personal care formulation is an important factor in the availability of the acid and the stability of the formulation and a low pH is necessary in order to enhance the penetration of the acid into the stratum corneum (e.g., [0077]). The personal care formulation has a pH from about 2.80 to about 4.10 (e.g., [0077]).
The specific combination of features claimed is disclosed within the broad generic ranges taught by Moy et al but such “picking and choosing” within several variables does not necessarily give rise to anticipation (Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989)). That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious” (KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 U.S.C. 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ” (KSR at 1741). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton” (Id. at 1742).
Consistent with this reasoning, 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 have selected various combinations of various disclosed ingredients of a personal care formulation from within the prior art disclosure of Moy et al and arrive at a dermatological chemical peel and/or dermatological exfoliating formulation comprising an alpha hydroxy acid being mandelic acid from about 2 to about 22 wt. % or from about 7 to about 15 wt. %, a beta hydroxy acid being salicylic acid from about 0.5 to about 10 wt. %, from about 1.5 to about 3 wt. %, or from about 1.5 to about 2 wt. %, a polyhydroxy acid being gluconolactone from about 2 to about 20 wt. %, from about 7 to about 20 wt. %, from about 10 to about 15 wt. % by weight, or from about 2 to about 10 wt. %, a penetration agent being ethanol from about 5 to about 99 wt. %, from about 25 to about 70 wt. %, from about 45 to about 55 wt. %, or from about 5 to about 25 wt. %, a humectant being glycerin from about 1 to about 20 wt. %, from about 5 to about 10 wt. %, or from about 10 to about 15 wt. %, and a carrier being water from 5 to about 90 wt. %, or from about 5 to about 50 wt. %, where wt. % is based on the total weight of the formulation, wherein the formulation has a pH from about 2.80 to about 4.10, a weight ratio of alpha hydroxy acid to polyhydroxy acid of about 5:1 to about 1:4, and a weight ratio of beta hydroxy acid to polyhydroxy acid of about 1:1 to about 1:11.
The formulation of Moy et al renders obvious the composition of instant claims 1-4, 6-8, and 11. Regarding the ranges required by the instant claims, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
Conclusion
No claims are allowable.
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/K.E.O./Examiner, Art Unit 1619
/NICOLE P BABSON/Primary Examiner, Art Unit 1619