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
Receipt of Applicant’s response dated 06/01/2026 is acknowledged.
Claims 1-18 are pending.
Claims 1-2, 4, 6-7, and 11 are amended.
Claims 13-18 are new.
Claims 9-10 and 12 remain withdrawn from consideration as being drawn to a nonelected invention.
Claim 5 remains withdrawn from consideration as being drawn to a nonelected species.
Claims 1-4, 6-8, 11, and 13-18 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.
OBJECTIONS/REJECTIONS WITHDRAWN
Specification
The objection to the specification set forth in the Office action dated 02/26/2026 is hereby withdrawn in light of Applicant’s amendments to the specification.
Claim Objections
The objections to claims 6 and 11 set forth in the Office action dated 02/26/2026 are hereby withdrawn in light of Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112(b)
The indefiniteness rejections of claims 2, 4, and 6-7 set forth in the Office action dated 02/26/2026 are hereby withdrawn in light of Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 103
The obviousness rejection of claims 1-4, 6-8, and 11 over Moy et al set forth in the Office action dated 02/26/2026 is hereby withdrawn in light of Applicant’s amendments to the claims and in favor of the new grounds of rejection set forth below as necessitated by Applicant’s amendments to the claims.
NEW GROUNDS OF REJECTION
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 7 and 17 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.
Claim 7 recites “The composition of claim 1, further comprising at least one humectant” and depends on claim 1 which recites “A skin peeling composition comprising…optionally at least one humectant”. Claim 7 is indefinite in the aforementioned recitation because it is unclear whether the at least one humectant further comprised in the composition of claim 7 is the same as the at least one humectant of claim 1, in addition to and different from the at least one humectant of claim 1, or whether something else is meant by the recitation. As written, one skilled in the art would not be reasonably apprised of the metes and bounds of the claims. Claim 17 is rejected for depending from claim 7 without resolving the ambiguity of claim 7.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11 and 14-15 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
(a) Claim 11, which depends on claim 1, omits limitations that are required by claim 1, i.e., the limitation that the salicylic acid is solubilized, the limitation that the composition optionally comprises at least one humectant, and the limitation that the salicylic acid is solubilized in the monoalcohol(s) and, if present, the at least one humectant prior to addition of the solubilized salicylic acid to the composition, and thus the scope of claim 11 is broadened relative to the scope of claim 1. Therefore, claim 11 is rejected both for failing to further limit the subject matter of claim 1 and for failing to include all of the limitations of claim 1.
(b) Claim 14 recites “the mandelic acid is present in an amount of from about 1% to about 10% by weight” and depends on claim 4, however, claim 4 (which depends on claim 1) requires that mandelic acid be present in the composition from about 10% to about 50% by weight. Because the weight percent range required by claim 14 does not further limit the weight percent range required by claim 4 and is outside of the weight percent range required by claim 4, claim 14 is rejected both for failing to further limit the subject matter of claim 4 and for failing to include all of the limitations of claim 4. The Examiner suggests amending claim 14 to require a weight percent range of the alpha hydroxy acid(s)/mandelic acid that further limits the requirement of claim 4 in order to overcome the rejection.
(c) Claim 15 recites “the gluconolactone is present in an amount of from about 1% to about 10% by weight” and depends on claim 6, however, claim 6 (which depends on claim 1) requires that gluconolactone be present in the composition from about 1% to about 10% by weight. Because the weight percent range required by claim 15 does not further limit the weight percent range required by claim 6, i.e. the weight percent ranges are the same, claim 15 is rejected for failing to further limit the subject matter of claim 6. The Examiner suggests amending claim 15 to require a weight percent range of the polyhydroxy acid(s)/gluconolactone that further limits the requirement of claim 6 in order to overcome the rejection.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 11, and 13-18 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]).
Moy et al teach that the personal care formulation may comprise anhydrous ethyl alcohol, witch hazel, salicylic acid, vegetable refined glycerin, polyglutamic acid, gluconolactone, lactic acid, mandelic acid and demineralized water (e.g., [0076]).
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, at least, 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.
Instant claim 1 is a product-by-process claim and therefore the product is given patentable weight, not the process by which the product is made. “[Elven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorne, 777 F.2d 695, 698, 227 USPQ S64, 966 (Fed. Cir. 1985). Therefore, claim 1 is being examined to the extent of the resultant composition, i.e. “a skin peeling composition comprising: (a) about 50% by weight or less of water, (b) about 5% to about 30% by weight of monoalcohol(s), wherein the amount of water present in the composition is greater than the amount of monoalcohol(s) present in the composition, (c) about 10% to about 50% by weight of alpha hydroxy acid(s), (d) more than 1% to about 3% by weight of solubilized salicylic acid, (e) about 1% to about 10% by weight of polyhydroxy acid(s), and (f) optionally at least one humectant, all weights being with respect to the total weight of the composition”, and is not being examined to the extent of the method of obtaining the composition, i.e. “wherein the salicylic acid is solubilized in the monoalcohol(s) and, if present, the at least one humectant prior to addition of the solubilized salicylic acid to the composition.”
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)).
The formulation of Moy et al renders obvious the composition of instant claims 1-4, 6-8, 11, and 13-18.
Response to Applicant’s Arguments
Applicant’s arguments filed on 06/01/2026 have been considered.
Applicant argues that Moy does not teach, suggest, or recognize compositions including salicylic acid solubilized in monoalcohol(s) and optionally humectant(s) prior to combination with other claims and that Moy’s preparation procedures involves water and alcohol being first combined and then all hydroxy acids including salicylic acid are added to this mixture. Applicant argues the characteristic of salicylic acid solubility in low amounts of monoalcohol(s) has unexpected properties with respect to the amount of salicylic acid present in the composition and that Moy does not teach, suggest, or recognize any such characteristics or properties with respect to salicylic acid solubility, and such effects associated with the claimed compositions could not have been expected from Moy’s disclosure.
The above arguments regarding the preparation procedures of Moy et al differing from the instant invention have been fully considered but are not found persuasive because the claims under consideration are drawn to a composition, not drawn to a method of making a composition, and instant claim 1 is a product-by-process claim being examined to the extent of the composition rather than the method of obtaining the composition and, therefore, it is not a requirement that Moy et al teach the same preparation method as the instant invention. The above arguments regarding Moy not teaching, suggesting, or recognizing the salicylic acid being solubilized have been fully considered by the Examiner but are not found persuasive because sufficient evidence has not been established that the salicylic acid in the formulation of Moy et al is not solubilized. Suitable evidence would include a comparison of the inventive composition obtained by the process comprising the solubilization of the salicylic acid in the monoalcohol(s) and, if present, the at least one humectant prior to addition of the solubilized salicylic acid to the composition to the corresponding composition obtained by a process without the solubilization of the salicylic acid in the monoalcohol(s) and, if present, the at least one humectant prior to addition of the solubilized salicylic acid to the composition. Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983) (The claims were directed to a zeolite manufactured by mixing together various inorganic materials in solution and heating the resultant gel to form a crystalline metal silicate essentially free of alkali metal. The prior art described a process of making a zeolite which, after ion exchange to remove alkali metal, appeared to be "essentially free of alkali metal." The court upheld the rejection because the applicant had not come forward with any evidence that the prior art was not "essentially free of alkali metal" and therefore a different and nonobvious product.). See MPEP 2113. The above argument regarding Moy not recognizing the unexpected properties of salicylic acid solubility in low amounts of monoalcohol(s) with respect to the amount of salicylic acid present in the composition has been fully considered by the Examiner but is not found persuasive because it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Applicant is reminded that "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAELEIGH ELIZABETH OLSEN whose telephone number is (703)756-1962. The examiner can normally be reached M-F 8-5 PM.
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/K.E.O./Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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