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 .
DETAILED ACTION
The Applicant’s reply filed on 11/21/25 is acknowledged. Claims 46-65, 72, 73 and 76-81 are pending. Claims 46-62 and 65 have been withdrawn. Claim 63 has been amended. Claim 81 is new. Claims 63, 64, 72, 73 and 76-81 are under consideration.
Rejections Withdrawn
The rejection of Claims 63, 64, 66-73 and 76-80 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in view of the amended claim.
The rejection of Claims 63 and 64 under 35 U.S.C. 103 as being unpatentable over Lu et al. (US 2016/0374912) is withdrawn in view of the amended claims.
Rejections Maintained and New Grounds of Rejections
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 2/16/26. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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. 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 63, 64, 72 and 81 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (US 2016/0374912) in view of Trumbore et al. (US 2017/0087178).
Lu et al. teach a topically applicable chemical peel composition and method of use having from about 5% to about 25%, by weight, of alpha hydroxy acid (e.g. abstract and paragraph 0001) for the treatment of photodamaged skin, hyperpigmentation, and acne vulgaris (e.g. paragraph 0003, and Claim 18). Lu et al. teach that the alpha hydroxy acids include lactic acid, mandelic acid, and pyruvic acid (e.g. paragraph 0019; Claim 7). Lu et al. teach that the solvent includes ethanol (e.g. 0030 and 0031; Claim 2). It would have been obvious to one of ordinary skill in the art at the time of filing to select the combination of lactic acid, mandelic acid, and pyruvic acid as the alpha hydroxy acids in the composition of Lu et al. Lu et al. teach the inclusion of alpha hydroxy acids and mixtures thereof, and it would have been obvious to have selected any of the recited acids, including lactic acid, mandelic acid, and pyruvic acid as claimed. “When 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).
While Lu et al. teach about 5% to about 25%, by weight, of alpha hydroxy acids, they do not teach individual concentrations for lactic, pyruvic, and mandelic acids. This is made up for by the teachings of Trumbore et al.
Trumbore et al. teach formulations that, once applied to the skin, increase dermal GAG concentrations comprising a first formulation, which is a peel (e.g. paragraphs 0026-0028; Examples). Trumbore et al. teach that the peel comprises 1-4 wt% lactic acid and 1-4 wt% mandelic acid (e.g. paragraphs 01160120). Trumbore et al. also teach the inclusion of pyruvic acid, but do not disclose a concentration (e.g. paragraph 0068).
Regarding Claims 63, 72 and 81, it would have been obvious to one of ordinary skill in the art at the time of filing to look to the teachings of Trumbore et al. for selection of appropriate lactic and mandelic acid concentrations for use in the peels of Lu et al. One of ordinary skill in the art would have predicted success as they are both drawn to skin peel composition, and one would have been motivated to seek further guidance on appropriate individual concentrations, as Lu et al. are silent. Lu et al. teach about 5% to about 25%, by weight of total alpha hydroxy acids, and Trumbore et al. teach that the peel comprises 1-4 wt% lactic acid and 1-4 wt% mandelic acid (e.g. paragraphs 01160120). After including pyruvic acid, this results in an amount of greater than 0 to 17 wt% pyruvic acid. These values and resulting ratios are within or overlap the claimed values. 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) (MPEP 2144.05.I).
Regarding Claim 64, as evidenced by the instant Specification Examples, amounts as low as 0.2-0.1% lactic acid and pyruvic acid inhibit the growth of harmful bacteria. As Lu et al. teach 5% to about 25% by weight of alpha hydroxy acid, then the limitation “effective amount” has been reached.
Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (US 2016/0374912) and Trumbore et al. (US 2017/0087178) as applied to claims 63, 64, 72 and 81 above, and further in view of Epstein et al. (US 6,017,548; cited previously).
Regarding Claims 63, 64, 72 and 81, the teachings of Lu et al. and Trumbore et al. are described supra. Lu et al. teach the inclusion of pyruvic acid, but do not teach the salt sodium pyruvate. This is made up for by the teachings of Epstein et al.
Epstein et al. teach compositions for treating skin comprising an acid material (e.g. abstract). Epstein et al. teach that the acidic component is preferably an alpha-hydroxy acid including lactic acid, mandelic acid, and pyruvic acid and mixtures thereof (e.g. column 2, lines 29-50; Claim 10). Epstein et al. teach that the presence of the acidic component aids in the ability to deliver humectant (e.g., glycerin) to the stratum corneum in amounts beyond that predictable from simple consideration of humectant concentration (e.g. column 2, line 65-column 3, line 2). Epstein further teach that cations such as Na enhance the ability of the emulsions of this invention to transport moisturizers across the skin membrane (i.e. sodium pyruvate) (e.g. column 5, lines 6-11).
Regarding Claims 73, it would have been obvious to one of ordinary skill in the art at the time of filing to include the alpha-hydroxy acid sodium pyruvate of Epstein et al. in the composition of Lu and Trumbore. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as Lu, Trumbore, and Epstein et al. all teach a mixture of alpha-hydroxy acids for application for skin. One of ordinary skill in the art would have been motivated to include the sodium pyruvic of Epstein et al. in order to enhance the delivery. In addition, as both Lu et al. and Epstein teach topical skin compositions it would have been obvious to combine the compositions. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
Claims 76-80 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (US 2016/0374912) and Trumbore et al. (US 2017/0087178) as applied to claims 63, 64, 72 and 81, and further in view of Dreher (US 2014/0315995; cited previously).
Regarding Claims 63, 64, 72 and 81, the teachings of Lu et al. and Trumbore et al. are described supra. Lu et al. teach that the composition may further include antioxidants (e.g. paragraph 0034). They do not teach the inclusion of one or more agents selected from the group consisting of 4-butyl resorcinol, hexylresorcinol, Silybum marianum extract, and dimethylmethoxy chromanol. This is made up for by the teachings Dreher.
Dreher teaches a non-irritating, stable topical compositions including at least Vitamin C, Vitamin E and a polyphenol antioxidant, which may be in the form of a skin care product or exfoliant (e.g. abstract, paragraph 0155). Dreher teaches the composition may comprise 0.01-15 wt% of 4-butyl resorcinol, 0.01-15 wt% hexylresorcinol, 0.01-0.5 wt% milk thistle (i.e. Silybum marianum extract), and 0.01-1 wt% dimethylmethoxy chromanol (e.g. paragraphs 0022, 0023, 0025, 0085, 0086, 0202, 0203). Dreher teaches that the compositions provide improved and/or superior antioxidant activity that are suitable for topical application and/or administration (e.g. paragraph 0007).
Regarding Claims 76-80, it would have been obvious to one of ordinary skill in the art at the time of filing to include the antioxidants and skin agents of Dreher in the composition of Lu et al. and Trumbore et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as all of Lu, Trumbore and Dreher teach compositions for skin, which may include antioxidants. One of ordinary skill in the art would have been motivated to include the agents of Dreher in order to enhance the skin through inclusion of the additional antioxidants and skin agents, which is suggested by Lu et al.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 63, 64, 72, 73 and 81 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19 and 25 of copending Application No. 18/458,702 in view of Lu et al. (US 2016/0374912) and Trumbore et al. (US 2017/0087178).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and copending claims recite,
A method comprising administering to the skin of a patient, an effective amount of a personal care composition comprising a plurality of short chain fatty acids; and a cosmetically acceptable carrier. Copending claim 25 specifies that the blend may comprise pyruvic and lactic acids, but does not include mandelic acid.
This is made up for by the teachings Lu et al., whose teachings are described supra.
It would have been obvious to one of ordinary skill in the art at the time of filing to include the alpha-hydroxy acid mandelic acid of Lu et al. to the method of ‘702. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as Lu and ‘702 both teach a mixture of alpha-hydroxy acids for application for skin. One of ordinary skill in the art would have been motivated to include the mandelic acid of Lu in order to enhance exfoliation of the skin. In addition, as both Lu and ‘702 teach topical skin compositions it would have been obvious to combine the compositions. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
Regarding the amounts of the ingredients, Lu et al. teach about 5% to about 25%, by weight of total alpha hydroxy acids, and Trumbore et al. teach that the peel comprises 1-4 wt% lactic acid and 1-4 wt% mandelic acid (e.g. paragraphs 01160120). After including pyruvic acid, this results in an amount of greater than 0 to 17 wt% pyruvic acid. These values and resulting ratios are within or overlap the claimed values. 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) (MPEP 2144.05.I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 76-80 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19 and 25 of copending Application No. 18/458,702 in view of Lu et al. (US 2016/0374912) and Trumbore et al. (US 2017/0087178), and further in view of Dreher (US 2014/0315995; cited in parent).
Regarding Claims 63, 64, 72, 73, and 81, the teachings of ‘702 and Lu and Trumbore. Neither teach the inclusion of one or more agents selected from the group consisting of 4-butyl resorcinol, hexylresorcinol, Silybum marianum extract, and dimethylmethoxy chromanol. This is made up for by the teachings Dreher.
Dreher teaches a non-irritating, stable topical compositions including at least Vitamin C, Vitamin E and a polyphenol antioxidant, which may be in the form of a deodorant (e.g. abstract, paragraph 0155). Dreher teaches the composition may comprise 0.01-15 wt% of 4-butyl resorcinol, 0.01-15 wt% hexylresorcinol, 0.01-0.5 wt% milk thistle (i.e. Silybum marianum extract), and 0.01-1 wt% dimethylmethoxy chromanol (e.g. paragraphs 0022, 0023, 0025, 0085, 0086, 0202, 0203). Dreher teaches that the compositions provide improved and/or superior antioxidant activity that are suitable for topical application and/or administration (e.g. paragraph 0007).
Regarding Claims 76-80, it would have been obvious to one of ordinary skill in the art at the time of filing to include the antioxidants and skin agents of Dreher in the composition of Lu, Trumbore, and ‘702. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as Lu, Trumbore, ‘702 and Dreher all teach compositions for skin, which may include antioxidants. One of ordinary skill in the art would have been motivated to include the agents of Dreher in order to enhance the skin through inclusion of the additional antioxidants and skin agents, which is suggested by Lu.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 63, 64, 72, 73 and 81 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of copending Application No. 18/240,795 in view of Lu et al. (US 2016/0374912) and Trumbore et al. (US 2017/0087178).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and copending claims recite,
A method comprising administering to the skin of a patient, an effective amount of a personal care composition comprising a plurality of short chain fatty acids; and a cosmetically acceptable carrier. Copending claim 8 specifies that the blend may comprise pyruvic and lactic acids, but does not include mandelic acid.
This is made up for by the teachings Lu et al., whose teachings are described supra.
It would have been obvious to one of ordinary skill in the art at the time of filing to include the alpha-hydroxy acid mandelic acid of Lu et al. to the method of ‘795. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as Lu and ‘795 both teach a mixture of alpha-hydroxy acids for application for skin. One of ordinary skill in the art would have been motivated to include the mandelic acid of Lu in order to enhance exfoliation of the skin. In addition, as both Lu and ‘795 teach topical skin compositions it would have been obvious to combine the compositions. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
Regarding the amounts of the ingredients, Lu et al. teach about 5% to about 25%, by weight of total alpha hydroxy acids, and Trumbore et al. teach that the peel comprises 1-4 wt% lactic acid and 1-4 wt% mandelic acid (e.g. paragraphs 01160120). After including pyruvic acid, this results in an amount of greater than 0 to 17 wt% pyruvic acid. These values and resulting ratios are within or overlap the claimed values. 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) (MPEP 2144.05.I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 76-80 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19 of copending Application No. 18/240,795 in view of Lu et al. (US 2016/0374912) and Trumbore et al. (US 2017/0087178), and further in view of Dreher (US 2014/0315995; cited in parent).
Regarding Claims 63, 64, 72, 73, 81, the teachings of ‘795 and Lu and Trumbore. Neither teach the inclusion of one or more agents selected from the group consisting of 4-butyl resorcinol, hexylresorcinol, Silybum marianum extract, and dimethylmethoxy chromanol. This is made up for by the teachings Dreher.
Dreher teaches a non-irritating, stable topical compositions including at least Vitamin C, Vitamin E and a polyphenol antioxidant, which may be in the form of a deodorant (e.g. abstract, paragraph 0155). Dreher teaches the composition may comprise 0.01-15 wt% of 4-butyl resorcinol, 0.01-15 wt% hexylresorcinol, 0.01-0.5 wt% milk thistle (i.e. Silybum marianum extract), and 0.01-1 wt% dimethylmethoxy chromanol (e.g. paragraphs 0022, 0023, 0025, 0085, 0086, 0202, 0203). Dreher teaches that the compositions provide improved and/or superior antioxidant activity that are suitable for topical application and/or administration (e.g. paragraph 0007).
Regarding Claims 76-80, it would have been obvious to one of ordinary skill in the art at the time of filing to include the antioxidants and skin agents of Dreher in the composition of Lu, Trumbore, and ‘795. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as Lu, Trumbore, ‘795 and Dreher all teach compositions for skin, which may include antioxidants. One of ordinary skill in the art would have been motivated to include the agents of Dreher in order to enhance the skin through inclusion of the additional antioxidants and skin agents, which is suggested by Lu.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 63, 64, 72, 73 and 81 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35 and 36 of copending Application No. 18/305,746.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and copending claims recite,
A method comprising administering to the skin of a patient, an effective amount of a personal care composition comprising a plurality of short chain fatty acids; and a cosmetically acceptable carrier. Copending claim 1 specifies that the composition may comprise mandelic acid, and claim 9 indicates that the composition can further comprise additional acids including lactic acid and pyruvic acid.
Regarding Claim 63, it would have been obvious to one of ordinary skill in the art at the time of filing to include lactic and pyruvic acid of claim 9 in addition to the mandelic acid of claim 1. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results, as the combination is expressly permitted by ‘746.
Regarding Claims 64, 72, 73, and 80 ‘746 claim 1-30 wt% of acids (e.g. claim 6) and 2-20 wt% mandelic acid, 0.5-10 wt% sodium pyruvate, and 1-30 wt% of lactic acid (e.g. claim 18). These values and resulting ratios are within or overlap the claimed values. 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) (MPEP 2144.05.I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 76-80 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15, 16, 19, 20 of copending Application No. 18/305,746 and further in view of Dreher (US 2014/0315995; cited in parent).
Regarding Claims 63, 64, 72, 73 and 81, the teachings of ‘746 are described supra. They do not teach the inclusion of one or more agents selected from the group consisting of 4-butyl resorcinol, hexylresorcinol, Silybum marianum extract, and dimethylmethoxy chromanol. This is made up for by the teachings Dreher.
Dreher teaches a non-irritating, stable topical compositions including at least Vitamin C,
Vitamin E and a polyphenol antioxidant, which may be in the form of a deodorant (e.g. abstract, paragraph 0155). Dreher teaches the composition may comprise 0.01-15 wt% of 4-butyl resorcinol, 0.01-15 wt% hexylresorcinol, 0.01-0.5 wt% milk thistle (i.e. Silybum marianum extract), and 0.01-1 wt% dimethylmethoxy chromanol (e.g. paragraphs 0022, 0023, 0025, 0085, 0086, 0202, 0203). Dreher teaches that the compositions provide improved and/or superior antioxidant activity that are suitable for topical application and/or administration (e.g. paragraph 0007).
Regarding Claims 76-80, it would have been obvious to one of ordinary skill in the art at the time of filing to include the antioxidants and skin agents of Dreher in the composition of ‘746. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as ‘746 and Dreher all teach compositions for skin, which may include antioxidants. One of ordinary skill in the art would have been motivated to include the agents of Dreher in order to enhance the skin through inclusion of the additional antioxidants and skin agents.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 11/21/25 have been fully considered but they are not persuasive.
Applicant argues that the instant application clearly demonstrates that the specific combination of lactic acid, mandelic acid, and pyruvic acid (L+M+P) as an "SCFA Blend" provides unexpected synergistic results in inhibiting tyrosinase and collagenase activity and that the claims are now commensurate in scope with the data, being limited to a ratio of 4:2:1.
This is not found persuasive. First, while the claims have limited to a specific ratio, the concentration of the ingredients is not recited in Claim 63. Applicant has not demonstrated an effect for all concentrations within the scope of claim 63, and has not provided any data for ratios other than 4:2:1. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960) (see MPEP 716.02).
Second, the claimed method is directed to “treating, preventing or ameliorating a symptom associated with a disease, disorder or condition of the skin… wherein the disease, disorder, or condition of the skin is selected from hyperpigmentation, inflammation caused by excessive sun exposure, and acne…wherein the personal care composition is a peel”. It is not clear that the claimed peel would provide an unexpected outcome on hyperpigmentation, inflammation caused by excessive sun exposure, and acne. It is noted that the concentrations tested are far below those recited in the Specification for a personal care composition (e.g. paragraphs 0116-0118) and Claims 72 and 81. It is unclear what effect would be demonstrated on skin in the claimed amounts. The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992).
Third, the data in the specification appears to be inconsistent. For Example, in Table A, the % Tyrosinase Inhibition for 0.312 wt% lactic acid is 2.23, while in Table 1 0.312 wt% lactic acid is 52.72 and in Table 4 it is 1.23. Similarly, in Table A, the % Tyrosinase Inhibition for 0.078 wt% pyruvic acid is 0.37, while in Table 1 it is 29.29. Comparing Tables A and 1 it appears that L+P performs far greater than L+M+P in terms of tyrosinase inhibition.
Given these points, it is not clear that a synergism can be extrapolated for a personal care peel which is administered to skin comprising the ingredients of Claim 63.
Accordingly, the rejections are maintained.
Conclusion
No claim is allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619