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 . Claims included in prosecution are claims 1-7, 11-12, 14-17, and 21.
Previous Rejections
Applicants' arguments, filed 6/23/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
1. Claim 15 is 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 15 recites “wherein the hydroxycinnamic acid comprises ferulic acid”. Claim 1, from which claim 15 depends, recites “a hydroxycinnamic acid comprising coumaric acid”. Ferulic acid is not a coumaric acid. As such, it is unclear how the hydroxycinnamic acid can comprise ferulic acid if it is coumaric acid.
Claim Rejections - 35 USC § 103 (New)
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.
1. Claims 1-7, 11, 14, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sanzgiri et al. (US 2005/0100517, May 12, 2005) (hereinafter Sanzgiri) in view of Pan et al. (US 2018/0116936, May 3, 2018) (hereinafter Pan), Imaizumi et al. (WO 2014168095, Oct. 16, 2014) (hereinafter Imaizumi), and Boice et al. (US 2018/0116928, May 3, 2018) (hereinafter Boice).
Sanzgiri teaches a cosmetic composition comprising vitamin B6, vitamin B3, and an organic acid that acts synergistically to enhance skin lightening (Abstract). According to a preferred embodiment the composition comprises: 0.05-10 wt. % vitamin B6 or a derivative thereof; 0.05-10 wt.% vitamin B3 or a derivative thereof; 0.05-20 wt.% at least one organic acid selected from the group consisting of C1-C16 monocarboxylic acids, dicarboxylic acids, polycarboxylic acids, phenolic acids, and esters/salts or other derivatives thereof; and 0.1 to 25 wt.% of a cosmetically acceptable vehicle, wherein the pH of the composition is between 3 and 11 (satisfies pH of claim 1 & 13) (¶ [0019-0025]). The composition may be in the form of emulsions including water-in-oil and oil-in-water (satisfies emulsion of claim 1) (¶ [0027]). An essential ingredient of the composition is niacinamide which is a biologically active form of vitamin B3 (niacinamide of claim 1) (¶ [0030]). Particularly preferred monocarboxylic acids include lactic acid (satisfies buffer of claim 1) (¶ [0032]). Particularly preferred phenolic acids include ferulic acid (satisfies HCA of claim 15) (¶ [0038]). The composition may comprise sunscreen agents such as salicylates (¶ [0045]). Suitable vehicles include emollients, thickeners, solvents, and humectants (¶ [0059]). Suitable solvents include water (¶ [0062]). Preferred humectants include polyhydric alcohols such as propylene glycol and dipropylene glycol (satisfies claim 6-7) (¶ [0063]). Optional cosmetic ingredients include pharmaceutical ingredients such as antioxidants (satisfies claim 11) (¶ [0079]). In Example 2, the inventive compositions contained 10 wt.% polyhydric alcohols (i.e., co-solvent), 1 wt.% vitamin B3, 1 wt.% ferulic acid, and water (¶ [0085-0089]).
Sanzgiri differs from the instant claims insofar as not disclosing wherein the composition contains a coumaric acid such as p-coumaric acid as the hydroxycinnamic acid.
However, Pan discloses compositions containing phenolic compounds having synergistic antioxidant benefits (Title). Suitable phenolic compounds include ferulic acid and p-coumaric acid (¶ [0036]). The composition may be topically applied to the skin (¶ [0069]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07. As discussed above, Sanzgiri discloses wherein the composition comprises at least one organic acid such as phenolic acids. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated p-coumaric acid into the composition of Sanzgiri since it is a known and effective phenolic acid for use in skin care compositions as taught by Pan.
Alternatively, it is obvious to replace one component for another equivalent component if it is recognized in the art that the two components are equivalent and is not based on the Applicant disclosure. See MPEP 2144.06. Accordingly, it would have been obvious for one of ordinary skill in the art ordinary skill in the art, prior to the filing of the instant application, to have formulated Sanzgiri’s composition to comprise p-coumaric acid in place of ferulic acid because they are taught as equivalents for use in skin care compositions by Pan.
The combined teachings of Sanzgiri and Pan do not disclose wherein the composition comprises an amino acid derivative such as dihexyldecyl lauroyl glutamate.
However, Imaizumi discloses an emulsion composition which has excellent emulsion stability (Abstract). The emulsion is preferably an oil-in-water emulsion (¶ [0019]). The emulsion composition of the present invention contains an acyl glutamic acid ester (¶ [0040]). Since the emulsion composition of the present invention contains a specific acyl glutamic acid ester, the emulsion stability of the emulsion composition can be enhanced (¶ [0043]). From the viewpoint of emulsion stability of the emulsion composition dihexyldecyl lauroyl glutamate is used as the acyl glutamic acid ester (¶ [0056]). In the composition one type of specific acyl glutamic acid ester may be used alone, or two or more types may be used in combination (¶ [0057]). The content of the specific acyl glutamic acid ester in the emulsion composition preferably 0.001% by mass or more and less than 15% by mass (¶ [0058]). The composition may be used in a cosmetic preparation (¶ [0084]). The composition may comprise phenol compounds as additive components that exhibit useful effects when used in cosmetics (¶ [0091]).
As discussed above, the composition of Sanzgiri may be in the form of an oil-in-water emulsion. Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant claims, to have modified the composition of Sanzgiri in view of Pan to comprise 0.001 to 15 wt.% dihexyldecyl lauroyl glutamate motivated by the desire to achieve the enhanced emulsion stability taught by Imaizumi. One of ordinary skill in the art would have had a reasonable expectation of success since Imaizumi discloses that dihexyldecyl lauroyl glutamate is known for use in cosmetic oil-in-water emulsions which may comprise phenol compounds.
The combined teachings of Sanzgiri, Pan, and Imaizumi do not disclose wherein the composition comprises polyacrylate crosspolymer-6.
However, Boice teaches compositions that are useful in treating the signs of ageing in mammals via topical application to the skin (Abstract). Thickeners can be utilized in the composition where suitable thickeners include polyacrylate crosspolymer-6 (¶ [0167]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Sanzgiri discloses wherein the composition may comprise thickeners. Accordingly, it would have been prima facie obvious for one of ordinary skill in the art to have formulated the composition of Sanzgiri to comprise polyacrylate crosspolymer-6, since it is a known thickener for use in skin care compositions as taught by Boice.
Regarding the amounts of niacinamide, HCA, lactic acid, and polar emollient recited in instant claim 1, (i.e., about 0.1 % to about 10% & about 0.5% to about 3%), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(A). As discussed above, the composition of Sanzgiri in view Pan, Imaizumi, and Boice may comprise 0.05-10 wt.% vitamin B3; 0.05-20 wt.% at least one organic acid; and 0.001 to 15 wt.% dihexyldecyl lauroyl glutamate, where suitable acids include lactic acid and p-coumaric acid. Accordingly, because the amounts recited in the instant claims overlap with the amounts disclosed by Sanzgiri in view Pan, Imaizumi, and Boice, the amounts disclosed by Sanzgiri in view Pan, Imaizumi, and Boice meet the instantly recited limitations.
Regarding claim 1 reciting a “buffering system”, as discussed above, the composition of Sanzigiri’s composition preferably comprises lactic acid. Therefore, the presence of lactic acid would meet the limitation of “buffering system” because the acid would perform this function because this would be a property of the acid, whether the prior art discloses such use or not.
Regarding claim 2 reciting wherein the composition reduces the appearance of marks on a user’s skin, as discussed above, Sanzgiri discloses wherein the composition is to be applied to the skin and acts to enhance skin lightening. As noted by page 3, lines 23-25 of the instant specification, “marks” encompass hyperpigmentation. As such, since the composition of Sanzgiri may be applied to the skin and enhances skin lightening, it would be reasonable for one of ordinary skill in the art to conclude that the composition of Sanzgiri would be useable to reduce the appearance of marks on a user’s skin.
Regarding the ratio between the hydroxycinnamic acid and the polar emollient recited in instant claim 4 (i.e., about 1:1 to about 1: 10), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(A). As discussed above, the composition of Sanzgiri in view of Pan, Imaizumi, and Boice composition comprises 0.05-20 wt.% of at least one organic acid such as p-coumaric acid and 0.001 to 15 wt.% dihexyldecyl lauroyl glutamate. Accordingly, the claimed weight ratio would have been obvious from one selecting amounts of p-coumaric acid and dihexyldecyl lauroyl glutamate from these ranges and arriving at a weight ratio that overlaps with the claimed range.
Regarding the amount of co-solvent recited in instant claim 5 (i.e., less than 20%), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(A). As discussed above, Sanzgiri’s composition may comprise 0.1 to 25 wt.% of a cosmetically acceptable vehicle and suitable vehicles include humectants such as propylene glycol and dipropylene glycol. Accordingly, because the amounts recited in the instant claims overlap with the amounts disclosed by Sanzgiri, the amounts disclosed by Sanzgiri meet the instantly recited limitation.
Regarding the amount of antioxidant recited in instant claim 11 (i.e., about 0.001 % to about 5%), where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). As discussed above, antioxidants are pharmaceutical ingredients, which makes amounts thereof a result effective variable, since amounts directly impact the therapeutic effect. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amounts of antioxidant to yield the desired antioxidant therapeutic effect.
Regarding the limitation recited in claim 16, the amount of 4-vinylphenol present is descriptive and thus would be a property of the claimed composition. Sanzgiri in view of Pan, Imaizumi, and Boice discloses substantially the same composition comprising: a vitamin B3 compound, p-coumaric acid, lactic acid, polyacrylate corsspolymer-6, water, a co-solvent, and a pH of between 3.5 and 6. Therefore, it would be reasonable for one of ordinary skill in the art to conclude that the composition of Sanzgiri would have substantially the same property, comprising less than 1000 ppm 4-vinylphenol, as the composition of the instant claims.
Regarding claim 17 reciting wherein the composition exhibits less than about 10% HCA degradation, as noted by page 7, lines 26-32 of the instant specification, formulating compositions at a low pH and including an antioxidant reduces oxidation and/or degradation of the HCA. As discussed above, Sanzgiri discloses wherein the composition may comprise antioxidants and wherein the composition may have a pH of between 3.5 and 5. Therefore, it would be reasonable for one of ordinary skill in the art to conclude that the composition of Sanzgiri would have substantially the same property, exhibiting less than about 10% HCA degradation, as the composition of the instant claims.
Therefore, the combined teachings of Sanzgiri, Pan, Imaizumi, and Boice render obvious claims 1-7, 11, 14, and 15-17.
3. Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sanzgiri et al. (US 2005/0100517, May 12, 2005) (hereinafter Sanzgiri) in view of Pan et al. (US 2018/0116936, May 3, 2018) (hereinafter Pan), Imaizumi et al. (WO 2014168095, Oct. 16, 2014) (hereinafter Imaizumi), and Boice et al. (US 2018/0116928, May 3, 2018) (hereinafter Boice) and further in view of Carle et al. (US 2021/0346275, Nov. 11, 2021) (hereinafter Carle).
The teachings of Sanzgiri, Pan, Imaizumi, and Boice are discussed above.
The combined teachings of Sanzgiri, Pan, Imaizumi, and Boice differ from the instant claims insofar as not explicitly disclosing the exact amount of antioxidant included and wherein the composition comprises sodium sulfite.
However, Carle discloses compositions useful to improve the brightness of skin (Abstract). The composition may include an antioxidant in amounts of 0.0001% to 99.9% by weight (¶ [0023]). Suitable antioxidants include sodium sulfite (¶ [0066]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07. As discussed above, Sanzgiri discloses wherein the composition may comprise antioxidants. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have included sodium bisulfite in the composition of Sanzgiri in an amount of 0.001% to 5% by weight, since it is a known and effective antioxidant and amount thereof in skin care compositions as taught by Carle.
Therefore, the combined teachings of Sanzgiri, Pan, Imaizumi, Boice, and Carle render obvious claims 11-12.
3. Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Sanzgiri et al. (US 2005/0100517, May 12, 2005) (hereinafter Sanzgiri) in view of Pan et al. (US 2018/0116936, May 3, 2018) (hereinafter Pan), Imaizumi et al. (WO 2014168095, Oct. 16, 2014) (hereinafter Imaizumi), and Boice et al. (US 2018/0116928, May 3, 2018) (hereinafter Boice) and further in view of Saito et al. (US 2008/0299058, Dec. 4, 2008) (hereinafter Saito).
The teachings of Sanzgiri, Pan, Imaizumi, and Boice are discussed above.
The combined teachings of Sanzgiri, Pan, Imaizumi, and Boice differ from the instant claims insofar as not disclosing wherein the composition comprises isopropyl lauroyl sarcosinate.
However, Saito discloses cosmetic compositions for the delivery of skin care actives useful for protecting and/or treating the skin (¶ [0002]). Vitamin B3 compounds such as niacinamide are preferred skin care actives (¶ [0076]). Suitable emollients include isopropyl lauroyl sarcosinate (¶ [0099]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07. As discussed above, Sanzgiri discloses wherein the composition may comprise an emollient. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated isopropyl lauroyl sarcosinate into the composition of Sanzgiri since it is a known and effective emollient for use in skin care compositions comprising vitamin B3 compounds as taught by Saito.
Therefore, the combined teachings of Sanzgiri, Pan, Imaizumi, Boice, and Saito render obvious claim 21.
Response to Arguments
Applicant’s arguments with respect to claims 1-7, 11-12, 14-17, and 21 have been considered but are moot because new rejections necessitated by Applicant’s amendment have been made. As discussed in the current rejections, Sanzgiri teaches a cosmetic composition comprising vitamin B6, vitamin B3, and an organic acid that acts synergistically to enhance skin lightening but does not expressly disclose wherein the composition contains coumaric acid. However, Pan is relied upon for this teaching. Furthermore, Imaizumi’s teaching in reference to dihexyldecyl lauroyl glutamate is applied to meet the requirements of the limitation “wherein the polar emollient is an amino acid derivative” in view of the amendments to claim 3. Finally, Boice’s teaching in reference to polyacrylate crosspolymer-6 is applied to meet the requirements of the new limitation “wherein the composition further comprises a low-pH tolerant polymer thickener comprising polyacrylate crosspolymer-6”.
Although Applicant’s arguments are moot because new rejections necessitated by Applicant’s amendment have been made, the Examiner will address those aspects of Applicant’s arguments insofar as they remain relevant to the new grounds of rejection.
Regarding Applicant’s arguments that the cited prior art does not recognize issues such as HCA crystallization or polyacrylate crosspolymer-6’s tolerance of low-pH compositions, the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See MPEP 2144 IV. A reason to make a skin-brightening composition comprising the components of the instant claims does not have to be for the same reason as Applicant. Therefore, one of ordinary skill in the art would reasonably conclude that the compositions of Sanzgiri in view of Pan, Imaizumi, and Boice, comprising a combination suggested therein at a pH suggested therein would satisfy the composition instantly claimed.
Further, the Examiner would point to the fact that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. MPEP 2145 II. As such, Applicant’s recognition of the fact that a composition comprising HCA suggested by of Sanzgiri in view of Pan, Imaizumi, and Boice is free of HCA crystals when at a pH suggested by of Sanzgiri in view of Pan, Imaizumi, and Boice does not appear to render nonobvious the composition suggested by Sanzgiri in view of Pan, Imaizumi, and Boice. Further, Applicant’s recognition of the fact that a composition comprising polyacrylate crosspolymer-6 as a thickener suggested by of Sanzgiri in view of Pan, Imaizumi, and Boice where said polyacrylate crosspolymer-6 is tolerant of a pH suggested by of Sanzgiri in view of Pan, Imaizumi, and Boice does not appear to render nonobvious the composition suggested by Sanzgiri in view of Pan, Imaizumi, and Boice.
Regarding Applicant’s arguments with respect to improper hindsight, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant’s disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As discussed above, where Sanzgiri discloses a skin brightening composition in the form of an oil-in-water emulsion comprising lactic acid, phenolic compounds, and Pan discloses that suitable phenolic compounds for use in topical skin compositions include p-coumaric acid, it would have been obvious for one of ordinary skill in the art to have formulated the composition of Sanzgiri to comprise p-coumaric acid. Further, where Imaizumi provides strong motivation for one of ordinary skill in the art to utilize dihexyldecyl lauroyl glutamate in such emulsion, it would have been obvious for one of ordinary skill in the art to have formulated the composition of Sanzgiri to comprise dihexyldecyl lauroyl glutamate. Finally, where Boice discloses that suitable thickeners for use in topical skin compositions include polyacrylate crosspolymer-6, it would have been obvious for one of ordinary skill in the art to have formulated the composition of Sanzgiri to comprise polyacrylate crosspolymer-6. Accordingly, no improper hindsight was used in the conclusion of obviousness in the rejection of record.
In light of the foregoing, the Examiner does not find Applicant’s arguments to be persuasive and the rejection is maintained.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
1. Claims 1-7, 11-12, 14-17, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,036,298 B2 (hereinafter ‘298).
Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a skin care composition comprising: a. about 0.1 % to about 10% of a vitamin B3 compound; b. about 0.1 % to about 10% of a hydroxycinnamic acid; c. water; d. a co-solvent with a Hansen solubility parameter distance of less than 15 from the hydroxycinnamic acid; wherein a pH of the composition is 5.0 or less; wherein the composition is free of hydroxycinnamic acid crystals. The difference between the instant claims and the claims of ‘298 lies in the fact that the claims of ‘298 further recite a method of reducing the appearance of post-acne marks. Thus, the claims of ‘298 are a species of the generic invention of the instant claims. It would have been obvious for one of ordinary skill in the art to have used the composition of the instant claims in the method of ‘298 since they both utilize the same components and actives.
2. Claims 1-7, 11-12, 14-17, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,144,882 B2 (hereinafter ‘882).
Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a skin care composition comprising: a. about 0.1 % to about 10% of a vitamin B3 compound; b. about 0.1 % to about 10% of a hydroxycinnamic acid; c. water; d. a co-solvent with a Hansen solubility parameter distance of less than 15 from the hydroxycinnamic acid; wherein a pH of the composition is 5.0 or less; wherein the composition is free of hydroxycinnamic acid crystals. The difference between the instant claims and the claims of ‘882 lies in the fact that the claims of ‘882 further recite a method of reducing the appearance of post-acne marks. Thus, the claims of ‘882 are a species of the generic invention of the instant claims. It would have been obvious for one of ordinary skill in the art to have used the composition of the instant claims in the method of ‘882 since they both utilize the same components and actives.
3. Claims 1-7, 11-12, 14-17, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12, 280,132 B2 (hereinafter ‘332) in view of Pojasek et al. (US 2010/0278784, Nov. 4, 2010) (hereinafter Pojasek).
Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a skin care composition comprising: a. about 0.1 % to about 10% of a vitamin B3 compound; b. about 0.1 % to about 10% of a hydroxycinnamic acid; c. water; d. a co-solvent with a Hansen solubility parameter distance of less than 15 from the hydroxycinnamic acid; wherein a pH of the composition is 5.0 or less; wherein the composition is free of hydroxycinnamic acid crystals. The difference between the instant claims and the claims of ‘332 lies in the fact that the composition of ‘332 further includes a hydrotope such as sodium salicylate.
However, Pojasek discloses methods and compositions for the treatment of aging-related skin conditions (e.g., wrinkles), pigmentation disorders, acne, and scar formation (Abstract). In certain embodiments, an anti-inflammatory agent such as sodium salicylate can be used in the compositions (¶ [0245]).
Accordingly, it would have been obvious for one of ordinary skill in the art to have modified the ‘332 composition to further comprise sodium salicylate motivated by the desire to utilize its anti-inflammatory properties in a skin care composition as taught by Pojasek.
4. Claims 1-7, 11-12, 14-17, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,409,119 B2 (hereinafter ‘119) in view of Willemin (US 2008/0159970, Jul. 3, 2008) (hereinafter Willemin).
Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a skin care composition comprising: a. about 0.1 % to about 10% of a vitamin B3 compound; b. about 0.1 % to about 10% of a hydroxycinnamic acid; c. water; d. a co-solvent with a Hansen solubility parameter distance of less than 15 from the hydroxycinnamic acid; wherein a pH of the composition is 5.0 or less; wherein the composition is free of hydroxycinnamic acid crystals. The difference between the instant claims and the claims of ‘119 lies in the fact that the composition of ‘119 further includes a sensory improving ingredient such as a sugar alcohol.
However, Willemin discloses a formulation of cosmetic and/or dermatological active agents, in particular a moisturizer agent, for improving the appearance of keratin materials, in particular the skin (¶ [0002]). Suitable moisturizers or humectants for use include xylitol (¶ [0328]). Suitable depigmenting agents for use include ferulic acid and vitamin B3 (¶ [0354]). The compositions according to the invention are especially intended for treating skin disorders associated with an impairment in the pigmentation of the skin (¶ [0739]).
Accordingly, it would have been obvious for one of ordinary skill in the art to have modified the ‘119 composition to further comprise xylitol motivated by the desire to utilize its moisturizing properties in a skin care composition as taught by Willemin.
Response to Arguments
Regarding the rejection of claims 1-7, 11-12, 14-17, and 21 on the grounds of non-statutory double patenting, Applicants‘ arguments and the amendment have been fully considered and deemed unpersuasive for the reasons that follow.
Applicants have not submitted arguments or documentation (i.e. terminal disclaimer) in response to the double patenting rejection. Therefore, the previous rejections of non- statutory double patenting are maintained.
Conclusion
Claims 1-7, 11-12, 14-17, and 21 are rejected.
No claims are 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 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 Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.A./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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