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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/30/2026 has been entered.
Applicants’ arguments, filed 06/30/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (US 2011/0105406 A1, publication date 05/05/2011), as evidenced by Nihon (Pyroter GPI-25, Nihon Emulsion Co. ltd, 2026 [retrieved 7/31/2026], https://www.nihon-emulsion.co.jp/products/detail/PYROTER%20GPI-25?lang=en).
Li discloses a composition comprising 5% w/w niacinamide, 4% w/w pentylene glycol, 6% w/w butylene glycol, 2% w/w dipropylene glycol, 0.15% Pyroter GPI-25 (i.e., Glycereth-25 PCA Isostearate) and water q.s. to 100 [p. 5, Table 1. Ex. 1]. In the case of Example 1, water q.s. to 100 is 80.96% w/w.
Niacinamide is also called vitamin B3 according to the instant specification at page 9.
Glycereth-25 PCA Isostearate has an HLB value of 14, as evidenced by Nihon.
The prior art anticipates instant claims 1-3 because it discloses a composition comprising 12% w/w at least one glycol comprising pentylene glycol and further comprising butylene glycol and dipropylene glycol (i.e., C4-C10 glycols; instant claims 2-3), 0.15% w/w surfactant with HLB value from 8-20 (Glycereth-25 PCA Isostearate; HLB value of 14), 5% w/w vitamin B3 (niacinamide) and 80.96 % w/w water. The composition of Example 1 does not comprise oils and does not comprise glycerol.
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 (i.e., changing from AIA to pre-AIA ) 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, 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 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 2011/0105406 A1, publication date 05/05/2011), as evidenced by Nihon (Pyroter GPI-25, Nihon Emulsion Co. ltd, 2026 [retrieved 7/31/2026], https://www.nihon-emulsion.co.jp/products/detail/PYROTER%20GPI-25?lang=en) as applied to instant claims 1-3 above.
Li does not anticipate instant claims 5 and 6 because it does not discloses compositions comprising the surfactants of instant claims 5 and 6 in one example or embodiment.
Li discloses that suitable emulsifiers include Glycereth-25 PCA Isostearate and polyglyceryl esters of C1-C30 fatty acids, such as polyglyceryl-4 isostearate [0067].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have simply substituted the Glycereth-25 PCA Isostearate of example 1 for polyglyceryl-4 isostearate because Li discloses they are both suitable surfactants for the disclosed compositions. The skilled artisan would have been motivated to have substituted the polyglyceryl-4 isostearate of Li in place of the Glycereth-25 PCA Isostearate of Li’s example 1 with a reasonable expectation of success. The simple substitution of one known element (e.g., the polyglyceryl-4 isostearate of Li) in place of another (e.g., the Glycereth-25 PCA Isostearate of Li’s example 1) in order to achieve predictable results (emulsifier) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
2) Claims 1-3, 5-6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Philippon et al. (US 2016/0303017 A1, publication date 08/20/2016) in view of Bissett et al (International Journal of Cosmetic Science, 2004, 26, p. 231–238) and Li et al. (US 2011/0105406 A1, publication date 05/05/2011).
Regarding instant claims 1, 5, and 6, Philippon “relates to a composition comprising, in a physiologically acceptable aqueous medium, at least one monosaccharide or a polysaccharide containing up to six sugar units, a polyol and a betaine, said composition being free of potassium sorbate” [abstract]. “The polyol, preferably 1,3-propanediol, may be present in the composition in a content of between 2% and 35% by weight relative to the total weight of the composition” [0018]. “The betaine may be chosen from cetyl betaine, lauryl betaine, cocamidopropyl betaine and cocoyl betaine” (i.e., lauryl betaine has HLB value between 8 and 20 according to instant claim 9) [0022] and “may be present in the composition in a content of between 0.01 % and 5% by weight relative to the total weight of the composition” [0026]. “The composition may comprise water present in a content of between 60% and 95% by weight” [0033]. “The composition advantageously comprises a cosmetic or dermatological active agent” [0057] selected from antiaging, blemish removing, depigmenting and bleaching active agents [0058] which may be present in amounts from 0.001-10% w/w of the composition [0059]. “According to a preferred embodiment of the invention, the composition is free of oil (zero content)” [0036]. Philippon discloses an exemplary composition comprising niacinamide [0106, composition 2].
1,3-Propanediol falls within the scope of the instantly claimed pentylene glycol according to the instant specification at page 5, paragraph 4: “In the present invention, the definition of glycols includes all possible isomers. For example, pentylene glycol comprises 1,5-pentylene glycol, 2,4-pentylene glycol, etc.”
Niacinamide is also called vitamin B3 according to the instant specification at page 9.
Philippon does not explicitly disclose vitamin B3 as the active agent.
Bissett studied the effects of topical niacinamide and discloses “[n]iacinamide was well tolerated by the skin and provided significant improvements versus control in end points evaluated previously: fine lines/wrinkles, hyperpigmentation spots, texture, and red blotchiness” [p. 231, synopsis].
Li discloses aqueous compositions comprising pentylene glycol, butylene glycol and dipropylene glycol with niacinamide as the active agent (see Table 1 on page 5). According to Li, “nonionic emulsifiers, anionic emulsifiers, cationic emulsifiers and amphoteric emulsifiers can be employed” [0066] and niacinamide is present as a whitening agent to improve hyperpigmentation [0052].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07. In the present case, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have selected the niacinamide of Bissett and Li for the depigmenting and bleaching active agent desired by Philippon because Bisset and Li disclose niacinamide is a suitable skin whitening and depigmentation agent for cosmetic compositions. A skilled artisan would have had an expectation of success because Philippon welcomes niacinamide and Li teaches niacinamide is an effective whitening agent in a similar composition. Similarly, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have selected the lauryl betaine of Philippon as the betaine desired by Philippon because Philippon discloses lauryl betaine is a suitable betaine for the compositions disclosed therein.
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(I). In the present case, the instantly claimed ranges for the glycol comprising pentylene glycol (2-40% w/w), surfactant (0.001-3% w/w), vitamin B3 (0.1-15% w/w) and water (60-90% w/w) overlap with the ranges taught by the prior art for pentylene glycol (i.e., 1,3-pentanediol; 2% and 35% w/w), lauryl betaine (0.01-5% w/w), vitamin B3 (niacinamide; 0.001-10% w/w) and water (60-95%) and so a prima facie case of obviousness exists for each range.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a composition comprising pentylene glycol (1,3-pentanedion), a betaine surfactant having an HLB value of 8-20 at the temperature of 25 deg. C, vitamin B3 (niacinamide) and water. Wherein each component is present within the instantly claimed amounts. Wherein the composition is oil free. The prior art composition is considered free of glycerin because glycerin is not a required component of the prior art invention.
Regarding instant claims 2, 3 and 9, Philippon discloses “the polyol according to the invention may be chosen from glycerol, propylene glycol, butylene glycol, pentylene glycol, hexylene glycol, dipropylene glycol, diethylene glycol, 1,3-propanediol” [0017]. Philippon also discloses the composition is free of additional surfactants [0036].
Given the disclosure of each component individually, it would have been prima facie obvious for a person having ordinary skill in the art at, before the effective filling date of the claimed invention, to have selected and combined known components for their established functions with predictable results by following the teachings of Philippon. MPEP 2143 and 2144.06(I).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, the prior art teaches ranges for polyol (i.e., butylene glycol, pentylene glycol and dipropylene glycol; 2% and 35% w/w), lauryl betaine (0.01-5% w/w), vitamin B3 (niacinamide; 0.001-10% w/w) and water (60-95%) which overlap with the ranges of instant claim 9 for the glycol butylene glycol, pentylene glycol and dipropylene glycol (2-40% w/w), lauryl betaine (0.005-1% w/w), vitamin B3 (1-8% w/w) and so a prima facie case of obviousness exists for each range.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have to have formulated a composition comprising a combination of butylene glycol, pentylene glycol and dipropylene glycol, lauryl betaine as the only surfactant, vitamin B3 (niacinamide) and water. Wherein each component is present within the instantly claimed amounts. Wherein the composition is oil free. The prior art composition is considered free of glycerin because glycerin is not a required component of the prior art invention.
3) Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Philippon et al. (US 2016/0303017 A1, publication date 08/20/2016) in view of Bissett et al (International Journal of Cosmetic Science, 2004, 26, p. 231–238) and Li et al. (US 2011/0105406 A1, publication date 05/05/2011) as applied to claims 1-3, 5-6, and 9 above, and further in view of Chen et al. (US 20060018860 A1, publication date 01/26/2006), as evidenced by Malaprade et al (US 20240407534 A1, publication date 12/12/2024).
Philippon, Bissett and Li, which are taught above, differ from the instant claims insofar as they do not teach the instantly claimed viscosity of 50 UD (deviation units). Philippon discloses “the composition according to the invention is in the form of a solution [or] in the form of a lotion” [0062]. Philippon also discloses that in some embodiments the compositions are “free of additional surfactants” [0036].
Chen relates to “a composition comprising: (1) from about 0.001% to about 10% of a flavonoid compound; (2) from about 0.01% to about 15% of a vitamin B3 compound; and (3) a dermatologically acceptable single aqueous phase carrier” [abstract]. Wherein the composition may comprise butylene glycol (1,3 butanediol), pentylene glycol (1,2-pentanediol) and dipropylene glycol [0058]. Chen further discloses that “a viscosifying agent that provides the composition a viscosity of from about 10 mPas to about 1,000,000 mPas, preferably from about 10 mPas to about 1000,000 mPas. The present composition may have a wide range of viscosity. The viscosifying agent is selected according to the product type, for example, dews and toners typically have a water like low viscosity, while viscous moisturizing gels may have a high viscosity” [0048].
55 UD is about 0.37 Pa.s (i.e., 370 mPa.s), as evidenced by Malaprade at paragraph 47.
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the composition taught by Philippon, Bisset and Li to have a viscosity within the instantly claimed range. It has been held that it is not inventive to discover the optimum workable ranges by routine experimentation where, as is here, the general conditions of the claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One of ordinary skill in the art would have been motivated to optimize the viscosity of the compositions taught by Philippon, Bisset and Li because Chen teaches viscosities should be modified according to product type. A skilled artisan would have had an expectation of success because Chen teaches the viscosity of aqueous compositions comprising polyols and niacinamide may be tuned with viscosifying agents. Additionally, one would have had an expectation of success because Chen discloses compositions of toners and dews (i.e., low viscosities of 10-100000 mPa.s) which Philippon desires in the disclosure of “in the form of a solution”.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have to have formulated a composition comprising at least one glycol comprising pentylene glycol, a betaine surfactant (lauryl betaine) as the only surfactant, vitamin B3 (niacinamide) and water. Wherein the viscosity is within the instantly claimed range. Wherein the composition is oil free. The prior art composition is considered free of glycerin because glycerin is not a required component of the prior art invention.
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 1-3, 5, 6, 9 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-15 of copending Application No. 18/250,308 in view of Unilever (WO 2012/152567 A2; publication date 11/15/2012; cited in IDS 06/20/2023) and Special Chem (Hydriol PGCH.4, Special Chem, 03/20/2019 [retrieved 12/05/2025], https://www.specialchem.com/cosmetics/product/hydrior-hydriol-pgch-4).
Both the instant application and the copending application claim a composition comprising pentylene glycol, dipropylene glycol [claim 2; instant claims 1-2], niacinamide (i.e., vitamin B3 derivative) [claim 9; instant claim 1] and water and a C2-C4 glycol (e.g., butylene glycol) [claim 10; instant claim 3 and 10], all present in overlapping amounts [claims 3 and 7; instant claims 4 and 8] (which renders those ranges obvious. See MPEP 2144.05(I)). The copending claims discloses the composition may further comprise a surfactant [claim 8]. The copending claims disclose niacinamide [claim 9]. The copending claims do not disclose glycerin.
The copending claims the instantly claimed surfactant.
Unilever relates to a method of lightening skin [abstract] and teaches a composition comprising an extract, an activity enhancer and a cosmetically acceptable vehicle [p. 14, claim 1]. The activity enhancer comprises a mixture of an organic amine, a polyhydric alcohol and a non-ionic surfactant [p. 14, claim 1] wherein the non-ionic surfactant has an HLB value of at least 9.0 [p. 15, claim 8]. Suitable cosmetic vehicles include water (i.e., instant claim 10) [p. 8, lines 1-2]. Unilever discloses the composition may further comprise a vitamin B3 compound or its derivatives (e.g., vitamin B3) [p. 15, claim 9].
Special Chem discloses polyglyceryl-4 caprate “is used in cosmetics. It acts as a surfactant and a solubilizer. It offers benefits such as PEG-free, substantivity and skin-smoothening effect” [p. 1, para. 1] and its HLB value is 16 [p. 2, ‘Other Properties’].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have to have simply substituted the niacinamide of the copending claims for vitamin B3, because Unilever discloses that are suitable for the same purpose. See MPEP 2143, Exemplary Rationale B.
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected the polyglyceryl-4 caprate as the surfactant desired by the copending claims because Special Chem discloses it is suitable for cosmetic compositions. See MPEP 2144.07.
"[W]here 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 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). It would have been obvious to one of ordinary skill in the art, at the time of filling, to have optimized the amount of surfactant to find the optimal workable range.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
1) On pages 7 and 8 of their Remarks, Applicant argues that a combination of at least one glycol according to Claim 1 and at least one surfactant with a HLB value of 8-20 at the temperature of °C can improve the penetration of niacinamide into the skin after topical application.
Evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973). In the present case instant claim 1 is anticipated and so the showing of allegedly unexpected results cannot overcome the rejection.
2) On page 10 of their Remarks, Applicant argues that one of ordinary skill would believe that propylene glycol and pentylene glycol would perform equally based upon the description of Unilever.
This argument is moot in view of the new rejections set forth above.
3) On pages 10 and 11, Applicant argues that a skilled artisan would not have been able to predict the increased penetration of niacinamide in compositions comprising pentylene glycol as compared to compositions comprising propylene glycol as demonstrated in the Declaration under 37 C.F.R. § 1.132, by Yue Wang and filed 03/11/2026.
Evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973). In the present case instant claim 1 is anticipated and so the showing of allegedly unexpected results cannot overcome the rejection.
Instant claim 15 differs from instant claim 1 in the viscosity of the compositions and the specific surfactants. However, the claimed viscosity is not part of the unexpected results alleged by Applicant on pages 10 and 11, rather Applicant relies on showing in the Declaration that pentylene glycol improves the penetration of niacinamide as compared to propylene glycol. Therefore, a skilled artisan would have expected the compositions of instant claim 15 and of the Li et al., as discussed above, to have the same penetration properties because they both comprise pentylene glycol. Furthermore, instant claim 15 is not commensurate in scope with the objective evidence. The polysorbate 20 and polyglyceryl-2 oleate of the examples do not reasonably represent the surfactants “consisting of salts of amino acids, [and/or] betaines” recited by instant claim 15.
4) On page 13 of their Remarks, Applicant request the double patenting rejections be held in abeyance pending identification of allowable subject matter in the present application.
The instant claims continue to read on the copending claims, as set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLMAN WELLES whose telephone number is (571)272-3843. The examiner can normally be reached Monday - Friday, 8:30am - 5:00pm ET.
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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