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 .
Applicants’ arguments, filed 03/11/2026, have been fully considered. Rejections and/or objections not reiterated from previous office action are hereby withdrawn.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 – New by Amendment
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.
Claim 8 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 8 recites the limitation "the brightening and/or whitening ingredient selected from vitamin B3 and derivatives thereof " (emphasis added). There is insufficient antecedent basis for this limitation.
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 1-4, 7, 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Unilever (WO 2012/152567 A2; publication date 11/15/2012; cited in IDS 06/20/2023) and Gan et al. (US 9,913,799 B2; date of patent 03/13/2018).
Regarding instant claims 1-3 and 10, 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 derivatives) [p. 15, claim 9]. Examples of polyhydric alcohols include butanediol and pentanediol [p. 6, line 32]. Unilever also discloses the composition may further comprise thickeners [p. 12, line 11].
According to the instant specification “the definition of glycols includes all possible isomers” [p. 5, line 7] therefore the examiner is interpreting butanediol and pentanediol to read on the butylene glycol and pentylene glycol of claims 3 and 10.
Unilever also does not expressly disclose the composition may be oil-free.
Gan relates to a composition for “reducing the appearance of dark spots or hyperpigmentation” comprising extracts and niacinamide (i.e., vitamin B3 derivative) [abstract]. Gan discloses “examples of suitable vehicles include emulsions … creams, lotions, solutions (both aqueous and hydro-alcoholic), anhydrous bases (such as lipsticks and powders), gels, and ointments” [col. 9, lines 60-66] and that compositions may be oil-free [col. 5, lines 32-33]. Finaly, Gan discloses suitable thickeners include dipropylene glycol [col. 16, line 55].
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, at the time of filling, to have selected the oil-free vehicle, and formulation, of Gan for the composition of Unilever because Gan discloses they are suitable skin lightening compositions comprising extracts and vitamin B3 derivatives.
Similarly, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected dipropylene glycol as the thickener desired by Unilever because Gan discloses it is a suitable thickener for skin whitening compositions comprising extracts and vitamin B3 derivatives.
Additionally, 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 HLB value of the prior art overlaps with the instantly claimed value and so a prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising at least one C4-C10 glycol with a log P from -0.5 to 4 comprising propylene glycol (i.e., a combination of butanediol, pentanediol and dipropylene glycol), a surfactant with an HLB value within the instantly claimed range and a vitamin B3 derivative. Wherein the composition in oil-free and further comprises water. The composition taught by Unilever and Gan does not comprise glycerin because Unilever does not require glycerin.
Regarding instant claims 4, 7 and 8, Unilever discloses “[w]hen included polyhydric alcohols are present in 0.01 to 10 %” [p. 7, lines 1-2], “[t]he non-ionic surfactant may be present in 0.01 to 10 %” [p. 8, lines 10-11] and teaches additional skin lightening agents, such as vitamin B3 compounds, are present from 0.1 to 10% by weight [p. 10, lines 6-11].
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 polyhydric alcohols (2-40%), surfactant (0.001-3%) and vitamin B3 compounds (0.1-15%) all overlap with the ranges of the prior art and so a prima facie case of obviousness exists for each.
2) Claims 5, 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Unilever (WO 2012/152567 A2; publication date 11/15/2012; cited in IDS 06/20/2023) and Gan et al. (US 9,913,799 B2; date of patent 03/13/2018) as applied to claims 1-4, 7, 8 and 10 above, and further in view of Special Chem (Hydriol PGCH.4, Special Chem, 03/20/2019 [retrieved 12/05/2025], https://www.specialchem.com/cosmetics/product/hydrior-hydriol-pgch-4).
Unilever and Gan, which are taught above, differ from the instant claims insofar as they do not teach surfactants selected from a group consisting of esters of fatty acids and glycerol or polyglycerol, salts of amino acid, betaines, and a mixture thereof. However, Unilever discloses that “[s]mooth, soft and glowing skin with even skin tone and colour is thus desired by all” [p. 2, lines 20-21]. Unilever also discloses that activity enhancer (i.e., organic amine, polyhydric alcohol and non-ionic surfactant) “act through different mechanisms including enhanced solubility of the organic aromatic acids present in the plant extract, providing enhanced transdermal delivery of the primary skin lightening actives or a combination of the two to provide overall enhanced skin lightening” [p. 7, lines 7-17].
Regarding instant claims 5 and 6, 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’].
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, at the time of filling, to have to have selected a C6-C30 fatty acid ester of polyglycerol (i.e., polyglyceryl-4 caprate) for the surfactant having an HLB value greater than 9 as desired by Unilever, because Special Chem discloses it is a surfactant having an HLB value greater than 9 which is suitable for cosmetic compositions. Additionally, one would have been motivated to make this selections because polyglyceryl-4 caprate provides additional affects such as skin smoothing and solubilizing, which are desired by Unilever. One would have had an expectation of success because polyglyceryl-4 caprate falls within the requirements of Unilever, i.e., a non-ionic surfactant having an HLB value greater than 9.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to formulated the composition taught by Unilever and Gan, wherein non-ionic surfactant is polyglyceryl-4 caprate.
Regarding instant claim 9, Unilever discloses “[w]hen included polyhydric alcohols are present in 0.01 to 10 %” [p. 7, lines 1-2], “[t]he non-ionic surfactant may be present in 0.01 to 10 %” [p. 8, lines 10-11] and teaches additional skin lightening agents, such as vitamin B3 compounds, are present from 0.1 to 10% by weight [p. 10, lines 6-11].
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 polyhydric alcohols (8-20%), surfactant (0.005-1%) and vitamin B3 compounds (1-8%) all overlap with the ranges of the prior art and so a prima facie case of obviousness exists for each.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising a combination of butylene glycol, pentylene glycol and dipropylene glycol in amounts as instantly claimed, polyglyceryl-4 caprate in amounts as instantly claimed and vitamin B3 in amounts as instantly claimed. Wherein the composition does not comprise water.
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 1-10 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 do not disclose glycerin.
The copending claims do not disclose vitamin B3 or 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 page 13 of their remarks, Applicant argues that one of ordinary skill would have believed that propylene glycol and pentylene glycol would have performed equally as penetration enhancers based upon the description of Unilever. Applicant asserts that the pentylene glycol unexpectedly enhances penetration of niacinamide as compared to propylene glycol. Applicant cites the Declaration under 37 C.F.R. § 1.132 filed 03/11/2026.
This argument is not persuasive. To begin, the disclosure as originally filed does not disclose that pentylene glycol is responsible for any unexpected or surprising results. Now, in regard to the Declaration under 37 C.F.R. § 1.132 filed 03/11/2026, overcoming a rejection based on unexpected results requires the combination of three different elements: (i) the results must fairly compare with the prior art, (ii) the results must truly be unexpected and (iii) the claims must be commensurate in scope. MPEP §716.02. The burden rests with Applicant to establish results are unexpected and significant. MPEP §716.02(b). Applicant's showing of allegedly unexpected results does not satisfy any of these requirements.
(i) In the present case, Applicant has not compared the allegedly unexpected results of the instant formulations to the result of the closest prior art formulation; Example 4 in Table 1 on page 13 of Unilever, reproduced below:
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While the formulations representing the prior art compositions in the Declaration are similar to the compositions of Unilever, Unilever does not disclose hydroxyacetophenone.
(ii) 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) (MPEP 716.02(b)). In the present case, it does not appear that the degree of niacinamide penetration in compositions comprising pentylene glycol as compared to composition comprising propylene glycol is in fact unexpected in view of the prior art. For example, see Durachera et al. (Internation Journal of Pharmaceutics, 2009, 374, p. 39-45).
Durachera discloses relates the influence of alcohol, propylene glycol and 1,2-pentanediol on permeability of an active agent through the skin [title]. Durachera discloses “[i]n order to investigate a possible influence of these compounds [alcohol, pentylene glycol and propylene glycol], we followed diffusion from an aqueous solution with caffeine followed by a series of different vehicles, their compositions were: (1) in water as a control; (2) in propylene glycol/ethanol/water (25:25:48; v/v/v); (3) in 1,2-pentanediol/water (2.5:95.5, v/v); (4) in 1,2-pentanediol/water (5:93, v/v); in propylene glycol/water (5:93; v/v); and in ethanol/water (5:93; v/v)” [abstract]. Durachera found that “1,2-pentanediol was presented as the most effective enhancer; with a low proportion of this compound (only 5%), caffeine penetrated the skin quicker and in a greater extent” [abstract].
Therefore, a skilled artisan would have expected pentylene glycol to provide improved skin penetration as compared to propylene glycol.
(iii) The "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support" (see MPEP 716.02(d) quoting In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)). In the present case the claims are not commensurate in scope with the showing of objective evidence. The Declaration discloses composition comprising 3% pentylene glycol, 5% niacinamide, hydroxyacetophenone and water. The claims are not commensurate in scope because the independent claim does not recite niacinamide, hydroxyacetophenone and water.
The Examiner acknowledges that “Applicant respectfully notes that according to the present amendment of Claim 1, pentylene glycol is present in the composition. Therefore, similar results may be expected for compositions according to Claim 1.” However, there is no explanation as to why a skilled artisan would have reasonably expected niacinamide to represent the claimed “vitamin B3 derivatives”, as the instant specification discloses “Niacinamide is also called vitamin B3” (i.e., not a vitamin B3 derivative) [p. 9, line 14]. Furthermore, applicant has not explained why the specific amounts in the Declaration reasonably represent any amounts of the claimed components, as instantly claimed. Finally, there is no explanation as to why the compositions comprising water and hydroxyacetophenone of the Declaration reasonably represent the instantly claimed compositions, which require neither.
2) On page 15 of their remarks, Applicant request requests that the double patenting rejections be held in abeyance pending identification of allowable subject matter in the present application.
The conflicting claims continue to read on the instant claims and the double patenting rejection in maintained for the reasons above and of record.
Conclusion
THIS ACTION IS MADE FINAL. 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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana 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.
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/C.T.W./ Examiner, Art Unit 1612
/WALTER E WEBB/ Primary Examiner, Art Unit 1612