DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 19 May 2025, was filed after the mailing date of the non-final Office Action on 16 May 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendments
Status of Claims
The amendment, filed on 12 August 2025, is acknowledged.
Claims 21, 23, and 26-28 have been amended.
New claims 41-43 have been added.
Claims 39-40 were previously withdrawn from further consideration as being drawn to a nonelected invention
Claims 21-38 and 41-43 are pending and under consideration in the instant Office Action, to the extent of the following elected species:
the emollient caprylic/capric triglycerides;
the humectant glycerin;
the emulsifier cetyl polyethylene glycol (PEG)/polypropylene glycol (PPG)-10/1-dimethicone and lauryl PEG-8 dimethicone; and
the other ingredient a preservative.
Objections Withdrawn
Objections to Claims
Applicant’s amendment to claim 28, submitted on 12 August 2025, has overcome the objection to the claims set forth in the Office Action mailed on 16 May 2025. Accordingly, the relevant objection is withdrawn.
Rejections Withdrawn
Rejections pursuant to 35 U.S.C. § 112
The rejection of claim 23 under 35 U.S.C. § 112 is withdrawn in view of Applicant’s amendment to the claim to further limit claim 21, the claim upon which it depends.
Rejections pursuant to 35 U.S.C. § 103
The rejection of claims 21-38 under 35 U.S.C. § 103 is withdrawn in view of Applicant’s amendments and in favor of the new grounds of rejection presented below.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
Claim 21 was amended to recite “a total amount of organosilicone compounds in the composition is between about 3.0 wt. % to about 6.0 wt. %”. Applicant did not point to where support for the amendment could be found in the original disclosure. Although the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims, when filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP § 714.02 and 2163.06 (“Applicant should therefore specifically point out the support for any amendments made to the disclosure.”). The examiner reviewed the specification and there does not appear to be sufficient support for the limitation in this amendment, as the original claim 21 recited dimethicone to be present in an amount from “about 3.0 wt. % to about 3.5 wt. %”, and the specification does not provide support for a limitation for the total quantity of organosilicone compounds. Instant claims 21-38 now recite limitations, which were not clearly disclosed in the specification as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in amended claim 21, which did not appear in the specification, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in the amended claims in the specification or claims, as-filed, or remove these limitations from the claims in response to this Office Action.
Claims 22-38, which depend from claim 21, necessarily incorporate the new matter from amended claim 21 and are also rejected.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 21-38 and 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Lademann et al. (WIPO International Publication No. WO 2019/043450 A2, published on 7 March 2019, provided by Applicant in IDS filed on 20 September 2022, hereafter referred to as Lademann) in view of Spaulding et al. (U.S. Patent Application Publication No. US 2017/0189293 A1, published on 6 July 2017, hereafter referred to as Spaulding).
Lademann teaches a cosmetic composition that possesses antioxidant properties, one or more sunscreen agents, and provides users light protection of the skin (Abstract and pg. 2, lines 3-6). The composition is taught to possess UVA and UVB filters, which are organic compounds that absorb radiation in the wavelength ranges of UVA and UVB, and one or more pigments, which may be titanium dioxide, zinc oxide, or other metal oxides, in addition to other components (pg. 3, lines 1-13 and pg. 6, lines 30-35). The amount of metal oxide in the composition is taught to be 2-30% relative to the total weight of the composition, which encompasses the range of “about 3.0 wt. % to about 20.0 wt. %” in instant claim 21 (pg. 3, lines 5-7 and claim 1). Titanium and zinc oxide are also taught to serve a double purpose, acting as both pigments and “mineral filters” which reflect light in the visible and UV ranges and offer additional light protection to the skin (pg. 17, lines 23-37).
One of the additional components taught to be in the cosmetic composition is a plant extract, which can serve as both a radical scavenger and humectant (claim 1 and pg. 20, lines 19-21). The compositions are taught to contain plant extracts in an amount of 0.1-5% w/w, overlapping with the range recited in instant claim 29 (claim 2). In Example 8, a cosmetic composition formulated as a non-foaming sun protection lotion is taught to comprise the plant extracts green tea, Scutellaria Baicalensis, and Saussurea Involucrata as humectants and radical scavengers, as well as the humectant propylene glycol in an amount of 5% w/w.
The formulation in Example 8 further comprises the emollients caprylic/capric triglycerides at an amount of 10% w/w, falling within the range recited in instant claim 26, and 6% w/w C12-C15 alkyl benzoate, falling within the range recited in instant claim 21. It also comprises water in an amount of 41% w/w, falling within the range of “30.0 wt. % or more” recited in instant claim 21. Two additional components are arachidyl glucoside (3.5% w/w) and myristyl glucoside (1.5%), totaling 5% w/w of the formulation (Example 8). Lademann teaches emulsifiers may be used in their compositions, including polyglucosides (pg. 10, lines 31-36), indicating Example 8 contains 5% w/w of emulsifiers, falling within the range of “about 2.0 wt. % to about 10 wt. %” disclosed in instant claim 21. Finally, in Example 6 a sun protection milk formulation, which is determined to be equivalent to a non-foaming lotion, is taught to comprise 5% w/w dimethicone, a preservative, and no starches, pectins, or gums.
Lademann does not teach a composition that comprises a total amount of organosilicone compounds in the range of 3.0-6.0% w/w, glycerin as a humectant, the mixture of cetyl polyethylene glycol (PEG)/polypropylene glycol (PPG)-10/1 dimethicone and lauryl PEG-8 dimethicone as an emulsifier, or an octyldodecyl citrate crosspolymer as a film former nor the amount of the film former in their composition. These deficiencies are offset by the teachings of Spaulding.
Spaulding teaches a photoprotective cosmetic composition that comprises one or more photoactive agents and a synergistic combination of polymers, which can provide a substantially complete film, in the form of a liquid that is dispensed via bottle, pump, or spray (Abstract). The composition provides protection from UVA and UVB radiation, which are known to damage or harm the skin, by forming a film that comprises one or more photoactive agents (para. [0006] and [0011]). Examples of photoactive agents include, among others, metal oxides such as zinc oxide and titanium dioxide and comprise “about 0.1 wt. % to about 40 wt. %” of the composition (para. [0051-0052]).
The synergistic combination of polymers is taught to comprise an alkyl dimethicone, a polymer with ester linkages, or a phenyl silicon or styrene (para. [0013]). In one embodiment, the alkyl dimethicone is taught to be lauryl PEG-8 dimethicone (trade name SILUBE® J208-612) (para. [0053]). In another embodiment, the polymer with ester linkages may be octyldodecyl citrate cross polymer (trade name COSMOSURF® CE-100) (para. [0060]). The combination of polymers is taught to comprise “about 0.1 wt. % to about 5 wt. %” of the alkyl dimethicone, polymer with ester linkages, and phenyl silicon or styrene, rendering obvious the range recited in instant claim 35 (claim 24). Further, the total amount of organosilicone compounds would be 0.2-10% w/w, which encompasses the range of 3.0-6.0% w/w recited in amended claim 21 (claim 24).
Additional components that are taught to be in the composition include the emollient capric/caprylic triglycerides (trade name DERMOL M5), the emulsifier cetyl PEG/PPG-10/1 dimethicone (trade name ABIL® EM-90), and the humectant glycerin (trade name Emery 917) (para. [0060] and [0113]). The combination of lauryl PEG-8 dimethicone and cetyl PEG/PPG-10/1 dimethicone is taught to also act as an emulsifier (claim 14). Finally, the composition is taught to further comprise water, an emulsifier, an emollient, a humectant, a film former, and a preservative, or any combinations thereof (claim 13).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Lademann and Spaulding to arrive at the claimed invention because simple substitution of one known element for another in related inventions produces predictable results. Lademann teaches compositions which, in some embodiments, comprise ZnO and/or TiO-2- as pigments and UV protectants, plant extracts, caprylic/capric triglycerides as an emollient, and water, in quantities that overlap with or fall within the ranges recited in the instant claims, and formulated as non-foaming lotions. One of ordinary skill in the art would be motivated in view of the teachings of Spaulding to substitute the humectant glycerin, the mixture of cetyl polyethylene glycol (PEG)/polypropylene glycol (PPG)-10/1 dimethicone and lauryl PEG-8 dimethicone as an emulsifier, and an octyldodecyl citrate crosspolymer as a film former in the invention of Lademann because Spaulding taught the components to work in a photoprotective cosmetic composition and that the polymers worked in synergy to form a protective film while also acting as an emulsifier. An artisan would desire an effective composition, including a synergistic mixture of polymers that display multiple functions at amounts that produce a total of 3.0-6.0% w/w organosilicone compounds, and it would have been obvious for them to substitute the components taught by Spaulding into the invention of Lademann to produce an optimized product. As a result, there is a reasonable expectation of success in arriving at the invention of claims 21-38 and 41-43 in view of the teachings of Lademann and Spaulding.
Response to Arguments
The Applicant’s arguments, filed on 12 August 2025, have been fully considered but are not persuasive.
In para. 2 of pg. 8 of the remarks, Applicant argues that “Lademann fails to teach a sunscreen active selected from the group consisting of a metal oxide”. However, Lademann does teach metal oxides, repeated here in brief for clarity, “one or more pigments, which may be titanium dioxide, zinc dioxide, or other metal oxides” (vide supra). Applicant further argues in para. 3 of pg. 8 that Lademann teaches organosilicones at higher concentrations than in amended claim 1, citing examples 5 and 6 in Lademann. However, as described in further detail above, the amendment to claim 1 does not have support in the original disclosure (see new ground of rejection under 35 U.S.C. § 102) and is obvious in view of the prior art cited above (see new ground of rejection under 35 U.S.C. § 103).
Finally, Applicant argues in para. 4 of pg. 8 that the composition presented in Example 1 of the instant specification “clearly demonstrates the unexpected and surprising results of Applicant’s composition”, arising from the concentrations of C12-15 alkyl benzoate and an organosilicone compound including dimethicone, imparting improvements in sensory properties and thickness. Guidelines on determining whether results are expected or unexpected are provided in MPEP § 716.02. To demonstrate that results are unexpected and significant, the Applicant must provide evidence that establishes “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). “Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims” (bold added for emphasis). See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and MPEP § 716.02(d) - § 716.02(e).
Example 1 is compared to Comparative Example 1, which is a commercially available mineral sunscreen lotion (para. [0048]) that comprises 11% w/w ZnO and TiO2 and no C12-15 alkyl benzoate (para. [0049]). Example 1 is a composition comprising:
≥15.0% w/w C12-15 alkyl benzoate (para. [0049]);
one or more other emollients selected from plant-derived oil, dimethicone, glyceryl stearate, and/or butyloctyl salicylate in an amount from 0.1-6.0% w/w (para. [0049]);
glycerin and/or stearyl/octyldodecyl citrate crosspolymer in an amount from 1.5-7.5% w/w (para. [0050]);
an emulsifier that may be cetyl PEG/PPG-10/1 dimethicone, lauryl PEG-8 dimethicone, and/or caprylic/capric triglyceride and stearalkonium bentonite and propylene carbonate in an amount from 2.0-10.0% w/w (para. [0050]);
VP/eicosane copolymer or stearyl/octyldodecyl citrate crosspolymer in an amount <4.0% w/w (para. [0050]);
water in an amount of ≥30.0% w/w (para. [0051]);
an additional ingredient selected from phenoxyethanol and ethylhexylglycerine, sodium chloride, alcohol, extracts, bismuth oxychloride and mica and iron oxide, mica and iron oxides and TiO2, ethylhexyl methoxycrylene, and/or polyhydrostearic acid in an amount from 0.01-5.0% w/w (para. [0051]); and
11.5% w/w ZnO and/or TiO2 (Table 2).
Table 2 presents a comparison of sensory attributes of Example 1 and Comparative Example 1, using a numerical rating system based upon ASTM E 1490 – 03 Standard Practice for Descriptive Skinfeel Analysis of Creams and Lotions (para. [0048]).
The comparison of Example 1 and Comparative Example 1 is not a persuasive demonstration of unexpected and surprising results. The only comparison of the two compositions allowed by the information provided is of the relative concentrations of ZnO/TiO2, which is approximately equal, and the relative concentrations of C12-15 alkyl benzoate, which is ≥15.0% w/w in Example 1 and 0% w/w in Comparative Example 1 – no analysis regarding the additional ingredients has been presented. The only conclusion that can be drawn from Table 2 is that the inclusion of C12-15 alkyl benzoate at a concentration of ≥15.0% w/w appears to increase the rub-in, spreadability, and sticky/tackiness attributes and decrease the thickness, though no analysis has been provided that would demonstrate the attribute changes did not arise from other ingredients increasing/decreasing in concentration. Further, the Applicant states that “a rating difference of greater than one (1) point signifies a statistically significant change”, but does not provide a statistical analysis to support this assertion.
The Applicant has not demonstrated unexpected results commensurate in scope with the claimed invention. “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(d). Only one example outside the claimed range has been provided (Comparative Example 1) and the concentration of C12-15 alkyl benzoate in Example 1 is only stated as ≥15.0% w/w, which encompasses values outside of the claimed range of 5.0-30.0% w/w and therefore does not demonstrate the criticality of the claimed range.
The Applicant also has not compared their invention with the closest prior art. See MPEP § 716.02(e). The comparison provided in the instant specification is within an unidentified commercially available mineral sunscreen lotion that does not contain a C12-15 alkyl benzoate. Lademann et al. (WIPO International Publication No. WO 2019/043450 A2), which was provided by Applicant in the IDS filed on 20 September 2022 and used in a rejection under 35 U.S.C. § 103 in the previous Office Action, teach compositions that comprise 2-30% w/w metal oxides, which may be ZnO and/or TiO2, and comprise a C12-15 alkyl benzoate, in one embodiment at a concentration that falls within the claimed range of 5.0-30.0% w/w. Therefore, a comparison with the closest subject matter in the prior art should include a comparison to Lademann et al.
Conclusion
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 Sean J. Steinke, whose telephone number is (571) 272-3396. The examiner can normally be reached Monday - Friday, 09:00 - 17:00 ET.
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/S.J.S./
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619