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 .
Status of Claims
Applicant’s attention is drawn to MPEP 714(II)C, “The current status of all of the claims in the application, including any previously canceled or withdrawn claims, must be given. Status is indicated in a parenthetical expression following the claim number by one of the following status identifiers: (original), (currently amended), (previously presented), (canceled), (withdrawn), (new), or (not entered). The status identifier (withdrawn – currently amended) is also acceptable for a withdrawn claim that is being currently amended.” In particular, the status of the withdrawn claims should be properly indicated.
The amendments and arguments filed 23 June 2025 are acknowledged and have been fully considered. Claims 1-8, 10-12, and 15-16 are currently pending. Claims 1 and 10 are amended; claims 9 and 13-14 are cancelled; claims 5-7, 11-12, and 15-16 withdrawn; no claims are new.
Claims 1-4, 8, and 10 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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, and constitute the complete set presently being applied to the instant application.
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.
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 1-4, 8, and 10 are MAINTAINED rejected under 35 U.S.C. 103 as being unpatentable over Maruyama et al. (WO 2011/061864; of record).
Claim 1 is drawn to a photoprotective composition comprising:
an aqueous phase comprising from 0% to 99.9% by weight of the composition, based on the total weight of the composition;
an oil phase comprising from 0% to 99.9% by weight of the composition, based on the total weight of the composition;
an active sun block agent (more specifically the combination of octocrylene, homosalate, ethylhexyl salicylate, and butyl methoxydibenzoyl methane (Applicant’s elected species)); and
a micronized, non-solubilized natural wax comprising 0.1% to 10% by weight of the composition (more specifically 1% to 5% (Claim 4)), based on the total weight of the composition;
wherein the wax has a D50 particle size of 1 to 100 µm (more specifically 1 to 50 µm (Claim 2)) and a melting point of at least 70°C (more specifically 70 to 100°C (Claim 3));
and wherein the composition comprises at least 50% by weight of at least one of the aqueous phase or the oil phase (more specifically the aqueous phase (Applicant’s elected species)).
Claim 8 is drawn to the composition of claim 1, formulated as a lotion.
Maruyama et al. teach the sunscreen lotion composition “Example” in Table 1 (pg. 25) comprising:
38.80% by weight an aqueous phase;
59.2% by weight an oily phase;
the active sun block agents ethylhexyl methoxycinnamate and titanium dioxide; and
2% by weight a powder phase of synthetic wax;
wherein the wax particles have an average diameter of 6 to 8 µm.
Maruyama et al. further teach the composition being produced by “mixing all ingredients for phase C listed in Table 1 at room temperature. The oily phase (Phase A) was prepared by mixing all- ingredients for phase A listed in Table 1 at 65 °C in a turbine mixer which has a turbine type impeller. After cooling phase A to room temperature, phase C was added to phase A, and the resulting mixture was emulsified by using the turbine mixer to obtain a water-in-oil emulsion composition. Then, the resulting emulsion composition was allowed to cool to room temperature. The powder phase (phase B) was introduced and mixed into the emulsion by using the turbine mixer to disperse the powders, that is, wax particles in the emulsion to obtain the emulsion composition comprising the wax particles” (Pg. 26). As such, the wax of Maruyama et al. reads on non-solubilized wax as defined in paragraph [0082] of the instant specification.
As such, Maruyama et al. teach a photoprotective composition comprising an aqueous phase comprising from 0% to 99.9% by weight of the composition, based on the total weight of the composition; an oil phase comprising from 0% to 99.9% by weight of the composition, based on the total weight of the composition; an active sun block agent; and a micronized, non-solubilized wax comprising 1% to 5% by weight of the composition, based on the total weight of the composition; wherein the wax has a D50 particle size of 1 to 50 µm and wherein the composition comprises at least 50% by weight of the oil phase, wherein the composition is formulated as a lotion.
The composition of Maruyama et al. differs from the instantly claimed composition in the following ways:
the composition of Maruyama et al. does not comprise octocrylene, homosalate, ethylhexyl salicylate, and butyl methoxydibenzoyl methane;
the composition of Maruyama et al. does not comprise at least 50% by weight of the aqueous phase;
the composition of Maruyama et al. does not comprise a natural wax; and
Maruyama et al. is silent as to the melting point of the wax in the composition.
Yet, as to 1: Maruyama et al. further teach the use of butyl methoxy dibenzoylmethane as a lipophilic UVA filter (Pg. 9 last paragraph) and octocrylene, homosalate, and ethylhexyl salicylate and combinations thereof as lipophilic UVB filters (Pgs. 11-12 bridging paragraph).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Maruyama et al. to comprise octocrylene, homosalate, ethylhexyl salicylate, and butyl methoxydibenzoyl methane. It would have been obvious to substitute one UV filter for another with a reasonable expectation of success.
As to 2: Maruyama et al. further teach compositions in the form of an emulsion preferably comprising 15-30% by weight UV filters; 5-20% by weight dimethicone; 1-10% by weight wax particles; 3 to 10% by weight ethanol, and 3 to 10% by weight glycerol (Pg. 23 third paragraph and pg. 16 third paragraph). As calculated by examiner, these preferred ranges allow for 20-73% by weight water, corresponding to aqueous phases ranging from 40-79% by weight of the total composition, overlapping with the instantly claimed range of at least 50% by weight.
And as to 3 and 4: Maruyama et al. further teach the use of carnauba wax (i.e., a natural wax) as the micronized wax in the composition (Pg. 16 first paragraph). As evidenced by the instant specification in Par. [0137], the melting point of carnauba wax is 82°C.
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Maruyama et al. by substituting the synthetic wax for carnauba wax. It would have been obvious to substitute one micronized wax suitable for use in sunscreen compositions for another, with a reasonable expectation of success.
Based on all of the foregoing, claims 1-4 and 8 are rejected as prima facie obvious.
Claim 10 is drawn to a topically-applicable cosmetic formulation-composition for ultraviolet-photoprotection of skin against the damaging effects of ultraviolet irradiation comprising (a) an active sun block agent and (b) a micronized, non-solubilized natural wax, wherein the wax has a D50 particle size of 1 to 100 µm and a melting point of at least 70°C, formulated into (c) a topically-applicable, cosmetically acceptable carrier.
Maruyama et al. teach the sunscreen lotion composition “Example” in Table 1 (pg. 25) comprising:
the active sun block agents ethylhexyl methoxycinnamate and titanium dioxide; and
2% by weight a powder phase of synthetic wax; and
oily and aqueous carrier phases
wherein the wax particles have an average diameter of 6 to 8 µm.
Maruyama et al. further teach the composition being produced by “mixing all ingredients for phase C listed in Table 1 at room temperature. The oily phase (Phase A) was prepared by mixing all- ingredients for phase A listed in Table 1 at 65 °C in a turbine mixer which has a turbine type impeller. After cooling phase A to room temperature, phase C was added to phase A, and the resulting mixture was emulsified by using the turbine mixer to obtain a water-in-oil emulsion composition. Then, the resulting emulsion composition was allowed to cool to room temperature. The powder phase (phase B) was introduced and mixed into the emulsion by using the turbine mixer to disperse the powders, that is, wax particles in the emulsion to obtain the emulsion composition comprising the wax particles” (Pg. 26). As such, the wax of Maruyama et al. reads on non-solubilized wax as defined in paragraph [0082] of the instant specification.
The sunscreen lotion composition of Maruyama et al. reads on the instantly claimed topically-applicable cosmetic formulation-composition for ultraviolet-photoprotection of skin against the damaging effects of ultraviolet irradiation The oil and aqueous phases of the composition of Maruyama et al. read on the instantly claimed topically-applicable, cosmetically acceptable carrier.
As such, Maruyama et al. teach a topically-applicable cosmetic formulation-composition for ultraviolet-photoprotection of skin against the damaging effects of ultraviolet irradiation comprising (a) an active sun block agent and (b) a micronized, non-solubilized, formulated into (c) a topically-applicable, cosmetically acceptable carrier.
The composition of Maruyama et al. differs from the instantly claimed composition in the following way:
the composition of Maruyama et al. does not comprise a natural wax having a melting point of at least 70°C.
Yet, as to 1: Maruyama et al. further teach the use of carnauba wax (i.e., a natural wax) as the micronized wax in the composition (Pg. 16 first paragraph). As evidenced by the instant specification in Par. [0137], the melting point of carnauba wax is 82°C.
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Maruyama et al. by substituting the synthetic wax for carnauba wax. It would have been obvious to substitute one micronized wax suitable for use in sunscreen compositions for another, with a reasonable expectation of success.
As such, claim 10 is rejected as prima facie obvious.
Claim 1 is ADDITIONALLY maintained rejected under 35 U.S.C. 103 as being unpatentable over Maruyama et al. as applied to claims 1-4, 8, and 10 above, and further in view of Pistorio et al. (US 2014/0105943; of record).
The teachings of Maruyama et al. have been set forth above.
Claim 1 is drawn to a photoprotective composition comprising:
an aqueous phase comprising from 0% to 99.9% by weight of the composition, based on the total weight of the composition;
an oil phase comprising from 0% to 99.9% by weight of the composition, based on the total weight of the composition;
an active sun block agent; and
a micronized, non-solubilized natural wax comprising 0.1% to 10% by weight of the composition (more specifically carnauba wax and rice bran wax (Applicant’s elected species)), based on the total weight of the composition;
wherein the wax has a D50 particle size of 1 to 100 µm;
and wherein the composition comprises at least 50% by weight of at least one of the aqueous phase or the oil phase.
Maruyama et al. do not teach the composition comprising Applicant’s elected species of wax: the combination of carnauba wax and rice bran wax.
However, Pistorio et al. teach similar sunscreen composition comprising micronized wax particles (Abstract). Pistorio et al. further teach the wax particles comprising combinations of waxes such as carnauba wax and rice bran wax (Par. [0062]) and carnauba wax and rice bran wax both being hard waxes with similar melting points (Pars. [0068] and [0070]).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Maruyama et al. by substituting the combination of carnauba wax and rice bran wax in the place of carnauba wax. It would have been obvious to substitute one wax suitable for use as a micronized wax in cosmetic compositions for another, with a reasonable expectation of success.
As such, claim 1 is rejected as prima facie obvious.
Response to Arguments
Applicant's arguments filed 23 June 2025 have been fully considered but they are not persuasive.
Applicant argues on pg. 6 that as Maruyama et al. does not disclose the melting point of the wax that it is uncertain whether it melts when mixed into the composition, and as such, is no teaching present of the instantly claimed micronized, non-solubilized natural wax.
This argument is not persuasive. As discussed in the rejection of claim 1 above, the substitution of carnauba wax for the synthetic wax is obvious in view of the teachings of Maruyama et al. as Maruyama et al. teach both waxes to be suitable waxes suitable for use in sunscreen compositions. As such, substituting one wax for another is prima facie obvious (see MPEP 2143(I)).
Further, Maruyama et al. explicitly teach the cooling of the mixture to room temperature before adding the micronized wax and additionally teach the presence of wax particles in the emulsion (Pg. 26), indicating that the wax has not melted.
As such, the teachings of Maruyama et al. render prima facie obvious the instantly claimed composition comprising a micronized, non-solubilized natural wax.
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.
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/PAUL HOERNER/Examiner, Art Unit 1611
/CRAIG D RICCI/Primary Examiner, Art Unit 1611