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 .
Claim Status
Claims 1-20 are pending and under examination.
Claim Interpretation
As best understood by the Examiner, the Hansen solubility parameter units are interpreted to be measured in MPa1/2, as is standardly used in the art.
Claim Rejections - 35 USC § 112(a) - Enablement
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.
Claim 6 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to a sunscreen composition comprising three or more film formers, each having a Hansen solubility parameter delta D, delta P and delta H between 3 and 4 units of one another; and an organic UV filter. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. Claim 6 recites a list of “film formers”, however, not all of the listed components are understood in the art as film formers. As an illustrative example, Fleming et al (WO 2021226196, hereinafter “Fleming”) describes film formers in sunscreen compositions as distinct cosmetic ingredients including polymers, copolymers, etc., that provide a substantially homogenous and/or structured hydro-lipidic film on skin, and separately identifies solvents and other formulation components, including sunscreen actives (including octocrylene, etc.), emollients, etc. (¶¶ 17, 36-41). In embodiments, the film formers were included in solvents, such as an alcohol, an ether, a fatty acid, a silicone fluid, an ester, etc. (¶ 37), suggesting that the solvents themselves, as well as the sunscreen active agents, are not typically understood as having the function of forming films.
2. The breadth of the claims
The claims are thus very broad insofar as they suggest that any combination of three or more components of claim 6 would be capable of serving the function of forming films in a sunscreen composition, while also meeting the Hansen solubility parameters as recited in claim 1.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for practicing the claimed invention in its “full scope”. No reasonably specific guidance is provided concerning useful protocols for combining any three or more of those components as recited in claim 6 as “film formers”, other than the polyurethane-34, VP/eicosane copolymer (Ganex V220), KP Acrylates/Dimethicone copolymer (KP-549), and trimethylsiloxysilicate embodiments from the working examples, all of which appear to be known film formers in the prior art. The specification does not establish that three or more of any of the recited components will function as the claimed film formers while also satisfying the Hansen solubility parameter relationship, nor does the specification provide direction for a skilled artisan to determine which combinations will provide the claimed result without undue experimentation.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art and that many of the recited components are not recognized as film formers, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that any combination of three or more of the instantly claimed agents could be predictably used as film formers, where the claim recites various components from different categories of cosmetic function (e.g., solvents, emollients, UV filters, etc.), and in any amounts, as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Claim Rejections - 35 USC § 112(b) or pre-AIA 2nd ¶
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.
Claims 1-20 are 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 1 recites Hansen solubility parameters delta D, delta P, and delta H “between 3 and 4 units of one another”. It is not clear if each individual film former must have a delta D, delta P, and delta H between 3 and 4 units of each other within the same film former, or if the corresponding delta D, delta P, and delta H values among the different film formers must be between 3 and 4 units.
Claims 2-10 and 12-20 are rejected for the same reasons for depending upon or including all limitations of rejected claim 1.
Claim 6 recites the term “FAME”, which appears to be an acronym. It is not clear to the examiner what FAME represents. For purposes of examination, the Examiner best understands “FAME” as fatty acid methyl esters, thought the Examiner is not sure.
Claim 6 also recites “film formers”, however, from the recited components it is not clear of the scope of the term “film former” as used in the instant claim, where the list includes components that are ordinarily understood to serve different functions, such as solvents, UV filters, emollients, etc. For example, a non-limiting list of those recited include toluene, 1,4-dioxiane, d-Limonene, iso-butyl isobutyrate, iso-pentyl acetate, Ektapro EEP, methyl iso-butyl carbinol, n-amyl acetate, n-butyl acetate, di-isobutyl ketone, sec-butyl acetate, t-butyl acetate, Ectasolv EEH, cyclopentyl methyl ester, methanol, ethanol, etc., which are solvents. Other listed “film formers” include avobenzone, homosalate, octisalate, and octocrylene which are also recited in claim 14 as UV filters, not film formers. Looking to the instant specification, paragraph 50 recites solvents, film formers, emollients, UV absorbers, etc., as different categories of cosmetic ingredients, but claim 6 also includes components ordinarily characterized as solvents, UV absorbers, active agents, etc., rendering the claim indefinite.
Claim 10 recites percentage amounts of the film formers, and it is unclear if the percentages are a weight percent, volume percent, mol percent, or something else. For purposes of examination, the claim is interpreted as a weight percent based on total weight of the composition.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 6 recites the broad recitation “1,4-dioxane”, and the claim also recites “(high P)” which is the narrower statement of the range/limitation. Additionally, “high” is a relative term which renders the claim indefinite and it is also not clear what “P” represents. For purposes of examination, the limitation is interpreted as simply “1,4-dioxane”.
Claim 6 also recites the broad recitation “Caprolactone”, and the claim also recites “(Epsilon)” which is the narrower statement of the range/limitation. For purposes of examination, the limitation is interpreted as simply “caprolactone”.
Claims 7 and 9-11 recite the broad recitations “VP/eicosane copolymer” and “KP acrylates/dimethicone copolymer”, and the claims also recite “(Ganex V220)” and “(KP-549)”, respectively, which are the narrower statement of the range/limitation. For purposes of examination, the limitations are interpreted as simply “VP/eicosane copolymer” and “acrylates/dimethicone copolymer”.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 6 contains the trademark/trade names Ganex V220, Ektapro Eep, Corapan Tq, Ektasolve Eeh, Finsolv Tpp, Solastay S1, KF 7312L, Kp549, and Methyl Cellosolve. For purposes of examination, the Examiner best understands Ganex V220 as VP/eicosane copolymer and Kp549 as acrylates/dimethicone copolymer.
Claims 7 and 9-11 contain the trademark/trade names Ganex V220, KP acrylates/dimethicone copolymer (appearing to refer to the Shin-Etsu KP produce series), and KP-549. Where KP appears to be a Shin-Etsu product series, for purposes of examination, the Examiner best understands the limitation as simply “acrylates/dimethicone copolymer” without the “KP” recitation.
Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe film formers and, accordingly, the identification/description is indefinite.
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 1-8 and 12-20, are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Norman (US 20130195779 A1), as evidenced by INKEEDecoder (Acrylates/C12-22 Alkyl Methacrylate Copolymer, retrieved 2026).
Norman discloses sunscreen compositions comprising a combination of octocrylene, avobenzone, octisalate, homosalate, and oxybenzone, and a combination of VP/eicosane copolymer, acrylates/C12-22 alkyl methacrylate copolymer, trimethylsiloxysilicate, and acrylates/dimethicone copolymer, wherein the emulsion has a sun protection factor of at least 50 (abs). As evidenced by INKEEDecoder, acrylates/C12-22 alkyl methacrylate copolymer is a film former. Also disclosed is a method of protecting skin from UV radiation comprising applying the emulsion to skin in need thereof, wherein the emulsion is applied to facial skin (claims 10, 11). In another embodiment, the composition is applied to hands (¶ 12).
Regarding claims 1, 6, and 7, where Norman discloses a sunscreen composition comprising organic UV filters as instantly claimed, and appear to comprise three or more of the same film formers as instantly claimed, it appears the limitation of each film former having Hansen solubility parameters delta D, delta P, and delta H between 3 and 4 units of each other is met as evidenced by instant claim 7.
Regarding claims 2-5, where the instant specification evidences VP/eicosene copolymer, trimethylsiloxysilicate, and acrylates/dimethicone copolymer as examples of acceptable film-formers having the desired Hansen solubility parameters of a delta D from 13.2 to 19.8, a delta P from 1.2 to 15.5, and a delta H from 0.4 to 13.4, it appears the limitations are met.
Regarding claim 8, where Norman discloses a sunscreen composition comprising a fourth film former, the limitation appears to be met.
Regarding claim 12, the sunscreen composition of Norman is in the form of an emulsion, thereby meeting the claimed limitation.
Regarding claims 13-15, where Norman discloses a sunscreen composition comprising a combination of the organic UV filters octocrylene, avobenzone, octisalate, homosalate, and oxybenzone, the limitations are met.
Regarding claims 16 and 17, where Norman discloses the sunscreen composition has a SPF of at least 50, the limitations are met.
Regarding claims 18-20, where Norman discloses a method of protecting skin from UV radiation comprising applying the composition to the skin, including facial skin and hand skin, the limitations are met.
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 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Norman (US 20130195779 A1), in view of Fleming et al (WO 2021226196, hereinafter “Fleming”, cited on IDS dated 03/07/2025).
Norman discloses sunscreen compositions comprising a combination of octocrylene, avobenzone, octisalate, homosalate, and oxybenzone, and a combination of VP/eicosane copolymer, acrylates/C12-22 alkyl methacrylate copolymer, trimethylsiloxysilicate, and acrylates/dimethicone copolymer, wherein the emulsion has a sun protection factor of at least 50 (abs). Also disclosed is a method of protecting skin from UV radiation comprising applying the substantive emulsion of claim 1 to skin in need thereof, wherein the emulsion is applied to facial skin (claims 10, 11). In another embodiment, the composition is applied to hand skin (¶ 12). The film formers are 3 to 5 wt% of the composition (abs).
Norman does not teach polyurethane-34.
Fleming teaches mineral sunscreen compositions comprising a sunscreen active and a film former (abs). The sunscreen active substantially absorbs, scatters, and/or deflects UV radiation on a keratinous substrate, such as skin and hair (¶¶ 4, 17). Sunscreen actives include oxybenzone, homosalate, octyl methoxycinnamate, octyl salicylate, butylmethoxydibenzoyl-methane, octocrylene, p-aminobenzoic acid (PABA), etc., and combinations thereof (¶¶ 3, 17). Film formers include one or more of acrylate/dimethicone copolymer, trimethylsiloxysilicate, polyurethane (e.g., 34), VP/eicosene copolymer, trimethylsiloxysilicate, and acrylate/dimethicone copolymer (¶ 38). The instant specification evidences polyurethane-34, VP/eicosene copolymer, trimethylsiloxysilicate, and KP acrylates/dimethicone copolymer as examples of acceptable film-formers having the desired Hansen solubility parameters of a delta D from 13.2 to 19.8, a delta P from 1.2 to 15.5, and a delta H from 0.4 to 13.4 (see ¶ 39 of the instant specification and instant claim 7). The film former may, for example, be present in an amount between about 0.1 wt. % to about 5.0 wt. %, including 0.09 wt. %, 0.9 wt. %, 1.0 wt. %, 2.0 wt. %, 3.0 wt. %, 4.0 wt. %, 5.0 wt. %, 5.5 wt. %, including every number and/or fraction therebetween, based on the total weight of the sunscreen composition (¶¶ 12, 39, table 1). Other additional ingredients may be included, including additional film formers, etc., in amounts of about 0.01 wt% to about 99.0 wt% (¶ 42). The sunscreen composition may include one or more formulation formats such as, without limitation, an emulsion, a lotion, a gel, an ointment, etc. (¶ 43). The sun protection factor (SPF) of a sunscreen composition may be greater than or equal to 15 (¶ 19). The working embodiments were applied to the skin (¶ 48, table 2).
Claim 8 is discussed above, and purely arguendo, if somehow the fourth film former does not read on the claim, it would have been obvious to substitute other known film formers suitable for sunscreen compositions comprising organic UV filters for the acrylates/C12-22 alkyl methacrylate copolymer, such as polyurethane-34, as taught by Fleming. See MPEP 2132 I.(B).
Regarding claims 9 and 11, it would have been obvious to substitute polyurethane-34 for the acrylates/C12-22 alkyl methacrylate copolymer of Fleming, for the same reasons discussed above, thereby resulting in a sunscreen composition comprising organic UV filters, polyurethane-34, VP/eicosene copolymer, trimethylsiloxysilicate, and acrylate/dimethicone copolymer, appearing to meet the claimed limitations.
Regarding claim 10, where Norman teaches the polymers are included from 3-5 wt%, and where Fleming teaches film formers may be included from about 0.1 wt% to about 5 wt%, it would have been obvious to select from those disclosed ranges for each film former, overlapping the claimed ranges. 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). Further, it would have been well within the relative skills of the skilled artisan to have routinely optimized the amount of film formers in order to achieve desired homogeneity, viscosity, hydro-lipidic properties, etc., as taught by Fleming.
Purely arguendo, if somehow the film former range refers to the total amount of film formers in the composition, Fleming also teaches in addition to those above, additional components including addition film formers can be added in amounts ranging from about 0.1 to about 99.0 wt%, and it would have been obvious to select among either range in order to achieve desired formulation properties for the same reasons discussed above.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Norman (US 20130195779 A1), in view of Fleming et al (WO 2021226196, hereinafter “Fleming”, cited on IDS dated 03/07/2025), in view of Shin Etsu (KP-549, 2016, pp. 1-2).
Norman and Fleming are discussed above and purely arguendo if somehow the acrylates/dimethicone copolymer does not meet the claimed limitations, the following applies.
Shin Etsu teaches KP-549, an acrylates/dimethicone copolymer, was a known film former used in sunscreens in amounts ranging from 0.5-10% (pg 1).
It would have been obvious to substitute KP-549 of Shin Etsu for the acrylates/dimethicone copolymer of Norman, where both were known acrylates/dimethicone copolymers suitable for sunscreen applications. See MPEP 2132 I.(B). KP-549 appears to meet the limitations of Hansen solubility parameters as instantly claimed as evidenced by claims 7, 9, 10 and 11, which depend from claim 1.
Where the instant specification evidences polyurethane-34, VP/eicosene copolymer, trimethylsiloxysilicate, and KP-549 as examples of acceptable film-formers having the desired Hansen solubility parameters of a delta D from 13.2 to 19.8, a delta P from 1.2 to 15.5, and a delta H from 0.4 to 13.4, it appears the limitations are met.
The additional limitations of claims 1-20 are obvious for the same reasons discussed above in view of Fleming, as applied to each and every claimed limitation.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fleming et al (WO 2021226196, hereinafter “Fleming”, cited on IDS dated 03/07/2025).
Fleming teaches mineral sunscreen compositions comprising a sunscreen active and a film former (abs). The sunscreen active substantially absorbs, scatters, and/or deflects UV radiation on a keratinous substrate, such as skin and hair (¶¶ 4, 17). Sunscreen actives include oxybenzone, homosalate, ocytl methoxycinnamate, octyl salicylate, butylmethoxydibenzoyl-methane, octocrylene, p-aminobenzoic acid (PABA), etc., and combinations thereof (¶¶ 3, 17). Film formers include one or more of acrylate/dimethicone copolymer, trimethylsiloxysilicate, polyurethane (e.g., 34), VP/eicosene copolymer, trimethylsiloxysilicate, and acrylate/dimethicone copolymer (¶ 38). The instant specification evidences polyurethane-34, VP/eicosene copolymer, trimethylsiloxysilicate, and KP acrylates/dimethicone copolymer as examples of acceptable film-formers having the desired Hansen solubility parameters of a delta D from 13.2 to 19.8, a delta P from 1.2 to 15.5, and a delta H from 0.4 to 13.4 (see ¶ 39 of the instant specification and instant claim 7). The film former may, for example, be present in an amount between about 0.1 wt. % to about 5.0 wt. %, including 0.09 wt. %, 0.9 wt. %, 1.0 wt. %, 2.0 wt. %, 3.0 wt. %, 4.0 wt. %, 5.0 wt. %, 5.5 wt. %, including every number and/or fraction therebetween, based on the total weight of the sunscreen composition (¶¶ 12, 39, table 1). Other additional ingredients may be included, including additional film formers, etc., in amounts of about 0.01 wt% to about 99.0 wt% (¶ 42). The sunscreen composition may include one or more formulation formats such as, without limitation, an emulsion, a lotion, a gel, an ointment, etc. (¶ 43). The sun protection factor (SPF) of a sunscreen composition may be greater than or equal to 15 (¶ 19). The working embodiments were applied to the skin (¶ 48, table 2).
Regarding claims 1, 6, 7, 8, 9, and 11, it would have been obvious to formulate the sunscreen composition of Fleming comprising an organic UV filter, such as oxybenzone, with three or more film formers including polyurethane-34, VP/eicosane copolymer, acrylates/dimethicone copolymer, and trimethylsiloxysilicate, where Fleming teaches the suitable film formers may be used in combination.
Regarding the Hansen solubility parameters of claim 1, it appears the limitation of each film former having Hansen solubility parameters delta D, delta P, and delta H between 3 and 4 units of each other is met, as evidenced by claims 7, 9, 10 and 11, which depend from claim 1, and appear to comprise the same film former combination as made obvious by the reference above.
Regarding claims 2-5, where the instant specification evidences polyurethane-34, VP/eicosene copolymer, trimethylsiloxysilicate, and acrylates/dimethicone copolymer as examples of acceptable film-formers having the desired Hansen solubility parameters of a delta D from 13.2 to 19.8, a delta P from 1.2 to 15.5, and a delta H from 0.4 to 13.4, it appears the limitations are met.
Regarding claim 10, where Fleming teaches the film formers may be included from about 0.1 wt% to about 5 wt%, it would have been obvious to select from those disclosed ranges for each film former, overlapping the claimed ranges. 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). Further, it would have been well within the relative skills of the skilled artisan to have routinely optimized the amount of film formers in order to achieve desired homogeneity, viscosity, hydro-lipidic properties, etc., as taught by Fleming.
Purely arguendo, if somehow the film former range refers to the total amount of film formers in the composition, Fleming also teaches in addition to those above, additional components including addition film formers can be added in amounts ranging from about 0.1 to about 99.0 wt%, and it would have been obvious to select among either range in order to achieve desired formulation properties for the same reasons discussed above.
Regarding claim 12, it would have been obvious to formulate the composition as an emulsion, a lotion, a gel, or an ointment, as taught by Fleming, depending on the desired formulation type and desired use.
Regarding claims 13 and 14, where oxybenzone (a benzophenone, see ¶ 15 of the instant specification) is made obvious above, the limitations are met.
Regarding claim 15, it would have been obvious to further include an additional organic UV filter, including homosalate, where Fleming teachings combinations of sunscreen actives can be used, such as in order to achieve desired UV protection properties.
Regarding claims 16 and 17, it would have been obvious to formulate the composition made obvious above with an SPF of greater than or equal to 15, overlapping the claimed range. 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). Further, it would have been well within the relative skills of the skilled artisan to have routinely optimized the SPF for desired sun protection.
Regarding claim 18, it would have been obvious to apply the composition made obvious above to the skin for the method of protecting skin from UV radiation, where Fleming teaches the compositions provide UV protection and are applied to the skin.
Regarding claims 19 and 20, where the method of applying the composition made obvious above to the skin is made obvious above, it would have been obvious to apply the composition to any area where skin is present, including facial skin and the skin on a user’s arms or hands, thereby meeting the claimed limitations.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fleming et al (WO 2021226196, hereinafter “Fleming”, cited on IDS dated 03/07/2025), in view of Shin Etsu (KP-549, 2016, pp. 1-2).
Fleming is discussed above and purely arguendo if somehow the acrylates/dimethicone copolymer does not meet the claimed limitations, the following applies.
Shin Etsu teaches KP-549, an acrylates/dimethicone copolymer, was a known film former used in sunscreens in amounts ranging from 0.5-10% (pg 1).
It would have been obvious to substitute KP-549 of Shin Etsu for the acrylates/dimethicone copolymer of Fleming, where both were known acrylates/dimethicone copolymers suitable for sunscreen applications. See MPEP 2132 I.(B). KP-549 appears to meet the limitations of Hansen solubility parameters as instantly claimed as evidenced by claims 7, 9, 10 and 11.
Where the instant specification evidences polyurethane-34, VP/eicosene copolymer, trimethylsiloxysilicate, and KP-549 as examples of acceptable film-formers having the desired Hansen solubility parameters of a delta D from 13.2 to 19.8, a delta P from 1.2 to 15.5, and a delta H from 0.4 to 13.4, it appears the limitations are met.
The additional limitations of claims 1-20 are obvious for the same reasons discussed above in view of Fleming, as applied to each and every claimed limitation.
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.
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11648187 B2, hereinafter ‘187, in view of Fleming et al (WO 2021226196, hereinafter “Fleming”, cited on IDS dated 03/07/2025) and Shin Etsu (KP-549, 2016, pp. 1-2). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘187 disclose a method of applying a cosmetic to the skin, the cosmetic comprising a film former and UVA and UVB sunscreen agents. The composition comprises 5-10 wt% of the film former. The film former consists of VP/eicosene copolymer, etc. The compositions have an SPF of at least about 15. The UVA filter is 4-tert-butyl-4′-methoxydibenzoylmethane (avobenzone).
The claims of ‘187 do not specifically disclose the Hansen solubility parameters of claims 1-5, the particular combination of film formers instantly claimed, nor the amounts of claim 10.
Fleming and Shin Etsu are discussed above.
It would have been obvious to modify the claims of ‘187 by including other known film formers suitable for sunscreen compositions comprising an organic UV filter, such as by formulating a sunscreen composition comprising three or more film formers including polyurethane-34, VP/eicosane copolymer, acrylates/dimethicone copolymer, and trimethylsiloxysilicate, where Fleming teaches the suitable film formers may be used in combination.
Purely arguendo, if the acrylates/dimethicone copolymer does not read on the claimed film former, it would have been obvious to substitute KP-549 for the acrylates/dimethicone copolymer made obvious above, for the same reasons discussed above by Shin Etsu.
Regarding the Hansen solubility parameters, the limitations appear to be met for the same reasons discussed above.
Regarding the amounts, where the claims of ‘187 disclose the film formers in an amount of 5-10 wt%, it would have been obvious to adjust the amount of each film former made obvious above, falling within the claimed range. 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). Further, it would have been well within the relative skills of the skilled artisan to have routinely optimized the amounts of the film formers in order to achieve desired film forming properties and for the same reasons discussed above by Fleming.
Where the composition made obvious above is applied to the skin and comprises UV filters, it would have been obvious to use the composition for the method of protecting skin from UV radiation, including face, arms, or hands.
Conclusion
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
