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 the Claims
Claims 1-16 are pending and under current examination.
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.
Claims 1 and 3-16 are rejected under 35 U.S.C. 103 as being unpatentable over Shiroya et al. (US 20200163864; publication date: 05/28/2020) in view of Hayashi (US 20190231655; publication date: 08/01/2019) and further in view of Novikov et al. (US 20040013633; publication date: 01/22/2004).
With regard to claims 1 and 13-16, Shiroya discloses a skin cosmetic composition comprising: (a) at least one particle, comprising at least one cationic polymer and at least one amphoteric polymer, at least one anionic polymer and at least one amphoteric polymer, or at least one amphoteric polymer; and at least one non-polymeric acid having two or more pKa values or salt(s) thereof or at least one non-polymeric base having two or more pKb values or salt(s) thereof; and (b) at least one physiologically acceptable volatile medium (abstract), wherein the physiologically acceptable medium may be water (0312), and which may further comprise optional additives such as surfactants (0431). The anionic polymer can be selected from a group that includes the polysaccharide, hyaluronic acid (0208; claim 5). Shiroya mentions cationic hyaluronic acid as a choice for cationic polymer (0129). As cationic polymers Shiroya also discloses inter alia dialkyldiallylammonium such as (co)polydiallyldialkyl ammonium chloride, (co)polyamines such as (co)polylysines, cationic (co)polyaminoacids such as collagen (0021). The composition is used to form a cosmetic film by applying the composition to a keratin substrate, preferably skin followed by drying the composition (0001; claims 17 and 18).
Although embraced by the broader disclosure, Shiroya does not particularly focus on hyaluronic acid (the anionic polymer required by the instant claims) or modified hyaluronic acids and discloses cationic hyaluronic acid as a cationic rather than amphoteric polymer.
Hayashi teaches hyaluronan (i.e. hyaluronic acid) particles (abstract) containing hyaluronan in a complex with a cationized polymer capable of forming a composite particle together (0015, 0016) such as cationized polysaccharide (0020) having a degree of cationization of 0.2 or more (0028). The term “cationic polymer” as used by Hayashi embraces amphoteric polymers showing cationicity as a whole, and also embraces cationized polysaccharides such as cationic cellulose polymers (0084, 0085) and diallyldialkylammonium chloride (0087). The particle may also be formed with basic polypeptides such as polylysine or collagen (i.e. a cationic polymer within the scope of the instant invention; 0096). The particles taught by Hayashi have the advantage of entering into the skin where they provide further cosmetic benefit (0063-0065). Thus, in view of Hayashi, the artisan of ordinary skill would have understood that the negatively charged polysaccharide, hyaluronic acid, can form particles with positively charged polymers, including amphoteric polymers having overall positive charge, and that these particles can penetrate the skin to provide further cosmetic benefit of the hyaluronic acid.
It would have been prima facie obvious to one of ordinary skill to particularly select hyaluronic acid as the anionic polymer to form Shiroya’s particles. The skilled artisan would have been motivated to do so in order to deliver the benefits of hyaluronic acid into the skin and had reasonable expectation of success because Hayashi demonstrates formation of the particle to be possible in examples using the same types of cationic polymers disclosed by Shiroya.
With regard to claims 1, 8, and 15, as noted above Shiroya teaches including a surfactant in the composition. Shiroya discloses further that the composition is intended to have a moisturizing effect (0085) but does not disclose a surfactant that is a polyglyceryl fatty acid ester.
Novikov, in the analogous art of moisturizing composition to be applied topically (shaving gels specifically; abstract) discloses that polyglyceryl fatty ester surfactants provide a soft, moisturizing skin feel. Ideally, it will have an HLB of at least 9 or greater, preferably at least 10 or greater, more preferably at least 12 or greater. The polyglyceryl fatty ester surfactant has the formula:
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wherein n is 1 to 10, preferably 4 to 8, and X is a hydrogen atom or a long chain acyl group (as defined below), provided that at least one X is a long chain acyl group (0007-0009). The above structure embraces fatty acid monoesters of polyglycerols.
It would have been prima facie obvious to add a polyglycerol fatty acid ester to Shiroya’s composition because the polyglycerol fatty acid monoester was known in the art to serve the same purpose of increasing moisturizing effect of a composition. See MPEP 2144.06.
With regard to claims 3 and 4, Shiroya discloses the cationic polymer has at least one positively chargeable and/or positively charged moiety selected from the group consisting of a primary, secondary or tertiary amino group, a quaternary ammonium group, a guanidine group, a biguanide group, an imidazole group, an imino group, and a pyridyl group (claim 2) and as noted above dialkyldiallylammonium such as (co)polydiallyldialkyl ammonium chloride, (co)polyamines such as (co)polylysines, cationic (co)polyaminoacids such as collagen as cationic polymers (0021).
With regard to claim 5, Shiroya teaches the amount of the polymer(s), in the composition is from 0.001 to 25% by weight (claim 8). This would give the artisan of ordinary skill a starting point to optimize the amounts of the polymers within the particle (see MPEP 2144.05).
With regard to claim 6, Shiroya teaches that the non-polymeric acid having two or more pKa values or salt(s) thereof may be an organic acid or salt(s) thereof (0279), in particular, phytic acid (0030).
With regard to claim 7, the amount of the non-polymeric acid having two or more pKa values or salt(s) thereof or the non-polymeric base having two or more pKb values or salt(s) thereof in the composition is from 0.0001 to 30% (Shiroya, claim 13).
With regard to claim 8, Shiroya teaches inclusion of substances that are surfactants and/or emulsifiers, which may be nonionic (0469 and paragraphs that follow listing example emulsifiers).
With regard to claim 9, the emulsifier(s) in the composition according to the present invention may be from 0.01 to 15% by weight (0479).
With regard to claim 10, the physiologically acceptable medium, water, may be present in an amount of from 50-99% by weight (0312, 0314).
With regard to claim 11, the pH of the composition may range from 3 to 9 (0035).
With regard to claim 12, the composition may optionally contain an oil (0431).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Shiroya et al. (US 20200163864; publication date: 05/28/2020), Hayashi (US 20190231655; publication date: 08/01/2019), and Novikov et al. (US 20040013633; publication date: 01/22/2004) as applied to claims 1 and 3-16 above, and further in view of Asaoka et al. (US 20100197904; publication date: 08/05/2010).
The relevant disclosures of Shiroya and Hayashi are set forth above.
Shiroya teaches further that amphoteric polymer may have a positively charged moiety selected from inter alia a quaternary ammonium group; and at least one negatively chargeable and/or negatively charged moiety selected from a carboxylic group and a carboxylate group (0025 – 0026). As discussed above, Shiroya also mentions cationic hyaluronic acid as a choice for cationic polymer (0129). As mentioned above Hayashi teaches hyaluronan (i.e. hyaluronic acid) particles (abstract) containing hyaluronan in a complex with a cationized polymer capable of forming a composite particle together (0015, 0016) such as cationized polysaccharide (0020) having a degree of cationizaton of 0.2 or more (0028). The term “cationic polymer” as used by Hayashi embraces amphoteric polymers showing cationicity as a whole, thus, in view of Hayashi, one having ordinary skill would have recognized that the anionic polysaccharide hyaluronic acid can form a particle with an amphoteric polymer that is partially cationized and has overall cationic character and would have recognized in view of Shiroya that hyaluronic acid (i.e. a polymer with pendant carboxylate groups) can be cationized. Finally, in view of Shiroya and Hayashi, the artisan of ordinary skill would have recognized cationized hyaluronic acid as falling within the scope of Shiroya’s amphoteric polymer having pendant positive charge and negative carboxylate groups.
Neither reference discloses cationized hyaluronic acid having a degree of cationization of 0.05 to 0.6, as require by instant claim 2.
Asaoka discloses a cationized hyaluronic acid and/or a salt thereof comprising a quaternary ammonium group-containing group and having a degree of cationization of 0.15 to 0.6 (0005).
It would have been prima facie obvious to use a cationized hyaluronic acid and/or a salt thereof comprising a quaternary ammonium group-containing group and having a degree of cationization of 0.15 to 0.6 (noting this range falls within the range recited in the instant claims) to form a particle with the relevant polymers described by Shiroya. The artisan of ordinary skill would have been motivated to do so in order to take further advantage of the benefits of hyaluronic acid delivery into the skin. The artisan of ordinary skill would have had reasonable expectation of success because Shiroya and Hayashi together teach that the overall charge on a cationized amphoteric polymer can be optimized to precipitate into particles with another charged polymer. Furthermore, one of ordinary skill would have recognized Asaoka’s cationized hyaluronic acid as falling within the scope of Shiroya’s amphoteric polymer having pendant positively charged quaternary ammonium groups and negative carboxylate groups, providing further expectation of success.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Shiroya et. al (WO 2021125069; publication date: 06/24/2021; filed 12/04/2020 with priority to JP2019-227501, filed 12/17/2019; available as prior art under 35 USC 102(a)(1) and 102(a)(2); cited in the IDS filed 06/13/2024) in view of Novikov et al. (US 20040013633; publication date: 01/22/2004), as evidenced by Gruning et al. (US 20010003776; publication date: 07/14/2001).
The applied reference has a common inventors and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 citing prior art that is available under 35 USC 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Please note that Shiroya et. al (WO 2021125069) is prior art under 35 U.S.C. 102(a)(2), and it is also applicable as prior art under 35 U.S.C. 102(a)(1). Prior art available under 35 U.S.C. 102(a)(1) cannot be excepted under the 35 U.S.C. 102(b)(2)(C) exception noted above.
Applicant may overcome this rejection under 35 U.S.C. 102(a)(1) by a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application, and is therefore, not prior art as set forth in 35 U.S.C. 102(b)(1)(A). Alternatively, applicant may rely on the exception under 35 U.S.C. 102(b)(1)(B) by providing evidence of a prior public disclosure via an affidavit or declaration under 37 CFR 1.130(b).
With regard to claims 1 and 13-16, Shiroya discloses a composition comprising: (a) at least one particle comprising at least one cationic polymer and at least one anionic polymer, at least one cationic polymer and at least one amphoteric polymer, at least one anionic polymer and at least one amphoteric polymer, or at least one amphoteric polymer, and at least one non-polymeric acid having two or more pKa values or salt(s) thereof or at least one non-polymeric base having two or more pKb values or salt(s) thereof; and (b) water, wherein the anionic polymer is selected from hyaluronic acid and derivatives thereof, and the amphoteric polymer is selected from cationized hyaluronic acid and salts thereof (abstract). Shiroya discloses further a film of polyion complex particles, as well as a process for preparing a film by using polyion complex particles and a cosmetic process using polyion complex particles (page 1, lines 10-13). The film is formed by a process comprising: applying onto a substrate, preferably a keratin substance, the composition according to the present invention; and drying the composition (page 3, lines 8-11).
Shiroya does not disclose a single example or embodiment wherein a surfactant is present; however Shiroya does state that the composition according to the present invention may comprise, in addition to the aforementioned components, components typically employed in cosmetics, specifically, surfactants or emulsifiers (page 32, lines 23-25). It would have been prima facie obvious to include a surfactant in Shiroya’s composition because such was contemplated in the broader disclosure and also because this would merely be combining typical ingredients for cosmetic compositions (see MPEP 2143(A) regarding the obviousness of combining prior art elements according to known methods to yield predictable results).
With regard to claims 1, 8, and 15, as noted above Shiroya teaches including a surfactant in the composition. Shiroya discloses further that the composition is intended to have a moisturizing effect (0085) but does not disclose a surfactant that is a polyglyceryl fatty acid ester.
Novikov, in the analogous art of moisturizing composition to be applied topically (shaving gels specifically; abstract) discloses that polyglyceryl fatty ester surfactants provide a soft, moisturizing skin feel. Ideally, it will have an HLB of at least 9 or greater, preferably at least 10 or greater, more preferably at least 12 or greater. The polyglyceryl fatty ester surfactant has the formula:
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wherein n is 1 to 10, preferably 4 to 8, and X is a hydrogen atom or a long chain acyl group (as defined below), provided that at least one X is a long chain acyl group (0007-0009). The above structure embraces fatty acid monoesters of polyglycerols.
It would have been prima facie obvious to add a polyglycerol fatty acid ester to Shiroya’s composition because the polyglycerol fatty acid monoester was known in the art to serve the same purpose of increasing moisturizing effect of a composition. See MPEP 2144.06.
With regard to claim 2, claim 2 of Shiroya recites the cationized hyaluronic acid has at least one quaternary ammonium group-containing group and has a degree of cationization of 0.05 to 0.6, preferably from 0.1 to 0.5, and more preferably from 0.15 to 0.4 (claim 2).
With regard to instant claim 3, claim 3 of Shiroya recites the composition according to Claim 1 or 2, wherein the cationic polymer has at least one positively chargeable and/or positively charged moiety selected from the group consisting of a secondary or tertiary amino group, a quaternary ammonium group, a guanidine group, a biguanide group, an imidazole group, an imino group, a pyridyl group, and an amino group.
With regard to instant claim 4, claim 4 of Shiroya recites the composition according to any one of Claims 1 to 3, wherein the cationic polymer is selected from the group consisting of cyclopolymers of alkyldiallylamine and cyclopolymers of dialkyldiallylammonium such as (co)polydiallyldialkyl ammonium chloride, (co)polyamines such as (co)polylysines, cationic (co)polyaminoacids such as collagen, cationic cellulose polymers, and salts thereof.
With regard to instant claim 5, claim 5 of Shiroya recites the composition according to any one of Claims 1 to 4, wherein the total amount of the cationic and/or anionic and/or amphoteric polymer(s) forming the (a) particle in the composition is from 0.01% to 15% by weight, preferably from 0.05% to 10% by weight, and more preferably from 0.1% to 5% by weight, relative to the total weight of the composition.
With regard to instant claim 6, claim 6 of Shiroya recites the composition according to any one of Claims 1 to 5, wherein the non-polymeric acid having two or more pKa values or salt(s) thereof is an organic acid or salt(s) thereof, preferably a hydrophilic or water-soluble organic acid or salt(s) thereof, and more preferably phytic acid or salts thereof.
With regard to instant claim 7, claim 7 of Shiroya recites the composition according to any one of Claims 1 to 6, wherein the amount of the non-polymeric acid having two or more pKa values or salt(s) thereof or non- polymeric base having two or more pKb values or salt(s) thereof in the composition is from 0.01% to 15% by weight, preferably from 0.02% to 10% by weight, and more preferably from 0.03% to 5% by weight, relative to the total weight of the composition.
With regard to instant claim 8, Shiroya discloses including sugars and that the term sugar embraces sugar esters of fatty acids (e.g. page 27). Although Shiroya refers to these substances as “sugars”, they also fall within the scope of non-ionic surfactants (see Gruning: 0028).
With regard to instant claim 9, as noted above, the surfactant is categorized as an optional ingredient. Shiroya teaches according to the present invention may comprise the above optional additive(s) in an amount of from 0.01% to 50% by weight (page 32). Although Shiroya describes the composition as preferably lacking surfactant or emulsifier and having 1% or less of surfactant, this amount overlaps with the amount required by the instant claims (see MPEP 2144.05).
With regard to instant claim 10, claim 9 of Shiroya the composition according to any one of Claims 1 to 8, wherein the amount of the (b) water in the composition is from 50% to 99.9% by weight, preferably from 60% to 99.8% by weight, and more preferably from 70% to 99.7% by weight, relative to the total weight of the composition.
With regard to instant claim 11, claim 10 of Shiroya recites the composition according to any one of Claims 1 to 9, wherein the pH of the composition is from 3 to 9, preferably from 3.3 to 8.0, and more preferably from 3.5to 8.
With regard to instant claim 12, claim 11 of Shiroya recites the composition according to any one of Claims 1 to 10, wherein the composition further comprises (c) at least one oil.
Response to Arguments
Applicant's arguments filed 06/30/2026 have been fully considered but they are not persuasive.
On page 10, Applicant points out that Shiroya does not disclose a combination of an anionic polymer and a cationic polymer.
The foregoing notwithstanding, the examiner points out that no claim currently requires such a combination, although they embrace this combination.
On pages 11 and 13, Applicant argues that the amendment to require a polyglycerol fatty acid ester defines the instant invention over the cited prior art.
This new limitation has been addressed by the new grounds of rejection above.
On pages 11 and 13, Applicant points to examples of the specification as showing that formulations containing a polyglyceryl fatty acid ester surfactant show a superior effect over comparative examples.
Insomuch as this may be an assertion of unexpected results, please refer to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
In the instant case, the data is not sufficient to overcome the obviousness rejection with a persuasive showing of unexpected results because polyglycerol fatty acid esters were recognized in the art as of the instant effective filing date to increase the moisturizing effect of topical personal care compositions (see rejection above). Thus, the benefit of the instant invention, as claimed, does not appear to be unexpected. Additionally, the data are entirely subjective and the statistical significance of the observed effect cannot be evaluated.
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.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12453691 (which issued from the US national stage application from Shiroya et. al (WO 2021125069), cited in the obviousness rejection above) in view of Shiroya et al. (US 20200163864; publication date: 05/28/2020) and Novikov et al. (US 20040013633; publication date: 01/22/2004).
The claims of the ‘691 patent embrace a composition, comprising: at least one particle comprising at least one cationic polymer and at least one anionic polymer, at least one cationic polymer and at least one amphoteric polymer, at least one anionic polymer and at least one amphoteric polymer, or at least one amphoteric polymer, and at least one non-polymeric acid having two or more pKa values or salts thereof or at least one non-polymeric base having two or more pKb values or salts thereof; and water wherein the anionic polymer is selected from hyaluronic acid and esters and salts thereof, and the amphoteric polymer is selected from cationized hyaluronic acid and salts thereof.
The claims of the ‘691 patent do not require a surfactant.
Shiroya discloses a skin cosmetic composition comprising: (a) at least one particle, comprising at least one cationic polymer and at least one amphoteric polymer, at least one anionic polymer and at least one amphoteric polymer, or at least one amphoteric polymer, and at least one non-polymeric acid having two or more pKa values or salt(s) thereof or at least one non-polymeric base having two or more pKb values or salt(s) thereof; and (b) at least one physiologically acceptable volatile medium (abstract), wherein the physiologically acceptable medium may be water (0312), and which may further comprise optional additives such as surfactants, which may be non-ionic surfactants (0431, 0469).
It would have been prima facie obvious to add a surfactant including nonionic surfactants to the invention of the ‘681 patent because Shiroya teaches doing so in a nearly identical composition therefore this would merely have been combining prior art elements according to known methods to yield predictable results (see MPEP 2143(A)).
With regard to claims 1, 8, and 15, as noted above Shiroya teaches including a surfactant in the composition.
Novikov, in the analogous art of moisturizing composition to be applied topically (shaving gels specifically; abstract) discloses that polyglyceryl fatty ester surfactants provide a soft, moisturizing skin feel. Ideally, it will have an HLB of at least 9 or greater, preferably at least 10 or greater, more preferably at least 12 or greater. The polyglyceryl fatty ester surfactant has the formula:
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wherein n is 1 to 10, preferably 4 to 8, and X is a hydrogen atom or a long chain acyl group (as defined below), provided that at least one X is a long chain acyl group (0007-0009). The above structure embraces fatty acid monoesters of polyglycerols.
It would have been prima facie obvious to add a polyglycerol fatty acid ester to the claimed composition. One having ordinary skill would have been motivated to do so in order to increase the moisturizing effect and had reasonable expectation of success because this substance was known to serve this purpose as of the instant effective filing date.
Claims 1 and 3-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-16 of U.S. Patent No. 11389379;
claims 1-21 of U.S. Patent No. 11819564; and
claims 1-17 of U.S. Patent No. 11975093
in view of Hayashi (US 20190231655; publication date: 08/01/2019) and Novikov et al. (US 20040013633; publication date: 01/22/2004).
Inter alia the claims of the cited patents embrace a composition, comprising: (a) at least one polyion complex particle, comprising at least one cationic polymer and at least one anionic polymer, at least one cationic polymer and at least one amphoteric polymer, at least one anionic polymer and at least one amphoteric polymer, or at least one amphoteric polymer, and at least one non-polymeric acid having two or more pKa values or salt(s) thereof, or at least one non-polymeric base having two or more pKb values or salt(s) thereof; (b) at least one oil; (c) water; and a surfactant/emulsifier.
The claims of the cited patents do not recite any limitation requiring the presence of either hyaluronic acid or amphoteric cationically modified hyaluronic acid.
Hayashi teaches hyaluronan (i.e. hyaluronic acid) particles (abstract) containing hyaluronan in a complex with a cationized polymer capable of forming a composite particle together (0015, 0016). The particle may also be formed with basic polypeptides such as polylysine or collagen (i.e. a cationic polymer within the scope of the instant invention; 0096). The particles taught by Hayashi have the advantage of entering into the skin where they provide further cosmetic benefit (0063-0065).
It would have been prima facie obvious to one of ordinary skill to particularly select hyaluronic acid as the anionic polymer to form particles embraced by the cited patents. The skilled artisan would have been motivated to do so in order to deliver the benefits of hyaluronic acid not only to the surface but into the skin and had reasonable expectation of success because Hayashi demonstrates formation of the particle to be possible in examples using the same types of cationic polymers embraced by the cited patents.
With regard to claims 1, 8, and 15, as noted above Shiroya teaches including a surfactant in the composition.
Novikov, in the analogous art of moisturizing composition to be applied topically (shaving gels specifically; abstract) discloses that polyglyceryl fatty ester surfactants provide a soft, moisturizing skin feel. Ideally, it will have an HLB of at least 9 or greater, preferably at least 10 or greater, more preferably at least 12 or greater. The polyglyceryl fatty ester surfactant has the formula:
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wherein n is 1 to 10, preferably 4 to 8, and X is a hydrogen atom or a long chain acyl group (as defined below), provided that at least one X is a long chain acyl group (0007-0009). The above structure embraces fatty acid monoesters of polyglycerols.
It would have been prima facie obvious to add a polyglycerol fatty acid ester to the claimed composition. One having ordinary skill would have been motivated to do so in order to increase the moisturizing effect and had reasonable expectation of success because this substance was known to serve this purpose as of the instant effective filing date.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-16 of U.S. Patent No. 11389379;
claims 1-21 of U.S. Patent No. 11819564; and
claims 1-17 of U.S. Patent No. 11975093
in view of Hayashi (US 20190231655; publication date: 08/01/2019) and Novikov et al. (US 20040013633; publication date: 01/22/2004) as applied to claims 1 and 3-16 above, and further in view of Asaoka et al. (US 20100197904; publication date: 08/05/2010).
The relevant limitations of the cited patents and the disclosure of Hayashi are set forth above.
Hayashi teaches hyaluronan (i.e. hyaluronic acid) particles (abstract) containing hyaluronan in a complex with a cationized polymer capable of forming a composite particle together (0015, 0016) such as cationized polysaccharide (0020) having a degree of cationizaton of 0.2 or more (0028). The term “cationic polymer” as used by Hayashi embraces amphoteric polymers showing cationicity as a whole, thus, in view of Hayashi, one having ordinary skill would have recognized that anionic polysaccharides can form a particle with an amphoteric polymer that is partially cationized and has overall cationic character and would have recognized that such a partially cationized amphoteric polymer could from a particle with the relevant charged polymers embraced by the cited patents.
None of the cited patented claims require cationized hyaluronic acid having a degree of cationization of 0.05 to 0.6, as require by instant claim 2.
Asaoka discloses a cationized hyaluronic acid and/or a salt thereof comprising a quaternary ammonium group-containing group and having a degree of cationization of 0.15 to 0.6 (0005).
It would have been prima facie obvious to use a cationized hyaluronic acid and/or a salt thereof comprising a quaternary ammonium group-containing group and having a degree of cationization of 0.15 to 0.6 (noting this range falls within the range recited in the instant claims) to form a particle with the relevant polymers embraced by the cited patents. The artisan of ordinary skill would have been motivated to do so in order to take further advantage of the benefits of hyaluronic acid taught by Hayashi. The artisan of ordinary skill would have had reasonable expectation of success because Hayashi teaches that the overall charge on a cationized amphoteric polymer can be optimized to precipitate into particles with another charged polymer. Furthermore, one of ordinary skill would have recognized Asaoka’s cationized hyaluronic acid as falling within the scope of the term amphoteric polymer recited in the patented claims cited above, providing further expectation of success.
Claims 1 and 3-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11452676 in view of Hayashi (US 20190231655; publication date: 08/01/2019) and further in view of Shiroya et al. (US 20200163864; publication date: 05/28/2020) and Novikov et al. (US 20040013633; publication date: 01/22/2004).
Inter alia the claims of the cited patent embrace a composition, comprising: (a) at least one polyion complex particle, comprising at least one cationic polymer and at least one anionic polymer, at least one cationic polymer and at least one amphoteric polymer, at least one anionic polymer and at least one amphoteric polymer, or at least one amphoteric polymer, and at least one non-polymeric acid having two or more pKa values or salt(s) thereof, or at least one non-polymeric base having two or more pKb values or salt(s) thereof; (b) at least one oil; and (c) water.
The claims of the cited patent do not recite any limitation requiring the presence of either hyaluronic acid or amphoteric cationically modified hyaluronic acid.
Hayashi teaches hyaluronan (i.e. hyaluronic acid) particles (abstract) containing hyaluronan in a complex with a cationized polymer capable of forming a composite particle together (0015, 0016). The particle may also be formed with basic polypeptides such as polylysine or collagen (i.e. a cationic polymer within the scope of the instant invention; 0096). The particles taught by Hayashi have the advantage of entering into the skin where they provide further cosmetic benefit (0063-0065).
It would have been prima facie obvious to one of ordinary skill to particularly select hyaluronic acid as the anionic polymer to form particles embraced by the cited patent. The skilled artisan would have been motivated to do so in order to deliver the benefits of hyaluronic acid not only to the surface but into the skin and had reasonable expectation of success because Hayashi demonstrates formation of the particle to be possible in examples using the same types of cationic polymers embraced by the cited patent.
The claims of the ‘676 patent also do not require a surfactant.
Shiroya discloses a skin cosmetic composition comprising: (a) at least one particle, comprising at least one cationic polymer and at least one amphoteric polymer, at least one anionic polymer and at least one amphoteric polymer, or at least one amphoteric polymer, and at least one non-polymeric acid having two or more pKa values or salt(s) thereof or at least one non-polymeric base having two or more pKb values or salt(s) thereof; and (b) at least one physiologically acceptable volatile medium (abstract), wherein the physiologically acceptable medium may be water (0312), and which may further comprise optional additives such as surfactants, which may be non-ionic surfactants (0431, 0469).
It would have been prima facie obvious to add a surfactant including nonionic surfactants to the invention of the ‘681 patent because this would merely have been combining prior art elements according to known methods to yield predictable results (see MPEP 2143(A)).
With regard to claims 1, 8, and 15, as noted above Shiroya teaches including a surfactant in the composition.
Novikov, in the analogous art of moisturizing composition to be applied topically (shaving gels specifically; abstract) discloses that polyglyceryl fatty ester surfactants provide a soft, moisturizing skin feel. Ideally, it will have an HLB of at least 9 or greater, preferably at least 10 or greater, more preferably at least 12 or greater. The polyglyceryl fatty ester surfactant has the formula:
PNG
media_image1.png
86
891
media_image1.png
Greyscale
wherein n is 1 to 10, preferably 4 to 8, and X is a hydrogen atom or a long chain acyl group (as defined below), provided that at least one X is a long chain acyl group (0007-0009). The above structure embraces fatty acid monoesters of polyglycerols.
It would have been prima facie obvious to add a polyglycerol fatty acid ester to the claimed composition. One having ordinary skill would have been motivated to do so in order to increase the moisturizing effect and had reasonable expectation of success because this substance was known to serve this purpose as of the instant effective filing date.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11452676 in view of Hayashi (US 20190231655; publication date: 08/01/2019) and Shiroya et al. (US 20200163864; publication date: 05/28/2020) and Novikov et al. (US 20040013633; publication date: 01/22/2004) as applied to claims 1 and 3-16 above and further in view of Asaoka et al. (US 20100197904; publication date: 08/05/2010).
The relevant limitations of the ‘676 patent and disclosures of Shiroya and Hayashi are set forth above.
Shiroya teaches further that amphoteric polymer may have a positively charged moiety selected from inter alia a quaternary ammonium group; and at least one negatively chargeable and/or negatively charged moiety selected from a carboxylic group and a carboxylate group (0025 – 0026). Shiroya also mentions cationic hyaluronic acid as a choice for cationic polymer (0129). As mentioned above Hayashi teaches hyaluronan (i.e. hyaluronic acid) particles (abstract) containing hyaluronan in a complex with a cationized polymer capable of forming a composite particle together (0015, 0016) such as cationized polysaccharide (0020) having a degree of cationizaton of 0.2 or more (0028). The term “cationic polymer” as used by Hayashi embraces amphoteric polymers showing cationicity as a whole, thus, in view of Hayashi, one having ordinary skill would have recognized that the anionic polysaccharide hyaluronic acid can form a particle with an amphoteric polymer that is partially cationized and has overall cationic character and would have recognized in view of Shiroya that hyaluronic acid (i.e. a polymer with pendant carboxylate groups) can be cationized. Finally, in view of Shiroya and Hayashi, the artisan of ordinary skill would have recognized cationized hyaluronic acid as falling within the scope of the term amphoteric polymer as used in the cited patent.
Neither the patented claims nor the Shiroya or Hayashi references disclose cationized hyaluronic acid having a degree of cationization of 0.05 to 0.6, as require by instant claim 2.
Asaoka discloses a cationized hyaluronic acid and/or a salt thereof comprising a quaternary ammonium group-containing group and having a degree of cationization of 0.15 to 0.6 (0005).
It would have been prima facie obvious to use a cationized hyaluronic acid and/or a salt thereof comprising a quaternary ammonium group-containing group and having a degree of cationization of 0.15 to 0.6 (noting this range falls within the range recited in the instant claims) to form a particle with the relevant polymers embraced by the ‘676 patent. The artisan of ordinary skill would have been motivated to do so in order to take further advantage of the benefits of hyaluronic acid. The artisan of ordinary skill would have had reasonable expectation of success because Shiroya and Hayashi together teach that the overall charge on a cationized amphoteric polymer can be optimized to precipitate into particles with another charged polymer. Furthermore, one of ordinary skill would have recognized Asaoka’s cationized hyaluronic acid as falling within the scope of Shiroya’s amphoteric polymer having pendant positively charged quaternary ammonium groups and negative carboxylate groups, providing further expectation of success.
Claims 1 and 3-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-15 of copending Application No. 18256580;
claims 1-15 of copending Application No. 18721056;
claims 1-15 of copending Application No. 19115113;
claims 1-15 of copending Application No. 19117907; and
claims 1-15 of copending Application No. 19139793
in view of Shiroya et al. (US 20200163864; publication date: 05/28/2020) and Novikov et al. (US 20040013633; publication date: 01/22/2004).
Inter alia the claims of the cited applications embrace a composition comprising at least one cationic polymer, at least one anionic polymer that is hyaluronic acid, water, and a non-polymeric acid having two or more pKa values or salt(s) thereof. The claims of the ‘580 and ‘056 applications recite a limitation requiring the polymers to be within a particle. The claims of the ‘113, ‘907, and ‘793 applications do not indicate that the polymers are in the form of a particle.
Shiroya discloses a skin cosmetic composition comprising: (a) at least one particle, comprising at least one cationic polymer and at least one amphoteric polymer, at least one anionic polymer and at least one amphoteric polymer, or at least one amphoteric polymer; and at least one non-polymeric acid having two or more pKa values or salt(s) thereof or at least one non-polymeric base having two or more pKb values or salt(s) thereof; and (b) at least one physiologically acceptable volatile medium (abstract), wherein the physiologically acceptable medium may be water (0312). The particles form a stable dispersion and can be used to make a cosmetic film.
It would have been prima facie obvious to one of ordinary skill to particularly to form particles using the cationic and hyaluronic acid polymers embraced by the ‘113, ‘907, and ‘793 applications. The skilled artisan would have been motivated to do so in order to deliver the benefits of hyaluronic acid as a cosmetic film formed from stable particles and had reasonable expectation of success because Shiroya demonstrates formation of a stable particle to be possible in examples using the same types of cationic polymers.
The claims of all cited applications are silent with respect to including a surfactant in the composition.
Shiroya discloses a skin cosmetic composition comprising: (a) at least one particle, comprising at least one cationic polymer and at least one amphoteric polymer, at least one anionic polymer and at least one amphoteric polymer, or at least one amphoteric polymer, and at least one non-polymeric acid having two or more pKa values or salt(s) thereof or at least one non-polymeric base having two or more pKb values or salt(s) thereof; and (b) at least one physiologically acceptable volatile medium (abstract), wherein the physiologically acceptable medium may be water (0312), and which may further comprise optional additives such as surfactants, which may be non-ionic surfactants (0431, 0469).
It would have been prima facie obvious to add a surfactant including nonionic surfactants to the invention of the cited applications because Shiroya teaches doing so in a nearly identical composition therefore this would merely have been combining prior art elements according to known methods to yield predictable results (see MPEP 2143(A)).
With regard to claims 1, 8, and 15, as noted above Shiroya teaches including a surfactant in the composition.
Novikov, in the analogous art of moisturizing composition to be applied topically (shaving gels specifically; abstract) discloses that polyglyceryl fatty ester surfactants provide a soft, moisturizing skin feel. Ideally, it will have an HLB of at least 9 or greater, preferably at least 10 or greater, more preferably at least 12 or greater. The polyglyceryl fatty ester surfactant has the formula:
PNG
media_image1.png
86
891
media_image1.png
Greyscale
wherein n is 1 to 10, preferably 4 to 8, and X is a hydrogen atom or a long chain acyl group (as defined below), provided that at least one X is a long chain acyl group (0007-0009). The above structure embraces fatty acid monoesters of polyglycerols.
It would have been prima facie obvious to add a polyglycerol fatty acid ester to the claimed composition. One having ordinary skill would have been motivated to do so in order to increase the moisturizing effect and had reasonable expectation of success because this substance was known to serve this purpose as of the instant effective filing date.
This is a provisional nonstatutory double patenting rejection.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-15 of copending Application No. 18256580;
claims 1-15 of copending Application No. 18721056;
claims 1-15 of copending Application No. 19115113;
claims 1-15 of copending Application No. 19117907; and
claims 1-15 of copending Application No. 19139793
in view of Shiroya et al. (US 20200163864; publication date: 05/28/2020) and Novikov et al. (US 20040013633; publication date: 01/22/2004) as applied to claims 1 and 3-16 above, and further in view of Hayashi (US 20190231655; publication date: 08/01/2019) and Asaoka et al. (US 20100197904; publication date: 08/05/2010).
The relevant limitations of the cited applications and disclosures of Shiroya are set forth above.
Shiroya teaches further that amphoteric polymer may have a positively charged moiety selected from inter alia a quaternary ammonium group; and at least one negatively chargeable and/or negatively charged moiety selected from a carboxylic group and a carboxylate group (0025 – 0026). Shiroya also mentions cationic hyaluronic acid as a choice for cationic polymer (0129).
Neither the copending claims nor Shiroya disclose cationized hyaluronic acid having a degree of cationization of 0.05 to 0.6, as require by instant claim 2.
Hayashi teaches hyaluronan (i.e. hyaluronic acid) particles (abstract) containing hyaluronan in a complex with a cationized polymer capable of forming a composite particle together (0015, 0016). The term “cationic polymer” as used by Hayashi embraces amphoteric polymers such as cationized polysaccharide (0020) having a degree of cationizaton of 0.2 or more (0028) showing cationicity as a whole, thus, in view of Hayashi, one having ordinary skill would have recognized that the anionic polysaccharide hyaluronic acid can form a particle with an amphoteric polymer that is partially cationized and has overall cationic character and would have recognized in view of Shiroya that hyaluronic acid (i.e. a polymer with pendant carboxylate groups) can be cationized. Finally, in view of Shiroya and Hayashi, the artisan of ordinary skill would have recognized cationized hyaluronic acid as falling within the scope of Shiroya’s amphoteric polymer having pendant positive charge and negative carboxylate groups.
Asaoka discloses a cationized hyaluronic acid and/or a salt thereof comprising a quaternary ammonium group-containing group and having a degree of cationization of 0.15 to 0.6 (0005).
It would have been prima facie obvious to use a cationized hyaluronic acid and/or a salt thereof comprising a quaternary ammonium group-containing group and having a degree of cationization of 0.15 to 0.6 (noting this range falls within the range recited in the instant claims) to form a particle with the relevant polymers embraced by the copending claims cited above. The artisan of ordinary skill would have been motivated to do so in order to take further advantage of the benefits of hyaluronic acid. The artisan of ordinary skill would have had reasonable expectation of success because Shiroya and Hayashi together teach that the overall charge on a cationized amphoteric polymer can be optimized to precipitate into particles with another charged polymer. Furthermore, one of ordinary skill would have recognized Asaoka’s cationized hyaluronic acid as falling within the scope of Shiroya’s amphoteric polymer having pendant positively charged quaternary ammonium groups and negative carboxylate groups, providing further expectation of success.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19140234 in view of Shiroya et al. (US 20200163864; publication date: 05/28/2020) and Novikov et al. (US 20040013633; publication date: 01/22/2004).
Inter alia, the claims of the ‘234 application embrace a composition, comprising: (a) at least one polyion complex (i.e. particle), comprising at least one cationic polymer and at least one anionic polymer, at least one cationic polymer and at least one amphoteric polymer, at least one anionic polymer and at least one amphoteric polymer, or at least one amphoteric polymer, and at least one non-polymeric acid having two or more pKa values or salt(s) thereof, or at least one non-polymeric base having two or more pKb values or salt(s) thereof; and (c) water, wherein the anionic polymer is selected from hyaluronic acid, salts thereof, and derivatives thereof, and the amphoteric polymer is selected from cationized hyaluronic acid and salts thereof.
The claims of the ‘234 application do not require a surfactant.
Shiroya discloses a skin cosmetic composition comprising: (a) at least one particle, comprising at least one cationic polymer and at least one amphoteric polymer, at least one anionic polymer and at least one amphoteric polymer, or at least one amphoteric polymer, and at least one non-polymeric acid having two or more pKa values or salt(s) thereof or at least one non-polymeric base having two or more pKb values or salt(s) thereof; and (b) at least one physiologically acceptable volatile medium (abstract), wherein the physiologically acceptable medium may be water (0312), and which may further comprise optional additives such as surfactants, which may be non-ionic surfactants (0431, 0469).
It would have been prima facie obvious to add a surfactant including nonionic surfactants to the invention of the ‘234 application because Shiroya teaches doing so in a nearly identical composition therefore this would merely have been combining prior art elements according to known methods to yield predictable results (see MPEP 2143(A)).
With regard to claims 1, 8, and 15, as noted above Shiroya teaches including a surfactant in the composition.
Novikov, in the analogous art of moisturizing composition to be applied topically (shaving gels specifically; abstract) discloses that polyglyceryl fatty ester surfactants provide a soft, moisturizing skin feel. Ideally, it will have an HLB of at least 9 or greater, preferably at least 10 or greater, more preferably at least 12 or greater. The polyglyceryl fatty ester surfactant has the formula:
PNG
media_image1.png
86
891
media_image1.png
Greyscale
wherein n is 1 to 10, preferably 4 to 8, and X is a hydrogen atom or a long chain acyl group (as defined below), provided that at least one X is a long chain acyl group (0007-0009). The above structure embraces fatty acid monoesters of polyglycerols.
It would have been prima facie obvious to add a polyglycerol fatty acid ester to the claimed composition. One having ordinary skill would have been motivated to do so in order to increase the moisturizing effect and had reasonable expectation of success because this substance was known to serve this purpose as of the instant effective filing date.
This is a provisional nonstatutory double patenting rejection.
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.
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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617
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