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 .
Priority
The instant application claims foreign priority to PCTCN2021130217 filed 11/21/2021 and EP21217667.1 filed 12/24/2021. The instant application is a 371 of PCT/EP2022/079350 filed 10/21/2022.
Information Disclosure Statement
The information disclosure statement (IDS) dated 10/16/2024 complies with provisions of 37 CFR 1.97, 1.98 and MPEP §609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 13 been renumbered 14.
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.
A) Claims 1-4, 7-9, 11-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al (US Patent Application Publication 20060188533A1), Har-Shai (US Patent Application Publication 20150307258A1) and Tong et al. (provided in the IDS filed 10/16/2024).
Brown recites a composition suitably adapted to deliver a bio-available compound to a user's skin, said composition comprising: a substantially anhydrous carrier particle suitably adapted to carry a bio-available compound; and a substantially anhydrous topical formulation, wherein said topical formulation is suitably adapted to at least one of suspend and substantially separate a plurality of anhydrous carrier particles (Brown at claim 1). Brown recites a personal care composition that is rinsed off (Brown at claim 18). Brown teaches that the composition may provide delivery of vitamin C (ascorbic acid) in a shelf-stable form that the consumer may use for subsequent application, for example, to their skin (Brown at [0011]). Brown teaches that representative bio-available compounds that may be delivered via carrier particles, consistent with various exemplary embodiments of the present invention, may include, for example: dermatological active agents, nutritional supplements, cosmetically active ingredients, pharmaceutical preparations, and/or the like (Brown at [0022]). Brown teaches that the compound includes vitamins, such as, for example: vitamin B1 (thiamin), vitamin B2 (riboflavin), niacin (nicotinic acid, nicotinamide, vitamin PP), vitamin H (biotin), vitamin B6, vitamin B12, and/or the like (Brown at [0049]) and fragrance materials citronella oil (Brown at [0052]). Brown teaches that the carrier particles may also be colored to impart an aesthetic appeal to the product formulation for the user (Brown at [0024-0025]). Brown recites wherein said bio-available compound comprises at least one of: a preservative; a dermatological active agent; ascorbic acid; a nutritional supplement; a cosmetically active ingredient; a pharmaceutical preparation; an anti-acne agent; an anti-acne active agent; a fruit juice; a fruit extract; a vegetable juice; a vegetable extract; an alpha hydroxy acid; a beta hydroxy acid; hyaluronic acid; an antibiotic; a natural antibiotic; a vitamin; an amino acid; a protein; a peptide, a peptide combination; a fragrance material; a polar extract of fragrance material; a botanical material; a polar extract of a botanical material; a juice of a botanical material; glitter; a special-effect pigment; a coloring agent; a dye; a color shifting pigment; and an active agent (Brown at claim 2). Brown recites according to various aspects of the present invention, an anhydrous facial mask may be further adapted to provide a substantially “self-heating” function to bring the formulation to a suitable temperature upon application or hydration and/or to signify that cleaning activation has occurred or that a given period of time has elapsed (such as a timer function), indicating that the mask may be subsequently rinsed from the user's skin (Brown at [0027]).
The teachings of Brown differ from the instant claims insofar as they do not teach specifically that the carrier is a nanoclay. The teachings of Har-Shai cure this deficit.
Har-Shai teaches that nanoclays are easily compounded and thus present an attractive alternative to traditional compatibilizers. Nanoclays have been known to stabilize different crystalline phases of polymers, and to possess the ability of improving mechanical and thermal properties. For improved performance and compatibility, nanoclays are typically modified so as to be associated with organic moieties, and the modified nanoclays are often referred to as organomodified nanoclays. Organomodified nanoclays are typically prepared by treatment with organic salts. Negatively charged nanoclays (e.g., montmorillonites) are typically modified with cationic surfactants such as organic ammonium salts or organic phosphonium salts, and positively charged nanoclays (e.g., LDH) are typically modified by anionic surfactants such as carboxylates, sulfonates, etc (Har-Shai at [0342]). Har-Shai teaches the nanoclay comprises montmorillonite treated with a cationic surfactant such as an organic ammonium salt or organic amminium salt (Har-Shai at [0360]). Har-Shai teaches the term “nanoclay” (or NC) refers to particles of a clay material, useful for making nanocomposites, which particles can comprise layers or platelet particles (platelets) obtained from particles comprising layers and, depending on the stage of production, can be in a stacked, intercalated, or exfoliated state (Har-Shai at [0377]). Har-Shai teaches personal care products such as shaving, shower and shampooing gels, toothpaste, liquid soap and shampoo, sun care products (Har-Shai at [0147]).
The teachings of Har-Shai differ from the instant claims insofar as they do not specifically teach the use of citronella.
It would have been prima facie obvious to one of ordinary skill in the art to have used the nanoclays of Har-Shai as the carriers of the botanical and dye of Brown as Har-Shai teaches the use of nanoclays as carriers in personal care products for their benefit of improving mechanical and thermal properties. See MPEP 2144(III). See MPEP 2144.07.
The teachings of Har-Shai and Brown differ from the instant claims insofar as they do not teach the use of octadecyl trimethylammonium. The teachings of Tong cure this deficit.
Tong teaches octadecyl trimethylammonium montmorillonite which is used to adsorb a dye (Tong at whole document). Tong teaches that the basal spacing of montmorillonite and OTA-montmorillonite was 1.48 and 2.35 nm by XRD analysis (Tong at 3.1 XRD analysis). However, the low intensity and broadening of the basal reflection of OTA-montmorillonite indicated a low degree of ordering of this industrial product. The thickness and chain length of octadecyl trimethylammonium ions are about 0.4 and 2.76 nm. Thus, the interlayer arrangement of octadecyl trimethylammonium ions was consistent with a paraffin-type monolayer arrangement. (Tong at 3.1 XRD analysis).
Tong differs from the instant claims insofar as it does not specifically teach the loadable octadecyl trimethylammonium montmorillonite specifically in personal care products. It would have been prima facie obvious for one of ordinary skill in the art to have used the octadecyl trimethylammonium montmorillonite as a nanoclay carrier particle of Brown and Har-Shai as it is a specific montmorillonite with a benefit to uptake dye well. See MPEP 2144(III). See MPEP 2144.07. One would have a reasonable expectation of success because Tong teaches a octadecyl trimethylammonium montmorillonite that uptakes dye and Brown is looking for a nanocarrier for dye.
Regarding instant claim 1, Brown recites a composition suitably adapted to deliver a bio-available compound to a user's skin, said composition comprising: a substantially anhydrous carrier particle suitably adapted to carry a bio-available compound; and a substantially anhydrous topical formulation, wherein said topical formulation is suitably adapted to at least one of suspend and substantially separate a plurality of anhydrous carrier particles (Brown at claim 1). Brown teaches that representative bio-available compounds that may be delivered via carrier particles, consistent with various exemplary embodiments of the present invention, may include, for example: dermatological active agents, nutritional supplements, cosmetically active ingredients, pharmaceutical preparations, and/or the like (Brown at [0022]). Brown teaches that the carrier particles may also be colored to impart an aesthetic appeal to the product formulation for the user (Brown at [0024-0025]). Brown recites that the bio-available compound comprises botanical material and dye (Brown at claim 2). Har-Shai teaches the term “nanoclay” (or NC) refers to particles of a clay material, useful for making nanocomposites, which particles can comprise layers or platelet particles (platelets) obtained from particles comprising layers and, depending on the stage of production, can be in a stacked, intercalated, or exfoliated state (Har-Shai at [0377]). Negatively charged nanoclays (e.g., montmorillonites) are typically modified with cationic surfactants such as organic ammonium salts or organic phosphonium salts, and positively charged nanoclays (e.g., LDH) are typically modified by anionic surfactants such as carboxylates, sulfonates, etc (Har-Shai at [0342]). Tong teaches octadecyl trimethylammonium montmorillonite which is used to adsorb a dye (Tong at whole document). Tong teaches that the basal spacing of montmorillonite and OTA-montmorillonite was 1.48 and 2.35 nm by XRD analysis (Tong at 3.1 XRD analysis).
Regarding instant claim 2, Tong teaches octadecyl trimethylammonium montmorillonite which is used to adsorb a dye (Tong at whole document).
Regarding instant claim 3, Tong teaches octadecyl trimethylammonium montmorillonite which is used to adsorb a dye (Tong at whole document).
Regarding instant claim 4, Brown teaches that representative bio-available compounds that may be delivered via carrier particles, consistent with various exemplary embodiments of the present invention, may include, for example: dermatological active agents, nutritional supplements, cosmetically active ingredients, pharmaceutical preparations, and/or the like (Brown at [0022]). Brown teaches that the compound includes vitamins, such as, for example: vitamin B1 (thiamin), vitamin B2 (riboflavin), niacin (nicotinic acid, nicotinamide, vitamin PP), vitamin H (biotin), vitamin B6, vitamin B12, and/or the like (Brown at [0049]) and fragrance materials citronella oil (Brown at [0052]).
Regarding instant claim 7, Tong teaches octadecyl trimethylammonium montmorillonite which is used to adsorb a dye (Tong at whole document). Tong teaches that the basal spacing of montmorillonite and OTA-montmorillonite was 1.48 and 2.35 nm by XRD analysis (Tong at 3.1 XRD analysis).
Regarding instant claim 8, Har-Shai teaches the term “nanoclay” (or NC) refers to particles of a clay material, useful for making nanocomposites, which particles can comprise layers or platelet particles (platelets) obtained from particles comprising layers and, depending on the stage of production, can be in a stacked, intercalated, or exfoliated state (Har-Shai at [0377]). Platelets would be non-spherical.
Regarding instant claim 9, Tong teaches octadecyl trimethylammonium montmorillonite which is used to adsorb a dye (Tong at whole document). Har-Shai teaches the term “nanoclay” (or NC) refers to particles of a clay material, useful for making nanocomposites, which particles can comprise layers or platelet particles (platelets) obtained from particles comprising layers and, depending on the stage of production, can be in a stacked, intercalated, or exfoliated state (Har-Shai at [0377]).
Regarding instant claim 11, Brown teaches that the composition may provide delivery of vitamin C (ascorbic acid) in a shelf-stable form that the consumer may use for subsequent application, for example, to their skin (Brown at [0011]). Brown recites according to various aspects of the present invention, an anhydrous facial mask may be further adapted to provide a substantially “self-heating” function to bring the formulation to a suitable temperature upon application or hydration and/or to signify that cleaning activation has occurred or that a given period of time has elapsed (such as a timer function), indicating that the mask may be subsequently rinsed from the user's skin (Brown at [0027]). Har-Shai teaches personal care products such as shaving, shower and shampooing gels, toothpaste, liquid soap and shampoo, sun care products (Har-Shai at [0147]).
Regarding instant claim 12, Negatively charged nanoclays (e.g., montmorillonites) are typically modified with cationic surfactants such as organic ammonium salts or organic phosphonium salts, and positively charged nanoclays (e.g., LDH) are typically modified by anionic surfactants such as carboxylates, sulfonates, etc (Har-Shai at [0342]).
Regarding instant claim 14, Brown teaches that the composition may provide delivery of vitamin C (ascorbic acid) in a shelf-stable form that the consumer may use for subsequent application, for example, to their skin (Brown at [0011]).
B) Claims 5-6, 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al (US Patent Application Publication 20060188533A1), Har-Shai (US Patent Application Publication 20150307258A1) and Tong et al. (provided in the IDS filed 10/16/2024) as applied to claims 1-4, 7-9, 11-12 and 14 above, and further in view of Petit et al. (US Patent Application Publication 20030044469A1).
The teachings of Brown, Har-Shai and Tong are discussed above.
The teachings of Brown, Har-Shai and Tong differ from the instant claims insofar as they do not specifically discuss the amount of carrier particles in the composition. The teachings of Petit cure this deficit.
Petit recites skin treatment preparations containing an effective quantity of microcapsules with mean diameters of 0.1 to 5 mm which are obtained by (a) processing aqueous preparations of retinol or retinolic acid with oil components in the presence of emulsifiers to form o/w emulsions, (b) treating the emulsions thus obtained with aqueous solutions of anionic polymers, (c) contacting the matrix obtained with aqueous chitosan solutions to form a membrane and (d) separating the encapsulation products obtained, optionally in the presence of thickeners, from the aqueous phase (Petit at claim 1). Petit recites characterized in that they contain the microcapsules in quantities of 0.1 to 10% by weight, based on the final preparations (Petit at claim 2). Petit teaches anionic, nonionic, cationic and/or amphoteric or zwitterionic surfactants may be present as surfactants and normally make up about 1 to 70% by weight, preferably 5 to 50% by weight and more particularly 10 to 30% by weight of the preparations. Typical examples of anionic surfactants are soaps, alkyl benzenesulfonates, alkanesulfonates, olefin sulfonates, alkylether sulfonates, glycerol ether sulfonates, α-methyl ester sulfonates, sulfofatty acids, alkyl sulfates, fatty alcohol ether sulfates, glycerol ether sulfates, fatty acid ether sulfates, hydroxy mixed ether sulfates, monolyceride (ether) sulfates, fatty acid amide (ether) sulfates, mono- and dialkyl sulfosuccinates, mono- and dialkyl sulfosuccinamates, sulfotrigly-cerides, amide soaps, (Petit at [0020]). Petit teaches that for consistency the factors proved to be particularly effective are bentonites, for example Bentone® Gel VS-5PC (Rheox) which is a mixture of cyclopentasiloxane, Disteardimonium Hectorite and propylene carbonate (Petit at [0058]). Petit teaches Ssuitable swelling agents for aqueous phases are montmorillonites, clay minerals, Pemulen and alkyl-modified Carbopol types (Goodrich). Other suitable polymers and swelling agents can be found in R. Lochhead's review in Cosm. Toil. 108, 95 (1993) (Petit at [0111]). Petit teaches natural perfumes include the extracts of blossoms, stems and leaves, fruits, fruit peel, roots, woods, herbs and grasses, needles and branches, resins and balsams (Petit at [0095]). Petit teaches the use of citronellol (Petit at [0095]). Petit teaches the use of dyes at 0.001 to 1% (Petit at [0133]). Petit teaches that the total percentage content of auxiliaries and additives may be from 1 to 50% by weight and is preferably from 5 to 40% by weight, based on the particular preparation (Petit at [0134]). Petit teaches that the amount of active in the microcapsule 0.005 to 5% (Petit at [0016]).
It would have been prima facie obvious to one of ordinary skill in the art to have used the amount of microcapsule taught in Petit for the amount of carrier particle or platelet of Brown, Har-Shai, and Tong as Petit teaches it is a useful amount for a skin composition. See MPEP 2144.07. One would have a reasonable expectation of success because Petit also teaches microcapsules, bentonite, montmorillonites, botanical extracts, citronellol and dyes.
Regarding instant claim 5, Petit teaches that the total percentage content of auxiliaries and additives may be from 1 to 50% by weight and is preferably from 5 to 40% by weight, based on the particular preparation (Petit at [0134]). Petit teaches that the amount of active in the microcapsule 0.005 to 5% (Petit at [0016]). Brown teaches wherein said bio-available compound comprises a concentration of about at least 0.1% to approximately 50% ascorbic acid (wt/wt of carrier particle) (Brown at claim 10). Ascorbic acid being an active loaded on the carrier particle. Capsules with these ranges of actives would have a ratio of capsule to active that can fall within the instantly claimed range of 1:8 to 5:1. It would be prima facie obvious to have routinely optimized the amount of active in the capsule or platelet in order to provide the appropriate thickness of capsule and dosage of active. See MPEP 2144.05(II).
Regarding instant claim 6, Petit teaches anionic, nonionic, cationic and/or amphoteric or zwitterionic surfactants may be present as surfactants and normally make up about 1 to 70% by weight, preferably 5 to 50% by weight and more particularly 10 to 30% by weight of the preparations. Typical examples of anionic surfactants are soaps, alkyl benzenesulfonates, alkanesulfonates, olefin sulfonates, alkylether sulfonates, glycerol ether sulfonates, α-methyl ester sulfonates, sulfofatty acids, alkyl sulfates, fatty alcohol ether sulfates, glycerol ether sulfates, fatty acid ether sulfates, hydroxy mixed ether sulfates, monolyceride (ether) sulfates, fatty acid amide (ether) sulfates, mono- and dialkyl sulfosuccinates, mono- and dialkyl sulfosuccinamates, sulfotrigly-cerides, amide soaps, (Petit at [0020]).
Regarding instant claim 10, Petit recites characterized in that they contain the microcapsules in quantities of 0.1 to 10% by weight, based on the final preparations (Petit at claim 2), which overlaps the instantly claimed range of 0.1 to 2%. 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).
Regarding instant claim 13, Petit teaches the use of alkylbetaines, alkylamidobetaines, amino-propionates, aminoglycinates, imidazolinium betaines and sulfobetaines (Petit at [0020]).
Conclusion
No claims are presently allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA MICHELLE PETRITSCH whose telephone number is (571)272-6812. The examiner can normally be reached M-F 08:30-17:00 EST ALT Fridays.
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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