CTNF 18/258,777 CTNF 66646 3Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claims 1-13 and 16-18 are presented for examination. Claims 14 and 15 are withdrawn from consideration. Restriction/Election 08-05 AIA Claim s 13 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention , there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/10/ 08-25 AIA Applicant's election with traverse of Group I, claims 1-13 and 16-18 in the reply filed on 02/10/2026 is acknowledged. The traversal is on the ground(s) that Restriction is only proper if the claims of the restricted groups are independent or patentably distinct and there would be a serious burden placed on the Examiner if restriction is not required (MPEP §803). The burden is on the Examiner to provide reasons and/or examples to support any conclusion in regard to patentable distinction (MPEP §803) . This is not found persuasive because even though the inventions of these groups require the technical feature of a bi-phase composition of claim 1, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Frelichowska et al. (submitted by the applicant). Frelichowska teaches Surfactant-free emulsions stabilized by solid particles (Pickering emulsions) have been evaluated in the terms of skin absorption of lipophilic drugs. The behavior of three formulations: a surfactant-based emulsion, a Pickering emulsion stabilized by silica particles and a solution in triglyceride oil, were compared in order to assess the effect of the surface coating of Pickering emulsions as new dosage forms for topical application. Such comparative investigation was performed in vitro on excised pig skin in Franz diffusion cells with all-trans retinol as model lipophilic drug. Surfactant-based (classical, CE) and Pickering (PE) oil- in-water emulsions containing retinol were prepared with the same chemical composition (except the Skin penetration Skin delivery stabilizing agent: surfactant or silica particles), the same droplet size and the same viscosity. No permeation through the skin sample was observed after 24 h exposure because of the high lipophilic character of retinol. Penetration of retinol was 5-fold larger for both CE and PE than for the solution in triglyceride. The distribution of retinol inside the skin layers depended significantly on the emulsions type: the classical emulsion allowed easy diffusion through the stratum corneum, so that large amounts reached the viable epidermis and dermis. Conversely, high storage of retinol inside the stratum corneum was favored by the Pickering emulsion. The retinol content in stratum corneum evaluated by skin stripping, demonstrated the increased retinol accumulation from PE. Therefore Pickering emulsions are new drug penetration vehicles with specific behavior: they are well-suited either for targeting the stratum corneum or aimed at slow release of drug from stratum corneum used as a reservoir to the deeper layers of skin. See the abstract. the use of retinol, caprylic retinol, caprylic, capric triglyceride, alpha-tocopherol acetate, silica and water is taught in table 1. Applicant’s attention is further directed to the following: (a)the inventions have acquired a separate status in the art in view of their different classification; (b) the inventions have acquired a separate status in the art due their recognized divergent subject matter; (c) the inventions have acquired a different field of search (for example searching different classes/subclasses or electronic resources, or employing different search queries); (d) the prior at applicable to one invention would not likely be applicable to another invention; (e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112 first paragraph .The requirement is still deemed proper and is therefore made FINAL. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-03-aia AIA Claim(s) 1-8, 10, 12, 13 and 16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Frelichowska et al. (submitted by the applicant) . Regarding claim 1, Frelichowska teaches Surfactant-free emulsions stabilized by solid particles (Pickering emulsions) have been evaluated in the terms of skin absorption of lipophilic drugs. The behavior of three formulations: a surfactant-based emulsion, a Pickering emulsion stabilized by silica particles and a solution in triglyceride oil, were compared in order to assess the effect of the surface coating of Pickering emulsions as new dosage forms for topical application. Such comparative investigation was performed in vitro on excised pig skin in Franz diffusion cells with all-trans retinol as model lipophilic drug. Surfactant-based (classical, CE) and Pickering (PE) oil- in-water emulsions containing retinol were prepared with the same chemical composition (except the Skin penetration Skin delivery stabilizing agent: surfactant or silica particles), the same droplet size and the same viscosity. No permeation through the skin sample was observed after 24 h exposure because of the high lipophilic character of retinol. Penetration of retinol was 5-fold larger for both CE and PE than for the solution in triglyceride. The distribution of retinol inside the skin layers depended significantly on the emulsions type: the classical emulsion allowed easy diffusion through the stratum corneum, so that large amounts reached the viable epidermis and dermis. Conversely, high storage of retinol inside the stratum corneum was favored by the Pickering emulsion. The retinol content in stratum corneum evaluated by skin stripping, demonstrated the increased retinol accumulation from PE. Therefore Pickering emulsions are new drug penetration vehicles with specific behavior: they are well-suited either for targeting the stratum corneum or aimed at slow release of drug from stratum corneum used as a reservoir to the deeper layers of skin. See the abstract. the use of retinol, caprylic retinol, caprylic, capric triglyceride, alpha-tocopherol acetate, silica and water is taught in table 1. Regarding claim 2 , Frelichowska teaches the use of alpha-tocopherol acetate, which is an antioxidant Regarding claim 3, Frelichowska teaches the water being 83%. See table 1. Regarding claim 4 , Frelichowska teaches the use of caprylic, capric triglyceride, which is a fatty alcohol ester in table 1. Regarding claim 5, Frelichowska teaches the concentration of oil phase is 9.4%. See table 1. Regarding claim 6, Frelichowska teaches the use of retinol, which a retinoid. See the abstract and table 1. Regarding claims 7 and 8 , Frelichowska teaches the use of retinol as an active agent. See the abstract and table 1. Regarding claim 10 , Frelichowska teaches the use of silica as a stabilizing agent. See table 1. Regarding claim 12 , Frelichowska teaches the use of alpha-tocopherol acetate, which is an antioxidant. See table 1. Regarding claim 13 , Frelichowska teaches the concentration of alpha-tocopherol being 0.5%, which falls within the claimed range. See table 1 . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim (s) 1-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frelichowska et al. (submitted by the applicant) in view of Habif et al. (US Patent 5744148 submitted by the applicant) and further in view of Lanzendoerfer et al. (US 20050214333) . Regarding claim 1 , Frelichowska teaches Surfactant-free emulsions stabilized by solid particles (Pickering emulsions) have been evaluated in the terms of skin absorption of lipophilic drugs. The behavior of three formulations: a surfactant-based emulsion, a Pickering emulsion stabilized by silica particles and a solution in triglyceride oil, were compared in order to assess the effect of the surface coating of Pickering emulsions as new dosage forms for topical application. Such comparative investigation was performed in vitro on excised pig skin in Franz diffusion cells with all-trans retinol as model lipophilic drug. Surfactant-based (classical, CE) and Pickering (PE) oil- in-water emulsions containing retinol were prepared with the same chemical composition (except the Skin penetration Skin delivery stabilizing agent: surfactant or silica particles), the same droplet size and the same viscosity. No permeation through the skin sample was observed after 24 h exposure because of the high lipophilic character of retinol. Penetration of retinol was 5-fold larger for both CE and PE than for the solution in triglyceride. The distribution of retinol inside the skin layers depended significantly on the emulsions type: the classical emulsion allowed easy diffusion through the stratum corneum, so that large amounts reached the viable epidermis and dermis. Conversely, high storage of retinol inside the stratum corneum was favored by the Pickering emulsion. The retinol content in stratum corneum evaluated by skin stripping, demonstrated the increased retinol accumulation from PE. Therefore Pickering emulsions are new drug penetration vehicles with specific behavior: they are well-suited either for targeting the stratum corneum or aimed at slow release of drug from stratum corneum used as a reservoir to the deeper layers of skin. See the abstract. the use of retinol, caprylic retinol, caprylic, capric triglyceride, alpha-tocopherol acetate, silica and water is taught in table 1. Regarding claim 2, Frelichowska teaches the use of alpha-tocopherol acetate, which is an antioxidant Regarding claim 3, Frelichowska teaches the water being 83%. See table 1. Regarding claim 4, Frelichowska teaches the use of caprylic, capric triglyceride, which is a fatty alcohol ester in table 1. Regarding claim 5, Frelichowska teaches the concentration of oil phase is 9.4%. See table 1. Regarding claim 6, Frelichowska teaches the use of retinol, which a retinoid. See the abstract and table 1. Regarding claims 7 and 8, Frelichowska teaches the use of retinol as an active agent. See the abstract and table 1. Regarding claim 9, Frelichowska does not teach the hydrophobic particles are in the form of spherical or lamellar. However, Habif teaches an Oil-in-water emulsions containing an unstable retinoid in an oil phase. The retinoid is stabilized in the emulsions, despite the presence of from about 50% to about 98% of an aqueous phase. See The abstract. Habif teaches Powders may be incorporated into the cosmetic composition of the invention. These powders include chalk, talc, Fullers earth, kaolin, starch, smectite clays, chemically modified magnesium aluminum silicate, organically modified montmorillonite clay, hydrated aluminum silicate, fumed silica, aluminum starch octenyl succinate and mixtures thereof. See (62). Habif teaches spherical oil droplets about 50 microns in diameter, surrounded by a crystalline barrier layer. See (17). It would have been obvious to a person skilled in the art to obtain a spherical oil droplet covered by hydrophobic particles in the composition of Frelichowska, motivated by the teachings of Habif, which teaches the particle C can be in a spherical form. Furthermore, the determination of theshapes of particles is within the skill of artisan in the absence of evidence to the contrary. Regarding claim 10, Frelichowska teaches the use of silica as a stabilizing agent. See table 1. Habif also teaches teaches Powders may be incorporated into the cosmetic composition of the invention. These powders include chalk, talc, Fullers earth, kaolin, starch, smectite clays, chemically modified magnesium aluminum silicate, organically modified montmorillonite clay, hydrated aluminum silicate, fumed silica, aluminum starch octenyl succinate and mixtures thereof. See (62). Regarding claim 11 , Habif teaches the concentration of silicate being 0.6%. See Example 8 . Regarding claim 12 , Frelichowska teaches the use of alpha-tocopherol acetate, which is an antioxidant. See table 1. Regarding claim 13, Frelichowska teaches the concentration of alpha-tocopherol being 0.5%, which falls within the scope of the claimed range. See table 1. Regarding claim 16 , Frelichowska teaches the use of caprylic/ capric triglyceride as oil. See table 1. Regarding claim 17, Frelichowska does not teach the use of vitamin B group in the composition for treating keratin . However, Lanzendoerfer, teaches a cosmetic formulation, which may advantageously contain besides one or more aqueous phases one or more oil phases, and be present in the form of W/O, O/W, W/O/W, or O/W/O emulsions. Preferably, such formulations may also be a microemulsion (for example, a PIT emulsion), solids emulsion (i.e. an emulsion that is stabilized by solids, for example a Pickering emulsion). See Para [0268]. Lanzendoerfer teaches the use of vitamin B and derivatives thereof in the cosmetic pickering emulsions as old and well known. See claim 4. It would have been obvious to a person skilled in the art to add vitamin B group components to the composition of Frelichowska, motivated by the teachings of Lanzendoerfer, which teaches the use of vitamin B group compounds in pickering emulsions as old and well known. Regarding Claim 18 , Habif teaches the use of retinyl acetate and propionate in an oil in water emulsion for skin conditioning. See claim 1. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ZOHREH A FAY/Primary Examiner, Art Unit 1617 Application/Control Number: 18/258,777 Page 2 Art Unit: 1617 Application/Control Number: 18/258,777 Page 3 Art Unit: 1617 Application/Control Number: 18/258,777 Page 4 Art Unit: 1617 Application/Control Number: 18/258,777 Page 5 Art Unit: 1617 Application/Control Number: 18/258,777 Page 6 Art Unit: 1617 Application/Control Number: 18/258,777 Page 7 Art Unit: 1617 Application/Control Number: 18/258,777 Page 8 Art Unit: 1617 Application/Control Number: 18/258,777 Page 9 Art Unit: 1617
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