DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Amendment filed on 06/14/2026 is acknowledged.
Claims 1 and 13 are amended. Claim 2 remain cancelled.
Claims 1 and 3-15 are pending and being examined on merits herein.
Priority
The instant application, filed on 06/10/2022, is a 371 of PCT/JP2020/046447, filed on 12/08/2020, which claims foreign priority to Japan 2019-228433, filed on 12/18/2019.
Withdrawn Objections/Rejections
All previous claim Objection(s) / Rejection(s) as set forth in the previous Office action (mailed 03/17/2026) that are not repeated and/or maintained in the instant Office action are withdrawn, in light of applicant’s amendment and remark filed on 06/14/2026.
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 3-15 are rejected under 35 U.S.C. 103 as being unpatentable over Walt (US20130089508, 04/11/2013), in view of Thakkar (WO2019228996, 12/05/2019, PTO-892).
Walt throughout the reference teaches compositions for enhancing keratin health and growth, e.g., nail and cuticle, which are primarily composed of the protein keratin (e.g., [0002-0003]).
For Claim 1, Walt specifies that the composition is oil-in-water emulsion (e.g., Claim 6; [0035]; [0036]), self-emulsifying with little or no agitation in a soft gelatin or viscous paste concentrated form (e.g., [1016]), stable, simple to prepare, and have good pharmacokinetic properties (e.g., [1019]). Walt teaches that the composition can comprise an oil having a specific gravity from 0.95 to 1.07 (overlapping with the range of more than 0.97 in instant claim 1), and a stearate surfactant [0211] (corresponding to c) anionic surfactant); such as, Anise oil, and a stearate surfactant [0212]; Castor oil, and a stearate surfactant [0213]; Clove oil, and a stearate surfactant [0214]; Cassia oil, and a stearate surfactant [0215]; Cinnamon oil, and a stearate surfactant [0216]; medium-chain triglycerides (corresponding to a) triglyceride in instant claim 1) and nonionic surfactants [1017]; polyglycerol fatty acid esters having a HLB of 10 or greater, such as decaglyceryl mono- and dioleate and the like [0064] (corresponding to instant claim 1b), overlapping with HLB of 8 to 11); combining with thickeners and other excipients [1018], such as polymers of acrylic acid, carbomer 1342 (e.g., Claim 9; [0018]), polyacrylates such as carbomer [0014] (corresponding to instant claim 1 d) acrylic thickener); and water (e.g., [0020]).
For Claim 3, Walt teaches that the oil is present in the emulsion at a concentration selected from the group consisting of 1.25%, 0.01-10.0%, 0.1-5.0%, etc. (e.g., Claim 16) (overlapping with amount range from 0.01% to 25% in instant claim 2).
For Claims 4 and 5, Walt teaches polyglycerol fatty acid esters having a HLB of 10 or greater, such as decaglyceryl mono- and dioleate and the like [0064], wherein the polyglyceryl fatty acid ester contains 10 glycerol units with 18 carbon atoms of the fatty acid moiety of the monooleate (overlapping with 12 to 24 carbon atoms and 4 to 10 glycerol units in instant claims 4 and 5 respectively).
For Claim 6, Walt teaches the polyglycerol fatty acid esters and glycerol esters as specific surfactants (e.g., [0064]; Claim 15), the surfactant can present in a concentration of 0.01-10.0% by weight of the composition (e.g., Claim 17) (same range as instantly claimed).
For Claim 9, Walt teaches that the composition can comprise any known pharmaceutically acceptable surfactants including nonionic, anionic, cationic, and combinations thereof, remaining HLB excess of 10 when combined (e.g., [0062]), and the surfactant amount can present at 0.01-10.0% by weight of the composition (e.g., Claim 17) (same range as instantly claimed).
For Claims 10 and 11, Walt teaches using 0.05-0.1% of carbomer 1342 in the composition (e.g., Claim 9; [0032]; [0014]; [0018]), as evidenced by SpecialChem, carbomer 1342 is acrylates/C10-C30 alkyl acrylate cross polymer as recited in instant claim 10; the prior art amount overlaps with 0.01-5% of acrylic thickener in instant claim 11. MPEP 2112.01.II states "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable, as indicated in MPEP 2112.01.II. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. . For this instance, being acrylic thickener is the property of the compound acrylates/C10-C30 alkyl acrylate cross polymer, which has been taught by prior art. Therefore, the property of functioning as acrylic thickener would necessarily present in prior art.
For Claim 12, Walt exemplifies emulsion compositions comprising, e.g., 1.2% w/w polysorbate 80, 1.0% w/w glycerine, 1.50% w/w castor oil, 0.05% w/w pemulin TR-2, 2.5% w/w mannitol, sodium hydroxide to a pH of 7.4 and purified water at 93.75% (calculated from 100%-1.2%-1.0%-1.50%-0.05%-2.5% = 93.75%). Walt teaches the surfactant phase may comprise about 10% to 90%, or about 10% to 70%, or about 40% to about 60% by weight of the composition (e.g., [0065]), and oil can present up to 10% in the composition (e.g., Claim 16), which would result in the water phase amount roughly 10% to 90%.
For Claim 13, it is interpreted as property of the composition. If prior art teaches the composition, the property of the O/W emulsion would necessarily present in the prior art. Walt teaches the composition is stable and fine as discussed above regarding claim 1, for enhancing keratin health and growth, while indicating that growth of fingernails require 3 to 6 months to regrow completely, toenails require approx. 12 to 18 months (e.g., [0005]), and the composition can be administered in a frequency of up to four times a week, six times a day (e.g., [0012]). It is understood that room temperature, e.g., 25 C, is the product being kept in storage and usage for customers when no specific instruction is given. In order to effectively enhance the nail growth and health, the emulsion composition would inevitably require to keep stable and fine during the growth period, e.g., 3 to 6 months, or 12 to 18 months, which would exceed the instantly claimed time duration.
For Claim 14, Walt indicates the composition is for enhancing nail growth and health, which is mainly cosmetic in nature (e.g., [0008]).
For Claim 15, Walt teaches that compositions can be administered topically to the nail bed, nail matrix, the end or tip of the nail and cuticle in an amount effective to enhance nail health and/or cuticle health (e.g., [0012]).
Walt does not teach the composition comprising caprylic/capric succinic triglyceride as recites in claim 1 a), or anionic surfactant selected from the compounds having formula (A) as recited in instant claim 7 or selected from the group consisting of the species as recited in instant claim 8.
Thakkar throughout the reference teaches a stable oil-in-water dispersion comprising at least one oil and a continuous aqueous phase comprising at least one polymer (e.g., Claim 1; Abstract).
Thakkar teaches the stable composition can comprise sodium dilauramidoglutamide lysine (e.g., Pg. 12, Line 10), which displays a specific anionic surfactant as evidenced by instant invention (Spec. Page 2, Lines 15-17), as an exemplary compound corresponding to the anionic surfactant represented by formula A in instant claim 7 and listed as an anionic surfactant in instant claim 8. MPEP 2112.01.II states "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable, as indicated in MPEP 2112.01.II. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. For this instance, being anionic surfactant is the property of the compound sodium dialuramidoglutamide lysine, which has been taught by prior art, and the property would necessarily present in prior art.
Thakkar also teaches hydrocarbon-based oils of plant origin based on triglycerides, in particular the triglycerides of a fatty acid containing from 4 to 22 carbon atoms, such as capric/caprylic acid triglycerides and caprylic/capric/succinic triglyceride, are suitable for the composition (e.g., Pg. 7, Lines 19-24). Thakkar exemplifies caprylic/capric/succinic triglyceride presents in the composition at 0.8% in formulations F6 or F7 with water amount at about 70% (e.g., Pg. 16-17, Table 3), corresponding to component in instant claim 1 a), overlapping with water amount from 50% to 90% in instant claim 12.
It would have been prima facie obvious for one of ordinary skill in the art prior to filing date to incorporate the teaching from Thakkar to incorporate the specific components into the O/W stable emulsion in Walt to arrive at current invention. Because Walt already indicates that triglycerides are suitable for the composition and the O/W emulsion is stable, while Thakkar specifies that caprylic/capric/succinic triglyceride is proper for the oil in water dispersion to achieve the stable composition, as well as the component of sodium dilauramidoglutamide lysine, even when the surfactant can be limited to equal to less than 1.5% by weight of the composition (e.g., Claim 5, Thakkar), an artisan would be motivated to implement such components for stabilizing oil-in-water emulsion. It is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). For this instance, all the ingredient amount ranges, carbon numbers, HLB values, and gravity value overlap with those taught by prior art. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Response to Arguments
Applicant’s arguments filed on 06/14/2026 with respect to prior art rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Please refer to the entire office action as a complete response to the arguments.
Conclusion
No claim is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DONGXIU ZHANG SPIERING whose telephone number is (703)756-4796. The examiner can normally be reached 7:30am-5:00pm (Except for Fridays).
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/DX.Z./Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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