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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/15/2025 has been entered.
Formal Matters
Receipt of Applicant’s response, dated 12/15/2025, is acknowledged.
Claims 24-43 are pending.
Claims 1-23 are canceled.
Claims 24 and 42 are amended.
Claims 42-43 remain withdrawn from consideration as being drawn to a nonelected invention.
Claims 24-41 are under consideration in the instant Office action to the extent of the elected species, i.e., the organic particles are nanoemulsion particles, the inorganic particles are titania, and the active ingredient is bakuchiol.
Information Disclosure Statement
The information disclosure statement (IDS) filed 02/09/2026 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
REJECTIONS WITHDRAWN
Claim Rejections - 35 USC § 103
The following obviousness rejections set forth in the Office action dated 09/23/2025 are hereby withdrawn in light of Applicant’s amendments to the claims and in favor of the new grounds of rejection set forth below:
The rejection of claims 24-32 and 37-40 over Hanasaki et al as evidenced by Haji et al;
The rejection of claims 33-36 over Hanasaki et al as evidenced by Haji et al and further in view of Fernandez et al; and
The rejection of claim 41 over Hanasaki et al as evidenced by Haji et al and further in view of Friedman et al.
NEW GROUNDS OF OBJECTION/REJECTION
Specification
The disclosure is objected to because “descried” appearing on Page 34 Line 9 of the specification should be amended to “described” in order to remedy the typographical error.
Appropriate correction is required. Applicant’s cooperation is requested in checking the rest of the disclosure for informality errors and making changes accordingly.
Claim Objections
Claim 24 is objected to because each recitation of “and” appearing in the sixth to last line and the third to last line of the claim should be deleted for grammatical correctness.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 24-32 and 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over Ho O et al (US 2010/0272765 A1, published 10/28/2010) in view of Hanasaki et al (US 2019/0281852 A, published 09/19/2019, cited in IDS dated 08/16/2022).
Ho O et al teach a stable emulsion comprising (a) an oil; (b) water; (c) a surfactant; and (d) solid particulate material (See entire document, e.g., Abstract). The emulsion can be an oil-in-water (o/w) emulsion, meaning an emulsion where oil is dispersed as droplets and water is the continuous phase, wherein "dispersed phase" refers to the droplets in the emulsion (e.g., [0019]). The droplets in the emulsion generally have a particle size distribution having a d50 value of below 1 micron and a d90 value of below 5 microns (e.g., [0020]-[0021]). The emulsion is pourable and has a relatively low viscosity, e.g. below 10 Pa.s at a shear rate of 1,000 s-1 (e.g., [0022]). The amount of oil is at least 0.1 wt % and at most 99 wt %, the amount of water is at least 0.1 wt % and at most 99 wt %, and the total weight of oil and water is at most 99 wt%, wherein wt % is based on the total weight of the emulsion (e.g., [0026]).
The solid particulate material can be any solid particulate material known in the art as suitable to enhance the storage lifetime and thermal stability of the emulsion, wherein particularly suitable solid particulate materials are synthetic polymers, such as polyethylene, and inorganic oxygen-containing particulate material, such as titanium dioxide (i.e., titania) (e.g., [0030]). These solid particulate materials generally have an average particle size which is at least five times lower (i.e. the particles are five times smaller on average than the droplet size), preferably at least 10 times lower, and most preferably at least 20 times lower than the average droplet size, and typically, the d50 value of the solid particulate material is at least 5 nm and at most 200 nm (e.g., [0031]). The amount of solid particulate material is between 0.1 and 100 wt %, based on the total weight of the dispersed phase (e.g., [0032]).
Ho O et al teach, in the examples, that the preparation of the emulsion includes making a colloidal solution from water and solid particulate material and adding the colloidal solution to the starting emulsion, e.g., adding 4.82 g colloidal solution to 20 g starting emulsion (e.g., Table 3, [0051]-[0052]).
The emulsion can be used in applications including cosmetics (e.g., [0041]) and may comprise a cosmetically-active ingredient (e.g., claim 14).
Ho O et al do not teach the solid particulate material particles being adhered to each other on a surface of the oil phase and surrounding the surface of the oil phase so as to form an interface between the oil phase and the water phase or the solid particulate material particles being continuously located on the surface of the oil phase to form the interface between the oil phase and the water phase.
These deficiencies are made up for in the teaching of Hanasaki et al.
Hanasaki et al teach an oil-in-water emulsion composition, having applications including cosmetics, comprising solid particles, a surfactant, an oil phase, and an aqueous phase, wherein the solid particles are distributed along the interface between the oil phase and the aqueous phase (See entire document, e.g., Abstract, [0079], [0287]). Hanasaki et al teach that such a structure allows an oil-in-water emulsion composition to have temperature drop resistance and heat resistance and to contain particles with a uniform particle size, regardless of before or after heating (e.g., [0257]). Hanasaki et al teach that such a structure can be achieved, during preparation of the emulsion, by preliminary addition of the solid particles to the aqueous phase component and the oil phase component in advance (e.g., [0278]-[0280]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, based on the teachings of Ho O et al and Hanasaki et al, to provide a stable oil-in-water emulsion comprising an oil, water, a surfactant, and solid particulate material, wherein the oil droplets have a d50 value below 1 micron and a d90 value below 5 microns, wherein the emulsion is pourable and has a relatively low viscosity, e.g., below 10 Pa.s at a shear rate of 1,000 s-1, wherein oil is present from 0.1 to 99 wt %, water is present from 0.1 to 99 wt %, and the total amount of oil and water is at most 99 wt%, where wt% is based on the total weight of the emulsion, wherein the solid particulate material is a synthetic polymer such as polyethylene and/or an inorganic oxygen-containing particulate material such as titania in the form of particles having an average particle size which is at least five times lower, preferably at least 10 times lower, and most preferably at least 20 times lower than the average droplet size, and the d50 value of the solid particulate material is at least 5 nm and at most 200 nm, wherein the solid particulate material is present from 0.1 and 100 wt % based on the total weight of the dispersed phase, wherein the emulsion is used in a cosmetic further comprising a cosmetically-active ingredient, wherein preparation of the emulsion includes the step of adding the solid particulate material to the water phase and the oil phase in advance of making the emulsion in order to result in a structure wherein the solid particulate material particles are distributed along the interface between the oil phase and the water phase and includes the steps of making a colloidal solution from water and the solid particulate material and adding the colloidal solution to the starting emulsion, e.g., 4.82 g colloidal solution to 20 g starting emulsion.
One of ordinary skill in the art would have been motivated to add the solid particulate material to the water phase and the oil phase in advance of making the emulsion because Hanasaki et al teach that this results in a structure allowing for the oil-in-water emulsion composition to have temperature drop resistance and heat resistance and to contain particles with a uniform particle size, regardless of before or after heating. There would have been a reasonable expectation of success because both the emulsion of Ho O et al and Hanasaki et al are oil-in-water emulsions comprising solid particles, a surfactant, an oil phase, and an aqueous phase for applications in cosmetics.
Regarding the ranges required by the instant claims, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (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)).
The Examiner interprets “nanoemulsion particles” to mean that the size of the particles is nanoscale, and therefore, the solid particulate material particles in the emulsion of Ho O et al in view of Hanasaki et al being a synthetic polymer such as polyethylene and/or an inorganic oxygen-containing particulate material such as titania in the form of particles having d50 value of at least 5 nm and at most 200 nm that are distributed along the interface between the oil phase and the water phase renders obvious the limitations required by the instant claims that the interfacial particles comprise nanoemulsion particles as the elected species of organic particles and further comprise titania as the elected species of inorganic particles.
Regarding the limitation required by the instant claims that the interfacial particles are not surface-treated, Ho O et al are silent regarding whether the solid particulate material is surface-treated. Thus, a skilled artisan would have understood that the solid particulate material is not surface-treated. See AC Technologies S.A. v. Amazon.com, Inc., 912 F.3d 1358, 1367 (Fed. Cir. 2019) (“[A] reference need not state a feature’s absence in order to disclose a negative limitation.”); Sud-Chemie, Inc. v. Multisorb Techs., Inc., 554 F.3d 1001, 1004–05 (Fed. Cir. 2009) (affirming finding that reference disclosed “uncoated” film where it did not describe the film as coated and did not suggest necessity of coatings).
Regarding the recited properties of instant claims 39-40, because the emulsion of Ho O et al in view of Hanasaki et al is the same as the emulsion composition of the instant claims, the emulsion of Ho O et al in view of Hanasaki et al would necessarily exhibit a yield stress of 0.1-1.0 Pa when viscosity depending on shear stress is measured or/and exhibit an interval in which viscosity is increased as shear stress is increased, in at least a part of a shear stress interval of 100-1,000 Pa, when viscosity depending on shear stress is measured, and exhibit a decrease in viscosity by 30% or more out of the yield stress of 0.1-1.0 Pa. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Thus, the modified emulsion of Ho O et al in view of Hanasaki et al renders obvious the emulsion composition of instant claims 24-32 and 37-40.
Claims 33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Ho O et al (as cited above) in view of Hanasaki et al (as cited above) as applied to claims 24-32 and 37-40 above, and further in view of Fernandez et al (US 2013/0336902 A1, published 12/19/2013, cited in Notice of References Cited dated 03/10/2025).
The modified emulsion of Ho O et al in view of Hanasaki et al has been discussed supra.
Although Ho O et al teach that the emulsion may be used in a cosmetic further comprising a cosmetically-active ingredient (see supra), Ho O et al do not teach suitable cosmetically-active ingredients or teach the structural relationship of the cosmetically-active ingredient to the emulsion. Hanasaki et al additionally teach that the solid particles may contain any active component inside the solid particles or carry any active component on the surface of the solid particles (e.g., [0097], [0199]), for which the active component may be any active component which can be expected to exert a desired physiological effect in biological bodies, in the oil phase or the solid particles, and examples of the active component that can be expected to exert a physiological effect include fats, trace elements, vitamins, amino acids, minerals, and medicinal ingredients derived from any natural materials or synthetic compounds (e.g., [0187], [0262]). However, neither Ho O et al nor Hanasaki et al teach the cosmetically-active ingredient being bakuciol or how much of the cosmetically-active ingredient may be present in the emulsion.
These deficiencies are made up for in the teachings of Fernandez et al.
Fernandez et al teach a personal care composition, including as a cosmetic composition, in the form of an emulsion, including as an oil-in-water emulsion, comprising an aqueous phase, an oil phase, and a skin lightening agent (See entire document, e.g., [0004]-[0005], [0034]-[0035]), where the skin lightening agent may be bakuchiol (e.g., [0201]). The skin lightening agent is present in the composition in an amount of from 0.0001% to 50% by weight of the composition (e.g., [0201]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use bakuchiol from 0.0001% to 50% by weight as the cosmetically-active ingredient in the emulsion of Ho O et al in view of Hanasaki et al. One of ordinary skill in the art would have been motivated to do so in order to provide an effect of skin lightening to the emulsion, which would be specifically beneficial for use as a cosmetic. There would have been a reasonable expectation of success because Ho O et al teach compatibility of the emulsion with a cosmetically-active ingredient.
Regarding the limitation of weight percent of bakuchiol as the elected species of the active ingredient required by instant claim 36, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
Thus, the modified emulsion of Ho O et al in view of Hanasaki et al further in view of Fernandez et al comprising from 0.0001% to 50% by weight of bakuchiol as the cosmetically-active ingredient present inside of or carried on the surface of the solid particulate material particles renders obvious instant claims 33-36.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Ho O et al (as cited above) in view of Hanasaki et al (as cited above) as applied to claims 24-32 and 37-40 above, and further in view of Friedman et al (TW 474822 B, published 02/01/2002, cited in Notice of References Cited dated 03/10/2025).
The modified emulsion of Ho O et al in view of Hanasaki et al has been discussed supra.
Neither Ho O et al nor Hanasaki et al teach the emulsion formulated as a freeze-dried formulation.
This deficiency is made up for in the teaching of Friedman et al.
Friedman et al teach that freeze-drying emulsions provides fine, substantially dry substances that can be stored for a long period of time without damage, and which can be reconstituted into oil-in-water emulsions (See Page 5 Lines 6-8 of English translation). The oil-water emulsions of Friedman et al can be used for topical applications, including cosmetics (See Page 5 Lines 9-10 of English translation).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to freeze-dry the emulsion of Ho O et al in view of Hanasaki et al. One of ordinary skill in the art would have been motivated to do so in order to increase the storage life of the emulsion, which would be useful for a cosmetic. There would have been a reasonable expectation of success because Friedman et al teach that oil-in-water emulsions suffer from disadvantages including poor stability in long-term storage (See Lines 2-7 of Description on Page 2 of English translation) and, additionally, Friedman et al teach that the methodology of freeze-drying is used in various patents for food and pharmaceutical applications including emulsions (See Description Lines 6-8 on Page 2 of English translation).
Thus, the modified emulsion of Ho O et al in view of Hanasaki et al further in view of Friedman et al being prepared as a freeze-dried formulation renders obvious instant claim 41.
Response to Applicant’s Arguments
Applicant’s arguments filed on 11/24/2025 have been considered.
Applicant argues that the solid particles taught by Hanasaki are surface-modified by a surfactant, and therefore, its emulsification system differs from that of the claimed emulsion composition and that the emulsion composition set forth in the present claims fundamentally differs in configuration from Hanasaki in that it contains a colloidal solution as the emulsifier for emulsifying the aqueous phase part and the oil phase part without surface-treating the interfacial particles. Applicant argues that the claimed emulsion composition provides the unexpected advantage that interfacial stability is maintained even in the absence of surface-treated particles, which constitutes a remarkable effect that could not have been anticipated by a person skilled in the art from the technical teaching of Hanasaki. Applicant argues that the claimed emulsion composition differs from that of Hanasaki in terms of the surface characteristics of the interfacial particles, the configuration of the emulsifier, and the dispersion properties of the organic particles. Applicant argues that the emulsion composition set forth in the present claims differs from that of Haji in both the emulsification mechanism and the structure of the emulsified particles. Applicant argues that Fernandez and Friedman do not disclose the surface characteristics of the interfacial particles, the emulsifier configuration, or the dispersion properties of the organic particles of the claimed emulsion composition set forth in the present claims.
The above arguments regarding the teaching of Hanasaki et al have been fully considered by the Examiner but are not found persuasive because the rejection under 35 USC 103 over Hanasaki et al as evidenced by Haji et al set forth in the Office action dated 09/23/2025 has been withdrawn and the teaching of Hanasaki et al is relied upon in the instant Office action for it being prima facie obvious to one of ordinary skill in the art, during the preparation of the emulsion of Ho O et al, to add the solid particulate material to the water phase and the oil phase in advance of making the emulsion (see the new grounds of rejection above for more details) and the teaching of Hanasaki et al is not relied upon in the instant Office action for any of “surface characteristics of the interfacial particles”, “configuration of the emulsifier”, or “dispersion properties of the organic particles”. Further, the modified emulsion of Ho O et al in view of Hanasaki et al meets all of the limitations of amended claim 24, as well as of claims 25-32 and 37-40 (see the new grounds of rejection above for more details). The above arguments regarding the teaching of Haji et al have been fully considered by the Examiner but are not found persuasive because the rejection under 35 USC 103 over Hanasaki et al as evidenced by Haji et al set forth in the Office action dated 09/23/2025 has been withdrawn and the teaching of Haji et al is neither applied in the instant Office action as a prior art reference or as an evidentiary reference. The above arguments regarding the teachings of Fernandez et al and Friedman et al have been fully considered by the Examiner but are not found persuasive because, as can be seen in the new grounds of rejection under 35 USC 103 above, neither reference is relied upon for disclosure of “surface characteristics of the interfacial particles”, “emulsifier configuration”, nor “dispersion properties of the organic particles”, but rather the teaching of Fernandez et al is relied upon for it being prima facie obvious to one of ordinary skill in the art to use bakuchiol from 0.0001% to 50% by weight as the cosmetically-active ingredient in the emulsion of Ho O et al in view of Hanasaki et al and the teaching of Friedman et al is relied upon for it being prima facie obvious to one of ordinary skill in the art to freeze-dry the emulsion of Ho O et al in view of Hanasaki et al (see the new grounds of rejection above for more details).
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAELEIGH ELIZABETH OLSEN whose telephone number is (703)756-1962. The examiner can normally be reached M-F 8-5 PM.
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, David Blanchard can be reached at (571)272-0827. 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.
/K.E.O./Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
Prosecution Insights