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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 ambiguously recites, “wherein the W/O/W emulsion has an inositol content of 0.01 to 1.4 wt%” without specifying whether the mass basis is the emulsion or solely the aqueous phase. Claim 8 is also vague and indefinite for analogous reasons.
For the sake of compact prosecution, it is assumed that the concentration is based on the total weight of the emulsion for prior art consideration only. Applicant must amend the claims or provide explanation why the claims are not ambiguous in order to overcome this rejection.
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.
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 1-4, 6, 9-19 are rejected under 35 U.S.C. 103 as being unpatentable over Inoue et al. (WO 2021066098 A1, April 8, 2021, cited in IDS) in view of Gheradi et al. (US 20210369583 A1, published on December 2, 2021) (“Gheradi” hereunder).
Inoue teaches a W/O/W emulsion comprising an inner water phase, an oil phase in which the inner water phase is dispersed, and an outer water phase in which the oil phase is dispersed. See US Equivalent US 20220362112 A1, abstract. The inner water phase includes an osmotic pressure-adjusting agent, which creates an osmotic pressure difference between the inner and outer water phases and a high viscosity and fresh feel with a relatively small amount of the oil phase. See [0002, 0046-47].
Although Inoue teaches using sugar alcohols as the osmotic pressure adjusting agent suitable for the emulsion, the reference fails to specifically mention inositol.
Gheradi teaches inositol is a well known osmolyte useful in making cosmetic emulsions. The reference mentions that W/O/W emulsion among the suitable emulsion that can be made according to the teachings of the reference. See [0061]. Example 1 teaches that inositol is provided in powder form and added to an aqueous solution. Inositol is used with proline, serine and betaine.
It is well settled in patent law that combining or substituting art-recognized functional equivalents is prima facie obvious. See MPEP 2144.06, I and II. In this case, as Gheradi discloses inositol or the combination comprising inositol as an osmolyte for an aqueous phase useful to stabilize oil and water emulsions, adding the osmolyte with the osmotic pressure adjusting agents in Inoue, or substituting one for the other, to make a similarly stable W/O/W emulsion, would have been prima facie obvious. See the present claim 1, 2, 16 and 17.
Regarding claim 3, Inoue teaches that the blending amount of the osmotic pressure regulators, including sugar alcohols, is preferably 0.01 to 5 % by weight, and particularly 0.1 to 3 % by weight in the total amount of the composition. See [0019]. The reference teaches that the concentration is a result-effective variables as a sufficient amount of the osmotic pressure regulator should be used to improve the skin feel, yet too much of the agent would deteriorate the stability. Thus, using inositol within such amount to stabilize the W/O/W of Inoue would have been prima facie obvious.
Regarding claims 4, 9 and 10, Inoue suggests using solid fat including waxes. See [0023-0024]. Silicone surfactants are mentioned in [0029--0031]. Using a water-soluble polymer such as acrylic acid/alkyl methacrylate copolymer is specifically mentioned. See [0036-0037]. See claim 18.
Regarding claim 6, Example discloses PEG-9 polydimethylsiloxyethyl dimethicone.
Regarding claim 11, Inoue teaches that monovalent metal salts of amino acids can be used as osmotic pressure regulators. See [0016].
Regarding claim 12, Example 1-3 in Table 1 shows that the weight percentages of the inner aqueous phase and the oil phase are 5.01 wt % and 16.6 wt %, respectively, and well within the range of 10/90 to 90/10. See also claim 19.
Regarding claims 13-15, the Inoue composition is a cosmetic composition providing improved stability and skin feel. The reference mentions cosmetic creams as comparable prior art, which suggests that the disclosed invention is useful to make a cream product. See [0003].
Regarding claim 16, Inoue teaches, a w/o emulsion is produced by stirring and mixing with an emulsification equipment, and then the w/o emulsion and an outer aqueous phase comprising an alkyl-modified carboxyvinylpolymer is mixed and emulsified to obtain a w/o/w emulsion composition. See [0043].
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Inoue and Gheradi as applied to claims 1-4, 6 and 9-19 above, and further in view of Kanazawa et al. (US 20200138691 A1, published on May 7, 2020) (“Kanazawa” hereunder).
The silicone surfactant used in the Inoue Example 1-3, PEG-9 polydimethylsiloxyethyl dimethicone, has an HLB of 4.5. See Kanazawa, [0213].
Inoue fails to specifically mention the silicone surfactants of the present claim 7.
Kanazawa teaches cosmetic W/O emulsion comprising modified silicone surfactants, which can be chosen from among PEG-9 polydimethylsiloxyethyl dimethicone, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, and two others. See [0093-0094]. The reference further teaches using modified silicone surfactants having a HLB value of greater than 1 and less than 6, and most preferably in a range of 2-5. See [0091]. The HLB of PEG-9 polydimethylsiloxyethyl dimethicone and lauryl PEG-9 polydimethylsiloxyethyl dimethicone are 4.5 and 3, respectively. See [0213].
It is well settled in patent law that combining or substituting art-recognized functional equivalents is prima facie obvious. See MPEP 2144.06, I and II. In this case, as Kanazawa establishes that the modified silicone surfactants in the Inoue example and the present claim 7 are functionally equivalent surfactants which have an HLB value between 2-5 and are useful in making cosmetic W/O emulsions, one of ordinary skill in the art before the effective filing date of the present application would have found it prima facie obvious to combine these surfactants or substitute one for the other to make another W/O emulsion useful for same purposes.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Inoue and Gheradi as applied to claims 1-4, 6 and 9-19 above, and further in view of Watae et al. (US 20220175652 A1, filed on March 19, 2020) (“Watae” hereunder).
Inoue fails to teach the amount of a solid oil used in the W/OW emulsion.
Watae teaches a cosmetic oily mixture composition comprising a silicone surfactant having an HLB of 6 or less and an oil phase thickener having a melting point of at least 55°C, which includes waxes, higher alcohols, etc. See [0058-0060]. The reference teaches that the amount of the oil phase thickener can be preferably used in the amount of 5-15 %,
Given the teaching of using a solid fat in the oil phase, one of ordinary skill in the art before the effective filing date of the present application would have been obviously motivated to look to prior art such as Watae for specific teachings on the amount of the solid fat to make the W/O/W emulsion of Inoue. Since Watae teaches using solid fats as an oil phase thickener in an amount 5-15% by weight of the composition, the skilled artisan would have been obviously motivated to combine the teachings of the references with a reasonable expectation of successfully increasing the viscosity of the oil phase.
Conclusion
No claims are allowed.
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/GINA C JUSTICE/ Primary Examiner, Art Unit 1617
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