4734DETAILED 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
Receipt of Remarks/Amendments filed on 11/06/2025 is acknowledged. Claims 1-21 and 25 are amended. In accordance with the previous restriction/election requirement, claims 11-12 and 22-25 are withdrawn. Claims 1-10, 13-21 are under examination on the merits herein.
Priority
The instant application filed 01/09/2023, is a 371 filing of PCT/EP2021/069076, filed 07/08/2021, which claims foreign priority to FR2007347, filed 07/10/2020.
Withdrawn Rejections
Claims 3, 5, and 15 were rejected under 35 U.S.C. 112(b). Applicant’s amendment to claims 3, 5, and 15 have overcome these rejections and they are withdrawn.
Claims 1-10, 13-18, and 20-21 were rejected under 35 U.S.C. 103 over Lorant in view of Leuridan and Ibe. Applicant’s amendments have overcome the rejection and the rejection is withdrawn.
Claims 1-10 and 13-21 were rejected under 35 U.S.C. 103 over Lorant, Leuridan, and Ibe and further in view of Skincare basics. Applicant’s amendments have overcome the rejection and the rejection is withdrawn.
The following rejections are new as necessitated by amendments:
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 1-10, 13-18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Recardo, C. M., (GB 2560209 A, 09/05/2018, IDS dated 01/09/2023), hereinafter Recardo in view of Leuridan, M., et al. (WO 2011073185 A2, 06/23/2011, IDS dated 01/09/2023), hereinafter Leuridan, as evidenced by Evonik Nutrition & Care GmbH (2019). ISOLAN® GI 34 Technical Information (PTO-892), hereinafter Evonik, and Azelis (2026). LAMEFORM® TGI (PTO-892), hereinafter Azelis.
Recardo discloses an emulsifying composition for forming a water-in-oil high internal phase emulsion comprising at least one polyglycerol ester, at least one sorbitan ester, and at least one emollient ester. The formed emulsion is at least 75% internal phase by weight and preferably the composition contains less than 1% silicone oil (abstract).
Regarding claim 1: Recardo teaches water-in-oil emulsions (abstract). Example 10 teaches a high internal phase emulsion which comprises an emulsifier composition and squalane as oily components (p. 20, lines 21-27), thereby making up an oily phase as instantly claimed. The emulsifier composition comprises polyglyceryl-3 dioleate, sorbitan sesquioleate, and isopropyl palmitate (p. 21, lines 1-5). Polyglyceryl-3 dioleate, which is derived from the C18 fatty acid, oleic acid, reads on an emulsifier chosen from esters of C8-C30 fatty acid and polyglycerol as instantly claimed. Squalane and isopropyl palmitate read on a non-silicone oil with the density as instantly claimed, as evidenced by Table 6 in the instant specification (p. 31). The emulsion of Example 10 further comprises glycerin, MgSO4, and water (p. 20, lines 21-27), which may be characterized as an aqueous phase as instantly claimed. Together, glycerin, MgSO4, and water make up 92% of the total emulsion which reads on a content of at least 70% with respect to the total composition as instantly claimed. Example 10 comprises no modified polysaccharide as instantly claimed.
Recardo further teaches wherein the polyglycerol ester must have an HLB of 2 to 7, preferably from 2 to 5.5 (p. 3, lines 5-11; p. 4, lines 27-29).
Regarding claims 3 and 4: The aqueous phase in Example 10 can be characterized as comprising the glycerin, the MgSO4, and the water, which totals to 92% of the total emulsion. Such an amount falls within the range of claim 4 (i.e., 74-95%). The oily phase can be characterized as the emulsifier composition and the squalane, which totals to 8% of the total emulsion. Thus, the ratio of the aqueous phase to the oily phase is 92/8 which falls within the range of claim 3 (i.e., 70/30-95/5).
Regarding claims 13 and 14: Example 10 teaches squalane, a C30 alkane, as an oil component which reads on the instantly claimed and elected oil.
Regarding claim 15: Recardo teaches that high internal phase emulsions (HIPEs) are particularly suitable for use for products to be applied to the skin as they have a suitable rheometry but do not require the use of additional water thickeners as is the case in oil-in-water emulsions. Water-in-oil emulsions also usually have a low viscosity. In order to thicken water-in-oil emulsions, an oil thickener is typically required in large quantities. Suitable thickeners include wax, Bentone Gel® and fumed silica. Disadvantages of using these thickeners in sufficient quantities include making the resultant product too heavy and also too greasy. As such, one of ordinary skill in the art would have been led to not include thickeners in the composition. The composition of Example 10 comprises no components which are explicitly defined as a thickener or gelling agent (i.e., wax, Bentone Gel® and fumed silica as taught by Recardo).
Regarding claim 16: As discussed above the aqueous phase comprises glycerin at 5% which reads on a polyol within the instantly claimed range (i.e., 0.5-20%).
Regarding claim 18: The composition of Example 10 comprises magnesium sulfate (MgSO4) at 1% thereby reading on a salt at an amount that falls within the instantly claimed range (i.e., 0.2-2%).
Regarding claim 21: As discussed above, Example 10 teaches an oily phase comprising a polyglycerol ester emulsifier (i.e., polyglyceryl-3 dioleate) and at least one non-silicone oil with the claimed density (i.e., squalane and isopropyl palmitate).
The teachings of Recardo differ from that of the instant invention in that Recardo does not explicitly teach at least two emulsifiers chosen from esters of C8-C30 fatty acid and of polyglycerol as recited in claims 1 and 21. Likewise, Recardo also fails to explicitly teach the ratio of the at least two polyglycerol ester emulsifiers to the oil as defined in claims 1-2 and 21, a total content of the at least two polyglycerol ester emulsifiers as defined in claim 5, their structure as defined in claims 6-8 and 10, and the ratio of the two emulsifiers to one another as defined in claim 9. Recardo also fails to explicitly teach a specific embodiment comprising the cosmetic adjuvant or active principle of claims 17 and 20.
Leuridan teaches a water-in-oil emulsion comprising an aqueous phase emulsified in a fatty phase, comprising one or more volatile linear alkane(s), especially C7-C14 alkane(s), a non-silicone polyglycerolated surfactant and a polar wax (abstract). The non-silicone polyglycerolated surfactant is selected from polyglyceryl-4 isostearate, polyglyceryl-3 diisostearate and a mixture thereof. Specifically, Example 1 of Leuridan teaches a composition with a fatty phase comprising 2.04% by weight of polyglyceryl-4 isostearate (Isolan GI 34), 2.04% of polyglyceryl-3 diisostearate (Lameform TGI), and 16% of a mixture of n-undecane and n-tridecane, in which the majority compound in the mixture is n-undecane (p. 33-34, example 1). The emulsifier system of Example 1 therefore reads on at least two emulsifiers chosen from esters of C8-C30 fatty acid and of polyglycerol as defined in claims 1 and 21. The polyglyceryl-4 isostearate and polyglyceryl-3 diisostearate further read on the instantly elected emulsifiers of claim 10 and also those defined by claims 6-8. The HLB of polyglyceryl-4 isostearate (i.e., Isolan GI 34) is approximately 5 as evidenced by Evonik and the HLB of polyglyceryl-3 diisostearate (i.e., Lameform TGI) is approximately 4 as evidenced by Azelis.
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 provide the composition of Recardo with the two polyglycerol ester emulsifiers of Leuridan since such an emulsifier system is known and routine in the art as taught by Leuridan. It would have been prima facie obvious to replace the polyglyceryl ester emulsifier of Recardo (i.e., polyglyceryl-3 dioleate) with the dual emulsifier system of Leuridan (i.e., polyglyceryl-4 isostearate and polyglyceryl-3 diisostearate) since this is a simple substitution of one known element (i.e., esters of C8-C30 fatty acid and polyglycerol emulsifiers) for another to obtain predictable results. See MPEP 2143. The polyglyceryl-4 isostearate and polyglyceryl-3 diisostearate emulsifiers read on the at least two emulsifiers of claims 1 and 21, and as further defined by Applicant’s species election and claims 6-8 and 10.
One of ordinary skill in the art would have had a reasonable expectation of success and predictability since Recardo requires polyglycerol esters with an HLB from 2 to 7, and the polyglycerols of Leuridan have HLB values within this range (i.e., polyglyceryl-4 isostearate HLB ~ 5; polyglyceryl-3 diisostearate HLB ~ 4).
Regarding the ratio of the two polyglycerol ester emulsifiers to oil as defined in claims 1-2 and 21, Example 10 of Recardo comprises 1.25% of the polyglycerol ester emulsifier and a total amount of non-silicone oil (i.e., squalane and isopropyl palmitate) of 6.5%. It would have been obvious when substituting the polyglyceryl-4 isostearate and polyglyceryl-3 diisostearate for the polyglyceryl-3 dioleate, as discussed above, to maintain the total amount of the polyglycerol ester emulsifier as taught by Recardo since this is a known and effective amount to include in the composition of the invention. Thus, the ratio of the two polyglycerol ester emulsifiers to the oil would be 1.25/6.5 which gives a ratio of 1/5.2 that falls within the instantly claimed range (i.e., 1/25 to 1/5).
Regarding the ratio when squalane alone is the at least one oil, as defined by Applicant’s species election and claims 13-14, one of ordinary skill in the art would have been motivated to adjust the ratio of the polyglycerol esters to the squalane by increasing the amount of squalane in the combined composition as needed in order to provide the most stable emulsion. Recardo teaches a starting point from which the ratio could have been easily optimized until desired stability is achieved. The optimization of a result effective parameter such as stability is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B). As a result, one of ordinary skill in the art would have arrived to the instantly claimed ratio through no more than routine optimization.
As discussed above, it would have been obvious when substituting the polyglycerol ester emulsifier, to maintain the total amount of the polyglycerol ester emulsifier as taught by Recardo (i.e., 1.25%) since this is a known and effective amount to include in the composition of the invention. Such an amount falls within the instantly claimed range of claim 5 (i.e., < 5%).
Regarding claim 9, Leuridan teaches an emulsifier system of polyglyceryl-4 isostearate and polyglyceryl-3 diisostearate wherein both are present at equal amounts to give a 1:1 ratio by weight. It would have been obvious to maintain this ratio when using the emulsifiers of Leuridan in the emulsion of Lorant since it is a known and effective ratio to incorporate polyglyceryl-4 isostearate and polyglyceryl-3 diisostearate together in a water-in-oil emulsion. Additionally, one of ordinary skill in the art would have been motivated to adjust this ratio in the combined composition as needed in order to provide the desired HLB for giving the most stable emulsion. Leuridan teaches a starting point from which the ratio could have been easily optimized until desired stability is achieved. The optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B). As a result, one of ordinary skill in the art would have arrived to the instantly claimed ratio through no more than routine optimization.
Regarding claims 17 and 20: Recardo teaches that pigments, fragrances, dyes and/or pharmaceutical actives may be incorporated into the emulsion (abstract; p. 9, lines 1-2). The emulsion can additionally contain a preservative as well (p. 9, lines 3-8). While not explicitly included in the composition of Example 10, it would have been prima facie obvious to one of ordinary skill in the art to incorporate a preservative, fragrance, pigment, dye, or active into the composition to yield the instantly claimed invention since such ingredients are known and routine in the emulsions of Recardo. One of ordinary skill in the art would have been motivated to add any of these components into the composition of Example 10 in order to increase consumer appeal (i.e., by adding a fragrance, pigment, or dye) and/or storage stability (i.e., by adding a preservative) and/or to treat a specific condition (i.e., by adding an active). One of ordinary skill in the art could have combined these prior art elements according to known methods, which are taught by Recardo, in order to predictably yield the instant invention. There would have been a reasonable expectation of success since Recardo encourages the use of such ingredients in the emulsion of the invention.
As such, the prior art teaches all the components of the composition as claimed with amounts and ratios within the instantly claimed ranges. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Claims 1-10 and 13-21 are rejected under 35 U.S.C. 103 as being unpatentable over Recardo and Leuridan as applied to claims 1-10, 13-18, and 20-21 above, and further in view of Lorant, R., (WO 2009080657 A1, 07/02/2009, on record), hereinafter Lorant and Beauty South Africa, Skincare basics: Salicylic Acid (05/22/2019, on record), hereinafter Skincare basics.
The combined teaching of Recardo and Leuridan are discussed above.
As discussed above, Recardo teaches that pharmaceutical actives may be incorporated into the emulsion (abstract; p. 9, lines 1-2).
The combined teachings of Recardo and Leuridan differ from that of the instantly claimed invention in that neither explicitly teach the actives and amount of claim 19.
Lorant teaches a composition in the form of a water-in-oil emulsion comprising an aqueous phase dispersed in an oily phase and containing: a) at least one fatty acid ester of a polyol (abstract). The aqueous phase preferably represents from 70% to 85% by weight relative to the total weight of the composition (p. 19, lines 3-6). The composition of Lorant advantageously contains at least one cosmetic or dermatological active agent ranging from 0.1% to 1% by weight, relative to the total weight of the composition. Examples of active agents include salicylic acids and its derivatives (p. 27, lines 25-37).
Skincare basics teaches that salicylic acid is known for its amazing anti-inflammatory properties and exfoliating abilities (p. 2). Cosmetic products comprising salicylic acid include spot treatments, daily washes, moisturizers, emulsions, cleansing bars, lotions, and sheet masks (p. 4-5).
It would have been prima facie obvious to one of ordinary skill in the art to incorporate 0.1 to 1% by weight of salicylic acid as taught by Lorant and Skincare basics, into the combined composition of Recardo and Leuridan since this is a known and effective amount of an active agent to incorporate into high internal phase W/O emulsions as taught by Lorant. One of ordinary skill in the art would have been motivated to choose an active ingredient such as salicylic acid since it is a widely known for its beneficial properties and use in cosmetic and dermatological products as taught by Skincare basics. There would have been a reasonable expectation of success in incorporating 0.1 to 1% by weight of salicylic acid since the incorporation of active agents into a cosmetic or dermatological composition is routine in the art of formulation and Lorant teaches this amount and this active as acceptable in high internal phase W/O emulsion compositions comprising polyglycerol ester emulsifiers similar to the composition of Recardo.
Response to Arguments
Applicant’s arguments with respect Lorant as the primary reference 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.
Conclusion
No claims are 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 SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex).
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616