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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/04/2026 has been entered.
Status of Claims
Receipt of Remarks/Amendments filed on 05/04/2026 is acknowledged. Claim 22 is canceled and claim 26 is new. In accordance with the previous restriction/election requirement, claims 11-12 and 23-25 are withdrawn Claims 1-10, 13-21, and 26 are currently examined on the merits herein.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.
Claim Rejections - 35 USC § 102
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 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 –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9, 13-14, 16-18, 20-21, and 26 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Von Der Fecht et al. (US 20150011654 A1, 01/08/2015, IDS dated 01/15/2025), hereinafter Von Der Fecht, as evidenced by EWG Skin Deep. (2026). Diisostearoyl Polyglyceryl 3 Dimer Dilinoleate (PTO-892), hereinafter EWG Skin Deep, and Skin Safe. (2026). Paraffinum Liquidum (Mineral Oil) (PTO-892), hereinafter Skin Safe, and National Center for Biotechnology Information (2026). PubChem Compound Summary for CID 8907, Isopropyl Palmitate (PTO-892), hereinafter NCBI.
Von Der Fecht discloses cosmetic and/or dermatological preparations based on a water-in-oil emulsion comprising at least two W/O emulsifiers which differ in their HLB value up to a maximum of 1 lead to sensorily acceptable preparations and at the same stable W/O emulsions (abstract).
Regarding claim 1: The preparation is based on a water-in-oil emulsion comprising at least two W/O emulsifiers (claim 18). The two W/O emulsifiers comprise diisostearoyl polyglyceryl-3 dimer dilinoleate and polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate (claim 21; Examples). Both emulsifiers are esters of isostearic acid and polyglycerol, as evidenced by EWG Skin Deep and the instant specification (see paragraph [0040]). Isostearic acid reads on a C8-C30 fatty acid as evidenced in the instant specification (see paragraph [0040]). The preparation further comprises lipids which include paraffinum liquidum, isopropyl palmitate, C13-16 isoparaffin, cera microcristallina, cetyl palmitate, Vaseline and natural oils (claim 30). Example 4 specifically includes paraffinum liquidum, isopropyl palmitate, and C13-16 isoparaffin, which together read on at least one nonsilicone oil with a density relative to water of less than 0.9, as evidenced by the instant specification ([0073]; [0113]; Table 6) and Skin Safe. Together, the emulsifiers make up 2.2% by weight of the total composition and the oils having the appropriate density: paraffinum liquidum, isopropyl palmitate, and C13-16 isoparaffin, make up 17.5% by weight of the total composition (Example 4). Thus, the ratio by weight of the two emulsifiers to the at least one oil is approximately 1/8, which reads on the instantly claimed ratio (i.e., less than 1/5). Example 4 comprises 64.7% water (i.e., 100 minus every other component) and 10% glycerol, which one of ordinary skill in the art would recognize as the minimum components in the aqueous phase. Together, water and glycerol make up 74.7% by weight of the total composition which reads on an aqueous phase representing a content of at least 70% by weight of the total composition. No mention is made of the preparations comprising modified polysaccharides.
Regarding claim 2: As discussed above, the ratio by weight of the two emulsifiers (i.e., diisostearoyl polyglyceryl-3 dimer dilinoleate and polyglyceryl-4 diisostearate/polyhydroxystearate/ sebacate) to the at least one oil having the appropriate density (paraffinum liquidum, isopropyl palmitate, and C13-16 isoparaffin) in Example 4 is 1/8, which reads on the instantly claimed ratio (i.e., between 1/25 and 1/5).
Regarding claims 3 and 4: As discussed above, Example 4 specifically comprises 64.7% water and 10% glycerol, which one of ordinary skill in the art would recognize as components of the aqueous phase. Together, water and glycerol make up 74.7% by weight of the total composition (i.e., 74% to 95%) making the ratio by weight of the aqueous to oily phase 74.7/25.3 (i.e., 70/30 to 95/5).
Regarding claim 5: The preparation comprises from 2% to 2.6% by weight of W/O emulsifiers (claim 24), with Example 4 specifically comprising 2.2% by weight of the two emulsifiers ([0086]-[0087]). Both amounts fall within the instantly claimed range (i.e., less than 5%).
Regarding claim 6: The two W/O emulsifiers are diisostearoyl polyglyceryl-3 dimer dilinoleate and polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate (claim 21; Examples). Both emulsifiers are esters of isostearic acid and polyglycerol, as evidenced by EWG Skin Deep and the instant specification (see paragraph [0040]). Isostearic acid contains a C16-C20 hydrocarbon chain as evidenced in the instant specification (see paragraph [0033]).
Regarding claim 7: The two W/O emulsifiers are diisostearoyl polyglyceryl-3 dimer dilinoleate and polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate (claim 21; Examples), which comprise 3 and 4 glycerol units, respectively, as evidenced by their name.
Regarding claim 8: The two W/O emulsifiers are diisostearoyl polyglyceryl-3 dimer dilinoleate and polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate (claim 21; Examples), both of which comprise esters of isostearic acid and a polyglycerol, as evidenced by EWG Skin Deep and the instant specification (see paragraph [0040]).
Regarding claim 9: Example 4 comprises 0.8% of the polyglyceryl-4 diisostearate/ polyhydroxystearate/sebacate and 1.4% of the diisostearoyl polyglyceryl-3 dimer dilinoleate ([0117]-[0118]), meaning the ratio between the two is either 1:1.75 or 1.75:1, both of which fall within the instantly claimed range (i.e., 1:2 to 2:1).
Regarding claim 13: The isopropyl palmitate of Example 4 reads on a fatty ester of formula R1COOR2 in which R1 represents the residue of a fatty acid comprising from 8 to 30 carbon atoms and R2 represents a linear or branched hydrocarbon chain containing from 6 to 30 carbon atoms, as defined by the instant specification (See paragraph [0113]). The C13-16 isoparaffin of Example 4 read on a C8-C30 alkane as evidenced by the instant specification (See paragraph [0073]).
Regarding claim 14: Isopropyl palmitate reads on a C16-C20 fatty acid ester, as evidenced by the NCBI, while the C13-16 isoparaffin further reads on C8-C15 and C15-C28 alkanes.
Regarding claim 16: The preparation comprises a total of from 5% to 20% by weight, based on a total weight of the preparation, of at least one skin moisturizer, such as glycerol (i.e., a polyol) (claims 27-28). Specifically, Example 4 comprises 10% glycerol.
Regarding claim 17: The preparation of Example 4 further comprises perfume ([0134]), which reads on a fragrance.
Regarding claim 18: The preparation of Example 4 further comprises 0.15% of potassium sorbate, 0.7% of magnesium sulfate, and 0.2% of sodium citrate ([0096]-[0097]), which totals to 1.05% by weight of at least one salt (i.e., 0.2% to 2%).
Regarding claim 20: The preparation comprises a skin moisturizer in the form of glycerol (claims 27-28; Example 4), which reads on an active principle.
Regarding claim 21: As discussed above, the preparation comprising at least two W/O emulsifiers, specifically diisostearoyl polyglyceryl-3 dimer dilinoleate and polyglyceryl-4 diisostearate/ polyhydroxystearate/sebacate (claim 21; Examples). Both emulsifiers are esters of isostearic acid and polyglycerol, as evidenced by EWG Skin Deep and the instant specification (see paragraph [0040]). Isostearic acid reads on a C8-C30 fatty acid as evidenced in the instant specification (see paragraph [0040]). The preparation further comprises lipids which include paraffinum liquidum, isopropyl palmitate, C13-16 isoparaffin, cera microcristallina, cetyl palmitate, Vaseline and natural oils (claim 30). Example 4 specifically includes paraffinum liquidum, isopropyl palmitate, and C13-16 isoparaffin, which together read on at least one nonsilicone oil with a density relative to water of less than 0.9, as evidenced by the instant specification ([0073]; [0113]; Table 6) and Skin Safe. Together, the emulsifiers make up 2.2% by weight of the total composition and the oils having the appropriate density: paraffinum liquidum, isopropyl palmitate, and C13-16 isoparaffin, make up 17.5% by weight of the total composition (Example 4). Thus, the ratio by weight of the two emulsifiers to the at least one oil is approximately 1/8, which reads on the instantly claimed ratio (i.e., less than 1/5).
Regarding claim 26: The two W/O emulsifiers are diisostearoyl polyglyceryl-3 dimer dilinoleate and polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate (claim 21; Examples). Both emulsifiers are esters of isostearic acid and polyglycerol, as evidenced by EWG Skin Deep and the instant specification (see paragraph [0040]). Isostearic acid comprises a saturated C16-C20 hydrocarbon chain, as evidenced by the instant specification (see paragraph [0044]).
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, 20-21, and 26 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 (on record), hereinafter Evonik, and Azelis (2026). LAMEFORM® TGI (on record), 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 (i.e., an ester of a C8-C30 fatty acid and polyglycerol), sorbitan sesquioleate, and isopropyl palmitate (p. 21, lines 1-5). Squalane and isopropyl palmitate read on at least one non-silicone oil with the density as instantly claimed, as evidenced by the instant specification (Table 6). The emulsion of Example 10 further comprises glycerin, MgSO4, and water (p. 20, lines 21-27), which may be characterized as the 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. Example 10 comprises no modified polysaccharide.
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 (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 (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. The isopropyl palmitate further reads on fatty ester of formula R1COOR2 in which R1 represents the residue of a fatty acid comprising from 8 to 30 carbon atoms and R2 represents a linear or branched hydrocarbon chain containing from 6 to 30 carbon atoms, as defined by the instant specification (See paragraph [0113]), and a C16-C20 fatty acid ester.
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. 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, 10, and 26, 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 alkanes and a non-silicone polyglycerolated surfactant (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) (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 and 26, as evidenced by the instant specification (See paragraph ([0040] and [0044]). 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. Furthermore, the combination of prior art elements according to known methods (i.e., emulsification of W/O emulsions) to yield predictable results is considered prima facie obvious. The polyglyceryl-4 isostearate and polyglyceryl-3 diisostearate emulsifiers read on the at least two emulsifiers of claims 1, 6-8, 10, 21, and 26. 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 the oil as defined in claims 1-2 and 21, Example 10 of Recardo comprises 1.25% of a polyglycerol ester emulsifier and a total amount of non-silicone oil (i.e., squalane and isopropyl palmitate) of 6.5%. It would have been prima facie obvious to one of ordinary skill in the art 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). In any case, the amount of emulsifier and oil in a water-in-oil emulsion (i.e., their ratio) is directly related to the emulsion’s stability and is therefore a results effective parameter. 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 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 discussed above, it would have been prima facie 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).
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 (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, 13-21, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Recardo and Leuridan as applied to claims 1-10, 13-18, 20-21, and 26 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, prior to the effective filing date of the claimed invention, 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 argues that one of ordinary skill in the art, following Recardo, would not reasonably expect any combination of surfactants to result in a stable HIPE, let alone the specific combination set forth in the claims. Applicant argues that following Recardo, one of ordinary skill would believe that something more than mere surfactants (for example, wax) would be necessary to make the HIPE stable. Applicant asserts that Recardo does not teach or suggest that polyglyceryl esters alone or in combination, result in acceptable HIPE compositions. Specifically, Recardo teaches that acceptably stable HIPE compositions are not provided by surfactants alone, rather something else is needed to stabilize the compositions something like wax (p. 6-8 of remarks). Applicant asserts that both Recardo and Leuridan lead to the expectation of an unacceptably stable composition when only polyglyceryl ester surfactants are used and teach the need to add an additional ingredient like a wax.
In response to these arguments it is noted that the composition of claim 1 is defined by the transitional phrase "comprising", which is open claim language. Thus, instant claim 1 does not prohibit the presence of an additional stabilizer such as MgSO4, glycerin, or wax, nor additional surfactants such as sorbitan sesquioleate. Regarding claim 15 which does define the instant invention as devoid of a thickening agent (i.e., wax), the cited composition of Recardo (Example 10) does not contain a wax. In fact, Applicant cites Recardo for stating that "emulsions can be formed in the absence of MgSO4, glycerin and wax. However, the stability after a week is poor. It appears that the inclusion of the metal salt is particularly important to increasing the stability of the HIPE. Glycerin is less important for stability" and no mention is made to the criticality of wax. Recardo immediately goes on to teach inventive Example 10, as cited above, which comprises the critical MgSO4 but no wax. As such, Example 10 of Recardo does not indicate that wax is necessary. Additionally , formulation 4 in table 9 comprises no wax and has good stability at 1 week under both conditions. As such, these examples are evidence that wax is not critical and an HIPE can be formed without it. Moreover, the claim language of comprising does not prohibit salts or additional surfactants as stated above. There is no reason why one of ordinary skill in the art could not replace the polyglyceryl ester emulsifier of Recardo with the two polyglyceryl ester emulsifiers of Leuridan since these are known and routine polyglyceryl ester emulsifier systems for W/O emulsions in the art. One of ordinary skill in the art would have a reasonable expectation of success in maintaining the stability of the emulsion since Recardo teaches that polyglycerol esters having an HLB of 2 to 7 are ideal and the polyglycerols of Leuridan have HLB values within this range. More specific evidence, such as a comparative data, is necessary to overcome the prima facie case.
Conclusion
No claims allowed.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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