DETAILED ACTION
Continued Examination Under 37 C.F.R. § 1.114
A request for continued examination under 37 C.F.R. § 1.114, including the fee set forth in 37 C.F.R. § 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 C.F.R. § 1.114, and the fee set forth in 37 C.F.R. § 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 C.F.R. § 1.114. Applicant’s submission filed on October 03, 2025 has been entered.
Status of Claims
The amendments, and arguments, filed October 03, 2025, are acknowledged and have been fully considered. Claims 1-5, 7-28, 31-32 and 34-36 are pending and currently under consideration. Claim 1 has been amended; and claims 29-30 have been cancelled; and claims 6 and 33 were previously cancelled. 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 Office Action: Final
Withdrawn Claim Rejections
The rejection of claims 1-5, 7-10, 17-18, 23-30 and 34 under 35 U.S.C. § 103 over DOERR (US 2011/0015279 A1), in view of ALBRECHT (US 2018/0071190 A1) and GAN (US 2015/0147357 A1) (at par. 6-30 of the 06/03/2025 Office action), is withdrawn in light of applicant’s 10/03/2025 amendments (in particular, the amendment to independent claim 1 reciting “tocopherol, wherein said composition comprises from 0.00005 to 0.005 % w/w tocopherol”), in favor of the new rejections, discussed below. Applicant’s 10/03/2025 arguments are acknowledged, but are moot in light of the new rejections presented herein.
The rejection of claims 11-12 and 21-22 under 35 U.S.C. § 103 over DOERR, in view of ALBRECHT and GAN, and further in view KAHLE (EP 3 554 465 B1) (at par. 31-35 of the 06/03/2025 Office action), is withdrawn in light of applicant’s 10/03/2025 amendments, in favor of the new rejections, discussed below.
The rejection of claims 13-14 under 35 U.S.C. § 103 over DOERR, in view of ALBRECHT and GAN, and further in view ILNYTSKA (J. Drugs Dermatol., 15 (June 2016) pp. 684-690) (at par. 36-40 of the 06/03/2025 Office action), is withdrawn in light of applicant’s 10/03/2025 amendments, in favor of the new rejections, discussed below.
The rejection of claims 15-16, 19-20 and 31-32 under 35 U.S.C. § 103 over DOERR, in view of ALBRECHT and GAN, and further in view HAHN (US 2003/0031727 A1) (at par. 41-45 of the 06/03/2025 Office action), is withdrawn in light of applicant’s 10/03/2025 amendments, in favor of the new rejections, discussed below.
Claim Rejections – 35 U.S.C. § 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. § 103(a) 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 C.F.R. § 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 1-5, 7-10, 17-18, 23-28 and 34-35 are rejected under 35 U.S.C. § 103 as being unpatentable over DOERR (US 2011/0015279 A1, Publ. Jan. 20, 2011; on 06/16/2022 IDS; hereinafter, “Doerr”; of record), in view of ALBRECHT (US 2018/0071190 A1, Publ. Mar. 15, 2018; hereinafter, “Albrecht”; of record), GAN (US 2015/0147357 A1, Publ. May 28, 2015; hereinafter, “Gan”) and DREHER (US 2013/0017286 A1, Publ. Jan. 17, 2013).
Doerr is directed to:
Skin care composition
Abstract
The invention relates to skin care compositions containing special polyurethanes for application to the skin. The invention also relates to the use of said polyurethanes for producing skin care products.
Doerr, title & abstract. In this regard, Doerr exemplifies an O/W emulsion:
APPLICATION EXAMPLES
[0251] The quantitative data in the tables below are% by weight based on the total amount of the compositions.
PNG
media_image1.png
200
400
media_image1.png
Greyscale
PNG
media_image2.png
200
400
media_image2.png
Greyscale
Doerr, par. [0251], Ex.’s 1-10.
Regarding independent claim 1 and the requirements:
1. A skin care composition comprising:
distearyldimonium chloride,
dicaprylyl ether,
oleyl erucate,
Glycine soya oil,
a Calendula officinalis extract, wherein said composition comprises from about 0.00125 to about 0.125 % w/w C. officinalis extract,
hydrogenated cottonseed oil,
tocopherol, wherein said composition comprises from 0.00005 to 0.005 % w/w tocopherol, and
glycerin.
Doerr clearly teaches an exemplary O/W emulsion (Doerr, par. [0251], O/W emulsion, Ex. 10), whereby it is noted:
1.0 wt.% “Distearyldimmonium chloride” (Doerr, par. [0251], O/W emulsion, Ex. 10) is “distearyldimonium chloride” of claims 1-2;
1.0 wt.% “Dicaprylyl ether” (Doerr, par. [0251], O/W emulsion, Ex. 10) is “dicaprylyl ether” of claims 1 and 3; and
5.0 wt.% “Glycerol” (Doerr, par. [0251], O/W emulsion, Ex. 10) is “glycerin” of claims 1 and 8.
However, it is noted that:
(i) although Doerr teaches the incorporation of oils:
[0163] Oils can be used in W/O, W/Si and O/W emulsions.
[0164] If present, the fatty phase of the composition according to the invention can comprise one non-volatile oil and/or volatile oils and waxes. The O/W composition comprises advantageously 0.01 to 45% by weight of oils, based on the total weight of the composition, and particularly advantageously 0.01 to 20% by weight of oils. The W/O or W/Si composition advantageously comprises at least 20% by weight of oils, based on the total weight of the composition.
[0165] The non-volatile oil is advantageously selected from the group of mineral, animal, vegetable or synthetic origin, polar or nonpolar oils and mixtures thereof.
[...]
[0167] The polar oils are advantageously selected from the group:
a) esters of saturated and/or unsaturated, branched and/or unbranched alkanecarboxylic acids of chain length from 3 to 30 carbon atoms and saturated and/or unsaturated, branched and/or unbranched alcohols of chain length from 3 to 30 carbon atoms,b) esters of aromatic carboxylic acids and saturated and/or unsaturated, branched and/or unbranched alcohols of chain length from 3 to 30 carbon atoms.
[0168] Such ester oils can then advantageously be selected from the group: [...], oleyl erucate, [...].
[...].
e) of dialkyl ethers and dialkyl carbonates, e.g. dicaprylyl ether (Cetiol® OE from Cognis) and/or dicaprylyl carbonate (for example Cetiol® CC from Cognis) are advantageous
(Doerr, par. [0163]-[0165] & [0167]-[0168]), wherein it is noted that “oleyl erucate” (Doerr, par. [0168]) is “oleyl erucate” of claims 1 and 4, Doerr DOES NOT EXPRESSLY TEACH a single exemplary embodiment containing “oleyl erucate” with the other components of claim 1;
(ii) although Doerr teaches the incorporation of additives such as humectants:
[0196] The composition according to the invention for the preparation of the skincare products can additionally comprise additives which are customary in cosmetics, such as antioxidants, photoprotective agents and/or other auxiliaries and additives, such as, for example, emulsifiers, interfaceactive substances, antifoams, thickeners, surfactants, active ingredients, humectants, filler, UV filters, film formers, solvents, coalescing agents, aroma substances, odour absorbers, perfumes, gel formers and/or other polymer dispersions, such as, for example, dispersions based on polyacrylates, pigments, dyes, flow agents and/or thixotropic agents, suppleness agents, softeners, preservatives. The amounts of the various additives are known to the person skilled in the art for the range to be used and are, for example, in the range from 0 to 25% by weight, based on the total weight of the composition.
[...]
[0229] The skincare compositions according to the invention can furthermore comprise humectants.
[0230] Particularly advantageous humectants or moisturizers within the context of the present invention are, for example, glycerol, polyglycerol, sorbitol, dimethyl isosorbide, lactic acid and/or lactates, in particular sodium lactate, butylene glycol, propylene glycol, biosaccaride gum-1, glycine soya, hydroxyethylurea, ethylhexyloxyglycerol, pyrrolidonecarboxylic acid and urea. In addition, it is especially advantageous to use polymeric "moisturizers" from the group of water-soluble and/or water-swellable and/or water-gellable polysaccharides. For example, hyaluronic acid, chitosan and/or a fucose-rich polysaccharide, which is available under the name Fucogel™ 1000 from SOLABIA S.A., are especially advantageous.
(Doerr, par. [0196] & [0229]-[0230]), wherein “glycine soya” (Doerr, par. [0230]) is noted as “Glycine soya oil” of claims 1 and 5, Doerr DOES NOT EXPRESSLY TEACH a single exemplary embodiment containing “Glycine soya oil” with the other components of claim 1;
(iii) Doerr DOES NOT TEACH:
“Calendula officinalis extract” as required by claims 1 and 5, or
“hydrogenated cottonseed oil” as required by claims 1 and 6; OR
(iv) Doerr DOES NOT TEACH “tocopherol, wherein said composition comprises from 0.00005 to 0.005 % w/w tocopherol” as required by claim 1.
Based on the state of the art, an artisan of ordinary skill would have found each of these features obvious.
Regarding (i) and (ii), it is noted that a reference is analyzed using its broadest teachings. MPEP § 2123 [R-5] states: “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to rearrange Doerr’s exemplary O/W emulsion (Doerr, par. [0251], O/W emulsion, Ex. 10) by incorporating (i) “dicaprylyl ether (Cetiol® OE from Cognis)” (Doerr, par. [0168]) and “oleyl erucate” (Doerr, par. [0168]), as well as (ii) “glycine soya” (Doerr, par. [0230]), per Doerr’s broader disclosure.
Therefore, Doerr renders (i) and (ii) obvious.
With respect to (iii), Albrecht, for instance, is directed to:
COSMETIC PRODUCT AND CONCENTRATE FOR PRODUCING THE COSMETIC PRODUCT
ABSTRACT
A cosmetic product is described which in addition to water, contains at least one hydrogenated phospholipid in a concentration of at least 0.7% by weight, at least one divalent and/or trivalent alcohol, and at least one wax. In the cosmetic product, the weight ratio of hydrogenated phospholipid to the wax varies between 1:0.3 and 1:1.5, more preferably between 1 :0.7 and 1: 1, wherein the hydrogenated phospholipid is at least partially present in an ortho-rhombic lamellar crystalline structure and the wax is incorporated in the ortho-rhombic lamellar crystalline structure and/or is attached to the ortho-rhombic lamellar crystalline structure.
Albrecht, title & abstract. In this regard, Albrecht teaches the incorporation of suitable “skin-care active substances,” inter alia, “hydrogenated cottonseed oil”:
[0025] The preferred skin-care active ingredients which are optionally present individually or as a mixture in the cosmetic product according to the invention are in particular [...], hydrogenated cottonseed oil, [...].
[0026] Depending on the respective active substance and the intended use, the preferred concentration of the skin-care active substances listed above varies between 0.005% by weight and 40% by weight.
(Albrecht, par. [0025]-[0026]), and “softening active ingredients,” inter alia, “calendula officinalis extract”:
[0028] The group of softening active ingredients includes in particular [...], calendula officinalis extract, [...]. The preferred concentration of these softening active ingredients is between 0.5% by weight and 40% by weight.
(Albrecht, par. [0028]). With further regard to the use of “Calendula officinalis extract” in skin-treating compositions, Gan, for instance, is directed to:
COMPOSITIONS FOR SENSITIVE SKIN
ABSTRACT
Disclosed are compositions and methods for their use that include a combination of hydrolyzed algin, escin, Ruscus aculeatus root extract, ammonium glycyrrhizate, Centella asiatica extract, hydrolyzed yeast protein, and Calendula ojficinalis flower extract.
Gan, title & abstract. In this regard, Gan discloses that “Calendula officinalis flower extract can be used as an anti-oxidant on skin in need of an anti-oxidant,” and suitable amounts thereof, “0.0001 % to 1 % w/w of Calendula officinalis flower extract.” Gan, par. [0007].
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to formulate Doerr’s O/W emulsion (Doerr, par. [0251], O/W emulsion, Ex. 10), rearranged as discussed above for (i) and (ii), and to have further incorporated “calendula officinalis extract” and “hydrogenated cottonseed oil” per Albrecht and Gan (Albrecht, par. [0025] & [0028]; Gan, par. [0007]). One would have been motivated to do so with a reasonable expectation of success since both Doerr and Albrecht are concerned with similar problems in the art, namely formulations for the skin. Doer, abstract; Albrecht, par. [0003]. Further, it is well within the skill of the ordinary artisan to select suitable active ingredients, “which are customary in cosmetics” (Doerr, par. [0196]), and in suitable amounts for sensitive skin (Gan, title & abstract). Doing so amounts to no more than combining prior art elements according to known methods to yield predictable results, namely the formulation of Doerr’s O/W emulsion (Doerr, par. [0251], O/W emulsion, Ex. 10) with:
“hydrogenated cottonseed oil” in order to obtain the advantage of a known “skin-care active ingredients” (Albrecht, par. [0025]); and
“calendula officinalis extract” in order to obtain the advantage of known “softening active ingredients” (Albrecht, par. [0028]) and “anti-oxidant” in suitable amounts ranging from “0.0001 % to 1 % w/w of Calendula officinalis flower extract” (Gan, par. [0007]) for sensitive skin (Gan, title); see MPEP § 2144.05 (I) regarding the obviousness of prior art overlapping claimed numerical ranges.
Therefore, the prior art renders (iii) obvious.
Regarding (iv), Albrecht, for instance, teaches:
[0016] Furthermore, another embodiment of the cosmetic product according to the invention provides for the extension of the storage stability and for the prevention of undesirable oxidation in that the cosmetic product according to the invention here has at least one antioxidant. Preferably, this antioxidant is selected from the group consisting of tocopherols, [...]. Depending on the particular antioxidant, the concentration thereof preferably varies between 0.01 % by weight and 10% by weight, based on the ready-for-use cosmetic product.
Albrecht, par. [0016]. With regard to suitable amounts of antioxidant in a composition for the skin, Gan teaches the incorporation of an antioxidant “additional ingredient,” wherein “[t]he amounts of such ingredients can range from 0.0001% to 99.9% by weight. Gan, par. [0013]. With particular regard to tocopherol, Dreher is directed to:
POMEGRANATE BASED SKIN PROTECTANT AND TOPICAL APPLICATION
ABSTRACT
A cosmetic composition is provided having ingredients that may prevent signs or conditions of aging and/or damage in skin, improve the aesthetic appearance of skin, and promote recovery from environmental stresses. The composition includes natural ingredients, including pomegranate juice concentrate; pomegranate extract; pomegranate seed oil; and at least one pharmaceutically or cosmetically acceptable vehicle.
(Dreher, title & abstract), and teaches the incorporation of “[a]n antioxidant mixture such as tertbutylhydroxyquinone (TBHQ) at 50-200 ppm, tocopherols at 50-200 ppm and/or ascorbyl palmitate at 50-200 ppm is generally helpful” for “deodorizing”:
[0133] The stabilized pomegranate seed oil goes through a deodorizing step to remove unpleasant qualities of pomegranate seed oil such as its offensive odor when extracted in raw form. The elimination or prevention of offensive odor of pomegranate seed oil is referred to as deodorizing. Deodorizing is generally carried out by placing seed oil under vacuum pressure ( e.g., 18-28 mm Hg) and heating the seed oil to a set temperature (e.g., 180-210° C.) for a set time such as 30-120 minutes and sparging using steam or nitrogen gas. The deodorizing step also involves cooling the seed oil to 40-90° C. and coarse filtering. An antioxidant mixture such as tertbutylhydroxyquinone (TBHQ) at 50-200 ppm, tocopherols at 50-200 ppm and/or ascorbyl palmitate at 50-200 ppm is generally helpful. Other quantities of tocopherol, TBHQ and ascorbyl palminate are however also within the scope and spirit of making the PSO. The elimination or prevention of offensive odor of pomegranate seed oil may be carried out by heating the oil using a heating apparatus and vacuum to a target temperature range below 210° C. The deodorization may occur by taking bleached pomegranate seed oil under
(Dreher, par. [0133]), wherein tocopherols at 50-200 ppm are in an amount of about 0.005 wt.% to 0.02 wt.%.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to formulate Doerr’s O/W emulsion (Doerr, par. [0251], O/W emulsion, Ex. 10), rearranged as discussed above for (i), (ii), and (iii), and to have further incorporated “tocopherols” as an antioxidant per Gan, Albrecht and Dreher (Gan, par. [0013]; Albrecht, par. [0016]; Dreher, par. [0133]). One would have been motivated to do so in order to obtain the advantage of “provid[ing] for the extension of the storage stability and for the prevention of undesirable oxidation in that the cosmetic product” (Albrecht, par. [0016]), for example, “deodorizing” a composition containing a natural extract (Dreher, par. [0133]). Doing so amounts to no more than combining prior art elements according to known methods to yield predictable results, namely the incorporation of an antioxidant at levels known the the art, e.g., “between 0.01 % by weight and 10% by weight” (Albrecht, par. [0016]), or even as low as “from 0.0001% to 99.9% by weight” (Gan, par. [0013]) or “50-200 ppm” (Dreher, par. [0133]). See MPEP § 2144.05 (I) regarding the obviousness of prior art overlapping claimed numerical ranges, absent evidence of the criticality of the claimed range.
Therefore, the prior art renders (iv) obvious.
Thus, the prior art renders claim 1 obvious.
Regarding claims 2-5 and 7-8 and the requirements:
2. The skin care composition of claim 1, wherein said composition comprises from about 0.05 to about 50% w/w distearyldimonium chloride.
3. The skin care composition of claim 1, wherein said composition comprises from about 0.15 to about 15% w/w dicaprylyl ether.
4. The skin care composition of claim 1, wherein said composition comprises from about 0.15 to about 15% w/w oleyl erucate.
5. The skin care composition of claim 1, wherein said composition comprises from about 0.5 to about 50% w/w G. soya oil.
[…]
7. The skin care composition of claim 1, wherein said composition comprises from about 0.075 to 7.5% w/w hydrogenated cottonseed oil.
8. The skin care composition of claim 1, wherein said composition comprises from about 1 to about 50% w/w glycerin.
it is noted that MPEP § 2144.05 (I), states, “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).” Since it would be obvious to formulate Doerr’s O/W emulsion (Doerr, par. [0251], O/W emulsion, Ex. 10), rearranged as discussed above for (i) and (ii), (iii) and (iv), to have further incorporated “calendula officinalis extract” and “hydrogenated cottonseed oil” per Albrecht (Albrecht, par. [0025] & [0028]), one would have been motivated to arrive at a compositing containing:
1.0 wt.% “Distearyldimmonium chloride” (Doerr, par. [0251], O/W emulsion, Ex. 10);
1.0 wt.% “Dicaprylyl ether” (Doerr, par. [0251], O/W emulsion, Ex. 10);
“[t]he O/W composition comprises advantageously 0.01 to 45% by weight of oils, based on the total weight of the composition, and particularly advantageously 0.01 to 20% by weight of oils” (Doerr, par. [0164]) such as “oleyl erucate” (Doerr, par. [0168]);
humectants such as “glycine soya” (Doerr, par. [0230]), wherein “[t]he composition according to the invention for the preparation of the skincare products can additionally comprise additives which are customary in cosmetics, [...], humectants,” wherein “[t]he amounts of the various additives are known to the person skilled in the art for the range to be used and are, for example, in the range from 0 to 25% by weight, based on the total weight of the composition” (Doerr, par. [0196]);
“softening active ingredients” such as “calendula officinalis extract,” wherein “[t]he preferred concentration of these softening active ingredients is between 0.5% by weight and 40% by weight” (Albrecht, par. [0028]);
“hydrogenated cottonseed oil” (Albrecht, par. [0025]), wherein “the preferred concentration of the skin-care active substances listed above varies between 0.005% by weight and 40% by weight” (Albrecht, par. [0025]); AND
5.0 wt.% “Glycerol” (Doerr, par. [0251], O/W emulsion, Ex. 10).
Thus, the prior art render claims 2-5 and 7-8 obvious.
Regarding claims 9-10 and the requirements:
9. The skin care composition of claim 1, further comprising cetyl alcohol.
10. The skin care composition of claim 9, wherein said composition comprises from about 0.3 to about 30% w/w cetyl alcohol.
Doerr clearly teaches an exemplary O/W emulsion contiaing 2.5 wt.% “Cetyl alcohol.” Doerr, par. [0251], O/W emulsion, Ex. 10. See MPEP § 2144.05 (I) regarding the obviousness of prior art overlapping claimed numerical ranges.
Thus, the prior art render claims 9-10 obvious.
Regarding claims 17-18 and the requirements:
17. The skin care composition of claim 1, further comprising jojoba esters.
18. The skin care composition of claim 17, wherein said composition comprises from about 0.035 to about 3.5% w/w jojoba esters.
Doerr teaches that “[t]he O/W composition comprises advantageously 0.01 to 45% by weight of oils, based on the total weight of the composition, and particularly advantageously 0.01 to 20% by weight of oils” (Doerr, par. [0164]), inter alia, “ester oils such as “jojba oil” (Doerr, par. [0168]). See MPEP § 2144.05 (I) regarding the obviousness of prior art overlapping claimed numerical ranges.
Thus, the prior art render claims 17-18 obvious.
Regarding claims 23-24 and the requirements:
23. The skin care composition of claim 1, further comprising potassium sorbate.
24. The skin care composition of claim 23, wherein said composition comprises from about 0.008 to about 0.8% w/w potassium sorbate.
Doerr teaches the incorporation of additives such as preservatives (Doerr, par. [0196]), wherein Doerr’s Doerr’s O/W emulsion contains “Preservative” (Doerr, par. [0251], O/W emulsion, Ex. 10), e.g., 0.15 to 0.4 wt.% “Potassium sorbate” (Doerr, par. [0251], W/O emulsion, Ex.’s 3 & 5). See MPEP § 2123 [R-5] regarding the obviousness of rearranging a reference according to the teachings of that same reference; see also MPEP § 2144.05 (I) regarding the obviousness of prior art overlapping claimed numerical ranges.
Thus, the prior art render claims 23-24 obvious.
Regarding claims 25-26 and the requirements:
25. The skin care composition of claim 1, further comprising trisodium ethylenediamine disuccinate.
26. The skin care composition of claim 25, wherein said composition comprises from about 0.005 to about 0.5% w/w trisodium ethylenediamine disuccinate.
Doerr teaches an O/W emulsion containing 1 wt.% “Trisodium EDTA” (Doerr, par. [0251], O/W emulsion, Ex.’s 3 & 8) which can be incorporated into Doerr’s O/W emulsion, Ex. 10, per Doerr’s broader disclosure. See MPEP § 2123 [R-5] regarding the obviousness of rearranging a reference according to the teachings of that same reference; see also MPEP § 2144.05 (I) regarding the obviousness of prior art overlapping claimed numerical ranges.
Thus, the prior art render claims 25-26 obvious.
Regarding claims 27-28 and the requirements:
27. The skin care composition of claim 1, further comprising sodium chloride.
28. The skin care composition of claim 27, wherein said composition comprises from about 0.005 to about 0.5% w/w sodium chloride.
Doerr teaches: “[t]he aqueous phase can also comprise stabilizers,” e.g., “sodium chloride” (Doerr, par. [0162]), e.g., 10.0 wt.% “Sodium chloride” (Doerr, par. [0251], W/O emulsion, Ex. 4) to 0.7 wt.% “Sodium chloride” (Doerr, par. [0251], W/Si emulsion, Ex. 2). See MPEP § 2123 [R-5] regarding the obviousness of rearranging a reference according to the teachings of that same reference; see also MPEP § 2144.05 (I) regarding the obviousness of prior art overlapping claimed numerical ranges.
Thus, the prior art render claims 27-28 obvious.
Regarding claim 34 and the requirements:
34. The skin care composition of claim 1, wherein said composition is formulated as a lotion or cream.
Doerr teaches: “Within the context of the present invention, the skincare compositions can advantageously be present in the following forms: cream, lotion, milk, gel, oil, balm, aqueous solution.” Doerr, par. [0124]. See MPEP § 2123 [R-5] regarding the obviousness of rearranging a reference according to the teachings of that same reference.
Thus, the prior art renders claim 34 obvious.
Regarding claim 35 and the requirements:
35. ([…]) The skin care composition of claim 1, wherein said composition comprises:
about 2.5 to about 7.5% w/w distearyldimonium chloride,
about 0.75 to about 2.25% w/w dicaprylyl ether,
about 0.75 to about 2.25% w/w oleyl erucate,
about 3 to about 9% w/w Glycine soya oil,
about 0.00125 to about 0.125 % w/w C. officinalis extract,
about 0.38 to about 1.1 % w/w hydrogenated cottonseed oil,
about 0.17 to about 0.51 % w/w jojoba esters,
0.00005 to 0.005 % w/w tocopherol, and
about 6 to about 18% w/w glycerin.
it would be obvious to formulate Doerr’s O/W emulsion (Doerr, par. [0251], O/W emulsion, Ex. 10), rearranged as discussed above for (i), (ii), (iii) and (iv), as well as claims 2-5 and 7-8 in order to arrive at a compositing containing:
1.0 wt.% “Distearyldimmonium chloride” (Doerr, par. [0251], O/W emulsion, Ex. 10);
1.0 wt.% “Dicaprylyl ether” (Doerr, par. [0251], O/W emulsion, Ex. 10) is “dicaprylyl ether” of claims 1 and 3; and
“[t]he O/W composition comprises advantageously 0.01 to 45% by weight of oils, based on the total weight of the composition, and particularly advantageously 0.01 to 20% by weight of oils” (Doerr, par. [0164]) such as “oleyl erucate” (Doerr, par. [0168]);
humectants such as “glycine soya” (Doerr, par. [0230]), wherein “[t]he composition according to the invention for the preparation of the skincare products can additionally comprise additives which are customary in cosmetics, [...], humectants,” wherein “[t]he amounts of the various additives are known to the person skilled in the art for the range to be used and are, for example, in the range from 0 to 25% by weight, based on the total weight of the composition” (Doerr, par. [0196]);
“softening active ingredients” such as “calendula officinalis extract,” wherein “[t]he preferred concentration of these softening active ingredients is between 0.5% by weight and 40% by weight” (Albrecht, par. [0028]);
“hydrogenated cottonseed oil” (Albrecht, par. [0025]), wherein “the preferred concentration of the skin-care active substances listed above varies between 0.005% by weight and 40% by weight” (Albrecht, par. [0025]);
“[t]he O/W composition comprises advantageously 0.01 to 45% by weight of oils, based on the total weight of the composition, and particularly advantageously 0.01 to 20% by weight of oils” (Doerr, par. [0164]), inter alia, “ester oils such as “jojba oil” (Doerr, par. [0168]);
“tocopherols” as an antioxidant (Gan, par. [0013]; Albrecht, par. [0016]; Dreher, par. [0133]) at levels known the the art, e.g., “between 0.01 % by weight and 10% by weight” (Albrecht, par. [0016]), or even as low as “from 0.0001% to 99.9% by weight” (Gan, par. [0013]) or “50-200 ppm” (Dreher, par. [0133]); and
5.0 wt.% “Glycerol” (Doerr, par. [0251], O/W emulsion, Ex. 10).
See MPEP § 2144.05 (I) regarding the obviousness of prior art overlapping claimed numerical ranges, absent evidence of the criticality of the claimed ranges.
Thus, the prior art renders claim 35 obvious.
Claims 11-12 and 21-22 are rejected under 35 U.S.C. § 103 as being unpatentable over DOERR (US 2011/0015279 A1, Publ. Jan. 20, 2011; on 06/16/2022 IDS; hereinafter, “Doerr”; of record), in view of ALBRECHT (US 2018/0071190 A1, Publ. Mar. 15, 2018; hereinafter, “Albrecht”; of record) GAN (US 2015/0147357 A1, Publ. May 28, 2015; hereinafter, “Gan”) and DREHER (US 2013/0017286 A1, Publ. Jan. 17, 2013), as applied to claims 1-5, 7-10, 17-18, 23-28 and 34-35, above, and further in view of KAHLE (EP 3 554 465 B1, Publ. Oct. 23, 2019; hereinafter, “Kahle”; of record).
The teachings of Doerr and Albrecht, as set forth above are hereby incorporated. However, the references DO NOT TEACH:
“polyglyceryl-6 distearate,” and amounts thereof, of claims 11-12:
11. The skin care composition of claim 1, further comprising polyglyceryl-6 distearate.
12. The skin care composition of claim 11, wherein said composition comprises from about 0.1 to about 10% w/w polyglyceryl-6 distearate.
And “polyglyceryl-3 beeswax,” and amounts thereof, of claims 21-22:
21. The skin care composition of claim 1, further comprising polyglyceryl-3 beeswax.
22. The skin care composition of claim 21, wherein said composition comprises from about 0.014 to about 1.4% w/w polyglyceryl-3 beeswax.
Based on the state of the art, an artisan of ordinary skill would have found each of these features obvious.
Kahle, for instance, is directed to:
COSMETIC PREPARATION IN GEL FORM
[0001] The present invention relates to a cosmetic composition to be applied to the eye area in the form of a gelatinous emulsion and to the production and use thereof.
[0002] Cosmetic preparations for making up the skin or the semi-mucous membranes are commonly known in the form of makeup pencils, as soft pastes, or in the form of loose or pressed powders. Makeup pencils or pastes often come in an anhydrous form as mixtures of vegetable, animal, or synthetic oils, fats, and waxes in which a powder phase of pigments, pearlescing agents, and fillers approved for cosmetics is dispersed. Pressed powders often consist of mixtures of pigments, pearlescing agents, and fillers with an oil- or emulsion-based binder that is added to make them easier to handle and process. There are cosmetic preparations in the form of an emulsion for various applications and in many variations from liquid to solid.
[...]
[0013] The object of the invention is therefore to provide a liquid preparation that is smudge-, water-, and oil-resistant, as well as easy and comfortable to apply.
[0014] Furthermore, it was an object of the present invention to provide a preparation that is easy and comfortable to use in sensitive areas such as around the eye and that remains water-, oil-, and smudge-resistant, and durable after application, that does not burn or irritate the eyes, that dries quickly, and that produces strong, lasting coloring. In addition, the applied mass should also be easy to remove again.
Kahle, title & par. [0001]-[0002] & [0013]-[0014]. In this regard, Kahle teaches an emulsion-based cosmetic preparation, wherein the emulsifier is “Emulium Mellifera,” or “a mixture containing polyglyceryl-6 distearate and/or polyglyceryl-3 beeswax”:
1. Emulsion-based cosmetic preparation in the form of a gel that comprises:
a) a lipid phase comprising at least one poly(acrylate-co-siloxane)-based film former in an amount of 3% to 30% by mass, and at least one solvent
b) an aqueous phase comprising at least one water-soluble or water-dispersible film former based on acrylate or polyurethane in an amount of at least 8% by mass, and an aqueous medium
c) at least one emulsifier based on polyglyceryl fatty acid ester
d) at least one pigment
wherein the dynamic viscosity of the preparation, measured without shear entry using a rheometer according to DIN 54453, is between 100 and 900 Pa·s.
2. Cosmetic composition according to Claim 1, characterized in that the emulsifier is Emulium Mellifera, polyglyceryl-10 diisostearate, polyglyceryl-5 dioleate, a mixture containing polyglyceryl-6 distearate and/or polyglyceryl-3 beeswax, or a combination thereof.
(Kahle, claims 1-2), wherein “Emulium Mellifera” is “a mixture of polyglyceryl-6 distearate, jojoba esters, polyglyceryl-3 beeswax, and cetyl alcohol, and other ingredients” (Kahle, par. [0038]), which is “polyglyceryl-6 distearate” of claims 11-12, and “polyglyceryl-3 beeswax” of claims 21-22. Further in this regard, Kahle teaches suitable amounts of emulsifier:
[0039] The mass fraction percentage of the emulsifier in the total composition of the preparation according to the present invention is 1 to 10% by mass, preferably 1.5 to 7.5% by mass, particularly preferably 2 to 5% by mass. The exact mass fraction percentage of the emulsifier depends on the chemical nature of the other components and the emulsifier used in each case. A specialist can determine the most suitable amount in each case in simple routine tests.
Kahle, par. [0039].
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to formulate Doerr’s rearranged O/W emulsion per Albrecht (as discussed above), and to have incorporated “Emulium Mellifera” per Kahle (Kahle, claim 2). One would have been motivated to do so with a reasonable expectation of success since both Doerr and Kahle are concerned with similar problems in the art, namely the formulation of compositions for the skin. Doerr, abstract; Kahle, par. [0001]-[0002]. Further, it is well within the skill of the ordinary artisan to select a suitable emulsifier. Doing so amounts to no more than combining prior art elements according to known methods to yield predictable results, namely the formulation of Doerr’s rearranged O/W emulsion per Albrecht with “Emulium Mellifera” (Kahle, claim 1) or “polyglyceryl-6 distearate” and “polyglyceryl-3 beeswax” (Kahle, par. [0038]) in amounts “1 to 10% by mass” (Kahle, par. [0039]), in order to obtain the advantage of an emulsifier suitable for compositions that are “easy and comfortable to use in sensitive areas such as around the eye and that remains water-, oil-, and smudge-resistant, and durable after application, that does not burn or irritate the eyes, that dries quickly, and that produces strong, lasting coloring” (Kahle, title & par. [0014]). See MPEP § 2144.05 (I) regarding the obviousness of prior art overlapping claimed numerical ranges.
Thus, the prior art renders claims 11-12 and 21-22 obvious.
Claims 13-14 are rejected under 35 U.S.C. § 103 as being unpatentable over DOERR (US 2011/0015279 A1, Publ. Jan. 20, 2011; on 06/16/2022 IDS; hereinafter, “Doerr”; of record), in view of ALBRECHT (US 2018/0071190 A1, Publ. Mar. 15, 2018; hereinafter, “Albrecht”; of record), GAN (US 2015/0147357 A1, Publ. May 28, 2015; hereinafter, “Gan”) and DREHER (US 2013/0017286 A1, Publ. Jan. 17, 2013), as applied to claims 1-5, 7-10, 17-18, 23-28 and 34-35, above, and further in view of ILNYTSKA (Ilnytska, O. et al., Colloidal Oatmeal (Avena Sativa) Improves Skin Barrier Through Multi-Therapy Activity, J. Drugs Dermatol., 15 (June 2016) pp. 684-690; hereinafter, “Ilnytska”; of record).
The teachings of Doerr and Albrecht, as set forth above are hereby incorporated. However, the references DO NOT TEACH “colloidal oatmeal,” and amounts thereof, as required by claims 13-14:
13. The skin care composition of claim 1, further comprising colloidal oatmeal.
14. The skin care composition of claim 13, wherein said composition comprises from about 0.1 to about 10% w/w colloidal oatmeal.
which is well within the purview of the ordinarily skilled artisan.
Ilnytska, for instance, is directed to:
Colloidal Oatmeal (Avena Sativa) Improves Skin Barrier Through Multi-Therapy Activity
ABSTRACT
Oats (Avena sativa) are a centuries-old topical treatment for a variety of skin barrier conditions, including dry skin, skin rashes, and eczema; however, few studies have investigated the actual mechanism of action for the skin barrier strengthening activity of colloidal oatmeal. Four extracts of colloidal oatmeal were prepared with various solvents and tested in vitro for skin barrier related gene expres-sion and activity. Extracts of colloidal oatmeal were found to induce the expression of genes related to epidermal differentiation, tight junctions and lipid regulation in skin, and provide pH-buffering capacity. Colloidal oatmeal boosted the expression of multiple target genes related to skin barrier, and resulted in recovery of barrier damage in an in vitro model of atopic dermatitis. In addition, an investigator-blinded study was performed with 50 healthy female subjects who exhibited bilateral moderate to severe dry skin on their lower legs. Subjects were treated with a colloidal oatmeal skin protectant lotion. Clinically, the colloidal oatmeal lotion showed significant clinical improvements in skin dryness, moisturization, and barrier. Taken together, these results demonstrate that colloidal oatmeal can provide clinically effective benefits for dry and compromised skin by strengthening skin barrier.
(Ilnytska, title & abstract), which is noted as “colloidal oatmeal” of claims 13-14.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to formulate Doerr’s rearranged O/W emulsion per Albrecht (as discussed above), and to have incorporated extracts of colloidal oatmeal per Ilytska (Ilnytska, title & abstract). One would have been motivated to do so in order to obtain the advantage of an active that “can provide clinically effective benefits for dry and compromised skin by strengthening skin barrier.” Ilnytska, abstract. With regard to amounts of “colloidal oatmeal” as an active agent, it is noted that dosage/amount of an active ingredient is a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). In this respect, Doer teaches that “[t]he composition according to the invention for the preparation of the skincare products can additionally comprise additives which are customary in cosmetics,” wherein “[t]he amounts of the various additives are known to the person skilled in the art for the range to be used and are, for example, in the range from 0 to 25% by weight, based on the total weight of the composition.” Doerr, par. [0196]. Therefore, an ordinary skilled artisan would also be motivated to manipulate and optimize the dosage depending on a patient’s weight, age, tolerance, sex, and condition being treated “in the range from 0 to 25% by weight, based on the total weight of the composition.” Doerr, par. [0196].
Thus, the prior art render claims 13-14 obvious.
Claims 15-16, 19-20 and 31-32 are rejected under 35 U.S.C. § 103 as being unpatentable over DOERR (US 2011/0015279 A1, Publ. Jan. 20, 2011; on 06/16/2022 IDS; hereinafter, “Doerr”; of record), in view of ALBRECHT (US 2018/0071190 A1, Publ. Mar. 15, 2018; hereinafter, “Albrecht”; of record), GAN (US 2015/0147357 A1, Publ. May 28, 2015; hereinafter, “Gan”) and DREHER (US 2013/0017286 A1, Publ. Jan. 17, 2013), as applied to claims 1-5, 7-10, 17-18, 23-28 and 34-35, above, and further in view of HAHN (US 2003/0031727 A1, Publ. Feb. 13, 2003; hereinafter, “Hahn”; of record).
The teachings of Doerr and Albrecht, as set forth above are hereby incorporated. Although Doerr teaches the incorporation of additives such as preservatives, wherein “[t]he amounts of the various additives are known to the person skilled in the art for the range to be used and are, for example, in the range from 0 to 25% by weight, based on the total weight of the composition” (Doerr, par. [0196]), the references, however DO NOT TEACH the requirements of:
claims 15-16 for “benzyl alcohol”:
15. The skin care composition of claim 1, further comprising benzyl alcohol.
16. The skin care composition of claim 15, wherein said composition comprises from about 0.05 to about 5% w/w benzyl alcohol.
claims 19-20 for “sodium benzoate”:
19. The skin care composition of claim 1, further comprising sodium benzoate.
20. The skin care composition of claim 19, wherein said composition comprises from about 0.016 to about 1.6% w/w sodium benzoate.
claims 31-32 for “one of more fragrances”:
31. The skin care composition of claim 1, further comprising one or more fragrance compounds.
32. The skin care composition of claim 31, wherein said composition comprises from about 0.07 to about 7% w/w of said one or more fragrance compounds.
Based on the state of the art, an artisan of ordinary skill would have found each of these features obvious.
Hahn, for instance, is directed to:
TOPICAL PRODUCT FORMULATIONS CONTAINING STRONTIUM FOR REDUCING SKIN IRRITATION
ABSTRACT
Topical formulations containing aqueous-soluble divalent strontium cation in a suitable topical formulation vehicle, and methods of using these formulations to inhibit skin irritation, are disclosed.
Hahn, title & abstract. In this regard, Hahn discloses suitable preservatives, inter alia, “benzyl alcohol” and “sodium benzoate” (Hahn, par. [0072]), which are respectively noted as “benzyl alcohol” of claims 15-16, and “sodium benzoate” of claims 19-20. Hahn also discloses “one or more fragrance compounds” of claims 31-32: “[l]otions and creams also may optionally contain moisturizers and emollients (especially in the case of skin care products), as well as fragrances, dyes/colorants, preservatives and active ingredients.” Hahn, par. [0067].
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to formulate Doerr’s rearranged O/W emulsion per Albrecht (as discussed above), and to have incorporated preservatives such as “benzyl alcohol” and “sodium benzoate,” as well as fragrances per Hahn (Hahn, par. [0067] & [0072]). One would have been motivated to do so with a reasonable expectation of success since both Doerr and Hahne are concerned with similar problems in the art, namely the formulation of compositions for the skin. Doerr, abstract; Hahn, abstract. Further, it is well within the skill of the ordinary artisan to select a suitable preservatives and additives such as fragrances in suitable amounts, wherein “[t]he amounts of the various additives are known to the person skilled in the art for the range to be used and are, for example, in the range from 0 to 25% by weight, based on the total weight of the composition” (Doerr, par. [0196]). Doing so amounts to no more than combining prior art elements according to known methods to yield predictable results. See MPEP § 2144.05 (I) regarding the obviousness of prior art overlapping claimed numerical ranges.
Thus, the prior art renders claims 15-16, 19-20 and 31-32 obvious.
Allowable Subject Matter
Claim 36 is drawn to allowable subject matter.
Summary/Conclusion
Claims 1-5, 7-28, 31-32 and 34-35 are rejected. Claim 36 is allowable.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DOMINIC LAZARO/Primary Examiner, Art Unit 1611