DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Status of the claims: Newly presented claims 59-75, 77, and 79-80 are pending.
Priority: This application is a 371 of PCT/EP2013/073586 (11/12/2013) and claims foreign priority to GERMANY 10 2012 221 227.2 (11/20/12).
Claim Construction
Exemplary independent claims 59 and 70 are to “A hydrodispersion …” which “comprises” the ingredients listed in the claim and does not exclude additional, unrecited elements. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“[L]ike the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended.”); Invitrogen Corp. v. Biocrest Manufacturing, L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) (“The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc.,793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). See also MPEP 2111.03.
The claim term “hydrodispersion” is defined in the specification as a “low-emulsifier or emulsifier-free formulations” that contain “small amounts of emulsifier (up to 2% by weight)” (Specification at page 1, lines 12-20). Hydrodispersions are also defined as a dispersion of liquid, either semisolid or solid inner lipid phase in an outer aqueous phase (Id.). Therefore, the claim term “hydrodispersion” is interpreted as a composition dispersed in an outer aqueous phase and having small amounts of emulsifier.
Claims 75-78 are to cosmetic or dermatological compositions used for skincare or eye cream. Recitations of an intended utility in the preamble of the product claim which otherwise stand alone is not considered a further limitation of the claim. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951); In re Spada, 15 USPQ.2d 1655 (Fed. Cir. 1990). Such intended uses should be properly claimed as a process or method claim. See 35 U.S.C. 100(b), 101. See also, Clinical Products v. Brenner, 255 F. Supp. 131, 149 USPQ 475, 477 (DDC 1966).
Maintained Rejections
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 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.
Claims 59-61, 63-65, 67, 68, 70, 72-75, and 79-80 are rejected under 35 U.S.C. 103 as being unpatentable over Kruse et al. (EP 1 889 596) in view of Amela et al., WO 2009/043533.
Regarding claim 59, Kruse teaches A hydrodispersion (claim 1: “Cosmetic preparation of the oil-in-water type”), wherein the hydrodispersion exhibits at least one melting range between 5 C and 30 C by DSC and comprises, based on a total mass of the dispersion:
(a) from 60 % to 95 % by weight of water (claim 1: “Cosmetic preparation of the oil-in-water type”; Table water “ad 100”),
(b) from 0.05 % to 5 % by weight of at least one thickener (The aqueous phase may contain thickeners (Xanthan Gum) [0060], See also Examples 1-3 at pages 8-9; and comprises 0.5 or 0.3 wt.% of the thickener xanthan gum, See Examples 1-3),
(c) from 2 % to 20 % by weight of one or more waxes, at least one wax having a melting point Tonset below 30°C and being selected from one or more of fats (triglycerides), mono- and diglycerides, natural and synthetic waxes, fatty alcohols, wax alcohols, fatty acids, esters of fatty alcohols and fatty acids, fatty acid amides, ([0022]: “Preferred waxes according to the invention having melting points of from 25 to 45 ° C. are those having the INCI names” hydrogenated coco-glycerides and shea butter; [0023]: “the concentration of these waxes - based on the total weight of the preparation - from the range of 1 to 10 wt.%, preferably from 2.5 to 7.5 wt.%”; Examples 1-5; Claim 7: “the wax or waxes with a melting point of 25 to 45 ° C from the group Hydrogenated Cocoglycerides, Mristyl Myristate, Myristyl Lactate, Caprylic / Capric / Isostearic / Adipic Triglyceride, Shea Butter, Stearyl Dimethicone , Hydrogenated Vegetable Oil can be chosen.”; [0022]: “Particular preference is Shea Butter, Myristyl Lactate.”), and
(d) from 1 % to 10 % by weight of one or more oils ([0019]: “the concentration of light oils - based on the total weight of the preparation - from the range of 5 to 15 wt.%, preferably from 10 to 12 wt.%”), a total concentration of the one or more waxes being higher than a total concentration of the one or more oils (claim 1, [0008]: “wherein the total amount of light oils is less than the total amount of medium heavy oils and waxes”) ;
(d) comprising at least one oil selected from esters of saturated and/or unsaturated, branched and/or unbranched alkane-carboxylic acids having a chain length of from 3 to 30 C atoms and saturated and/or unsaturated, branched and/or unbranched alcohols having a chain length of from 3 to 30 C atoms, esters of aromatic carboxylic acids and saturated and/or unsaturated, branched and/or unbranched alcohols having a chain length of from 3 to 30 C atoms, dialkyl ethers, dialkyl carbonates, petrolatum, paraffin oil, mineral oil, squalane, squalene, hydrogenated polyisobutene, isohexadecane, natural oils, vegetable oils, silicone oils ([0018]: Light oils - “Particularly preferred are cyclomethicones, isohexadecanes, dicaprylyl carbonates, dicapyrlyl ethers”; Examples 1-5; claim 5, [0020]: medium oils are preferably mineral oil).
Kruse teaches the concentration of wax as being in the range of 1 to 10 wt.%. Kruse ([0023]; claim 8). The concentration of light oil is disclosed as being in the range of 5 to 15 wt. % ([0019]). The concentration of medium oil is disclosed as being in the range of 2.5 to 20 wt. % ([0021]). If the highest concentration of wax is picked and the lowest concentrations of the oils are picked the wax would be 10% wt.% and the oils would be 7.5 wt.% (5 wt. % light oil and 2.5 wt.% medium oil). All these ranges are disclosed by Kruse, making it obvious to pick any point in the range to make a composition according to Kruse. There is reason to pick the lowest amount of light oils because Kruse discloses that when "the total amount of light oils is less than the total amount of medium-heavy oils and waxes, can solve these tasks," i.e., of a cosmetic preparation "which can in particular improve the skin's moisture and very easy to spread on the skin, quickly absorbed and thereby should be rich and nourishing." ([0007], [0008]).
With respect to the claimed "melting range between 5° C and 30° C by DSC" and melting point T onset of wax below 30° C, Kruse discloses waxes having a melting point of 25 to 45°C. [0007], [0008], [0022]). Absent evidence to the contrary, Kruse's disclosed range overlaps with the claimed range, making the claimed range prima facie obvious. See In re Peterson, 315 F.3d 1325, 1329-1330 (Fed. Cir. 2003) (when there is a range disclosed in the prior art, and the claimed range overlaps or falls within that range, there is a presumption of prima facie case obviousness (citing Titanium Metals Corp. v. Banner, 778 F.2d 775, 783 (Fed. Cir. 1985).). No evidence of criticality of the claimed ranges or unexpected results are of record. In re Geisler, 116 F.3d 1465, 1469-1470 (Fed. Cir. 1997).
With respect to the selection of was, Kruse discloses shea butter is preferred ([0022]). With respect to the amount of water, Kruse discloses “ad 100” (claim 1) which is the remaining weight percent and would be within the instant claim range. With respect to the oil, Kruse discloses cyclomethicone (a silicone oil) is preferred ([0018]). One of ordinary skill in the art would have considered the same wax, amount of water, and oil as these are disclosed by Kruse.
With respect to a cooling effect, Kruse ([0012]) teaches a hydrodispersion preparation that increases the skin moisture and the depth of moisture in the skin, and that the moisturizing effect persists for several hours or even for an entire day. Kruse ([0061]) teaches a list of water-based moisturizers, for example, glycerin, lactic acid and/or lactates. While Kruse does not explicitly disclose the exact phrase “cooling effect, it would have been obvious to a person of ordinary skill in the art (POSITA) to recognize and understand that hydration at the skin surface would produce a corresponding cooling sensation, due to the moisturizers. As evidence by Purnamawati (page 76, left col.) teaches “Water-based moisturizers provides cooling effect from water evaporation on the skin surface…” Therefore, a POSITA would expect hydrodispersion comprising water and humectants, would eventually produce a temporary cooling sensation by increasing the skin hydration. (Purnamawati S, Indrastuti N, Danarti R, Saefudin T. Clin Med Res. 2017 Dec;15(3-4):75-87).
Furthermore, one of ordinary skill in the art routinely optimizes ratios of oils and waxes in cosmetics to improve properties such as was done by Kruse – i.e. [0040]: “improve the sensory and cosmetic properties of the formulations and, for example, cause or enhance a velvety or silky feel on the skin”. In addition, Kruse teaches [0010]: “high proportions of highly viscous, fatty and only slightly spreading oils and waxes with a melting point of 25 to 45 °C would nevertheless be light on the skin and significantly reduced stickiness and in particular can be spread very easily on the skin, be absorbed quickly and still be very rich and caring.” Thus, one of skill in the art following the teaching of Kruse would have a reasonable expectation of success in arriving at the claimed invention.
Thus, claim 59 is rejected as prima facie obvious.
Regarding claim 60 and 72, Kruse does not explicitly teach olus oil.
However, Amela (page 2; page 20, Example 1 to 12) teaches meta-stable o/w emulsions (hydrodispersion), wherein phase C includes Cegesoft® PS 6 (olus oil) at 3% w/w, a well-known cosmetic triglyceride emollient derived from vegetable oil, reading on the instant claim. Therefore, it would have been obvious to a POSITA to modify Kruse’s teachings in view of Amela’s disclosure, by substituting hydrogenated vegetable oil with olus oil, because olus oil is a lighter triglyceride-based vegetable emollient known to offer a smoother, more aesthetically pleasant skin feel compared with a waxy hydrogenated vegetable oil, to arrive at the claimed invention.
Regarding claim 61, Kruse teaches mineral oil is a preferred oil and at the low end range is 2.5% which one of ordinary skill in the art would have considered through routine optimization.
Regarding claim 63, Kruse further teaches that “(b)” is xanthan gum (The aqueous phase may contain thickeners (Xanthan Gum) [0060], See also Examples 1-3 at pages 8-9; and comprises 0.5 or 0.3 wt.% of the thickener xanthan gum, See Examples 1-3).
Regarding claim 64, wherein (b) comprises sodium polyacrylate, Kruse teaches thickeners “particularly advantageous from the group of polyacrylates” and carbopols ([0060]) which include sodium polyacrylate. One of ordinary skill in the art routinely interchanges elements of a formulation among those well-known in the art to optimize desirable characteristics such as what a thickener provides. Thus, one of ordinary skill in the art would reasonably consider sodium polyacrylate and arrive at the claimed invention.
Regarding claim 65, Kruse teaches the wax is “hydrogenated vegetable oil” (claim 7).
Regarding claim 67, Kruse teaches preferred cyclic and linear silicone oils ([0018]: cyclomethicone; [0020]: dimethicone).
Regarding claim 68, Kruse teaches ad 100 water which meets the claim limitation.
Regarding independent claim 70, as with the claims rejected above, Kruse teaches the hydrodispersion including water, thickener (xanthan gum), waxes (hydrogenated vegetable oil), and oils (mineral and silicone oils).
Regarding claim 73, Kruse teaches preferred cyclic and linear silicone oils ([0018]: cyclomethicone; [0020]: dimethicone).
Regarding claim 74, wherein (b) comprises sodium polyacrylate, Kruse teaches thickeners “particularly advantageous from the group of polyacrylates” and carbopols ([0060]) which include sodium polyacrylate. One of ordinary skill in the art routinely interchanges elements of a formulation among those well-known in the art to optimize desirable characteristics such as what a thickener provides. Thus, one of ordinary skill in the art would reasonably consider sodium polyacrylate and arrive at the claimed invention.
Regarding claims 75, Kruse is entitled “cosmetic preparation” and teaches a cosmetic composition comprising the hydrodispersion as rejected above and further that the field of cosmetics includes application to skin and eye region ([0004], [0005]). Thus, one of ordinary skill in the art would have considered forming the same composition for use as a skincare cream.
Regarding claim 79, Kruse does not explicitly teach hydrodispersion comprises olus oil and candelilla wax.
However, Amela (page 20) teaches O/W emulsion (hydrodispersion) as shown in Example 1-12, where Cegesoft® PS 6 (olus oil) at 3% w/w is used as part of the oil phase. Amela (page 16, line 20-21; emphasis added) also teaches
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Therefore, Amela clearly discloses that in addition of natural oils, such as olus oil, natural waxes such as candelilla wax may be included in the same cosmetic preparation, as an example. Therefore, it would have been obvious to a POSITA to combine the teachings of Kruse and Amela to arrive at the claim invention. This indicates that Amela provides clear guidance on the use of olus oil and candelilla wax together in the same hydrodispersion, which would improve moisturizing, stabilizing and texturizing of the formulation.
Regarding claim 80, Kruse ([0022] and [0061]) teaches a hydrodispersion containing emollients such as shea butter and humectants such as glycerin. Kruse ([0060]) teaches the use of polyacrylate polymers as thickening agent, which is also supported by Amela (page 14, line 25-28). While Kruse does not explicitly disclose sodium polyacrylate, however, sodium polyacrylate is a known species within the broader class of polyacrylate-based polymers and widely used in personal-care compositions. Therefore, it would have been obvious to a POSITA to select sodium polyacrylate as a suitable polyacrylate polymer based because of its solubility and also more cost effective than other synthetic polyacrylate-based polymer such as cabopoles, to arrive at the claimed invention. Given that sodium polyacrylate is a thickening agent and functioned similarly to other polyacrylate polymer, thus selecting sodium polyacrylate would be an obvious option because of improving water retention more than a polyacrylate polymer.
Claims 62, 66, 69, 71 are rejected under 35 U.S.C. 103 as being unpatentable over Kruse et al. (EP 1 889 596) as applied to claims 59-61, 63-65, 67, 68, 70, 72-76 and 79-80 above and further in view of Heidenfelder et al. (US PG-PUB 2003/0124158).
Regarding claims 62 and 71, “wherein the hydrodispersion is free of emulsifiers”, the instant specification states “in accordance with the invention, are still regarded as being ‘free of’ emulsifiers and surfactants if the proportion thereof does not exceed 0.1% by weight, based on the total mass of the formulation” (Spec. p. 12). Kruse does not specifically teach “emulsifier free”, however Heidenfelder teaches emulsifier free oil-in-water cosmetic compositions that reduce or avoid the use of emulsifiers to avoid allergic reactions ([0017]). One of ordinary skill in the art following the teaching of Kruse would reasonably consider formulations to reduce or eliminate emulsifiers as suggested by Heidenfelder and arrive at the claimed invention.
Regarding claim 69, as with claim 62 and not containing any surfactants, Kruse does not teach surfactants. Almirall, LLC v. Amneal Pharm., 28 F.4th 265, 273 (Fed. Cir. 2022) (“"[A] reference need not state a feature's absence in order to disclose a negative limitation." AC Techs., S.A. v. Amazon.com, Inc. , 912 F.3d 1358, 1367 (Fed. Cir. 2019).”).
Regarding claim 66, Kruse teaches the use of waxes but does not specify candelilla wax. However, candelilla wax was well known in the art in cosmetic compositions as taught by Heidenfelder ([0141]). One of ordinary skill in the art would have considered using well-known waxes in the art and arrive at the claimed invention.
Response to argument
Applicant argues that the moisturizers cited by Kruse, such as glycerin, lactic acid, and/or lactates; cannot be considered “water-based” because these individual compounds do not themselves contain water. Applicant’s argument is not persuasive, because Applicant does not properly represent how the term water-based moisturizers is used in the cosmetic and dermatology art. The term water-based in this context does not mean that the ingredient must chemically contain water as past of its molecular structure composition. Instead, the term refers to substances that are highly hydrophilic, hygroscopic and function by binding, retaining, or attracting water within an aqueous phase. In other words, the compounds are “water-based” because their moisturizing mechanism depends on water affinity, not water content. This is exactly how Kruse uses the term when it identifies “advantageous moisturizers” such as glycerin, lactic acid, and/or lactates; which are universally recognized in the art as classic water-binding humectants. This is further supported by SkinCare (page 2, Table 3) discloses the water-holding capacities of several well-known moisturizers, including glycerin and lactate. As is shown, sodium lactate has the highest water-holding capacity, making it the most effective moisturizer. Therefore, the combined teachings of Kruse and Skincare further highlight that the moisturizing action is fundamentally dependent on water interaction, which is precisely why they are categorized as water-based moisturizer in the art.
Applicant argues that Kruse’s disclosure of moisturizers is not “water-based” because they are oil-in-water emulsions containing an oil phase in addition to an aqueous phase. Applicant’s argument is not persuasive because the presence of an oil phase does not negate or diminish the function of the water phase, which contains humectants to exert function of binding water and enhancing hydration. The existence of an oil phase does not interfere with humectant solubility, property or activity; humectants do not require a single-phase aqueous solution, only access to water molecule within the continuous phase. Therefore, Kruse’s teachings still disclose a composition in which humectants are present and function within a water-based environment. Thus, Applicant’s assertation that Kruse’s formulation as “not water-based” is technically inaccurate and does not undermine the relevance of the aqueous phase as disclosed in proper context.
Applicant further argues that Purnamawati’s statement “Water-based moisturizers provide cooling effect from water evaporation on the skin surface ...” is only refereeing to a finished moisturizing composition that contain water, and not about individual moisturizing compounds such as glycerin, lactic acids or lactates. Applicant’s argument is not persuasive, because Purnamawati explicitly identifies glycerin and lactic acid as humectants used in moisturizers, and further explains that humectants are “hygroscopic substances which help the stratum corneum to absorb water by attracting water from dermis and a humid environment into the epidermis.” This suggests that humectant moisturizing function is inherently water-dependent. Thus, a POSITA would understand that a moisturizer that functions by attracting, binding, and mobilizing water is, by definition, operating through a water-based mechanism, regardless of whether the ingredient pure form contains water. This is further supported by SkinCare (page 2, Table 3) discloses the water-holding capacities of several well-known moisturizers, including glycerin and lactate. As is shown, sodium lactate has the highest water-holding capacity, making it the most effective moisturizer. Thus, the exceptional water-binding capacity of sodium lactate would logically support its classification as a water-based compound within the meaning used in the cosmetic and dermatology art.
Applicant also argues Pumamawati states that water-based moisturizers provide a cooling
effect from water evaporation on the skin surface, and that some moisturizers may contain menthol as additive, which suggests that the cooling effect is attributed only to menthol, and therefore there is no reason to modify Kruse’s teachings. Applicant’s argument is not persuasive because it does not properly interpret Pumamawati’s teachings. For example, Pumamawati clearly identifies two separate sources of cooling sensation. First, Pumamawati discloses “Water-based moisturizers provide cooling effect from water evaporation on the skin surface,” here the cooling effect is attributed to evaporation of water from the moisturizer itself. Second, Pumamawati also discloses “some moisturizers may contain menthol as additive, which provides cooling sensation and therefore reducing itch symptoms,” here menthol is merely an optional additive providing an additional or supplemental cooling sensation, rather than the sole source of cooling. Given that Pumamawati explicitly identifies glycerin and lactic acid as humectants used in moisturizers, thus a POSITA would have understood that the disclosed cooling effect primarily results from evaporation of water associated with the water-based moisturizing formulation itself, independent of whether menthol is there or not.
In response to Applicant’s arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Furthermore, it is important to highlight that Kruse teaches a hydrodispersion composition comparable to the instant claim, but Kruse does not explicitly teach olus oil and emulsifier free, as an example. Amela and Heidenfelder cure these deficiencies by disclosing Cegesoft® PS 6 (olus oil), and emulsifier free oil-in-water cosmetic compositions that reduce or avoid the use of emulsifiers to avoid allergic reactions; respectively. Therefore, the combined teachings of the prior art explicitly teach the relevant claim limitation as recited in the claimed invention; thus, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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