DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Status of Claims
The amendment, filed on 31 October 2025, is acknowledged.
Claims 18, 22, and 35-36 have been amended.
Claims 36-37 were previously withdrawn from consideration in the Non-Final Rejection, mailed 1 August 2025, as being drawn to a nonelected invention.
Claims 18-35 are pending and under consideration in the instant Office Action, to the extent of the following previously elected species:
the continuous fatty phase comprises the volatile hydrocarbon-based oil C15-19 alkane and the nonvolatile hydrocarbon-based oil dicaprylyl ether;
the aqueous phase comprises water, ethanol, and glycerin;
the polyglycerol ester is polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate;
the polyglycerol fatty acid ester is polyglyceryl-4 isostearate;
the preservatives are potassium sorbate and salicylic acid;
the emulsifying surfactant is glyceryl stearate; and
the filler is lauroyl lysine.
Rejections Withdrawn
Rejections pursuant to 35 U.S.C. § 112
The rejections of claims 18, 22, 25, 29, and 35 under 35 U.S.C. § 112 are withdrawn in view of Applicant’s amendments to claim 18.
Maintained Grounds of Rejection
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, 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 18-29, 31 and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Von der Fecht et al. (WIPO International Patent Publication No. WO 2013/120823 A2, published on 22 August 2013, references to English translation, hereafter referred to as Von der Fecht) in view of Debeaud et al. (U.S. Patent Application Publication No. US 2020/0069542 A1, published on 5 March 2020, hereafter referred to as Debeaud).
Von der Fecht teaches a water-in-oil emulsion cosmetic preparation comprising two or more emulsifiers (Abstract). Emulsifiers are taught to be important for stabilizing formulations and impacting the rheology and flowability of emulsions, but polyethylene glycol (PEG) and its derivatives, which are commonly used as emulsifiers in the art, are taught to be undesirable because they enhance penetration of chemicals through the skin of users and are photo-unstable (pg. 2, Description, para. 3-12). To overcome these issues with PEG-derived emulsifiers, Von der Fecht teaches the use of the emulsifiers polyglycerol-4 diisostearate polyhydroxystearate sebacate (GPS) and diisostearoyl polyglyceryl-3 dimer dilinoleate (IGL), which impart satisfactory aesthetic and sensory aspects and produce a stable cosmetic composition while avoiding a sticky, oily feeling (pg. 3, para. 1-18 and claim 4). The polyglycerol ester GPS and polyglycerol fatty acid ester IGL are present in a range of 1.0-5.5% by weight, with GPS comprising 0.1-2.5% by weight, overlapping with the range recited in instant claim 21 (claims 5-6). Von der Fecht teaches IGL to be present in a range of 0.1-3.0% by weight, resulting in a range of polyglycerol ester: polyglycerol fatty acid ester ratios from 0.033-25, encompassing the ratios recited in instant claims 18 and 35 (claim 6).
The oil phase of the cosmetic composition is taught to be 0.1-40.0% by weight, preferably 10-30.0%, overlapping with the range recited in instant claim 25 (pg. 5, para. 16 and claim 9). Complementarily, the aqueous phase is taught by Von der Fecht to account for 40.0-80.0% by weight, overlapping with the range recited in instant claims 18 and 29 (claim 14). The fatty phase of the composition is further taught to comprise a C13-16 isoparaffin, which is interpreted as a branched alkane (claim 10). Example 6 teaches an exemplary cosmetic preparation comprising the emulsifiers above, the filler talc, 57.0% w/w water, 12.0% w/w of the nonvolatile synthetic ether dicaprylyl ether, 12.0% w/w of the polyol glycerin, 0.15% w/w of the preservative potassium sorbate, and no silicone oils (pg. 7-8). The cosmetic preparation is also taught to include further cosmetic adjuvants, including waxes, moisturizing substances, and alcohols (pg. 5, para. 25). Finally, Von der Fecht teaches the rheological property of viscosity to particularly be important, with the composition of Example 4 displaying a viscosity of 5.4 Pa·s and possessing the sensory properties of being “easily spreadable with a pleasant, nourishing residue (pg. 4, Table 2).
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “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). These guidelines apply to the ranges of weight composition of the aqueous and fatty phases, the polyglycerol ester, the polyglycerol fatty acid ester, and silicone oil(s), the ratio of polyglycerol ester: polyglycerol fatty acid ester, and the viscosity. Each of these recited ranges either fall within or significantly overlap with the ranges taught by Von der Fecht and are therefore prima facie obvious.
Von der Fecht does not teach the cosmetic composition to comprise the polyglycerol fatty acid ester polyglyceryl-4 isostearate, glyceryl trihydroxystearate, the emulsifying surfactant glyceryl stearate, nor ethanol in the aqueous phase. These deficiencies are offset by the teachings of Debeaud.
Debeaud teaches a cosmetic composition in the form of a water-in-oil emulsion that moisturizes skin and forms an occlusive barrier to maintain moisture and improve sensory properties (Abstract and para. [0001-0004]). Debeaud teaches that polymer surfactants help achieve the “realization of the compositions” and specifically teaches the use of glyceryl isostearate and polyglyceryl-4 isostearate, sold as Isolan GI 34 by Evonik Goldschmidt, as polymers that enable the skin benefits taught above (para. 0180-0185] and Examples 3-5). Debeaud also teaches that waxes help achieve the goal of a moisturizing cosmetic composition, and among the ester waxes teaches that a preferable was is an ester in which all of the hydroxyl functional groups of glycerol are esterified, such as in trihydroxystearine, also known as glyceryl trihydroxystearate (para. [0099-0109]). The content of the hydrocarbon-based wax is taught to be 0.5-15.0% w/w (para. [0113]). In the aqueous phase of the composition, Debeaud teaches the inclusion of solvents in addition to water, which are water-soluble, and that “mention can be made in particular to monoalcohols having from 1 to 5 carbon atoms such as ethanol” (para. [0344-0351]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Von der Fecht and Debeaud to arrive at the invention of instant claims 18-29 and 31-35 because simple substitution of known prior art elements according to known methods to impart known benefits yields predictable results. Von der Fecht teaches a cosmetic composition comprising the polyglycerol ester GPS, in a ratio with a polyglycerol fatty acid ester that can be above 1.0, fatty and aqueous phases present in ranges that overlap with those recited in the instant application, as well as the volatile oil C13-16 isoparaffin, water, the nonvolatile synthetic ether dicaprylyl ether, the polyol glycerin, and no silicone oils. The cosmetic preparation is also taught to include further cosmetic adjuvants, including waxes, moisturizing substances, and alcohols, but does not provide specific examples of these genera. In view of the teachings of Debeaud, the ordinary artisan would be motivated to include the ester wax glyceryl trihydroxystearate and the emulsifiers glyceryl isostearate and polyglyceryl-4 isostearate, which is a polyglycerol fatty acid ester, because Debeaud teaches these components to provide moisturization and protection to the skin of users. One of ordinary skill would recognize these properties as desirable in a cosmetic composition and utilize the components, as they fall within the genera Von der Fecht taught as useful but did not include specific species. Further, a person of ordinary skill would be motivated to use ethanol as a solvent in the aqueous phase of the cosmetic composition because Von der Fecht teaches the inclusion of the genus alcohols, but does not teach specific species, and Debeaud teaches ethanol to enable a cosmetic composition that has beneficial moisturizing and protecting effects to the skin of users. As a result, there is a reasonable expectation of success in arriving at the invention of claims 18-29, 31, and 33-35 in view of the teachings of Von der Fecht and Debeaud.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Von der Fecht (WIPO International Patent Publication No. WO 2013/120823 A2, published on 22 August 2013, references to English translation) in view of Debeaud (U.S. Patent Application Publication No. US 2020/0069542 A1, published on 5 March 2020) as applied to claims 18-29, 31 and 33-35 above, and further in view of the Cosmetic Ingredient Review Expert Panel Safety Assessment of Salicylic Acid and its derivatives (Int. J. Toxic. 2003, 22 (3 suppl.), 1., prepared by M. Z. Flume, hereafter referred to as Flume).
Von der Fecht and Debeaud teach the above, and particularly relevant to claim 30 Von der Fecht teaches their composition to comprise the preservative potassium sorbate and Debeaud teaches their composition to comprise a member of the genus preservatives (Examples 1-5).
Von der Fecht and Debeaud do not teach a cosmetic composition comprising the specific preservative salicylic acid. This deficiency is offset by the teachings of Flume.
Flume teaches that salicylic acid and its derivatives have long been used in cosmetic formulations for a variety of purposes, including as a skin-conditioning agent, a preservative, and light absorber (pg. 1, left column, para. 1). While the function of salicylic acid can change based upon its salt or functionalization, salicylic acid itself is taught to be used as a common preservative in cosmetics in Europe, at concentrations below 5% w/w, and in Japan, at concentrations below 0.2% w/w (pg. 8, right column, final para. - pg. 9, left column, para. 2). Flume concludes that salicylic acid is “safe as used when formulated to avoid skin irritation and…to avoid increasing the skin’s sun sensitivity” (pg. 99, Conclusion).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to modify the invention rendered obvious by the teachings of Von der Fecht and Debeaud with the teachings of Flume to arrive at the invention of instant claim 30 because the combination of prior art elements according to known methods yields predictable results. Von der Fecht and Debeaud both teach their cosmetic compositions to comprise preservatives, but neither specify the preservative salicylic acid. An ordinary artisan would be motivated to use salicylic acid as a preservative in the cosmetic composition rendered obvious by Von der Fecht and Debeaud because Flume teaches the inclusion of salicylic acid to be a common practice in Europe and Japan, to impart preservative properties, and to be safe to the skin of users. As a result, there is a reasonable expectation of success in arriving at the invention of instant claim 30 in view of the teachings of Von der Fecht and Debeaud and further in view of the teachings of Flume.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Von der Fecht (WIPO International Patent Publication No. WO 2013/120823 A2, published on 22 August 2013, references to English translation) in view of Debeaud (U.S. Patent Application Publication No. US 2020/0069542 A1, published on 5 March 2020) as applied to claims 18-29, 31, and 33-35 above, and further in view of Kobayashi et al. (J. Soc. Cosmet. Chem. Jpn. 2018, 52 (2), 92., references to English translation, hereafter referred to as Kobayashi).
Von der Fecht and Debeaud teach the above, and particularly relevant to claim 32 Von der Fecht teaches their composition to comprise the filler talc and Debeaud teaches their composition to comprise an unidentified species of the genus fillers (para. [0412] and [0430-0432]).
Von der Fecht and Debeaud do not teach a cosmetic composition comprising the filler lauroyl lysine. This deficiency is offset by the teachings of Kobayashi.
Kobayashi teaches lauroyl lysine to be an organic powder that is commonly used in cosmetic applications (Abstract). Lauroyl lysine is taught to be a “well known…beneficial ingredient in various cosmetic applications” and that its “excellent lubricity, water-repellency and non-greasy emolliency make it an ideal ingredient especially for makeups” (Abstract). Lauroyl lysine on its own is taught to be inherently hydrophobic and therefore insoluble in water, leading Kobayashi to synthesize new bis-lauroyl lysine compounds which are water soluble, link the two lauroyl lysine moieties via an alkylene chain, and retain the beneficial properties of lauroyl lysine (Abstract, Figure 3, Table 1).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to modify the invention rendered obvious by the teachings of Von der Fecht and Debeaud with the teachings of Kobayashi to arrive at the invention of instant claim 32 because the combination of prior art elements according to known methods yields predictable results. Von der Fecht and Debeaud both teach their cosmetic compositions to comprise fillers, with the former specifically teaching talc and the latter not specifying a species. An ordinary artisan would be motivated to formulate a cosmetic composition with lauroyl lysine as a filler in view of the teachings of Kobayashi because they teach lauroyl lysine to be insoluble in water, which is the solvent present in the largest concentration, and is desirable for a filler in a cosmetic composition, as disclosed by the applicant in specification pg. 22, lines 5-29. By remaining insoluble in lauroyl lysine, the molecule is able to impart the beneficial effects to the cosmetic composition as taught by Kobayashi, specifically providing lubricity to the composition, acting as an emollient to the user’s skin, and forming a water-repellant barrier on the user’s skin. As a result, there is a reasonable expectation of success in arriving at the invention of instant claim 32 in view of the teachings of Von der Fecht and Debeaud and further in view of the teachings of Kobayashi.
Response to Arguments
The Applicant’s arguments, filed on 31 October 2025, have been fully considered but are not persuasive.
From the final para. of pg. 8 of the Remarks to para. 2 of pg. 9, Applicant argues that the polyglyceryl-3 dimer dilinoleate taught by the Von der Fecht reference is “a very specific ester of polyglycerol” and cannot be characterized as a polyglycerol fatty acid ester as claimed. This is not found persuasive the polyglyceryl-3 dimer dilinoleate was not argued to fall within the genus of a polyglycerol fatty acid ester with 4-15 glycerol units and one or more linear or branched, saturated or unsaturated C6-24 fatty acids. Instead, the teachings of Von der Fecht were used to motivate a combination of components with the claimed polyglycerol-4 isostearate in view of the teachings of Debeaud. A person of ordinary skill in the art would be capable of identifying both molecules as fatty acid esters of polyglycerol and would be motivated to use the latter component to impart the benefits taught by the Debeaud reference, namely the occlusive skin barrier that preserves desirable properties.
In para. 3 of pg. 9, Applicant argues that Von der Fecht teaches in para. [0038] that no further additional emulsifiers should be included in their invention, which would discourage addition of any other emulsifiers. However, this is one of a number of embodiments taught by the Von der Fecht reference. For example, the Abstract, claims 18-19 and 21, para. [0026], etc. all teach “at least two W/O emulsifiers” (bold added for emphasis). “[T]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See MPEP § 2141.02.VI. and 2123. An artisan of ordinary skill would not be motivated to select only the embodiment(s) in which two emulsifiers are present, but would be motivated to try multiple combinations in view of the combination of references above to obtain an optimal composition.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, in the penultimate para. of pg. 9, Applicant argues that the Debeaud reference does not provide a teaching or motivation to select polyglyeryl-4 isostearate as a surfactant to combine with the teachings of Von der Fecht. Debeaud teaches cosmetic compositions with water-in-oil emulsifiers, and is therefore relevant to both the Von der Fecht reference and the instant application. Debeaud teaches that the emulsifiers in their composition can impart an occlusive barrier to the skin of the user which helps maintain water and improve sensory properties (e.g., para. [0004]), which a person of ordinary skill in the art would recognize as beneficial in cosmetic compositions and would therefore be motivated to use.
Additionally, Applicant argues that the “stability of water-in-oil emulsions is not predictable by simply combining separately disclosed surfactants”. The Supreme Court has previously stated that "[a] person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. See MPEP § 2141.03. “Office personnel may also take into account ‘the inferences and creative steps that a person of ordinary skill in the art would employ.’ KSR at 418, 82 USPQ2d at 1396.” While an ordinary artisan may not be able to predict the stability of a composition with a combination of any surfactants, they would be able to make inferences and take creative steps when combining surfactants taught to be suitable for cosmetic compositions, formulated as water-in-oil emulsions, to achieve a stable composition as taught by the Von der Fecht and Debeaud references.
In the final para. of pg. 9, Applicant argues that neither Von der Fecht nor Debeaud suggest the ratio of polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate: polyglyceryl-4 isostearate recited in instant claims 18 and 35. This is not found to be persuasive because the ratio is taught by Von der Fecht, pertaining to the ratio of polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate: polyglyceryl-3 dimer dilinoleate, and the rejection above is based upon the combination of the Von der Fecht and Debeaud references and using the ratio with polyglyceryl-4 isostearate as taught by Debeaud.
Applicant also states that the specification provides evidence that the ratio of 0.7 produces an unstable emulsion and that it confirms the “weight-ratio thresholds recited in claims 18 and 35 were not obvious from the prior art”. The Applicant directs the reader to “as-filed specification, p. 33, II. 1-6”, which is not clear as pg. 33, Table 2, and formulas 1-6 compare oil-in-water vs water-in-oil emulsions. Table 4 on pg. 35, which contains formula 13 – a formulation outside the invention with a weight ratio of 0.7 – appears more relevant to the argument regarding the nonobviousness of the claimed range. However, the argument is not found to be persuasive because the ratio range taught by Von der Fecht is from 0.033-25, which significantly overlaps with the recited range of greater than 0.7 (instant claim 18) or 1.0 (instant claim 35) and therefore still renders the range prima facie obvious. As stated above, a person of ordinary skill in the art is not an automaton and would be capable of optimizing within the range taught by Von der Fecht to find a stable weight ratio (vide supra and MPEP § 2141.I.A. and 2141.03.).
In para. 2 of pg. 10, Applicant argues that the Flume reference “merely describes the use of salicylic acid as a common preservative and provides no motivation to arrive at Applicant’s specific composition having the claimed emulsifier system and critical weight ratio”. The latter part of the sentence regarding the emulsifiers and weight ratio is not found persuasive because of the reasons above. Regarding the first part of the argument regarding the use of salicylic acid as a preservative, both the Von der Fecht and Debeaud references teach the inclusion of preservatives but do not teach the benefits of a specific species. Flume teaches salicylic acid to be a commonly used preservative that imparts preservative properties and is safe to the skin of users, which would motivate an ordinary artisan to use it as the preservative in the invention rendered obvious by the teachings of Von der Fecht and Debeaud.
Finally, in the penultimate para. of pg. 10, the Applicant argues that the teachings of the Kobayashi reference “relate only to the physical behavior of organic powders” and that the “inherent hydrophobicity [of N-lauroyl lysine] makes it difficult to disperse in aqueous media”, but does not provide an argument regarding the combination used in the rejection of instant claim 32 under 35 U.S.C. § 103. As stated above, the combination of emulsifiers and claimed weight ratio are obvious in view of the teachings of Von der Fecht and Debeaud. Further, Kobayashi not only teaches teach lauroyl lysine to be insoluble in water, but teaches that the species is desirable for a filler in a cosmetic composition because it is water insoluble. By remaining insoluble in water, lauroyl lysine is able to impart the beneficial effects to the cosmetic composition as taught by Kobayashi, specifically providing lubricity to the composition, acting as an emollient to the user’s skin, and forming a water-repellant barrier on the user’s skin, which the ordinary artisan would find desirable in a cosmetic composition.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 18-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-21, 24-28, and 31-32 of copending Application No. 18/717,809 in view of Von der Fecht (WIPO International Patent Publication NO. WO 2013/120823 A2, published on 22 August 2013, references to English translation), Debeaud (U.S. Patent Application Publication No. US 2020/0069542 A1, published on 5 March 2020), and Kobayashi (J. Soc. Cosmet. Chem. Jpn. 2018, 52 (2), 92., references to English translation).
This is a provisional nonstatutory double patenting rejection.
Copending Application No. 18/717,809 recites a cosmetic composition comprising at least one continuous fatty phase, at least one aqueous phase at a concentration of ≥50.0% w/w, at least two esters of polyglycerol with at least one C8-30 fatty acid, glyceryl trihydroxystearate, and a filler at a concentration of ≥6.0% w/w, which may be in one embodiment a C8-22 N-acyl amino acid (claim 16). The esters of polyglycerol and fatty acids are further limited to comprise at least one derived from an esterification reaction of at least one poly(hydroxystearic acid) and carboxylic acids (claim 17), wherein the polyglycerol contains 4 units (claim 18) and the carboxylic acid is a C16-20 monocarboxylic acid (claim 19), and the ester(s) comprise 0.5-15.0% w/w of the composition (claim 20). The glyceryl trihydroxystearate is recited to comprise 0.01-2.0% w/w of the composition (claim 21).
Application ‘809 further recites the composition to comprise 5.0-50.0% w/w of the at least one fatty phase (claim 24), less than 2.0% w/w of silicone oil(s) (claim 25), and from 50.0-95.0% w/w of the at least one aqueous phase (claim 27). The composition is further recited to contain at least one oil chosen from linear and/or branched C15-19 alkanes, C10-40 synthetic ethers, and mixtures thereof (claim 26). Claim 28 of ‘809 recites the composition to comprise at least one cosmetic active agent, one embodiment of which is salicylic acid (claim 32). Finally, Application ‘809 recites an embodiment in which the at least one ester is polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate (claim 31).
Copending Application No. 18/717,809 does not recite the composition to comprise the specific polyglycerol fatty acid ester polyglyceryl-4 isostearate, the aqueous phase to comprise water, ethanol, and glycerin, the ratio of esters present in the composition, the specific synthetic ether dicaprylyl ester, the preservative potassium sorbate, the specific emulsifying surfactant glyceryl stearate, the specific C8-22 N-acyl amino acid filler to be lauroyl lysine, nor the viscosity of the composition. These deficiencies are offset by the teachings of Von der Fecht, Debeaud, and Kobayashi.
Von der Fecht teaches a water-in-oil emulsion cosmetic preparation comprising two or more emulsifiers (Abstract). Emulsifiers are taught to be important for stabilizing formulations and impacting the rheology and flowability of emulsions, but polyethylene glycol (PEG) and its derivatives, which are commonly used as emulsifiers in the art, are taught to be undesirable because they enhance penetration of chemicals through the skin of users and are photo-unstable (pg. 2, Description, para. 3-12). To overcome these issues with PEG-derived emulsifiers, Von der Fecht teaches the use of the emulsifiers polyglycerol-4 diisostearate polyhydroxystearate sebacate (GPS) and diisostearoyl polyglyceryl-3 dimer dilinoleate (IGL), which impart satisfactory aesthetic and sensory aspects and produce a stable cosmetic composition while avoiding a sticky, oily feeling (pg. 3, para. 1-18 and claim 4). The polyglycerol ester GPS and polyglycerol fatty acid ester IGL are present in a range of 1.0-5.5% by weight, with GPS comprising 0.1-2.5% by weight, overlapping with the range recited in instant claim 21 (claims 5-6). Von der Fecht teaches IGL to be present in a range of 0.1-3.0% by weight, resulting in a range of polyglycerol ester: polyglycerol fatty acid ester ratios from 0.033-25, encompassing the ratios recited in instant claims 18 and 35 (claim 6).
Example 6 teaches an exemplary cosmetic preparation comprising the emulsifiers above, the filler talc, 57.0% w/w water, 12.0% w/w of the nonvolatile synthetic ether dicaprylyl ether, 12.0% w/w of the polyol glycerin, 0.15% w/w of the preservative potassium sorbate, and no silicone oils (pg. 7-8). The cosmetic preparation is also taught to include further cosmetic adjuvants, including waxes, moisturizing substances, and alcohols (pg. 5, para. 25). Finally, Von der Fecht teaches the rheological property of viscosity to particularly be important, with the composition of Example 4 displaying a viscosity of 5.4 Pa·s and possessing the sensory properties of being “easily spreadable with a pleasant, nourishing residue (pg. 4, Table 2).
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “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). These guidelines apply to the ranges of weight composition of the aqueous and fatty phases, the polyglycerol ester, the polyglycerol fatty acid ester, and silicone oil(s), the ratio of polyglycerol ester: polyglycerol fatty acid ester, and the viscosity. Each of these recited ranges either fall within or significantly overlap with the ranges taught by Von der Fecht and are therefore prima facie obvious.
Debeaud teaches a cosmetic composition in the form of a water-in-oil emulsion that moisturizes skin and forms an occlusive barrier to maintain moisture and improve sensory properties (Abstract and para. [0001-0004]). Debeaud teaches that polymer surfactants help achieve the “realization of the compositions” and specifically teaches the use of glyceryl isostearate and polyglyceryl-4 isostearate, sold as Isolan GI 34 by Evonik Goldschmidt, as polymers that enable the skin benefits taught above (para. 0180-0185] and Examples 3-5). In the aqueous phase of the composition, Debeaud teaches the inclusion of solvents in addition to water, which are water-soluble, and that “mention can be made in particular to monoalcohols having from 1 to 5 carbon atoms such as ethanol” (para. [0344-0351]).
Kobayashi teaches lauroyl lysine to be an organic powder that is commonly used in cosmetic applications (Abstract). Lauroyl lysine is taught to be a “well known…beneficial ingredient in various cosmetic applications” and that its “excellent lubricity, water-repellency and non-greasy emolliency make it an ideal ingredient especially for makeups” (Abstract). Lauroyl lysine on its own is taught to be inherently hydrophobic and therefore insoluble in water, leading Kobayashi to synthesize new bis-lauroyl lysine compounds which are water soluble, link the two lauroyl lysine moieties via an alkylene chain, and retain the beneficial properties of lauroyl lysine (Abstract, Figure 3, Table 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the filing of the instant application, to combine the invention recited by copending Application No. 18/717,809 with the teachings of Von der Fecht, Debeaud, and Kobayashi to arrive at the invention of instant claims 18-35 because the combination of prior art elements according to known methods yields predictable results. Application ‘809 recites a cosmetic composition comprising at least one fatty phase and at least one aqueous phase, with the former accounting for 5.0-50.0% w/w of the composition and the latter accounting for ≥50.0% w/w of the composition. ‘809 further recites the composition to comprise a C15-19 alkane and a C10-40 synthetic ether in the fatty phase, at least two esters of polyglycerol with at least one C8-30 fatty acid accounting for 0.5-15.0% w/w of the composition, one of which is polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate, glyceryl trihydroxystearate at 0.01-2.0% w/w of the composition, <2.0% w/w of silicone oil(s), a filler which may be in one embodiment a C8-22 N-acyl amino acid, and at least one cosmetic active agent, one embodiment of which is salicylic acid.
In view of the teachings of Von der Fecht, an ordinary artisan would be motivated use esters in a ratio of polyglycerol ester: polyglycerol fatty acid ester above 1.0 because, while Application ‘809 recites the total composition of esters, it does not recite the relative amounts nor ratios of the esters with respect to each other. Von der Fecht teaches a ratio that produces a stable composition with desirable sensory properties and the artisan would be motivated to use the ratio to achieve a similar effect in the invention of ‘809. In one exemplary embodiment, Von der Fecht teaches a stable cosmetic composition with the components dicaprylyl ether, water, glycerin, the preservative potassium sorbate, and no silicone oils. A person of ordinary skill would be motivated to use water and glycerin in the aqueous phase of the composition recited in ‘809 because the copending application recites an aqueous phase, but does not recite specific solvents present in the phase. The artisan would be motivated to select dicaprylyl ether as the C10-40 synthetic ether in the fatty phase because Von der Fecht teaches its use in a stable composition and ‘809 provides the genus but not a specific species and to use the preservative potassium sorbate because Von der Fecht demonstrates its usefulness by requiring its presence in all of their taught examples. Finally, copending Application ‘809 does not recite a specific viscosity of the composition and Von der Fecht teaches that a viscosity of ~5.4 Pa·s produces a cosmetic composition that is stable and possesses desirable sensory properties.
In view of the teachings of Debeaud, the one of ordinary skill would be motivated to include the emulsifiers glyceryl isostearate and polyglyceryl-4 isostearate, which is a polyglycerol fatty acid ester, in the composition recited in ‘809 because Debeaud teaches these components to provide moisturization and protection to the skin of users. A person of ordinary skill would recognize these properties as desirable in a cosmetic composition and utilize the components, as they fall within the genera of esters recited in Application 18/717,809 and which Von der Fecht taught as useful but did not include specific species. Further, a person of ordinary skill would be motivated to use ethanol as a solvent in the aqueous phase of the cosmetic composition because the copending application recites an aqueous phase, but does not recite specific solvents present in the phase, and Von der Fecht teaches the inclusion of the genus alcohols, but does not teach specific species. Debeaud teaches ethanol to enable a cosmetic composition that has beneficial moisturizing and protecting effects to the skin of users, which the ordinary artisan would recognize as beneficial in a cosmetic composition.
Finally, one of ordinary skill would be motivated to formulate a cosmetic composition with lauroyl lysine as a filler in view of the teachings of Kobayashi because Application ‘809 recites the use of a C8-22 N-acyl amino acid as a filler, but does not recite a specific species. Kobayashi teaches lauroyl lysine to be insoluble in water, enabling the filler to impart the beneficial effects to the cosmetic composition as taught by Kobayashi, specifically providing lubricity to the composition, acting as an emollient to the user’s skin, and forming a water-repellant barrier on the user’s skin. As a result, there is a reasonable expectation of success in arriving at the invention of instant claims 18-35 in view of the invention recited in copending Application No. 18/717,809 and in view of the teachings of Von der Fecht, Debeaud, and Kobayashi.
Claims 18-35 are directed to an invention not patentably distinct from claims 16-21, 24-28, and 31-32 of commonly assigned copending Application No. 18/717,809 in view of Von der Fecht, Debeaud, and Kobayashi. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned copending Application No. 18/717,809, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Remarks
In para. 2 of pg. 6 of the remarks filed on 31 October 2025, Applicant “respectfully requests that [the nonstatutory double patenting (NSDP) rejections] be held in abeyance until allowable subject matter is indicated. Applicant will consider the propriety of filing a Terminal Disclaimer at that point in time.” A complete response to a NSDP rejection is either a reply by the Applicant showing that the claims subject to the restriction are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/S.J.S./
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619