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 .
Status of the Claims
The listing of claims filed 31 May 2025, have been examined. Claims 1-18 are pending.
Specification Objection
The title of the invention is objected to under 37 CFR § 1.72. The title of the invention is not descriptive. The title “Cosmetic Composition” fails to reflect the structural and functional aspects of the invention (e.g., water-in-oil type emulsion, polyglycerol surfactants, solvent comprising both polar and non-polar oils). A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: “Water-in-Oil Cosmetic Composition with Polyglycerol Surfactants and Dual-Oil Solvent System”. Failure to respond to the objection within the statutory period is required to avoid abandonment.
In addition, the specification is objected to on the grounds that “squalene” ((6E,10E,14E,18E)-2,6,10,15,19,23-hexamethyltetracosa-2,6,10,14,18,22-hexaene), which is distinct from the much more stable, oxidation-resistant, hydrogenated form “squalane” (2,6,10,15,19,23-hexamethyltetracosane), lacks antecedent basis as a non-polar oil. The instant specification recites “squalane” in ¶[0082], ¶[0084]-[0089], ¶[0095]-[0097], Table 1, Table 2, and Tables 6-9, whereas it uses “squalene” in ¶[0098], ¶[0130], and Table 1. These two terms are not interchangeable, as they are chemically distinct. Clarification is required. If “squalane” is intended instead of “squalene”, claims 5 and 17 should be amended to correctly reflect the distinction. The specification should also be amended to reflect the correct term, where applicable.
Claim Objections
Claims 1-5, and 17 are objected to because of the following informalities:
Claim 1 contains a typographical as, “no more that 40%”, which should read “no more than 40%”. Correction is required. Claim 2 recites, “wherein the at two polyglycerol-type surfactants” and is missing the word “least”. The claim should be corrected to read “wherein the at least two”. Claim 2 is also objected to for “polyglyceryl-3 diisosterate”, which is misspelled and should be corrected to read diisostearate” and “polyglyceryl-6-polyhydrixystearate” which is misspelled and should be “polyhydroxystearate”. Claim 17 contains the same spelling errors “diisosterate” and “polyhydrixystearate” as noted above for claim 2. Correction is required.
Claim 3 recites, “wherein the at two polyglycerol-type surfactants” and is missing the word “least”. Correction is required. Claim 4 is inconsistent, wherein the other claims recite “polyglycerol-type”, claim 4 recites “polyglyceryl-type”. Claim 5 contains a subject-verb agreement error in, “wherein the at least one polar oil comprise” and should be “comprises” (singular).
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which Applicant regards as his invention.
Claims 1-18 are rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 1 is rejected as indefinite because the term “polyglycerol-type” renders the scope of the claim unclear. The specification recites “polyglycerol-type” as a replacement for “or the like”. The phrase “-type” does not provide sufficient structural or compositional definition to inform one of ordinary skill in the art what compounds are encompassed beyond polyglycerol itself. It is unclear what other surfactants, derivatives, or analogues fall within the scope of “polyglycerol-type,” and thus the metes and bounds of the claim are not reasonably ascertainable. Dependent claims 2-18 are included in this rejection because they do not cure the defect noted above.
Claims 2 and 3 are also rejected as indefinite. Claim 2 recites “the at two polyglycerol-type surfactants comprise at least two of polyglyceryl-6 polyricinoleate, polyglyceryl-3 diisosterate and polyglyceryl-6-polyhydrixystearate”. The use of “comprise” following a numerical limitation of “at least two polyglycerol-type surfactants” makes it unclear what else the claimed “at least two” may encompass beyond the listed options. This creates an improper Markush-like ambiguity because the claim does not clearly indicate whether the recited list is exclusive or merely exemplary (see MPEP § 2173.05(h), wherein the use of “comprising” in a Markush grouping may be indefinite if it is unclear whether additional members are allowed beyond those recited). Moreover, claim 3 recites “the at two polyglycerol-type surfactants comprise polyglyceryl-6 polyricinoleate” without any punctuation or closing language. The claim as presented is incomplete and it is unclear whether the claim terminates prematurely or whether additional elements were intended.
Claim 14 is rejected as indefinite for the same reason as claim 2. Claim 14 depends from claim 13 and recites “the at least one UV scattering powder comprises at least one of zinc oxide powder or titanium oxide powder.” The use of “comprises” in conjunction with “at least one of” makes it unclear whether other UV scattering powders beyond zinc oxide and titanium oxide are included. The claim does not provide a closed list, and therefore the scope of “at least one of” is indefinite.
In addition, claim 10 is rejected for lack of antecedent basis, wherein claim 10 depends from claim 8 and lacks antecedent basis for “the bentonite”. Claim 10 depends from claim 8, which depends from claim 1 and neither claim introduces bentonite. Bentonite first appears and is introduced in claim 9. Therefore, “the bentonite” in claim 10 lacks antecedent basis unless claim 10 is amended to depend from claim 9. Correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. § 102 and 103 (or as subject to pre-AIA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7, 8, 11-14, and 18 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by He et al. (CN-110897907-A; published 24 March 2020, hereinafter referred to as “He”).
He teaches a water-in-oil cosmetic composition for application to lips, which constitute a keratinous surface (Abstract). He teaches a composition comprising at least two polyglycerol-type surfactants/emulsifiers including polyglyceryl-3 diisostearate, polyglyceryl polyricinoleate, polyglyceryl ricinoleate, polyglyceryl-6 polyhydroxystearate, and polyglyceryl-6 polyricinoleate (claim 3). He further teaches total polyglycerol-type surfactant contents of 1-15 wt% (claim 1), encompassing instant claim 4. He Table 1, Examples 4 and 7 expressly contain multiple polyglycerol surfactants. He further teaches a solvent comprising at least one polar oil and at least one non-polar oil in claim 2, wherein the oil phase ingredients including squalane (non-polar hydrocarbon oil) and further oil materials including glyceryl caprylate and diisostearyl malate, which are ester-containing oils having polar functionality. Thus, He teaches an oil phase comprising both polar and non-polar oils.
Example 7 has a polyglycerol-type surfactant (15%) to non-polar oil (15%; neopentyl glycol diheptate plus squalane, wherein 15% is from 10-20% non-polar oil) ratio of 1:1 and use an 8% hydrophobic thickener dispersed in caprylic/capric triglyceride and polyglycerol-type surfactants (which may include caprylic/capric triglyceride, disteardimonium chloride hectorite, polyglyceryl-3 diisostearate, and polyglyceryl-3 polyricinoleate per claim 5, similar to instant specification ¶[0098]; which is within 6-10%). Example 7 contains approximately 15 wt% non-polar oil, encompassing the instant claimed 10-20 wt% range and 15 wt% polyglycerol surfactants, yielding a ratio of approximately 1:1, within the instant claimed ratio range for polyglycerol surfactants:non-polar oil.
He Table 1, Examples 4 and 7 contain all five, having 10% and 3% polyglycerol-3 diisostearate, respectively, 1% and 7% polyglycerol-3 polyricinoleate and polyglycerol-3 ricinoleate mixture, respectively, and 2% and 5% polyglycerol-6 polyhydroxystearate and polyglycerol-6 polyricinoleate mixture, respectively. He specifies in claim 4 that the polyglycerol-6 polyhydroxystearate to polyglycerol-6 polyricinoleate ratio is 1:1-3:1. Given this ratio range, the 5% mixture in Table 1, Examples 6 and 7 would result in a 2.5-3.75% polyglycerol-6 polyhydroxystearate concentration and a 1.25-2.5% polyglycerol-6 polyricinoleate concentration, which both are encompassed within the 1-5% range of instant claim 17.
He further teaches water constituting no more than 40 wt% (5-20 parts water phase, claim 1, representing 5-20 wt%; wherein the water phase may be deionized water, claim 6). The disclosed range falls within the claimed limitation. He teaches the inclusion of 0.1-5% pigments (claim 1), wherein the pigments may be selected from one or more ingredients including alumina iron oxides, silica powder, CI77492 iron oxide (which includes UNIPURE® YELLOW LC182), CI77491 and CI77499 iron oxides (which includes UNIPURE® RED LC381), the UV scattering CI77891 titanium dioxide powder (claim 7).
He teaches the use of the non-polar hydrocarbon oils including squalane. However, He does not explicitly teach wherein the at least one polar oil comprises 8-12% ethylhexyl olivate and wherein the at least one non-polar oil comprises 12-18% squalene, as per the limitations of instant claims 5 and 17. He does not explicitly teach the specific solvent mass of 15-40%, as per the limitation of instant claim 6, and He does not explicitly teach the use of 6-10% bentonite as a thickener, as per the limitations of instant claims 9 and 10. He also does not explicitly teach wherein at least one powder has a hydrophobically treated surface and wherein the composition explicitly comprises at least one UV-absorbing organic molecule, as required per the limitations of instant claims 15 and 16.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. § 102 and 103 (or as subject to pre-AIA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claims 1, 6, 8-10, 12, 15 and 16 are rejected under 35 U.S.C. § 103 as being unpatentable over He et al. (CN-110897907-A; published 24 March 2020, hereinafter referred to as “He”), in view of Clavel et al. (US-20140079656-A1; published 20 March 2014, hereinafter referred to as “Clavel”), and in further view of Demarcq and Faugue (FR-2988590-A1; published 04 October 2013, herein after referred to as “Demarcq”).
He teaches the limitations of instant claims 1, 8, and 12, as described above, from which instant claims 6, 9, 10, 15 and/or 16 depend. However, He does not explicitly teach the limitations of instant claims 6, 9, 10, 15 and 16.
He does not explicitly teach the use of 6-10% bentonite as a thickener. He teaches 1-15% of an oil phase thickener (claim 1), wherein the thickener may be selected from one or more ingredients including selea-ammonium chloride hectorite [disteardimonium hectorite], a modified smectite clay thickener in the same family as bentonite (claim 5; wherein the instant specification includes disteardimonium hectorite as an example of commercially available bentonite in ¶[0079]).
Evidentiary reference Bourgeteau and Fordiani (US-20210085577-A1; published 25 March 2021, hereinafter referred to as “Bourgeteau”) teaches that cross-functionality within the cosmetic formulations of bentonite and hectorite clays was known in the art at the time of the instant invention. Bourgeteau explicitly teaches that the phyllosilicate "is hectorite, montmorillonite, bentonite or mixtures thereof" (¶[0019]). This directly supporting direct equivalence and functional substitution of bentonite for hectorite within the same formulation (i.e., showing they are interchangeable options for the same purpose).
One of ordinary skill would recognize bentonite as a similarly acting clay thickener that could be substituted for hectorite with predictable results, wherein adjusting the amount of clay thickener to 6-10% would have been routine optimization, given that He teaches if the content of the oil phase is too small, spreadability and stability are poor (¶[0027]), guiding one of skill in the art to select effective amounts. Substitution of bentonite for hectorite remains an obviousness rationale because both are phyllosilicate clays, both function as rheology modifiers, and interchangeability is shown by the instant specification and the evidentiary reference.
He does not explicitly teach wherein the solvent constitutes from 15-40 mass% of the composition or wherein at least one powder has a hydrophobically treated surface and wherein the composition explicitly comprises at least one UV-absorbing organic molecule.
.Clavel teaches water-in-oil (W/O) emulsion cosmetic compositions (¶[0020]) comprising at least one polyglyceryl polyricinoleate surfactant (¶[0072]; specifically, polyglyceryl-3 polyricinoleates, polyglyceryl-6 polyricinoleates and mixtures thereof in ¶[0084] and ¶[0086]); an oil continuous phase including non-polar volatile alkanes of plant origin (¶[0116]-[0122]; ¶[0050]-[0059]) and polar oils including isononyl isononanoate and isopropyl myristate and isopropyl palmitate (¶[0144]); and an aqueous internal phase (¶[0109]-[0115]) including water ranging from 5-80% by weight, relative to the total weight of the composition (¶[0110]), for cosmetic application to the skin or lips (¶[0001]).
Clavel teaches a fatty phase (solvent) content ranging preferably from 15-70% by weight of the total composition (¶[0119]) and a volatile linear alkane (non-polar oil) content is preferably from 8-25% by weight of the total composition (¶[0070]). Clavel teaches that the composition may comprise pigments (¶[0031]) including the use of pigments including powder forms, titanium dioxide, zinc oxide, iron oxide (¶[0209]), hydrophobic surface treated pigments (¶[0233]), fillers that can include lauroylysine (¶[0243]), and anti-UV protective agents (¶[0253]), including organic UV absorbers cinnamic derivatives, salicylic derivatives, camphor derivatives, triazine derivatives, benzophenone derivatives, dibenzolemethane derivatives, β-diphenylacrylate derivatives, and p-aminobenzoic acid derivatives (¶[0249]).
In addition, hydrophobic surface treatment of pigments was standard practice in cosmetics long before the effective filing date, as evidenced by L'Alloret (US-20040223925-A1; published 11 November 2004) which teaches compositions with pigments and fillers in a W/O emulsion (¶[0008] and ¶[0084]). Clavel also teaches the inclusion of modified clays as lipophilic gelling agents such as modified magnesium silicate (Rheox Bentone® gel VS38) and hectorite modified with distearyldimethylammonium chloride (disteardimonium hectorite; Rheox Bentone® 38CE or Elementis Bentone® 38V) (¶[0194] and ¶[0195]).
Clavel also explicitly teaches a cosmetic method of applying the composition for making up and/or caring for keratin materials (¶[0027]). However, Clavel does not explicitly require two polyglycerol-type surfactants, nor explicitly disclose a polar oil in combination with a non-polar oil, or the explicit inclusion of a UV-absorbing organic molecule. Evidentiary reference Andre et al. (US-20070218019-A1; published 20 September 2007) teaches that it was known in the art at the time of the instant invention that zinc and titanium oxide possess UV-absorbing functionality. Andre et al. explicitly states, "Finely divided zinc oxide or titanium dioxide is found in cosmetic sunscreens as UV-absorbing pigments" (¶[0002]).
Further, Demarcq also teaches plural polyglycerol surfactants in W/O cosmetic compositions applied to the keratinous material (claim 15) comprising polyglyceryl polyricinoleate (including polyglyceryl-3 polyricinoleate and polyglyceryl-6 polyricinoleate; claim 3), an additional polyglycerol ester surfactant (including polyglyceryl-3 diisostearate; claim 8), oils (including squalane; page 6, ¶2), oil-phase structuring agents, and at least one pigment, to improve interfacial organization, emulsion stability, and sensorial performance (Abstract). The composition according to Demarcq’s invention may have a total content of oils ranging from 1 to 70% by weight, preferably from 10 to 50% by weight, better still from 10 to 40% and even more preferably from 10 to 30% by weight, relative to the total weight of the composition (page 6, ¶3).
More specifically, Examples 1, 2 compositions B and C, 3 compositions D-F, and 4 composition G meet many of the limitations of instant claim 1 (dicaprylyl ether or carbonate (polar ester), caprylic/capric triglyceride (non-polar) and PG-3 polyricinoleate plus PG-3 diisostearate polyglycerol surfactants), wherein the quantum sufficit (qsp) water constitutes roughly an estimated 25% of the composition, given the 4-5% glycerin, 1.5% magnesium sulfate, 0.2% xanthan gum, water-soluble actives and preservatives in the aqueous phase. However, the examples do not expressly disclose all limitations of claim 1 because water is listed as q.s., and the examples do not explicitly identify the required polar/non-polar oil arrangement. Demarcq also teaches pigments, that water is preferably present in an amount ranging from 10- 50% by weight relative to the total weight of the composition (page 6, ¶ 3), and the fatty phase is ≥5%, and more preferably 10-70% (page 5, ¶3), encompassing the 15-40% solvent oil phase of instant claim 6.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to combine the W/O emulsion base of He with the polar oil teachings and UV absorber teachings of Clavel, and further supported by the plural polyglycerol surfactant systems of Demarcq. He, as the primary reference, provides the core polyglycerol surfactant blend (two or more polyglycerol esters) that solves stability issues in W/O emulsions. He teaches working examples (Examples 1-8) demonstrating that such polyglycerol blends successfully form stable W/O emulsions. Clavel teaches the missing polar oil component (isononyl isononanoate, isopropyl myristate, isopropyl palmitate) and the combination of polar and non-polar oils in the same composition. Clavel also teaches the solvent range (15-70%), non-polar oil range (8-25%), organic UV absorbers, and clay thickeners. Demarcq expressly teaches plural polyglycerol surfactants (polyglyceryl-3 polyricinoleate plus polyglyceryl-3 diisostearate) in W/O emulsions with oil phases containing both polar and non-polar oils, and water contents of 10-50%, directly overlapping with the instant claims.
One would be motivated to combine He, Clavel, and Demarcq because Clavel teaches that polyglyceryl polyricinoleate surfactants can cause instability requiring polyols (¶[0010]-[0014]). He solves this stability problem by using a blend of two or more polyglycerol surfactants. One of skill in the art would have been motivated to replace Clavel’s single polyglyceryl polyricinoleate with the more stable blend taught by He to improve emulsion stability without increasing polyol content. Demarcq further provides motivation to optimize W/O emulsions by adjusting surfactant architecture, oil polarity balance, and internal water level to improve stability, sensory feel, and pigment dispersion (Abstract). Combining multiple polyglycerol surfactants represents routine formulation optimization of known result-effective variables.
One would have a reasonable expectation of success in doing so because He provides working examples demonstrating stable W/O emulsions with polyglycerol blends. Both Clavel and He employ similar oil phases (hydrocarbons, esters) and water contents. The use of surfactant blends to optimize HLB and stability is routine in emulsion chemistry (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007), wherein substitution of one element for another known in the art according to known methods to yield predictable results is obvious; In re Aller, 220 F.2d 454, 456 (CCPA 1955), wherein optimization of result-effective variables is ordinarily obvious; and In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003), wherein overlapping ranges create prima facie obviousness.
Claims 1, 5, and 17 are rejected under 35 U.S.C. § 103 as being unpatentable over He et al. (CN-110897907-A; published 24 March 2020, hereinafter referred to as “He”), in view of Clavel et al. (US-20140079656-A1; published 20 March 2014, hereinafter referred to as “Clavel”), and in further view of Demarcq and Faugue (FR-2988590-A1; published 04 October 2013, herein after referred to as “Demarcq”), Hallstar Sun Care Examples (Fall 2021; hereinafter referred to as “Hallstar”), Gardel et al. (US-20060024251-A1; published 02 February 2006, hereinafter referred to as “Gardel”), and Ionidis (US-20190224085-A1; published 25 July 2019).
He teaches the limitations of instant claim 1, as described above, from which instant claims 5 and 17 depend. However, He does not explicitly teach the limitations of instant claims 5 and 17.
He teaches the use of the non-polar hydrocarbon oils including squalane. However, He does not explicitly teach wherein the at least one polar oil comprises 8-12% ethylhexyl olivate and wherein the at least one non-polar oil comprises 12-18% squalene. Although, one of skill in the art would recognize that both squalane and squalene provide similar emollient and moisturizing functions and a very lightweight, non-greasy, quickly absorbing skin feel. The applicant has not indicated why squalene, having less desirable physical properties and a higher cost, would be preferred over squalane as an emollient and moisturizer in cosmetic formulations, however substituting the squalene for the squalane taught by He, would be recognized by one skilled in the art to produce the same moisturizing and skin feel effect.
Evidentiary reference, Bernoud et al. (US-20200383888-A1; published 10 December 2020, hereinafter referred to as “Bernoud”), teaches "Squalane (C30H62), obtained by hydrogenation of squalene (C30H50), is a cosmetic ingredient which is commonly used, in particular, for its very special sensory characteristics which it confers to the composition in which it is integrated, for its exceptional technical qualities in terms of formulation, and for its dermatological properties." (¶[0002]), and that squalane and squalene both share similar functional properties in cosmetic compositions as, "A cosmetic ingredient comprising at least one plant squalane and at least one mixture of C24 to C48 alkanes ... can advantageously be substituted for a plant squalane in cosmetic formulations, while preserving and even improving the sensory characteristics of said plant squalane." (¶[0008]). Thus, supporting the proposition that one of ordinary skill would recognize squalane and squalene as interchangeable in cosmetic formulations based on their shared emollient, moisturizing, and sensory properties. Accordingly, substituting squalene for squalane, or vice versa, would have represented no more than the substitution of one known emollient for another known emollient, both recognized in the art as providing equivalent sensory and functional properties in cosmetic compositions. Such a substitution is prima facie obvious under KSR International Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Further, optimization of the non-polar oil squalane to 12-18% would be a matter of routine optimization.
He still does not explicitly teach the limitation of wherein the at least one polar oil comprises 8-12% ethylhexyl olivate. Clavel teaches polar oils including isononyl isononanoate and other esters (¶[0144]), and non-polar volatile alkanes (¶[0050]-[0059]). Demarcq teaches oils may include squalane and esters of fatty acids, such as the oils of formulas R1COOR2 and R1OR2 in which R1 represents the residue of a fatty acid or of a fatty alcohol containing from 8 to 29 carbon atoms, and R2 represents a hydrocarbon chain, branched or unbranched, containing from 3 to 30 carbon atoms (page 6, ¶2), wherein ethylhexyl olivate is a fatty acid ester with an R1 oleic acid residue with 17 carbons and an R2 is 2-ethylhexyl which is branched with 8 carbons, encompassed with this criteria. The composition according to Demarcq’s invention may have a total content of oils ranging from 1 to 70% by weight, most preferably from 10 to 30% by weight, relative to the total weight of the composition (page 6, ¶3).
Hallstar Sun Care Examples (Fall 2021), Facial Moisturizer Cream SPF 50 (Formula Number: JZ14-49B; pages 24 and 35) demonstrates ethylhexyl olivate (Sensolene®) was known in the art ahead of the invention to be used as an emollient in cosmetic formulations.
Gardel teaches W/O cosmetic emulsion compositions 5-30% w/w of fatty acid esters of glycerol or fatty acid esters of polyglycerol, 5-20% w/w of water, co-surfactants and optionally co-solvents, with optimization of oil phase ingredient percentages to achieve particular spreadability values (Abstract) to achieve improved glide and a light sensory feel (¶[0001]). Motivating one of skill in the art to optimize the ratio of nonpolar and polar oils in the oil phase of Clavel and He and substitute other polar oils for those taught by Clavel and He with superior spreadability profiles to achieve a lighter feeling formulation.
Ionidis further provides motivation to alter the oil selection of Clavel and He and use the squalane of Demarcq with esters of fatty acids, such as the oils of formulas R1COOR2 and R1OR2 in which R1 represents the residue of a fatty acid or of a fatty alcohol containing from 8 to 29 carbon atoms, and R2 represents a hydrocarbon chain, branched or unbranched, containing from 3 to 30 carbon atoms (page 6, ¶2), such as ethylhexyl olivate, commercially known to be used in cosmetic formulations for a lighter sensory feel as evidenced by Hallstar, by teaching a composition with a light fluid texture and good sliding properties when applied to the skin (¶[0013]) as desirable. This is achieved through the optimization of the oil ingredient selection in the oil-phase based on application properties and optimizing the ratio of oils, polyols and water (¶[0005]-[0010]).
Thus, oil ester identity and oil spreadability are recognized result-effective variables and formulation parameters in W/O cosmetics. Together, Gardel and Ionidis support W/O oil-phase optimization with sensory-driven ester selection, as a predictable formulation substitution. A person of ordinary skill in cosmetic formulation would have understood that oil identity, polarity balance, spreading coefficient, and sensorial profile are recognized result-effective variables in W/O emulsion design.
The claimed composition in claim 17 is a mere aggregation of known elements each used in their conventional manner and in conventional amounts. The ranges are broad and overlapping with ranges disclosed in the prior art. Selecting specific concentrations within disclosed ranges does not impart patentability (see In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003), wherein optimization of parameters in a known process is ordinarily obvious unless the results are unexpected). No unexpected results have been demonstrated by the applicant (e.g., the comparative data in the specification shows only incremental improvement; Table 3 shows Example 1 slightly smoother but not dramatically different; Table 4 shows stability but comparative formulation lacked polyglycerol blend).
Hence, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to substitute ethylhexyl olivate as the polar oil in a W/O emulsion solvent in the oil-phase of the formulations of He and Clavel, and encompassed within the teachings of Demarcq and specifically taught for use in cosmetic applications by Hallstar, because the oils serve the same function as polar emollients. Substituting ethylhexyl olivate as a cosmetically acceptable ester-type polar oil, and using squalane as taught by He and Demarcq or similarly, squalene, as a cosmetically acceptable hydrocarbon-type non-polar oil, would therefore have represented no more than routine optimization of known formulation variables.
One would be motivated to do so to achieve predictable improvements in glide, spreadability, a lighter sensory feel, and stability with a reasonable expectation of success. The cited references uniformly teach that W/O performance depends strongly on oil phase selection, sensory optimization is desirable, oil polarity balance influences pigment wetting and application feel (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007), wherein a substitution of one element for another known in the art according to known methods to yield predictable results is obvious; In re Aller, 220 F.2d 454 (CCPA 1955), wherein optimization of result-effective variables is ordinarily obvious). The claimed ranges are encompassed within the prior art and selecting specific amounts within broad prior art ranges is a matter of routine optimization.
Claim Rejections – Nonstatutory 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).
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 8, 9, 14-20, 23, 26 and 27 of co-pending US Application No. 17/775,263 (hereinafter referred to as “’263”). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons set forth below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of the instant application are not patentably distinct from the claims of the co-pending application because the presently claimed subject matter constitutes an obvious variation of the emulsified cosmetic compositions, emulsifier systems, oil phase systems, rheology modifiers, powders, pigments, and sunscreen systems recited in the co-pending application. The claims differ only in obvious ingredient selections, overlapping concentration ranges, optimization of result-effective variables, and conventional cosmetic additives routinely employed in the same field of cosmetic compositions by one of skill in the art.
Instant claim 1 recites a water-in-oil type emulsified cosmetic composition comprising: (a) at least two polyglycerol-type surfactants; (b) a solvent comprising at least one polar oil and at least one non-polar oil; and (c) water (no more than 40% by mass). Co-pending ’263 claim 2 recites a cosmetic composition comprising at least one silicone resin, at least one emulsifier, and less than about 10% water. Co-pending ’263 claim 8 recites that the at least one emulsifier comprises at least one water-in-oil emulsifier. Co-pending ’263 claim 14 recites that the at least one emulsifier comprises at least one polyglyceryl emulsifier. Co-pending ’263 claim 15 recites that the at least one polyglyceryl emulsifier comprises *at least one of a polyglyceryl-6 ester and a polyglyceryl-3 ester (e.g., polyglyceryl-6 polyricinoleate and polyglyceryl-3 diisostearate). Co-pending ’263 claim 23 recites at least one thickening agent. Co-pending ’263 claim 27 recites a method of applying the composition to a keratinous surface.
The ’263 claim 2 does not require a silicone resin to be present in all embodiments of the emulsifier, rather, claim 2 is a generic cosmetic composition with an emulsifier. Claim 14 expressly allows the emulsifier to be a polyglyceryl emulsifier. Nothing in claim 2, 8, or 14 excludes the presence of two or more polyglyceryl surfactants, a polar oil, or a non-polar oil. The water limitation in claim 2 (less than about 10% water) falls within the instant claim 1’s water limit (no more than 40%). Thus, every element of instant claim 1 is either explicitly recited in or an obvious variant of the combination of ’263 claims 2, 8, and 14.
Instant claim 2 requires that the “at least two polyglycerol-type surfactants comprise at least two of” polyglyceryl-6 polyricinoleate, polyglyceryl-3 diisostearate, and polyglyceryl-6-polyhydroxystearate. Co-pending ’263 claim 15 recites “at least one of a polyglyceryl-6 ester and a polyglyceryl-3 ester.” Co-pending ’263 claim 26 recites “at least one polyglyceryl-6 ester and at least one polyglyceryl-3 ester” as part of a solubilized emulsifier system.
A person of ordinary skill in the art reading ’263 claim 15 and claim 26 would understand that using both a polyglyceryl-6 ester and a polyglyceryl-3 ester is expressly contemplated. The specific esters recited in instant claim 2 (polyglyceryl-6 polyricinoleate, polyglyceryl-3 diisostearate, polyglyceryl-6-polyhydroxystearate) are within the genus “polyglyceryl-6 ester” and “polyglyceryl-3 ester” of ’263 claim 15. Selecting two or three of these specific, commercially available polyglyceryl esters is an obvious optimization over the broader recitation in the ’263 claims.
Instant claim 5 requires the polar oil to be ethylhexyl olivate and the non-polar oil to be squalene. Co-pending ’263 claim 2 (cosmetic composition with emulsifier) does not limit the oil phase. The ’263 claim 2, read in light of the ordinary meaning of “cosmetic composition” encompasses compositions with polar oils and non-polar oils. Squalene is a known non-polar hydrocarbon oil and ethylhexyl olivate is a known polar ester oil. Substituting one common polar oil for another is obvious.
Instant claim 8 recites a mass ratio between the at least two polyglycerol-type surfactants and the at least one non-polar oil of 1:1 to 1:10. Co-pending ’263 claim 16 recites a solubilized emulsifier amount of about 0.01 mass % to about 7 mass %. Co-pending ’263 claim 7 recites a solubilized silicone resin amount of about 0.01 mass % to about 40 mass %, but the oil phase in claim 2 is not limited to silicone resin alone. The combination of ’263 claims 2, 14, and 16 teaches that one of ordinary skill can adjust the relative amounts of emulsifier and oil phase (including non-polar oils) within broad ranges. The claimed 1:1 to 1:10 ratio is merely an optimization of result-effective variables.
Instant claim 9 requires a thickener comprising bentonite and instant claim 10 requires bentonite from 6 mass % to 10 mass %. Co-pending ’263 claim 23 recites “at least one thickening agent.” Thickening agents in cosmetic compositions routinely include clays such as bentonite. The specific range 6-10 mass % is within the scope of thickening agent amounts taught by the ’263 claim 24 (1.0 mass % to 20.0 mass %). No inventive distinction arises from selecting bentonite as the thickening agent or from choosing a concentration within the disclosed range.
Instant claims 11-16 (pigments, powders, UV scattering powder, zinc oxide/titanium oxide, hydrophobically treated surface, UV-absorbing organic molecule). Co-pending ’263 claim 17 recites “at least one pigment.” Co-pending ’263 claim 18 recites “at least one treated pigment.” Co-pending ’263 claim 20 recites pigment amounts from about 0.01 mass % to about 30.00 mass %. UV scattering powders (e.g., zinc oxide, titanium dioxide) and UV-absorbing organic molecules are conventional additives in cosmetic compositions. The ’263 claim 2 does not exclude them. Therefore, adding these optional elements to the composition of ’263 claim 2 is obvious.
Instant claim 17 recites a specific formulation with narrow ranges of polyglyceryl-6 polyricinoleate, at least one of polyglyceryl-3 diisostearate/polyglyceryl-6-polyhydroxystearate, bentonite, ethylhexyl olivate, and squalene. Co-pending ’263 claim 26 expressly recites a composition comprising: at least one solubilized silicone resin (polyphenylsilsesquioxane/trimethylsiloxysilicate) and at least one solubilized emulsifier comprising at least one polyglyceryl-6 ester and at least one polyglyceryl-3 ester* in amounts from about 0.01 mass % to about 7 mass %. The ’263 claim 26 does not require the silicone resin to be the only oil. One of ordinary skill could replace part or all of the silicone resin with a blend of polar oil (ethylhexyl olivate) and non-polar oil (squalene) while retaining the polyglyceryl emulsifier system. Adding bentonite as a thickener (’263 claim 23) and adjusting amounts within the broad ranges of ’263 claims 16 (0.01-7 mass % emulsifier) and 24 (1-20 mass % thickener) directly leads to the formulation of instant claim 17 without any unexpected results.
Instant claim 18 recites a method of applying the composition of claim 1 to a keratinous surface. Co-pending ’263 claim 27 recites a method of applying the composition of claim 1 to a keratinous surface. Because instant claim 1 is not patentably distinct from ’263 claim 2, 8, and 14 in combination, claim 18 similarly is not patentably distinct from ’263 claim 27.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, and 14-25 of co-pending US Application No. 18/851,876 (hereinafter referred to as “’876”). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons set forth below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of the instant application are not patentably distinct from the claims of the co-pending application because the presently claimed subject matter constitutes an obvious variation of the emulsified cosmetic compositions, emulsifier systems, oil phase systems, rheology modifiers, powders, pigments, and sunscreen systems recited in the co-pending application. The claims differ only in obvious ingredient selections, overlapping concentration ranges, optimization of result-effective variables, and conventional cosmetic additives routinely employed in the same field of cosmetic compositions by one of skill in the art.
Instant claim 1 recites a water-in-oil type emulsified cosmetic composition comprising: (a) at least two polyglycerol-type surfactants; (b) a solvent comprising at least one polar oil and at least one non-polar oil; and (c) water ≤40% by mass. Co-pending ’876 claim 1 recites a cosmetic composition comprising: (a) a modified hectorite organoclay; (b) at least one hydrophobic solvent; and (c) at least one amphiphilic agent. Co-pending ’876 claim 2 recites that the composition of claim 1 is a water-in-oil type emulsified composition. Co-pending ’876 claim 14 recites that the composition further comprises at least one amphiphilic surfactant. Co-pending ’876 claim 16 recites that the at least one amphiphilic surfactant comprises at least one polyglyceryl surfactant. Co-pending ’876 claim 17 recites that the at least one amphiphilic surfactant comprises at least one surfactant selected from polyglyceryl-2 diisostearate, polyglyceryl-6 polyricinoleate, and combinations thereof. Co-pending ’876 claim 7 recites that the at least one hydrophobic solvent comprises at least one non-polar oil solvent. Co-pending ’876 claim 18 recites that the amount of amphiphilic surfactant is from 0.1 mass % to 15 mass %.
’876 claim 1 does not require a modified hectorite organoclay to be present in every embodiment of the amphiphilic agent or hydrophobic solvent- the organoclay is a separate component. One of ordinary skill could omit the organoclay and still practice the combination of ’876 claims 1, 2, 14, and 16, arriving at a water-in-oil composition with at least one polyglyceryl surfactant and a hydrophobic solvent. To arrive at two polyglyceryl surfactants (instant claim 1(a)), one need only look to ’876 claim 17, which explicitly lists two different polyglyceryl surfactants as a combination.
To arrive at a solvent comprising both a polar oil and a non-polar oil (instant claim 1(b)): ’876 claim 7 recites a non-polar oil solvent, and the specification (referenced only to define “hydrophobic solvent”) indicates that hydrophobic solvents can include polar oils such as esters. More directly, a person of ordinary skill reading ’876 claims 7 and 14 together would find it obvious to combine a non-polar oil with a polar ester oil as part of the hydrophobic solvent system, because such blends are routine in water-in-oil emulsions.
The water limitation in instant claim 1 (≤40%) is subsumed by the ordinary understanding of a “water-in-oil type emulsified composition” in ’876 claim 2, which inherently contains water in the internal phase. No upper limit on water is recited in ’876 claim 2, but ≤40% is a routine and conventional range for such emulsions.
Instant claim 2 (at least two of specific polyglyceryl esters) is obvious over ’876 claim 17, which explicitly names polyglyceryl-6 polyricinoleate and polyglyceryl-2 diisostearate (polyglyceryl-3 diisostearate being an obvious homolog). Instant claim 4 (surfactants 1-15 mass %) falls squarely within ’876 claim 18 (0.1-15 mass %). The narrower subrange (1-15%) is an obvious selection. Instant claim 5 (ethylhexyl olivate as polar oil; squalene as non-polar oil) is obvious over ’876 claim 7 (non-polar oil solvent) in combination with the understanding that hydrophobic solvents include polar esters. Squalene is a known non-polar hydrocarbon oil and ethylhexyl olivate is a known polar ester oil. The ’876 claim 1 does not forbid such oils, and their selection is routine.
Instant claim 8 (surfactant-to-non-polar-oil ratio 1:1 to 1:10). ’876 claim 18 teaches surfactant amounts of 0.1-15 mass %. ’876 claim 4 teaches organoclay amounts of 0.01-20 mass %, but the non-polar oil amount is not fixed. A person of ordinary skill would adjust the non-polar oil amount relative to the surfactant to achieve desired emulsion properties. The claimed ratio is an obvious optimization, not a patentable distinction. Instant claim 9 (thickener comprising bentonite). ’876 claim 1(a) requires a modified hectorite organoclay. Bentonite is a type of hectorite clay. ’876 claim 3 specifically identifies disteardimonium hectorite, a modified hectorite. Thus, bentonite is directly within the scope of ’876 claim 1(a). Instant claim 9 adds no new limitation beyond what ’876 claim 1 already recites. Instant claim 10 (bentonite 6-10 mass %). ’876 claim 4 recites an amount of modified hectorite organoclay from 0.01 mass % to 20 mass %. The range 6-10 mass % is entirely within that broader range. Selecting a subrange is obvious.
Instant claims 11-16 (pigments, powders, UV scattering powder, zinc oxide/titanium oxide, hydrophobically treated surface, UV-absorbing organic molecule). ’876 claim 21 recites “one or more pigments.” ’876 claim 19 recites “one or more UV scattering powder.” ’876 claim 20 recites “one or more UV absorbing organic molecules.” Thus, each of these optional additives is expressly claimed in ’876. The hydrophobically treated surface is a routine treatment for powders in cosmetic compositions. Adding these to the composition of ’876 claim 1 is explicitly contemplated by the ’876 claims themselves.
Regarding instant claim 17, ‘876 claim 24 recites a specific composition comprising 0.5-5% disteardimonium hectorite (bentonite), 5-15% volatile oil, 5-15% non-volatile oil, 1-7% of at least one surfactant selected from polyglyceryl-2 diisostearate and polyglyceryl-6 polyricinoleate. The differences between instant claim 17 and ’876 claim 24 are: ethylhexyl olivate instead of a general volatile/non-volatile oil; squalene as a specific non-volatile oil; inclusion of polyglyceryl-3 diisostearate or polyglyceryl-6-polyhydroxystearate as an optional second surfactant; and slightly different concentration ranges (e.g., 6-10% bentonite in instant claim 17 vs. 0.5–5% in ’876 claim 24). A person of ordinary skill would find it obvious to adjust the bentonite concentration upward within the broader range of ’876 claim 4 (0.01-20%), to substitute ethylhexyl olivate for other ester oils, to substitute squalene for other non-polar oils, and to use a polyglyceryl-3 ester as an alternative or additional surfactant given ’876 claim 17’s listing of polyglyceryl-2 diisostearate (a polyglyceryl-3 equivalent being a close homolog). These are routine formulation optimizations.
Regarding instant claim 18, ’876 claim 25 recites a cosmetic method comprising applying the composition of claim 1 to a keratinous surface. Because instant claim 1 is not patentably distinct from ’876 claim 1 in combination with claims 2, 14, and 16, claim 18 similarly is not patentably distinct from ’876 claim 25.
To overcome these provisional rejections, a Terminal Disclaimer (37 C.F.R. § 1.321(c)) may be filed (see MPEP § 804.01(a)), or alternatively, the applicant may traverse the rejection by demonstrating that the claimed subject matter is patentably distinct from the claims of the reference applications. The applicant must show that the differences between the claimed inventions are such that the claimed subject matter as a whole would not have been obvious over the reference claims (see In re Berg, 140 F.3d 1428, 1432 (Fed. Cir. 1998).
Conclusion
No claims are allowed.
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/RL Scotland/
Examiner, Art Unit 1615
/Jeffrey T. Palenik/Primary Examiner, Art Unit 1615
Prosecution Insights