DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/13/2026 has been entered.
Response to Amendment
The Amendment filed 02/13/2026 has been entered. Applicant’s amendments are in response to in the Final Office Action mailed 11/13/2025. Applicant’s claims have been amended in the following manner: independent claim 17 has been modified by requirement of squalane (which is moved from dependent claim 23). The previous 103 rejection is modified by a new ground of rejection (by pointing to a different section of LaHousse to teach squalane) that is prompted by the amendment to address the squalane requirement of claim 17.
The Examiner further acknowledges the following:
Claims 17-20, 23-28 and 30-32 are pending.
Claims 17-20, 23-28 and 30-32 are presented for examination and rejected as set forth below.
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.
Claims 17-20, 23-28, and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng (WO 2017197587 A1; cited on IDS filed 10/03/2022), and in further view of LaHousse (US 20190015314 A1), Keen (Indian Dermatology Online Journal, 2016).
Applicant’s independent claim 17 is directed to a multiphasic composition comprising a first polar oily phase and a second apolar oily phase (i.e., newly required squalane) that are immiscible. The oily phases are limited to ingredients defined by surface tension values and solubility parameters calculated by HSPiP software (see Specification [31]), and are further described through example ingredients in the claim set and specification (Tables 1-4). A third aqueous phase is specified in claim 25 that is immiscible with the first and second oily phases. The intended use of claim 31 (anti-aging serum) does not hold patentable weight. Particularly, a recitation of an intended use will not limit the scope of the claim because it merely defines a context in which the invention may operate. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Furthermore, claim 32 recites a process of applying a composition to skin. The Examiner notes a number of solubility and surface tension values for instant ingredients that are defined for individual ingredients by Applicant in the Specification (see Tables 1-4).
For clarity (by repetition of claim limitations of instant claim 17 and 23), Applicant names suitable polar solvents (e.g., dipropylene glycol dibenzoate, propylene glycol dibenzoate, triethyl citrate, castor oil) and apolar solvents (e.g., isohexadecane, isododecane, undecane, tridecane, polyisobutene, squalane) of the multiphase composition.
Cheng discloses a composition for makeup removal or to clean keratin surfaces (abstract), where there are at least four visually distinct immiscible phases such as a first oil phase, a second oil phase, a silicon oil phase, and an aqueous phase (pg 2, summary of invention). Cheng states the reason for separate phases is that a product with different phases is visually appealing to shoppers (pg 1, background of invention). Cheng also teaches that makeup removers in two and three phases are known, and reasons for the separate phases are improved visual appearances, possible increase in ingredient number, and maximizing cleansing effect by incorporation of ingredients solvated by different solvents (pg 1, background of invention).
Regarding claim 17, 19-20, 23, 25, and 29: Cheng teaches a multiphase cosmetic composition (applied to the keratin surface; pg 8-9, ‘the method’) comprising a first oil phase, a second oil phase, and an aqueous phase that is without a surfactant (pg 2, ‘summary of the invention’). All phases are visually immiscible with one another, as demonstrated when the composition is at rest (before and after shaking) (pg 7, last paragraph; pg 8, first paragraph). There is no requirement for a surfactant (term not found in whole document).
Cheng teaches an immiscible oil phase comprising polyisobutene (defined as an apolar solvent of the second oily phase by instant claim 23) (pg 5-6, the first oil phase).
Regarding claim 24: Cheng teaches meadowfoam seed and jojoba seed oil (pg 5-6, the first oil phase).
Regarding claims 26-27: Cheng teaches sodium chloride, glycerin, and glycols (pg 7, the aqueous phase).
Regarding claims 30-32: Cheng teaches the composition to remove polycyclic aromatic hydrocarbons (PAH) or makeup from the keratin surface (i.e., skin on the face, as in ‘detailed description’) (abstract, technical field, Cheng – claim 7). Thus, a method of applying Cheng’s compositions to the skin is a prima facie obvious use of the prior art compositions for the purpose they’ve been designed to provide. “Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.”
In summary, Cheng teaches a multiphase composition (that could be formulated in 2, 3, or 4 phases, using different oil and aqueous phases) that includes oils such as polyisobutene for makeup removal or to clean keratin surfaces with the teaching that compositions with separate phases are attractive and can accommodate more types of ingredients. However, Cheng does not teach the surface tension and solubility parameters (instant claims 17-20), the solvent of the oily (polar) phase (instant claims 17-18), the squalane (i.e., apolar solvent) (instant claim 17), and a cosmetic active ingredient such as a vitamin (instant claim 28).
LaHousse teaches a cosmetic composition comprising incompatible hydrocarbon and silicone oils intended for making and/or caring (abstract, LaHousse – claim 1, [0059]). LaHousse teaches antioxidants, vitamins, moisturizing agents, neutralizing agents, fragrances, etc. [0454] (instant claim 28). Regarding the instant “polar” solvents, LaHousse teaches an oil phase that may comprise propylene glycol dibenzoate, dipropylene glycol dibenzoate [0082], triethyl citrate [0086], or castor oil [0088] (instant claims 17 and 29). Regarding the instant “apolar” solvents, LaHousse teaches squalane [0113], and the linear alkanes such as undecane, tridecane, isododecane, etc. [0264]. Additionally, LaHousse teaches a method of determining whether two oils are compatible (or miscible) [0057-0061], which does not require the calculation of surface tension value and solubility parameters using proprietary software as stated in the instant specification [31]. LaHousse teaches a direct mixing method of two different oils, and visual inspection to determine oil compatibility (or miscibility) [0057-0061]. Thus, LaHousse’s method of determining immiscibility of two oils would encompass the technique of narrower scope demonstrated by the instant application that determines immiscibility of a polar and an apolar oil, effectively making the concept of combining immiscible oils based on certain parameters prima facie obvious.
Keen motivates incorporation of vitamins and antioxidants (instant claim 28), as taught by LaHousse, into the compositions of Cheng, because Keen discusses the ability of vitamins (such as vitamin E) to protect the skin form deleterious effects of solar radiation in cosmetic dermatology products as a vitamin/antioxidant (abstract).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine polyisobutene taught in Cheng’s multiphasic cosmetic composition, with the ingredients (i.e., propylene glycol dibenzoate, dipropylene glycol dibenzoate [0082], triethyl citrate [0086], or castor oil [0088] and squalane [0113], undecane, tridecane, isododecane, etc. [0264]) taught in LaHousse’s multiphasic cosmetic composition to create a multi-phasic cosmetic composition. LaHousse teaches these oils as suitable for a cosmetic composition intended for making up or caring (abstract) that includes two immiscible (incompatible) oils, and LaHousse teaches a method of discerning whether these oils would be immiscible with the other oil phase taught by Cheng in order to create the multiphasic composition of the instant claims. One would be motivated to develop a multiphasic cosmetic product comprising these ingredients because it would be visually appealing, as stated by Cheng (pg 1, background of invention), and Cheng allows for oils that are immiscible with other layers in the composition (pg 2, summary of invention).
Furthermore, Keen motivates incorporation of vitamins and antioxidants (instant claim 28), as taught by LaHousse, into the compositions of Cheng, because Keen discusses the ability of vitamins (such as vitamin E) to protect the skin form deleterious effects of solar radiation in cosmetic dermatology products as a vitamin/antioxidant (abstract).
Finally, with respect to the instant surface tension and solubility parameters (instant claims 17-20), individual species of the first oily phase (e.g., propylene glycol dibenzoate, dipropylene glycol dibenzoate [0082], triethyl citrate [0086], or castor oil [0088]) and second oily phase (e.g., polyisobutene (Cheng, pg 5-6, the first oil phase), undecane, tridecane, isododecane, squalane, etc. [0113, 0264]) from the obviousness analysis of the prior art, are identified by Applicants specification with the appropriate parameters to be suitable to form the oily phases of the instant claims (Specification Table 2 [36] and Table 4 [50]). Thus, the surface tension and solubility parameter requirements of the composition of instant claim 17 are expected by mixing the species of the art. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Thus, mixing the instant species (which are identified by the combined prior art) will provide compositions, where the property ranges of the polar and apolar layers overlap with the instant ranges, and renders the instant ranges as obvious. In order to break the obviousness of the analysis for a composition, an unexpected result must be demonstrated for the properties of the instant ranges, by demonstration of criticality of range (see arguments section for additional discussion).
Additionally, with respect to the surface tension values and solubility parameters (of instant claims 17-20) (as calculated by HSPiP software as stated in the specification [31]), the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Response to Arguments
Applicants arguments, see pg 6-11, filed 02/13/2026, with respect to the 103 rejection of claims 17-20, 23-28 and 30-32 under rejection have been fully considered but they are not persuasive. The 103 rejection has been modified with respect to amendments made to the claim set. The thrust of the rejection remains similar to before, but pointing to different sections of LaHousse for squalane.
On page 6-9, Applicant recites specific teachings from Cheng, as being different from the instant invention because Cheng’s phase separation is based on “specific gravity values” of the first and second oil phases (also inclusive of a silicone oil phase), Cheng teaches a composition of four phases, Cheng does not disclose the polar solvent (i.e., dipropylene glycol dibenzoate, propylene glycol dibenzoate, triethyl citrate, castor oil) nor squalane (i.e., newly required by instant claim 17), etc. However, in an obviousness analysis, specific embodiments do not define the teachings of a reference: “Applicants erroneously point to specific embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).” The fact that Cheng teaches a composition with four immiscible phases, does not detract from a broader teaching of Cheng: “Cheng states the reason for separate phases is that a product with different phases is visually appealing to shoppers (pg 1, background of invention). Cheng also teaches that makeup removers in two and three phases are known, and reasons for the separate phases are improved visual appearances, possible increase in ingredient number, and maximizing cleansing effect by incorporation of ingredients solvated by different solvents (pg 1, background of invention).” These teachings from Cheng are directly relevant to the obviousness analysis presented in the 103, as applied to the instant claim set.
Additionally, this argument is piecemeal and an obviousness analysis does not require a single reference to teach all elements but relies on the teaching of a combination of references: All elements of each prior art reference need not read on the claimed invention, rather, the proper test for obviousness is what the combined teachings would have suggested to a person of ordinary skill in the art. In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). In this case, Cheng is referenced primarily to demonstrate the obviousness of biphasic/multiphasic cosmetic compositions (that comprise oils and/or water). Furthermore, LaHousse teaches squalane and the additional polar solvents as obvious in multiphasic compositions. Finally, LaHousse teaches a method of determining miscibility that does not require an understanding of specific gravity or solvent polarity of solvents, solely by mixing different solvents [0057-0061]. For example, a PHOSITA could mix an oil and water, and see that they are not miscible; or a PHOSITA could mix a polar and nonpolar to determine whether or not they are immiscible. Thus, where the Prior Art guides the ingredients as obvious to multiphasic compositions, miscibility (or determining whether a composition is multiphasic) would be determined visually. Therefore, a rationale and feasible pathway toward synthetically constructing the instant multiphasic composition is possible based on the Prior Art teachings.
It should also be remembered that for a composition, the method of making does not have weight in terms of patentability. It must be remembered: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). When Applicant demonstrates the formation of the multi-phasic composition (see Example 2 on pg 18 of Applicant’s Specification [92-94] by example) by simple mixing of certain polar and apolar solvents, the manufacturing process is not considered to add any novel patentable weight to the final composition.
Furthermore, the method of producing an immiscible composition based on the criteria of surface tension and solubility parameter is also not considered to provide patentable weight to a composition by the above guidance on product-by-process. In view of this, the strategy of selecting a polar and nonpolar solvent (whereby a solubility parameter is a numerical representation of polarity, whereby Applicant’s Specification specifically states that “Hansen solublity parameters…allow predicting whether one substance will be soluble in another” [22]) with the intention of producing an immiscible composition is not novel, as taught by Sigma-Aldrich (2019). Sigma-Aldrich directly teaches the concept of “liquids tend to be miscible with liquids of a similar polarity, and the same is true for nonpolar substances” (pg 5). This further bolsters the rationale to combine a polar and apolar oil chosen from multiphasic compositions of the Prior Art (i.e., Cheng and LaHousse) in order to make multiphasic cosmetic compositions, which Cheng describes as visually appealing (pg 1, background of invention). By example, Sigma-Aldrich provides a limiting chart where immiscibility of polar and nonpolar solvents is demonstrated (pg 6), where the data was determined by the simple mixing test that is useful for testing miscibility of novel/new solvent combinations (pg 4-5, ‘how to determine miscibility’), that is also disclosed by LaHousse [0057-0061].
Finally, the establishment of the surface tension and solubility limitations (e.g., Hansen solubility parameters predict miscibility per Applicant’s Specification [22]) do not appear to provide an unexpected result and/or characteristic of the final composition (i.e., they are meant to inform on immiscibility of layers, but do not lead to improved properties, as demonstrated by evidence), in comparison to selecting known polar and nonpolar solvents of the Art, which are found to be immiscible by experimentation. In fact, Applicant states that the first and second oil phases specific surface tension and solubility parameters are intended only to make the first and second oil phases immiscible (on page 9 of the Arguments), and thus, not unexpected property or effect of the actual cosmetic is argued based on objective evidence (e.g., superior cleansing ability, etc.), except that the cosmetic is multi-layered.
On page 8-10, Applicant argues against the teachings of LaHousse by specifically emphasizing particular details of a specific embodiment of LaHousse. Again, specific embodiments of LaHousse do not define all of the teachings of LaHousse. Furthermore, this is again a piecewise argument, where the obviousness analysis relies on the combination of the Prior Art references. Similar to the arguments made against Cheng above in the response to arguments, the 103 rejection provides all necessary rationale to demonstrate the obviousness of the instant Application (including where LaHousse supports the teachings of Cheng). Thus, the limitations of the instant claim set are taught through the combination of the Prior Art, including the newly amended limitation of squalane [0113] by LaHousse.
On page 11, Applicant concludes.
Correspondence
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/R.P./Examiner, Art Unit 1614 3/5/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614