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 .
Response to Amendment
The Amendment filed 06/22/2026 has been entered. Applicant’s amendments are in response to in the Non-Final Office Action mailed 03/20/2026. Applicant’s claims have been amended in the following manner: independent claim 17 has been modified by inclusion of “two oily phases and one aqueous phase”, and “a third phase which is an aqueous phase immiscible with the first and second oily phases” (which finds support at [56] of the Specification, or also found in the now-cancelled claim 25). Because claim 25 was covered by the previous 103 rejection, the same ground of rejection is applied to this Amendment (i.e., the amended claim set is not considered patentably distinct from the prior claim set, and only modification of the rationale was necessary).
The following objections/rejections are withdrawn: none.
The Examiner further acknowledges the following:
Claims 17-20, 23-24, 26-28 and 30-32 are pending.
Claims 17-20, 23-24, 26-28 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, 23-24, 26-28, 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), and 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., comprising 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 which 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, 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 06/22/2026, 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 slightly modified with respect to minor amendments made to the claim set.
On page 6-7, Applicant summarizes the status of the Application.
On page 7-10, Applicant separates arguments into an A-E format, which will be followed for reply (see below).
On page 7, Missing Elements of Cheng (A): In response to instant limitations not taught by Cheng, 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. Furthermore, Cheng is not required to teach all elements: 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). Additionally, see In re Keller, 642 F.2d 413, 426 (C.C.P.A. 1981) (citing Application of Young, 403 F.2d 754, 757 (C.C.P.A. 1968) (indicating that "[O]ne cannot show non-obviousness by attacking references individually where ... the rejections are based on combinations of references"). Thus, LaHousse provides the recited missing elements, per the 103 rejection above.
On page 7-8, Teaches Away from Triphasic Architecture (B): Cheng does not teach away from a tri-phasic mixture, nor does Applicant claim one (i.e., the instant claims recite a composition “comprising” two oily phases and one aqueous phase, whereby “comprising” is open-ended language).
Finally, the open-ended nature of the transitional term “comprising” in independent claim 17 does not preclude additional layers. The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) ("[L]ike the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended.").
On page 8-9, LaHousse does not teach ingredients as apolar or polar (C): First, regarding the selection of particular ingredients that comprise the layers of the combined Prior Art, it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985). The obviousness rejection provides rationale for combination, whereby not all concepts are bodily incorporated in the combination, but rather relies on what the references convey considered as a whole to a skilled artisan of the technology. Second, the Prior Art (i.e., Cheng and LaHousse) is sufficiently analogous to the instant invention of a multi-phasic composition. Applicant is reminded that the scope of analogous art is to be considered broadly. Wyers v. Master Lock Co., No. 2009-1412, 2010 WL 2901839 (Fed. Cir. July 22, 2010). Art is analogous if it is (1) from the same field of endeavor, regardless of the problem addressed, or (2) reasonably pertinent to the particular problem with which the inventor is involved. In re Clay, 966 F.2d 656, 658–59 (Fed. Cir. 1992). Thus, Cheng and LaHousse pertain to multi-phasic cosmetic compositions (i.e., even when Applicant provides specific details attempting to separate the references from the instant Application and/or each other; in which case references need not be analogous to one another).
Furthermore, the instant ingredients that make up the instant composition itself are obvious based on the combined Prior Art. In this case, Cheng and LaHousse teach oils and aqueous layers suitable for multi-layer cosmetic compositions. Especially, Cheng’s compositions demonstrate the obviousness to incorporate any oil (i.e., Cheng teaches oils both above and below a specific gravity of 0.92 in Cheng – claim 1, whereby specific gravity is a property, that describes relative density, that is known by a PHOSITA to predict the orientation of immiscible liquids – see Cheng at pg 5: “The term “specific gravity” means the density of a liquid compared to the density of water at 25℃. and 1 atmosphere pressure. The density of water at this temperature and pressure is 1.00.”; at pg 7-8: the visually distinct (i.e., immiscible) “phases will orient themselves based upon their specific gravity with the phases having the highest specific gravity forming the bottom phase and the phase with the lowest specific gravity the top phase with the other phases orienting between the bottom and the top dependent on their specific gravities in decreasing numerical order from bottom to top.”). Furthermore, the combination of Cheng and LaHousse teaches 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]). Thus, the phase separation is expected because when these ingredients are mixed, because their properties inherently provide separation into 3 layers (i.e., Sigma-Aldrich (2019) teaches elements of molecules that allow for separation of layers on pg 4-7). Applicant has not provided objective data to invalidate the expected outcome of phase separation, after obvious combination of the Prior Art ingredients. Furthermore, Howell (J. Phys. Chem. B, 2017) teaches Hansen solubility parameters (pg 4192) and surface tension (pg 4191, paragraph 3) are known considerations for solvent miscibility (pg 4191, paragraph 1-2), and thus separation of layers based on these principles is an expected result, based on the Art. However, the Office has neither the time nor resources to mathematically prove that the mixture of ingredients would phase separate similarly to the parameters of the instant claims.
On page 8-9, Cheng and LaHousse rely on silicone oils (C-1): Note that the claims as written do not preclude silicone. Limitations are being argued that are not claimed: Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1571-72, 7 USPQ2d 1057, 1064-1065 (Fed. Cir.), cert. denied, 488 U.S. 892 (1988) (Various limitations on which appellant relied were not stated in the claims; the specification did not provide evidence indicating these limitations must be read into the claims to give meaning to the disputed terms.); In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) (although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims). The references are still analogous to instant Application as a multi-phasic composition.
Furthermore, the open-end nature of the transitional term “comprising” in claim 17 would allow for silicone oils in the instant composition. The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) ("[L]ike the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended.").
Further note that specific embodiments do not define the teachings: “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).” Thus, the inclusion of silicone in Cheng and LaHousse do not preclude the overall teachings related to oils and components of the organic and aqueous phases in multi-layered cosmetics, in relation to the instant composition.
On page 9, Highly Unpredictable (C-2): Applicant’s claim that separating polar organic esters from apolar organic hydrocarbons in a single surfactant free matrix without a silicone phase is highly unpredictable. Applicant has not provided evidence the specific unpredictability of the Art to challenge the obviousness of the modification. This is a per se argument. In fact, Sigma-Aldrich (2019) provides an entire example table, demonstrating how routine a determination for miscibility of esters and hydrocarbons is, based on simple mixing tests (pg 4-7). For example, hexanes (non-polar oil) and ethyl acetate (polar oil) are not miscible according to the table (which is demonstrated by a simple mixing test), which are, as organic molecules, both further immiscible from water (pg 6), which quickly demonstrates the core 3-layer architecture of Applicant’s invention (made by 2 organic and 1 aqueous layer), as enabled by the Prior Art. Furthermore, Howell (J. Phys. Chem. B, 2017) teaches Hansen solubility parameters (pg 4192) and surface tension (pg 4191, paragraph 3) are known considerations for solvent miscibility (pg 4191, paragraph 1-2), and thus separation of layers based on these principles is an expected result, based on the Art. Thus, the result of the 103 modification of a multi-phasic compositions of the combined Prior Art, that incorporates specific ingredients, is enabled for production.
Additionally, note that the patentability of a composition is generally based on the composition’s structure itself (except for a demonstration of non-obviousness through objective data), and not the method of making the composition (i.e., including method of ingredient selection process). 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). Therefore, Applicant’s “method” of using certain solubility and surface tension parameters to select for immiscibility are not considerations of a composition claim. The obviousness for the specific ingredients of the multi-phasic composition is provided in the 103 rejection above.
Furthermore, it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985). Thus, the selection of the instant ingredients on the basis of the many disclosed of the combined Prior Art is still obvious.
Finally, Cheng provides motivation to select ingredients of the Prior Art that will phase separate on mixing. Regarding motivation: See In re Sernaker, 702 F.2d 989, 994-95 (Fed. Cir. 1983) (“The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.”). Thus, Cheng 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).
On page 9-10, Impermissible Hindsight (D): As for the assertion that the rejection is based on hindsight, as noted in MPEP 2145, “[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper.” In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). The Examiner has pointed to nothing other than what the art available at the time the instant application was filed to teach or suggest each and every limitation of the invention claimed, and relied on nothing other than the art to rationalize their combination in the manner you put forth.
If there is concern that specific ingredients are selected from a large number of ingredients within multiple references, it should be remembered that it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985). The so-called “portions” of LaHousse all fall within the LaHousse reference as a whole, and are obvious oils and esters that would be selected as a part of the larger generic genus of oils taught by Cheng for multi-layered compositions (Cheng – claim 1, ‘first oil phase’, ‘second oil phase’). Thus, when the combined Prior Art teaches a basic structure of a composition that comprises two immiscible organic layers and an immiscible aqueous layer, and the instant ingredients are named as obvious, and are expected to separate into distinct layers, then the instant composition as a whole is obvious. The arguments herein against the proposed modification in the 103 rejection are not persuasive, and no objective evidence has been yet provided to demonstrate non-obviousness of the modification.
Note, the parameter-based immiscibility framework of the instant claims is a by-product (i.e., a secondary effect) of selecting the Prior Art ingredients that are demonstrated as obvious for the production of multi-phasic compositions (i.e., the instant ingredients inherently have specific surface tension and solubility values, that Howell discusses as determinants for solvent immiscibility). Applicant has not provided objective evidence that a composition made of the ingredients selected from the Art (as disclosed in the 103 modification) would not result in a multi-phasic composition.
On page 10, Keen (E): Keen has only been incorporated to motivate the additional ingredients vitamins and antioxidants (instant claim 28), whereas the main arguments are addressed by Cheng and LaHousse as described above.
On page 11, Applicant concludes.
Correspondence
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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/R.P./Examiner, Art Unit 1614 7/27/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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