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 .
Summary
Receipt of Applicant's Remarks and Amendments filed on 04/07/2026 is acknowledged. Claims 1-12 are pending. Claim 7 is cancelled. Claim 1 is amended. Claims 1-6 and 8-12 are pending and under examination in this application.
Priority
The current application filed on 09/29/2023 claims priority to Korean patent application No. 10-2023-0003604 filed on 01/10/2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/02/2026 and 09/29/2023 are in compliance with the provisions of 37 CFR 1.98. Accordingly, the information disclosure statements have been considered by the examiner. Signed copies have been attached to this office action.
New Rejection Necessitated by Amendment
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 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sun (KR 20140123295 A) in view of Morley (US 2011/0158920 A1) and further in view of Takada (JP 2005-179243 A).
Sun teaches a cosmetic composition containing a transparent ceramide emulsion prepared by using ceramide, lecithin, heavy chain triglyceride, glycerin, water and an anionic surfactant, wherein the transparent ceramide emulsion has a small ceramide particle size, improves the skin barrier function, and strengthens the skin moisturizing power by reducing the amount of water-loss of the hard-skin surface (abstract). Furthermore, Sun teaches the gelling agents used to stabilize the transparent ceramide emulsion are typically conventional water-soluble polymers; for example, Sun discloses cellulose derivatives, microcrystalline cellulose (¶ 0008), and use of Carbopol (a well-known carbomer) (¶ 0078) as a standard means to achieve the desired viscosity for a cosmetic product while maintaining the transparency of the ceramide particles. The gelling agents in Sun's composition differ from Applicant's ethyl cellulose complex; however, the general teaching and use of a cellulose-based polymer gelling agent in a translucent cosmetic composition for stabilizing ceramide is taught, and it would have been obvious to a PHOSITA through routine substitution to select a specific commercial blend such as isostearyl alcohol/butylene glycol cocoate/ethyl cellulose in order to optimize to the “gel cream” texture.
Regarding claims 1, 2, 3, 8 and 10, Sun teaches a transparent ceramide emulsion comprising 0.1 to 5% by weight of ceramide, from 0.01 to 5% by weight of lecithin, from 1 to 15% by weight of heavy chain triglyceride, from 1 to 50% by weight of glycerin, from 30 to 70% water, and 0.01 to 5% by weight of the cosmetic composition (¶ 0008). Moreover, Sun explicitly teaches ceramide NP (ceramide 3B) (¶¶ 0002-0003, 0040). Furthermore, Sun discloses in Examples 1 and 2 that triglyceride is kept at 1.0 wt%, and teaches from 1 to 15 wt% of heavy chain triglyceride (claim 3 of Sun).
claim 5, Sun teaches 0.1 to 5 wt% of ceramide in the transparent cosmetic composition, and in Example 3, the ceramide concentration is at 0.5 wt% in order to maintain the “transparent” result (¶¶ 0054-0056).
Regarding claim 6, Sun teaches in Examples 1 and 2 that caprylic/capric triglyceride is utilized at 1 wt% as the oil phase to maintain a “transparent” state.
Regarding claim 9, Sun teaches hydrogenated lecithin (saturated lecithin) (¶¶ 0038-0039).
Regarding claim 11, Sun teaches caprylic/capric triglyceride (¶¶ 0056, 0078).
Regarding claim 12, Sun teaches an emulsified gel cream formulation (¶ 0008, second paragraph, and claim 6 of Sun).
Sun fails to specifically teach the individual ratios of ceramide, gelling agent, lecithin, and oil as claimed.
Morley teaches a method for producing a bigel, the method comprising: (a) providing an oleogel comprising at least one oily agent gelled with at least one cellulose polymer; (b) providing an aqueous gel comprising at least one component whose viscosity is pH-dependent, such as a carbomer; (c) mixing the oleogel and the aqueous gel together to form a bigel; and (d) subsequently adjusting the viscosity of the bigel under high flow and low shear stirring to obtain a bigel of a desired viscosity (abstract). Furthermore, Morley teaches that the level of gelling provided by ethyl cellulose in the oleogel, and hence its viscosity, depends upon both the proportion and the grade of the ethyl cellulose — specifically, higher amounts of ethyl cellulose will generally be used when the grade of the ethyl cellulose is lower (¶ 0033). To adjust viscosity, suitable components include carbomers and/or sodium carboxymethylcellulose (¶ 0053), and carbomer is a generic name for a family of polymers known as Carbopols® (¶ 0054). As noted above in view of Sun, it would have been obvious to a PHOSITA through routine substitution to select a specific commercial blend such as isostearyl alcohol/butylene glycol cocoate/ethyl cellulose in order to optimize the “gel cream” texture.
Regarding claims 4 and 5, Morley teaches providing an oleogel comprising at least one oily agent gelled with at least one cellulose polymer (¶ 0012), wherein the cellulose polymer may be chosen from ethyl cellulose, non-sodium carboxymethylcellulose, and mixtures thereof (¶ 0026), and ethyl cellulose is present in a proportion of between about 0.01 and 5% or 0.1 and 10% by weight (¶¶ 0031-0032). Morley further discloses that in one specific embodiment the oily phase comprises ethyl cellulose in a proportion of between about 1 and about 10% by weight (¶ 0034), and suggests higher weight percentages to ensure stability (¶¶ 0035-0044). Therefore, the limitation of gelling agent greater than or equal to about 1 wt% is taught.
Regarding claim 6, Morley teaches the preparation of bigels where the oil phase is gelled by a polymer, and that the ratio of gelling agent to the oil phase must be sufficient to trap the oil within the polymer matrix. For ethyl cellulose, this typically requires the polymer concentration to be equal to or greater than the oil concentration when the total oil phase concentration is low, approximately 1 wt% (¶¶ 0054-0070).
Takada teaches isostearyl alcohol (¶ 0020), ethyl cellulose (¶ 0033), coconut oil (¶ 0018), coconut oil fatty acid (¶¶ 0024, 0028), and fatty acid esters (¶ 0027), which correspond to butylene glycol cocoate — each of which is a standard cosmetic solvent compatible with ethyl cellulose-based gels, used to modify texture and solubility. Therefore, the amended limitations of claim 1 are explicitly taught by the combined references.
It would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention to arrive at the claimed translucent composition by modifying Sun’s transparent ceramide cosmetic composition through optimization and adjustment of the claimed ratios of ceramide, gelling agent, lecithin, and oil to achieve the “translucent gel cream” cosmetic composition.
Sun teaches a clear baseline for achieving a translucent appearance by utilizing a specific lipid ratio of ceramide, lecithin, and oil and maintaining nano-sized droplets in the formulation. However, Sun does not teach the technical “feel” and lightness of a modern skincare product. Morley teaches the technical solution of utilizing ethyl cellulose-based gelling agents to transform liquid lipid phases into stable, semi-solid gel creams. Accordingly, it would have been reasonably obvious to combine Sun with Morley, and a PHOSITA would have been motivated to combine the known cosmetic ingredients (ceramide, lecithin, and triglycerides) and optimize the structure using a standard cellulosic polymer. The resulting ratios (gelling agent ≥ ceramide and gelling agent ≥ oil) are the predictable outcome of combining the minimum polymer concentration required for gelation (1 wt%) as taught by Morley with the maximum oil/lipid concentration permissible for translucency (1 wt%) as taught by Sun.
Moreover, it would have been prima facie obvious to a PHOSITA to combine the references because the claimed invention employs known elements and methods to yield predictable results. Sun explicitly teaches ceramide NP (ceramide 3B), hydrogenated lecithin, and caprylic/capric triglyceride as the optimal combination for a transparent skin barrier product. The claimed ranges (0.5–1.0 wt% ceramide and ≤1 wt% oil) are explicitly disclosed as the “ideal” working embodiments in Sun for achieving translucency. Moreover, the addition of a specific ethyl cellulose gelling agent as taught by Morley to the emulsion of Sun to create a “gel cream” is a routine formulation modification intended to improve the product’s shelf stability and sensory profile.
The prior art explicitly teaches motivation to combine. Sun provides the ceramide, lecithin, oil, and translucent base. Morley provides the solution to convert liquid oil phases into a stable gel cream using ethyl cellulose, thereby preventing ceramide precipitation, a known stability concern in ceramide emulsions (see Sun ¶ 0012 discussing stability issues). Takada teaches that isostearyl alcohol (¶ 0020), ethyl cellulose (¶ 0033), coconut oil (¶ 0018), coconut oil fatty acid (¶¶ 0024, 0028), and fatty acid esters (¶ 0027), which correspond to butylene glycol cocoate, are standard cosmetic solvents compatible with ethyl cellulose-based gels used to modify texture and solubility. A PHOSITA would have been motivated to substitute or supplement Sun’s carbomer- or cellulose-based gelling agent with Morley’s ethyl cellulose system and add common fatty alcohol/ester solvents to achieve a gel cream texture while maintaining translucency and ceramide stability. This is a predictable optimization. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). The claimed invention amounts to the combination of known elements (ceramide nanoemulsion + ethyl cellulose oleogel + standard cosmetic solvents), each performing its expected function, yielding predictable results.
Response to Arguments
Applicant argues that the specific gelling agent complex (isostearyl alcohol + butylene glycol cocoate + ethyl cellulose) provides unexpected ceramide stabilization and that Sun’s transparency would be destroyed by combining with Morley. These arguments are unpersuasive for the following reasons:
1. Motivation to Combine is Clearly Established
Sun teaches a transparent ceramide nanoemulsion for skin barrier repair. A known problem in Sun is stability and texture. Morley teaches that ethyl cellulose-based oleogels can transform liquid oils into stable, semi-solid gel creams while maintaining optical clarity or translucency. A PHOSITA seeking to improve Sun’s texture and prevent ceramide precipitation would have been motivated to incorporate Morley’s gelation technology. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007) (combination of familiar elements according to known methods is likely obvious when it yields predictable results).
2. No Destruction of Sun’s Primary Purpose
Applicant argues that adding Morley’s gelling system would destroy “transparency.” However, Sun itself uses gelling agents (cellulose derivatives and Carbopol) to stabilize the emulsion while maintaining transparency — see Sun ¶¶ 0008, 0078. Morley’s ethyl cellulose gelling does not inherently destroy transparency; it forms clear or translucent bigels (Morley ¶¶ 0012, 0026, 0054-0070). Furthermore, the claimed composition is “translucent,” not “transparent.” Thus, a minor reduction in transparency does not constitute a teaching away. In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994) (a reference does not teach away unless it criticizes, discredits, or discourages the modification).
3. Specific Gelling Agent Complex Is Obvious (Routine Substitution)
Applicant argues that the specific blend (isostearyl alcohol * butylene glycol cocoate * ethyl cellulose) is not taught. However, Morley explicitly teaches ethyl cellulose as the gelling polymer (¶¶ 0026, 0031-0034). Isostearyl alcohol and butylene glycol cocoate are common cosmetic solvents/emollients well known in the art. Their combination with ethyl cellulose in a commercial oleogel blend is a routine formulation choice. A PHOSITA would have expected that combining ethyl cellulose with standard fatty alcohols and esters would produce a stable oleogel without undue experimentation. In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012) (substitution of one known ingredient for another where properties are similar is obvious).
4. Unexpected Results Not Shown
Applicant cites Comparative Examples 1 and 2 to show ceramide precipitation without the claimed complex. However, Comparative Example 1 omits the entire gelling agent, not merely the specific complex. Accordingly, these comparative examples do not establish the unpredictability of the claimed combination relative to alternative gelling agents. No comparative data is provided showing that the claimed complex is superior to, for example, ethyl cellulose alone or ethyl cellulose combined with a different fatty alcohol or ester. Without such evidence, the argument of unexpected results fails. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (unexpected results must be shown by factual evidence, not mere attorney argument).
5. Rejection Under 35 U.S.C. § 103 Sustained in its Entirety
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDRE MACH whose telephone number is (571)272-2755. The examiner can normally be reached 0800 - 1700 M-F.
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/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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