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
Amendments to the Claims and Arguments/Remarks filed 16 December 2025, in response to the Office Correspondence dated 06 October 2025, are acknowledged.
The listing of claims filed 16 December 2025, have been examined. Claims 1-10 are pending. Claims 1-8 are amended and claims 9 and 10 are newly added. The examiner has reviewed the amendments for compliance with 35 U.S.C. § 132(a) and finds that the claims are supported by the originally-filed disclosure (support for the newly added claims is found in ¶[0024] and ¶[0034] of the specification).
Response to Amendment
The claims have been fully reconsidered in light of the applicant's remarks.
Claim 8 has been amended to recite that hardness is measured “at a room temperature ranging from 20°C to 28°C.” The applicant further relies on ¶[0055] of the specification describing hardness measurement using a FUDOH rheometer. The Examiner acknowledges that the applicant has now specified a temperature range for hardness measurement in the claim, and identified a measurement instrument and conditions in the specification. When read in light of the specification, the claim now provides a person of ordinary skill in the art with reasonable certainty as to the scope of the hardness limitation. Accordingly, the rejection of claim 8 under 35 U.S.C. § 112(b) is hereby withdrawn.
The claims have been amended and the examiner has carefully reconsidered the rejections under 35 U.S.C. § 103 in light of the applicant's arguments, however, the arguments are not persuasive for the reasons set forth below in the Response to Arguments. The rejection of claims 1-8 under 35 U.S.C. § 103 is maintained. In addition, new 35 U.S.C. § 103 rejections have been made for the newly added claims 9 and 10, as outlined below. An objection to the newly added claim 10 has been made as well for a typographical error in the claim.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 06 October 2025, since the art which was previously cited continues to read on the amended/newly cited limitations.
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 1-8 are rejected under 35 U.S.C. § 103 as being unpatentable over Goutayer et al. (US20190254941A1; published 2019-08-22, hereinafter referred to as “Goutayer”) in view of Lee et al. (KR20040009547A; published 2004-01-31, hereinafter referred to as “Lee”).
Goutayer discloses multilayered double water-in-oil-in-water emulsions having a gelled fatty phase used in preparing cosmetic compositions (¶[0001]). The emulsions of the invention comprise an internal aqueous phase, an intermediate gelled fatty phase, and an external aqueous phase (¶[0011]).
Goutayer teaches suitable hydrogel-forming material as carrageenan, xanthan gum, starch, and cellulose (¶[0303]), thus teaching the limitation of instant claim 2, wherein, “…a method of the invention may further comprise a step d) to add a viscosity-enhancing solution to the external aqueous phase…In one embodiment, the viscosity-enhancing solution comprises a base, in particular an alkaline hydroxide such as sodium hydroxide.” (¶[0345]), thus teaching the limitation of instant claim 3.
Goutayer teaches suitable organogel-forming material as, “…made of the esters of dextrin and fatty acid, such as dextrin palmitates” (¶[0091]), thus teaching the limitation of instant claim 4. Further, in Example 1 Goutayer discloses a multilayered emulsion comprising 0.20% by mass of an hydrogel forming material (Carbopol Ultrez 21) and 0.01 % by weight of sodium hydroxide, a salt of alkali metal, based on the total weight of the inner phase (¶[0375]-[0377]), disclosing all but the phosphate salt limitation of instant claim 5.
Example 1 also includes isononyl isononanoate oil, 20% by weight of the total intermediate phase dextrin palmitate organogel-forming materia,l and a stabilizer in the organogel intermediate layer (wherein a stabilizer, as described by the instant specification, exhibits a thickening effect to enhance stabilization of the organogel (¶[0030])) as 38.2% by weight of the total intermediate phase dipentaerythrityl hexacaprylate/hexacaprate (¶[0375]-[0377]), encompassing both the range limitation of instant claim 1 and 6. Example 1 also teaches the use of a water-soluble thickener in the outer aqueous phase as 0.09% carbomer based on the total weight of the outer phase, encompassed within the limitation range of instant claim 7.
Goutayer teaches viscosity of the emulsion measured at 25° C to be of 1-500,000 mPa·s (¶[0027]; 0.01-5000 dyne seconds/cm²), however the final viscosity of the gelled fatty phase intermediate phase is > 20,000 mPa·s (¶[0068]; 200 dyne seconds/cm²), which exceeds the range limitation of instant claim 6. The instant specification recites, “The organogel of the intermediate phase may have a hardness of 5 dyne/cm2 to 60 dyne/cm2, for example, 10 dyne/cm2 to 30 dyne/cm2. When the hardness of the organogel is less than the above range, gelation does not proceed and it thus becomes difficult to maintain the particle shape, and as a result, the multilayer emulsion structure may not be maintained. In contrast, when the hardness exceeds the above range, the hardening rate becomes fast, and thus it is not suitable for forming a multilayer emulsion, and spreadability on the skin may be poor.” (¶[0036]), however, the emulsion of Goutayer appears to be particularly stable (¶[0067]; also, for example embodiments as in ¶[0393] and ¶[0407]), with a final viscosity of the gelled fatty phase intermediate phase is > 20,000 mPa·s (¶[0068]; 200 dyne seconds/cm²), in which stability maybe optionally enhanced by the addition of 0.10% weight cationic polymer (Carbomer Tego 340FD; Evonik) to the intermediate phase droplets (¶[0394] and ¶[0408]). Thus, the hardness of the organogel of the intermediate phase, to achieve a suitable forming, spreadable and stable emulsion, then is a matter of routine experimental optimization, that can be tuned to achieve the desired softness/stiffness based the specific gelator and additives used. One would be motivated to try the 5-60 dyne seconds/cm2 of the instant claimed range for the intermediate phase, as it falls within the 0.01-5000 dyne seconds/cm² range disclosed as desirable for the final viscosity of the emulsion, as disclosed by Goutayer, indicating that this is range typical for cosmetic gel emulsions.
Goutayer discloses, “Additionally, when an emulsion of the invention in particular the fatty phase of droplets (G1), also comprises at least one fragrance, the external aqueous phase, even internal aqueous phase, may also comprise at least one buffer having a pKa of between 4.0 and 9.0, selected in particular from the group formed by phosphate buffers.” (¶[0330]), indicating the suitable addition of a phosphate salt to the inner hydrogel layer, however, does not explicitly require the use of a phosphate salt, nor more specifically at 0.0025-0.25 wt % based on the total weight of the inner phase, as required by the limitations of instant claims 1 and 5, respectively.
Lee discloses the use of sodium pyrophosphate, as a hydrogel matrix stabilizer (claim 3), used in an amount of 0.01 to 1.0% by weight based on the total weight of the hydrogel matrix layer (page 3, paragraph 2).
Thus, It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to add the missing limitation of adding 0.0025-0.25 wt % phosphate salt to the invention of Goutayer, as Goutayer discloses the optional use of phosphate buffers, which could be easily selected and applied by a person skilled in the art from salts which have buffering capacity, are used as pH adjusters for adjusting the pH of the inner water phase (see ¶[0307]), and the range of the compositional ratio could be derived by optimization through conventional formulation experimentation. Further, Lee discloses the use of sodium pyrophosphate as a gel stabilizer in a range overlapping the instant claimed range.
In addition, the hardness of the organogel could be selected and adjusted as appropriate by a person skilled in the art from the features in Goutayer, because the claimed range lies within the range taught by Goutayer to be suitable for gel emulsion cosmetics, achieved by conventional testing means according to the desired cosmetic properties, wherein the value reflects a gel-type texture firmness of the oil phase, that can be tuned to attain sufficiently predicted resultant technical effects. In summary, it would have been obvious to a formulator to combine these known elements to create a stable, multi-textured cosmetic within the limitations of the claimed ranges and ingredients as a result of routine optimization.
New Objections/Rejections
The following new rejections are made from the previous Office Correspondence dated 06 October 2025, as the Applicant's amendment necessitated the new grounds of rejection presented below based on the amended/newly cited limitations.
Claim Objections
Claim 10 is objected to because of the following informalities:
Claim 10 describes a group consisting of “retyl palmitate”, which is believed to be a typographical error, intended to be “retinyl palmitate”. Appropriate correction is required.
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, 9 and 10 are rejected under 35 U.S.C. § 103 as being unpatentable over Goutayer et al. (US20190254941A1; published 2019-08-22, hereinafter referred to as “Goutayer”) in view of Lee et al. (KR20040009547A; published 2004-01-31, hereinafter referred to as “Lee”).
Goutayer and Lee teach the limitations of instant claim 1, as described above, from which instant claims 9 and 10 depend.
New claims 9 and 10 recite the inclusion of specific active ingredients in the inner phase and intermediate phase, respectively. Goutayer discloses incorporation of active cosmetic ingredients into internal aqueous phases and oil phases (¶[0020], ¶[0031], ¶[0330], ¶[0393]-[0407]), specifically mentioning vitamin C [ascorbic acid] as an active substance (¶[0322]). Goutayer claim 15 recites that active substances maybe selected from among depigmenting agents, UV filters, peeling agents, antioxidants, active substances stimulating the synthesis of dermal and/or epidermal macromolecules, and anti-age agents or mixtures thereof, wherein in the specification teaches, “Said active substances are notably described in FR 1 558 849” (¶[0309]; referring to FR1558849A; published as FR3041251A1 on 24 March 2017) and notes, “Evidently, those skilled in the art will take care to select any above-mentioned additional compound(s) and/or active substance(s) and/or respective amounts thereof so that the advantageous properties of the emulsion of the invention are not or are not substantially altered by the envisaged addition. In particular, the type and/or amount of the additional compound(s) or active substance(s) are dependent on the aqueous or fatty nature of the phase under consideration of the emulsion of the invention. These adjustments are within the reach of skilled persons.” (¶[0331]).
FR1558849A, referenced by Goutayer (published as Michel (FR3041251A1; published 24 March 2017)), teaches, “A composition according to the invention may furthermore comprise at least one active agent, preferably chosen from … depigmenting agents, UV-screening agents, desquamating agents, antioxidants, active agents stimulating the synthesis of macromolecular dermal and / or epidermal, … and / or anti-aging agents,…and mixtures thereof…As a representative of anti-wrinkle or anti-aging agents that can be used in the present invention, mention may be made more particularly of adenosine, retinol and its derivatives [retinyl palmitate, retinol, retinal, tretinoin, retinoic acid, adapalene, tazarotene, isotretinoin], ascorbic acid and its derivatives, such as magnesium ascorbyl phosphate and ascorbyl glucoside; tocopherol and its derivatives, such as tocopheryl acetate; nicotinic acid and its precursors [niacinamide], such as nicotinamide; ubiquinone; glutathione and its precursors, such as L-2-oxothiazolidine-4-carboxylic acid; C-glycoside compounds and their derivatives, as described in particular below; …α-hydroxy acids [glycolic acid, kojic acid]; β-hydroxyacids, such as salicylic acid and n-octanoyl-5-salicylic acid; oligopeptides and pseudodipeptides and their acylated derivatives, in particular {2- [acetyl- (3-trifluoromethyl-phenyl) -amino] -3-methyl-butyrylamino} acetic acid and lipopeptides marketed by SEDERMA under the trade names Biopeptide CL, Matrixyl 500 and Matrixyl 3000…” (page 11, under “Additional compound(s)” heading).
Thus, It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to incorporate these well-known active ingredients into the respective aqueous or oil phases of the multilayer emulsion taught by Goutayer, as modified by Lee, to achieve their known cosmetic benefits (e.g., whitening, anti-aging, anti-oxidant) as such placement is conventional and predictable. The dependent claims merely represent the obvious application of known actives to a known cosmetic base. The applicant has not demonstrated any unexpected technical effect arising from the specific actives in combination with the claimed phosphate-regulated hydrogel system.
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 16 December 2025, have been fully considered. Claim 1 has been amended and the examiner has carefully reconsidered the § 103 rejection in view of the narrow phosphate salt concentration range (0.05–0.125 wt%), the functional requirement that this range yields spherical hydrogel particles with uniform particle size, and the applicant’s argument that the phosphate salt acts as a curing-rate modulator, not merely as a stabilizer or buffer.
The applicant argues that the combination of Goutayer and Lee fails to disclose the specific recited list of phosphate salts, and that the claimed amount of phosphate salt was not recognized as a result-effective variable for forming spherical, uniform particles. The applicant's arguments have been carefully considered but are not persuasive for the reasons set forth below.
Regarding the specific phosphate salt, Goutayer explicitly teaches the use of phosphate buffers as an optional component in the internal aqueous phase (¶[0330]). Lee specifically names sodium pyrophosphate (claim 3; page 3, paragraph 2). The list recited in amended claim 1, which includes disodium pyrophosphate and tetrasodium pyrophosphate, directly overlaps with and encompasses the specific sodium pyrophosphate taught by Lee. One of ordinary skill in the art, seeking to stabilize the hydrogel of Goutayer's emulsion, would be directly led to Lee's teaching of sodium pyrophosphate as a "hydrogel matrix stabilizer." The selection of a specific phosphate from the broader class of "phosphate buffers" taught by Goutayer, guided by Lee's explicit disclosure, is a matter of obvious selection. The mere recitation of a short list of known phosphate salts does not render the claim patentable when the prior art provides a direct roadmap to at least one member of that group.
Regarding the result-effective variable argument, the applicant argues that the claimed narrow range (0.05 wt% to 0.125 wt%) is critical because it controls the curing rate to produce spherical, uniform particles, and that Lee does not recognize this effect. This argument is unpersuasive. Lee discloses a broad range of 0.01 to 1.0 wt% for the sodium pyrophosphate stabilizer. The instant claimed range of 0.05 wt% to 0.125 wt% overlaps with and falls entirely within Lee's broader, disclosed range. There is a strong prima facie case of obviousness when the claimed range overlaps with a prior art range. The burden shifts to the applicant to show that the claimed range is critical and produces unexpected results. The applicant has provided argument regarding the criticality of the range but has not provided objective evidence (e.g., comparative examples) demonstrating that amounts outside the claimed range (e.g., 0.01 wt% or 0.5 wt%) fail to form spherical, uniform particles, or that the results are unexpectedly superior to what would be achieved by optimizing within the known range of 0.01 to 1.0 wt%.
Lee recognizes that sodium pyrophosphate is a "stabilizing agent" (page 3). The instant specification merely refines the understanding of how it stabilizes (i.e., by controlling curing rate). Recognizing the mechanism behind a known stabilizer's function does not make the stabilizer or its effective concentration range new. The variable, concentration of phosphate salt, was already recognized in the art as a factor affecting the properties of a hydrogel matrix. Optimizing that known variable to achieve a desired property (e.g., uniform particles) is precisely the type of routine experimentation that the obviousness statute is intended to cover (see In re Applied Materials, Inc., 692 F.3d 1289 (Fed. Cir. 2012), wherein optimization of a result-effective variable through routine experimentation is obvious).
Regarding the limitation "wherein hydrogel particles formed in the inner phase...have a spherical structure with a uniform particle size," this is an intended result or a property inherent in the product produced by the process. If Goutayer's emulsion, modified by the addition of Lee's phosphate stabilizer at an overlapping concentration, results in hydrogel particles, one would expect them to be generally spherical and uniform as a function of the emulsification process and stabilization. The applicant has not shown that this functional recitation patentably distinguishes the product from what would be obvious from the combination of prior art teachings.
The applicant argues that dependent claims 2-8 are allowable due to their dependency on claim 1. However, as the base claim is not in condition for allowance, the dependency argument fails. Furthermore, each of these limitations is taught by or would have been obvious from the combination of Goutayer and Lee.
More specifically, Goutayer explicitly lists carrageenan, xanthan gum, starch, and cellulose (¶[0303]), which falls within the applicant's list for claim 2. Goutayer teaches the use of sodium hydroxide (an alkali metal salt) in the inner phase (¶[0345], ¶[0377]), teaching the limitations of claim 3. Goutayer teaches "esters of dextrin and fatty acid, such as dextrin palmitates" (¶[0091]), which is within the applicant's list for claim 4. Goutayer discloses 0.20% hydrogel-forming material and 0.01% sodium hydroxide (¶[0375]-[0377]), which overlaps the claimed ranges. The addition of Lee's phosphate salt at a concentration (0.01-1.0%) that encompasses the claimed range makes the subject matter of claim 5 obvious. Goutayer's Example 1 includes dipentaerythrityl hexacaprylate/hexacaprate at 38.2 wt% of the intermediate phase (¶[0375]), which falls within the claimed 5-40 wt% range for a stabilizer. Goutayer also teaches these compounds as contributing to structure and stability, which is the function of a stabilizer, as defined by the applicant, thus teaching the limitations of claim 6. Goutayer's Example 1 uses 0.09% carbomer (a water-soluble thickener) in the outer phase (¶[0375]), which falls within the claimed range of 0.05-10 wt% of claim 7. Regarding claim 8, as previously established, Goutayer teaches that the final emulsion viscosity can be tuned within a broad range (0.01-5000 dyne seconds/cm², ¶[0027]). Achieving a specific target hardness (e.g., 5-60 dyne/cm²) within that broad, known range through routine formulation adjustments of the gelator and oil phase components would have been obvious to one of ordinary skill.
New claims 9 and 10 recite the inclusion of specific active ingredients in the inner phase and intermediate phase, respectively. The examiner acknowledges that Goutayer expressly discloses incorporation of active cosmetic ingredients into internal aqueous phases and oil phases (¶[0020], ¶[0031], ¶[0330], ¶[0393]-[0407]). Lee similarly teaches cosmetic actives within hydrogel matrices. The mere selection of known cosmetic actives from a finite list for incorporation into known phases of a cosmetic emulsion is considered prima facie obvious absent evidence of unexpected results or functional interaction. Accordingly, new ground of rejection is made for claims 9 and 10 under 35 U.S.C. § 103 as being unpatentable over Goutayer in view of Lee, as detailed below.
For the reasons set forth above, the pending claims 1-10 are not considered patentable.
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 (87 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 REBECCA L. SCOTLAND whose telephone number is (571) 272-2979. The examiner can normally be reached M-F 9:00 am to 5:00 pm EST.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615