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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 29 May 2026 has been entered.
Status of the Claims
Amendments to the Claims and Arguments/Remarks filed 29 May 2026, in response to the Office Correspondence dated 02 March 2026, are acknowledged.
The listing of Claims filed 29 May 2026, have been examined. Claims 1, 2, 4, and 6-11 are pending. Claims 1 and 10 have been amended, claims 3 and 5 have been canceled, and new claim 11 has been added.
Response to Amendment
The applicant's Amendment and Remarks filed 29 May 2026 have been fully considered. The applicant has amended claim 10 to correct the typographical error. Accordingly, the prior objection to claim 10 is withdrawn.
The applicant's amendments change the legal posture of the previous Office Correspondence 35 U.S.C. § 103 rejections. In particular, the amended of independent claim 1 introduces new limitations. The amendment narrows claim 1 by reciting a specified phosphate salt, phosphate concentration of 0.05-0.125 wt%, calcium concentration of 0.005-0.5 wt%, phosphate modulating the curing rate of the hydrogel by calcium, and production of spherical hydrogel particles having a uniform particle size. Accordingly, the prior rejections under 35 U.S.C. §103 based on independent claim 1 prior to amendment are withdrawn.
Upon evaluation of the newly recited limitations against the prior art, claims 1, 2, 4, and 6-11 are however newly rejected under 35 U.S.C. §103 based on the cited prior art because the newly added limitations would have been obvious to one of ordinary skill in the cosmetic hydrogel formulation art for the reasons outlined below.
Claim Objections
Claims 4 and 7 are objected to because of the following informalities:
Claim 4 contains potential typographical/spelling errors. "Polyimide-2" appears alongside "polyamide-3", "polyamide-5", and "polyamide-8." The term "polyimide-2" may be a typographical error for "polyamide-2", consistent with the other polyamide entries. The specification should be checked and verified as well. The applicant should confirm whether "polyimide-2" is correct or amend the claim to "polyamide-2."
In addition, the recitation "glyceryl behenate/eicosadioate" contains a non-standard term "eicosadioate." The intended INCI or chemical name is unclear. The intended compound may be "glyceryl behenate/eicosadienoate" or a similar recognized INCI name. The specification should be verified, and the correct term/spelling should be used consistently.
Claim 7 contains the phrase "water soluble thickener" which lacks a hyphen and should be corrected to "water-soluble thickener" to match standard scientific grammar and its representation in the specification.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which Applicant regards as his invention.
Claims 1, 2, 4, and 6-11 are rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
In claim 1, the term "sodium tetraphosphates" as recited in claim 1 is ambiguous and non-standard in chemical nomenclature. The specification uses the same term without providing a chemical formula, CAS number, or other definition that would allow a person of ordinary skill in the art to ascertain with reasonable certainty which specific compound(s) fall within the scope of this term. The term does not correspond to a recognized common name for a specific phosphate salt.
For example, the plural sodium tetraphosphates could be interpreted as singular sodium tetraphosphate (Na₆P₄O₁₃), or could be intended to refer to known phosphate salts of sodium including sodium pyrophosphate (tetrasodium pyrophosphate, Na₄P₂O₇; already separately recited), sodium tripolyphosphate (Na₅P₃O₁₀; already separately recited), sodium hexametaphosphate ((NaPO₃)₆), sodium trimetaphosphate (Na₃P₃O₉), and sodium orthophosphate (trisodium phosphate, Na₃PO₄; already separately recited) or specific known phosphate such as sodium hexametaphosphate or sodium polyphosphate.
Because the scope of the claim term "sodium tetraphosphates" cannot be determined with reasonable certainty, the claim is indefinite (see Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910 (2014)). Appropriate correction is required to clarify the intended compound, such as by providing the chemical formula, CAS number, or substituting a recognized common name, or changing the plural to singular if sodium tetraphosphate is intended (see MPEP 2173.05(e)).
Further, the phrase "wherein hydrogel particles formed in the inner phase" lacks proper antecedent basis. Claim 1 initially introduces "an inner phase of a hydrogel layer", but never establishes or defines the creation of distinct "hydrogel particles" from said layer. Because the claim shifts from a "hydrogel layer" to "hydrogel particles" without clarifying the process or structural relationship between the layer and the particles, the exact physical form of the inner phase is left ambiguous. Appropriate correction to resolve the lack of antecedent basis for "hydrogel particles" in claim 1 is required.
Dependent claims 2, 4, and 6-11 are included in this rejection because they do not cure the defect noted above in claim 1, from which they depend.
Claim 8 is indefinite for the phrase "a hardness of the organogel of the intermediate phase" which lacks clean antecedent basis. Claim 1 recites "an intermediate phase of an organogel layer". The phrase should refer to "the organogel layer" to maintain structural consistency. Appropriate correction to resolve the lack of antecedent basis for "the organogel" in claim 8 is required.
Claim 11 is rejected as indefinite as well. Claim 11 states that the calcium salt is contained in an amount of 0.1 wt% and the phosphate salt is contained in an amount of 0.1 wt% based on the total weight of the inner phase. However, claim 1 explicitly requires that the phosphate salt must be contained in an amount of 0.05 wt% to 0.125 wt% to "modulate a rate of curing" and ensure that the hydrogel particles "have a spherical structure with a uniform particle size".
By fixing the phosphate salt amount at "0.1 wt%" and the calcium salt at "0.1 wt%," claim 11 effectively eliminates the variability that claim 1 establishes as essential to the "modulation" function. This creates a contradictory claim construction scenario where the scope of the invention is unclear. The examiner questions whether a composition with a fixed 1:1 ratio of these specific salts can simultaneously satisfy the requirement for the phosphate salt to be "in an amount" within a range defined to allow modulation, when the very act of modulation implies a variable ratio or concentration adjustment to achieve the desired cure rate. The indefinite nature lies in the inconsistency between the functional requirement for a modulatable system in claim 1 and the rigidly fixed, single-point composition of claim 11. Therefore, the claim fails to particularly point out and distinctly claim the subject matter which the applicant regards as the invention.
In addition, according to the specification's explicit teachings in Table 2, Example 4 illustrates that a co-equal dosing of 0.1 wt% calcium chloride and 0.1 wt% tetrasodium pyrophosphate successfully creates an operative, uniform spherical hydrogel. However, claim 11 is broadly drafted to encompass any calcium salt and any phosphate salt listed in the Markush group at those exact 0.1 wt% ratios, wherein the specification warns that if the ratio or concentration of the specific phosphate salt relative to the specific calcium salt breaks down, the rate of delaying the curing velocity becomes either insufficient or excessive.
Because claim 11 generalizes this co-equal weight percentage across chemically distinct alternative species (e.g., “sodium tetraphosphates” or disodium pyrophosphate vs. calcium carbonate or calcium sulfate) without factoring in their highly disparate molecular weights, solubilities, and stoichiometric ion releases, the 0.1 wt%/0.1 wt% ratio will inevitably generate inoperative embodiments that fail to gel or fail to form uniform spherical particles. Accordingly, it is not clear how claim 11 achieves the asserted utility over its entire scope.
To overcome this rejection, one possibility would be to limit claim 11 to the 0.1 wt% ratio strictly to the operative calcium chloride and tetrasodium pyrophosphate species pair and consider removing the functional modulation language from the claim in which it depends.
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, 2, 4, and 6-11 are rejected under 35 U.S.C. § 103 as being unpatentable over Goutayer et al. (US20190254941A1; published 2019-08-22, hereinafter “Goutayer”) in view of Lee et al. (KR20040009547A; published 2004-01-31, hereinafter “Lee”), and in further view of Schmidt and Means (US4603054A; published 1986-07-29, hereinafter “Schmidt”) and, Goldenberg and Beekman (US20020001619A1; published 2002-01-03, hereinafter “Goldenberg”).
Goutayer discloses cosmetic a water-in-oil-in-water emulsion comprising an external continuous aqueous phase, droplets comprising a continuous fatty phase, and an internal aqueous phase (Abstract). Goutayer further explain that the emulsion comprises an internal aqueous phase, an intermediate gelled fatty phase, an external aqueous phase, and that the intermediate fatty phase contains a lipophilic gelling agent (¶[0006]-[0015]). Accordingly, Goutayer teaches the claimed three-layer cosmetic emulsion architecture.
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]).
Goutayer teaches an organogel intermediate phase as a fatty phase containing one or more oils together with one or more lipophilic gelling agents and that the amount of gelling agent may range from about 0.5-99.99 wt%, preferably 1-70 wt%, including narrower preferred ranges (¶[0064]-[0073]). 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]).
Example 1 also includes isononyl isononanoate oil, 20% by weight of the total intermediate phase dextrin palmitate organogel-forming material 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.
Thus, the instant claimed requirement that the intermediate phase comprise oil and an organogel-forming material present at 5-40 wt% therefore overlaps Goutayer's disclosed preferred ranges. Where the claimed range overlaps a range disclosed by the prior art, a prima facie case of obviousness exists (see MPEP §2144.05 and In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003).
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 teaches the outer aqueous phase as the external phase is an aqueous phase containing water and optional viscosity modifiers, bases, and other cosmetic ingredients (¶[0032]-[0044]). 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.
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).
Lee discloses a hydrogel matrix patch for tooth whitening comprising a hydrogel layer containing a water-soluble adhesive (hydrogel-forming material; e.g., polyacrylic acid), a neutralizing agent (e.g., sodium hydroxide), a cross-linking agent, an emulsifier, and a stabilizer (e.g., tetrasodium pyrophosphate; page 3, lines 35-48.) Lee teaches that the stabilizer "stabilizes effective whitening components" (page 3, lines 43-44). 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). Lee's Table 1 shows formulations containing 0.5 wt% tetrasodium pyrophosphate (a phosphate salt) with polyacrylic acid (a hydrogel-forming material) and a calcium salt (potassium aluminum sulfate) (page 5, Table 1 showing tetrasodium pyrophosphate and potassium aluminum sulfate).
Lee further discloses the use of calcium salt crosslinking agents, such as calcium chloride and calcium oxide, preferably used in an amount of 0.01 to 5.0% by weight based on the total weight of the hydrogel matrix layer (page 2, second to last paragraph).
The phosphate salt is present as a stabilizer, and one of ordinary skill in the art would have understood that phosphate salts such as tetrasodium pyrophosphate are known to modulate the crosslinking/curing of hydrogel-forming materials, particularly in the presence of multivalent cations such as calcium, by sequestering calcium ions, as evidence by Schmidt.
Schmidt explains the chemistry of calcium-alginate gel formation. Specifically, Schmidt teaches that sodium tripolyphosphate, sodium hexametaphosphate, pyrophosphate and related phosphate salts act as sequestrants which temporarily bind calcium ions and thereby delay gel formation. Schmidt states that sodium tripolyphosphate is employed in alginate/calcium systems and explains that increasing sequestrant concentration progressively delays calcium availability because calcium ions preferentially bind the phosphate before reacting with alginate, wherein increasing sequestrant concentration produces progressively weaker gels because more calcium remains complexed with phosphate before becoming available for alginate crosslinking. (col. 1, lines 26-63; col. 8, lines 1-7; col. 9, lines 23-32). Thus, Schmidt expressly teaches regulating calcium-induced gelation by controlling phosphate concentration.
Goldenberg teaches a hydrogel-forming material (including alginate) in an aqueous inner phase, wherein a hydrophilic polymer and polyvalent calcium ions react to form sustained-release alginate hydrogel beads (¶[0012]-[0014]; claims 18-26). The specification states, "Polyvalent cations are known to react with alginates and spontaneously form gels." (¶[0005]). Thus, Goldenberg teaches an aqueous hydrogel phase comprising water, a hydrogel-forming polymer, inclusion of a calcium salt in the aqueous hydrogel phase, and calcium-responsive gelation.
In summary, Goutayer discloses a cosmetic double emulsion having an internal aqueous phase, an intermediate gelled fatty phase, and an external aqueous phase for encapsulating cosmetic actives. Lee provides the specific combination of a calcium salt and a phosphate salt in the hydrogel-forming material. Goldenberg teaches formation of calcium-crosslinked hydrogel particles from alginate-containing aqueous droplets. Schmidt teaches that phosphate salts such as sodium tripolyphosphate and pyrophosphate function as calcium sequestrants that delay calcium availability and thereby regulate the rate of calcium-alginate gel formation.
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 the calcium-crosslinked alginate hydrogel system of Goldenberg into the aqueous internal phase of Goutayer's cosmetic multilayer emulsion because the references all address encapsulation of active ingredients within aqueous compartments while improving structural stability and sustained release.
It would have been obvious to one of ordinary skill in the cosmetic formulation art to incorporate the calcium-crosslinked hydrogel system of Goldenberg into the aqueous internal phase of Goutayer's cosmetic multilayer emulsion because both references address encapsulation of active ingredients within aqueous compartments while improving structural stability and sustained release. Doing so merely substitutes components of one known hydrogel encapsulation technology for another predictable hydrogel encapsulation technology, wherein combining familiar elements according to known methods to obtain predictable results is obvious (see MPEP §2143(I)(B) and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007)).
Further, it would have been obvious to incorporate the calcium salt and a phosphate salt in the hydrogel-forming material as taught by Lee into Goldenberg's calcium-alginate system because Schmidt's teaches phosphate salt sequestrants delay calcium release and thereby regulate the timing and kinetics of gel formation. A skilled cosmetic formulator seeking to produce uniform encapsulated hydrogel particles within Goutayer's emulsion would have recognized that delaying gelation permits improved droplet formation before complete crosslinking. The modification therefore represents the predictable application of a known gelation-control technique to a known alginate encapsulation system (see MPEP §2143(I)(D)).
Goldenberg teaches bead formation, which would be considered a spherical structure with a general uniform particle size and Goutayer teaches monodisperse droplets. Schmidt teaches delayed calcium availability and controlled gelation through sequestration, which strongly supports this instant claimed limitation that the phosphate concentration "modulates a rate of curing" is a predictable result. The claimed concentration ranges and resulting particle morphology would have been obtained through routine optimization of known result-effective variables rather than representing an unexpected result.
Furthermore, optimization of phosphate concentration to obtain an appropriate gelation rate constitutes optimization of a recognized result-effective variable. Schmidt expressly teaches that sequestrant concentration affects gelation kinetics and gel strength. Once a parameter is recognized as affecting the desired result, discovering an optimum or workable value through routine experimentation is ordinarily obvious (see MPEP §2144.05 and In re Aller, 220 F.2d 454 (CCPA 1955). Likewise, selection of workable calcium concentrations for alginate crosslinking would have been routine optimization (see In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003)).
The presently claimed organogel-forming materials constitute members of a well-known class of cosmetic lipophilic gelling agents used interchangeably to structure oil phases, as taught by Goutayer. Selection of one known cosmetic organogelator from another known cosmetic organogelator would have represented nothing more than routine formulation design based upon desired viscosity, sensory feel, transparency, or stability (see MPEP §2144).
Goutayer teaches that the fatty phase may include numerous optional formulation ingredients used to improve emulsion stability, viscosity, and long-term kinetic stability. The reference further teaches adjustment of fatty phase composition to obtain desired stability. Thus, selection of an effective concentration would have been routine optimization (see MPEP §2144.05).
Goutayer expressly teaches that the external aqueous phase may be gelled and possess a viscosity sufficient to suspend the encapsulated droplets (¶[0032]-[0044]) disclose viscosity modifiers and aqueous gelling systems. Increasing viscosity of the external aqueous phase through water-soluble thickeners represents a conventional cosmetic formulation technique. Optimization of thickener concentration constitutes optimization of a recognized result-effective variable (see MPEP §2144.05).
Goutayer teaches measurement of viscosity and rheological properties of the gelled oil phase and explains that gel strength depends upon gelling-agent concentration. Mechanical hardness is an inherent property of organogel composition. Optimization of hardness through adjustment of gelling-agent concentration would have been routine experimentation (see MPEP §2144.05). Goutayer also broadly teaches encapsulation of cosmetic active ingredients within the internal aqueous phase (¶[0002]-[0016]). The applicant's listed ingredients were well-known hydrophilic cosmetic actives before the effective filing date. Selection of a particular cosmetic active from among known hydrophilic cosmetic actives would have been obvious based upon desired cosmetic benefit (MPEP §2144).
A 0.1 wt% calcium salt and 0.1 wt% phosphate salt are encompassed within the ranges taught by Lee. Further, Goldenberg recognizes calcium concentration as governing gel formation. Schmidt recognizes phosphate concentration as governing sequestration and gelation rate. Thus, both variables are recognized result-effective variables. Once the prior art recognizes that calcium concentration controls crosslinking, and phosphate concentration controls sequestration, determining suitable working concentrations through routine experimentation would have been obvious (see MPEP §2144.05, In re Aller, 220 F.2d 454 (CCPA 1955), and In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003)). The applicant's selection of 0.1 wt% calcium salt and 0.1 wt% phosphate salt represents optimization of recognized result-effective variables absent evidence of criticality or unexpected results.
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 29 May 2026, have been fully considered.
Regarding amended claim 1, it is noted that the phrase "wherein the amount of the phosphate salt modulates a rate of curing" is a functional statement. It does not impart a patentable structural distinction to the physical composition itself. In a composition claim, the patentability of the product is determined by its physical, structural composition, not by how it behaves during manufacturing (e.g., curing rate, particularly wherein the claim does not recite a measurable curing rate, a numerical delay, a percentage reduction, a diffusion coefficient, gelation time, etc.) when it happens naturally when mixing the ingredients. The "modulates the curing rate" language merely states the functional consequence of having those ingredients together, wherein virtually every phosphate capable of chelating calcium will modulate calcium crosslinking to some extent. It does not require a particular degree of modulation. The claim recites no quantitative curing-rate limitation or process parameter. Accordingly, patentable distinction resides in the recited structural composition rather than the statement of the mechanism by which the composition functions.
The final particle shape is a predictable outcome of the prior art teachings, when mixing the ingredients. One of ordinary skill would reasonably expect the modified Goutayer emulsion to produce spherical hydrogel particles as Goldenberg teaches calcium-mediated ionic gelation produces substantially spherical hydrogel particles having narrow particle-size distributions suitable for encapsulation. The claimed "uniform particle size" is general and lacks a clear objective standard/meaning for the structural properties within the claim and specification. Thus, incorporating those teachings into Goutayer's multilayer emulsion would have predictably yielded hydrogel particles having the claimed morphology. Such optimization represents the predictable application of known hydrogel gelation principles to a known cosmetic multilayer emulsion (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007)). If the prior art composition predictably achieves a curing modulation and spherical particles because it contains substantially the same ingredients in overlapping concentrations, then the functional language does not distinguish the claim.
The applicant argues that Goutayer merely employs phosphate as a buffer and Lee merely employs sodium pyrophosphate as a stabilizer, and therefore neither reference recognizes phosphate as controlling calcium-mediated curing. However, the rejection is not predicated upon either reference expressly describing phosphate using the terminology "curing-rate modulator." Rather, the rejection relies upon the collective teachings of the references viewed from the perspective of one of ordinary skill in the hydrogel formulation art. Goutayer teaches a multilayer cosmetic emulsion containing an internal aqueous hydrogel phase and expressly teaches incorporation of phosphate buffers within the aqueous phase. Lee teaches incorporation of sodium pyrophosphate into hydrogel matrices as a stabilizing component.
Although Lee characterizes sodium pyrophosphate as a stabilizer, one of ordinary skill would have understood that stabilization of calcium-crosslinked hydrogel systems is achieved through regulation of calcium ion availability during gel formation thus, appreciating that phosphate salts participate in the hydrogel crosslinking environment rather than functioning solely as inert excipients.
Moreover, the examiner finds that phosphate concentration was known to influence the behavior of calcium-containing hydrogel systems. The additional prior art now cited expressly supports that phosphate concentration was recognized as influencing calcium-mediated gelation kinetics, by teaching phosphate-mediated control of calcium crosslinking. As cited above, Schmidt teaches that condensed phosphates, such as sodium hexametaphosphate, complexes and sequesters calcium and retards calcium alginate gelation, and thereby regulating alginate gelation kinetics and gel formation.
Thus, the examiner relies upon the combined teachings of the art to show that a person of ordinary skill would have understood phosphate concentration to influence calcium-mediated gelation kinetics rather than indirect recognition of phosphate as a "curing-rate modulator” from the teachings of Lee alone. Optimization of the amount of such phosphate to obtain desirable gel properties would have represented ordinary formulation practice (see MPEP §2143 and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007)).
The applicant also argues that phosphate concentration was not recognized in the prior art as affecting curing rate and therefore cannot constitute a result-effective variable. This argument is not persuasive.
The relevant variable is not the applicant's newly stated functional language (i.e., "curing-rate modulation"), but rather the concentration of phosphate present during calcium-mediated hydrogel formation. Lee expressly teaches inclusion of sodium pyrophosphate within hydrogel compositions over a concentration range encompassing the presently claimed range. Because Lee identifies phosphate concentration as a formulation component affecting hydrogel stability, Lee necessarily recognizes phosphate concentration as influencing hydrogel properties.
Once a formulation parameter is recognized as affecting a property of the composition, discovering an optimum value ordinarily constitutes routine optimization (see MPEP §2144.05, In re Aller, 220 F.2d 454 (CCPA 1955), and In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003)). The Federal Circuit further explained in E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996 (Fed. Cir. 2018) that optimization of overlapping ranges remains prima facie obvious where the prior art recognizes the parameter as affecting the relevant property.
The applicant's attempt to distinguish between "stabilization" and "curing-rate modulation" is not persuasive because both relate to control of hydrogel formation and resulting gel properties. Recognition of a more detailed physicochemical explanation for why phosphate stabilizes the hydrogel does not render the underlying formulation parameter patentable (see Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342 (Fed. Cir. 1999).
The applicant further argues that Examples 4-6 demonstrate criticality of the claimed phosphate range. This argument is not persuasive. To overcome a prima facie case based upon overlapping ranges, the applicant must establish that the claimed range is critical and produces unexpected results commensurate in scope with the claims (see MPEP §2144.05 and In re Geisler, 116 F.3d 1465 (Fed. Cir. 1997)).
The comparative data relied upon by the applicant do not satisfy this standard.
First, the comparisons evaluate only three phosphate concentrations. Second, the applicant does not compare the claimed invention against the closest prior art formulations. Third, no statistical analysis or replicate testing is presented. Fourth, the applicant has not demonstrated that substantially all compositions falling within the claimed range achieve the asserted morphology while compositions immediately outside the claimed range consistently fail. Thus, the evidence therefore does not establish that the entire claimed range possesses a critical property absent from adjacent values. Accordingly, the submitted examples are insufficient to rebut the prima facie case arising from the overlapping prior-art range.
The applicant argues that the examiner improperly relied upon inherency for spherical hydrogel particles. Accordingly, inherency is not relied upon to sustain the new rejection. The examiner finds that once one of ordinary skill selected phosphate concentration within the overlapping range taught by Lee while preparing the multilayer hydrogel emulsion taught by Goutayer, obtaining improved hydrogel morphology would have represented the predictable consequence of routine optimization of known hydrogel formulation parameters. The prior art compositions are capable of exhibiting these exact physical attributes when mixed.
Optimization of hydrogel particle morphology through adjustment of known formulation variables represents ordinary formulation experimentation (see In re Applied Materials, Inc., 692 F.3d 1289 (Fed. Cir. 2012)). The recited spherical morphology therefore constitutes an expected performance characteristic resulting from optimization of known formulation variables rather than a patentably distinct structural limitation.
In addition, the applicant argues that the rejection relies upon impermissible hindsight. This argument is not persuasive. Goutayer supplies the multilayer cosmetic emulsion architecture, Lee supplies the expressly disclosed sodium pyrophosphate hydrogel additive and overlapping concentration range, and recognized hydrogel formulation knowledge provides the motivation to optimize hydrogel formulation variables to obtain desirable gel properties.
The combination merely applies known hydrogel formulation techniques to known cosmetic emulsions using known phosphate additives for their recognized effects on hydrogel systems. Such predictable use of known elements according to their established functions constitutes obviousness (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 417 (2007)). Thus, the rejection independently established a prima facie obviousness case, rather than relying on reconstruction of the applicant's invention using the disclosure as a template.
Regarding newly added claim 11, 0.1 wt% calcium salt and 0.1 wt% phosphate salt concentrations fall within the ranges disclosed by the combined teachings relied upon in the rejection. Selection of a single concentration from within an otherwise obvious disclosed range ordinarily would have been obvious absent persuasive evidence of criticality (see MPEP § 2144.05 and Titanium Metals Corp. v. Banner, 778 F.2d 782 (Fed. Cir. 1985)).
The applicant relies solely upon one working example from the specification. As discussed above, that single example does not establish that the selected concentrations possess unexpected properties compared with neighboring concentrations or the closest prior art. Accordingly, claim 11 remains obvious for the same reasons discussed with respect to claim 1.
Conclusion
No claims are allowed.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at: http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at (866) 217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call (800) 786-9199 (IN USA OR CANADA) or (571) 272-1000.
/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights