DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/02/2025 has been entered.
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 .
Claims 8-16 and 21 are examined; claims 1-7 and 17-20 are currently withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions.
Applicant’s arguments, filed 11/20/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 8-15 stand rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (CN 112515992A, 03/19/2021) (hereinafter Huang) in view of McCook et al. (US 2008/0233183 A1, 09/25/2008) (hereinafter McCook).
Huang discloses a stable aqueous composition comprising 0.1-10% by weight (p.6, ¶5) of triethyl citrate; glycine (abs); and an active agent that hydrolyzes to ammonia, wherein the weight ratio of the active agent to triethyl citrate is from 1:1 to 100:1 (p.3, last ¶)), or preferably from 1:1 to 10:1 (p.4, ¶2). The active agent includes urea (p.4, ¶1). The glycine has good solubility in aqueous solution (p.7) and may be included from 1-20% by weight (p.7, ¶5). The pH of the composition may be adjusted to between 4.0 and 7 (p.10, last ¶ to p.11, ¶1). The composition exhibits improved pH stability of the urea aqueous solution at 48 °C for 3 months (p.11, ¶7). The composition can also be added into external skin preparations (i.e. instantly claimed complementary composition) to achieve the moisturizing effect (p.3, ¶6).
Huang differs from the instant claims insofar as not explicitly disclosing wherein the aqueous composition comprises sodium lactate or triethanolamine.
However, McCook discloses lotions or creams comprising water, amines such as triethanolamine, salts such as sodium lactate, and acids such as lactic acid, to neutralize acidic components and adjust and maintain the final pH of a cream at about 4.8 to about 6 ([0062]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included triethanolamine, sodium lactate, and lactic acid in the aqueous composition of Huang since each is taught as a known and effective component to adjust and maintain pH of a topical composition comprising an aqueous phase as taught by McCook.
Regarding the claims reciting an amount of urea or a derivative thereof, it would have been obvious to one of ordinary skill in the art to have selected a weight ratio of urea from the disclosed range of 1:1 to 100:1 of active agent : triethyl citrate, based on the disclosed range of 0.1-10 wt. % triethyl citrate. Such ratios selected would have equated to an amount that overlaps with the claimed range (i.e. about 25-40 wt. %), thus making the claimed range obvious. Additionally, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). Moreover, in any case, the selection of appropriate weight ratios would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in weight percentages. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding the claims reciting ranges of various components or of the composition, the claimed ranges (i.e. about 5-9 wt. % glycine, about 0.2-2wt. % triethyl citrate, and a pH of about 4.0-6.0, etc.) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. 1-20 wt. % glycine, 0.1-10 wt.% triethyl citrate, and a pH of about 4.0-7). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding the claim reciting specific stability conditions, as discussed above, Huang discloses a composition comprising 0.1-10% by weight triethyl citrate, 1-20% by weight glycine, urea in amounts of 1:1 to 100:1 of the amount of triethyl citrate, glycerin, and citric acid. Since the composition of Huang comprises substantially the same components (i.e. urea, triethyl acetate, glycine, and glycerin) in substantially the same amounts, one of ordinary skill in the art would reasonably conclude that the composition of Huang would demonstrate structural and pH stability for periods of up to about 8 weeks under temperature conditions that range from 4 "C up to 45 "C and through freeze thaw cycles from -20 "C through 20 "C, characterized as the absence of any or sustained visible crystallization and the stabilization of pH at or under a pH of about 7, like the claimed invention.
Response to Arguments
Applicant argues because Huang discloses a weight ratio of urea to triethyl citrate in the range of 1:1 to 100:1, and 0.1-10 wt. % of triethyl citrate, that it’s unreasonable to interpret Huang to overlap the instantly claimed urea range of 25-40 wt. %. Rather, one of ordinary skill in the art would understand a factor of 100:1 at the low end of the triethyl citrate (0.1 wt. %) would give an upper amount of 10 wt.%, which means that the entire range from 1:1 to 100:1 for the ratio of urea to triethyl citrate can fall within the explicitly disclosed range of urea of 1-20 wt.% based on the explicitly disclosed range of 0.1-10 wt.% for triethyl citrate. Thus Huang does not suggest, let alone disclose or necessitate, that urea may be present outside the range of 1-20 wt.%.
The Examiner does not find the argument persuasive. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See MPEP 2123(I). Here, although Huang discloses that in some embodiments, the composition may comprise 1-20% by weight of the active agent (e.g., urea or a derivative thereof), Huang also discloses wherein the weight ratio of the active agent, such as urea, to triethyl citrate is from 1:1 to 100:1, or preferably 1:1 to 10:1. Therefore, Huang does not limit the amount of urea to an embodiment of 1-20 wt.%. Similarly, the claims of Huang do not disclose wherein the active agent (urea) must be limited to 1-20 wt.%. Accordingly, since Huang discloses wherein triethyl citrate may be included in amounts of 0.1-10% by weight, it would have been obvious to one of ordinary skill in the art to have selected an amount of triethyl citrate from such range, and derived a weight ratio from the disclosed 1:1 to 100:1 or 1:1 to 10:1. Such selected weight ratios would have equated to amounts that overlap with the claimed range, thus making the claimed range obvious. As supported by MPEP § 2144.05(I), generally, a prima facie case of obviousness exists where the claimed ranges or amounts overlap with the ranges of the prior art. Applicant is relying on a narrow interpretation of Huang’s disclosure, and since Applicant has not provided objective evidence showing the criticality of the claimed range, Applicant’s argument is unpersuasive. See MPEP 2144.05(III)(A).
Applicant’s argument regarding the claimed buffer system is moot because new grounds of rejection necessitated by Applicant’s amendment have been made. Moreover, Applicant’s allegation of unexpected results in the stabilization of urea is merely a conclusory statement. Mere conclusory statements in the specification, unsupported by objective evidence, are entitled to little weight when the PTO questions the efficacy of those statements. In re Greenfield, 571 F.2d 1185, 197 U.S.PQ. 227, 229 (C.C.P.A. 1978). Therefore, in any case, Applicant’s argument is unpersuasive since Applicant has not shown wherein the combination provides better stabilizing effect.
Claims 16 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (CN 112515992A, 03/19/2021) (hereinafter Huang) in view of McCook et al. (US 2008/0233183 A1, 09/25/2008) (hereinafter McCook), further in view of Moberg (US 5,525,635 A, 06/11/1996) (hereinafter Moberg).
The disclosures of Huang and McCook are discussed in detail above. Huang further discloses wherein the compositions may comprise a cosmetically acceptable vehicle (p.8, ¶ 5).
Huang and McCook differ from the instant claims insofar as not explicitly disclosing propylene glycol.
However, Moberg discloses compositions for the skin, containing propylene glycol and urea (abs). Propylene glycol is an atoxic solvent used as a vehicle in local preparations (§ Detail, ¶1), known as a favorable solvent and penetration promoting agent, and can be used to dissolve urea (§ Background).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included propylene glycol in the composition of Huang since it is a known and effective vehicle that can dissolve urea as taught by Moberg.
Response to Arguments
Applicant does not present specific argument with regards to Huang, McCook and Moberg.
Since the Examiner has discussed Huang above, this rejection is maintained.
Technological Background Material
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
“Ultra K Anti-Roughness Cream” (Mintel, XP055941399, IDS reference), drawn to a urea cream comprising urea, glycerin, glycine and triacetin.
KR 20190060378 A, (Kim et al., 06/03/2019), drawn to a cosmetic composition comprising urea, triacetin, an alpha-hydroxy acid and an alkali metal salt.
Conclusion
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/LUCY M TIEN/ Examiner, Art Unit 1612
/SAHANA S KAUP/ Supervisory Primary Examiner, Art Unit 1612