DETAILED ACTION
Applicant’s arguments, filed 17 February 2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Note: A marked up copy in compliance with MPEP 714(II)(C) have been submitted pursuant to a telephonic conversation, and is included with the Office 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 .
Claim Objections
Claim 1 is objected to because of the following informalities: “mammal, s” in line 2 should be recited as --- mammal, ---. Appropriate correction is required.
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 1-11 and 16-25 are rejected under 35 U.S.C. 103 as being unpatentable over Agarkhed et al. (US 2019/0175473, 06/13/2019, IDS reference) (hereinafter Agarkhed) in view of Kelly (US 2005/0208111 A1, 09/22/2005, IDS reference).
Agarkhed discloses a topical antimicrobial composition comprising 0.1-10% by weight of niacinamide in a cosmetically acceptable base and 0.01-5% by weight of a quaternary ammonium salt (abs) suitable for application to topical surfaces including of a human body (i.e. skin) ([0009]). The quaternary ammonium salt includes benzalkonium chloride (BKC) ([0036]). The composition further contains skin lightening agents including a hydroxycarboxylic acid like lactic acid and their salts, e.g. sodium lactate ([0053]); emollients including cetyl alcohol and stearyl alcohol ([0062]); about at least one surfactant (claim 10); and essential oils ([0072]). The composition base may be an emulsion ([0045]).
Agarkhed differs from the instant claims insofar as not explicitly disclosing wherein the composition is used in a wipe.
However, Kelly discloses a flexible, disposable article suitable for cleansing, conditioning, sanitizing and disinfecting skin (i.e. personal care) and hard surfaces, adaptable for inclusion of a cleaning composition (abs, [0031]). The article comprises an outer layer comprised of nonwovens and can comprise abrasive particles incorporated therein to provide a rough or abrasive surface on at least one face of the article ([0043]). This abrasive or embossed surface serves to enhance the cleaning or exfoliating effect ([0044]). The core layer possesses high absorbency and contains the composition adapted for cleaning, sanitizing or disinfecting hard surfaces or for personal cleansing and conditioning (abs). The composition may be added onto or impregnated and penetrates into the core layer and is releasably associated therewith ([0058]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included a wipe having absorbency, comprising a nonwoven material with an abrasive surface, with the composition of Agarkhed, since it is a known and effective article suitable for cleansing and/or sanitizing skin and adaptable for inclusion of a cleaning composition, to provide enhanced cleaning or exfoliating effect as taught by Kelly.
As noted by para. [0017] of the instant Specification, niacinamide is a sebostatic agent of instant claims 1 and 7.
As noted by para. [0014] of the instant Specification, BKC is an antiseptic as claimed instantly.
Regarding claims 1 and 2 reciting “for” statements, since the claims are directed to a product, the “for” statements are therefore interpreted as intended use. Where the same active agents are present in the prior art as instantly claimed, the intended use is met.
Regarding claims 2-5, as noted by para. [0016] of the instant Specification, lactic acid is a alpha-hydroxy acid (i.e. organic acid) that is a exfoliating agent, serving to remove old skin cells from the outermost layer of the epidermis. Accordingly, the lactic acid of Agarkhed meets the limitation of a keratolytic agent as instantly claimed.
Regarding claims 6 and 18-21, as discussed above, Agarkhed discloses wherein the composition comprises lactic acid (i.e. instantly claimed organic acid) and sodium lactate (i.e. instantly claimed organic acid salt as buffering agent). Agarkhed differs from the instant claims insofar as not explicitly disclosing amounts of lactic acid and sodium lactate. However, since Agarkhed discloses lactic acid and sodium lactate as skin lightening agents, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amounts of lactic acid (i.e. 0.01-5% by weight) and sodium lactate (i.e. an amount necessary to achieve a pH between 3 and 6) through routine experimentation based on the level of skin lightening effect desired. "[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 claim 8 reciting amounts niacinamide, the claimed ranges (i.e. about 0.1-5% by weight) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. 0.1-10% by weight). 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 claims 9-10, as discussed above, Agarkhed discloses wherein the composition comprises cetyl and stearyl alcohol (i.e. instantly claimed barrier-forming emollient). Regarding claim 10 reciting amounts of cetyl and stearyl alcohol, although Agarkhed does not explicitly disclose an amount, Agarkhed discloses cetyl alcohol and stearyl alcohol as emollients. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount of cetyl and stearyl alcohol (i.e. about 0.01-5% by weight) through routine experimentation based on the level of emollient effect desired. "[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 claim 11, Agarkhed differs from the instant claim insofar as not explicitly disclosing amounts of surfactant. However, the amounts of surfactants are result effective variables since they affect the interface between oil and water phases. Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount of surfactant (i.e. about 0.01-5% by weight) through routine experimentation based on the level of surface tension desired between oil and water phases. "[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 claims 16 and 17, Agarkhed further discloses wherein the composition may comprise 1% by weight of glycerin ([0080]).
As noted by para. [0018] of the instant Specification, glycerin is a humectant. Accordingly, the claimed range (i.e. about 0.01% - 5% by weight) would have been obvious to one of ordinary skill in the art since they overlap with the range of the prior art. 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 claim 22, Agarkhed further discloses wherein the composition may comprise a balance of water ([0061], [0080]).
Regarding claim 23, Agarkhed further discloses wherein the composition may comprise a liquid carrier or mixture of carriers, constituting from 30-95% by weight of the composition, including hydrophilic carriers comprising water and/or a mono or polyhydric alcohol or a water-miscible homologue ([0070]). Agarkhed differs from the instant claim insofar as not explicitly disclose an oil-in-water emulsion. However, since Agarkhed discloses an emulsion comprising liquid hydrophilic carriers as high as 95% by weight of the composition, it would have been obvious to one of ordinary skill in the art that the composition of Agarkhed would be an oil-in-water emulsion since the hydrophilic carrier, comprising water and/or mono/polyhydric alcohols, makes up the majority of the volume of the composition of Agarkhed.
Response to Arguments
Applicant asserts Agarkhed in view of Kelly does not render amended claim 1 obvious as it lacks a reasoned motivation and a reasonable expectation of success. Agarkhed’s compositions are formulated to be applied directly to the skin, whereas Kelly focuses on disposable cleaning articles that are substantially dry and activated upon wetting. The proposed modification changes the principle of operation of the primary reference rather than applying a known equivalent. Applicant further argues there s no reasonable expectation of success for a preloaded, ready-to-use wipe. The cited art does not teach Applicant’s formulation approach for wipe compatibility, and thus hindsight is required to arrive at the claimed combination.
The Examiner does not find the Applicant’s argument persuasive. Agarkhed discloses a topical composition for skin, and Kelly discloses a wipe that may be impregnated with a composition for skin. As such, both Agarkhed and Kelly relate to topical compositions providing cleansing, moisturizing, and/or antimicrobial effects, and the principle of operation is not changed. Moreover, in response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this instant case, Agarkhed discloses a topical antimicrobial composition comprising substantially the same niacinamide suitable as sebostatic agent; benzalkonium chloride (BKC) suitable as an antiseptic agent; and cetyl and stearyl alcohol suitable as barrier-forming emollients, said composition suitable for application to topical surfaces including of a human body (i.e. skin). Kelly discloses a flexible, disposable article (i.e. wipe) comprising a nonwoven layer having an abrasive or embossed surface to provide enhanced cleaning or exfoliating effects, adaptable for inclusion of a cleansing/treatment composition that may be impregnated onto the article. Kelly further discloses the article as being suitable for cleansing, conditioning, sanitizing and disinfecting skin (i.e. personal care) and hard surfaces. Accordingly, it would appear to have been obvious to one of ordinary skill in the art to have impregnated the topical composition of Agarkhed, comprising substantially the same ingredients as the claimed invention, onto the article of Kelly, since it explicitly teaches wherein the article is adaptable for inclusion of a cleansing/treatment composition. Moreover, since the composition of Agarkhed comprises substantially the same ingredients as the amended antiseptic composition of instant claim 1, one of ordinary skill in the art would reasonably expect the composition of Agarkhed to possess substantially the same properties as claimed.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Agarkhed et al. (US 2019/0175473, 06/13/2019, IDS reference) (hereinafter Agarkhed) in view of Kelly (US 2005/0208111 A1, 09/22/2005, IDS reference), further in view of Modak et al. (US 2014/0242198 A1, 08/28/2014, IDS reference) (hereinafter Modak).
The disclosures of Agarkhed and Kelly have been discussed in detail above, and differ from the instant claims insofar as not explicitly disclosing wherein the surfactant is a non-ionic surfactant.
However, Modak discloses antimicrobial compositions (abs) comprising surfactants, including nonionic surfactants such as polyethoxylates ([0138]).
Agarkhed discloses wherein the composition comprises at least one surfactant. Accordingly, it would have been obvious to one of ordinary skill in the art to have included a nonionic surfactant since it is a known and effective surfactant suitable for antimicrobial compositions as taught by Modak.
Regarding claims 13-14, Modak further discloses wherein the composition comprises essential oils, such as eucalyptus oil ([0103]), have been found to possess antibacterial and antifungal activity ([0004]).
Agarkhed discloses wherein the composition comprises essential oils, but does not limit a specific oil. Accordingly, it would have been obvious to one of ordinary skill in the art to have included eucalyptus oil since it is a known and effective essential oil capable of providing antibacterial and antifungal activity in antimicrobial compositions as taught by Modak.
Regarding claim 14 reciting an amount of essential oil, although Agarkhed does not explicitly disclose an amount, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount of essential oil (i.e. about 0.01-1% by weight) through routine experimentation based on the level of antibacterial effect desired. "[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 claim 15, as discussed above, Agarkhed discloses wherein the composition may comprise 30-95% by weight of liquid carriers, including hydrophilic carriers comprising water and/or a mono or polyhydric alcohol (i.e. instantly claimed alcoholic solvent) ([0070]).
Accordingly, the claimed amount (i.e. about 5-70% by weight) of alcoholic solvent would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art. 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).
Response to Arguments
Applicant mainly asserts neither Agarkhed nor Modak teach or suggest providing the claimed composition as a preloaded wipe having an abrasive surface and a non-woven absorbent substrate in which the composition is absorbed.
The Examiner does not find the Applicant’s assertion persuasive. As this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. As discussed in the rejections above, Kelly provides the motivation to include a wipe with the composition of Agarkhed. See MPEP 2141(III). Moreover, Applicant’s assertions are moot because new rejections necessitated by Applicant’s amendment have been made.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schmaus et al. (US 2010/0196504 A1, 08/05/2010), directed to antimicrobial compositions comprising niacinamide, lactic acid, sodium lactate, nonionic surfactant, cetyl alcohol and stearyl alcohol.
Chu et al. (US 2021/0030646 A1, 02/04/2021), directed to antimicrobial composition comprising essential oil, niacinamide, cetyl alcohol, stearyl alcohol, lactic acid, sodium lactate, and water.
Conclusion
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 LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612