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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 15 April 2026, has been entered.
Status of the Claims
Amendments to the Claims and Arguments/Remarks filed 15 April 2026, in response to the Office Correspondence dated 16 January 2026, are acknowledged.
The listing of Claims filed 15 April 2026, have been examined. Claims 1-3, 6, 7, 10, 12, and 15-27 are pending. Claims 1-3 are amended, claims 4, 5, 8, 9, 11, 13, and 14 are canceled, and new claims 22-27 have been added.
Response to Amendment
The applicant’s amendment has been entered. The amended claims and Remarks have been full considered. Claims 1-3, 6-7, 10, 12, and 15-27 are rejected under 35 U.S.C. § 103 as being unpatentable over Leslie, in view of Allen, and in further view of Croda’s Practical Guide to Adjuvants, as detailed below, wherein supplementary evidentiary references have also been added, where appropriate.
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 1-3, 6-7, 10, 12, and 15-27 are rejected under 35 U.S.C. § 103 as being unpatentable over Leslie et al. (WO-2019055925-A1; publication date 21 March 2019, hereinafter referred to as Leslie), in view of Allen et al. (US-9506013-B2; published 29 November 2016, hereinafter referred to as Allen) and Practical Guide to Adjuvants (Croda; published October 2020).
Leslie teaches disinfecting compositions comprising one or more C1-C6 alcohols, including ethanol and isopropanol, in amounts generally ranging from about 10-40 wt.% (¶[00035]). Leslie further teaches Example 6 compositions comprising 50 wt.% ethanol (Table 6, ¶[00099]). Leslie additionally teaches compositions comprising polymeric surfactant/enhancer systems including alkyl polyglucosides in amounts from about 0.5-3 wt.% (¶[00016]; Example 5, Table 5, ¶[00097]), secondary enhancers including 1,2-octane diol (caprylyl glycol) in amounts from about 0.01-5 wt.% (¶[00008]), optional nonionic surfactants (¶[00043]-¶[00045]), acidic pH values below 3 including pH values as low as about 1.5 (¶[00020], ¶[00060], claim 11), disinfecting surfaces by contacting the surface with the composition (¶[00031] and ¶[00032]), wipes comprising the composition (¶[00031]), and efficacy against bacterial spores (¶[00088]). However, Leslie teaches or does not expressly disclosing that the polymeric enhancer comprises an alkoxylated polyol ester, and instead uses alkyl polyglucosides.
Allen teaches alkoxylated polyol esters for use in cleaning, sanitizing, and disinfecting compositions. Specifically, Allen teaches that alkoxylated fatty esters and related derivatives may be incorporated into compositions for use as surfactants, emulsifiers, rheological modifiers, biocides, and “biocide potentiators,” including in “sanitizers and disinfectants” (col. 11, lines 21-31). Allen further teaches that such materials are useful in formulations requiring low foaming, wetting, spreading, compatibility with aqueous-organic systems, and formulation stability under acidic conditions. Thus, a person of ordinary skill in the art would therefore have reasonably expected that incorporation of Allen’s alkoxylated polyol esters into Leslie’s formulations would improve surface wetting, spreading, deposition, and retention of antimicrobial actives while maintaining acceptable formulation stability and compatibility in high-alcohol acidic systems. Allen however, does not explicitly name or exemplify CAS No. 1685270-84-1.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to substitute or supplement Leslie’s alkyl polyglucoside polymeric enhancer system with the alkoxylated polyol esters taught by Allen because both references are directed to the same field of endeavor, namely alcohol-containing disinfecting and sanitizing formulations, and both references teach the use of nonionic surfactant/polymeric enhancer systems to improve disinfectant formulation performance. The substitution of one known nonionic polymeric enhancer system for another known nonionic polymeric enhancer system to obtain predictable improvements in wetting, spreading, and formulation performance constitutes the predictable use of prior art elements according to their established functions (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007)). Further, substitution of one known surfactant or enhancer species for another structurally and functionally similar species constitutes routine optimization within the ordinary skill in the art (see MPEP § 2144.06).
Evidentiary reference Elliott et al. (US-20160157479-A1; published 09 June 2016) teaches the use of adjuvants for antifungal compositions, “…selected from one or more of: alkyl polyglycosides, polysorbates, polysaccharides, alcohol ethoxylates, block copolymers, ethoxylated tallow amines and alkoxylated fatty alcohols. In another embodiment the adjuvant is selected from one or more of: Agnique PG 8107G, Tween 20, Atplus 2575, Atplus UEP 100, Brij CS 17, Lutensol XL 80, Lutensol TO 8, Lutensol AO 8, Pluronic PE, Tomah E14-2, Tomah E14-5, Plurafac LF 031 and Plurafac LF 431. In a further embodiment, the adjuvant is an alkyl polyglycoside. In a further embodiment, the adjuvant is C8-10 alkyl polyglycoside (Commercially available as Agnique PG 8107G). In one embodiment the composition comprises an adjuvant in an amount between about about 2% and about 15%. In a further embodiment the composition comprises between about 3% and about 6% of adjuvant.” (¶[0063]), wherein the instant specification explicitly details that the exemplary alkoxylated polyol ester assigned CAS number 1685270-84-1, is currently available as Atplus™ UEP-100 manufactured by Croda International Plc (Snaith, England), comprising fatty acids, C18-unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol, and stearic acid, and has a minimum number average molecular weight (in amu) of 1,100. Thus, it was known in the art that the alkyl polyglycosides of Leslie could be substituted with the use of Atplus™ UEP-100 (CAS number 1685270-84-1) as an adjuvant in antifungal compositions.
Further evidentiary reference Kaab et al. (US-20200390097-A1; published 17 December 2020) teaches a composition comprising Cynara cardunculus plant extract fraction or myricitrin and explicitly teaches the use of Atplus™ UEP-100 (Table 2) as a commercially available adjuvant/surfactant suitable for use in aqueous formulations containing organic solvents and oils.
Moreover, Croda’s Practical Guide to Adjuvants shows superior deposit formation and increased humectancy with Atplus™ UEP-100, which is linked to keeping the active ingredient in a more bioavailable state which results in increased delivery and/or delivery over a longer period of time. The evaporation rate is significantly lower (probability value of significance <0.05) with Atplus™ UEP-100 when compared with glycerin and polysorbate 20 (page 3, Figure 5), which one of skill in the art would recognize as being advantages for compositions comprising > 50 wt.% C1-C10 alcohol. Thus, these addition references, provide motivation and a reasonable expectation of success in specifically using the specific alkoxylated polyol ester species of CAS No. 1685270-84-1.
Thus, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to substitute Leslie's alkyl polyglucoside polymeric enhancer with the specifically disclosed CAS No. 1685270-84-1 (Atplus™ UEP-100), as both serve as non-ionic polymeric adjuvants in aqueous formulations and Croda’s Practical Guide to Adjuvants shows that Atplus™ UEP-100 decrease evaporation rates allowing increased C1-C10 alcohol over a longer period of time, which one of skill in the art would recognize as a distinct advantage for formulations using >50% C1-C10 alcohol. The expectation of success is high because Kaab demonstrates that Atplus™ UEP-100 is compatible with formulation components (oils, surfactants, water) analogous to those that would be used in Leslie's disinfectant compositions.
Leslie’s Example 6 (Table 6, ¶[00099]) shows compositions with exactly 50 wt.% ethanol. Leslie’s general range is 10-40 wt.% (¶[00035]). Leslie does not disclose any composition with greater than 50 wt.% alcohol and warns about skin irritation and flammability concerns at higher alcohol levels (¶[00033]). However, evidentiary reference Macinga et al. (US-20120129950-A1; published 24 May 2012) teaches a method for rapid surface sanitization that includes contacting the surface with an effective amount of an antimicrobial composition comprising ≥50 wt. % of a C1-6 alcohol, based upon the total weight of the antimicrobial composition (Abstract). Evidentiary reference Ali et al. (US-20080249187-A1; published 09 October 2008) teaches an antimicrobial skin sanitizing composition that contains ≥60 percent of an aliphatic alcohol having from 1 to 4 carbon atoms (Abstract). Evidentiary reference Holopainen (US-20210204552-A1; published 08 July 2021) teaches an antimicrobial composition wherein the amount of alcohol is in the range of from about 50-95 weight % (claim 2).
Evidentiary reference Korb and Bhargava (US-20160081333-A1; published 24 March 2016) teaches a antimicrobial sanitizing composition ≥60 weight percent of a C1 to C4 alcohol (claim 1). Evidentiary reference Jampani and Newman (US-6022551-A; published 08 February 2000) teaches a rapidly acting antimicrobial alcohol-containing composition and method of using the composition to disinfect surfaces (Abstract), comprising from about 55-90% by volume alcohol (claim 1). Evidentiary reference Fitchmun (US-20080045491-A1; published 21 February 2008) teaches a surface sanitizer composition, comprising a water-miscible alcohol component that constitutes about 50-90% of the composition (claim 1).
These six evidentiary references collectively establish that alcohol concentrations exceeding 50 wt.% were not novel as of the effective filing date of the instant invention and demonstrate that >50 wt.% alcohol disinfectants were routine and well-understood in the art. Thus, Leslie's failure to teach alcohol levels exceeding 50 wt.% is not a genuine gap in the prior art teachings. One of ordinary skill would have been motivated to increase alcohol concentration based on these numerous evidentiary reference teachings that >50 wt.% alcohol compositions are effective and desirable for disinfection.
Collectively, these references demonstrate that increasing alcohol concentration above 50 wt.% for improved antimicrobial performance represented a well-known result-effective variable and routine formulation optimization in the disinfectant art (see In re Peterson, 315 F.3d 1325, 1329-30 (Fed. Cir. 2003)). A person of ordinary skill in the art would have been motivated to increase Leslie’s alcohol concentration modestly above 50 wt.% in order to improve disinfecting efficacy and drying performance while remaining within the well-established operable ranges recognized in the art. Leslie does not criticize, discredit, or otherwise discourage the use of alcohol concentrations above 50 wt.%, rather, Leslie merely identifies routine formulation tradeoffs associated with alcohol-containing disinfectants. Recognition of potential disadvantages does not constitute teaching away where the art nonetheless recognizes the claimed range as workable and beneficial (see In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)). The numerous evidentiary references discussed above confirm that disinfectant formulations containing greater than 50 wt.% alcohol were conventional and widely used in the art.
Leslie expressly teaches alkyl polyglucoside polymeric enhancer concentrations from about 0.5-3 wt.% (¶[00016]) and 0.5-1.5 wt.% (Example 5), which overlap and encompass the claimed ranges. Substituting Allen’s alkoxylated polyol esters at comparable use levels would have constituted routine optimization. Leslie expressly teaches 1,2-octane diol secondary enhancer concentrations of about 0.01-5 wt.% (¶[00008]), encompassing the claimed range. Instant claim 12 recites one or more nonionic surfactants. Leslie expressly teaches nonionic surfactants and mixtures thereof (¶[00043]-¶[00045]). Leslie expressly teaches disinfecting compositions having pH values below 3 and as low as about 1.5 (¶[00020], ¶[00060], claim 11), encompassing the instant claimed limitations. Leslie expressly teaches contacting surfaces with the disinfecting compositions, wipe embodiments, and sporicidal activity (¶[00031]-¶[00032], and ¶[00088]).
Leslie teaches caprylyl glycol (1,2-octane diol) as a secondary enhancer (¶[0008]), wherein hexylene glycol and dipropylene glycol are structurally analogous diols known in the art to be interchangeable as secondary enhancers in disinfectants. Substituting with other diols known in the art to have similar solvent and antimicrobial enhancement properties is prima facie obvious wherein no unexpected synergy or criticality is shown (see MPEP § 2144.05).
Further, evidentiary reference Schroeder et al. (US-5591395-A; published 07 January 1997), teaches a liquid disinfecting composition that includes a glycol or mixtures of glycols, including dipropylene glycol as an active disinfecting agent (claims 1, 3, 4, and 7) and evidentiary reference Gilbard et al. (US-20120288575-A1; published 15 November 2012), teaches anti-microbial cleanser compositions comprising a diol, such as a glycol (which includes dipropylene glycol and hexylene glycol) as a secondary enhancer to other active ingredients (Abstract, claim 1-3), preferable dipropylene glycol (claims 13 and 14). Thus, the use of dipropylene glycol and mixtures of diol glycols were well-known for use as components in disinfecting compositions long before the instant effective filing date for use as effective.
Thus, it would have been obvious to substitute hexylene glycol and/or dipropylene glycol for Leslie’s caprylyl glycol because these compounds were known members of the same class of glycol-based antimicrobial enhancer solvents used in disinfecting formulations to improve solvency, wetting, antimicrobial enhancement, and formulation stability. Substitution of one known equivalent glycol enhancer for another represents routine optimization of result-effective variables.
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 15 April 2026, have been fully considered.
The applicant relies on Leslie ¶[00082], asserting that Leslie teaches improved disinfection efficiency below 40 wt.% alcohol and that increased alcohol inhibits performance. This argument is not persuasive. Leslie describes micelle formation and optimization but does not state that compositions above 40 wt.% are ineffective, inoperable, or to be avoided entirely. To the contrary, Leslie acknowledges that alcohol levels up to 50 wt.% are within the scope of the invention (see claim 8).
A reference teaches away only where it criticizes, discredits, or otherwise discourages the claimed path. Mere disclosure of preferred embodiments or identification of another range as advantageous does not constitute teaching away. Here, Leslie does not state that alcohol levels above 50 wt.% are inoperable, unsuitable, or incompatible with disinfecting compositions. Rather, Leslie merely discusses one embodiment in which certain micellar interactions may be optimized below 40 wt.%.
Further, Leslie Example 6 expressly discloses formulations including alcohol levels up to 50 wt.%, a range touching or closely approaching the claimed range. A reference cannot simultaneously “teach away” from a feature and expressly disclose that feature as an operative embodiment. Accordingly, movement from 50 wt.% to greater than 50 wt.%, particularly within the presently claimed 60 wt.%, would have been an obvious matter of routine optimization of a result-effective variable. Thus, the applicant’s teaching away argument is rejected.
The applicant contends that Leslie and Allen do not specifically disclose the alkoxylated polyol ester assigned CAS No. 1685270-84-1. The argument is acknowledged but not persuasive. Allen expressly teaches alkoxylated polyol esters as useful additives for disinfecting and sanitizing compositions, including use as surfactants, biocide potentiators, emulsifiers, and formulation stabilizers. The presently claimed CAS-numbered material constitutes a species within the genus of alkoxylated polyol esters taught by Allen. Selection of a known species from a known genus is prima facie obvious absent evidence of criticality, unexpected properties, or demonstrated unpredictability (see In re Baird, 16 F.3d 380 (Fed. Cir. 1994)). The applicant has not provided comparative evidence establishing that CAS No. 1685270-84-1 exhibits a property materially distinct from the alkoxylated polyol ester class broadly taught by Allen. Accordingly, the species limitation does not overcome the obviousness rejection.
Leslie teaches glycol-type secondary enhancers and antimicrobial potentiators, including diol co-solvents and related secondary enhancement agents (claims 7 and 8) used to improve antimicrobial efficacy, wetting, and formulation performance. The instant limitation merely selects two known diols. Hexylene glycol and dipropylene glycol were well-known formulation solvents and humectant/co-solvent materials in disinfectant compositions at the time of filing (as shown by the evidentiary references cited above). Selection of known members of a known class of antimicrobial co-solvents for predictable formulation purposes constitutes routine optimization (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)).
The phrase “consisting of” merely closes the secondary enhancer group to the recited members. It does not impart patentable distinction where the recited members themselves are known formulation materials. Once hexylene glycol and dipropylene glycol are recognized as obvious secondary enhancer choices, limiting the secondary enhancer group to those known members constitutes an obvious selection absent demonstrated criticality. The applicant has not identified any criticality, unexpected results, or materially different functionality associated with selecting these specific glycols over the broader class of known glycol co-solvents.
The applicant asserts that the claims recite a “surprising synergistic efficacy” that would not have been obvious. The examiner is not persuaded because the claims contain no functional limitation requiring synergy or any particular efficacy threshold. The claims are directed to composition elements and ranges and the specification’s statements of synergy are not comparative against the closest prior art. Without data comparing the claimed combinations to formulations lacking alkoxylated polyol esters or using alternative polymeric enhancers, the assertions of synergy are unsubstantiated attorney argument.
Unclaimed unexpected properties do not confer patentability on otherwise obvious compositions. Thus, the applicant has not provided any comparative data, unexpected results, or objective evidence of nonobviousness to overcome the prima facie case. The applicant is reminded that under MPEP § 716.01(c), attorney arguments and conclusory statements unsupported by factual evidence are insufficient to rebut a prima facie case of obviousness.
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