Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
This action is in response to Applicant’s amendment filed December 29, 2025 in reply to the Non-final Office Action mailed September 30, 2025. Claims 44 and 46 have been amended; claims 1-43, 47-50, 54, 57, and 61 have been canceled; and claim 62 has been newly added. Claims 58-60 have been withdrawn. Claims 44-46, 51-53, 55, 56, and 62 are currently under examination in the application.
Claim Interpretation
Claim 51 is directed to an antimicrobial composition comprising the recited elements, including “a single C1-10 alkane diol consisting of 1,2-decanediol”. The phrase “a single C1-10 alkane diol consisting of 1,2-decanediol” is being interpreted as a long-winded way of simply saying “1,2-decanediol”. In other words, the claim provides that one of the requisite elements in the composition is 1,2-decanediol. However, the claim never actually definitively states that 1,2-decanediol is strictly the only C1-10 alkane diol present in the entire composition as a whole. Stating that the composition necessarily comprises 1,2-decanediol is not the same as saying the composition also necessarily excludes any and all other C1-10 alkane diols.
Claim 62 is directed to an antimicrobial composition comprising the recited elements, including “from 0.1-1 wt%” of “the single C1-10 alkane diol”. This limitation is being interpreted as only one C1-10 alkane diol is present in the amount of 0.1-1 wt%. However, the claim never states that this one C1-10 alkane diol compound present in the amount of 0.1-1 wt% is strictly the only C1-10 alkane diol compound present in the entire composition as a whole. Hence, in addition to the C1-10 alkane diol compound that is present in the amount of 0.1-1 wt%, the composition can further contain other alkane diol compounds in their own respective amounts.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 44-46, 51-53, 55, 56, and 62 are rejected under 35 U.S.C. 103(a) as being unpatentable over Fernandez de Castro et al. (U.S. Patent Application Pub. No. 2007/0065383), in view of Schmaus et al. (U.S. Patent Application Pub. No. 2005/0222276), and Kabara (U.S. Patent No. 5,208,257).
Applicant Claims
Applicant’s elected subject matter is directed to an antimicrobial composition comprising at least 60 wt% ethanol, 0.1-1 wt% 1,2-decanediol, 0.002-4 wt% siloxane polymer surfactant, and 0.1-1 wt% glyceryl laurate.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Fernandez de Castro et al. disclose an antimicrobial composition for skin sanitization comprising e.g. at least 60 wt% C1-4 alcohol, preferably ethanol; and 0.01 to 5 wt% siloxane polymer foaming surfactant, such as polysiloxane dimethicone copolyol; wherein the composition can further comprise an additional antimicrobial agent (abstract; paragraphs 0027, 0030, 0038, 0040, 0054, 0064, 0079, 0080, 0085; claim 32).
Schmaus et al. disclose an antimicrobial composition for e.g. skin sanitization preferably comprising 0.1-5 wt% of at least two C5-C10 alkane diols to provide a synergistic antimicrobial effect; wherein the composition can further comprise glycerol monolaurate (i.e. glyceryl laurate, i.e. monolaurin) as an auxiliary antimicrobial agent (abstract; paragraphs 0012, 0014, 0032, 0034-0037, 0040, 0049, 0050, 0066, 0256, 0272, 0273; Table 3). More specifically, Schmaus et al. exemplify an antimicrobial composition (i.e. DE3) in which 3 wt% 1,2-decanediol is the one and only C1-10 alkane diol present in the entire composition; and also exemplify a composition (i.e. HE/OC/DE) in which 1 wt% 1,2-decanediol is present in combination with one or more other C1-10 alkane diol compounds (see Table 3). Moreover, Schmaus et al. provide in the examples that the auxiliary antimicrobial agent (e.g. Euxyl K400) can be included in the amount of e.g. 0.05-0.1 wt%.
Kabara discloses an antimicrobial composition for e.g. topical application to skin comprising e.g. about 0.05-2 wt% monolaurin (i.e. glyceryl laurate) as a safe and effective antimicrobial agent.
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.012)
Fernandez de Castro et al. do not explicitly disclose that the further antimicrobial agents include 1,2-decanediol and glyceryl laurate. These deficiencies are cured by the teachings of Schmaus et al. and Kabara.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time of the present invention to combine the respective teachings of Fernandez de Castro et al., Schmaus et al., and Kabara, outlined supra, to devise Applicant’s presently claimed composition.
Fernandez de Castro et al. disclose an antimicrobial composition for skin sanitization comprising e.g. at least 60 wt% C1-4 alcohol, preferably ethanol; and at least 0.01 to 5 wt% siloxane polymer foaming surfactant, such as polysiloxane dimethicone copolyol; wherein the composition can further comprise an additional antimicrobial agent. Since Schmaus et al. disclose that skin sanitizing compositions containing e.g. about 1-3 wt% 1,2-decanediol, together with e.g. glycerol monolaurate, exhibit potent antimicrobial action; and since Kabara discloses that e.g. about 0.05-2 wt% monolaurin (i.e. glyceryl laurate) as a safe and effective antimicrobial agent for topical application to skin for an antimicrobial effect; one of ordinary skill in the art would be motivated to incorporate e.g. about 1-3 wt% 1,2-decanediol and about 0.05-2 wt% glycerol monolaurate as additional antimicrobial agents in the Fernandez de Castro et al. composition, with the reasonable expectation that the resulting composition will successfully produce an enhanced antimicrobial effect when applied to skin.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed December 29, 2025 have been fully considered but they are not persuasive.
i) Applicant contends that “claim 51 recites a single C1-10 alkane diol consisting of 1,2-decanediol”; that “Schmaus teaches that its synergistic antimicrobial effect is exclusively derived from mixtures of…1,2-alkanediols having chain lengths of 5 to 10 C atoms”, yet “the Office Action twists the…clear teachings of the Schmaus reference…to allege that Schmaus instead teaches the single C1-C10 alkane diol consisting of 1,2-decanediol”; moreover, “the effectiveness of 1,2-decanediol as a preservative agent after 28 days is…unrelated to the scope of the instant claims” since “Table 3 of Schmaus does not record…the rapid antimicrobial efficacy” set forth in the present application, that “the instant application sets forth the unexpected finding that the inclusion of a single C1-10 alkane diol, alone, in a hydroalcoholic sanitizing composition enhances the rapid efficacy of the alcohol component” wherein “the rapid efficacy of the inventive composition is expressed in minutes or seconds, as opposed to the range of 1-28 days of the Schmaus reference”.
The Examiner, however, would like to point out the following:
1. As already explained, supra, in the context of the present claims, the element “a single C1-10 alkane diol consisting of 1,2-decanediol” is being interpreted as a long-winded way of simply saying “1,2-decanediol”. In other words, the claim provides that one of the requisite elements in the composition is 1,2-decanediol. The claim never actually definitively states that 1,2-decanediol is strictly the only C1-10 alkane diol present in the entire composition as a whole. Stating that the composition necessarily comprises 1,2-decanediol is not the very same as saying the composition also necessarily excludes any and all other C1-10 alkane diols. Therefore, as interpreted, claim 51 is thus directed to a composition comprising at least 60 wt% of a C1-6 alcohol, 1,2-decanediol, and 0.1-1 wt% of an auxiliary antimicrobial agent selected from those recited.
2. Schmaus is good for all that it expressly discloses and reasonably suggests to one of ordinary skill in the art, who is one of ordinary creativity and not an automaton. While Schmaus does expressly teach that combinations of C5-10 alkane diols do provide a synergistic antimicrobial effect, at least against certain microbes, Schmaus also clearly teaches that 1,2-decanediol alone also exhibits a significant antimicrobial effect; see, for example composition DE3 in Table 3. Indeed, as Table 3 makes crystal clear to one of ordinary skill in the art, 3 wt% 1,2-decanediol by itself is just as effective against common microbes like E. coli, S. aureus, and C. albicans at day 28 as e.g. the combination of 1 wt% decanediol, 1 wt% octanediol., and 1 wt% hexanediol. This teaching cannot simply be ignored. Moreover, as Table 9 in Schmaus would suggest, the combination of a single 1,2-alkane diol with another auxiliary antimicrobial agent can also have “a synergistically intensified antimicrobial action”. For example, at day 28, the count of A. niger was 32,000 when treated with 0.1 wt% Euxyl K400 (i.e. an “auxiliary antimicrobial”). The same count was 60,000 when treated with the combination of 0.5 wt% hexanediol and 0.5 wt% octanediol. However, the count was only 2,800 when treated with the combination of 0.25 wt% hexanediol, 0.25 wt% octanediol, and 0.05 wt% Euxyl K400. Further, Schmaus expressly discloses that glycerol laurate is one such “auxiliary antimicrobial” (see paragraph 0066).
3. Hence, not only would one of ordinary skill in the art understand from Schmaus that e.g. 3 wt% decanediol by itself would be a potently effective antimicrobial agent against at least one microbe, one of ordinary skill in the art would no doubt also expect that further including e.g. glyceryl laurate as an additional antimicrobial agent is expected to enhance the antimicrobial effect. And from the examples of Schmaus, one of ordinary skill in the art would understand that the additional antimicrobial agent need only be present in a small amount, such as e.g. 0.05-0.1 wt%. Kabara confirms that antimicrobial compositions for application to skin can contain e.g. about 0.05-2 wt% monolaurin (i.e. glyceryl laurate) as a safe and effective antimicrobial agent.
4. Fernandez de Castro is the cited primary reference, not Schmaus. Fernandez de Castro discloses an antimicrobial composition for skin sanitization comprising e.g. at least 60 wt% C1-4 alcohol, preferably ethanol; and that the composition can further comprise an additional antimicrobial agent. Schmaus, merely a secondary reference, is directed to antimicrobial compositions for e.g. skin sanitization, and teaches not only that 3 wt% decanediol by itself would be a potently effective antimicrobial agent against at least one microbe, but suggests that the combination of decanediol with an auxiliary antimicrobial agent, such as glyceryl laurate, would be expected to have a synergistic antimicrobial effect. The issue here is whether it would be obvious to one of ordinary skill in the art to employ decanediol, or the combination of decanediol and glyceryl laurate, as the “additional antimicrobial agent” in the Fernandez de Castro composition with a reasonable expectation of success. Indeed, it would be without question, and Applicant has simply provided no evidence to the contrary.
5. Again, as just noted, supra, Fernandez de Castro is the cited primary reference, not Schmaus. Fernandez de Castro discloses an antimicrobial composition for skin sanitization comprising e.g. at least 60 wt% C1-4 alcohol, preferably ethanol; and that the composition can further comprise an additional antimicrobial agent. Without question, the Fernandez de Castro composition itself, even without any C1-10 alkane diol, would absolutely be expected to exhibit the property of “provides a log reduction against a marker organism of at least 3 in less than 1 minute”. Anyone of ordinary skill in the art has generally known for decades, and certainly would have known at the time of the present invention, that C1-4 alcohols, particularly e.g. isopropyl alcohol and e.g. ethanol, provide significant bacterial log reduction, with 60-70 wt% concentrations achieving near-complete kill (>5-6 log reduction) against common bacteria like S. aureus, E. coli, P. aeruginosa within seconds. Hence, one of ordinary skill in the art would recognize that the Fernandez de Castro composition itself, with 60 wt% isopropanol or ethanol, and without any C1-C10 alkane diol at all, will thus “provide a log reduction against a marker organism of at least 3 in less than 1 minute”. With addition of 1,2-decanediol as the “additional antimicrobial agent” to the Fernandez de Castro composition, the resulting composition will still, without question, continue to “provide a log reduction against a marker organism of at least 3 in less than 1 minute”. This is only to be expected. In other words, the fact that the combination of 60 wt% ethanol and 0.1-1 wt% 1,2-decanediol “provide a log reduction against a marker organism of at least 3 in less than 1 minute” is not unexpected at all, even if 1,2-decanediol alone does not provide this degree of efficacy within seconds.
For the foregoing reasons, the 35 USC 103 rejection is hereby maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (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.
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/DAVID BROWE/Primary Examiner, Art Unit 1617