DETAILED ACTION
Receipt of Arguments/Remarks filed on December 15 2025 is acknowledged. Claims 9, 11 and 13 were/stand cancelled. Claims 1-8, 10, 12 and 14-25 are pending. Claims 23-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 28 2023. Claims 1-8, 10, 12 and 14-22 are directed to the elected invention.
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 Rejections - 35 USC § 103
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 of this title, 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 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 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 1-8, 10, 12 and 14-22 are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser et al. (US Patent No. 6383505, cited on PTO Form 1449) in view of Guthery (WO 9629867, cited in the Office action mailed on September 8 2023) and Gerashchenko et al. (USPGPUB No. 20160271294, cited in the Office action mailed on December 12 2024).
Applicant Claims
The instant application claims an antimicrobial composition comprising: (a) an antimicrobial agent, (b) a sequestering agent for slowing release of the antimicrobial agent, and (c) a release agent comprising a double chained cationic surfactant selected from didodecyldimethylammonium bromide (DDAB), didecyldimethylammonium bromide, dioctadecyldimethylammonium bromide, ethonium, and combinations thereof, wherein the sequestering agent is a phospholipid capable of forming a barrier on a surface and the surfactant endows the barrier with a positive charge, and wherein the composition is alcohol free.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Kaiser et al. is directed to fast-acting antimicrobial lotion with enhanced efficacy. Taught is a lotion comprising 0.25-8% of a nonionic emulsifier (reading on instantly claimed non-ionic surfactant of claims 6-7), 0.1-2% of an anionic emulsifier, 0.5-10% of a thickener, 0-15% of a humectant, 0.02-5% of a skin conditioner, 2-20% of an oil and 0.25-5% of a cationic antimicrobial selected from the group consisting of chlorhexidine, benzalkonium chloride, benzethonium chloride, polyhexamethylene biguanide, and combinations thereof; and water (claim 26). Nonionic surfactants include phospholipid complexes (claim 2) as well as glycol fatty acid esters, fatty acid ester of sorbitan, etc. (column 3, lines 40-51). Thickeners include waxes as well as fatty acid esters, polymeric thickeners (claims 12). Humectants include glycolic acid, glycolate salts, lactate salts, etc. Humectants are used in amounts from 2-15% (column 5). The composition includes a safe and effective amount of at least one active antimicrobial ingredient (column 4, lines 33-43). It is taught that the composition is preferably used as a leave-on composition, which is applied to the skin and left in place to provide both immediate and long term antimicrobial activity and moisturizing functions (column 2, lines 33-43).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Kaiser et al. teaches phospholipids, Kaiser et al. does not teach phosphatidylethanolamine or phosphatidylcholine. However, this deficiency is cured by Guthery.
Guthery is directed to fast acting and persistent topical antiseptics. It is taught that it is preferred to have an antiseptic that not only quickly kills microorganisms with a high log ratio kill on contact with the skin but also has the ability to penetrate throughout the levels of the skin, bind to lipids or proteins in the intercellular layers of the epidermis to produce a prolonged kill or persistence (page 13). Also included with the quick kill component is a persistent component. In order to achieve persistence in excess of six hours, it is necessary to incorporate or more of the persistent components (page 18). Persistent components are lipids such as phospholipids and glycosphingolipids (page 19). Phospholipids include phosphatidylcholine, phosphatidyl ethanolamine, phosphatidylserine (page 24).
While Kaiser et al. teaches one or more cationic antimicrobials and specifically teaches antimicrobials falling within the scope of claim 2, Kaiser et al. does not expressly teach a double chained cationic surfactant as claimed. However, this deficiency is cured by Gerashchenko et al.
Gerashchenko et al. is directed to a pharmaceutical preparation and method of its production and use. The composition comprises one or both of a cationic surfactant and an antimicrobial substance (abstract, claim 1, paragraph 0016). The cationic surfactant is present in an amount from 0.2 to 4 wt% and antimicrobial substance is present in an amount of 0.5 to 10 wt% (paragraph 0022). Preferably both a cationic surfactant and an antimicrobial substance are present (paragraph 0052). Cationic surfactants are either mono- or bis-quaternary ammonium compounds. Preferred cationic surfactants include ethonium and benzalkonium chloride (paragraph 0294). Compositions can be in the form of a powder, a suspension, a gel, an ointment, etc. (paragraph 0299). The composition may comprise a single cationic surfactant or may comprise 2 or more different cationic surfactants (paragraph 0322). A preferred mono-quaternary ammonium compound is benzalkonium chloride. This compound is taught has having a wide spectrum of antimicrobial activity (paragraph 0323). Preferred bis-quaternary ammonium compounds are ethonium. Ethonium is taught has having activity against gram positive bacteria, fungi and viruses (paragraph 0324).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Kaiser et al., Guthery and Gerashchenko et al. and utilize phospholipids such as phosphatidylcholine or phosphatidyl ethanolamine, reading on the instantly claimed sequestering agent. One skilled in the art would have been motivated to utilize these phospholipids in order to provide for persistence of the composition as taught by Guthery. One skilled in the art would have a reasonable expectation of success as Kaiser et al. teaches phospholipids can be included and teaches the compositions provide for immediate and long term antimicrobial activity.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Kaiser et al., Guthery and Gerashchenko et al. and utilize ethonium, a cationic surfactant, in combination with benzalkonium chloride (instantly claimed antimicrobial agent). One skilled in the art would have been motivated to add ethonium (reading on instantly claimed release agent) as it is a known cationic surfactant with antimicrobial activity as taught by Gerashchenko et al. Since both benzalkonium chloride and ethonium are cationic surfactants with antimicrobial activity as taught by Gerashchenko et al. their combination is obvious. As a general principle it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06. Furthermore, the inclusion of multiple antimicrobials would be expected to provide for more of a broader spectrum of activity against a variety of microbes. MPEP 2144.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Kaiser et al., Guthery and Gerashchenko et al. and utilize sorbitan esters or fatty acid esters of polyhydroxy compounds, i.e. glycol fatty acid esters, fatty acid ester of sorbitan. One skilled in the art would have been motivated to utilize these compounds as they are specifically taught non-ionic surfactants (reading on instant claims 6-7). All of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Regarding the alcohol free recitation, while cetyl alcohol and alcohols in general are taught and claimed, there are additional species taught which are not alcohols. Therefore, alcohol free compositions are contemplated.
Regarding claim 2, Kaiser et al. teaches that the antimicrobial is selected from chlorhexidine, benzalkonium chloride, benzethonium chloride, polyhexamethylene biguanide. There are only 4 choices for the antimicrobial of which two fall within the scope claimed. Where selection of one named species from a list of alternatives is all that is required to arrive at the instantly claimed subject matter, that species is anticipated. Ex Parte A., 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990). See also In re Sivaramakrishnan, 213 USPQ 441 (CCPA 1982). MPEP 2131.02.
Regarding the claimed dispersing agent (claim 10), Kaiser et al. teaches anionic emulsifiers which read on the instantly claimed dispersing agent as Kaiser et al. teaches a dispersion in which a fine dispersion of oil phase droplets is held in the surrounding water phase by suitable emulsifiers (column 2, lines 48-55).
Regarding the claimed concentration of antimicrobial agent (claim 3), sequestering agent (claim 5) by way of concentration of non-ionic surfactant/emulsifier, and dispersing agent (claim 12) by way of the concentration of the anionic emulsifier, Kaiser et al. teaches an overlapping range. Regarding the claimed concentration of antimicrobial and cationic surfactant (claim 8), Gerashchenko et al. teaches an overlapping range. 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.
Regarding claims 14, firstly, the prior art suggests the same combination of ingredients. Secondly, Guthery recognizes that the phospholipids allow for a persistent (i.e. sustained effect) effect. Since the composition contains the same antimicrobials, the inclusion of the phospholipid would be expected to provide not only an immediate effect but also a sustained effect. Furthermore, Kaiser et al. teaches that the lotion when rubbed into the skin and left on to continue moisturizing and killing microbes for up to 12 hours (abstract). Kaiser et al. teaches which is applied to the skin and left in place to provide both immediate and long term antimicrobial activity and moisturizing functions. Therefore, the combination of prior art suggests a sustained effect overlapping with a time period claimed.
Regarding claims 15-21, it is taught that the lotion when rubbed into the skin and left on to continue moisturizing and killing microbes for up to 12 hours (abstract). The compositions are taught as antimicrobial (example 4). Since the same antimicrobial agents are included, it would be expected to provide for the same effect.
Regarding claim 22, the composition is a disinfectant for hands reading on the claimed hand sanitizer.
Response to Arguments
Applicants’ arguments filed December 15 2025 have been fully considered but they are not persuasive.
Applicants argue (page 5-6) that (1) a person of ordinary skill in the art would have had no motivation to combine the ethonium of Geraschenko with the antimicrobial composition of kaiser and Guthery. Rather, one skilled in the art would have been taught away from combining the references because Guthery teaches that fatty acids need to be free fatty acids for the best activity and that cationic surfactant impair the free fatty acid performance in microbial activity. Furthermore, Geraschenko does not teach a lipid further evidencing to the ordinary skilled artisan that they should not combine the ethonium of Geraschenko with the composition of Kaiser or Guthery. There is no motivation to combine the cationic surfactants of the non-lipid powder composition of Gerashchenko with the oil-in-water antimicrobial composition of Kaiser.
Regarding Applicants’ first argument, the examiner cannot agree that Guthery teaches away. While Guthery teaches that an anionic, cationic or non-ionic surfactant may impair the free fatty acid performance in microbicidal activity, free fatty acids are not required. Guthery teaches that the persistent agent may be a lipid such as fatty acids, fatty acid ester, phospholipids, glycosphingolipids and mixtures thereof. Therefore, the above rejection is based on using phospholipids (which are not free fatty acid) with the composition of Kaiser. Furthermore, while Guthery does teach this, Guthery teaches the use of quaternary ammonium compounds which include dodecyldimethyl ammonium chloride, benzalkonium chloride, etc. (pages 31-32, claim 8). In fact, Guthery teaches other preferred lipids include phospholipids (page 24). Therefore, the examiner cannot agree that Guthery teaches away from combining phospholipids with the composition of Kaiser, especially in light of Kaiser's teachings that phospholipids can be included.
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Therefore, in order to render the claims obvious it is not a requirement that each reference cited teach all the claimed limitations. What the combination of references would have been suggested to one of ordinary skill in the art is the requirement. Guthery clearly provides the motivation that adding the phospholipids would be expected to provide for persistence of the composition. One skilled in the art would have been motivated to add ethonium as it is also an antimicrobial agent. Since both ethonium and benzalkonium chloride have the same function, namely antimicrobial activity, their combination is obvious. MPEP 2144.
Applicants argue (page 6-7) that (2) there is no expectation that the combination would yield predictable results. The combination of the amicrobial agent, the phospholipid sequestering and the double chained cationic surfactant provides surprising and unexpected results that would not be obvious based on the teachings of Kaiser, Guthery and Geraschenko. The claimed components act together to provide sustained release of therapeutic levels of the antimicrobial over several days. The instant examples show that the combination of the antimicrobial agent and the phospholipid sequestering agent (Formula 2) led to reduced level and duration of activity compared to antimicrobial agent only (formulation 1). However, when the double chained cationic surfactant release agent was added, the effects of the sequestering agent were counteracted resulting in increased level and duration of activity. The surfactants of Kaiser stabilize the oil-in-water composition whereas the instantly claimed surfactant destabilizes or acts as a release agent for the antimicrobial agent.
Regarding Applicants’ arguments, the instant specification states on page 15: “Surprisingly, this sequestering of BAC by PC appeared to be reversed to some extend by the presence of myristyl alcohol”. However, myristyl alcohol is not allowed to be present in the instant claimed composition as the composition is expressly claimed as alcohol free. Looking at table 2, the examiner can see for formulation 1 which is the combination of BAC and PC the effect does not last as long and reduces over the first day. However, formulation 4 shows less reduction on day 2 and a longer effect (to day 4). The examiner notes that formulation 5 does not fall within the scope claimed and therefore cannot be utilized to establish an unexpected effect. None of the results show the effect of ethonium alone. Geraschenko et al. teaches preferred bis-quaternary ammonium compounds are ethonium. Ethonium is taught has having activity against gram positive bacteria, fungi and viruses. Since ethonium has activity itself, the expectation would be that adding it would be expected to increase the inhibition. Therefore, the examiner cannot agree that the data shows an unexpected. Firstly, nothing establishes the expected effect when ethonium was added. Secondly, these results are at a single concentration with a specific combination of ingredients and nothing in the record establishes that any purported “unexpected” effect occurs over the full scope of the claims. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) Note: MPEP 716.02(d). Finally, regarding the argument on stabilization vs. destabilization. It is not clear where this is taught in the instant specification. As argued by Applicants the inclusion of ethonium, the surfactant, results in an increased level and duration of activity. How does that equate to destabilization?
Conclusion
THIS ACTION IS MADE FINAL. 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 ABIGAIL VANHORN whose telephone number is (571)270-3502. The examiner can normally be reached M-Th 6 am-4 pm EST.
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/ABIGAIL VANHORN/ Primary Examiner, Art Unit 1636