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 Status
Claims 1-30, 41-43 and 52 are cancelled.
Claims 31-40, 44-51, 53 and 54 are pending. Applicants’ amendments have necessitated modification of the existing rejections. Accordingly, this Action is FINAL.
Withdrawn rejections
Applicants’ Declaration of Mark Willcox under 37 C.F.R. § 1.132, amendments and arguments filed 8/18/26 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claim(s) 31-39, 44-49 and 51 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (CN102302033A). Applicant has amended the claims to overcome the rejection.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
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, 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.
Claims 31-40 and 44-51 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (CN102302033A) and Abe et al. (EP0897755A2).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, 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.
Applicant claims for example:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of an aerosol disinfection scientist who possesses conventional knowledge in aerosol physics, microbiology, and chemical engineering to analyze, generate, and neutralize airborne pathogens. Such an artisan has knowledge of conventional chemical disinfectants (e.g., quaternary ammonium compounds) and conventional physical methods to inactivate pathogens. Furthermore, such an artisan has expertise in particle size distribution, concentration, and deposition, as well as understanding the stability and inactivation mechanisms of pathogens in airborne states or within respiratory droplets. In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 31-39 and 51, Li et al. disclose a disinfecting atomization agent (Abstract) and methods of air disinfection that can prevent and kill gonite, mycobacteria, virus, fungus and spore thereof, which are suspended in the air in a space, through an ultra-micron atomizer (Claim 9), thereby inherently producing an atomized/aerosolized mist of fine droplets of the composition into the space because that is the function of the atomizer, where the atomization agent comprises:
Monohydric alcohol 0.01 ~ 10%; where the monohydric alcohol is ethanol (Claims 1 and 5), where the tilde symbol “~” placed before a number means "about" or "approximately", and reads on amounts greater than 10%;
0.01-10% by mass n-alkyl dimethyl benzyl ammonium chloride with an “n” from 8-18 (Claims 1 and 4), which overlaps the claimed ranges of between about 0.01 % w/v and about 3% w/v and between about 0.01% w/v and about 1% w/v;
0.01-5% by mass polyhexamethylene biguanide (Claims 1 and 3), which is a polyhexanide, and overlaps the range of 0.05% w/v and about 5% w/v and between about 0.05% by mass and 3% by mass;
Water (Claim 1) where when the amounts of all the components are added up the amount of water is between about 70% v/v and about 90% v/v or between about 80% v/v and about 90% v/v.
Since there is no propellant present, then those proportions are calculated based on the total volume of the composition excluding a propellant. Also note MPEP 2144.05(I): In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Li et al. disclose in embodiment 5:
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Cetalkonium chloride is a synonym for the alkyl-benzyldimethylammonium chloride where n = 16 benzyldimethylhexadecylammonium chloride of instant claim 38. Please note that a specific example in the prior art which is within a claimed range anticipates the range (MPEP 2131.03(I)). The instant specification teaches that polyhexamethylenebiguanide has an average MW of between about 3000 and 3600 Da [0058-0059]. Accordingly, Li et al. disclose a method for killing or inactivating any virus suspended in air in a space by dispensing an aerosol composition as claimed into the space.
Regarding claims 44-48, since the method of Li et al. disinfects any virus in the air, then it is implicit in the method of Li et al., which employs the same active agents claimed, to kill/inactivate enveloped viruses suspended in air such as coronavirus, herpes virus or influenza virus, including coronavirus is 229E, NL63, OC43, HKU1, SARS-CoV-2, SARS-CoV or MERS-CoV. See MPEP 2112(II): MPEP 2112 II: “INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).”
Regarding claim 49, Li et al. disclose, for example, disinfection inside a railroad care, boat cabin and the inside of a car (Claim 9), which are enclosed spaces or if a window is open then it is a partly enclosed space.
As noted above, Li et al. teach using an ultra-micron atomizer (Claim 9).
Abe et al. teach a chemical liquid atomizer for use in methods of eliminating harmful organisms (Title; Abstract; claims 9-15)) where the composition includes a propellant (Claim 13) and makes fine particles of 20 µm or less (Claim 9). Abe et al. also teach that commercially available aerosol products have manual push button operation with flow valves [0012], which the Examiner reasonably interprets to be a spray can.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Li et al. is that Li et al. do not expressly teach adding a propellant, a spray can or the particles size of the droplets. This deficiency in Li et al. is cured by the teachings of Abe et al. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the method of LI et al. and add a propellant to the composition and produce fine droplets of 10 µm or less or 5 µm or less or use a spray can, as suggested by Abe et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because in the art of disinfection with an atomizer the artisan knows to add a propellant, as taught by Abe et al. and the resulting droplets/particles are less than 20 µm in size, which overlaps the claimed range thus rendering the claimed range obvious to the ordinary artisan. See MPEP 2144.05(I): In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Use of a conventional spray can with a propellant as an alternative spray device is obvious over the combined references. Accordingly, the ordinary artisan would have a reasonable expectation of success in adding a propellant and obtaining the claimed droplet size.
The difference between the instant application and Li et al. is that Li et al. do not expressly teach adding isopropanol. However, Li et al. teach adding a monohydric alcohol (Abstract) which renders obvious at least the common monohydric alcohols such as propanol, iso-propanol, butanol, t-butyl alcohol etc…The ordinary artisan would add isopropanol with a reasonable expectation of success. Especially given the known antimicrobial activity of isopropanol.
Claims 53 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (CN102302033A) and Abe et al. (EP0897755A2), as applied to claims 31-40 and 44-51 above, in view of Premachandran et al. (WO2017189589).
Applicant claims:
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Claim interpretation: Please note that: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.” See M.P.E.P § 2111.04; see also M.P.E.P §§ 2103(C) and 2173.05(h).
The references of Li et al. and Abe et al. are discussed in detail above and that discussion is incorporated by reference. In embodiment 5 of Li et al., trihydroxypropane is utilized, which can serve as a corrosion inhibitor.
Premachandran et al. teach antimicrobial aerosol compositions (Claim 18) that are used for disinfecting (Claim 16) with a wide range of antimicrobial agents including bronopol, which is 2-bromine-2-nitro-1,3-propylene glycol, and other non-glycol antimicrobial agents (Claim 10).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
Li et al. do not expressly teach an aerosol composition that does not contain any glycol compounds. The composition of Li et al. contains 2-bromine-2-nitro-1,3-propylene glycol, dihydric alcohol and polyatomic alcohol (Abstract; claim 1). However, Li et al. teaches that the dihydric and polyalcohol, which would be considered glycols, can be present from 0-30% by mass (Claim 1), which renders obvious embodiments with 0% by mass of any glycols. Consequently, embodiments that do not contain any dihydric and polyalcohol compounds are within the scope of the disclosure of Li et al. Moreover, the ordinary artisan in this art understands that 2-bromine-2-nitro-1,3-propylene glycol is an antimicrobial agent that has many non-glycol functional equivalents as taught by Premachandran et al. It is then obvious to substitute any other equivalent non-glycol antimicrobial agent for the 2-bromine-2-nitro-1,3-propylene glycol of Li et al. with a reasonable expectation of success. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Moreover, “Where two known alternatives are interchangeable for a desired function, an express suggestion to substitute one for the other is not needed to render a substitution obvious." In re Fout 675 F.2d 297, 301 (CCPA 1982).
Li et al. do not expressly teach an aerosol composition that consists of the components of claim 54. However, it would be obvious to formulate an aerosol composition that consists of the claimed components of an alcohol selected from ethanol and isopropanol, an alkyldimethylbenzylammonium compound, polyhexanide, optional corrosion inhibitor, optional propellant and water to use as a control composition for observing the effectiveness of adding other antimicrobial agents, such as bronopol or any other antimicrobial agent, to the composition. The ordinary artisan would do so with a reasonable expectation of success.
The difference between the instant application and Li et al. is that Li et al. do not expressly teach adding isopropanol. However, Li et al. teach adding a monohydric alcohol (Abstract) which renders obvious at least the common monohydric alcohols such as propanol, iso-propanol, butanol, t-butyl alcohol etc…The ordinary artisan would add isopropanol with a reasonable expectation of success. Especially given the known antimicrobial activity of isopropanol.
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.
From the combined 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 combined references, especially in the absence of evidence to the contrary.
Response to Declaration and Arguments:
The Declaration filed on 8/18/26 has been carefully considered but is not persuasive. In paragraph 7, the Declarant states: “This declaration is made to rebut the Office's 35 US.C. § 102 rejection by explaining that Li does not disclose a method for killing or inactivating any virus suspended in air in a space”. However, a declaration cannot overcome a 102 rejection and rejection has been withdrawn due to amendment. Consequently, the Declarant’s arguments are moot.
In paragraph 8, the Declarant states: “The application of a disinfectant composition into the air is not equivalent to inactivating a virus suspended in air. A composition which is applied into the air may merely settle onto surfaces and inactivate any viruses which are present on the surfaces. A composition which is applied into the air does not necessarily, or inherently, inactivate any viruses which are suspended in the air.” This is mere speculation by the Declarant and given no probative weight. It is understood by the ordinary artisan that a disinfecting composition applied to the air will contact any microorganisms suspended in the air to inactive them. It appears to be the Declarant’s position that the prior art composition will only inactivate viruses on a surface. That is simply geography as it does not matter if the virus is on a surface or in the air. In other words, the disinfecting composition does not care if the virus is on a surface or in the air. It will inactivate the virus/microorganism no matter the location.
In paragraphs 9-11, the Declarant cites Table 4 of Li and states: “Li does not explain what the test results in Table 4 are measuring or how they were obtained. The measurement of efficacy of an aerosol composition in killing or inactivating pathogens that are suspended in air is not trivial, as I discuss below. In the absence of any detail as to how the 'air' measurements were undertaken, l do not consider it likely that a measurement of killing or inactivating pathogens that are suspended in air was actually undertaken.” However, the ordinary artisan immediately understands that “cfu/m³” stands for colony-forming units per cubic meter, which is the standard measurement used to express the concentration of living, reproducible microorganisms (like bacteria or fungi) in a specific volume of air. The data provided by Li expressly demonstrates inactivation/killing of those microorganisms by the decrease in cfu/m³.
In paragraph 12, the Declarant states: “the killing or inactivation of a virus suspended in air is considerably more difficult than a bacteria suspended in air due to the smaller size of the virus compared to the bacteria.” However, the applied reference teaches the same components in the same amounts provided to the same air space. The only reasonable conclusion is that while it might be difficult to do, the same composition will also kill and inactivate viruses suspended in the air.
In paragraph 13, the Declarant states: “the efficacy of an aerosol composition in killing or inactivating pathogens that are suspended in air is also not trivial to measure. No standardised tests or procedures exist in this regard.” However, how it is measured is not a metric in the obviousness analysis.
In paragraphs 14-16, the Declarant states: “even though Li suggests the compositions disclosed therein may be used to disinfect 'air', I do not find this to be a plausible suggestion of killing or inactivating a virus suspended in air in a space, and my expectation of success would be low”, “The compositions of the present invention contain around 10% w/w or more alcohol”, and “The fact that the exemplified and claimed compositions are effective in killing or inactivation of a virus suspended in air in a space is unexpected in view of Li for the reasons discussed above.” However, Li suggests ~10% monohydric alcohol which overlaps the claimed range and Li has unambiguously demonstrated inactivation of microorganisms in air (Table 4) and expressly teach: “can effectively prevent and kill vegetative forms of bacteria, mycobacterium, virus, fungi and spore thereof” (Claim 9). Consequently, the ordinary artisan then has a reasonable expectation of success in inactivating/killing viruses suspended in air. Appellant has provided no evidence to the contrary but rather confirmed the combination of components of Li inactivate/kill viruses in the air. The Declaration is not probative.
With regard to Table 4 of Li, Applicant asserts: “it is unknown whether the quantification of pathogens in 'air' is a measure of pathogens actually suspended in air, or of pathogens which have settled from the air onto a testing surface.” However, Li distinguishes between “air” and “surface” in table 4. Thus, one is a measure of pathogens in the air, and the other is a measure of pathogens on a surface.
Applicant asserts: “even where a document may assert that a particular composition could be used to kill or inactivate a virus suspended in air, in the absence of any experimental demonstration, the a[sic] skilled person's expectation of success would be low.” The Examiner does not agree. Li expressly provided data concerning disinfecting the air with the composition (Table 4). Li expressly teaches killing/inactivating viruses with the composition. Applicant has failed to produce any evidence that the compounds employed by Li would not be expected to kill/inactivate viruses. Thus, the expectation of success by the ordinary artisan is high for killing and inactivation of viral particles in air and not low or unexpected as asserted by Applicant. In fact, Li does recognize the problem of airborne microorganisms including viruses which is why Li expressly teaches the sterilization of air (Claim 9). The term “sterilization of air” means completely destroying or removing all living microorganisms—such as bacteria, viruses, fungi, and mold spores—from a given volume of air. Applicants’ arguments are not persuasive.
Applicant argues: “Li's generalized reference to disinfecting "air'' does not provide a reason to select the ingredients and proportions of amended claim 31 for the specific purpose of killing or inactivating a virus suspended in air. As Dr. Willcox explains in the Wilcox Declaration submitted herewith, applying or atomizing a disinfectant composition into a space is not equivalent to inactivating viruses while they remain suspended in the air.” The Declaration by Dr. Wilcox is not probative as discussed above. Any arguments provided by Applicant concerning the Declaration by Dr. Wilcox are moot. It simply cannot be considered inventive to employ a prior art composition taught to be used in methods of disinfecting viruses in an air space. That is simply following the guidance of Li.
Applicant asserts: “Applicant does not contend that obviousness requires absolute certainty. Rather, the record must provide a sound technical basis for a reasonable expectation of achieving the claimed result.” The Examiner has provided the art of Li which provides a sound technical basis for the claimed method with the claimed composition. None of Applicant’s arguments are persuasive.
Applicant argues: “while Premachandran may teach non-glycol antimicrobial agents, the skilled person would not expect that a composition excluding glycol compounds would retain efficacy in killing or inactivation of a virus suspended in air in a space.” However, Applicant has provided no objective evidence to substantiate that assertion. Accordingly, it is merely attorney arguments and given no weight.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after review of all the facts, Applicant’s arguments are not persuasive. The Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts, which is more convincing than the evidence which has been offered in opposition to it.
Conclusion
No claims are allowed.
Applicants’ 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 ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
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