DETAILED 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 .
Specification
The use of the terms “Tween”® on page 16, lines 19-20 and “Luer-Lok” ® on page 20, lines 18-19, which are a trade name or a mark used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore each term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 7 and 16-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Eatoo and Mishra (“Busting the myth of spontaneous formation of H2O2 at the air-water interface: contributions of the liquid-solid interface and dissolved oxygen exposed;” hereinafter “Eatoo”) disclose that the reduction of dissolved oxygen and oxidation of the solid surface result in the formation of hydrogen peroxide in sprayed water microdroplets. See the abstract and “Conclusion” section. Gallo et al. (“On the formation of hydrogen peroxide in water microdroplets;” hereinafter “Gallo”) disclose that hydrogen peroxide formation in water microdroplets was not observed and hypothesizes that the high regional ozone concentration in Santa Clara County during the years around the time the instant invention was made is the “primary reason being the H2O2 formation in those reports.” See “Discussion” and “Conclusion” sections. Chen and Williams (“Are Hydroxyl Radicals Spontaneously Generated in Unactivated Water Droplets?;" hereinafter “Chen”) disclose the spontaneous formation of hydroxyl radicals “do not originate form unactivated pure water droplets and these species must have been formed by an unrelation mechanism” such as “some form of energy transfer from the nebulization source.” See page 4. Therefore, the full scope of the invention is not enabled by the disclosure. The claims have a considerable breadth as the mechanism for generating hydrogen peroxide and the one or more reactive oxygen species has not been explicitly recited in claim 1 and the starting component has not been expressly recited. The prior art of reducing pathogens and generating hydrogen peroxide and reactive oxygen species is well understood and well developed. The level of one of ordinary skill in the art is high and the amount of predictability in the art is high. The amount of direction provided by the inventor is low as only a result has been provided and the chemical mechanisms in which the recited method utilizes has not been disclosed. A working example has not been provided as only the theory of a method of reducing a pathogen population has been disclosed. No specific apparatus or parameters for operation has been provided. From the above references, a vast quantity of experimentation would be needed to make or use the invention based on the content of the disclosure as the above references show that the invention was neither fully understood in a manner that one of ordinary skill in the art could make or use the claimed method at the time of invention. Eatoo makes clear that dissolved oxygen and surface oxidation are needed in order to result in the formation of hydrogen peroxide and radicals. Gallo discloses that high environment ozone levels are needed to result in hydrogen peroxide production. Chen discloses that an unrelated mechanism, such as energy transfer from the nebulization source, is needed in order to create hydroxyl radicals in pure water. Therefore, as it was not understood at the time of invention how the hydrogen peroxide and one or more reactive species were formed as evidenced by the above references, the original disclosure did not enable one skilled in the art to make or use the invention as claimed.
Claims 1-5, 7 and 16-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In light of the references of Eatoo, Chen and Gallo discussed above, it is clear that the applicant did not possess the entire scope of the claimed invention as the method does not work without high environmental ozone concentrations, dissolved oxygen, oxidation of a solid surface, and/or some form of energy transfer from the nebulization source. As Applicant did not possess this knowledge or understanding at the time of filing the disclosure falls short of having possession of the claimed invention. Further, as disagreement regarding the mechanics of how the hydrogen peroxide and one or more reactive oxygen species form is still present and actively discussed the in scientific community as noted by the references of Eatoo, Chen and Gallo further evidence that possession of the entire scope of the claimed invention has still not been obtained.
Response to Arguments
Applicant's arguments filed 26 May 2026 have been fully considered but they are not persuasive.
Applicant argues that the claims are “adequately enabled because the specification provides sufficient guidance to make and use the invention and experimental examples have been provided which demonstrate that the invention works and achieves the results in the manner claimed.” The Examiner respectfully disagrees. From the above cited references, a vast quantity of experimentation would be needed to make or use the invention based on the content of the disclosure as the above references show that the invention was neither fully understood in a manner that one of ordinary skill in the art could make or use the claimed method at the time of invention. Eatoo makes clear that dissolved oxygen and surface oxidation are needed in order to result in the formation of hydrogen peroxide and radicals. Gallo discloses that high environment ozone levels are needed to result in hydrogen peroxide production. Chen discloses that an unrelated mechanism, such as energy transfer from the nebulization source, is needed in order to create hydroxyl radicals in pure water. Therefore, as it was not understood at the time of invention how the hydrogen peroxide and one or more reactive species were formed as evidenced by the above references, the original disclosure did not enable one skilled in the art to make or use the invention as claimed as evidence exists that the results are unable to be duplicated using the disclosed method. It is further noted that the amendment adding the subject matter of previous claim 6 does not regard a “mechanism” in which hydrogen peroxide, hydroxyl radical and/or superoxide is formed, but rather merely a method step taken. It is further noted that four of the five exhibits cited by Applicant have an author who is also an inventor of the instant application, and do not explicitly respond to the findings made by at least Eatoo. The other exhibit, Krushinski et al., did “not attempt to determine the mechanism by which H2O2 is generated, and would also suffer from the experimental deficiencies discussed by Eatoo (the reduction of dissolved oxygen and oxidation of the solid surface result in the formation of hydrogen peroxide in sprayed water microdroplets). Therefore, the enablement rejection has been maintained as it was not understood at the time of invention how the hydrogen peroxide and one or more reactive species were formed as evidenced by the above references, the original disclosure did not enable one skilled in the art to make or use the invention as claimed.
Applicant argues that as the “claims now recite specific methods for generating microdroplets that contain hydrogen peroxide and reactive oxygen species in the absence of an electric field” and “the allegations made by Eatoo, Chen and Gallo references have been rebutted in the scientific literature which lends credence to the experimental evidence provided in the instant specification.” The Examiner respectfully disagrees. The Examiner notes that four of the five cited pieces of “scientific literature” include an author who is also an inventor of the instant application. Further, the Examiner notes that the Eatoo reference has not been refuted. Exhibit B, which shares an author with an inventor of the instant application, was cited to demonstrate “that the need for a liquid-solid interface […] by the observation of the formation of hydrogen peroxide in liquid-liquid phase contact such as oil in water or water in oil.” However, it is noted that the experiment of Exhibit B regards aqueous microdroplets in emulsified water-hexadecane mixtures and not a method germane to the instant method. It is not explained by Applicant how the experiment or findings of Exhibit B specifically refute the “allegations” of Eatoo. Even if the Exhibit B were to refute the findings of Eatoo, Applicant still did not possess this knowledge or understanding at the time of filing. Therefore, the written description rejection is maintained as disagreement regarding the mechanics of how the hydrogen peroxide and one or more reactive oxygen species form is still present and actively discussed the in scientific community as noted by the references of Eatoo, Chen and Gallo evidence that possession of the entire scope of the claimed invention has still not been obtained.
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 TIMOTHY C CLEVELAND whose telephone number is (571)270-5041. The examiner can normally be reached M-F 9:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached at (571) 270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY C CLEVELAND/Primary Examiner, Art Unit 1774
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