DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
2. The disclosure is objected to because of the following informalities:
In par 0009, “make the pathogen inactive” should read –making the pathogen inactive-.
In par 0010, “lassa virus” should read –Lassa virus-- and “marburg virus” should read –Marburg virus--.
In par 0010, “SARA-CoV-2” should read –SARS-CoV-2--.
In par 0028, “not particular limited” should read –not particularly limited--.
In par 0029, “mega Ohms” should read –megaohms--.
In par 0041, “the Amhaze Stadium device the Hurricane 1800 Flex device” should read --the Amhaze Stadium device and the Hurricane 1800 Flex device--.
The use of the terms Tween® 80 and SKC Biosampler®, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the 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.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Appropriate correction is required.
Claim Objections
3. Claim 6 is objected to because of the following informalities: “the method forms the sanitizing composition in the space that is non-visible to the human eye” should read –the method forms the sanitizing composition in a dispersion that is not visible to the human eye--, for clarity. Appropriate correction is required.
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
5. Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
6. Regarding claim 3, the limitation "the total amount of the triethylene glycol in the space" appears in reference to a total concentration of TEG aerosol and a TEG vapor (per the Specification par 0013), but the aerosol concentration ranges are dissimilar, and no such vapor has been introduced in the claim. Accordingly, there is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
7. 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.
8. Claims 1, 3-5, 14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al (US 20180093006 A1) in view of Rosebury et al (“Disinfection of Clouds of Meningopneumonitis and Psittacosis Viruses with Triethylene Glycol Vapor”, J Exp Med. 1947 Jan 1;85(1):65–76).
9. Regarding claim 1, Kelly discloses a method for sanitizing an indoor space (maintaining a desired level of an aerosolized disinfectant within a human-occupiable space, Title/Abstract, par 0009), comprising: dispersing a sanitizing composition comprising triethylene glycol into the space (aerosol generator was used that produces a controlled output of an airborne disinfectant, which to date has been composed of triethylene glycol , par 0009) at a selected frequency (sensing and operation altering steps are repeated periodically, Abstract) to maintain the sanitizing composition in an aerosol form at a concentration (to maintain the desired concentration of the compound within the space, Abstract).
Kelly further teaches that the triethylene glycol compound would be detected at a level in a range of about 0-2 ppm during sanitization (FIG. 1), but does not specifically teach that the desired concentration would be ranging from about 0.02 mg/m3 to about 0.09 mg/m3 in the space.
Rosebury teaches that triethylene vapor in low concentrations of 1:100,000,000 or lower is sufficient to create significant killing effects (page 67 first par), equal to a range of about 0.05 mg triethylene per m3 air or less, demonstrating effectiveness against influenza virus, salmonella, pneumococci, and streptococci (page 66 last par). Where the claimed ranges overlap, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), see MPEP 2144.05(I).
Therefore, 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 dispersing of aerosol in the method of Kelly to maintain a concentration ranging from about 0.02 to 0.09 mg/m3 in the space as taught by Rosebury, because a skilled artisan would understand how to obtain the claimed range through routine experimentation (see MPEP 2144.05(II)(A)) and would expect these concentrations to provide significant germicidal effectiveness with a reasonable expectation of success based on the teachings of Rosebury. See MPEP 2143(I)(G).
10. Regarding claim 3, Kelly in view of Rosebury teaches the method of claim 1, wherein aerosolized glycol rapidly comes into equilibrium with the gas phase, resulting in an environmentally defined distribution of gaseous and liquid phase glycol distributed within the accessible air volume (Kelly par 0009). As discussed above, Rosebury teaches the range of about 0.05 mg triethylene per m3 air or less (page 67 first par). While the combination does not specifically teach wherein the total amount of the triethylene glycol in the space is maintained at a concentration ranging from about 0.4 mg/m3 to about 2 mg/m3, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), see MPEP 2144.05(II)(A). The total amount/concentration of TEG is not deemed critical, and an skilled artisan would expect a higher concentration than the 0.05 mg triethylene per m3 air described to be sufficient by Rosebury to similarly provide significant germicidal effect.
Therefore, 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 dispersing of aerosol in the method of Kelly to maintain a concentration ranging from about 0.4 to 2 mg/m3 in the space, because a skilled artisan would understand how to obtain the claimed range through routine experimentation (see MPEP 2144.05(II)(A)) and would expect these concentrations to provide significant germicidal effectiveness with a reasonable expectation of success based on the teaching of Rosebury. See MPEP 2143(I)(G).
11. Regarding claim 4, Kelly in view of Rosebury teaches the method of claim 1, and Rosebury teaches that triethylene vapor in low concentrations of 1:100,000,000 or lower is sufficient to create significant killing effects (page 67 first par), equal to a range of about 0.05 mg triethylene per m3 air or less, demonstrating effectiveness against influenza virus, salmonella, pneumococci, and streptococci (page 66 last par). Where the claimed ranges overlap, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), see MPEP 2144.05(I).
Therefore, 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 dispersing of Kelly such that the sanitizing composition in an aerosol form has a concentration ranging from about 0.02 to 0.09 mg/m3 in the space as taught by Rosebury, because a skilled artisan would understand how to obtain the claimed range through routine experimentation (see MPEP 2144.05(II)(A)) and would expect these concentrations to provide significant germicidal effectiveness with a reasonable expectation of success based on the teachings of Rosebury. See MPEP 2143(I)(G).
12. Regarding claim 5, Kelly in view of Rosebury teaches the method of claim 1, wherein the sanitizing composition is in a steady state in the space (maintenance of a predefined glycol gas-phase concentration, Kelly par 0016).
13. Regarding claim 14, Kelly in view of Rosebury teaches the method of claim 1, wherein dispersing the sanitizing composition forms a mixture comprising an aerosol and a vapor (aerosolized glycol rapidly comes into equilibrium with the gas phase, resulting in an environmentally defined distribution of gaseous and liquid phase glycol distributed within the accessible air volume, Kelly par 0009).
14. Regarding claim 16, Kelly in view of Rosebury teaches the method of claim 1, wherein the method is performed by an atomizer or a vaporizer (aerosol generator…resulting in an environmentally defined distribution of gaseous and liquid phase glycol distributed within the accessible air volume, Kelly par 0009).
15. Regarding claim 17, Kelly in view of Rosebury teaches the method of claim 1, wherein the selected frequency is determined based on sensor data representing a concentration of the sanitizing composition in the space (concentration over time of a glycol compound with a space to be treated as determined by a photoionization detection device, Kelly par 0006; Kelly FIG. 2 shows dispersion frequency based on sensor data; Kelly FIG. 4, repeating the sensing and altering step periodically during the treatment period).
16. Regarding claim 18, Kelly in view of Rosebury teaches the method of claim 1, wherein the selected frequency is a predetermined frequency (Kelly FIG. 2 represents on/off sequence that is predetermined for experimental study, Kelly par 0014).
17. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kelly and Rosebury as applied to claim 1 above, and further in view of Robert et al (US 7930068 B2).
Regarding claim 2, Kelly in view of Rosebury teaches the method of claim 1, wherein Kelly incorporates by reference a dispensing system controlled using a duty cycle according to U.S. Patent 7,930,068 (par 0009) but does not specifically teach wherein the method comprises dispersing the sanitizing composition for a dispersing period of from about 5 seconds to about 1000 seconds, followed by a non-dispersing period of from about 15 seconds to about 10 minutes.
Robert teaches a dispersing system and method for periodic diffusion of a liquid into an atmosphere (Abstract) wherein control based on a duty cycle can be programmed to e.g. have an operation time of one minute and a pause of three minutes (col 8 lines 30-51).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to disperse the sanitizing composition in the method of modified Kelly for a dispersing period of from about 5 seconds to about 1000 seconds, followed by a non-dispersing period of from about 15 seconds to about 10 minute as taught by Robert, because Kelly references Robert as a suitable aerosol generator to carry out the method, and a person having ordinary skill in the art would recognize that this timing would provide a duty cycle for quasi-steady state aerosol concentration in the same manner with a reasonable expectation of success. See MPEP 2143(I)(G).
18. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kelly and Rosebury as applied to claim 1 above, and further in view of Grosvenor (US 2595674 A).
Regarding claim 6, Kelly in view of Rosebury teaches the method of claim 1, and Kelly further teaches the appropriate effective concentration is maintained for the desired efficacy without the distribution of an excess amount of disinfectant that may precipitate on top of surfaces in the treated space and possibly be wasteful of the disinfectant (par 0010), indicating a preference toward avoiding excessive droplet generation. The combination does not specifically teach that the sanitizing composition is formed in a manner that is non-visible to human eyes.
Grosvenor teaches a similar process for supplying triethylene glycol vapor in effective amount (col 1 lines 1-14) through periodic vaporization below the saturation point of the glycol (col 6 lines 18-32) that avoids the objectionable fog and condensation i.e. visible effects that supersaturation produces (col 1 lines 1-14)
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to tune the method of modified Kelly such that the dispersed aerosol is non-visible to human eyes as taught by Grosvenor, because dispersing triethylene glycol below the saturation point would predictably avoid the generation of objectionable visible fog in the same manner with a reasonable expectation of success. See MPEP 2143(I)(G).
19. Claims 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly and Rosebury as applied to claim 1 above, and further in view of Schroeder et al (US 5591395 A).
20. Regarding claim 7, Kelly in view of Rosebury teaches the method of claim 1, though the combination above is silent regarding the sanitizing composition required to disperse the desired airborne concentration, thus does not teach wherein the triethylene glycol is in an amount of from about 10% to about 90% by weight of the sanitizing composition.
Schroeder teaches an analogous method of disinfecting air by dispersing particles of glycols (Abstract) wherein the particular concentration of the active material in the concentrate contained within the package suitable for use in the method of the present invention can range from as low as about 5% active to up to 100% active material (col 2 lines 16-27), with a preferred diluent of water, overlapping closely with the claimed range (see also Example 2, col 3 lines 43-50). Where the claimed ranges overlap, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), see MPEP 2144.05(I).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use a TEG sanitizing composition for the method of Kelly where triethylene glycol is in an amount of from about 10% to about 90% by weight of the sanitizing composition as taught by Schroeder, because this concentration would predictably enable triethylene glycol to be volatilized into air in the same manner (Schroeder col 2 lines 3-14) and involves simple substitution of one known element (glycol concentration) for another to obtain predictable results. See MPEP 2143(I)(B).
21. Regarding claims 8 and 9, Kelly in view of Rosebury teaches the method of claim 1, though the combination above is silent regarding the sanitizing composition required to disperse the desired airborne concentration, thus does not teach wherein the sanitizing composition further comprises water, nor wherein the water is in an amount of from about 5% to about 90% by weight of the sanitizing composition.
Schroeder teaches an analogous method of disinfecting air by dispersing particles of glycols (Abstract) wherein triethylene glycol is a preferred glycol material (col 2 lines 3-14) and the preferred diluent is water (col 2 lines 15-27), with a formulation of 0% diluent at 100% active material to about 95% diluent at about 5% active material. Where the claimed ranges overlap, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), see MPEP 2144.05(I).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use a TEG sanitizing composition for the method of Kelly that also comprises water in an amount of about 5%-90% by weight of the sanitizing composition taught by Schroeder, because such a water diluent would predictably enable triethylene glycol to be volatilized into air in the same manner (Schroeder col 2 lines 3-14) and involves simple substitution of one known element (glycol formulation) for another to obtain predictable results. See MPEP 2143(I)(B).
22. Regarding claims 10 and 11, Kelly in view of Rosebury teaches the method of claim 1, and both references teach that propylene glycol has germicidal effects like triethylene glycol (Kelly par 0009, Rosebury pages 65-66). However, the combination does not teach a mixture of TEG and PG thus does not teach wherein the sanitizing composition further comprises propylene glycol, nor wherein the propylene glycol is in an amount of from about 0.5% to about 20% by weight of the sanitizing composition.
Schroeder teaches an analogous method of disinfecting air by dispersing particles of glycols (Abstract) wherein triethylene glycol and propylene glycol are both a preferred glycol material that may be used as a mixture (col 1 line 59 to col 2 line 1), where cosolvents should be used in generally less than 15% of the total formulation (col 2 lines 3-14) and the active material should comprise from as low as about 5% active to up to 100% active material (col 2 lines 16-27). Where the claimed ranges overlap, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), see MPEP 2144.05(I). A skilled artisan would expect that inclusion of propylene glycol in an amount from 0.5%-20% by weight would provide similar if not better germicidal effects, not least because Rosebury evidences that both PG and TEG have efficacy as a germicide under different conditions (Rosebury pages 66-67).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use a TEG sanitizing composition for the method of Kelly that also comprises propylene glycol in an amount of about 0.5%-20% by weight of the sanitizing composition taught by Schroeder, because such a propylene glycol diluent would predictably enable triethylene glycol to be volatilized into air in the same manner (Schroeder col 2 lines 3-14) and involves simple substitution of one known element (glycol formulation) for another to obtain predictable results. See MPEP 2143(I)(B).
23. Regarding claim 12, Kelly in view of Rosebury teaches the method of claim 1, though the combination above is silent regarding the sanitizing composition required to disperse the desired airborne concentration, thus does not teach wherein the sanitizing composition comprises from about 10% to about 90% by weight triethylene glycol, and from about 10% to about 90% by weight water.
Schroeder teaches an analogous method of disinfecting air by dispersing particles of glycols (Abstract) wherein triethylene glycol is a preferred glycol material (col 2 lines 3-14) and the preferred diluent is water (col 2 lines 15-27), with a formulation of 0% diluent at 100% active material to about 95% diluent at about 5% active material. Where the claimed ranges overlap, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), see MPEP 2144.05(I).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use a TEG sanitizing composition for the method of Kelly that comprises about 10%-90% by weight of TEG and from about 10%-90% by weight water as taught by Schroeder, because such a water diluent concentration would predictably enable triethylene glycol to be volatilized into air in the same manner (Schroeder col 2 lines 3-14) and involves simple substitution of one known element (glycol formulation) for another to obtain predictable results. See MPEP 2143(I)(B).
24. Regarding claim 13, Kelly in view of Rosebury teaches the method of claim 1, and both references teach that propylene glycol has germicidal effects like triethylene glycol (Kelly par 0009, Rosebury pages 65-66). However, the combination above is silent regarding the sanitizing composition required to disperse the desired airborne concentration, thus does not teach wherein the sanitizing composition comprises about 52.25% by weight triethylene glycol, about 1% by weight propylene glycol, and about 46.75% by weight water.
Schroeder teaches an analogous method of disinfecting air by dispersing particles of glycols (Abstract) wherein triethylene glycol and propylene glycol are both a preferred glycol material that may be used as a mixture (col 1 line 59 to col 2 line 1), where cosolvents should be used in generally less than 15% of the total formulation (col 2 lines 3-14) and the active material should comprise from as low as about 5% active to up to 100% active material (col 2 lines 16-27), the balance being the preferred diluent of water (col 2 lines 16-27). Where the claimed ranges overlap, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), see MPEP 2144.05(I). A skilled artisan would expect that inclusion of propylene glycol in a small amount of 1% by weight would provide similar if not better germicidal effects, not least because Rosebury evidences that both PG and TEG have efficacy as a germicide under different conditions (Rosebury pages 66-67), and could optimize the formulation to arrive at the claimed composition through routine experimentation. See MPEP 2144.05(II)(A).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use a TEG sanitizing composition for the method of Kelly that comprises about 52.25% by weight of TEG, about 1% by weight propylene glycol, and about 46.75% by weight water as generally taught by Schroeder, because such a water diluent concentration would predictably enable the germicidally active glycols to be volatilized into air in the same manner (Schroeder col 2 lines 3-14) and involves simple substitution of one known element (glycol formulation) for another to obtain predictable results. See MPEP 2143(I)(B).
25. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kelly and Rosebury as applied to claim 14 above, and further in view of Schroeder et al (US 5591395 A).
Regarding claim 15, Kelly in view of Rosebury teaches the method of claim 14, wherein the aerosol comprises liquid droplets (aerosolized glycol rapidly comes into equilibrium with the gas phase, resulting in an environmentally defined distribution of gaseous and liquid phase glycol distributed within the accessible air volume, Kelly par 0009). The combination does not specify these droplets as having an average diameter of from about 10 nm to about 10 microns.
Schroeder teaches an analogous method of disinfecting air by dispersing particles of glycols (Abstract) wherein triethylene glycol is a preferred glycol material (col 2 lines 3-14), generate particles such that over 90% of the particles have a particle size within the range of from about 0.16 to about 5 microns, a size at which the air sanitizer materials are very effective (col 2 lines 56-64).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to disperse the liquid droplets in the method of Kelly in a manner that produces droplets having an average diameter from about 10 nm to 10 microns as taught by Schroeder, as these small diameter particles would predictably provide a similar germicidal effectiveness and involves simple substitution of one known element (aerosol particle size) for another to obtain predictable results. See MPEP 2143(I)(B).
Conclusion
26. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Puck ("The Mechanism of Aerial Disinfection by Glycols and Other Chemical Agents", J Exp Med (1947) 85 (6): 741-757) teaches comprehensive theory and experimental results that effectively apply triethylene glycol as an air sanitizing agent under various concentration and humidity conditions, establishing that triethylene glycol is well-known as an air disinfecting agent by the 1940s.
27. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Talbert whose telephone number is (703)756-5538. The examiner can normally be reached Mon-Fri 8:00-5:00 Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC TALBERT/Examiner, Art Unit 1758
/SEAN E CONLEY/Primary Examiner, Art Unit 1799
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