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 .
Response to Amendment
Claim amendments filed 11 November 2025 are acknowledged. Claims 1-20 are pending.
Amendments to the specification and drawings are sufficient to overcome each and every objection previously presented in the Non-Final Office Action mailed 11 July 2025.
Response to Arguments
Applicant’s arguments, see pages 12-13 of the applicant’s response, filed 11 November 2025, with respect to the rejections of claims 1, 9, and 15 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, new grounds of rejection is made in view of Golkowski in view of Mole (US 20170056543 A1).
Applicant argues that Golkowski does not teach the newly presented limitation “a portion of droplets are routed through the cold plasma generator”. However, Golkowski discloses that the disinfection effluent containing the nebulized droplets will be recirculated through the cold plasma generator during sterilization (recirculated effluent passes through the plasma generator, paragraph [0300], and effluent of reactive species and vaporized hydrogen peroxide, paragraph [0065]). Additionally, applicant argues that Golkowski does not teach a device that fully encloses all aspects of the invention into a “box”. However, Golkowski presents multiple examples of self-contained units. Applicant calls attention to one such unit shown in Figures 30A. Golkowski additionally presents examples of applications of the taught disinfection system in paragraph [0487]-[0511] and Figures 30A-30I, 31A-31C, 32A-32H, 33A-33B, 34A-34B, and 35A-35C. Finally Golkowski explicitly discloses that the above mentions examples are examples of applications for the described sterilization system (paragraph [0486]).
Golkowski lacks teaching to anticipate the limitation “generate submicron diameter droplets”. However, Mole teaches aerosol generation which creates droplets of less than 0.5 microns (paragraph [0105]). Therefore, a combination of Golkowski and Mole would render the current invention obvious.
Following the above logic, the 35 U.S.C. 102(a)(1) rejections of claims 2, 8-10, 12-13, 15-18, and 20 and the 35 U.S.C. 103 rejections of claims 11 and 14 are withdrawn. However, upon further consideration, new grounds of rejection is made in view of Golkowski in view of Mole (US 20170056543 A1).
The 35 U.S.C. 103 rejections of claims 3, 5, and 7 are withdrawn. However, upon further consideration, new grounds of rejection is made in view of Golkowski and Mole in view of Murayama.
The 35 U.S.C. 103 rejections of claims 4 and 6 are withdrawn. However, upon further consideration, new grounds of rejection is made in view of Golkowski, Mole, and Murayama in view of Shane.
The 35 U.S.C. 103 rejection of claim 19 are withdrawn. However, upon further consideration, a new ground of rejection is made in view of Golkowski and Mole in view of Shane.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 8-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Golkowski (US 20210023250 A1) in view of Mole (US 20170056543 A1).
Regarding claim 1, Golkowski teaches a disinfection device (disinfection system, abstract), comprising: an enclosure comprising an interior cavity (Figure 1A disinfection chamber “10”) and a chamber (Figure 2A effluent generator “46”); a closable loading port for providing access to the interior cavity (front loading hinged door, paragraph [0488]); the chamber positioned within the interior cavity (chambers encased in a housing, paragraph [0172]) and having an air inlet and air outlet respectively coupled to an outlet and an inlet of the interior cavity for providing airflow between the chamber and the interior cavity (Figure 1A air flow is provided between effluent generator “46” and disinfection chamber “10” via conduits “34” and “36”); a cold plasma generator disposed in the chamber (Figure 2A plasma generator “30” disposed in effluent generator “46”, and plasma generator can be cold plasma generator, paragraph [0018]); a fan arranged within or in proximity to the outlet of the chamber such that air from the interior cavity is forced through the air inlet of the chamber and routed to the cold plasma generator (Figure 2A blower “14” in effluent generator to distribute flow to plasma generator “30”); a heater disposed within the enclosure (chamber may be directly heated by elements in the chamber, paragraph [0350]); and a nebulizer (vaporizer unit is a nebulizer, paragraph [0075]), wherein the cold plasma generator, the fan, and the nebulizer are arranged in the disinfection device such that: plasma species generated by the cold plasma generator are routed to an area to which droplets formed by the nebulizer are discharged (sterilant vapor and plasma are mixed before entering the chamber, paragraph [0330]), and wherein a portion of droplets are routed through the cold plasma generator (recirculated effluent passes through the plasma generator, paragraph [0300], and effluent of reactive species and vaporized hydrogen peroxide, paragraph [0065]); and the interior cavity is exposed to a mixture of the droplets and the plasma species (providing mixture to chamber, abstract), but does not teach wherein submicron diameter droplets are generated. However, Mole teaches wherein submicron diameter droplets are generated (produce micro-droplets typically less than 0.5 microns, paragraph [0105]).
Golkowski and Mole are considered analogous to the current invention because all are in the field of plasma sterilizing devices. Therefore, it would have been obvious to one of ordinary skill in the art to combine the sterilizing device taught by Golkowski with the submicron droplet diameter taught by Mole because Mole teaches the hydrocarbon micro-droplets enhances the hydroxyl radical output and increases the solubility of ozone (paragraphs [0106]-[0107]).
Regarding claim 2, the combination of Golkowski and Mole teaches wherein the nebulizer is arranged in the chamber downstream from the cold plasma generator (Figure 39 nebulizer is located downstream of the ozone generator, Golkowski).
Regarding claim 8, the combination of Golkowski and Mole teaches an electronic control system comprising a processor (methods implemented by computing device including a processor, paragraph [0562], Golkowski) and a storage medium comprising program instructions executable by the processor (memory for storing instructions to be executed by the processor, paragraph [0565], Golkowski) for: activating the fan (controller signals blower to adjust flow, paragraph [0193], Golkowski); activating the cold plasma generator (controller unit regulates the operation of the plasma generator, paragraph [0198], Golkowski); activating the nebulizer (controller regulates the operation of the evaporator, paragraph [0198], Golkowski); terminating operation of the nebulizer (nebulizer turned off, paragraph [0555], Golkowski); terminating operation of the cold plasma generator after a set time period subsequent to terminating operation of the nebulizer (disinfection cycle maintained for a pre-set time period, paragraph [0556], and Figure 18C plasma generator is turned on “630” and turned off “635” after H2O2 valve has closed between steps “610” and “620”, Golkowski), and activating the heater for a set period of time (after drying period for example five minutes the heater is turned off, paragraphs [0406]-[0407], Golkowski).
Regarding claim 9, Golkowski teaches a disinfection device (disinfection system, abstract), comprising: an enclosure comprising an interior cavity (Figure 1A disinfection chamber “10”) and a chamber (Figure 2A effluent generator “46”); a closable loading port for providing access to the interior cavity (front loading hinged door, paragraph [0488]); a cold plasma generator within the chamber (system can be a self-contained unit, paragraph [0487]), wherein the disinfection device is configured such that plasma species generated by the cold plasma generator are discharged in the interior cavity (Figure 2A plasma generator “30” delivers effluent to chamber “10” via conduit “34”, and cold plasma generator is used, paragraph [0185]); a nebulizer, wherein the disinfection device is configured such that droplets generated by the nebulizer are discharged in the interior cavity (Figure 2A vaporizer“32” delivering droplets to chamber “10” via conduit “34”, and vaporizer unit is a nebulizer, paragraph [0075]) and wherein a portion of droplets are routed through the cold plasma generator (recirculated effluent passes through the plasma generator, paragraph [0300], and effluent of reactive species and vaporized hydrogen peroxide, paragraph [0065]); a fan arranged in the disinfection device to move air, the plasma species and the droplets in the disinfection device (Figure 2A blower “14” in effluent generator to distribute flow from plasma generator “30” and vaporizer “32” to the chamber “10”); an electronic control system comprising a processor (methods implemented by computing device including a processor, paragraph [0562]) and a storage medium comprising program instructions executable by the processor (memory for storing instructions to be executed by the processor, paragraph [0565]) for: activating the fan (controller signals blower to adjust flow, paragraph [0193]); activating the cold plasma generator (controller unit regulates the operation of the plasma generator, paragraph [0198]); activating the nebulizer (controller regulates the operation of the evaporator, paragraph [0198]); terminating operation of the nebulizer (nebulizer turned off, paragraph [0555]); and terminating operation of the cold plasma generator after a set time period subsequent to terminating operation of the nebulizer (disinfection cycle maintained for a pre-set time period, paragraph [0556], and Figure 18C plasma generator is turned on “630” and turned off “635” after H2O2 valve has closed between steps “610” and “620”), but does not teach wherein submicron diameter droplets are generated. However, Mole teaches wherein submicron diameter droplets are generated (produce micro-droplets typically less than 0.5 microns, paragraph [0105]).
Golkowski and Mole are considered analogous to the current invention because all are in the field of plasma sterilizing devices. Therefore, it would have been obvious to one of ordinary skill in the art to combine the sterilizing device taught by Golkowski with the submicron droplet diameter taught by Mole because Mole teaches the hydrocarbon micro-droplets enhances the hydroxyl radical output and increases the solubility of ozone (paragraphs [0106]-[0107]).
Regarding claim 10, the combination of Golkowski and Mole teaches wherein the set time period is between approximately 5 minutes and approximately 15 minutes (disinfecting sub-cycle lasts for between about 10-15 minutes, paragraph [0556], Golkowski).
Regarding claim 11, while the combination of Golkowski and Mole does not explicitly teach wherein the program instructions for terminating the operation of the nebulizer comprises terminating the operation of the nebulizer while maintaining operation of the fan and the cold plasma generator, Golkowski teaches the controller unit regulates the operation of the plasma generator, the evaporator, and the fans (paragraph [0198]), the nebulizer may be cycled on and off during the sterilization cycle to maintain the humidity (paragraph [0555]), and that the free radical generator and fan are run through the sterilization cycle (Figure 3A phase II “71”). Therefore, it would have been obvious to one of ordinary skill in the art that the controller taught by Golkowski would have been inherently capable of operating the nebulizer by terminating the operation of the nebulizer while maintaining the operation of the fan and cold plasma generator. Additionally, it would have been obvious to one of ordinary skill in the art to program instructions to turn off the nebulizer while the fan and plasma generator are run during the sterilization cycle because it advantageously maintains the relative humidity below the condensation point of the disinfection device (paragraph [0555]).
Regarding claim 12, the combination of Golkowski and Mole teaches wherein the storage medium further comprises program instructions executable by the processor for: terminating operation of the cold plasma generator prior to or at the same time as the step of terminating operation of the nebulizer (during free radical neutralization step ozone generator and nebulizer can be turned off, paragraph [0466], Golkowski); reactivating the cold plasma generator, wherein the step of terminating operation of the cold plasma generator after a set period subsequent to terminating operation of the nebulizer comprises terminating operation of the reactivated cold plasma generator (ozone generator can be cycled on and off during sterilization phase, paragraph [0555], and plasma generator is turn off for a predetermined period of time, paragraph [0446], Golkowski); and maintaining operation of the fan between the steps of terminating operation and reactivating the cold plasma generator (Figure 3A blowers turn on “81” and remain on until full cycle is over “92” even when plasma generator turns off “87”, Golkowski).
Regarding claim 13, the combination of Golkowski and Mole teaches a heating element arranged in the disinfection device to heat the interior cavity (Figure 2A heater “64” connected to chamber “10”, Golkowski), wherein the storage medium further comprises program instructions executable by the processor for activating the heating element at the time or subsequent to the step of terminating operation of the cold plasma generator (Figure 3A turn on heater step “88” occurs after turning off the plasma generator “87”, Golkowski).
Regarding claim 14, while the combination of Golkowski and Mole does not explicitly teach activating the fan may comprise program instructions for activating the fan to operate at a flow rate of at least 0.3 m3 per minute, Golkowski does teach operating the blower to circulate the air at range of chamber exchanges per minute including about 25 to 30 chamber exchanges per minute (paragraph [0177]). Additionally, Golkowski teaches a range of volumes that chamber can be including 10 L (paragraph [0173]). From this information, it can be extrapolated that the fan in Golkowski is able to operate at a range of 250 to 300 L/min or 0.25 to 0.3 m3/min. Therefore, it would have been obvious to one of ordinary skill in the art to optimize the fan speed to a flow rate of 0.3m3/min to achieve the desired sterilization speed (See MEPE 2144.05 I-II).
Regarding claim 15, Golkowski teaches a disinfection device (disinfection system, abstract), comprising: an enclosure comprising an interior cavity (Figure 1A disinfection chamber “10”) and a chamber (Figure 2A effluent generator “46”); a closable loading port for providing access to the interior cavity (front loading hinged door, paragraph [0488]); the chamber positioned within the interior cavity (chambers encased in a housing, paragraph [0172]) and having an air inlet and air outlet respectively coupled to an outlet and an inlet of the interior cavity for providing airflow between the chamber and the interior cavity (Figure 1A air flow is provided between effluent generator “46” and disinfection chamber “10” via conduits “34” and “36”); a cold plasma generator disposed in the chamber (Figure 2A plasma generator “30” disposed in effluent generator “46”, and plasma generator can be cold plasma generator, paragraph [0018]); a fan arranged within or in proximity to the outlet of the chamber such that air from the interior cavity is forced through the air inlet of the chamber and routed to the cold plasma generator (Figure 2A blower “14” in effluent generator to distribute flow to plasma generator “30”); and a nebulizer (vaporizer unit is a nebulizer, paragraph [0075]), wherein the cold plasma generator, the fan, and the nebulizer are arranged in the disinfection device such that: plasma species generated by the cold plasma generator are routed to an area to which droplets formed by the nebulizer are discharged in the interior cavity (sterilant vapor and plasma are mixed before entering the chamber, paragraph [0330]) and wherein a portion of droplets are routed through the cold plasma generator (recirculated effluent passes through the plasma generator, paragraph [0300], and effluent of reactive species and vaporized hydrogen peroxide, paragraph [0065]); and a heating element to heat the interior cavity (Figure 2A heater “64” connected to chamber “10” ), but does not teach wherein submicron diameter droplets are generated. However, Mole teaches wherein submicron diameter droplets are generated (produce micro-droplets typically less than 0.5 microns, paragraph [0105]).
Golkowski and Mole are considered analogous to the current invention because all are in the field of plasma sterilizing devices. Therefore, it would have been obvious to one of ordinary skill in the art to combine the sterilizing device taught by Golkowski with the submicron droplet diameter taught by Mole because Mole teaches the hydrocarbon micro-droplets enhances the hydroxyl radical output and increases the solubility of ozone (paragraphs [0106]-[0107]).
Regarding claim 16, the combination of Golkowski and Mole teaches wherein the heating element and the disinfection device are configured to raise and maintain a temperature in the interior cavity to be between approximately 40°C and approximately 60°C (interior of chamber heated to about 45°C to about 50°C, paragraph [0024], Golkowski) for a predetermined amount of time (Figure 3A drying occurs for a few minutes “89” before heater is turned off “90”, Golkowski).
Regarding claim 17, the combination of Golkowski and Mole teaches an electronic control system comprising a processor (methods implemented by computing device including a processor, paragraph [0562], Golkowski) and a storage medium comprising program instructions executable by the processor (memory for storing instructions to be executed by the processor, paragraph [0565], Golkowski) for: activating the cold plasma generator (Figure 3A turn on plasma generator “85”, Golkowski); terminating operation of the cold plasma generator (Figure 3A turn off plasma generator “87”, Golkowski); activating the heating element at the same time or subsequent to the step of terminating operating of the cold plasma generator (Figure 3A heater is turned on “88” after turning off the plasma generator “87”, Golkowski).
Regarding claim 18, the combination of Golkowski and Mole teaches wherein the storage medium further comprises program instructions executable by the processor for: activating the nebulizer (controller regulates the operation of the evaporator, paragraph [0198], Golkowski); and terminating operation of the nebulizer prior to the step of terminating the cold plasma generator (Figure 18C plasma generator is turned on “630” and turned off “635” after H2O2 valve has closed between steps “610” and “620”, Golkowski).
Regarding claim 20, the combination of Golkowski and Mole teaches wherein the interior cavity comprises a volume between approximately 0.1 liters and approximately 100 liters (chamber may have a volume ranging from about 10L to about 50L, paragraph [0173], Golkowski).
Claims 3, 5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Golkowski and Mole in view of Murayama (US 20150273097 A1).
Regarding claim 3, the combination of Golkowski and Mole teaches all aspects of the current invention expect wherein the nebulizer is arranged in the interior cavity. However, Murayama teaches wherein the nebulizer is arranged in the interior cavity (sprayer includes a spray nozzles which a liquid is atomized, paragraph [0075], and Figure 1 sprayer “120” is in the working chamber “200”).
Golkowski, Mole, and Murayama are considered analogous to the current invention because all are in the field of plasma sterilizing devices. Therefore, it would have been obvious to one of ordinary skill in the art to combine disinfection device taught by Golkowski and Mole with the nebulizer placement taught by Murayama because Murayama teaches supplying the liquid is an atomized manner promotes gasification and reducing the purge time of sterilization process (paragraph [0036]).
Regarding claim 5, the combination of Golkowski and Mole teaches all aspects of the current invention except wherein the nebulizer is arranged in the chamber, and wherein the chamber comprises a fluid outlet for passing droplets formed by the nebulizer into the interior cavity. However, Murayama teaches wherein the nebulizer is arranged in the chamber, and wherein the chamber comprises a fluid outlet for passing droplets formed by the nebulizer into the interior cavity (Figure 13B sterilizing component source “140” is separate from plasma generator “460” and working chamber “200” and fluid is supplied to working chamber through atomizing sprayer “621”).
Golkowski, Mole, and Murayama are considered analogous to the current invention as discussed above. Therefore, it would have been obvious to one of ordinary skill in the art to combine the disinfection device taught by Golkowski and Mole with the additional chamber for the nebulizer taught by Murayama because Murayama teaches that if the fluids from the nebulizer and the plasma generator do not come in to contact before being sprayed the gasification effects will be further increased and the purge time will be decreased (paragraph [0206]).
Regarding claim 7, the combination of Golkowski and Mole teaches all aspects of the current invention except wherein the nebulizer is configured and arranged in the disinfection device such that the droplets having a diameter of 10 microns or greater are discharged into the interior cavity. However, Murayama teaches wherein the nebulizer is configured and arranged in the disinfection device such that the droplets having a diameter of 10 microns or greater are discharged into the interior cavity (atomized into a small size of about several tens of microns, paragraph [0075]).
Golkowski, Mole, and Murayama are considered analogous to the current invention as discussed above. Therefore, it would have been obvious to one of ordinary skill in the art to combine the disinfection device of Golkowski and Mole with the microdroplet size taught by Murayama because Golkowski teaches that microdroplets allow the sterilant to interact with surfaces within the chamber and kill pathogens even if the surface is wet (paragraph [0432]).
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Golkowski, Mole, and Murayama as applied to claims 3 and 5 above, and further in view of Shane (US 20190201565 A1).
Regarding claim 4, the combination of Golkowski, Mole, and Murayama teaches all aspects of the current invention including wherein the nozzle of the nebulizer discharges droplets toward and area in the interior cavity adjacent the air outlet of the chamber (Figure 13B sprayer with nozzle “621” is adjacent to the outlet of the plasma generator “460” in the working chamber “200”, Murayama), but does not teach wherein the nebulizer is arranged within 12 inches of the air outlet of the chamber. However, it has been established that a rearrangement of parts is not sufficient to differentiate an invention over prior art (See MPEP 2144.04 VI (C)). Additionally, Shane teaches that spraying nozzles can produce a fan-shaped spray patter up to 12 inches wide (paragraph [0012]). Therefore, it would have been obvious to one of ordinary skill in the part to optimize the placement of the chamber outlet and the nozzle to be within 12 inches of each other to ensure the two fluids interact as Golkowski teaches that the mix of reactive species causes unique and diverse sterilization reactions to occur at low temperature (paragraph [0157]) (See MPEP 2144.05 II (A)).
Regarding claim 6, the combination of Golkowski, Mole, and Murayama teaches all aspects of the current invention including wherein the air outlet of the chamber in which the cold plasma generator is arranges and the fluid outlet of the additional chamber are configured in the disinfection device to direct their discharge to a common area in the interior cavity (Figure 13B sprayer with nozzle “621” is adjacent to the outlet of the plasma generator “460” in the working chamber “200”, Murayama), but does not teach wherein the outlets are within approximately 12 inches of each other. However, it has been established that a rearrangement of parts is not sufficient to differentiate an invention over prior art (See MPEP 2144.04 VI (C)). Additionally, Shane teaches that spraying nozzles can produce a fan-shaped spray patter up to 12 inches wide (paragraph [0012]). Therefore, it would have been obvious to one of ordinary skill in the part to optimize the placement of the chamber outlet and the nozzle to be within 12 inches of each other to ensure the two fluids interact as Golkowski teaches that the mix of reactive species causes unique and diverse sterilization reactions to occur at low temperature (paragraph [0157]) (See MPEP 2144.05 II (A)).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Golkowski and Mole in view of Shane.
Regarding claim 19, the combination of Golkowski and Mole teaches all aspects of the current invention expect wherein the nebulizer is configured to generate microdroplets having a mean diameter of approximately 5 µm or less. However, Shane teaches wherein the nebulizer is configured to generate microdroplets having a mean diameter of approximately 5 µm or less (aerosol droplets are 5 µm , paragraph [0015]).
Golkowski, Mole, and Shane are considered analogous to the current invention because all are in the field of plasma disinfection devices. Therefore, it would have been obvious to one of ordinary skill in the art to combine the disinfection device taught by Golkowski and Mole with the droplet size taught by Shane because Golkowski teaches that microdroplets allow the sterilant to interact with surfaces within the chamber and kill pathogens even if the surface is wet (paragraph [0432]).
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.
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/K.R.S./Examiner, Art Unit 1799
/DONALD R SPAMER/Primary Examiner, Art Unit 1799