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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 22 December 2025 has been entered.
Response to Amendment
Claim amendments filed 22 December 2025 are acknowledged. Claims 1-30 are pending.
Response to Arguments
Applicant’s arguments, see pages 7-15 of the applicant’s response, filed 22 December 2025, with respect to the rejections of claims 1-6, 10, 12, 14-21, 25, 27, and 29-30 under 23 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 Therefore, the rejection has been withdrawn.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 are made in view of 35 U.S.C. 103 with respect to Matsui in view of Schoen (US 3532270 A).
The additional limitations requiring a temperature sensor, temperature controller, and a pressure regulator are sufficient to overcome the previously presented 35 U.S.C. 102(a)(2) rejections. However, Schoen teaches a pressure regulator to control the inflow pressure of the gas in the tank (Figure 6 pressure regulator “32” to facilitate dry air delivery “30” to humidification chamber “38”). Additionally, Schoen teaches calculating and controlling specific humidity from the temperature and pressure of the gas (determine the change in specific humidity with time due to pressure change, column 6 lines 36-37, and dew point temperature plotted against specific humidity, column 7 lines 56-57). Therefore, a combination of Matsui and Schoen would render the current invention obvious.
Following the above logic, the previously presented 35 U.S.C. 103 rejections of claims 7-9, 11, 22-24, and 26 are withdrawn. However, upon further consideration, new grounds of rejection are made in view of 35 U.S.C. 103 with respect to Matsui in view of Schoen (US 3532270 A).
Additionally, the previously presented 103 rejections of claims 13 and 28 are withdrawn. However, upon further consideration, new grounds of rejection are made in view of 35 U.S.C. 103 with respect to Matsui and Schoen in view of Campbell.
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 1-12, 14-27, and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Matsui (JP 2017051555 A) in view of Schoen (US 3532270 A).
Regarding claim 1, Matsui teaches a sterilization apparatus for sterilizing medical instruments (sterilizing an object in the medical field, paragraph [0002]), including: a device for controlling specific humidity, SH, of flow of a gas or gas mixture (humidity adjusting unit is provided to adjust the humidity in the processing chamber, paragraph [0006], and absolute humidity may be used instead of relative humidity, paragraph [0020], and amount of water vapor in mixed gas stream is adjusted, paragraph [0012]), including a tank for storing a volume of water (Figure 2 humidity adjusting unit “11” includes a water tank “22”), wherein the tank has an inflow port for receiving sad gas or gas mixture (Figure 2 mixed gas is provided to the humidity adjusting unit “11” via a conduit “6”); wherein the apparatus includes a temperature sensor, a temperature controller, the temperature sensor being arranged to measure a temperature of the water in the tank (temperature adjustment mechanism to adjust water temperature in water tank, paragraph [0020]); wherein a temperature of the water are controlled for a required SH (temperature inside the processing chamber can be adjusted to control the humidity in the processing chamber, paragraph [0019]); and wherein the tank has an outflow port for allowing said humidified gas or gas mixture at the required SH to exit the tank toward the medical instruments (Figure 2 water tank “22” has outflow port “21c” to carry out mixed gas with increased water vapor content), but does not teach a pressure regulator, the pressure regulator being arranged in communication with the inflow port for controlling and maintaining a pressure of said gas or gas mixture in the tank; wherein the pressure of the received gas or gas mixture are controlled for a required SH. However, Schoen teaches a pressure regulator, the pressure regulator being arranged in communication with the inflow port for controlling and maintaining a pressure of said gas or gas mixture in the tank (Figure 6 pressure regulator “32” to facilitate dry air delivery “30” to humidification chamber “38”); wherein the pressure of the received gas or gas mixture are controlled for a required SH (determine the change in specific humidity with time due to pressure change, column 6 lines 36-37).
Matsui and Schoen are considered analogous to the current invention because all are in the field of humidity control apparatuses. Therefore, it would have been obvious to combine the medical instrument sterilization apparatus taught by Matsui with the pressure regulator taught by Schoen because Schoen teaches the mass flow rate of the input flow is dependent on upstream pressure thus requires a precise pressure regulator (column 4 lines 3-6).
Regarding claim 2, the combination of Matsui and Schoen teaches wherein the inflow port is arranged to have a gas or gas mixture enter the volume of water below a water surface therefor (Figure 2 inflow port “21b” of conduit “6” enters under the surface of the water “24”, Matsui).
Regarding claim 3, the combination of Matsui and Schoen teaches wherein the outflow port is in communication with a gas head inside the tank (Figure 2 water tank “22” has outflow port “21c” to carry out mixed gas with increased water vapor content, Matsui).
Regarding claim 4, the combination of Matsui and Schoen teaches a processor arranged for receiving a desired SH value and for determining values for a required temperature and/or required pressure on the basis of the desired SH value (control device controls the humidity adjusting unit so that the humidity is within a predetermined range, paragraph [0006], and vapor pressure can be calculated based on temperature and humidity values, paragraph [0017], Matsui).
Regarding claim 5, the combination of Matsui and Schoen teaches wherein the temperature sensor (temperature sensor installed in the chamber, paragraph [0017], Matsui), and a temperature controller are configured for maintaining the water at a controlled temperature (water adjustment mechanism to adjust water temperature in tank, paragraph [0020], Matsui).
Regarding claim 6, the combination of Matsui and Schoen teaches wherein the processor is arranged for receiving a controlled temperature value as input, and for determining the required pressure on the basis of the desired SH and the controlled temperature value (vapor pressure can be calculated based on temperature and humidity values, paragraph [0017], Matsui).
Regarding claim 7, the combination of Matsui and Schoen teaches wherein the pressure regulator is configured for maintaining a pressure in the tank at a controlled pressure (precision balanced pressure regulator, column 3 lines 67-68, Schoen).
Regarding claim 8, the combination of Matsui and Schoen teaches wherein the processor is arranged for receiving a controlled pressure value as an input, and for determining the required temperature on the basis of the desired SH and the controlled pressure value (determine the change in dew point temperature as specific humidity changes from pressure, column 6 lines 36-37, Schoen).
Regarding claim 9, the combination of Matsui and Schoen teaches wherein the processor is arranged for controlling the temperature and/or pressure in the tank on the basis of the required temperature and/or pressure (controlling the temperature of the temperature of the water on the basis of pressure regulation, column 4 lines 17-29, Schoen).
Regarding claim 10, the combination of Matsui and Schoen teaches wherein the processor is arranged for receiving an indication representative of desired sterilization parameter and determining the desired SH value of the basis thereof (control device controls humidity within suitable range to achieve uniform decontamination, paragraph [0012], Matsui).
Regarding claim 11, the combination of Matsui and Schoen teaches a water supply port for maintaining a water level of the volume of water within a predetermined interval (Figure 6 make up water supply to humidification chamber “38”, Schoen).
Regarding claim 12, the combination of Matsui and Schoen teaches a plasma source having an ionization chamber in communication with the device for controlling specific humidity (Figure 1 plasma generating unit “4” in communication with humidity adjusting unit “11” via conduit “6”, Matsui).
Regarding claim 14, the combination of Matsui and Schoen teaches one or more of: a RH sensor, temperature sensor, pressure sensor, and flow sensor, in connection from the outflow port of the device to a gas input of the ionization chamber (temperature sensor for measuring temperature of the gas introduced into the plasma generating unit is upstream of the plasma generating unit, paragraph [0017], Matsui).
Regarding claim 15, the combination of Matsui and Schoen teaches a chamber arranged for placing a medical instrument therein (Figure 1 processing chamber “2” with article “3” placed inside, Matsui); and a temperature control unit arranged for controlling a temperature of the medical instrument and/or the chamber such that the temperature of the medical instrument is below the temperature of the chamber for allowing a sterilizing agent to at least partially condense onto the medical instrument (installing a heating/cooling mechanism inside the processing chamber to keep it within a suitable humidity range for disinfection, paragraph [0017], Matsui).
Regarding claim 16, Matsui teaches a method for sterilizing a medical instrument (sterilizing an object in the medical field, paragraph [0002]), including: placing the medical instrument in a chamber (items can be inserted and removed from the processing chamber, paragraph [0010]); supplying a humidified gas stream to the medical instrument, wherein said humidified gas stream has a controlled specific humidity (supplies plasma excited gas and a control device controls the humidity in the chamber within a predetermined range, paragraph [0006], and absolute humidity may be used instead of relative humidity, paragraph [0020], and amount of water vapor in mixed gas stream is adjusted, paragraph [0012]) and is obtained by: providing a gas stream into a tank storing a volume of water via an inflow port (Figure 2 mixed gas is provided to the humidity adjusting unit “11” having a water tank “22” via a conduit “6”), controlling a temperature of the water using a temperature sensor, and a temperature controller, the temperature sensor being arranged to measure the temperature of the water tank (water adjustment mechanism to adjust water temperature in tank to adjust the amount of water vapor in the mixed gas, paragraph [0020]); flowing said humidified gas stream having the controlled specific humidity from the tank via an outflow port towards the medical instrument in the chamber (Figure 2 water tank “22” has outflow port “21c” to carry out mixed gas with increased water vapor content), but does not teach controlling a gas pressure using a pressure regulator and the pressure regulator being arranged in communication with the inflow port for controlling and maintaining said gas pressure of said supplied humidified gas stream in the tank. However, Schoen teaches controlling a gas pressure using a pressure regulator and the pressure regulator being arranged in communication with the inflow port for controlling and maintaining said gas pressure of said supplied humidified gas stream in the tank (Figure 6 pressure regulator “32” to facilitate dry air delivery “30” to humidification chamber “38”).
Matsui and Schoen are considered analogous to the current invention as discussed above. Therefore, it would have been obvious to combine the medical instrument sterilization apparatus taught by Matsui with the pressure regulator taught by Schoen because Schoen teaches the mass flow rate of the input flow is dependent on upstream pressure thus requires a precise pressure regulator (column 4 lines 3-6).
Regarding claim 17, the combination of Matsui and Schoen teaches having the gas stream enter the tank below a water surface of the volume of water (Figure 2 inflow port “21b” of conduit “6” enters under the surface of the water “24”, Matsui).
Regarding claim 18, the combination of Matsui and Schoen teaches flowing the humidified gas stream having the controlled specific humidity from a gas head inside the tank (Figure 2 water tank “22” has outflow port “21c” to carry out mixed gas with increased water vapor content, Matsui).
Regarding claim 19, the combination of Matsui and Schoen teaches using a processor for retrieving a desired SH value and for determining values for required temperature and/or required pressure on the basis of the desired SH value (control device controls the humidity adjusting unit so that the humidity is within a predetermined range, paragraph [0006], and vapor pressure can be calculated based on temperature and humidity values, paragraph [0017], Matsui).
Regarding claim 20, the combination of Matsui and Schoen teaches using the temperature sensor (temperature sensor installed in the chamber, paragraph [0017], Matsui), and using temperature controller for maintaining the water at the controlled temperature (water adjustment mechanism to adjust water temperature in tank, paragraph [0020], Matsui).
Regarding claim 21, the combination of Matsui and Schoen teaches the processor receiving a controlled temperature value as input, and determining a required pressure on the basis of the desired SH and the controlled temperature value (vapor pressure can be calculated based on temperature and humidity values, paragraph [0017], Matsui).
Regarding claim 22, the combination of Matsui and Schoen teaches controlling the gas pressure using the pressure regulator for maintaining a pressure in the tank at a controlled pressure (precision balanced pressure regulator, column 3 lines 67-68, Schoen).
Regarding claim 23, the combination of Matsui and Schoen teaches the processor receiving controlled pressure value as input, and determining a required temperature on the basis of the desired SH and the controlled pressure value (determine the change in dew point temperature as specific humidity changes from pressure, column 6 lines 36-37, Schoen).
Regarding claim 24, the combination of Matsui and Schoen teaches the processor controlling the temperature and/or a pressure in the tank on the basis of the required temperature and/or required pressure (controlling the temperature of the temperature of the water on the basis of pressure regulation, column 4 lines 17-29, Schoen).
Regarding claim 25, the combination of Matsui and Schoen teaches the processor receiving an indication representative of desired sterilization parameter and determining the desired SH value on the basis thereof (control device controls humidity within suitable range to achieve uniform decontamination, paragraph [0012], Matsui).
Regarding claim 26, the combination of Matsui and Schoen teaches automatically maintaining a water level of the volume of water in the tank within a predetermined interval (Figure 6 make up water supply to humidification chamber “38”, Schoen).
Regarding claim 27, the combination of Matsui and Schoen teaches at least partly ionizing the humidification gas stream having the controlled specific humidity using a plasma source prior to supplying the humidified gas stream to the medical instrument (Figure 1 plasma generating unit “4” in between humidity adjusting unit “11” and chamber “2” all connected via conduit “6”, Matsui).
Regarding claim 29, the combination of Matsui and Schoen teaches measuring one or more of: relative humidity, temperature, pressure, and flow, in a connection from the tank to the plasma source (temperature sensor for measuring temperature of the gas introduced into the plasma generating unit is upstream of the plasma generating unit, paragraph [0017]).
Regarding claim 30, the combination of Matsui and Schoen teaches controlling a temperature of the medical instrument and/or the chamber such that the temperature of the medical instrument is below the temperature of the chamber for allowing a sterilizing agent to at least partially condense onto the medical instrument (installing a heating/cooling mechanism inside the processing chamber to keep it within a suitable humidity range for disinfection, paragraph [0017]).
Claims 13 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Matsui and Schoen in view of Campbell (US 5115166 A).
Regarding claim 13, the combination of Matsui and Schoen teaches all aspects of the current invention except the outflow port of the device is connected to a gas input of the ionization chamber via a choke. However, Campbell teaches the outflow port of the device is connected to a gas input of the ionization chamber via a choke (distal end of the tube forms a smooth surfaced venturi restriction, column 7 lines 19-20).
Matsui and Schoen are analogous to the current invention as described above. Campbell is considered analogous to the current invention because both are in the field of ozone disinfection apparatuses. Therefore, it would have been obvious to one of ordinary skill in the art to combine the disinfection system taught by Matsui and Schoen with the choke connection taught by Campbell because Campbell teaches the restriction provides a pressure that is optimal for plasma generation (column 7 lines 34-36).
Regarding claim 28, the combination of Matsui and Schoen teaches all aspects of the current invention except the outflow port of the device is connected to a gas input of the ionization chamber via a choke. However, Campbell teaches the outflow port of the device is connected to a gas input of the ionization chamber via a choke (distal end of the tube forms a smooth surfaced venturi restriction, column 7 lines 19-20).
Matsui, Schoen, and Campbell are considered analogous to the current invention because all are in the field of ozone disinfection apparatuses. Therefore, it would have been obvious to one of ordinary skill in the art to combine the disinfection system taught by Matsui and Schoen with the choke connection taught by Campbell because Campbell teaches the restriction provides a pressure that is optimal for plasma generation (column 7 lines 34-36).
Conclusion
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/K.R.S./Examiner, Art Unit 1799
/DONALD R SPAMER/Primary Examiner, Art Unit 1799