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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Arguments
Applicant's arguments filed 17 June 2026 have been fully considered but they are not persuasive.
As discussed in the Final Rejection mailed 22 August 2025, the examiner acknowledges the difference between specific, relative, and absolute humidity. However, as previously state, while Matsui does not explicitly say the humidity control unit controls the specific humidity, the device and method taught by Matsui would ultimately control the specific humidity. Additionally, it should be noted that the inventions of independent claims 1 and 16 are, as of the Non-Final Office Action mailed 20 February 2026, rejected under 35 U.S.C. 103 with respect to combination of Matsui and Schoen, and Schoen directly teaches controlling the specific humidity (determine the change in the specific humidity due to a change in mass flow rate, column 6 lines 36-37). Therefore, because a combination of Matsui and Schoen controls the water temperature and gas pressure in the tank to control the resulting humidity, this combination would directly control the specific humidity of the resulting gas stream. As established in the Final Rejection mailed 22 August 2025, all measures of humidity are intrinsic and as long as temperature and pressure of the system are being controlled/measured any one relative, absolute, and specific humidity can be determined and are controlled for a required humidity.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Additionally, the applicant argues that Matsui does not teach a temperature sensor that measures the water temperature of the tank. While the examiner concedes that the claim mapping for this limitation was not as clear as intended in the Non-Final Office Action mailed 20 February 2026, the examiner continues to assert that Matsui teaches a temperature sensor that measures the water temperature of the tank. Please refer to paragraph [0017] more specifically lines 401 and 402 where Matsui discloses at least two temperature sensors on which the operation of the humidity adjustment unit is based. The limitation mapping of claim 1 will be updated to make reference to the features of Matsui more clear.
Finally, the applicant argues that the pressure regulator taught by Schoen does not fulfill the limitation “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”. However Schoen explicitly discloses a pressure regulator in communication within the inflow port (Figure 6 pressure regulator “32” in line with the inflow port “46” of the humidifier “38”, and air flow rate is essentially dependent on nozzle inlet pressure and regulating inlet pressure, column 3 lines 39-40). It should be noted that the phrase “in communication” does not define the proximity of components, some connection between the components exists.
In response to applicant's argument that the method of humidification as taught by Schoen is different from the method of humidification in the instant application, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's argument that the incorporation of the pressure regulator taught by Schoen would require the reconstruction of the system taught by Matsui, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, 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 that the mass flow rate of the input flow is dependent on upstream pressure and thus requires a precise pressure regulator (column 4 lines 3-6).
Regarding the applicant’s arguments against the rejection of claim 16, the applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Following the above logic, the 35 U.S.C. 103 rejections of claims 2-12, 14-15, 17-27, 29-30 30 with respect to Matsui in view of Schoen are maintained. Similarly the rejections of claims 13 and 28 under 35 U.S.C. 103 with respect Matsui and Schoen in view of Campbell are maintained.
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], and at least two temperature sensors on which the operation of the humidity adjustment unit is based, paragraph [0017] specifically lines 401-402); 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
THIS ACTION IS MADE FINAL. 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 KAYLA ROSE SARANTAKOS whose telephone number is (703)756-5524. The examiner can normally be reached Mon-Fri 7:00-4:00.
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/K.R.S./Examiner, Art Unit 1799
/DONALD R SPAMER/Primary Examiner, Art Unit 1799
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