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
This is an office action in response to Applicant's arguments and remarks filed on 6/2/2026. Claims 1-6, 9-15 and 17-23 are pending in the application. Claims 1-6 and 9 have been withdrawn and claims 10-15 and 17-23 are being examined herein.
Status of Objections and Rejections
The objection to the claims has been withdrawn in view of Applicant's amendment.
All rejections from the previous office action are withdrawn in view of Applicant's amendment.
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 10-15 and 17-23 are rejected under 35 U.S.C. 103 as being unpatentable over Golkowski et al. (US 20190314535 A1) in view of Henniges et al. (US 20200237939 A1).
Regarding claim 10, Golkowski teaches a system for adjusting a cycle time of a treatment process (Fig. 1A, [0186]), the system comprising:
a chamber configured to receive an object for a first treatment stage therein (Fig. 1A, 10);
a treatment agent delivery system in fluid communication with the chamber and configured to introduce a treatment agent into the chamber (Fig. 1A, vaporizer 32, [0199-0200]);
a concentration sensor in communication with the chamber and configured to measure a concentration of the treatment agent in the chamber during the first treatment stage (sensor within chamber configured to sense humidity = understood to measure concentration of vaporized sterilant, [0045], [0060], [0148]);
a pressure sensor in communication with the chamber and configured to measure a pressure in the chamber during the first treatment stage (sensor within chamber to sense pressure [0045]); and
a controller in signal communication with the concentration sensor and the pressure sensor (Fig. 1A, 12), the controller configured to: compare the concentration of the treatment agent to a threshold concentration valve to obtain a comparison value; and output a control signal in order to adjust a cycle time of the first treatment stage based on the comparison value and the pressure (controller communicably coupled to concentration/pressure sensor and used to adjust cycle time based on pressure and concentration threshold via the blower 14, see [0148], [0153], [0155], [0160], [0179-0181]).
However, Golkowski does not teach wherein the threshold concentration value is at least a minimal area under the curve (AUC) value required for efficacy of the treatment process.
One having ordinary skill in the art would be concerned with determining the optimal concentration of sterilant is present within the chamber to ensure the desired level of sterilization was reached, motivating one to turn towards Henniges. Henniges teaches a sterilization enclosure for surgical instruments [abstract] comprising a gas concentration sensor configured to detect the concentration of a sterilant gas within a sensor [0122], wherein the gas concentration sensor is in communication with a processor that is configured to determine if a concentration of sterilization gas reaches a predetermined threshold condition [0125]. Henniges further teaches wherein the processor can be used to calculate the area under the curve of the concentration of the sterilization gas over time and compare the area with a corresponding threshold to ensure a desired level of sterilization is reached in the chamber [0125].
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the controller as taught by Golkowski to include the processor as taught by Henniges because Henniges teaches the processor to determine if a concentration of sterilization gas reaches a predetermined threshold condition by calculating the area under the curve of the concentration of the sterilization gas over time and comparing the area with a corresponding threshold to ensure a desired level of sterilization is reached in the chamber [0125] and this involves the combination of elements (the controller of Golkowski and the processor of Henniges) to yield a predictable result (a controller that calculates a threshold concentration of sterilant by using an area under the curve calculation to ensure sterilization efficacy) with a reasonable expectation of success. See MPEP 2143(I)(A).
Regarding claim 11, Modified Golkowksi teaches the system of claim 10, including sensor configured to measure the concentration of sterilant with the sterilization chamber (Golkowski, [0043]), but does not teach wherein the sensor comprises an electrochemical sensor, a photolysis sensor, a photometric sensor, a metal-oxide sensor, or a combination thereof.
Henniges teaches a sterilization enclosure for surgical instruments [abstract] comprising a gas concentration sensor configured to detect the concentration of a sterilant gas within a sensor, wherein the sensor may be an electrochemical sensor [0122].
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the sensor as taught by Modifeid Golkowski with the electrochemical sensor as taught by Henniges since Henniges teaches the sensor to detect a concentration of vaporous sterilant [0122] and this involves the substitution of parts to yield a predictable result. See MPEP 2143(I)(B), 2143(I)(G), and 2144.06(II).
Regarding claim 12, Modified Golkowksi teaches the system of claim 10, wherein- the controller is configured to reduce the cycle time of the first treatment stage if the concentration of the treatment agent meets or exceeds the threshold concentration value (Golkowski, controller configured to reduce cycle time based on threshold concentration of sterilant [0148]).
Regarding claim 13, Modified Golkowksi teaches the system of claim 10, wherein the controller is configured to adjust a parameter of a second treatment stage based on the adjusted cycle time of the first treatment stage (Golkowski, controller configured to adjust parameter of second treatment stage [plasma] such as recycle ratio of plasma to vapor based on adjusted cycle time ([0147-0148], [0153]).
Regarding claim 14, Modified Golkowksi teaches the system of claim 13, further comprising a plasma generator configured to expose the object to a plasma in the second treatment stage (Golkowski, Fig. 1A, plasma generator 30, [0143]).
Regarding claim 15, Modified Golkowksi teaches the system of claim 13, wherein the controller is configured to reduce a cycle time a first treatment stage based on a concentration of sterilant and a sensed pressure (Golkowski, controller communicably coupled to concentration/pressure sensor and used to adjust cycle time based on pressure and concentration threshold via the blower 14, see [0148], [0153], [0155], [0160], [0179-0181]) but does not teach wherein the controller is configured to reduce a cycle time of the second treatment stage based on the reduced cycle time of the first treatment stage.
Golkowski further contemplates how the controller may be programmed to run various types of cycles including low disinfection cycles and high disinfection cycles, wherein the high disinfection cycle corresponds to a longer cycle time than the shorter [0179]. Golkowski also contemplates how cycle times are readily adjustable by a user given context and can run multiple cycles of sterilization as required [0180-181].
One having ordinary skill in the art would be concerned with optimizing the sterilization process by minimizing resource usage of the sterilant and plasma while maximizing disinfection. One having ordinary skill would also recognize the disclosure of Golkowski as identify a finite number of predictable solutions to the problem (i.e. adjusting fan at various speeds to recycle plasma to reduce cycle time). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the controller as taught by Modified Golkowski to reduce a cycle time of the second treatment stage (plasma being introduced into chamber from plasma generator) based on the reduced cycle time of the first treatment stage (hydrogen peroxide vapor being introduced into chamber) in order to minimize usage of the sterilant and plasma while maximizing disinfection. See MPEP 2143(I)(E).
Regarding claim 17, Modified Golkowksi teaches the system of claim 10, wherein the system comprises a sterilization system (Golkowski, [abstract]) and the object is a medical device (Golkowski, [0009], [0117]).
Regarding claim 18, Modified Golkowksi teaches a system comprising a processor coupled to a non-transitory, wherein the non-transitory memory comprises machine executable instructions that, when executed by the processors cause the processor to memory (Golkowski, Fig. 1A. controller 12 understood to be processor coupled to a non-transitory memory with machine executable instructions (Golkowski, [0323-0338]): introduce a treatment agent comprising hydrogen peroxide into a chamber at a first treatment stage therein (Golkowski, Fig. 1A, uses vaporizer 32 to introduce sterilant into chamber 10, [0199-0200]);
measure, using a concentration sensor, a concentration of the treatment agent in the chamber (Golkowski, sensor within chamber configured to sense humidity = understood to measure concentration of vaporized sterilant, [0045], [0060], [0148]);
measure, using a pressure sensor, a pressure in the chamber (Golkowski, sensor within chamber to sense pressure [0045]);
compare the concentration of the treatment agent to a threshold concentration value to obtain a comparison value; and adjust a cycle time of the first treatment stage based on the comparison value and the pressure (Golkowski, controller communicably coupled to concentration/pressure sensor and adjusts cycle time based on pressure and concentration threshold via the blower 14, see [0148], [0153], [0155], [0160], [0179-0181]).
Regarding claim 19, Modified Golkowksi teaches the system of claim 18 wherein the machine executable instructions further cause the processor to reduce the cycle time of the first treatment stage if the concentration of the treatment agent meets or exceeds the threshold concentration value (Golkowski, controller operable to reduce cycle time based on threshold concentration of sterilant [0148]).
Regarding claim 20, Modified Golkowksi teaches the system of claim 18, wherein the system comprises a sterilization system (Golkowski, [abstract]) and an object positioned within the chamber is a medical device (Golkowski, [0009], [0117]).
Regarding claim 21, Modified Golkowksi teaches the system of claim 10, wherein the treatment agent comprises hydrogen peroxide (Golkowski, [0166-0167]), and the concentration of the treatment agent comprises hydrogen peroxide vapor (Golkowski, [0038]).
Regarding claim 22, Modified Golkowksi teaches the system of claim 18, wherein the treatment agent comprises hydrogen peroxide (Golkowski, [0166-0167]), and the concentration of the treatment agent comprises hydrogen peroxide vapor (Golkowski, [0038]).
Regarding claim 23, Modified Golkowksi teaches the system of claim 10, wherein the cycle time is reduced, maintained, or increased based on a predicted time to reach the threshold concentration value (Golkowski, controller communicably coupled to concentration/pressure sensor and adjusts cycle time based on pressure and concentration threshold via the blower 14, see [0148], [0153], [0155], [0160], [0179-0181]; Henniges, [0125] = cycle time understood to be changed based on predicted time to reach threshold concentration value).
Response to Arguments
In the arguments presented on page 7 of the amendment, filed 6/2/2026, the Applicant argues that Golkowski does not teach a controller or processor configured to compare the concentration of the treatment agent to a threshold concentration value to obtain a comparison value, wherein the threshold concentration value is at least a minimal area under the curve (AUC) value required for efficacy of the treatment process with respect to the rejection(s) of claim(s) 10 and 18 under 35 U.S.C. 103.
This argument has been fully considered and is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the prior art Henniges et al. (US 20200237939 A1) which was referenced and cited in the previous action. See rejection above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20150374868 teaches a sterilization container capable of performing an area under the curve calculation to determine if a sterilant threshold has been reached to confirm sterilization efficacy.
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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/N.S.S./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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