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 .
Election/Restrictions
Applicant's election with traverse of Group II, claims 10-20, in the reply filed on 11/24/2025 is acknowledged. The traversal is on the ground(s) that Wiget (US 20150265738) does not teach the newly amended limitations of a “pressure sensor in communication with the chamber and configured to measure a pressure in the chamber during the first treatment stage” and “adjust[ing] a cycle time of the first treatment stage based on the comparison value and the pressure.” This is found persuasive.
However, the technical features of a treatment chamber, a treatment agent comprising hydrogen peroxide, a sensor configured to measure a concentration of the treatment agent in the chamber, a pressure sensor in communication with the chamber and configured to measure a pressure in the chamber during the first treatment stage, and adjust[ing] a cycle time of the first treatment stage based on the comparison value and the pressure still fail to make contribution over the cited art as evidenced by Golkowski et al. (US 20190314535 A1). See rejection below.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 13, please change “valve” to “value”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 10, 12-14, 17-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Golkowski et al. (US 20190314535 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]).
Regarding claim 12, Golkwoski 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 (controller configured to reduce cycle time based on threshold concentration of sterilant [0148]).
Regarding claim 13, Golkowski 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 (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, Golkowski teaches the system of claim 13, further comprising a plasma generator configured to expose the object to a plasma in the second treatment stage (Fig. 1A, plasma generator 30, [0143]).
Regarding claim 17, Golkowski teaches the system of claim 10, wherein the system comprises a sterilization system [abstract] and the object is a medical device ([0009], [0117]).
Regarding claim 18, Golkowski 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 (Fig. 1A. controller 12 understood to be processor coupled to a non-transitory memory with machine executable instructions [0323-0338]: introduce a treatment agent comprising hydrogen peroxide into a chamber at a first treatment stage therein (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 (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 (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 (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, Golkowski 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 (controller operable to reduce cycle time based on threshold concentration of sterilant [0148]).
Regarding claim 20, Golkowski teaches the system of claim 18, wherein the system comprises a sterilization system [abstract] and an object positioned within the chamber is a medical device ([0009], [0117]).
Regarding claim 21, Golkowski teaches the system of claim 10, wherein the treatment agent comprises hydrogen peroxide [0166-0167], and the concentration of the treatment agent comprises hydrogen peroxide vapor [0038].
Regarding claim 22, Golkowski teaches the system of claim 18, wherein the treatment agent comprises hydrogen peroxide [0166-0167], and the concentration of the treatment agent comprises hydrogen peroxide vapor [0038].
Claim Rejections - 35 USC § 103
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.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Golkowski et al. (US 20190314535 A1) further in view of Henniges et al. (US 20200237939 A1).
Regarding claim 11, Golkowksi teaches the system of claim 10, including sensor configured to measure the concentration of sterilant with the sterilization chamber [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 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).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Golkowski et al. (US 20190314535 A1).
Regarding claim 15, Golkowski 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 (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 Golkowski to reduce a cycle time of the second treatment stage (plasma being introducer 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20200230279 A1 teaches a combined plasma and hydrogen peroxide sterilizer.
US 20180353633 A1 teaches a combined plasma and hydrogen peroxide apparatus and an adaptive control system.
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/N.S.S./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758