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 without traverse of claims 1-7 in the reply filed on 6/1/2026 is acknowledged. Claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Wadmark (WO 2008004930 A1) in view of Decoster (WO 2018011501 A1).
Regarding claim 1, Wadmark teaches An hydrogen peroxide sterilization device (abstract: The invention relates to a sterilising medium for sterilisation of packaging material for food packaging containing an aqueous solution of hydrogen peroxide), comprising:
a vaporization chamber, an inlet is formed at an upper side of the vaporization chamber and an outlet is formed at a lower side of the vaporization chamber, a packaging film is extended into the vaporization chamber from the inlet and extended out of the vaporization chamber from the outlet (Fig. 4: chamber 44);
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a nozzle, the hydrogen peroxide steam is sprayed on a surface of the packaging film in the vaporization chamber through the nozzle (Fig. 4: spray nozzle 42).
but does not teach
wherein the device is ultrasonic-assisted
an ultrasonic atomizer, arranged at a top of the vaporization chamber, the ultrasonic atomizer is externally connected to a liquid storage tank and capable of atomizing liquid hydrogen peroxide into hydrogen peroxide steam by means of ultrasonic waves; and
wherein the nozzle is a slit nozzle,
arranged at an atomization outlet of the ultrasonic atomizer.
Wadmark teaches a spray nozzle but does not teach a mechanism for producing the sprayed sterilant.
Decoster teaches an atomizing device for spraying disinfectant (abstract: An atomising device for air disinfection, comprising: • - an ultrasonic head (1)… for supplying the product to be sprayed to the ejection surface), which fulfills the need of Wadmark for a specific mechanism for spraying the sterilant. For this purpose, Decoster teaches an ultrasonic atomizer (abstract: an ultrasonic head) comprising an ultrasonic generator (abstract: transducer (2); pg. 9 par. 2: The transducer 2 may consist of one or more piezoceramic slats) and a cylinder for receiving liquid and transferring vibrations to the liquid (abstract: a sonotrode (3) configured to transmit the vibrations from the transducer (2) to a particle ejection surface (30), the sonotrode (3) comprising a supply channel (31) for supplying the product to be sprayed to the ejection surface). Hydrogen peroxide can be sprayed (pg. 7 4th last par.: According to one embodiment, the disinfecting product is chosen from (or include) the following products, if appropriate in a mixture: - hydrogen peroxide). The ultrasonic head is attached to a liquid storage tank for the liquid sterilant, wherein the liquid is pumped to the ultrasonic head via a peristaltic pump located on a feed pipe (pg. 5 par. 1: The liquid is sprayed on the surface of the working plate via a spray nozzle, from a tank via a conveyor and through a feed pipe; pg. 7 par. 5: A peristaltic pump is configured to route the product to be sprayed to the supply channel of the ultrasonic head).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spray nozzle of Wadmark to be connected to an ultrasonic atomizer composed of a piezoelectric transducer and a sonotrode, wherein the ultrasonic atomizer is connected to a tank full of liquid sterilant (hydrogen peroxide in this case) via a feed pipe and a peristaltic pump on the feed pipe for pumping the liquid sterilant to the ultrasonic atomizer, as taught by Decoster, in order to provide a mechanism for supplying sprayed hydrogen peroxide to a sterilization chamber. The ultrasonic head would be attached to the spray nozzles and placed behind the wall of chamber 44.
Wadmark modified by Decoster still does not teach wherein the spray nozzle is a slit nozzle.
However, in the absence of any teaching to the contrary, the shape of the nozzle does not affect operation in any unexpected way since it would still be capable of spraying out hydrogen peroxide sterilant. Absent a showing of significance or unexpected results, the shape of X is prima facie obviousness and do not modify the operation of the invention and further, does not add patentable significance. MPEP 2144.04.B: In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant). In this case, one of ordinary skill in the art would understand that modifying the shape of the nozzle changes the distribution of the spray, which may be useful for sterilizing certain shapes and forms of sterilization targets. This is an expected effect. Accordingly, the claimed dimensions and shapes are considered to be not patentably distinct from the disclosed device of Wadmark modified by Decoster. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the nozzle opening of Wadmark modified by Decoster to be slit-shaped, with a reasonable expectation that it would still be capable of effectively spraying hydrogen peroxide for sterilization, but in a desired distribution to adapt to the sterilization target.
Regarding claim 2, Wadmark modified by Decoster teaches the ultrasonic-assisted hydrogen peroxide sterilization device according to claim 1, as set forth above, but does not teach further comprising a heating portion, the heating portion is arranged at a bottom of the vaporization chamber for heating and decomposing residual hydrogen peroxide after sterilization.
Wadmark teaches a different embodiment with a heating chamber downstream of a station for soaking the packaging material in hydrogen peroxide, wherein there is motivation to optimize the removal of residual hydrogen peroxide (Fig. 2; pg. 11 lines 26- pg. 12 line 4: The experiments carried out as described hereinafter were made in a machine using this sterilisation system, by dipping the web of packaging material 21 into a shallow bath 22. Squee-gee rollers 23 are removing surplus of sterilisation liquid from the web and then the web is led through a heating chamber 25. In order to improve the efficency of this sterilisation process and reduce the sterilising medium residual content, the system is equipped with a special so-called blister roller 24 with a rough surface, which breaks down the liquid droplets on the packaging material surface to smaller ones, in the heating chamber 25. In order to improve the efficiency still further, an extra heating and drying unit 26, with additional supply of heat and air flow, may be connected to the heating chamber 25).
Therefore, there would be motivation to have a heating portion in chamber 44 of the embodiment of Fig. 4, in order to also optimize the removal of residual hydrogen peroxide.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chamber 44 of the embodiment of Fig. 4 of Wadmark modified by Decoster to have a heating portion, as taught by Wadmark, in order to hasten the removal of residual hydrogen peroxide before the packaging material is used.
Wadmark modified by Decoster still does not teach wherein the heating portion is arranged at a bottom of the vaporization chamber.
However, in the absence of any teaching to the contrary, the location of the heating portion does not affect operation in any unexpected way since it would still be capable of providing heat within the chamber and the placement only determines the rate at which the heat is administered. Absent a showing of significance or unexpected results, the claimed locations of the components are prima facie obvious and do not modify the operation of the invention and further, do not add patentable significance. The Manual of Patent Examining Procedures discloses that in In re Japikse, 181 F.2d 1019, 86 USPQ 70(CCPA 1950), a mere rearrangement of parts for a design change has no patentable significance unless a new and unexpected result is produced. In this case, the expected result is that placing the heating portion at a bottom of the vaporization chamber may optimize the rate at which hydrogen peroxide is evaporated while allowing enough time for the sprayed hydrogen peroxide to eliminate bacteria while remaining on the surface of the packaging material. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the chamber 44 of Wadmark modified by Decoster to have its heating element located at a bottom of the chamber with a reasonable expectation that the sterilization and drying efficiency of the process is optimized.
Regarding claim 3, Wadmark modified by Decoster teaches the ultrasonic-assisted hydrogen peroxide sterilization device according to claim 1, as set forth above, but does not teach wherein a plurality of rollers are sequentially arranged in the vaporization chamber at intervals in a staggered manner, and the packaging film entering the vaporization chamber from the inlet passes through the plurality of rollers in sequence and exits the vaporization chamber from the outlet after.
Fig. 2 of Wadmark teaches a plurality of rollers in staggered intervals that the packaging film must pass through before exiting the chamber. The rollers help increase the amount of surface area of the packaging material exposed to the sterilant at one time, which increases sterilization efficiency and effectiveness. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify chamber 44 of Wadmark modified by Decoster to have at least two rollers at staggered intervals that the packaging material passes through, as taught by Wadmark, in order to increase the amount of surface area of the packaging material exposed to the sterilant at a single time, which increases sterilization efficiency and effectiveness.
Regarding claim 4, Wadmark modified by Decoster teaches the ultrasonic-assisted hydrogen peroxide sterilization device according to claim 1, as set forth above, and teaches wherein the ultrasonic atomizer comprises an ultrasonic generator (see Decoster modification in claim 1 rejection for piezoelectric transducer) and an oscillating spring (NOTE: since Applicant’s Specification and Drawings do not specify any further structure or functionality for the oscillating spring, this feature is interpreted as a structure that liquid passes through that transfers vibrations to the liquid, in which case the sonotrode from the Decoster modification in claim 1 would read on the oscillating spring, see above), and the liquid storage tank communicates with an interior of the oscillating spring through a pipeline (see Decoster modification in claim 1 rejection, wherein liquid is pumped from the tank to the ultrasonic head, whereby it passes through the sonotrode).
Regarding claim 5, Wadmark modified by Decoster teaches the ultrasonic-assisted hydrogen peroxide sterilization device according to claim 4, as set forth above, and teaches wherein a peristaltic pump is arranged at the pipeline (see Decoster modification in claim 1 rejection).
Regarding claim 6, Wadmark modified by Decoster teaches the ultrasonic-assisted hydrogen peroxide sterilization device according to claim 1, as set forth above, and teaches wherein the slit nozzle is arranged at the atomization outlet at a bottom of the ultrasonic atomizer (NOTE: the spray nozzles are attached to an ultrasonic head, which has an atomization outlet, so the nozzles are interpreted to be at a bottom of the ultrasonic heads based on defining the top as wherever the ultrasonic head is located relative to the nozzles).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wadmark modified by Decoster in view of Golkowski (WO 2019084203 A1).
Regarding claim 7, Wadmark modified by Decoster teaches the ultrasonic-assisted hydrogen peroxide sterilization device according to claim 4, as set forth above, but does not teach wherein a concentration sensor and a temperature sensor are mounted in the vaporization chamber to detect temperature and concentration of atomized hydrogen peroxide in the vaporization chamber, respectively.
Wadmark already has motivation to closely monitor sterilization process parameters comprising of the sterilant concentration and the temperature (pg. 4 lines 11-15: Although it is possible to keep the sterilisation process under close control in order to reach sufficient and adequate sterilisation with the presently used hydrogen peroxide sterilising medium, it is desirable to have a wider operation window for the relevant parameters, such as production speed and contact time, temperatures and concentrations of the sterilising agent).
Golkowski teaches a sterilization chamber (abstract: A sterilization, disinfection, sanitization, or decontamination system having a chamber defining a region, and a generator for creating a free radical effluent with reactive oxygen, nitrogen, and other species and/or a vaporizer). Golkowski teaches using sensors in its chamber to monitor and/or control concentration and temperature (par. 200: As mentioned briefly above, in several embodiments, one or more sensors are used to monitor various aspects of the components and/or performance of the sterilization/disinfection systems. For example, sensors may be used to monitor and/or regulate the amount of sterilant/disinfectant that is moved into the chamber, the concentration of sterilant/disinfectant in the chamber at a given point (or points) in the cycle… as well as a variety of other parameters, including but not limited to temperature).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chamber 44 of Wadmark modified by Decoster to have concentration and temperature sensors for monitoring the atomized hydrogen peroxide, as taught by Golkowski, in order to fulfill the known need to monitor and control sterilization process parameters.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANGRU CHEN whose telephone number is (571)272-1201. The examiner can normally be reached Monday-Friday 7:30-5:30.
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/C.C./Examiner, Art Unit 1796
/KEVIN JOYNER/Primary Examiner, Art Unit 1799
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