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 .
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9 reads a (or the) “second fluidly connected to” in two instances and it is believed the limitation is directed towards a (or the) “second valve fluidly connected to” in both instances.
Appropriate correction is required.
Claim Interpretation
This application contains limitations being interpreted under 112(f), including:
“first regulating means that are controlled to inject hydrogen peroxide selectively” and
“treatment means configured to neutralize residual hydrogen peroxide vapor”
Looking to the disclosure it appears the corresponding structure is, respectively:
A heater and equivalents according to paragraph [0239] as filed
Water and equivalents as disclosed in pars. 183-185 in the specification as filed
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-7 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 and 5 are rejected for reciting the limitation “at least one pipe that selectively connects the evaporator to a pipe” because it cannot be determined from the claim nor disclosure how the pipe “selectively” connects to the evaporator. A pipe is a physical structure that, on its own, could not selectively connect to something else. The limitation could also be interpreted as being analogous to the term “optionally”, which would also render the claim indefinite. It cannot be determined how the pipe is selectively or optionally connected to another pipe and therefore the claims are indefinite. For the purpose of examination, it is interpreted that the pipe is or is not connected to the evaporator.
Claims 4 and 6-7 recite “the first regulating means” and “the second regulating means” and there is a lack of antecedent basis in the claims for those limitations. For the purposes of examination, it is interpreted that the means are the valves in claim 1 from which claims 4 and 6-7 depend.
Claim 9 is rejected for reciting “the subsequent evaporation phase” and there is a lack of antecedent basis for the limitation in the claim. For the purpose of examination, it is interpreted there is an evaporation taking place during some phase.
The remaining claims are rejected for being dependent on and including all of the limitations of one of the claims above.
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.
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 1-7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Buczynski (US 2008/0279719) in view of Neubauer (US 9,149,972) in view of Nagatani (US 2009/0169421) in view of Rickloff (US 5,445,792).
Regarding claim 1, Buczynski (US 2008/0279719) discloses –
A device for sterilizing gas filtration means (Abstract, specifically HEPA filter 152 is sterilized necessarily and inherently), the device comprising:
a first circuit (at least the circuit including heater 120, dryer 90, HEPA filter 152 and isolator 12) comprising an air heater configured to deliver hot pressurized air at a specified target temperature of about 220 degrees C (heater 120 for preheating air 120 is pressurized by pump 110; Paragraph [0028]);
a second circuit (the circuit including vaporizer 130, filter 176, hydrogen peroxide supply 160, and isolator 12) comprising a first regulating means controlled by a control unit to selectively permit passage of pressurized liquid hydrogen peroxide (Paragraph [0026] discloses the pump 170 is metered to control the injection of peroxide); and
at least one evaporator (vaporizer 130) configured to prepare a gaseous mixture comprising hot pressurized air from the first circuit and sequential injections of the pressurized liquid hydrogen peroxide from the second circuit(Paragraphs [0024]-[0025] discloses a hydrogen peroxide solution being evaporated into air, furthermore this component is well capable of performing this function and is reasonably expected to do so, MPEP 2114, II) wherein the hot pressurized air is circulated to evaporate deposited hydrogen peroxide and thermally activate the vapor to generate sterilizing radicals (the hot air and circulation thereof disclosed by Buczynski is well capable of performing this function and is reasonably expected to do so, MPEP 2114, II);
a second regulating means (injection blower 110)
fluidly connected to at least one pipe (Fig. 1 shows the conduit extending from the blower 110)
the at least one pipe being fluidly connected between the at least one evaporator (fig. 1 shows the two components being connected),
the second regulating means being controlled to release the gaseous mixture (par. 28 discloses the injection blower blows fluid through the conduit 22), the hydrogen peroxide vapor of the gaseous mixture being a fraction of a specified amount of a liquid hydrogen peroxide that is supplying the second circuit (the vaporized hydrogen peroxide is a fraction of the total hydrogen peroxide available from the peroxide supply 160), and wherein the evaporator is configured to maintain a temperature sufficient to prevent condensation and ensure complete vaporization of the injected hydrogen peroxide (the vaporizer 130 is well capable of performing this function and is reasonably expected to do so, see MPEP 2114, II).
Regarding the limitation directed towards the regulating means being specifically valves: Buczynski teaches various valves for controlling the flow throughout the system (valve 82, valve 72, valve 192) and 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 Buczynski such that the first and second regulating means include specifically valves. One would have been motivated to do so to better regulate and control the flow of fluids through the system as is known in the art to arrive at an improved device.
Regarding the limitation that the heating means can deliver hot pressurized air at a specified target temperature of about 220 degrees Celsius: Apparatus claims cover what a device is, not what a device does and a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (see MPEP 2114, II). The claim does not positively recite the heating of the air to any temperature, merely that the heating means be configured to heat to a temperature of about 220 degrees Celsius. The heater 120 disclosed by Buczynski is well capable of heating to a specified target temperature and is reasonably expected to perform this function. Therefore, all the limitations of the claim are met. Buczynski appears to be silent with regards to the device sterilizing gas filtration means of a blow-molding circuit. Furthermore, Nagatani (US 2009/0169421) discloses a hydrogen peroxide system that uses hot air and hydrogen peroxide to sterilize a space including a filter (abstract) wherein the mixture is heated to a temperature of not lower than 75 degrees Celsius (par. 40), overlapping with the claimed range of about 220 degrees Celsius. 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 device disclosed by Buczynski such that the heater is configured to deliver hot air at 220 degrees Celsius as taught by Nagatani to arrive at the claimed invention. One would have been motivated to do so because the claimed range overlaps with a range disclosed in the prior art, and in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Furthermore, this modification is nothing more than one of routine optimization, and differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See MPEP 2144.05(II)(A).
Neubauer (US 9,149,972) discloses a blow molding circuit including filter means (Title, Column 3 lines 24 - 36) including a sterilizing means (the abstract discloses the application of a flowable sterilization agent, claim 12 discloses the agent being hydrogen peroxide). 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 device disclosed by Neubauer such that the sterilization means disclosed by Buczynski are attached to the blow molding circuit for the purpose of sterilizing the blow molding circuit and its gas filtration means to arrive at the claimed invention. One would have been motivated to do so to apply a known-effective hydrogen peroxide sterilization device to a workpiece including the gas filtration means of a blow molding circuit as is known to be desirable in the art to arrive at an improved blow molding circuit with improved sterility. The combination of familiar prior art elements, including blow molding circuits including filter means and hydrogen peroxide sterilization means, according to known means to arrive at results that are nothing more than predictable is prima facie obvious. MPEP 2143(I)(A).
Regarding the limitation that the injections are separated by a defined time interval: Rickloff (US 5,445,792) discloses a hydrogen peroxide vapor sterilization method (abstract) wherein injections of the peroxide are separated by defined time intervals (see fig. 3, flow through portion G-H with sequential injections; Col. 13 lines 35-44) to control a particular concentration and pressure for better efficiency (col. 13 lines 45-50). 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 device disclosed by Buczynski such that the injections are separated by a defined time interval to arrive at the claimed invention. One would have been motivated to do so to successfully maintain a desired operating pressure, concentration, and humidity to arrive at an improved peroxide sterilization device.
Regarding dependent claim 2, modified Buczynski further teaches –
the second circuit comprises at least one reservoir with a specified capacity that is intended to be filled with hydrogen peroxide in the liquid state (decontaminant supply 160, Paragraphs [0024]-[0025]).
Regarding claims 3 and 5, modified Buczynski further teaches –
at least one pipe (conduit 22 immediately after the vaporizer 130 downstream towards the isolator 12) that selectively connects the evaporator to a pipe that comprises said filtration means of the blow molding circuit (the conduit 22 after the flow sensor 150 comprises the HEPA filter 152 and is connected to the vaporizer by a pipe, and the incorporation of Buczynski into Neubauer would result in the same connection of pipes).
Regarding dependent claims 4 and 6-7, Buczynski further teaches a control unit (controller 202) for selectively controlling the first and/or second regulating means of the first circuit and/or of the second circuit between at least one open position and one closed position (the pumps and valves reading on regulating means, including pump 66, pump 170, valves 72 and 82, are all controlled by the controller 202; Paragraphs [0037]-[0039]).
Regarding claim 9, Buczynski teaches –
A device for sterilizing a circuit, the device comprising:
a first circuit comprising an air heater configured to deliver hot pressurized air at a specified target temperature of about 220 C (at least the circuit including heater 120, dryer 90, HEPA filter 152 and isolator 12; the heater 120 heats air, par. 28; the device is well capable of performing this function and is expected to do so);
a second circuit comprising a first regulating means being controlled by a control unit to permit the selective passage of pressurized liquid hydrogen peroxide (the circuit including vaporizer 130, filter 176, hydrogen peroxide supply 160, and isolator 12; Paragraph [0026] discloses the pump 170 is metered to control the injection of peroxide, controller 202 );
at least one evaporator configured to prepare a gaseous mixture comprising hot pressurized air from the first circuit and at least one selective injection of the pressurized liquid hydrogen peroxide from the second circuit (vaporizer 130 receives liquid hydrogen peroxide pressurized by the pump 170 and also receives hot air from the heater 120), the gaseous mixture comprising a combination of hot air and hydrogen peroxide vapor from the second circuit (par. 46); wherein the hot pressurized air is circulated to evaporate deposited hydrogen peroxide and thermally activate the vapor to generate sterilizing radicals (the hot air and circulation thereof disclosed by Buczynski is well capable of performing this function and is reasonably expected to do so, MPEP 2114, II) and
a second regulating means fluidly connected to at least one pipe, the at least one pipe being fluidly connected between the at least one evaporator, the second regulating means being controlled to release the gaseous mixture, the hydrogen peroxide vapor of the gaseous mixture being a fraction of a specified amount of a liquid hydrogen peroxide that is supplying the second circuit (par. 28 discloses the injection blower blows fluid through the conduit 22, the vaporized hydrogen peroxide is a fraction of the total hydrogen peroxide available from the peroxide supply 160), wherein the device comprises a control unit configured to regulate the timing and duration of the system (controller 202, par. 37).
Regarding the limitation that the heating means can deliver hot pressurized air at a specified target temperature of about 220 degrees Celsius: Apparatus claims cover what a device is, not what a device does and a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (see MPEP 2114, II). The claim does not positively recite the heating of the air to any temperature, merely that the heating means be configured to heat to a temperature of about 220 degrees Celsius. The heater 120 disclosed by Buczynski is well capable of heating to a specified target temperature and is reasonably expected to perform this function. Therefore, all the limitations of the claim are met. Buczynski appears to be silent with regards to the device sterilizing gas filtration means of a blow-molding circuit. Furthermore, Nagatani (US 2009/0169421) discloses a hydrogen peroxide system that uses hot air and hydrogen peroxide to sterilize a space including a filter (abstract) wherein the mixture is heated to a temperature of not lower than 75 degrees Celsius (par. 40), overlapping with the claimed range of about 220 degrees Celsius. 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 device disclosed by Buczynski such that the heater is configured to deliver hot air at 220 degrees Celsius as taught by Nagatani to arrive at the claimed invention. One would have been motivated to do so because the claimed range overlaps with a range disclosed in the prior art, and in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Furthermore, this modification is nothing more than one of routine optimization, and differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See MPEP 2144.05(II)(A).
Buczynski appears to be silent with regards to the device sterilizing gas filtration means of a blow-molding circuit, and the injections being separated by a defined time interval.
Neubauer (US 9,149,972) discloses a blow molding circuit including filter means (Title, Column 3 lines 24 - 36) including a sterilizing means (the abstract discloses the application of a flowable sterilization agent, claim 12 discloses the agent being hydrogen peroxide). 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 device disclosed by Neubauer such that the sterilization means disclosed by Buczynski are attached to the blow molding circuit for the purpose of sterilizing the blow molding circuit and its gas filtration means to arrive at the claimed invention. One would have been motivated to do so to apply a known-effective hydrogen peroxide sterilization device to a workpiece including the gas filtration means of a blow molding circuit as is known to be desirable in the art to arrive at an improved blow molding circuit with improved sterility. The combination of familiar prior art elements, including blow molding circuits including filter means and hydrogen peroxide sterilization means, according to known means to arrive at results that are nothing more than predictable is prima facie obvious. MPEP 2143(I)(A).
Regarding the limitation that the injections are separated by a defined time interval: Rickloff (US 5,445,792) discloses a hydrogen peroxide vapor sterilization method (abstract) wherein injections of the peroxide are separated by defined time intervals (see fig. 3, flow through portion G-H with sequential injections; Col. 13 lines 35-44) to control a particular concentration and pressure for better efficiency (col. 13 lines 45-50). 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 device disclosed by Buczynski such that the injections are separated by a defined time interval to arrive at the claimed invention. One would have been motivated to do so to successfully maintain a desired operating pressure, concentration, and humidity to arrive at an improved peroxide sterilization device.
Regarding claim 10, Buczynski discloses –
A device for sterilizing gas filtration means, the device comprising:
a first circuit that comprises an air heater configured to deliver hot air at a specified target temperature (at least the circuit including heater 120, dryer 90, HEPA filter 152 and isolator 12; the heater 120 heats air, par. 28; the device is well capable of performing this function and is expected to do so);
a reservoir comprising a quantity of hydrogen peroxide in the liquid state, the quantity thereof being a specified amount that is sufficient to sterilize the filtration means for a sterilization cycle (hydrogen peroxide supply 160 holds an amount that is sufficient to sterilize the filtration means);
a second circuit that comprises at least regulating means to control the selective injection of hydrogen peroxide (the circuit including vaporizer 130, filter 176, hydrogen peroxide supply 160, and isolator 12; Paragraph [0026] discloses the pump 170 is metered to control the injection of peroxide, the pump reading on the limitation specifically); and
at least one evaporator for preparing a gaseous mixture that consists of hot air and hydrogen peroxide vapor (vaporizer 130), wherein
a control unit (controller 202) wherein the hot air is circulated to evaporate the deposited hydrogen peroxide and thermally activate the vapor (the hot air and circulation thereof disclosed by Buczynski is well capable of performing this function and is reasonably expected to do so, MPEP 2114, II); and
wherein the device further comprises a discharge pipe downstream of the workpiece, the discharge pipe including a treatment means configured to neutralize residual hydrogen peroxide vapor (destroyer 60, connected to discharge pipe 42; par. 31).
Regarding the limitation that the heating means can deliver hot pressurized air at a specified target temperature of about 220 degrees Celsius: Apparatus claims cover what a device is, not what a device does and a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (see MPEP 2114, II). The claim does not positively recite the heating of the air to any temperature, merely that the heating means be configured to heat to a temperature of about 220 degrees Celsius. The heater 120 disclosed by Buczynski is well capable of heating to a specified target temperature and is reasonably expected to perform this function. Therefore, all the limitations of the claim are met. Buczynski appears to be silent with regards to the device sterilizing gas filtration means of a blow-molding circuit. Furthermore, Nagatani (US 2009/0169421) discloses a hydrogen peroxide system that uses hot air and hydrogen peroxide to sterilize a space including a filter (abstract) wherein the mixture is heated to a temperature of not lower than 75 degrees Celsius (par. 40), overlapping with the claimed range of about 220 degrees Celsius. 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 device disclosed by Buczynski such that the heater is configured to deliver hot air at 220 degrees Celsius as taught by Nagatani to arrive at the claimed invention. One would have been motivated to do so because the claimed range overlaps with a range disclosed in the prior art, and in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Furthermore, this modification is nothing more than one of routine optimization, and differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See MPEP 2144.05(II)(A).
Buczynski appears to be silent with regards to the device sterilizing gas filtration means of a blow-molding circuit, and the injections being separated by a defined time interval.
Neubauer (US 9,149,972) discloses a blow molding circuit including filter means (Title, Column 3 lines 24 - 36) including a sterilizing means (the abstract discloses the application of a flowable sterilization agent, claim 12 discloses the agent being hydrogen peroxide). 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 device disclosed by Neubauer such that the sterilization means disclosed by Buczynski are attached to the blow molding circuit for the purpose of sterilizing the blow molding circuit and its gas filtration means to arrive at the claimed invention. One would have been motivated to do so to apply a known-effective hydrogen peroxide sterilization device to a workpiece including the gas filtration means of a blow molding circuit as is known to be desirable in the art to arrive at an improved blow molding circuit with improved sterility. The combination of familiar prior art elements, including blow molding circuits including filter means and hydrogen peroxide sterilization means, according to known means to arrive at results that are nothing more than predictable is prima facie obvious. MPEP 2143(I)(A).
Regarding the limitation that the injections are separated by a defined time interval: Rickloff (US 5,445,792) discloses a hydrogen peroxide vapor sterilization method (abstract) wherein injections of the peroxide are separated by defined time intervals (see fig. 3, flow through portion G-H with sequential injections; Col. 13 lines 35-44) to control a particular concentration and pressure for better efficiency (col. 13 lines 45-50). 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 device disclosed by Buczynski such that the injections are separated by a defined time interval to arrive at the claimed invention. One would have been motivated to do so to successfully maintain a desired operating pressure, concentration, and humidity to arrive at an improved peroxide sterilization device.
Response to Arguments
Applicant’s remarks directed towards the 112(a) rejections are persuasive and the rejections are withdrawn.
Applicant has not presented any arguments directed towards the 112(b) rejections that have been maintained and the rejections are maintained as such.
Applicant’s remarks directed towards the 103 rejections are not persuasive. The newly cited Nagatani and Rickloff, as necessitated by Applicant’s amendment, remedy any alleged deficiencies of the prior art. Applicant does not present any arguments directed towards the references as used in the combination in which they are relied upon in this rejection, and therefore the arguments are not persuasive.
The claims remain rejected herein.
Conclusion
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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/BRENDAN A HENSEL/Examiner, Art Unit 1758