DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after M-arch 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/04/2024 and 12/11/2025 are being considered by the examiner.
Claim Objections
Claims 1, 9, 11 and 19 are objected to because of the following informalities:
Claim 1, line 6, recites “at least one equipment sensor, each of the at least one equipment sensor being configure” should read -- at least one equipment sensor, each of the at least one equipment sensor being configured – .
Claim 9, line 1 recites “wherein the refrigerant parameter is one of a refrigerant” should read -- wherein the target refrigerant parameter is one of a refrigerant --.
Claim 11, line 5 recites “measuring via at least on equipment sensor an operating parameter of the cooling” should read -- measuring via at least one equipment sensor an operating parameter of the cooling --.
Claim 19, line 1 recites “wherein the refrigerant parameter is one of a refrigerant” should read -- wherein the target refrigerant parameter is one of a refrigerant --.
Appropriate correction is required.
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 1-10 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 1 recites the limitation "each of the at least one external environment sensors" in line 3. There is insufficient antecedent basis for this limitation in the claim as it is unclear whether there are multiple external environment sensors or simply one environment sensor. Claims 2-10 are rejected by virtue of dependency on claim 1.
Claim 1 recites the limitation "each of the at least one equipment sensor" in line 6. There is insufficient antecedent basis for this limitation in the claim as it is unclear whether there are multiple equipment sensors or simply one equipment sensor. Claims 2-10 are rejected by virtue of dependency on claim 1.
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.
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.
Claim(s) 1, 2, 5, 6, 8, 9, 11, 12, 15, 16, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buckley et al. (US 20170056087) herein referred to as “Buckley” as Buckley embodiment 1 in view of Buckley embodiment 2.
Regarding claim 1, Buckley discloses a cryoablation cooling system (cryotherapeutic system, Paragraph [0172], Figure 7), comprising:
cooling equipment having at least one operating parameter (cryotherapeutic device 700, Paragraph [0172]);
at least one external environment sensor (temperature sensor 716, Paragraph [0173]),
each of the at least one external environment sensors being configured to measure an environmental parameter external to the cooling equipment (the temperature sensor can send a signal to the processor 712 causing valve 704 to open and pre-cooling to increase if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is higher or to close and pre-cooling to decrease if a detected temperature is lower than a desired value, Paragraph [0173]);
and a sub-cooler control system configured to determine an adjustment to at least one operating parameter of the cooling equipment to obtain a target refrigerant parameter based at least in part on the at least one measured external environmental parameter and at least one of a measured operating parameter and a predetermined operating parameter (the temperature sensor can send a signal to the processor 712 causing valve 704 to open and pre-cooling to increase if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is higher or to close and pre-cooling to decrease if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is lower than a desired value, Paragraph [0173]).
However Buckley embodiment 1 does not explicitly disclose at least one equipment sensor, each of the at least one equipment sensor being configure to measure an operating parameter of the cooling equipment.
Buckley embodiment 2 discloses at least one equipment sensor (console 502 can include a pressure sensor 570, Paragraph [0156]),
each of the at least one equipment sensor being configure to measure an operating parameter of the cooling equipment (pressure sensor 570 can be coupled to the controller 518 to serve as a feedback mechanism that controls the supply control valve 508 and/or the backpressure control valve 513, and thereby regulates refrigerant flow to and/or from the cooling assembly 530 in response to a pressure sensed at the cooling assembly 530. For example, the pressure sensor 570 can be configured to indicate a pressure above a predetermined threshold (e.g., within a range of a burst pressure of the expansion chamber), Paragraph [0156]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Buckley embodiment 1 to incorporate the teachings of Buckley embodiment 2 by including at least one equipment sensor, each of the at least one equipment sensor being configure to measure an operating parameter of the cooling equipment. The motivation to do so being to monitor the pressure of a portion of the cooling assembly to serve as a feedback mechanism to regulate refrigerant flow to and/or from the cooling assembly (Buckley, Paragraph [0156]).
Regarding claim 2, Buckley embodiment 1 in view of Buckley embodiment 2 discloses the system of Claim 1.
Buckley embodiment 1 further discloses wherein the adjustment is based on a transfer function that relates a given set of operating parameters and external environment parameters to a target refrigerant parameter (the temperature sensor can send a signal to the processor 712 causing valve 704 to open and pre-cooling to increase if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is higher or to close and pre-cooling to decrease if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is lower than a desired value, Paragraph [0173]).
Regarding claim 5, Buckley embodiment 1 in view of Buckley embodiment 2 discloses the system of Claim 2.
Buckley embodiment 1 further discloses wherein determining the adjustment includes: setting the target refrigerant parameter (desired value, Paragraph [0173]); and determining at least one operating parameter setting based on the transfer function and the set target refrigerant parameter (the temperature sensor can send a signal to the processor 712 causing valve 704 to open and pre-cooling to increase if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is higher or to close and pre-cooling to decrease if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is lower than a desired value, Paragraph [0173])..
Regarding claim 6, Buckley embodiment 1 in view of Buckley embodiment 2 discloses the system of Claim 1.
However Buckley embodiment 1 does not explicitly disclose wherein the at least one measured operating parameter is one of a condenser fan speed, a compressor speed and a charging pressure.
Buckley embodiment 2 discloses wherein the at least one measured operating parameter is one of a condenser fan speed, a compressor speed and a charging pressure (pressure sensor 570 can be coupled to the controller 518 to serve as a feedback mechanism that controls the supply control valve 508 and/or the backpressure control valve 513, and thereby regulates refrigerant flow to and/or from the cooling assembly 530 in response to a pressure sensed at the cooling assembly 530. For example, the pressure sensor 570 can be configured to indicate a pressure (seen as a charging pressure) above a predetermined threshold (e.g., within a range of a burst pressure of the expansion chamber), Paragraph [0156]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Buckley embodiment 1 to incorporate the teachings of Buckley embodiment 2 by including wherein the at least one measured operating parameter is one of a condenser fan speed, a compressor speed and a charging pressure. The motivation to do so being to monitor the pressure of a portion of the cooling assembly to serve as a feedback mechanism to regulate refrigerant flow to and/or from the cooling assembly (Buckley, Paragraph [0156]).
Regarding claim 8, Buckley embodiment 1 in view of Buckley embodiment 2 discloses the system of Claim 6.
Buckley embodiment 1 further discloses wherein the target cooling power is determined based at least in part on a transfer function having inputs that include at least one measured external environmental parameter (the temperature sensor can send a signal to the processor 712 causing valve 704 to open and pre-cooling to increase if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is higher or to close and pre-cooling to decrease if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is lower than a desired value, Paragraph [0173])..
However Buckley embodiment 1 does not explicitly disclose wherein the input includes at least one measured operating parameter.
Buckley embodiment 2 discloses wherein the input includes at least one measured operating parameter (pressure sensor 570 can be coupled to the controller 518 to serve as a feedback mechanism that controls the supply control valve 508 and/or the backpressure control valve 513, and thereby regulates refrigerant flow to and/or from the cooling assembly 530 in response to a pressure sensed at the cooling assembly 530. For example, the pressure sensor 570 can be configured to indicate a pressure above a predetermined threshold (e.g., within a range of a burst pressure of the expansion chamber), Paragraph [0156]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Buckley embodiment 1 to incorporate the teachings of Buckley embodiment 2 by including at least one equipment sensor, each of the at least one equipment sensor being configure to measure an operating parameter of the cooling equipment. The motivation to do so being to monitor the pressure of a portion of the cooling assembly to serve as a feedback mechanism to regulate refrigerant flow to and/or from the cooling assembly (Buckley, Paragraph [0156]).
Regarding claim 9, Buckley embodiment 1 in view of Buckley embodiment 2 discloses the system of Claim 1.
However Buckley embodiment 1 does not explicitly disclose wherein the refrigerant parameter is one of a refrigerant pressure, a refrigerant temperature, and a refrigerant cooling power.
Buckley embodiment 2 discloses wherein the refrigerant parameter is one of a refrigerant pressure (pressure sensor 570 can be coupled to the controller 518 to serve as a feedback mechanism that controls the supply control valve 508 and/or the backpressure control valve 513, and thereby regulates refrigerant flow to and/or from the cooling assembly 530 in response to a pressure sensed at the cooling assembly 530. For example, the pressure sensor 570 can be configured to indicate a pressure above a predetermined threshold (e.g., within a range of a burst pressure of the expansion chamber), Paragraph [0156]), a refrigerant temperature, and a refrigerant cooling power.
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Buckley embodiment 1 to incorporate the teachings of Buckley embodiment 2 by including wherein the refrigerant parameter is one of a refrigerant pressure, a refrigerant temperature, and a refrigerant cooling power. The motivation to do so being to monitor the pressure of a portion of the cooling assembly to serve as a feedback mechanism to regulate refrigerant flow to and/or from the cooling assembly (Buckley, Paragraph [0156]).
Regarding claim 11, Buckley discloses a method in a cryoablation cooling system, the method comprising: providing cooling equipment having at least one operating parameter (cryotherapeutic device 700, Paragraph [0172]); measuring via at least one external environment sensor an environmental parameter external to the cooling equipment (temperature sensor 716, Paragraph [0173], the temperature sensor can send a signal to the processor 712 causing valve 704 to open and pre-cooling to increase if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is higher or to close and pre-cooling to decrease if a detected temperature is lower than a desired value, Paragraph [0173]); determining an adjustment to at least one operating parameter of the cooling equipment to obtain a target refrigerant parameter based at least in part on the at least one measured external environmental parameter and at least one of a measured operating parameter and a predetermined operating parameter (the temperature sensor can send a signal to the processor 712 causing valve 704 to open and pre-cooling to increase if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is higher or to close and pre-cooling to decrease if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is lower than a desired value, Paragraph [0173]).
However Buckley embodiment 1 does not explicitly disclose measuring via at least on equipment sensor an operating parameter of the cooling equipment (pressure sensor 570 can be coupled to the controller 518 to serve as a feedback mechanism that controls the supply control valve 508 and/or the backpressure control valve 513, and thereby regulates refrigerant flow to and/or from the cooling assembly 530 in response to a pressure sensed at the cooling assembly 530. For example, the pressure sensor 570 can be configured to indicate a pressure above a predetermined threshold (e.g., within a range of a burst pressure of the expansion chamber), Paragraph [0156]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Buckley embodiment 1 to incorporate the teachings of Buckley embodiment 2 by including at least one equipment sensor, each of the at least one equipment sensor being configure to measure an operating parameter of the cooling equipment. The motivation to do so being to monitor the pressure of a portion of the cooling assembly to serve as a feedback mechanism to regulate refrigerant flow to and/or from the cooling assembly (Buckley, Paragraph [0156]).
.
Regarding claim 12, Buckley embodiment 1 in view of Buckley embodiment 2 discloses the method of Claim 11.
Buckley embodiment 1 further discloses wherein the adjustment is based on a transfer function that relates a given set of operating parameters and external environment parameters to a target refrigerant parameter (the temperature sensor can send a signal to the processor 712 causing valve 704 to open and pre-cooling to increase if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is higher or to close and pre-cooling to decrease if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is lower than a desired value, Paragraph [0173]).
Regarding claim 15, Buckley embodiment 1 in view of Buckley embodiment 2 discloses the method of Claim 12.
Buckley embodiment 1 further discloses wherein determining the adjustment includes: setting the target refrigerant parameter (desired value, Paragraph [0173]); and determining at least one operating parameter setting based on the transfer function and the set target refrigerant parameter (the temperature sensor can send a signal to the processor 712 causing valve 704 to open and pre-cooling to increase if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is higher or to close and pre-cooling to decrease if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is lower than a desired value, Paragraph [0173]).
Regarding claim 16, Buckley embodiment 1 in view of Buckley embodiment 2 discloses the method of Claim 11.
However Buckley embodiment 1 does not explicitly disclose wherein the at least one measured operating parameter is one of a condenser fan speed, a compressor speed and a charging pressure.
Buckley embodiment 2 discloses wherein the at least one measured operating parameter is one of a condenser fan speed, a compressor speed and a charging pressure (pressure sensor 570 can be coupled to the controller 518 to serve as a feedback mechanism that controls the supply control valve 508 and/or the backpressure control valve 513, and thereby regulates refrigerant flow to and/or from the cooling assembly 530 in response to a pressure sensed at the cooling assembly 530. For example, the pressure sensor 570 can be configured to indicate a pressure (seen as a charging pressure) above a predetermined threshold (e.g., within a range of a burst pressure of the expansion chamber), Paragraph [0156]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Buckley embodiment 1 to incorporate the teachings of Buckley embodiment 2 by including wherein the at least one measured operating parameter is one of a condenser fan speed, a compressor speed and a charging pressure. The motivation to do so being to monitor the pressure of a portion of the cooling assembly to serve as a feedback mechanism to regulate refrigerant flow to and/or from the cooling assembly (Buckley, Paragraph [0156]).
Regarding claim 18, Buckley embodiment 1 in view of Buckley embodiment 2 discloses the method of Claim 16.
Buckley embodiment 1 further discloses wherein the target cooling power is determined based at least in part on a transfer function having inputs that include at least one measured external environmental parameter (the temperature sensor can send a signal to the processor 712 causing valve 704 to open and pre-cooling to increase if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is higher or to close and pre-cooling to decrease if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is lower than a desired value, Paragraph [0173])..
However Buckley embodiment 1 does not explicitly disclose wherein the input includes at least one measured operating parameter.
Buckley embodiment 2 discloses wherein the input includes at least one measured operating parameter (pressure sensor 570 can be coupled to the controller 518 to serve as a feedback mechanism that controls the supply control valve 508 and/or the backpressure control valve 513, and thereby regulates refrigerant flow to and/or from the cooling assembly 530 in response to a pressure sensed at the cooling assembly 530. For example, the pressure sensor 570 can be configured to indicate a pressure above a predetermined threshold (e.g., within a range of a burst pressure of the expansion chamber), Paragraph [0156]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Buckley embodiment 1 to incorporate the teachings of Buckley embodiment 2 by including at least one equipment sensor, each of the at least one equipment sensor being configure to measure an operating parameter of the cooling equipment. The motivation to do so being to monitor the pressure of a portion of the cooling assembly to serve as a feedback mechanism to regulate refrigerant flow to and/or from the cooling assembly (Buckley, Paragraph [0156]).
Regarding claim 19, Buckley embodiment 1 in view of Buckley embodiment 2 discloses the method of Claim 11.
However Buckley embodiment 1 does not explicitly disclose wherein the refrigerant parameter is one of a refrigerant pressure, a refrigerant temperature, and a refrigerant cooling power.
Buckley embodiment 2 discloses wherein the refrigerant parameter is one of a refrigerant pressure (pressure sensor 570 can be coupled to the controller 518 to serve as a feedback mechanism that controls the supply control valve 508 and/or the backpressure control valve 513, and thereby regulates refrigerant flow to and/or from the cooling assembly 530 in response to a pressure sensed at the cooling assembly 530. For example, the pressure sensor 570 can be configured to indicate a pressure above a predetermined threshold (e.g., within a range of a burst pressure of the expansion chamber), Paragraph [0156]), a refrigerant temperature, and a refrigerant cooling power.
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Buckley embodiment 1 to incorporate the teachings of Buckley embodiment 2 by including wherein the refrigerant parameter is one of a refrigerant pressure, a refrigerant temperature, and a refrigerant cooling power. The motivation to do so being to monitor the pressure of a portion of the cooling assembly to serve as a feedback mechanism to regulate refrigerant flow to and/or from the cooling assembly (Buckley, Paragraph [0156]).
Claim(s) 3, 4, 7, 13, 14, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buckley embodiment 1 in view of Buckley embodiment 2 further in view of Gong et al. (US 20220287757) herein referred to as “Gong”.
Regarding claim 3, Buckley embodiment 1 in view of Buckley embodiment 2 discloses the system of Claim 2.
However Buckley embodiment 1 in view of Buckley embodiment 2 does not explicitly disclose wherein the transfer function is predetermined based on measurements of the target refrigerant parameter for a number of sets of operating parameters.
Gong discloses a temperature-controllable cryoablation system (Abstract) wherein the transfer function is predetermined based on measurements of the target refrigerant parameter for a number of sets of operating parameters (the target temperature value may be suppled to the main PID control loop, a target pressure value at the set temperature may be calculated according to the equation (7) and the set target temperature, the main PID control loop (PID1) calculates an output signal, Paragraph [0077]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Buckley embodiment 1 in view of Buckley embodiment 2 to incorporate the teachings of Gong by including wherein the transfer function is predetermined based on measurements of the target refrigerant parameter for a number of sets of operating parameters. The motivation to do so being to calculate a value for an operating parameter in order to set the target temperature for treatment (Gong, Paragraph [0077]).
Regarding claim 4, Buckley embodiment 1 in view of Buckley embodiment 2 and Gong discloses the system of Claim 3.
Buckley embodiment 1 further discloses wherein determining at least one operating parameter based on the transfer function is further based on a difference between the target refrigerant parameter and a measured refrigerant parameter (the temperature sensor can send a signal to the processor 712 causing valve 704 to open and pre-cooling to increase if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is higher or to close and pre-cooling to decrease if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is lower than a desired value, Paragraph [0173]).
Regarding claim 7, Buckley embodiment 1 in view of Buckley embodiment 2 discloses the system of Claim 1.
However Buckley embodiment 1 in view of Buckley embodiment 2 does not explicitly disclose wherein the sub-cooler control system includes a sub-cooler proportional-integral-derivative (PID) controller configured to determine a control signal based at least in part on the target refrigerant parameter and a measured refrigerant parameter, the control signal controlling an operational parameter of the cooling equipment.
Gong discloses a temperature-controllable cryoablation system (Abstract) wherein the sub-cooler control system includes a sub-cooler proportional-integral-derivative (PID) controller configured to determine a control signal based at least in part on the target refrigerant parameter and a measured refrigerant parameter, the control signal controlling an operational parameter of the cooling equipment (the target temperature value may be supplied to the main PID control loop, a target pressure value at the set temperature may be calculated according to the equation (7) and the set target temperature, the main PID control loop (PID1) calculates an output signal (i.e., the pressure of the input-side regulating valve after adjustment) using the equations (8) and (9) of the PID control algorithm, Paragraph [0077], ultimately, the temperature of the balloon at the distal end of the catheter 12 is controlled to infinitely approach the set target temperature value, Paragraph [0078]-[0079]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Buckley embodiment 1 in view of Buckley embodiment 2 to incorporate the teachings of Gong by including wherein the sub-cooler control system includes a sub-cooler proportional-integral-derivative (PID) controller configured to determine a control signal based at least in part on the target refrigerant parameter and a measured refrigerant parameter, the control signal controlling an operational parameter of the cooling equipment. The motivation to do so being to control the temperature of the balloon at the distal end of the catheter to ensure it approaches the set temperature (Gong, Paragraph [0078]).
Regarding claim 13, Buckley embodiment 1 in view of Buckley embodiment 2 discloses the method of Claim 12.
However Buckley embodiment 1 in view of Buckley embodiment 2 does not explicitly disclose wherein the transfer function is predetermined based on measurements of the target refrigerant parameter for a number of sets of operating parameters.
Gong discloses a temperature-controllable cryoablation system (Abstract) wherein the transfer function is predetermined based on measurements of the target refrigerant parameter for a number of sets of operating parameters (the target temperature value may be supplied to the main PID control loop, a target pressure value at the set temperature may be calculated according to the equation (7) and the set target temperature, the main PID control loop (PID1) calculates an output signal, Paragraph [0077]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Buckley embodiment 1 in view of Buckley embodiment 2 to incorporate the teachings of Gong by including wherein the transfer function is predetermined based on measurements of the target refrigerant parameter for a number of sets of operating parameters. The motivation to do so being to calculate a value for an operating parameter in order to set the target temperature for treatment (Gong, Paragraph [0077]).
Regarding claim 14, Buckley embodiment 1 in view of Buckley embodiment 2 and Gong discloses the method of Claim 13.
Buckley embodiment 1 further discloses wherein determining at least one operating parameter based on the transfer function is further based on a difference between the target refrigerant parameter and a measured refrigerant parameter (the temperature sensor can send a signal to the processor 712 causing valve 704 to open and pre-cooling to increase if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is higher or to close and pre-cooling to decrease if a detected temperature of the cooling assembly or tissue proximate the cooling assembly is lower than a desired value, Paragraph [0173]).
Regarding claim 17, Buckley embodiment 1 in view of Buckley embodiment 2 discloses the method of Claim 11.
However Buckley embodiment 1 in view of Buckley embodiment 2 does not explicitly disclose wherein the sub-cooler control system includes a sub-cooler proportional-integral-derivative (PID) controller configured to determine a control signal based at least in part on the target refrigerant parameter and a measured refrigerant parameter, the control signal controlling an operational parameter of the cooling equipment.
Gong discloses a temperature-controllable cryoablation system (Abstract) wherein the sub-cooler control system includes a sub-cooler proportional-integral-derivative (PID) controller configured to determine a control signal based at least in part on the target refrigerant parameter and a measured refrigerant parameter, the control signal controlling an operational parameter of the cooling equipment (the target temperature value may be supplied to the main PID control loop, a target pressure value at the set temperature may be calculated according to the equation (7) and the set target temperature, the main PID control loop (PID1) calculates an output signal (i.e., the pressure of the input-side regulating valve after adjustment) using the equations (8) and (9) of the PID control algorithm, Paragraph [0077], ultimately, the temperature of the balloon at the distal end of the catheter 12 is controlled to infinitely approach the set target temperature value, Paragraph [0078]-[0079]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Buckley embodiment 1 in view of Buckley embodiment 2 to incorporate the teachings of Gong by including wherein the sub-cooler control system includes a sub-cooler proportional-integral-derivative (PID) controller configured to determine a control signal based at least in part on the target refrigerant parameter and a measured refrigerant parameter, the control signal controlling an operational parameter of the cooling equipment. The motivation to do so being to control the temperature of the balloon at the distal end of the catheter to ensure it approaches the set temperature (Gong, Paragraph [0078]).
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buckley embodiment 1 in view of Buckley embodiment 2 further in view of Buckley embodiment 3.
Regarding claim 10, Buckley embodiment 1 in view of Buckley embodiment 2 discloses the system of Claim 1.
Buckley embodiment 1 discloses wherein the at least one measured external environmental parameter is a temperature (temperature sensor 716, Paragraph [0173]).
However Buckley embodiment 1 does not explicitly disclose wherein the temperature is measured by a thermocouple nor wherein at least one measured operating parameter is a pressure measured by a transducer.
Buckley embodiment 2 discloses wherein at least one measured operating parameter is a pressure measured by a transducer (console 502 can include a pressure transducer or sensor 570, Paragraph [0156]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Buckley embodiment 1 to incorporate the teachings of Buckley embodiment 2 by including wherein at least one measured operating parameter is a pressure measured by a transducer. The motivation to do so being to monitor the pressure of a portion of the cooling assembly to serve as a feedback mechanism to regulate refrigerant flow to and/or from the cooling assembly (Buckley, Paragraph [0156]).
Further Buckley embodiment 3 discloses wherein a temperature sensor that is a thermocouple configured to measure an external environmental parameter of the device (sensor 138 can be a thermocouple positioned on an outer surface of the balloon 142 and configured to provide a real-time temperature reading of the external temperature of the balloon 142, Paragraph [0129]).
It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to use a thermocouple, since applicant has not disclosed that using a thermocouple solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a temperature sensor, as temperature sensors and thermocouples are equivalent in the art as taught by Buckley.
Regarding claim 20, Buckley embodiment 1 in view of Buckley embodiment 2 discloses the method of Claim 11.
Buckley embodiment 1 discloses wherein the at least one measured external environmental parameter is a temperature (temperature sensor 716, Paragraph [0173]).
However Buckley embodiment 1 does not explicitly disclose wherein the temperature is measured by a thermocouple nor wherein at least one measured operating parameter is a pressure measured by a transducer.
Buckley embodiment 2 discloses wherein at least one measured operating parameter is a pressure measured by a transducer (console 502 can include a pressure transducer or sensor 570, Paragraph [0156]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Buckley embodiment 1 to incorporate the teachings of Buckley embodiment 2 by including wherein at least one measured operating parameter is a pressure measured by a transducer. The motivation to do so being to monitor the pressure of a portion of the cooling assembly to serve as a feedback mechanism to regulate refrigerant flow to and/or from the cooling assembly (Buckley, Paragraph [0156]).
Further Buckley embodiment 3 discloses wherein a temperature sensor that is a thermocouple configured to measure an external environmental parameter of the device (sensor 138 can be a thermocouple positioned on an outer surface of the balloon 142 and configured to provide a real-time temperature reading of the external temperature of the balloon 142, Paragraph [0129]).
It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to use a thermocouple, since applicant has not disclosed that using a thermocouple solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a temperature sensor, as temperature sensors and thermocouples are equivalent in the art as taught by Buckley.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dana Stumpfoll whose telephone number is (703)756-4669. The examiner can normally be reached 9-5 pm (CT), M-F.
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/D.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794