DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 01/22/2026 has been entered. Claims 1-5, 7-18 and 20-22 remain pending in the application. Claims 6 and 19 have been cancelled. Applicant's arguments filed 01/22/2026 have been fully considered but they are not persuasive.
Response to Arguments
Applicant’s arguments, see page 8 lines 6-27 and page 9 lines 1-37 and page 10 lines 1-13, filed 02/22/2026, with respect to the rejection(s) of claim(s) 1 under U.S.C. § 101 have been fully considered but they are not persuasive.
Applicant argues traversal of the U.S.C. § 101 rejection however, examiner respectfully disagrees. Applicant argues that ‘claim 12 requires at least one computing device communicatively couple to a cryoablation probe […] where the at least one computing device performs the above quoted operations. The computing device is seen as a generic computing device, further the operations are seen as well-known process to the industry, and the operation preformed are seen as requiring no more than a generic computer to perform generic computer functions that are well known and previously known to the industry. Which is a limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception (See MPEP 2106.05(1)(A))
Applicant further argues ‘ claims represent a specific technological improvement to existing cryoablation systems that cannot be implemented via existing cryoablation systems described by the prior art of record’. Examiner respectfully disagrees. While the system holds dome patentable weight, it is limited; the method does not claim the device. Further the method initiates a heating cycle on generic components and does not actively apply heat. Therefore, the U.S.C. § 101 rejection stands.
Applicant’s arguments, see page 11 lines 21-37 and page 12 lines 1-21, filed 02/22/2026, with respect to the rejection(s) of claim(s) 1 under U.S.C. § 103 have been fully considered but they are not persuasive.
Applicant argues there is a mischaracterization of claimed subject matter: “a first heater located at a first heating location on the cryo-fluid supply, and a second heater located at a second heating location on the cryo-fluid supply each of the first heating location and the second heating location located upstream of the cryoablation probe”. However, Chang discloses the first and second heating elements, the second being located upstream from the cryoprobe (Chang, [Figure 3a, (303) and (315)]) wherein the heating elements are located the fluid transportation tube ([0074], [0085]). Further Ramadyani discloses a first heating element located upstream of the cryoprobe (Ramadyani [0044]) and it would be obvious to one of ordinary skill in the art to place the heating element upstream of the cryoprobe to achieve the predictable result of heating the fluid to a temperature suitable for cryoablation (Ramadyani, [0062]
However, the claim limitation mentioned is taught by not only Chang. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant further argues that the prior art does not teach “a third heater at a third location on a return line”. However, Chang discloses the third heating element ([Figure 3a]; (315)) Ramadyani discloses a third heating element on a return line (Ramadyani, [0079]) It is obvious to place a third heating element on the fluid return line to exchange heat with the returning liquid ([0071]). Therefore, the rejection stands.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 12-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed a judicial exception (i.e., an abstract idea) without significantly more.
Step 1 – Statutory Categories
As indicated in the preamble of the claim, the examiner finds the claim is directed to a process, machine, manufacture, or compositions of matter. Claims 12-20 are processes (methods)
Step 2A – Prong 1: was there a Judicial Exception Recited
Claim 12 recites the following abstract concepts that are found to include “abstract ideas”:
A method of sequentially heating for a cryoablation system comprising a cryoablation probe, a cryo-fluid supply coupled to the cryoablation probe, a first heater located at a first heating location on the cryo-fluid supply, [[and]] a second heater located at a second heating location on the cryo-fluid supply, wherein each of the first heating location and the second heating location located upstream of the cryoablation probe, a third heater at a third heater location on a return line from the cryoablation probe, and at least one computing device communicatively coupled to the cryoablation probe, the method by the at least one computing device and comprising: obtaining temperature information at the first heating location and the second heating location on the cryo-fluid supply via the at least one computing device (Observation) comparing a first temperature at the first heating location to an expected first temperature (evaluation); initiating a first heating cycle by energizing the first heater at the first heating location if the first temperature at the first heating location is less than the expected first temperature (judgement); comparing a second temperature at the second heating location to an expected second temperature (evaluation), the second heating location disposed downstream of the first heating location; and initiating a second heating cycle by energizing the second heater at the second heating location if the second temperature is less than the expected second temperature after de-energizing the first heater comparing a third temperature at the third heating location to an expected third temperature; and initiating a third heating cycle by energizing the third heater at the third heating location if the third temperature is less than the expected third temperature (judgement).
Claim 12 is directed to a series of steps for measuring temperature at a location and initiating heaters based on the temperatures, which is a commercial/legal interaction and thus grouped as a certain method of organizing human interactions and/or a mental process (see above notations). Thus, the claim recites an abstract idea. See MPEP §2106.4(a).
Step 2A – Prong 2: Can the Judicial Exception Recited be integrated into a practical application
Limitation that are indicative of integration into a practical application:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying or using a judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo
Limitations that are not indicative of integration into a practical application:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
This judicial exception is not integrated into a practical application because temperature sensor, and computing device are merely generically recited computer elements that do not add a meaningful limitation to the abstract idea because they amount to simply the abstract idea on a generic computer. Accordingly, alone and in combination, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. See Specification [0059] discussing the multiple types of generic electronic devices that could be used. The claim is directed to an abstract idea.
Step 2B – Significantly More Analysis
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and in combination first electronic device, second electronic device, computer-readable media, processor, cameras, and computing device amounts a general machine. Further the general machine is merely an object with which the method operates and the steps amount to mere data gathering. Thus, claim 12 is not patent eligible.
Dependent claims 13-20 fail to provide additional elements that are sufficient to amount to significantly more than the judicial exception. Claim 13 introduces the additional element of a sensor. See [0021] discussing the generic replace sensors. Sensors amounts to mere instructions to apply the exception using a generic computer component. Therefore, claims 13-20 are rejected for the same reasons as stated in the rejection from independent claim from which they depend.
Claim Rejections - 35 USC § 103
Claim(s) 1-5, 7-9 and 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (US 20220110669 A1) herein referred to as “Chang” in view of view of Ramadhyani et al (US 20210045793 A1) herein referred to as “Ramadhyani” further in view of Kelly et al. (US 20140316398 A1) herein referred to as “Kelly”.
Regarding claim 1, Chang discloses: A system for performing a cryoablation treatment (FIG.1-3), the system comprising a cryoablation probe ([0090]; Chang discloses a core shaft (310)), a cryo-fluid supply fluidly coupled to the cryoablation probe ([0090]; Chang discloses the core shaft (310) attached to fluid supply pipe (305)), a first heater located at a first heating location on the cryo-fluid supply, a second heater located at a second heating location on the cryo-fluid supply ( [Figure 3a]; Chang discloses heating location (303) and (306), [0074]; Heating element (303) disclosed on fluid transport line,[0085]; Heating element (306)) wherein each of the first heating location and the second heating location arelocated upstream of the cryoablation probe ([Figure 3a]; disclosed on fluid transport line to the right of the core shaft and closer to the fluid supply and is therefore, seen as upstream), a third heater ([105]; Third heating element (315))and at least one computing device (110, 120, 210, 220), the at least one computing device configured to: obtain temperature information at a plurality of heating locations on the cryo-fluid supply, (heating components 303, 306. See [0075]: "The first heating component 303 is disposed on the fluid transportation pipe 305, particularly at the distal end of the fluid transportation pipe 305". See also [0085]: "With continued reference to Fig. 3a, preferably, the electrophysiology catheter 300 further includes a second heating component 306 disposed on the fluid transportation pipe 305, specifically at a proximal end of the fluid transportation pipe 305 [...]") the plurality of heating locations comprising a first heating location (303) and a second heating location (306) the second heating element located upstream of the cryoablation probe ( [Figure 3a]; Chang discloses heating location (303) and (306) to the right of the core shaft and closer to the fluid supply and is therefore, seen as upstream); compare a first temperature at the first heating location to an expected first temperature ([0067]; Specifically, Chang discloses control device that uses a first temperature sensor to modulate the temperature of a heating component); initiate a first heating cycle by energizing a first heater at the first heating location if the first temperature at the first heating location is less than the expected first temperature ([0104]; Specifically, Chang discloses the heating control unit using feedback from the first temperature sensor to regulate the first heating component ensuring it stays within a predetermined range); compare a second temperature at the second heating location to an expected second temperature, the second heating location disposed downstream of the first heating location ([0025]; Specifically, Chang discloses control device that uses a second temperature sensor to modulate a second heating component); and initiate a second heating cycle by energizing a second heater at the second heating location if the second temperature is less than the expected second temperature([0085]; Specifically, Chang discloses the heating control unit using feedback from the second temperature sensor to regulate the second heating component ensuring it stays within a predetermined range) compare a third temperature at the third heating location to an expected third temperature; and initiate a third heating cycle by energizing the third heater at the third heating location if the third temperature is less than the expected third temperature. ([0105]; Chang discloses a third heater at a third heating location that uses a sensor to determine if the temperature is within a predetermined range and control the heating element to keep the surface temperature within that range)
Chang does not explicitly disclose: the first heating element located upstream of the cryoablation probe and the activation of the second heater after de-energizing the first heater. A third heater at a third heater location on a return line from the cryoablation probe.
However, Ramadhyani discloses: the first heating element located upstream of the cryoablation probe. ([0044];” The primary fluid circuit 110 may also include a primary-primary heat exchanger 120 configured for heat exchange (e.g., recuperative heat exchange) between the high pressure stream of the primary fluid and the low pressure stream of the primary fluid. The primary-primary heat exchanger 120 includes a primary-primary inlet 122 and a primary-primary outlet 124. The primary-primary inlet 122 may be fluidly coupled to the primary supply conduit 112 to receive the high pressure stream of the primary fluid. The primary-primary outlet 124 may be fluidly coupled to a primary conduit 128 (e.g., a primary capillary tube) to deliver the primary fluid toward the distal operating tip 108.” Wherein the operating tip is seen as a cryoprobe and further seen as downstream of the primary heat exchanger) A third heater at a third heater location on a return line from the cryoablation probe. ([0071]; Ramadhyani discloses the heat exchange coils (200) surrounding the return conduit (144), which is seen as on the return line)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the cryoablation probe as disclosed by Chang with the heat exchanger located upstream from the tip and the third heated on the return line. The motivation being the use of multiple heaters for the predictable result of more predictable thermal control ([0062]) of cryo-fluid and to exchange heat with the high pressure stream ([0071]) respectively.
However, Kelly discloses: And the activation of the second heater after de-energizing the first heater. ([0040];’ Accordingly, each electrode heating element 136 may be independently controllable via its respective wire 140. As such, an operator may selectively activate or deactivate a particular heating element 136 in order to vary the resulting ablation pattern. Numerous combinations of activated heating elements are possible, so a single device may be utilized to effectuate various ablation patterns.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the cryoablation probe as disclosed by Chang with the individually activated heaters as disclosed by Kelly the motivation being to utilize various ablation patterns ([0040])
Regarding claim 2: Chang in view of Ramadhyani further in view of Kelly disclose: the system of claim 1. Chang further discloses: further comprising one or more temperature sensors coupled to the at least one computing device, wherein the at least one computing device obtains the temperature information from one or more temperature sensors. ([0075]: "The first temperature sensor 304 is arranged at the distal end of the catheter body 301 to capture temperature information of the catheter body 301". See also [0087]: "With continued reference to Fig. 3c, the electrophysiology catheter 300 further includes a second temperature sensor 307. The second temperature sensor 307 may be disposed at the proximal end of the catheter body 301 to capture temperature information of the catheter body 301")
Regarding claim 3, Chang in view of Ramadhyani further in view of Kelly disclose: The system of claim 1, Chang further discloses: wherein the first heater and the second heater each comprise a heating coil positioned s on the cryo-fluid supply located upstream of the cryoablation probe. ([0017]; “Optionally, the first heating component and/or second heating component are/is an electrical resistance wire or induction coil.“ ; [0083]; "Optionally, the second helical section 303a may be implemented as an electrical resistance wire or an induction coil, which, when energized, are able to heat a fluid in the fluid transportation pipe 305"; [Figure 3a]; Chang discloses heating location (303) and (306) to the right of the core shaft and closer to the fluid supply and is therefore, seen as upstream.)
Regarding claim 4: Chang in view of Ramadhyani further in view of Kelly disclose: the system of claim 3. Chang further discloses: wherein each heating coil is configured to send a temperature signal to the at least one computing device, the temperature signal corresponding to a temperature at the corresponding heating location on the cryo-fluid supply. ([0083] "Optionally, the second helical section 303a may be implemented as an electrical resistance wire or an induction coil, which, when energized, are able to heat a fluid in the fluid transportation pipe 305".)
Regarding claim 5, Chang in view of Ramadhyani further in view of Kelly disclose: the system of claim 4. Chang further discloses: wherein each heating coil is also configured to selectively heat a cryo-fluid in the cryo-fluid supply at the corresponding heating location. ([0083] "Optionally, the second helical section 303a may be implemented as an electrical resistance wire or an induction coil, which, when energized, are able to heat a fluid in the fluid transportation pipe 305".)
Regarding claim 7, Chang in view of Ramadhyani further in view of Kelly disclose: The system of claim 1. Chang further discloses: wherein the at least one computing device if further configured to: compare a third temperature at a third heating location to an expected third temperature, the third heating location disposed upstream of the cryoablation probe and downstream of the first heating location and the second heating location; and initiate a third heating cycle by energizing a third heater at the third heating location if the third temperature is less than the expected third temperature ([0084]: " A plurality of first temperature sensors 304 may be provided at different locations of the first helical section 305a [...] However, the number and positions of the first temperature sensors 304 may vary depending on the actual requirements, which are not limited in present application"; [Figure 3a]; Chang discloses third heating element (313) located downstream relative to first heating element (303) and second heating element (306)).
Chang does not disclose: after de- energizing the second heater.
However, Kelly discloses: And the activation of the second heater after de-energizing the first heater. ([0040];’ Accordingly, each electrode heating element 136 may be independently controllable via its respective wire 140. As such, an operator may selectively activate or deactivate a particular heating element 136 in order to vary the resulting ablation pattern. Numerous combinations of activated heating elements are possible, so a single device may be utilized to effectuate various ablation patterns.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the cryoablation probe as disclosed by Chang with the individually activated heaters as disclosed by Kelly the motivation being to utilize various ablation patterns ([0040])
Regarding claim 9, Chang in view of Ramadhyani further in view of Kelly disclose: the system of claim 1. Chang further discloses: wherein the first heating cycle comprises a first temperature profile ([0104]; Specifically, Chang teaches the heating control unit using feedback from the first temperature sensor to regulate the first heating component ensuring it stays within a predetermined range 50 degrees Celsius to 80 degrees Celsius); and the second heating cycle comprises a second heating profile, the first temperature profile and the second temperature profile being different ([0085]; Specifically, Chang teaches the heating control unit using feedback from the second temperature sensor to regulate the second heating component ensuring it stays within a predetermined range about 37 degrees Celsius).
Regarding claim 8, Chang in view of Ramadhyani further in view of Kelly disclose: The system of claim 1. Chang further discloses: wherein the second heating location is disposed upstream of the cryoablation probe. ( [Figure 3a]; Chang discloses heating location (303) and (306) to the right of the core shaft and closer to the fluid supply and is therefore, seen as upstream)
Regarding claim 12, Chang discloses: A method of sequentially heating for a cryoablation system ([Figure 6]; Chang discloses a system of cryoablation) comprising a cryoablation probe ([0090]; Chang discloses a core shaft (310)), a cryo-fluid supply coupled to the cryoablation probe ([0090]; Chang discloses the core shaft (310) attached to fluid supply pipe (305)), the plurality of heating locations comprising a first heating location (303), a second heating location (306) each located upstream of the cryoablation probe ( [Figure 3a]; Chang discloses heating location (303) and (306) to the right of the core shaft and closer to the fluid supply and is therefore, seen as upstream); and at least one computing device (110, 120, 210, 220), the method comprising: obtaining temperature information at a plurality of heating locations on the cryo-fluid supply via the at least one computing device (heating components 303, 306. See [0075]: "The first heating component 303 is disposed on the fluid transportation pipe 305, particularly at the distal end of the fluid transportation pipe 305". See also [0085]: "With continued reference to Fig. 3a, preferably, the electrophysiology catheter 300 further includes a second heating component 306 disposed on the fluid transportation pipe 305, specifically at a proximal end of the fluid transportation pipe 305 [...]") [0023]; Chang discloses a control device, which is seen as a computing device, configured to obtain temperature information from a heating component)comparing a first temperature at the first heating location to an expected first temperature ([0067]; Specifically, Chang discloses control device that uses a first temperature sensor to modulate the temperature of a heating component); initiating a first heating cycle by energizing a first heater at the first heating location if the first temperature at the first heating location is less than the expected first temperature ([0104]; Specifically, Chang discloses the heating control unit using feedback from the first temperature sensor to regulate the first heating component ensuring it stays within a predetermined range); comparing a second temperature at the second heating location to an expected second temperature, the second heating location disposed downstream of the first heating location ([0025]; Specifically, Chang discloses control device that uses a second temperature sensor to modulate a second heating component); and initiating a second heating cycle by energizing a second heater at the second heating location if the second temperature is less than the expected second temperature ([0085]; Specifically, Chang discloses the heating control unit using feedback from the second temperature sensor to regulate the second heating component ensuring it stays within a predetermined range); comparing a third temperature at a the third heating location to an expected third temperature; and initiating a third heating cycle by energizing the third heater at the third heating location if the third temperature is less than the expected third temperature. ([0105]; Chang discloses a third heater at a third heating location that uses a sensor to determine if the temperature is within a predetermined range and control the heating element to keep the surface temperature within that range)
Chang does not disclose: The activation of the second heater after de-energizing the first heater. a third at a third heater location on a return line from the cryoablation probe
However, Kelly discloses: And the activation of the second heater after de-energizing the first heater. ([0040];’ Accordingly, each electrode heating element 136 may be independently controllable via its respective wire 140. As such, an operator may selectively activate or deactivate a particular heating element 136 in order to vary the resulting ablation pattern. Numerous combinations of activated heating elements are possible, so a single device may be utilized to effectuate various ablation patterns.”) a third at a third heater location on a return line from the cryoablation probe ([0071]; Ramadhyani discloses the heat exchange coils (200) surrounding the return conduit (144), which is seen as on the return line)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the cryoablation probe as disclosed by Chang with the individually activated heaters as disclosed by Kelly the motivation being to utilize various ablation patterns ([0040])
Regarding claim 13, Chang in view of Ramadhyani further in view of Kelly disclose: the system of claim 12. Chang further discloses: further comprising one or more temperature sensors coupled to the at least one computing device, wherein the at least one computing device obtains the temperature information from one or more temperature sensors. ([0075]: "The first temperature sensor 304 is arranged at the distal end of the catheter body 301 to capture temperature information of the catheter body 301". See also [0087]: "With continued reference to Fig. 3c, the electrophysiology catheter 300 further includes a second temperature sensor 307. The second temperature sensor 307 may be disposed at the proximal end of the catheter body 301 to capture temperature information of the catheter body 301")
Regarding claim 14, Chang in view of Ramadhyani further in view of Kelly disclose: The method of claim 12. Chang further discloses: wherein the first heater and the second heater each comprise a heating coil positioned on the cryo-fluid supply. ([0017]; "Optionally, the first heating component and/or second heating component are/is an electrical resistance wire or induction coil.”)
Regarding claim 15, Chang in view of Ramadhyani further in view of Kelly disclose: The method of claim 14. Chang further discloses: wherein each heating coil is configured to send a temperature signal to at least one computing device, the temperature signal corresponding to a temperature at the corresponding location on the cryo- fluid supply. ([0085]; Specifically, Chang discloses the heating control unit using feedback at first heating component (303) and second heating component (306) to regulate the second heating component ensuring it stays within a predetermined range)
Regarding claim 16, Chang in view of Ramadhyani further in view of Kelly disclose: The method of claim 15. Chang further discloses: wherein each heating coil is also configured to selectively heat a cryo-fluid in the cryo-fluid supply at the corresponding heating location. ([0085]; Specifically, Chang discloses selective heating of heating component (303) to ablation temperatures and second heating component (306) to physiologically safe temperatures)
Regarding claim 17, Chang in view of Ramadhyani further in view of Kelly disclose: The method of claim 12. Chang does not disclose: further comprising pausing for a predetermined period of time between de-energizing the first heater and energizing the second heater.
However, Kelly discloses: And the activation of the second heater after de-energizing the first heater. ([0040];’ Accordingly, each electrode heating element 136 may be independently controllable via its respective wire 140. As such, an operator may selectively activate or deactivate a particular heating element 136 in order to vary the resulting ablation pattern. Numerous combinations of activated heating elements are possible, so a single device may be utilized to effectuate various ablation patterns.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the cryoablation probe as disclosed by Chang with the individually activated heaters as disclosed by Kelly the motivation being to utilize various ablation patterns ([0040])
Regarding claim 18, Chang in view of Ramadhyani further in view of Kelly disclose: The method of claim 12. Chang further discloses: further comprising: comparing a third temperature at a third heating location to an expected third temperature ([0036]; Chang discloses a third heating component and control of the temperature of the heating component based on temperature information), the third heating location disposed downstream of the first heating location and the second heating location ([Figure 3a]; Chang discloses a third heating location (313) that is downstream from first heating component (303) and second heating component (306); and initiating a third heating cycle by energizing a third heater at the third heating location if the third temperature is less than the expected third temperature ([0036])
Chang does not disclose: after de- energizing the second heater.
However, Kelly discloses: And the activation of the second heater after de-energizing the first heater. ([0040];’ Accordingly, each electrode heating element 136 may be independently controllable via its respective wire 140. As such, an operator may selectively activate or deactivate a particular heating element 136 in order to vary the resulting ablation pattern. Numerous combinations of activated heating elements are possible, so a single device may be utilized to effectuate various ablation patterns.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the cryoablation probe as disclosed by Chang with the individually activated heaters as disclosed by Kelly the motivation being to utilize various ablation patterns ([0040])
Regarding claim 20, Chang in view of Ramadhyani further in view of Kelly disclose: the method of claim 12. Chang further discloses: wherein the first heating cycle comprises a first temperature profile ([0104]; Specifically, Chang teaches the heating control unit using feedback from the first temperature sensor to regulate the first heating component ensuring it stays within a predetermined range 50 degrees Celsius to 80 degrees Celsius); and the second heating cycle comprises a second heating profile, the first temperature profile and the second temperature profile being different. ([0085]; Specifically, Chang teaches the heating control unit using feedback from the second temperature sensor to regulate the second heating component ensuring it stays within a predetermined range about 37 degrees Celsius).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of view of Ramadhyani further in view of Kelly further in view of Koblish et al. (US 20200107877 A1) herein referred to as “Koblish”.
Regarding claim 10, Chang in view of view of Ramadhyani further in view of Kelly disclose: the system of claim 1. Chang does not disclose: wherein the first heating cycle comprises an amplitude modulated power profile.
However, Koblish discloses: wherein the first heating cycle comprises an amplitude modulated power profile. ([0380]; Specifically, Koblish discloses the use of amplitude and pulse width profiles in ablation systems and [0384]; Specifically, Koblish discloses that the methods can be used to stimulate, modulate, heat and/or otherwise affect tissue)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to use the amplitude modulated power profile as disclosed by Koblish with first heating cycle as disclosed by Chang the motivation being amplitude and pulse width power profiles are reliable electrophysiology markers that provide useful information about the outcome of ablation (See Koblish [0380]).
Regarding claim 11, Chang in view of view of Ramadhyani further in view of Kelly disclose: the system of claim 1. Chang does not disclose: wherein the first heating cycle comprises a pulse width modulated (PWM) power profile. However, Koblish discloses: wherein the first heating cycle comprises a pulse width modulated (PWM) power profile ([0380]; Specifically, Koblish discloses the use of amplitude and pulse width profiles in ablation systems and [0384]; Specifically, Koblish discloses that the methods can be used to stimulate, modulate, heat and/or otherwise affect tissue)
Therefore, it would have been obvious to a person of ordinary skill in the before the effective filling date art of the claimed invention use the pulse width power profile as disclosed by Koblish with first heating cycle as disclosed by Chang the motivation being amplitude and pulse width power profiles are reliable electrophysiology markers that provide useful information about the outcome of ablation (See Koblish [0380]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of view of Ramadhyani further in view of Kelly further in view of Shaw (US 4206759 A) herein referred to as “Shaw”.
Regarding claim 21, Chang in view of view of Ramadhyani further in view of Kelly disclose: The system of claim 1. Chang discloses: A cryoablation probe ([Figure 3A]; (302)) Chang in view of Ramadhyani further in view of Kelly do not explicitly disclose: wherein the system comprises a vaporizer coupled to the cryoablation probe via the return line.
However, Shaw discloses: wherein the system comprises a vaporizer coupled to the cryoablation probe via the return line. ([(7)]; Shaw discloses a heat source, which is seen as a vaporizer, that is coupled to surgical probe and intakes fluid on a return line to vaporize.)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system and cryoablation probe as disclosed by Chang in view of Ramadhyani further in view of Kelly with the vaporizer coupled to surgical probe via a return line. The motivation being to control heat exchange in the probe ([(7)])
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of view of Ramadhyani further in view of Kelly further in view of Hamilton (US 5207674 A) herein referred to as “Hamilton”
Regarding claim 22, Chang in view of Ramadhyani further in view of Kelly disclose: The system of claim 1. Chang in view of Ramadhyani further in view of Kelly do not explicitly disclose: wherein the at least one computing device is further configured to determine that a thaw cycle is needed based on a received input and, in response to the determination, obtain the temperature information at the first heating location.
However, Hamiton discloses: wherein the at least one computing device is further configured to determine that a thaw cycle is needed based on a received input ([(14)]; Hamilton discloses control unit 24 used to activate a thaw cycle based on received input) and, in response to the determination, obtain the temperature information at the first heating location. ([(20)]; Hamilton discloses temperature feedback used to inform thaw cycle which is seen as obtaining temperature information at a first heating location)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system as disclosed by Chang in view of Ramadhyani further in view of Kelly with the thaw cycle as disclosed by Hamilton. The motivation being to control level of damage applied to tissue ([(14)]).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY GEORGE CHA whose telephone number is (571)272-0749. The examiner can normally be reached Monday-Friday 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CASEY GEORGE CHA/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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