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 December 2nd, 2025 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Non-Final Office Action mailed September 5th, 2025.
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 4th, 2025 is being considered by the examiner.
Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20 is missing a period at the end of line 25. Appropriate correction is required.
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.
Claims 1, 12-14, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al. (US 2023/0404663) herein referred to as “Sharma embodiment 1” and “Sharma embodiment 2” further in view of Sartler et al. (US 2020/0251984) herein referred to as “Sartler” further in view of Oskin et al. (US 20090069796 A1) herein referred to as “Oskin”.
Regarding claim 1, Sharma embodiment 1 discloses a power generator that is capable of switching between different sources of ablating energy for treating a heart rhythm disorder (a system 10, comprising a generator, 50, to generate an ablating energy to treat cardiac issues such as arrhythmias, Figure 1, Paragraphs [0035] and [0044]), the power generator comprising: a first output port configured to be coupled to a first conductive wire of a catheter for delivery of ablation energy (the system, 10, includes a plurality of catheters wherein the first catheter may be for ablation and wherein such catheter is connected by a wire to the generator, 50, via a patient interface un it, 30, Figure 1, Paragraph [0039] and [0044]-[0045]); a second conductive wire of the catheter for sensing (the system, 10, includes a plurality of catheters wherein the second catheter may be for sensing, Figure 1, Paragraph [0039] and [0044]-[0045]), a thermocouple junction formed at an electrode of the catheter (a thermocouple temperature sensor embedded in electrode, 15, Figure 2A, Paragraph [0049]), generating a waveform suitable for radiofrequency ablation (RFA) (wherein the generator, 50, may be adapted to produce a radiofrequency energy for ablation using at least one of the one or more electrodes, Figure 1, Paragraph [0044]), and a control circuit configured to receive input indicating a selected ablation modality (a patient interface unit 30, and workstation 55, for controlling the operation of the system including operating the specific ablation modality at the specific electrodes, Figure 1, Paragraphs [0044]-[0045]).
However Sharma embodiment 1 does not explicitly disclose a second output port configured to be coupled to a second wire of the catheter.
Sharma embodiment 2 discloses a second output port configured to be coupled to a second wire of the catheter (wherein the catheter may comprise a basket catheter, 600A, comprising a plurality of spines and electrodes such that there exists a second wire of a catheter that is connected at some second port, Figure 6A, Paragraph [008]).
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 Sharma embodiment 1 to incorporate the teachings of Sharma embodiment 2 by including a second output port configured to be coupled to a second wire of the catheter. The motivation to do so being to incorporate wherein the catheter may provide a plurality of electrodes wherein the electrodes may be used to deliver a RF energy or a PF energy to ablate in an area and modality as needed (Sharma, Paragraph [0068]).
However Sharma embodiment 1 in view of Sharma embodiment 2 does not explicitly disclose a first power driver and a second power driver; a switching circuit coupled to the first power driver and the second power driver, the switching circuit configured to selectively connect the first power driver or the second power driver on a selected ablation modality; and a control circuit configured to receive input indicating a selected ablation modality and to control the switching circuit to select a connection to the first power driver or the second power driver.
Sartler discloses a first power driver and a second power driver (comprising a plurality of driver circuits, 180, connected to a respective power supply, Figure 1, Paragraph [0021]); a switching circuit coupled to the first power driver and the second power driver, the switching circuit configured to selectively connect the first power driver or the second power driver on a selected ablation modality (comprising switching power supplies through the use of switching devices according to switching control signal 162a and 166a, Figure 1, Paragraph [0018]); and a control circuit configured to receive input indicating a selected ablation modality and to control the switching circuit to select a connection to the first power driver or the second power driver (wherein the switching signals, 162a and 166a, that switch power supply is controlled by control terminals, Figure 1, Paragraph [0018]).
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 Sharma embodiment 1 in view of Sharma embodiment 2 to incorporate the teachings of Sartler by including a first power driver and a second power driver; a switching circuit coupled to the first power driver and the second power driver, the switching circuit configured to selectively connect the first power driver or the second power driver on a selected ablation modality; and a control circuit configured to receive input indicating a selected ablation modality and to control the switching circuit to select a connection to the first power driver or the second power driver. The motivation to do so being to be able to have a plurality of power source or drivers and also have the means to be able to switch between these options (Sartler, Paragraph [0003]).
Further Sharma embodiment 1 in view of Sharma embodiment 2 does not explicitly disclose wherein the thermocouple junction is formed by dissimilar metals to form the thermocouple junction. However this limitation is a product by process limitation and therefore holds no patentable weight. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698; 227 USPQ 964, 966 (Fed. Cir. 1985).
Further Sharma embodiment 1 in view of Sharma embodiment 2 does not explicitly disclose an in-line resistive isolator carried in part of a sensing circuit that includes the thermocouple junction, the isolator configured to provide electrical isolation for the sensing circuit from ablation energy surge.
Oskin discloses an ablation system (Abstract) wherein the system includes an in-line resistive isolator carried in part of a sensing circuit (line filter 82, Figure 7, Paragraph [0033]) that includes the thermocouple junction (thermistor, Paragraph [0039]), the isolator configured to provide electrical isolation for the sensing circuit from ablation energy surge (the line filter 82 treats the power to, for example, eliminate surges, harmonic transient currents, spike etc. in the current being delivered to the console 4, Paragraph [0033]).
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 Sharma embodiment 1 in view of Sharma embodiment 2 to incorporate the teachings of Oskin by including a an in-line resistive isolator carried in part of a sensing circuit that includes the thermocouple junction, the isolator configured to provide electrical isolation for the sensing circuit from ablation energy surge. The motivation to do so being to eliminate surges, harmonic transient currents, spikes etc., in the current being delivered to the console (Oskin, Paragraph [0033]).
Regarding claim 12, Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin discloses the power generator of claim 1.
However Sharma embodiment 1 in view of Sharma embodiment 2 does not explicitly disclose wherein the control circuit comprises a processor that is associated with firmware instructions, wherein the instructions, when executed, cause the processor to dynamic control a switching of PFA and RFA based on detected signals.
Sartler discloses wherein the control circuit comprises a processor that is associated with firmware instructions, wherein the instructions, when executed, cause the processor to dynamic control a switching of PFA and RFA based on detected signals (the power conversion system 110 also includes switch power supplies 170 and driver circuits 180 coupled to the respective switch circuits of the rectified 130 and the inverter 150 to deliver drive signals to control terminals of the switching devices S1-S6 and S7-S12 according the switching control signals 162a and 166a, Paragraph [0018], the individual driver circuits 180 receive one or two switching control signals from the controller 160, Paragraph [0018]).
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 Sharma embodiment 1 in view of Sharma embodiment 2 to incorporate the teachings of Sartler by including wherein the control circuit comprises a processor that is associated with firmware instructions, wherein the instructions, when executed, cause the processor to dynamic control a switching of PFA and RFA based on detected signals. The motivation to do so being to be able to operate high and low side switches associated with a given phase of corresponding AC nodes (Sartler, Paragraph [0018]).
Regarding claim 13, Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin discloses the power generator of claim 1.
Sharma embodiment 1 further discloses wherein the control circuit is configured to deliver alternating RFA and PFA waveforms to adjacent electrodes on the catheter within a coordinated time sequence to generate hybrid lesions (the RF signals and the high voltage pulse can be applied either sequentially or simultaneously to the organ tissue, Paragraph [0059], RF signals can be generated using alternating current (AC) and the PF signals can be generated using direct current (DC), another example can have both signals generated at the same time or at least having some overlap of application of the RF and PF signals (seen as a coordinated time sequence), Paragraph [0066] and [0063]-[0064]).
Regarding claim 14, Sharma embodiment 1 in view of Sharma embodiment 2 and Sartler discloses the power generator of claim 1.
Sharma embodiment 1 discloses wherein each electrode of the catheter is electrically connected to both an ablation energy delivery path and a sensing circuit configured to detect temperature using a thermocouple (the electrode assembly 15 serves to deliver ablative energy from the ablation generator 50 to the desired ablation site, the electrode assembly 15 and ring electrodes can be made from noble metals, in some embodiments the catheter 14 can also include six thermocouple temperature sensors that are embedded in the tip electrode 15, Paragraph [0049]).
Regarding claim 19, Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin discloses the power generator of claim 1.
Sharma embodiment 1 further discloses wherein the control circuit is configured to coordinate timing of activation among the distributed power driver modules to reduce simultaneous peak current load and improve thermal efficiency (the RF signals and the high voltage pulses can be applied either sequentially or simultaneously to the organ tissue (seen as coordinating timing of activation among the power driver modules), Paragraph [0059] and [0066]).
Regarding claim 20, Sharma embodiment 1 discloses a system for treating a heart rhythm disorder (a system, 10, to treat cardiac issues such as arrhythmias, Figure 1, Paragraph [0035]), the system comprising: a power generator for generating ablating energy (a system, 10, comprising a generator, 50, to generate an ablating energy, Figure 1, Paragraphs [0035] and [0044]) the power generator comprising: a first output port (the system 10 includes a plurality of catheters wherein the first catheter may be for ablation and wherein such catheter is connected by a wire to the generator 50, may be adapted to produce radiofrequency energy for ablation using at least one of the one or more electrodes, Figure 1, Paragraph [0044]); generating a waveform suitable for pulsed field ablation (PFA) (wherein the generator 50 may be adapted to produce a pulsed-field energy for ablation using at least one of the one or more electrodes, Figure 1, Paragraph [0044]); and a control circuit configured to receive input indicating a selected ablation modality (a patient interface unit, 30, and workstation, 55, for controlling the operation of the system including operating the specific ablation modality at the specific electrodes, Figure 1, Paragraph [0044]-[0045]); and a catheter configured to be connectable to the generator (wherein the catheter is connected to the generator, Paragraph [0047]), the catheter comprising: a first conductive wire to be coupled to the first output port for delivery of ablation energy (the system 10 includes a plurality of catheters wherein the first catheter may be for ablation and wherein such catheter is connected by a wire to the generator 50 via a patient interface unit 30, Figure 1, Paragraphs [0039] and [0044]-[0045]); and a second conductive wire of a catheter for sensing (the system 10 includes a plurality of catheters wherein the second catheter may be for sensing; Figure 1, Paragraph [0039]-[0044]-[0045]); a thermocouple junction formed at an electrode of the catheter (a thermocouple temperature sensor embedded in electrode 15, Figure 2A, Paragraph [0049]).
However Sharma embodiment 1 does not explicitly disclose a second output port configured to be coupled to a to a second wire of the catheter.
Sharma embodiment 2 discloses a second output port configured to be coupled to a to a second wire of the catheter (wherein the catheter may comprise a basket catheter, 600A, comprising a plurality of spines and electrodes such that there exists a second wire of a catheter that is connected at some second port, Figure 6A, Paragraph [0068]).
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 Sharma embodiment 1 to incorporate the teachings of Sharma embodiment 2 by including a second output port configured to be coupled to a second wire of the catheter. The motivation to do so being to incorporate wherein the catheter may provide a plurality of electrodes wherein the electrodes may be used to deliver a RF energy or a PF energy to ablate in an area and modality as needed (Sharma, Paragraph [0068]).
However Sharma embodiment 1 in view of Sharma embodiment 2 does not explicitly disclose a first power driver and a second power driver; a switching circuit coupled to the first power driver and the second power driver, the switching circuit configured to selectively connect the first power driver or the second power driver on a selected ablation modality; and a control circuit configured to receive input indicating a selected ablation modality and to control the switching circuit to select a connection to the first power driver or the second power driver.
Sartler discloses a first power driver and a second power driver (comprising a plurality of driver circuits, 180, connected to a respective power supply, Figure 1, Paragraph [0021]); a switching circuit coupled to the first power driver and the second power driver, the switching circuit configured to selectively connect the first power driver or the second power driver on a selected ablation modality (comprising switching power supplies through the use of switching devices according to switching control signal 162a and 166a, Figure 1, Paragraph [0018]); and a control circuit configured to receive input indicating a selected ablation modality and to control the switching circuit to select a connection to the first power driver or the second power driver (wherein the switching signals, 162a and 166a, that switch power supply is controlled by control terminals, Figure 1, Paragraph [0018]).
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 Sharma embodiment 1 in view of Sharma embodiment 2 to incorporate the teachings of Sartler by including a first power driver and a second power driver; a switching circuit coupled to the first power driver and the second power driver, the switching circuit configured to selectively connect the first power driver or the second power driver on a selected ablation modality; and a control circuit configured to receive input indicating a selected ablation modality and to control the switching circuit to select a connection to the first power driver or the second power driver. The motivation to do so being to be able to have a plurality of power source or drivers and also have the means to be able to switch between these options (Sartler, Paragraph [0003]).
Further Sharma embodiment 1 in view of Sharma embodiment 2 does not explicitly disclose wherein the thermocouple junction is formed by dissimilar metals to form the thermocouple junction. However this limitation is a product by process limitation and therefore holds no patentable weight. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698; 227 USPQ 964, 966 (Fed. Cir. 1985).
Further Sharma embodiment 1 in view of Sharma embodiment 2 does not explicitly disclose an in-line resistive isolator carried in part of a sensing circuit that includes the thermocouple junction, the isolator configured to provide electrical isolation for the sensing circuit from ablation energy surge.
Oskin discloses an ablation system (Abstract) wherein the system includes an in-line resistive isolator carried in part of a sensing circuit (line filter 82, Figure 7, Paragraph [0033]) that includes the thermocouple junction (thermistor, Paragraph [0039]), the isolator configured to provide electrical isolation for the sensing circuit from ablation energy surge (the line filter 82 treats the power to, for example, eliminate surges, harmonic transient currents, spike etc. in the current being delivered to the console 4, Paragraph [0033]).
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 Sharma embodiment 1 in view of Sharma embodiment 2 to incorporate the teachings of Oskin by including a an in-line resistive isolator carried in part of a sensing circuit that includes the thermocouple junction, the isolator configured to provide electrical isolation for the sensing circuit from ablation energy surge. The motivation to do so being to eliminate surges, harmonic transient currents, spikes etc., in the current being delivered to the console (Oskin, Paragraph [0033]).
Claims 2 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin further in view of Iasiello “Effects of Pulsed Radiofrequency Source on Cardiac Ablation” herein referred to as Iasiello (see attached).
Regarding claim 2, Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin discloses the power generator of claim 1.
Sharma embodiment 1 discloses wherein the first power driver is configured to generate a frequency in a range from 100 kHz to 10 MHz (the radiofrequency signals may have a frequency of approximately 350 kHz to approximately 500 kHz (falls within the specified range), Paragraph [0061]).
However Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin does not explicitly disclose a continuous or modulated sinusoidal waveform.
Iasiello discloses a continuous or modulated sinusoidal waveform (wherein ablation procedures may utilize a pulsed or continuous models using functions like sine waves, wherein using a modulated wave may also pose some benefits, Figure 2, Page 2, Paragraphs 2-3, see attached).
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 Sharma embodiment 1 in view of Sharma embodiment 2 and Sartler to incorporate the teachings of Iasiello by including a continuous or modulated sinusoidal waveform. The motivation to do so being to be able to use a continuous wave for a radiofrequency ablation or a pulsed ablation that may use a modulated wave as both pose different potential benefits (Iasiello, Page 2, Paragraphs 2-3, see attached).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin further in view of Viswanathan et al. (US 2017/0189097) herein referred to as Viswanathan.
Regarding claim 3, Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin discloses the power generator of claim 1.
Sharma embodiment 1 discloses wherein the second power driver is configured to generate pulsed waveforms (wherein the system may provide therapy via pulsed field ablation energy which would comprises generating pulsed waveform, Paragraph [0044]).
However Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin does not explicitly disclose wherein the second power driver is configured to generate pulsed waveforms having a voltage amplitude in a range from 500 volts to 5000 volts and a pulse duration in a range from 0.5 microseconds to 100 microseconds.
Viswanathan discloses a power driver configured to generate pulsed waveforms having a voltage amplitude in a range from 500 volts to 5000 volts and a pulse duration in a range from 0.5 microseconds to 100 microseconds (wherein a pulsed waveform for an ablation device comprises a voltage within a range including about 400 volts to about 5000 volts and a pulse duration within a range including about 0.5 microseconds to 100 microseconds, Paragraph [0042], and claims 2 and 5).
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 Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin to incorporate the teachings of Viswanathan by including wherein the power driver is configured to generate pulsed waveforms having a voltage amplitude in a range from 500 volts to 5000 volts and a pulse duration in a range from 0.5 microseconds to 100 microseconds. The motivation to do so being to be able to use useful ranges of voltage amplitudes and pulse durations that are useful for an ablation procedure (Iowa, Paragraphs [0019] and [0042]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin as evidenced by Linhart et al. (US 2018/0103991) herein referred to as Linhart.
Regarding claim 4, Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin discloses the power generator of claim 1.
However Sharma embodiments 1 and 2 do not explicitly disclose wherein the switching circuit is capable of switching signals with voltages up to 5000 volts and currents up to 5 amps.
Sartler discloses wherein the switching circuit is capable of switching signals with voltages and currents (comprising switching power supplies through the use of switching devices according to switching control signal 162a and 166a and wherein power comprises voltages and currents, Figure 1, Paragraphs [0018] and [0031]).
However Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin does not explicitly disclose voltages up to 5000 volts and currents up to 5 amps.
However, it would have been obvious to one of ordinary skill in the art prior to the relevant date to have optimized the device to be able to switch between voltages up to 5000 volts and currents up to 5 amps, as evidenced by Linhart in order to provide a range of operation values, including voltages and currents, in order to be able to address a range of applications such as healing a tissue (Linhart, Paragraphs [0017]-[0019], [0061] and [0088]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the relevant date to have modified the power generator of Sharma embodiment 1 in view of Sharma embodiment 2 wherein the switching circuit is capable of switching signals with voltages up to 5000 volts and currents up to 5 amps as disclosed by Sartler in order to be able to have a plurality of power sources or drivers and also have the means to be able to switch between these options (Sartler, Paragraph [0003]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin further in view of Krimsky et al. (US 2020/0398048) herein referred to as Krimsky.
Regarding claim 5, Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin discloses the power generator of claim 1.
Sharma embodiment 1 discloses a workstation 55 for controlling operation of the system 10 with a user interface capability (Paragraph [0045-0046]). However Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin does not explicitly disclose wherein the control circuit is configured to receive the selected ablation modality via a user interface configured to receive physician input.
Krimsky discloses a device configured to transmit energy to a body in the form of pulsed electric fields (Abstract) wherein the control circuit is configured to receive the selected ablation modality via a user interface configured to receive physician input (the generator 104 includes a user interface 150, Paragraph [0078], the user interface 150 can include a touch screen to allow for the operator to enter patient data, select a treatment algorithm, initiate energy delivery etc., Paragraph [0081], the user interface 150 is configured to receive operator-defined inputs, the operator-defined inputs can include a duration of energy delivery, one or more other timing aspects of the energy delivery pulse, power, and/or mode of operation, wherein the modes of operation include: energy delivery, algorithm selection, Paragraph [0082]).
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 Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin to incorporate the teachings of Krimsky by including wherein the control circuit is configured to receive the selected ablation modality via a user interface configured to receive physician input. The motivation to do so being to be able to allow for the operator to communicate with the generator to control energy delivery (Krimsky, Paragraphs [0081]-[0082]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin further in view of Hegde et al. (US 2002/0188289) herein referred to as Hegde.
Regarding claim 6, Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin discloses the power generator of claim 1.
However Sharma embodiment 1 in view of Sharma embodiment 2 and Sartler does not explicitly disclose wherein the control circuit is configured to automatically select the ablation modality based on real-time data from sensing elements indicating tissue temperature.
Hegde discloses an expandable electrode body used in ablating body tissue (Paragraph [0001]) wherein the control circuit is configured to automatically select the ablation modality based on real-time data from sensing elements indicating tissue temperature (the controller 140 may be associated with the RF generator 130, tissue temperature and/or additional temperatures sensed by the one or more temperature sensors are processed by the controller 140, based upon temperature input the controller 140 may adjust the time and power level of the RF energy transmissions by the RF generator 130, Paragraph [0024]).
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 Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin to incorporate the teachings of Hegde by including wherein the control circuit is configured to automatically select the ablation modality based on real-time data from sensing elements indicating tissue temperature. The motivation to do so being to adjust the time and power level of the generator in order to achieve desired lesion patterns and other ablation objectives (Hegde, Paragraph [0024]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin further in view of Suwalski et al. (US 20230065381) herein referred to as Suwalski.
Regarding claim 7, Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin discloses the power generator of claim 1.
However Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin does not explicitly disclose wherein the generator further comprises a signal processing module configured to measure voltage at the second output port and calculate temperature at the thermocouple junction based on a sensed millivolt signal in a range from 0.1 mV to 50 mV.
Suwalski discloses a cryoprobe for minimally invasive cardiac ablation (Abstract) wherein the generator further comprises a signal processing module configured to measure voltage at the second output port and calculate temperature at the thermocouple junction based on a sensed millivolt signal in a range from 0.1 mV to 50 mV (the temperature measuring system 6 consists of a thermocouple, e.g., type K, the system 6 measures the voltage of the thermocouple connector, the type K thermocouple connector receives connector voltage of approx. 16.5 mV for living tissue with a temperature of approx.. 36 C and approx. -20 mV for a temperature of -80C, assumed in the embodiment as the ablation temperature of the tissue, Paragraph [0038]).
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 Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin to incorporate the teachings of Suwalski by including wherein the generator further comprises a signal processing module configured to measure voltage at the second output port and calculate temperature at the thermocouple junction based on a sensed millivolt signal in a range from 0.1 mV to 50 mV. The motivation to do so being to calculate the temperature based on the measured voltage (Hegde, Paragraph [0038]).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin further in view of Dando et al. (US 20080161788) herein referred to as Dando.
Regarding claim 8, Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin discloses the power generator of claim 1.
However Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin does not explicitly disclose wherein the generator further comprises a signal isolation circuit comprising a resistive element having a resistance value in a range from 10 kilo-ohms to 1 mega- ohm and electrically coupled in series with a thermocouple wire.
Dando discloses wherein the generator further comprises a signal isolation circuit comprising a resistive element having a resistance value in a range from 10 kilo-ohms to 1 mega- ohm and electrically coupled in series with a thermocouple wire (at the input to the temperature discriminator 80’, resistors 181a, 181b, and 181n respectively function as a low pass filter for each input to remove high frequency noise from the input signal, in one example the resistors are 10K ohms, Figure 12 shows the resistors in series with thermocouples T1, T2, and Tn, Paragraph [0089]).
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 Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin to incorporate the teachings of Dando by including wherein the generator further comprises a signal isolation circuit comprising a resistive element having a resistance value in a range from 10 kilo-ohms to 1 mega- ohm and electrically coupled in series with a thermocouple wire. The motivation to do so being to remove high frequency noise from the input signal (Dando, Paragraph [0089]).
Regarding claim 9, Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin discloses the power generator of claim 8.
However Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin does not explicitly disclose wherein the resistive element is located within a catheter handle, within a catheter shaft, or within the housing of the power generator.
Dando discloses wherein the resistive element is located within a catheter handle, within a catheter shaft, or within the housing of the power generator (a temperature discriminator 80 is interposed between an array of remote thermocouple junction T1, T2, Tn, temperature sensors (e.g., located in the ablation electrode section 20 described above) and a temperature feedback input 85 of a radiofrequency generator 84 (seen as being located within catheter shaft in order to be connected to temperature sensors), Figures 10-12, Paragraph [0075]).
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 Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin to incorporate the teachings of Dando by including wherein the resistive element is located within a catheter handle, within a catheter shaft, or within the housing of the power generator. The motivation to do so protect the components from any damage (Dando, Paragraph [0075]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin further in view of Ibrahim et al. (US 20120123411) herein referred to as Ibrahim.
Regarding claim 10, Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin discloses the power generator of claim 1.
However Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin does not explicitly disclose wherein the control circuit is configured to alternate the ablation modality between the first power driver and the second power driver within a time interval in a range from 1 millisecond to 2 minutes.
Ibrahim discloses a surgical system for delivering an ablation treatment (Abstract) wherein the control circuit is configured to alternate the ablation modality between the first power driver and the second power driver within a time interval in a range from 1 millisecond to 2 minutes (ESU can be configured to automatically change modes, wherein switching may occur at 15 second intervals or faster, in some instances, switching may occur as fast as 0.1 second intervals, Paragraph [0128]).
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 Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin to incorporate the teachings of Ibrahim by including wherein the control circuit is configured to alternate the ablation modality between the first power driver and the second power driver within a time interval in a range from 1 millisecond to 2 minutes. The motivation to do so being to switch rapidly between ablation mode during a single ablation application (Ibrahim, Paragraph [0128]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin further in view of Henderson et al. (US 20200078119) herein referred to as Henderson.
Regarding claim 11, Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin discloses the power generator of claim 1.
However Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin does not explicitly disclose wherein the power generator includes a modular architecture comprising a plurality of independent power driver modules each configured to deliver RFA or PFA to an individual electrode of the catheter.
Henderson discloses a modular surgical system (Abstract) wherein the power generator includes a modular architecture comprising a plurality of independent power driver modules each configured to deliver RFA or PFA to an individual electrode of the catheter (aspects of the present disclosure include a first energy-generator module, and a second energy-generator module, Paragraphs [0110]-[0111], the generator module 140 may comprise a serious of monopolar, bipolar, and/or ultrasonic generator modules, Paragraph [0113], the control circuit 760 controls the delivery of the RF energy to the RF electrode 796, Paragraph [0234], [0241])
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 Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin to incorporate the teachings of Henderson by including wherein the power generator includes a modular architecture comprising a plurality of independent power driver modules each configured to deliver RFA or PFA to an individual electrode of the catheter. The motivation to do so being to being to be able to deliver multiple energy modalities to a surgical instrument (Henderson, Paragraph [0241]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin further in view of Wiener et al. (US 20190207911) herein referred to as Wiener.
Regarding claim 15, Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin discloses the power generator of claim 1.
However Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin does not explicitly disclose wherein the generator further comprises an isolation circuit configured to electrically isolate patient-contacted electrodes from the control electronics during delivery of pulsed field ablation.
Wiener discloses wherein the generator further comprises an isolation circuit configured to electrically isolate patient-contacted electrodes from the control electronics during delivery of pulsed field ablation (patient isolated circuit is provided through an interface circuit 920, Paragraph [0298]).
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 Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin to incorporate the teachings of Wiener by including wherein the generator further comprises an isolation circuit configured to electrically isolate patient-contacted electrodes from the control electronics during delivery of pulsed field ablation. The motivation to do so being to being to provide an input/output communications between the processor and the interface circuit (Wiener, Paragraph [0298]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin further in view of Stevenson et al. (US 20100023000) herein referred to as Stevenson.
Regarding claim 16, Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin discloses the power generator of claim 1.
However Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin does not explicitly disclose wherein the signal path associated with the second output port includes one or more transient voltage suppression diodes configured to suppress voltage transients.
Stevenson discloses decoupling circuits for transferring energy from an MRI pulsed RF field to an energy dissipating surface (Abstract) wherein the signal path associated with the second output port includes one or more transient voltage suppression diodes configured to suppress voltage transients (transient voltage suppressors 152 and 152’ are nonlinear circuit elements, bypass any high voltage induced current such that these currents not flow through the relatively sensitive bandstop passive component inductor and capacitor elements, Figure 52, Paragraph [0198]).
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 Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin to incorporate the teachings of Stevenson by including wherein the signal path associated with the second output port includes one or more transient voltage suppression diodes configured to suppress voltage transients. The motivation to do so being to be able bypass any high voltage induced current such that these currents do not flow through the relatively sensitive bandstop passive component inductor and capacitor elements (Stevenson, Paragraph [0198]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin further in view of O’ Boyle et al. (US 20030208252) herein referred to as Boyle.
Regarding claim 17, Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin discloses the power generator of claim 1.
However Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin does not explicitly disclose wherein the generator further comprises a filtering circuit coupled to the second output port, the filtering circuit comprising low-pass filters configured to attenuate electromagnetic interference from ablation pulses.
Boyle discloses an ablation catheter (Abstract) wherein the generator further comprises a filtering circuit coupled to the second output port, the filtering circuit comprising low-pass filters configured to attenuate electromagnetic interference from ablation pulses (a technical limitation of radio frequency energy delivery and electrophysiologic signal acquisition in the scanner is electromagnetic interference, to overcome this problem, special RF filters and shielding were designed and constructed to suppress these harmonic signals and permit simultaneous RF ablation and electrophysiological monitoring during imaging, these multi-stage, low-pass filters consist of an arrangement of non-magnetic electrical components, the output of the generator is directed to the ablation catheter through these fully shielded filter assemblies, Paragraph [0064]).
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 Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin to incorporate the teachings of Boyle by including wherein the generator further comprises a filtering circuit coupled to the second output port, the filtering circuit comprising low-pass filters configured to attenuate electromagnetic interference from ablation pulses. The motivation to do so being to be able overcome the problem of electromagnetic interference which results in signal degradation (Boyle, Paragraph [0064]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin further in view of Simpson et al. (US 6049737) herein referred to as Simpson.
Regarding claim 18, Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin discloses the power generator of claim 1.
However Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin does not explicitly disclose wherein the generator comprises distributed power drivers configured to independently control ablation energy delivery to at least four separate electrodes.
Simpson discloses wherein the generator comprises distributed power drivers configured to independently control ablation energy delivery to at least four separate electrodes (the single microprocessor 42, which again is part of the controller 20, controls the duty cycle and the phase of each channel individually in this embodiment, this multi-channel approach permits more individual control over each electrode, for example, the duty cycle of the power applied to each electrode can be individually controlled, Col. 10, lines 4-16).
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 Sharma embodiment 1 in view of Sharma embodiment 2, Sartler, and Oskin to incorporate the teachings of Simpson by including wherein the generator comprises distributed power drivers configured to independently control ablation energy delivery to at least four separate electrodes. The motivation to do so being to be able to have more individual control over each electrode (Simpson, Col. 10, lines 12-13).
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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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794