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. Applicant’s amendments to the claims have overcome the claim objections and 112(b) rejections previously set forth in the Non-Final Rejection mailed September 11th, 2025.
Response to Arguments
Applicant’s arguments, see pages 9-10, filed December 2nd, 2025, with respect to the rejection(s) of claim(s) 1 and 11 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art that teaches the newly disclose claim limitations.
Regarding Applicant’s arguments on pages 8-9 with respect to the 112(b) rejection of claim 5, these arguments are found persuasive and the rejection is withdrawn.
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.
Claims 1, 3-4, 6-8, 11, 15-17 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (U.S. Pub. No. 20230371836, earliest effective filing date & previously cited), in view of Altmann et al. (U.S. Pub. No. 20210186604, cited in IDS), herein referred to as “Altmann” and Ryu et al. (U.S. Pub. No. 20120172867), herein referred to as “Ryu”.
Regarding claim 1, Govari discloses a medical treatment apparatus (Abstract: A medical apparatus), comprising:
a catheter (electroporation catheter 26) having a plurality of electrodes configured to deliver pulsed electric field (PEF) energy to a target tissue in a heart ([0017]: Distal assembly 30 comprises a basket 32 with electroporation electrodes 34 distributed along the spines of the basket; see Fig. 1 where the tissue is that of a heart) and further configured for taking therapy assessment measurements in the target tissue including a first measurement and a second measurement ([0019]: controller 42 may measure the impedance between two selected electrodes 34; [0032]: FIG. 2 is a schematic view of window 59 on display screen 58 of apparatus 20, illustrating a method for computing an ablation index from an impedance integral; wherein Fig. 2/the impedance integral includes taking multiple measurements and Fig. 2 shows both temperature and impedance measurements);
a tracking system configured to track a position of a selected electrode of the plurality of electrodes or of a selected tracking element ([0022]: Controller 42 may be further configured to track the respective positions of electrodes 34 during the IRE procedure, using any suitable tracking technique. For example, distal assembly 30 may comprise one or more electromagnetic position sensors (not shown) … for each electrode 34, controller 42 may ascertain the respective impedances between the electrode and multiple external electrodes 56 coupled to the body surface of patient 24 at various different locations, and then compute the location of electrode 34 within heart 27 based on the ratios between these impedances); and
a processing circuit (controller 42) configured to estimate a therapeutic effect of the PEF-energy delivery based on the first measurement, the second measurement,
wherein the first measurement is taken prior to the respective time instance of PEF-energy delivery; and wherein the second measurement is taken after the respective time instance of PEF-energy delivery ([0034]: Controller 42 initially measures a steady-state impedance value 122, defined as the steady-state impedance before the start of the ablation, i.e., before time T.sub.s. Controller 42 continually computes an integral I(t) of the difference between curve 110 and steady-state impedance value 122 up to the present time t. Controller 42 converts the integral I(t) into a suitable ablation index value, for example normalizing or otherwise scaling the present value of the integral, and displays the ablation index in a text box 120 to be viewed by physician 22; wherein integrating over time includes a time instance for which the integral is integrated).
While Govari discloses a tracking system, Govari fails to explicitly disclose a tracking system configured to track a position of a selected electrode of the plurality of electrodes or of a selected tracking element to determine a first displacement of the plurality of electrodes with respect to the target tissue between the first measurement and a respective time instance of PEF-energy delivery and a second displacement of the plurality of electrodes with respect to the target tissue between the respective time instance of PEF-energy delivery and the second measurement; and
a processing circuit configured to estimate a therapeutic effect of the PEF-energy delivery based on the first displacement and the second displacement.
However, Altmann discloses a medical treatment apparatus (Abstract: A method includes, using a probe), comprising:
a tracking system ([0029]: processor 46 typically tracks a location and an orientation of distal end 22 of the probe) configured to track a position of a selected electrode of the plurality of electrodes or of a selected tracking element to determine a first displacement of the plurality of electrodes with respect to the target tissue between a respective time instance of PEF-energy delivery and a second displacement of the plurality of electrodes with respect to the target tissue between the respective time instance of PEF-energy delivery ([0023]: a physician irreversibly electroporates tissue with a catheter over a time period to form a lesion in the tissue. During the time period measurements are made of a contact force applied by the catheter and the irreversibly electroporative power used for the tissue; [0045]: FIGS. 2A, 2B, and 2C are schematic graphs of force, power, depth, and FTP_IRE vs. time, according to an embodiment of the present invention. The graphs illustrate how estimated depth and the IRE index may look when both the power and the force change. The graph of IRE index vs. time shows that the estimated IRE index is designed to increase linearly with duration of IRE treatment; wherein these graphs include tracking a probe position over instances of energy delivery and time & see Fig. 1 where the target tissue is that in a heart); and
a processing circuit (processor 46) configured to estimate a therapeutic effect of the PEF-energy delivery based on the first displacement and the second displacement ([0050]: In a calculation step 106, as the IRE treatment proceeds, processor 46 calculates, on a recurring basis, the value of the integral used in Eq. 5, i.e., the value of ablation index I.sub.FTP_IRE in Eq. 9. In an IRE index estimation step 108, the processor calculates a value of the estimated IRE index, using equation Eq. 9; see equation 5 in [0039], equation 9 in [0044] and where both include the variable CF, the contact force, and time components, wherein the contact force measurements are seen as multiple displacement measurements). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the medical treatment apparatus of Govari to include the tracking system and processing circuit of Altmann for the purpose of enabling adjustment of the theoretical fields displayed by taking into account the IRE index, or the contact force of the electrodes with the cells, and/or the proximity of the cells to the electrodes, by providing an IRE index, a catheter-based IRE treatment can be made safer and more effective (Altmann: [0024-[0025]).
While Altmann discloses contact force over time, which in a heart would include cyclic cardiac motion, Govari in view of Altmann fail to explicitly disclose wherein each of the first displacement and the second displacement is caused at least in part by cyclic motion of the heart.
However, Ryu discloses:
a processing circuit configured to estimate a therapeutic effect of the PEF-energy delivery based on the first measurement, the second measurement, the first displacement, and the second displacement, wherein each of the first displacement and the second displacement is caused at least in part by cyclic motion of the heart ([0029]: ECU 28 may also use the information to generate contractility or volumetric indices including, for example, peak velocity of one or more sensors 40, 42, 46 to indicate how quickly or forcefully heart 12 is contracting, peak excursion (distance) (absolute or along a tomographic direction such as radial) of sensors 40, 42, 46 in contact with heart 12 to indicate an amount of ejection, changes in position of sensors 40, 42, 46 or distance between sensors 40, 42, 46 at points in time gated to end diastole and/or end systole to estimate heart chamber dimension, chamber volume, stroke volume and/or ejection fraction, and indices of synchrony or dyssyncrony derived from correlation or coordination of motion among multiple sensors 40, 42, 46 in contact with heart 12; [0031]: The position of position sensors 40 may be monitored over a period of time encompassing periods before, during and after ablation is performed near the ostium 62. Prior to the delivery of ablation energy, the tissue with which position sensors 40 are in contact will exhibit at least some movement. If the ablation near the ostium 62 is successfully carried out, however, the electrical pathway between the pulmonary vein 56 and the left atrium 58 should be severed thereby eliminating or reducing motion of the tissue in pulmonary vein 56 distal of the ostium 62. Position sensors 40 in contact with this tissue will therefore indicate a relatively constant output (corrected for general patient and respiratory movement) indicative of a lack of motion during the cardiac cycle. ECU 28 may determine whether the movement of sensors 40 is less than a threshold amount and provide an indicator of the electrical conductivity in the tissue).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the processor of Govari in view of Altmann to include the processor of Ryu for the purpose of assessing the impact of ablation therapy during or after administration of the therapy, enabling a clinician to better assess the efficacy and safety of ablation therapy, and the motion of the position sensors is used to infer motion of the cardiac tissue and this motion is used to assess the impact of ablation therapy on a variety of characteristics associated with the heart, including tissue motion, blood flow velocity, electrical conductivity and changes to the blood, that are affected by ablation therapy and are indicative of the success or failure of that therapy and risks associated with that therapy (Ryu: [0010], [0042])
Regarding claim 3, Govari discloses wherein the first measurement includes a first impedance measurement using a first electrode pair of the plurality of electrodes and a second impedance measurement using a second electrode pair of the plurality of electrodes; and wherein the second measurement includes a third impedance measurement using the first electrode pair and a fourth impedance measurement using the second electrode pair ([0014]: This measurement provides an indication of the impedance of the ablated tissue. (Alternatively or additionally, the electrical impedance may be measured between pairs of IRE electrodes.); [0023]: Controller 42 displays on display screen 58 a window 59, showing the impedance measured over time between one or more pairs of electrodes 34, as well as an ablation index computed on the basis of the measured impedance; [0031]: Controller 42 measures the electrical impedance between pairs of electrodes 34 and computes an ablation index based on this measured impedance. Controller 42 outputs the ablation index to window 59 on display screen 58; wherein as shown in Fig. 2, impedance is tracked over time such that for each time instance shown in Fig. 2, multiple impedance measurements may be made between pairs of IRE electrodes such that this is seen as four impedance measurements corresponding to electrode pairs).
Regarding claim 4, Govari discloses wherein the first measurement includes a first temperature measurement and a first impedance measurement; and wherein the second measurement includes a second temperature measurement and a second impedance measurement ([0033]: Graphic display 102 comprises a curve 110 showing the impedance measured by controller 42 as a function of measurement time, and a curve 112 showing a temperature measured by controller 42 as a function of time; wherein this graph displays a first temperature measurement, a first impedance measurement, a second temperature measurement and a second impedance measurement).
Regarding claim 6, Govari discloses a waveform generator (IRE pulse generator 44) in electrical communication with the plurality of electrodes to apply thereto a sequence of pulses of the PEF energy ([0018]: Catheter 26 is connected to console 46 via an electrical interface 48, such as a port or socket, through which IRE pulses are carried from IRE pulse generator 44 to distal assembly 30; [0028]: IRE pulse generator 44 generates IRE pulses, which are carried through catheter 26 over different respective electrical channels (not shown) to electroporation electrodes 34), wherein the processing circuit is further configured to estimate the therapeutic effect based on a time delay between a pair of consecutive pulses of the PEF energy in the sequence of pulses ([0014]: During the ablation, the impedance may be sensed during the IRE pulse trains, as well as between the trains; [0034]: Controller 42 converts the integral I(t) into a suitable ablation index value, for example normalizing or otherwise scaling the present value of the integral, and displays the ablation index in a text box 120 to be viewed by physician 22).
Regarding claim 7, Govari discloses wherein the processing circuit is further configured to estimate the therapeutic effect based on a cumulative measure of completeness computed as a weighted sum of a plurality of different individual measures of completeness ([0032]: FIG. 2 is a schematic view of window 59 on display screen 58 of apparatus 20, illustrating a method for computing an ablation index from an impedance integral, in accordance with an example of the disclosure; [0034]: Controller 42 initially measures a steady-state impedance value 122, defined as the steady-state impedance before the start of the ablation, i.e., before time T.sub.s. Controller 42 continually computes an integral I(t) of the difference between curve 110 and steady-state impedance value 122 up to the present time t. Controller 42 converts the integral I(t) into a suitable ablation index value, for example normalizing or otherwise scaling the present value of the integral, and displays the ablation index in a text box 120 to be viewed by physician 22; wherein computation using integration is seen as a weighted sum of a plurality of different individual measures of completeness).
Regarding claim 8, Govari discloses wherein the plurality of different individual measures of completeness includes two or more individual measures of completeness selected from the group consisting of:
a pair of individual measures of completeness corresponding to different respective time instances of the PEF-energy delivery (see Fig. 2 of the measures of impedance over time; [0032]: FIG. 2 is a schematic view of window 59 on display screen 58 of apparatus 20, illustrating a method for computing an ablation index from an impedance integral, in accordance with an example of the disclosure; [0034]: Controller 42 initially measures a steady-state impedance value 122, defined as the steady-state impedance before the start of the ablation, i.e., before time T.sub.s. Controller 42 continually computes an integral I(t) of the difference between curve 110 and steady-state impedance value 122 up to the present time t. Controller 42 converts the integral I(t) into a suitable ablation index value, for example normalizing or otherwise scaling the present value of the integral, and displays the ablation index in a text box 120 to be viewed by physician 22; wherein computation using integration is seen as a weighted sum of a plurality of different individual measures of completeness);
a pair of individual measures of completeness corresponding to different respective types of measured values;
a pair of individual measures of completeness corresponding to different respective subsets of the plurality of electrodes; and
a pair of individual measures of completeness corresponding to different respective sets of displacement values.
Regarding claim 11, Govari discloses a therapy assessment method ([0001]: The present disclosure relates generally to medical devices, and particularly to devices and methods for irreversible electroporation of physiological tissues; [0009]: FIG. 2 is a schematic view of a display screen of a medical apparatus, illustrating a method for computing an ablation index), comprising:
receiving, with a processing circuit (controller 42), a stream of therapy assessment measurements obtained with a plurality of electrodes of a catheter configured to deliver pulsed electric field (PEF) energy to a target tissue in a heart (electroporation catheter 26; [0017]: Distal assembly 30 comprises a basket 32 with electroporation electrodes 34 distributed along the spines of the basket), the therapy assessment measurements including a first measurement taken prior to a respective time instance of PEF-energy delivery and a second measurement taken after the respective time instance of PEF-energy delivery ([0019]: controller 42 may measure the impedance between two selected electrodes 34; [0022]: Controller 42 may be further configured to track the respective positions of electrodes 34 during the IRE procedure, using any suitable tracking technique … Alternatively or additionally, for each electrode 34, controller 42 may ascertain the respective impedances between the electrode and multiple external electrodes 56 coupled to the body surface of patient 24 at various different locations, and then compute the location of electrode 34 within heart 27 based on the ratios between these impedances; [0032]: FIG. 2 is a schematic view of window 59 on display screen 58 of apparatus 20, illustrating a method for computing an ablation index from an impedance integral; wherein Fig. 2/the impedance integral includes taking multiple measurements, Fig. 2 shows both temperature and impedance measurements and wherein integrating over time includes a time instance for which the integral is integrated);
a tracking system configured to track a position of a selected electrode of the plurality of electrodes or of a selected tracking element ([0022]: Controller 42 may be further configured to track the respective positions of electrodes 34 during the IRE procedure, using any suitable tracking technique. For example, distal assembly 30 may comprise one or more electromagnetic position sensors (not shown) … for each electrode 34, controller 42 may ascertain the respective impedances between the electrode and multiple external electrodes 56 coupled to the body surface of patient 24 at various different locations, and then compute the location of electrode 34 within heart 27 based on the ratios between these impedances); and
estimating, with the processing circuit, a therapeutic effect of the PEF-energy delivery based on the first measurement, the second measurement ([0034]: Controller 42 initially measures a steady-state impedance value 122, defined as the steady-state impedance before the start of the ablation, i.e., before time T.sub.s. Controller 42 continually computes an integral I(t) of the difference between curve 110 and steady-state impedance value 122 up to the present time t. Controller 42 converts the integral I(t) into a suitable ablation index value, for example normalizing or otherwise scaling the present value of the integral, and displays the ablation index in a text box 120 to be viewed by physician 22).
While Govari discloses a tracking system, Govari fails to explicitly disclose determining, with the processing circuit, a first displacement of the plurality of electrodes with respect to the target tissue between the first measurement and the respective time instance of PEF-energy delivery and a second displacement of the plurality of electrodes with respect to the target tissue between the respective time instance of PEF-energy delivery and the second measurement, the determining being based on position measurements received from a tracking system configured to track a position of a selected electrode of the plurality of electrodes or of a selected tracking element
estimating, with the processing circuit, a therapeutic effect of the PEF-energy delivery based on the first displacement, and the second displacement.
However, Altmann discloses a therapy assessment method (Abstract: A method includes, using a probe, applying irreversible electroporation (IRE) pulses to tissue over a time period to form a lesion in the tissue. A contact force applied to the tissue by the probe is measured over the time period. An IRE index is calculated based on the measured contact force and on a power level of the IRE pulses), comprising:
determining, with the processing circuit (processor 46), a first displacement of the plurality of electrodes with respect to the target tissue between the first measurement and the respective time instance of PEF-energy delivery and a second displacement of the plurality of electrodes with respect to the target tissue between the respective time instance of PEF-energy delivery and the second measurement, the determining being based on position measurements received from a tracking system configured to track a position of a selected electrode of the plurality of electrodes or of a selected tracking element ([0023]: a physician irreversibly electroporates tissue with a catheter over a time period to form a lesion in the tissue. During the time period measurements are made of a contact force applied by the catheter and the irreversibly electroporative power used for the tissue; [0045]: FIGS. 2A, 2B, and 2C are schematic graphs of force, power, depth, and FTP_IRE vs. time, according to an embodiment of the present invention. The graphs illustrate how estimated depth and the IRE index may look when both the power and the force change. The graph of IRE index vs. time shows that the estimated IRE index is designed to increase linearly with duration of IRE treatment; wherein these graphs include tracking a probe position over instances of energy delivery and time).
estimating, with the processing circuit, a therapeutic effect of the PEF-energy delivery based on the first displacement, and the second displacement ([0050]: In a calculation step 106, as the IRE treatment proceeds, processor 46 calculates, on a recurring basis, the value of the integral used in Eq. 5, i.e., the value of ablation index I.sub.FTP_IRE in Eq. 9. In an IRE index estimation step 108, the processor calculates a value of the estimated IRE index, using equation Eq. 9; see equation 5 in [0039], equation 9 in [0044] and where both include the variable CF, the contact force, and time components, wherein the contact force measurements are seen as multiple displacement measurements). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Govari to include the steps and processing circuit of Altmann for the purpose of enabling adjustment of the theoretical fields displayed by taking into account the IRE index, or the contact force of the electrodes with the cells, and/or the proximity of the cells to the electrodes, by providing an IRE index, a catheter-based IRE treatment can be made safer and more effective (Altmann: [0024-[0025]).
While Altmann discloses contact force over time, which in a heart would include cyclic cardiac motion, Govari in view of Altmann fail to explicitly disclose wherein each of the first displacement and the second displacement is caused at least in part by cyclic motion of the heart.
However, Ryu discloses:
determining, with the processing circuit, a first displacement of the plurality of electrodes with respect to the target tissue between the first measurement and the respective time instance of PEF-energy delivery and a second displacement of the plurality of electrodes with respect to the target tissue between the respective time instance of PEF-energy delivery and the second measurement; wherein each of the first displacement and the second displacement is caused at least in part by cyclic motion of the heart. ([0029]: ECU 28 may also use the information to generate contractility or volumetric indices including, for example, peak velocity of one or more sensors 40, 42, 46 to indicate how quickly or forcefully heart 12 is contracting, peak excursion (distance) (absolute or along a tomographic direction such as radial) of sensors 40, 42, 46 in contact with heart 12 to indicate an amount of ejection, changes in position of sensors 40, 42, 46 or distance between sensors 40, 42, 46 at points in time gated to end diastole and/or end systole to estimate heart chamber dimension, chamber volume, stroke volume and/or ejection fraction, and indices of synchrony or dyssyncrony derived from correlation or coordination of motion among multiple sensors 40, 42, 46 in contact with heart 12; [0031]: The position of position sensors 40 may be monitored over a period of time encompassing periods before, during and after ablation is performed near the ostium 62. Prior to the delivery of ablation energy, the tissue with which position sensors 40 are in contact will exhibit at least some movement. If the ablation near the ostium 62 is successfully carried out, however, the electrical pathway between the pulmonary vein 56 and the left atrium 58 should be severed thereby eliminating or reducing motion of the tissue in pulmonary vein 56 distal of the ostium 62. Position sensors 40 in contact with this tissue will therefore indicate a relatively constant output (corrected for general patient and respiratory movement) indicative of a lack of motion during the cardiac cycle. ECU 28 may determine whether the movement of sensors 40 is less than a threshold amount and provide an indicator of the electrical conductivity in the tissue).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the processing circuit of Govari in view of Altmann to include the processing circuit of Ryu for the purpose of assessing the impact of ablation therapy during or after administration of the therapy, enabling a clinician to better assess the efficacy and safety of ablation therapy, and the motion of the position sensors is used to infer motion of the cardiac tissue and this motion is used to assess the impact of ablation therapy on a variety of characteristics associated with the heart, including tissue motion, blood flow velocity, electrical conductivity and changes to the blood, that are affected by ablation therapy and are indicative of the success or failure of that therapy and risks associated with that therapy (Ryu: [0010], [0042])
Regarding claim 15, Govari discloses wherein the estimating is further based on a time delay between a pair of consecutive pulses of the PEF energy in a sequence of pulses applied to the plurality of electrodes by a waveform generator (IRE pulse generator; [0014]: During the ablation, the impedance may be sensed during the IRE pulse trains, as well as between the trains; [0034]: Controller 42 continually computes an integral I(t) of the difference between curve 110 and steady-state impedance value 122 up to the present time t. Controller 42 converts the integral I(t) into a suitable ablation index value, for example normalizing or otherwise scaling the present value of the integral, and displays the ablation index in a text box 120 to be viewed by physician 22).
Regarding claim 16, Govari discloses wherein the estimating is further based on a cumulative measure of completeness computed as a weighted sum of a plurality of different individual measures of completeness ([0032]: FIG. 2 is a schematic view of window 59 on display screen 58 of apparatus 20, illustrating a method for computing an ablation index from an impedance integral, in accordance with an example of the disclosure; [0034]: Controller 42 initially measures a steady-state impedance value 122, defined as the steady-state impedance before the start of the ablation, i.e., before time T.sub.s. Controller 42 continually computes an integral I(t) of the difference between curve 110 and steady-state impedance value 122 up to the present time t. Controller 42 converts the integral I(t) into a suitable ablation index value, for example normalizing or otherwise scaling the present value of the integral, and displays the ablation index in a text box 120 to be viewed by physician 22; wherein computation using integration is seen as a weighted sum of a plurality of different individual measures of completeness).
Regarding claim 17, Govari discloses wherein the plurality of different individual measures of completeness includes two or more individual measures of completeness selected from the group consisting of:
a pair of individual measures of completeness corresponding to different respective time instances of the PEF-energy delivery (see Fig. 2 of the measures of impedance over time; [0032]: FIG. 2 is a schematic view of window 59 on display screen 58 of apparatus 20, illustrating a method for computing an ablation index from an impedance integral, in accordance with an example of the disclosure; [0034]: Controller 42 initially measures a steady-state impedance value 122, defined as the steady-state impedance before the start of the ablation, i.e., before time T.sub.s. Controller 42 continually computes an integral I(t) of the difference between curve 110 and steady-state impedance value 122 up to the present time t. Controller 42 converts the integral I(t) into a suitable ablation index value, for example normalizing or otherwise scaling the present value of the integral, and displays the ablation index in a text box 120 to be viewed by physician 22; wherein computation using integration is seen as a weighted sum of a plurality of different individual measures of completeness);
a pair of individual measures of completeness corresponding to different respective types of measured values;
a pair of individual measures of completeness corresponding to different respective subsets of the plurality of electrodes; and
a pair of individual measures of completeness corresponding to different respective sets of displacement values.
Regarding claim 20, Govari discloses a non-transitory computer-readable medium storing instructions that, when executed by an electronic processor, cause the electronic processor to perform operations comprising the method of claim 11 ([0027]: Typically, the functionality of controller 42, as described herein, is implemented at least partly in software. For example, controller 42 may comprise a programmed digital computing device comprising at least a central processing unit (CPU) and random-access memory (RAM). Program code, including software programs and/or data, is loaded into the RAM for execution and processing by the CPU. The program code and/or data may be downloaded to the controller in electronic form, over a network, for example. Alternatively or additionally, the program code and/or data may be provided and/or stored on non-transitory tangible media, such as magnetic, optical, or electronic memory. Such program code and/or data, when provided to the controller, produce a machine or special-purpose computer, configured to perform the tasks described herein).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Altmann as applied to claim 1 above, and further in view of Govari et al. (U.S. Pub. No. 20210401490, previously cited), herein referred to as “Govari 2”.
Regarding claim 2, Govari in view of Altmann fail to disclose wherein the first measurement includes a first temperature measurement using a first electrode of the plurality of electrodes and a second temperature measurement using a second electrode of the plurality of electrodes; and wherein the second measurement includes a third temperature measurement using the first electrode and a fourth temperature measurement using the second electrode.
However, Govari 2 discloses wherein the first measurement includes a first temperature measurement using a first electrode of the plurality of electrodes and a second temperature measurement using a second electrode of the plurality of electrodes; and wherein the second measurement includes a third temperature measurement using the first electrode and a fourth temperature measurement using the second electrode ([0064]: After and/or during the application of the pulse train, temperature controller 25 measures, using thermocouples 21, maximal temperatures T.sub.i and T.sub.j of tissue 62 adjacent spines 30i and 30j, respectively, in a temperature measurement step 512; see path from step 512 > 514 > 516 > 510 > 512 in Fig. 6 such that there are four temperature measurements, but to the same pair of electrodes).
While Govari 2 does not explicitly disclose “a first temperature measurement using a first electrode of the plurality of electrodes…”, Govari 2 does disclose in [0048]: “Spines 30a-30f comprise long segments of a resilient material, which is conductive or has a conductive coating or a conductive member attached to it. For example, spines 30a-30f may comprise a nickel-titanium alloy, known as nitinol. Each spine 30 has one or more thermocouples 21 attached to it for measuring the local temperature of tissue 62 adjacent to the thermocouple” such that in reference to the instant application’s Specification [0070]: “For example, in some embodiments, a temperature sensor is implemented using copper and constantan wire leads connected to an electrode 24 to form an end of a thermocouple thereat”, the structures are the same so that Govari 2 is seen as “a first temperature measurement using a first electrode of the plurality of electrodes…” & so forth for the remaining temperature measurements & electrodes.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the medical treatment apparatus of Govari in view of Altmann to include the temperature measurements, as taught by Govari 2, for the purpose of knowing a temperature of the tissue contacted by the spines to mitigate the lack of irrigation which may lead to overheating of tissue as no irrigation fluid is available for carrying away the thermal energy that the IRE signals inject into the tissue (Govari 2: [0026]-[0027]).
Claims 5 & 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Altmann as applied to claim 1 above, and further in view of Stewart et al. (U.S. Pub. No. 20160166310, cited in IDS), herein referred to as “Stewart”.
Regarding claim 5, Govari in view of Altmann fail to disclose a cardiac-cycle monitor, wherein the processing circuit is further configured to estimate the therapeutic effect based on one or more cardiac-cycle phases selected from the group consisting of: a first cardiac-cycle phase corresponding to the first measurement; a second cardiac-cycle phase corresponding to the respective time instance of PEF-energy delivery; and a third cardiac-cycle phase corresponding to the second measurement; and
wherein each of the one or more cardiac-cycle phases is determined based on a respective time between times of two respective consecutive R-waves in the heart.
However, Stewart discloses a cardiac-cycle monitor, wherein the processing circuit is further configured to estimate the therapeutic effect based on one or more cardiac-cycle phases selected from the group consisting of: a first cardiac-cycle phase corresponding to the first measurement; a second cardiac-cycle phase corresponding to the respective time instance of PEF-energy delivery; and a third cardiac-cycle phase corresponding to the second measurement ([0019]: The energy delivery device 12 may include one or more energy delivery electrodes 18 for delivering an electrical current, and may further include one or more electrodes such as mapping electrodes, PFA electrodes, and/or electrodes for measuring characteristics such as impedance (not shown); [0022]: Similarly, the generator 22 and/or control unit 14 may be able to automatically determine optimal timing of ablative energy deliveries; [0036]: Further, to enhance the effectiveness of pulsed field ablation energy in certain cases, it may be desired to create more extensively ablated regions. In such cases, the optimal timing of pulsed field delivery may be at multiple time points in the cardiac cycle; [0039]: (t) the time in the cardiac cycle and the timing of the respiration cycle as determined by transthoracic and intracardiac impedance measurements (for example, taken from two, three, or four electrodes). All or any of the measurements involved in (a)-(t) may be taken continuously during the PFA procedure; [0045]: Further, to enhance the effectiveness of the pulsed field ablation energy in certain cases, it may be desired to create more extensively ablated regions. In such cases, the optimal timing of pulsed field delivery may be at multiple time points in the cardiac cycle. By delivering pulsed fields at more than one or multiple time points in the cardiac motion cycle, the effect of PFA may be more broadly distributed over a tissue surface; wherein Stewart’s control unit functions are seen as estimating a therapeutic effect based a second cardiac-cycle phase corresponding to the respective time instant if it is timing the energy delivery based on the cardiac cycle for the best therapeutic outcome, it is additionally capable of basing a therapeutic effect on a first cardiac-cycle phase corresponding to the first measurement and a third cardiac-cycle phase corresponding to the second measurement if the impedance measurements are made to determine points within the cardiac cycle (see Fig. 7)),
wherein each of the one or more cardiac-cycle phases is determined based on a respective time between times of two respective consecutive R-waves in the heart ([0008]: The cardiac cycle timing may be determined using body surface electrocardiograms or intracardiac electrograms. The heart may include a ventricle, and determining the optimal time within the cardiac cycle for energy delivery may include identifying depolarization of the ventricle and repolarization of the ventricle within the cardiac cycle. Further, energy may be delivered to the target tissue after depolarization of the ventricle and before repolarization of the ventricle. Determining cardiac cycle timing may further include measuring a QT interval that includes an R wave, an S wave, and a T wave; [0041]: Once cardiac capture is achieved after a brief series of pacing pulses, for example, capturing the heart for five heartbeats, the energy delivered may be timed to follow the last pacing stimulus within the desired time window and when selected criteria are met that indicate proximity of the energy delivery electrodes 18 to the target tissue; wherein capturing the heart for five heartbeats and measuring the cardiac cycle timing is seen as a respective time between times of two respective consecutive R-waves of the heart).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the medical treatment apparatus of Govari in view of Altmann to include a cardiac cycle monitor and processing circuit of Stewart for the purpose of enhancing the effectiveness of the pulsed field ablation energy in certain cases, it may be desired to create more extensively ablated regions. In such cases, the optimal timing of pulsed field delivery may be at multiple time points in the cardiac cycle (Stewart: [0045]).
Regarding claim 12, Govari in view of Altmann fails to disclose wherein the estimating is further based on one or more cardiac-cycle phases selected from the group consisting of: a first cardiac-cycle phase corresponding to the first measurement; a second cardiac-cycle phase corresponding to the respective time instance of PEF-energy delivery; and a third cardiac-cycle phase corresponding to the second measurement; and
wherein each of the one or more cardiac-cycle phases is determined based on a respective time between times of two respective consecutive R-waves in the heart.
However, Stewart discloses wherein the estimating is further based on one or more cardiac-cycle phases selected from the group consisting of: a first cardiac-cycle phase corresponding to the first measurement; a second cardiac-cycle phase corresponding to the respective time instant; and a third cardiac-cycle phase corresponding to the second measurement ([0019]: The energy delivery device 12 may include one or more energy delivery electrodes 18 for delivering an electrical current, and may further include one or more electrodes such as mapping electrodes, PFA electrodes, and/or electrodes for measuring characteristics such as impedance (not shown); [0022]: Similarly, the generator 22 and/or control unit 14 may be able to automatically determine optimal timing of ablative energy deliveries; [0036]: Further, to enhance the effectiveness of pulsed field ablation energy in certain cases, it may be desired to create more extensively ablated regions. In such cases, the optimal timing of pulsed field delivery may be at multiple time points in the cardiac cycle; [0039]: (t) the time in the cardiac cycle and the timing of the respiration cycle as determined by transthoracic and intracardiac impedance measurements (for example, taken from two, three, or four electrodes). All or any of the measurements involved in (a)-(t) may be taken continuously during the PFA procedure; [0045]: Further, to enhance the effectiveness of the pulsed field ablation energy in certain cases, it may be desired to create more extensively ablated regions. In such cases, the optimal timing of pulsed field delivery may be at multiple time points in the cardiac cycle. By delivering pulsed fields at more than one or multiple time points in the cardiac motion cycle, the effect of PFA may be more broadly distributed over a tissue surface; wherein Stewart’s control unit functions are seen as estimating a therapeutic effect based a second cardiac-cycle phase corresponding to the respective time instant if it is timing the energy delivery based on the cardiac cycle for the best therapeutic outcome, it is additionally capable of basing a therapeutic effect on a first cardiac-cycle phase corresponding to the first measurement and a third cardiac-cycle phase corresponding to the second measurement if the impedance measurements are made to determine points within the cardiac cycle (see Fig. 7)); and
wherein each of the one or more cardiac-cycle phases is determined based on a respective time between times of two respective consecutive R-waves in the heart ([0008]: The cardiac cycle timing may be determined using body surface electrocardiograms or intracardiac electrograms. The heart may include a ventricle, and determining the optimal time within the cardiac cycle for energy delivery may include identifying depolarization of the ventricle and repolarization of the ventricle within the cardiac cycle. Further, energy may be delivered to the target tissue after depolarization of the ventricle and before repolarization of the ventricle. Determining cardiac cycle timing may further include measuring a QT interval that includes an R wave, an S wave, and a T wave; [0041]: Once cardiac capture is achieved after a brief series of pacing pulses, for example, capturing the heart for five heartbeats, the energy delivered may be timed to follow the last pacing stimulus within the desired time window and when selected criteria are met that indicate proximity of the energy delivery electrodes 18 to the target tissue; wherein capturing the heart for five heartbeats and measuring the cardiac cycle timing is seen as a respective time between times of two respective consecutive R-waves of the heart).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Govari in view of Altmann to include the steps of Stewart for the purpose of enhancing the effectiveness of the pulsed field ablation energy in certain cases, it may be desired to create more extensively ablated regions. In such cases, the optimal timing of pulsed field delivery may be at multiple time points in the cardiac cycle (Stewart: [0045]).
Regarding claim 13, Govari discloses wherein the estimating is further based on a time delay between a pair of consecutive pulses of the PEF energy in a sequence of pulses applied to the plurality of electrodes by a waveform generator (IRE waveform generator; [0014]: During the ablation, the impedance may be sensed during the IRE pulse trains, as well as between the trains; [0034]: Controller 42 converts the integral I(t) into a suitable ablation index value, for example normalizing or otherwise scaling the present value of the integral, and displays the ablation index in a text box 120 to be viewed by physician 22).
Regarding claim 14, Govari discloses wherein the estimating is further based on a cumulative measure of completeness computed as a weighted sum of a plurality of different individual measures of completeness ([0032]: FIG. 2 is a schematic view of window 59 on display screen 58 of apparatus 20, illustrating a method for computing an ablation index from an impedance integral, in accordance with an example of the disclosure; [0034]: Controller 42 initially measures a steady-state impedance value 122, defined as the steady-state impedance before the start of the ablation, i.e., before time T.sub.s. Controller 42 continually computes an integral I(t) of the difference between curve 110 and steady-state impedance value 122 up to the present time t. Controller 42 converts the integral I(t) into a suitable ablation index value, for example normalizing or otherwise scaling the present value of the integral, and displays the ablation index in a text box 120 to be viewed by physician 22; wherein computation using integration is seen as a weighted sum of a plurality of different individual measures of completeness).
Claims 9-10 & 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Altmann as applied to claim 1 above, and further in view of Gutbrod et al. (U.S. Pub. No. 20210369341, previously cited), herein referred to as “Gutbrod”.
Regarding claim 9, Govari in view of Altmann fail to disclose wherein the processing circuit includes circuitry configured to generate a zoned PEF-energy effect map for an individual PEF-energy application point corresponding to the respective time instance of PEF-energy delivery based on the first measurement, the second measurement, the first displacement, and the second displacement.
However, Gutbrod discloses wherein the processing circuit includes circuitry configured to generate a zoned PEF-energy effect map for an individual PEF-energy application point corresponding to the respective time instance of PEF-energy delivery based on the first measurement, the second measurement, the first displacement, and the second displacement ([0091]: FIGS. 4A-4D are diagrams illustrating graphical representations that can be displayed in the overlay of the graphical representation of the electric field on the anatomical map, in accordance with embodiments of the subject matter of the disclosure. In embodiments, the console 130 is configured to display these and other graphical representations in the overlay of the graphical representation of the electric field on the anatomical map on the display 92; [0102]: FIG. 4D is a diagram illustrating lesions 430 previously created in the cardiac tissue 302 intersecting with electric field lines 432 in the overlay of the graphical representation of the electric field on the anatomical map, in accordance with embodiments of the subject matter of the disclosure; [0112]: Also, in embodiments, the method includes dynamically changing, by the controller, the graphical representations of the electric fields based on one or more of changes in position of the catheter relative to surrounding tissue, changes in the catheter, changes in pulse parameters to be provided to the electrodes of the catheter; and changes in measured impedance values of the surrounding tissue; see steps 500-510 in Fig. 5). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the processing circuit of Govari in view of Altmann to include the processing circuitry of Gutbrod for the purpose of enabling the capability to enhance the efficiency of clinical workflows, including enhancement of planning the ablation of portions of the patient's heart by irreversible electroporation (Gutbrod: [0064]).
Regarding claim 10, Govari in view of Altmann and Gutbrod disclose wherein the circuitry is configured to generate a treatment completeness map by combining a plurality of zoned PEF-energy effect maps corresponding to different individual PEF-energy application points (Gutbrod: [0102] FIG. 4D is a diagram illustrating lesions 430 previously created in the cardiac tissue 302 intersecting with electric field lines 432 in the overlay of the graphical representation of the electric field on the anatomical map, in accordance with embodiments of the subject matter of the disclosure; see Fig. 4D where two different individual PEF-energy application points are shown as lesion 430).
Regarding claim 18, Govari in view of Altmann fail to disclose generating, with the processing circuit, a zoned PEF-energy effect map for an individual PEF-energy application point corresponding to the respective time instance of PEF-energy delivery based on the first measurement, the second measurement, the first displacement, and the second displacement.
However, Gutbrod discloses generating, with the processing circuit, a zoned PEF-energy effect map for an individual PEF-energy application point corresponding to the respective time instance of PEF-energy delivery based on the first measurement, the second measurement, the first displacement, and the second displacement ([0091]: FIGS. 4A-4D are diagrams illustrating graphical representations that can be displayed in the overlay of the graphical representation of the electric field on the anatomical map, in accordance with embodiments of the subject matter of the disclosure. In embodiments, the console 130 is configured to display these and other graphical representations in the overlay of the graphical representation of the electric field on the anatomical map on the display 92; [0102]: FIG. 4D is a diagram illustrating lesions 430 previously created in the cardiac tissue 302 intersecting with electric field lines 432 in the overlay of the graphical representation of the electric field on the anatomical map, in accordance with embodiments of the subject matter of the disclosure; [0112]: Also, in embodiments, the method includes dynamically changing, by the controller, the graphical representations of the electric fields based on one or more of changes in position of the catheter relative to surrounding tissue, changes in the catheter, changes in pulse parameters to be provided to the electrodes of the catheter; and changes in measured impedance values of the surrounding tissue; see steps 500-510 in Fig. 5). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method and processing circuit of Govari in view of Altmann to include the steps and processing circuitry of Gutbrod for the purpose of enabling the capability to enhance the efficiency of clinical workflows, including enhancement of planning the ablation of portions of the patient's heart by irreversible electroporation (Gutbrod: [0064]).
Regarding claim 19, Govari in view of Altmann and Gutbrod disclose generating, with the processing circuit, a treatment completeness map by combining a plurality of zoned PEF-energy effect maps corresponding to different individual PEF-energy application points (Gutbrod: [0102] FIG. 4D is a diagram illustrating lesions 430 previously created in the cardiac tissue 302 intersecting with electric field lines 432 in the overlay of the graphical representation of the electric field on the anatomical map, in accordance with embodiments of the subject matter of the disclosure; see Fig. 4D where two different individual PEF-energy application points are shown as lesion 430).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794