DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status: Claims 1-30 are pending. Claims 23 and 26 have been withdrawn from consideration.
Election/Restrictions
Applicant’s election without traverse of Species B (fig. 19) in the reply filed on May 6, 2026 is acknowledged.
Claims 23 and 26 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species A (fig. 16, tip electrode 1526 and para. [0096]), there being no allowable generic or linking claim. As shown and described in fig. 19A and para. [00120], a NAV sensor 1610 is located proximally. Election was made without traverse in the reply filed on May 6, 2026.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9, 14-20, 22, 24, 25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Gross (US 2017/0007157A1) in view of Rosenberg et al. (US 2021/0082157).
Re Claim 1, Gross discloses a system for delivering therapeutic energy during tissue modification treatment (para. [0299], a system 20 for ablating and/or stimulating nerve tissue of a blood vessel of a subject, such as a renal artery), the system comprising:
at least one catheter (fig. 1, para. [0299], an elongate shaft 40);
an energy delivery body configured with the at least one catheter (para. [0299], system 20 is configured to stimulate, sense, and/or ablate the nerve tissue of the blood vessel; para. [0303], fig. 1, figs. 2A, 2B, During activation of electrode unit 30 for ablating nerve tissue, as described above, it is important that there be good contact between intrarenal electrodes 71 and a wall 119 of renal artery 108; para. [0305], apply electrical pulses between a pair of electrodes, such as between (a) pair 42 of intrarenal electrodes 44);
a plurality of spline electrodes configured with the at least one catheter (fig. 1, para. [0299], [0300], In FIG. 1, electrode unit 30 comprises four pairs 42 of intrarenal electrodes 44, Electrode unit 30 typically further comprises one or more support struts 46, to which intrarenal electrodes 44 are fixed.);
at least one impedance sensor configured with the at least one catheter, each of the at least one impedance sensor respectively associated with at least one of the plurality of spline electrodes (para. [0305], [0306], calculate at least one time-varying component of electrode-tissue impedance based on applying the pulses);
at least one processor configured by executing instructions stored on processor-readable media to process information associated with the at least one impedance sensor (para. [0304]-[0309], control circuitry 70 configured to calculate at least one time-varying component of electrode-tissue impedance based on applying the pulses); and
a display that is configured to provide information processed by the at least one processor (fig. 1, para. [0004], [0010], [0229], a user interface is configured to output the level of contact),
wherein the at least one processor is further configured to:
determine a baseline impedance value, wherein the baseline impedance value is based on impedance sensed by the at least one impedance sensor (para. [0316], a calibration process is performed outside the subject's body (e.g., In saline solution), or inside the subject's body (for example, in the aorta), to measure the impedance when there is no contact between intrarenal electrodes 44 and the wall of the renal artery. This calibration measurement may serve as a predefined value for the threshold that is used to ascertain the level of contact between the intrarenal electrodes and the wall of the renal artery.);
define a threshold impedance value (para. [0316], a calibration process is performed outside the subject's body (e.g., In saline solution), or inside the subject's body (for example, in the aorta), to measure the impedance when there is no contact between intrarenal electrodes 44 and the wall of the renal artery. This calibration measurement may serve as a predefined value for the threshold that is used to ascertain the level of contact between the intrarenal electrodes and the wall of the renal artery.);
detect, by the at least one impedance sensor, a local impedance associated with at least one of the spline electrodes navigating via the at least one catheter about an organ (para. [0305], control circuitry 70 is configured to apply electrical pulses between a pair of electrodes, such as between (a) pair 42 of intrarenal electrodes 44, (b) one of intrarenal electrodes 44 and intracorporeal reference electrode 50, or (c) one of intrarenal electrodes 44 and external ground electrode 52, para. [0306], calculate at least one time-varying component of electrode-tissue impedance based on applying the pulses);
determining, by the at least one processor, a change in impedance from the baseline impedance to the local impedance (para. [0316], a calibration process is performed outside the subject's body (e.g., In saline solution), or inside the subject's body (for example, in the aorta), to measure the impedance when there is no contact between intrarenal electrodes 44 and the wall of the renal artery. This calibration measurement may serve as a predefined value for the threshold that is used to ascertain the level of contact between the intrarenal electrodes and the wall of the renal artery; para. [0306], calculate at least one time-varying component of electrode-tissue impedance based on applying the pulses; para. [0309], based on the level of correlation, ascertain a level of contact between the at least one intrarenal electrode 44 and wall 110 of renal artery 108. – Change in level of contact is driven from a change in impedance from baseline where there is no contact.); and
wherein the tissue modification apparatus delivers the therapeutic energy via the energy delivery body (para. [0299], system 20 is configured to stimulate, sense, and/or ablate the nerve tissue of the blood vessel; para. [0303], fig. 1, figs. 2A, 2B, During activation of electrode unit 30 for ablating nerve tissue, as described above, it is important that there be good contact between intrarenal electrodes 71 and a wall 119 of renal artery 108).
Gross is silent regarding the at least one processor is further configured to display, on the display, an impedance indicator that is configured with a plurality of spokes, each of the spokes respectively associated with respective ones of the spline electrodes, wherein each of the spokes is configured to represent the baseline impedance value; altering, by the at least one processor, as a function of the change in impedance, at least one respective spoke of the impedance indicator to generate an altered impedance indicator; displaying, on the display, the altered impedance indicator.
Rosenberg discloses an ablation catheter with a basket, a plurality of electrodes disposed on the surface, and a graphical user interface (abstract).
Rosenberg teaches that at least one processor is further configured to display, on the display, an impedance indicator that is configured with a plurality of spokes (para. [0023], FIG. 9 represents an illustration of a radar-plot of baseline impedance that may be provided in a sector of GUI display; para. [0025], FIG. 11 represents an illustration of a circle bar plot of baseline impedance that may be provided in a sector in GUI display), each of the spokes respectively associated with respective ones of the spline electrodes (fig. 3, electrodes 33; para. [0072], fig. 9, Illustration 300 includes a depiction of each of the electrodes 1-10. Overlaid on the electrode depiction is an initial impedance 206. Initial impedance 206 may include an impedance value for each of the depicted electrodes; fig. 11, para. [0077], Overlaid on the electrode depiction is an initial impedance 507. Initial impedance 507 may include an impedance value for each of the depicted electrodes.),
wherein each of the spokes is configured to represent the baseline impedance value (para. [0023], FIG. 9 represents an illustration of a radar-plot of baseline impedance that may be provided in a sector of GUI display; para. [0075], initial impedance value 206; fig. 11, para. [0077], Overlaid on the electrode depiction is an initial impedance 507.);
altering, by the at least one processor, as a function of the change in impedance, at least one respective spoke of the impedance indicator to generate an altered impedance indicator; displaying, on the display, the altered impedance indicator (para. [0024], FIG. 10 represents an illustration of a radar-plot of baseline impedance and real-time impedance during and/or at end of ablation, that may be provided in a sector of GUI display; para. [0074], [0075], impedance value 216; para. [0026], [0080], FIG. 12 represents an illustration of circle bar plot of baseline impedance and real-time impedance during and/or at end of ablation, that may be provided in second sector for display in GUI display.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Gross, by configuring at least one processor to display, on the display, an impedance indicator that is configured with a plurality of spokes, each of the spokes respectively associated with respective ones of the spline electrodes, wherein each of the spokes is configured to represent the baseline impedance value; altering, by the at least one processor, as a function of the change in impedance, at least one respective spoke of the impedance indicator to generate an altered impedance indicator; displaying, on the display, the altered impedance indicator, as taught by Rosenberg, for the purpose of guiding medical professional 14 through the procedure by providing display of relevant pre-ablation, ablation and post-ablation data, recommendations, notifications, and alerts (para. [0044]).
Re Claim 2, Gross as modified by Rosenberg discloses the claimed invention substantially as set forth in claim 1.
Gross is silent regarding wherein each of the spokes is configured to have a single length to represent the baseline, and further wherein the at least one processor is configured to alter respective ones of the at least one spoke by extending the length of the respective ones of the at least one respective spoke.
However, Rosenberg discloses that each of the spokes is configured to have a single length to represent the baseline (para. [0023], FIG. 9 represents an illustration of a radar-plot of baseline impedance that may be provided in a sector of GUI display; para. [0075], initial impedance value 206; fig. 11, para. [0077], Overlaid on the electrode depiction is an initial impedance 507.), and further wherein the at least one processor is configured to alter respective ones of the at least one spoke by extending the length of the respective ones of the at least one respective spoke (para. [0024], FIG. 10 represents an illustration of a radar-plot of baseline impedance and real-time impedance during and/or at end of ablation, that may be provided in a sector of GUI display; para. [0074], [0075], impedance value 216; para. [0026], [0080], FIG. 12 represents an illustration of circle bar plot of baseline impedance and real-time impedance during and/or at end of ablation, that may be provided in second sector for display in GUI display.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Gross as modified by Rosenberg, by configuring each of the spokes to have a single length to represent the baseline and configuring the at least one processor to alter respective ones of the at least one spoke by extending the length of the respective ones of the at least one respective spoke, as taught by Rosenberg, for the purpose of guiding medical professional 14 through the procedure by providing display of relevant pre-ablation, ablation and post-ablation data, recommendations, notifications, and alerts (para. [0044]).
Re Claims 3-5, Gross discloses that the at least one processor is further configured to: define a threshold impedance value (para. [0057]-[0061], [0016]-[0022], a threshold level of contact which is based on the electrode-tissue impedance),
Gross is silent regarding wherein each of the spokes is configured with a color to represent the baseline, and further wherein the at least one processor is further configured to alter the at least one spoke by changing the color of the at least one respective spoke when the detected local impedance crosses the threshold value.
Rosenberg discloses that each of the spokes is configured with a color to represent the baseline, and further wherein the at least one processor is further configured to alter the at least one spoke by changing the color of the at least one respective spoke when the detected local impedance crosses the threshold value, wherein the at least one processor is further configured to: define a plurality of threshold impedance values, and alter the at least one spoke by altering the changed color of the at least one respective spoke when the detected local impedance crosses each of the plurality of threshold values, wherein the at least one processor is further configured to alter the changed color by altering at least one of the changed color’s intensity, shade, hue, saturation, and brightness (fig. 6D, coloring according to impedance drop from low to high; para. [0060], a preference 670 may be used to select if the indicators are based on impedance and/or temperature measurements by the balloon electrodes. If the impedance is within a certain range of values, and/or the temperature is below a certain value, it is a good surrogate for contact of the electrode with the tissue. The color setting may be set to indicate color tones; para. [0064], [0066], Representation 1010D includes dynamic coloring of the electrodes on the 2D view, according to the values of impedance drop.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Gross as modified by Rosenberg, by configuring each of the spokes with a color to represent the baseline, and configuring the at least one processor to alter the at least one spoke by changing the color of the at least one respective spoke when the detected local impedance crosses the threshold value, wherein the at least one processor is further configured to: define a plurality of threshold impedance values, and alter the at least one spoke by altering the changed color of the at least one respective spoke when the detected local impedance crosses each of the plurality of threshold values, wherein the at least one processor is further configured to alter the changed color by altering at least one of the changed color’s intensity, shade, hue, saturation, and brightness, as taught by Rosenberg, for the purpose of guiding medical professional 14 through the procedure by providing display of relevant pre-ablation, ablation and post-ablation data, recommendations, notifications, and alerts (para. [0044]).
Re Claim 6, Gross discloses that the at least one catheter further includes a center electrode (fig. 1, para. [0302], an intracorporeal reference electrode 50).
Re Claim 7, Gross discloses that the detected local impedance is based on impedance sensed by at least one impedance sensor associated with at least one of the plurality of spline electrodes and at least one impedance sensor associated with the center electrode (para. [0305], [0306], apply electrical pulses between a pair of electrodes, such as between one of intrarenal electrodes 44 and intracorporeal reference electrode 50 and calculate at least one time-varying component of electrode-tissue impedance based on applying the pulses).
Re Claim 8, Gross discloses that the at least one catheter includes a treatment catheter and a mapping catheter (para. [0299], system 20 is configured to stimulate, sense, and/or ablate the nerve tissue of the blood vessel; para. [0190], [0234], [0344], The control circuitry is configured to activate the at least one intrarenal electrode to ablate a renal nerve of the subject, in response to the level of contact being at least a threshold level of contact; para. [0303], A level of contact between at least one intrarenal electrode 44 and wall 110 of renal artery 108 is ascertained. The contact of each of intrarenal electrodes 44 is separately ascertained, or of each pair 42 of intrarenal electrodes 44, and, optionally, separately outputted to the user of the system. Further alternatively, the contact level of intrarenal electrodes 44 in more than one pair is simultaneously ascertained.).
Re Claim 9, Gross discloses that the at least one processor is further configured to: analyze, as a function of time, electrode measurements to determine contact stability (para. [0304], [0308], [0309], [0310], control circuitry 70 is configured to calculate a level of correlation between the at least one time-varying component of the electrode tissue impedance and the periodic hemodynamic signal; based on the level of correlation, ascertain a level of contact between the at least one intrarenal electrode 44 and wall 110 of renal artery 108. User interface 72 is configured to output the level of contact; para. [0368], [0369], control circuitry 70 is configured to ascertain the level of contact based on a shape of graph 200 of the time-varying signal rate during application of the electrical current. control circuitry 70 is configured to ascertain the level of contact based on the stability of the time-varying signal rate during application of the electrical current.).
Re Claim 14, Gross discloses a method for delivering therapeutic energy during tissue modification treatment (para. [0299], a system 20 for ablating and/or stimulating nerve tissue of a blood vessel of a subject, such as a renal artery), the method comprising:
determining a baseline impedance value (para. [0316], a calibration process is performed outside the subject's body (e.g., In saline solution), or inside the subject's body (for example, in the aorta), to measure the impedance when there is no contact between intrarenal electrodes 44 and the wall of the renal artery. This calibration measurement may serve as a predefined value for the threshold that is used to ascertain the level of contact between the intrarenal electrodes and the wall of the renal artery.), by a tissue modification apparatus that includes at least one catheter (fig. 1, para. [0299], an elongate shaft 40), an energy delivery body (para. [0299], system 20 is configured to stimulate, sense, and/or ablate the nerve tissue of the blood vessel; para. [0303], fig. 1, figs. 2A, 2B, During activation of electrode unit 30 for ablating nerve tissue, as described above, it is important that there be good contact between intrarenal electrodes 71 and a wall 119 of renal artery 108; para. [0305], apply electrical pulses between a pair of electrodes, such as between (a) pair 42 of intrarenal electrodes 44), at least one impedance sensor (para. [0305], [0306], calculate at least one time-varying component of electrode-tissue impedance based on applying the pulses), at least one processor (para. [0304]-[0309], control circuitry 70 configured to calculate at least one time-varying component of electrode-tissue impedance based on applying the pulses), and a user interface (fig. 1, para. [0004], [0010], [0229], a user interface is configured to output the level of contact),
wherein the at least one catheter includes a plurality of spline electrodes (fig. 1, para. [0299], [0300], In FIG. 1, electrode unit 30 comprises four pairs 42 of intrarenal electrodes 44, Electrode unit 30 typically further comprises one or more support struts 46, to which intrarenal electrodes 44 are fixed.);
defining, by the at least one processor, a threshold impedance value (para. [0316], a calibration process is performed outside the subject's body (e.g., In saline solution), or inside the subject's body (for example, in the aorta), to measure the impedance when there is no contact between intrarenal electrodes 44 and the wall of the renal artery. This calibration measurement may serve as a predefined value for the threshold that is used to ascertain the level of contact between the intrarenal electrodes and the wall of the renal artery.);
detecting, by the at least one impedance sensor, a local impedance associated with at least one of the spline electrodes navigating via the at least one catheter about an organ (para. [0305], control circuitry 70 is configured to apply electrical pulses between a pair of electrodes, such as between (a) pair 42 of intrarenal electrodes 44, (b) one of intrarenal electrodes 44 and intracorporeal reference electrode 50, or (c) one of intrarenal electrodes 44 and external ground electrode 52, para. [0306], calculate at least one time-varying component of electrode-tissue impedance based on applying the pulses);
determining, by the at least one processor, a change in impedance from the baseline impedance to the local impedance (para. [0316], a calibration process is performed outside the subject's body (e.g., In saline solution), or inside the subject's body (for example, in the aorta), to measure the impedance when there is no contact between intrarenal electrodes 44 and the wall of the renal artery. This calibration measurement may serve as a predefined value for the threshold that is used to ascertain the level of contact between the intrarenal electrodes and the wall of the renal artery; para. [0306], calculate at least one time-varying component of electrode-tissue impedance based on applying the pulses; para. [0309], based on the level of correlation, ascertain a level of contact between the at least one intrarenal electrode 44 and wall 110 of renal artery 108. – Change in level of contact is driven from a change in impedance from baseline where there is no contact.); and
delivering, by the tissue modification apparatus, therapeutic energy (para. [0299], system 20 is configured to stimulate, sense, and/or ablate the nerve tissue of the blood vessel; para. [0303], fig. 1, figs. 2A, 2B, During activation of electrode unit 30 for ablating nerve tissue, as described above, it is important that there be good contact between intrarenal electrodes 71 and a wall 119 of renal artery 108).
Gross is silent regarding a display, displaying, on the display, an impedance indicator that is configured with a plurality of spokes, each of the spokes respectively associated with respective ones of the spline electrodes, wherein each of the spokes is configured to represent the baseline impedance value; altering, by the at least one processor, as a function of the change in impedance, at least one respective spoke of the impedance indicator to generate an altered impedance indicator; and displaying, on the display, the altered impedance indicator.
Rosenberg discloses an ablation catheter with a basket, a plurality of electrodes disposed on the surface, and a graphical user interface (abstract).
Rosenberg teaches displaying, on the display, an impedance indicator that is configured with a plurality of spokes (para. [0023], FIG. 9 represents an illustration of a radar-plot of baseline impedance that may be provided in a sector of GUI display; para. [0025], FIG. 11 represents an illustration of a circle bar plot of baseline impedance that may be provided in a sector in GUI display), each of the spokes respectively associated with respective ones of the spline electrodes (fig. 3, electrodes 33; para. [0072], fig. 9, Illustration 300 includes a depiction of each of the electrodes 1-10. Overlaid on the electrode depiction is an initial impedance 206. Initial impedance 206 may include an impedance value for each of the depicted electrodes; fig. 11, para. [0077], Overlaid on the electrode depiction is an initial impedance 507. Initial impedance 507 may include an impedance value for each of the depicted electrodes.),
wherein each of the spokes is configured to represent the baseline impedance value (para. [0023], FIG. 9 represents an illustration of a radar-plot of baseline impedance that may be provided in a sector of GUI display; para. [0075], initial impedance value 206; fig. 11, para. [0077], Overlaid on the electrode depiction is an initial impedance 507.);
altering, by the at least one processor, as a function of the change in impedance, at least one respective spoke of the impedance indicator to generate an altered impedance indicator; displaying, on the display, the altered impedance indicator (para. [0024], FIG. 10 represents an illustration of a radar-plot of baseline impedance and real-time impedance during and/or at end of ablation, that may be provided in a sector of GUI display; para. [0074], [0075], impedance value 216; para. [0026], [0080], FIG. 12 represents an illustration of circle bar plot of baseline impedance and real-time impedance during and/or at end of ablation, that may be provided in second sector for display in GUI display.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Gross, by adding a display and steps of displaying, on the display, an impedance indicator that is configured with a plurality of spokes, each of the spokes respectively associated with respective ones of the spline electrodes, wherein each of the spokes is configured to represent the baseline impedance value; altering, by the at least one processor, as a function of the change in impedance, at least one respective spoke of the impedance indicator to generate an altered impedance indicator; displaying, on the display, the altered impedance indicator, as taught by Rosenberg, for the purpose of guiding medical professional 14 through the procedure by providing display of relevant pre-ablation, ablation and post-ablation data, recommendations, notifications, and alerts (para. [0044]).
Re Claim 15, Gross as modified by Rosenberg discloses the claimed invention substantially as set forth in claim 14.
Gross is silent regarding wherein each of the spokes is configured to have a length to represent the baseline, and further wherein altering the at least one spoke comprises extending the length of the at least one respective spoke.
However, Rosenberg discloses that each of the spokes is configured to have a length to represent the baseline (para. [0023], FIG. 9 represents an illustration of a radar-plot of baseline impedance that may be provided in a sector of GUI display; para. [0075], initial impedance value 206; fig. 11, para. [0077], Overlaid on the electrode depiction is an initial impedance 507.), and further wherein altering the at least one spoke comprises extending the length of the at least one respective spoke (para. [0024], FIG. 10 represents an illustration of a radar-plot of baseline impedance and real-time impedance during and/or at end of ablation, that may be provided in a sector of GUI display; para. [0074], [0075], impedance value 216; para. [0026], [0080], FIG. 12 represents an illustration of circle bar plot of baseline impedance and real-time impedance during and/or at end of ablation, that may be provided in second sector for display in GUI display.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Gross as modified by Rosenberg, by configuring each of the spokes to have a length to represent the baseline, and configuring altering the at least one spoke to comprise extending the length of the at least one respective spoke, as taught by Rosenberg, for the purpose of guiding medical professional 14 through the procedure by providing display of relevant pre-ablation, ablation and post-ablation data, recommendations, notifications, and alerts (para. [0044]).
Re Claims 16-18, Gross as modified by Rosenberg discloses the claimed invention substantially as set forth in claim 14.
Gross discloses defining, by the at least one processor, a threshold impedance value (para. [0057]-[0061], [0016]-[0022], a threshold level of contact which is based on the electrode-tissue impedance).
Gross is silent regarding wherein each of the spokes is configured with a color to represent the baseline, and further wherein altering the at least one spoke comprises changing the color of the at least one respective spoke when the detected local impedance crosses the threshold value; defining, by the at least one processor, a plurality of threshold impedance values, further wherein altering the at least one spoke comprises altering the changed color of the at least one respective spoke when the detected local impedance crosses each of the plurality of threshold values, wherein altering the color comprises: altering at least one of the changed color’s intensity, shade, hue, saturation, and brightness.
Rosenberg discloses that wherein each of the spokes is configured with a color to represent the baseline, and further wherein altering the at least one spoke comprises changing the color of the at least one respective spoke when the detected local impedance crosses the threshold value; defining, by the at least one processor, a plurality of threshold impedance values, further wherein altering the at least one spoke comprises altering the changed color of the at least one respective spoke when the detected local impedance crosses each of the plurality of threshold values, wherein altering the color comprises: altering at least one of the changed color’s intensity, shade, hue, saturation, and brightness (fig. 6D, coloring according to impedance drop from low to high; para. [0060], a preference 670 may be used to select if the indicators are based on impedance and/or temperature measurements by the balloon electrodes. If the impedance is within a certain range of values, and/or the temperature is below a certain value, it is a good surrogate for contact of the electrode with the tissue. The color setting may be set to indicate color tones; para. [0064], [0066], Representation 1010D includes dynamic coloring of the electrodes on the 2D view, according to the values of impedance drop.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Gross as modified by Rosenberg, configuring each of the spokes with a color to represent the baseline, and further wherein altering the at least one spoke comprises changing the color of the at least one respective spoke when the detected local impedance crosses the threshold value; defining, by the at least one processor, a plurality of threshold impedance values, further wherein altering the at least one spoke comprises altering the changed color of the at least one respective spoke when the detected local impedance crosses each of the plurality of threshold values, wherein altering the color comprises: altering at least one of the changed color’s intensity, shade, hue, saturation, and brightness, as taught by Rosenberg, for the purpose of guiding medical professional 14 through the procedure by providing display of relevant pre-ablation, ablation and post-ablation data, recommendations, notifications, and alerts (para. [0044]).
Re Claim 19, Gross discloses that the at least one catheter further includes a center electrode (fig. 1, para. [0302], an intracorporeal reference electrode 50).
Re Claim 20, Gross discloses that the at least one catheter includes a treatment catheter and a mapping catheter (para. [0299], system 20 is configured to stimulate, sense, and/or ablate the nerve tissue of the blood vessel; para. [0190], [0234], [0344], The control circuitry is configured to activate the at least one intrarenal electrode to ablate a renal nerve of the subject, in response to the level of contact being at least a threshold level of contact; para. [0303], A level of contact between at least one intrarenal electrode 44 and wall 110 of renal artery 108 is ascertained. The contact of each of intrarenal electrodes 44 is separately ascertained, or of each pair 42 of intrarenal electrodes 44, and, optionally, separately outputted to the user of the system. Further alternatively, the contact level of intrarenal electrodes 44 in more than one pair is simultaneously ascertained.).
Re Claim 22, Gross discloses a system for delivering therapeutic ablative energy to tissue (para. [0299], a system 20 for ablating and/or stimulating nerve tissue of a blood vessel of a subject, such as a renal artery), the system comprising:
at least one catheter (fig. 1, para. [0299], an elongate shaft 40);
an energy delivery body configured with the at least one catheter (para. [0299], system 20 is configured to stimulate, sense, and/or ablate the nerve tissue of the blood vessel; para. [0303], fig. 1, figs. 2A, 2B, During activation of electrode unit 30 for ablating nerve tissue, as described above, it is important that there be good contact between intrarenal electrodes 71 and a wall 119 of renal artery 108; para. [0305], apply electrical pulses between a pair of electrodes, such as between (a) pair 42 of intrarenal electrodes 44),
wherein the energy delivery body includes a plurality of spline electrodes that are arranged circumferentially to form a basket structure (fig. 1, para. [0299], [0300], In FIG. 1, electrode unit 30 comprises four pairs 42 of intrarenal electrodes 44, Electrode unit 30 typically further comprises one or more support struts 46, to which intrarenal electrodes 44 are fixed.);
a reference electrode located within the basket structure (fig. 1, para. [0302], an intracorporeal reference electrode 50) and configured to function as an impedance sensor (para. [0158], electrode-tissue impedance; para. [0305], control circuitry 70 is configured to apply electrical pulses between a pair of electrodes, such as between (a) pair 42 of intrarenal electrodes 44, (b) one of intrarenal electrodes 44 and intracorporeal reference electrode 50, or (c) one of intrarenal electrodes 44 and external ground electrode 52, para. [0306], calculate at least one time-varying component of electrode-tissue impedance based on applying the pulses);
at least one processor configured by executing instructions stored on processor-readable media to process information associated with the impedance sensor (para. [0304]-[0309], control circuitry 70 configured to calculate at least one time-varying component of electrode-tissue impedance based on applying the pulses); and
a user interface that is configured to provide information processed by the at least one processor (fig. 1, para. [0004], [0010], [0229], a user interface is configured to output the level of contact),
wherein the at least one processor is further configured to:
calculate an initial baseline impedance value for each of the plurality of spline electrodes, wherein the baseline impedance value for each spline electrode is based on impedance sensed by the impedance sensor (para. [0316], a calibration process is performed outside the subject's body (e.g., In saline solution), or inside the subject's body (for example, in the aorta), to measure the impedance when there is no contact between intrarenal electrodes 44 and the wall of the renal artery. This calibration measurement may serve as a predefined value for the threshold that is used to ascertain the level of contact between the intrarenal electrodes and the wall of the renal artery.); and
wherein the tissue modification apparatus delivers the therapeutic energy via the energy delivery body (para. [0299], system 20 is configured to stimulate, sense, and/or ablate the nerve tissue of the blood vessel; para. [0303], fig. 1, figs. 2A, 2B, During activation of electrode unit 30 for ablating nerve tissue, as described above, it is important that there be good contact between intrarenal electrodes 71 and a wall 119 of renal artery 108).
Gross is silent regarding a display and the at least one processor further configured to: display, on the display, an impedance indicator that indicates, for each spline electrode a change in impedance from the baseline impedance value to a present impedance value measured in real time by the impedance sensor for the respective spline electrode.
Rosenberg discloses an ablation catheter with a basket, a plurality of electrodes disposed on the surface, and a graphical user interface (abstract).
Rosenberg teaches that the at least one processor further configured to: display, on the display, an impedance indicator that indicates, for each spline electrode a change in impedance from the baseline impedance value to a present impedance value measured in real time by the impedance sensor for the respective spline electrode (para. [0023], FIG. 9 represents an illustration of a radar-plot of baseline impedance that may be provided in a sector of GUI display; para. [0025], FIG. 11 represents an illustration of a circle bar plot of baseline impedance that may be provided in a sector in GUI display; para. [0024], FIG. 10 represents an illustration of a radar-plot of baseline impedance and real-time impedance during and/or at end of ablation, that may be provided in a sector of GUI display; para. [0074], [0075], impedance value 216; para. [0026], [0080], FIG. 12 represents an illustration of circle bar plot of baseline impedance and real-time impedance during and/or at end of ablation, that may be provided in second sector for display in GUI display; para. [0072], [0077] – depiction of each of the electrodes).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Gross, by adding a display and configuring the at least one processor to: display, on the display, an impedance indicator that indicates, for each spline electrode a change in impedance from the baseline impedance value to a present impedance value measured in real time by the impedance sensor for the respective spline electrode, as taught by Rosenberg, for the purpose of guiding medical professional 14 through the procedure by providing display of relevant pre-ablation, ablation and post-ablation data, recommendations, notifications, and alerts (para. [0044]).
Re Claim 24, Gross discloses that the reference electrode is located at a proximal end of the basket (para. [0302], system 20 further comprises an intracorporeal reference electrode 50, which is configured to be disposed in the renal artery not in contact with the wall of the renal artery, intracorporeal reference electrode 50 may be positioned, for example, on central shaft 48 of electrode unit 30 (e.g., as shown, or elsewhere, such as at a distal tip of electrode unit 30), or on elongate shaft 40 (e.g., similar to sensor 60, as described below)).
Re Claim 25, Gross discloses that the baseline impedance value and the present impedance value for each spline electrode are based on an impedance calculation between the reference electrode and the respective spline electrode (para. [0305], control circuitry 70 is configured to apply electrical pulses between a pair of electrodes, such as between (a) pair 42 of intrarenal electrodes 44, (b) one of intrarenal electrodes 44 and intracorporeal reference electrode 50, or (c) one of intrarenal electrodes 44 and external ground electrode 52, para. [0306], calculate at least one time-varying component of electrode-tissue impedance based on applying the pulses).
Re Claim 27, Gross discloses that the processor is further configured to calculate for each spline electrode a contact stability value and compare it to a threshold contact stability value to determine whether the respective electrode contact with tissue is stable over a predetermined period of time (para. [0057]-[0061], (c) based on the electrical signal, ascertain a level of contact between the at least one intrarenal current-application electrode and a wall of the renal artery. In response to the level of contact being less than a threshold level of contact, adjusting a disposition of the at least one intrarenal current-application electrode in the renal artery; para. [0120]-[0127], the control circuitry to ascertain the level of contact based on a shape of the time-varying signal rate).
Claims 13 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Gross (US 2017/0007157A1) as modified by Rosenberg et al. (US 2021/0082157) and further in view of Truckai et al. (US 2007/0118144A1).
Re Claim 13, Gross as modified by Rosenberg discloses the claimed invention substantially as set forth in claim 1.
Gross and Rosenberg is silent regarding haptics configured with the at least one catheter, wherein the processor is further configured to: provide haptic-based feedback associated with a state of the impedance indicator.
However, Truckai discloses a system 100 provides means for ohmically heating a body structure about the surface of the expanding plume 165 of fill material to effectively seal intravertebral vasculature to prevent emboli from entering the venous system (para. [0095]) and teaches haptics configured with the at least one catheter, wherein the processor is further configured to: provide haptic-based feedback associated with a state of the impedance indicator (para. [0124], In FIG. 16, it can be seen that the retrograde flow 290 of bone cement 120 along the cannula 110A passes by, and in one embodiment may contact, first and second electrodes 280a and 280b, which will alter the impedance (or other sensed parameter) measured between the first and second electrodes 280a, 280b from the normal tissue impedance. The control algorithms advantageously create a signal to notify the physician of the variation in impedance measurement. The signal can be a tone, a visual signal such as a light and or a tactile signal such as a vibrator in the handle of the introducer 110A; para. [0140], In one embodiment, the electrodes 565a, 565b can be used to sense a retrograde flow of bone cement, where the signals (e.g., of impedance as discussed above) are communicated to the controller 125B, which in turn generates a signal (e.g., visual, tactile, auditory) to notify the operator of the retrograde flow, as discussed above.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Gross as modified by Rosenberg, by adding haptics configured with the at least one catheter, wherein the processor is further configured to: provide haptic-based feedback associated with a state of the impedance indicator, as taught by Truckai, for the purpose of notifying the physician of the variation in impedance measurement (para. [0124]).
Re Claim 28, Gross as modified by Rosenberg discloses the claimed invention substantially as set forth in claim 22.
Gross discloses that the processor is configured to determine that at least a threshold degree of contact between the energy delivery body and tissue has been achieved and that delivery of the therapeutic energy can begin (para. [0053], [0190], [0343], the control circuitry is configured to activate the at least one intrarenal electrode to apply an excitatory current to a renal nerve of the subject, in response to the level of contact being at least a threshold level of contact).
Gross is silent regarding the processor further configured to provide haptic feedback to a user by generating a vibration or pulse in a handle of the at least one catheter which provides confirmation that at least a threshold degree of contact between the energy delivery body and tissue has been achieved and delivery of the therapeutic energy can begin.
However, Truckai discloses a system 100 provides means for ohmically heating a body structure about the surface of the expanding plume 165 of fill material to effectively seal intravertebral vasculature to prevent emboli from entering the venous system (para. [0095]) and teaches that the processor further configured to provide haptic feedback to a user by generating a vibration or pulse in a handle of the at least one catheter associated with a state of the impedance indicator (para. [0123], [0124], In FIG. 16, it can be seen that the retrograde flow 290 of bone cement 120 along the cannula 110A passes by, and in one embodiment may contact, first and second electrodes 280a and 280b, which will alter the impedance (or other sensed parameter) measured between the first and second electrodes 280a, 280b from the normal tissue impedance. The control algorithms advantageously create a signal to notify the physician of the variation in impedance measurement. The signal can be a tone, a visual signal such as a light and or a tactile signal such as a vibrator in the handle of the introducer 110A; para. [0140], In one embodiment, the electrodes 565a, 565b can be used to sense a retrograde flow of bone cement, where the signals (e.g., of impedance as discussed above) are communicated to the controller 125B, which in turn generates a signal (e.g., visual, tactile, auditory) to notify the operator of the retrograde flow, as discussed above.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Gross as modified by Rosenberg, by configuring the processor to provide haptic feedback to a user by generating a vibration or pulse in a handle of the at least one catheter which provides confirmation that at least a threshold degree of contact between the energy delivery body and tissue has been achieved and delivery of the therapeutic energy can begin, as taught by Truckai, for the purpose of notifying the physician of the variation in impedance measurement (para. [0124]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Gross (US 2017/0007157A1) as modified by Rosenberg et al. (US 2021/0082157) and further in view of Solomon (US 2008/0312521 A1).
Re Claim 21, Gross as modified by Rosenberg discloses the claimed invention substantially as set forth in claim 14.
Gross is silent regarding the baseline impedance value being determined by measuring impedance in blood.
However, Solomon discloses system and method for determining electrode-tissue contact using phase difference (abstract) and teaches that the baseline impedance value is determined by measuring impedance in blood (para. [0004], A baseline impedance measurement can be taken when the electrode is known to reside entirely within the blood stream, and contact with tissue is assumed to have occurred when the impedance has increased by a predetermined amount set empirically for a given system.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Gross as modified by Rosenberg, by determining the baseline impedance by measuring impedance in blood, as taught by Solomon, for the purpose of detecting contact with tissue when the impedance has increased from the baseline (para. [0004]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Gross (US 2017/0007157A1) as modified by Rosenberg et al. (US 2021/0082157) and further in view of Elia et al. (US 2019/0313970A1).
Re Claim 10, Gross as modified by Rosenberg discloses the claimed invention substantially as set forth in claim 1.
Gross and Rosenberg are silent regarding the impedance indicator representing a sum of all electrode inputs in the form of a vector.
Elia discloses an apparatus for monitoring for accumulation of lung fluid comprises a feeding tube having first electrode(s) positioned thereon for electrical contact with tissue of an esophagus of a target patient including a lower esophageal sphincter (LES) and/or tissue in proximity to the LES, second electrode(s) sized and shaped for contacting skin of the target patient (abstract) and teaches that the impedance indicator representing a sum of all electrode inputs in the form of a vector (para. [0153], [0190], The impedance score is computed based on the complex impedance value. The impedance score may be computed, for example, as the vector length of a vector representation of the complex impedance value, the value of the real component of the complex impedance value, and/or the value of the imaginary component of the complex impedance value. The impedance score may be computed as an aggregation of multiple sub-impedance scores each computed for an impedance value measured at a certain AC frequency. Alternatively or additionally, the impedance score may be computed as an aggregation of multiple sub-impedance scores each computed for a distinct pair of electrodes, when the feeding tube includes multiple intra-body electrodes and/or when multiple extracorporeal electrodes are positioned on the skin of the patient.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Gross as modified by Rosenberg, by configuring the impedance indicator to represent a sum of all electrode inputs in the form of a vector, as taught by Elia, for the purpose of determining a reflux event, monitoring correct positioning of the tube, and/or estimating amount of fluid in the stomach (para. [0013]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gross (US 2017/0007157A1) as modified by Rosenberg et al. (US 2021/0082157) and Elia et al. (US 2019/0313970A1) and further in view of Valderrabano (US 2019/0059782A1).
Re Claim 11, Gross as modified by Rosenberg and Elia discloses the claimed invention substantially as set forth in claims 1 and 10.
Elia further discloses displaying impedance score as a value on a graph within a graphical user interface (para. [0037]) and generating tomographical impedance map of fluid in the lung according to their respective locations (para. [0108]); thus, Elia discloses a mapping component (para. [0108]).
Gross, Rosenberg, and Elia are silent regarding the at least one processor is further configured to transmit, to the mapping component the vector, and further wherein the mapping component displays the vector as a three-dimensional vector on a moving catheter graphic.
However, Valderrabano discloses an ablation catheter, an esophageal electrode, and an electric meter (para. [0025]) and teaches a three-dimensional mapping system coupled to the electric meter to receive data associated with atrio-esophageal electric coupling and configured to process and render, via a display, a three-dimensional representation of the atrio-esophageal impedance (para. [0025], [0026], para. [0031], [0032], para. [0082], The 3D mapping system acquires three-dimensional coordinates (e.g., x, y, and z coordinates) of the ablation catheter tip electrode as the catheter is moved, or roved, around the left atrium.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Gross as modified by Rosenberg and Elia, by configuring the at least one processor to transmit, to the mapping component the vector, and further wherein the mapping component displays the vector as a three-dimensional vector on a moving catheter graphic, as taught by Valderrabano, for the purpose of indicating and/or highlighting areas of risk, particularly, areas of high risk (para. [0031], [0032], the atrio-esophageal electric coupling map has a color scheme that indicates regions of high electric coupling, wherein the regions identify heart tissues having proximity to the esophagus and likely to be associated with esophageal damage if ablative energy is applied there or nearto; para. [0081], visualization of 3D mapping of atrio-esophageal impedance, in areas in the heart, may be performed, during ablation procedures, to indicate and/or highlight areas of risk, particularly, areas of high risk.).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gross (US 2017/0007157A1) as modified by Rosenberg et al. (US 2021/0082157) and further in view of Sulkin (CN 110891508 A – Please refer to the translation copy provided).
Re Claim 12, Gross as modified by Rosenberg discloses the claimed invention substantially as set forth in claim 1.
Gross and Rosenberg are silent regarding the processor further configured to: determine a summative impedance vector/direction by principal component analysis or a statistical analysis using time-varying data.
Sulkin discloses an electrophysiology system comprising a catheter having a flexible catheter body with a distal portion; and an electrode disposed on the distal portion (abstract; page 5, ablation catheter 102 may be used to map and/or ablate myocardial tissue using ring electrodes 118A, 118B, and 118C, electrodes 122A, 122B, and 122C, and/or tissue ablation electrode 120 when in a patient’s vasculature or heart) and teaches a processor further configured to: determine a summative impedance vector/direction by principal component analysis or a statistical analysis using time-varying data (page 8, multiple impedance measurement may be aggregated using statistical or other mathematical methods to determine an impedance metric. For example, impedance measurements from various sets of electrodes may be assigned corresponding weights (eg, based on electrode location, signal quality, etc.), and weighted averages or other linear or non-linear combinations of weighted impedance measurements may be determined and used); page 9, the mapping processor determines based on local impedance metrics (eg, initial local impedance, change (eg, increase or decrease) in local impedance, integral of the impedance signal over time, derivative of the impedance signal over time, etc.) damage characteristics.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Gross as modified by Rosenberg, by configuring the processor to: determine a summative impedance vector/direction by principal component analysis or a statistical analysis using time-varying data, as taught by Sulkin, for the purpose of determining damage characteristics based on a local impedance measure (page 8 and page 9).
Allowable Subject Matter
Claims 29 and 30 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
The closest prior art is JP 2014528328, which teaches signal quality associated with each of the plurality of active electrode areas being compared to select which electrodes to use for collecting physiological data (para. [0008]). It also discloses a detection module configured to detect contact between at least two adjacent electrode tiles of the biopotential array and the user's skin and electrically coupling the at least two adjacent electrode tiles to form an active electrode area in the biopotential electrode array (para. [0010]).
However, JP 2014528328 is silent regarding a processor configured to determine an integrity of the present impedance value of one respective spline electrode by comparing the present impedance value of one respective spline electrode to the present impedance value of adjacent spline electrodes.
Claim 29 and claims dependent thereon in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, in combination with other limitations of the claim, the processor configured to determine an integrity of the present impedance value of one respective spline electrode by comparing the present impedance value of one respective spline electrode to the present impedance value of adjacent spline electrodes.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, July 25, 2026Examiner, Art Unit 3792
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