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
Amendments filed 04/21/2025 have been entered. Claims 1-2, 7, 9-14, 18-19, and 21-24 have been amended. Claims 25-29 have been added. Claims 1-2, 6-7, 9-14, 18-19, and 21-29 are pending on the application.
Response to Arguments
Applicant’s arguments filed 04/21/2025 have been considered but are not persuasive.
Applicant has moderately amended the language of independent claims 1 and 13, but has not substantially altered the claimed material.
Applicant agrees that the method of operation of the device is consistent with the Carto 3 system, but claims that theirs is a “new way of using Carto 3 body surface patches”, by setting a weight to each patch corresponding to a location or relative location on the body.
Applicant argues that Cho (US 20130109994 A1) in view of Rodriguez (US 20200022649 A1), and further in view of Krimsky (US 20190175057 A1) fails to disclose or suggest "comput[ing] an index of a measurement of diaphragm movement" and "providing a higher weight for indexing purposes to the first body surface patch than the second body surface patch based on the relative locations indicating that the first body surface patch is located closer to the diaphragm than the second body surface patch".
However, Krimsky discloses par [0073] “Processor 204 may also apply different weights to different reference sensors 174. For example, reference sensors 174 that are closer to the region of interest may be weighted heavier than reference sensors 174 that are further away from the region of interest”, clearly demonstrating that the phrenic nerve would be obvious to use as considered a region of interest by the disclosure of Cho (Cho, par [0045]), and as such the disclosure of Cho in view of Rodrigue and Krimsky would indeed suggest setting such weights as claimed by the amended claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 27 rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 27 recites “wherein increasing the alert increases in brightness” in line 1-2 of the claim. This limitation is incomprehensible and as such the boundaries of the limitation are unclear. However, for examination purposes, the limitation will be taken as meaning something similar to “wherein increasing the strength of the alert includes an increase in brightness”.
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 1-2, 6-7, 9-14, 18-19, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Cho (US 20130109994 A1) in view of Rodriguez (US 20200022649 A1), and further in view of Krimsky (US 20190175057 A1).
Regarding Claim 1, Cho discloses
An ablation system, comprising:
a catheter including at least one electrode, and configured to be inserted into a chamber of a heart of a living subject (Cho Fig 4 (14) par [0028]);
an ablation power generator configured to apply an electrical signal to the at least one electrode to ablate tissue of the chamber (Cho Fig 4 (22) par [0030]);
a body surface patch, the body surface patch being configured to be applied to a body surface of the living subject, and provide at least one signal (Cho Fig 4 body surface patch (12,30) par [0035] surface patch may include sensors such as accelerometers),
wherein sensing-electrodes of the catheter supply signals that are detected (Cho par [0031] catheter 14 may include sensors), and
a processor (Cho Fig 4 (16) par [0034]) configured to: compute an index of a measurement of diaphragm movement responsively to the at least one signal (Cho par [0041]),
output an alert to an output device responsively to the index (Cho par [0044]);
output the alert to the output device responsively to the index exceeding a given threshold (Cho par [0045]);
receive a user input setting the given threshold (Cho par [0041]); and perform an action responsively to the index (Cho par [0039]),
wherein the index is indicative of a status of a phrenic nerve of the living subject (Cho par [0045]).
Cho fails to explicitly disclose
at least a first and a second body surface patch,
provide at least one position signal
each body surface patch including a magnetic sensor, the at least one position signal being determined by an impedance-based position-tracking method,
wherein sensing-electrodes of the catheter supply signals that are detected at the first and second body surface patches and are correlated with a matrix,
wherein the matrix maps an impedance measured by the sensing-electrodes with a position that was previously acquired from magnetic location-calibrated position signals, the magnetic sensor being configured to provide respective position signals responsively to sensing alternating magnetic fields generated by magnetic field generator coils,
wherein relative locations of the first and second body surface patches are determined based on the respective magnetic sensors of the first and second body surface patches responsive to the alternating magnetic fields;
wherein computing the index includes weighting the at least one position signal of each body surface patch according to a proximity of the respective body surface patch to a diaphragm of the living subject, and providing a higher weight for indexing purposes to the first body surface patch than the second body surface patch based on the relative locations indicating that the first body surface patch is located closer to the diaphragm than the second body surface patch;
wherein the index is indicative of proximity of the at least one electrode to a phrenic nerve of the living subject.
However, Rodriguez discloses a system in the same field of endeavor comprising the Carto 3 module (Rodriguez par [0371]; compare with instant Spec page 14 first paragraph) and using an impedance-based position-tracking method wherein sensing-electrodes of the catheter supply signals that are detected at the first and second body surface patches and are correlated with a matrix (Rodriguez par [0159-0160] impedance may be measured between sensing electrode of catheter and external body surface sensor; see also par [0212]), wherein the matrix maps an impedance measured by the sensing-electrodes with a position that was previously acquired from magnetic location-calibrated position signals (Rodriguez par [0164]), the magnetic sensor being configured to provide position signals responsively to sensing alternating magnetic fields generated by magnetic field generator coils (Rodriguez par [0371] may use Carto 3 module).
Furthermore, Krimsky discloses a system for measuring movement of a chest using at least a first and a second body surface patch (Krimsky, Fig 1 body surface patches (174), par [0058]) configured to provide at least one position signal (Krimsky par [0047]), each body surface patch including a magnetic sensor, the at least one position signal being determined by a position-tracking method (Krimsky par [0042]), wherein sensors of the catheter supply signals that are detected (Krimsky Fig 1 (194) par [0044,0048]), wherein the system maps a signal measured by the sensing-electrodes with a position that was previously acquired from magnetic location-calibrated position signals (Krimsky par [0048,0071]), the magnetic sensor being configured to provide respective position signals (Krimsky par [0041-0042] detected sensor positions),
wherein relative locations of the first and second body surface patches are determined based on the respective magnetic sensors of the first and second body surface patches (Krimsky par [0042]; knowing the location of each sensor inherently determines their relative positions);
wherein computing the index includes weighting the at least one position signal of each body surface patch according to a proximity of the respective body surface patch to a region of interest of the living subject, and providing a higher weight for indexing purposes to the first body surface patch than the second body surface patch based on the relative locations indicating that the first body surface patch is located closer to the region of interest than the second body surface patch (Krimsky, Fig 1 body surface patches (174), par [0058] the position signal from body surface patch 174 may be weighted based on, for example, a distance from the region of interest);
wherein the index is indicative of proximity of the at least one electrode to a phrenic nerve of the living subject.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Cho to utilize more modern mapping technologies such as the Carto 3 system such as disclosed by Rodriguez, as the Carto 3 can collect and process data and present parameters and indices to the operator (Rodriguez par [0371]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Cho in view of Rodriguez with the weighting system of Krimsky so as to better track thoracic motion, as such a manner of weighting for proximity to the region of interest allows for preferential selection of the sensors in question (Krimsky, par [0073] can exclude sensors not measuring diaphragm movement).
Regarding Claim 2, Cho in view of Rodriguez and Krimsky discloses the system according to claim 1. Cho further discloses wherein the processor is configured to control the ablation power generator responsively to the index (Cho par [0039]).
Regarding Claim 6, Cho in view of Rodriguez and Krimsky discloses the system according to claim 1. Cho further discloses wherein the alert is selected from a group consisting of: a current value of the index; an alert message; a tactile alert; and an audio alert (Cho par [0038] visual or audible alert).
Regarding Claim 7, Cho in view of Rodriguez and Krimsky discloses the system according to claim 1. Cho further discloses wherein the processor is configured to: compute indices of the measurement of diaphragm movement over time responsively to at least one of the position signals (Cho Fig 8 (114,116) par [0045]); and
output the alert to the output device while adjusting a strength of the alert responsively to the indices over time (Cho par [0031-0032] one or more alerts may be generated in response to computed indices; alert going from off or 0% to on or 100% is adjusting a strength of the alert).
Regarding Claim 9, Cho in view of Rodriguez and Krimsky discloses the system according to claim 1. Krimsky further discloses wherein multiple position signals are combined from the first and second body surface patches to compute the index (Krimsky par [0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Cho in view of Rodriguez with the weighting system of Krimsky so as to better create detailed and accurate models (Krimsky par [0058]).
Regarding Claim 10, Cho in view of Rodriguez and Krimsky discloses the system according to claim 1. Cho further discloses wherein: the first and second body surface patches each comprise at least one respective electrode (Cho par [0037]), and wherein the processor is configured to compute the index responsively to the at least one position signal (Cho par [0041]). Cho fails to explicitly disclose that the electrode is configured to provide the at least one position signal.
However, Rodriguez discloses using a tracking system including position signals based on body surface patch electrodes (Rodriguez par [0166]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Cho to use more modern mapping technology such as a Carto 3 system, as the Carto 3 can collect and process data and present parameters and indices to the operator (Rodriguez par [0371]).
Regarding Claim 11, Cho in view of Rodriguez and Krimsky discloses the system according to claim 1. Cho further discloses wherein the processor is configured to compute the index responsively to a measurement of velocity of the diaphragm movement (Cho par [0035] sensor may be accelerometer which measures velocity and acceleration).
Regarding Claim 12, Cho in view of Rodriguez and Krimsky discloses the system according to claim 1. Cho further discloses wherein the processor is configured to compute the index responsively to a measurement of acceleration of the diaphragm movement (Cho par [0035] sensor may be accelerometer which measures velocity and acceleration).
Regarding Claim 13, Cho discloses
An ablation method, comprising:
applying an electrical signal to at least one electrode of a catheter inserted into a chamber of a heart of a living subject to ablate tissue of the chamber (Cho Fig 4 (14) par [0028]);
providing at least one signal (Cho par [0035]),
a body surface patch being attached to a body surface of the living subject (Cho Fig 4 body surface patch (12,30) par [0035]);
wherein sensing-electrodes of the catheter supply signals that are detected (Cho par [0031] catheter 14 may include sensors)
computing an index of a measurement of diaphragm movement responsively to the at least one signal (Cho par [0041]),
outputting an alert to an output device responsively to the index (Cho par [0044]), wherein the outputting includes outputting the alert to the output device responsively to the index exceeding a given threshold (Cho par [0045]);
receiving a user input setting the given threshold (Cho par [0041]); and
performing an action responsively to the index (Cho par [0039]),
wherein the index is indicative of a status of a phrenic nerve of the living subject (Cho par [0045]).
Cho fails to explicitly disclose
at least a first and a second body surface patch,
providing at least one position signal
each body surface patch including a magnetic sensor, the at least one position signal being determined by an impedance-based position-tracking method,
wherein sensing-electrodes of the catheter supply signals that are detected at the first and second body surface patches and are correlated with a matrix,
wherein the matrix maps an impedance measured by the sensing-electrodes with a position that was previously acquired from magnetic location-calibrated position signals, the magnetic sensor being configured to provide respective position signals responsively to sensing alternating magnetic fields generated by magnetic field generator coils,
wherein relative locations of the first and second body surface patches are determined based on the respective magnetic sensors of the first and second body surface patches responsive to the alternating magnetic fields;
providing a higher weight for indexing purposes to a first position signal of the first body surface patch than a second position signal of the second body surface patch based on the relative locations indicating that the first body surface patch is located closer to the diaphragm than the second body surface patch, wherein the at least one position signal includes the first and second position signals;
wherein the index is indicative of proximity of the at least one electrode to a phrenic nerve of the living subject.
However, Rodriguez discloses a system in the same field of endeavor comprising the Carto 3 module (Rodriguez par [0371]; compare with instant Spec page 14 first paragraph) and using an impedance-based position-tracking method wherein sensing-electrodes of the catheter supply signals that are detected at the first and second body surface patches and are correlated with a matrix (Rodriguez par [0159-0160] impedance may be measured between sensing electrode of catheter and external body surface sensor; see also par [0212]), wherein the matrix maps an impedance measured by the sensing-electrodes with a position that was previously acquired from magnetic location-calibrated position signals (Rodriguez par [0164]), the magnetic sensor being configured to provide position signals responsively to sensing alternating magnetic fields generated by magnetic field generator coils (Rodriguez par [0371] may use Carto 3 module).
Furthermore, Krimsky discloses a system for measuring movement of a chest using at least a first and a second body surface patch (Krimsky, Fig 1 body surface patches (174), par [0058]) configured to provide at least one position signal (Krimsky par [0047]), each body surface patch including a magnetic sensor, the at least one position signal being determined by a position-tracking method (Krimsky par [0042]), wherein sensors of the catheter supply signals that are detected (Krimsky Fig 1 (194) par [0044,0048]), wherein the system maps a signal measured by the sensing-electrodes with a position that was previously acquired from magnetic location-calibrated position signals (Krimsky par [0048,0071]), the magnetic sensor being configured to provide respective position signals (Krimsky par [0041-0042] detected sensor positions),
wherein relative locations of the first and second body surface patches are determined based on the respective magnetic sensors of the first and second body surface patches (Krimsky par [0042]; knowing the location of each sensor inherently determines their relative positions);
wherein computing the index includes weighting the at least one position signal of each body surface patch according to a proximity of the respective body surface patch to a region of interest of the living subject, and providing a higher weight for indexing purposes to the first body surface patch than the second body surface patch based on the relative locations indicating that the first body surface patch is located closer to the region of interest than the second body surface patch (Krimsky, Fig 1 body surface patches (174), par [0058] the position signal from body surface patch 174 may be weighted based on, for example, a distance from the region of interest);
wherein the index is indicative of proximity of the at least one electrode to a phrenic nerve of the living subject.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Cho to utilize more modern mapping technologies such as the Carto 3 system such as disclosed by Rodriguez, as the Carto 3 can collect and process data and present parameters and indices to the operator (Rodriguez par [0371]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Cho in view of Rodriguez with the weighting system of Krimsky so as to better track thoracic motion, as such a manner of weighting for proximity to the region of interest allows for preferential selection of the sensors in question (Krimsky, par [0073] can exclude sensors not measuring diaphragm movement).
Regarding Claim 14, Cho in view of Rodriguez and Krimsky discloses the method according to claim 13. Cho further discloses controlling an ablation power generator responsively to the index (Cho par [0039]).
Regarding Claim 18, Cho in view of Rodriguez and Krimsky discloses the method according to claim 13. Cho further discloses wherein the alert is selected from a group consisting of: a current value of the index; an alert message; a tactile alert; and an audio alert (Cho par [0038] visual or audible alert).
Regarding Claim 19, Cho in view of Rodriguez and Krimsky discloses the method according to claim 13. Cho further discloses computing indices of the measurement of diaphragm movement over time responsively to at least one of the position signals (Cho Fig 8 (114,116) par [0045]), wherein the outputting includes outputting the alert to the output device while adjusting a strength of the alert responsively to the computed indices over time (Cho par [0031-0032] one or more alerts may be generated in response to computed indices; alert going from off or 0% to on or 100% is adjusting a strength of the alert).
Regarding Claim 21, Cho in view of Rodriguez and Krimsky discloses the method according to claim 13. Krimsky further discloses wherein multiple position signals are combined from the first and second body surface patches to compute the index (Krimsky par [0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Cho in view of Rodriguez with the weighting system of Krimsky so as to better create detailed and accurate models (Krimsky par [0058]).
Regarding Claim 22, Cho in view of Rodriguez and Krimsky discloses the method according to claim 13. Cho further discloses wherein: a body surface patch comprises at least one respective electrode (Cho par [0037]), and wherein the processor is configured to compute the index responsively to the at least one position signal (Cho par [0041]). Cho fails to explicitly disclose that the electrode is configured to provide the at least one position signal.
However, Rodriguez discloses using a tracking system including position signals based on body surface patch electrodes (Rodriguez par [0166]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Cho to use more modern mapping technology such as a Carto 3 system, as the Carto 3 can collect and process data and present parameters and indices to the operator (Rodriguez par [0371]).
Regarding Claim 23, Cho in view of Rodriguez and Krimsky discloses the method according to claim 13. Cho further discloses wherein the computing includes computing the index responsively to a measurement of velocity of the diaphragm movement (Cho par [0035] sensor may be accelerometer which measures velocity and acceleration).
Regarding Claim 24, Cho in view of Rodriguez and Krimsky discloses the method according to claim 13. Cho further discloses wherein the computing includes computing the index responsively to a measurement of acceleration of the diaphragm movement (Cho par [0035] sensor may be accelerometer which measures velocity and acceleration).
Regarding Claim 28, Cho in view of Rodriguez and Krimsky discloses the system according to claim 1. Cho further discloses wherein the index is computed based on a displacement and an acceleration of the diaphragm movement (Cho acceleration shown in Fig 9-10, see par [0035]; par [0011] amplitude of thoracic excursion is a displacement value).
Cho fails to explicitly disclose computing the index based on velocity.
However, Krimsky discloses using displacement sensors to monitor the patient (Krimsky par [0042]), as well as measuring displacement over time, otherwise known as velocity (Krimsky par [0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Cho to also take into account displacement data and displacement over time (velocity), allowing for a more comprehensive picture of chest movement (Krimsky par [0052]).
Regarding Claim 29, Cho in view of Rodriguez and Krimsky discloses the system according to claim 1. Rodriguez further discloses wherein a current value of the index is numerically displayed on a display device (Rodriguez par [0174] parameters displayed during procedure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Cho to display procedure-relevant information, as such a modification would allow the operating physician to make important decisions during treatment (Rodriguez par [0553])
Claims 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Cho (US 20130109994 A1) in view of Rodriguez (US 20200022649 A1) and Krimsky (US 20190175057 A1), and further in view of Boveja (US 10413185 B1).
Regarding Claims 25 and 27, Cho in view of Rodriguez and Krimsky discloses the system according to claim 1. Cho fails to explicitly disclose wherein a strength or frequency of the alert increases according to a current value of the index, or
wherein increasing the alert increases in brightness based on a current value of the index.
However, Boveja discloses a similar invention for monitoring safety and providing alerts thereby during a cardiac-adjacent medical procedure (Boveja col 17 line 12-14), wherein a strength or frequency of the alert increases according to a current value of the safety-adjacent index and wherein increasing the alert increases in brightness based on a current value of the index (Boveja col 18 line 11-16 audio and visual intensity dependent on value).
Claims 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Cho (US 20130109994 A1) in view of Rodriguez (US 20200022649 A1) and Krimsky (US 20190175057 A1) Boveja (US 10413185 B1), and further in view of Honda (US 20160143684 A1).
Regarding Claim 26, Cho in view of Rodriguez and Krimsky and Boveja discloses the system according to claim 25. Krimsky further discloses an alert using tactile feedback (Krimsky par [0073]). Cho fails to explicitly disclose wherein increasing the frequency of the alert includes providing a higher frequency of tactile feedback to a user of the catheter.
However, Honda discloses an invention in the same field of endeavor, that of energy-based surgical treatment (Honda par [0028]), wherein a change in the notification includes providing a change in tactile feedback (Honda par [0100]). As the only options to change the tactile feedback are to increase or decrease the strength or frequency of the feedback, these changes may be considered as obvious to try by routine optimization in order to find an appropriate method of conveying such information in a tactile manner (see MPEP 2144.05).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Cho in view of Rodriguez and Krimsky and Boveja to alter the frequency of the tactile feedback in a similar manner as that disclosed by Honda in order to better convey information to the operator (Honda par [0099]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Schuler (US 20210177509 A1) discloses phrenic nerve mapping using electrical pacing from catheter; Fig 7 (724) par [0093] discloses checking if ablation device is “too close” to phrenic nerve, also par [0040].
Lang (US 20210137634 A1) discloses tracking diaphragm motion with catheter in magnetic field.
Jung (US 20200077938 A1) discloses Fig 1 a body patch for automatically tracking phrenic nerve stimulation during ablation and alerting user (par [0051]). Using diaphragm movement feedback to control electrical stimulation par [0070].
Howard (US 20190038171 A1) discloses sensors on body patches for monitoring diaphragm movement during ablation.
Rosenberg (US 20110054559 A1) discloses using diaphragm movement and localization methods to determine electrode proximity to phrenic nerve.
Brada (US 20100191137 A1) discloses using accelerometer during ablation to monitor diaphragm movement and thus phrenic nerve activity.
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 Matthew Becton whose telephone number is (571)272-9570. The examiner can normally be reached Monday-Friday 9am-5pm ET.
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/MATTHEW DAVID BECTON/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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