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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/27/25 is being considered by the examiner.
Claim Objections
Claims 1, 16, and 17 are objected to because of the following informalities: the limitation of “an inhibited pacing mode, a ventricular fusion pacing mode, an atrioventricular synchronous pacing mode, and an atrial fibrillation pacing mode” see claim 1, lines 15-16 for example. Applicant is encouraged to change the limitation to recite --the inhibited pacing mode, the ventricular fusion pacing mode, the atrioventricular synchronous pacing mode, and the atrial fibrillation pacing mode -- to properly refer back to “an inhibited pacing mode, a ventricular fusion pacing mode, an atrioventricular synchronous pacing mode, and an atrial fibrillation pacing mode,” see claim 1, lines 6-7 for example. Appropriate correction is required.
Claims 2 and 18 are objected to because of the following informalities: the limitation “the right atrium.” Applicant is encouraged to recite –a right atrium—since a right atrium is not positively recited previously. Appropriate correction is required.
Claims 4 and 20 are objected to because of the following informalities: the limitation “the left bundle branch of the patient's heart or the His bundle of the patient's heart.” Applicant is encouraged to recite -- a left bundle branch of the patient's heart or a His bundle of the patient's heart--, since a left bundle branch and a His bundle are not positively recited previously. Appropriate correction is required.
Claims 6, 9, 11-13, 21, and 24 are objected to because of the following informalities: the limitation “the patient’s is undergoing atrial fibrillation” is incorrect grammar. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: the limitations “selecting a conducted atrial fibrillation response pacing mode in response to a pacing capture threshold (PCT) greater than or equal to a PCT threshold or in response to ineffective capture; and selecting a cardiac resynchronization pacing mode in response to a pacing capture threshold (PCT) less than the PCT threshold and effective capture.” Applicant is encouraged to further clarify the language as PCT is defined as a pacing capture threshold and then later recites PCT threshold, which is a pacing capture threshold threshold. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: line 15 recites “;;” and Applicant is encouraged to change the limitation to recite --;--. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4, 7, 16-18, 20, 22, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Ghosh ‘062 (US 20220032062 filed on 6/28/21) in view of Van Gelder (US 20060235478 filed on 4/19/05).
Regarding claim 1, Ghosh ‘062 teaches an implantable medical device comprising: a computing apparatus comprising processing circuitry (¶9-the deice may further include a computing apparatus comprising processing circuitry) and operably coupled to one or more implantable electrodes (¶9-the computing apparatus may be operably coupled to the plurality of implantable electrodes; ¶59-IMD 16 may deliver defibrillation shocks to heart 12 via any combination of elongated electrodes 62, 64, 66, and housing electrode 58) comprising a cardiac conduction system pacing electrode positionable proximate a portion of a patient's cardiac conduction system (¶39-cardiac conduction system electrode, of the cardiac conduction system pacing therapy lead 23; ¶36-cardiac conduction system pacing therapy lead 23 (e.g., His-bundle or bundle-branch pacing lead) extends through one or more veins and the vena cava, and into the right atrium 26 of heart 12 to pace the cardiac conduction system (e.g., triangle of Koch, septal wall, left bundle branch, right bundle branch, the His bundle, etc.); ¶40-cardiac conduction system pacing therapy can be performed by other leads. Another illustrative lead, including two or more pacing electrodes, can be used to deliver multisite pacing pulses to the bundle of His or one or both bundle branches; Fig. 3A), wherein the computing apparatus is configured to: provide an inhibited pacing mode (¶74-the pacer timing and control module may include programmable counters which control the basic time intervals associated with DDD, VVI, DVI, VDD, AAI, DDI, DDDR, VVIR, DVIR, VDDR, AAIR, DDIR and other modes of single and dual chamber pacing, I” may indicate inhibited pacing (e.g., no pacing)), and an atrial fibrillation pacing mode (¶74-the pacer timing and control module may include programmable counters which control the basic time intervals associated with VVI, VVIR and other modes of single and dual chamber pacing; ¶21-configured to provide therapy to a heart of patient suffering from atrial fibrillation); perform a conduction test (¶83-the measured intrinsic AV delay may be used when testing various paced AV delays) comprising: delaying delivery of cardiac conduction system pacing therapy to allow intrinsic cardiac activation (¶83-the process 210 may include delivering cardiac conduction system pacing therapy to the patient's cardiac conduction system using the cardiac conduction system electrode at a plurality of different paced AV delays that are less than the intrinsic AV delay 214; ¶127-periodically ceasing delivery of pacing therapy and monitor intrinsic electrical activity of the patient using the left ventricular electrode during intrinsic cardiac electrical activation; ¶95); monitoring intrinsic electrical activity of the patient's heart using the one or more implantable electrodes during intrinsic cardiac activation (¶127-monitor intrinsic electrical activity of the patient using the left ventricular electrode during intrinsic cardiac electrical activation); determine one or more metrics based on the monitored intrinsic electrical activity (¶85-one or more metrics may be derived or determined from the far-field electrical activity that may be used to determine the most effective or optimal paced AV delay for the cardiac conduction system pacing therapy; ¶82- measuring an intrinsic AV delay, the intrinsic AV delay is a time period between a sensed intrinsic, or naturally-occurring, atrial event (e.g., depolarization of the atrium, p-wave in an electrocardiogram, etc.) and a sensed intrinsic, or naturally-occurring, ventricular event (e.g., depolarization of the left ventricle or both ventricles, r-wave in an electrocardiogram, etc.); ¶48-various pacing settings may be adjusted, or configured, based on various sensed signals, QRS within a near-field or far-field signal may be used to adjust or configure the VV delay between cardiac conduction system pacing therapy and traditional left ventricular pacing therapy); and select one of an inhibited pacing mode and an atrial fibrillation pacing mode based on the determined one or more metrics (Abstract-the adaptive cardiac conduction system pacing therapy may adjust AV delay and VV delay based on various signals and metrics; ¶86-the paced AV delay may be adjusted accordingly according the selected AV delay percentage; ¶95-adjusting the paced AV delay 260, e.g., periodically, based on measuring the intrinsic AV delay in the absence of delivery of pacing therapy and using the previously-determined AV delay percentage to determine the new paced AV delay; ¶48-various pacing settings may be adjusted, or configured, based on various sensed signals, QRS within a near-field or far-field signal may be used to adjust or configure the VV delay between cardiac conduction system pacing therapy and traditional left ventricular pacing therapy; ¶74-the pacer timing and control module may include programmable counters which control the basic time intervals associated with VVI, VVIR and other modes of single and dual chamber pacing, inhibited pacing (e.g., no pacing); ¶21-configured to provide therapy to a heart of patient suffering from atrial fibrillation; ¶102-determining whether the pacing therapy has selective or non-selective capture of the cardiac conduction system based on the derivative signal may be performed, or executed, a variety of different ways and using a variety of different metrics); and deliver cardiac conduction system pacing using the cardiac conduction system pacing electrode according to the selected mode (¶93-then the process 250 may return to delivering cardiac conduction system pacing therapy at the newly-adjusted pacing output and monitoring local electrical activity; ¶74).
However, Ghosh ‘062 does not explicitly teach a ventricular fusion pacing mode and an atrioventricular synchronous pacing mode.
Van Gelder provides a simple and automatic method for determining an optimal AV interval and/or range of AV intervals for LV-only pacing. Such a method provides significant advantages for patients while reducing burdens related to post-implant follow-up by clinicians in that it greatly reduces the need for doing echocardiographic-based AV interval optimization procedures as well as providing a way to dynamically optimize AV intervals as the patient moves about their activities of daily living (ADL) (¶2). Van Gelder further teaches the invention using the following steps:
a ventricular fusion pacing mode (¶9-ventricular fusion; ¶15; ¶19; ¶85) and an atrioventricular synchronous pacing mode (¶47-operate as a dual- or triple-chamber pacing system having an AV synchronous operating mode for restoring upper and lower heart chamber synchronization; ¶15; ¶19).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include a ventricular fusion pacing mode and an atrioventricular synchronous pacing mode of Van Gelder in order to function in an energy efficient pacing mode (Van Gelder, ¶19) and provide a way to dynamically optimize AV intervals as the patient moves about their activities of daily living (ADL) (Van Gelder, ¶2).
Regarding claim 2, the combination of Ghosh ‘062 and Van Gelder teaches the device as in claim 1, wherein the computing apparatus is further configured to execute comprises: monitoring far-field electrical activity of the patient's heart using at least one of the one or more implantable electrodes positioned outside of the right atrium of the patient's heart (Ghosh ‘062, ¶48-various near-field and far-field signals may be sensed by one or more electrodes of the IMD 16 and/or other devices operatively coupled thereto; ¶42-a lead configured to perform multi-site pacing, which is different than LV coronary sinus lead 20 , can be placed in the ventricular septum with the first (distal) electrode on the left side of the ventricular septum for left bundle branch pacing; ¶71-receives signals from electrodes 40 , 42 , which are used for pacing and sensing in right ventricle 28 of heart 12); and determining an electrical atrial activation based on the monitored far-field electrical activity (Ghosh ‘062, ¶37-an atrial activation may refer to an atrial sense or event (As) or an atrial pace or artifact of atrial pacing (Ap); ¶48-various near-field and far-field signals may be sensed by one or more electrodes of the IMD 16 and/or other devices operatively coupled thereto), wherein delivering cardiac conduction system pacing comprises delivering cardiac conduction system pacing based on the determined electrical atrial activation (Ghosh ‘062, ¶48-various pacing settings may be adjusted, or configured, based on various sensed signals. For example, various near-field and far-field signals may be sensed by one or more electrodes of the IMD 16 and/or other devices operatively coupled thereto. For example, Vp to QRS end or offset within a near-field or far-field signal may be used to adjust or configure the AV delay of cardiac conduction system pacing therapy).
Regarding claim 4, the combination of Ghosh ‘062 and Van Gelder teaches the device as in claim 1, wherein the cardiac conduction system pacing electrode is configured to deliver cardiac conduction system pacing therapy to the left bundle branch of the patient's heart (Ghosh ‘062, ¶121-wherein the cardiac conduction system electrode is positioned proximate the patient's left bundle branch bundle to deliver cardiac conduction system pacing therapy; ¶16-delivering pacing therapy to the patient's heart using one or more of a plurality of implantable electrodes, monitoring a near-field signal over a sensing time period proximate the left bundle branch using the plurality of implantable electrodes; ¶36) or the His bundle of the patient's heart (Ghosh ‘062, ¶120-wherein the cardiac conduction system electrode is positioned proximate the patient's bundle of His to deliver cardiac conduction system pacing therapy; ¶58-electrode 50 may be used for pacing and/or sensing of the His bundle or bundle branch tissue; ¶36; ¶64).
Regarding claim 7, the combination of Ghosh ‘062 and Van Gelder teaches the device as in claim 1, wherein the delivery of cardiac conduction system pacing is in response to expiration of an inhibiting atrioventricular delay following an atrial activation without sensing an intrinsic ventricular activation or in response to maintenance of a baseline heart rate (Van Gelder, ¶72-the pacing electrodes of lead 16 activate the atria and the pacing electrodes of lead 52 activate the LV upon expiration of the A-LVp interval; ¶87-the LV chamber receives pre-excitation pacing therapy upon the expiration of the physiologically-derived AV delay; ¶88-fusion pacing ensues upon expiration of the newly programmed AV delay interval).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include wherein the delivery of cardiac conduction system pacing is in response to expiration of an inhibiting atrioventricular delay following an atrial activation without sensing an intrinsic ventricular activation or in response to maintenance of a baseline heart rate of Van Gelder so that the inventive AV optimization routine can be performed when a patient is sleeping, resting, mildly exercising or undergoing significant physical exertion and to the extent that the fusion/transition AV intervals differ a discrete interval can be programmed that corresponds to the actual heart rate of the patient (Van Gelder, ¶11).
Regarding claim 16, Ghosh ‘062 teaches a system comprising: one or more implantable electrodes to sense electrical activity a patient's heart (¶59-electrodes 58, 62, 64, 66 may also be used to deliver cardioversion pulses to heart 12) and deliver cardiac therapy to the patient's heart (¶88-deliver cardiac conduction system pacing therapy to the patient's cardiac conduction system), wherein the one or more implantable electrodes (¶59-IMD 16 may deliver defibrillation shocks to heart 12 via any combination of elongated electrodes 62, 64, 66, and housing electrode 58) comprise a cardiac conduction system pacing electrode positionable proximate a portion of the patient's cardiac conduction system to deliver cardiac conduction system pacing therapy to the portion of the patient's cardiac conduction system (¶39-cardiac conduction system electrode, of the cardiac conduction system pacing therapy lead 23; ¶36-cardiac conduction system pacing therapy lead 23 (e.g., His-bundle or bundle-branch pacing lead) extends through one or more veins and the vena cava, and into the right atrium 26 of heart 12 to pace the cardiac conduction system (e.g., triangle of Koch, septal wall, left bundle branch, right bundle branch, the His bundle, etc.); ¶40-cardiac conduction system pacing therapy can be performed by other leads. Another illustrative lead, including two or more pacing electrodes, can be used to deliver multisite pacing pulses to the bundle of His or one or both bundle branches; Fig. 3A); and a computing apparatus comprising processing circuitry (¶9-the deice may further include a computing apparatus comprising processing circuitry) and operably coupled to the one or more implantable electrodes (¶9-the computing apparatus may be operably coupled to the plurality of implantable electrodes), wherein the computing apparatus is configured to: provide an inhibited pacing mode (¶74-the pacer timing and control module may include programmable counters which control the basic time intervals associated with DDD, VVI, DVI, VDD, AAI, DDI, DDDR, VVIR, DVIR, VDDR, AAIR, DDIR and other modes of single and dual chamber pacing, I” may indicate inhibited pacing (e.g., no pacing)), and an atrial fibrillation pacing mode (¶74-the pacer timing and control module may include programmable counters which control the basic time intervals associated with VVI, VVIR and other modes of single and dual chamber pacing; ¶21-configured to provide therapy to a heart of patient suffering from atrial fibrillation); perform a conduction test (¶83-the measured intrinsic AV delay may be used when testing various paced AV delays) comprising: delaying delivery of cardiac conduction system pacing therapy to allow intrinsic cardiac activation (¶83-the process 210 may include delivering cardiac conduction system pacing therapy to the patient's cardiac conduction system using the cardiac conduction system electrode at a plurality of different paced AV delays that are less than the intrinsic AV delay 214; ¶127-periodically ceasing delivery of pacing therapy and monitor intrinsic electrical activity of the patient using the left ventricular electrode during intrinsic cardiac electrical activation; ¶95); monitoring intrinsic electrical activity of the patient's heart using the one or more implantable electrodes during intrinsic cardiac activation (¶127-monitor intrinsic electrical activity of the patient using the left ventricular electrode during intrinsic cardiac electrical activation); determining one or more metrics based on the monitored intrinsic electrical activity (¶85-one or more metrics may be derived or determined from the far-field electrical activity that may be used to determine the most effective or optimal paced AV delay for the cardiac conduction system pacing therapy; ¶82-measuring an intrinsic AV delay, the intrinsic AV delay is a time period between a sensed intrinsic, or naturally-occurring, atrial event (e.g., depolarization of the atrium, p-wave in an electrocardiogram, etc.) and a sensed intrinsic, or naturally-occurring, ventricular event (e.g., depolarization of the left ventricle or both ventricles, r-wave in an electrocardiogram, etc.); ¶48-various pacing settings may be adjusted, or configured, based on various sensed signals, QRS within a near-field or far-field signal may be used to adjust or configure the VV delay between cardiac conduction system pacing therapy and traditional left ventricular pacing therapy); and select one of an inhibited pacing mode and an atrial fibrillation pacing mode based on the determined one or more metrics (Abstract-the adaptive cardiac conduction system pacing therapy may adjust AV delay and VV delay based on various signals and metrics; ¶86-the paced AV delay may be adjusted accordingly according the selected AV delay percentage; ¶95-adjusting the paced AV delay 260, e.g., periodically, based on measuring the intrinsic AV delay in the absence of delivery of pacing therapy and using the previously-determined AV delay percentage to determine the new paced AV delay; ¶48-various pacing settings may be adjusted, or configured, based on various sensed signals, QRS within a near-field or far-field signal may be used to adjust or configure the VV delay between cardiac conduction system pacing therapy and traditional left ventricular pacing therapy; ¶74-the pacer timing and control module may include programmable counters which control the basic time intervals associated with VVI, VVIR and other modes of single and dual chamber pacing, inhibited pacing (e.g., no pacing); ¶21-configured to provide therapy to a heart of patient suffering from atrial fibrillation; ¶102-determining whether the pacing therapy has selective or non-selective capture of the cardiac conduction system based on the derivative signal may be performed, or executed, a variety of different ways and using a variety of different metrics); and deliver cardiac conduction system pacing using a cardiac conduction system pacing electrode according to the selected mode (¶93-then the process 250 may return to delivering cardiac conduction system pacing therapy at the newly-adjusted pacing output and monitoring local electrical activity; ¶74).
However, Ghosh ‘062 does not explicitly teach a ventricular fusion pacing mode and an atrioventricular synchronous pacing mode.
Van Gelder teaches a ventricular fusion pacing mode (¶9-ventricular fusion; ¶15; ¶19; ¶85) and an atrioventricular synchronous pacing mode (¶47-operate as a dual- or triple-chamber pacing system having an AV synchronous operating mode for restoring upper and lower heart chamber synchronization; ¶15; ¶19).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include a ventricular fusion pacing mode and an atrioventricular synchronous pacing mode of Van Gelder in order to function in an energy efficient pacing mode (Van Gelder, ¶19) and provide a way to dynamically optimize AV intervals as the patient moves about their activities of daily living (ADL) (Van Gelder, ¶2).
Regarding claim 17, Ghosh ‘062 teaches a method comprising: providing an inhibited pacing mode (¶74-the pacer timing and control module may include programmable counters which control the basic time intervals associated with DDD, VVI, DVI, VDD, AAI, DDI, DDDR, VVIR, DVIR, VDDR, AAIR, DDIR and other modes of single and dual chamber pacing, I” may indicate inhibited pacing (e.g., no pacing)), and an atrial fibrillation pacing mode (¶74-the pacer timing and control module may include programmable counters which control the basic time intervals associated with VVI, VVIR and other modes of single and dual chamber pacing; ¶21-configured to provide therapy to a heart of patient suffering from atrial fibrillation); performing a conduction test (¶83-the measured intrinsic AV delay may be used when testing various paced AV delays) comprising: delaying delivery of cardiac conduction system pacing therapy to allow intrinsic cardiac activation (¶83-the process 210 may include delivering cardiac conduction system pacing therapy to the patient's cardiac conduction system using the cardiac conduction system electrode at a plurality of different paced AV delays that are less than the intrinsic AV delay 214; ¶127-periodically ceasing delivery of pacing therapy and monitor intrinsic electrical activity of the patient using the left ventricular electrode during intrinsic cardiac electrical activation; ¶95); monitoring intrinsic electrical activity of a patient's heart using one or more implantable electrodes during the intrinsic cardiac activation (¶127-monitor intrinsic electrical activity of the patient using the left ventricular electrode during intrinsic cardiac electrical activation); determining one or more metrics based on the monitored intrinsic electrical activity (¶85-one or more metrics may be derived or determined from the far-field electrical activity that may be used to determine the most effective or optimal paced AV delay for the cardiac conduction system pacing therapy; ¶82-measuring an intrinsic AV delay, the intrinsic AV delay is a time period between a sensed intrinsic, or naturally-occurring, atrial event (e.g., depolarization of the atrium, p-wave in an electrocardiogram, etc.) and a sensed intrinsic, or naturally-occurring, ventricular event (e.g., depolarization of the left ventricle or both ventricles, r-wave in an electrocardiogram, etc.); ¶48-various pacing settings may be adjusted, or configured, based on various sensed signals, QRS within a near-field or far-field signal may be used to adjust or configure the VV delay between cardiac conduction system pacing therapy and traditional left ventricular pacing therapy); and selecting one of an inhibited pacing mode and an atrial fibrillation pacing mode based on the determined one or more metrics (Abstract-the adaptive cardiac conduction system pacing therapy may adjust AV delay and VV delay based on various signals and metrics; ¶86-the paced AV delay may be adjusted accordingly according the selected AV delay percentage; ¶95-adjusting the paced AV delay 260, e.g., periodically, based on measuring the intrinsic AV delay in the absence of delivery of pacing therapy and using the previously-determined AV delay percentage to determine the new paced AV delay; ¶48-various pacing settings may be adjusted, or configured, based on various sensed signals, QRS within a near-field or far-field signal may be used to adjust or configure the VV delay between cardiac conduction system pacing therapy and traditional left ventricular pacing therapy; ¶74-the pacer timing and control module may include programmable counters which control the basic time intervals associated with VVI, VVIR and other modes of single and dual chamber pacing, inhibited pacing (e.g., no pacing); ¶21-configured to provide therapy to a heart of patient suffering from atrial fibrillation; ¶102-determining whether the pacing therapy has selective or non-selective capture of the cardiac conduction system based on the derivative signal may be performed, or executed, a variety of different ways and using a variety of different metrics); and delivering cardiac conduction system pacing using a cardiac conduction system pacing electrode positionable proximate a portion of the patient's cardiac conduction system according to the selected mode (¶39-cardiac conduction system electrode, of the cardiac conduction system pacing therapy lead 23; ¶36-cardiac conduction system pacing therapy lead 23 (e.g., His-bundle or bundle-branch pacing lead) extends through one or more veins and the vena cava, and into the right atrium 26 of heart 12 to pace the cardiac conduction system (e.g., triangle of Koch, septal wall, left bundle branch, right bundle branch, the His bundle, etc.); ¶40-cardiac conduction system pacing therapy can be performed by other leads. Another illustrative lead, including two or more pacing electrodes, can be used to deliver multisite pacing pulses to the bundle of His or one or both bundle branches; Fig. 3A; ¶93-then the process 250 may return to delivering cardiac conduction system pacing therapy at the newly-adjusted pacing output and monitoring local electrical activity; ¶74).
However, Ghosh ‘062 does not explicitly teach a ventricular fusion pacing mode and an atrioventricular synchronous pacing mode.
Van Gelder teaches a ventricular fusion pacing mode (¶9-ventricular fusion; ¶15; ¶19; ¶85) and an atrioventricular synchronous pacing mode (¶47-operate as a dual- or triple-chamber pacing system having an AV synchronous operating mode for restoring upper and lower heart chamber synchronization; ¶15; ¶19).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include a ventricular fusion pacing mode and an atrioventricular synchronous pacing mode of Van Gelder in order to function in an energy efficient pacing mode (Van Gelder, ¶19) and provide a way to dynamically optimize AV intervals as the patient moves about their activities of daily living (ADL) (Van Gelder, ¶2).
Regarding claim 18, the combination of Ghosh ‘062 and Van Gelder teaches the method as in claim 17, wherein the method further comprises: monitoring far-field electrical activity of the patient's heart using at least one of the one or more implantable electrodes positioned outside of the right atrium of the patient's heart (Ghosh ‘062, ¶48-various near-field and far-field signals may be sensed by one or more electrodes of the IMD 16 and/or other devices operatively coupled thereto; ¶42-a lead configured to perform multi-site pacing, which is different than LV coronary sinus lead 20 , can be placed in the ventricular septum with the first (distal) electrode on the left side of the ventricular septum for left bundle branch pacing; ¶71-receives signals from electrodes 40 , 42 , which are used for pacing and sensing in right ventricle 28 of heart 12); and determining an electrical atrial activation based on the monitored far-field electrical activity (Ghosh ‘062, ¶37-an atrial activation may refer to an atrial sense or event (As) or an atrial pace or artifact of atrial pacing (Ap); ¶48-various near-field and far-field signals may be sensed by one or more electrodes of the IMD 16 and/or other devices operatively coupled thereto), wherein delivering cardiac conduction system pacing comprises delivering cardiac conduction system pacing based on the determined electrical atrial activation (Ghosh ‘062, ¶48-various pacing settings may be adjusted, or configured, based on various sensed signals. For example, various near-field and far-field signals may be sensed by one or more electrodes of the IMD 16 and/or other devices operatively coupled thereto. For example, Vp to QRS end or offset within a near-field or far-field signal may be used to adjust or configure the AV delay of cardiac conduction system pacing therapy).
Regarding claim 20, the combination of Ghosh ‘062 and Van Gelder teaches the method of claim 17, wherein the cardiac conduction system pacing electrode is configured to deliver cardiac conduction system pacing therapy to one or both of the left bundle branch of the patient's heart (Ghosh ‘062, ¶121-wherein the cardiac conduction system electrode is positioned proximate the patient's left bundle branch bundle to deliver cardiac conduction system pacing therapy; ¶16-delivering pacing therapy to the patient's heart using one or more of a plurality of implantable electrodes, monitoring a near-field signal over a sensing time period proximate the left bundle branch using the plurality of implantable electrodes; ¶36) and the His bundle of the patient's heart (Ghosh ‘062, ¶120-wherein the cardiac conduction system electrode is positioned proximate the patient's bundle of His to deliver cardiac conduction system pacing therapy; ¶58-electrode 50 may be used for pacing and/or sensing of the His bundle or bundle branch tissue; ¶36; ¶64).
Regarding claim 22, the combination of Ghosh ‘062 and Van Gelder teaches the method as in claim 17, wherein the delivery of cardiac conduction system pacing is in response to expiration of an inhibiting atrioventricular delay following an atrial activation without sensing an intrinsic ventricular activation or in response to maintenance of a baseline heart rate (Van Gelder, ¶72-the pacing electrodes of lead 16 activate the atria and the pacing electrodes of lead 52 activate the LV upon expiration of the A-LVp interval; ¶87-the LV chamber receives pre-excitation pacing therapy upon the expiration of the physiologically-derived AV delay; ¶88-fusion pacing ensues upon expiration of the newly programmed AV delay interval).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include wherein the delivery of cardiac conduction system pacing is in response to expiration of an inhibiting atrioventricular delay following an atrial activation without sensing an intrinsic ventricular activation or in response to maintenance of a baseline heart rate of Van Gelder so that the inventive AV optimization routine can be performed when a patient is sleeping, resting, mildly exercising or undergoing significant physical exertion and to the extent that the fusion/transition AV intervals differ a discrete interval can be programmed that corresponds to the actual heart rate of the patient (Van Gelder, ¶11).
Regarding claim 25, the combination of Ghosh ‘062 and Van Gelder teaches the method as in claim 17, wherein the delivery of cardiac conduction system pacing is in response to expiration of a fusion atrioventricular delay following an atrial activation (Van Gelder, ¶72-the pacing electrodes of lead 16 activate the atria and the pacing electrodes of lead 52 activate the LV upon expiration of the A-LVp interval; ¶87-the LV chamber receives pre-excitation pacing therapy upon the expiration of the physiologically-derived AV delay; ¶88-fusion pacing ensues upon expiration of the newly programmed AV delay interval; ¶75-a LEPARS interval 711 promoting fusion resulting from LV-only pacing is defined as the time elapsed from Atrial activation (AP) to sensed RV depolarization (in FIG. 7 concealed as the "VP" event)), wherein the fusion atrioventricular delay is less than a smallest measured intrinsic atrioventricular delay (Van Gelder, ¶20-AV intervals greater than this transition point provide pressure development in the LV (LV dP/dtmax) of greater magnitude; ¶116-a fusion/transition point; This means that the AV interval being greater than the fusion/transition point is the same as the claim language of the fusion point being less than the AV interval; ¶44-AV delay interval; ¶117).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include wherein the delivery of cardiac conduction system pacing is in response to expiration of a fusion atrioventricular delay following an atrial activation, wherein the fusion atrioventricular delay is less than a smallest measured intrinsic atrioventricular delay of Van Gelder in order to provide a way to dynamically optimize AV intervals as the patient moves about their activities of daily living (ADL) (Van Gelder, ¶2).
Claims 3, 5, 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ghosh ‘062 in view of Van Gelder as applied to claims 1 and 17 above, and further in view of Ghosh ‘348 (US 20210060348 filed on 8/24/20).
Regarding claim 3, the combination of Ghosh ‘062 and Van Gelder teaches the device as in claim 1. However, the combination of Ghosh ‘062 and Van Gelder does not teach wherein the computing apparatus is further configured to execute comprises: monitoring mechanical activity of the patient's heart using a mechanical cardiac activation sensor to monitor mechanical activity of the patient's heart; and determining a mechanical atrial activation based on the monitored mechanical activity, wherein delivering cardiac conduction system pacing comprises delivering cardiac conduction system pacing based on the determined mechanical atrial activation.
Ghosh ‘348 teaches wherein the computing apparatus is further configured to execute comprises: monitoring mechanical activity of the patient's heart using a mechanical cardiac activation sensor to monitor mechanical activity of the patient's heart (¶62-the motion sensor 11 may be used to monitor mechanical activity, such as atrial mechanical activity (e.g., an atrial contraction) and/or ventricular mechanical activity (e.g., a ventricular contraction); ¶83-utilizing mechanical activity may facilitate confirmation of whether atrial activation has occurred); and determining a mechanical atrial activation based on the monitored mechanical activity (¶83-utilizing mechanical activity may facilitate confirmation of whether atrial activation has occurred. In particular, an atrial kick typically follows normal or paced atrial activation. The atrial kick may manifest as a distinguishable amplitude change on mechanical activity sensed, for example, by an integrated accelerometer), wherein delivering cardiac conduction system pacing comprises delivering cardiac conduction system pacing based on the determined mechanical atrial activation (¶98-adjusting a pacing parameter or mode based on whether the electrical activity and the mechanical activity are indicative of atrial fibrillation; ¶21-cardiac therapy systems may measure mechanical activity using a motion sensor to facilitate the determination of whether the patient's heart is in AF. Based on the AF determination, the system may be configured to mode switch or adjust P-wave sensitivity levels to better detect far-field P-waves when the patient's heart is not in AF).
Ghosh ‘348 generally relates to cardiac therapy and particularly relates to cardiac resynchronization therapy (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include wherein the computing apparatus is further configured to execute comprises: monitoring mechanical activity of the patient's heart using a mechanical cardiac activation sensor to monitor mechanical activity of the patient's heart; and determining a mechanical atrial activation based on the monitored mechanical activity, wherein delivering cardiac conduction system pacing comprises delivering cardiac conduction system pacing based on the determined mechanical atrial activation of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
Regarding claim 5, the combination of Ghosh ‘062 and Van Gelder teaches the device as in claim 1, wherein the one or more metrics comprises QRS complex width or P-wave-to-R-wave (PR) interval (Van Gelder, ¶81-the physiologic P-R interval is measured and stored; ¶86).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include wherein the one or more metrics comprises QRS complex width or P-wave-to-R-wave (PR) interval of Van Gelder in order to determine the intrinsic ventricular delay between the LV and the RV (Van Gelder, ¶81) and generate a pre-excitation pacing interval for the LV chamber ("A-LVp") (Van Gelder, ¶81).
However, the combination of Ghosh ‘062 and Van Gelder does not explicitly teach and at least one atrial fibrillation indicator, wherein the at least one atrial fibrillation indicators comprise one or more of R-wave-to-R-wave (RR) interval consistency, T-wave-to-P-wave (TP) interval consistency, and far-field P-wave morphology.
Ghosh ‘348 teaches at least one atrial fibrillation indicator (¶88-facilitate more accurate detection of a P-wave and, therefore, more accurate detection of AF using sensed electrical activity), wherein the at least one atrial fibrillation indicators comprise one or more of R-wave-to-R-wave (RR) interval consistency, T-wave-to-P-wave (TP) interval consistency, and far-field P-wave morphology (¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶86-a small peak below a threshold value indicates that the P-wave was not, or was unlikely, to have been present in the far-field signal, for example, due to the patient’s heart being in AF).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include at least one atrial fibrillation indicator, wherein the at least one atrial fibrillation indicators comprise one or more of R-wave-to-R-wave (RR) interval consistency, T-wave-to-P-wave (TP) interval consistency, and far-field P-wave morphology of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
Regarding claim 12, the combination of Ghosh ‘062 and Van Gelder teaches the device as in claim 1. However, the combination of Ghosh ‘062 and Van Gelder does not teach wherein the one or more metrics comprises at least one atrial fibrillation indicator, wherein the at least one atrial fibrillation indicators comprise one or more of R-wave-to-R-wave (RR) interval consistency, T- wave-to-P-wave (TP) interval consistency, and far-field P-wave morphology, wherein performing the conduction test further comprises performing a prolonged conduction test in response to, at least, the atrial fibrillation indicators indicating the patient's is undergoing atrial fibrillation.
Ghosh ‘348 teaches wherein the one or more metrics comprises at least one atrial fibrillation indicator (¶88-facilitate more accurate detection of a P-wave and, therefore, more accurate detection of AF using sensed electrical activity), wherein the at least one atrial fibrillation indicators comprise one or more of R-wave-to-R-wave (RR) interval consistency, T- wave-to-P-wave (TP) interval consistency, and far-field P-wave morphology (¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶86-a small peak below a threshold value indicates that the P-wave was not, or was unlikely, to have been present in the far-field signal, for example, due to the patient’s heart being in AF), wherein performing the conduction test further comprises performing a prolonged conduction test (¶113-determine whether the electrical activity of one or both atria sensed by the second electrode is indicative of atrial fibrillation; ¶114-in response to determining that the electrical activity of one or both atria is indicative of atrial fibrillation, determine whether mechanical activity of the patient's heart sensed by the motion sensor represents atrial contraction) in response to, at least, the atrial fibrillation indicators indicating the patient's is undergoing atrial fibrillation (¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶86-a small peak below a threshold value indicates that the P-wave was not, or was unlikely, to have been present in the far-field signal, for example, due to the patient’s heart being in AF; ¶139-wherein determining whether the electrical activity of one or both atria is indicative of atrial fibrillation comprises determining whether a P-wave is detected).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include wherein the one or more metrics comprises at least one atrial fibrillation indicator, wherein the at least one atrial fibrillation indicators comprise one or more of R-wave-to-R-wave (RR) interval consistency, T- wave-to-P-wave (TP) interval consistency, and far-field P-wave morphology, wherein performing the conduction test further comprises performing a prolonged conduction test in response to, at least, the atrial fibrillation indicators indicating the patient's is undergoing atrial fibrillation of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
Regarding claim 19, the combination of Ghosh ‘062 and Van Gelder teaches the method as in claim 17. However, the combination of Ghosh ‘062 and Van Gelder does not teach wherein the method further comprises: monitoring mechanical activity of the patient's heart using a mechanical cardiac activation sensor to monitor mechanical activity of the patient's heart; and determining a mechanical atrial activation based on the monitored mechanical activity, wherein delivering cardiac conduction system pacing comprises delivering cardiac conduction system pacing based on the determined mechanical atrial activation.
Ghosh ‘348 teaches wherein the method further comprises: monitoring mechanical activity of the patient's heart using a mechanical cardiac activation sensor to monitor mechanical activity of the patient's heart (¶62-the motion sensor 11 may be used to monitor mechanical activity, such as atrial mechanical activity (e.g., an atrial contraction) and/or ventricular mechanical activity (e.g., a ventricular contraction); ¶83-utilizing mechanical activity may facilitate confirmation of whether atrial activation has occurred); and determining a mechanical atrial activation based on the monitored mechanical activity (¶83-utilizing mechanical activity may facilitate confirmation of whether atrial activation has occurred. In particular, an atrial kick typically follows normal or paced atrial activation. The atrial kick may manifest as a distinguishable amplitude change on mechanical activity sensed, for example, by an integrated accelerometer), wherein delivering cardiac conduction system pacing comprises delivering cardiac conduction system pacing based on the determined mechanical atrial activation (¶98-adjusting a pacing parameter or mode based on whether the electrical activity and the mechanical activity are indicative of atrial fibrillation; ¶21-cardiac therapy systems may measure mechanical activity using a motion sensor to facilitate the determination of whether the patient's heart is in AF. Based on the AF determination, the system may be configured to mode switch or adjust P-wave sensitivity levels to better detect far-field P-waves when the patient's heart is not in AF).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include monitoring mechanical activity of the patient's heart using a mechanical cardiac activation sensor to monitor mechanical activity of the patient's heart; and determining a mechanical atrial activation based on the monitored mechanical activity, wherein delivering cardiac conduction system pacing comprises delivering cardiac conduction system pacing based on the determined mechanical atrial activation of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ghosh ‘062 in view of Van Gelder, and further in view of Ghosh ‘348 as applied to claim 5 above, and further in view of Mangual-Soto (US 20210016097 filed on 5/11/20).
Regarding claim 6, the combination of Ghosh ‘062, Van Gelder, and Ghosh ‘348 teaches the device as in claim 5, and the atrial fibrillation indicators indicating that the patient's is undergoing atrial fibrillation (Ghosh ‘348, ¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶86-a small peak below a threshold value indicates that the P-wave was not, or was unlikely, to have been present in the far-field signal, for example, due to the patient’s heart being in AF).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include the atrial fibrillation indicators indicating that the patient's is undergoing atrial fibrillation of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
While the combination teaches inhibited pacing (e.g., no pacing) (Ghosh ‘062, ¶74), the combination of Ghosh ‘062, Van Gelder, and Ghosh ‘348 does not teach wherein the inhibited pacing mode is selected in response to, at least, the QRS complex width being less than or equal to a QRS complex width threshold, the PR interval being less than or equal to a PR interval threshold, the intra-atrial conduction delay (IACD) may also be measured (operation 2215)), wherein the inhibited pacing mode comprises delivery of cardiac conduction system pacing when intrinsic ventricular activation does not occur.
Mangual-Soto teaches wherein the inhibited pacing mode is selected in response to, at least (¶16-inhibiting backup pacing of the ventricle when the time between application of the impulse and onset of the measured response is less than the first delay; ¶128; ¶136; ¶435), the QRS complex width being less than or equal to a QRS complex width threshold (¶363-measured QRS width is less than a predetermined percentage of the baseline QRS width; ¶42-determining whether a QRS duration of the response is less than the baseline QRS duration; ¶364), the PR interval being less than or equal to a PR interval threshold (¶310-analyzed to determine whether the measured time between pacing of the HIS bundle and a corresponding response of the RV falls within the H.sub.P-RV.sub.P delay; ¶356-in patients without long P-R intervals (e.g., P-R intervals below about 150 ms), the intra-atrial conduction delay (IACD) may also be measured (operation 2215)), wherein the inhibited pacing mode comprises delivery of cardiac conduction system pacing when intrinsic ventricular activation does not occur (¶362-a HIS pacing impulse is applied and, at operation 2302, various response characteristics are measured, which may include the intrinsic conduction time between application of the HIS pacing impulse and response of the LV and the QRS width/duration; ¶309-the RV is paced only when a backup impulse is required; ¶311-a timer is started when the pacing impulse is applied to the HIS bundle and is configured to stop when either activation of the RV is identified or the timer exceeds the H.sub.P-RV.sub.P delay. In the former case, backup pacing of the RV (i.e., RV.sub.P) is inhibited because the RV activated within the prescribed window of time and the backup impulse/RV.sub.P counter is reset (operation 1922); ¶297-the delay between an atrial event (sensing or pacing) and that of the ventricle (referred to herein as the “A-V” delay) is programmed significantly shorter than the nominal A-V interval such that the HIS bundle is preemptively paced).
Mangual-Soto relates generally to implantable cardiac stimulating devices. More specifically, the present disclosure is directed to a cardiac stimulation device that includes a lead for HIS bundle pacing and that includes logic for automatically identifying and implementing settings of the cardiac stimulation device for delivering HIS bundle pacing (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include wherein the inhibited pacing mode is selected in response to, at least, the QRS complex width being less than or equal to a QRS complex width threshold, the PR interval being less than or equal to a PR interval threshold, the intra-atrial conduction delay (IACD) may also be measured (operation 2215)), wherein the inhibited pacing mode comprises delivery of cardiac conduction system pacing when intrinsic ventricular activation does not occur of Mangual-Soto in order for backup impulses to only be provided only when necessary, thereby conserving energy and extending the operation life of the stimulation device (Mangual-Soto, ¶314).
Claims 8 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Ghosh ‘062 in view of Van Gelder as applied to claims 1 and 17 above, and further in view of Demmer (US 20160129261 filed on 4/23/15).
Regarding claim 8, the combination of Ghosh ‘062 and Van Gelder teaches the device as in claim 1. However, the combination of Ghosh ‘062 and Van Gelder does not teach wherein the atrioventricular synchronous pacing mode is selected in response to, at least, pacing being delivered for at least two cardiac cycles out of four cardiac cycles.
Demmer teaches wherein the atrioventricular synchronous pacing mode is selected in response to, at least, pacing being delivered for at least two cardiac cycles out of four cardiac cycles (¶144-processing module 40 controls LPD 10A to switch back to the sensing without pacing mode (or the atrio-ventricular synchronous pacing mode if LPD 10A was in the atrio-ventricular synchronous pacing mode prior to switching to the asynchronous ventricular pacing mode) after a predetermined number of cardiac cycles (e.g., two, three, or four, or five cardiac cycles); ¶46-if, after switching to the atrio-synchronous ventricular pacing mode, the processing module senses a threshold number of cardiac cycles in which atrial oversensing occurs, each of these cardiac cycles being referred to herein as an atrial oversensing event, within a particular number of cardiac cycles, then the processing module may switch the LPD from the atrio-ventricular synchronous pacing mode to an asynchronous ventricular pacing mode; ¶104).
Demmer relates to cardiac pacing, and more particularly, to cardiac pacing using a leadless pacing device (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include wherein the atrioventricular synchronous pacing mode is selected in response to, at least, pacing being delivered for at least two cardiac cycles out of four cardiac cycles of Demmer in order to check for intrinsic A-V conduction and to determine whether atrial oversensing is continuing to occur (Demmer, ¶144).
Regarding claim 23, the combination of Ghosh ‘062 and Van Gelder teaches the method as in claim 17. However, the combination of Ghosh ‘062 and Van Gelder does not teach wherein the atrioventricular synchronous pacing mode is selected in response to, at least, pacing being delivered for at least two cardiac cycles out of four cardiac cycles.
Demmer teaches wherein the atrioventricular synchronous pacing mode is selected in response to, at least, pacing being delivered for at least two cardiac cycles out of four cardiac cycles (¶144-processing module 40 controls LPD 10A to switch back to the sensing without pacing mode (or the atrio-ventricular synchronous pacing mode if LPD 10A was in the atrio-ventricular synchronous pacing mode prior to switching to the asynchronous ventricular pacing mode) after a predetermined number of cardiac cycles (e.g., two, three, or four, or five cardiac cycles); ¶46-if, after switching to the atrio-synchronous ventricular pacing mode, the processing module senses a threshold number of cardiac cycles in which atrial oversensing occurs, each of these cardiac cycles being referred to herein as an atrial oversensing event, within a particular number of cardiac cycles, then the processing module may switch the LPD from the atrio-ventricular synchronous pacing mode to an asynchronous ventricular pacing mode; ¶104).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include wherein the atrioventricular synchronous pacing mode is selected in response to, at least, pacing being delivered for at least two cardiac cycles out of four cardiac cycles of Demmer in order to check for intrinsic A-V conduction and to determine whether atrial oversensing is continuing to occur (Demmer, ¶144).
Claims 9-10 and 24 rejected under 35 U.S.C. 103 as being unpatentable over Ghosh ‘062 in view of Van Gelder as applied to claims 1 and 17 above, and further in view of Stadler (US 20170303840 filed on 7/6/17) and Ghosh ‘348.
Regarding claim 9, the combination of Ghosh ‘062 and Van Gelder teaches the device as in claim 1. However, the combination of Ghosh ‘062 and Van Gelder does not teach wherein the one or more metrics comprises QRS complex width, P-wave-to-R-wave (PR) interval, and at least one atrial fibrillation indicator, wherein the ventricular fusion pacing mode is selected in response to, at least, the QRS complex width being greater than a QRS complex width threshold, the PR interval being less than or equal to a PR interval threshold, and the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation, wherein the ventricular fusion pacing mode comprises delivery of cardiac conduction system pacing to initiate cardiac depolarization at the same time as intrinsic ventricular activation.
Stadler teaches wherein the one or more metrics comprises QRS complex width (¶16-activation times for typical widened QRS intrinsic rhythm; ¶80; ¶82), P-wave-to-R-wave (PR) interval (¶6-PR interval), wherein the ventricular fusion pacing mode is selected in response to, at least (¶127-degrees of fusion between the left ventricular pace; ¶151), wherein the ventricular fusion pacing mode is selected in response to, at least (¶127-degrees of fusion between the left ventricular pace; ¶151), the QRS complex width being greater than a QRS complex width threshold (¶80-if the next QRS is longer than the expected RR interval, lengthen the expected RR interval by e.g., 30 ms at block 1408; ¶82-widened QRS), the PR interval being less than or equal to a PR interval threshold (¶77-the timing to deliver the ultrasonic pace is less than the expected PR interval), wherein the ventricular fusion pacing mode comprises delivery of cardiac conduction system pacing to initiate cardiac depolarization at the same time as intrinsic ventricular activation (¶77-fusion of the paced depolarization with the intrinsic ventricular depolarization. Thus, timing of the ultrasound pace with respect to intrinsic depolarization of the ventricle is important; ¶127-achieve different degrees of fusion between the left ventricular pace and the intrinsic activation of the ventricles).
Stadler relates to electrophysiology and, more particularly, to evaluating the electrical activation patterns of the heart (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include wherein the one or more metrics comprises QRS complex width, P-wave-to-R-wave (PR) interval, wherein the ventricular fusion pacing mode is selected in response to, at least, wherein the ventricular fusion pacing mode is selected in response to, at least, the QRS complex width being greater than a QRS complex width threshold, the PR interval being less than or equal to a PR interval threshold, wherein the ventricular fusion pacing mode comprises delivery of cardiac conduction system pacing to initiate cardiac depolarization at the same time as intrinsic ventricular activation of Stadler in order to determine the minimum electrical dyssynchrony possible from a given pacing location (Stadler, ¶77).
While the combination teaches if AF is detected in a patient with LV pacing using the LEPARS interval-based pacing modality, a mode switch should occur to a non-tracking mode with bi-ventricular pacing (Van Gelder, ¶46), the combination does not teach at least one atrial fibrillation indicator, and the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation.
Ghosh ‘348 teaches at least one atrial fibrillation indicator (¶88-facilitate more accurate detection of a P-wave and, therefore, more accurate detection of AF using sensed electrical activity), and the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation (¶87-without an atrial kick, the system may be able to determine that AF is not present; ¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶21-when the patient's heart is not in AF; ¶85-the absence of a P-wave may be indicative of AF).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include at least one atrial fibrillation indicator, and the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
Regarding claim 10, the combination of Ghosh ‘062, Van Gelder, Stadler, and Ghosh ‘348 teaches the device as in claim 9, wherein the delivery of cardiac conduction system pacing is in response to expiration of a fusion atrioventricular delay following an atrial activation (Van Gelder, ¶72-the pacing electrodes of lead 16 activate the atria and the pacing electrodes of lead 52 activate the LV upon expiration of the A-LVp interval; ¶87-the LV chamber receives pre-excitation pacing therapy upon the expiration of the physiologically-derived AV delay; ¶88-fusion pacing ensues upon expiration of the newly programmed AV delay interval; ¶75-a LEPARS interval 711 promoting fusion resulting from LV-only pacing is defined as the time elapsed from Atrial activation (AP) to sensed RV depolarization (in FIG. 7 concealed as the "VP" event)), wherein the fusion atrioventricular delay is less than a smallest measured intrinsic atrioventricular delay (Van Gelder, ¶20-AV intervals greater than this transition point provide pressure development in the LV (LV dP/dtmax) of greater magnitude; ¶116-a fusion/transition point; This means that the AV interval being greater than the fusion/transition point is the same as the claim language of the fusion point being less than the AV interval; ¶44-AV delay interval; ¶117).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include wherein the delivery of cardiac conduction system pacing is in response to expiration of a fusion atrioventricular delay following an atrial activation, wherein the fusion atrioventricular delay is less than a smallest measured intrinsic atrioventricular delay of Van Gelder in order to provide a way to dynamically optimize AV intervals as the patient moves about their activities of daily living (ADL) (Van Gelder, ¶2).
Regarding claim 24, the combination of Ghosh ‘062 and Van Gelder teaches the method as in claim 17. However, the combination of Ghosh ‘062 and Van Gelder does not teach wherein the one or more metrics comprises QRS complex width, P-wave-to-R-wave (PR) interval, and at least one atrial fibrillation indicator, wherein the ventricular fusion pacing mode is selected in response to, at least, the QRS complex width being greater than a QRS complex width threshold, the PR interval being less than or equal to a PR interval threshold, and the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation, wherein the ventricular fusion pacing mode comprises delivery of cardiac conduction system pacing to initiate cardiac depolarization at the same time as intrinsic ventricular activation.
Stadler teaches wherein the one or more metrics comprises QRS complex width (¶16-activation times for typical widened QRS intrinsic rhythm; ¶80; ¶82), P-wave-to-R-wave (PR) interval (¶6-PR interval), wherein the ventricular fusion pacing mode is selected in response to, at least (¶127-degrees of fusion between the left ventricular pace; ¶151), the QRS complex width being greater than a QRS complex width threshold (¶80-if the next QRS is longer than the expected RR interval, lengthen the expected RR interval by e.g., 30 ms at block 1408; ¶82-widened QRS), the PR interval being less than or equal to a PR interval threshold (¶77-the timing to deliver the ultrasonic pace is less than the expected PR interval), wherein the ventricular fusion pacing mode comprises delivery of cardiac conduction system pacing to initiate cardiac depolarization at the same time as intrinsic ventricular activation (¶77-fusion of the paced depolarization with the intrinsic ventricular depolarization. Thus, timing of the ultrasound pace with respect to intrinsic depolarization of the ventricle is important; ¶127-achieve different degrees of fusion between the left ventricular pace and the intrinsic activation of the ventricles).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include wherein the one or more metrics comprises QRS complex width, P-wave-to-R-wave (PR) interval, wherein the ventricular fusion pacing mode is selected in response to, at least, the QRS complex width being greater than a QRS complex width threshold, the PR interval being less than or equal to a PR interval threshold, wherein the ventricular fusion pacing mode comprises delivery of cardiac conduction system pacing to initiate cardiac depolarization at the same time as intrinsic ventricular activation of Stadler in order to determine the minimum electrical dyssynchrony possible from a given pacing location (Stadler, ¶77).
While the combination teaches if AF is detected in a patient with LV pacing using the LEPARS interval-based pacing modality, a mode switch should occur to a non-tracking mode with bi-ventricular pacing (Van Gelder, ¶46), the combination does not teach at least one atrial fibrillation indicator, and the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation.
Ghosh ‘348 teaches at least one atrial fibrillation indicator (¶88-facilitate more accurate detection of a P-wave and, therefore, more accurate detection of AF using sensed electrical activity), and the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation (¶87-without an atrial kick, the system may be able to determine that AF is not present; ¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶21-when the patient's heart is not in AF; ¶85-the absence of a P-wave may be indicative of AF).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include at least one atrial fibrillation indicator, and the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ghosh ‘062 in view of Van Gelder as applied to claim 1 above, and further in view of Ternes (US 20200179705 filed on 12/9/19) and Ghosh ‘348.
Regarding claim 11, the combination of Ghosh ‘062 and Van Gelder teaches the device as in claim 1. However, the combination of Ghosh ‘062 and Van Gelder does not teach wherein the one or more metrics comprises P-wave-to-R-wave (PR) interval and at least one atrial fibrillation indicator, wherein the atrioventricular synchronous pacing mode is selected in response to, at least, the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation, the PR interval being greater than a PR interval threshold, wherein the atrioventricular synchronous pacing mode comprises delivery of cardiac conduction system pacing in response to expiration of a fixed atrioventricular delay following an atrial activation.
Ternes teaches wherein the one or more metrics comprises P-wave-to-R-wave (PR) interval (¶41-PR interval), wherein the atrioventricular synchronous pacing mode is selected in response to, at least (¶54-control the delivery of HBP according to patient atrioventricular (AV) conduction status)), the PR interval being greater than a PR interval threshold (¶41-first-degree AV block refers to AV conduction delay, usually in the AV node, manifest by a prolonged P wave to R wave interval greater than 200 milliseconds (msec) and is commonly due to a delay in the AV node irrespective of QRS width; ¶63-long PR intervals), wherein the atrioventricular synchronous pacing mode comprises delivery of cardiac conduction system pacing in response to expiration of a fixed atrioventricular delay following an atrial activation (¶43-generate HBP pulses to stimulate a His bundle or a bundle branch; ¶26-detecting an AV block pattern, and delivering the HBP pulses in accordance with the detected AV block pattern; ¶45-the AV conduction guided HBP may help avoid or reduce chances of HBP pulses competing with the intrinsic atrial impulses that propagate through the heart's naturally conduction system; ¶111-if the AVI.sub.S exceeds the sensed AVI threshold, then at 540 HBP may be delivered at expiration; ¶54).
Ternes relates generally to medical systems, and more particularly, to systems, devices and methods for pacing of cardiac conductive tissue, such as a His bundle or a bundle branch (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include wherein the one or more metrics comprises P-wave-to-R-wave (PR) interval, wherein the atrioventricular synchronous pacing mode is selected in response to, at least, the PR interval being greater than a PR interval threshold, wherein the atrioventricular synchronous pacing mode comprises delivery of cardiac conduction system pacing in response to expiration of a fixed atrioventricular delay following an atrial activation of Ternes in order for dynamic control of His-bundle pacing (HBP) according to patient AV conduction status (Ternes, ¶6).
While the combination teaches if AF is detected in a patient with LV pacing using the LEPARS interval-based pacing modality, a mode switch should occur to a non-tracking mode with bi-ventricular pacing (Van Gelder, ¶46), the combination does not teach at least one atrial fibrillation indicator, the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation.
Ghosh ‘348 teaches at least one atrial fibrillation indicator (¶88-facilitate more accurate detection of a P-wave and, therefore, more accurate detection of AF using sensed electrical activity), the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation (¶87-without an atrial kick, the system may be able to determine that AF is not present; ¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶21-when the patient's heart is not in AF; ¶85-the absence of a P-wave may be indicative of AF).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include at least one atrial fibrillation indicator, the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ghosh ‘062 in view of Van Gelder, and further in view of Ghosh ‘348 as applied to claim 12 above, and further in view of Ternes.
Regarding claim 13, the combination of Ghosh ‘062, Van Gelder, and Ghosh ‘348 teaches the device as in claim 12, monitoring intrinsic electrical activity of the patient's heart using the one or more implantable electrodes during intrinsic cardiac activation (Ghosh ‘062, ¶127-monitor intrinsic electrical activity of the patient using the left ventricular electrode during intrinsic cardiac electrical activation), wherein the atrial fibrillation pacing mode is selected in response to, at least, the atrial fibrillation indicators indicating the patient's is undergoing atrial fibrillation (Ghosh ‘348, ¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶86-a small peak below a threshold value indicates that the P-wave was not, or was unlikely, to have been present in the far-field signal, for example, due to the patient’s heart being in AF; ¶98-adjusting a pacing parameter or mode based on whether the electrical activity and the mechanical activity are indicative of atrial fibrillation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include wherein the atrial fibrillation pacing mode is selected in response to, at least, the atrial fibrillation indicators indicating the patient's is undergoing atrial fibrillation of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
However, the combination of Ghosh ‘062, Van Gelder, and Ghosh ‘348 does not teach wherein the prolonged conduction test occurs over a prolonged conduction time period, wherein the prolonged conduction time period is greater than or equal to 30 seconds.
Ternes teaches wherein the prolonged conduction test (¶96-initiate a test to determine AV block types periodically at a specific time period, such as every 21 hours. In an example, the test may last for 5 to 10 minutes, during which the AV intervals are monitored. The recognition of AV block pattern may be based on AV intervals corresponding to conducted ventricular beats prior to a conduction block to the ventricle) occurs over a prolonged conduction time period, wherein the prolonged conduction time period is greater than or equal to 30 seconds (¶91-the AV conduction reevaluation may be carried out on a periodic basis (e.g., every specific number of cardiac cycles, or a specific time period such as specific number of hours, days, or weeks), or triggered by a user (e.g., by a clinician during an office visit or device follow-up); ¶96).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include wherein the prolonged conduction test occurs over a prolonged conduction time period, wherein the prolonged conduction time period is greater than or equal to 30 seconds of Ternes in order for dynamic control of His-bundle pacing (HBP) according to patient AV conduction status (Ternes, ¶6).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ghosh ‘062 in view of Van Gelder and Ghosh ‘348, and further in view of Ternes as applied to claim 12 above, and further in view of Mangual-Soto.
Regarding claim 14, the combination of Ghosh ‘062, Van Gelder, Ghosh ‘348, and Ternes teaches the device as in claim 13. However, the combination of Ghosh ‘062, Van Gelder, Ghosh ‘348, and Ternes does not teach wherein the one or more metrics comprises QRS complex width, wherein selection of the atrial pacing mode comprises: selecting an inhibited atrial fibrillation response pacing mode in response to the QRS complex width being less than or equal to a QRS complex width threshold; selecting a conducted atrial fibrillation response pacing mode in response to a pacing capture threshold (PCT) greater than or equal to a PCT threshold or in response to ineffective capture; and selecting a cardiac resynchronization pacing mode in response to a pacing capture threshold (PCT) less than the PCT threshold and effective capture.
Mangual-Soto teaches wherein the one or more metrics comprises QRS complex width (¶223-QRS width), wherein selection of the atrial pacing mode (¶317-permanent HIS bundle pacing (HBP) was initially demonstrated to improve cardiac function in heart failure patients with atrial fibrillation; ¶400-direct the pulse generator to deliver an impulse at one or more HIS pacing sites as HBP) comprises: selecting an inhibited atrial fibrillation response pacing mode (¶128-inhibit the stimulation pulses; ¶136-inhibit the atrial and ventricular pulse generators 70, 72, respectively, in a demand fashion in response to the absence or presence of cardiac activity in the appropriate chambers of the heart; ¶317) in response to the QRS complex width being less than or equal to a QRS complex width threshold (¶42-determining whether a QRS duration of the response is less than the baseline QRS duration; ¶363-if the measured QRS width is less than a predetermined percentage of the baseline QRS width; ¶364); selecting a conducted atrial fibrillation response pacing mode (¶317-permanent HIS bundle pacing (HBP) was initially demonstrated to improve cardiac function in heart failure patients with atrial fibrillation; ¶400-direct the pulse generator to deliver an impulse at one or more HIS pacing sites as HBP) in response to a pacing capture threshold (PCT) greater than or equal to a PCT threshold or in response to ineffective capture (¶142-a capture threshold search would begin at a desired starting point (either a high energy level or the level at which capture is currently occurring) and decrease the energy level until capture is lost. The minimum energy at which capture is consistently obtained is known as the capture threshold; ¶167-the automatic capture threshold test may instead be initiated after a certain number of impulses fail to capture the HIS bundle or after similar criteria are met; ¶206-initiate a capture threshold test when the number of loss of capture events exceeds a predetermined quantity; MPEP 2114-[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)); and selecting a cardiac resynchronization pacing mode (¶107-another possible clinical application of HBP is cardiac resynchronization therapy (CRT); ¶116; ¶295) in response to a pacing capture threshold (PCT) less than the PCT threshold and effective capture (¶142-a capture threshold search would begin at a desired starting point (either a high energy level or the level at which capture is currently occurring) and decrease the energy level until capture is lost. The minimum energy at which capture is consistently obtained is known as the capture threshold; ¶275-non-selective capture by evaluating whether the peak-to-peak time interval is less than approximately 40 ms; MPEP 2114-[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include wherein the one or more metrics comprises QRS complex width, wherein selection of the atrial pacing mode comprises: selecting an inhibited atrial fibrillation response pacing mode in response to the QRS complex width being less than or equal to a QRS complex width threshold; selecting a conducted atrial fibrillation response pacing mode in response to a pacing capture threshold (PCT) greater than or equal to a PCT threshold or in response to ineffective capture; and selecting a cardiac resynchronization pacing mode in response to a pacing capture threshold (PCT) less than the PCT threshold and effective capture of Mangual-Soto in order to for identifying electrical impulses settings for inducing His bundle capture for a particular patient and self-configuring output settings of the cardiac stimulation device to output such electrical impulses (Mangual-Soto, ¶14).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ghosh ‘062 in view of Van Gelder as applied to claim 1 above, and further in view of Ghosh ‘215 (US 20180326215 filed on 5/9/18).
Regarding claim 15, the combination of Ghosh ‘062 and Van Gelder teaches the device as in claim 1, wherein the monitoring intrinsic electrical activity of the patient's heart using the one or more implantable electrodes (Ghosh ‘062, ¶127-monitor intrinsic electrical activity of the patient using the left ventricular electrode during intrinsic cardiac electrical activation).
However, the combination of Ghosh ‘062 and Van Gelder does not teach occurring over a testing number of intrinsic heart beats, wherein the testing number of intrinsic heart beats is less than or equal to 10.
Ghosh ‘215 teaches occurring over a testing number of intrinsic heart beats (¶190-an intrinsic rhythm during a conduction test beat; ¶124), wherein the testing number of intrinsic heart beats is less than or equal to 10 (¶126-a measured activation time, or AT, may be measured and calculated continuously or periodically for a selected number of, or N, heartbeats (e.g., 10 successive heartbeats); ¶128-for a first selected number of, or M, beats (e.g., 5 heartbeats) out a second selected number of, or N, beats (e.g., 10 heartbeats); ¶124).
Ghosh ‘215 relates to a determination being made as to whether cardiac resynchronization pacing therapy (CRT pacing) is appropriate based upon the heart activity sensed using the SD (¶8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include occurring over a testing number of intrinsic heart beats, wherein the testing number of intrinsic heart beats is less than or equal to 10 of Ghosh ‘215 in order to determine whether the AV delay should be adjusted (Ghosh ‘215, ¶128).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ghosh ‘062 in view of Van Gelder as applied to claim 17 above, and further in view of Mangual-Soto and Ghosh ‘348.
Regarding claim 21, the combination of Ghosh ‘062 and Van Gelder teaches the method as in claim 17. However, the combination of Ghosh ‘062 and Van Gelder does not teach wherein the one or more metrics comprises QRS complex width, P-wave-to-R-wave (PR) interval, and at least one atrial fibrillation indicator, wherein the inhibited pacing mode is selected in response to, at least, the QRS complex width being less than or equal to a QRS complex width threshold, the PR interval being less than or equal to a PR interval threshold, and the atrial fibrillation indicators indicating that the patient's is undergoing atrial fibrillation, wherein the inhibited pacing mode comprises delivery of cardiac conduction system pacing when intrinsic ventricular activation does not occur.
Mangual-Soto teaches wherein the one or more metrics comprises QRS complex width (¶233-QRS width), P-wave-to-R-wave (PR) interval (¶352-P-R interval), wherein the inhibited pacing mode is selected in response to, at least (¶16-inhibiting backup pacing of the ventricle when the time between application of the impulse and onset of the measured response is less than the first delay; ¶128; ¶136; ¶435), the QRS complex width being less than or equal to a QRS complex width threshold (¶363-measured QRS width is less than a predetermined percentage of the baseline QRS width; ¶42-determining whether a QRS duration of the response is less than the baseline QRS duration; ¶364), the PR interval being less than or equal to a PR interval threshold (¶310-analyzed to determine whether the measured time between pacing of the HIS bundle and a corresponding response of the RV falls within the H.sub.P-RV.sub.P delay; ¶356-in patients without long P-R intervals (e.g., P-R intervals below about 150 ms), the intra-atrial conduction delay (IACD) may also be measured (operation 2215)), wherein the inhibited pacing mode comprises delivery of cardiac conduction system pacing when intrinsic ventricular activation does not occur (¶362-a HIS pacing impulse is applied and, at operation 2302, various response characteristics are measured, which may include the intrinsic conduction time between application of the HIS pacing impulse and response of the LV and the QRS width/duration; ¶309-the RV is paced only when a backup impulse is required; ¶311-a timer is started when the pacing impulse is applied to the HIS bundle and is configured to stop when either activation of the RV is identified or the timer exceeds the H.sub.P-RV.sub.P delay. In the former case, backup pacing of the RV (i.e., RV.sub.P) is inhibited because the RV activated within the prescribed window of time and the backup impulse/RV.sub.P counter is reset (operation 1922); ¶297-the delay between an atrial event (sensing or pacing) and that of the ventricle (referred to herein as the “A-V” delay) is programmed significantly shorter than the nominal A-V interval such that the HIS bundle is preemptively paced).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include wherein the one or more metrics comprises QRS complex width, P-wave-to-R-wave (PR) interval, wherein the inhibited pacing mode is selected in response to, at least, the QRS complex width being less than or equal to a QRS complex width threshold, the PR interval being less than or equal to a PR interval threshold, wherein the inhibited pacing mode comprises delivery of cardiac conduction system pacing when intrinsic ventricular activation does not occur of Mangual-Soto in order for backup impulses to only be provided only when necessary, thereby conserving energy and extending the operation life of the stimulation device (Mangual-Soto, ¶314).
While the combination teaches if AF is detected in a patient with LV pacing using the LEPARS interval-based pacing modality, a mode switch should occur to a non-tracking mode with bi-ventricular pacing (Van Gelder, ¶46), the combination does not teach and at least one atrial fibrillation indicator, and the atrial fibrillation indicators indicating that the patient's is undergoing atrial fibrillation.
Ghosh ‘348 teaches at least one atrial fibrillation indicator (¶88-facilitate more accurate detection of a P-wave and, therefore, more accurate detection of AF using sensed electrical activity), and the atrial fibrillation indicators indicating that the patient's is undergoing atrial fibrillation (Ghosh ‘348, ¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶86-a small peak below a threshold value indicates that the P-wave was not, or was unlikely, to have been present in the far-field signal, for example, due to the patient’s heart being in AF).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include at least one atrial fibrillation indicator, and the atrial fibrillation indicators indicating that the patient's is undergoing atrial fibrillation of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, 7-8, 15-17, 20, 22-23, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/116079 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. See a matching of the claims in the table below for anticipation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims of the Present Application (19/116074)
Claims of US Application 19/116079
1
1, 11, 12
4
2
7
5
8
6, 18
15
13
16
11, 12, 15
17
11, 12, 16
20
2
22
5
23
6, 18
25
8
Claims 2 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/116079 in view of Ghosh '062 (US 20220032062).
This is a provisional nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include the subject matter of Ghosh ‘062 as shown below.
Claims of the Present Application (19/116074)
Claims of US Application 19/116079
Secondary Reference Ghosh '062 (US 20220032062)
2
Ghosh '062 teaches wherein the computing apparatus is further configured to execute comprises: monitoring far-field electrical activity of the patient's heart using at least one of the one or more implantable electrodes positioned outside of the right atrium of the patient's heart (Ghosh ‘062, ¶48-various near-field and far-field signals may be sensed by one or more electrodes of the IMD 16 and/or other devices operatively coupled thereto; ¶42-a lead configured to perform multi-site pacing, which is different than LV coronary sinus lead 20 , can be placed in the ventricular septum with the first (distal) electrode on the left side of the ventricular septum for left bundle branch pacing; ¶71-receives signals from electrodes 40 , 42 , which are used for pacing and sensing in right ventricle 28 of heart 12); and determining an electrical atrial activation based on the monitored far-field electrical activity (Ghosh ‘062, ¶37-an atrial activation may refer to an atrial sense or event (As) or an atrial pace or artifact of atrial pacing (Ap); ¶48-various near-field and far-field signals may be sensed by one or more electrodes of the IMD 16 and/or other devices operatively coupled thereto), wherein delivering cardiac conduction system pacing comprises delivering cardiac conduction system pacing based on the determined electrical atrial activation (Ghosh ‘062, ¶48-various pacing settings may be adjusted, or configured, based on various sensed signals. For example, various near-field and far-field signals may be sensed by one or more electrodes of the IMD 16 and/or other devices operatively coupled thereto. For example, Vp to QRS end or offset within a near-field or far-field signal may be used to adjust or configure the AV delay of cardiac conduction system pacing therapy). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include wherein the computing apparatus is further configured to execute comprises: monitoring far-field electrical activity of the patient's heart using at least one of the one or more implantable electrodes positioned outside of the right atrium of the patient's heart; and determining an electrical atrial activation based on the monitored far-field electrical activity, wherein delivering cardiac conduction system pacing comprises delivering cardiac conduction system pacing based on the determined electrical atrial activation of Ghosh ‘062 in order to provide adaptive cardiac conducting system pacing therapy (Ghosh ‘062, ¶2).
18
Ghosh '062 teaches wherein the method further comprises: monitoring far-field electrical activity of the patient's heart using at least one of the one or more implantable electrodes positioned outside of the right atrium of the patient's heart (Ghosh ‘062, ¶48-various near-field and far-field signals may be sensed by one or more electrodes of the IMD 16 and/or other devices operatively coupled thereto; ¶42-a lead configured to perform multi-site pacing, which is different than LV coronary sinus lead 20 , can be placed in the ventricular septum with the first (distal) electrode on the left side of the ventricular septum for left bundle branch pacing; ¶71-receives signals from electrodes 40 , 42 , which are used for pacing and sensing in right ventricle 28 of heart 12); and determining an electrical atrial activation based on the monitored far-field electrical activity (Ghosh ‘062, ¶37-an atrial activation may refer to an atrial sense or event (As) or an atrial pace or artifact of atrial pacing (Ap); ¶48-various near-field and far-field signals may be sensed by one or more electrodes of the IMD 16 and/or other devices operatively coupled thereto), wherein delivering cardiac conduction system pacing comprises delivering cardiac conduction system pacing based on the determined electrical atrial activation (Ghosh ‘062, ¶48-various pacing settings may be adjusted, or configured, based on various sensed signals. For example, various near-field and far-field signals may be sensed by one or more electrodes of the IMD 16 and/or other devices operatively coupled thereto. For example, Vp to QRS end or offset within a near-field or far-field signal may be used to adjust or configure the AV delay of cardiac conduction system pacing therapy). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include wherein the method further comprises: monitoring far-field electrical activity of the patient's heart using at least one of the one or more implantable electrodes positioned outside of the right atrium of the patient's heart; and determining an electrical atrial activation based on the monitored far-field electrical activity, wherein delivering cardiac conduction system pacing comprises delivering cardiac conduction system pacing based on the determined electrical atrial activation of Ghosh ‘062 in order to provide adaptive cardiac conducting system pacing therapy (Ghosh ‘062, ¶2).
Claims 3, 5-6, 9-12, 19, 21, and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/116079 in view of Ghosh ‘348 (US 20210060348).
This is a provisional nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include the subject matter of Ghosh ‘348 as shown below.
Claims of the Present Application (19/116074)
Claims of US Application 19/116079
Secondary Reference Ghosh ‘348 (US 20210060348)
3
Ghosh ‘348 teaches wherein the computing apparatus is further configured to execute comprises: monitoring mechanical activity of the patient's heart using a mechanical cardiac activation sensor to monitor mechanical activity of the patient's heart (¶62-the motion sensor 11 may be used to monitor mechanical activity, such as atrial mechanical activity (e.g., an atrial contraction) and/or ventricular mechanical activity (e.g., a ventricular contraction); ¶83-utilizing mechanical activity may facilitate confirmation of whether atrial activation has occurred); and determining a mechanical atrial activation based on the monitored mechanical activity (¶83-utilizing mechanical activity may facilitate confirmation of whether atrial activation has occurred. In particular, an atrial kick typically follows normal or paced atrial activation. The atrial kick may manifest as a distinguishable amplitude change on mechanical activity sensed, for example, by an integrated accelerometer), wherein delivering cardiac conduction system pacing comprises delivering cardiac conduction system pacing based on the determined mechanical atrial activation (¶98-adjusting a pacing parameter or mode based on whether the electrical activity and the mechanical activity are indicative of atrial fibrillation; ¶21-cardiac therapy systems may measure mechanical activity using a motion sensor to facilitate the determination of whether the patient's heart is in AF. Based on the AF determination, the system may be configured to mode switch or adjust P-wave sensitivity levels to better detect far-field P-waves when the patient's heart is not in AF). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include wherein the computing apparatus is further configured to execute comprises: monitoring mechanical activity of the patient's heart using a mechanical cardiac activation sensor to monitor mechanical activity of the patient's heart; and determining a mechanical atrial activation based on the monitored mechanical activity, wherein delivering cardiac conduction system pacing comprises delivering cardiac conduction system pacing based on the determined mechanical atrial activation of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
5
3
Ghosh ‘348 teaches at least one atrial fibrillation indicator (¶88-facilitate more accurate detection of a P-wave and, therefore, more accurate detection of AF using sensed electrical activity), wherein the at least one atrial fibrillation indicators comprise one or more of R-wave-to-R-wave (RR) interval consistency, T-wave-to-P-wave (TP) interval consistency, and far-field P-wave morphology (¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶86-a small peak below a threshold value indicates that the P-wave was not, or was unlikely, to have been present in the far-field signal, for example, due to the patient’s heart being in AF). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include at least one atrial fibrillation indicator, wherein the at least one atrial fibrillation indicators comprise one or more of R-wave-to-R-wave (RR) interval consistency, T-wave-to-P-wave (TP) interval consistency, and far-field P-wave morphology of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
6
4, 17
Ghosh '348 teaches the atrial fibrillation indicators indicating that the patient's is undergoing atrial fibrillation (Ghosh ‘348, ¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶86-a small peak below a threshold value indicates that the P-wave was not, or was unlikely, to have been present in the far-field signal, for example, due to the patient’s heart being in AF). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include the atrial fibrillation indicators indicating that the patient's is undergoing atrial fibrillation of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
9
7, 19
Ghosh ‘348 teaches at least one atrial fibrillation indicator (¶88-facilitate more accurate detection of a P-wave and, therefore, more accurate detection of AF using sensed electrical activity), and the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation (¶87-without an atrial kick, the system may be able to determine that AF is not present; ¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶21-when the patient's heart is not in AF; ¶85-the absence of a P-wave may be indicative of AF). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include at least one atrial fibrillation indicator, and the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
10
8
11
Ghosh ‘348 teaches at least one atrial fibrillation indicator (¶88-facilitate more accurate detection of a P-wave and, therefore, more accurate detection of AF using sensed electrical activity), the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation (¶87-without an atrial kick, the system may be able to determine that AF is not present; ¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶21-when the patient's heart is not in AF; ¶85-the absence of a P-wave may be indicative of AF). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include at least one atrial fibrillation indicator, the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
12
Ghosh ‘348 teaches wherein the one or more metrics comprises at least one atrial fibrillation indicator (¶88-facilitate more accurate detection of a P-wave and, therefore, more accurate detection of AF using sensed electrical activity), wherein the at least one atrial fibrillation indicators comprise one or more of R-wave-to-R-wave (RR) interval consistency, T- wave-to-P-wave (TP) interval consistency, and far-field P-wave morphology (¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶86-a small peak below a threshold value indicates that the P-wave was not, or was unlikely, to have been present in the far-field signal, for example, due to the patient’s heart being in AF), wherein performing the conduction test further comprises performing a prolonged conduction test (¶113-determine whether the electrical activity of one or both atria sensed by the second electrode is indicative of atrial fibrillation; ¶114-in response to determining that the electrical activity of one or both atria is indicative of atrial fibrillation, determine whether mechanical activity of the patient's heart sensed by the motion sensor represents atrial contraction) in response to, at least, the atrial fibrillation indicators indicating the patient's is undergoing atrial fibrillation (¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶86-a small peak below a threshold value indicates that the P-wave was not, or was unlikely, to have been present in the far-field signal, for example, due to the patient’s heart being in AF; ¶139-wherein determining whether the electrical activity of one or both atria is indicative of atrial fibrillation comprises determining whether a P-wave is detected). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include wherein the one or more metrics comprises at least one atrial fibrillation indicator, wherein the at least one atrial fibrillation indicators comprise one or more of R-wave-to-R-wave (RR) interval consistency, T- wave-to-P-wave (TP) interval consistency, and far-field P-wave morphology, wherein performing the conduction test further comprises performing a prolonged conduction test in response to, at least, the atrial fibrillation indicators indicating the patient's is undergoing atrial fibrillation of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
19
Ghosh ‘348 teaches wherein the method further comprises: monitoring mechanical activity of the patient's heart using a mechanical cardiac activation sensor to monitor mechanical activity of the patient's heart (¶62-the motion sensor 11 may be used to monitor mechanical activity, such as atrial mechanical activity (e.g., an atrial contraction) and/or ventricular mechanical activity (e.g., a ventricular contraction); ¶83-utilizing mechanical activity may facilitate confirmation of whether atrial activation has occurred); and determining a mechanical atrial activation based on the monitored mechanical activity (¶83-utilizing mechanical activity may facilitate confirmation of whether atrial activation has occurred. In particular, an atrial kick typically follows normal or paced atrial activation. The atrial kick may manifest as a distinguishable amplitude change on mechanical activity sensed, for example, by an integrated accelerometer), wherein delivering cardiac conduction system pacing comprises delivering cardiac conduction system pacing based on the determined mechanical atrial activation (¶98-adjusting a pacing parameter or mode based on whether the electrical activity and the mechanical activity are indicative of atrial fibrillation; ¶21-cardiac therapy systems may measure mechanical activity using a motion sensor to facilitate the determination of whether the patient's heart is in AF. Based on the AF determination, the system may be configured to mode switch or adjust P-wave sensitivity levels to better detect far-field P-waves when the patient's heart is not in AF). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include monitoring mechanical activity of the patient's heart using a mechanical cardiac activation sensor to monitor mechanical activity of the patient's heart; and determining a mechanical atrial activation based on the monitored mechanical activity, wherein delivering cardiac conduction system pacing comprises delivering cardiac conduction system pacing based on the determined mechanical atrial activation of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
21
4, 17
Ghosh ‘348 teaches at least one atrial fibrillation indicator (¶88-facilitate more accurate detection of a P-wave and, therefore, more accurate detection of AF using sensed electrical activity), and the atrial fibrillation indicators indicating that the patient's is undergoing atrial fibrillation (Ghosh ‘348, ¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶86-a small peak below a threshold value indicates that the P-wave was not, or was unlikely, to have been present in the far-field signal, for example, due to the patient’s heart being in AF). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ghosh ‘062 to include at least one atrial fibrillation indicator, and the atrial fibrillation indicators indicating that the patient's is undergoing atrial fibrillation of the copending application in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
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7, 19
Ghosh ‘348 teaches at least one atrial fibrillation indicator (¶88-facilitate more accurate detection of a P-wave and, therefore, more accurate detection of AF using sensed electrical activity), and the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation (¶87-without an atrial kick, the system may be able to determine that AF is not present; ¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶21-when the patient's heart is not in AF; ¶85-the absence of a P-wave may be indicative of AF). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include at least one atrial fibrillation indicator, and the atrial fibrillation indicators not indicating that the patient's is undergoing atrial fibrillation of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
Claims 13-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/116079 in view of Ghosh ‘062, Ghosh ‘348, and Ternes (US 20200179705).
This is a provisional nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include the subject matter of Ghosh ‘062, Ghosh ‘348, and Ternes as shown below.
Claims of the Present Application (19/116074)
Claims of US Application 19/116079
Secondary Reference Ghosh '062 (US 20220032062)
Secondary Reference Ghosh ‘348 (US 20210060348)
Secondary Reference Ternes (US 20200179705)
13
Ghosh '062 teaches monitoring intrinsic electrical activity of the patient's heart using the one or more implantable electrodes during intrinsic cardiac activation (Ghosh ‘062, ¶127-monitor intrinsic electrical activity of the patient using the left ventricular electrode during intrinsic cardiac electrical activation). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include monitoring intrinsic electrical activity of the patient's heart using the one or more implantable electrodes during intrinsic cardiac activation of Ghosh ‘062 in order to provide adaptive cardiac conducting system pacing therapy (Ghosh ‘062, ¶2).
Ghosh '348 teaches activity of the patient using the left ventricular electrode during intrinsic cardiac electrical activation), wherein the atrial fibrillation pacing mode is selected in response to, at least, the atrial fibrillation indicators indicating the patient's is undergoing atrial fibrillation (Ghosh ‘348, ¶39-detect a far-field atrial signal, such as a far-field P- wave signal; ¶88-the P-wave detection sensitivity may also be described as an atrial activation threshold, such as based on magnitude of a peak where the P-wave is expected, to detect the P-wave; ¶86-a small peak below a threshold value indicates that the P-wave was not, or was unlikely, to have been present in the far-field signal, for example, due to the patient’s heart being in AF; ¶98-adjusting a pacing parameter or mode based on whether the electrical activity and the mechanical activity are indicative of atrial fibrillation).Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include wherein the atrial fibrillation pacing mode is selected in response to, at least, the atrial fibrillation indicators indicating the patient's is undergoing atrial fibrillation of Ghosh ‘348 in order for more accurate detection of AF (Ghosh ‘348, ¶88) to utilize mode switching to administer different sensing and pacing modes, for example, during CRT based on the presence of AF (Ghosh ‘348, ¶5).
Ternes teaches wherein the prolonged conduction test (¶96-initiate a test to determine AV block types periodically at a specific time period, such as every 21 hours. In an example, the test may last for 5 to 10 minutes, during which the AV intervals are monitored. The recognition of AV block pattern may be based on AV intervals corresponding to conducted ventricular beats prior to a conduction block to the ventricle) occurs over a prolonged conduction time period, wherein the prolonged conduction time period is greater than or equal to 30 seconds (¶91-the AV conduction reevaluation may be carried out on a periodic basis (e.g., every specific number of cardiac cycles, or a specific time period such as specific number of hours, days, or weeks), or triggered by a user (e.g., by a clinician during an office visit or device follow-up); ¶96). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include wherein the prolonged conduction test occurs over a prolonged conduction time period, wherein the prolonged conduction time period is greater than or equal to 30 seconds of Ternes in order for dynamic control of His-bundle pacing (HBP) according to patient AV conduction status (Ternes, ¶6).
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12
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20210361953: a cardiac region of the human or animal heart is stimulated with the His electrode, with the at least one further electrode and/or with a stimulation unit configured to stimulate a cardiac region of the heart (¶49).
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/LAURA HODGE/Examiner, Art Unit 3792
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