DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 4, 7-23, and 25-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards an abstract idea.
Step 1 – Is the claim to a statutory category of invention
Claims 1, and 3-20 recite a machine (i.e., a device); Claims 21-28 recite a process (i.e., a method). Therefore, the claims are to a statutory category of invention.
Step 2A, prong 1 – Does the claim recite a judicial exception?
Independent claim 1 recites: “determine a surrogate LV activation time based on the monitored electrical activity for each of the one or more pacing configurations, wherein the surrogate LV activation time is representative of an LV activation time…”. The recited subject matter is both an abstract idea mental process and mathematical calculation. The claimed subject matter is a mental process in that one of ordinary skill in the art, such as a physician or cardiologist, could determine a surrogate activation time in there own head based on judgements and observations made from electrical activity monitors, such as an ECG displays. Further, the claimed subject matter is claimed so broadly as to include calculations of surrogate activation times based mathematical calculations performed with data from electrodes. One of ordinary skill could perform the same calculations to determine a surrogate activation time.
Further, claim 1 recites: “determine whether the LBB pacing has captured the LBB for each of the one or more pacing configurations based on the determined surrogate LV activation time for each of the one or more pacing configurations.” The recited subject matter is both an abstract idea mental process and mathematical calculation. The claimed subject matter is a mental process in that one of ordinary skill in the art, such as a physician or cardiologist, could determine whether LBB pacing has captured the LBB for configurations based on observations and judgements from ECG data and surrogate activation times, and they would be able to do this in their own mind. Further, the claim is recited so broadly that it includes mathematical calculations that could be performed to determine LBB capture. One of ordinary skill in the art would be able to perform calculations to using ECG data to determine LBB capture based on calculated activation times.
Independent claim 21 recites the same judicial exceptions as claim 1.
Step 2A, prong 2 – Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claim 1 recites: “An implantable medical device comprising: one or more implantable electrodes comprising an LBB electrode positionable proximate a portion of a patient's left bundle branch (LBB)…”. The recited subject matter generally links the judicial exception to a field of use, as well as reciting general structure (electrodes) for obtaining heart data. The claim does not integrate the judicial exception into a practical application since one of ordinary skill would recognize implantable electrodes used for measuring (or monitoring) electrical activity and delivering pacing pulses to be generic in the field cardiac pacing. As in Alice Corp. v. CLS Bank, 573 U.S. 208, 223 (2014), limiting an abstract idea to a field of use or adding generic hardware does not integrate the exception into a practical application.
Claim 1 further recites: “a computing apparatus comprising processing circuitry and operably coupled to the one or more implantable electrodes…”. One of ordinary skill would recognize a computing apparatus and processing circuitry to be generic computer structure for executing insignificant extra-solution activity and performing an abstract idea mental process.
Claim 1 also recites: “deliver LBB pacing proximate to the LBB using the LBB electrode at one or more pacing configurations; monitor electrical activity using the one or more implantable electrodes during delivery of the LBB pacing at the one or more pacing configurations.” The recited subject matter is insignificant extra-solution activity in that one of ordinary skill would recognize that delivering pulses and monitoring electrical activity in a heart is merely data gathering. One would recognize that applying pacing and monitoring heart activity is merely pre-solution activity performed for obtaining heartbeat data. See example c) in MPEP §2106.04(d)(2). Therefore, claim 1 does not recite additional elements that integrate the abstract idea into a practical application.
The additional elements of claim 21 recite the same field of use and insignificant extra-solution activity additional elements of claim 1, and do not integrate the judicial exception into a practical application.
Step 2B – Do the additional elements add significantly more to the judicial exception?
Claim 1 recites: “An implantable medical device comprising: one or more implantable electrodes comprising an LBB electrode positionable proximate a portion of a patient's left bundle branch (LBB)…”. The recited subject matter generally links the judicial exception to a field of use, as well as reciting general structure (electrodes) for obtaining heart data. The claim does not integrate the judicial exception into a practical application since one of ordinary skill would recognize implantable electrodes used for measuring (or monitoring) electrical activity and delivering pacing pulses to be generic in the field cardiac pacing.
Claim 1 further recites: “a computing apparatus comprising processing circuitry and operably coupled to the one or more implantable electrodes…”. One of ordinary skill would recognize a computing apparatus and processing circuitry to be generic computer structure for executing insignificant extra-solution activity and performing an abstract idea mental process.
Claim 1 also recites: “deliver LBB pacing proximate to the LBB using the LBB electrode at one or more pacing configurations; monitor electrical activity using the one or more implantable electrodes during delivery of the LBB pacing at the one or more pacing configurations.” The recited subject matter is insignificant extra-solution activity in that one of ordinary skill would recognize that delivering pulses and monitoring electrical activity in a heart is merely data gathering. One would recognize that applying pacing and monitoring heart activity is merely pre-solution activity performed for obtaining heartbeat data. Therefore, claim 1 does not recite additional elements that amount to significantly more than the judicial exception.
The additional elements of claim 21 recite the same field of use and insignificant extra-solution activity elements of claim 1, and do not amount to significantly more than the judicial exception.
Dependent claims
Claim 3 and 22 recite generic electrode structure for delivering stimulation and monitoring electrical activity in the heart.
Claim 4, 22, and 23 further defines insignificant extra-solution activity.
Claims 7-20, and 25-28 further define mental process and mathematical concept abstract ideas.
The Examiner notes that claims 5, 6, and 24 are not rejected under 35 USC 101. Claim 5 recites: “wherein the computing apparatus is further configured to execute, or the method further comprises: select a pacing configuration of the plurality of pacing configurations based on the surrogate LV activation time for each of the plurality of pacing configurations and a paced setting of each of the plurality of pacing configurations; and deliver LBB pacing at the selected pacing configuration.” Selecting the electrode configuration based on abstract idea determinations of claim 1 and then delivering stimulation based on the selected stimulation is an additional element that integrates the abstract idea into a practical application and is significantly more than the abstract idea. Claim 6 is dependent on claim 5 and also includes the same additional elements.
Claim 24 recites the same additional elements of selecting a configuration and delivering therapy based on the selected pacing configuration.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 12, 14, 15, 18, 21, 23, 24, and 26-28 and are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Ghosh (US 20200352470 A1).
Regarding claim 1, Ghosh teaches an implantable medical device (para. [0006]; "In one or more embodiments, the systems and methods may be described as being invasive in that such systems and methods may utilize implantable electrodes to monitor electrical activity for using in evaluating engagement of the patient's posterior left bundle branch by cardiac therapy. Additionally, it is be understood that both invasive and non-invasive apparatus and processes may be used at the same time or simultaneously in some embodiments."; para. [0057]: " The illustrative systems and methods described herein may be used to provide noninvasive assistance to a user in the evaluation and assessment of posterior left bundle branch engagement by cardiac therapy such as VfA cardiac pacing, left ventricular septal-basal cardiac pacing, etc. Further, the illustrative systems and methods described herein may be used in the configuration of cardiac therapy being presently-delivered to the patient (e.g., by an implantable medical device such as a VfA pacing device)"; para. [0061]: "The method 200 may include delivery of cardiac therapy 204 such as cardiac pacing therapy using an implantable or non-implantable device intended to pace or deliver electrical paces to one or more areas or regions of the patient's heart."; Fig. 7) comprising: one or more implantable electrodes (Fig. 7; para. [0088]: " It is to be understood that although device 10 is described herein as including a single dart electrode assembly, the device 10 may include more than one dart electrode assembly placed, or configured to be placed, through the atrial myocardium and the central fibrous body, and into the ventricular myocardium 14, or along the ventricular septum, without perforating entirely through the ventricular endocardial or epicardial surfaces. Additionally, each dart electrode assembly may carry, or include, more than a single electrode at the distal end region, or along other regions (e.g., proximal or central regions), of the shaft."; para. [0089]: "The cardiac therapy system 2 may also include a separate medical device 50 (depicted diagrammatically in FIG. 7), which may be positioned outside the patient's heart 8 (e.g., subcutaneously) and may be operably coupled to the patient's heart 8 to deliver cardiac therapy thereto. In one example, separate medical device 50 may be an extravascular ICD. In some embodiments, an extravascular ICD may include a defibrillation lead including, or carrying, a defibrillation electrode. A therapy vector may exist between the defibrillation electrode on the defibrillation lead and a housing electrode of the ICD. Further, one or more electrodes of the ICD may also be used for sensing electrical signals related to the patient's heart 8. The ICD may be configured to deliver shock therapy including one or more defibrillation or cardioversion shocks. For example, if an arrhythmia is sensed, the ICD may send a pulse via the electrical lead wires to shock the heart and restore its normal rhythm. In some examples, the ICD may deliver shock therapy without placing electrical lead wires within the heart or attaching electrical wires directly to the heart (subcutaneous ICDs).") comprising an LBB electrode positionable proximate a portion of a patient's left bundle branch (LBB) (para. [0036] discloses that a position for the electrodes can be selected: "For example, some metrics may be computed from signals recorded, or monitored, from electrodes positioned about a selected area of the patient such as, e.g., the left side of the patient, the right side of the patient, etc."; para. [0087] also discloses selection for electrode positioning: "The dart electrode assembly 12 may carry, or include, an electrode at a distal end region of the shaft such that the electrode may be positioned within the ventricular myocardium for sensing ventricular signals and delivering ventricular pacing pulses (e.g., to depolarize the left ventricle and/or right ventricle to initiate a contraction of the left ventricle and/or right ventricle). In some examples, the electrode at the distal end region of the shaft is a cathode electrode provided for use in a bipolar electrode pair for pacing and sensing. While the implant region 4 as illustrated may enable one or more electrodes of the dart electrode assembly 12 to be positioned in the ventricular myocardium, it is recognized that a device having the aspects disclosed herein may be implanted at other locations for multiple chamber pacing (e.g., dual or triple chamber pacing), single chamber pacing with multiple chamber sensing, single chamber pacing and/or sensing, or other clinical therapy and applications as appropriate."); and a computing apparatus (Fig. 1; computing apparatus 140 and remote computing device 160) comprising processing circuitry and operably coupled to the one or more implantable electrodes (para. [0036]: "For example, one cardiac cycle, or one heartbeat, of a plurality of cardiac cycles, or heartbeats, represented by the electrical signals collected or monitored by the electrode apparatus 110 may be analyzed and evaluated for one or more metrics including activation times and electrical heterogeneity information that may be pertinent to the assessment and evaluation of posterior left bundle branch engagement."), wherein the computing apparatus is configured to: deliver LBB pacing proximate to the LBB using the LBB electrode at one or more pacing configurations (para. [0037]: "One or both of the computing apparatus 140 and the remote computing device 160 may include data storage that may allow for access to processing programs or routines and/or one or more other types of data, e.g., for analyzing a plurality of electrical signals captured by the electrode apparatus 110, for determining EHI, for determining QRS onsets, QRS offsets, medians, modes, averages, peaks or maximum values, valleys or minimum values, for determining electrical activation times, for evaluating posterior left bundle branch engagement by cardiac therapy, for determining whether the patient has left or right ventricular delays or blocks, for determining whether one or more adjustments to pacing settings of cardiac therapy may increase posterior left bundle branch engagement, for driving a graphical user interface configured to noninvasively assist a user in configuring one or more pacing parameters, or settings, such as, e.g., pacing rate, ventricular pacing rate, A-V interval, V-V interval, pacing pulse width, pacing vector, multipoint pacing vector (e.g., left ventricular vector quad lead), pacing voltage, pacing configuration (e.g., biventricular pacing, right ventricle only pacing, left ventricle only pacing, etc.), and arrhythmia detection and treatment, rate adaptive settings and performance, etc."); monitor electrical activity using the one or more implantable electrodes during delivery of the LBB pacing at the one or more pacing configurations (para. [0037]: " e.g., for analyzing a plurality of electrical signals captured by the electrode apparatus 110"); determine a surrogate LV activation time based on the monitored electrical activity for each of the one or more pacing configurations (para. [0009]: "The present disclosure describes systems and methods that provide more efficient resynchronization (e.g., using VfA pacing, LBB pacing, left ventricular septal basal pacing, etc.) based on engagement of posterior fascicle or posterior LBB, which if done successfully should result in complete preactivation of posterior surface of the body as reflected on the surrogate activation time maps. Further, the new metrics disclosed herein may also be used and tied to the concept of titration of pacing to maximize engagement of left posterior bundle."; para. [0036]: "More specifically, for example, the QRS complex of a single cardiac cycle may be evaluated for one or more metrics such as… average left ventricular or thoracic surrogate electrical activation times (LVAT)."; Additionally, para. [0210] discloses where the pacing is adjusted depending on engagement of the LBB: " After the illustrative method 200 has determined posterior left bundle branch engagement 208, the method 200 may further including adjusting, or modifying, the cardiac therapy 210 to, for example, increase the posterior left bundle branch engagement in an effort to provide more effective heart functionality."), wherein the surrogate LV activation time is representative of an LV activation time (para. [0036]: " average left ventricular or thoracic surrogate electrical activation times (LVAT), and referenced to earliest activation time."); and determine whether the LBB pacing has captured the LBB for each of the one or more pacing configurations based on the determined surrogate LV activation time for each of the one or more pacing configurations (para. [0009]: "The present disclosure describes systems and methods that provide more efficient resynchronization (e.g., using VfA pacing, LBB pacing, left ventricular septal basal pacing, etc.) based on engagement of posterior fascicle or posterior LBB, which if done successfully should result in complete preactivation of posterior surface of the body as reflected on the surrogate activation time maps.").
Regarding claim 12, Gosh teaches the implantable medical device of claim 1 (see rejection above), wherein determining whether the LBB pacing has captured the LBB for each of the one or more pacing configurations comprises determining that the LBB pacing has captured the LBB if the surrogate LV activation time is within a selected percentage of one or more surrogate LV activation times determined from electrical activity monitored during delivery of LBB pacing using other pacing configurations of the one or more pacing configurations (para. [0072]: "In one or more embodiments, the percentage of surrogate early-activation electrical activation times monitored by the posterior electrodes (PEPA) may be used to evaluate posterior left bundle branch engagement. To determine whether a posterior electrode, or activation monitored by the posterior electrode, constitutes early activation, the activation time may be compared to an early-activation threshold."; para. [0073]: "Thus, the early-activation electrodes, as determined by the early-activation threshold, may be divided by the total amount of posterior electrodes to provide the PEPA, and then the PEPA may be used to determine the degree of posterior left bundle branch engagement. For example, if the PEPA is greater than 75%, then it may be determined that the left bundle branch is sufficiently engaged. Further, for example, if the PEPA is greater than or equal to 50% and less than or equal to 75%, then it may be determined that the left bundle branch is partially engaged. Still further, for example, if the PEPA is less than 50%, then it may be determined that the left bundle branch is insufficiently engaged."; para. [0082]: "It may be described that processes 206, 208, 210 define a “closed-loop.” For example, processes 206, 208, 2010 may continue looping for a plurality of different pacing settings or configurations, and for each of the plurality of different pacing settings or configurations, EHI information may be generated 206 and posterior left bundle branch engagement may be determined 208. The EHI generated for the plurality of different pacing settings or configurations, and in turn, the determinization of posterior left bundle branch engagement may then be used to determine selected pacing settings of the cardiac pacing therapy 212. The selected pacing settings for the cardiac conduction therapy may, in some embodiments, be referred to as the “optimal” pacing settings as, for example, the pacing settings providing the most complete posterior left bundle branch engagement may be selected." The closed-loop aspect means that the determination can be made with either the same or different configurations, and the process can be repeated with new configurations to make the determination). The Examiner notes that the structure recited in Ghosh is sufficient to perform the claimed function of determining LBB activation, and therefore, meets the contingent limitation (see MPEP 2111.04(II)).
Regarding claim 14, Ghosh teaches the implantable medical device of claim 12 (see above), wherein the one or more surrogate LV activation times determined using the other pacing configurations of the one or more pacing configurations comprises a previously determined surrogate LV activation time that was determined from electrical activity monitored during delivery of LBB pacing using a most recently used pacing configuration (para. [0082]: "It may be described that processes 206, 208, 210 define a ‘closed-loop.’ For example, processes 206, 208, 2010 may continue looping for a plurality of different pacing settings or configurations, and for each of the plurality of different pacing settings or configurations, EHI information may be generated 206 and posterior left bundle branch engagement may be determined 208. The EHI generated for the plurality of different pacing settings or configurations, and in turn, the determinization of posterior left bundle branch engagement may then be used to determine selected pacing settings of the cardiac pacing therapy 212." The pacing configuration is a closed-loop process and the settings can be determined based on the previous configuration; Additionally, the EHI is disclosed as surrogate electrical activation in para. [0036]: "More specifically, for example, the QRS complex of a single cardiac cycle may be evaluated for one or more metrics such as, e.g., QRS onset, QRS offset, QRS peak, various electrical heterogeneity information (EHI) such as electrical activation times, left ventricular or thoracic standard deviation of electrical activation times (LVED), standard deviation of activation times (SDAT), average left ventricular or thoracic surrogate electrical activation times (LVAT).").
Regarding claim 15, Ghosh teaches the implantable medical device of claim 1 (see above), wherein determining whether the LBB pacing has captured the LBB for each of the one or more pacing configurations comprises determining that the LBB pacing has captured the LBB if the determined surrogate LV activation time is within a selected percentage of a threshold surrogate LV activation time. (para. [0010]: "Another illustrative metric of EHI may be the percentage of posterior electrodes activating earlier than a certain time threshold (e.g., 35 milliseconds), which may be referred to as a percentage of early posterior activation (PEPA), indicating a degree of spread of early activation on the posterior aspect of the body."; para. [0071]: "In one or more embodiments, the mean of surrogate posterior electrical activation times monitored by the posterior electrodes (MPAT) may be used to evaluate posterior left bundle branch engagement. The MPAT may be compared against one or more thresholds or ranges to determine the degree to which the posterior left bundle branch is engaged. For example, if the MPAT is less than or equal to 30 milliseconds, then it may be determined that the left bundle branch is sufficiently engaged. Further, if the MPAT is greater than 30 milliseconds and less than 50 milliseconds, then it may be determined that the left bundle branch is partially engaged. Still further, for example, if the MPAT is greater than or equal to 50 milliseconds, then it may be determined that the left bundle branch is insufficiently engaged. It is to be understood that such thresholds and ranges in this embodiment are only one example, and other similar thresholds and ranges are contemplated by the present disclosure."). The Examiner notes that the structure recited in Ghosh is sufficient to perform the claimed function of determining LBB activation, and therefore, meets the contingent limitation (see MPEP 2111.04(II)).
Regarding claim 18, Ghosh teaches the implantable medical device of claim 1 (see 102 rejection above), wherein determining whether the LBB pacing has captured the LBB for each of the one or more pacing configurations comprises determining that the LBB pacing has captured the LBB if the surrogate LV activation time is within a selected percentage of one or more surrogate LV activation times determined from electrical activity monitored during delivery of LBB pacing using the same pacing configuration of the one or more pacing configurations (para. [0072]: "In one or more embodiments, the percentage of surrogate early-activation electrical activation times monitored by the posterior electrodes (PEPA) may be used to evaluate posterior left bundle branch engagement. To determine whether a posterior electrode, or activation monitored by the posterior electrode, constitutes early activation, the activation time may be compared to an early-activation threshold."; para. [0073]: "Thus, the early-activation electrodes, as determined by the early-activation threshold, may be divided by the total amount of posterior electrodes to provide the PEPA, and then the PEPA may be used to determine the degree of posterior left bundle branch engagement. For example, if the PEPA is greater than 75%, then it may be determined that the left bundle branch is sufficiently engaged. Further, for example, if the PEPA is greater than or equal to 50% and less than or equal to 75%, then it may be determined that the left bundle branch is partially engaged. Still further, for example, if the PEPA is less than 50%, then it may be determined that the left bundle branch is insufficiently engaged."; para. [0082]: "It may be described that processes 206, 208, 210 define a “closed-loop.” For example, processes 206, 208, 2010 may continue looping for a plurality of different pacing settings or configurations, and for each of the plurality of different pacing settings or configurations, EHI information may be generated 206 and posterior left bundle branch engagement may be determined 208. The EHI generated for the plurality of different pacing settings or configurations, and in turn, the determinization of posterior left bundle branch engagement may then be used to determine selected pacing settings of the cardiac pacing therapy 212. The selected pacing settings for the cardiac conduction therapy may, in some embodiments, be referred to as the “optimal” pacing settings as, for example, the pacing settings providing the most complete posterior left bundle branch engagement may be selected." The closed-loop aspect means that the determination can be made with either the same or different configurations, and the process can be repeated with new configurations to make the determination.”). The Examiner notes that the structure recited in Ghosh is sufficient to perform the claimed function of determining LBB activation, and therefore, meets the contingent limitation (see MPEP 2111.04(II)).
Regarding claim 21, Ghosh teaches a method comprising: delivering LBB pacing proximate to a patient's left bundle branch (LBB) using an LBB electrode (Fig. 7; para. [0088]: " It is to be understood that although device 10 is described herein as including a single dart electrode assembly, the device 10 may include more than one dart electrode assembly placed, or configured to be placed, through the atrial myocardium and the central fibrous body, and into the ventricular myocardium 14, or along the ventricular septum, without perforating entirely through the ventricular endocardial or epicardial surfaces. Additionally, each dart electrode assembly may carry, or include, more than a single electrode at the distal end region, or along other regions (e.g., proximal or central regions), of the shaft."; para. [0089]: "The cardiac therapy system 2 may also include a separate medical device 50 (depicted diagrammatically in FIG. 7), which may be positioned outside the patient's heart 8 (e.g., subcutaneously) and may be operably coupled to the patient's heart 8 to deliver cardiac therapy thereto. In one example, separate medical device 50 may be an extravascular ICD. In some embodiments, an extravascular ICD may include a defibrillation lead including, or carrying, a defibrillation electrode. A therapy vector may exist between the defibrillation electrode on the defibrillation lead and a housing electrode of the ICD. Further, one or more electrodes of the ICD may also be used for sensing electrical signals related to the patient's heart 8. The ICD may be configured to deliver shock therapy including one or more defibrillation or cardioversion shocks. For example, if an arrhythmia is sensed, the ICD may send a pulse via the electrical lead wires to shock the heart and restore its normal rhythm. In some examples, the ICD may deliver shock therapy without placing electrical lead wires within the heart or attaching electrical wires directly to the heart (subcutaneous ICDs).") positioned proximate a portion of the LBB at one or more pacing configurations (para. [0037]: "One or both of the computing apparatus 140 and the remote computing device 160 may include data storage that may allow for access to processing programs or routines and/or one or more other types of data, e.g., for analyzing a plurality of electrical signals captured by the electrode apparatus 110, for determining EHI, for determining QRS onsets, QRS offsets, medians, modes, averages, peaks or maximum values, valleys or minimum values, for determining electrical activation times, for evaluating posterior left bundle branch engagement by cardiac therapy, for determining whether the patient has left or right ventricular delays or blocks, for determining whether one or more adjustments to pacing settings of cardiac therapy may increase posterior left bundle branch engagement, for driving a graphical user interface configured to noninvasively assist a user in configuring one or more pacing parameters, or settings, such as, e.g., pacing rate, ventricular pacing rate, A-V interval, V-V interval, pacing pulse width, pacing vector, multipoint pacing vector (e.g., left ventricular vector quad lead), pacing voltage, pacing configuration (e.g., biventricular pacing, right ventricle only pacing, left ventricle only pacing, etc.), and arrhythmia detection and treatment, rate adaptive settings and performance, etc."); monitoring electrical activity using the one or more implantable electrodes during delivery of the LBB pacing at the one or more pacing configurations (para. [0037]: " e.g., for analyzing a plurality of electrical signals captured by the electrode apparatus 110"); determining a surrogate LV activation time based on the monitored electrical activity for each of the one or more pacing configurations (para. [0009]: "The present disclosure describes systems and methods that provide more efficient resynchronization (e.g., using VfA pacing, LBB pacing, left ventricular septal basal pacing, etc.) based on engagement of posterior fascicle or posterior LBB, which if done successfully should result in complete preactivation of posterior surface of the body as reflected on the surrogate activation time maps. Further, the new metrics disclosed herein may also be used and tied to the concept of titration of pacing to maximize engagement of left posterior bundle."; para. [0036]: "More specifically, for example, the QRS complex of a single cardiac cycle may be evaluated for one or more metrics such as… average left ventricular or thoracic surrogate electrical activation times (LVAT)."; Additionally, para. [0210] discloses where the pacing is adjusted depending on engagement of the LBB: " After the illustrative method 200 has determined posterior left bundle branch engagement 208, the method 200 may further including adjusting, or modifying, the cardiac therapy 210 to, for example, increase the posterior left bundle branch engagement in an effort to provide more effective heart functionality."), wherein the surrogate LV activation time is representative of an LV activation time (para. [0036]: " average left ventricular or thoracic surrogate electrical activation times (LVAT), and referenced to earliest activation time."); and determining whether the LBB pacing has captured the LBB for each of the one or more pacing configurations based on the determined surrogate LV activation time for each of the one or more pacing configurations (para. [0009]: "The present disclosure describes systems and methods that provide more efficient resynchronization (e.g., using VfA pacing, LBB pacing, left ventricular septal basal pacing, etc.) based on engagement of posterior fascicle or posterior LBB, which if done successfully should result in complete preactivation of posterior surface of the body as reflected on the surrogate activation time maps.").
Regarding claim 23, Ghosh teaches the method of claim 21 (see above), wherein monitoring electrical activity using the one or more electrodes during delivery of the LBB pacing at the one or more pacing configurations comprises monitoring electrical activity using the LBB electrode proximate to the LBB (para. [0103]: "For example, the CA signals collected at the electrode 304 may be processed along a first sensing channel to identify the first signal component associated with the LBB evoked response, while the same or different CA signals collected at the electrode 304 may be processed along a second sensing channel to identify the second signal component associated with the VS event.").
Regarding claim 24, Ghosh teaches the method of claim 21 (see above), wherein the one or more pacing configurations comprises a plurality of pacing configurations (para. [0081]: “Then, the method 200 may again adjust the cardiac pacing therapy 210, generate EHI 206, determine posterior left bundle branch engagement 208, and continue looping until a plurality of different cardiac pacing therapy configurations, each having at least one different pacing parameter, have been attempted.”), wherein the method further comprises: selecting a pacing configuration (para. [0082]: "The EHI generated for the plurality of different pacing settings or configurations, and in turn, the determinization of posterior left bundle branch engagement may then be used to determine selected pacing settings of the cardiac pacing therapy 212. The selected pacing settings for the cardiac conduction therapy may, in some embodiments, be referred to as the “optimal” pacing settings as, for example, the pacing settings providing the most complete posterior left bundle branch engagement may be selected.") of the plurality of pacing configurations based on the surrogate LV activation time for each of the plurality of pacing configurations (para. [0036]: "More specifically, for example, the QRS complex of a single cardiac cycle may be evaluated for one or more metrics such as, e.g., QRS onset, QRS offset, QRS peak, various electrical heterogeneity information (EHI) such as electrical activation times, left ventricular or thoracic standard deviation of electrical activation times (LVED), standard deviation of activation times (SDAT), average left ventricular or thoracic surrogate electrical activation times (LVAT), and referenced to earliest activation time, QRS duration (e.g., interval between QRS onset to QRS offset), difference between average left surrogate and average right surrogate activation times, relative or absolute QRS morphology, differences between a higher percentile and a lower percentile of activation times"; Fig. 4; the EHI in 206, which includes surrogate LVAT, is used to determine LBB engagement, which is used to adjust cardiac therapy) and a paced setting of each of the plurality of pacing configurations (para. [0082]: "The selected pacing settings for the cardiac conduction therapy may, in some embodiments, be referred to as the “optimal” pacing settings as, for example, the pacing settings providing the most complete posterior left bundle branch engagement may be selected."); and delivering LBB pacing at the selected pacing configuration (Fig. 4; 204; delivery of cardiac therapy; para. [0082]: "It may be described that processes 206, 208, 210 define a “closed-loop.”…The selected pacing settings for the cardiac conduction therapy may, in some embodiments, be referred to as the “optimal” pacing settings as, for example, the pacing settings providing the most complete posterior left bundle branch engagement may be selected).
Regarding claim 26, Ghosh teaches the method of claim 21 (see above), Regarding claim 26, Ghosh teaches the method of claim 21 (see above), wherein determining whether the LBB pacing has captured the LBB for each of the one or more pacing configurations comprises determining that the LBB pacing has captured the LBB if the surrogate LV activation time is within a selected percentage of one or more surrogate LV activation times determined from electrical activity monitored during delivery of LBB pacing using other pacing configurations of the one or more pacing configurations (para. [0072]: "In one or more embodiments, the percentage of surrogate early-activation electrical activation times monitored by the posterior electrodes (PEPA) may be used to evaluate posterior left bundle branch engagement. To determine whether a posterior electrode, or activation monitored by the posterior electrode, constitutes early activation, the activation time may be compared to an early-activation threshold."; para. [0073]: "Thus, the early-activation electrodes, as determined by the early-activation threshold, may be divided by the total amount of posterior electrodes to provide the PEPA, and then the PEPA may be used to determine the degree of posterior left bundle branch engagement. For example, if the PEPA is greater than 75%, then it may be determined that the left bundle branch is sufficiently engaged. Further, for example, if the PEPA is greater than or equal to 50% and less than or equal to 75%, then it may be determined that the left bundle branch is partially engaged. Still further, for example, if the PEPA is less than 50%, then it may be determined that the left bundle branch is insufficiently engaged."; para. [0082]: "It may be described that processes 206, 208, 210 define a “closed-loop.” For example, processes 206, 208, 2010 may continue looping for a plurality of different pacing settings or configurations, and for each of the plurality of different pacing settings or configurations, EHI information may be generated 206 and posterior left bundle branch engagement may be determined 208. The EHI generated for the plurality of different pacing settings or configurations, and in turn, the determinization of posterior left bundle branch engagement may then be used to determine selected pacing settings of the cardiac pacing therapy 212. The selected pacing settings for the cardiac conduction therapy may, in some embodiments, be referred to as the “optimal” pacing settings as, for example, the pacing settings providing the most complete posterior left bundle branch engagement may be selected." The closed-loop aspect means that the determination can be made with either the same or different configurations, and the process can be repeated with new configurations to make the determination.).
Regarding claim 27, Ghosh teaches the method of claim 21 (see above), wherein determining whether the LBB pacing has captured the LBB for each of the one or more pacing configurations comprises determining that the LBB pacing has captured the LBB if the determined surrogate LV activation time is within a selected percentage of a threshold surrogate LV activation time. (para. [0010]: "Another illustrative metric of EHI may be the percentage of posterior electrodes activating earlier than a certain time threshold (e.g., 35 milliseconds), which may be referred to as a percentage of early posterior activation (PEPA), indicating a degree of spread of early activation on the posterior aspect of the body."; para. [0071]: "In one or more embodiments, the mean of surrogate posterior electrical activation times monitored by the posterior electrodes (MPAT) may be used to evaluate posterior left bundle branch engagement. The MPAT may be compared against one or more thresholds or ranges to determine the degree to which the posterior left bundle branch is engaged. For example, if the MPAT is less than or equal to 30 milliseconds, then it may be determined that the left bundle branch is sufficiently engaged. Further, if the MPAT is greater than 30 milliseconds and less than 50 milliseconds, then it may be determined that the left bundle branch is partially engaged. Still further, for example, if the MPAT is greater than or equal to 50 milliseconds, then it may be determined that the left bundle branch is insufficiently engaged. It is to be understood that such thresholds and ranges in this embodiment are only one example, and other similar thresholds and ranges are contemplated by the present disclosure.").
Regarding claim 28, Ghosh teaches the method of claim 21 (see above), wherein determining whether the LBB pacing has captured the LBB for each of the one or more pacing configurations comprises determining that the LBB pacing has captured the LBB if the surrogate LV activation time is within a selected percentage of one or more surrogate LV activation times determined from electrical activity monitored during delivery of LBB pacing using the same pacing configuration of the one or more pacing configurations (para. [0072]: "In one or more embodiments, the percentage of surrogate early-activation electrical activation times monitored by the posterior electrodes (PEPA) may be used to evaluate posterior left bundle branch engagement. To determine whether a posterior electrode, or activation monitored by the posterior electrode, constitutes early activation, the activation time may be compared to an early-activation threshold."; para. [0073]: "Thus, the early-activation electrodes, as determined by the early-activation threshold, may be divided by the total amount of posterior electrodes to provide the PEPA, and then the PEPA may be used to determine the degree of posterior left bundle branch engagement. For example, if the PEPA is greater than 75%, then it may be determined that the left bundle branch is sufficiently engaged. Further, for example, if the PEPA is greater than or equal to 50% and less than or equal to 75%, then it may be determined that the left bundle branch is partially engaged. Still further, for example, if the PEPA is less than 50%, then it may be determined that the left bundle branch is insufficiently engaged."; para. [0082]: "It may be described that processes 206, 208, 210 define a “closed-loop.” For example, processes 206, 208, 2010 may continue looping for a plurality of different pacing settings or configurations, and for each of the plurality of different pacing settings or configurations, EHI information may be generated 206 and posterior left bundle branch engagement may be determined 208. The EHI generated for the plurality of different pacing settings or configurations, and in turn, the determinization of posterior left bundle branch engagement may then be used to determine selected pacing settings of the cardiac pacing therapy 212. The selected pacing settings for the cardiac conduction therapy may, in some embodiments, be referred to as the “optimal” pacing settings as, for example, the pacing settings providing the most complete posterior left bundle branch engagement may be selected." The closed-loop aspect means that the determination can be made with either the same or different configurations, and the process can be repeated with new configurations to make the determination.).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 20220040484 A1, "Li") in view of Ghosh (US 20200352470 A1).
Regarding claim 1, Li teaches an implantable medical device (Fig. 3A-4D) comprising: one or more implantable electrodes (para. [0096]: " FIG. 3A illustrates a graphical representation of a heart with one or more electrodes located select pacing and sensing sites relative to the specialized conduction system. Electrodes are located in the RA and in the septal wall proximate to the LBB in accordance with embodiments herein.") comprising an LBB electrode positionable proximate a portion of a patient's left bundle branch (LBB) (para. [0013]: "The system may further comprise a first lead including, as one of the electrodes, an LBB electrode configured to be implanted through a septal wall to a depth sufficient to be located proximate to the LBB site."; para. [0096]: " FIG. 3A illustrates a graphical representation of a heart with one or more electrodes located select pacing and sensing sites relative to the specialized conduction system. Electrodes are located in the RA and in the septal wall proximate to the LBB in accordance with embodiments herein. For example, an RA electrode 302 is located proximate the SA node and an LBB electrode 304 is tunneled in the septal wall at a point and depth proximate to a proximal end of the LBB."); and a computing apparatus (programmable controller 60; Fig. 2) comprising processing circuitry (para. [0076]: "For example, the programmable controller 60 may represent one or more processors…") and operably coupled to the one or more implantable electrodes (para. [0033]: "FIG. 4A illustrates a process for managing stimulation timing for the electrode configuration shown in FIG. 3A in accordance with embodiments herein"; para. [0076]: "The programmable controller 60 includes an AV delay manager 65 that is configured to implement the operations described herein, including operations described in connection with FIGS. 4A-4D."), wherein the computing apparatus is configured to: deliver LBB pacing proximate to the LBB using the LBB electrode at one or more pacing configurations (para. [0093]: "In accordance with new and unique aspects herein, embodiments are described to stimulate the LBB at a select time relative to an intrinsic waveform propagating along the RBB to activate the ventricles in a preferred physiologic manner. For example, in accordance with certain electrode configurations, the LBB is stimulated at a select point in time (also referred to as “fused”) slightly before (e.g., such as 5 ms-20 ms, or more preferably between 5 ms and 10 ms) the intrinsic waveform passes through a corresponding segment of the RBB."; para. [0099]: "FIG. 4A illustrates a process for managing stimulation timing for the electrode configuration shown in FIG. 3A in accordance with embodiments herein. In accordance with new and unique aspects herein, embodiments support connection of an LBB electrode to an RV header port while managing the AV delay management algorithm within the IMD to output/applied stimulation to the RV header port at a point in time when it is desirable for the stimulation to be delivered at a proximal end of the left bundle branch at a select point in time (e.g., fused) slightly before (e.g., such as 5 ms-20 ms, or more preferably between 5 ms and 10 ms) an intrinsic wave front propagates to or beyond a corresponding point along the right bundle branch. The process of FIG. 4A is implemented in connection with an IMD having leads implanted with electrodes at the positions noted in FIG. 3A, with the LBB electrode coupled to an RV header port. The IMD utilizes stimulation parameters associated with a “DDD” mode for the IMD. The stimulation parameters include an atrial-ventricular (AV) delay (AVD) that is defined based on a programmed or previously measured interval between an intrinsic or paced atrial event and an intrinsic ventricular event."); monitor electrical activity using the one or more implantable electrodes during delivery of the LBB pacing at the one or more pacing configurations (para. [0103]: "Additionally or alternatively, the LBB evoked response may be directly measured from the CA signals and utilized to calculate an atrial-LBB interval between the paced or sensed atrial event and the evoked response occurring at the proximal end of the LBB. When it is desirable to detect the LBB evoked response, optionally, separate sensing channels may be utilized to collect CA signals associated with the first and second signal components."; Fig. 4A, 412; para. [0109]: "At 412, the one or more processors manage the DDD mode of operation of the IMD utilizing the new candidate AVD for one or more cardiac beats. At 412, the one or more processors further measure a QRS characteristic of interest (COI). For example, the QRS COI may correspond to a duration of the QRS. As another example, the QRS COI may correspond to a morphology of the QRS. The operations at 410 and 412 may be implanted in connection with a single cardiac beat or a desired number of beats. For example, the one or more processors may utilize the candidate AVD in connection with an ensemble of beats (e.g., 5-10). The QRS COI may be separately measured for each of the beats within the ensemble, and then combined through a select mathematical combination (e.g., averaging) to form an ensemble QRS COI. Alternatively, the ensemble of beats may be combined through a select mathematical combination (e.g., averaging), and then the one or more processors determines the QRS COI for the ensemble."); and determine whether the LBB pacing has captured the LBB (para. [0082]: "The microcontroller 60 detects a depolarization signal during a window following a stimulation pulse, the presence of which indicates that capture has occurred.") for each of the one or more pacing configurations (para. [0093]: "For example, in accordance with certain electrode configurations, the LBB is stimulated at a select point in time (also referred to as “fused”) slightly before (e.g., such as 5 ms-20 ms, or more preferably between 5 ms and 10 ms) the intrinsic waveform passes through a corresponding segment of the RBB. Embodiments utilize various timing algorithms to determine when conduction occurs through the native specialized conduction system (e.g., HIS, RBB and LBB) and to deliver a pacing impulse appropriate timed to achieve fusion between the paced LBB stimulus and an intrinsic wave front propagating along the RBB."). However, Li does not expressly disclose where the computing apparatus is configured to determine a surrogate LV activation time based on the monitored electrical activity for each of the one or more pacing configurations, wherein the surrogate LV activation time is representative of an LV activation time or where the determination of whether LBB pacing has captured the LBB is based on LV activation times for each configuration.
Ghosh, in the same field of endeavor of cardiac pacing and therapy, discloses a computing device for a cardiac pacing delivery system. Ghosh discloses where a computing device (computing apparatus 140 and remote computing device 160) is configured to: determine a surrogate LV activation time based on the monitored electrical activity for each of the one or more pacing configurations (para. [0009]: "The present disclosure describes systems and methods that provide more efficient resynchronization (e.g., using VfA pacing, LBB pacing, left ventricular septal basal pacing, etc.) based on engagement of posterior fascicle or posterior LBB, which if done successfully should result in complete preactivation of posterior surface of the body as reflected on the surrogate activation time maps. Further, the new metrics disclosed herein may also be used and tied to the concept of titration of pacing to maximize engagement of left posterior bundle."; para. [0036]: "More specifically, for example, the QRS complex of a single cardiac cycle may be evaluated for one or more metrics such as… average left ventricular or thoracic surrogate electrical activation times (LVAT)."; Additionally, para. [0210] discloses where the pacing is adjusted depending on engagement of the LBB: " After the illustrative method 200 has determined posterior left bundle branch engagement 208, the method 200 may further including adjusting, or modifying, the cardiac therapy 210 to, for example, increase the posterior left bundle branch engagement in an effort to provide more effective heart functionality."), wherein the surrogate LV activation time is representative of an LV activation time (para. [0036]: " average left ventricular or thoracic surrogate electrical activation times (LVAT) and referenced to earliest activation time."); and determine whether the LBB pacing has captured the LBB for each of the one or more pacing configurations based on the determined surrogate LV activation time for each of the one or more pacing configurations (para. [0009]: "The present disclosure describes systems and methods that provide more efficient resynchronization (e.g., using VfA pacing, LBB pacing, left ventricular septal basal pacing, etc.) based on engagement of posterior fascicle or posterior LBB, which if done successfully should result in complete preactivation of posterior surface of the body as reflected on the surrogate activation time maps.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Li to include the technique of determining a surrogate activation time and using the surrogate activation time to determine LBB capture, as disclosed by Ghosh. One would recognize that Ghosh, like Li, is trying to determine LBB capture, and that Ghosh’s technique of using a surrogate LV activation time could be used to indicate LBB capture. One of ordinary skill would recognize that LBB engagement is indicative of therapeutic efficacy, and would expect, with a reasonable expectation of success, that the technique of Ghosh could be used for determining LBB engagement. Therefore, it would have been an obvious improvement to the device of Li to include the technique of Ghosh to determine LBB engagement during cardiac pacing.
Regarding claim 3, Li, in combination with Ghosh, discloses the implantable medical device of claim 1 (see 103 rejection above). Li further discloses wherein the one or more implantable electrodes further comprises an RV electrode proximate a portion of the patient's right ventricle (RV) (para. [0096]: "The RV electrode 304 is located distal to the HIS bundle such that the LBB electrode 304 is positioned to induce an evoked response into a proximal portion of the LBB without substantially invoking an evoked response into the RBB."), and wherein monitoring electrical activity using the one or more electrodes during delivery of the LBB pacing at the one or more pacing configurations comprises monitoring electrical activity using the RV electrode proximate to the RV (para. [0097]: "The IMD (and a baseline AV delay management algorithm) is generally configured to assume that CA signals, carried through a sensing channel associated with the RV header port, represent CA signals sensed by one or more RV electrodes.").
Regarding claim 4, Li, in combination with Ghosh, discloses the implantable medical device of claim 1 (see 103 rejection above). Li further discloses wherein monitoring electrical activity using the one or more electrodes during delivery of the LBB pacing at the one or more pacing configurations comprises monitoring electrical activity using the LBB electrode proximate to the LBB (para. [0103]: "For example, the CA signals collected at the electrode 304 may be processed along a first sensing channel to identify the first signal component associated with the LBB evoked response, while the same or different CA signals collected at the electrode 304 may be processed along a second sensing channel to identify the second signal component associated with the VS event.").
Regarding claim 5, Li, in combination with Ghosh, discloses the implantable medical device of claim 1 (see 103 rejection above). Li further discloses wherein the one or more pacing configurations comprises a plurality of pacing configurations (para. [0082]: "The microcontroller 60 is further coupled to a memory 94 by a suitable data/address bus 96, wherein the programmable operating parameters used by the microcontroller 60 are stored and modified, as required, in order to customize the operation of the stimulation device 10 to suit the needs of a particular patient. Such operating parameters define, for example, pacing pulse amplitude, pulse duration, electrode polarity, rate, sensitivity, automatic features, arrhythmia detection criteria, and the amplitude, waveshape and vector of each shocking pulse to be delivered to the patient's heart 12 within each respective tier of therapy."). However, Li does not explicitly disclose wherein the computing apparatus is configured to select a pacing configuration of the plurality of pacing configurations based on the surrogate LV activation time for each of the plurality of pacing configurations and a paced setting of each of the plurality of pacing configurations and deliver LBB pacing at the selected pacing configuration from the surrogate activation.
Ghosh discloses a computing apparatus (140 and 160) configured to: select a pacing configuration (para. [0082]: "The EHI generated for the plurality of different pacing settings or configurations, and in turn, the determinization of posterior left bundle branch engagement may then be used to determine selected pacing settings of the cardiac pacing therapy 212. The selected pacing settings for the cardiac conduction therapy may, in some embodiments, be referred to as the “optimal” pacing settings as, for example, the pacing settings providing the most complete posterior left bundle branch engagement may be selected.") of the plurality of pacing configurations based on the surrogate LV activation time for each of the plurality of pacing configurations (para. [0036]: "More specifically, for example, the QRS complex of a single cardiac cycle may be evaluated for one or more metrics such as, e.g., QRS onset, QRS offset, QRS peak, various electrical heterogeneity information (EHI) such as electrical activation times, left ventricular or thoracic standard deviation of electrical activation times (LVED), standard deviation of activation times (SDAT), average left ventricular or thoracic surrogate electrical activation times (LVAT), and referenced to earliest activation time, QRS duration (e.g., interval between QRS onset to QRS offset), difference between average left surrogate and average right surrogate activation times, relative or absolute QRS morphology, differences between a higher percentile and a lower percentile of activation times"; Fig. 4; the EHI in 206, which includes surrogate LVAT, is used to determine LBB engagement, which is used to adjust cardiac therapy) and a paced setting of each of the plurality of pacing configurations (para. [0082]: "The selected pacing settings for the cardiac conduction therapy may, in some embodiments, be referred to as the “optimal” pacing settings as, for example, the pacing settings providing the most complete posterior left bundle branch engagement may be selected."); and deliver LBB pacing at the selected pacing configuration (Fig. 4; 204; delivery of cardiac therapy; para. [0082]: "It may be described that processes 206, 208, 210 define a “closed-loop.”…The selected pacing settings for the cardiac conduction therapy may, in some embodiments, be referred to as the “optimal” pacing settings as, for example, the pacing settings providing the most complete posterior left bundle branch engagement may be selected).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Li to include the technique of determining a surrogate activation time and using the surrogate activation time to determine a pacing configuration for stimulation therapy delivery, as disclosed by Ghosh. One of ordinary skill would recognize that it would have been obvious to include therapy configuration selection based on surrogate LV activation times since this it would optimize the stimulation based on the most LBB engagement (and therefore most effective therapy). Therefore, it would have been an obvious improvement to the device of Li to include the technique of Ghosh to determine select cardiac pacing based on surrogate LV activation time.
Regarding claim 6, Li, in combination with Ghosh, discloses the implantable medical device of claim 6 (see 103 rejection above). However, Li does not disclose selecting a further one or more pacing configurations of the plurality of pacing configurations, wherein the further one or more pacing configurations are each determined as capturing the LBB based on the determined surrogate LV activation time; and selecting one of the further one or more pacing configurations of the plurality of pacing configurations, wherein the one pacing configuration comprises the lowest pacing output of the further one or more pacing configurations, and wherein the one pacing configuration is the selected pacing configuration.
Ghosh discloses wherein selecting a pacing configuration of the plurality of pacing configurations based on the surrogate LV activation time for each of the plurality of pacing configurations and a paced setting of each of the plurality of pacing configurations further comprises: selecting a further one or more pacing configurations of the plurality of pacing configurations (para. [0082]: "It may be described that processes 206, 208, 210 define a “closed-loop.”…The selected pacing settings for the cardiac conduction therapy may, in some embodiments, be referred to as the “optimal” pacing settings as, for example, the pacing settings providing the most complete posterior left bundle branch engagement may be selected), wherein the further one or more pacing configurations are each determined as capturing the LBB based on the determined surrogate LV activation time (para. [0036]: "More specifically, for example, the QRS complex of a single cardiac cycle may be evaluated for one or more metrics such as, e.g., QRS onset, QRS offset, QRS peak, various electrical heterogeneity information (EHI) such as electrical activation times, left ventricular or thoracic standard deviation of electrical activation times (LVED), standard deviation of activation times (SDAT), average left ventricular or thoracic surrogate electrical activation times (LVAT), and referenced to earliest activation time, QRS duration (e.g., interval between QRS onset to QRS offset), difference between average left surrogate and average right surrogate activation times, relative or absolute QRS morphology, differences between a higher percentile and a lower percentile of activation times"; Fig. 4; the EHI in 206, which includes surrogate LVAT, is used to determine LBB engagement, which is used to adjust cardiac therapy); and selecting one of the further one or more pacing configurations of the plurality of pacing configurations, wherein the one pacing configuration comprises the lowest pacing output of the further one or more pacing configurations, and wherein the one pacing configuration is the selected pacing configuration (para. [0083]: "As such, a plurality of different pacing settings may be utilized 210, and an MPAT may be generated for each of the plurality of different pacing settings 2018. In this example, the lowest MPAT may be indicative of the most complete posterior left bundle branch engagement for the cardiac pacing therapy, and thus, the cardiac pacing therapy settings having, or corresponding to, the lowest MPAT may be selected 212 to be used with the cardiac pacing therapy.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Li to include the technique of selecting further stimulation configurations based on surrogate LV activation times and selecting a pacing configuration based on the lowest pacing output, as disclosed by Ghosh. One of ordinary skill would recognize that it would have been obvious to include therapy configuration selection based on the lowest therapy output since the lowest MPAT is disclosed by Ghosh as being the indicative of LBB engagement. Therefore, it would have been an obvious improvement to optimize therapy efficacy to include the techniques of Ghosh in the device of Li.
Claim 7-11, 20, and 25 are rejected under 35 U.S.C. 103 as being unpatentable Ghosh (US 20200352470 A1) in view of Curtin et al. (US 20190192029 A1, "Curtin").
Regarding claims 7 and 25, Ghosh teaches the implantable medical device of claim 1 and the method of claim 21 (see 102 rejections above). However, Ghosh does not explicitly teach wherein the surrogate LV activation time extends between a LBB pacing pulse of the delivered LBB pacing and a fiducial point within the monitored electrical activity.
Curtin, in the same field of endeavor of cardiac pacing and therapy, discloses a cardiac therapy device. Curtin discloses a computing apparatus and processing circuitry (para. [0004]) configured to determine a surrogate activation time (para. [0035]: “The display apparatus 130 and the computing apparatus 140 may be configured to display and analyze data such as, e.g., electrical signals (e.g., electrocardiogram data), cardiac information representative of at least one of mechanical cardiac functionality and electrical cardiac functionality, etc. Cardiac information may include, e.g., electrical heterogeneity information or electrical dyssynchrony information, body surface cardiac activation information, surrogate cardiac electrical activation information or data, etc.”), wherein the surrogate LV activation time extends between a LBB pacing pulse of the delivered LBB pacing and a fiducial point within the monitored electrical activity. (para. [0047]: " In one or more embodiments, measurement of activation times can be performed by measuring the period of time between an onset of cardiac depolarization (e.g., onset of QRS complex) and an appropriate fiducial point such as, e.g., a peak value, a minimum value, a minimum slope, a maximum slope, a zero crossing, a threshold crossing, etc.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device and methods of Ghosh to include the LV activation time extending between the LBB pacing pulse and a fiducial point since Curtin discloses using this technique to determine the surrogate activation time. One of ordinary skill would recognize that fiducial points can be used to measure an end point of a surrogate activation time, as disclosed by Curtin. One would further recognize that the surrogate activation time is beneficial in measuring a signal to indicate the most effective pacing configuration, and that surrogate activation time can be measured using the technique of Curtin to indicate effective therapy. Therefore, it would have been obvious to implement the techniques of Curtin to improve the device and methods of Ghosh.
Regarding claim 8, Ghosh, in combination with Curtin, discloses the implantable medical device of claim 7 (see 103 rejection above). However, Ghosh does not explicitly disclose wherein the fiducial point is a maximum slope of the monitored activity within a lookback time window, wherein the lookback time window precedes a maximum peak of the monitored electrical activity within a post-pace time window following the LBB pacing pulse.
Curtin discloses wherein the fiducial point is a maximum slope of the monitored activity within a lookback time window (para. [0047]: "In one or more embodiments, measurement of activation times can be performed by measuring the period of time between an onset of cardiac depolarization (e.g., onset of QRS complex) and an appropriate fiducial point such as, e.g., a peak value, a minimum value, a minimum slope, a maximum slope, a zero crossing, a threshold crossing, etc."), wherein the lookback time window precedes a maximum peak of the monitored electrical activity within a post-pace time window following the LBB pacing pulse (para. [0043]: "In one or more embodiments, measurement of activation times can be performed by measuring the period of time between an onset of cardiac depolarization (e.g., onset of QRS complex) and an appropriate fiducial point such as, e.g., a peak value, a minimum value, a minimum slope, a maximum slope, a zero crossing, a threshold crossing, etc."; Since the measurement time includes up to the start of cardiac depolarization, it would precede the R-peak of the ECG, which is the maximum peak; The disclosed activation time is in regards to detected myocardium activation after a pulse is delivered, and is therefore within a post-pace time window).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ghosh to include the LV activation time extending between the LBB pacing pulse and a fiducial point since Curtin discloses using this technique to determine the surrogate activation time. One of ordinary skill would recognize that fiducial points can be used to measure an end point of a surrogate activation time, as disclosed by Curtin. One would further recognize that the surrogate activation time is beneficial in measuring a signal to indicate the most effective pacing configuration, and that surrogate activation time can be measured using the technique of Curtin to indicate effective therapy. Further, one of ordinary skill would recognize that the fiducial point could be a maximum slope within a lookback time window, and that the window would precede a post-pace-time window, as disclosed by Curtin. Therefore, it would have been obvious to implement the techniques of Curtin to improve the device of Ghosh.
Regarding claim 9, Ghosh, in combination with Curtin, discloses the implantable medical device of claim 8 (see 103 rejection above). However, Ghosh does not explicitly disclose wherein the lookback time window is less than or equal to 75 milliseconds (ms) (Fig. 6A; activation duration 388; Would have been obvious depending on what fiducial point is chosen) and the post- pace time window is less than or equal to 350 ms. (Fig. 6A; total time is only 180 ms, which means the post pace window is less than 350 ms).
Curtin discloses wherein the lookback time window is less than or equal to 75 milliseconds (ms) (Fig. 6A; activation duration 388; One would recognize that the lookback window could have been any duration based on what fiducial point is chosen since the lookback time window depends on the fiducial point) and the post- pace time window is less than or equal to 350 ms. (Fig. 6A; total time is only 180 ms, which means the post pace window is less than 350 ms).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ghosh to include lookback time window and post-pace window durations disclosed by Curtin. One of ordinary skill would recognize that the lookback time window duration could vary to be less than or equal to 75ms depending on the selected fiducial point measurement (Curtin discloses different selections for fiducial points in para. [0043]: "In one or more embodiments, measurement of activation times can be performed by measuring the period of time between an onset of cardiac depolarization (e.g., onset of QRS complex) and an appropriate fiducial point such as, e.g., a peak value, a minimum value, a minimum slope, a maximum slope, a zero crossing, a threshold crossing, etc."; It would have been obvious for the lookback widow to be this duration based on the activation time of Curtin). Further, it would have been obvious to include a post-pace window less than 350 ms since Curtin discloses a total time window less than 350 ms, meaning the post-pace window would be only a fraction of the total duration. One of ordinary skill would recognize that these measurements could be used to determine surrogate activation times and therefore, determine LBB engagement, which is an obvious improvement to determine the most effective stimulation configuration. Therefore, it would have been obvious to include the techniques of Curtin in the device of Ghosh.
Regarding claim 10 and claim 11, Ghosh in combination with Curtin, discloses the implantable medical device of claim 7 (see 103 rejection above). However, Ghosh does not explicitly disclose wherein the fiducial point is a maximum peak of the monitored activity within a post-pace time window following the LBB pacing pulse and wherein the post-pace time window is less than or equal to 350 ms.
Curtin discloses wherein the fiducial point is a maximum peak of the monitored activity within a post-pace time window following the LBB pacing pulse. (para. [0043]: "In one or more embodiments, measurement of activation times can be performed by measuring the period of time between an onset of cardiac depolarization (e.g., onset of QRS complex) and an appropriate fiducial point such as, e.g., a peak value, a minimum value, a minimum slope, a maximum slope, a zero crossing, a threshold crossing, etc."), and wherein the post-pace time window is less than or equal to 350 ms. (Fig. 6A; total time is only 180 ms, which means the post pace window is less than 350 ms).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ghosh to include the post-pace window duration and fiducial point as disclosed by Curtin. One of ordinary skill would recognize that it would have been obvious to include a post-pace window less than 350 ms since Curtin discloses a total time window less than 350 ms, meaning the post-pace window would be only a fraction of the total duration. One would also recognize that a maximum peak could be used to determine an activation time for a surrogate heartbeat. One of ordinary skill would recognize that these measurements could be used to determine surrogate activation times and therefore, determine LBB engagement, which is an obvious improvement to determine the most effective stimulation configuration. Therefore, it would have been obvious to include the techniques of Curtin in the device of Ghosh.
Regarding claim 20, Ghosh in combination with Curtin, discloses the implantable medical device of claim 18 (see 102 rejection above). However, Ghosh does not explicitly disclose using a most recent heartbeat during a determination of a determination of a surrogate LV activation time.
Curtin discloses wherein the one or more surrogate LV activation times determined using the same pacing configuration of the one or more pacing configurations comprises a previously determined surrogate LV activation time (para. [0092]: "Still further, for example, an activation duration 388”) that was determined from electrical activity monitored during delivery of LBB pacing using a most recent heartbeat (para. [0092]: "Still further, for example, an activation duration 388 may be determined between the earliest body surface activation time (as indicated by the earliest activation time indicator 372) and the latest activation time (as indicated by the latest activation time indicator 376) as indicated on the single-cycle graph 350 of FIG. 6A. Also, an activation duration to QRS end delay 389 may be determined between the latest activation time (as indicated by the latest activation time indicator 376) and the latest QRS offset time (as indicated by the posterior offset time indicator 370).")
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ghosh to include determining a previous LV activation time based on a most recent heartbeat, as disclosed by Curtin. One of ordinary skill would recognize that it would have been obvious to use the technique of determining previous LV activation times with a most recent heartbeat since this would provide the most updated activation time, which would in turn improve accuracy of the activation time measurements. Therefore, it would have been obvious to improve the device of Ghosh to include the most recent heartbeat activity, as disclosed by Curtin.
Claims 13, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable Ghosh (US 20200352470 A1).
Regarding claim 13, Ghosh teaches the implantable medical device of claims 12, 17, and 19 (see above). However, Ghosh does not explicitly disclose wherein the selected percentage is 20%. Ghosh does disclose using a threshold activation time to determine LBB engagement (para. [0071]: “In one or more embodiments, the mean of surrogate posterior electrical activation times monitored by the posterior electrodes (MPAT) may be used to evaluate posterior left bundle branch engagement. The MPAT may be compared against one or more thresholds or ranges to determine the degree to which the posterior left bundle branch is engaged.”). Further, Ghosh discloses that the percentage of engagement can be based on activation maps (para. [0077]: “As shown in FIG. 6A, the posterior map shows homogenous, early activation and the associated PEPA, i.e., 78% (39 of 50 electrodes), is greater than 75%, which indicates sufficient posterior left bundle branch engagement. As shown in FIG. 5B, the posterior map shows partial early activation and the associated PEPA, i.e., 54% (27 of 50 electrodes), is less than 75% but greater than 50%, which indicates partial posterior left bundle branch engagement. As shown in FIG. 5C, the posterior map shows a small amount of early activation and the associated PEPA, i.e., 14% (7 of 50 electrodes), is less 50%, which indicates insufficient posterior left bundle branch engagement.”).
It would have been for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ghosh to include a 20% range of LV and activation times based on surrogate LV activation times. One of ordinary skill would recognize that a 20% would the threshold required for LBB engagement. Further, one of ordinary skill would be able to determine the optimal threshold percentage based on the teachings of mapping LBB engagement to activation times. It would have been a matter of routine experimentation to arrive at the claimed threshold based on the mappings of the activation times and LBB engagement and arrive at the claimed percentage based on the teachings of Ghosh.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable Ghosh (US 20200352470 A1) in view of Brooke et al. (US 20080071318 A1, "Brooke").
Regarding claim 16, Ghosh discloses the implantable medical device of claim 15 (see 102 rejection above). However, Ghosh does not explicitly disclose wherein threshold surrogate LV activation time is determined from electrical activity of a template paced heartbeat.
Brooke, in the same field of endeavor of cardiac pacing, discloses a system and method for determining cardiac stimulation parameters. Brooke discloses determining a threshold surrogate LV activation time from electrical activity of a template paced heartbeat (para. [0012]: "According to one implementation, the strength-duration relationship for the desired activation is determined by performing a test to determine a capture amplitude threshold for cardiac pacing. An amplitude threshold for the undesirable activation is provided. The capture amplitude threshold is compared during a capture threshold test to the undesirable activation threshold. One or more test energy parameters, such as stimulation pulse width and/or stimulation pulse amplitude, are modified based on the comparison. The energy parameters for the therapeutic electrical stimulation are selected based on the modified test energy parameters." The threshold test is a template paced heartbeat used for determining an threshold activation time.)
It would have been for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ghosh to include the threshold test (template paced heartbeat) as disclosed by Brooke. One of ordinary skill would recognize that a template heartbeat is a technique used to compare threshold that would be useful in setting an activation threshold. One would further recognize that a threshold test would allow the user to set the threshold at an undesired level of stimulation. It would have been obvious to implement the technique of Brooke in the device of Ghosh to improve the accuracy and delivery of stimulation within a desired range for effective stimulation based on a known undesirable test threshold.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ghosh (US 20200352470 A1) in view of Li et al. (US 20220040484 A1, "Li").
Regarding claim 22, Ghosh teaches the method of claim 21 (see 102 rejection above). However, Ghosh does not disclose monitoring electrical activity using an RV electrode proximate a portion of the patient's right ventricle (RV).
Li, in the same field of endeavor of cardiac pacing and therapy, discloses a system and method for managing atrial-ventricular delay adjustments. Li discloses monitoring electrical activity using an RV electrode (Fig. 3A; RV electrode 304; para. [0096]: "The RV electrode 304 is located distal to the HIS bundle such that the LBB electrode 304 is positioned to induce an evoked response into a proximal portion of the LBB without substantially invoking an evoked response into the RBB.") proximate a portion of the patient's right ventricle (RV). (para. [0096]: “. The RV electrode 304 is located distal to the HIS bundle such that the LBB electrode 304 is positioned to induce an evoked response into a proximal portion of the LBB without substantially invoking an evoked response into the RBB.”; para. [0097]: "The IMD (and a baseline AV delay management algorithm) is generally configured to assume that CA signals, carried through a sensing channel associated with the RV header port, represent CA signals sensed by one or more RV electrodes.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ghosh to include monitoring a patient’s right ventricle with an RV electrode, as disclosed by Li. One of ordinary skill would recognize that cardiac monitoring performed using an RV electrode would improve sensing and pacing of the LBB since stimulation would be able to be provided to the proximal end of the LBB at desired time and location at a select point in time. Therefore, it would have been an obvious improvement to include the RV monitoring technique and electrode, as disclosed by Li, in the method Ghosh.
Conclusion
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/O.L.M./Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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