DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status: Claims 1-20 are pending; Claims 3, 4, 11, and 12 have been withdrawn from consideration due to being directed to non-elected species.
Election/Restrictions
Applicant's election with traverse of Species A and Species Y in the reply filed on April 14, 2026 is acknowledged. The traversal is on the ground(s) that there is no serious search or examination burden. This is not found persuasive because:
Species A, B, and C recites different electrical pairings for primary pacing mode and backup mode. The difference in functional configurations and programmed settings yield a search and examination burden.
Species X and Y have difference in back up mode functions as described on page 10, line 26 - page 11, line 2 of instant specification. The difference in functional configurations and programmed settings yield a search and examination burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 3-4 and 11-12 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Species B and C, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on April 14, 2026.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1, 2, 5-10, and 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou et al. (WO 2022/240669).
Re Claim 1, Zhou discloses a method of controlling operation of a medical device to provide electrical cardiac pacing therapy to a subject, the method comprising:
delivering electrical cardiac pacing energy to a left conduction bundle branch (LBB) area of the subject according to a primary pacing mode that uses a tip electrode of an implantable cardiac lead connected to the medical device for cathodal capture in the LBB area (para. [0020], fig. 6, FIG. 7 is a diagram of electrocardiogram (ECG) signals that may be sensed during a normal ventricular conduction condition (panel A) and during a left bundle branch (LBB) block condition (panel B) and during LBB pacing therapy (panel C) selected in response to detecting the LBB block condition according to one example; para. [0031], ventricular pacing via the left bundle branch (LBB); para. [0045] As used herein, the term “bipolar bilateral BB pacing” refers to bilateral BB pacing using a single bipolar electrode pair that captures, at least partially or wholly, both the LBB and the RBB simultaneously by capturing one bundle branch via anodal capture at the pacing anode electrode and one bundle branch via cathodal capture at the pacing cathode electrode. In some instances, unipolar pacing of one bundle branch, right or left, may directly capture that bundle branch while virtual current or break excitation generated by the pacing electrode may excite the other bundle branch, potentially resulting in unipolar bilateral BB pacing, with capture of both the LBB and RBB; para. [0068], the pacing pulse output may be adjusted to capture both the LBB and the RBB by cathodal capture at the pacing tip electrode 32 and anodal capture of the RBB at the pacing ring electrode 34 or vice versa; para. [0075], a single bipolar pacing electrode vector, e.g., tip electrode 32 paired with any one of electrodes 34, 42 or 44, may be selected to deliver bipolar bilateral BB pacing including cathodal and anodal capture.);
monitoring for loss of cathodal capture of the LBB area when delivering the electrical cardiac pacing energy in the primary pacing mode (para. [0126], [0157], Control circuit 80 may adjust the pacing pulse output and/or the pacing electrode configuration to regain capture of both of the RBB and the LBB at block 326 when loss of capture is detected at block 322; para. [0162], the conduction check may be performed after verifying pacing capture at each of the pacing sites of the VCS plus LV myocardial pacing sites to avoid determining a change in a ventricular conduction condition when loss of capture is occurring during the conduction check.); and
changing to a backup pacing mode when the loss of cathodal capture is detected (para. [0039], the pacing electrode configuration may be adjusted during a given pacing therapy to promote reliable capture of ventricular pacing sites in accordance with the VCS pacing therapy based on determining capture or loss of capture at a given pacing site),
wherein the backup pacing mode uses a ring electrode of the implantable cardiac lead for anodal capture in an interventricular septum of the subject (para. [0075], As described above, multiple pacing electrode configurations are selectable for delivering bundle branch pacing using electrodes 32, 34, 42 and/or 44 in various unipolar and/or bipolar pacing electrode vectors and selectable anode and cathode polarity assignments of each electrode 32, 34, 42 and 44; para. [0072], fig. 2B, lead 18 may be advanced to position BB pacing tip electrode 32 in the left portion of the interventricular septum 12, in the vicinity of the LBB, for pacing the LBB in a bipolar pacing electrode configuration between tip electrode 32 as the cathode and ring electrode 34 as the return anode electrode; para. [0070], BB pacing electrodes 32 and 34 may be selected in a bipolar ventricular pacing and/or sensing electrode pair or one or both electrodes carried by BB pacing lead 18 may be used in combination with pacemaker housing 15 or one of coil electrodes 37 or 39 (if present) for delivering unipolar pacing pulses and/or receiving a unipolar cardiac electrical signal for sensing cardiac electrical events by cardiac electrical signal sensing circuitry. – Electrode 34 is a ring electrode).
Re Claim 2, Zhou discloses that the primary pacing mode is a unipolar pacing mode that uses the tip electrode of the implantable cardiac lead and a device electrode included on the medical device, and the backup pacing mode is a unipolar pacing mode that uses the ring electrode of the implantable cardiac lead and the device electrode (para. [0075], As described above, multiple pacing electrode configurations are selectable for delivering bundle branch pacing using electrodes 32, 34, 42 and/or 44 in various unipolar and/or bipolar pacing electrode vectors and selectable anode and cathode polarity assignments of each electrode 32, 34, 42 and 44; para. [0072], fig. 2B, lead 18 may be advanced to position BB pacing tip electrode 32 in the left portion of the interventricular septum 12, in the vicinity of the LBB, for pacing the LBB in a bipolar pacing electrode configuration between tip electrode 32 as the cathode and ring electrode 34 as the return anode electrode; para. [0070], BB pacing electrodes 32 and 34 may be selected in a bipolar ventricular pacing and/or sensing electrode pair or one or both electrodes carried by BB pacing lead 18 may be used in combination with pacemaker housing 15 or one of coil electrodes 37 or 39 (if present) for delivering unipolar pacing pulses and/or receiving a unipolar cardiac electrical signal for sensing cardiac electrical events by cardiac electrical signal sensing circuitry. – Electrode 34 is a ring electrode. Electrode 32 is a tip electrode; para. [0039], the pacing electrode configuration may be adjusted during a given pacing therapy to promote reliable capture of ventricular pacing sites in accordance with the VCS pacing therapy based on determining capture or loss of capture at a given pacing site).
Re Claim 5, Zhou discloses performing, by the medical device, an automatic capture threshold test for anodal capture using the ring electrode; and
enabling the change to the backup pacing mode when a capture threshold is found by the automatic capture threshold test for the anodal capture (para. [0045], The selected pacing electrode configuration may depend on the pacing capture thresholds for the RBB and the LBB and the available electrodes coupled to the pacemaker; para. [0075], The selected electrode combination may be based on anodal and cathodal pacing capture thresholds of the LBB and RBB and/or the greatest improvement in ventricular electrical synchrony based on an analysis of ECG and/or EGM signals according to the techniques disclosed herein; para. [0077], A processor of pacemaker 14 or external device processor 52 may analyze ECG and/or EGM signals and determine QRS signal features for determining a ventricular conduction condition and selecting a VCS pacing therapy as well as corresponding pacing electrode configuration, pacing pulse output settings (based on pacing capture thresholds) and pacing timing intervals (e.g., AV delay and VV delay). The VCS pacing therapy may be selected based on the determined ventricular conduction condition, e.g., LBB block, RBB block, or complete BB block as examples. The pacing electrode configuration and pacing pulse output settings that result in capture at selected pacing sites to provide correction of LBB block and/or RBB block during a VCS pacing therapy delivered to the LBB and/or RBB may be used to deliver pacing pulses according to the selected VCS pacing therapy; para. [0120], For instance, if the first VCS pacing therapy is LBB plus LV myocardial pacing for addressing a ventricular conduction condition of LBB block and LV conduction delay, control circuit 80 may withhold the LV myocardial pacing pulse and analyze the QRS signal following a LBB pacing pulse (that is verified to be greater than the LBB capture threshold). If the LV conduction delay is corrected, control circuit 80 may determine that therapy change criteria are met at block 206. A change in VCS pacing therapy from the LBB plus LV myocardial pacing therapy to LBB pacing therapy (without LV myocardial pacing) may be made at block 212; para. [0120]-[0130], fig. 5, a different unipolar or bipolar pacing electrode vector may be selected or the pacing electrode polarities may be changed; para. [0075], As described above, multiple pacing electrode configurations are selectable for delivering bundle branch pacing using electrodes 32, 34, 42 and/or 44 in various unipolar and/or bipolar pacing electrode vectors and selectable anode and cathode polarity assignments of each electrode 32, 34, 42 and 44 - Electrode 34 is a ring electrode.).
Re Claim 6, Zhou discloses that the changing to the backup mode includes: running an automatic capture threshold test with the medical device in the primary pacing mode when detecting the loss of capture of the LBB area; and changing operation of the medical device to the backup pacing mode when a capture threshold is not found by the automatic capture threshold test (para. [0130], The pacing capture test may include varying the pacing pulse output, e.g., by adjusting the pacing pulse amplitude to multiple settings, for determining the capture threshold based on detecting a pacing evoked response at the lowest pacing pulse output tested. The pacing pulse output may be set to a safety margin greater than the capture threshold. In some cases, when capture is not detected at a given pacing site and the maximum pacing pulse output is reached, control circuit 80 may change a pacing electrode vector or an electrode polarity selected for pacing at a given site in order to improve the likelihood of achieving capture. For example, a different unipolar or bipolar pacing electrode vector may be selected or the pacing electrode polarities may be changed).
Re Claim 7, Zhou discloses that changing to the backup pacing mode includes: changing to a backup unipolar pacing mode between the ring electrode of the implantable cardiac lead and a device electrode included on the medical device as the backup pacing mode (para. [0070], BB pacing electrodes 32 and 34 may be selected in a bipolar ventricular pacing and/or sensing electrode pair or one or both electrodes carried by BB pacing lead 18 may be used in combination with pacemaker housing 15 or one of coil electrodes 37 or 39 (if present) for delivering unipolar pacing pulses and/or receiving a unipolar cardiac electrical signal for sensing cardiac electrical events by cardiac electrical signal sensing circuitry. – Electrode 34 is a ring electrode. Electrode 32 is a tip electrode; fig. 5, para. [0120]-[0130], When control circuit 80 determines that pacing therapy change criteria are met, control circuit 80 may select a different VCS pacing therapy at block 212 and control therapy delivery circuit 84 to deliver ventricular pacing according to the second VCS pacing therapy at block 212.); and performing, by the medical device, an automatic capture threshold test when changing to the backup unipolar pacing mode (para. [0128], [0129], Control circuit 80 may control the therapy delivery circuit 84 to deliver a pacing pulse to each of the ventricular pacing sites of the VCS pacing therapy one at a time to verify capture at each pacing site individually during a pacing capture test; para. [0130], The pacing capture test may include varying the pacing pulse output, e.g., by adjusting the pacing pulse amplitude to multiple settings, for determining the capture threshold based on detecting a pacing evoked response at the lowest pacing pulse output tested. The pacing pulse output may be set to a safety margin greater than the capture threshold; fig. 5 shows that after selection of different pacing therapy, verification of capture and conduction check are carried out again.).
Re Claim 8, Zhou discloses triggering an alert regarding operation of the medical device in response to the changing to the backup pacing mode (para. [0060], Remote patient management systems including a centralized patient database may be configured to utilize the presently disclosed techniques to enable a clinician to be notified when a recommended VCS pacing therapy is changed).
Re Claim 9, Zhou discloses an implantable medical device, the device comprising:
a therapy circuit configured to provide electrical cardiac pacing energy to a left conduction bundle branch (LBB) area of a subject when operatively connected to an implantable cardiac lead that includes a tip electrode configured for placement inf the left bundle branch (para. [0020], fig. 6, FIG. 7 is a diagram of electrocardiogram (ECG) signals that may be sensed during a normal ventricular conduction condition (panel A) and during a left bundle branch (LBB) block condition (panel B) and during LBB pacing therapy (panel C) selected in response to detecting the LBB block condition according to one example; para. [0031], ventricular pacing via the left bundle branch (LBB); para. [0045] As used herein, the term “bipolar bilateral BB pacing” refers to bilateral BB pacing using a single bipolar electrode pair that captures, at least partially or wholly, both the LBB and the RBB simultaneously by capturing one bundle branch via anodal capture at the pacing anode electrode and one bundle branch via cathodal capture at the pacing cathode electrode. In some instances, unipolar pacing of one bundle branch, right or left, may directly capture that bundle branch while virtual current or break excitation generated by the pacing electrode may excite the other bundle branch, potentially resulting in unipolar bilateral BB pacing, with capture of both the LBB and RBB; para. [0068], the pacing pulse output may be adjusted to capture both the LBB and the RBB by cathodal capture at the pacing tip electrode 32 and anodal capture of the RBB at the pacing ring electrode 34 or vice versa; para. [0075], a single bipolar pacing electrode vector, e.g., tip electrode 32 paired with any one of electrodes 34, 42 or 44, may be selected to deliver bipolar bilateral BB pacing including cathodal and anodal capture.);
a cardiac signal sensing circuit configured to sense cardiac signals when operatively coupled to implantable electrodes (para. [0006], a sensing circuit configured to sense at least one cardiac electrical signal; para. [0009], a therapy delivery circuit configured to generate pacing pulses according to a first pacing therapy by generating pacing pulses for delivery to a first combination of ventricular pacing sites comprising at least a first ventricular conduction system pacing site); and
a control circuit operatively coupled to the therapy circuit and the cardiac signal sensing circuit (para. [0009], a control circuit configured to: control the therapy delivery circuit to withhold a pacing pulse from at least one ventricular pacing site of the first combination of ventricular pacing sites for at least one ventricular cycle; determine a QRS signal feature from the at least one cardiac electrical signal sensed by the sensing circuit during the at least one ventricular cycle), and configured to:
initiate delivery of the electrical cardiac pacing energy to the LBB area using a primary pacing vector that includes the tip electrode of the implantable cardiac lead (para. [0020], fig. 6, FIG. 7 is a diagram of electrocardiogram (ECG) signals that may be sensed during a normal ventricular conduction condition (panel A) and during a left bundle branch (LBB) block condition (panel B) and during LBB pacing therapy (panel C) selected in response to detecting the LBB block condition according to one example; para. [0031], ventricular pacing via the left bundle branch (LBB); para. [0045] As used herein, the term “bipolar bilateral BB pacing” refers to bilateral BB pacing using a single bipolar electrode pair that captures, at least partially or wholly, both the LBB and the RBB simultaneously by capturing one bundle branch via anodal capture at the pacing anode electrode and one bundle branch via cathodal capture at the pacing cathode electrode. In some instances, unipolar pacing of one bundle branch, right or left, may directly capture that bundle branch while virtual current or break excitation generated by the pacing electrode may excite the other bundle branch, potentially resulting in unipolar bilateral BB pacing, with capture of both the LBB and RBB; para. [0068], the pacing pulse output may be adjusted to capture both the LBB and the RBB by cathodal capture at the pacing tip electrode 32 and anodal capture of the RBB at the pacing ring electrode 34 or vice versa; para. [0075], a single bipolar pacing electrode vector, e.g., tip electrode 32 paired with any one of electrodes 34, 42 or 44, may be selected to deliver bipolar bilateral BB pacing including cathodal and anodal capture.);
monitor for loss of cardiac capture by the primary pacing vector (para. [0126], [0157], Control circuit 80 may adjust the pacing pulse output and/or the pacing electrode configuration to regain capture of both of the RBB and the LBB at block 326 when loss of capture is detected at block 322; para. [0162], the conduction check may be performed after verifying pacing capture at each of the pacing sites of the VCS plus LV myocardial pacing sites to avoid determining a change in a ventricular conduction condition when loss of capture is occurring during the conduction check.); and
change delivery of the electrical cardiac pacing energy to a backup pacing vector when the loss of cardiac capture is detected (para. [0039], the pacing electrode configuration may be adjusted during a given pacing therapy to promote reliable capture of ventricular pacing sites in accordance with the VCS pacing therapy based on determining capture or loss of capture at a given pacing site),
wherein the backup pacing vector uses a ring electrode of the implantable cardiac lead for anodal capture in an interventricular septum of the subject (para. [0075], As described above, multiple pacing electrode configurations are selectable for delivering bundle branch pacing using electrodes 32, 34, 42 and/or 44 in various unipolar and/or bipolar pacing electrode vectors and selectable anode and cathode polarity assignments of each electrode 32, 34, 42 and 44; para. [0072], fig. 2B, lead 18 may be advanced to position BB pacing tip electrode 32 in the left portion of the interventricular septum 12, in the vicinity of the LBB, for pacing the LBB in a bipolar pacing electrode configuration between tip electrode 32 as the cathode and ring electrode 34 as the return anode electrode; para. [0070], BB pacing electrodes 32 and 34 may be selected in a bipolar ventricular pacing and/or sensing electrode pair or one or both electrodes carried by BB pacing lead 18 may be used in combination with pacemaker housing 15 or one of coil electrodes 37 or 39 (if present) for delivering unipolar pacing pulses and/or receiving a unipolar cardiac electrical signal for sensing cardiac electrical events by cardiac electrical signal sensing circuitry. – Electrode 34 is a ring electrode).
Re Claim 10, Zhou discloses a device electrode formed on the implantable medical device (para. [0070], [0074], BB pacing electrodes 32 and 34 may be selected in a bipolar ventricular pacing and/or sensing electrode pair or one or both electrodes carried by BB pacing lead 18 may be used in combination with pacemaker housing 15. When two leads 18 and 28 are provided, one or both may be unipolar leads carrying a single electrode for pacing in a unipolar pacing electrode vector with pacemaker housing 15. Any available pacing electrode vector may be selected from the four electrodes 32, 34, 42, 33 and 44 and pacemaker housing 15 for delivering LBB pacing, RBB pacing or bilateral BB pacing; para. [0089], Housing 15 is depicted as an electrode coupled to pacemaker circuitry in FIG. 4 for the sake of convenience because housing 15 may be selected as an electrode in a unipolar pacing or sensing electrode vector in some examples); and
wherein the primary pacing vector is a unipolar pacing vector that includes the tip electrode and the device electrode, and the backup pacing vector is a unipolar pacing vector that includes the ring electrode and the device electrode (para. [0075], As described above, multiple pacing electrode configurations are selectable for delivering bundle branch pacing using electrodes 32, 34, 42 and/or 44 in various unipolar and/or bipolar pacing electrode vectors and selectable anode and cathode polarity assignments of each electrode 32, 34, 42 and 44; para. [0072], fig. 2B, lead 18 may be advanced to position BB pacing tip electrode 32 in the left portion of the interventricular septum 12, in the vicinity of the LBB, for pacing the LBB in a bipolar pacing electrode configuration between tip electrode 32 as the cathode and ring electrode 34 as the return anode electrode; para. [0070], BB pacing electrodes 32 and 34 may be selected in a bipolar ventricular pacing and/or sensing electrode pair or one or both electrodes carried by BB pacing lead 18 may be used in combination with pacemaker housing 15 or one of coil electrodes 37 or 39 (if present) for delivering unipolar pacing pulses and/or receiving a unipolar cardiac electrical signal for sensing cardiac electrical events by cardiac electrical signal sensing circuitry. – Electrode 34 is a ring electrode. Electrode 32 is a tip electrode; para. [0039], the pacing electrode configuration may be adjusted during a given pacing therapy to promote reliable capture of ventricular pacing sites in accordance with the VCS pacing therapy based on determining capture or loss of capture at a given pacing site).
Re Claim 13, Zhou discloses that the control circuit is configured to: perform an automatic capture threshold test for the backup pacing vector; and enable use of the backup pacing vector when a capture threshold for the backup pacing vector is found by the automatic capture threshold test (para. [0045], The selected pacing electrode configuration may depend on the pacing capture thresholds for the RBB and the LBB and the available electrodes coupled to the pacemaker; para. [0075], The selected electrode combination may be based on anodal and cathodal pacing capture thresholds of the LBB and RBB and/or the greatest improvement in ventricular electrical synchrony based on an analysis of ECG and/or EGM signals according to the techniques disclosed herein; para. [0077], A processor of pacemaker 14 or external device processor 52 may analyze ECG and/or EGM signals and determine QRS signal features for determining a ventricular conduction condition and selecting a VCS pacing therapy as well as corresponding pacing electrode configuration, pacing pulse output settings (based on pacing capture thresholds) and pacing timing intervals (e.g., AV delay and VV delay). The VCS pacing therapy may be selected based on the determined ventricular conduction condition, e.g., LBB block, RBB block, or complete BB block as examples. The pacing electrode configuration and pacing pulse output settings that result in capture at selected pacing sites to provide correction of LBB block and/or RBB block during a VCS pacing therapy delivered to the LBB and/or RBB may be used to deliver pacing pulses according to the selected VCS pacing therapy; para. [0120], For instance, if the first VCS pacing therapy is LBB plus LV myocardial pacing for addressing a ventricular conduction condition of LBB block and LV conduction delay, control circuit 80 may withhold the LV myocardial pacing pulse and analyze the QRS signal following a LBB pacing pulse (that is verified to be greater than the LBB capture threshold). If the LV conduction delay is corrected, control circuit 80 may determine that therapy change criteria are met at block 206. A change in VCS pacing therapy from the LBB plus LV myocardial pacing therapy to LBB pacing therapy (without LV myocardial pacing) may be made at block 212; para. [0120]-[0130], fig. 5, a different unipolar or bipolar pacing electrode vector may be selected or the pacing electrode polarities may be changed; para. [0075], As described above, multiple pacing electrode configurations are selectable for delivering bundle branch pacing using electrodes 32, 34, 42 and/or 44 in various unipolar and/or bipolar pacing electrode vectors and selectable anode and cathode polarity assignments of each electrode 32, 34, 42 and 44 - Electrode 34 is a ring electrode.).
Re Claim 14, Zhou discloses that the control circuit is configured to: perform an automatic capture threshold test for the primary pacing vector when detecting the loss of capture of the LBB area; and change to delivery of the electrical cardiac pacing energy using the backup pacing vector when the automatic capture threshold test fails to find a capture threshold for the primary pacing vector (para. [0130], The pacing capture test may include varying the pacing pulse output, e.g., by adjusting the pacing pulse amplitude to multiple settings, for determining the capture threshold based on detecting a pacing evoked response at the lowest pacing pulse output tested. The pacing pulse output may be set to a safety margin greater than the capture threshold. In some cases, when capture is not detected at a given pacing site and the maximum pacing pulse output is reached, control circuit 80 may change a pacing electrode vector or an electrode polarity selected for pacing at a given site in order to improve the likelihood of achieving capture. For example, a different unipolar or bipolar pacing electrode vector may be selected or the pacing electrode polarities may be changed).
Re Claim 15, Zhou discloses a device electrode formed on the implantable medical device (para. [0070], [0074], BB pacing electrodes 32 and 34 may be selected in a bipolar ventricular pacing and/or sensing electrode pair or one or both electrodes carried by BB pacing lead 18 may be used in combination with pacemaker housing 15. When two leads 18 and 28 are provided, one or both may be unipolar leads carrying a single electrode for pacing in a unipolar pacing electrode vector with pacemaker housing 15. Any available pacing electrode vector may be selected from the four electrodes 32, 34, 42, 33 and 44 and pacemaker housing 15 for delivering LBB pacing, RBB pacing or bilateral BB pacing; para. [0089], Housing 15 is depicted as an electrode coupled to pacemaker circuitry in FIG. 4 for the sake of convenience because housing 15 may be selected as an electrode in a unipolar pacing or sensing electrode vector in some examples);
wherein the backup pacing vector is a backup unipolar pacing vector that includes the ring electrode and the device electrode (para. [0075], As described above, multiple pacing electrode configurations are selectable for delivering bundle branch pacing using electrodes 32, 34, 42 and/or 44 in various unipolar and/or bipolar pacing electrode vectors and selectable anode and cathode polarity assignments of each electrode 32, 34, 42 and 44; para. [0072], fig. 2B, lead 18 may be advanced to position BB pacing tip electrode 32 in the left portion of the interventricular septum 12, in the vicinity of the LBB, for pacing the LBB in a bipolar pacing electrode configuration between tip electrode 32 as the cathode and ring electrode 34 as the return anode electrode; para. [0070], BB pacing electrodes 32 and 34 may be selected in a bipolar ventricular pacing and/or sensing electrode pair or one or both electrodes carried by BB pacing lead 18 may be used in combination with pacemaker housing 15 or one of coil electrodes 37 or 39 (if present) for delivering unipolar pacing pulses and/or receiving a unipolar cardiac electrical signal for sensing cardiac electrical events by cardiac electrical signal sensing circuitry. – Electrode 34 is a ring electrode. Electrode 32 is a tip electrode); and
wherein the control circuit is configured to perform an automatic capture threshold test for the backup unipolar pacing vector when changing to the backup unipolar pacing vector (para. [0128], [0129], Control circuit 80 may control the therapy delivery circuit 84 to deliver a pacing pulse to each of the ventricular pacing sites of the VCS pacing therapy one at a time to verify capture at each pacing site individually during a pacing capture test; para. [0130], The pacing capture test may include varying the pacing pulse output, e.g., by adjusting the pacing pulse amplitude to multiple settings, for determining the capture threshold based on detecting a pacing evoked response at the lowest pacing pulse output tested. The pacing pulse output may be set to a safety margin greater than the capture threshold; fig. 5 shows that after selection of different pacing therapy, verification of capture and conduction check are carried out again.).
Re Claim 16, Zhou discloses that the control circuit is configured to trigger an alert regarding operation of the medical device in response to the changing to the backup pacing mode (para. [0060], Remote patient management systems including a centralized patient database may be configured to utilize the presently disclosed techniques to enable a clinician to be notified when a recommended VCS pacing therapy is changed).
Re Claim 17, Zhou discloses a cardiac rhythm management system, the system comprising:
an implantable lead including a left bundle branch (LBB) pacing electrode configured for placement in an LBB of a subject, and a ring electrode proximal to the LBB pacing electrode (para. [0020], fig. 6, FIG. 7 is a diagram of electrocardiogram (ECG) signals that may be sensed during a normal ventricular conduction condition (panel A) and during a left bundle branch (LBB) block condition (panel B) and during LBB pacing therapy (panel C) selected in response to detecting the LBB block condition according to one example; para. [0031], ventricular pacing via the left bundle branch (LBB); para. [0045] As used herein, the term “bipolar bilateral BB pacing” refers to bilateral BB pacing using a single bipolar electrode pair that captures, at least partially or wholly, both the LBB and the RBB simultaneously by capturing one bundle branch via anodal capture at the pacing anode electrode and one bundle branch via cathodal capture at the pacing cathode electrode. In some instances, unipolar pacing of one bundle branch, right or left, may directly capture that bundle branch while virtual current or break excitation generated by the pacing electrode may excite the other bundle branch, potentially resulting in unipolar bilateral BB pacing, with capture of both the LBB and RBB; para. [0068], the pacing pulse output may be adjusted to capture both the LBB and the RBB by cathodal capture at the pacing tip electrode 32 and anodal capture of the RBB at the pacing ring electrode 34 or vice versa; para. [0075], a single bipolar pacing electrode vector, e.g., tip electrode 32 paired with any one of electrodes 34, 42 or 44, may be selected to deliver bipolar bilateral BB pacing including cathodal and anodal capture. – Electrode 34 is a ring electrode, which is proximal to a tip electrode 32);
a medical device (fig. 2A, para. [0069], pacemaker housing 15) for coupling to the implantable lead (fig. 2A, para. [0070], BB pacing lead 18), the medical device including: a housing containing electronic circuits of the medical device within the housing (fig. 2A, para. [0069], circuitry enclosed within pacemaker housing 15) and a device electrode on the outside of the housing (para. [0070], [0074], BB pacing electrodes 32 and 34 may be selected in a bipolar ventricular pacing and/or sensing electrode pair or one or both electrodes carried by BB pacing lead 18 may be used in combination with pacemaker housing 15. When two leads 18 and 28 are provided, one or both may be unipolar leads carrying a single electrode for pacing in a unipolar pacing electrode vector with pacemaker housing 15. Any available pacing electrode vector may be selected from the four electrodes 32, 34, 42, 33 and 44 and pacemaker housing 15 for delivering LBB pacing, RBB pacing or bilateral BB pacing; para. [0089], Housing 15 is depicted as an electrode coupled to pacemaker circuitry in FIG. 4 for the sake of convenience because housing 15 may be selected as an electrode in a unipolar pacing or sensing electrode vector in some examples);
a therapy circuit configured to provide electrical cardiac pacing energy to the LBB pacing electrode (para. [0006], a therapy delivery circuit configured to generate pacing pulses according to a first pacing therapy by generating pacing pulses for delivery to a combination of ventricular pacing sites including at least one ventricular conduction system pacing site; para. [0031], ventricular pacing via the left bundle branch (LBB); para. [0045], As used herein, the term “bipolar bilateral BB pacing” refers to bilateral BB pacing using a single bipolar electrode pair that captures, at least partially or wholly, both the LBB and the RBB simultaneously by capturing one bundle branch via anodal capture at the pacing anode electrode and one bundle branch via cathodal capture at the pacing cathode electrode. In some instances, unipolar pacing of one bundle branch, right or left, may directly capture that bundle branch while virtual current or break excitation generated by the pacing electrode may excite the other bundle branch, potentially resulting in unipolar bilateral BB pacing, with capture of both the LBB and RBB; para. [0068], the pacing pulse output may be adjusted to capture both the LBB and the RBB by cathodal capture at the pacing tip electrode 32 and anodal capture of the RBB at the pacing ring electrode 34 or vice versa);
a sensing circuit configured to sense cardiac signals (para. [0006], a sensing circuit configured to sense at least one cardiac electrical signal); and
a control circuit operatively coupled to the therapy circuit and the sensing circuit (para. [0009], a control circuit configured to: control the therapy delivery circuit to withhold a pacing pulse from at least one ventricular pacing site of the first combination of ventricular pacing sites for at least one ventricular cycle; determine a QRS signal feature from the at least one cardiac electrical signal sensed by the sensing circuit during the at least one ventricular cycle), and configured to:
initiate delivery of the electrical cardiac pacing energy to the LBB area using a primary pacing vector that includes the LBB pacing electrode (para. [0020], fig. 6, FIG. 7 is a diagram of electrocardiogram (ECG) signals that may be sensed during a normal ventricular conduction condition (panel A) and during a left bundle branch (LBB) block condition (panel B) and during LBB pacing therapy (panel C) selected in response to detecting the LBB block condition according to one example; para. [0031], ventricular pacing via the left bundle branch (LBB); para. [0045] As used herein, the term “bipolar bilateral BB pacing” refers to bilateral BB pacing using a single bipolar electrode pair that captures, at least partially or wholly, both the LBB and the RBB simultaneously by capturing one bundle branch via anodal capture at the pacing anode electrode and one bundle branch via cathodal capture at the pacing cathode electrode. In some instances, unipolar pacing of one bundle branch, right or left, may directly capture that bundle branch while virtual current or break excitation generated by the pacing electrode may excite the other bundle branch, potentially resulting in unipolar bilateral BB pacing, with capture of both the LBB and RBB; para. [0068], the pacing pulse output may be adjusted to capture both the LBB and the RBB by cathodal capture at the pacing tip electrode 32 and anodal capture of the RBB at the pacing ring electrode 34 or vice versa; para. [0075], a single bipolar pacing electrode vector, e.g., tip electrode 32 paired with any one of electrodes 34, 42 or 44, may be selected to deliver bipolar bilateral BB pacing including cathodal and anodal capture.);
monitor for loss of cardiac capture by the primary pacing vector (para. [0126], [0157], Control circuit 80 may adjust the pacing pulse output and/or the pacing electrode configuration to regain capture of both of the RBB and the LBB at block 326 when loss of capture is detected at block 322; para. [0162], the conduction check may be performed after verifying pacing capture at each of the pacing sites of the VCS plus LV myocardial pacing sites to avoid determining a change in a ventricular conduction condition when loss of capture is occurring during the conduction check.); and
change delivery of the electrical cardiac pacing energy to a backup unipolar pacing vector when the loss of cardiac capture by the primary pacing vector is detected (para. [0039], the pacing electrode configuration may be adjusted during a given pacing therapy to promote reliable capture of ventricular pacing sites in accordance with the VCS pacing therapy based on determining capture or loss of capture at a given pacing site),
wherein the backup unipolar pacing vector includes the ring electrode and the device electrode (para. [0075], As described above, multiple pacing electrode configurations are selectable for delivering bundle branch pacing using electrodes 32, 34, 42 and/or 44 in various unipolar and/or bipolar pacing electrode vectors and selectable anode and cathode polarity assignments of each electrode 32, 34, 42 and 44; para. [0072], fig. 2B, lead 18 may be advanced to position BB pacing tip electrode 32 in the left portion of the interventricular septum 12, in the vicinity of the LBB, for pacing the LBB in a bipolar pacing electrode configuration between tip electrode 32 as the cathode and ring electrode 34 as the return anode electrode; para. [0070], BB pacing electrodes 32 and 34 may be selected in a bipolar ventricular pacing and/or sensing electrode pair or one or both electrodes carried by BB pacing lead 18 may be used in combination with pacemaker housing 15 or one of coil electrodes 37 or 39 (if present) for delivering unipolar pacing pulses and/or receiving a unipolar cardiac electrical signal for sensing cardiac electrical events by cardiac electrical signal sensing circuitry. – Electrode 34 is a ring electrode).
Re Claim 18, Zhou discloses that the primary pacing vector includes the LBB pacing electrode and the device electrode (para. [0070], [0074], BB pacing electrodes 32 and 34 may be selected in a bipolar ventricular pacing and/or sensing electrode pair or one or both electrodes carried by BB pacing lead 18 may be used in combination with pacemaker housing 15. When two leads 18 and 28 are provided, one or both may be unipolar leads carrying a single electrode for pacing in a unipolar pacing electrode vector with pacemaker housing 15. Any available pacing electrode vector may be selected from the four electrodes 32, 34, 42, 33 and 44 and pacemaker housing 15 for delivering LBB pacing, RBB pacing or bilateral BB pacing - Electrode 32 is a tip electrode; para. [0089], Housing 15 is depicted as an electrode coupled to pacemaker circuitry in FIG. 4 for the sake of convenience because housing 15 may be selected as an electrode in a unipolar pacing or sensing electrode vector in some examples).
Re Claim 19, Zhou discloses that the primary pacing vector includes the LBB pacing electrode and the ring electrode (para. [0075], a single bipolar pacing electrode vector, e.g., tip electrode 32 paired with any one of electrodes 34, 42 or 44, may be selected to deliver bipolar bilateral BB pacing including cathodal and anodal capture. - Electrode 34 is a ring electrode.; para. [0031], ventricular pacing via the left bundle branch (LBB); para. [0045], As used herein, the term “bipolar bilateral BB pacing” refers to bilateral BB pacing using a single bipolar electrode pair that captures, at least partially or wholly, both the LBB and the RBB simultaneously by capturing one bundle branch via anodal capture at the pacing anode electrode and one bundle branch via cathodal capture at the pacing cathode electrode.).
Re Claim 20, Zhou discloses that the control circuit is configured to determine that delivering electrical pacing energy to the ring electrode produces capture of the right ventricle (RV) of the subject before including the ring electrode in the backup unipolar pacing vector (para. [0044], The LBB pacing site may be accessed from the right ventricular septum such that a pacing electrode may be advanced toward the LBB pacing site; para. [0067], BB pacing lead 18 may be advanced transvenously into the right ventricle (RV) via the right atrium (RA) for positioning BB pacing and sensing electrodes 32 and 34 within the interventricular septum 12 - Electrode 34 is a ring electrode; para. [0039], the pacing electrode configuration may be adjusted during a given pacing therapy to promote reliable capture of ventricular pacing sites in accordance with the VCS pacing therapy based on determining capture or loss of capture at a given pacing site; para. [0094], Using ring electrode 34, features of the EGM signal may be determined by processor 148 of control circuit 80 for use in determining a ventricular conduction condition for selecting a VCS pacing therapy as described below and for verifying pacing capture and selecting a pacing interval; para. [0132], fig. 5, capture verification and conduction checks; para. [0157], Control circuit 80 may perform capture threshold tests to verify capture of both the LBB and RBB by delivering premature bipolar bilateral BB pacing pulses or individual premature LBB pacing pulses and premature RBB pacing pulses at varying pulse outputs; para. [0032], When ventricular myocardial pacing is combined with a ventricular conduction system pacing site in a VCS pacing therapy, the ventricular myocardial pacing site may be any selected myocardial pacing location, such as the left ventricular lateral free wall, interventricular septum (right or left side), or a right ventricular location; para. [0075], As described above, multiple pacing electrode configurations are selectable for delivering bundle branch pacing using electrodes 32, 34, 42 and/or 44 in various unipolar and/or bipolar pacing electrode vectors and selectable anode and cathode polarity assignments of each electrode 32, 34, 42 and 44; para. [0070], BB pacing electrodes 32 and 34 may be selected in a bipolar ventricular pacing and/or sensing electrode pair or one or both electrodes carried by BB pacing lead 18 may be used in combination with pacemaker housing 15 or one of coil electrodes 37 or 39 (if present) for delivering unipolar pacing pulses and/or receiving a unipolar cardiac electrical signal for sensing cardiac electrical events by cardiac electrical signal sensing circuitry. – Electrode 34 is a ring electrode.).
Conclusion
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, July 25, 2026Examiner, Art Unit 3792
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