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 Objections
Applicant is advised that should claim 16 be found allowable, claim 17 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The Examiner notes that claim 17 is identical to claim 16.
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 1-4 and 11-15 are rejected under 35 U.S.C. 101 because the claimed inventions are directed towards an abstract idea without significantly more.
Step 1 – Is the claim to a statutory category of invention?
Claims 1-11 recite a machine (i.e., a device or a system). Claims 12-20 recite a method. Therefore, the claims are to a statutory category of invention.
Step 2A, prong 1 – Does the claim recite a judicial exception?
Claim 1 recites: “determine a first conduction time of the first pacing pulse from the left-ventricular septum to the coronary sinus based on the sensing of the first depolarization; determine a second conduction time of the second pacing pulse from the coronary sinus to the left-ventricular septum based on the sensing of the second depolarization; and determine, based on the first conduction time and the second conduction time, whether the first pacing pulse comprises left bundle branch pacing.” Determining conduction times is considered to be both an abstract idea mental process in that one of ordinary skill, such as a cardiologist or physician, could make observations and judgements to determine the conduction time based on the sensed depolarization data to determine a conduction time in their own head. Further, the claim language of determining conduction times is so broad as to include calculating a conduction time, which is a mathematical concept that could be performed with a pencil and paper. Lastly, a physician could make a determination or judgement, based on the observed or calculated conduction times, that the pacing pulse is left bundle branch pacing. Therefore, the claims recite judicial exception abstract ideas.
Claim 12 recites the same judicial exceptions of claim 1 as steps in a method.
Step 2A prong 2 – Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claim 1 recites the additional elements: “An implantable medical device comprising: a connector block configured to couple to a plurality of leads comprising: a first lead carrying a first set of electrodes and configured to be implanted in an inter-ventricular septum of a heart to position at least one electrode of the first set of electrodes in a left bundle branch area proximate a left-ventricular septum; and a second lead carrying a second set of electrodes and configured to be implanted in a coronary sinus of the heart; and sensing circuitry configured to: sense, via the second set of electrodes, a first depolarization resulting from a first pacing pulse delivered by the first set of electrodes; and sense, via the first set of electrodes, a second depolarization resulting from a second pacing pulse delivered by the second set of electrodes”. A connector block, a plurality of leads with electrodes, sensing circuitry, and processing circuitry recite generic elements of a pacing device used to implement the judicial exception. One of ordinary skill would recognizes that the connector, leads, electrodes, and sensing circuitry are all generic elements for extra-solution activity data gathering of cardiac signals, and that any generic electrodes pacing devices could sense depolarizations (such as a standard ECG). Additionally, a processor is a generic computer structure for implementing the abstract ideas recited above (see MPEP 2106.05(b)(I-III) – Particular Machine – for more details). Therefore, claim 1 does not recite additional elements that integrate the abstract idea judicial exception into a practical application.
Claim 12 recites: “sensing, via a second set of electrodes of a second lead of an implantable medical device, a first depolarization resulting from a first pacing pulse delivered by a first set of electrodes of a first lead of the implantable medical device, wherein the second set of electrodes is positioned in the coronary sinus, wherein the first set of electrodes is implanted in an inter-ventricular septum of a heart, and wherein at least one electrode of the first set of electrodes in a left bundle branch area proximate a left-ventricular septum; and sensing, via the first set of electrodes, a second depolarization resulting from a second pacing pulse delivered by the second set of electrodes.” Sensing depolarizations via electrodes on a lead is extra-solution activity in that one would recognize the recited steps as merely gathering data. As in claim 1, one would recognize the lead and electrodes to be generic structures for measuring cardiac activity, and that any generic lead and electrode structures sense depolarizations. Therefore, the additional elements of claim 12 do not integrate the judicial exception into an abstract idea.
Step 2B – Do the additional elements add significantly more to the judicial exception?
Claim 1 recites the additional elements: “An implantable medical device comprising: a connector block configured to couple to a plurality of leads comprising: a first lead carrying a first set of electrodes and configured to be implanted in an inter-ventricular septum of a heart to position at least one electrode of the first set of electrodes in a left bundle branch area proximate a left-ventricular septum; and a second lead carrying a second set of electrodes and configured to be implanted in a coronary sinus of the heart; and sensing circuitry configured to: sense, via the second set of electrodes, a first depolarization resulting from a first pacing pulse delivered by the first set of electrodes; and sense, via the first set of electrodes, a second depolarization resulting from a second pacing pulse delivered by the second set of electrodes” A connector block, a plurality of leads with electrodes, sensing circuitry, and processing circuitry recite generic elements of a pacing device used to implement the judicial exception. One of ordinary skill would recognizes that the leads, electrodes, and sensing circuitry are all generic elements for extra-solution activity data gathering of cardiac signals, and that any generic electrodes pacing devices could sense depolarizations (such as a standard ECG). Additionally, a processor is a generic computer structure for implementing the abstract ideas recited above (see MPEP 2106.05(b)(I-III) – Particular Machine – for more details). Therefore, claim 1 does not recite additional elements that add significantly more to the judicial exception.
Claim 12 recites: “sensing, via a second set of electrodes of a second lead of an implantable medical device, a first depolarization resulting from a first pacing pulse delivered by a first set of electrodes of a first lead of the implantable medical device, wherein the second set of electrodes is positioned in the coronary sinus, wherein the first set of electrodes is implanted in an inter-ventricular septum of a heart, and wherein at least one electrode of the first set of electrodes in a left bundle branch area proximate a left-ventricular septum; and sensing, via the first set of electrodes, a second depolarization resulting from a second pacing pulse delivered by the second set of electrodes.” Sensing depolarizations via electrodes on a lead is extra-solution activity in that one would recognize the recited steps as merely gathering data. As in claim 1, one would recognize the lead and electrodes to be generic structures for measuring cardiac activity, and that any generic lead and electrode structures sense depolarizations. Therefore, the additional elements of claim 12 do not add significantly more to the judicial exception.
Dependent claims
Claims 2 and 13 further recite abstract idea mental process determinations made by a generic computer processor, as well as mathematical concept abstract idea calculations made by that processor (differences and comparisons to a threshold).
Claims 3 and 14 further limit the abstract idea mathematical concept calculations made by a processor.
Claim 11 recites generic leads and electrodes from claim 1, as well as a generic external device for outputting an indication. Outputting an indication is merely insignificant extra-solution activity data outputting (see MPEP 2106.05(g)(3)).
Claims 4 and 15 further recite abstract idea mental processes and mathematical concepts performed by generic processing circuitry.
Regarding claim 5, the Examiner notes that the limitation, “responsive to determining that the first conduction time is greater than or equal to the first conduction time threshold, control delivery of cardiac resynchronization therapy via the first set of electrodes and the second set of electrodes” adds significantly more to the judicial exception of claim 1 since the judicial exception is being used to control stimulation therapy parameters. Similarly, claim 16 recites the same limitation that adds significantly more to the judicial exception.
For these reasons, claims 5-10 and 16-20 are not rejected under 35 USC 101.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites: “A medical system comprising: the implantable medical device of claim 1; a plurality of leads comprising the first lead and the second lead, the implantable medical device coupled to the plurality of lead;”. Claim 1 recites “a first lead” and “a second lead,” and claim 11 references the plurality of leads comprises. However, claim 11 then recites that the implantable medical device is coupled to the plurality of leads. It is unclear how the implantable medical device of claim 1, which includes the first and second lead, can be coupled to the same leads that comprise the implantable medical device. It is not exactly clear if the plurality of leads coupled to the medical device (line 4) are the same leads from claim 1 and claim 11 (line 3). The claim is therefore rendered indefinite. For examination purposes, the plurality of leads coupled to the medical device are the same first and second lead recited in claim 1.
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, 4-10, 12, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou (US 20190111264 A1), Mangual-Soto et al. (US 11235158 B2, "Mangual"), and Ghosh (US 20180326215 A1).
Regarding claim 1, Zhou discloses an implantable medical device (Fig. 3A; implantable medical device 16) comprising: a connector block (Fig. 3A; connector block 34) configured to couple to a plurality of leads (Fig. 3A; leads 18, 20, and 23) comprising: a first lead (para. [0076]: "In particular, a lead configured to perform multi-site pacing, which is different than LV coronary sinus lead 20, can be placed in the ventricular septum with the first (distal) electrode on the left side of the ventricular septum for left bundle branch pacing and with the second electrode (proximal) on the right side of the septum for pacing the right bundle branch") carrying a first set of electrodes (para. [0076]: "the first (distal) electrode on the left side of the ventricular septum for left bundle branch pacing and with the second electrode (proximal) on the right side of the septum for pacing the right bundle branch") and configured to be implanted in an inter-ventricular septum of a heart to position at least one electrode of the first set of electrodes in a left bundle branch area proximate a left-ventricular septum (Abstract: "A left bundle branch (LBB) cathode electrode may be implanted a left side of the septum of the patient's heart proximate to the LBB"; Fig. 3A; para. [0015]: " The plurality of electrodes includes a left bundle branch (LBB) cathode electrode positionable, when implanted, on a left side of the septum of the patient's heart proximate to the LBB"; para. [0076]: "In particular, a lead configured to perform multi-site pacing, which is different than LV coronary sinus lead 20, can be placed in the ventricular septum with the first (distal) electrode on the left side of the ventricular septum for left bundle branch pacing and with the second electrode (proximal) on the right side of the septum for pacing the right bundle branch"); and a second lead (Fig. 3A; coronary sinus lead 20) carrying a second set of electrodes (para. [0080]: "IMD 16 may sense electrical signals attendant to the depolarization and repolarization of heart 12 via electrodes (not shown in FIGS. 2A-B) coupled to at least one of leads 18, 20, 23." leads 18, 20, and 23 house electrodes) and configured to be implanted in a coronary sinus of the heart (para. [0068]: " Left ventricular (LV) coronary sinus lead 20 extends through one or more veins, the vena cava, right atrium 26, and into the coronary sinus 30 to a region adjacent to the free wall of left ventricle 32 of heart 12."); and sensing circuitry (para. [0080]: "IMD 16 may sense electrical signals attendant to the depolarization and repolarization of heart 12 via electrodes (not shown in FIGS. 2A-B) coupled to at least one of leads 18, 20, 23. In some examples, IMD 16 provides pacing pulses to heart 12 based on the electrical signals sensed within heart 12. The configurations of electrodes used by IMD 16 for sensing and pacing may be unipolar or bipolar. IMD 16 may also provide defibrillation therapy and/or cardioversion therapy via electrodes located on at least one of leads 18, 20, 23."; Fig. 5; sensing module 86) configured to: sense, via the second set of electrodes, a first depolarization resulting from a first pacing pulse delivered by the first set of electrodes (para. [0068]: "Leads 18, 20, 23 extend into heart 12 of patient 14 to sense electrical activity of heart 12 and/or deliver electrical stimulation to heart 12."; para. [0080]: "IMD 16 may sense electrical signals attendant to the depolarization and repolarization of heart 12 via electrodes (not shown in FIGS. 2A-B) coupled to at least one of leads 18, 20, 23. In some examples, IMD 16 provides pacing pulses to heart 12 based on the electrical signals sensed within heart 12. The configurations of electrodes used by IMD 16 for sensing and pacing may be unipolar or bipolar."); and sense, via the first set of electrodes, a second depolarization resulting from a second pacing pulse delivered by the second set of electrodes (para. [0068]: "Leads 18, 20, 23 extend into heart 12 of patient 14 to sense electrical activity of heart 12 and/or deliver electrical stimulation to heart 12."; para. [0080]: "IMD 16 may sense electrical signals attendant to the depolarization and repolarization of heart 12 via electrodes (not shown in FIGS. 2A-B) coupled to at least one of leads 18, 20, 23. In some examples, IMD 16 provides pacing pulses to heart 12 based on the electrical signals sensed within heart 12. The configurations of electrodes used by IMD 16 for sensing and pacing may be unipolar or bipolar."; para. [0187] also discloses biphasic stimulation, meaning one electrode is stimulating (positive) and the other is sensing (negative), and the pulse is propagating between the electrodes: "; For example, in RV lead recording, if the EGM morphology of the RV tip-ring (e.g., the tip towards LV) is biphasic from a positive direction to a negative direction, meaning the propagation is from LV to RV, then the left bundle pacing may be delayed until a positive monophasic waveform followed with a relatively long small negative waveform is recorded." Additionally, para. [0187] discloses that the same can be done in the opposite direction: "A similar method can be used to detect the activation propagation in the left ventricle."; A similar method can be used to detect the activation propagation in the left ventricle; Additionally, para. [0172] discloses that a QRS interval and duration may be determined: “Sensed heart activity may be used to determine, or may include, one or more of: an intraventricular interval, a QRS duration, a QRS morphology, a QRS vector, an R-wave timing, a bundle-pacing to left- or right-ventricular-activation interval, and an atrial-sensing to left- or right-ventricular-activation interval.” This is representative of a cardiac depolarization). However, Zhou does not expressly teach where processing circuitry is configured to: determine a first conduction time of the first pacing pulse from the left-ventricular septum to the coronary sinus based on the sensing of the first depolarization; determine a second conduction time of the second pacing pulse from the coronary sinus to the left-ventricular septum based on the sensing of the second depolarization; and determine, based on the first conduction time and the second conduction time, whether the first pacing pulse comprises left bundle branch pacing.
Mangual, in the same field of endeavor of cardiac pacing, discloses systems and methods for measuring conduction delays between multiple locations in the heart. Mangual discloses processing circuitry (microcontroller 220) configured to: determine a first conduction time of the first pacing pulse from the left-ventricular septum to the coronary sinus (para. (7): "The measuring the intrinsic VV intervals may further comprise delivering a paced event at each of the LV electrodes and measuring an associated conduction time to an RV electrode."; para. (39): "For example, the microcontroller 220 may measure the conduction time for an event propagation between the RA electrode 123 and each of the LV electrodes 132-138. The microcontroller 220 may initiate a paced event at the RA electrode 123, or may sense an intrinsic event at the RA electrode 123. The microcontroller 220 measures conduction time (e.g., the conduction time) for a conduction wave to propagate between the pacing/sensed event at the RA electrode 123 to a sensed event at each of the LV electrodes 132-138. The microcontroller 220 may compare the amount of time received at the LV electrodes 132-138. The microcontroller 220 identifies the conduction time received by the LV electrodes 132-138 relative to each other, to identify the lowest conduction time (lowest intrinsic A/LV interval 302-305) relative to the LV electrodes 132-138."); determine a second conduction time of the second pacing pulse from the coronary sinus to the left-ventricular septum (Fig. 3-5 demonstrate that multiple conduction times are determined for each electrode location: “RA-LV conduction time”; “RA-RV conduction time”; “LV-RV conduction time”).
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 Zhou to include the technique of determining conduction times between electrodes, as disclosed by Mangual. One of ordinary skill would recognize that conduction time can be used for determining delays between electrical conduction in different areas of the heart. One of ordinary skill would further recognize that conduction time can be used to optimize which therapy delay is most effective for cardiovascular resynchronization therapy. Lastly, one would expect with a reasonable expectation of success that that the conduction time technique of Magual could be implemented in the processor of Zhou to determine the conduction time between the electrodes Zhou, which are placed on the coronary sinus and left ventricular septum, to measure the conduction between the electrodes placed in those anatomical regions of the heart.
Although neither reference explicitly discloses where the processor is configured to determine, based on the first conduction time and the second conduction time, whether the first pacing pulse comprises left bundle branch pacing, Zhou discloses that the difference in conduction time between left and right ventricles may be indicative “dyssynchrony” and a need for left bundle block correction (para. [0191]: "In patients with pacing leads in RV and LV, the time difference between an RV sensed signal and an LV sensed signal may be used to represent the dyssynchrony between RV and LV. If the time difference increases, then dyssynchrony may be present, and pacing time in RV or LV may be adjusted or pacing time in LBB or RBB may be adjusted."; para. [0198]: "In another example, when an LV lead is available, if bundle-pacing to RV-sensing interval is 40 ms, and bundle-pacing to LV-sensing interval is 85 ms, then bundle branch pacing may be delivered and LV pacing with the LV lead may be adjusted to be delivered 40-50 ms earlier than bundle pacing, as a result, RV and LV activation may occur at almost the same time."), and that pacing at the left bundle branch would synchronize with the chambers to avoid bundle block (para. [0153]: “FIG. 11A graphically depicts the intrinsic rhythm when LBBB is present and pacing has not yet begun to be delivered to the left bundle branch (LBB). Low-output pacing at left bundle branch (or fibers destined for left bundle branch) may correct left bundle branch block with a trait of right bundle branch block. By adjusting atrial to His-bundle or bundle-branch pacing delay, right bundle branch block can be corrected. The atrial to His-bundle or bundle-branch pacing delay may be defined as the time when an electrical impulse, which may represent depolarization or contraction, is sensed or detected from the atrium and the time in which the pacing pulse is generated from the pulse generator. As shown in FIG. 11B in which an AV delay of 40 ms was employed, LBBB is not present, but RBBB remains. Increasing the pacing AV delay interval from 40 ms to 100 ms, as shown in FIG. 11C, neither LBBB or RBBB are present; para. [0154]: “By adjusting timing of delivering His-bundle or bundle-branch pacing, the present disclosure may re-synchronize His-bundle or bundle-branch pacing with activation from the atrium (pacing or intrinsic) in order to achieve synchronized ventricular activation via both left and right bundle branches and hence contraction, thereby improving pacing therapy. In the event of complete AV block, one bundle branch pacing can be synchronized with the pacing on the other ventricular chamber, for example, if pacing at the left bundle branch, it can be synchronized with the pacing in the right ventricle to avoid right bundle branch block or vice versa.”).
It would have been obvious to one of ordinary skill in the art that the device of Zhou would determine whether the first pacing pulse comprises left bundle branch pacing based on Zhou’s teaching that resynchronization between timing would correct LBB. The device of Zhou would be able to determine if LBB pacing is delivered based on the efficacy in correcting detected LBB blockage. One would recognize that LBB pacing would be determined based on either synchronicity or delay between ventricular activations, and if the LBB is corrected. Therefore, Zhou suggests determining whether a first pacing pulse comprises LBB pacing depending on the efficacy of treating a left bundle branch blockage.
However, neither reference discloses that a determined first and second conduction time is based on a first and second depolarization.
Ghosh, in the same field of endeavor of cardiac pacing, discloses a system for estimating cardiac timings. Ghosh discloses where a conduction time is based on depolarization (para. [0034]: “To optimize or adjust the AV delay, a cardiac therapy device such as an IMD may measure a patient's intrinsic AV conduction time. A patient's intrinsic AV conduction time is the time between an intrinsic atrial event (e.g., depolarization of the right atrium) and an intrinsic ventricular event (e.g., depolarization of the right ventricle).”).
It would have been obvious for one of ordinary skill in the art to before the effective filing date of the claimed invention that the conduction time of Mangual could be determined based on depolarization and that the processor of Zhou could be further modified to include determined conduction times based on depolarization. Ghosh discloses that conduction time can be calculated using depolarization, and one would recognize that the same technique and calculations could be implemented in the modified device of Zhou. One would reasonably expect the modified device of Zhou and Mangual to successfully be able to determine conduction times using depolarization using the technique of Ghosh.
Regarding claim 4, the combination of Zhou, Mangual, and Ghosh disclose the modified device of claim 1 (see above). Zhou further discloses wherein the processing circuitry (Fig. 5; processor 80) is further configured to: determine a respective first conduction time of a plurality of first conduction times for each atrioventricular delay of a plurality of atrioventricular delays (Fig. 12; steps 302, 304, 306, 308, and 310; After the AV delay is adjusted at 308 or 310, the pacing timing loops back around to 304 to measure conduction time (see para. [0174]); this reads on a conduction time determined for a plurality of AV delays); and select one of the atrioventricular delays based on the plurality of first conduction times. (Fig. 12; 318; optimal AV delay is selected based on adjustments in pacing time from 304 and 306). However, Zhou does not explicitly disclose the processor performing the recited steps in response to determining the pacing is LBB pacing.
Zhou does disclose where bundle pacing timing is adjusted (Fig. 12; step 304) based on a determined morphology of the QRS signal, and that the QRS morphology may be representative of a left bundle branch blockage pattern (para. [0180]: “In another example, whether bundle pacing timing should be adjusted may be based on dyssynchrony, or a measure of dyssynchrony. Non-limiting examples of detecting dyssynchrony include using: a comparison of a bundle-pacing to RV-sensing interval with a bundle-pacing to LV-sensing interval, a QRS morphology change, or both. Using a QRS morphology change may include comparing a current QRS morphology to a predetermined QRS morphology representative of an RBBB or LBBB pattern in the patient's heart.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine a conduction time for each AV delay in response to determining the pacing is LBB pacing. One would have recognized that adjusting an AV delay can be used to optimize pacing, and that the delay correlates to left bundle branch blockage. It would be reasonable for one to perform this technique in response to detecting LBB pacing to optimize pacing timing.
Regarding claim 5, the combination of Zhou, Mangual, and Ghosh disclose the modified device of claim 1 (see above). Zhou further discloses wherein the processing circuitry (Fig. 5; processor 80) is further configured to: responsive to determining the first pacing pulse does not comprise left bundle branch pacing (Fig. 14; decision block 506; para. [0198]: "At decision block 506, a determination may be made as to whether RV sensing is occurring earlier than LV sensing (e.g., earlier than or at the same time). For example, during His or bundle branch pacing that corrects LBBB, if RV sensing is 50 ms earlier than LV sensing, this may mean that LV activation by bundle pacing is occurring later, so it may be beneficial to initiate bundle branch pacing for LBBB correction at an appropriate (earlier) time in synchronization with RV sensing."; para. [0198] discloses that the method includes determining that LBB pacing correction is required, which can be considered as LBB pacing not being delivered optimally), determine whether the first conduction time is greater than or equal to a first conduction time threshold (para. [0198] discloses adjusting the conduction times to be the same for RV and LV sensing for correcting LBB, which can be considered to be a threshold that needs to be met (the conduction times need to be the same); and responsive to determining that the first conduction time is greater than or equal to the first conduction time threshold (para. [0198], when the LV sensing conduction time is greater than the RV conduction time), control delivery of cardiac resynchronization therapy via the first set of electrodes and the second set of electrodes (para. [0198]: "At decision block 506, a determination may be made as to whether RV sensing is occurring earlier than LV sensing (e.g., earlier than or at the same time). For example, during His or bundle branch pacing that corrects LBBB, if RV sensing is 50 ms earlier than LV sensing, this may mean that LV activation by bundle pacing is occurring later, so it may be beneficial to initiate bundle branch pacing for LBBB correction at an appropriate (earlier) time in synchronization with RV sensing. In another example, when an LV lead is available, if bundle-pacing to RV-sensing interval is 40 ms, and bundle-pacing to LV-sensing interval is 85 ms, then bundle branch pacing may be delivered and LV pacing with the LV lead may be adjusted to be delivered 40-50 ms earlier than bundle pacing, as a result, RV and LV activation may occur at almost the same time.").
Regarding claim 6, the combination of Zhou, Mangual, and Ghosh disclose the modified device of claim 5 (see above). Zhou further discloses wherein the cardiac resynchronization therapy comprises delaying a pacing pulse delivered via the second set of electrodes relative to a pacing pulse delivered via the first set of electrodes by a left-ventricular pacing pulse delay length. (para. [0180]: "In another example, whether bundle pacing timing should be adjusted may be based on dyssynchrony, or a measure of dyssynchrony. Non-limiting examples of detecting dyssynchrony include using: a comparison of a bundle-pacing to RV-sensing interval with a bundle-pacing to LV-sensing interval, a QRS morphology change, or both. Using a QRS morphology change may include comparing a current QRS morphology to a predetermined QRS morphology representative of an RBBB or LBBB pattern in the patient's heart. In some embodiments, in response to determining that bundle-pacing timing should be adjusted using dyssynchrony, the method may determine that bundle-pacing output should be adjusted."; para. [0198]: "For example, during His or bundle branch pacing that corrects LBBB, if RV sensing is 50 ms earlier than LV sensing, this may mean that LV activation by bundle pacing is occurring later, so it may be beneficial to initiate bundle branch pacing for LBBB correction at an appropriate (earlier) time in synchronization with RV sensing. In another example, when an LV lead is available, if bundle-pacing to RV-sensing interval is 40 ms, and bundle-pacing to LV-sensing interval is 85 ms, then bundle branch pacing may be delivered and LV pacing with the LV lead may be adjusted to be delivered 40-50 ms earlier than bundle pacing, as a result, RV and LV activation may occur at almost the same time.").
Regarding claim 7, the combination of Zhou, Mangual, and Ghosh disclose the modified device of claim 5 (see above). Zhou further discloses wherein the processing circuitry is configured to determine the left-ventricular pacing pulse delay length based on a difference in a reference conduction time from the left-ventricular septum to the coronary sinus and a first conduction time, and wherein z is the left-ventricular pacing pulse delay length. (Fig. 12; para. [0174]: " When the heart rate changes, atrioventricular conduction time may change, and bundle pacing time may be adjusted with a new appropriate AV delay. Another determination can be made as to whether QRS duration is less than a threshold, such as about 120 ms. By including two different conditions that check whether QRS duration is greater than or equal to the threshold and another condition of checking whether QRS duration is less than the same or different threshold, the logic of the flow diagram causes the AV delay to converge to an optimal AV delay by gradually adjusting the AV delay until a certain number of times are looped through the flow diagram."; the QRS duration is indicative of a conduction time; the threshold is considered to be a reference conduction time; para. [0010]: "The processor is also configured to, in response to determining whether the Vp should be delivered earlier or later, decrease an AV delay if the Vp should be delivered earlier or increase the AV delay in response to determining Vp should be delivered later. Further, the processor is configured to generate a set of AV delays that are stored in memory based on iterating through decreases or increases in the AV delay."; The iterative process of adjusting the AV delay based on previously store data is considered to be a reference conduction time). Although Zhou does not disclose the equation explicitly, Zhou discloses the relationship between reference and measured conduction times to determine an adjusted AV delay.
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 processor of Zhang to determine delay length based on a reference conduction time and a measured conduction time since Zhang discloses adjusting an AV delay iteratively based on comparisons of conduction time (QRS duration) to a threshold. It would have been obvious to one of ordinary skill that the AV delay could be optimized based on a reference conduction time and an actual conduction time. One of ordinary skill would have found that the equation is a matter of routine optimization of the delay length, and based on the teachings of Zhou, would have been inclined to optimize the delay length based on reference and measured conduction times. Further, one would also recognize also that the scaling factor (1.5) multiplied by the reference time could be found based on routine experimentation until an optimal scaling factor was determined for the most effective AV delay length.
Regarding claim 8, the combination of Zhou, Mangual, and Ghosh disclose the modified device of claim 5 (see above). Although Zhou does not explicitly disclose wherein the reference conduction time is about 85 milliseconds, Zhou does disclose an LV sensing interval of 85 milliseconds (para. [0198]: "In another example, when an LV lead is available, if bundle-pacing to RV-sensing interval is 40 ms, and bundle-pacing to LV-sensing interval is 85 ms, then bundle branch pacing may be delivered and LV pacing with the LV lead may be adjusted to be delivered 40-50 ms earlier than bundle pacing, as a result, RV and LV activation may occur at almost the same time.").
Magual discloses plots between patient populations of various conduction times between electrodes in the heart (Fig. 1B; plots 160, 162, 164, and 170; para. [0075]-[0077]; Mangual discloses in para. [0076] that a conduction time between 80 ms to 150 ms is preferred).
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 reference conduction time to be 85 milliseconds since Zhou discloses 85 milliseconds to be a reasonable LV sensing interval. Further, it would have been obvious to set the threshold conduction time to be 85 ms based on Mangual’s teachings since 85 milliseconds is within the disclosed preferred range of Mangual. One would recognize that routine experimentation could be performed with a patient population to find a healthy conduction time to use as the threshold conduction time as Mangual does with a patient population in Fig. 1B. One would be able to arrive at a conduction time of 85 ms as an optimal conduction time and implement this a reference.
Regarding claim 9, the combination of Zhou, Mangual, and Ghosh disclose the modified device of claim 5 (see above). Although Zhou does not explicitly disclose where a reference time threshold is 85 milliseconds, Zhou does disclose where an LV sensing interval is 85 milliseconds (para. [0198]: "In another example, when an LV lead is available, if bundle-pacing to RV-sensing interval is 40 ms, and bundle-pacing to LV-sensing interval is 85 ms, then bundle branch pacing may be delivered and LV pacing with the LV lead may be adjusted to be delivered 40-50 ms earlier than bundle pacing, as a result, RV and LV activation may occur at almost the same time.").
Magual discloses plots between patient populations of various conduction times between electrodes in the heart (Fig. 1B; plots 160, 162, 164, and 170; para. [0075]-[0077]; Mangual discloses in para. [0076] that a conduction time between 80 ms to 150 ms is preferred).
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 threshold interval to be 85 milliseconds since Zhou discloses 85 milliseconds to be a reasonable LV sensing interval. Further, it would have been obvious to set the threshold conduction time to be 85 ms based on Mangual’s teachings since 85 milliseconds is within the disclosed preferred range of Mangual. One would recognize that routine experimentation could be performed with a patient population to find a healthy conduction time to use as the threshold conduction time as Mangual does with a patient population in Fig. 1B. One would be able to arrive at a conduction time of 85 ms as an optimal conduction time, and implement this as the threshold.
Regarding claim 10, the combination of Zhou, Mangual, and Ghosh disclose the modified device of claim 5 (see above). Zhou further discloses wherein the processing circuitry is further configured to: responsive to determining that the first conduction time is less than the first conduction time threshold (Fig. 12; 304, 306, 308, and 310 show a determination that the pacing should be earlier or later), determine a respective first conduction time of a plurality of first conduction times for each atrioventricular delay of a plurality of atrioventricular delays (Fig. 12; steps 304, 306, 308, and 310 loop back around to 304 where a determinization is made as to whether the pacing timing should be adjusted based on each AV delay, which reads on a plurality of AV delays since this process is repeated); and select one of the atrioventricular delays based on the plurality of first conduction times (Fig. 12; 316; optimal AV delay is selected).
Regarding claim 12, Zhou teaches a method comprising: sensing, via a second set of electrodes (para. [0080]: "IMD 16 may sense electrical signals attendant to the depolarization and repolarization of heart 12 via electrodes (not shown in FIGS. 2A-B) coupled to at least one of leads 18, 20, 23." leads 18, 20, and 23 house electrodes) of a second lead (Fig. 3A; coronary sinus lead 20) of an implantable medical device (Fig. 3A; implantable medical device 16), a first depolarization resulting from a first pacing pulse (para. [0068]: "Leads 18, 20, 23 extend into heart 12 of patient 14 to sense electrical activity of heart 12 and/or deliver electrical stimulation to heart 12."; para. [0080]: "IMD 16 may sense electrical signals attendant to the depolarization and repolarization of heart 12 via electrodes (not shown in FIGS. 2A-B) coupled to at least one of leads 18, 20, 23. In some examples, IMD 16 provides pacing pulses to heart 12 based on the electrical signals sensed within heart 12. The configurations of electrodes used by IMD 16 for sensing and pacing may be unipolar or bipolar.") delivered by a first set of electrodes (para. [0076]: "the first (distal) electrode on the left side of the ventricular septum for left bundle branch pacing and with the second electrode (proximal) on the right side of the septum for pacing the right bundle branch") of a first lead (para. [0076]: "In particular, a lead configured to perform multi-site pacing, which is different than LV coronary sinus lead 20, can be placed in the ventricular septum with the first (distal) electrode on the left side of the ventricular septum for left bundle branch pacing and with the second electrode (proximal) on the right side of the septum for pacing the right bundle branch") of the implantable medical device (Fig. 3A; implantable medical device 16), wherein the second set of electrodes is positioned in the coronary sinus (para. [0068]: "Left ventricular (LV) coronary sinus lead 20 extends through one or more veins, the vena cava, right atrium 26, and into the coronary sinus 30 to a region adjacent to the free wall of left ventricle 32 of heart 12.") , wherein the first set of electrodes is implanted in an inter-ventricular septum of a heart (Abstract: "A left bundle branch (LBB) cathode electrode may be implanted a left side of the septum of the patient's heart proximate to the LBB"; Fig. 3A; para. [0015]: " The plurality of electrodes includes a left bundle branch (LBB) cathode electrode positionable, when implanted, on a left side of the septum of the patient's heart proximate to the LBB"; para. [0076]: "In particular, a lead configured to perform multi-site pacing, which is different than LV coronary sinus lead 20, can be placed in the ventricular septum with the first (distal) electrode on the left side of the ventricular septum for left bundle branch pacing and with the second electrode (proximal) on the right side of the septum for pacing the right bundle branch"), and wherein at least one electrode of the first set of electrodes in a left bundle branch area proximate a left-ventricular septum (Abstract: "A left bundle branch (LBB) cathode electrode may be implanted a left side of the septum of the patient's heart proximate to the LBB"; Fig. 3A; para. [0015]: " The plurality of electrodes includes a left bundle branch (LBB) cathode electrode positionable, when implanted, on a left side of the septum of the patient's heart proximate to the LBB"; para. [0076]: "In particular, a lead configured to perform multi-site pacing, which is different than LV coronary sinus lead 20, can be placed in the ventricular septum with the first (distal) electrode on the left side of the ventricular septum for left bundle branch pacing and with the second electrode (proximal) on the right side of the septum for pacing the right bundle branch"); and sensing, via the first set of electrodes (para. [0076]: "the first (distal) electrode on the left side of the ventricular septum for left bundle branch pacing and with the second electrode (proximal) on the right side of the septum for pacing the right bundle branch"), a second depolarization resulting from a second pacing pulse delivered by the second set of electrodes (para. [0068]: "Leads 18, 20, 23 extend into heart 12 of patient 14 to sense electrical activity of heart 12 and/or deliver electrical stimulation to heart 12."; para. [0080]: "IMD 16 may sense electrical signals attendant to the depolarization and repolarization of heart 12 via electrodes (not shown in FIGS. 2A-B) coupled to at least one of leads 18, 20, 23. In some examples, IMD 16 provides pacing pulses to heart 12 based on the electrical signals sensed within heart 12. The configurations of electrodes used by IMD 16 for sensing and pacing may be unipolar or bipolar."; para. [0187] also discloses biphasic stimulation, meaning one electrode is stimulating (positive) and the other is sensing (negative), and the pulse is propagating between the electrodes: "; For example, in RV lead recording, if the EGM morphology of the RV tip-ring (e.g., the tip towards LV) is biphasic from a positive direction to a negative direction, meaning the propagation is from LV to RV, then the left bundle pacing may be delayed until a positive monophasic waveform followed with a relatively long small negative waveform is recorded." Additionally, para. [0187] discloses that the same can be done in the opposite direction: "A similar method can be used to detect the activation propagation in the left ventricle."; A similar method can be used to detect the activation propagation in the left ventricle; Additionally, para. [0172] discloses that a QRS interval and duration may be determined: “Sensed heart activity may be used to determine, or may include, one or more of: an intraventricular interval, a QRS duration, a QRS morphology, a QRS vector, an R-wave timing, a bundle-pacing to left- or right-ventricular-activation interval, and an atrial-sensing to left- or right-ventricular-activation interval.” This is representative of a cardiac depolarization). However, Zhou does not explicitly teach determining, by processing circuitry of the implantable medical device, a first conduction time of the first pacing pulse from the left-ventricular septum to the coronary sinus based on the sensing of the first depolarization; determining, by the processing circuitry, a second conduction time of the second pacing pulse from the coronary sinus to the left-ventricular septum based on the sensing of the second depolarization; and determining, by the processing circuitry, based on the first conduction time and the second conduction time, whether the first pacing pulse comprises left bundle branch pacing.
Mangual, in the same field of endeavor of cardiac pacing, discloses systems and methods for measuring conduction delays between multiple locations in the heart. Mangual discloses determining, by processing circuitry (microcontroller 220) of the implantable medical device (implantable medical device 100) a first conduction time of the first pacing pulse from the left-ventricular septum to the coronary sinus (para. (7): "The measuring the intrinsic VV intervals may further comprise delivering a paced event at each of the LV electrodes and measuring an associated conduction time to an RV electrode."; para. (39): "For example, the microcontroller 220 may measure the conduction time for an event propagation between the RA electrode 123 and each of the LV electrodes 132-138. The microcontroller 220 may initiate a paced event at the RA electrode 123, or may sense an intrinsic event at the RA electrode 123. The microcontroller 220 measures conduction time (e.g., the conduction time) for a conduction wave to propagate between the pacing/sensed event at the RA electrode 123 to a sensed event at each of the LV electrodes 132-138. The microcontroller 220 may compare the amount of time received at the LV electrodes 132-138. The microcontroller 220 identifies the conduction time received by the LV electrodes 132-138 relative to each other, to identify the lowest conduction time (lowest intrinsic A/LV interval 302-305) relative to the LV electrodes 132-138."); determining, by the processing circuitry (microcontroller 220), a second conduction time of the second pacing pulse from the coronary sinus to the left-ventricular septum (Fig. 3-5 demonstrate that multiple conduction times are determined for each electrode location: “RA-LV conduction time”; “RA-RV conduction time”; “LV-RV conduction time”).
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 Zhou to include the technique of determining conduction times between electrodes, as disclosed by Mangual. One of ordinary skill would recognize that conduction time can be used for determining delays between electrical conduction in different areas of the heart. One of ordinary skill would further recognize that conduction time can be used to optimize which therapy delay is most effective for cardiovascular resynchronization therapy. Lastly, one would expect with a reasonable expectation of success that that the conduction time technique of Magual could be implemented in the processor of Zhou to determine the conduction time between the electrodes Zhou, which are placed on the coronary sinus and left ventricular septum, to measure the conduction between the electrodes placed in those anatomical regions of the heart.
Although neither reference explicitly discloses where the processor is configured for determining based on the first conduction time and the second conduction time, whether the first pacing pulse comprises left bundle branch pacing, Zhou discloses that the difference in conduction time between left and right ventricles may be indicative “dyssynchrony” and a need for left bundle block correction (para. [0191]: "In patients with pacing leads in RV and LV, the time difference between an RV sensed signal and an LV sensed signal may be used to represent the dyssynchrony between RV and LV. If the time difference increases, then dyssynchrony may be present, and pacing time in RV or LV may be adjusted or pacing time in LBB or RBB may be adjusted."; para. [0198]: "In another example, when an LV lead is available, if bundle-pacing to RV-sensing interval is 40 ms, and bundle-pacing to LV-sensing interval is 85 ms, then bundle branch pacing may be delivered and LV pacing with the LV lead may be adjusted to be delivered 40-50 ms earlier than bundle pacing, as a result, RV and LV activation may occur at almost the same time."), and that pacing at the left bundle branch would synchronize with the chambers to avoid bundle block (para. [0153]: “FIG. 11A graphically depicts the intrinsic rhythm when LBBB is present and pacing has not yet begun to be delivered to the left bundle branch (LBB). Low-output pacing at left bundle branch (or fibers destined for left bundle branch) may correct left bundle branch block with a trait of right bundle branch block. By adjusting atrial to His-bundle or bundle-branch pacing delay, right bundle branch block can be corrected. The atrial to His-bundle or bundle-branch pacing delay may be defined as the time when an electrical impulse, which may represent depolarization or contraction, is sensed or detected from the atrium and the time in which the pacing pulse is generated from the pulse generator. As shown in FIG. 11B in which an AV delay of 40 ms was employed, LBBB is not present, but RBBB remains. Increasing the pacing AV delay interval from 40 ms to 100 ms, as shown in FIG. 11C, neither LBBB or RBBB are present; para. [0154]: “By adjusting timing of delivering His-bundle or bundle-branch pacing, the present disclosure may re-synchronize His-bundle or bundle-branch pacing with activation from the atrium (pacing or intrinsic) in order to achieve synchronized ventricular activation via both left and right bundle branches and hence contraction, thereby improving pacing therapy. In the event of complete AV block, one bundle branch pacing can be synchronized with the pacing on the other ventricular chamber, for example, if pacing at the left bundle branch, it can be synchronized with the pacing in the right ventricle to avoid right bundle branch block or vice versa.”).
It would have been obvious to one of ordinary skill in the art that the device of Zhou would determine whether the first pacing pulse comprises left bundle branch pacing based on Zhou’s teaching that resynchronization between timing would correct LBB. The device of Zhou would be able to determine if LBB pacing is delivered based on the efficacy in correcting detected LBB blockage. One would recognize that LBB pacing would be determined based on either synchronicity or delay between ventricular activations, and if the LBB is corrected. Therefore, Zhou suggests determining whether a first pacing pulse comprises LBB pacing depending on the efficacy of treating a left bundle branch blockage.
However, neither reference discloses that a determined first and second conduction time is based on a first and second depolarization.
Ghosh, in the same field of endeavor of cardiac pacing, discloses a system for estimating cardiac timings. Ghosh discloses where a conduction time is based on sensing of a depolarization (para. [0034]: “To optimize or adjust the AV delay, a cardiac therapy device such as an IMD may measure a patient's intrinsic AV conduction time. A patient's intrinsic AV conduction time is the time between an intrinsic atrial event (e.g., depolarization of the right atrium) and an intrinsic ventricular event (e.g., depolarization of the right ventricle).”).
It would have been obvious for one of ordinary skill in the art to before the effective filing date of the claimed invention that the conduction time of Mangual could be determined based on depolarization and that the processor of Zhou could be further modified to include determined conduction times based on depolarization. Ghosh discloses that conduction time can be calculated using depolarization, and one would recognize that the same technique and calculations could be implemented in the modified device of Zhou. One would reasonably expect the modified device of Zhou and Mangual to successfully be able to determine conduction times using depolarization using the technique of Ghosh.
Regarding claim 15, the combination of Zhou, Mangual, and Ghosh disclose the modified method of claim 12 (see above). Zhou further discloses wherein the method further comprises: determining, by the processing circuitry (microcontroller 220), a respective first conduction time of a plurality of first conduction times for each atrioventricular delay of a plurality of atrioventricular delays (Fig. 12; steps 302, 304, 306, 308, and 310; After the AV delay is adjusted at 308 or 310, the pacing timing loops back around to 304 to measure conduction time (see para. [0174]); this reads on a conduction time determined for a plurality of AV delays); and selecting, by the processing circuitry (microcontroller 220), one of the atrioventricular delays based on the plurality of first conduction times. (Fig. 12; 318; optimal AV delay is selected based on adjustments in pacing time from 304 and 306). However, Zhou does not explicitly disclose performing the recited steps in response to determining the pacing pulse is LBB pacing.
Zhou does disclose where bundle pacing timing is adjusted (Fig. 12; step 304) based on a determined morphology of the QRS signal, and that the QRS morphology may be representative of a left bundle branch blockage pattern (para. [0180]: “In another example, whether bundle pacing timing should be adjusted may be based on dyssynchrony, or a measure of dyssynchrony. Non-limiting examples of detecting dyssynchrony include using: a comparison of a bundle-pacing to RV-sensing interval with a bundle-pacing to LV-sensing interval, a QRS morphology change, or both. Using a QRS morphology change may include comparing a current QRS morphology to a predetermined QRS morphology representative of an RBBB or LBBB pattern in the patient's heart.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine a conduction time for each AV delay in response to determining the pacing is LBB pacing. One would have recognized that adjusting an AV delay can be used to optimize pacing, and that the delay correlates to left bundle branch blockage. It would be reasonable for one to perform this technique in response to detecting LBB pacing to optimize pacing timing.
Regarding claim 16, the combination of Zhou, Mangual, and Ghosh disclose the modified method of claim 12 (see above). Zhou further discloses where the method further comprises: responsive to determining the first pacing pulse does not comprise left bundle branch pacing (Fig. 14; decision block 506; para. [0198]: "At decision block 506, a determination may be made as to whether RV sensing is occurring earlier than LV sensing (e.g., earlier than or at the same time). For example, during His or bundle branch pacing that corrects LBBB, if RV sensing is 50 ms earlier than LV sensing, this may mean that LV activation by bundle pacing is occurring later, so it may be beneficial to initiate bundle branch pacing for LBBB correction at an appropriate (earlier) time in synchronization with RV sensing."; para. [0198] discloses that the method includes determining that LBB pacing correction is required, which can be considered as LBB pacing not being delivered optimally), determining, by the processing circuitry (microcontroller 220), whether the first conduction time is greater than or equal to a first conduction time threshold (para. [0198] discloses adjusting the conduction times to be the same for RV and LV sensing for correcting LBB, which can be considered to be a threshold that needs to be met (the conduction times need to be the same); and responsive to determining that the first conduction time is greater than or equal to the first conduction time threshold (para. [0198], when the LV sensing conduction time is greater than the RV conduction time), controlling, by the processing circuitry (microcontroller 220), delivery of cardiac resynchronization therapy via the first set of electrodes and the second set of electrodes (para. [0198]: "At decision block 506, a determination may be made as to whether RV sensing is occurring earlier than LV sensing (e.g., earlier than or at the same time). For example, during His or bundle branch pacing that corrects LBBB, if RV sensing is 50 ms earlier than LV sensing, this may mean that LV activation by bundle pacing is occurring later, so it may be beneficial to initiate bundle branch pacing for LBBB correction at an appropriate (earlier) time in synchronization with RV sensing. In another example, when an LV lead is available, if bundle-pacing to RV-sensing interval is 40 ms, and bundle-pacing to LV-sensing interval is 85 ms, then bundle branch pacing may be delivered and LV pacing with the LV lead may be adjusted to be delivered 40-50 ms earlier than bundle pacing, as a result, RV and LV activation may occur at almost the same time.").
Claim 17 is a duplicate of claim 16 and is rejected for the same reason.
Regarding claim 18, the combination of Zhou, Mangual, and Ghosh disclose the modified method of claim 17 (see above). Zhou further discloses wherein the cardiac resynchronization therapy comprises delaying a pacing pulse delivered via the second set of electrodes relative to a pacing pulse delivered via the first set of electrodes by a left-ventricular pacing pulse delay length. (para. [0180]: "In another example, whether bundle pacing timing should be adjusted may be based on dyssynchrony, or a measure of dyssynchrony. Non-limiting examples of detecting dyssynchrony include using: a comparison of a bundle-pacing to RV-sensing interval with a bundle-pacing to LV-sensing interval, a QRS morphology change, or both. Using a QRS morphology change may include comparing a current QRS morphology to a predetermined QRS morphology representative of an RBBB or LBBB pattern in the patient's heart. In some embodiments, in response to determining that bundle-pacing timing should be adjusted using dyssynchrony, the method may determine that bundle-pacing output should be adjusted."; para. [0198]: "For example, during His or bundle branch pacing that corrects LBBB, if RV sensing is 50 ms earlier than LV sensing, this may mean that LV activation by bundle pacing is occurring later, so it may be beneficial to initiate bundle branch pacing for LBBB correction at an appropriate (earlier) time in synchronization with RV sensing. In another example, when an LV lead is available, if bundle-pacing to RV-sensing interval is 40 ms, and bundle-pacing to LV-sensing interval is 85 ms, then bundle branch pacing may be delivered and LV pacing with the LV lead may be adjusted to be delivered 40-50 ms earlier than bundle pacing, as a result, RV and LV activation may occur at almost the same time.").
Regarding claim 19, the combination of Zhou, Mangual, and Ghosh disclose the modified method of claim 18 (see above). Zhou further discloses determining, by the processing circuitry (microcontroller 220), the left-ventricular pacing pulse delay length based on a difference in a reference conduction time from the left-ventricular septum to the coronary sinus and a first conduction time, and wherein z is the left-ventricular pacing pulse delay length. (Fig. 12; para. [0174]: " When the heart rate changes, atrioventricular conduction time may change, and bundle pacing time may be adjusted with a new appropriate AV delay. Another determination can be made as to whether QRS duration is less than a threshold, such as about 120 ms. By including two different conditions that check whether QRS duration is greater than or equal to the threshold and another condition of checking whether QRS duration is less than the same or different threshold, the logic of the flow diagram causes the AV delay to converge to an optimal AV delay by gradually adjusting the AV delay until a certain number of times are looped through the flow diagram."; the QRS duration is indicative of a conduction time; the threshold is considered to be a reference conduction time; para. [0010]: "The processor is also configured to, in response to determining whether the Vp should be delivered earlier or later, decrease an AV delay if the Vp should be delivered earlier or increase the AV delay in response to determining Vp should be delivered later. Further, the processor is configured to generate a set of AV delays that are stored in memory based on iterating through decreases or increases in the AV delay."; The iterative process of adjusting the AV delay based on previously store data is considered to be a reference conduction time). Although Zhou does not disclose the equation explicitly, Zhou discloses the relationship between reference and measured conduction times to determine an adjusted AV delay.
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 processor of Zhang to determine delay length based on a reference conduction time and a measured conduction time since Zhang discloses adjusting an AV delay iteratively based on comparisons of conduction time (QRS duration) to a threshold. It would have been obvious to one of ordinary skill that the AV delay could be optimized based on a reference conduction time and an actual conduction time. One of ordinary skill would have found that the equation is a matter of routine optimization of the delay length, and based on the teachings of Zhou, would have been inclined to optimize the delay length based on reference and measured conduction times. Further, one would also recognize also that the scaling factor (1.5) multiplied by the reference time could be found based on routine experimentation until an optimal scaling factor was determined for the most effective AV delay length.
Regarding claim 20, the combination of Zhou, Mangual, and Ghosh disclose the modified method of claim 17 (see above). Zhou further discloses wherein the method further comprises: responsive to determining that the first conduction time is less than the first conduction time threshold (Fig. 12; 304, 306, 308, and 310 show a determination that the pacing should be earlier or later), determining, by the processing circuitry (microcontroller 220), a respective first conduction time of a plurality of first conduction times for each atrioventricular delay of a plurality of atrioventricular delays (Fig. 12; steps 304, 306, 308, and 310 loop back around to 304 where a determinization is made as to whether the pacing timing should be adjusted based on each AV delay, which reads on a plurality of AV delays since this process is repeated); and selecting, by the processing circuitry (microcontroller 220), one of the atrioventricular delays based on the plurality of first conduction times (Fig. 12; 316; optimal AV delay is selected).
Claims 2, 3, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou (US 20190111264 A1), Mangual-Soto et al. (US 11235158 B2, "Mangual"), Ghosh (US 20180326215 A1), and Mangual-Soto et al. (US 20220288399 A1, "Mangual B").
Regarding claim 2, the combination of Zhou, Mangual, and Ghosh discloses the implantable medical device of claim 1 (see above). However, the references do not explicitly disclose wherein the processing circuitry is configured to determine whether the first pacing pulse comprises left bundle branch pacing by determining whether a difference of the second conduction time minus the first conduction time is greater than or equal to a conduction time differential threshold.
Mangual B, in the same field of endeavor of cardiac pacing, discloses a system and methods for determining conduction times in the heart. Mangual B discloses determining whether a difference of the second conduction time minus the first conduction time is greater than or equal to a conduction time differential threshold. (Fig. 3A; 308; para. [0072] discloses LBB pacing conduction time differences in both electrode directions to predict which stimulation mode is most effective for achieving desired pacing, including LBB pacing in an LBB electrode in para. [0123]); Further, para. [0008] discloses a threshold comparison of the difference between conduction times: "Optionally, the at least one processor may be further configured to: when calculating the relation, compare the threshold to at least one of i) the RV-LV conduction time, ii) the LV-RV conduction time, or iii) a difference between the RV-LV and LV-RV conduction times; and when setting the pacing mode, to perform at least one of: i) set the pacing mode to the BiV pacing mode when the difference exceeds the threshold and to set the pacing mode to the LV only pacing mode when the difference equals or is below the threshold; ii) set the pacing mode to the BiV pacing mode when the RV-LV conduction time is below the threshold and to set the pacing mode to the LV only pacing mode when the difference equals or exceeds the threshold; or iii) set the pacing mode to the BiV pacing mode when the LV-RV conduction time is below the threshold and to set the pacing mode to the LV only pacing mode when the difference equals or exceeds the threshold.").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Zhou to include Mangual B’s technique of comparing a difference in conduction times to a threshold. One of ordinary skill in the art would recognize that the technique of Mangual B would be useful for optimizing therapy for treating left bundle branch block. One would also have a reasonable expectation of success that the technique of Mangual B could be implemented into the modified device of Zhou to determine LBB pacing based on the technique of comparing a difference in electrode conduction times to a threshold since Mangual B demonstrates optimizing LBB pacing using the technique of comparing differences to a threshold.
Regarding claim 3, the combination of Zhou, Mangual, Ghosh, and Mangual B disclose the modified device of claim 2 (see above). Mangual B further discloses wherein the conduction time differential threshold is 20 milliseconds (para. [0078]: "The plots 172, 174 further indicate that patients who have VV CT difference greater than 0 ms, more preferably greater than 20 ms, and even more preferably between 10 ms and 100 ms, are more likely to experience a greater reduction in QRS complex duration when treated with biventricular therapy, as compared to LV only pacing.").
It would have been further obvious to implement the disclosed difference threshold since Mangual B discloses that a 20 ms difference is preferable and leads to a greater reduction in QRS complex duration (conduction time). It would have been obvious to use the disclosed threshold to improve conduction during cardiac pacing.
Regarding claim 13, the combination of Zhou, Mangual, and Ghosh discloses the implantable method of claim 12 (see above). However, the references do not explicitly disclose wherein the processing circuitry is configured to determine whether the first pacing pulse comprises left bundle branch pacing by determining whether a difference of the second conduction time minus the first conduction time is greater than or equal to a conduction time differential threshold.
Mangual B, in the same field of endeavor of cardiac pacing, discloses a system and methods for determining conduction times in the heart. Mangual B discloses determining, by the processing circuitry (para. [0101]: “The method 300 may be under control of one or more processors configured with specific executable instructions.”), whether a difference of the second conduction time minus the first conduction time is greater than or equal to a conduction time differential threshold. (Fig. 3A; 308; para. [0072] discloses LBB pacing conduction time differences in both electrode directions to predict which stimulation mode is most effective for achieving desired pacing, including LBB pacing in an LBB electrode in para. [0123]); Further, para. [0008] discloses a threshold comparison of the difference between conduction times: "Optionally, the at least one processor may be further configured to: when calculating the relation, compare the threshold to at least one of i) the RV-LV conduction time, ii) the LV-RV conduction time, or iii) a difference between the RV-LV and LV-RV conduction times; and when setting the pacing mode, to perform at least one of: i) set the pacing mode to the BiV pacing mode when the difference exceeds the threshold and to set the pacing mode to the LV only pacing mode when the difference equals or is below the threshold; ii) set the pacing mode to the BiV pacing mode when the RV-LV conduction time is below the threshold and to set the pacing mode to the LV only pacing mode when the difference equals or exceeds the threshold; or iii) set the pacing mode to the BiV pacing mode when the LV-RV conduction time is below the threshold and to set the pacing mode to the LV only pacing mode when the difference equals or exceeds the threshold.").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Zhou to include Mangual B’s technique of comparing a difference in conduction times to a threshold. One of ordinary skill in the art would recognize that the technique of Mangual B would be useful for optimizing therapy for treating left bundle branch block. One would also have a reasonable expectation of success that the technique of Mangual B could be implemented into the modified device of Zhou to determine LBB pacing based on the technique of comparing a difference in electrode conduction times to a threshold since Mangual B demonstrates optimizing LBB pacing using the technique of comparing differences to a threshold.
Regarding claim 14, the combination of Zhou, Mangual, Ghosh, and Mangual B disclose the method of claim 13 (see above). Mangual B further discloses wherein the conduction time differential threshold is 20 milliseconds (para. [0078]: "The plots 172, 174 further indicate that patients who have VV CT difference greater than 0 ms, more preferably greater than 20 ms, and even more preferably between 10 ms and 100 ms, are more likely to experience a greater reduction in QRS complex duration when treated with biventricular therapy, as compared to LV only pacing.").
It would have been further obvious to implement the disclosed difference threshold since Mangual B discloses that a 20 ms difference is preferable and leads to a greater reduction in QRS complex duration (conduction time). It would have been obvious to use the disclosed threshold to improve conduction during cardiac pacing.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Zhou (US 20190111264 A1), Mangual-Soto et al. (US 11235158 B2, "Mangual"), Ghosh (US 20180326215 A1), and Zhou et al. (US 20220023640 A1, “Zhou B”).
Regarding claim 11, the combination of Zhou, Mangual, and Ghosh disclose the implantable medical device of claim 1 (see above). Zhou further discloses a medical system (abstract: “cardiac pacing system”); a plurality of leads comprising the first lead (para. [0076]: "In particular, a lead configured to perform multi-site pacing, which is different than LV coronary sinus lead 20, can be placed in the ventricular septum with the first (distal) electrode on the left side of the ventricular septum for left bundle branch pacing and with the second electrode (proximal) on the right side of the septum for pacing the right bundle branch") and the second lead (Fig. 3A; coronary sinus lead 20), the implantable medical device coupled to the plurality of leads (Fig. 3A; para. [0091]: “FIG. 3A is a conceptual diagram illustrating IMD 16 and leads 18, 20, 23 of therapy system 10 in greater detail.”); and an external device (Fig. 7; external device 192) configured to: communicatively couple to the implantable medical device (Fig. 7; 192 coupled wirelessly to network 192, which is coupled to IMD 16 via access point 198; para. [0141]); and output an indication (para. [0146]: "In some cases, external device 192 may automatically send the report via input/output device 202 to one or more of computing devices 194A-194N as an alert, such as an audio or visual alert. In some cases, external device 192 may send the report to another device, such as programmer 24, either automatically or upon request. In some cases, external device 192 may display the report to a user via input/output device 202."); and output an indication (para. [0146]: "In some cases, external device 192 may automatically send the report via input/output device 202 to one or more of computing devices 194A-194N as an alert, such as an audio or visual alert. In some cases, external device 192 may send the report to another device, such as programmer 24, either automatically or upon request. In some cases, external device 192 may display the report to a user via input/output device 202."). However, Zhou does not explicitly disclose where the indication is of whether the first pacing pulse comprises left bundle branch pacing.
Zhou B, in the same field of endeavor of cardiac pacing, discloses a processor for sensing left bundle branch pacing. Zhou B discloses where an output indication is whether a first pacing pulse comprises left bundle branch pacing (para. [0146]: “In response to data received from processor 52, display unit 54 may generate a visual representation of RBB and/or LBB capture determinations and in some cases corresponding RBB capture threshold and/or LBB capture threshold according to one or more pacing electrode configurations and pacing pulse outputs. The visual representation may further include representations of cardiac electrical signals received during bundle branch pacing to enable a user to observe changes in the cardiac electrical signals that occur during bundle branch pacing, which may be indicative of worsening or improving ventricular electrical synchrony.”).
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 Zhou to include an output indication of whether a first pacing pulse comprises left bundle branch pacing, as disclosed by Zhou B. One of ordinary skill would recognize that a visual indication would be useful in alerting a clinician that stimulation parameters may need to be changed. One would recognize that the processor of Zhou could be modified to output this LBB capture information to improve the stimulation configuration as Zhou B does. It would be an obvious improvement to modify Zhou to include the LBB capture determination outputs as Zhou B does.
Conclusion
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/O.L.M./Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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