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 .
Priority
This application is a continuation of US Application no. 17/586,845, now US Patent no. 12,128,240 filed 28 January 2022, which claims the benefit of domestic priority from US Provisional Application no. 63/159,494 filed 11 March 2021.
Claim Objections
Claim 1 is objected to because of the following informalities: line 15 recites “a responsive RV sensed events” which is intended to instead recite “a responsive RV sensed event”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: line 10 recites “a responsive RV sensed events” which is intended to instead recite “a responsive RV sensed event”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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.
Claims 1-9 and 11-19 are 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.
In regard to claim 1, the recitation of “or” at the end of line 15 makes the claim indefinite since it is ambiguous if the step to “calculate a relation between…” is intended to comprise a third alternative to the steps set forth for “determining at least one of” step set forth in line 9. However, the step to calculate the relation requires either of the conduction times found in steps i or ii. It is unclear whether the determining the conduction time is required before calculating the relation, or whether the calculating the relation is an alternative operation. Clarification is respectfully requested.
In regard to claim 5, line 8 recites an “LV-RV conduction time” wherein claim 1 defines an “LBB-RV conduction time” not an “LV-RV conduction time”. It is unclear if the claim intends to use the LV-RV conduction time as determined from the RV/LV intervals or LBB-RV conduction time as consistent with claim 1. Moreover, there is no step set forth that positively recites the determination of a LV-RV conduction time. Clarification is respectfully requested.
In regard to claim 6, line 8 recites an “LV-RV conduction intrinsic conduction times” which is inconsistent with its antecedent in claim 5 requiring “LV-RV conduction time”. Additionally, the same issues arise as in claim 5 as it is unclear if the claim intends to use the LV-RV conduction time as determined from the RV/LV intervals or LBB-RV conduction time as consistent with claim 1. Moreover, there is no step set forth that positively recites the determination of a LV-RV conduction time. Clarification is respectfully requested.
In regard to claim 11, the preamble recites a “computer implemented arrhythmia detection method”. There is no step that positively sets for the determination of an arrhythmia. Clarification is respectfully requested.
Further in regard to claim 11, the recitation of “or” at the end of line 10 makes the claim indefinite since it is ambiguous if the step to “calculate a relation between…” is intended to comprise a third alternative to the steps set forth for “determining at least one of” step set forth in line 4. However, the step to calculate the relation requires either of the conduction times found in steps i or ii. It is unclear whether the determining the conduction time is required before calculating the relation, or whether the calculating the relation is an alternative operation. Clarification is respectfully requested.
In regard to claim 14, lines 3-4 recite the limitation "utilizing multiple LV electrodes", and lines 5-6 recite “at the RV electrode”. There is insufficient antecedent basis for either of these limitations in the claim or in base claim 11. Appropriate correction is required.
In regard to claims 15 and 16, the antecedent basis issue with respect to claim 14 applies to these claims.
In regard to claim 18, line 3 recites the limitation "i) the LBB electrode, ii) the RV electrode, or iii) one of the one or more LV electrodes”. There is insufficient antecedent basis for any electrodes in base claim 11. Appropriate correction is required.
In regard to claim 19, line 4 recites the limitation "i) the LBB electrode, ii) the RV electrode, or iii) one of the one or more LV electrodes”. There is insufficient antecedent basis for any electrodes in base claim 11. Appropriate correction is required.
In regard to claim 20, the antecedent basis issue with respect to claim 19 applies to this claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-8 and 11-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou (US Publication no. 2019/0111270) in view of Min et al. (US Publication no. 2020/0078591 – disclosed by Applicant).
In regard to claim 1, Zhou discloses a system comprising: a left bundle branch (LBB) electrode (para 68, 69, and 112, leads 23 provides stimulation pulses to the His bundle or bundle branch);
at least one of i) a right ventricular (RV) electrode or ii) one or more left ventricular (LV) electrodes (para 68, 102-103, RV lead 18, LV lead 20);
at least one processor 80 (fig. 5 para 110-111); and
a memory 82 coupled to the at least one processor 80, wherein the memory stores program instructions, wherein the program instructions are executable by the at least one processor to (para 110):
determine at least one of (method of figure 14 which begins with step 502 delivering pacing to the His bundle or one or both branches) :
i) a left bundle branch to left ventricular (LBB-LV) conduction time representative of a conduction time between a LBB paced or sensed event and one or more responsive LV sensed events (para 198, steps 506 and 510 determine conduction time from bundle pacing to RV or LV sensing); or
ii) a left bundle branch to right ventricular (LBB-RV) conduction time representative of a conduction time between a LBB paced or sensed event and a responsive RV sensed events (para 198, steps 506 and 510 determine conduction time from bundle pacing to RV or LV sensing).
Zhou teaches determining the claimed LBB-RV conduction time and the LBB-LV conduction time which establishes a right side conduction time and a left side conduction in order to determine whether ventricular pacing should be adjusted to improve ventricular synchronization. However, does not teach calculating the relation between a threshold and the determined LBB-RV or LBB-LV conduction time.
Min et al. discloses a method for selecting between biventricular and left-ventricular only pacing. Min et al. calculates conduction time intervals between atrial pacing and ventricular sensing. A first conduction time (i.e., first AV delay, AVD1) is between the right atrium and LV, the second conduction time (i.e., second AV delay, AVD2) (para 59-61). Min et al. calculate a relation between a threshold and the at least one of the AVD1 (a left conduction time) conduction time or AVD2 (a right conduction time) conduction time (para 61, a relation is determined between AVD1 and AVD2 with respect to the criteria specifying that the times be within a certain percentage of one another, the criteria considered to comprise a threshold. Here it is considered that Min et al. teach that cardiac timing measurements may be mathematically related and that the calculated relationship may be compared with a predetermined criterion or threshold); and
set a pacing mode of an implantable medical device (IMD) to one of i) a biventricular (BiV) pacing mode and ii) an LV only pacing mode based on the relation (para 62, if the AVD1 and AVD2 are outside the criteria, the processor determines that conduction may be slower on a left side of the heart compared to the right in which case a left ventricular pacing scheme is preferred; should the opposite be true, that the conduction time on the right side is slower, biventricular pacing is the preferred scheme (para 62-64)). Thus, Min et al. teach setting an implantable medical device to either a BiV pacing more or an LV only pacing mode based on a relation of right side conduction time and left side conduction time to a set criteria or threshold.
Therefore, it is considered to have been obvious to one of ordinary skill in the art to employ the technique for calculating a relation between conduction time to select the pacing mode as described in Min et al. to the conduction time determination technique of Zhou in order to prevent unnecessary pacing when it is determined the right-side conduction is normal, thereby conserving power consumption of the implantable device.
In regard to claim 2, Zhou as modified in view of Min et al. is considered to teach the processor 80 is further configured to: determine both of the LBB-LV conduction time and the LBB-RV conduction time (Zhou, para 198); and calculate the relation based on the threshold, the LBB-LV conduction time and the LBB-RV conduction time (Min et al., para 61-64). It would have been obvious to one of ordinary skill in the art modify Zhou to calculate a relation as in Min et al. in order to provide objective criterion to guide the pacing mode selection.
In regard to claim 3, Zhou as modified in view of Min et al. is considered to teach the processor 80 is configured for when calculating the relation, compare the threshold to at least one of i) the LBB- LV conduction time, ii) the LBB-RV conduction time, or iii) a difference between the LBB- LV and LBB-RV conduction times; and when setting the pacing mode, to 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 (Zhou teaches comparing the relative bundle-RV and bundle-LV conduction times to determine whether ventricular pacing should be adjusted to improve ventricular synchronization (para 198-200). Min et al. teaches using a predetermined criteria or threshold applied to cardiac conduction timing to distinguish between a conduction warranting BiV pacing or LV only pacing. It would have been obvious to apply the technique of Min et al. to Zhou’s bundle -RV, -LV conduction times including the difference between, to provide an objective criterion for selecting the proper pacing mode.
In regard to claim 4, Zhou as modified in view of Min et al. is considered to teach the processor 80 is further configured to determine both of the LBB-LV conduction time and the LBB-RV conduction time (para 198-200) and calculate, as the relation, a mathematical relation between the LBB - LV conduction time and the LBB - RV conduction time (para 198, Zhou determines relative timing between the two conduction times), the pacing mode set based on the mathematical relation (para 198, if the relative timing of the left side sensing is longer than right side pacing, the left side pacing is adjusted).
In regard to claim 5, Zhou as modified in view of Min et al. teaches comprising an LV lead (Min, lead 114) having multiple LV electrodes configured to detect LV sensed events and to deliver LV paced events (Min, para 25, electrodes 132, 134, 136, 138), wherein the at least one processor is further configured to: measure intrinsic RV/LV intervals between an RV intrinsic event, measured at the RV electrode, and LV intrinsic events, measured at the corresponding LV electrodes; and based on the measured intrinsic RV/LV intervals, select one of the LV electrodes as an LV pace/sense site to use to determine at least one of the LBB-LV conduction time or an LV - RV conduction time (Min, para 58 and 65; conduction time between RV electrode 126 and each of LV electrodes 132-138, wherein the LV pacing site is selected based on longest VV interval). It would have been obvious to one of ordinary skill in the art to modify Zhou to have multiple LV electrodes and employ the technique of Min et al. for determining the LV-RV conduction time to select the most optimal position in the ventricle to apply LV only pacing.
In regard to claim 6, Min et al. further teach that the LV pace/sense site selected represents at least one of: i) the one of the LV electrodes having a longest one of the RV - LV intrinsic conduction times; or ii) the LV pace/sense site represents a site of latest LV activation within the multiple LV electrodes (para 58 and 65).
In regard to claim 7, Min et al. teach that at least one processor (microcontroller 220) is further configured to identify a site of latest LV activation to be utilized to determine the LBB - LV conduction time (Min, para 58 and 65). It is considered to have been obvious to utilize the technique of Min et al. that finds the LV site that exhibited the latest conduction time or longest VV interval to select an LV electrode to determine Zhou’s LBB-LV conduction time in order to optimize the sensing vector.
In regard to claim 8, Zhou teaches that IMD comprises a leadless IMD that is configured to be implanted proximate to one of the LBB, RV or LV and includes a corresponding one of i) the LBB electrode, ii) the RV electrode or iii) one of the one or more LV electrodes (para 161-166, 189, 207-223, and 229-233, LPD 616).
In regard to claim 11, Zhou discloses a computer implemented arrhythmia detection method, comprising: under control of one or more processors 80 configured with specific executable instructions (fig. 5, para 110-111, memory 82 stores computer implemented instructions), determining at least one of:
i) a left bundle branch to left ventricular (LBB-LV) conduction time representative of a conduction time between a LBB paced or sensed event and one or more responsive LV sensed events (para 198, steps 506 and 510 determine conduction time from bundle pacing to RV or LV sensing); or
ii) a left bundle branch to right ventricular (LBB-RV) conduction time representative of a conduction time between a LBB paced or sensed event and a responsive RV sensed events (para 198, steps 506 and 510 determine conduction time from bundle pacing to RV or LV sensing).
Zhou teaches determining the claimed LBB-RV conduction time and the LBB-LV conduction time which establishes a right side conduction time and a left side conduction in order to determine whether ventricular pacing should be adjusted to improve ventricular synchronization. However, does not teach calculating the relation between a threshold and the determined LBB-RV or LBB-LV conduction time.
Min et al. discloses a method for selecting between biventricular and left-ventricular only pacing. Min et al. calculates conduction time intervals between atrial pacing and ventricular sensing. A first conduction time (i.e., first AV delay, AVD1) is between the right atrium and LV, the second conduction time (i.e., second AV delay, AVD2) (para 59-61). Min et al. calculate a relation between a threshold and the at least one of the AVD1 (a left conduction time) conduction time or AVD2 (a right conduction time) conduction time (para 61, a relation is determined between AVD1 and AVD2 with respect to the criteria specifying that the times be within a certain percentage of one another, the criteria considered to comprise a threshold. Here it is considered that Min et al. teach that cardiac timing measurements may be mathematically related and that the calculated relationship may be compared with a predetermined criterion or threshold); and
set a pacing mode of an implantable medical device (IMD) to one of i) a biventricular (BiV) pacing mode and ii) an LV only pacing mode based on the relation (para 62, if the AVD1 and AVD2 are outside the criteria, the processor determines that conduction may be slower on a left side of the heart compared to the right in which case a left ventricular pacing scheme is preferred; should the opposite be true, that the conduction time on the right side is slower, biventricular pacing is the preferred scheme (para 62-64)). Thus, Min et al. teach setting an implantable medical device to either a BiV pacing more or an LV only pacing mode based on a relation of right side conduction time and left side conduction time to a set criteria or threshold.
Therefore, it is considered to have been obvious to one of ordinary skill in the art to employ the technique for calculating a relation between conduction time to select the pacing mode as described in Min et al. to the conduction time determination technique of Zhou in order to prevent unnecessary pacing when it is determined the right-side conduction is normal, thereby conserving power consumption of the implantable device.
In regard to claim 12, Zhou as modified in view of Min et al. is considered to teach the processor 80 is further configured to: determine both of the LBB-LV conduction time and the LBB-RV conduction time (Zhou, para 198); and calculate the relation based on the threshold, the LBB-LV conduction time and the LBB-RV conduction time (Min et al., para 61-64). It would have been obvious to one of ordinary skill in the art modify Zhou to calculate a relation as in Min et al. in order to provide objective criterion to guide the pacing mode selection.
In regard to claim 13, Zhou as modified in view of Min et al. is considered to teach the processor 80 is configured for when calculating the relation, compare the threshold to at least one of i) the LBB- LV conduction time, ii) the LBB-RV conduction time, or iii) a difference between the LBB- LV and LBB-RV conduction times; and when setting the pacing mode, to 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 (Zhou teaches comparing the relative bundle-RV and bundle-LV conduction times to determine whether ventricular pacing should be adjusted to improve ventricular synchronization (para 198-200). Min et al. teaches using a predetermined criteria or threshold applied to cardiac conduction timing to distinguish between a conduction warranting BiV pacing or LV only pacing. It would have been obvious to apply the technique of Min et al. to Zhou’s bundle -RV, -LV conduction times including the difference between, to provide an objective criterion for selecting the proper pacing mode.
In regard to claim 14, Zhou as modified in view of Min et al. teaches comprising an LV lead (Min, lead 114) having multiple LV electrodes configured to detect LV sensed events and to deliver LV paced events (Min, para 25, electrodes 132, 134, 136, 138), wherein the at least one processor is further configured to: detecting an RV intrinsic event; detecting LV intrinsic events, associated with the RV intrinsic event, utilizing multiple LV electrodes; measuring intrinsic RV-LV intervals between the RV intrinsic event, measured at the RV electrode, and the LV intrinsic events, measured at the corresponding LV electrodes; and based on the measured intrinsic RV - LV intervals, setting a configuration mode of the IMD to utilize one of the LV electrodes as an LV pace/sense site when determining the RV - LV conduction time and the LV - RV conduction time. (Min, para 58 and 65; conduction time between RV electrode 126 and each of LV electrodes 132-138, wherein the LV pacing site is selected based on longest VV interval). It would have been obvious to one of ordinary skill in the art to modify Zhou to have multiple LV electrodes and employ the technique of Min et al. for determining the LV-RV conduction time to select the most optimal position in the ventricle to apply LV only pacing.
In regard to claims 15 and 16, Min et al. further teach that the LV pace/sense site selected represents at least one of: i) the one of the LV electrodes having a longest one of the RV - LV intrinsic conduction times; or ii) the LV pace/sense site represents a site of latest LV activation within the multiple LV electrodes (para 58 and 65).
In regard to claim 17, Min et al. teach that at least one processor (microcontroller 220) is further configured to identify a site of latest LV activation to be utilized to determine the LBB - LV conduction time (Min, para 58 and 65). It is considered to have been obvious to utilize the technique of Min et al. that finds the LV site that exhibited the latest conduction time or longest VV interval to select an LV electrode to determine Zhou’s LBB-LV conduction time in order to optimize the sensing vector.
In regard to claim 18, Zhou teaches that IMD comprises a leadless IMD that is configured to be implanted proximate to one of the LBB, RV or LV and includes a corresponding one of i) the LBB electrode, ii) the RV electrode or iii) one of the one or more LV electrodes (para 161-166, 189, 207-223, and 229-233, LPD 616).
Claim(s) 9, 10, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou (US Publication no. 2019/0111270) in view of Min et al. (US Publication no. 2020/0078591 – disclosed by Applicant), further in view of Edmondson et al. (US Publication no. 2020/0129771).
In regard to claims 9 and 19, Zhou teaches a first IMD (fig. 15, LPD 616) connected to one of i) the LBB electrode, ii) the RV electrode or iii) one of the one or more LV electrodes; and a second IMD (fig. 15, IMD 630) the first and second IMDs including first and second telemetry circuits, respectively, configured to communicate with one another in connection with determining the at least one of the LBB-LV conduction time or LBB-RV conduction time (para 218, LPD 616 and IMD 630 may be configured to communicate with each other provide alternative electrical stimulation therapies). However, Zhou, nor Min et al. teach that the second IMD is connected to the other of the i) the LBB electrode, ii) the RV electrode or iii) one of the one or more LV electrodes to provide sensing and pacing.
In regard to claims 10 and 20, Zhou in view of Min et al. is considered to substantially suggest the invention as claimed, wherein Zhou teaches a first IMD 616 that is leadless, and a second IMD 630 that is located subcutaneous, however extracardiac location. The second IMD 630 does have a subcutaneous lead, however does not teach that the lead bears the other of i) the LBB electrode, ii) the RV electrode or iii) one of the one or more LV electrodes. Edmondson et al. depicts an implantable system comprising a leadless pacemaker 14 that is located in the left ventricle and includes the LV electrodes, and an intracardiac IMD 115 that is located in the right ventricle and includes the RV electrodes (figure 2, para 38). It would be obvious to modify Zhou to be implemented on the leadless pacemaker/transvenous IMD arrangement of Edmondson et al. to provide coordinated sensing and pacing at different heart chamber locations while retaining the advantages of a leadless device at one of the locations.
Edmondson et al. depicts an implantable system comprising a leadless pacemaker 14 that is located in the left ventricle and includes the LV electrodes, and an intracardiac IMD 115 that is located in the right ventricle and includes the RV electrodes (figure 2, para 38). It would be obvious to modify Zhou to be implemented on the leadless pacemaker/transvenous IMD arrangement of Edmondson et al. to provide coordinated sensing and pacing at different heart chamber locations while retaining the advantages of a leadless device at one of the locations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kramer et al. (EP 1 703 944) teaches that patients with impaired left ventricular function benefit from biventricular and left ventricular only pre-excitation pacing.
Mangual-Soto et al. (EP 4 056 226) switches between a biventricular pacing mode and a left ventricular only pacing mode based on the relation between RV-LV conduction time and the LV-RV conduction time. This reference does not qualify as prior art.
Min (US Patent no. 10,668,289) switches between a biventricular pacing mode and a left ventricular only pacing mode based on the S1 heart sound.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 23 July 2026
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