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. 17/813,925, now US Patent no. 12,076,569, filed 20 July 2022, which is a continuation of US Application no. 16/833,965, now US Patent no. 11,420,067, filed 30 March 2020, which claims the benefit of domestic priority from US Provisional Application no. 62/830,020 filed 5 April 2019.
Claim Objections
Claim 8 is objected to because of the following informalities: line 2 recites “at least one:” is considered to be grammatically incomplete and should read “at least one of:”. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: line 2 recites “at least one:” is considered to be grammatically incomplete and should read “at least one of:”. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: line 2 recites “a therapy delivery” which is considered to be incomplete, and should properly recite as “a therapy delivery circuit. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: line 11 recites “selecting” which is inconsistent with preceding infinitive verbs employed and is suggested to recite as “select”. 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.
Claim 16 recites the limitation "the sensor signal" in line 2. There is insufficient antecedent basis for this limitation in the claim. The base claim does not recite sensing a signal from a sensor. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 8-16, and 18-21 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhou (US Publication no. 2019/0111270).
The applied reference has a common Applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
In regard to claim 1, Zhou discloses a medical device (IMD 16) comprising:
a sensor configured to sense a signal (para 110 and 114-117, figure 5, sensing module 86 acquires signals from the heart; para 171, the method begins by sensing a signal via sensing module 84);
a therapy delivery circuit configured to deliver conduction system pacing pulses (para 110 and 111-113, figure 5, stimulation generator 84 delivers stimulation therapy to the heart; para 68, 78, 111-112, the stimulation is delivered to the His Bundle or a bundle branch which comprise the conduction system pacing scheme as claimed); and
a control circuit (processor 80) configured to (para 111):
control the therapy delivery circuit to deliver at least one conduction system pacing pulse at each of a plurality of pacing intervals (para 172, 175-179, pacing is delivered for a variety of AV delay intervals; para 175, the system determines whether bundle pacing should be delivered; para 176, paces the bundle over successive AV delay intervals wherein the AV delay interval duration is increased or decreased; para 177-178, the process is repeated and each AV delay is stored creating a set of AV to bundle pacing delay intervals; para 179, the optimal AV delay to bundle pacing delay is selected from the set of intervals stored in memory);
determine a first synchrony metric from the signal for each pacing interval of the plurality of pacing intervals (para 179, a QRS duration is determined for each AV delay tested, wherein the QRS duration is considered to comprise the synchrony metric) by determining the first synchrony metric following at least one conduction system pacing pulse delivered at the pacing interval of the plurality of pacing intervals (para 175-178, these sections describe the process for changing the AV delay and iterating the process for testing various AV-bundle pacing delays; para 179, a QRS duration is determined for each respective AV delay);
compare the first synchrony metrics to each other (para 179, here the processor determines the optimal AV delay by comparing the stored synchrony metrics (i.e, QRS duration) associated with the AV delays resulting in the minimal QRS duration); and
based on the comparison of the first synchrony metrics to each other, select one of the plurality of pacing intervals (para 179, AV delays of 80, 90, 100, 11, and 120 ms are stored along with the synchrony metric (i.e., QRS duration) associated with delay, the optimal AV delay resulting in the minimal QRS duration (i.e., 93 ms) is selected); and
wherein the therapy delivery circuit is further configured to deliver conduction system pacing pulses at the selected one of the plurality of pacing intervals (para 181, the selected optimal AV delay interval is used to provide the optimized atrial-activation to bundle pacing intervals).
In regard to claim 2, in Zhou the control circuit (processor 80) is further configured to determine the first synchrony metric for each pacing interval of the plurality of pacing intervals by: determining a first feature from the signal following at least one conduction system pacing pulse delivered at the pacing interval; and determining the first synchrony metric based on at least the first feature (para 173, the synchrony metric of Zhou is the QRS complex, which the Q-wave is the first feature of the QRS complex. The QRS complex is measured following the bundle pacing pulse for each of the AV delay tested as in paragraphs 175-179).
In regard to claim 3, in Zhou the control circuit (processor 80) is further configured to determine the first synchrony metric as a time interval to the first feature (para 172, the pacing to RV sensing or pacing to LV sensing interval is measured, wherein the QRS complex is the ventricular activity in the RV or LV sensing).
In regard to claim 4, in Zhou the control circuit (processor 80) is further configured to determine the first synchrony metric for each of the plurality of the pacing intervals by: determining a second feature from the signal following at least one conduction system pacing pulse delivered at the pacing interval of the plurality of pacing intervals; and determining the first synchrony metric based on at least the first feature and the second feature (para 173, the QRS complex is the synchrony metrics, wherein the Q-wave is the first feature of this complex and the S wave is the second feature following the Q- and R-waves thus forming the complex).
In regard to claim 5, in Zhou the control circuit (processor 80) is further configured to determine the first synchrony metric as a time interval from the first feature to the second feature (para 172, 173, 178-179, the QRS complex width or duration is used as the synchrony metric, wherein the QRS duration is the time interval from the Q wave to the S wave).
In regard to claim 6, in Zhou the control circuit (processor 80) is further configured to: determine a second synchrony metric from the sensor signal; determine that at least one of the first synchrony metric or the second synchrony metric is improved for a first pacing interval of the plurality of pacing intervals compared to a second pacing interval of the plurality of pacing intervals; and select one of the plurality of pacing intervals by selecting the first pacing interval in response to determining that at least one of the first synchrony metric or the second synchrony metric is improved for the first pacing interval; and wherein the therapy delivery circuit is further configured to deliver the conduction system pacing pulses at the selected first one of the plurality of pacing intervals (para 176, Zhou collects QRS durations (synchrony metric) for various AV delays, wherein for each AV delay of 80, 90, 100, 110, and 120 ms, a corresponding QRS duration is measured and respectively corresponds as 120, 100, 95, 93, and 99 ms to each AV delay, wherein the minimal QRS duration correspondence (i.e., 93 ms) is selected as the improved or optimal delay). In regard to claim 8, in Zhou the control circuit (processor 80) is further configured to determine the first synchrony metric from the signal as at least one: a cardiac event signal width (para 82, 173, QRS duration); a cardiac event signal amplitude; a cardiac event signal number of peaks; or a cardiac event signal maximum slope. Zhou satisfies the requirements of the claims. The other features are considered to be obvious alternative equivalents.
In regard to claim 10, Zhou includes a tissue penetrating electrode coupled to the therapy delivery circuit (para 213, 220 and 221); and
wherein the therapy delivery circuit is further configured to deliver the conduction system pacing pulse via the tissue penetrating electrode (para 213, 220 and 221).
In regard to claim 11, Zhou discloses a medical device (IMD 16) for performing a method comprising:
sensing a signal (para 110 and 114-117, figure 5, sensing module 86 acquires signals from the heart; para 171, the method begins by sensing a signal via sensing module 84);
delivering conduction system pacing pulses at each of a plurality of pacing intervals (para 110 and 111-113, figure 5, stimulation generator 84 delivers stimulation therapy to the heart; para 68, 78, 111-112, the stimulation is delivered to the His Bundle or a bundle branch which comprise the conduction system pacing scheme as claimed; (para 172, 175-179, pacing is delivered for a variety of AV delay intervals; para 175, the system determines whether bundle pacing should be delivered; para 176, paces the bundle over successive AV delay intervals wherein the AV delay interval duration is increased or decreased; para 177-178, the process is repeated and each AV delay is stored creating a set of AV to bundle pacing delay intervals; para 179, the optimal AV delay to bundle pacing delay is selected from the set of intervals stored in memory)); and
determining a first synchrony metric from the signal for each pacing interval of the plurality of pacing intervals (para 179, a QRS duration is determined for each AV delay tested, wherein the QRS duration is considered to comprise the synchrony metric) by determining the first synchrony metric following at least one conduction system pacing pulse delivered at the pacing interval of the plurality of pacing intervals (para 175-178, these sections describe the process for changing the AV delay and iterating the process for testing various AV-bundle pacing delays; para 179, a QRS duration is determined for each respective AV delay);
comparing the first synchrony metrics to each other (para 179, here the processor determines the optimal AV delay by comparing the stored synchrony metrics (i.e, QRS duration) associated with the AV delays resulting in the minimal QRS duration); and
based on the comparison of the first synchrony metrics to each other, select one of the plurality of pacing intervals (para 179, AV delays of 80, 90, 100, 11, and 120 ms are stored along with the synchrony metric (i.e., QRS duration) associated with delay, the optimal AV delay resulting in the minimal QRS duration (i.e., 93 ms) is selected); and
delivering conduction system pacing pulses at the selected one of the plurality of pacing intervals (para 181, the selected optimal AV delay interval is used to provide the optimized atrial-activation to bundle pacing intervals).
In regard to claim 12, in Zhou the control circuit (processor 80) is further configured to determine the first synchrony metric for each pacing interval of the plurality of pacing intervals by: determining a first feature from the signal following at least one conduction system pacing pulse delivered at the pacing interval; and determining the first synchrony metric based on at least the first feature (para 173, the synchrony metric of Zhou is the QRS complex, which the Q-wave is the first feature of the QRS complex. The QRS complex is measured following the bundle pacing pulse for each of the AV delay tested as in paragraphs 175-179).
In regard to claim 13, in Zhou the control circuit (processor 80) is further configured to determine the first synchrony metric as a time interval to the first feature (para 172, the pacing to RV sensing or pacing to LV sensing interval is measured, wherein the QRS complex is the ventricular activity in the RV or LV sensing).
In regard to claim 14, in Zhou the control circuit (processor 80) is further configured to determine the first synchrony metric for each of the plurality of the pacing intervals by: determining a second feature from the signal following at least one conduction system pacing pulse delivered at the pacing interval of the plurality of pacing intervals; and determining the first synchrony metric based on at least the first feature and the second feature (para 173, the QRS complex is the synchrony metrics, wherein the Q-wave is the first feature of this complex and the S wave is the second feature following the Q- and R-waves thus forming the complex).
In regard to claim 15, in Zhou the control circuit (processor 80) is further configured to determine the first synchrony metric as a time interval from the first feature to the second feature (para 172, 173, 178-179, the QRS complex width or duration is used as the synchrony metric, wherein the QRS duration is the time interval from the Q wave to the S wave).
In regard to claim 16, in Zhou the control circuit (processor 80) is further configured to: determine a second synchrony metric from the sensor signal; determine that at least one of the first synchrony metric or the second synchrony metric is improved for a first pacing interval of the plurality of pacing intervals compared to a second pacing interval of the plurality of pacing intervals; and select one of the plurality of pacing intervals by selecting the first pacing interval in response to determining that at least one of the first synchrony metric or the second synchrony metric is improved for the first pacing interval; and wherein the therapy delivery circuit is further configured to deliver the conduction system pacing pulses at the selected first one of the plurality of pacing intervals (para 176, Zhou collects QRS durations (synchrony metric) for various AV delays, wherein for each AV delay of 80, 90, 100, 110, and 120 ms, a corresponding QRS duration is measured and respectively corresponds as 120, 100, 95, 93, and 99 ms to each AV delay, wherein the minimal QRS duration correspondence (i.e., 93 ms) is selected as the improved or optimal delay). In regard to claim 18, in Zhou the control circuit (processor 80) is further configured to determine the first synchrony metric from the signal as at least one: a cardiac event signal width (para 82, 173, QRS duration); a cardiac event signal amplitude; a cardiac event signal number of peaks; or a cardiac event signal maximum slope. Zhou satisfies the requirements of the claims. The other features are considered to be obvious alternative equivalents.
In regard to claim 20, Zhou includes a tissue penetrating electrode coupled to the therapy delivery circuit (para 213, 220 and 221); and
wherein the therapy delivery circuit is further configured to deliver the conduction system pacing pulse via the tissue penetrating electrode (para 213, 220 and 221).
In regard to claim 21, Zhou discloses a medical device (IMD 16) comprising a non-transitory computer-readable storage medium (para 110, memory 82 includes computer readable instructions) comprising a set of instructions, which when executed by processing circuitry (processor 80) of a medical device 16, cause the medical device 16 to:
sense a signal (para 110 and 114-117, figure 5, sensing module 86 acquires signals from the heart; para 171, the method begins by sensing a signal via sensing module 84);
deliver conduction system pacing pulses at each of a plurality of pacing intervals (para 110 and 111-113, figure 5, stimulation generator 84 delivers stimulation therapy to the heart; para 68, 78, 111-112, the stimulation is delivered to the His Bundle or a bundle branch which comprise the conduction system pacing scheme as claimed; (para 172, 175-179, pacing is delivered for a variety of AV delay intervals; para 175, the system determines whether bundle pacing should be delivered; para 176, paces the bundle over successive AV delay intervals wherein the AV delay interval duration is increased or decreased; para 177-178, the process is repeated and each AV delay is stored creating a set of AV to bundle pacing delay intervals; para 179, the optimal AV delay to bundle pacing delay is selected from the set of intervals stored in memory)); and
determine a first synchrony metric from the signal for each pacing interval of the plurality of pacing intervals (para 179, a QRS duration is determined for each AV delay tested, wherein the QRS duration is considered to comprise the synchrony metric) by determining the first synchrony metric following at least one conduction system pacing pulse delivered at the pacing interval of the plurality of pacing intervals (para 175-178, these sections describe the process for changing the AV delay and iterating the process for testing various AV-bundle pacing delays; para 179, a QRS duration is determined for each respective AV delay);
compare the first synchrony metrics to each other (para 179, here the processor determines the optimal AV delay by comparing the stored synchrony metrics (i.e, QRS duration) associated with the AV delays resulting in the minimal QRS duration); and
based on the comparison of the first synchrony metrics to each other, select one of the plurality of pacing intervals (para 179, AV delays of 80, 90, 100, 11, and 120 ms are stored along with the synchrony metric (i.e., QRS duration) associated with delay, the optimal AV delay resulting in the minimal QRS duration (i.e., 93 ms) is selected); and
deliver conduction system pacing pulses at the selected one of the plurality of pacing intervals (para 181, the selected optimal AV delay interval is used to provide the optimized atrial-activation to bundle pacing intervals).
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) 7, 9, 17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou (US Publication no. 2019/0111270).
In regard to claims 7 and 17, Zhou does not teach that the sensor module 86 is configured to sense the signal as a cardiac mechanical signal. However, in another embodiment, Zhou teaches that a motion sensor may be incorporated to measure mechanical motions of the heart to confirm cardiac conditions. Additionally, a pressure sensor may be used to sense pressure changes associated with mechanical motions of the heart. These sensors are considered suitable alternative equivalents to the QRS duration to determine of the chambers of the heart are synchronized. Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the sensing module to include a motion sensor to obtain the cardiac signal for assessing cardiac synchrony during optimization of the pacing interval since it is explicitly suggested by Zhou that a motion sensor may be included and it is considered that the motion sensor is a suitable alternative equivalent to determining synchronized activity of the heart.
In regard to claims 9 and 19, Zhou does not teach that the sensor module 86 is configured to sense the signal as a cardiac motion signal. However, in another embodiment, Zhou teaches that a motion sensor may be incorporated to measure mechanical motions of the heart to confirm cardiac conditions. Additionally, a pressure sensor may be used to sense pressure changes associated with mechanical motions of the heart. These sensors are considered suitable alternative equivalents to the QRS duration to determine of the chambers of the heart are synchronized. Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the sensing module to include a motion sensor to obtain the cardiac signal for assessing cardiac synchrony during optimization of the pacing interval since it is explicitly suggested by Zhou that a motion sensor may be included and it is considered that the motion sensor is a suitable alternative equivalent to determining synchronized activity of the heart.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Demmer et al. (US Publication no. 2018/0117337 – disclosed by Applicant) acquires a motion signal of cardiac tissue to set an AV delay to control timing of ventricular pacing relative to atrial events to ensure synchrony between ventricular pacing and atrial events. However, Demmer et al. does not disclose maintaining synchrony from pacing at the cardiac conduction system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 20 July 2026
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