DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perschbacher et al. (US 2018/0256053; hereinafter “Perschbacher”).
Regarding claim 1, Perschbacher discloses a medical system, comprising: a first electrode configured to deliver pacing signals to a conduction system of a heart, wherein the first electrode is configured to capture the conduction system of the heart when the first electrode delivers the pacing signals and the first electrode is positioned within tissues of the heart (e.g. ¶¶ 46 – “The RV tip electrode 120A, RV ring electrode 120B, or an electrode formed on the can of IMD 105 allow for sensing an RV electrogram signal representative of RV depolarizations and delivering RV pacing pulses. The 1 MB 105 includes a sense amplifier circuit to provide amplification or filtering of the sensed signal. Sensing and pacing allows the 1 MB 105 to adjust timing of the heart chamber contractions.”); an electrode support supporting the first electrode, wherein the electrode support is configured to engage tissue of the heart to position the first electrode within the tissues of the heart (e.g. ¶¶ 50 – “helix-shaped fixation mechanisms”); a defibrillation element configured to deliver a defibrillation shock to the heart of a patient, wherein the defibrillation element is configured to position within a ventricle of the heart (e.g. ¶¶ 46 – distal defibrillation electrode 118); a monitor device including operating circuitry (e.g. Fig. 6), wherein the operating circuitry is configured to: monitor one or physiological signals of the patient, detect a current or imminent arrhythmia using the one or more physiological signals (e.g. ¶¶ 59-60 – sensing circuit 610), cause, in response to detecting the current or imminent arrhythmia, the first electrode to deliver the pacing signals to the conduction system of the heart, and cause, following delivery of the pacing signals, and if the arrhythmia continues or another arrhythmia is detected, the defibrillation element to deliver a shock to the heart of the patient (e.g. ¶¶ 85 – “The control circuit 615 may initiate delivery of the electrical pacing therapy according to a first pacing therapy mode, and change the pacing therapy mode according to the value of total time duration of the detected AF episode. In some examples, the therapy circuit provides cardioversion or defibrillation shock therapy to the subject. The control circuit 615 may initiate delivery of the shock therapy when the total time duration of the detected AF episode exceeds a specified time duration threshold.”).
Regarding claim 16, Perschbacher discloses a medical system, comprising: a first electrode configured to deliver pacing signals to a conduction system of a heart, wherein the first electrode is configured to capture the conduction system of the heart when the first electrode delivers the pacing signals and the first electrode is positioned within tissues of the heart (e.g. ¶¶ 46 – “The RV tip electrode 120A, RV ring electrode 120B, or an electrode formed on the can of IMD 105 allow for sensing an RV electrogram signal representative of RV depolarizations and delivering RV pacing pulses. The 1 MB 105 includes a sense amplifier circuit to provide amplification or filtering of the sensed signal. Sensing and pacing allows the 1 MB 105 to adjust timing of the heart chamber contractions.”); an electrode support supporting the first electrode, wherein the electrode support is configured to engage tissue of the heart to position the first electrode within the tissues of the heart (e.g. ¶¶ 50 – “helix-shaped fixation mechanisms”); a defibrillation element configured to deliver a defibrillation shock to the heart of a patient, wherein the defibrillation element is configured to position within a ventricle of the heart (e.g. ¶¶ 46 – distal defibrillation electrode 118); a monitor device including operating circuitry (e.g. Fig. 6), wherein the operating circuitry is configured to: monitor one or physiological signals of the patient and detect a current or imminent arrhythmia using the one or more physiological signals (e.g. ¶¶ 59-60 – sensing circuit 610), determine an intrinsic heart rate of the heart (e.g. ¶¶ 47, 70, etc.), cause, in response to detecting the current or imminent arrhythmia, the first electrode to deliver the pacing signals to the conduction system of the heart, wherein the pacing signals are configured to pace the heart at a heart rate greater than the intrinsic heart rate to cause high rate pacing of the heart, and cause, following delivery of the pacing signals, and if the arrhythmia continues or another arrhythmia is detected, the defibrillation element to deliver a shock to the heart of the patient (e.g. ¶¶ 85 – “The control circuit 615 may initiate delivery of the electrical pacing therapy according to a first pacing therapy mode, and change the pacing therapy mode according to the value of total time duration of the detected AF episode. In some examples, the therapy circuit provides cardioversion or defibrillation shock therapy to the subject. The control circuit 615 may initiate delivery of the shock therapy when the total time duration of the detected AF episode exceeds a specified time duration threshold.”).
Regarding claim 19, Perschbacher discloses a method of using a medical system, comprising: monitoring, using operating circuitry, one or physiological signals of a patient to detect a current or imminent arrhythmia using the one or more physiological signals (e.g. ¶¶ 59-60 – sensing circuit 610); causing, using the operating circuitry, and in response to detecting the current or imminent arrhythmia, a first electrode to deliver pacing signals to a conduction system of a heart (e.g. ¶¶ 85 – “The control circuit 615 may initiate delivery of the electrical pacing therapy according to a first pacing therapy mode, and change the pacing therapy mode according to the value of total time duration of the detected AF episode. In some examples, the therapy circuit provides cardioversion or defibrillation shock therapy to the subject. The control circuit 615 may initiate delivery of the shock therapy when the total time duration of the detected AF episode exceeds a specified time duration threshold.”), wherein the first electrode is configured to capture the conduction system of the heart when the first electrode delivers the pacing signals and the first electrode is positioned within tissues of the heart (e.g. ¶¶ 46 – “The RV tip electrode 120A, RV ring electrode 120B, or an electrode formed on the can of IMD 105 allow for sensing an RV electrogram signal representative of RV depolarizations and delivering RV pacing pulses. The 1 MB 105 includes a sense amplifier circuit to provide amplification or filtering of the sensed signal. Sensing and pacing allows the 1 MB 105 to adjust timing of the heart chamber contractions.”), and wherein an electrode support supporting the first electrode is configured to engage tissue of the heart to position the first electrode within the tissues of the heart (e.g. ¶¶ 50 – “helix-shaped fixation mechanisms”); and causing, using the operating circuitry, and following delivery of the pacing signals, and if the arrhythmia continues or another arrhythmia is detected by the operating circuitry, a defibrillation element to deliver a shock to the heart of the patient, wherein the defibrillation element is configured to position within a ventricle of the heart. (e.g. ¶¶ 46 – distal defibrillation electrode 118).
Regarding claims 2 and 20, Perschbacher discloses the pacing signals are configured to cause high rate pacing of the heart (e.g. ¶¶ 70).
Regarding claims 3 and 18, Perschbacher discloses the operating circuitry is configured to: cause the first electrode to cease delivering the pacing signals, pause between causing the first electrode to cease and causing the defibrillation element to deliver the shock. (e.g. ¶¶ 85).
Regarding claim 4, Perschbacher discloses the pause is at least partially defined by one or more of a chronological period or by the one or more physiological signals. (e.g. ¶¶ 67-69).
Regarding claims 5 and 17, Perschbacher discloses the operating circuitry is configured to cause the first electrode to deliver the pacing signals over a time span, and wherein the pacing signals are configured to cause a heart rate of the heart to increase over the time span. (e.g. ¶¶ 70).
Regarding claim 6, Perschbacher discloses the pacing signals are configured to cause conduction system pacing of the heart at a first rate, and wherein the operating circuitry is configured to cause the first electrode to deliver second pacing signals to the heart, wherein the second pacing signals are configured to cause conduction system pacing of the heart at a second rate different than the first rate. (e.g. ¶¶ 85).
Regarding claim 7, Perschbacher discloses the operating circuitry is configured to cause a first electrode to deliver the pacing signals to at least one of a Bundle of His of the heart, a Left Bundle Branch of the heart, or Purkinje fibers of the heart. (e.g. ¶¶ 46).
Regarding claim 8, Perschbacher discloses a first lead supporting the first electrode, wherein the first lead includes a first conductor electrically connecting the first electrode and the operating circuitry; a second lead supporting the defibrillation element, wherein the second lead includes a second conductor electrically connecting the defibrillation element and the operating circuitry. (e.g. ¶¶ 46-49).
Regarding claim 9, Perschbacher discloses the distal portion is configured to position within the right ventricle, the left ventricle, or the atrium when the first electrode positions within the tissues of the heart, wherein the proximal portion is configured to position outside of the heart when the first electrode positions within the tissues of the heart, and wherein the device housing is configured to position outside the heart when the first electrode positions within the tissues of the heart. (e.g. ¶¶ 52, 60, etc).
Regarding claim 10, Perschbacher discloses the distal lead portion is configured to position within the ventricle of the heart when the defibrillation element positions within the ventricle of the heart, wherein the proximal lead portion is configured to position outside of the heart when the distal lead portion positions within the ventricle of the heart, and wherein the device housing is configured to position outside the heart when the distal lead portion positions within the ventricle of the heart (e.g. ¶¶ 59-63).
Regarding claim 11, Perschbacher discloses a lead including a distal portion supporting the first electrode, the electrode support, and the defibrillation element, and including a proximal portion supported by device housing, wherein the distal portion is configured to allow the electrode support to position within the ventricle of the heart when the first electrode positions within the tissues of the heart, and wherein the distal portion is configured to position within an apex of the ventricle of the heart when the electrode support positions within the ventricle of the heart. (e.g. ¶¶ 46).
Regarding claim 12, Perschbacher discloses the proximal portion is configured to position outside of the heart when the distal portion positions within the ventricle of the heart, and wherein the device housing is configured to position outside the heart when the proximal portion positions outside the heart (e.g. Fig. 1, #105/190).
Regarding claim 13, Perschbacher discloses the lead supports an attachment structure configured to engage heart tissues of the heart to substantially maintain the position of the first electrode within the tissues of the heart (e.g. ¶¶ 50 – “helix-shaped fixation mechanisms”).
Regarding claim 14, Perschbacher discloses a lead supporting the defibrillation element, wherein the device housing supports the electrode support at a proximal end of the device housing, wherein the device housing is configured to position within the ventricle of the heart when the electrode support is positioned within the ventricle of the heart (e.g. ¶¶ 46-49), and wherein the lead includes a distal portion supporting the defibrillation element and a proximal portion supported by the device housing. (e.g. ¶¶ 50 – “helix-shaped fixation mechanisms”).
Regarding claim 15, Perschbacher discloses the device housing supports a device attachment structure configured to engage heart tissues of the heart to substantially maintain the position of the first electrode within the tissues of the heart (e.g. ¶¶ 50 – “helix-shaped fixation mechanisms”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796
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