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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/13/2025 is being considered by the examiner.
Claim Objections
Claims 1-15 are objected to because of the following informalities:
Claim 1, line 1, reads “Leadless device” should read “A leadless device”.
Claim 1, line 2, reads “the device” should read “the leadless device”.
Claim 1, line 2, reads “atrium (A);” should read “atrium (A); and”.
Claims 2-11, line 1, read “Leadless device” should read “The leadless device”.
Claims 2-4, 6, 7, and 11, line 1, read “the device” should read “the leadless device”.
Claim 4, line 2, reads “the one or more P-P intervals” should read “the determined one or more P-P intervals”.
Claim 4, line 3, reads “set value;” should read “set value; and”.
Claim 5, lines 2 and 4, read “the P-P intervals” should read “the determined one or more P-P intervals”.
Claim 5, line 2, reads “comprise” should read “comprises”.
Claim 5, line 3, reads “the variabilities comprise” should read “the at least one variability comprises”.
Claim 5, lines 3-4 reads “of adjacent pairs of the P-P intervals” should read “pairs of the adjacent P-P intervals”.
Claim 5, line 5, reads “AF” should read “atrial fibrillation (AF)”.
Claims 12, line 1, reads “system” should read “a system”.
Claim 13, line 1, reads “system” should read “the system”.
Claim 14, line 1, reads “method” should read “a method”.
Claim 14, line 8 reads “an atrial activity status” should read “the atrial activity status”.
Claim 14, lines 4, 6-7, and 8, reads “the device” should read “the at least one leadless device”.
Claim 15, line 1, reads “computer program” should read “a computer program”.
Appropriate correction is required.
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.
Claim 15 is rejected under 35 U.S.C. 101 as not falling within one of the four categories of invention. The broadest reasonable interpretation of a claim drawn to a computer program/storage medium typically covers forms on non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of storage medium, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. 101 as covering non- statutory subject matter. A claim drawn to such a storage medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. 101 by adding the preamble "a non-transitory medium comprising instruction to perform the method of claim 14" to the claim.
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.
(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 1-3, 6-7, and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al. (US 20190290905 A1), hereinafter Yang.
Regarding claim 1, Yang teaches a leadless device (Fig. 1, element 10 - intracardiac medical device, para. 0049 (a leadless implantable medical device)) for implanting into an atrium of a heart (para. 0048 (device is implanted in the right atrium of the patient’s heart)), comprising:
a connector (Fig. 1, element 20 - fixation member) for connecting the device to an inner wall of the atrium (para. 0048 (device may include fixation members that anchor a distal end of the device against the atrial endocardium), 0008 (may be anchored to a wall of the heart via a fixation mechanism));
a sensor (Fig. 4, elements (22, 24, 87)) for directly sensing an atrial activity of the heart (para. 0068 (electrodes 22 and 24 may be used to sense atrial P-waves for use in controlling atrial pacing pulses and for controlling atrial-synchronized ventricular pacing pulses delivered using the tip electrode 42 as a cathode and the proximal housing-based electrode 24 as the return anode)).
Regarding claim 2, Yang teaches the leadless device according to claim 1, wherein the device is configured to determine one or more P-P intervals of the heart based at least in part on the directly sensed atrial activity (para. 0079 (control circuit 80 may determine cardiac event time intervals, e.g., PP intervals between consecutive P-wave sensed event signals received from the atrial sensing channel), 0077 (atrial sensing channel may include cardiac event detection circuitry for detecting P-waves)).
Regarding claim 3, Yang teaches the leadless device according to claim 2, wherein the device is configured to determine an atrial activity status based at least in part on the determined one or more P-P intervals (para. 0079 (control circuit 80 may determine cardiac event time intervals, e.g., PP intervals between consecutive P-wave sensed event signals received from the atrial sensing channel), 0077 (atrial sensing channel may include cardiac event detection circuitry for detecting P-waves)).
Regarding claim 6, Yang teaches the leadless device according to claim 3, wherein the device is further configured to determine the atrial activity status based at least in part on a motion state of the device (Fig. 1, element 11 - motion detector, para. 0064 (motion detector may be used to monitor mechanical activity, such as atrial mechanical activity (e.g., an atrial contraction) and/or ventricular mechanical activity)).
Regarding claim 7, Yang teaches the leadless device according to claim 3, wherein the device further comprises an additional sensor (Fig. 1, element 12 - dart electrode) for sensing a ventricular activity of the heart (para. 0050 (dart electrode may carry an electrode at the distal end region of the shaft for positioning the electrode within the ventricular myocardium for sensing ventricular signals and delivering ventricular pulses)), and the leadless device is further configured to determine the atrial activity status based at least in part on the sensed ventricular activity (para. 0077 (ventricular sensing channel 89 may include cardiac event detection circuitry for detecting R-waves from the cardiac electrical signals received by the channel)).
Regarding claim 8, Yang teaches the leadless device according to claim 1, further comprising a stimulator for a direct stimulation of the atrium of the heart (para. 0081 (atrial pacing circuit may be coupled to the distal housing-based electrode and the proximal housing-based electrode to deliver atrial pacing pulses)).
Regarding claim 9, Yang teaches the leadless device according to claim 8, wherein the stimulator is adapted to stimulate the atrium based at least in part on the directly sensed atrial activity (para. 0078 (the sensed event signals [a cardiac electrical event based on a sensing threshold crossing] may be used by the control circuit for setting pacing escape interval timers that control the basic time intervals used for scheduling cardiac pacing pulses. A sensed event signal may trigger or inhibit a pacing pulse depending on the particular programmed pacing mode)).
Regarding claim 10, Yang teaches the leadless device according to claim 9, wherein the stimulator is adapted to, if the directly sensed atrial activity indicates a supraventricular tachycardia, apply stimulation bursts to the atrium adapted to counteract the supraventricular tachycardia and/or switch to a non-tracking mode (para. 0078 (the sensed event signals [a cardiac electrical event based on a sensing threshold crossing] may be used by the control circuit for setting pacing escape interval timers that control the basic time intervals used for scheduling cardiac pacing pulses. A sensed event signal may trigger or inhibit a pacing pulse depending on the particular programmed pacing mode)).
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.
Claims 4-5 and 14-15 are rejected under 35 U.S.C. 103 as being anticipated by Yang and in further view of Greenhut et al. (US 20220288387 A1), hereinafter Greenhut.
Regarding claim 4, Yang teaches the leadless device according to claim 3.
Yang does not teach wherein the device is further configured to:
determine at least one variability of a duration of the one or more P-P intervals;
compare said at least one variability to a set value;
determine the atrial activity status based at least in part on said at least one variability being larger or smaller than the set value.
Greenhut teaches a leadless device (Fig. 1, element 14) further configured to:
determine at least one variability of a duration of the one or more P-P intervals (para. 0126 (control circuit 206 may be used for… determining atrial event intervals, also referred to herein as PP intervals or “PPIs,” which may be used by control circuit 242 in detecting AT/AF));
compare said at least one variability to a set value (para. 0182 (Each PPI is compared to the AT/AF detection interval to identify AT/AF intervals as PPIs that are less (shorter) than the AT/AF detection interval));
determine the atrial activity status (para. 0006 (atrial tachyarrhythmia and/or atrial fibrillation (AT/AF) episode)) based at least in part on said at least one variability being larger or smaller than the set value (para. 0134 (an AT/AF detection interval may be defined which is compared to a PPI by AT/AF detector circuit 240. The AT/AF detection interval may be programmable… [a counter counts] how many PPIs are less than or equal to the AT/AF detection interval out of the most recent PPIs. When at least X of Y AT/AF intervals are detected…AT/AF onset criteria may be met)).
Yang and Greenhut are considered to be analogous to the claimed invention because they are in the same field of implantable leadless device that detect atrial activity. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yang’s device to incorporate the teachings of Greenhut and provide the variability between the P-P intervals and comparing the variabilities to a set value.
Although Yang teaches sensing P-P intervals, Yang does not disclose comparing the variabilities of the P-P intervals to an atrial activity status. Therefore, incorporating the teachings of Greenhut provides an improvement in detecting atrial activity status by increasing the accuracy and reliability of atrial activity classification based on the sensed P-P intervals.
Regarding claim 5, Yang (in view of Greenhut) teaches the leadless device according to claim 4, wherein:
the P-P intervals comprise a predetermined number of adjacent P-P intervals (para. 0079 (control circuit 80 may determine cardiac event time intervals, e.g., PP intervals between consecutive P-wave sensed event signals received from the atrial sensing channel));
the variabilities comprise variabilities of two respective durations of adjacent pairs of the P-P intervals (para. 0079 (control circuit 80 may determine cardiac event time intervals, e.g., PP intervals between consecutive P-wave sensed event signals received from the atrial sensing channel)).
Yang does not teach that the leadless device is configured to detect an AF status if at least a minimum number of the variabilities of two respective durations is larger than the set value.
Greenhut further discloses the P-P intervals comprise a predetermined number of adjacent P-P intervals (para. 0134 (When a PPI falls is less than or equal to the AT/AF detection interval, a counter may be increased to count the number of AT/AF intervals. In some examples a counter may be configured to count the number of PPIs determined to be an AT/AF interval out of a rolling, predetermined number of most recent PPIs));
the variabilities comprise variabilities of two respective durations of adjacent pairs of the P-P intervals (para. 0149 (The atrial event may be... an intrinsic P-wave sensed by P-wave sensing channel. The time interval between two consecutive atrial events… may be determined as a PPI, which represents one atrial cycle)); and
the leadless device is configured to detect an AF status if at least a minimum number of the variabilities of two respective durations is larger than the set value (para. 0135 (“AT/AF onset criteria,” therefore, refers to criteria that require at least a predetermined number of atrial cycles (PPIs) that are less than or equal to a programmed AT/AF detection interval threshold as evidence of atrial tachyarrhythmia)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yang’s device to incorporate the teachings of Greenhut and provide determined atrial fibrillation based on the predetermined number of adjacent P-P interval variabilities with a set value. Doing so would have would have improved the reliability of atrial fibrillation detection by reducing the likelihood of false detections.
Regarding claim 14, Yang teaches a method for determining an atrial activity status of a heart (para. 0010 (method that includes monitoring activity of the right atrium of a patient's heart)) with at least one leadless device implanted into an atrium of the heart (para. 0049 (a leadless implantable medical device), 0048 (device is implanted in the right atrium of the patient’s heart)), comprising:
determining one or more P-P intervals of the heart by directly sensing an atrial activity of the heart by the device (para. 0079 (control circuit 80 may determine cardiac event time intervals, e.g., PP intervals between consecutive P-wave sensed event signals received from the atrial sensing channel), 0077 (atrial sensing channel may include cardiac event detection circuitry for detecting P-waves));
Yang does not teach determining at least one variability of the duration of the one or more P-P intervals by the device;
comparing said at least one variability to a set value by the device;
determining an atrial activity status based at least in part on said at least one variability being larger or smaller than the set value by the device.
Greenhut further discloses determining one or more P-P intervals of the heart by directly sensing an atrial activity of the heart by the device;
determining at least one variability of the duration of the one or more P-P intervals by the device (para. 0126 (control circuit 206 may be used for… determining atrial event intervals, also referred to herein as PP intervals or “PPIs,” which may be used by control circuit 242 in detecting AT/AF));
compare said at least one variability to a set value by the device (para. 0182 (Each PPI is compared to the AT/AF detection interval to identify AT/AF intervals as PPIs that are less (shorter) than the AT/AF detection interval));
determining an atrial activity status based at least in part on said at least one variability being larger or smaller than the set value by the device (para. 0006 (atrial tachyarrhythmia and/or atrial fibrillation (AT/AF) episode)) based at least in part on said at least one variability being larger or smaller than the set value (para. 0134 (an AT/AF detection interval may be defined which is compared to a PPI by AT/AF detector circuit 240. The AT/AF detection interval may be programmable… [a counter counts] how many PPIs are less than or equal to the AT/AF detection interval out of the most recent PPIs. When at least X of Y AT/AF intervals are detected…AT/AF onset criteria may be met)).
Although Yang teaches sensing P-P intervals, Yang does not disclose comparing the variabilities of the P-P intervals to an atrial activity status. Greenhut teaches sensing PP intervals that are used by the control circuit to detect AT/AF, by comparing the PP intervals to a AT/AF detection interval (para. 0182). When a PP interval is less than or equal to the AT/AF detection interval, an AT/AF episode may be suspected (para. 0134). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yang’s device to incorporate the teachings of Greenhut listed above, and provide the variability between the P-P intervals and comparing the variabilities to a set value by the device. Doing so improves the detection of an atrial activity status by increasing the accuracy and reliability of atrial activity classification based on sensed P-P intervals.
Regarding claim 15, Yang (in view of Greenhut) teaches a computer program comprising instructions to perform the method of claim 14, when the instructions are executed by a computer (para. 0180 (methods, and interfaces may be implemented using one or more computer programs executed on programmable computers)).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Yang and in further view of Carney et al. (US 20160067490 A1), hereinafter Carney.
Regarding claim 11, Yang teaches the leadless device according to claim 1, wherein the device is configured for cooperating with at least one further device. (Fig. 1, element 50 – medical device, para. 0054 (the device (10) and the separate medical device (50) may cooperate to provide cardiac therapy to the patient’s heart)).
Yang does not teach at least one further implantable leadless device.
Carney teaches wherein the device (Fig. 2, element 100 – atrial device, para. 0046 (leadless atrial pacemaker device… implantation within right atrium of a patient)) is configured for cooperating with at least one further implantable leadless device (Fig. 4, element 200 – ventricular device, para. 0059 (leadless ventricular pacemaker device), 0069 (establishment of a communication link between atrial device and ventricular device on an as-needed basis to help maintain synchronous pacing of the heart)).
Yang and Carney are considered to be analogous to the claimed invention because they are in the same field of implantable leadless devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yang to incorporate the teachings of Carney and provide an additional implantable leadless device for cooperation with the main device.
Although Yang teaches the leadless device cooperating with a separate medical device, this additional device is positioned outside the patient’s heart (para. [0051]). Carney teaches an additional implantable medical device that cooperates with the primary device. Therefore, it would have been obvious include an additional implantable medical device within Yang’s device. Doing so would improve the coordination of the cardiac therapy by exchanging data, and allows for pacing/sending between multiple implantable leadless devices.
Regarding claim 12, Yang (in view of Carney) teaches a system comprising the leadless device and the at least one further implantable leadless device according to claim 11 (Fig. 1, element 2 – cardiac therapy system).
Regarding claim 13, Yang (in view of Carney) teaches the system according to claim 12.
Yang does not teach wherein the at least one further implantable leadless device is adapted as a pacer stimulating a ventricle based at least in part on the directly sensed atrial activity.
Carney teaches wherein the at least one further implantable leadless device is adapted as a pacer stimulating a ventricle based at least in part on the directly sensed atrial activity (para. 0059 (leadless ventricular pacemaker device… may be configured to pace the ventricle, sense intrinsic ventricular depolarizations, and inhibit ventricular pacing in response to detected ventricular depolarization)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yang to incorporate the teachings of Carney and provide a ventricular pacing device responsive to the sensed atrial activity. Doing so would allow the system to have coordinate ventricular stimulation based on the sensed atrial events, improving pacing effectiveness.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant' s disclosure. Strandberg et al. (US 6871097 B1) is another example of an implantable pacemaker with an atrial signal/p-wave detector and a non-tracking mode.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EILEEN ROBLES whose telephone number is (571)429-9383. The examiner can normally be reached Monday-Friday: 8:00 - 5:00 PM.
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/EILEEN ROBLES/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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