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 Heneghan et al. (US 2022/0249026; hereinafter “Heneghan”).
Regarding claim 1, Heneghan discloses a system for monitoring a patient at risk of cardiac arrhythmia, the system comprising: an ambulatory monitor device configured to: sense a cardiac signal from the patient via a cardiac sensor; and intermittently collect data segments of the sensed cardiac signal in accordance with a data segment collection rate or schedule over a monitoring period, the data segments each having a segment duration (e.g. ¶¶ 34 – where the examiner notes the PPG device of Heneghan is the same ambulatory monitor device used as an example in the present application’s disclosure) and an arrhythmia analysis device communicatively coupled to the ambulatory monitor device, the arrhythmia analysis device configured to detect a cardiac arrhythmia using the intermittently collected data segments received from the ambulatory monitor device (e.g. ¶¶ 77), wherein the ambulatory monitor device is configured to transmit the intermittently collected data segments to the arrhythmia analysis device in accordance with a transmission schedule (e.g. ¶¶ 77 – “the method may comprise periodically transferring one or more of the PPG signals”).
Regarding claim 13, Heneghan teaches a method of monitoring a patient at risk of cardiac arrhythmia, the method comprising: sensing a cardiac signal from the patient using a cardiac sensor; intermittently collecting data segments of the sensed cardiac signal in accordance with a data segment collection rate or schedule over a monitoring period using an ambulatory monitor device, the data segments each having a segment duration (e.g. ¶¶ 34 – where the examiner notes the PPG device of Heneghan is the same ambulatory monitor device used as an example in the present application’s disclosure); transmitting the intermittently collected data segments to an arrhythmia analysis device in accordance with a transmission schedule (e.g. ¶¶ 77 – “the method may comprise periodically transferring one or more of the PPG signals”); and detecting a cardiac arrhythmia using the intermittently collected data segments received from the ambulatory monitor device using the arrhythmia analysis device (e.g. ¶¶ 77).
Regarding claims 2 and 14, Heneghan discloses the arrhythmia analysis device is configured to determine a confidence of the detection of the cardiac arrhythmia; and the ambulatory monitor device is configured to adjust the segment duration, including to increase the segment duration in response to the determined confidence falling below a confidence threshold, and to maintain or decrease the segment duration in response to the determined confidence exceeding a confidence threshold (e.g. ¶¶ 73 – “cause the control program to begin transmitting data to host computer 110 at higher temporal resolution or frequency when the control program 124 detects signs of AF or arrhythmias.”).
Regarding claims 3 and 15, Heneghan discloses the arrhythmia analysis device is configured to determine an instability of the detected cardiac arrhythmia; and the ambulatory monitor device is configured to adjust the segment duration, including to increase the segment duration in response to the determined instability exceeding an instability threshold, and to maintain or decrease the segment duration in response to the determined instability falling below the instability threshold (e.g. ¶¶ 73 – “cause the control program to begin transmitting data to host computer 110 at higher temporal resolution or frequency when the control program 124 detects signs of AF or arrhythmias.”).
Regarding claims 4 and 16, Heneghan discloses the ambulatory monitor device is configured to collect the data segments periodically with a data collection period longer than the segment duration (e.g. ¶¶ 70 – “The arrhythmia event data may describe one or more arrhythmia types and arrhythmia durations that are associated with the one or more arrhythmia types.”).
Regarding claim 5, Heneghan discloses the ambulatory monitor device is configured to intermittently collect the data segments in accordance with a data collection schedule such that a time interval between at least two adjacent collections is longer than the segment duration (e.g. ¶¶ 70 – “The arrhythmia event data may describe one or more arrhythmia types and arrhythmia durations that are associated with the one or more arrhythmia types.”).
Regarding claims 6 and 17, Heneghan discloses the ambulatory monitor device is configured to adjust the data segment collection rate or schedule, including to: intermittently collect the data segments in accordance with a first data segment collection rate or schedule over a first monitoring period; and intermittently collect the data segments in accordance with a second data segment collection rate or schedule different than the first data segment collection rate or schedule over a second monitoring period (e.g. ¶¶ 80).
Regarding claim 7, Heneghan discloses the arrhythmia analysis device is configured to determine a characteristic of the detected cardiac arrhythmia, wherein the ambulatory monitor device is configured to adjust the data segment collection rate or schedule based on the determined characteristic of the detected cardiac arrhythmia (e.g. ¶¶ 70, 80, etc.).
Regarding claim 8, Heneghan discloses the characteristic of the detected cardiac arrhythmia includes one or more of a heart rate or a duration of the detected cardiac arrhythmia (e.g. ¶¶ 54, 75, etc.).
Regarding claims 9 and 18, Heneghan discloses the arrhythmia analysis device is configured to determine a risk of the cardiac arrhythmia in the patient; and the ambulatory monitor device is configured to adjust the data segment collection rate or schedule based on the risk of the cardiac arrhythmia (e.g. ¶¶ 119).
Regarding claims 10 and 19, Heneghan discloses the arrhythmia analysis device is configured to determine a risk of the cardiac arrhythmia in the patient based on at least one of a physiological signal different from the cardiac signal sensed from the patient, a time of a day during the monitoring period, or an arrhythmia history of the patient (e.g. ¶¶ 71, 74, 80, etc.).
Regarding claim 11, Heneghan discloses the arrhythmia analysis device is configured to detect the cardiac arrhythmia including an atrial fibrillation (AF) episode from each of the intermittently collected data segments (e.g. ¶¶ 52).
Regarding claims 12 and 20, Heneghan discloses a user interface coupled to the arrhythmia analysis device, the user interface is configured to receive a user adjudication of the detected cardiac arrhythmia as a true-positive or a false-positive detection, wherein the ambulatory monitor device is configured to adjust one or more of the segment duration or the data segment collection rate or schedule in response to the true-positive detection (e.g. ¶¶ 81-83).
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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