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 .
Response to Arguments
Applicant’s arguments with respect to the previous rejection(s) of the claims have been fully considered and are not found persuasive.
Regarding claims 1 and 13, Applicant contends that the cited portions of Heneghan teach selectively obtaining and storing segments based on motion detection and is distinct from applicant’s claims requiring when and how often to collect data. The examiner disagrees and respectfully notes that the prior art is specifying when and how often to collect data - when a motion threshold set by the motion detector is reached, collection of PPG data segments occurs. This disclosure reads on the language requiring collection of data “in accordance with a data segment collection schedule over a monitoring period…” as claimed.
Regarding claims 6 and 17, applicant contends that changing frequency sample rate from 25-100 Hz does not read on the language. Examiner agrees and notes that ¶¶ 80 only briefly mentions a different sample rate / resolution – but the majority of the paragraph discusses alternative options for frequency in data collection through describing a plurality of events where the schedule may change from what was discussed above w/ regard to the motion sensor, to a circular buffer of 10 seconds of data or data surrounding the detection of arrhythmia, etc. which reads on the second data segment collection rate or schedule language.
Regarding claims 2 and 3, applicant contends that the prior art does not teach determining a confidence or instability metric quantifying the reliability of arrythmia detection; however, the claims do not require a quantitative determination. The disclosure is clear that in order to ensure an arrhythmia is detected, a higher temporal resolution threshold is generated. This is as a result of not being confident or lacking stability with the output and data from the default level of resolution.
Regarding claims 4-5 and 16, applicant contends that the cited portions do not address the claim language; however, the examiner cited the portions in the prior art that describe an embodiment where not only arrhythmia data segments are periodically collected, but also data collection periods which as “associated with” the one or more arrhythmia types.
Accordingly, the rejections are maintained below.
Claim 11 has been amended and the rejection has been withdrawn below.
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 1-10, 13-18, and 20-21 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 claim 10, 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 20, Heneghan discloses receiving 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).
Regarding claim 21, Heneghan discloses the data segment schedule is a predetermined data segment collection schedule (e.g. ¶¶ 79-80 – where the predetermined collection schedule is based on the motion sensor threshold).
Allowable Subject Matter
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 22 is allowed.
Conclusion
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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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