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 remarks filed 2/23/2026 have been fully considered but are not persuasive.
On p. 7, Applicant alleges that the Hughes reference does not teach producing a request signal immediately after a parameter is determined to be out of a predetermined range.
Under BRI, the teaching of Hughes which produces a request immediately after one of the events (as noted by Applicant in the diagram), this limitation is met by Hughes in ¶[0155]. Furthermore, Applicant provides no guidance as to the time scale of “immediately”. The Examiner is considering “immediately after” to be met by a lack of intervening steps. Furthermore, Applicant’s characterization of Hughes in ¶¶[0167-0168] mischaracterizes the request in ¶[0168] as merely “further analysis.” By contrast, Hughes ¶[0168] states that the request for transmission is produced when a confidence exceeds a threshold, therefore meeting the requirement for an immediate request after a parameter is out of a predetermined range (the confidence exceeding a threshold).
Lastly, even though the Examiner considers the above sufficient to teach this limitation, Mass further teaches immediately requesting transmission upon a parameter exceeding a threshold in ¶[0129].
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification as filed lacks any antecedent basis for the phrase “immediately after” as no specific immediacy is apparently described.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3, 9, and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hughes et al. (U.S. Patent Application Publication No. 2017/0188872) hereinafter referred to as Hughes; in view of Zhang et al. (U.S. Patent Application Publication No. 2013/0317336) hereinafter referred to as Zhang; in view of Mass (U.S. Patent Application Publication No. 2013/0310896) hereinafter referred to as Mass.
Regarding claim 3, Hughes teaches an electrocardiographic measurement system comprising:
an electrocardiographic transmitter (¶[0122] ECG circuit, ¶[0142] extract, transmit, and analyze electrocardiographic signal data) that includes a processor (¶[0181], ¶[0187], ¶[0188] processors), an electrocardiographic signal detection circuit configured to detect an electrocardiographic signal (¶[0122] ECG circuit) and a wireless communication circuit configured to wirelessly transmit the electrocardiographic signal (¶[0137]), the electrocardiographic transmitter being attachable to a body of a subject (¶[0095] flexible body and electrodes for wearing by the subject, Figs. 9A-9F); and
a terminal configured to receive the electrocardiographic signal that is wirelessly transmitted from the electrocardiographic transmitter (¶[0145] communication device receives data wirelessly, ¶[0153] server),
wherein:
the electrocardiographic signal detection circuit (¶[0122] ECG circuit) comprises:
a detection circuit for detecting a feature wave which is any one of an R-wave, a P-wave, a Q-wave, an S-wave or a T-wave in the electrocardiographic signal (¶[0162] R, Q, T peaks, ¶[0143] QRS complex onset or offset); and
the terminal (¶[0145] communication device receives data wirelessly, ¶[0153] server) is further configured to: (i) compute a parameter of the electrocardiographic signal, the parameter being obtained in real time (¶[0152] real-time estimate of R-peak location in the ECG, ¶[0161] real-time QRS complex detection algorithm) from a synchronous pulse (¶¶[0162-0164], ¶¶[0166-0167] feature extraction based on timing of a detected peak—the Examiner considers the timing of the peak to be a synchronous pulse for the purpose of computing a parameter though the synchronous pulse producer is taught below in combination with Zhang); (ii) determine whether or not the parameter is out of a predetermined range (¶¶[0166-0167]); and (iii) produce a request signal immediately after the parameter is determined to be out of the predetermined range (¶[0155] request signal for 90-second events in full resolution to support comprehensive analysis as the result of a triage approach, ¶¶[0167-0168] confidence of determination of arrhythmia, i.e. heart parameter is out of health range and may indicate arrhythmia and there is no intervening process therefore the request is produced immediately after a confidence exceeds a threshold);
the processor is further configured: (i) to transmit real time (¶[0150] transmit, in real-time or near real-time) electrocardiogram data based on the electrocardiographic signal through the wireless communication circuit to the terminal (¶[0145] communication device receives data wirelessly, ¶[0153] server), upon receipt of the request signal from the terminal, when the parameter is determined to be out of the predetermined range (¶[0155] request signal for 90-second events in full resolution to support comprehensive analysis as the result of a triage approach, ¶¶[0167-0168] confidence of determination of arrhythmia, i.e. heart parameter is out of health range and may indicate arrhythmia); and (ii) not to transmit the real time electrocardiogram data to the terminal when the parameter is determined to be within the predetermined range (¶[0155] only selected features are transmitted for every beat, and the full resolution signal is only sent upon request when an abnormality is detected, ¶[0150] transmit, in real-time or near real-time, specific sections, therefore not all of the signal); and
the power consumption in the electrocardiographic transmitter is reduced by not transmitting the real-time electrocardiogram data, but only the synchronous pulse, to the terminal when the parameter is determined to be within the predetermined range (¶[0142] selective transmission of extracted data allows for decreased power consumption because the wearable patch is not required to transmit all recorded data).
Hughes does not teach a synchronous pulse producer for producing a synchronous pulse synchronizing with the feature wave, the synchronous pulse being supplied to the processor; the synchronous pulse is a periodic signal; the processor is configured to transmit the synchronous pulse. Hughes also does not teach the immediate real-time transmission including currently acquired ECG data.
Attention is brought to the Zhang reference, which teaches a synchronous pulse producer for producing a synchronous pulse synchronizing with the feature wave (Fig. 4, R-wave detection and trigger pulse generation), the synchronous pulse being supplied to the processor (¶[0047]); wherein the synchronous pulse is a periodic signal (Fig. 4) and the processor is configured to transmit the synchronous pulse through a communication circuit to a terminal (Fig. 1), wherein monitoring and detection is performed in real time (¶[0024], ¶¶[0026-0027]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the signal transmission of Hughes to include a synchronous pulse producer producing a synchronous pulse, as taught by Zhang, because using ECG timing as a trigger for signal acquisition improves cardiac function imaging (Zhang, ¶[0003]) as well as compensating for natural circuit delay in any system relying on ECG synchronization (Zhang, ¶[0003], ¶[0005]).
Hughes as modified also does not teach the real-time transmission including currently acquired ECG data.
Attention is brought to the Mass reference, which teaches continuous real-time wireless transmission including currently acquired ECG (¶[0041] electrogram) data (¶[0344]), triggered immediately after a patient emergency (¶[0129]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the transmission criteria of Hughes as modified to include real-time streaming of currently acquired ECG data, as taught by Mass, because Mass teaches that “dynamically adjusting the type and quantity of (medical device) data needed to evaluate a patient’s condition is preferably implemented to conserve (medical device) power,” (Mass ¶[0342]).
Regarding claim 9, the claim is directed to substantially the same subject matter as claim 3 and is rejected under substantially the same sections of Hughes, Zhang, and Mass.
Regarding claims 11-12, Hughes as modified teaches the electrocardiographic measurement system/transmitter according to claim 3/9.
Hughes further teaches wherein the parameter is selected from the group consisting of average value, minimal value, maximal value, median value, most frequent value, dispersion, and standard deviation of a heart rate in a predetermined period of time (¶¶[0163-0164] minimum, range, maximum, R-R interval length refers to the timing between R-peaks therefore representing a heart rate).
Regarding claims 13-14, Hughes as modified teaches the electrocardiographic measurement system/transmitter according to claim 3/9.
Hughes further teaches transmitting electrocardiogram data based on the electrocardiographic signal through a wireless communication circuit to the terminal (¶[0145] communication device receives data wirelessly, ¶[0153] server), upon receipt of the request signal from the terminal, when the parameter is determined to be out of the predetermined range (¶[0155] request signal for 90-second events in full resolution to support comprehensive analysis as the result of a triage approach, ¶¶[0167-0168] confidence of determination of arrhythmia, i.e. heart parameter is out of health range and may indicate arrhythmia).
Mass further teaches wherein a processor (¶[0007]) is further configured to continuously transmit, in real time, the current electrocardiogram data based on the electrocardiographic signal through a wireless communication circuit (¶[0042]) to a terminal (¶[0037]), upon receipt of a request signal from the terminal (¶¶[0085-0086]), when a parameter is determined to meet an urgent or emergent criteria (¶[0344]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the transmission criteria of Hughes as modified to include real-time streaming of currently acquired ECG data, as taught by Mass, because Mass teaches that “dynamically adjusting the type and quantity of (medical device) data needed to evaluate a patient’s condition is preferably implemented to conserve (medical device) power,” (Mass ¶[0342]).
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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