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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/17/2026 has been entered.
Response to Arguments
Applicant’s amendments and remarks overcome the objection to the Specification and merit new grounds for rejection over Hughes et al. (U.S. Patent Application Publication No. 2017/0188872) hereinafter referred to as Hughes; in view of Stern. (U.S. Patent No. 3,742,938) hereinafter referred to as Stern; in view of Mass (U.S. Patent Application Publication No. 2013/0310896) hereinafter referred to as Mass.
Stern teaches a synchronous pulse producer for producing a synchronous pulse synchronizing with the feature wave (col. 6, lines 56-59 detecting the R wave, col. 6 lines 63-67 a pulse corresponding to the R wave), the synchronous pulse being supplied to the processor (col. 1, lines 55-63, col. 6, lines 63-67); wherein the synchronous pulse is a periodic signal (Fig. 3C is the pacer signal, in col. 6 lines 56-67, the embodiment without a pacer signal is nevertheless a periodic pulse corresponding to R waves “as is done with the pacer spike”) and the processor is configured to transmit the synchronous pulse through a communication circuit to a terminal (Fig. 2), wherein monitoring and detection is performed in real time (col. 1, lines 64-67) without accompanying any other signal (col. 6 lines 63-67 “only a pulse corresponding to the R wave need be transmitted”).
Applicant's remarks appear to be directed solely to the combination in view of the previously cited Zhang reference and are therefore unpersuasive in light of the new grounds for rejection in view of Stern.
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 Stern. (U.S. Patent No. 3,742,938) hereinafter referred to as Stern; 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 Stern); (ii) determine whether or not the parameter is out of a predetermined range (¶¶[0166-0167]); and (iii) produce a request signal 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 there is no intervening process therefore the request is produced when 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 Stern reference, which teaches a synchronous pulse producer for producing a synchronous pulse synchronizing with the feature wave (col. 6, lines 56-59 detecting the R wave, col. 6 lines 63-67 a pulse corresponding to the R wave), the synchronous pulse being supplied to the processor (col. 1, lines 55-63, col. 6, lines 63-67); wherein the synchronous pulse is a periodic signal (Fig. 3C is the pacer signal, in col. 6 lines 56-67, the embodiment without a pacer signal is nevertheless a periodic pulse corresponding to R waves “as is done with the pacer spike”) and the processor is configured to transmit the synchronous pulse through a communication circuit to a terminal (Fig. 2), wherein monitoring and detection is performed in real time (col. 1, lines 64-67) without accompanying any other signal (col. 6 lines 63-67 “only a pulse corresponding to the R wave need be transmitted”).
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 Stern, because the invention of Stern is “simple, inexpensive, convenient and reliable,” (Stern, col. 1 lines 30-32,) and detects arrhythmias particularly significant for a post-coronary patient (Stern, col. 6, lines 55-57). Further, real-time results provide an additional benefit provided by Stern, “early detection can lead to immediate examination by a cardiologist to determine exactly what is happening to the patient so that corrective steps may be taken at a time when they will be effective,” (Stern, col. 1, lines 43-47).
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 during 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, Stern, 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2013/0231576 to Tanaka et al. teaches transmitting a simple gating pulse to mark R-wave detections for a user.
U.S. Patent Application Publication No. 2016/0114168 to Demmer et al. teaches a simple pulse synchronized with P-waves transmitted, Fig. 11A, 11B.
U.S. Patent Application Publication No. 2019/0223742 to Morikawa teaches R-wave trigger pulses in Fig. 5
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMANDA L STEINBERG/Examiner, Art Unit 3792
Prosecution Insights