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 (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 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.
Claim(s) 1, 3, 5-9, 14 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koo et al. (Koo: Pub. No. 2010/0305414).
Regarding claim 1, with related comments applying to similarly worded claims 14 and 20, Koo discloses an electrocardiogram sensor (par. 0005, 0023, ECG), comprising: an input port configured to receive an electrocardiographic signal (inherently necessary for signal collection from sensor 111 of Fig. 2); at least one automated processor (controller 12), configured to: process a representation of the electrocardiographic signal to determine an electrocardiographic waveform for a heartbeat cycle (par. 0043, ECG waveform); and encode a set of quantitative parameters from the electrocardiographic waveform, dependent on a plurality of relationships within the electrocardiographic waveform comprising both amplitude-dependent features and time-dependent features of the electrocardiographic waveform (par. 0044, heart rate dependent upon relative amplitude/peaks of the ECG, e.g., QRS complex/R wave; heart rate variation dependent upon relative time differences between subsequent beats); and a communication device 15, under control of the at least one automated processor (see Fig. 2), configured to communicate the encoded set of quantitative parameters through a communication channel (Fig. 1, biological information wirelessly transmitted through communication channel to medical service device 3) wherein the at least one automated processor is further configured to operate the electrocardiogram sensor in a plurality of different power consumption modes comprising respectively different duty cycles of operation of the communication device (par. 0037 duty cycle adaptively controlled).
Regarding claim 3, see memory 14 configured to store biological information prior to transmission through the communications channel. Arrhythmia information may be transmitted (par. 0042) which inherently would require determination of arrhythmias prior to transmission (abnormal state determined, pars. 0027, 0029). Koo teaches that only portions of the data may need to be transmitted, thus not requiring the use of a stream of digitized values comprising the complete ECG (pars. 0034, 0038-0044; e.g., transmission of G1 information rather than the transmission of the waveforms of the ECG graph themselves).
Regarding claim 5, see biological information obtaining unit 11 of Fig. 2, where controller 12 receives the digitized information and determines heart rate as already discussed above.
Regarding claim 6, heart rate and heart rate variability are considered “standardized electrocardiographic features” comprising both amplitude and time-dependent features.
Regarding claims 7 and 9, note pars. 0007-0009.
Regarding claim 8, Koo teaches to generate different types of information packets dependent upon the intensity of the wireless signal received by relay device 2 (par. 0045). The ability of the receiver to receive is predicted by the intensity of the wireless signal.
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.
Claim(s) 4, 10, 11, 15 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koo et al. ‘414.
Regarding claims 4 and 15, receiver 3 (Fig. 1) is configured to receive the set of quantitative parameters which may be viewed by a medical expert to determine whether the wearer of the device is in an abnormal state (par. 0034). The particular type of known arrhythmia to be detected would clearly be a matter of obvious design dependent upon the patient’s condition and the expertise of the medical practitioner under whose care the patient resides.
Regarding claims 10 and 18, data storage unit 14 is considered a buffer that receives and stores the digitized ECG data prior to transmission in accordance with the selected transmission mode. Official Notice is taken that it is old and well-known in the art that portions of a data buffer are typically overwritten to make room for subsequent data. Such buffers are commonly used to temporarily hold data prior to transmission, and help to account for differences in processing speeds between components of the system. To utilize such a common storage means would have been considered a matter of obvious design by those of ordinary skill in the art.
Regarding the use of a trigger (claim 18), Koo teaches that transmission of various information may be triggered dependent upon various threshold values (par. 0044). When a threshold value is reached, the transmission of certain types of data is triggered. The examiner also additionally notes that it is old and well-known in the art to allow a patient and/or medical expert to trigger transmission of medical ECG data, such as when the patient is experiencing a heart abnormality, or when the medical expert requires information on demand. Official Notice of the latter feature is taken.
Regarding claim 11, Official Notice is taken that it is old and well-known in the ECG art to employ flexible adhesive patches to securely hold ECG electrodes on the body and thus permit the ECG to be measured. Such ubiquitous means offer a quick, stable, convenient, sterile and comfortable manner of applying and removing ECG electrodes to skin. Furthermore, while Koo discloses the use of wireless communication, the use of BLUETOOTH™ is not explicitly discussed. Official Notice is also taken that BLUETOOTH™ is a well-known wireless communication technique often used to transmit signals, and known for its low power usage, ease of use and convenience. To allow transmission using this well-known technique of data from the wearable ECG device to a peripheral receiving device would have clearly been seen as a matter of obvious design.
Claim(s) 2, 12, 13, 16, 19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koo as applied to claims 1, 3, 5-9, 14 and 20 above, and further in view of Crockford (Pub. No. 2013/0245480).
Regarding claim 2, Crockford teaches that absolute or relative amplitudes and absolute or relative timing of various features of the ECG including time duration of the QRS complex and time differences between R-waves, P-waves etc., may be employed in order to characterize the ECG and thus heart function (par. 0101). Such features are widely recognized for their value in diagnosing various cardiac abnormalities and arrhythmias as discussed by Crockford. To utilize this information in a heart monitoring device such as disclosed by Koo would have thus been considered clearly obvious to those of ordinary skill in the medical arts concerned with providing proper diagnosis.
Regarding claims 12 and 19, while Koo does not explicitly discuss identifying an R peak, QRS complex, P wave, and T wave (the calculation of heart rate and/or HRV such as required by Koo traditionally involves identification of at least an R peak and/or QRS complex), it is old and well-known to detect these important landmarks of the ECG in order to determine quantitative parameters such as ventricular heart rate (R-R interval), atrial heart rate (P-P interval), QRS morphology, ST segment deviation, T-wave morphology, etc., such that the heart’s condition can be accurately diagnosed. Crockford, for example, teaches that ECG monitors typically identify these features in order to diagnose cardiac abnormalities (pars. 0042 and 0101). To identify such features within the ECG signal would have therefore been considered clearly obvious to artisans of ordinary skill in the medical arts.
Regarding claims 13, 16 and 21, Crockford teaches that absolute or relative amplitudes and absolute or relative timing of various features of the ECG may be employed in order to characterize the ECG and thus heart function (par. 0101), including QT intervals which represent latency or relative latency of ECG features. Once again, the particular needs of the patient and the expertise of the physician under whose care the patient resides would dictate the information of interest for diagnostic purposes.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-16 and 18-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
June 8, 2026
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