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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites, “a fidelity metric for the heart signal”, where the term “fidelity metric” lacks reasonable boundaries for its meaning. Although specification repeatedly states fidelity metric is determined, it doesn’t define what constitutes the fidelity metric, how the disturbance level is converted into the claimed fidelity metric, or form of the metric. As such, the scope of the claimed invention is unclear and indefinite.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 1-2, 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20100007413 A1 to Herleikson (hereinafter “Herleikson”) in view of US 20200138325 A1 to Govari (hereinafter “Govari”).
Regarding Claim 1 and 9, Herleikson teaches an electrocardiogram (ECG) system (see Para 01: “system capable of acquiring a patient electrocardiogram (ECG)”), the system comprises;
a signal generator configured to induce an ECG test signal into a tissue of a patient via a first plurality of electrodes (see Abstract: “A signal generator coupled to a reference electrode injects an alternating signal into the patient”, also Para 6-10, 18, 26);
a second plurality of electrodes configured to attach to skin of the patient to detect an ECG heart signal (see Para 26: “ an AC voltage V1 is delivered to the patient through reference electrode REF and the differential array amplifier 102 detects the AC signal as input signals for the ECG channels”, and Para 18-19: “The system 100 further includes a differential array amplifier 102 configured for a four-electrode ECG circuit. The four electrodes include one reference electrode REF and three sensing electrodes. Alternative embodiments of the invention, however, can include greater or fewer electrodes for coupling to a patient”) and further configured to detect the ECG test signal (see Abstract and Para 10);
a signal processor (see Para 20: “digital data are evaluated by conventional processing circuitry (not shown)”) configured to:
receive an ECG signal comprising a heart signal portion, based on the detected ECG heart signal, and a test signal portion, based on the detected ECG test signal (see Para 20-21: “In response to the input signals Ain, Bin, Cin from the patient electrodes, respective output signals Aout, Bout, Cout are generated by the op-amps 110A-110C and provided at output nodes 130A-130C. The Aout, Bout, and Cout signals are provided to a conventional analog-to-digital (A/D) converter (not shown) for converting the output signals into digital data representing the output signals. The digital data are evaluated by conventional processing circuitry (not shown) to determine whether any of the output signals exceed a threshold voltage …”, also Para 07, 26 (it should be noted that injected signal corresponds to test signal portion and acquired ECG signal corresponds to heart signal portion));
detect one or more disturbances in the test signal portion based on a comparison between the test signal portion and the induced ECG test signal (see Para 25-27: “… an AC voltage V1 is delivered to the patient through reference electrode REF and the differential array amplifier 102 detects the AC signal as input signals for the ECG channels. The differential array amplifier 102 dynamically measures the common mode rejection capability of the complete ECG measurement system while it is connected to the patient. Degraded common mode performance, as manifested by a different input gain or frequency response for one electrode than for another electrode, is an indication that the quality of the contact of an electrode is poor. The change in input gain or frequency response occurs when the electrode contact impedance is large enough such that the input impedance of the ECG system begins to cause phase shift and/or attenuation of the signal …” also Para 10 (compares the injected signal with expected injected signal for disturbances (phase shift, attenuation, gain change, frequency response)));
determine a disturbance level for the test signal portion based on the one or more disturbances (see Para 20: “The digital data are evaluated by conventional processing circuitry (not shown) to determine whether any of the output signals exceed a threshold voltage. Where an output signal does exceed the threshold voltage, it is indicative of poor electrode contact”, also Para 10, 26); and
determine a fidelity metric for the heart signal portion based on the disturbance level (see Para 20: “The digital data are evaluated by conventional processing circuitry (not shown) to determine whether any of the output signals exceed a threshold voltage”).
Herleikson teaches determining the ECG measurement quality based upon degradation of the injected signal by determine whether any of the output signals exceed a threshold voltage. However, does not explicitly teach determining a fidelity metric for the ECG based on the signal evaluation and threshold.
Another reference, Govari also teaches an electrocardiogram (ECG) system (an electrocardiogram (ECG) monitoring system 20, … to sense ECG signals from a heart (not shown) of a patient 24, so as to monitor cardiac irregularities (Para 23)), a second plurality of electrodes configured to attach to skin of the patient to detect an ECG heart signal (see Para 24-25: “system 20 comprises one or more external patches 22 adapted to adhere to the skin of patient 24 … each patch 22 comprises multiple electrodes (shown in an inset 26) configured to sense ECG signals from the patient heart …”), and further configured to detect the ECG test signal (see Para 28-30, 35 (reference electrode 30M as a baseline signal could corresponds to detected ECG test signal for further comparison));
a signal processor (see Para 30: “processing unit 40 further comprises a memory 48, connected to processor 44”) configured to:
receive an ECG signal comprising a heart signal portion, based on the detected ECG heart signal, and a test signal portion, based on the detected ECG test signal (see Para 28);
detect one or more disturbances in the test signal portion based on a comparison between the test signal portion and the induced ECG test signal (see Para 52);
determine a disturbance level for the test signal portion based on the one or more disturbances (see Para 34, 41-42);
determine a fidelity metric for the heart signal portion based on the disturbance level (see Para 34-35: “processor 44 is configured to estimate two or more noise levels associated with the ECG signals sensed by two or more respective pairs of electrodes …”, also Para 19, 21, 40-42, 49-54).
Accordingly, it would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the ECG system of Herleikson teaching by incorporating the ECG noise estimation and signal quality evaluation techniques of Govari to improve ECG quality. The modification would enable the system to use the disturbance measured in injected reference signal to quantify the fidelity of the ECG signal, thereby improving reliability and diagnostic accuracy of ECG monitoring.
Regarding Claim 2 and 12, Herleikson in view of Govari teach the modified system of claim above, Govari further teach wherein the signal processor is further configured to filter out at least a portion of the ECG signal upon detection of the one or more disturbances (see Para 42: “processor 44 is configured to estimate two or more noise levels associated with the ECG signals sensed by two or more respective pairs of electrodes among electrodes 30A . . . L. Subsequently, processor 44 is configured to select the electrical signals that have the smallest noise level, to store only these best-performing electrical signals in memory 48, and to discard all other electrical signals having noise level larger than the selected signals”, also Para 54-55, 06, 15, 17, 37).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the ECG system of Herleikson teaching in combination with Govari teaching to incorporate the ECG noise detection and evaluating signal quality for signal selection to predictably improve diagnostic reliability and reducing disturbance/noise sources in ECG signals. It involves combination of known technique to improve similar devices in the same field for expected benefit (see MPEP § 2143 (I)(C)).
Claim(s) 3, 8, 11, 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herleikson in view of Govari as applied to claim 1 and 9 above, and further in view of US 20190223741 A1 to Pemberton et al. (hereinafter “Pemberton”).
Regarding Claim 3, 11, and 13, Herleikson in view of Govari teach the modified system of claim above, where it compares measured output signal against a threshold (see Herleikson Para 20) and detects disturbance/noise and filter out and select acceptable signal (see Govari Para 34 and 42), but fails to explicitly teach comparing disturbance level to a disturbance threshold to filter out the signal.
Another reference, Pemberton teach an ECG monitoring system (see Abstract), wherein determining the fidelity metric further comprises (see Para 07-09):
comparing the disturbance level to a disturbance threshold (see Para 26: “The rapid acquisition module 11 further includes instructions executable to calculate a noise level in the initial ECG lead data, and compare the calculated noise level to a noise threshold. Accordingly, the rapid acquisition module 11 determines when a noise level in the initial ECG lead data recorded in each lead is less than the noise threshold”, also Para 32-33); and
filtering out at least a part of the ECG signal when the disturbance level meets or exceeds the disturbance threshold (see Para 28: “ECG dataset 40 has been automatically recorded that meets the noise level requirements, such as while the noise level in each lead is less than the noise threshold for that lead and/or below a general noise level threshold set for all leads, the ECG dataset 40 is stored (noisy ECG are not stored, only acceptable data, therefore filtering the noisy data)” also Para 20, 32-33).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the ECG system of Herleikson in view of Govari to incorporate the threshold based ECG acceptance taught by Pemberton, where measured disturbance/noise level is compared with a threshold and ECG exceeding that threshold is filtered out. Thereby improving ECG fidelity by preventing analysis of noisy signal portions and improving diagnostic processing.
Regarding Claim 8 and 15, Herleikson in view of Govari teach the modified system of claim above, where signal generator induces electrical signal into the patient through electrode (see Para 08, 18, 20), ECG electrode detecting patient ECG signals (see Para 18, 26) and controlled signal generator timing (see Para 08, 18, 29), however fail to teach first beat portion and a second beat portion of the ECG heart signal and induce the ECG test signal in between.
Another reference, Pemberton teach an ECG monitoring system (see Abstract), wherein the signal processor is further configured to: determine a first beat portion and a second beat portion of the ECG heart signal, based at least in part on the heart signal portion (see Para 03-04); and selectively control a timing of the signal generator to induce the ECG test signal between the first beat portion and the second beat portion of the ECG heart signal (see Para 04, 23-24, 32).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the ECG system of Herleikson in view of Govari to incorporate the processor based analysis taught by Pemberton, to incorporate the ECG waveform detection and timing analysis so that the signal generator timing is controlled relative to detected ECG waveform, thereby improve signal acquisition by avoiding interference.
Claim(s) 4 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herleikson in view of Govari as applied to claim 1 and 9 above, and further in view of US 20170143275 A1 to Levin et al. (hereinafter “Levin”).
Regarding Claim 4 and 14, Herleikson in view of Govari teach the modified system of claim above, where it teaches selecting injected signal of any frequency or waveform (see Herleikson Para 29), but fails to explicitly teach signal processor selectively control the signal generator so that the ECG test signal shares one or more spectral characteristics with the ECG heart signal.
Another Reference, Levin teaches signal measurement, and reduction of interference in signal measurement, and specifically to reduction of interference in electrocardiograph (ECG) measurements (see Para 01), wherein the signal processor is further configured to selectively control the signal generator so that the ECG test signal shares one or more spectral characteristics with the ECG heart signal (see Para 17-21: “ a processor, which is configured to … inject a known calibration signal to the subject via the injection electrode”, also Para 43-51 (processing unit 66 selects and controls characteristics of the generated signal), 27-28, 59, 73, 90-95).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the ECG system of Herleikson in view of Govari to incorporate selectively control the signal generator to produce a signal having selected frequencies within the expected ECG signal frequency range taught by Levin, thereby predictably improving accuracy of disturbance and fidelity determination also improving ECG signal quality by reducing noise.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herleikson in view of Govari as applied to claim 1 above, and further in view of US 20210228134 A1 to Trapero et al. (hereinafter “Trapero”).
Regarding Claim 5, Herleikson in view of Govari teach the modified system of claim above, where it teaches signal may be of any frequency or waveform (see Herleikson Para 29), but does not explicitly teach a rectangular pulse wave or frequencies associated with the one or more disturbances.
Another Reference, Trapero teaches a system for acquiring electrocardiograph (ECG) (see abstract), wherein the ECG test signal comprises a rectangular pulse wave (see Para 137-143: “ … impedance measurements can make use of a wideband stimulation signal, such as a square wave, chirp, maximum length sequence (MLS) or sinusoidal wave. A square wave usually suffers from lower magnitudes at higher frequencies and a chirp waveform often leads to a low signal-to-noise ratio. Consequently, a sinusoidal wave or a MLS may be preferably applied as the injection current …” (rectangular pulse wave is generally understood in the art to be a form of square wave)), and the signal processor is further configured to determine one or more frequencies associated with the one or more disturbances (see Para 13: “The ECG/BI measurement system can implement filters to promote a high signal-to-noise ratio, which permits even small R-peaks to be discerned in noisy conditions like those formed through motion or imprecise placement of electrodes. In some cases, because high-frequency noise can be a primary cause of ECG signal distortion, the ECG/BI measurement system can include a low-pass filter to reduce the overall processing system complexity”, also Para 148, 155).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the ECG system of Herleikson in view of Govari to incorporate well known signal processing techniques, a rectangular (square) pulse wave and to do frequency based analysis taught by Trapero to enable identification of frequency associated with detect disturbances, thereby improving signal characterization and assessment of signal quality.
Regarding Claim 6, Herleikson in view of Govari teach the modified system of claim above, but fails to teach wherein the ECG test signal comprises a sine wave, the signal processor is further configured to selectively control the signal generator to continuously increase the frequency of the sine wave.
Trapero teaches a system for acquiring electrocardiograph (ECG) (see abstract), wherein the ECG test signal comprises a sine wave (see Para 141: “a sinusoidal wave or a MLS may be preferably applied as the injection current” also Para 219), the signal processor is further configured to selectively control the signal generator to continuously increase the frequency of the sine wave (see Para 139: “the injection current includes a sweeping current (e.g., a current that changes frequency over time, such as changing frequency between a first endpoint and a second endpoint within the range of 1 kHz and 200 kHz” also Para 106, 148), and the signal processor is further configured to determine one or more frequencies associated with the one or more disturbances based, at least in part, on the changing frequency of the sine wave (see Para 148, 155-156, 218-220) .
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the ECG system of Herleikson in view of Govari to incorporate frequency swept sinusoidal signal taught by Trapero to describe frequency dependents signal behavior, thereby predictably improve the detection and analysis of disturbances across multiple frequencies, resulting more accurate signal quality.
Regarding Claim 7, Herleikson in view of Govari teach the modified system of claim above, but fail to integrate the electrode and processor into a wearable device.
Trapero teaches a system for acquiring electrocardiograph (ECG) (see abstract), wherein the first plurality of electrodes and the signal processor are integrated into a wearable device (see Para173 - 174: “wearable device 12110 may be a smartwatch, … smart patch … The wearable device 13110 may include … electrodes 13230 … the electrodes 13230 may only include two, three, four, five, or six electrodes … The sensor module 13200 … may include a wired connection to a signal processor)” also Para 16, 42, 179).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the ECG system of Herleikson in view of Govari to incorporate the system into a wearable device for monitoring, thereby made into smaller size, more comfortable, and more inconspicuous formats, as well as decreasing the number of points of failure in electrical conductivity between the system and the user. Thus, such wearable devices can be constructed more easily (e.g., with fewer parts, fewer connections, and/or fewer metal components). Additionally, the increased convenience to a user may improve user compliance, which can lead to more data acquisition, improved data acquisition over time (e.g., via further AI training), and improved ability for the wearable device to detect a medical condition or otherwise provide actionable feedback or data (see Para 16).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herleikson in view of Govari as applied to claim 9 above, and further in view of US 20190223741 A1 to Pemberton et al. (hereinafter “Pemberton”) also in view of US 20210228134 A1 to Trapero et al. (hereinafter “Trapero”).
Regarding Claim 10, Herleikson in view of Govari teach the modified system of claim above, but fail to explicitly teach receiving a first ECG signal at a first time; determining a patient heart rate based, at least partially, on the heart signal portion of the first ECG signal; receiving a second ECG signal at a second time; determining a change in the patient heart rate based, at least partially, on the heart signal portion of the second ECG signal; and determining a change in patient glucose level based, at least partially, on the determined change in patient heart rate, and determining a fidelity metric for each lead within the second plurality of electrodes; comparing each of the fidelity metrics to a fidelity threshold; and selectively recording the ECG signal detected by a lead within the second plurality of leads only when the fidelity metric corresponding to the lead meets or exceeds the fidelity threshold.
Pemberton teach an ECG monitoring system (see Abstract), where receiving a first ECG signal at a first time (see Para 03, 23-24); determining a patient heart rate based, at least partially, on the heart signal portion of the first ECG signal (see Para 03-04); receiving a second ECG signal at a second time (see Para 28 (acquire ECG datasets after the recording timer begins, demonstrate acquisition at a later time)); determining a change in the patient heart rate based, at least partially, on the heart signal portion of the second ECG signal (see Para 04); and determining a change in patient glucose level based, at least partially, on the determined change in patient heart rate.
Another reference, Trapero teaches system for acquiring electrocardiograph (ECG) (see Abstract), where determining a change in patient glucose level based, at least partially, on the determined change in patient heart rate (see Para 18, 52-55, 61, 184-202).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the ECG system of Herleikson in view of Govari to combine with the teaching of Pemberton and Trapero to configure the processor to determine the glucose level change based on change in patient heart rate to provide additional patient metabolic information without altering underlying ECG acquisition functionality.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20150216433 A1 - Generally relevant art as a whole.
US 20210236038 A1 - Art relevant as a whole (see abstract).
US 10772525 B2 - Art relevant as a whole (see detailed description).
US 10278602 B2 - Art relevant as a whole.
US 20160007928 A1 - Art relevant as a whole (see abstract).
US 20150223712 A1 - Art relevant as a whole.
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/I.J./Examiner, Art Unit 3792
/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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