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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/6/26 has been entered.
Status of Claims
Claims 1-18, 36, 40, 44, and 47 are rejected. Claims 19-35, 37-39, 41-43, 45-46, and 48-49 are canceled.
Response to Arguments
Claim Rejections - 35 USC § 101
Applicant’s arguments, see Remarks, filed 7/6/26, with respect to claims 1-18, 36, 40, 44, and 47 have been fully considered and are persuasive. Specifically, claims 1 and 36 recite a practical application “after detecting the cardiac arrhythmia, use the at least one therapy electrode to provide at least one of defibrillation or pacing to the patient.” The 101 rejection of claims 1-18, 36, 40, 44, and 47 has been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s arguments with respect to claims 1-18, 36, 40, 44, and 47 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.
Claim Objections
Claim 12 is objected to because of the following informalities: “an ECG electrode” should recite –an electrocardiogram (ECG) electrode—for clarity purposes. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: “ECG signal” should recite –electrocardiogram (ECG) signal—for clarity purposes. Appropriate correction is required.
Claim 36 is objected to because of the following informalities: “and” should be added between the last two steps of processing and filtering for clarity purposes. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 12 is amended to recite “an additional electrode that comprises at least one of an ECG electrode, a combination therapy and ECG electrode, a dry/capacitive electrode, or a fabric electrode, wherein the additional electrode includes an additional skin-contacting surface that is also configured to inject the at least one device-generated signal into the skin of the patient.” While ¶8 of the specification discloses “the skin-contacting surface can be part of at least one of a therapy electrode, an ECG electrode, a combination therapy and ECG electrode, a dry/capacitive electrode, and a fabric electrode,” the specification does not disclose “an additional electrode.” Therefore, the amended limitation in claim 12 is new matter.
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.
Claims 3, 9, 36, 40, 44, and 47 are 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.
The term “arbitrary relative” in claim 3 is a relative term which renders the claim indefinite. The term “arbitrary relative” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The use of the term arbitrary relative renders the phase as indefinite.
The term “relative” in claim 9 is a relative term which renders the claim indefinite. The term “relative” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The use of the term relative renders the quality metric as indefinite.
The term “arbitrary relative” in claim 36 is a relative term which renders the claim indefinite. The term “arbitrary relative” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The use of the term arbitrary relative renders the phase as indefinite.
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.
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.
Claims 1-12, 14, 17-18, 36, 40, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Lucci (US 20200245883 filed on 1/3/20) in view of Bossetti (US 20200077954 filed on 9/9/19), Zheng (CN 106725415 filed on 11/15/16), and Debarros (US 20210370070 filed on 10/2/19).
Regarding claim 1, Lucci teaches a system for removing device signals from surface electrical signals received from an ambulatory patient worn device, the system comprising: a wearable cardiac monitoring device configured to be continuously worn by a patient (¶61-a cardiac monitoring and/or treatment device; ¶169-the wearable medical device can be capable of continuous use by the patient), the wearable cardiac monitoring device comprising a garment that is wearable (¶76-a device includes a garment that is configured to be worn about the torso of the patient. The garment can be configured to house various components such as ECG sensing electrodes and therapy electrodes); at least one therapy electrode coupled to the garment and configured to provide at least one of defibrillation or pacing to the patient (¶14-a plurality of therapy electrodes operably coupled to the therapy delivery circuitry and configured to be coupled to the patient to deliver the therapy shock to the patient; ¶96-at least one therapeutic shock to the patient including one or more pacing or defibrillation therapeutic pulses; ¶173), the at least one therapy electrode including a skin-contacting surface (¶14-a plurality of therapy electrodes operably coupled to the therapy delivery circuitry and configured to be coupled to the patient to deliver the therapy shock to the patient; ¶68-a skin-contacting electrode surface); at least one sensing electrode configured to acquire at least one surface electrical signal from the skin of the patient (¶22-each of the plurality of sensing electrodes is configured to be coupled externally to a patient and to detect one or more ECG signals of the patient; ¶68-a skin-contacting electrode surface), the at least one surface electrical signal comprising at least one physiological signal generated by the patient (¶6-monitor each of the one or more sensing electrode pairs for ECG activity of the patient); provide the at least one physiological signal (¶6-detect one or more ECG signals), use the at least one physiological signal (¶6-monitor each of the one or more sensing electrode pairs for ECG activity of the patient) to detect a cardiac arrhythmia (¶114-the cardiac event detector 216 can be configured to monitor a patient's ECG signal for an occurrence of a cardiac event such as an arrhythmia), and after detecting the cardiac arrhythmia, use the at least one therapy electrode to provide at least one of defibrillation or pacing to the patient (¶76-provide treatment to the patient using the therapy electrodes; ¶97-pacing pulses can be used to treat cardiac arrhythmia conditions such as bradycardia (e.g., less than 30 beats per minute) and tachycardia (e.g., more than 150 beats per minute) using, for example, fixed rate pacing, demand pacing, anti-tachycardia pacing, and the like. Defibrillation pulses can be used to treat ventricular tachycardia and/or ventricular fibrillation).
However, Lucci does not explicitly teach by the patient signal generation circuitry configured to provide at least one device-generated signal having a predetermined frequency; configured to inject the at least one device-generated signal into a skin of the patient; the at least one device-generated signal; and processing circuitry different from the signal generation circuitry, the processing circuitry comprising at least one processor configured to sample the at least one surface electrical signal from the patient at a sampling frequency, wherein the sampling frequency is less than the predetermined frequency of the at least one device-generated signal, and wherein the predetermined frequency of the at least one device-generated signal is an integer multiple of the sampling frequency, identify, based on the predetermined frequency, aliasing content generated by the at least one device-generated signal within the at least one surface electrical signal, process the aliasing content identified within the at least one surface electrical signal to make a determination that at least one of the skin-contacting surface or the at least one sensing electrode has compromised contact with the skin of the patient, and filter the aliasing content generated by the at least one device-generated signal to isolate the at least one physiological signal from the at least one surface electrical signal.
Bossetti relates generally to systems and methods of processing physiological signals, and more particularly, to detecting contact with one or more electrodes of a physiological sensor (¶2). Bossetti further teaches the invention using the following steps:
by the patient signal generation circuitry configured to provide at least one device-generated signal having a predetermined frequency (¶36-test signal generator 530 and capacitor 538. In some examples, test signal generator 530 can be a square wave generator, a clock generator, a periodic signal generator or other suitable signal generator, the processor can change the frequency and/or amplitude of test signal 531 and/or enable and disable test signal generator 530; ¶41-the frequency of test signal 531 can be 100 Hz, 135 Hz, 200 Hz, 250 Hz, 400 Hz, 500 Hz, 600 Hz, or any other suitable frequency above 40 Hz); configured to inject the at least one device-generated signal into a skin of the patient (¶42-test signal generation can be periodically restarted to determine whether measurement electrode 502 is contacted; ¶39-the frequency of test signal 531 can be varied to determine the load of the signal paths at the respective frequency (e.g., the quality of the skin-to-electrode connection as a function of the test signal frequency can be determined); ¶44-it is understood that similar test signal circuitry can be integrated onto the signal path of reference electrode 504 to detect contact between the user (e.g., wrist) and reference electrode 504 in a similar manner (e.g., as illustrated in FIG. 12)); the at least one device-generated signal (¶43-the integration of the test signal circuitry with the physiological signal measurement circuitry; ¶41-the physiological signal can be mixed or otherwise added to test signal 531 generated by test signal generator 530); and processing circuitry different from the signal generation circuitry (¶5-processing circuitry), the processing circuitry comprising at least one processor configured to sample the at least one surface electrical signal from the patient at a sampling frequency (¶29-the DSP 206 can acquire a buffered sample of the physiological waveform (e.g., 3 second sample, 5 second sample, 10 second sample, 30 second sample, 60 second sample)), and to make a determination that at least one of the skin-contacting surface or the at least one sensing electrode has compromised contact with the skin of the patient (¶5-determine whether a user is in contact with the one or more measurement electrodes; ¶42-determine that contact has stopped and cease measuring and/or processing the physiological signal).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include by the patient signal generation circuitry configured to provide at least one device-generated signal having a predetermined frequency; configured to inject the at least one device-generated signal into a skin of the patient; the at least one device-generated signal; and processing circuitry different from the signal generation circuitry, the processing circuitry comprising at least one processor configured to sample the at least one surface electrical signal from the patient at a sampling frequency, and to make a determination that at least one of the skin-contacting surface or the at least one sensing electrode has compromised contact with the skin of the patient of Bossetti in order to obtain an accurate signal (Bossetti, ¶23) and monitor certain cardiac characteristics (e.g., heart rate, arrhythmias, changes due to medications or surgery, function of pacemakers, heart size, etc.) and ECG waveform characteristics (e.g., timing of certain waves, intervals, complexes of the ECG waveform) (Bossetti, ¶30).
While the combination of Lucci and Bossetti teaches sampling of the physiological waveform (Bossetti, ¶29), the combination does not teach wherein the sampling frequency is less than the predetermined frequency of the at least one device-generated signal, identify, based on the predetermined frequency, aliasing content generated by the at least one device-generated signal within the at least one surface electrical signal, process the aliasing content identified within the at least one surface electrical signal, and filter the aliasing content generated by the at least one device-generated signal to isolate the at least one physiological signal from the at least one surface electrical signal.
Zheng relates generally to the field of signal processing techniques and, more particularly, to a method and apparatus for processing an electrophysiological signal (Technical field section). Zheng further teaches the invention using the following steps:
wherein the sampling frequency is less than the predetermined frequency of the at least one device-generated signal (page 4, ¶3-when the sampling rate is less than twice the frequency interference, the occurrence of spectral aliasing), identify, based on the predetermined frequency, aliasing content generated by the at least one device-generated signal within the at least one surface electrical signal (page 2, ¶1-a sampling unit connected to the determination unit for determining, based on a sampling rate located within the frequency range, And a sampling unit connected to said sampling unit for determining a frequency spectrum of said electrophysiological signal), process the aliasing content identified within the at least one surface electrical signal (page 6, 2nd to last ¶-the processing unit 350 is connected to the calculation unit 340 for removing the spectral aliasing signal from the sampled electrophysiological signal according to the frequency of the spectral aliasing signal), and filter the aliasing content generated by the at least one device-generated signal to isolate the at least one physiological signal from the at least one surface electrical signal (page 2, ¶1-said ambient electric signal based on a sampling rate within said frequency range and a frequency of said power frequency interference signal And a processing unit connected to said calculation unit for removing said spectral aliasing signal from the sampled electrophysiological signal according to the frequency of said spectral aliasing signal; page 3, ¶5-electrophysiological signals are important information that reflects the physiological state of the human body, including but not limited to ECG).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include wherein the sampling frequency is less than the predetermined frequency of the at least one device-generated signal, identify, based on the predetermined frequency, aliasing content generated by the at least one device-generated signal within the at least one surface electrical signal, process the aliasing content identified within the at least one surface electrical signal, and filter the aliasing content generated by the at least one device-generated signal to isolate the at least one physiological signal from the at least one surface electrical signal of Zheng in order to avoid inaccuracy affecting the diagnosis and treatment of disease (Zheng, page 5, last ¶).
While the combination of Lucci, Bossetti, and Zheng teaches a predetermined frequency (Bossetti, ¶36-test signal generator 530 and capacitor 538. In some examples, test signal generator 530 can be a square wave generator, a clock generator, a periodic signal generator or other suitable signal generator, the processor can change the frequency and/or amplitude of test signal 531 and/or enable and disable test signal generator 530; ¶41-the frequency of test signal 531 can be 100 Hz, 135 Hz, 200 Hz, 250 Hz, 400 Hz, 500 Hz, 600 Hz, or any other suitable frequency above 40 Hz), the combination does not teach wherein the predetermined frequency of the at least one device-generated signal is an integer multiple of the sampling frequency.
Debarros relates to measurement of an electrophysiological signal from a human or animal body for closed-loop control of a stimulation signal applied to a target area of the body (¶1). Debarros further teaches the invention using the following step:
wherein the predetermined frequency of the at least one device-generated signal is an integer multiple of the sampling frequency (¶27-typically, the sampling frequency at which the electrophysiological signal is sampled is a plural integer value times the stimulation frequency at which the simulation pulses are generated).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include wherein the predetermined frequency of the at least one device-generated signal is an integer multiple of the sampling frequency of Debarros in order to enable the sampling rate to be selected to provide coverage of the full bandwidth of the electrophysiological signal without aliasing components, while maintaining the effect of avoiding artefacts from the stimulation signal (Debarros, ¶27).
Regarding claim 2, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the system of Claim 1, wherein the processing circuitry and the signal generation circuitry are asynchronous (Debarros, ¶156-the desynchronised case shown in FIG. 25; ¶149).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include wherein the processing circuitry and the signal generation circuitry are asynchronous of Debarros in order to be able to easily compare the analogue to digital conversion when synchronisation is enabled or disabled (Debarros, ¶137).
Regarding claim 3, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the system of Claim 1, wherein a phase of the at least one device-generated signal provided by the signal generation circuitry is arbitrary relative to a phase of the at least one device-generated signal within the at least one surface electrical signal (Bossetti, ¶55-the first and second stimulation signals can have a different phase relationship; ¶73).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include wherein a phase of the at least one device-generated signal provided by the signal generation circuitry is arbitrary relative to a phase of the at least one device-generated signal within the at least one surface electrical signal of Bossetti in order to obtain an accurate signal (Bossetti, ¶23) and monitor certain cardiac characteristics (e.g., heart rate, arrhythmias, changes due to medications or surgery, function of pacemakers, heart size, etc.) and ECG waveform characteristics (e.g., timing of certain waves, intervals, complexes of the ECG waveform) (Bossetti, ¶30).
Regarding claim 4, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the system of Claim 1, wherein the predetermined frequency is 100 Hz, 200 Hz, 300 Hz, 400 Hz, 500 Hz, 1 kHz, 2 kHz, 4 kHz, or 8 kHz (Bossetti, ¶41-the frequency of test signal 531 can be 100 Hz, 135 Hz, 200 Hz, 250 Hz, 400 Hz, 500 Hz, 600 Hz, or any other suitable frequency above 40 Hz).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include wherein the predetermined frequency is 100 Hz, 200 Hz, 300 Hz, 400 Hz, 500 Hz, 1 kHz, 2 kHz, 4 kHz, or 8 kHz of Bossetti in order to obtain an accurate signal (Bossetti, ¶23) and monitor certain cardiac characteristics (e.g., heart rate, arrhythmias, changes due to medications or surgery, function of pacemakers, heart size, etc.) and ECG waveform characteristics (e.g., timing of certain waves, intervals, complexes of the ECG waveform) (Bossetti, ¶30).
Regarding claim 5, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the system of Claim 4, wherein: the integer multiple is 2, 3, 4, 5, or 6 (Debarros, ¶28-a plural integer of four; ¶27-typically, the sampling frequency at which the electrophysiological signal is sampled is a plural integer value times the stimulation frequency at which the simulation pulses are generated).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include wherein: the integer multiple is 2, 3, 4, 5, or 6 of Debarros in order to enable the sampling rate to be selected to provide coverage of the full bandwidth of the electrophysiological signal without aliasing components, while maintaining the effect of avoiding artefacts from the stimulation signal (Debarros, ¶27).
Regarding claim 6, the combination of the combination of Lucci, Bossetti, Zheng, and Debarros teaches the system of Claim 1, wherein the integer multiple is 2, 3, 4, 5, or 6 (Debarros, ¶28-a plural integer of four).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include wherein the integer multiple is 2, 3, 4, 5, or 6 of Debarros in order to have a lower plural integer value N to provide a margin (Debarros, ¶127) and enable the sampling rate to be selected to provide coverage of the full bandwidth of the electrophysiological signal without aliasing components, while maintaining the effect of avoiding artefacts from the stimulation signal (Debarros, ¶27).
Regarding claim 7, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the system of Claim 1, wherein: the at least one processor is further configured to: control the signal generation circuitry to vary the predetermined frequency among a range of predetermined frequency values (Bossetti, ¶36-the processor can change the frequency and/or amplitude of test signal 531; ¶39-frequency of test signal 531 can be varied; ¶41; ¶60), determine a quality metric of the at least one surface electrical signal during provision of the at least one device-generated signal at each value of the range of predetermined frequency values (Bossetti, ¶39-frequency of test signal 531 can be varied to determine the load of the signal paths at the respective frequency (e.g., the quality of the skin-to-electrode connection as a function of the test signal frequency can be determined), test signal 531 can include a plurality of frequencies concurrently (e.g., test signal 531 can include multiple frequency components). In such an example, the reactance of the system to different frequencies can be determined at one time), and identify a predetermined frequency value at which the quality metric meets at least one predetermined criterion (Bossetti, ¶39-an initialization process can be used to select a frequency for differentiating between when measurement electrode 502 is contacted and when it is not contacted (e.g., a frequency for test signal 531 that results in an observable change in resulting test signal amplitude). In some examples, test signal 531 can include a plurality of frequencies concurrently (e.g., test signal 531 can include multiple frequency components). In such an example, the reactance of the system to different frequencies can be determined at one time).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include wherein: the at least one processor is further configured to: control the signal generation circuitry to vary the predetermined frequency among a range of predetermined frequency values, determine a quality metric of the at least one surface electrical signal during provision of the at least one device-generated signal at each value of the range of predetermined frequency values, and identify a predetermined frequency value at which the quality metric meets at least one predetermined criterion of Bossetti in order to obtain an accurate signal (Bossetti, ¶23) and monitor certain cardiac characteristics (e.g., heart rate, arrhythmias, changes due to medications or surgery, function of pacemakers, heart size, etc.) and ECG waveform characteristics (e.g., timing of certain waves, intervals, complexes of the ECG waveform) (Bossetti, ¶30).
Regarding claim 8, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the system of Claim 7, wherein the range of predetermined frequency values comprises one or more of 100 Hz, 200 Hz, 300 Hz, 400 Hz, 500 Hz, 1 kHz, 2 kHz, 4 kHz, or 8 kHz (Bossetti, ¶41-the frequency of test signal 531 can be 100 Hz, 135 Hz, 200 Hz, 250 Hz, 400 Hz, 500 Hz, 600 Hz, or any other suitable frequency above 40 Hz).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include wherein the range of predetermined frequency values comprises one or more of 100 Hz, 200 Hz, 300 Hz, 400 Hz, 500 Hz, 1 kHz, 2 kHz, 4 kHz, or 8 kHz of Bossetti in order to obtain an accurate signal (Bossetti, ¶23) and monitor certain cardiac characteristics (e.g., heart rate, arrhythmias, changes due to medications or surgery, function of pacemakers, heart size, etc.) and ECG waveform characteristics (e.g., timing of certain waves, intervals, complexes of the ECG waveform) (Bossetti, ¶30).
Regarding claim 9, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the system of Claim 7, wherein the at least one predetermined criterion comprises one or more of a threshold value or a relative quality metric (Bossetti, ¶41-filter the physiological signal and leave the test signal (e.g., test signal 540 ) to be compared against the threshold to determine whether measurement electrode 502 is contacted; ¶39-the quality of the skin-to-electrode connection as a function of the test signal frequency can be determined). In some examples, an initialization process can be used to select a frequency for differentiating between when measurement electrode 502 is contacted and when it is not contacted (e.g., a frequency for test signal 531 that results in an observable change in resulting test signal amplitude). In some examples, test signal 531 can include a plurality of frequencies concurrently (e.g., test signal 531 can include multiple frequency components). In such an example, the reactance of the system to different frequencies can be determined at one time).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include wherein the at least one predetermined criterion comprises one or more of a threshold value or a relative quality metric of Bossetti in order to obtain an accurate signal (Bossetti, ¶23) and monitor certain cardiac characteristics (e.g., heart rate, arrhythmias, changes due to medications or surgery, function of pacemakers, heart size, etc.) and ECG waveform characteristics (e.g., timing of certain waves, intervals, complexes of the ECG waveform) (Bossetti, ¶30).
Regarding claim 10, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the system of Claim 7, wherein the quality metric comprises one or more of a signal to noise ratio or an electrocardiogram (ECG) recognition metric (Debarros, ¶87-widespread aliasing can lead to an abnormally elevated noise floor and therefore a low SNR; ¶130; Fig. 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include wherein the quality metric comprises one or more of a signal to noise ratio or an electrocardiogram (ECG) recognition metric of Debarros in order to allow for high resolution data acquisition whilst removing the artefacts, and is therefore compatible with the oversampling technique classically used to improve SNR (Debarros, ¶130).
Regarding claim 11, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the system of Claim 1, wherein the at least one processor is further configured to identify the aliasing content generated by the at least one device-generated signal
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include wherein the at least one processor is further configured to identify the aliasing content generated by the at least one device-generated signal
Regarding claim 12, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the system of Claim 1, further comprising an additional electrode that comprises an ECG electrode, a combination therapy and ECG electrode, a dry/capacitive electrode, or a fabric electrode (Lucci, ¶6-a plurality of sensing electrodes; ¶14-a plurality of therapy electrodes), wherein the additional electrode includes an additional skin-contacting surface (Lucci, ¶14-a plurality of therapy electrodes operably coupled to the therapy delivery circuitry and configured to be coupled to the patient to deliver the therapy shock to the patient; ¶68-a skin-contacting electrode surface) to inject the at least one device-generated signal into the skin of the patient (Bossetti, ¶42-test signal generation can be periodically restarted to determine whether measurement electrode 502 is contacted; ¶39-the frequency of test signal 531 can be varied to determine the load of the signal paths at the respective frequency (e.g., the quality of the skin-to-electrode connection as a function of the test signal frequency can be determined); ¶44-it is understood that similar test signal circuitry can be integrated onto the signal path of reference electrode 504 to detect contact between the user (e.g., wrist) and reference electrode 504 in a similar manner (e.g., as illustrated in FIG. 12)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include injecting the at least one device-generated signal into the skin of the patient of Bossetti in order to obtain an accurate signal (Bossetti, ¶23) and monitor certain cardiac characteristics (e.g., heart rate, arrhythmias, changes due to medications or surgery, function of pacemakers, heart size, etc.) and ECG waveform characteristics (e.g., timing of certain waves, intervals, complexes of the ECG waveform) (Bossetti, ¶30).
Regarding claim 14, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the system of Claim 1, wherein the at least one processor is configured to implement at least a portion of the signal generation circuitry in software (Bossetti, ¶61-signal processing block diagram 1000 can be implemented in a digital signal processor or other processing circuit (e.g., DSP 206 , processors 650 / 950 , etc.), including, for example, application specific integrated circuits, programmable devices (field programmable gate array, programmable logic device, etc.) or software executed by a processor).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include wherein the at least one processor is configured to implement at least a portion of the signal generation circuitry in software of Bossetti in order to obtain an accurate signal (Bossetti, ¶23) and monitor certain cardiac characteristics (e.g., heart rate, arrhythmias, changes due to medications or surgery, function of pacemakers, heart size, etc.) and ECG waveform characteristics (e.g., timing of certain waves, intervals, complexes of the ECG waveform) (Bossetti, ¶30).
Regarding claim 17, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the system of Claim 1, further comprising a network interface coupled to the at least one processor, wherein to provide the at least one physiological signal comprises to transmit the at least one physiological signal to a remote server distinct from the wearable cardiac monitoring device via the network interface (Bossetti, ¶28-the ECG signal or other information from the analysis and processing can be relayed to another device (e.g., a tablet, laptop, smartphone, computer, server, etc.) via wired or wireless connection; ¶27).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include a network interface coupled to the at least one processor, wherein to provide the at least one physiological signal comprises to transmit the at least one physiological signal to a remote server distinct from the wearable cardiac monitoring device via the network interface of Bossetti in order to obtain an accurate signal (Bossetti, ¶23) and monitor certain cardiac characteristics (e.g., heart rate, arrhythmias, changes due to medications or surgery, function of pacemakers, heart size, etc.) and ECG waveform characteristics (e.g., timing of certain waves, intervals, complexes of the ECG waveform) (Bossetti, ¶30).
Regarding claim 18, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the system of Claim 1, wherein the at least one physiological signal comprises an ECG signal (Lucci, ¶6-monitor each of the one or more sensing electrode pairs for ECG activity of the patient).
Regarding claim 36, Lucci teaches a method for removing device signals from surface electrical signals received from an ambulatory patient worn device, the method comprising: using a skin-contacting surface of a therapy electrode (¶14-a plurality of therapy electrodes operably coupled to the therapy delivery circuitry and configured to be coupled to the patient to deliver the therapy shock to the patient; ¶68-a skin-contacting electrode surface); using at least one electrocardiogram electrode to acquire at least one surface electrical signal from the skin of the patient (¶22-each of the plurality of sensing electrodes is configured to be coupled externally to a patient and to detect one or more ECG signals of the patient; ¶68-a skin-contacting electrode surface); the at least one surface electrical signal comprising at least one electrocardiogram signal generated by the patient (¶6-monitor each of the one or more sensing electrode pairs for ECG activity of the patient); providing the at least one electrocardiogram signal (¶6-detect one or more ECG signals); detecting a cardiac arrhythmia in the at least one electrocardiogram signal (¶114-the cardiac event detector 216 can be configured to monitor a patient's ECG signal for an occurrence of a cardiac event such as an arrhythmia); and after detecting the cardiac arrhythmia, using the therapy electrode to provide at least one of defibrillation or pacing to the patient (¶76-provide treatment to the patient using the therapy electrodes; ¶97-pacing pulses can be used to treat cardiac arrhythmia conditions such as bradycardia (e.g., less than 30 beats per minute) and tachycardia (e.g., more than 150 beats per minute) using, for example, fixed rate pacing, demand pacing, anti-tachycardia pacing, and the like. Defibrillation pulses can be used to treat ventricular tachycardia and/or ventricular fibrillation).
However, Lucci does not explicitly teach generating at least one device-generated electrical signal at a predetermined frequency; to inject the at least one device-generated electrical signal into a skin of a patient; sampling the at least one surface electrical signal from the patient at a sampling frequency that is less than the predetermined frequency of the at least one device-generated electrical signal, wherein the predetermined frequency of the at least one device-generated electrical signal is an integer multiple of the sampling frequency, the at least one device-generated electrical signal, and wherein a phase of the at least one device-generated electrical signal as included in the at least one surface electrical signal is arbitrary relative to a phase of the at least one device-generated electrical signal as injected into the skin of the patient; identifying, based on the predetermined frequency, aliasing content generated by the at least one device-generated electrical signal within the at least one surface electrical signal; processing the aliasing content identified within the at least one surface electrical signal to make a determination that at least one of the skin-contacting surface or the at least one electrocardiogram electrode has compromised contact with the skin of the patient; and filtering the aliasing content generated by the at least one device-generated electrical signal to isolate the at least one electrocardiogram signal from the at least one surface electrical signal.
Bossetti teaches generating at least one device-generated electrical signal at a predetermined frequency (¶36-test signal generator 530 and capacitor 538. In some examples, test signal generator 530 can be a square wave generator, a clock generator, a periodic signal generator or other suitable signal generator, the processor can change the frequency and/or amplitude of test signal 531 and/or enable and disable test signal generator 530; ¶41-the frequency of test signal 531 can be 100 Hz, 135 Hz, 200 Hz, 250 Hz, 400 Hz, 500 Hz, 600 Hz, or any other suitable frequency above 40 Hz); to inject the at least one device-generated electrical signal into a skin of a patient (¶42-test signal generation can be periodically restarted to determine whether measurement electrode 502 is contacted; ¶39-the frequency of test signal 531 can be varied to determine the load of the signal paths at the respective frequency (e.g., the quality of the skin-to-electrode connection as a function of the test signal frequency can be determined); ¶44-it is understood that similar test signal circuitry can be integrated onto the signal path of reference electrode 504 to detect contact between the user (e.g., wrist) and reference electrode 504 in a similar manner (e.g., as illustrated in FIG. 12)); the at least one device-generated electrical signal (¶43-the integration of the test signal circuitry with the physiological signal measurement circuitry; ¶41-the physiological signal can be mixed or otherwise added to test signal 531 generated by test signal generator 530); wherein a phase of the at least one device-generated electrical signal as included in the at least one surface electrical signal is arbitrary relative to a phase of the at least one device-generated electrical signal as injected into the skin of the patient (¶55-the first and second stimulation signals can have a different phase relationship; ¶73); and to make a determination that at least one of the skin-contacting surface or the at least one electrocardiogram electrode has compromised contact with the skin of the patient (¶5-determine whether a user is in contact with the one or more measurement electrodes; ¶42-determine that contact has stopped and cease measuring and/or processing the physiological signal).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include generating at least one device-generated electrical signal at a predetermined frequency; to inject the at least one device-generated electrical signal into a skin of a patient; the at least one device-generated electrical signal; wherein a phase of the at least one device-generated electrical signal as included in the at least one surface electrical signal is arbitrary relative to a phase of the at least one device-generated electrical signal as injected into the skin of the patient; and to make a determination that at least one of the skin-contacting surface or the at least one electrocardiogram electrode has compromised contact with the skin of the patient of Bossetti in order to obtain an accurate signal (Bossetti, ¶23) and monitor certain cardiac characteristics (e.g., heart rate, arrhythmias, changes due to medications or surgery, function of pacemakers, heart size, etc.) and ECG waveform characteristics (e.g., timing of certain waves, intervals, complexes of the ECG waveform) (Bossetti, ¶30).
While the combination of Lucci and Bossetti teaches sampling of the physiological waveform (Bossetti, ¶29), the combination does not teach sampling the at least one surface electrical signal from the patient at a sampling frequency that is less than the predetermined frequency of the at least one device-generated electrical signal, identifying, based on the predetermined frequency, aliasing content generated by the at least one device-generated electrical signal within the at least one surface electrical signal; processing the aliasing content identified within the at least one surface electrical signal; and filtering the aliasing content generated by the at least one device-generated electrical signal to isolate the at least one electrocardiogram signal from the at least one surface electrical signal.
Zheng teaches sampling the at least one surface electrical signal from the patient at a sampling frequency that is less than the predetermined frequency of the at least one device-generated electrical signal (¶27-typically, the sampling frequency at which the electrophysiological signal is sampled is a plural integer value times the stimulation frequency at which the simulation pulses are generated), identifying, based on the predetermined frequency, aliasing content generated by the at least one device-generated electrical signal within the at least one surface electrical signal (page 2, ¶1-a sampling unit connected to the determination unit for determining, based on a sampling rate located within the frequency range, And a sampling unit connected to said sampling unit for determining a frequency spectrum of said electrophysiological signal); processing the aliasing content identified within the at least one surface electrical signal (page 6, 2nd to last ¶-the processing unit 350 is connected to the calculation unit 340 for removing the spectral aliasing signal from the sampled electrophysiological signal according to the frequency of the spectral aliasing signal); and filtering the aliasing content generated by the at least one device-generated electrical signal to isolate the at least one electrocardiogram signal from the at least one surface electrical signal (page 2, ¶1-said ambient electric signal based on a sampling rate within said frequency range and a frequency of said power frequency interference signal And a processing unit connected to said calculation unit for removing said spectral aliasing signal from the sampled electrophysiological signal according to the frequency of said spectral aliasing signal; page 3, ¶5-electrophysiological signals are important information that reflects the physiological state of the human body, including but not limited to ECG).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include sampling the at least one surface electrical signal from the patient at a sampling frequency that is less than the predetermined frequency of the at least one device-generated electrical signal, identifying, based on the predetermined frequency, aliasing content generated by the at least one device-generated electrical signal within the at least one surface electrical signal; processing the aliasing content identified within the at least one surface electrical signal; and filtering the aliasing content generated by the at least one device-generated electrical signal to isolate the at least one electrocardiogram signal from the at least one surface electrical signal of Zheng in order to avoid inaccuracy affecting the diagnosis and treatment of disease (Zheng, page 5, last ¶).
While the combination of Lucci, Bossetti, and Zheng teaches a predetermined frequency (Bossetti, ¶36-test signal generator 530 and capacitor 538. In some examples, test signal generator 530 can be a square wave generator, a clock generator, a periodic signal generator or other suitable signal generator, the processor can change the frequency and/or amplitude of test signal 531 and/or enable and disable test signal generator 530; ¶41-the frequency of test signal 531 can be 100 Hz, 135 Hz, 200 Hz, 250 Hz, 400 Hz, 500 Hz, 600 Hz, or any other suitable frequency above 40 Hz), the combination does not teach wherein the predetermined frequency of the at least one device-generated electrical signal is an integer multiple of the sampling frequency.
Debarros teaches wherein the predetermined frequency of the at least one device-generated electrical signal is an integer multiple of the sampling frequency (¶27-typically, the sampling frequency at which the electrophysiological signal is sampled is a plural integer value times the stimulation frequency at which the simulation pulses are generated).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include wherein the predetermined frequency of the at least one device-generated electrical signal is an integer multiple of the sampling frequency of Debarros in order to enable the sampling rate to be selected to provide coverage of the full bandwidth of the electrophysiological signal without aliasing components, while maintaining the effect of avoiding artefacts from the stimulation signal (Debarros, ¶27).
Regarding claim 40, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the method of Claim 36, wherein the method further comprises: varying the predetermined frequency among a range of predetermined frequency values (Bossetti, ¶36-the processor can change the frequency and/or amplitude of test signal 531; ¶39-frequency of test signal 531 can be varied; ¶41; ¶60); determining a quality metric of the at least one surface electrical signal during provision of the at least one device-generated electrical signal at each value of the range of predetermined frequency values (Bossetti, ¶39-frequency of test signal 531 can be varied to determine the load of the signal paths at the respective frequency (e.g., the quality of the skin-to-electrode connection as a function of the test signal frequency can be determined), test signal 531 can include a plurality of frequencies concurrently (e.g., test signal 531 can include multiple frequency components). In such an example, the reactance of the system to different frequencies can be determined at one time); and identifying a predetermined frequency value at which the quality metric meets at least one predetermined criterion (Bossetti, ¶39-an initialization process can be used to select a frequency for differentiating between when measurement electrode 502 is contacted and when it is not contacted (e.g., a frequency for test signal 531 that results in an observable change in resulting test signal amplitude). In some examples, test signal 531 can include a plurality of frequencies concurrently (e.g., test signal 531 can include multiple frequency components). In such an example, the reactance of the system to different frequencies can be determined at one time).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include wherein the method further comprises: varying the predetermined frequency among a range of predetermined frequency values; determining a quality metric of the at least one surface electrical signal during provision of the at least one device-generated electrical signal at each value of the range of predetermined frequency values; and identifying a predetermined frequency value at which the quality metric meets at least one predetermined criterion of Bossetti in order to obtain an accurate signal (Bossetti, ¶23) and monitor certain cardiac characteristics (e.g., heart rate, arrhythmias, changes due to medications or surgery, function of pacemakers, heart size, etc.) and ECG waveform characteristics (e.g., timing of certain waves, intervals, complexes of the ECG waveform) (Bossetti, ¶30).
Regarding claim 44, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the method of Claim 36, further comprising identifying the aliasing content generated by the at least one device-generated electrical signal within the at least one surface electrical signal either periodically or continuously (Bossetti, ¶42- even after contact with measurement electrode 502 is determined, test signal generator 530 continues providing test signal 531 . In such examples, a filter (e.g., a low-pass filter or band-pass filter) can be used to filter test signal 531 and leave the physiological signal for measurement and/or processing; ¶62-anti-aliasing).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include identifying the aliasing content generated by the at least one device-generated electrical signal within the at least one surface electrical signal either periodically or continuously of Bossetti in order to obtain an accurate signal (Bossetti, ¶23) and monitor certain cardiac characteristics (e.g., heart rate, arrhythmias, changes due to medications or surgery, function of pacemakers, heart size, etc.) and ECG waveform characteristics (e.g., timing of certain waves, intervals, complexes of the ECG waveform) (Bossetti, ¶30).
Claims 13, 16, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Lucci in view of Bossetti, Zheng, and Debarros as applied to claims 1 and 36 above, and further in view of Lee (WO 2022177059 filed on 3/15/21).
Regarding claim 13, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the system of Claim 1. However, the combination of does not teach wherein to provide the at least one device-generated signal comprises to modulate, by the signal generation circuitry, a base electrical signal at the predetermined frequency.
Lee teaches wherein to provide the at least one device-generated signal comprises to modulate, by the signal generation circuitry, a base electrical signal at the predetermined frequency (page 10, ¶5-the pulse width modulation module 422 may generate an external clock signal by applying pulse width modulation (PWM) to the reference clock signal received from the clock source 421 , and transmit the generated external clock signal to the sensor module. (430) may be provided. The pulse width modulation module 422 may change the duty ratio by adjusting the pulse width of the reference clock signal, and may change the frequency by adjusting the period of the reference clock signal).
Lee relates to electronic devices and methods that utilize selective clock synchronization (page 1, ¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include wherein to provide the at least one device-generated signal comprises to modulate, by the signal generation circuitry, a base electrical signal at the predetermined frequency of Lee so that the processor may more accurately acquire signal data from the sensor module without duplication or omission of signal data (Lee, page 9, ¶7).
Regarding claim 16, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the system of Claim 1, further comprising a clock circuit shared by the signal generation circuitry and the at least one processor (Bossetti, ¶36-a clock generator, the test signal generator 530 can be a clock output of processor 430).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include a clock circuit shared by the signal generation circuitry and the at least one processor of Bossetti in order to obtain an accurate signal (Bossetti, ¶23) and monitor certain cardiac characteristics (e.g., heart rate, arrhythmias, changes due to medications or surgery, function of pacemakers, heart size, etc.) and ECG waveform characteristics (e.g., timing of certain waves, intervals, complexes of the ECG waveform) (Bossetti, ¶30).
However, the combination of Lucci, Bossetti, Zheng, and Debarros does not teach the clock circuit configured to provide a common reference point to the signal generation circuitry and the at least one processor.
Lee teaches the clock circuit configured to provide a common reference point to the signal generation circuitry and the at least one processor (page 10, ¶4-the clock source 421 may generate a reference clock signal having a reference frequency).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include the clock circuit configured to provide a common reference point to the signal generation circuitry and the at least one processor of Lee so that the processor may more accurately acquire signal data from the sensor module without duplication or omission of signal data (Lee, page 9, ¶7).
Regarding claim 47, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the method of Claim 36, further comprising generating a clock signal (Bossetti, ¶36-a clock generator, the test signal generator 530 can be a clock output of processor 430).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include generating a clock signal of Bossetti in order to obtain an accurate signal (Bossetti, ¶23) and monitor certain cardiac characteristics (e.g., heart rate, arrhythmias, changes due to medications or surgery, function of pacemakers, heart size, etc.) and ECG waveform characteristics (e.g., timing of certain waves, intervals, complexes of the ECG waveform) (Bossetti, ¶30).
However, the combination of Lucci, Bossetti, Zheng, and Debarros does not teach to provide a common reference point for generating the at least one device-generated electrical signal at the predetermined frequency and sampling the at least one surface electrical signal from the patient at the sampling frequency.
Lee teaches to provide a common reference point for generating the at least one device-generated electrical signal at the predetermined frequency (page 10, ¶4-the clock source 421 may generate a reference clock signal having a reference frequency) and sampling the at least one surface electrical signal from the patient at the sampling frequency (page 16, ¶1-sample the biosignal at the sampling frequency of the generated signal by dividing the internal clock signal generated from the internal oscillator 731).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include providing a common reference point for generating the at least one device-generated electrical signal at the predetermined frequency and sampling the at least one surface electrical signal from the patient at the sampling frequency of Lee so that the processor may more accurately acquire signal data from the sensor module without duplication or omission of signal data (Lee, page 9, ¶7).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lucci in view of Bossetti, Zheng, and Debarros as applied to claim 1 above, and further in view of Yan (CN 113598934 filed on 8/28/21).
Regarding claim 15, the combination of Lucci, Bossetti, Zheng, and Debarros teaches the system of Claim 1, wherein: the at least one sensing electrode comprises a plurality of sensing electrodes (Lucci, ¶6-a plurality of sensing electrodes); the at least one surface electrical signal comprises a plurality of surface electrical signals (Lucci, ¶6-each of the plurality of sensing electrodes is configured to be coupled eternally to a patient and to detect one or more ECG signals). However, the combination of Lucci, Bossetti, Zheng, and Debarros does not teach to identify comprises to identify the aliasing content generated by the at least one device-generated signal within each surface electrical signal of the plurality of surface electrical signals.
Yan teaches to identify comprises to identify the aliasing content generated by the at least one device-generated signal within each surface electrical signal of the plurality of surface electrical signals (page 2, ¶6-the data acquisition unit collects ECG signals and aliased positioning signals. The data processing unit demodulates and separates positioning signals of different frequencies in three directions, and calculates The sign and amplitude of the signal and send real-time data to the upper computer).
Yan relates to the technical field of atrial fibrillation catheter ablation, and specifically relates to a positioning and mapping system for atrial fibrillation (page 1, ¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lucci to include identifying the aliasing content generated by the at least one device-generated signal within each surface electrical signal of the plurality of surface electrical signals of Yan in order to extract useful signals and improve accuracy (Yan, page 2, ¶2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20200260962: ¶85-decimate said signal to a second frequency lower than said first frequency; ¶119-the decimated signal (e.g., a 200 Hz signal) may be used for heart rate/heart rate variability measurement.
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