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 .
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 Interpretation
Applicant’s arguments, see Remarks, filed 4/6/26, with respect to the claim interpretation have been fully considered and are persuasive. The claim interpretation of claims 1, 17, and 36 has been withdrawn.
Claim Rejections - 35 USC § 101
Applicant's arguments filed 4/6/26 have been fully considered but they are not persuasive.
Applicant asserts that claims 1 and 36 recite multiple features which cannot practically be performed in the human mind, such as “sample…at least one surface electrical signal from [a] patient,” “identify… aliasing content generated by …at least one device-generated signal within the at least one surface electrical signal,” and “filter the aliasing content generated by the at least one device-generated signal to isolate…at least one physical signal.” However, the Examiner disagrees. The identifying and filtering steps are nothing more than a medical professional receiving print outs of the at least one device-generated signal within the at least one surface electrical signal, determining aliasing content based on a predetermined frequency, filtering the aliasing content from the data, and writing down the at least one physiological filtered signal. The sampling step amounts to pre-solution activity of data gathering from the ambulatory patient worn device.
Claim Rejections - 35 USC § 103
Applicant's arguments filed 4/6/26 have been fully considered but they are not persuasive.
Applicant asserts that previously applied references Bossetti, Zhang, and Debarros do not teach the amended limitation of “at a sampling frequency, wherein the sampling frequency is less than the predetermined frequency of the at least one device-generated signal.” However, the Examiner disagrees. While Bossetti teaches 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)), Bossetti does not teach wherein the sampling frequency is less than the predetermined frequency of the at least one device-generated signal. Zhang teaches 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).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-18, 36, 40, 44, and 47 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea.
Step 1
The claimed invention in claims 1-18, 36, 40, 44, and 47 are directed to statutory subject matter as the claims recite a system and a method for removing device signals from surface electrical signals.
Step 2A, Prong One
Regarding claims 1 and 36, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsection (III)).
Regarding claims 1 and 36, the limitations of “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, filter the aliasing content generated by the at least one device-generated signal to isolate the at least one physiological signal, and provide the at least one physiological signal” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional receiving print outs of the at least one device-generated signal within the at least one surface electrical signal, perform a simple threshold and if the sampling frequency is less than the predetermined frequency, determining aliasing content based on a predetermined frequency, filtering the aliasing content from the data, and writing down the at least one physiological filtered signal.
Step 2A, Prong Two
For claims 1 and 36, the judicial exception is not integrated into a practical application. In particular, claims 1 and 36 recite “an ambulatory patient worn device/wearable cardiac monitoring device, signal generation circuitry, at least one electrode, processing circuitry, and the injecting step.” The ambulatory patient worn device/wearable cardiac monitoring device, at least one electrode, and the injecting step amount to nothing more than pre-solution activity of data gathering. The signal generation circuitry and processing circuitry are recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into
a practical application, the additional elements of the ambulatory patient worn device/wearable cardiac monitoring device, at least one electrode, and the injecting step amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the
ambulatory patient worn device/wearable cardiac monitoring device and at least one electrode are recited at a high level of generality and are well-understood, routine, and conventional structures as evidenced by US 20170172500 (¶5-conventional wearable device; ¶34-if the physiological signal Sphy to be measured is an ECG signal or a skin conductance signal, the measurement circuit 114 may be arranged as an electronic signal measurement circuit having a plurality of electrodes), US 20180035910 (¶19-conventional EDA monitoring systems and methods, particularly those that are targeted for use in wearable electronic devices. For example, such conventional EDA monitoring systems and methods often employ so-called “dry” electrodes), and US 20200221968 (¶55- the wearable sensing device, here designated by 300, may be used with conventional ECG electrodes 30). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Regarding dependent claims 2-18, 40, 44 and 47, the limitations of claims 1 and 36 further define the limitations already indicated as being directed to the abstract idea.
Claims 2-3, 11, 13-14, and 44 further define parts of a generic computer.
Claims 4-6, 8-10, and 18 further define the abstract idea.
Claims 7 and 40 further defines parts of a computer and the abstract idea. The limitations of “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” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing prints outs of data for a quality metric and seeing when the quality metric meets at least one predetermined criterion.
Claim 12 further defines the data gathering. See above showing that an electrode is a well-understood, routine, and conventional structure.
Claim 15 further defines the data gathering and abstract idea itself.
Claims 16 and 47 recite a clock circuit which is part of the signal generation circuitry, which is part of a generic computer.
Claim 17 recites a network interface which his part of a generic computer.
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, 3-4, 11-12, 14, 17-18, 36, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Bossetti (US 20200077954 filed on 9/9/19) in view of Zheng (CN 106725415 filed on 11/15/16).
Regarding claim 1, Bossetti 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 (¶5-wearable device; ¶30-the signals from the physiological sensors 202 may facilitate the monitoring of certain cardiac characteristics (e.g., heart rate, arrhythmias, changes due to medications or surgery, function of pacemakers, heart size, etc.) and/or ECG waveform characteristics (e.g., timing of certain waves, intervals, complexes of the ECG waveform); ¶50-the contact and/or saturation detection can be performed continuously to indicate the quality of a physiological signal measurement during physiological signal measurement), the wearable cardiac monitoring device comprising 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); a skin-contacting surface 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)); at least one electrode configured to acquire at least one surface electrical signal from the skin of the patient (¶22-electrode 166A on the back side of wearable device 150 and/or electrode 166B on the backside of wearable device 150; ¶5-one or more electrode(s) for the measurement of a physiological signal (e.g., ECG signals)), the at least one surface electrical signal comprising the at least one device-generated signal and at least one physiological signal generated by the patient (¶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)). While Bossetti recites filter block 1002 can optionally include a high-pass filter to remove high frequency noise and/or a low-pass filter such as a decimation/anti-aliasing filter (¶62), Bossetti does not teach wherein the sampling frequency is less than the predetermined frequency of the at least one device-generated signal, to 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, filter the aliasing content generated by the at least one device-generated signal to isolate the at least one physiological signal, and provide the at least one physiological 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), filter the aliasing content generated by the at least one device-generated signal to isolate the at least one physiological signal and provide the at least one physiological 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 Bossetti to include wherein the sampling frequency is less than the predetermined frequency of the at least one device-generated signal, identifying, based on the predetermined frequency, aliasing content generated by the at least one device-generated signal within the at least one surface electrical signal, filtering the aliasing content generated by the at least one device-generated signal to isolate the at least one physiological signal, and providing the at least one physiological signal of Zheng in order to avoid inaccuracy affecting the diagnosis and treatment of disease (Zheng, page 5, last ¶).
Regarding claim 3, the combination of Bossetti and Zheng 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).
Regarding claim 4, the combination of Bossetti and Zheng 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).
Regarding claim 11, the combination of Bossetti and Zheng teaches the system of Claim 1, wherein the at least one processor is further configured to isolate the at least one device-generated signal from 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).
Regarding claim 12, the combination of Bossetti and Zheng teaches the system of Claim 1, wherein the skin-contacting surface is part of at least one of a therapy electrode, an ECG electrode, a combination therapy and ECG electrode, a dry/capacitive electrode, or a fabric electrode (Bossetti, ¶5-one or more electrode(s) for the measurement of a physiological signal (e.g., ECG signals); ¶23-the electrodes of physiological sensors 160 can be dry electrodes).
Regarding claim 14, the combination of Bossetti and Zheng 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).
Regarding claim 17, the combination of Bossetti and Zheng 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).
Regarding claim 18, the combination of Bossetti and Zheng teaches the system of Claim 1, wherein the at least one physiological signal comprises an ECG signal (Bossetti, ¶5-ECG signals).
Regarding claim 36, Bossetti teaches a method for removing device signals from surface electrical signals received from an ambulatory patient worn device, the method comprising: 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); injecting 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)); sampling at least one surface electrical signal from the patient at a predetermined rate (¶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); ¶42; ¶84), the at least one surface electrical signal comprising the at least one device-generated electrical signal and at least one physiological signal generated by the patient (¶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). While Bossetti recites filter block 1002 can optionally include a high-pass filter to remove high frequency noise and/or a low-pass filter such as a decimation/anti-aliasing filter (¶62), Bossetti does not teach at a sampling frequency that is less than the predetermined frequency of the at least one device-generated 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; filtering the aliasing content generated by the at least one device-generated electrical signal to isolate the at least one physiological signal; and providing the at least one physiological signal.
Zheng teaches at a sampling frequency that 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), 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); filtering the aliasing content generated by the at least one device-generated electrical signal to isolate the at least one physiological signal; and providing the at least one physiological 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 Bossetti to include at a sampling frequency that is less than the predetermined frequency of the at least one device-generated 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; filtering the aliasing content generated by the at least one device-generated electrical signal to isolate the at least one physiological signal; and providing the at least one physiological signal of Zheng in order to avoid inaccuracy affecting the diagnosis and treatment of disease (Zheng, page 5, last ¶).
Regarding claim 44, the combination of Bossetti and Zheng teaches the method of Claim 36, further comprising isolating the at least one device-generated electrical signal from 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).
Claims 2, 5-10, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Bossetti in view of Zheng as applied to claims 1, 4, and 36 above, and further in view of Debarros (US 20210370070 filed on 10/2/19).
Regarding claim 2, the combination of Bossetti and Zheng teaches the system of Claim 1. However, the combination of Bossetti and Zheng does not teach wherein the processing circuitry and the signal generation circuitry are asynchronous.
Debarros teaches wherein the processing circuitry and the signal generation circuitry are asynchronous (¶156-the desynchronised case shown in FIG. 25; ¶149).
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).
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 Bossetti 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 5, the combination of Bossetti and Zheng teaches the system of Claim 4. However, the combination of Bossetti and Zheng does not teach wherein :the predetermined frequency is an integer multiple of the sampling frequency.
Debarros teaches wherein: the predetermined frequency 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 Bossetti to include wherein: the predetermined frequency 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 6, the combination of Bossetti, Zheng, and Debarros teaches the system of Claim 5, 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 Bossetti 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 Bossetti and Zheng 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). However, the combination of Bossetti and Zheng does not teach wherein: the predetermined frequency is an integer multiple of the sampling frequency.
Debarros teaches wherein: the predetermined frequency 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 Bossetti to include wherein: the predetermined frequency 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 8, the combination of 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).
Regarding claim 9, the combination of 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).
Regarding claim 10, the combination of 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 Bossetti 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 40, the combination of Bossetti and Zheng 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). However, the combination of Bossetti and Zheng does not teach wherein a predetermined frequency is an integer multiple of the sampling frequency.
Debarros teaches a predetermined frequency 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 Bossetti to include wherein a predetermined frequency 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).
Claims 13, 16, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Bossetti in view of Zheng 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 Bossetti and Zheng teaches the system of Claim 1. However, the combination of Bossetti and Zheng 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 Bossetti 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 Bossetti and Zheng 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). However, the combination of Bossetti and Zheng 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 Bossetti 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 Bossetti and Zheng 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). However, the combination of Bossetti and Zheng 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 Bossetti 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 Bossetti in view of Zheng 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 Bossetti and Zheng teaches the system of Claim 1, wherein: the at least one electrode comprises a plurality of electrodes (Bossetti, ¶5-one or more electrode(s) for the measurement of a physiological signal (e.g., ECG signals)); the at least one surface electrical signal comprises a plurality of surface electrical signals (Bossetti, ¶24-measure electrical signals (e.g., ECG signals)). However, the combination of Bossetti and Zheng 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 Bossetti 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/L.N.H./Examiner, Art Unit 3792 /AMANDA L STEINBERG/Examiner, Art Unit 3792
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