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 1-4, 8, 10, 12, 15, 17, and 19 are currently amended.
Claims 14 and 18 are cancelled.
Claims 21-22 are added as newly added claims.
Response to Arguments
Applicant’s arguments, see pages 7-10, filed 4/6/2026, with respect to 35 U.S.C. 101 rejection have been fully considered and are persuasive. The 35 U.S.C. 101 rejection of claims 1-20 has been withdrawn.
35 U.S.C. 101:
The applicant argues that the subject matter of claim 1 achieves a concrete technological
improvement in the field of arrhythmia detection devices. After further consideration, the examiner argues that the blanking period is replaced with a NaN value to keep the rhythm (set in time) and this improves the calculated heart rate. See paragraphs [0028] and [0111]-[0112] of the instant application. Therefore, the 35 U.S.C. 101 rejection is withdrawn.
Applicant’s arguments, see pages 10-13, filed 4/6/2026, with respect to the rejection(s) of
claim(s) claims 1-20 under 35 U.S.C. 102 and 103 rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Armington.
35 U.S.C. 102 and 103:
Regarding claim 1, applicant argues that Brockway, alone or in combination with the prior art,
does not teach “wherein the samples in the blanking period are replaced with a not a number (NaN) value to keep the samples set in time; detect a plurality of dominant beats from the one or more ECG signals excluding at least a portion of the one or more ECG signals within the blanking period, wherein the plurality of dominant beats corresponds to a beat morphology occurring a highest number of times among detected beats in QRS complexes of the one or more ECG signals.” After further search and consideration, the examiner will now rely on Armington to teach this limitation (col. 3, lines 20-40). It is disclosed that “pacer blanker 12 blanks the ECG signal from 10 milliseconds before impulse 301 to 40 milliseconds after impulse 301 and calculates and substitutes therefore a linearly sloped portion 304. This blanking time is kept to a minimum so that closely coupled QRS complexes are not normally affected.” The digitized ECG signal is applied to a post pacer activity detector 16, which may be used to detect a plurality of dominant beats excluding the blanking periods. It is recognized that removing or zeroing the blanking period messed up the timing of signals and thus substituted a value. Although a NaN value is not disclosed, a ramp may work for that feature.
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 processing system of Brockway with the blanking periods from Armington for the benefit of reducing the amount of large pacer impulses because the presence of large pacer impulses can effect the sensitivity of QRS detector since it normally has an adjustable threshold level.
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.
Claims 1-3, 6-10, 14-15, and 17-18 are rejected under 35 U.S.C. 103 as being
unpatentable over Brockway et al. US Pub.: US 20220054090 A1, hereinafter Brockway in view of Armington et al. US Pat.: US 4934376 A, hereinafter Armington.
Regarding claim 1, Brockway teaches a medical system, comprising:
a plurality of electrocardiogram (ECG) electrodes (not shown) to sense one or more ECG signals of a patient (paragraph 64); The ECG waveform is derived from signals or measurements from multiple sensors (e.g., electrodes and/or leads or leadwires) positioned on a skin of a patient at various locations on a patient's body.
and a processor (412) in communication with the plurality of ECG electrodes, the processor (412) configured to: receive the one or more ECG signals (fig. 4; paragraph 80); Patient monitoring system 400 for ECG waveform includes a controller or control unit 412.
sample the one or more ECG signals at a predefined frequency (fig. 6-7B; paragraph 83 an 95-103); The pre-filtering sub-process may include application of a notch filter or adaptive filter adapted to filter out 50 Hz and/or 60 Hz noise (e.g., typical 50 Hz and/or 60 Hz line frequency or 50 Hz-60 Hz frequency components) from the ECG signals or other biosignals received by the denoising system 405.
determine whether a measurement of samples of the one or more EGG signals exceeds a noise threshold (fig. 6-7B; paragraph 95-103); Portions of the ECG waveform or signals that are likely to include artifact spikes or interference noise. The process 600 may include a threshold preliminary sub-process, which include frequency noise thresholds.
and provide a blanking period in response to a determination that if the measurement of the samples exceeds the noise threshold (fig. 6-7B; paragraph 95-103); Portions of the ECG waveform or signals that are likely to include artifact spikes or interference noise during stimulation may be “blanked” from the ECG waveform or signals. The process 600 may include a threshold preliminary sub-process.
However, Brockway does not teach wherein the samples in the blanking period are replaced with a not a number (NaN) value, to keep the samples set in time; detect a plurality of dominant beats from the one or more ECG signals excluding at least a portion of the one or more ECG signals within the blanking period, wherein the plurality of dominant beats corresponds to a beat morphology occurring a highest number of times among detected beats in QRS complexes of the one or more ECG signals; and calculate a heart rate based on the detected plurality of dominant beats.
Armington, teaches a method and system for detecting heartbeats, and further teaches wherein the samples in the blanking period are replaced with a not a number (NaN) value, to keep the samples set in time; detect a plurality of dominant beats from the one or more ECG signals excluding at least a portion of the one or more ECG signals within the blanking period, wherein the plurality of dominant beats corresponds to a beat morphology occurring a highest number of times among detected beats in QRS complexes of the one or more ECG signals; and calculate a heart rate based on the detected plurality of dominant beats (col. 3, lines 20-40). It is disclosed that “pacer blanker 12 blanks the ECG signal from 10 milliseconds before impulse 301 to 40 milliseconds after impulse 301 and calculates and substitutes therefore a linearly sloped portion 304. This blanking time is kept to a minimum so that closely coupled QRS complexes are not normally affected.” The digitized ECG signal is applied to a post pacer activity detector 16, which may be used to detect a plurality of dominant beats excluding the blanking periods. Removing or zeroing the blanking period messed up the timing of signals and thus substituted a value. Although a NaN value is not disclosed, a ramp may work for that feature.
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 processing system of Brockway with the blanking periods from Armington for the benefit of reducing the amount of large pacer impulses because the presence of large pacer impulses can effect the sensitivity of QRS detector since it normally has an adjustable threshold level.
Regarding claim 2, Brockway in view of Armington teaches the claimed invention and Brockway
further teaches wherein the processor (412) is further configured to determine a heart rate based on an R-R interval of QRS complexes detected from the one or more ECG signals excluding QRS complexes that are within the blanking period (fig. 4; paragraph 77-80 and 95-103). Determination of a heart rate based on an R-R interval of QRS complexes is disclosed. Portions of the ECG waveform or signals that are likely to include artifact spikes or interference noise during stimulation may be “blanked” from the ECG waveform or signals.
Regarding claims 3, 14, and 18, Brockway in view of Armington teaches the claimed invention
and Brockway further teaches wherein the processor is further configured to: detect a plurality of dominant beats from the one or more ECG signals excluding the one or more ECG signals within the blanking period; and calculate a heart rate based on an R-R interval of dominant beats (fig. 4; paragraph 95-103). Dominant beats refer to the peaks, that determines an R-R interval, as disclosed by the applicant (fig. 6-7; paragraph 100-102). Detection of dominant peaks is disclosed to be a pre-filtering sub-process adapted to filter out 50 Hz and/or 60 Hz noise. Portions of the ECG waveform or signals that are likely to include artifact spikes or interference noise during stimulation may be “blanked” from the ECG waveform or signals.
Regarding claims 6 and 9, Brockway in view of Armington teaches the claimed invention and
Brockway further teaches wherein the blanking period is implemented by a bi- directional filter configured to blank samples before and after the samples that exceed the noise threshold (fig. 6-7; paragraph 100-105). Detection of dominant peaks is disclosed to be a pre-filtering sub-process adapted to filter out 50 Hz and/or 60 Hz noise. The Butterworth filter equates to a bi-directional filter. Portions of the ECG waveform or signals that are likely to include artifact spikes or interference noise during stimulation may be “blanked” from the ECG waveform or signals.
Regarding claim 7, Brockway in view of Armington teaches the claimed invention and Brockway
further teaches wherein the processor (412) is configured to blank ECG signals having a duration of less than 30 seconds between two blanking periods (fig. 6; paragraph 96). The “blanking” may involve application of one or more decimation filters to permanently eliminate data points during the time of stimulation (e.g., by performing down sampling), thereby resulting in a data set that is smaller in size than the original dataset. the denoising sub-process 605 may start after 4 MS or after a time less than 4 ms (e.g., 2 ms, 3 ms, 1 ms).
Regarding claim 8, Brockway teaches method for filtering noise from one or more
electrocardiogram (ECG) signals, the method comprising:
detecting, using a plurality of ECG electrodes, the one or more ECG signals (paragraph 64); The ECG waveform is derived from signals or measurements from multiple sensors (e.g., electrodes and/or leads or leadwires) positioned on a skin of a patient at various locations on a patient's body.
sampling, using a noise filter module, the one or more ECG signals at a predefined frequency (fig. 6-7B; paragraph 83 an 95-103); The pre-filtering sub-process may include application of a notch filter or adaptive filter adapted to filter out 50 Hz and/or 60 Hz noise (e.g., typical 50 Hz and/or 60 Hz line frequency or 50 Hz-60 Hz frequency components) from the ECG signals or other biosignals received by the denoising system 405.
determining, using the noise filter module (405), whether a measurement of samples exceeds a noise threshold (fig. 6-7B; paragraph 95-103); Portions of the ECG waveform or signals that are likely to include artifact spikes or interference noise. The process 600 may include a threshold preliminary sub-process, which include frequency noise thresholds.
providing, using the noise filter module (405), a blanking period responsive to the measurement of the samples exceeding the noise threshold (fig. 6-7B; paragraph 95-103); Portions of the ECG waveform or signals that are likely to include artifact spikes or interference noise during stimulation may be “blanked” from the ECG waveform or signals. The process 600 may include a threshold preliminary sub-process.
and determining a heart rate based on an R-R interval of QRS complexes detected from the one or more ECG signals excluding the QRS complexes that are within the blanking period (fig. 4; paragraph 77-80 and 95-103). Determination of a heart rate based on an R-R interval of QRS complexes is disclosed. Portions of the ECG waveform or signals that are likely to include artifact spikes or interference noise during stimulation may be “blanked” from the ECG waveform or signals.
However, Brockway does not teach wherein the samples in the blanking period are replaced with a not a number (NaN) value, to keep the samples set in time; detect a plurality of dominant beats from the one or more ECG signals excluding at least a portion of the one or more ECG signals within the blanking period, wherein the plurality of dominant beats corresponds to a beat morphology occurring a highest number of times among detected beats in QRS complexes of the one or more ECG signals; and calculate a heart rate based on the detected plurality of dominant beats.
Armington, teaches a method and system for detecting heartbeats, and further teaches wherein the samples in the blanking period are replaced with a not a number (NaN) value, to keep the samples set in time; detect a plurality of dominant beats from the one or more ECG signals excluding at least a portion of the one or more ECG signals within the blanking period, wherein the plurality of dominant beats corresponds to a beat morphology occurring a highest number of times among detected beats in QRS complexes of the one or more ECG signals; and calculate a heart rate based on the detected plurality of dominant beats (col. 3, lines 20-40). It is disclosed that “pacer blanker 12 blanks the ECG signal from 10 milliseconds before impulse 301 to 40 milliseconds after impulse 301 and calculates and substitutes therefore a linearly sloped portion 304. This blanking time is kept to a minimum so that closely coupled QRS complexes are not normally affected.” The digitized ECG signal is applied to a post pacer activity detector 16, which may be used to detect a plurality of dominant beats excluding the blanking periods. Removing or zeroing the blanking period messed up the timing of signals and thus substituted a value. Although a NaN value is not disclosed, a ramp may work for that feature.
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 processing system of Brockway with the blanking periods from Armington for the benefit of reducing the amount of large pacer impulses because the presence of large pacer impulses can effect the sensitivity of QRS detector since it normally has an adjustable threshold level.
Regarding claims 10 and 17, Brockway in view of Armington teaches the claimed invention and
Brockway further teaches wherein the blanking period replaces the samples in the blanking period with a not a number (NaN) value, thereby keeping the samples set in time (fig. 6; paragraph 96). The “blanking” may involve application of one or more decimation filters to permanently eliminate data points during the time of stimulation (e.g., by performing down sampling), thereby resulting in a data set that is smaller in size than the original dataset. The eliminated data points (e.g., data values and certain memory locations) may not be replaced in these implementations. Therefore, a NaN value is disclosed.
Regarding claim 15, Brockway teaches a non-transitory computer-readable medium, encoded
with instructions for filtering noise from one or more electrocardiogram (ECG) signals stored thereon that, when executed by a computing device, cause the computing device to perform operations for filtering noise from the one or more ECG signals, the operations comprising (fig. 4 and 6-7A; paragraph 64 and 101-105):
receiving the one or more ECG signals from a patient via a plurality of ECG electrodes (paragraph 64); The ECG waveform is derived from signals or measurements from multiple sensors (e.g., electrodes and/or leads or leadwires) positioned on a skin of a patient at various locations on a patient's body.
sampling, using a noise filter module, the one or more ECG signals at a predefined frequency (fig. 6-7B; paragraph 83 an 95-103); The pre-filtering sub-process may include application of a notch filter or adaptive filter adapted to filter out 50 Hz and/or 60 Hz noise (e.g., typical 50 Hz and/or 60 Hz line frequency or 50 Hz-60 Hz frequency components) from the ECG signals or other biosignals received by the denoising system 405.
determining, using the noise filter module (405), whether a measurement of samples exceeds a noise threshold (fig. 6-7B; paragraph 95-103); Portions of the ECG waveform or signals that are likely to include artifact spikes or interference noise. The process 600 may include a threshold preliminary sub-process, which include frequency noise thresholds.
providing, using the noise filter module (405), a blanking period responsive to the measurement of the samples exceeding the noise threshold (fig. 6-7B; paragraph 95-103); Portions of the ECG waveform or signals that are likely to include artifact spikes or interference noise during stimulation may be “blanked” from the ECG waveform or signals. The process 600 may include a threshold preliminary sub-process.
and determining a heart rate based on an R-R interval of QRS complexes detected from the one or more ECG signals excluding the QRS complexes that are within the blanking period (fig. 4; paragraph 77-80 and 95-103). Determination of a heart rate based on an R-R interval of QRS complexes is disclosed. Portions of the ECG waveform or signals that are likely to include artifact spikes or interference noise during stimulation may be “blanked” from the ECG waveform or signals.
However, Brockway does not teach wherein the samples in the blanking period are replaced with a not a number (NaN) value, to keep the samples set in time; detect a plurality of dominant beats from the one or more ECG signals excluding at least a portion of the one or more ECG signals within the blanking period, wherein the plurality of dominant beats corresponds to a beat morphology occurring a highest number of times among detected beats in QRS complexes of the one or more ECG signals; and calculate a heart rate based on the detected plurality of dominant beats.
Armington, teaches a method and system for detecting heartbeats, and further teaches wherein the samples in the blanking period are replaced with a not a number (NaN) value, to keep the samples set in time; detect a plurality of dominant beats from the one or more ECG signals excluding at least a portion of the one or more ECG signals within the blanking period, wherein the plurality of dominant beats corresponds to a beat morphology occurring a highest number of times among detected beats in QRS complexes of the one or more ECG signals; and calculate a heart rate based on the detected plurality of dominant beats (col. 3, lines 20-40). It is disclosed that “pacer blanker 12 blanks the ECG signal from 10 milliseconds before impulse 301 to 40 milliseconds after impulse 301 and calculates and substitutes therefore a linearly sloped portion 304. This blanking time is kept to a minimum so that closely coupled QRS complexes are not normally affected.” The digitized ECG signal is applied to a post pacer activity detector 16, which may be used to detect a plurality of dominant beats excluding the blanking periods. Removing or zeroing the blanking period messed up the timing of signals and thus substituted a value. Although a NaN value is not disclosed, a ramp may work for that feature.
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 processing system of Brockway with the blanking periods from Armington for the benefit of reducing the amount of large pacer impulses because the presence of large pacer impulses can effect the sensitivity of QRS detector since it normally has an adjustable threshold level.
Claims 4-5, 12-13, and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over
Brockway in view of Armington in view of ARANDA HERNANDEZ et al. US Pub.: US 20230148939 A1, hereinafter Hernandez.
Regarding claims 4, 12, and 19, Brockway in view of Armington does not teach wherein the
measurement comprises a first measurement and a second measurement, and wherein the first measurement is an absolute value of an amplitude difference between consecutive samples and the second measurement is an absolute value of an amplitude difference between a first sample and a last sample in a series of samples.
Hernandez, in the same field of endeavor, teaches wherein the measurement comprises a first measurement and a second measurement, and wherein the first measurement is an absolute value of an amplitude difference between consecutive samples and the second measurement is an absolute value of an amplitude difference between a first sample and a last sample in a series of samples (paragraph 97, 154, 213 and 216). Each identified moving window measures a maximum or average of the absolute amplitudes of the gradient signal. Therefore, an absolute value is measured between consecutive signals. The control circuit is disclosed to perform absolute value operation to any two sample points. Therefore, a first and last sample absolute value may be measured.
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 processor of Brockway in view of Armington with the absolute value operation from Hernandez for the benefit of reducing the processing burden and determining various morphology parameters from a cardiac signal for detecting arrhythmia as described herein, which may include any of a mean period, spectral width, low slope content, signal pulse amplitudes, signal pulse intervals, etc.
Regarding claim 5, 13, and 20, Brockway in view of Armington does not teach wherein the noise
threshold comprises a first threshold and a second threshold, wherein the first threshold is about 2 mV/sample and the second threshold is about 5 mV, and wherein the first threshold corresponds to the first measurement and the second threshold corresponds to the second measurement.
Hernandez, in the same field of endeavor, teaches wherein the noise threshold comprises a first
threshold and a second threshold, wherein the first threshold is about 2 mV/sample and the second threshold is about 5 mV, and wherein the first threshold corresponds to the first measurement and the second threshold corresponds to the second measurement (fig. 3; paragraph 102-103). Each sensing channel 83 and 85 may be adjust to 2 mV/sample and 5 mV/sample by the control circuit 80.
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 processor of Brockway in view of Armington with the absolute value operation from Hernandez for the benefit of determining sensed event intervals for use in detecting tachyarrhythmia.
Regarding claim 21 and 22, Brockway in view of Armington does not teach further comprising a
discharge circuit configured to discharge electrical charge through the patient to deliver a therapy, wherein the processor is further configured to control, based on the calculated heart rate, the discharge circuit to discharge the electrical charge through the patient to deliver the therapy.
Hernandez, in the same field of endeavor, teaches further comprising a discharge circuit configured to discharge electrical charge through the patient to deliver a therapy, wherein the processor is further configured to control, based on the calculated heart rate, the discharge circuit to discharge the electrical charge through the patient to deliver the therapy (paragraph 114-115). Therapy delivery circuit 84 may include switching circuitry 95 that controls when the charge storage device(s) are discharged through an output circuit 96 across a selected pacing electrode vector or CV/DF shock vector.
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 processor of Brockway in view of Armington with the discharge circuit from Hernandez for the benefit of delivering electrical stimulation pulses for inducing tachyarrhythmia.
Claims 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Brockway in
view of Armington in view of TRAN et al. US Pub.: US 20200077892 A1, hereinafter Tran.
Regarding claims 11 and 16, Brockway in view of Armington teaches wherein the blanking
period is implemented by a bi-directional filter configured to blank samples before and after the samples that exceed the noise threshold (fig. 6-7; paragraph 100-105). Detection of dominant peaks is disclosed to be a pre-filtering sub-process adapted to filter out 50 Hz and/or 60 Hz noise. The Butterworth filter equates to a bi-directional filter. Portions of the ECG waveform or signals that are likely to include artifact spikes or interference noise during stimulation may be “blanked” from the ECG waveform or signals.
However, Brockway in view of Armington does not explicitly teach wherein the blanking period further comprises about 250 samples to about 450 samples before and after the samples that exceed the noise threshold.
Tran, in the same field of endeavor, teaches wherein the blanking period further comprises about 250 samples to about 450 samples before and after the samples that exceed the noise threshold (page 40, col. 2). Frame 1 contains the first 400 samples. The frame 2 also contains 400 samples, but begins at the 300th sample and continues until the 700th sample. The blanking period will start at least 400 samples, the sample will go through the noise threshold until the next frame period, which will start at 400 as well.
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 processing step of Brockway in view of Armington to keep the sampling size of the blanking period to 250-450 from Tran for the benefit of minimizing signal discontinuities at the beginning and end of each period.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.J.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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