DETAILED ACTIONS
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yonce et al. (US 2003/0023176 A1, hereinafter Yonce).
Regarding Claim 1, Yonce teaches,
A method for removing or extracting pacing signal artifacts, (Yonce, [0004] method for detecting pacing pulses within ECG data”) comprising:
receiving a signal comprising cardiac data, pacing data (Yonce, Figure 2, “[0014] In the graph labeled A in FIG. 1, there is show a waveform made up of an ECG signal that also contains a pacing pulse”), and background electrical noise (Figure 2, ,[0014] “noise bursts (such as minute ventilation signals”), at a first path (Figure 2 LPF path ) and a second path(Figure 2 HPF path ), wherein the background electrical noise comprises signals that do not originate from the cardiac data or the pacing data(noise bursts (such as minute ventilation signals)),;
first filtering the signal (Yonce, Figure 2-3, EKG signal input, Fig. 2), using a first filter in the first path (Figure 2, from EKG though LPF path (fig. 3), thereby outputting a first filtered version of the signal, wherein the first filtering amplifies the cardiac data of the signal and suppresses the pacing data of the signal; (Yonce, Figure 3, [0017], “The low-frequency energy from filter LPF is buffered by amplifier A2 NOTE: Pacing signal is high frequency see Yonce, [0013]” A pacing pulse is made up of positive and negative going edges that have significant energy in the high frequency band” and suppressed by the lowpass first filter and amplifies cardiac data)
second filtering the signal, using a second filter in the second path (Figure 2, from EKG though HPF path (fig. 3), thereby outputting a second filtered version of the signal, wherein the second filtering amplifies the pacing data of the signal and suppresses the cardiac data of the signal (Yonce, Figure 3, [0017], “The high-frequency energy from filter HPF is buffered by amplifier A1, NOTE: Pacing signal is high frequency see Yonce, [0013] above);
establishing a threshold amplitude value (Yonce, Figure 3, A3-A5 Random threshold, previous threshold, and fixed threshold ) and applying the threshold amplitude value to the first filtered version of the signal (Figure 3, [0017], “The low-frequency energy from filter LPF is buffered by amplifier A2 and then tested to determine if it exceeds the fixed threshold as defined by a voltage reference VREF by comparator A6”); or the second filtered version of the signal to output a threshold signal,
wherein parts of amplitude of the signal that are less than or equal to the threshold amplitude value are removed from the threshold signal. (Yonce, Figure 3, [0012] programmer incorporating a system in accordance with the invention
provides the clinician with a more informative ECG display, by showing either the isolated pacing pulses generated by the pacemaker or the ECG signal, with the pacing pulses removed”).
Regarding Claim 2, Yonce teaches the method of claim 1,
Yonce further teaches wherein the threshold amplitude value is applied to the first filtered version of the signal. (Yonce, Figure 3, A6, [0017] Still referring to FIG. 3, the input ECG signal is split and fed separately to the high-frequency and low-freqency bandpass filters HPF and LPF. The low-frequency energy from filter LPF is buffered by amplifier A2 and then tested to determine if it exceeds the fixed threshold as defined by a voltage reference VREF by comparator A6”)
Regarding Claim 3, Yonce teaches the method of claim 1,
Yonce further teaches wherein the threshold amplitude value is applied to the second filtered version of the signal. (Yonce, Figure A3-A5, [0017] “The high-frequency energy from filter HPF is buffered by amplifier A1, rectified by rectifier AV to result in the absolute value of the signal, and then passed to three separate threshold detectors. Comparator AS performs the same threshold test on the high-frequency energy signal as does comparator A6 on the low-frequency signal, using VREF as the fixed threshold”).
Regarding Claim 4, Yonce teaches the method of claim 1,
Yonce further teaches wherein the first filter is a low frequency bandpass filter. (Yonce, Figure 3, LPF).
Regarding Claim 5, Yonce teaches the method of claim 1,
Yonce further teaches wherein the second filer is a high frequency pass filter. (Yonce, Figure 3, HPF)
Regarding Claim 6, Yonce teaches the method of claim 1,
Yonce further teaches, wherein the threshold amplitude value comprises: a first parameter (Yonce, Figure 3, threshold, A5), wherein the first parameter has a constant value (Yonce, Figure 3, fixed threshold, A5); and
a second parameter, and wherein the method further comprises adjusting the second parameter based on an amplitude of the pacing data within the signal. (Yonce, Figure 3, [0017], If the detected high-frequency energy exceeds the fixed threshold, the Fixed Threshold signal is asserted. Comparator A3 performs a threshold test of a fraction of the high-frequency energy, as determined by
voltage divider VD, with respect to the output of the RMS-to-DC Converter CV1R. As described above, this is the dynamic noise floor and, if it is exceeded, the signal Random Noise Threshold is asserted by the comparator. Comparator A4 then tests whether the filtered input signal exceeds the previously stored peak in peak detector PD2. If so, the signal Previous Pace Threshold is asserted”).
Regarding Claim 7, Yonce teaches the method of claim 1,
Yonce further teaches wherein the threshold amplitude value comprises: a first parameter, wherein the first parameter has a constant value (Yonce, Figure 3, fixed threshold, A5); and a second parameter, and wherein the method further comprises adjusting the second parameter based on an amplitude of the cardiac data within the signal. (Yonce, [0017]” The low-frequency energy from filter LPF is buffered by amplifier A2 and then tested to determine if it exceeds the fixed threshold as defined by a voltage reference VREF by comparator A6. If so, the signal Low Freq Presence is asserted indicating that threshold energy has been detected in the low-frequency band”. [0019] “the state machine check, the low-frequency filtered input to determine whether there has been a low-frequency peak since the start of the timers, as indicated by assertion of Low Freq Presence (…) If there has been a low frequency peak, the state machine transitions to the VALID PACE state and asserts the Valid Pace signal. The machine also then asserts the Save Peak signal to move the peak value stored in peak detector PDl into peak detector PD2 and thereby reset the previous pace threshold.” NOTE: State machine update the threshold value based on cardiac data / low frequency data peak and timing, the comparator determines threshold value based on peaks amplitude and timing).
Regarding Claim 8, Yonce teaches the method of claim 1,
Yonce further teaches wherein the method is performed by a computer comprising one or more processors. (Yonce, Figure 2, [0018], [0018] The tests performed by the pulse detection circuitry are processed by logic circuitry in order to detect a pacing pulse. In this embodiment, the logic circuitry is a dedicated digital or sequential state machine DSM as depicted in FIG. 4. Such a state machine may be implemented, for example, as discrete logic components, in a field-programmable gate array (FPGA), or as software instructions executed by a processor”).
Regarding Claim 9, Yonce teaches,
A system for removing pacing signal artifacts from a signal (Yonce, Figure 2, [0004]” It is a primary object of the present invention to provide a system and method for detecting pacing pulses within ECG data”), the signal having cardiac data (Figure 2, ECG data) , pacing data (Yonce, Figure 2, “[0014] In the graph labeled A in FIG. 1, there is show a waveform made up of an ECG signal that also contains a pacing pulse”), and background electrical noise (Figure 2,[0014] noise bursts (such as minute ventilation signals), wherein the background electrical noise comprises signals that do not originate from the cardiac data or the pacing data, the system comprising: a first signal path, configured to receive the signal, (Random noise,noise bursts (such as minute ventilation signals) comprising:
a first filter (Figure 2, LPF) configured to amplify the cardiac data of the signal and suppress the pacing data of the signal and output a first filtered version of the signal anda first signal processing module configured to receive and square the first filtered version of the signal and output a first processed signal (Yonce, Figure 3, [0017], “The low-frequency energy from filter LPF is buffered by amplifier A2 NOTE: Pacing signal is high frequency see ( Yonce, [0013]” A pacing pulse is made up of positive and negative going edges that have significant energy in the high frequency band” and suppressed by the lowpass first filter and amplifies cardiac data; and
a second filter (Figure 2, from EKG though HPF path (fig. 3))path configured to receive the signal, comprising: a second filter (Figure 2, LPF) configured to amplify pacing data of the signal and suppress the cardiac data of the signal and to output a second filtered version; a second signal processing module configured to receive and square the second filtered version of the signal and output a second processed signal (Yonce, Figure 3, [0017], “The high-frequency energy from filter HPF is buffered by amplifier A1, NOTE: Pacing signal is high frequency see Yonce, [0013] above);
a thresholding generator (Fig.3 "RMS TO DC converter) configured to receive the first processed signal or the second processed signal and establish a threshold amplitude value (Yonce, Figure 3, A3-A5 Random threshold, previous threshold, and fixed threshold); and
a thresholding module configured to apply the threshold amplitude value to the signal and output a thresholded signal, (Figure 3, [0017], “The low-frequency energy from filter LPF is buffered by amplifier A2 and then tested to determine if it exceeds the fixed threshold as defined by a voltage reference VREF by comparator A6”); wherein parts of amplitude of the signal that are less than the threshold amplitude value are removed from the three sholded signal. (Yonce, Figure 3, [0012] programmer incorporating a system in accordance with the invention
provides the clinician with a more informative ECG display, by showing either the isolated pacing pulses generated by the pacemaker or the ECG signal, with the pacing pulses removed”).
Regarding Claim 10, Yonce teaches the system of claim 9,
Yonce further teaches wherein the threshold module is configured to apply the threshold amplitude value to the first processed signal (Yonce, Figure 3, A6, [0017] Still referring to FIG. 3, the input ECG signal is split and fed separately to the high-frequency and low-freqency bandpass filters HPF and LPF. The low-frequency energy from filter LPF is buffered by amplifier A2 and then tested to determine if it exceeds the fixed threshold as defined by a voltage reference VREF by comparator A6”).
Regarding Claim 11, Yonce teaches the system of claim 9,
Yonce further teaches wherein the threshold module is configured to apply the threshold amplitude value to the second processed signal. (Yonce, Figure A3-A5, [0017] “The high-frequency energy from filter HPF is buffered by amplifier A1, rectified by rectifier AV to result in the absolute value of the signal, and then passed to three separate threshold detectors. Comparator A5 performs the same threshold test on the high-frequency energy signal as does comparator A6 on the low-frequency signal, using VREF as the fixed threshold”).
Regarding Claim 12, Yonce teaches the system of claim 9,
Yonce further teaches, wherein the first filter is a low frequency bandpass filter. (Yonce, Figure 3, LPF).
Regarding Claim 13, Yonce teaches the system of claim 9,
Yonce further teaches wherein the second filter is a high frequency pass filter. (Yonce, Figure 3, HPF).
Regarding Claim 14, Yonce teaches the system of claim 9,
Yonce further teaches, wherein the threshold amplitude value comprises:
a first parameter, wherein the first parameter has a constant value (Yonce, Figure 3, fixed threshold, A5);
a second parameter, wherein the second parameter is adjusted based on the amplitude of the pacing data (Yonce, Figure 3, [0017], If the detected high-frequency energy exceeds the fixed threshold, the Fixed Threshold signal is asserted. Comparator A3 performs a threshold test of a fraction of the high-frequency energy, as determined by
voltage divider VD, with respect to the output of the RMS-to-DC Converter CV1R. As described above, this is the dynamic noise floor and, if it is exceeded, the signal Random Noise Threshold is asserted by the comparator. Comparator A4 then tests whether the filtered input signal exceeds the previously stored peak in peak detector PD2. If so, the signal Previous Pace Threshold is asserted”) or cardiac data within the cardiac signal; and
a third parameter, wherein the third parameter corresponds to a shape of the first processed signal or the second processed signal. (Yonce, [0016] In order for a high-frequency energy pulse to be considered as a valid pacing pulse edge, it must be above a fixed minimum noise level and also above a dynamic noise floor established by an RMS-to-DC converter CVTR and a peak detection circuit. Using these measurement techniques to produce the threshold allows a greater immunity against a wider variety of noise. The RMS measurement from converter CVTR provides a threshold floor in the case of a continuous noise source with a relatively low crest factor. An RMS detector responds poorly, however, to pulsed noise sources, such as power-line spikes. The peak detection circuitry, comprising peak detectors PDl and PD2 together with a comparator A4, accounts for this and keeps a measure of the previous peaks, decaying with a time constant of 0.8 seconds in this embodiment. The peak detector measurement is actually a sample-and-hold system made up of the two peak detectors PDl and PD2. This allows incoming signals to not disturb the peak detector
threshold until after the voltage comparisons are completed [0017], “Comparator A3 performs a threshold test of a fraction of the high-frequency energy, as determined by voltage divider VD, with respect to the output of the RMS-to-DC Converter CVTR. As described above, this is the dynamic noise floor and, if it is exceeded, the signal Random Noise Threshold is asserted by the comparator”. NOTE: “noise threshold” determined based on amplitude/ peak/ shape of the processed signal due to the presence of noise signal.see instant application specification ([0077] In 806a, the base threshold amplitude value can be adjusted based on the shape and amplitude of the received signal”).
Regarding Claim 15, Yonce teaches the system of claim 9,
Yonce further teaches wherein the system is configured to receive operator input to modify the first parameter, the second parameter, or the third parameter (Yonce, [0012] The present invention may be practiced in a number of different environments, but is particularly suitable for use in an external programmer used to program and receive data from implantable cardiac pacemakers. Such a programmer incorporating a system in accordance with the invention provides the clinician with a more informative ECG display, by showing either the isolated pacing pulses generated by the pacemaker or the ECG signal, with the pacing pulses removed. Other embodiments may present the user with a display on a screen to indicate pacing pulse width in numerical format, or with a pacing indicator included within”).
Regarding Claim 16, Yonce teaches,
A non-transitory computer-readable medium having instructions stored thereon that, when executed by one or more computing devices, cause the one or more computing devices to perform operations comprising (Yonce, Figure 2, [0018], [0018] The tests performed by the pulse detection circuitry are processed by logic circuitry in order to detect a pacing pulse. In this embodiment, the logic circuitry is a dedicated digital or sequential state machine DSM as depicted in FIG. 4. Such a state machine may be implemented, for example, as discrete logic components, in a field-programmable gate array (FPGA), or as software instructions executed by a processor”):
receiving a signal comprising cardiac data, pacing data (Yonce, Figure 2, “[0014] In the graph labeled A in FIG. 1, there is show a waveform made up of an ECG signal that also contains a pacing pulse”), and background electrical noise (Figure 2, ,[0014] “noise bursts (such as minute ventilation signals”), at a first path (Figure 2 LPF path ) and a second path(Figure 2 HPF path ), wherein the background electrical noise comprises signals that do not originate from the cardiac data or the pacing data(noise bursts (such as minute ventilation signals));
first filtering the signal (Yonce, Figure 2-3, EKG signal input, Fig. 2), using a first filter in the first path (Figure 2, from EKG though LPF path (fig. 3), thereby outputting a first filtered version of the signal, wherein the first filtering amplifies the cardiac data of the signal and suppresses the pacing data of the signal ; applying first signal processing to the first filtered version of the signal, wherein the first signal processing squares the first filtered version of the signal(Yonce, Figure 3, [0017], “The low-frequency energy from filter LPF is buffered by amplifier A2 NOTE: Pacing signal is high frequency see Yonce, [0013]” A pacing pulse is made up of positive and negative going edges that have significant energy in the high frequency band” and suppressed by the lowpass first filter and amplifies cardiac data ;
second filtering the signal, using a second filter in the second path (Figure 2, from EKG though HPF path (fig. 3), thereby outputting a second filtered version of the signal, wherein the second filtering amplifies the pacing data of the signal and suppresses the cardiac data of the signal; applying a second signal processing to the second filtered version of the signal, wherein the second signal processing squares the second filtered version of the signal; Yonce, Figure 3, [0017], “The high-frequency energy from filter HPF is buffered by amplifier A1, NOTE: Pacing signal is high frequency see Yonce, [0013] above);
establishing a threshold amplitude value (Yonce, Figure 3, A3-A5 Random threshold, previous threshold, and fixed threshold); and
applying the threshold amplitude value to the signal to output a threshold signal, wherein parts of amplitude of the signal that are less than or equal to the threshold amplitude value are removed from the threshold signal. (Figure 3, [0017], “The low-frequency energy from filter LPF is buffered by amplifier A2 and then tested to determine if it exceeds the fixed threshold as defined by a voltage reference VREF by comparator A6”).
Regarding Claim 17, Yonce teaches non-transitory computer-readable medium claim 16,
Yonce further teaches wherein the threshold amplitude value is applied to the first filtered version of the signal. (Yonce, Figure 3, A6, [0017] Still referring to FIG. 3, the input ECG signal is split and fed separately to the high-frequency and low-freqency bandpass filters HPF and LPF. The low-frequency energy from filter LPF is buffered by amplifier A2 and then tested to determine if it exceeds the fixed threshold as defined by a voltage reference VREF by comparator A6”).
Regarding Claim 18, Yonce teaches non-transitory computer-readable medium claim 16,
Yonce further teaches, wherein the threshold amplitude value is applied to the second filtered version of the signal. (Yonce, Figure A3-A5, [0017] “The high-frequency energy from filter HPF is buffered by amplifier A1, rectified by rectifier AV to result in the absolute value of the signal, and then passed to three separate threshold detectors. Comparator A5 performs the same threshold test on the high-frequency energy signal as does comparator A6 on the low-frequency signal, using VREF as the fixed threshold”).
Regarding Claim 19, Yonce teaches non-transitory computer-readable medium claim 16,
Yonce further teaches, 16, wherein the first filter is a low frequency bandpass filter (Yonce, Figure 3, LPF)., and the second filter is a high frequency pass filter(Yonce, Figure 3, HPF).
Regarding Claim 20, Yonce teaches non-transitory computer-readable medium claim 16,
Yonce further teaches wherein the threshold amplitude value (Yonce, Figure 3, threshold, A5), comprises: a first parameter, wherein the first parameter has a constant value (Yonce, Figure 3, fixed threshold, A5); and a second parameter, and wherein the operations further comprise adjusting the second parameter based on the amplitude of the pacing data within the signal. (Yonce, Figure 3, [0017], If the detected high-frequency energy exceeds the fixed threshold, the Fixed Threshold signal is asserted. Comparator A3 performs a threshold test of a fraction of the high-frequency energy, as determined by voltage divider VD, \\ith respect to the output of the RMS-to-DC Converter CV1R. As described above, this is the dynamic noise floor and, if it is exceeded, the signal Random Noise Threshold is asserted by the comparator. Comparator A4 then tests whether the filtered input signal exceeds the previously stored peak in peak detector PD2. If so, the signal Previous Pace Threshold is asserted”).
Conclusion
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nallathambi et al. (US 2022/0001184 A1) describes “A method and system for detecting pacing pulses originating from implanted pacemaker using surface Electrocardiogram (ECG) signals measured at a relatively low sampling rate and also rejecting the pacing artifacts from the recorded surface ECG signals. (Abstract).
REINKE et al. (US 2021/0267527 A1) The invention recites “ In situations in which an implantable medical device ( e.g., a subcutaneous ICD) is co-implanted with a leadless pacing device (LPD), it may be important that the subcutaneous ICD knows when the LPD is delivering pacing, such as anti-tachycardia pacing (ATP). Techniques are described herein for detecting, with the ICD and based on the sensed electrical signal, pacing pulses and adjusting operation to account for the detected pulses, e.g., blanking the sensed electrical signal or modifying a tachyarrhythmia detection algorithm. In one example, the ICD includes a first pace pulse detector configured to obtain a sensed electrical signal and analyze the sensed electrical signal to detect a first type of pulses having a first set of characteristics and a second pace pulse detector configured to obtain the sensed electrical signal and analyze the sensed electrical signal to detect a second type of pulses having a second set of characteristics” (Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DILARA SULTANA whose telephone number is (571)272-3861. The examiner can normally be reached Mon-Fri, 9 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, EMAN ALKAFAWI can be reached on (571) 272-4448. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DILARA SULTANA/Examiner, Art Unit 2858
/EMAN A ALKAFAWI/Supervisory Patent Examiner, Art Unit 2858 4/3/2026
Prosecution Insights