DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 – Claim 1 recites, in the second to last element, “in response to registering the pacing signal analyzing at least one of the first and the second derived ECG signals.” Please add a comma to read “in response to registering the pacing signal, analyzing at least one of the first and the second derived ECG signals,” as seen in Claim 11.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hedberg et al. (US 5740811 A)[hereinafter “Hedberg”] and Harvey et al., Automated Pacing Artifact Removal in Electrocardiograms, IEEE, 2020 [hereinafter “Harvey”].
Regarding Claims 1 and 11, Hedberg discloses a method for removal of a pacing artifact (and corresponding apparatus including a processor [Figs. 13 and 16, signal processing device 105 including the transforming units 101 and processing unit 130])[Column 2 lines 13-22 – “An object of the invention is to provide, from the implanted electrodes of an active implant (pacer and/or a defibrillator and/or implanted monitoring systems), a type of ECG which in appearance can be substituted for a surface ECG and which may be used especially postoperatively and for follow-ups (repeated) after the implantation of a stimulator or the like or for, e.g., checking the functioning of such a stimulator or for adjusting the parameters controlling the active implant whenever a programmer is in communication with the active implant.”Column 2 lines 34-41 – “Another object of the invention is to make use of the signals from each electrode and to be able to exclude and/or lessen the effects of the information in the signal of electrical activity in the very close proximity to the electrode. Yet another object is to be able to better distinguish between paced and spontaneous heart activities such as: capture, inhibition, fusion beats, etc.”], comprising:
registering that a pacing signal has been applied to a pacing location in a heart of a patient [See Fig. 13 and Column 8 lines 15-24 – “FIG. 13 shows a schematic presentation of a heart 10, having a right atrium 11 and a right ventricle 12. A system having five intracardiac electrodes is shown implanted in the heart 10: a ring electrode 20 and a tip electrode 21 in the atrium 11 and a ring electrode 22 and a tip electrode 23 in the ventricle 12 and a defibrillation electrode 25. The system also includes a patch electrode 27 in contact with the outside of the heart. A defibrillation electrode 24 is placed near the location where the superior vena cava 13 enters the right atrium. The system also includes a can electrode 26.”Column 7 lines 60-66 – “In the heart 10 a defibrillation electrode 24 is implanted in the superior vena cava and another defibrillation electrode 25, in the right ventricle 12 and a tip electrode 22. This embodiment also includes an electrode 26 formed by the can. The electrodes are all connected via conductors to the active implant for pacing and defibrillation as is usual.”Column 8 lines 48-50 – “Using the system shown schematically in FIG. 13, it is possible to register and/or process signals from two or more electrodes.”];
positioning a first electrode in a first location [Fig. 13, ring electrode 20 or tip electrode 21 in the atrium 11] in proximity to the pacing location [Fig. 13, see the locations of defibrillation electrode 24/25], and coupling a first circuitry, having a first transfer function, to receive a first electrocardiogram (ECG) signal, generated in response to the pacing signal, from the first electrode [See Fig. 13 and Column 9 lines 1-18 – “Below the schematic illustration of the heart 10, FIG. 13 shows a schematic drawing of the principle according to which the inventive signal processing is carried out. First the received signals will pass through filtering/transforming and blocking circuitry in the respective transforming units 101. As noted above, the measured signals can be obtained across two selected electrodes, each transforming unit 101 may operate using a virtual (floating) ground as reference. Each transforming unit 101 includes one or more amplifiers, filters, blocking and transfer functions. The reason for this first processing is that the intracardiac electrodes will each pick up information as to the electrical activity resulting from cardiac activity in the proximity of the electrode, but also will pick up activity in other parts of the heart. The electrical activity induced in the very near proximity of each electrode will of course give a considerably greater contribution to the signal than activity occurring comparatively farther away.”];
recording a first derived ECG signal from the first circuitry in response to the first ECG signal [See Fig. 13, each signal used in determining the synthesized ECG. Column 9 lines 19-22 – “The processed signals will then be fed to a second signal processing unit, referred to as a combining unit 130, for the summation, including weighting of the individual signals and processing to generate the synthesized surface ECG.”];
positioning a second electrode in a second location [Fig. 13, ring electrode 22 and a tip electrode 23 in the ventricle 12] in proximity to the pacing location [Fig. 13, see the locations of defibrillation electrode 24/25], and coupling a second circuitry, having a second transfer function different from the first transfer function, to receive a second ECG signal, generated in response to the pacing signal, from the second electrode [See Fig. 13 and Column 9 lines 1-18 – “Below the schematic illustration of the heart 10, FIG. 13 shows a schematic drawing of the principle according to which the inventive signal processing is carried out. First the received signals will pass through filtering/transforming and blocking circuitry in the respective transforming units 101. As noted above, the measured signals can be obtained across two selected electrodes, each transforming unit 101 may operate using a virtual (floating) ground as reference. Each transforming unit 101 includes one or more amplifiers, filters, blocking and transfer functions. The reason for this first processing is that the intracardiac electrodes will each pick up information as to the electrical activity resulting from cardiac activity in the proximity of the electrode, but also will pick up activity in other parts of the heart. The electrical activity induced in the very near proximity of each electrode will of course give a considerably greater contribution to the signal than activity occurring comparatively farther away.”]; and
recording a second derived ECG signal from the second circuitry in response to the second ECG signal [See Fig. 13, each signal used in determining the synthesized ECG. Column 9 lines 19-22 – “The processed signals will then be fed to a second signal processing unit, referred to as a combining unit 130, for the summation, including weighting of the individual signals and processing to generate the synthesized surface ECG.”].
Hedberg fails to disclose, in response to registering the pacing signal, analyzing at least one of the first and the second derived ECG signals; and in response to the analyzing, removing the pacing artifact from the least one of the first and the second derived ECG signals.
However, Harvey discloses analyzing pacing signals to eliminate pacing spikes [Abstract – “Sophisticated pacing systems like cardiac resynchronization therapy further complicate the problem by introducing pacing artifacts that are not only preceding but are also within the relevant ECG signal where they simply cannot be ignored. The pacing spike generates outliers that skews results and hinders both regression analysis and principal component analysis of the physiological signal. This is the first paper to show effective elimination of pacing spike outliers in ECGs. In order to eliminate pacing spikes, this paper proposes a novel filter and compares to prior techniques used in alternate fields.”See the signal with pacing spikes in Fig. 1b.See the effect of the filter in Fig. 4.Page 4, first column – “Figure 4 shows an example of how the novel filter works. It deletes all of the original information between the orange lines and backfills them with a hyperbolic cosine spline.”Page 4, second column – “The novel filter successfully filtered out all spikes on all patients with pacing spikes from CRT.”].
It would have been obvious to apply such a technique to the ECG signals in order to produce a more accurate synthesized ECG.
Regarding Claims 2 and 12, Hedberg discloses that the first circuitry and the second circuitry comprise common circuit components arranged in a common configuration [See Fig. 13 and Column 9 lines 1-18 – “Each transforming unit 101 includes one or more amplifiers, filters, blocking and transfer functions.”].
Regarding Claims 3 and 13, Hedberg discloses that one of the common circuit components of the first circuitry has a different electrical parameter value from the electrical parameter value of a respective component of the second circuitry [Column 9 lines 8-18 – “Each transforming unit 101 includes one or more amplifiers, filters, blocking and transfer functions. The reason for this first processing is that the intracardiac electrodes will each pick up information as to the electrical activity resulting from cardiac activity in the proximity of the electrode, but also will pick up activity in other parts of the heart. The electrical activity induced in the very near proximity of each electrode will of course give a considerably greater contribution to the signal than activity occurring comparatively farther away.” The different electrode locations will inherently produce different electrical parameter values.].
Regarding Claims 4 and 14, Hedberg discloses that the first circuitry and the second circuitry comprise different circuit components [Figs. 13 and 14, the components for each transforming unit 101].
Regarding Claims 5 and 15, Hedberg discloses that the first circuitry and the second circuitry comprise common circuit components [Figs. 13 and 14, the components for each transforming unit 101] arranged in a different configuration [Column 11 lines 6-11 – “The diagnostic device also includes a switching stage schematically shown at 70 for selective interconnection of the input signals from one or more electrodes before the signal processing units 101. These switches may be connected/disconnected in a multiplexing mode in order to facilitate the operating of the active implant[.]”].
Regarding Claims 6 and 16, Hedberg fails to disclose that analyzing the at least one of the first and the second derived ECG signals comprises computing a direct current (DC) voltage level thereof, and wherein removing the pacing artifact comprises applying the DC voltage level as a DC correction for the at least one of the first and the second derived ECG signal.
However, Harvey discloses the use of such a technique [Page 3, first column – “Whitaker and Hayes’ removed the spike by the neighbor interpolation method. Which is interpolating the mean of the values of the immediate data points before and after the spike that are below the threshold. This eliminates the spike outlier and smooths out the signal[.]”]. It would have been obvious to take such an approach in order to smooth out the impact of pacing spikes in the ECG signals.
Regarding Claims 7 and 17, the combination would disclose that analyzing the at least one of the first and the second derived ECG signals comprises computing a baseline fit function to compensate for a change in baseline slope of the at least one of the first and the second derived ECG signals [See the effect of the filter in Fig. 4 of Harvey.Page 4, first column of Harvey – “Figure 4 shows an example of how the novel filter works. It deletes all of the original information between the orange lines and backfills them with a hyperbolic cosine spline.”].
Regarding Claims 8 and 18, the combination would disclose applying a decay function to the baseline fit function [See the effect of the filter in Fig. 4 of Harvey which decays at the right side of the Backfilled Spline.Page 4, first column of Harvey – “Figure 4 shows an example of how the novel filter works. It deletes all of the original information between the orange lines and backfills them with a hyperbolic cosine spline.”].
Regarding Claims 9 and 19, the combination would disclose analyzing the at least one of the first and the second derived ECG signals comprises computing a bipolar ECG signal from the first and the second derived ECG signals [Column 4 lines 52-55 of Hedberg, per analysis using transforming units 101 – “FIG. 2 shows a heart 10 with two implanted bipolar electrodes, each having a tip electrode 21 and 23 and a ring electrode 20 and 22 in the atrium 11 and the ventricle 12, respectively.”], and wherein removing the artifact comprises removing the artifact from the bipolar ECG signal [See the effect of the filter in Fig. 4 of Harvey.Page 4, first column of Harvey – “Figure 4 shows an example of how the novel filter works. It deletes all of the original information between the orange lines and backfills them with a hyperbolic cosine spline.”].
Regarding Claims 10 and 20, the combination would disclose that analyzing the at least one of the first and the second derived ECG signals comprises cutting a pacing peak therefrom so as to produce a chopped signal, interpolating and filtering the chopped signal so as to produce a filtered signal, and restoring the pacing peak to the filtered signal [See the effect of the filter in Fig. 4 of Harvey.Page 4, first column of Harvey – “Figure 4 shows an example of how the novel filter works. It deletes all of the original information between the orange lines and backfills them with a hyperbolic cosine spline.”].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Li, Design of ECG Signal Detection Circuit Based on Pacing Pulse Suppression, IEEE, 2021
Plesnik et al., Improved removal of electrocardiogram baseline wandering, IEEE, 2013
Polpetta et al., Fully Digital Pacemaker Detection in ECG Signals Using a Non-Linear Filtering Approach, IEEE, 2008
US 5660184 A – Pacemaker Pulse Detection And Artifact Rejection
US 20230346293 A1 – SYSTEMS FOR SERIAL COMPARISON OF ELECTROCARDIOGRAMS
US 9174057 B1 – Cardiac Event Detection Based On Selective Pacing For Establishing A Paced Heart Signal Parameter Baseline
US 4105023 A – Pacemaker Artifact Suppression In Coronary Monitoring
US 8805498 B1 – Ischemia Detection Systems For Paced-patients Using Beat-type Dependent Baseline Datasets
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/KYLE R QUIGLEY/Primary Examiner, Art Unit 2857
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