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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 18/684,800, filed on 02/19/2024.
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.
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.
Claim(s) 16-27, 29, 34, and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hsu (US 20020019593 A1) in view of Welsh (US 20190200886 A1).
Regarding claim 16, Hsu teaches a method for determining a cardiac isolation status of a measurement location ([abstract] A cardiac complex in the two or more cardiac signals is isolated in an analysis window) in the presence of far field interference ([0035] the first, second and third cardiac complex 116, 120 and 124 are snapshots of the single cardiac cycle taken either at different locations within or on the heart and/or taken using different electrode configurations (e.g., far-field, near-field)) by analyzing a multi-channel intracardiac electrogram of the measurement location ([0035] the windowed cardiac complex 100 has a first cardiac channel 104, a second cardiac channel 108 and a third cardiac channel 112) via a control system ([0057] At 310, the cardiac complex present in the two or more cardiac signals is isolated in an analysis window (or "windowed" for analysis)), wherein: in an identification routine the control system applies an activation search algorithm ([0039] the information derived from the cardiac complexes in each of the cardiac channels is the time the repeatably identifiable feature of the cardiac complex occurred), in at least two different channels of the intracardiac electrogram ([0039] the information derived from the cardiac complexes in each of the cardiac channels is the time the repeatably identifiable feature of the cardiac complex occurred); the activation search algorithm identifies windows of local activation potentials inside of the analysis windows (Fig 1; [0038] the cardiac complexes sensed in the two or more cardiac channels are windowed with each of the signals of the cardiac complexes represented as a voltage at a function of time. FIG. 1 shows an example of the first, second and third cardiac complex (116, 120 and 124) sensed in the first, second and third cardiac channel (104, 108 and 112) being plotted as voltage as a function of time); and in a classification routine the control system analyzes the local activation potentials to determine the cardiac isolation status of the measurement location ([0038] Once the cardiac complex sensed in the two or more cardiac channels is represented in this fashion, information can be derived from the specific features of the cardiac complexes).
Hsu fails to fully teach to analysis windows of at least 400 ms. However, Welsh teaches to analysis windows of at least 400 ms ([0364] the second set of recorded data represents an instantaneous “snapshot” of the cardiac chamber, such as when the second period of time comprises a time period less than 0.5 seconds, such as less than 100 ms, or less than 30 ms). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein analysis windows of at least 400 ms, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 17, Hsu teaches the method according to claim 16, wherein the intracardiac electrogram was recorded during an atrial arrhythmia ([0055] The physician then uses the classes of cardiac complexes to define or designate classification vectors which are subsequently used to identify cardiac complexes and classify a cardiac arrhythmia that the patient may experience) ([0088] the morphology analyzer circuit 648 compares the cardiac complex monitored in the second signal to the second NSR representative complex to determine whether the cardiac complex is an arrhythmic complex. In one embodiment, the morphology analyzer circuit 648 compares the morphology of the cardiac complex monitored in the second signal to the second NSR representative complex to determine whether the cardiac complex is an arrhythmic complex) ([0101] After the cardiac complex detected in the first signal has been aligned with the first NSR representative complex, the cardiac complex detected in the second signal is compared to the second NSR representative complex to determine whether the cardia complex is an arrhythmic complex) and/or wherein the measurement location is at least partly located inside an atrium ([0092] In an alternative embodiment, the catheter 502 is implanted the supraventricular region of the heart for sensing or monitoring cardiac signals from the patient's atrial regions. In one embodiment, a pacing electrode at or adjacent the distal end of the intracardiac catheter is implanted in the coronary sinus vein to allow for rate signals to be sensed from the left atrium) or at the entrance of a pulmonary vein and/or wherein the measurement location is at least partly located inside a pulmonary vein ([0092] Other intracardiac catheter arrangements and configurations known in the art are also possible and considered to be within the scope of the present system).
Regarding claim 18, Hsu teaches the method according to claim 16, wherein in the classification routine the control system analyzes a morphology of the local activation potentials to determine the cardiac isolation status of the measurement location ([0083] In processing sensed cardiac complexes, the morphology analyzer circuit 648 windows a cardiac complex sensed in two or more cardiac signals. In one embodiment, the morphology analyzer circuit 648 locates and extracts information from one or more predetermined features of sensed cardiac complexes) ([[0082] The morphology analyzer circuit 648 receives and processes the cardiac complexes detected within the cardiac signals. In one embodiment, the morphology analyzer circuit 648 receives cardiac signals, including cardiac complexes representative of the cardiac cycle from the sensing system. Cardiac complexes analyzed by the morphology analyzer circuit 648 can include detected P-waves, QRS-complexes, and R-waves).
Regarding claim 19, Hsu teaches the method according to claim 18, wherein in the classification routine the control system classifies the local activation potentials into morphology groups and determines the cardiac isolation status based on the distribution of local activation potentials across the morphology groups ([0083] In processing sensed cardiac complexes, the morphology analyzer circuit 648 windows a cardiac complex sensed in two or more cardiac signals. In one embodiment, the morphology analyzer circuit 648 locates and extracts information from one or more predetermined features of sensed cardiac complexes) ([0086] After the cardiac signals and information relating to the cardiac complexes in the cardiac signals have been processed by the morphology analyzer circuit 648 and the template generator circuit 650, the signals are received by a signal feature comparison circuit 638. The signal feature comparison circuit 638 uses information contained in the cardiac signals to analyze and classify sensed cardiac complexes) ([0088] Once the predetermined features in the cardiac complex from the first signal is aligned with the corresponding predetermined feature in the first NSR representative complex, the morphology analyzer circuit 648 compares the cardiac complex monitored in the second signal to the second NSR representative complex to determine whether the cardiac complex is an arrhythmic complex. In one embodiment, the morphology analyzer circuit 648 compares the morphology of the cardiac complex monitored in the second signal to the second NSR representative complex to determine whether the cardiac complex is an arrhythmic complex).
Regarding claim 20, Hsu teaches the method according to claim 18, wherein in the classification routine the control system classifies the local activation potentials into morphology groups based on a number of characteristic peaks of the local activation potential ([0083] In processing sensed cardiac complexes, the morphology analyzer circuit 648 windows a cardiac complex sensed in two or more cardiac signals. In one embodiment, the morphology analyzer circuit 648 locates and extracts information from one or more predetermined features of sensed cardiac complexes) ([0088] Once the predetermined features in the cardiac complex from the first signal is aligned with the corresponding predetermined feature in the first NSR representative complex, the morphology analyzer circuit 648 compares the cardiac complex monitored in the second signal to the second NSR representative complex to determine whether the cardiac complex is an arrhythmic complex. In one embodiment, the morphology analyzer circuit 648 compares the morphology of the cardiac complex monitored in the second signal to the second NSR representative complex to determine whether the cardiac complex is an arrhythmic complex).
Regarding claim 21, Hsu teaches the method according to claim 20, wherein the control system classifies a peak with at least a predetermined amplitude ([0083] the type of information extracted by the morphology analyzer circuit 648 can include the time of occurrence of a predetermined feature and the amplitude value of a predetermined feature) ([0101] Additional morphology analysis techniques include amplitude distribution analysis and spectral analysis) and/or with at least a predetermined slope and/or with at most a predetermined slope and/or with at least a predetermined minimum peak distance and/or with at most a predetermined maximum peak distance and/or with a minimum peak angle and/or with a maximum peak angle as one of the number of characteristic peaks ([0036] predetermined features of the cardiac complexes that are useful in deriving information include a maximum deflection of the cardiac complex, a beginning of a cardiac complex as indicated by a predetermined deviation of the cardiac signal from a baseline signal, an ending of a cardiac complex as indicated by a return of the first cardiac signal to a baseline signal and a fiducial point (the point of greatest slope along the cardiac complex signal). Other features of the cardiac complex signal are also useful for deriving information) ([0039] In one embodiment, the information derived from the cardiac complexes in each of the cardiac channels is the time the repeatably identifiable feature of the cardiac complex occurred. Alternatively, the information derived is a time difference between pairs of repeatably identifiable features on a cardiac complex sensed in one of the two or more electrogram channels).
Regarding claim 22, Hsu teaches the method according to claim 20, wherein the morphology groups comprise a group for local activation potentials with a single characteristic peak and/or exactly two characteristic peaks and/or exactly three characteristic peaks and/or more than three characteristic peaks and/or at least two characteristic peaks separated by a predetermined time ([0083] In processing sensed cardiac complexes, the morphology analyzer circuit 648 windows a cardiac complex sensed in two or more cardiac signals. In one embodiment, the morphology analyzer circuit 648 locates and extracts information from one or more predetermined features of sensed cardiac complexes) ([0088] Once the predetermined features in the cardiac complex from the first signal is aligned with the corresponding predetermined feature in the first NSR representative complex, the morphology analyzer circuit 648 compares the cardiac complex monitored in the second signal to the second NSR representative complex to determine whether the cardiac complex is an arrhythmic complex. In one embodiment, the morphology analyzer circuit 648 compares the morphology of the cardiac complex monitored in the second signal to the second NSR representative complex to determine whether the cardiac complex is an arrhythmic complex) ([0039] In one embodiment, the information derived from the cardiac complexes in each of the cardiac channels is the time the repeatably identifiable feature of the cardiac complex occurred. Alternatively, the information derived is a time difference between pairs of repeatably identifiable features on a cardiac complex sensed in one of the two or more electrogram channels).
Regarding claim 23, Hsu teaches the method according to claim 16, but fails to fully teach wherein the method includes one or more of the following features: the analysis windows have a width of at least 400 ms; the analysis windows have a width of at least 800 ms; the analysis windows have a width of at least 1.25 s; the analysis windows have a width of at most 3 s; the analysis windows have a width of at most 2 s; and the analysis windows have a width of at most 1.75 s.
However, Welsh teaches wherein the method includes one or more of the following features: the analysis windows have a width of at least 400 ms ([0364] the second set of recorded data represents an instantaneous “snapshot” of the cardiac chamber, such as when the second period of time comprises a time period less than 0.5 seconds, such as less than 100 ms, or less than 30 ms); the analysis windows have a width of at least 800 ms ([0363] A first set of data can be recorded for a first period of time, such as for at least 5 seconds, 15 seconds, or 30 seconds, or for less than 1 minute or less than 5 minutes); the analysis windows have a width of at least 1.25 s ([0363] A first set of data can be recorded for a first period of time, such as for at least 5 seconds, 15 seconds, or 30 seconds, or for less than 1 minute or less than 5 minutes); the analysis windows have a width of at most 3 s ([0363] A first set of data can be recorded for a first period of time, such as for at least 5 seconds, 15 seconds, or 30 seconds, or for less than 1 minute or less than 5 minutes); the analysis windows have a width of at most 2 s ([0363] A first set of data can be recorded for a first period of time, such as for at least 5 seconds, 15 seconds, or 30 seconds, or for less than 1 minute or less than 5 minutes); and the analysis windows have a width of at most 1.75 s ([0363] A first set of data can be recorded for a first period of time, such as for at least 5 seconds, 15 seconds, or 30 seconds, or for less than 1 minute or less than 5 minutes). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the method includes one or more of the following features: the analysis windows have a width of at least 400 ms; the analysis windows have a width of at least 800 ms; the analysis windows have a width of at least 1.25 s; the analysis windows have a width of at most 3 s; the analysis windows have a width of at most 2 s; and the analysis windows have a width of at most 1.75 s, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 24, Hsu teaches the method according to claim 23, but fails to fully teach wherein the method includes one or more of the following features: the analysis windows are overlapping or non-overlapping sliding windows over a measurement time for each channel; at least two local activation potentials are extracted per channel; at least one local activation potential is extracted per analysis window; the measurement time is at least 1 s; the measurement time is at least 2.5 s; and the measurement time is at least 10 s.
However, Welsh teaches wherein the method includes one or more of the following features: the analysis windows are overlapping or non-overlapping sliding windows over a measurement time for each channel ([0192] FIG. 12 is an embodiment of a display of views of cardiac activation data. In the right-side view, the heart is shown from a first perspective with various bands of activation shown. The outermost band is the activated node band. The subsequent bands represent recently activated states. The activation status relates to the time indicated by the sliding window overlaid on the EGM, which has a horizontal time axis. The width of the sliding window reflects the 50 ms window width, referred to as “Propagation History”); at least two local activation potentials are extracted per channel (Fig 4); at least one local activation potential is extracted per analysis window (Fig 1); the measurement time is at least 1 s ([0363] A first set of data can be recorded for a first period of time, such as for at least 5 seconds, 15 seconds, or 30 seconds, or for less than 1 minute or less than 5 minutes); the measurement time is at least 2.5 s ([0363] A first set of data can be recorded for a first period of time, such as for at least 5 seconds, 15 seconds, or 30 seconds, or for less than 1 minute or less than 5 minutes); and the measurement time is at least 10 s ([0363] A first set of data can be recorded for a first period of time, such as for at least 5 seconds, 15 seconds, or 30 seconds, or for less than 1 minute or less than 5 minutes). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Hsu to include wherein the method includes one or more of the following features: the analysis windows are overlapping or non-overlapping sliding windows over a measurement time for each channel; at least two local activation potentials are extracted per channel; at least one local activation potential is extracted per analysis window. Doing so would allow for an appropriate number of potentials to be analyzed to make an accurate representation of the total measurement. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include the measurement time is at least 1 s; the measurement time is at least 2.5 s; and the measurement time is at least 10 s, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 25, Hsu teaches the method according to claim 16, but fails to fully teach wherein the control system carries out the identification routine and the classification routine on a multi- channel intracardiac electrogram of the measurement location recorded after an ablation procedure applied near to the measurement location to determine the cardiac isolation status of the measurement location.
However, Welsh teaches method according to claim 16, wherein the control system carries out the identification routine and the classification routine on a multi- channel intracardiac electrogram of the measurement location recorded after an ablation procedure applied near to the measurement location to determine the cardiac isolation status of the measurement location ([0359] The difference and/or change in functional characteristic before and after a clinical event, such as an ablation procedure, can be similarly displayed as a color map depicting regions of altered function arising from the clinical event). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Hsu to include wherein the control system carries out the identification routine and the classification routine on a multi- channel intracardiac electrogram of the measurement location recorded after an ablation procedure applied near to the measurement location to determine the cardiac isolation status of the measurement location. Doing so allows the analysis of the patient’s response after a procedure to ensure accurate recovery.
Regarding claim 26, Hsu teaches the method according to claim 25, but fails to fully teach wherein the control system carries out at least the identification routine on a multi-channel intracardiac electrogram of the measurement location recorded prior to the ablation procedure and determines the cardiac isolation status based on a comparison of the local activation potentials prior to and after the ablation procedure.
However, Welsh teaches wherein the control system carries out at least the identification routine on a multi-channel intracardiac electrogram of the measurement location recorded prior to the ablation procedure ([0359] The difference and/or change in functional characteristic before and after a clinical event, such as an ablation procedure, can be similarly displayed as a color map depicting regions of altered function arising from the clinical event) and determines the cardiac isolation status based on a comparison of the local activation potentials prior to and after the ablation procedure ([0359] The difference and/or change in functional characteristic before and after a clinical event, such as an ablation procedure, can be similarly displayed as a color map depicting regions of altered function arising from the clinical event). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Hsu to include wherein the control system carries out at least the identification routine on a multi-channel intracardiac electrogram of the measurement location recorded prior to the ablation procedure and determines the cardiac isolation status based on a comparison of the local activation potentials prior to and after the ablation procedure. Doing so allows the analysis of the patient’s response after a procedure in comparison to before the procedure to ensure accurate recovery.
Regarding claim 27, Hsu teaches the method according to claim 16, wherein the activation search algorithm comprises a peak detection algorithm for finding the local activation potentials and subsequently the windows of the local activation potentials ([0082] The cardiac signals are filtered through an analog peak detector to extract the maximum and minimum cardiac signal values for each sensed cardiac complex).
Regarding claim 29, Hsu teaches the method according to claim 16, wherein in the identification routine the control system identifies a fixed number of local activation potentials per channel and/or per analysis window (Fig 1; [0055] the number of cardiac complexes classified into each of the classes of cardiac complexes can be displayed).
Regarding claim 34, Hsu teaches the method according to claim 16, but fails to fully teach wherein the control system executes a quality control step, wherein in the quality control step the control system removes local activation potentials and/or time sections of electrogram channels and/or electrogram channels based on a quality parameter.
However, Welsh teaches wherein the control system executes a quality control step ([0201] In some embodiments, an algorithm is used to detect the noise from true activation by checking the amplitude of the electrogram in a time window around potential activations), wherein in the quality control step the control system removes local activation potentials and/or time sections of electrogram channels and/or electrogram channels based on a quality parameter ([0202] Since this activation does not meet amplitude threshold, it is removed in C). C) automatically detected activations after false positive removal. Activation that are of low amplitude/slope from A) are removed). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Hsu to include wherein the control system executes a quality control step, wherein in the quality control step the control system removes local activation potentials and/or time sections of electrogram channels and/or electrogram channels based on a quality parameter. Doing so Allows for the quality of the recordings to be analyzed and edited to only present accurate and high-quality results.
Regarding claim 35, Hsu teaches a control system configured to perform the method according to claim 16, wherein the control system is configured to receive and/or measure the multi-channel electrogram ([0075] The cardiac defibrillator 500 includes control system circuitry 600 for receiving cardiac signals from a heart 506 and delivering electrical energy to the heart 506. The control system circuitry 600 includes a sensing system 602 attached to at least one catheter).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hsu (US 20020019593 A1) in view of Welsh (US 20190200886 A1), further in view of Lee (US 20150359450 A1) and Chauhan (US 20180125385 A1).
Regarding claim 28, Hsu teaches the method according to claim 27, but fails to fully teach wherein the method includes one or more of the following features: the peak detection algorithm is based on non-linear filters; the peak detection algorithm is based on wavelet filters; the peak detection algorithm is based on a transformation of the electrogram; the peak detection algorithm is based on a wavelet transformation; and the peak detection algorithm comprises a peak detection by amplitude.
However, Welsh teaches wherein the method includes one or more of the following features: the peak detection algorithm is based on non-linear filters ([0238] 3. used with a model based on a higher-order function, perhaps a nonlinear model). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Hsu to include wherein the method includes one or more of the following features: the peak detection algorithm is based on non-linear filters. Doing so allows for the filtering of noise from the recordings for high quality results.
Further, Lee teaches the peak detection algorithm is based on a transformation of the electrogram ([0081] The wavelet transform unit 115 is used to execute wavelet transform process for the physiological signal output by said digital filter unit 113 to generate wavelet coefficients, in order to retrieve the characteristic values in said physiological signal, and save said generated wavelet coefficients in a wavelet coefficient memory 1151 (but no limited thereto, and can be in storage unit such as register etc.). The peak detection unit 117 utilizes a predetermined algorithm to perform waveform analysis and detection for wavelet coefficients in said wavelet coefficient memory 1151 in order to obtain peak presence time of each physiological signal, and output said detection result); the peak detection algorithm is based on a wavelet transformation ([0036] In step S103, characteristic values in said physiological signal are retrieved for detection of a predetermined waveform and output of a detection result. Specifically, the invention utilizes a predetermined algorithm (for example, Haar wavelet transform) at first to perform wavelet transform for the physiological signal from said subject and to retrieve the characteristic values thereof, and it is saved in a storage unit, such as memory or register, followed by using transformed wavelet coefficients to perform peak detection in order to find out every physiological signal peak). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Hsu to include the peak detection algorithm is based on wavelet filters; the peak detection algorithm is based on a transformation of the electrogram; the peak detection algorithm is based on a wavelet transformation; and the peak detection algorithm comprises a peak detection by amplitude. Doing so allows for advanced signal analysis to be performed for clearer and more accurate data recordings.
Further, Chauhan teaches the peak detection algorithm is based on wavelet filters ([0097] if another smoothing filter is applied (e.g. a wavelet-based filter), then a check may be performed to make sure that the gQRS peak is real); and the peak detection algorithm comprises a peak detection by amplitude ([0098] for each positive gQRS peak, identifying the subset of positive IQRS peaks within IX msec (which may be considered to be a proximity window) of the gQRS peak location and classifying the IQRS peak with the most positive amplitude in the subset or the IQRS peak that is closest to the corresponding gQRS peak as a normal positive peak). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Hsu to include peak detection algorithm is based on wavelet filters. Doing so allows for advanced signal analysis to be performed for clearer and more accurate data recordings.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hsu (US 20020019593 A1) in view of Welsh (US 20190200886 A1), further in view of Nappholz (US 5184615 A).
Regarding claim 30, Hsu teaches the method according to claim 29, wherein the method includes one or more of the following features: in the identification routine the control system identifies the fixed number of local activation potentials per time interval (Fig 1; [0055] the number of cardiac complexes classified into each of the classes of cardiac complexes can be displayed); in the identification routine the control system identifies the fixed number of local activation potentials per time interval per measurement window (Fig 1; [0055] the number of cardiac complexes classified into each of the classes of cardiac complexes can be displayed).
Hsu fails to fully teach the fixed number is based on a physiological and/or measured heart rate; the fixed number is a maximum of one local activation potential per at least 500 ms; the fixed number is a maximum of one local activation potential per at least 800 ms; and the fixed number is a maximum of one local activation potential per at least 1s.
However, Welsh teaches the fixed number is a maximum of one local activation potential per at least 500 ms ([0363] A first set of data can be recorded for a first period of time, such as for at least 5 seconds, 15 seconds, or 30 seconds, or for less than 1 minute or less than 5 minutes); the fixed number is a maximum of one local activation potential per at least 800 ms ([0363] A first set of data can be recorded for a first period of time, such as for at least 5 seconds, 15 seconds, or 30 seconds, or for less than 1 minute or less than 5 minutes); and the fixed number is a maximum of one local activation potential per at least 1s ([0363] A first set of data can be recorded for a first period of time, such as for at least 5 seconds, 15 seconds, or 30 seconds, or for less than 1 minute or less than 5 minutes). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the fixed number is a maximum of one local activation potential per at least 500 ms; the fixed number is a maximum of one local activation potential per at least 800 ms; and the fixed number is a maximum of one local activation potential per at least 1s, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Further, Nappholz teaches in the identification routine the control system identifies the fixed number of local activation potentials per time interval per measurement window ([29] After a predetermined number of polarization reversals (for example, four), the polarization artifact is sufficiently reduced and the pacemaker stores the newly determined optimum precharge duration. The pacemaker requires a number of polarization reversals to provide protection against incorrectly determining the proper precharge duration in the presence of fusion events); the fixed number is based on a physiological and/or measured heart rate ([20] Arrhythmia detection is comprised of two general operations, evoked potential analysis and cardiac rhythm analysis. It is standard in the art of cardiac pacemakers to measure the functional rate of the heart. Therefore, as an extension of the pacemaker's normal rate-tracking function, while performing the evoked potential sampling 159 sub-procedure, the pacemaker monitors heart rate) ([21] The pacemaker 17 performs the rate portion of arrhythmia detection by sensing cardiac events, updating an X out of Y detector (the X/Y detector) to measure the time interval between consecutive cardiac events, and inserting this interval into a memory containing a history of such intervals. The pacemaker compares at least one element of this history of intervals with a predetermined detection interval) ([40] The predetermined window boundaries may vary according to the rate of sensed cardiac activity). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Hsu to include in the identification routine the control system identifies the fixed number of local activation potentials per time interval per measurement window; the fixed number is based on a physiological and/or measured heart rate. Doing so allows the fixed number to be adjusted based on the patient’s heart rate for accurate and personalized recordings.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hsu (US 20020019593 A1) in view of Welsh (US 20190200886 A1), further in view of Penders (US 20200107771 A1).
Regarding claim 31, Hsu teaches the method according to claim 16, but fails to fully teach wherein the control system executes an interference signal removal step prior to the identification step, and wherein the interference signal removal step comprises complete or weighted blanking of time intervals around and/or relative to pacing artefacts and/or CS- potentials and/or ECG-waves.
However, Welsh teaches wherein the interference signal removal step comprises complete or weighted blanking of time intervals around and/or relative to pacing artefacts and/or CS- potentials and/or ECG-waves ([0081] Additionally, the bio-potential signal processing module 34 can also include “pace blanking”, which is the blanking of received information during a timeframe when, for example, a physician is “pacing” the heart). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Hsu to include the interference signal removal step comprises complete or weighted blanking of time intervals around and/or relative to pacing artefacts and/or CS- potentials and/or ECG-waves. Doing so allows for management of the time intervals based on the pace of the heartrate.
Further, Penders teaches wherein the control system executes an interference signal removal step prior to the identification step ([0247] For removing maternal QRS peaks, maternal R-peaks are removed by identifying each R-peak and an interval around each peak (e.g., +/−90 ms). Each identified R-peak and interval are blanked before fetal QRS peak identification). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Hsu to include the control system executes an interference signal removal step prior to the identification step. Doing so allows the identification step to be clear of noise that could interfere with its algorithm.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hsu (US 20020019593 A1) in view of Welsh (US 20190200886 A1), further in view of Penders (US 20200107771 A1) and El Haddad (US 20170181655 A1).
Regarding claim 32, Hsu teaches the method according to claim 31, but fails to fully teach wherein the pacing artefacts and/or CS-potentials and/or ECG-waves are detected on an electrogram different from the multi-channel intracardiac electrogram, and wherein the electrogram different from the multi-channel intracardiac electrogram is a coronary sinus or surface electrogram.
However, El Haddad teaches wherein the pacing artefacts and/or CS-potentials and/or ECG-waves are detected on an electrogram different from the multi-channel intracardiac electrogram ([0075] FIG. 4, and the alignment and averaging 125 of the detected atrial potentials in FIG. 5 for each at least one electrocardiogram. This detecting of the atrial potentials may for example comprise detecting QRS complexes 121 in a coregistered surface ECG Lead II electrocardiogram and blanking or masking 122 the time frames corresponding to the detected QRS complexes from a coregistered coronary sinus (CS) electrocardiogram. Thus, the atrial potentials corresponding to a plurality of heart beats may be identified 123 in the CS electrocardiogram), and wherein the electrogram different from the multi-channel intracardiac electrogram is a coronary sinus or surface electrogram ([0075] This detecting of the atrial potentials may for example comprise detecting QRS complexes 121 in a coregistered surface ECG Lead II electrocardiogram and blanking or masking 122 the time frames corresponding to the detected QRS complexes from a coregistered coronary sinus (CS) electrocardiogram). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Hsu to include wherein the pacing artefacts and/or CS-potentials and/or ECG-waves are detected on an electrogram different from the multi-channel intracardiac electrogram, and wherein the electrogram different from the multi-channel intracardiac electrogram is a coronary sinus or surface electrogram. Doing so allows for better analysis of the pacing artefacts and/or CS-potentials and/or ECG-waves by separating them on different electrograms.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hsu (US 20020019593 A1) in view of Welsh (US 20190200886 A1), further in view of Penders (US 20200107771 A1) and Nappholz (US 5184615 A).
Regarding claim 33, Hsu teaches the method according to claim 31, but fails to fully teach wherein the weighted blanking is an application of different weights to the electrogram inside the respective time interval, wherein the weights are predetermined to comprise a section of complete removal of the respective time interval and at least one section of reducing the amplitude of the electrogram.
However, Penders teaches wherein the weighted blanking is an application of different weights to the electrogram inside the respective time interval ([0247] For removing maternal QRS peaks, maternal R-peaks are removed by identifying each R-peak and an interval around each peak (e.g., +/−90 ms). Each identified R-peak and interval are blanked before fetal QRS peak identification), wherein the weights are predetermined to comprise a section of complete removal of the respective time interval ([0247] For removing maternal QRS peaks, maternal R-peaks are removed by identifying each R-peak and an interval around each peak (e.g., +/−90 ms). Each identified R-peak and interval are blanked before fetal QRS peak identification). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Hsu to include wherein the weighted blanking is an application of different weights to the electrogram inside the respective time interval, wherein the weights are predetermined to comprise a section of complete removal of the respective time interval. Doing so allows for the removal of unwanted signals for a more accurate and clean display of the electrogram.
Further, Nappholz teaches at least one section of reducing the amplitude of the electrogram ([29] Because the polarization artifact represents a sensing amplifier's (not shown) response to an offset voltage (polarization) on the lead electrodes, the pacemaker 17 uses the polarity of the first phase of the artifact to determine which direction to change the precharge duration for the refractory pulse to further reduce the artifact amplitude). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Hsu to include at least one section of reducing the amplitude of the electrogram. Doing so allows for ease of finding local activation potentials surrounding the interval.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 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, Joseph Stoklosa can be reached at 571-272-1213. 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.
/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794