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 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.
Claims 1-10, 12-13, and 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (US 2018/0116539, hereinafter referred to as Olson).
Regarding independent claim 1, Olson discloses mapping catheters may be used to detect electrophysiological characteristics of tissue in contact with the electrodes. Olson further discloses a method of assessing conduction block across a lesion in a tissue ([0036]: “Short interelectrode spacing (e.g., 2 mm×2 mm) may be desirable to sample electrical characteristics of tissue (e.g., voltages) indicative of ablation line gaps. In testing, embodiments of the present disclosure including short interelectrode spacings of the electrode array detected ablation line gaps via the sampling of low voltage paths between lesions only separated by a few millimeters.”), comprising:
applying a pacing signal to the tissue on a first side of the lesion ([0065]: “To conduct an electrophysiology mapping of the cardiac muscle in proximity to the ablation locations, both before and after the ablation therapy, pacing is conducted from epicenter 799.”), wherein the pacing signal comprises a plurality of pacing pulses ([0042]: “ The use of high-density electrode arrays, disclosed herein, facilitates the sampling of voltage measurements, for example, that are independent of effects associated with relative orientation of the catheter and electrical wavefront, making electrophysiology mapping of a cardiac muscle (and scar borders) much more reliable and precise. Moreover, embodiments of the present disclosure benefit from the collection of electrical signal timing information which is substantially independent from the electrode distribution.”; The examiner notes that electrical activation wavefronts, as seen in paras. [0033], [0040], inherently imply the presence of electrical pulses, which, if sensed, may have been applied similarly by pacing waveforms/wavefronts, i.e. pulses.);
sensing electrophysiological activity in the tissue ([0065]: “During the pacing procedure, each bipole pair samples the electrical characteristics of the tissue in between the pair. The resulting electrical signals are received and processed by controller circuitry.”; Note that the controller circuitry comprises signal processing circuitry per [0066].) on a second side of the lesion, wherein the second side of the lesion is opposite the first side of the lesion;
analyzing, in a signal processor ([0042]: “The regular spacing of electrodes in the high-density array further improves the accuracy of various metrics which are output from the OIS/OT algorithms and/or other signal processing techniques; for example, the En value (the estimate of the perpendicular bipole signal), an output of the Laplace equation, activation direction, conduction velocity, etc.”; [0051]: “Accordingly, aspects of the present disclosure are directed to placing signal processing circuitry (e.g., analog-to-digital converters, signal conditioning such as noise filtration and bandpass filters), and/or driver circuitry on the arms 103.sub.1-7 or in close proximity thereto.”), the sensed electrophysiological activity for a response evoked by the pacing signal ([0067]: “FIG. 7B depicts the vertical 705′, horizontal 710′, and omnipole 715′ electrophysiology maps based on the electrical data collected from the planar array of FIG. 7, after ablation of the contacted tissue.”);
outputting, via the signal processor, an indicator of conduction block status ([0011]: “The controller circuitry may produce an output indicative of the true electrical characteristics of the contacted tissue, independent of the orientation of the planar array catheter relative to the contacted tissue.”; Note that the controller circuitry comprises signal processing circuitry per [0066].), wherein the indicator of conduction block status comprises:
an indicator of conduction block when a preset number of consecutive pacing pulses do not evoke the response ([0066]: “A positive tissue identification region may be defined by a low voltage signal that is actually indicative of completely ablated tissue.”);
an indicator of no conduction block when the preset number of consecutive pacing pulses evoke the response ([0065]: “In other embodiments, the number of times the electrical signal exceeds a threshold voltage (or a voltage slope changes signs) during a sampling window may be visually displayed on the map.”); and
an indicator of uncertain block status otherwise ([0063]: “Signal processing circuitry may utilize OIS/OT features, such as wave crest direction, to determine which fractionated electrograms 602 to ignore when developing an electrophysiology map 600 of a cardiac muscle. As a result, a clinician need not re-orient a planar array 610 on target tissue to verify that an electrogram signal is representative of the true activation signal traveling through the target tissue.”; [0066]: “The controller circuitry may include signal processing circuitry which utilizes OIS/OT type algorithms to filter out low amplitude signals from bipole pairs that are misaligned with the activation direction of the pacing signal.”).
Olson is not specific to a first and second side of the lesion. However, combining the embodiments of Figs. 1A and Fig. 7 of Olson can depict this limitation. (See annotated Figs. 1A and 7.) The embodiment of Fig. 7 depicts the catheter electrode array 701 (equivalent to mapping catheter 101 in Fig. 1A) against cardiac muscle 700, and further ablated lesions 702.sub.A-B. Electrodes 703.sub.1-N (equivalent to the first plurality of electrodes 102.sub.1-N in Fig. 1A) can be seen on either side, i.e. a first and a second side of ablated lesions 702.sub.A-B. Rather than applying pacing pulses from the epicenter 799, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to utilize Olson’s embodiment shown in Fig. 1A to apply a pacing pulse from the first plurality of electrodes 102.sub.1-N on the “1st side of lesion” (shown in annotated Fig. 1A) and to sense electrophysiological activity in the tissue from the second plurality of electrodes 111.sub.1-N on the “2st side of lesion” (shown in annotated Fig. 1A). Additionally, the modified embodiment of Fig. 1A shows that the second side of the lesion is opposite the first side of the lesion.
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Regarding claim 2, in view of the combination set forth in claim 1, Olson discloses applying the pacing signal to the tissue on the first side of the lesion (“1st side of lesion” in annotated Fig. 1A) comprises applying the pacing signal to the tissue using a first plurality of electrodes (electrodes 102.sub.1-N in Fig. 1A) positioned on the first side of the lesion ([0047]: “In some embodiments, the electrodes 102.sub.1-N can be used in diagnostic, therapeutic, and/or mapping procedures. For example and without limitation, the electrodes 102 may be used for electrophysiological studies, pacing, cardiac mapping, and ablation.”); and
sensing electrophysiological activity in the tissue on the second side of the lesion (“2nd side of lesion” in annotated Fig. 1A) comprises sensing the electrophysiological activity using a second plurality of electrodes (one or more ring electrodes 111 in Fig. 1A; [0048]: “…the catheter shaft 107 can include one or more ring electrodes 111 disposed along a length of the catheter shaft 107. The ring electrodes 111 may be used for diagnostic, therapeutic, localization and/or mapping procedures, for example.”) positioned on the second side of the lesion (“2nd side of lesion” in annotated Fig. 1A).
Regarding claim 3, in view of the combination set forth in claim 2, Olson discloses that the first plurality of electrodes (electrodes 102.sub.1-N in Fig. 1A) and the second plurality of electrodes (one or more ring electrodes 111 in Fig. 1A) are mounted on a common catheter (each set of electrodes can be seen on the one catheter 101 in Fig. 1A).
Regarding claim 4, in view of the Olson embodiments combination set forth above, Olson discloses that the common catheter comprises a proximal shaft ([0044]: “This array of electrodes 102.sub.1-N is coupled to a flexible framework of seven arms 103.sub.1-7 which extend in a plane that is substantially parallel with a longitudinal axis of catheter shaft 107.”) and a distal plurality of expandable splines ([0037]: “Aspects of the present disclosure are directed toward planar array catheters and basket catheters for electrophysiology mapping. More specifically, many embodiments of the present disclosure utilize printed circuit boards (e.g., flexible printed circuit boards) to form the planar array arms and/or basket splines. Further, aspects of the present disclosure include a plurality of electrodes positioned along the planar array arms and/or basket splines. In such embodiments, the planar array arms and/or basket splines may have electrodes conductively coupled to the flexible circuit board(s) that at least partially comprise structures of the arms and/or splines.”), wherein first plurality of electrodes (electrodes 102.sub.1-N in Fig. 1A) are mounted on the distal plurality of expandable splines, and wherein the second plurality of electrodes (one or more ring electrodes 111 in Fig. 1A) are mounted on the proximal shaft ([0048]: “…the catheter shaft 107 can include one or more ring electrodes 111 disposed along a length of the catheter shaft 107. The ring electrodes 111 may be used for diagnostic, therapeutic, localization and/or mapping procedures, for example.”).
Regarding claim 5, in view of the Olson embodiments combination set forth above, Olson discloses applying a first increment of ablation therapy to the tissue prior to applying the pacing signal to the tissue ([0065]: “To conduct an electrophysiology mapping of the cardiac muscle in proximity to the ablation locations, both before and after the ablation therapy, pacing is conducted from epicenter 799.”) using a first plurality of electrodes (electrodes 102.sub.1-N in Fig. 1A; [0047]: “In some embodiments, the electrodes 102.sub.1-N can be used in diagnostic, therapeutic, and/or mapping procedures. For example and without limitation, the electrodes 102 may be used for electrophysiological studies, pacing, cardiac mapping, and ablation.”) positioned on the first side of the lesion (“1st side of lesion” in annotated Fig. 1A).
Regarding claim 6, in view of the Olson embodiments combination set forth above, Olson discloses that applying the first increment of ablation therapy to the tissue ([0065]: “To conduct an electrophysiology mapping of the cardiac muscle in proximity to the ablation locations, both before and after the ablation therapy, pacing is conducted from epicenter 799.”) comprises applying the first increment of ablation therapy to the tissue using a subset of the first plurality of electrodes ([0047]: “In some embodiments, the electrodes 102 can perform unipolar or bipolar ablation (e.g., via the use of bipole pairs of electrodes 104 and 104′).”).
Regarding claim 7, in view of the combination set forth in claim 2, Olson discloses that the second plurality of electrodes (one or more ring electrodes 111 in Fig. 1A) are mounted on a plurality of catheters (The one or more ring electrodes 111 in Fig. 1A disposed along shaft 107 diverges into a plurality of catheter arms 103.).
Regarding claim 8, in view of the combination set forth in claim 2, Olson discloses that applying the pacing signal to the tissue using a first plurality of electrodes (electrodes 102.sub.1-N in Fig. 1A; [0047]: “In some embodiments, the electrodes 102.sub.1-N can be used in diagnostic, therapeutic, and/or mapping procedures. For example and without limitation, the electrodes 102 may be used for electrophysiological studies, pacing, cardiac mapping, and ablation.”) positioned on the first side of the lesion (“1st side of lesion” in annotated Fig. 1A) comprises applying the pacing signal to the tissue using all of the first plurality of electrodes simultaneously ([0059]: “The data streams for each of the bipole pairs are collected simultaneously.”).
Regarding claim 9, in view of the combination set forth in claim 2, Olson discloses that applying the pacing signal to the tissue using a first plurality of electrodes (electrodes 102.sub.1-N in Fig. 1A; [0047]: “In some embodiments, the electrodes 102.sub.1-N can be used in diagnostic, therapeutic, and/or mapping procedures. For example and without limitation, the electrodes 102 may be used for electrophysiological studies, pacing, cardiac mapping, and ablation.”) positioned on the first side of the lesion (“1st side of lesion” in annotated Fig. 1A) comprises applying the pacing signal to the tissue using pairs of electrodes (bipole pairs 104 and 104’ in Fig. 1A; [0047]: “Importantly, as the electrode spacing between adjacent electrodes on an arm 103, and those on adjacent arms, are the same, bipole pairs 104 and 104′ with varying relative orientations may be sampled to determine electrical characteristics of the tissue in contact with the bipole pairs.”) selected from the first plurality of electrodes sequentially (Bipole pairs 104 and 104’ are shown to be from electrodes 102.sub.1-N in Fig. 1A.).
Regarding claim 10, in view of the Olson embodiments combination set forth above, Olson discloses that the indicator of no conduction block ([0065]) further comprises an indicator of a position of a gap in the lesion ([0036]: “Short interelectrode spacing (e.g., 2 mm×2 mm) may be desirable to sample electrical characteristics of tissue (e.g., voltages) indicative of ablation line gaps. In testing, embodiments of the present disclosure including short interelectrode spacings of the electrode array detected ablation line gaps via the sampling of low voltage paths between lesions only separated by a few millimeters.”).
Regarding claim 12, in view of the combination set forth in claim 1, Olson discloses delaying by a preset blanking interval between the step of applying the pacing signal to the tissue on the first side of the lesion (“1st side of lesion” in annotated Fig. 1A) and the step of analyzing, in the signal processor ([0042]: “The regular spacing of electrodes in the high-density array further improves the accuracy of various metrics which are output from the OIS/OT algorithms and/or other signal processing techniques; for example, the En value (the estimate of the perpendicular bipole signal), an output of the Laplace equation, activation direction, conduction velocity, etc.”; [0051]), the sensed electrophysiological activity for the response evoked by the pacing signal ([0065]: “During the pacing procedure, each bipole pair samples the electrical characteristics of the tissue in between the pair. The resulting electrical signals are received and processed by controller circuitry.”; Note that the controller circuitry comprises signal processing circuitry per [0066].).
Though Olson is not specific to delaying by a preset blanking interval between the step of applying the pacing signal and the step of analyzing the sensed electrophysiological activity, the examiner notes that the phrases “before” and “after” in para. [0065] imply different intervals, one in which the “pacing procedure” is occurring and another in which the sensed electrophysiological activity analysis is occurring. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to recognize that various steps of Olson would include a preset blanking interval between the step of applying the pacing signal and the step of analyzing the sensed electrophysiological activity to minimize the possibility of detecting an upstream pacing artifact, which Olson discloses ([0047]: “The sampled electrical characteristics may be processed to remove catheter orientation-based signal effects.”)
Regarding claim 13, in view of the combination set forth in claim 1, Olson discloses that the indicator of conduction block status ([0011]: “The controller circuitry may produce an output indicative of the true electrical characteristics of the contacted tissue, independent of the orientation of the planar array catheter relative to the contacted tissue.”) comprises one or more of a visual indicator of conduction block status ([0065]: “The resulting electrical signals are received and processed by controller circuitry. The controller circuitry develops an electrophysiology mapping by associating the signal samples from each bipole pair with a location of the tissue sampled by the bipole pair. The electrogram from each bipole pair may be analyzed and various electrical characteristics may be visually indicated on an electrophysiology map by color-coding (or other visual indication scheme, e.g., shading, patterning, etc.).”); an audible indicator of conduction block status; and a haptic indicator of conduction block status.
Regarding claim 15, in view of the combination set forth in claim 1, Olson discloses that the step of analyzing, in the signal processor ([0042]; [0051]), the sensed electrophysiological activity for the response evoked by the pacing signal ([0065]: “During the pacing procedure, each bipole pair samples the electrical characteristics of the tissue in between the pair. The resulting electrical signals are received and processed by controller circuitry.”; Note that the controller circuitry comprises signal processing circuitry per [0066].) comprises the signal processor ([0042]; [0051]) analyzing the sensed electrophysiological activity for a signal amplitude above a preset noise level threshold ([0065]: “In other embodiments, the number of times the electrical signal exceeds a threshold voltage (or a voltage slope changes signs) during a sampling window may be visually displayed on the map.”).
Regarding claim 16, in view of the Olson embodiments combination set forth above, Olson discloses that the signal processor ([0042]; [0051]) determines the preset noise level threshold according to an amplitude of the sensed electrophysiological activity ([0065]: “In other embodiments, the number of times the electrical signal exceeds a threshold voltage (or a voltage slope changes signs) during a sampling window may be visually displayed on the map.”) during a quiescent interval ([0065]: “FIG. 7 shows the cardiac muscle 700 after tissue ablation therapy has been conducted. The resulting ablation lesions 702.sub.A-B appear on the surface of the cardiac muscle 700 as white spots. To conduct an electrophysiology mapping of the cardiac muscle in proximity to the ablation locations, both before and after the ablation therapy, pacing is conducted from epicenter 799. Adjacent electrodes 703.sub.1-N are assigned to bipole pairings. During the pacing procedure, each bipole pair samples the electrical characteristics of the tissue in between the pair. The resulting electrical signals are received and processed by controller circuitry.”; the examiner notes that the phrases “before” and “after” imply different intervals, one in which the sensing/sampling interval has ended and data processing is occurring.).
Regarding independent claim 17, Olson discloses a system for assessing conduction block across a lesion in a tissue ([0011]: “…an electrophysiology mapping system including a planar array catheter and controller circuitry.”), comprising:
a pacing system (controlling circuitry coupled to electrodes 102.sub.1-N in Fig. 1A; [0011]: “The controller circuitry is communicatively coupled to each of the plurality of electrodes, and samples electrical signals received from each of the plurality of electrodes.”) configured to apply a pacing signal to the tissue on a first side of the lesion (“1st side of lesion” in annotated Fig. 1A), wherein the pacing signal comprises a plurality of pacing pulses ([0042]; The examiner notes that electrical activation wavefronts, as seen in paras. [0033], [0040], inherently imply the presence of electrical pulses, which, if sensed, may have been applied similarly by pacing waveforms/wavefronts, i.e. pulses.);
a sensing system (controlling circuitry coupled to electrodes 111.sub.1-N in Fig. 1A; [0011]) configured to sense electrophysiological activity in the tissue on a second side of the lesion (“2nd side of lesion” in annotated Fig. 1A; [0048]: “…the catheter shaft 107 can include one or more ring electrodes 111 disposed along a length of the catheter shaft 107. The ring electrodes 111 may be used for diagnostic, therapeutic, localization and/or mapping procedures, for example.”), wherein the second side of the lesion is opposite the first side of the lesion (“1st side of lesion” in annotated Fig. 1A); and
a conduction block signal processor ([0042]; [0051]; Note that the controller circuitry comprises signal processing circuitry per [0066].) configured to:
analyze the sensed electrophysiological activity for a response evoked by the pacing signal ([0067]: “FIG. 7B depicts the vertical 705′, horizontal 710′, and omnipole 715′ electrophysiology maps based on the electrical data collected from the planar array of FIG. 7, after ablation of the contacted tissue.”); and
output an indicator of conduction block status ([0011]: “The controller circuitry may produce an output indicative of the true electrical characteristics of the contacted tissue, independent of the orientation of the planar array catheter relative to the contacted tissue.”), wherein the indicator of conduction block status comprises:
an indicator of conduction block when a preset number of consecutive pacing pulses do not evoke the response ([0066]: “A positive tissue identification region may be defined by a low voltage signal that is actually indicative of completely ablated tissue.”);
an indicator of no conduction block when the preset number of consecutive pacing pulses evoke the response ([0065]: “In other embodiments, the number of times the electrical signal exceeds a threshold voltage (or a voltage slope changes signs) during a sampling window may be visually displayed on the map.”); and
an indicator of uncertain block status otherwise ([0063]: “Signal processing circuitry may utilize OIS/OT features, such as wave crest direction, to determine which fractionated electrograms 602 to ignore when developing an electrophysiology map 600 of a cardiac muscle. As a result, a clinician need not re-orient a planar array 610 on target tissue to verify that an electrogram signal is representative of the true activation signal traveling through the target tissue.”; [0066]: “The controller circuitry may include signal processing circuitry which utilizes OIS/OT type algorithms to filter out low amplitude signals from bipole pairs that are misaligned with the activation direction of the pacing signal.”).
Regarding claim 18, in view of the combination set forth in claim 17, Olson discloses that the pacing system (controlling circuitry coupled to electrodes 102.sub.1-N in Fig. 1A; [0011]), the sensing system (controlling circuitry coupled to electrodes 111.sub.1-N in Fig. 1A; [0011]), and the conduction block signal processor ([0042]; [0051]) are integrated into an electroanatomical mapping system ([0028]: “Various embodiments of the present disclosure are directed to flexible, high-density mapping catheters. In general, the tip portions of these high-density mapping catheters comprise an underlying support framework that is adapted to conform to and remain in contact with tissue (e.g., a beating heart wall).”).
Regarding claim 19, in view of the combination set forth in claim 18, Olson discloses a multi-electrode catheter operably coupled to both the pacing system (controlling circuitry coupled to electrodes 102.sub.1-N in Fig. 1A) and the sensing system (controlling circuitry coupled to electrodes 111.sub.1-N in Fig. 1A; [0011]: “…an electrophysiology mapping system including a planar array catheter and controller circuitry. The planar array catheter includes a catheter shaft, and a flexible, planar array coupled to a distal end of the catheter shaft. …The controller circuitry is communicatively coupled to each of the plurality of electrodes, and samples electrical signals received from each of the plurality of electrodes.”), wherein the multi-electrode catheter comprises a first plurality of electrodes (electrodes 102.sub.1-N in Fig. 1A) operably coupled to the pacing system (controlling circuitry coupled to electrodes 102.sub.1-N in Fig. 1A) to apply the pacing signal to the tissue on the first side of the lesion (“1st side of lesion” in annotated Fig. 1A) and a second plurality of electrodes (one or more ring electrodes 111 in Fig. 1A) operably coupled to the sensing system (controlling circuitry coupled to electrodes 111.sub.1-N in Fig. 1A; [0011]) to sense the electrophysiological activity in the tissue on the second side of the lesion (“2nd side of lesion” in annotated Fig. 1A; [0048]: “…the catheter shaft 107 can include one or more ring electrodes 111 disposed along a length of the catheter shaft 107. The ring electrodes 111 may be used for diagnostic, therapeutic, localization and/or mapping procedures, for example.”), and wherein the first plurality of electrodes (electrodes 102.sub.1-N in Fig. 1A) are positioned distally of the second plurality of electrodes on the multi-electrode catheter ([0047]: “In some embodiments, the electrodes 102.sub.1-N can be used in diagnostic, therapeutic, and/or mapping procedures. For example and without limitation, the electrodes 102 may be used for electrophysiological studies, pacing, cardiac mapping, and ablation.”).
Regarding claim 20, in view of the combination set forth in claim 19, Olson discloses that the pacing system (controlling circuitry coupled to electrodes 102.sub.1-N in Fig. 1A; [0011]) is configured to apply the pacing signal to the tissue using each electrode of the first plurality of electrodes (electrodes 102.sub.1-N in Fig. 1A; [0047]: “In some embodiments, the electrodes 102.sub.1-N can be used in diagnostic, therapeutic, and/or mapping procedures. For example and without limitation, the electrodes 102 may be used for electrophysiological studies, pacing, cardiac mapping, and ablation.”) simultaneously ([0059]: “The data streams for each of the bipole pairs are collected simultaneously.”).
Regarding claim 21, in view of the combination set forth in claim 17, Olson is silent to that the conduction block signal processor is further configured to determine the preset number of consecutive pacing pulses as a function of at least one of an intrinsic heartrate and a rate of the pacing signal.
However, Harlev teaches that the conduction block signal processor is further configured to determine the preset number of consecutive pacing pulses as a function of at least one of an intrinsic heartrate and a rate of the pacing signal ([col. 18, li. 53-64]: “The electronic processor can be further configured to select the subset of the measured signals based on the metric by selecting a subset of the measured signals for beats during which capture of a pacing signal occurred. The one or more electrodes can include electrodes configured to measure a pacing signal and a second signal located in a stable location and the electronic processor can be further configured to process measured signals by determining a timing difference between the pacing signal and an activation in the second signal, the timing difference providing information associated with capture of the pacing signal by the patient's heart.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the conduction block signal processor of Olson to further determine the preset number of consecutive pacing pulses as a function of at least one of an intrinsic heartrate and a rate of the pacing signal in order to set an appropriate cycle length for the pacing signal.
Claims 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Harlev et al. (US 9,277,872, hereinafter referred to as Harlev).
Regarding claim 11, in view of the combination set forth in claim 2, Olson is silent to that sensing electrophysiological activity in the tissue on the second side of the lesion further comprises sensing the electrophysiological activity using a surface electrocardiogram lead.
However, Harlev teaches the determination and representation of physiological information relating to a heart surface such as electroanatomical mapping and annotation. Harlev further teaches that sensing electrophysiological activity in the tissue on the second side of the lesion further comprises sensing the electrophysiological activity using a surface electrocardiogram lead ([col. 41, li. 3-10]: “In circumstances where the reconstructed physiological information is based on multiple measurements over several heart beats, the measurements are synchronized with one another so that the measurement are performed at approximately the same phase of the heart cycle. The signal measurements over multiple beats can be synchronized based on features detected from physiological data such as surface ECG or intracardiac electrograms.”).
Harlev teaches a similar pursuit to that of Olson and the instant application in teaching a catheter used for electroanatomical mapping of the heart. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Olson to include an electrocardiogram lead in order to measure the patient’s intrinsic cycle length and set an appropriate cycle length for the pacing signal.
Regarding claim 14, in view of the Olson/Harlev combination, Olson discloses outputting, via the signal processor ([0042]; [0051]), the indicator of conduction block status ([0011]: “The controller circuitry may produce an output indicative of the true electrical characteristics of the contacted tissue, independent of the orientation of the planar array catheter relative to the contacted tissue.”; Note that the controller circuitry comprises signal processing circuitry per [0066].).
Olson is silent to outputting a confidence value for the indicator of conduction block status.
However, Harlev teaches outputting a confidence value for the indicator of conduction block status ([col. 35, li. 1-4]: “The computer system assigns a confidence value to every annotation candidate of every electrogram. Many possible mappings from electrogram characteristics to confidence values are possible.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Olson to include the confidence value calculations of Harlev in order to correctly convey the estimated efficacy of an ablation procedure, i.e. a conduction block.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
He et al. (US 2005/0119647); and Govari (US 2018/0116539)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY G SCHLUETER whose telephone number is (703)756-4601. The examiner can normally be reached M-F 9:00am-5:30pm EST.
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/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796