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 .
Information Disclosure Statement
The information disclosure statement(s) filed 12/22/2023 and 02/13/2025 has/have been considered by the Examiner.
Claim Objections
Claim 21 is objected to because of the following informalities:
Claim 21 recites, “A computer software product comprising a non- transitory computer-readable medium in which program instructions are stored, which instructions, when read by a computer, cause the computer receive multiple EP data points…”, where the phrase, “the computer receive” is awkwardly worded. It is then interpreted by the Examiner that the phrase should read, “the computer to receive”, which should be amended if accurately interpreted. Appropriate correction is required.
Claim Interpretation
The term(s) “configured to” in the claim(s) may be interpreted as intended use. Intended use/functional language does not require that references teach or disclose the intended use of an element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP section 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART.
According to MPEP 2112.02, a prior art device anticipates a claimed process if the device carries out the process during normal operation. Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). Furthermore, where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993). Furthermore, the employment of the claimed steps must inherently produce the same intended results else the claims are incomplete for failing to recite a critical aspect of the invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-6, 11-16 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urman (US 20160038047 A1 – hereinafter Urman) in view of Thakur (US 20150119672 A1 – hereinafter Thakur).
Re. claim 1, Urman teaches method for generating an electrophysiological (EP) map (abstract – “A method, including recording parameters indicative of a quality of ablation performed at one or more sites in a region of a human heart, and receiving a set of electrophysiological signals indicative of a wave of electrical activation flowing through the region”; figures 3A-3F), comprising:
receiving multiple EP data points comprising respective locations and EP values (paragraph 0046 – “In an initial electrophysiological signal step 204, electrode 22 together with ECG module 36 is used to record electric potentials at positions 310, (illustrated in FIG. 3B) within region 300”),
generated from signals acquired by one or more electrodes of a catheter that are in contact with tissue of a cardiac chamber (paragraph 0033 – “Typically, probe 24 comprises a catheter which is inserted into the body of a human subject 26 during a mapping procedure performed by a user 28 of system 20”; paragraph 0032 – “A distal end 32 of probe 24 is assumed to have an electrode 22 attached to the distal end for acquiring the electrical signals processed by system 20. Those having ordinary skill in the art will be able to adapt the description for multiple probes that may have one or more electrodes, or for a single probe with multiple electrodes…”);
scoring the received data points with respective quality scores (paragraph 0063 – “In a mapping preparation step 212, the processing unit prepares a map showing locations identified in step 210 as expected blocking sites, herein assumed to correspond to ablation site locations 314. In addition, the processing unit calculates a confidence level for each identified site, where the confidence level is a measure of a quality of wavefront blocking”);
and rendering a map of the cardiac chamber to a display while coloring the regions of the map with hues selected responsively to the EP values of the data points in the regions (paragraph 0048 – “Typically the intermediate 3D map illustrates values of the derived parameters according to a color scale, so that the map is presented as a surface, with colors applied to regions of the surface corresponding to the value of the derived parameters of the regions. FIG. 3C schematically shows the colors of surface map as different gray scales”).
Urman does not teach the steps of computing respective quality metrics for multiple regions of the cardiac chamber responsively to the quality scores of the data points in the regions, and modulating respective colors of the regions responsively to the respective quality metrics.
Thakur similarly teaches a system for electrophysiological mapping (paragraph 0112 – “Mapping the electrophysiology of heart rhythm disorders often involves the introduction of a constellation catheter or other mapping/sensing device having a plurality of sensors into a cardiac chamber”) as well as scoring received EP data points with quality scores (calculating confidence levels of sensed “unique” signal patterns, paragraph 0130 – “Further, the processing system 32 may be configured to detect intrinsic electrical activity associated with multiple "unique" activation patterns of cellular wave excitation propagations…”; paragraph 0139 – “Similarly, the frequency of unique signal patterns may be calculated to establish a level of "confidence" for unique signal patterns initially matched by comparing unique signal patterns to one or more global template patterns”).
Thakur further teaches computing respective quality metrics for multiple regions of the cardiac chamber responsively to the quality scores of the data points in the regions (calculating direction vectors from confidence levels, paragraph 0144 – “As illustrated in FIG. 5A, the arrow that is used to represent the vector 74 has a length and thickness. The length and/or thickness may correlate to the "confidence" with which the processing system 32 has calculated the dominant direction vector. Further, the "confidence" may be directly proportional to the total number of cellular activations occurring in that particular direction over a time period”), and
modulating respective colors of the regions responsively to the respective quality metrics (paragraph 0144 – “It is contemplated that any attribute of any visual representation (e.g. vector arrow) may be changed to reflect a level of confidence (e.g. color, shape, transparency)”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/method of Urman, to incorporate the computed quality metrics and color modulation as taught by Thakur, since such modification would predictably result in displaying accurate and comprehensible EP activation maps.
Re. claim 2, Thakur of the combined invention further teaches wherein modulating the respective colors of the regions comprises reducing a luminance of a color as a function of decreasing quality (Thakur paragraph 0144 – “It is contemplated that any attribute of any visual representation (e.g. vector arrow) may be changed to reflect a level of confidence (e.g. color, shape, transparency)”).
Re. claim 3, Urman of the combined invention further teaches wherein modulating the respective colors of the regions comprises reducing a saturation of a color as a function of decreasing quality (Urman paragraph 0048 – “Typically the intermediate 3D map illustrates values of the derived parameters according to a color scale, so that the map is presented as a surface, with colors applied to regions of the surface corresponding to the value of the derived parameters of the regions”; paragraph 0067 – “The indication may be by any convenient method known in the art, such as changing a color and/or a size and/or a shape of a symbol of a given location according to its confidence level”).
Re. claim 4, Urman of the combined invention further teaches wherein modulating the respective colors of the regions comprises overlaying on the map a graphical layer having a property that varies as a function of the quality metrics (Urman paragraph 0048 – “The processing unit may overlay the derived parameters onto the map of step 202, and present the result in the form of an intermediate 3D electrophysiological surface map 320 on screen 48”; paragraph 0067 – “The indication may be by any convenient method known in the art, such as changing a color and/or a size and/or a shape of a symbol of a given location according to its confidence level”).
Re. claim 5, Thakur of the combined invention further teaches wherein rendering the map comprises modifying a transparency of the regions as a function of the quality metrics (Thakur paragraph 0144 – “It is contemplated that any attribute of any visual representation (e.g. vector arrow) may be changed to reflect a level of confidence (e.g. color, shape, transparency)”).
Re. claim 6, Urman of the combined invention further teaches wherein the EP values comprise local activation times (LATs) (Urman paragraph 0027 – “The data may be presented in the form of a three-dimensional (3D) map of local activation times (LATs) in the region, and is indicative of a wave of electrical activation flowing through the region”).
Re. claim 11, Urman teaches a medical apparatus (figure 1), comprising:
a display (figure 1, screen 48); and
a processor (figure 1, processing unit 42) configured to:
receive multiple EP data points comprising respective locations and EP values (paragraph 0046 – “In an initial electrophysiological signal step 204, electrode 22 together with ECG module 36 is used to record electric potentials at positions 310, (illustrated in FIG. 3B) within region 300”),
generated from signals acquired by one or more electrodes of a catheter that are in contact with tissue of a cardiac chamber (paragraph 0033 – “Typically, probe 24 comprises a catheter which is inserted into the body of a human subject 26 during a mapping procedure performed by a user 28 of system 20”; paragraph 0032 – “A distal end 32 of probe 24 is assumed to have an electrode 22 attached to the distal end for acquiring the electrical signals processed by system 20. Those having ordinary skill in the art will be able to adapt the description for multiple probes that may have one or more electrodes, or for a single probe with multiple electrodes…”);
score the received data points with respective quality scores (paragraph 0063 – “In a mapping preparation step 212, the processing unit prepares a map showing locations identified in step 210 as expected blocking sites, herein assumed to correspond to ablation site locations 314. In addition, the processing unit calculates a confidence level for each identified site, where the confidence level is a measure of a quality of wavefront blocking”);
and render a map of the cardiac chamber to the display while coloring the regions of the map with hues selected responsively to the EP values of the data points in the regions (paragraph 0048 – “Typically the intermediate 3D map illustrates values of the derived parameters according to a color scale, so that the map is presented as a surface, with colors applied to regions of the surface corresponding to the value of the derived parameters of the regions. FIG. 3C schematically shows the colors of surface map as different gray scales”).
Urman does not teach the steps of computing respective quality metrics for multiple regions of the cardiac chamber responsively to the quality scores of the data points in the regions, and modulating respective colors of the regions responsively to the respective quality metrics.
Thakur similarly teaches a system for electrophysiological mapping (paragraph 0112 – “Mapping the electrophysiology of heart rhythm disorders often involves the introduction of a constellation catheter or other mapping/sensing device having a plurality of sensors into a cardiac chamber”) which teaches scoring received data points with quality scores (calculating confidence levels of sensed “unique” signal patterns, paragraph 0130 – “Further, the processing system 32 may be configured to detect intrinsic electrical activity associated with multiple "unique" activation patterns of cellular wave excitation propagations…”; paragraph 0139 – “Similarly, the frequency of unique signal patterns may be calculated to establish a level of "confidence" for unique signal patterns initially matched by comparing unique signal patterns to one or more global template patterns”).
Thakur further teaches computing respective quality metrics for multiple regions of the cardiac chamber responsively to the quality scores of the data points in the regions (calculating direction vectors from confidence levels, paragraph 0144 – “As illustrated in FIG. 5A, the arrow that is used to represent the vector 74 has a length and thickness. The length and/or thickness may correlate to the "confidence" with which the processing system 32 has calculated the dominant direction vector. Further, the "confidence" may be directly proportional to the total number of cellular activations occurring in that particular direction over a time period”), and
modulating respective colors of the regions responsively to the respective quality metrics (paragraph 0144 – “It is contemplated that any attribute of any visual representation (e.g. vector arrow) may be changed to reflect a level of confidence (e.g. color, shape, transparency)”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/method of Urman, to incorporate the computed quality metrics and color modulation as taught by Thakur, since such modification would predictably result in displaying accurate and comprehensible EP activation maps.
Re. claim 12, Thakur of the combined invention further teaches wherein modulating the respective colors of the regions comprises reducing a luminance of a color as a function of decreasing quality (Thakur paragraph 0144 – “It is contemplated that any attribute of any visual representation (e.g. vector arrow) may be changed to reflect a level of confidence (e.g. color, shape, transparency)”).
Re. claim 13, Urman of the combined invention further teaches wherein modulating the respective colors of the regions comprises reducing a saturation of a color as a function of decreasing quality (Urman paragraph 0048 – “Typically the intermediate 3D map illustrates values of the derived parameters according to a color scale, so that the map is presented as a surface, with colors applied to regions of the surface corresponding to the value of the derived parameters of the regions”; paragraph 0067 – “The indication may be by any convenient method known in the art, such as changing a color and/or a size and/or a shape of a symbol of a given location according to its confidence level”).
Re. claim 14, Urman of the combined invention further teaches wherein modulating the respective colors of the regions comprises overlaying on the map a graphical layer having a property that varies as a function of the quality metrics (Urman paragraph 0048 – “The processing unit may overlay the derived parameters onto the map of step 202, and present the result in the form of an intermediate 3D electrophysiological surface map 320 on screen 48”; paragraph 0067 – “The indication may be by any convenient method known in the art, such as changing a color and/or a size and/or a shape of a symbol of a given location according to its confidence level”).
Re. claim 15, Thakur of the combined invention further teaches wherein the processor is configured to modify a transparency of the regions in the rendered map as a function of the quality metrics (Thakur paragraph 0144 – “It is contemplated that any attribute of any visual representation (e.g. vector arrow) may be changed to reflect a level of confidence (e.g. color, shape, transparency)”).
Re. claim 16, Thakur of the combined invention further teaches wherein the EP values comprise local activation times (LATs) (Urman paragraph 0027 – “The data may be presented in the form of a three-dimensional (3D) map of local activation times (LATs) in the region, and is indicative of a wave of electrical activation flowing through the region”).
Re. claim 21, Urman teaches a computer software product comprising a non- transitory computer-readable medium in which program instructions are stored (paragraph 0034 – “System 20 may be controlled by a system processor 40, comprising a processing unit 42 communicating with a memory 44”), which instructions, when read by a computer, cause the computer to:
receive multiple EP data points comprising respective locations and EP values (paragraph 0046 – “In an initial electrophysiological signal step 204, electrode 22 together with ECG module 36 is used to record electric potentials at positions 310, (illustrated in FIG. 3B) within region 300”),
generated from signals acquired by one or more electrodes of a catheter that are in contact with tissue of a cardiac chamber (paragraph 0033 – “Typically, probe 24 comprises a catheter which is inserted into the body of a human subject 26 during a mapping procedure performed by a user 28 of system 20”; paragraph 0032 – “A distal end 32 of probe 24 is assumed to have an electrode 22 attached to the distal end for acquiring the electrical signals processed by system 20. Those having ordinary skill in the art will be able to adapt the description for multiple probes that may have one or more electrodes, or for a single probe with multiple electrodes…”);
to score the received data points with respective quality scores (paragraph 0063 – “In a mapping preparation step 212, the processing unit prepares a map showing locations identified in step 210 as expected blocking sites, herein assumed to correspond to ablation site locations 314. In addition, the processing unit calculates a confidence level for each identified site, where the confidence level is a measure of a quality of wavefront blocking”).
Urman does not teach the steps of: to compute respective quality metrics for multiple regions of the cardiac chamber responsively to the quality scores of the data points in the regions, and modulating respective colors of the regions responsively to the respective quality metrics.
Thakur similarly teaches a system for electrophysiological mapping (paragraph 0112 – “Mapping the electrophysiology of heart rhythm disorders often involves the introduction of a constellation catheter or other mapping/sensing device having a plurality of sensors into a cardiac chamber”) which teaches scoring received data points with quality scores (calculating confidence levels of sensed “unique” signal patterns, paragraph 0130 – “Further, the processing system 32 may be configured to detect intrinsic electrical activity associated with multiple "unique" activation patterns of cellular wave excitation propagations…”; paragraph 0139 – “Similarly, the frequency of unique signal patterns may be calculated to establish a level of "confidence" for unique signal patterns initially matched by comparing unique signal patterns to one or more global template patterns”).
Thakur further teaches computing respective quality metrics for multiple regions of the cardiac chamber responsively to the quality scores of the data points in the regions (calculating direction vectors from confidence levels, paragraph 0144 – “As illustrated in FIG. 5A, the arrow that is used to represent the vector 74 has a length and thickness. The length and/or thickness may correlate to the "confidence" with which the processing system 32 has calculated the dominant direction vector. Further, the "confidence" may be directly proportional to the total number of cellular activations occurring in that particular direction over a time period”), and
modulating respective colors of the regions responsively to the respective quality metrics (paragraph 0144 – “It is contemplated that any attribute of any visual representation (e.g. vector arrow) may be changed to reflect a level of confidence (e.g. color, shape, transparency)”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/method of Urman, to incorporate the computed quality metrics and color modulation as taught by Thakur, since such modification would predictably result in displaying accurate and comprehensible EP activation maps.
Claim(s) 7-8 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urman (US 20160038047 A1 – hereinafter Urman) in view of Thakur (US 20150119672 A1 – hereinafter Thakur), and in further view of Gliner (US 20210177294 A1 – hereinafter Gliner).
Re. claims 7-8, the combined invention of Urman and Thakur (hereinafter the combined invention) teaches the claimed invention of claim 1 as stated above, but does not expressly teach wherein the EP values comprise bipolar potentials, and wherein the EP values comprise unipolar potentials.
Gliner similarly teaches a system for EP mapping (paragraph 0012 – “FIG. 2 is a flowchart that schematically illustrates a method for automated EP mapping, in accordance with an embodiment of the invention…”), and further teaches measuring EP values, wherein the EP values comprise bipolar potentials and unipolar potentials (paragraph 0018 – “In a disclosed embodiment, the processor displays a 3D map of a chamber of the heart in which EP parameter is being mapped. The 3D map is presented in a neutral color tone or monotone color, such as gray. The EP parameter may comprise, for example, a local activation time (LAT) measured in the myocardium or a bipolar or unipolar maximum voltage”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/method of the combined invention, to incorporate the bipolar and unipolar potential measurements as taught by Gliner, since such modification would predictably result in displaying accurate and comprehensible EP maps for identifying arrhythmia.
Re. claims 17-18, the combined invention of Urman and Thakur (hereinafter the combined invention) teaches the claimed invention of claim 11 as stated above, but does not expressly teach wherein the EP values comprise bipolar potentials, and wherein the EP values comprise unipolar potentials.
Gliner similarly teaches a system for EP mapping (paragraph 0012 – “FIG. 2 is a flowchart that schematically illustrates a method for automated EP mapping, in accordance with an embodiment of the invention…”), and further teaches measuring EP values, and wherein the EP values comprise bipolar potentials and unipolar potentials (paragraph 0018 – “In a disclosed embodiment, the processor displays a 3D map of a chamber of the heart in which EP parameter is being mapped. The 3D map is presented in a neutral color tone or monotone color, such as gray. The EP parameter may comprise, for example, a local activation time (LAT) measured in the myocardium or a bipolar or unipolar maximum voltage”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/method of the combined invention, to incorporate the bipolar and unipolar potential measurements as taught by Gliner, since such modification would predictably result in displaying accurate and comprehensible EP maps for identifying arrhythmia.
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urman (US 20160038047 A1 – hereinafter Urman) in view of Thakur (US 20150119672 A1 – hereinafter Thakur), and in further view of Han (US 20160217595 A1 – hereinafter Han).
Re. claim 9, the combined invention of Urman and Thakur (hereinafter the combined invention) teaches the claimed invention of claim 1 as stated above, but does not expressly teach wherein computing the quality metrics comprises averaging the quality scores of the data points within each of the regions.
Han teaches a system for localizing and tracking tumors (paragraph 0020) which acquires 2D image slices (paragraph 0036 – “The image acquisition device 170 can be configured to acquire one or more images of the patient's anatomy for a region of interest (e.g., a target organ, a target tumor or both). Each 2D slice can include one or more parameters (e.g., a 2D slice thickness, an orientation, and a location, etc.)”) and a response map for each 2D slice (paragraph 0074 – “A response map can be created for every 2D slice”),
and further teaches the known technique of averaging the quality scores of the data points within each of the regions (paragraph 0076 – “Alternatively, the processor 112 can use a weighted average of all the confidence scores for a particular location on the 2D slice. In an example, the processor 112 may compute the weighted average of the top N confidence scores, where N is a predetermined number”).
Since both the combined invention and Han all teach within the field of image acquisition system/methods, particularly with physiological mapping, confidence score and quality metric calculation, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the quality metric calculation of the combined invention, to incorporate the average confidence score calculation as taught by Han, since such modification would predictably result in displaying accurate EP maps for identifying arrhythmia.
Re. claim 19, the combined invention of Urman and Thakur (hereinafter the combined invention) teaches the claimed invention of claim 11 as stated above, but does not expressly teach wherein computing the quality metrics comprises averaging the quality scores of the data points within each of the regions.
Han teaches a system for localizing and tracking tumors (paragraph 0020) which acquires 2D image slices (paragraph 0036 – “The image acquisition device 170 can be configured to acquire one or more images of the patient's anatomy for a region of interest (e.g., a target organ, a target tumor or both). Each 2D slice can include one or more parameters (e.g., a 2D slice thickness, an orientation, and a location, etc.)”) and a response map for each 2D slice (paragraph 0074 – “A response map can be created for every 2D slice”),
and further teaches the known technique of averaging the quality scores of the data points within each of the regions (paragraph 0076 – “Alternatively, the processor 112 can use a weighted average of all the confidence scores for a particular location on the 2D slice. In an example, the processor 112 may compute the weighted average of the top N confidence scores, where N is a predetermined number”).
Since both the combined invention and Han all teach within the field of image acquisition system/methods, particularly with physiological mapping, confidence score and quality metric calculation, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the quality metric calculation of the combined invention, to incorporate the average confidence score calculation as taught by Han, since such modification would predictably result in displaying accurate EP maps for identifying arrhythmia.
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urman (US 20160038047 A1 – hereinafter Urman) in view of Thakur (US 20150119672 A1 – hereinafter Thakur), and in further view of Nguyen (US 20200281493 A1 – hereinafter Nguyen).
Re. claim 10, the combined invention of Urman and Thakur (hereinafter the combined invention) teaches the claimed invention of claim 1 as stated above, but does not expressly teach wherein scoring the received data points comprises computing a density of the data points in each of the locations.
Nguyen teaches a similar system for EP mapping using electrogram signals (paragraph 0257 – “The processor of console (12) may process the potentials from electrodes (146, 148, 154) and thereby provide an electrocardiogram signal. Such electrocardiogram signals may be used to provide EP mapping to thereby identify locations of aberrant electrical activity within the cardiac anatomy”).
Nguyen further teaches receiving data points (paragraph 0338 – “FIG. 17 is a table summarizing electrogram acquisition and performance measures…”), and computing density of the data points in each of the locations (paragraph 0198 – “FIG. 26B shows a violin plot comparison of EGM acquisition data for each catheter of the third study as to electrogram density”; paragraph 0356 – “FIGS. 25A-26B show violin plots comparison of EGM acquisition data for each catheter of the third study. In particular, FIGS. 25A-26B depict graphical comparisons of electrogram acquisition performance with normal ventricles as to the catheter of eight arms (140) shown in the darker, violin on the left of each graph and the lighter, violin corresponding to the catheter of five arms (140)”; paragraph 0351 – “Data acquisition was automated using the following inclusion criteria: … (3) EGM acquisition density, measured as the acquired number of EGMs per cm2 of LV…”).
Since both the combined invention and Nguyen all teach within the field of EP mapping, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the received data point scoring of the combined invention, to incorporate the data point (i.e. electrogram) density computations as taught by Nguyen, since such modification would predictably result in displaying accurate EP maps for identifying arrhythmia.
Re. claim 20, the combined invention of Urman and Thakur (hereinafter the combined invention) teaches the claimed invention of claim 11 as stated above, but does not expressly teach wherein scoring the received data points comprises computing a density of the data points in each of the locations.
Nguyen teaches a similar system for EP mapping using electrogram signals (paragraph 0257 – “The processor of console (12) may process the potentials from electrodes (146, 148, 154) and thereby provide an electrocardiogram signal. Such electrocardiogram signals may be used to provide EP mapping to thereby identify locations of aberrant electrical activity within the cardiac anatomy”).
Nguyen further teaches receiving data points (paragraph 0338 – “FIG. 17 is a table summarizing electrogram acquisition and performance measures…”), and computing density of the data points in each of the locations (paragraph 0198 – “FIG. 26B shows a violin plot comparison of EGM acquisition data for each catheter of the third study as to electrogram density”; paragraph 0356 – “FIGS. 25A-26B show violin plots comparison of EGM acquisition data for each catheter of the third study. In particular, FIGS. 25A-26B depict graphical comparisons of electrogram acquisition performance with normal ventricles as to the catheter of eight arms (140) shown in the darker, violin on the left of each graph and the lighter, violin corresponding to the catheter of five arms (140)”; paragraph 0351 – “Data acquisition was automated using the following inclusion criteria: … (3) EGM acquisition density, measured as the acquired number of EGMs per cm2 of LV…”).
Since both the combined invention and Nguyen all teach within the field of EP mapping, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the received data point scoring of the combined invention, to incorporate the data point (i.e. electrogram) density computations as taught by Nguyen, since such modification would predictably result in displaying accurate EP maps for identifying arrhythmia.
Conclusion
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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