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 .
Response to Arguments
Applicant's arguments, see pages 7-10 and 12-14, filed 1/13/2026, have been fully considered
but they are not persuasive.
35 U.S.C. 103:
Regarding independent claim 1, applicant argues that Laughner, alone or in combination with
the prior art, does not teach “wherein the processing unit is configured to segment the recorded patient data, employ the clustering routine to group the segments, and combine the segmented patient data, in that order.” After further search and consideration, the examiner respectfully disagrees and argues that one cannot show non-obviousness by attacking the references individually where, as here, the rejection is based on a combination of references. In re Keller, 642 F .2d 413, 208 USPQ 871 (CCPA 1981). In this case, Laughner teaches to “combine the segmented patient data” in order to generate a composite map of ECG signals (fig. 4; paragraph 54). Figure 4 clearly discloses the combination of segmented data represented in a clustered graph. Carson teaches “wherein the processing unit is configured to segment the recorded patient data, employ the clustering routine to group the segments (fig. 2A-5; paragraph 35- 37, 45, 58, and 61-66). Step 208 includes extracting EGM waveform beat segments from areas of interest disposed about each beat. The extracting step can be used to divide up the very long EGM waveform data into beat segments, with each beat segment including EGM waveform data for that beat. Step 212 includes clustering the EGM waveform beat segments into morphological or waveform identity groups, with each group having a morphological or shape identity between the members of that group.
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 processor of Laughner with the cardiac cycle segmentation and clustering steps from Carlson for the benefit of dividing each heartbeat from the next to classify which part of the cardiac cycle is irregular. This is also for the benefit of identifying and extracting similar groups from a data set to increase data collection accuracy.
Regarding claims 58-60, the applicant argue specific thresholds of 1,000, 2,000, and 5,000
segments are not arbitrary optimization parameters but reflect a technical basis rooted in the specification's recognition that "the continuous, global mapping of atrial fibrillation yields a tremendous volume of temporally-variable and spatially-variable activation patterns. A limited, discrete sampling of map data may be insufficient to provide a comprehensive picture of the drivers, mechanisms, and supporting substrate for the arrhythmia" [0024]. After further search and consideration, the examiner respectfully disagrees and argues at least 1000… biopotential segments means minimum of 1000 segments/2000 segments/5000 segments. The upper range is unlimited. A segment can be 1 sec or 0.5milliseconds, try to expand search to just say segments or points instead of specific numbers. The applicant has not provided reasonings as to why using these specific lower limit values are the most optimal. Carlson teaches segmenting data to have at least multiple segments (fig. 4-5; paragraph 54 and 59-60). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Laughner with the at least 1,000, 2,000, and 5,000 biopotential signal segments, 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] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Regarding claims 67, 76, and 78, the applicant argues that the combination of Laughner,
Werneth, Carlson, and Ruppersberg is impossible. The examiner respectfully disagrees and argues that the applicant has not provided reasons as to why the combination of said art would not work. The applicant is reminded that the rejection is based on the combination of art and one cannot show non-obviousness by attacking the references individually.
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.
Claims 1, 56-57, 61-66, 68-75, 77, and 79-81 are rejected under 35 U.S.C. 103 as being unpatentable by LAUGHNER et al U.S. Pat: US 2015/0257671 A1, hereinafter Laughner in view of Werneth et al. US Pub.: US 20150223757 A1, hereinafter Werneth in view of Carlson US Pub.: US 20030204146 A1.
Regarding claim 1, Laughner teaches a cardiac electrical activity diagnostic modeling system, comprising:
at least one diagnostic catheter (fig. 2, 14) insertable into the heart of a patient (paragraph 59);
they at least one diagnostic catheter (fig. 2, 14) comprising an electrode (fig. 2, 24) configured to record patient data over multiple cardiac cycles, the patient data comprising: biopotential data (paragraph 55 and 59); It is disclosed in [55] that electrical activity of multiple cardiac cycles is recorded as disclosed by an activation time map. Furthermore, electrogram data equate to biopotential data.
and stored and/or received localization data comprising the location of the at least one recording element (fig. 2, 24; paragraph 49 and 53); It is disclosed in [49 and 53] that the recording elements, electrodes, are configured to detect cardiac electrical activity at sensor locations for mapping the electrophysiology of heart.
and a processing unit (fig. 1, 32) comprising a clustering routine executable to: receive the recorded patient data (paragraph 78-79); A clustering routine of the recorded patient data is disclosed in [78-79].
wherein the system is configured to create one or more models of cardiac electrical activity of the patient based on the one or more composite recordings to guide a patient's treatment based on the one or more models of cardiac electrical activity (paragraph 55 and 69). It is disclosed in [55] that analyzing the anatomical map generated from the catheter electrodes will determine a location suitable for ablation for treatment. It is further disclosed in [69] that a cardiac waveform is generated, which is a composite recording.
and combine the ECG patient data (fig. 4; paragraph 54). Figure 4 clearly discloses the combination of segmented data represented in a clustered graph.
However, Laughner does not explicitly teach at least two recording elements, wherein one of the elements is an ultrasound transducer; segment the recorded patient data by cardiac cycle to produce segmented patient data comprising segments; employ a clustering routine to group the segments based on one or more characteristics of the segments to produce segmented data groups; and combine the segmented patient data within each segmented data group to produce one or more composite recording; wherein the processing unit is configured to segment the recorded patient data and employ the clustering routine to group the segments, in that order.
Werneth, in the same field of endeavor, teaches at least two recording elements, wherein one of the elements is an ultrasound transducer (paragraph 103-104). Splines 131 can include one or more electrodes 141 and/or one or more ultrasound transducers 151 arranged in any combination.
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 catheter electrodes of Laughner to incorporate a few ultrasound transducers from Werneth for the benefit of receiving ultrasound reflections to determine the range to a reflecting target used in the digital model creation of the anatomy.
Carlson, in the same field of endeavor, teaches segment the recorded patient data by cardiac cycle to produce segmented patient data comprising segments (fig. 4-5; paragraph 54 and 59-60);
employ a clustering routine to group the segments based on one or more characteristics of the segments to produce segmented data groups (fig. 4-5; paragraph 37, 45, 58, and 61-66);
and combine the segmented patient data within each segmented data group to produce one or more composite recording (fig. 4-5; paragraph 37, 45, 58, and 61-66);
wherein the processing unit is configured to segment the recorded patient data and employ the clustering routine to group the segments, in that order (fig. 2A-5; paragraph 35- 37, 45, 58, and 61-66). Step 208 includes extracting EGM waveform beat segments from areas of interest disposed about each beat. The extracting step can be used to divide up the very long EGM waveform data into beat segments, with each beat segment including EGM waveform data for that beat. Step 212 includes clustering the EGM waveform beat segments into morphological or waveform identity groups, with each group having a morphological or shape identity between the members of that group.
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 processor of Laughner with the cardiac cycle segmentation and clustering steps from Carlson for the benefit of dividing each heartbeat from the next to classify which part of the cardiac cycle is irregular. This is also for the benefit of identifying and extracting similar groups from a data set to increase data collection accuracy.
Regarding claim 56, Laughner in view of Werneth in view of Carlson teaches wherein the one or more models of cardiac electrical activity comprise two or more models of cardiac electrical activity (paragraph 55). It is disclosed in that the sensed cardiac electrical activity is processed to generate anatomical maps, identify near field signal components and far-field signal components. Different graphical models are generated and shown on figures 4-11.
Regarding claim 57, Laughner in view of Werneth in view of Carlson teaches wherein the biopotential data comprises biopotential signals recorded by each of the at least one recording elements (paragraph 49 and 53). It is disclosed in [49 and 53] that the recording elements, electrodes, are configured to detect cardiac electrical activity at sensor locations for mapping the electrophysiology of heart.
wherein segmenting the recorded patient data comprises segmenting each of the biopotential signals by cardiac cycle into multiple biopotential signal segments (paragraph 78-79); An activation time mapping is disclosed in [55]. Therefore, a recording of patient data is performed during one or more cardiac cycles. It is further disclosed in [78-79] that the patient data is separated into groups with similar characteristics for cluster analysis.
and/or wherein each of the one or more composite recordings comprises two or more of the multiple biopotential signal segments (paragraph 69 and 78). The collection of raw sensed cardiac electrical activity data is segmented into multiple electrograms. Each electrogram is generated and displayed overlapping or combined to generate one or more composite recording as shown in figure 4.
Regarding claim 61, Laughner in view of Werneth in view of Carlson teaches wherein the one or more segment characteristics are selected from the group consisting of: pattern; cycle length; signal morphology; amplitude; frequency; frequency components; wavelet composition; and combinations thereof (paragraph 69 and 78-79). It is disclosed in [69] and figure 4 that the signal segments are grouped based on a similar pattern and amplitude. Due to this, the signals form a cluster.
Regarding claim 62, Laughner in view of Werneth in view of Carlson teaches wherein the clustering routine comprises an algorithm selected from the group consisting of: a connectivity model-based algorithm; a centroid model-based algorithm; a density model-based algorithm; a distribution model-based algorithm; a graph-based model algorithm; a neural model-based algorithm; and combinations thereof (paragraph 78-79). It is disclosed in [78] that the Gaussian mixture model (GMM) analysis is a clustering routine and is another form of a density model-based algorithm.
Regarding claim 63, Laughner in view of Werneth in view of Carlson teaches wherein the clustering routine comprises a connectivity model-based algorithm comprising a hierarchical clustering algorithm, wherein the models are based on distance connectivity (paragraph 80). Connectivity model-based algorithm is based on the core idea of objects being more related to nearby objects than to objects farther away. It is disclosed in [80] and figures 7-8 that signals are being grouped together based on their localization and similarities. These groups are named “first group” and “second group.” As best represented by figure 8, it is clearly shown that a connectivity model-based algorithm is taken place.
Regarding claim 64, Laughner in view of Werneth in view of Carlson teaches wherein the clustering routine comprises a centroid model-based algorithm comprising a k-means clustering algorithm, wherein each cluster is represented by a single mean vector (paragraph 78). It is disclosed that the processing system uses a k-means clustering algorithm technique.
Regarding claim 65, Laughner in view of Werneth in view of Carlson teaches wherein the clustering routine comprises a density model-based algorithm that defines the clusters as connected dense regions in the data space (paragraph 78). The Gaussian mixture model (GMM) analysis is another form of a density model-based algorithm.
Regarding claim 66, Laughner in view of Werneth in view of Carlson teaches wherein the clustering routine comprises a distribution model-based algorithm comprising a Gaussian mixture model clustering algorithm, wherein the clusters are modeled using a statistical distribution comprising a multivariate normal distribution (paragraph 78).
Regarding claim 68, Laughner in view of Werneth in view of Carlson teaches wherein the processing unit further comprises an automatic timing annotation algorithm executable to identify and annotate one or more signal characteristics of the cardiac electrical activity (paragraph 83-86). It is disclosed that the peak-finding algorithm is configured to identify activation events, which equates to a signal characteristic.
Regarding claim 69, Laughner in view of Werneth in view of Carlson teaches wherein the characteristics correspond to cardiac tissue depolarization, activation, and/or repolarization (paragraph 83-86). Activation events are disclosed.
Regarding claim 70, Laughner in view of Werneth in view of Carlson teaches wherein the processing unit is configured to group the segments based on template matching (paragraph 78-80). The processed electrograms are compared to and grouped together using template matching. Processing may identify groups of electrograms which are similar to one another, or on the basis of certain features within each electrogram.
Regarding claim 71, Laughner in view of Werneth in view of Carlson teaches wherein the processing unit is configured to perform the template matching based on one or more segment templates (paragraph 78-80). It is disclosed that one or more electrogram segments are being compared to using the template matching procedure as disclosed above.
Regarding claim 72, Laughner in view of Werneth in view of Carlson teaches wherein the processing unit is configured to dynamically adjust the one or more segment templates (paragraph 78-80). The processor may perform a density-based algorithm adjustment to group the segment templates.
Regarding claim 73, Laughner in view of Werneth in view of Carlson teaches wherein the processing unit is configured to merge one or more of the segmented data groups to form a merged group of all segments within the one or more segmented data groups (paragraph 69 and 78-80). It is disclosed in [69] that the templates are merged into a composite map shown in figure 4.
Regarding claim 74, Laughner in view of Werneth in view of Carlson teaches further comprising a display (fig. 1, 40; paragraph 69-71).
Regarding claim 75, Laughner in view of Werneth in view of Carlson teaches wherein at least one of the at least one recording elements is configured to record at least a portion of the data recording when in contact with the cardiac tissue (paragraph 67). It is disclosed that the recording elements, electrodes 24, that contact healthy, responsive cellular tissue may sense cardiac electrical activity
Regarding claim 77, Laughner in view of Werneth in view of Carlson teaches wherein the processing unit is configured to process data recorded by recoding elements in contact with cardiac tissue separately from data recorded by recording elements not in contact with tissue (paragraph 69). It is disclosed that the processing system 32 may display each electrogram in a separate graph. Displaying such electrograms may allow a user to assess the quality of the sensed cardiac electrical activity. This equates to the recording elements being processed separately.
Regarding claim 79, Laughner in view of Werneth in view of Carlson teaches wherein the at least one recording element comprises an array of recording elements and wherein the array comprises at least 48 recording elements (paragraph 63). It is disclosed that an arrangement of sixty-four mapping electrodes 24 is shown disposed on basket structure 20 in figure 3.
Regarding claim 80, Laughner in view of Werneth in view of Carlson teaches wherein the clustering routine comprises a detect-reject algorithm executable to identify undesirable signal characteristics (paragraph 80). The “first group” is considered a desirable signal characteristic and the “second group” is considered as undesirable signal characteristics. This is shown in figure 7 and 8. It is clearly shown that the cluster of data on the left is denser and has a greater amount of biopotentials while the cluster of data on the right is limited. Therefore, the cluster of data on the right is undesirable and a detect-reject algorithm is present.
Regarding claim 81, Laughner in view of Werneth in view of Carlson teaches wherein the clustering routine is executable to filter inconsistent, erroneous, and/or otherwise unwanted data (paragraph 66 and 102). It is disclosed in [66] electrodes without strong contact to adjacent tissues may not be able to sense changes in electrical potential because fibrous, dead or functionally refractory tissue may be incapable of depolarizing and/or responding to changes in electrical potential. Therefore, this is unwanted data. Furthermore [102] discloses a filtering process technique.
Claims 58-60 are rejected under 35 U.S.C. 103 as being unpatentable over Laughner in view of Werneth in view of Carlson.
Regarding claims 58-60, Laughner in view of Werneth in view of Carlson discloses the claimed invention except for “wherein the two or more of the multiple biopotential signal segments comprises at least 1,000, 2,000, and 5,000 biopotential signal segments.” It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Laughner with the at least 1,000, 2,000, and 5,000 biopotential signal segments, 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] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Claims 67 are rejected under 35 U.S.C. 103 as being unpatentable over Laughner in view of Werneth in view of Carlson in view of RUPPERSBERG US Pub.: US 2018/0279896 A1, hereinafter Ruppersberg.
Regarding claim 67, Laughner in view of Werneth in view of Carlson does not teach wherein the clustering routine comprises a neural model-based algorithm comprising a self-organizing map and/or other unsupervised neural network, wherein an artificial neural network and/or other non-linear statistical data modeling tool is used to model complex relationships and patterns in data.
Ruppersberg, in the same field of endeavor, teaches wherein the clustering routine comprises a neural model-based algorithm comprising a self-organizing map and/or other unsupervised neural network, wherein an artificial neural network and/or other non-linear statistical data modeling tool is used to model complex relationships and patterns in data (paragraph 117). An artificial neural network interpolation method is disclosed.
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 processing unit of Laughner in view of Werneth in view of Carlson with the neural model-based algorithm of Ruppersberg for the benefit of generating surface estimation and/or surface/data interpolation processing techniques for cardiac mapping.
Claims 76 and 78 is rejected under 35 U.S.C. 103 as being unpatentable over Laughner in view of Werneth in view of Carlson in view of Deno et al. US Pub.: US 2019/0209034 A1, hereinafter Deno.
Regarding claim 76, Laughner in view of Werneth in view of Carlson does not teach wherein at least one of the at least one recording elements is configured to record at least a portion of the data recording not it contact with the cardiac tissue.
Deno, in the same field of endeavor, teaches wherein at least one of the at least one recording elements is configured to record at least a portion of the data recording not it contact with the cardiac tissue (paragraph 30).
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 electrodes of Laughner in view of Werneth in view of Carlson with the one or more electrodes from Deno for the benefit of generating a graphical representation from the plurality of electrophysiology data points.
Regarding claim 78, Laughner in view of Werneth in view of Carlson teaches the claimed invention and Laughner further teaches wherein the at least one diagnostic catheter comprises at least two diagnostic catheters (paragraph 52 and 58). Two catheters are disclosed. One being a mapping probe 14 and the other being an ablation probe 16. This is shown in figure 1.
However, Laughner in view of Werneth in view of Carlson does not teach wherein each diagnostic catheter comprises at least one recording element.
Deno, in the same field of endeavor, teaches wherein each diagnostic catheter comprises at least one recording element (paragraph 26-29). It is disclosed that the system 8 may comprise sixty-four electrodes on twelve catheters disposed within the heart and/or vasculature of the patient.
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 ablation probe of Laughner in view of Werneth in view of Carlson with one of the twelve catheters from Deno for the benefit of measuring electrical activity and biopotentials between different areas of the heart and of the cardiac wall.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached on (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.J.T./Examiner, Art Unit 3792
/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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