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 .
Status of Claims
Claims 3-22 were previously pending and subject to a non-final Office Action having a notification date of November 20, 2025 (“non-final Office Action”). Following the non-final Office Action, Applicant filed an amendment on May 20, 2026 (the “Amendment”), amending claims 3, 6, 12, 15, 20, and 21 and canceling claims 4, 5, 13, and 14.
The present Final Office Action addresses pending claims 3, 6-12, and 15-22 in the Amendment.
Response to Arguments
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §112
These rejections are withdrawn in view of the Amendment.
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §101
On page 9 of the Amendment, Applicant takes the position that a person cannot practically in their mind with pen and paper perform a consistency analysis by comparing conduction velocities at each of the common set of locations across the plurality of measurements. Applicant then asserts how condition velocity is computed by gradient-based estimation on a three-dimensional triangulated cardiac surface mesh and as a regularized global optimization function based on physiological ranges and loss functions defined from population-level data. However, the claims never recite actually computing conduction velocities as Applicant appears to be asserting. In contrast, the claims merely recite comparing conduction velocity data at each of the common set of locations across the measurements which is practically performable in the human mind with pen and paper. That is, a person could practically in their mind with pen and paper review and compare such conduction velocity data at each of the common set of locations (e.g., 2-3 locations) across the measurements (e.g., 2-3 measurements) in any appropriate manner (e.g., determining a largest of the conduction velocities, analyzing the conduction velocity in relation to a threshold, computing an average, etc.).
Applicant also asserts that the claimed system could not practically exist and the claimed method could not practically be performed without the recited electrode, processor, and display. However, these additional limitations merely amount to using a computer and other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
On page 11 of the Amendment in relation to Step 2A - prong 2 of the Alice/Mayo analysis, Applicant takes the position that wavefront direction and tissue rate response are physiological and electrophysiological conditions of cardiac activity, not mental observations. Applicant also asserts that by acquiring a plurality of measurements that differ in wavefront direction and tissue rate response at a common set of anatomic locations and performing a consistency analysis across those measurements, the system integrates the judicial exception into the "practical application" of reducing false-positive and false-negative bias inherent in single-condition measurements which "improves the specificity of detecting…abnormality" and thereby improves diagnostic confidence and therapy planning.
However, the alleged technological "improvement" asserted by Applicant (i.e., improving the specificity of detecting abnormality, diagnostic confidence, and thereby planning via reducing false-positive and false-negative bias inherent in single-condition measurements) arises due to the mental process abstract idea limitations (i.e., the high-level limitations directed to comparing conduction velocity data at each of the common locations across the measurements) rather than due to any "additional limitations." Furthermore, that the various measurements of the electric potential data differ from one another in wavefront direction and tissue rate response just serves to further define the mental process abstract idea. Still further, the additional limitations of the recited electrode, processor, and display merely amount to using a computer and other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
At pages 12-13 of the Amendment in relation to Step 2B - prong 2 of the Alice/Mayo analysis, Applicant takes the position that the recited combination of intracardiac biopotential acquisition under varied conditions, conduction-velocity-based consistency analysis across a plurality of measurements at a common set of locations, and visualization of the consistency analysis is not well-understood, routine, or conventional which provides "significantly more" than the abstract idea. However, the review/analysis of the electric potential/conduction velocity data under varying conditions and display of the consistency analysis is part of the abstract idea similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQe2d 1739 (Fed. Cir. 2016)). MPEP 2106.04(a)(2)(III). Furthermore, the additional limitations do not provide "significantly more" than the abstract idea for at least the same reasons discussed herein supporting why the additional limitations do not provide a "practical application" of the abstract idea.
The 35 USC 101 rejection is maintained.
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §102
At pages 13-14 of the Amendment, Applicant takes the position that Li "does not acquire multiple measurements at the same anatomic locations under varied wavefront direction and tissue rate response, and does not compare conduction velocity data at each location in a common set of locations across multiple such measurements. The Examiner's reading of Li's "neighboring data points" as the claimed "common set of locations" (Office Action dated 11/20/2025, p. 11) conflates spatial neighbors of one electrophysiology data point within one measurement with the recited cross-measurement comparison at the same locations."
Initially, the Examiner notes that the claims do not recite "acquiring multiple measurements at the same anatomic locations under varied wavefront direction and tissue rate response" or "cross-measurement comparison at the same locations" as Applicant is asserting. Instead, the claims recite "record a data set … including a plurality of measurements, the plurality of measurements differing from one another in wavefront direction and in tissue rate response associated with the cardiac activity, wherein each of the plurality of measurements includes activity data at each location in a common set of locations on an anatomy of a patient." In this regard, electrodes 12-18, 21, 22, 52, 54, 56 in Figures 1-2 of Li measure potentials/voltages/EP data points in the heart per [0026], [0029]-[0030], [0034]-[0038], [0041] of Li (recording a data set including a plurality of measurements); [0047], [0067], and Figure 4 of Li disclose/illustrate differing/varying activation wavefront directions (the measurements differ from one another in wavefront direction); NPL "Heart rate variability: a review" to Acharya et al. evidences that the time between consecutive heartbeats varies over time due to autonomic neural regulation of the heart and the circulatory system (the measurements differ from one another in tissue rate response); [0048] of Li discloses analyzing EP data points (the above-noted "measurements") within respective grid squares/regions of the heart (activity data measurements at each location in a common set of locations); and [0067] discusses analyzing EP data points (the above-noted "measurements") in a "particular region" of the cardiac surface (activity data measurements at each location in a common set of locations). The Examiner is interpreting the "common set of locations" to be locations that are in the same particular region/area/grid square of the patient's heart.
Applicant's assertion "The Office Action's reliance on Acharya (NPL, "Heart rate variability: a review") to supply the "tissue rate response" limitation confirms that Li alone does not disclose this limitation" is incorrect. In contrast, the Examiner's reliance on Acharya is to provide evidence that Li inherently discloses the measurements to vary in tissue rate response as required by the present claims.
On pages 14-15 of the Amendment, Applicant takes the position that Zhu does not disclose a "second energy delivery element" as recited in the claims. The Examiner disagrees and asserts that one of the auxiliary electrodes from the middle of [0209] is a "second energy delivery element" and additionally or alternatively asserts that [0229] discloses how numerous ablation (energy delivering) devices can be received in lumen 108, one of which includes first energy delivery element and another of which includes a second energy delivery element.
Applicant then asserts that Zhu "does not aggregate measurements across deliberately varied conditions at a common set of anatomic locations." However, claim 20 never recites "deliberately varied conditions at a common set of anatomic locations" as Applicant appears to be asserting. Rather, claim 20 recites the following which is disclosed by Zhou as set forth below:
a processor (processor 26) configured to aggregate a plurality of the recorded potential data representing cardiac activity for a consistency analysis of the data, the consistency analysis employing conduction velocity data ([0313] discloses aggregating propagation direction and conduction velocity data to determine consistency of conduction characteristics that can be derived from the raw surface data), the consistency analysis comparing conduction velocity data at each of the common set of locations across the plurality of measurements (determining the consistency of conduction velocity per [0313] (which can be in relation to a particular region/chamber/common set of locations per [0248]) necessarily requires comparing the conduction velocities at the various locations in the region/chamber).
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §103
On page 16 of the Amendment in relation to claims 8-10, 17, and 18, Applicant takes the position that Maccabee is non-analogous art to the cardiac mapping of Li and Zhu. However, the analogousness of a prior art reference in a 35 USC 103 rejection is made with respect to the claimed invention rather than with respect to other references in the rejection. MPEP 2141.01(a). Furthermore, a reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). In the present case, the Examiner notes that one problem faced by inventor is how to consolidate conduction velocity data to identify abnormal signal activity ([0150] of the present application). In this regard, using thresholds to identify slow/abnormal conduction velocities as taught by [0024]-[0026] of Maccabee is "reasonably pertinent" to the above-noted problem faced by the inventors (i.e., how to consolidate conduction velocity data to identify abnormal signal activity). Accordingly, Maccabee is analogous art to the claimed invention.
Applicant then takes the position that the Examiner's reasoning to modify Li in view of Zhu and Maccabee (i.e., facilitate diagnoses of diagnostic abnormalities) does not provide an articulated reasoning with a rational underpinning why a cardiac-mapping artisan would have modified Li or Zhu using a peripheral-nerve-demyelination reference. The Examiner disagrees and asserts that one of ordinary skill in the art would understand how use of conduction velocity thresholds to identify abnormal velocities would provide an efficient manner of facilitating diagnoses of diagnostic abnormalities.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 3, 6-12, and 15-19 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more:
Subject Matter Eligibility Criteria - Step 1:
Claims 3 and 6-11 are directed to a system (i.e., a machine) and claims 12 and 15-19 are directed to a method (i.e., a process). Accordingly, claims 3, 6-12, and 15-19 are all within at least one of the four statutory categories. 35 USC §101.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test (which collectively includes the guidance in the January 7, 2019 Federal Register notice and the October 2019 and July 2024 updates issued by the USPTO as incorporated into the MPEP, as supported by relevant case law), the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 3 includes limitations that recite at least one abstract idea. Specifically, independent claim 3 recites:
A system for analysis of heart tissue, comprising:
an electrode configured to record a data set of electric potential data representing cardiac activity at a plurality of time intervals, the data set including a plurality of measurements, the plurality of measurements differing from one another in wavefront direction and in tissue rate response associated with the cardiac activity, wherein each of the plurality of measurements includes activity data at each location in a common set of locations on an anatomy of a patient;
a processor configured to aggregate a plurality of the recorded potential data representing cardiac activity for a consistency analysis of the data, the consistency analysis employing conduction velocity data, the consistency analysis comparing conduction velocity data at each of the common set of locations across the plurality of measurements; and
a display configured to display to an operator a visualization of the consistency analysis.
The Examiner submits that the foregoing underlined limitations constitute "mental processes" because they are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind (e.g., with pen and paper). As an example, a medical professional could readily obtain electric potential data representing cardiac activity at a plurality of time intervals (e.g., such as by looking at it on a screen and writing it down) including a plurality of measurements (e.g., 2-3 measurements) at each location in a common set of locations (e.g., 2-3 locations) on an anatomy of a patient (e.g., heart), where the measurements differ in wavefront direction and tissue rate response. The medical professional could also readily compare/analyze conduction velocity data (e.g., percentage change, normalized values, etc.) at each of the common set of locations (e.g., 2-3 locations) across the measurements to conduct a "consistency analysis" of the data such as how often conduction velocity values are consistently abnormal, consistently normal, etc., and display a visualization of the analysis (e.g., with pen and paper). For instance, a threshold of 0.3m/s could be used as a threshold to differentiate normal from abnormal conduction velocity values. These recitations, under their broadest reasonable interpretation, are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQe2d 1739 (Fed. Cir. 2016)). MPEP 2106.04(a)(2)(III).
Claims "directed to collection of information, comprehending the meaning of that collected information, and indication of the results, all on a generic computer network operating in its normal, expected manner," fail step one of the Alice framework. In re Killian, 45 F.4th 1373, 1380 (Fed. Cir. 2022). Claims directed to collecting, analyzing, manipulating, and displaying data" are abstract. Univ. of Fla. Research Found., Inc. v. General Elec. Co., 916 F.3d 1363, 1368 (Fed. Cir. 2019). Claims directed to organizing, storing, and transmitting information determined to be directed to an abstract idea. Cyberfone Sys., L.L.C. v. CNN Interactive Grp., Inc., 558 F. App’x 988, 992 (Fed. Cir. 2014).
Accordingly, the claim recites at least one abstract idea.
Furthermore, dependent claims 4-11 and 13-19 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below:
-Claims 6 and 15 call for forming a composite (e.g., aggregate) of conduction velocity data from the plurality of measurements at the common set of locations on a patient's anatomy which is practically performable in the human mind with pen and paper ("mental processes").
-Claims 7 and 16 call for analyzing composite conduction velocity data to delineate minimum, mean, maximum, or median conduction velocities which is practically performable in the human mind with pen and paper ("mental processes").
-Claims 8 and 17 call for employing a threshold to assess as abnormal any conduction velocity that falls below the threshold and to display a consistency map that displays areas with consistently abnormal, normal, or inconsistently abnormal which is practically performable in the human mind with pen and paper ("mental processes").
-Claims 9 and 18 call for performing anatomic data co-registration which is practically performable in the human mind with pen and paper ("mental processes"), such as by aligning data to a common coordinate system.
-Claims 10 and 19 call for performing conduction velocity aberration/divergence modeling which is practically performable in the human mind with pen and paper ("mental processes"), such as by mentally determining when conduction velocity values are aberrant or diverge over time or at different locations.
-Claim 11 calls for determining a restitution score whereby the conduction velocity at a range of sites across varying pacing rates is analyzed which is practically performable in the human mind with pen and paper ("mental processes").
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements such as merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A system for analysis of heart tissue, comprising:
an electrode configured to record a data set of electric potential data representing cardiac activity at a plurality of time intervals, the data set including a plurality of measurements, the plurality of measurements differing from one another in wavefront direction and in tissue rate response associated with the cardiac activity, wherein each of the plurality of measurements includes activity data at each location in a common set of locations on an anatomy of a patient;
a processor configured to aggregate a plurality of the recorded potential data representing cardiac activity for a consistency analysis of the data, the consistency analysis employing conduction velocity data, the consistency analysis comparing conduction velocity data at each of the common set of locations across the plurality of measurements; and
a display configured to display to an operator a visualization of the consistency analysis.
For the following reasons, the Examiner submits that the above-identified additional limitations, when considered as a whole with the limitations reciting the at least one abstract idea, do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the system including the electrode, processor, and display, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application. Furthermore, looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 3 and analogous independent claim 12 do not recite additional elements that integrate the judicial exception into a practical application. Accordingly, representative independent claim 3 and analogous independent claim 12 are directed to at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
-In the event that performing anatomic data co-registration in claims 9 and 18 is not practically performable in the human mind with pen and paper, then the Examiner submits that these limitations amount to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)).
-In the event that performing conduction velocity aberration/divergence modeling in claims 10 and 19 is not practically performable in the human mind with pen and paper, then the Examiner submits that these limitations amount to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)).
When the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 1 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
As discussed above, the additional limitations of the system including the electrode, processor, and display amount to merely using a computer as a tool to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
-In the event that performing anatomic data co-registration in claims 9 and 18 is not practically performable in the human mind with pen and paper, then the Examiner submits that these limitations amount to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)).
-In the event that performing conduction velocity aberration/divergence modeling in claims 10 and 19 is not practically performable in the human mind with pen and paper, then the Examiner submits that these limitations amount to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)).
Therefore, claims 3, 6-12, and 15-19 are ineligible under 35 USC §101.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 3, 6, 7, 12, 16, and 17 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by U.S. Patent App. Pub. No. 2020/0121261 to Li et al. ("Li"):
Regarding claim 3, Li discloses a system for analysis of heart tissue (Figure 1), comprising:
an electrode configured to record a data set of electric potential data representing cardiac activity (electrodes 12-18, 21, 22, 52, 54, 56 in Figures 1-2 measure potentials/voltages in the heart per [0026], [0029]-[0030], [0034]-[0038], [0041] (data set of electric potential data representing cardiac activity) at a plurality of time intervals (Figure 4 and [0052]-[0056] shows/discusses how the data is recorded over time), the data set including a plurality of measurements ([0005] discloses a plurality of electrophysiology data points (data set including a plurality of measurements)), the plurality of measurements differing from one another in wavefront direction ([0047], [0067], and Figure 4 disclose/illustrate differing/varying activation wavefront directions) and in tissue rate response associated with the cardiac activity (it is known that the time between consecutive heartbeats varies over time (varying tissue rate response) due to autonomic neural regulation of the heart and the circulatory system (as evidenced by NPL "Heart rate variability: a review" to Acharya et al.)), wherein each of the plurality of measurements includes activity data at each location in a common set of locations on an anatomy of a patient ([0048] discloses analyzing EP data points within respective grid squares/regions of the heart (common set of locations); also, [0067] discusses analyzing EP data points in a "particular region" of the cardiac surface which amounts to activity data measurements at each location in a common set of locations);
a processor (processor 28 in Figure 1) configured to aggregate a plurality of the recorded potential data representing cardiac activity for a consistency analysis of the data, the consistency analysis employing conduction velocity data, the consistency analysis comparing conduction velocity data at each of the common set of locations across the plurality of measurements ([0048] discusses determining a magnitude/direction of a conduction velocity for a particular grid square (which is made up of a common set of locations as noted above) via interpolation of the conduction velocities at neighboring EP data points (aggregating data representing cardiac data for a consistency analysis via comparing conduction velocity data at each of the common set of locations across the measurements); also, [0067] discloses computing a spatial continuity index indicative of the consistency of the direction in which the activation wavefront is propagating from the conduction velocities of adjacent EP data points within a particular region of the cardiac surface (aggregating potential data representing cardiac data for a consistency analysis via comparing conduction velocity data at each of the common set of locations across the measurements)); and
a display configured to display to an operator a visualization of the consistency analysis ([0062] discloses graphically displaying the consistency analysis).
Regarding claim 6, Li discloses the system of claim 5, further including wherein the processor is configured to form a composite of conduction velocity data from the plurality of measurements at the common set of locations on a patient's anatomy ([0048] discusses determining a magnitude/direction of a conduction velocity for a particular grid square (which is made up of a common set of locations as noted above) via interpolation of the conduction velocities at neighboring EP data points (composite of conduction velocity data from plurality of measurements at common set of locations); also, [0067] discusses computation of a spatial continuity index from the conduction velocities of adjacent EP data points in a particular region (composite of conduction velocity data from plurality of measurements at common set of locations on patient's anatomy).
Regarding claim 7, Li discloses the system of claim 6, further including wherein the processor is configured to analyze composite conduction velocity data to delineate minimum, mean, maximum, or median conduction velocities ([0048] discusses determining a magnitude/direction of a conduction velocity for a particular grid square (which is made up of a common set of locations as noted above) via interpolation of the conduction velocities at neighboring EP data points (a mean conduction velocity for the grid square))
Claims 12, 15, and 16 are rejected in view of Li as respective discussed above in relation to claims 3, 6, and 7.
Claims 20 and 21 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by U.S. Patent App. Pub. No. 2019/0246930 to Zhu et al. ("Zhu"):
Regarding claim 20, Zhu discloses a system for treating tissue of a patient (Figures 1-5), the system comprising:
a first energy delivery device comprising a first energy delivery element configured to be positioned proximate target tissue of the patient (ablation catheter (first energy delivery device) includes ablation tip 514 (first energy delivery element) that delivers ablation energy to tissue per Figure 5 and [0230]; alternatively, the middle of [0209] discloses a plurality of auxiliary electrodes (first energy delivery device) for ablation purposes, one of which is a "first energy delivery element" and configured to be positioned proximate target tissue of the patient);
a second energy delivery element (another of auxiliary electrodes from the middle of [0209] is a "second energy delivery element"; additionally or alternatively, [0229] discloses how numerous ablation (energy delivering) devices can be received in lumen 108, one of which includes first energy delivery element and another of which includes a second energy delivery element);
an energy delivery console configured to provide energy between the first energy delivery element and the second energy delivery element (there is necessarily some "energy delivery console" that provides energy between the energy delivery elements; e.g., ablation system 510);
an electrode configured to record a data set of electric potential data representing cardiac activity at a plurality of time intervals (electrode(s) 12a record cardiac biopotential voltage data over time per [0190], [0209]; also, [0087] discloses recording sets of electric potential data representing cardiac activity at a plurality of time intervals), the data set including a plurality of measurements (the sets of electric potential data include "measurements" because they are obtained via one or more electrodes), the plurality of measurements differing from one another in wavefront direction ([0086] discloses variance in direction of wavefront propagation, [0304] discusses directional characteristics of activation patterns, and [0328] discloses multi-directional region of propagation) and in tissue rate response associated with the cardiac activity (it is known that the time between consecutive heartbeats varies over time (varying tissue rate response) due to autonomic neural regulation of the heart and the circulatory system (as evidenced by NPL "Heart rate variability: a review" to Acharya et al.)), wherein each of the plurality of measurements includes activity data at each location in a common set of locations on an anatomy of a patient ([0248] discusses how cardiac activation data can be obtained for different regions/chambers of the heart, where the locations in a particular region/chamber are part of a "common set of locations on an anatomy of a patient");
a processor (processor 26) configured to aggregate a plurality of the recorded potential data representing cardiac activity for a consistency analysis of the data, the consistency analysis employing conduction velocity data ([0313] discloses aggregating propagation direction and conduction velocity data to determine consistency of conduction characteristics that can be derived from the raw surface data), the consistency analysis comparing conduction velocity data at each of the common set of locations across the plurality of measurements (determining the consistency of conduction velocity per [0313] (which can be in relation to a particular region/chamber/common set of locations per [0248]) necessarily requires comparing the conduction velocities at the various locations in the region/chamber); and
a display configured to display to an operator a visualization of the consistency analysis ([0313] discloses graphically displaying the aggregated data as shown in Figure 13).
Regarding claim 21, Zhu discloses the system of claim 20, further including wherein the consistency analysis comprises forming a composite of conduction velocity data from the plurality of measurements at the common set of locations ([0248] discloses generating conduction velocity maps (composite of conduction velocity data) for each chamber (from multiple measurements at a common set of locations on the patient's anatomy)).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8-10, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2020/0121261 to Li et al. ("Li") in view of U.S. Patent App. Pub. No. 2019/0246930 to Zhu et al. ("Zhu") and U.S. Patent App. Pub. No. 2016/0270709 to Maccabee et al. ("Maccabee"):
Regarding claim 8, Li discloses the system of claim 7, but appears to be silent regarding wherein the processor is configured to employ a threshold to assess as abnormal any conduction velocity that falls below the threshold and to display a consistency map that displays areas with consistently abnormal, normal, or inconsistently abnormal.
Nevertheless, Zhu teaches ([0305]-[0306], [0313]) that it was known in the healthcare informatics art to calculate any conduction characteristics (which can be conduction velocity magnitude per [0248], [0309]) as a state index, compare the state index to a threshold, and display a graphical representation of a consistency of the conduction data over time (consistency map) which would advantageously allow medical professionals to monitor a patient's cardiac activity over time to facilitate identification of interesting cardiac events. Furthermore, Maccabee teaches ([0024]-[0026]) that it was known in the healthcare informatics art that conduction velocities below normal limits (below a threshold) can be described as slow and indicate axon derangement (abnormality) which would advantageously facilitate diagnoses of diagnostic abnormalities by medical professionals.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed a threshold to assess the conduction velocities of Li and display a consistency map/graphical representation that displays areas that are consistently below/above the threshold as taught by Zhu to advantageously allow medical professionals to monitor a patient's cardiac activity over time to facilitate identification of interesting cardiac events. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for conduction velocities below the threshold in the Li/Zhu combination to specifically indicate an "abnormal" conduction velocity as taught by Maccabee (such that the displayed consistency map displays areas with "consistently abnormal, normal, or inconsistently abnormal") to advantageously facilitate diagnoses of diagnostic abnormalities by medical professionals. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 9, the Li/Zhu/Maccabee combination discloses the system of claim 8, further including wherein the processor is configured to perform anatomic data co-registration (Figure 4 of Li discloses cardiac conduction velocity data 402 being superimposed over corresponding portions of cardiac model 404 (anatomic data co-registration)).
Regarding claim 10, the Li/Zhu/Maccabee combination discloses the system of claim 9, further including wherein the processor is configured to perform conduction velocity aberration/divergence modeling ([0086] of Zhu discloses graphically representing continuous lines following the directional pattern of the wave front, with highlighting of areas of congestion and convergence; directional dispersion (aberration/divergence) as a variance in direction of propagation; and/or angular velocity; furthermore, [0308] of Zhu discloses how after all time samples during the duration of cardiac activity have been included, a set of continuous and/or semi-continuous lines can be traced across the surface, providing the user with advanced information about regions of convergence and regions of divergence, regions of reentry or repetition, as well as regions of block that inhibit advancement of the active wave front while [0309] discloses how the cardiac activation (wavefront) data represents conduction velocity; therefore, the "aberration/divergence modeling" of Zhu is related to conduction velocity which advantageously provides medical professionals with information to help to identify potential sources of electrical instability, like those found in cardiac arrhythmias and the like; therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed conduction velocity aberration/divergence modeling in the system of the Li/Zhu/Maccabee combination as taught by Zhu to advantageously provide medical professionals with information to help to identify potential sources of electrical instability, like those found in cardiac arrhythmias and the like; A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.).
Claims 17 and 18 are rejected in view of the Li/Zhu/Maccabee combination as respectively discussed above in relation to claims 8 and 9.
Claims 11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2020/0121261 to Li et al. ("Li") in view of U.S. Patent App. Pub. No. 2019/0246930 to Zhu et al. ("Zhu") and U.S. Patent App. Pub. No. 2016/0270709 to Maccabee et al. ("Maccabee"), and further in view of NPL "Conduction Velocity Restitution of the Human Atrium—An Efficient Measurement Protocol for Clinical Electrophysiological Studies" to Weber et al. ("Weber"):
Regarding claim 11, the Li/Zhu/Maccabee combination discloses the system of claim 10 but appears to be silent regarding wherein the processor is configured to determine a restitution score whereby the conduction velocity at a range of sites across varying pacing rates is analyzed.
Nevertheless, Weber teaches (Abstract) that it was known in the healthcare informatics art to measure conduction velocity (CV) restitution via analyzing CV at different pacing rates and locations/sites (e.g., see various sites in Table II) to advantageously facilitate understanding of atrial arrhythmias.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have determined a restitution score whereby the conduction velocity at a range of sites across varying pacing rates is analyzed in the system of the Li/Zhu/Maccabee combination as taught by Weber to advantageously facilitate understanding of atrial arrhythmias. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claim 19 is rejected in view of the Li/Zhu/Maccabee/Weber combination as discussed above in relation to claims 10 and 11.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2019/0246930 to Zhu et al. ("Zhu") in view of U.S. Patent App. Pub. No. 2016/0270709 to Maccabee et al. ("Maccabee") and NPL "Conduction Velocity Restitution of the Human Atrium—An Efficient Measurement Protocol for Clinical Electrophysiological Studies" to Weber et al. ("Weber"):
Regarding claim 22, Zhu discloses the system of claim 21, further including
wherein the processor is configured to analyze composite conduction velocity data to delineate minimum, mean, maximum, or median conduction velocities ([0086] discloses max/min conduction velocity);
the processor is configured to employ a threshold to assess …any conduction velocity [relative to] the threshold and to display a consistency map that displays areas with consistently, …, or inconsistently … ([0305]-[0306], [0313] discloses calculating any conduction characteristics (which can be conduction velocity magnitude per [0248], [0309]) as a state index, comparing the state index to a threshold, and displaying a graphical representation of a consistency of the conduction data over time (consistency map);
the processor is configured to perform conduction velocity aberration/divergence modeling ([0086] discloses graphically representing continuous lines following the directional pattern of the wave front, with highlighting of areas of congestion and convergence; directional dispersion (aberration/divergence) as a variance in direction of propagation; and/or angular velocity; furthermore, [0308] discloses how after all time samples during the duration of cardiac activity have been included, a set of continuous and/or semi-continuous lines can be traced across the surface, providing the user with advanced information about regions of convergence and regions of divergence, regions of reentry or repetition, as well as regions of block that inhibit advancement of the active wave front while [0309] discloses how the cardiac activation (wavefront) data represents conduction velocity; therefore, the "aberration/divergence modeling" is related to conduction velocity); and
…
However, Zhu appears to be silent regarding a conduction velocity falling below the threshold specifically representing an abnormal condition, such that the consistency map displays areas with consistently abnormal, normal, or inconsistently abnormal.
Nevertheless, Maccabee teaches ([0024]-[0026]) that it was known in the healthcare informatics art that conduction velocities below normal limits (below a threshold) can be described as slow and indicate axon derangement (abnormality) which would advantageously facilitate diagnoses of diagnostic abnormalities by medical professionals.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for conduction velocities below the threshold in the system of Zhu to specifically indicate an "abnormal" conduction velocity as taught by Maccabee (such that the displayed consistency map displays areas with "consistently abnormal, normal, or inconsistently abnormal") to advantageously facilitate diagnoses of diagnostic abnormalities by medical professionals. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Furthermore, the Zhu/Maccabee combination appears to be silent regarding the processor is configured to determine a restitution score whereby the conduction velocity at a range of sites across varying pacing rates is analyzed.
Nevertheless, Weber teaches (Abstract) that it was known in the healthcare informatics art to measure conduction velocity (CV) restitution via analyzing CV at different pacing rates and locations/sites (e.g., see various sites in Table II) to advantageously facilitate understanding of atrial arrhythmias.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have determined a restitution score whereby the conduction velocity at a range of sites across varying pacing rates is analyzed in the system of the Zhu/Maccabee combination as taught by Weber to advantageously facilitate understanding of atrial arrhythmias. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
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