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 are pending in the present application with claims 1, 12, and 20 being independent, as set forth in the Preliminary Amendment dated October 18, 2024.
Claim Objections
Claim 20 is objected to because of the following informalities:
In claim 20, line 3, "targe" should be changed to --target--.
In claim 20, line 6, "a second" should be changed to --the second--.
Appropriate correction is required.
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 3-19 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 3-11 are directed to a system (i.e., a machine) and claims 12-19 are directed to a method (i.e., a process). Accordingly, claims 3-19 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;
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; 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), employ conduction velocity data (e.g., percentage change, normalized values, etc.) regarding recorded potential data representing cardiac activity 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 4 and 13 recite how the electric potential data includes measurements taken varying the wavefront direction and tissue rate response associated with the cardiac activity which just further defines the "mental processes" abstract idea discussed above.
-Claims 5 and 14 recite how each measurement is activity data at a common set of locations on the anatomy which just further defines the "mental processes" abstract idea discussed above.
-Claims 6 and 15 call for forming a composite (e.g., aggregate) of conduction velocity data from multiple measurements at a 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;
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; 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 1 and analogous independent claim 12 do not recite additional elements that integrate the judicial exception into a practical application. Accordingly, representative independent claim 1 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 3-19 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 3-7 and 12-16 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);
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 ([0009], [0051], [0055], [0056] discuss computing a composite (aggregate) conductive velocity for an EP data point based on conduction velocity constituents from neighboring data points, where each conductive velocity is computed from respective EP data points per [0045]; accordingly, aggregation of the conduction velocities is necessarily an aggregation of the recorded potential data; furthermore, [0010], [0057]-[0061] discuss computing a conduction velocity consistency index based on a degree of consistency of the conduction velocity constituents); and
a display configured to display to an operator a visualization of the consistency analysis ([0062] discloses graphically displaying the conduction velocity consistency index).
Regarding claim 4, Li discloses the system of claim 3, further including wherein the electric potential data includes measurements taken varying the wavefront direction and tissue rate response associated with the cardiac activity ([0047], [0067], and Figure 4 disclose/illustrate differing/varying activation wavefront directions while 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.)).
Regarding claim 5, Li discloses the system of claim 4, further including wherein each measurement is activity data at a common set of locations on the anatomy (the neighboring data points per [0009], [0051], [0045], [0055], [0056] are a "common set of locations on the anatomy" because they are all neighboring to the selected EP data point; accordingly, as each EP data point is processed, there is another "common set of locations" on the anatomy).
Regarding claim 6, Li discloses the system of claim 5, further including the processor is configured to form a composite of conduction velocity data from multiple measurements at a common set of locations on a patient's anatomy ([0009], [0051], [0055], [0056] discuss computing a composite (aggregate) conductive velocity for an EP data point based on conduction velocity constituents from neighboring data points (common set of locations on the 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 ([0056] discloses computing the mean of the conduction velocity constituents).
Claims 12-16 are rejected in view of Li as respective discussed above in relation to claims 3-7.
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 targe 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]);
a second energy delivery element (ground patch 516 which is known to disperse heat energy generated by tip and thus amounts to a "second energy delivery element");
an energy delivery console configured to provide energy between the first energy delivery element and a second energy delivery element (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]);
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); 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 electric potential data includes measurements taken varying the wavefront direction ([0248] discloses maps with direction of propagation such as multi-directional activation) and 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.))), each measurement is activity data at a common set of locations on the anatomy ([0248] discloses identification of patterns/cardiac characteristics for different regions where each region can be for instance a chamber; accordingly, the activity measurements for a particular chamber are part of a common location), and the processor is configured to form a composite of conduction velocity data from multiple measurements at a common set of locations on a patient's anatomy ([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 graphical representation 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 are 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The remaining references on the attached PTO-892 generally discuss analyzing cardiac electrical conduction data in various manners to facilitate diagnosis of abnormalities such as arrhythmias and the like.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHON A. SZUMNY whose telephone number is (303) 297-4376. The examiner can normally be reached Monday-Friday 7-5.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686