DETAILED ACTION
The Examiner acknowledges the amendments received 21 April 2025. Claims 1-16 are pending.
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 .
Specification
In view of the amendments received 21 April 2025, the Examiner withdraws the objection to the Abstract.
Claim Objections
In view of the amendments received 21 April 2025, the Examiner withdraws the objection to claims 1 and 9.
Claim Interpretation
In lines 7-8 of claim 1 and lines 8-9 of claim 9, claim limitation of “early meet late (EML) LAT range” is a term not known in the art. Based on pg. 4, last par. and pg. 5, par. 1 of the specification, Examiner interprets this limitation to refer to the wave propagation, where a "late" wavefront in the cycle meets the "early" wavefront of the next cycle, which are incorrect local activation times (LATS) that are either very short or very long.
In line 10 of claim 1 and line 12 of claim 9, claim limitation of “different EML areas” is a term not known in the art. Based on pg. 5, par. 2 of the specification, Examiner interprets this limitation to refer to potential areas of conduction block.
In line 14 of claim 1, lines 1-2 of claim 6, line 16 of claim 9, and line 2 of claim 14, claim limitation of “generating complex tags” is a term not known in the art. Examiner interprets this limitation to refer to the following:
-“wherein generating the complex tags (218) comprises annotating electrograms at fractioned regions, and extracting LAT values using the annotated electrograms” (Specification, pg. 15, In 18-21).
-“An algorithm that places complex tags at tissue locations according to magnitude of fractionations (indicative of stable arrhythmia) is described in U.S. Patent Application No. 17/548,558, titled, "Detection of Fractionated Signals in stable arrhythmias,” (Specification, pg.6, par. 1). (Application no. 17/548,558 corresponds to Ravuna et al. (US 2023/0181086 A1) (hereinafter "Ravuna")).
“Representing fractionation windows as triangles between 0 and 1, to facilitate identification of a shift in timing of the fractionation” (Ravuna, par. [0034]).
“Representing fractionation windows as rectangles between -1 and 1, to obtain a quick measure of the similarity between beats (speeding up CPU calculations)” (Ravuna, par. [0035]).
In line 3 of claim 6 and line 3 of claim 14, claim limitation of “fractioned regions” is a term not known in the art. Examiner interprets this limitation according to the following:
- “An algorithm that places complex tags at tissue locations according to magnitude of fractionations (indicative of stable arrhythmia) is described in U.S. Patent Application No. 17/548,558, titled, "Detection of Fractionated Signals in stable arrhythmias,” (Specification, pg. 6, par. 1). (Application no. 17/548,558 corresponds to Ravuna et al. (US 2023/0181086 A1) (hereinafter "Ravuna")).
“Electrograms that are fractionated (e.g., comprising irregular patterns such as burst of highly rapid deflections of the EGM) can be classified into two major types” (Ravuna, par. [0017]). Some show not characteristic cycle time while others show a nearly characteristic cycle time between episodes of signal fractionation (Ravuna, par. [0017]).
“The longer the fractionation, the higher the chance of the fractionation being indicative of arrhythmogenic tissue” (Ravuna, par. [0022]). “If the timing of fractionation occurrence, T, occurs in a mid-diastolic region of the cardiac cycle, it is also likely to be highly indicative of arrhythmogenic tissue” (Ravuna, par. [0022]).
“For each given EP signal, the algorithm returns a fractionation score” (Ravuna, par. [0048]). Between 0 (low) to 10 (high) (Ravuna, par. [0048]).
“Rationale for using the extended WOI is that mid-diastolic fractionations, which are clinically relevant, may be present in the middle of two consecutive WOIs. Namely, the fractionation starts before the end of one WOI and continues after the start of the next consecutive WOI. The extended WOI helps detect these fractionations by allowing a fractionation to end after the nominal WOI” (Ravuna, par. [0059]).
Claim Rejections - 35 USC § 112
In view of the amendments received 21 April 2025, the Examiner withdraws the rejection of claims 1-16 under 35 USC 112(b)/35 USC 112, second paragraph.
Claim Rejections - 35 USC § 101
In view of the amendments received 21 April 2025, the Examiner withdraws the rejection of claims 1-16 under 35 USC 101. However, new rejections under 35 USC 101 are presented below, in view of the amendments.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 9-16 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 9 requires “a catheter placed within the cardiac chamber” in lines 7-8. This limitation implicitly claims the human body as part of the inventive system. The claims should be amended to include “configured to” (“adapted to”, etc.) language to preclude this interpretation.
Response to Arguments
Applicant's arguments filed 21 April 2025 have been fully considered but they are not persuasive. The amendments to the claims will be addressed in the prior art rejections below. However, the Applicant additionally argues (pages 12-13, “Remarks”) various features lacking in Zhu, Bar-Tal, Rottman, and Haeusser.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-6, 9, and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (US 2022/0202338 A1 with PCT filing date 04/17/2020) (hereinafter "Zhu") in view of Bar-Tal et al. (US 2016/0045123 Al) (hereinafter "Bar-Tal").
Regarding claims 1 and 9, Zhu teaches a method/system for identifying candidate locations for ablation ("In particular, FIGS. 8A through 8C illustrate conduction isthmus visualization that may be provided by a system and method in accordance with principles of inventive concepts, for example, to aid a physician in a cardiac ablation procedure to treat or terminate an arrhythmia" (Zhu, par. [0172]).), the
method/system comprising:
-an interface (In Fig. 1 of Zhu, console 5000) configured receive ("Biopotential module 5020, localization module 5030, and anatomy module 5040 can each be configured to receive data from a plurality of different external functional elements (e.g. functional elements of one or more catheters 1000), process the received data, and generate outputs, such as generated information shown on one or more displays of system 10" (Zhu, par. [0107]). "In some embodiments, outputs generated by biopotential module 5020, localization module 5030, and/or anatomy module 5040 are received as data inputs to processor 5050 and/or other modules of console 5000" (Zhu, par. [0108]).).
-a processor (In Fig. 1 of Zhu, processor 5050), which is configured to:
-identify a set of shortest paths on the anatomical surface between different EML areas (See par. [0182]-[0183] of Zhu, which describes steps involved when employing Auto Path. "Shortest-path algorithms may be used to find candidate reentrant pathways and those candidate pathways may then be further evaluated to determine whether the pathways maintain normal physiological conduction" (Zhu, par. [0183]). "Reentry can be defined as an abnormal electrical impulse that continually self-sustains, instead of dying out, dissipating, or collapsing by colliding with unexcitable tissue" (Zhu, par. [0182]).);
-select one or more ranges of LAT values that are characterized by lowest prevalence over the data points of the EP map; generate complex tags for the positions having the LAT values within the one or more ranges of LAT values having the lowest prevalence (See labels A and B in Fig. 8A and par. [0176] of Zhu, which describes steps involved when employing Active Area Plots.
"In the lower half of FIG. 8A, labeled B, an AA plot shows the amount of depolarization tissue at each moment during the AT cycle length. A shaded vertical band overlay 802 highlights the valley in the AA plot" (Zhu, par. [0176]). Based on this description, shaded vertical band (in label B of Fig. 8A) corresponds to the range(s) of LAT values selected. "The highlighted area in the 3D map corresponds to the valley in the AA plot, shown in the shaded overlay" (Zhu, par. [0176]). Based on this description, highlighted area (in label A of Fig. 8A) corresponds to generated complex tags.
-It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the steps of employing Active Area Plots with the steps of employing Auto Path since Zhu expressly recites "a system in accordance with principles of inventive concepts may employ any one of, or any combination of, active area plots, streamline plots, or Auto Path plots" (Zhu, par. [0172]).);
-select a subset of the shortest paths based on
a direction of the activation wave velocity vectors relative to each of the shortest paths and (See par. [0183]-[0184] of Zhu, which describe steps involved when employing Auto Path. "Shortest-path algorithms may be used to find candidate reentrant pathways" (Zhu, par. [0183]). Candidate pathways between two vertices can be found by minimizing the sum of edgeweights to travel between the two vertices because more physiological conduction will have lower edgeweights" (Zhu, par. [0184]).
"The edgeweights between adjacent vertices may be constructed based on the angle between the conduction velocity and the distance vector between the two adjacent nodes, as well as the LAT time difference between the adjacent nodes" (Zhu, par. [0184]).
Based on the description, the shortest path is found by minimizing the sum of edgeweights, which takes into account the angle between conduction velocity and distance vector between adjacent nodes.
a density of the complex tags along the shortest paths
(Although the present embodiment of Auto Path does not describe selecting a subset of shortest paths based on (i) density of the complex tags along the shortest paths, embodiment of Active Area Plots describes "[t]he highlighted area in the 3D map corresponds to the valley in the AA plot, shown in the shaded overlay" (Zhu, Fig. 8A, par. [0176]). Based on this description of par. [0176], highlighted area (in label A of Fig. 8A) corresponds to generated complex tags.
-It would be obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to include "highlight[ing] area in the 3D map"
(Zhu, par. [0176]) of Active Area Plots in the shortest path determination of Auto
Path since Zhu expressly recites "a system in accordance with principles of
inventive concepts may employ any one of, or any combination of, active area
plots, streamline plots, or AutPath plots" (Zhu, par. [0172]), and furthermore, in
order to aid a physician in locating where the critical isthmus is located (Zhu, par.
[0172]).); and
-presenting the selected subset of the shortest paths as candidate slow-conduction areas for ablation ("Once the pathways are found, one or more of the pathways can be displayed on, or in conjunction with, the anatomy" (Zhu, par. [0199]). Also, see par. [0172] of Zhu.).
However, Zhu does not expressly teach receive an electrophysiological (EP) map comprising an anatomical surface of a cardiac chamber overlaid with (i) activation wave velocity vectors, (ii) data points comprising positions on the surface and respective local activation times (LAT), and (iii) areas designated by early meet late (EML) LAT range, the EP map being generated based on EP signals received from one or more electrodes located at a distal end of a catheter placed within the cardiac chamber.
Bar-Tal teaches "cardiac catheterization is performed by recording electrograms from a multi-electrode probe at respective locations in the heart, determining slopes and annotations in the
electrograms within time windows, establishing relationships among the slopes and annotations of the electrograms, and determining lines of conduction block in the heart from the relationships" (Bar-Tal, Abstract). Bar-Tal further teaches receive an electrophysiological (EP) map (See par. [0180] and Fig. 26 of Bar-Tal.) comprising an anatomical surface (In Fig. 26, see maps 247, 249.) of a cardiac chamber overlaid with (i) activation wave velocity vectors (In par. [0180], conduction velocity map), (ii) data points comprising positions on the surface and respective local activation times (LAT) (In par. [0180], activation map and matrix.), and (iii) areas designated by early meet late (EML) LAT range (In Fig. 26, see lines of block indicated by dots 243, 245.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the electroanatomic map and matrices of Bar-Tal in the invention of Zhu in order to aid the physician in identifying and diagnosing abnormalities, such as ventricular and atrial tachycardia and ventricular and atrial fibrillation, which result from areas of impaired electrical propagation in the heart tissue (Bar-Tal, par. [0011]).
Regarding claims 3 and 11, Zhu in view of Bar-Tal teaches the invention of claims 1 and 9, and further teaches wherein selecting the subset of the shortest paths comprises filtering out a path longer than a predefined path length ("i. [r]emove candidatePaths that do not meet some conditions (e.g., has a minimum path length, contains minimum cycle length, maintains conduction velocities within
physiological ranges) to form a set of confirmedReentrantPaths" (Zhu, par. [0195]).
Regarding claims 4 and 12, Zhu in view of Bar-Tal teaches the invention of claims 1 and 9, and further teaches wherein receiving the EP map with the areas designated by early meet late (EML) LAT range comprises receiving areas bound by a curve of blocked conduction (See par. [0180] and Fig. 26 of Bar-Tal. "[R]eceive an electrical signal from the electrodes and configured for recording electrograms
from the electrodes at respective locations in the heart, and determining from the relationships lines of conduction block in the heart" (Bar-Tal, par. [0022]). Based on these description of Bar-Tal, electrical data can contain information about relationship
lines of conduction block in the heart.).
Regarding claims 5 and 13, Zhu in view of Bar-Tal teaches the invention of claims 1 and 9, and further teaches wherein selecting the shortest paths based on the direction of the activation wave velocity vectors comprises filtering out a path for which the activation wave velocity vectors are parallel to a tangent to the path, up to a predetermined angular tolerance ("Remove candidatePaths that do not
meet some conditions (e.g., has a minimum path length, contains minimum cycle length, maintains conduction velocities within physiological ranges) to form a set of confirmedReentrantPaths" (Zhu, par. [0195]). When candidatePath has conduction velocities that are not within physiological ranges, that candidatePath gets removed.).
Regarding claims 6 and 14, Zhu in view of Bar-Tal teaches the invention of claims 1 and 9, and further teaches wherein generating the complex tags comprises annotating electrograms at fractioned regions, and extracting LAT values using the annotated electrograms ("FIG. 8A shows an example of an AA plot. In example embodiments, computed activation times from electrograms are directly used in computing the depolarized tissue area, employing charge density or unipolar voltage directly. The method shown here is similar to the method described in Automatic Identification of Reentry Mechanisms and Critical Sites during Atrial Tachycardia by
Analyzing Arcas of Activity, IEEE Trans. Biomed. Eng., no. February, 2018, T.G. Oesterlein, A. which is hereby incorporated by reference" (Zhu, par. [0175]). In par. 2 of the Section titled "2) Preprocessing" in Oesterlein et al., "QRS complexes were annotated based on the wavelet transform [23]". In par. 2 of the Section titled "3) Detection of Atrial Activity" in Oesterlein et al., "[e]specially in case of fractionation, annotation of the activity is more representative than common LAT annotation."
-"In the upper half of the figure, labeled A, is a local activation time (LAT) map with a stream line (SL) indicating the flow of conduction. The highlighted area in the 3D map corresponds to the valley in the AA plot, shown in the shaded overlay" (Zhu, par. [0176]). Based on the description, Oesterlein teaches annotating electrograms and Zhu teaches extracting LAT values by using the annotated electrograms.).
Regarding claims 8 and 16, Zhu in view of Bar-Tal teaches the invention of claims 1 and 9, and further teaches wherein the cardiac chamber is a ventricle exhibiting ventricular tachycardia ("Mapping the activation front and conduction fields aids the physician in identifying and diagnosing abnormalities, such as ventricular and atrial tachycardia" (Bar-Tal, par. [0011]).).
Claims 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu (US 2022/0202338 A1) in view of Bar-Tal (US 2016/0045123 A1) as applied to claims 1 and 9, and further in view of Rottman et al. (US 2022/0142551 Al filed 11/08/2021) (hereinafter "Rottman"). Zhu in view of Bar-Tal teaches the invention of claims 1 and 9, but does not expressly teach select the one or more ranges of the LAT values comprises selecting one or more LAT bins of a LAT histogram. Rottman teaches "[t]he processor is further configured to identify an atrial fibrillation driver based at least in part on the one or more activation time maps" (Rottman, par. [0005]), and teaches I/O
system 1320 and processor 1305 of Fig. 13. Rottman additionally teaches the polygon reentry model (Rottman, par. [0050]-[0051]). Rottman further teaches select the one or more ranges of the LAT values comprises selecting one or more LAT bins of a LAT histogram (See Fig. 4A of Rottman shows a histogram of location activation time values, and later Fig. 4B of Rottman shows the selected trajectories and LAT of the earliest and latest activation delay.).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the selection of earliest and latest activation time and indicators of Rottman in the invention of Bar-Tal, as modified thus far, in order to optimize AF treatment strategies and improve the accuracy of atrial fibrillation driver detections (Rottman, par. [0053]).
Claims 7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu (US 2022/0202338 A1) in view of Bar-Tal (US 2016/0045123 A1), as applied to claims 1 and 9 above, and further in view of Haeusser et al. (US 2022/0400951 A1 filed 01/09/2022) (hereinafter "Haeusser"). Zhu in view of Bar-Tal teaches the invention of claims 1 and 9. Bar-Tal teaches wherein the cardiac chamber is an atrium ("The procedures described herein detects atrial waves delineated by lines of block" (Bar-Tal, par. [0096]).), but does not expressly teach the atrium is exhibiting an atrial flutter.
Haeusser teaches "detect[ing] at least one location or type of at least one source of, or rotational phenomenon associated with, at least one cardiac rhythm disorder using intracardiac electrodes and a modified multi-frame Horn-Schunck algorithm to generate a map corresponding to a spatial map, the map being configured to reveal on a monitor or display to a user the at least one location of the at least one source of the at least one cardiac rhythm disorder" (Haeusser, Abstract). Haeusser further teaches
wherein the cardiac chamber is an atrium ("FIG. 2 shows an illustrative view of one embodiment of a distal portion of catheter 110 inside a patient's left atrium 14" (Haeusser, par. [0040]).) and the atrium is exhibiting an atrial flutter ("Various embodiments described and disclosed herein also relate to systems, devices, components and methods for discovering with enhanced precision the location(s) of the
source(s) of different types of cardiac rhythm disorders and irregularities. Such cardiac rhythm disorders and irregularities, include, but are not limited to, arrhythmias, atrial fibrillation (AF or A-fib), atrial tachycardia, atrial flutter" (Haeusser, par. [0091]).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the type of heart data of Haeusser in the invention of Zhu, as modified thus far, in order to "enable cardiac ablation procedures to be carried out with greater locational precision, and would result in higher rates of success in treating cardiac rhythm disorders such as AF" (Haeusser, par.
[0030]).
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 DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
Prosecution Insights