DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Terminal Disclaimer
The terminal disclaimers filed on 1/23/2026 are not proper, please see the Terminal Disclaimer Decision from 2/14/2026. The denial is due to the person who signed the TD’s is not listed as an attorney. The TD decision is included. It is suggested that once this is corrected an after final is filed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 9-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-8 of U.S. Patent No. 11,793,442. Although the claims at issue are not identical, they are not patentably distinct from each other. Common subject matter is underlined.
18/469,968
11,793,442
Claim 9:
An electroanatomical mapping system for mapping arrhythmic foci, comprising: a focus mapping module configured to: receive, from each electrode of a clique of three or more electrodes carried by a multi-dimensional electrophysiology catheter, a respective unipolar electrogram signal; compute, from the respective unipolar electrogram signals, an average unipolar voltage for the clique of three or more electrodes; compute a maximum bipolar voltage for the clique of three or more electrodes; and compute a focus score for the clique of three or more electrodes using a ratio of the computed average unipolar voltage for the clique of three or more electrodes to the identified maximum bipolar voltage for the clique of three or more electrodes.
Claim 8:
An electroanatomical mapping system for mapping arrhythmic foci, comprising: a focus mapping module configured: to receive as input an electrophysiology data point collected via a multi-dimensional catheter; to identify a clique of three or more electrodes carried by the multi-dimensional catheter; to identify a maximum bipolar voltage for the clique of three or more electrodes; to compute an average unipolar voltage for the clique of three or more electrodes; and to compute a focus score using a ratio of the computed average unipolar voltage for the clique of three electrodes to the identified maximum bipolar voltage for the clique of three or more electrodes.
Claim 1:
A method of mapping arrhythmic foci using electrophysiological measurements made by a multi-dimensional catheter, the method comprising: for a location in a patient's heart at which an electrophysiology data point is collected using the multi-dimensional catheter: identifying a clique of three or more electrodes carried by the multi-dimensional catheter; identifying a maximum bipolar voltage for the clique of three or more electrodes; computing an average unipolar voltage for the clique of three or more electrodes; and computing a focus score using a ratio of the computed average unipolar voltage for the clique of three electrodes to the identified maximum bipolar voltage for the clique of three or more electrodes.
Claim 10:
The electroanatomical mapping system according to claim 9, wherein the average unipolar voltage for the clique of three or more electrodes comprises an average peak-to-peak voltage for the clique of three or more electrodes.
Claim 2:
The method according to claim 1, wherein computing an average unipolar voltage for the clique of three or more electrodes comprises computing an average peak-to-peak voltage for the clique of three or more electrodes.
Claim 11:
The electroanatomical mapping system according to claim 9, wherein the average unipolar voltage for the clique of three or more electrodes comprises an average peak-negative voltage for the clique of three or more electrodes.
Claim 3:
The method according to claim 1, wherein computing an average unipolar voltage for the clique of three or more electrodes comprises computing an average peak-negative voltage for the clique of three or more electrodes.
Claim 12:
The electroanatomical mapping system according to claim 9, wherein the focus mapping module is further configured to: identify a location in a patient’s heart corresponding to a location of the clique of three or more electrodes; and define the location in the patient’s heart as a focal source when the focus score exceeds a preset threshold.
Claim 4:
The method according to claim 1, further comprising identifying the location in the patient's heart at which the electrophysiology data point is collected as a focal source when the focus score exceeds a preset threshold.
Claim 13:
The electroanatomical mapping system according to claim 9, wherein the focus mapping module is further configured to output a graphical representation of the focus score on a three-dimensional anatomical model of a patient’s heart.
Claim 6:
The method according to claim 5, further comprising outputting a graphical representation of the focus score map on a three-dimensional anatomical model.
Claim 14:
The electroanatomical mapping system according to claim 9, wherein the clique of three or more electrodes comprises a clique of four electrodes.
Claim 7:
The method according to claim 1, wherein identifying a clique of three or more electrodes carried by the multi-dimensional catheter comprises identifying a clique of four electrodes carried by the multi-dimensional catheter.
Claims 15-22 and 24-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-12 of U.S. Patent No. 11,134,879. Although the claims at issue are not identical, they are not patentably distinct from each other. Common subject matter is underlined.
18/469,968
11,134,879
Claim 15:
An electroanatomical mapping system for mapping arrhythmic foci, comprising: a focus mapping module configured to: receive as input a plurality of cardiac electrophysiology data points; and compute a focus score at a location in a patient’s heart at which a selected cardiac electrophysiology data point of the plurality of cardiac electrophysiology data points was collected by: defining an evaluation region about the location in the patient’s heart, the evaluation region encompassing a plurality of rods, wherein each rod of the plurality of rods is defined by a maximum amplitude bipole axis of a respective E-field loop; and computing the focus score according to rod orientation consistency within the evaluation region.
Claim 16:
The electroanatomical mapping system according to claim 15, wherein the focus mapping module is further configured to output a graphical representation of the focus score on a three-dimensional anatomical model of the patient’s heart.
Claim 17:
The electroanatomical mapping system according to claim 15, wherein the focus mapping module is further configured to compute a rod orientation confidence score for the evaluation region, and wherein the focus mapping module only computes the focus score at the location in the patient’s heart when the rod orientation confidence score for the evaluation region exceeds a preset rod orientation confidence threshold.
Claim 12:
An electroanatomical mapping system for mapping arrhythmic foci, comprising: a focus mapping module configured to: receive as input a plurality of electrophysiology data points collected via a multi-dimensional catheter at a respective plurality of locations in a patient's heart; to generate a focus score map by, for each electrophysiology data point collected at a respective location in the patient's heart: defining an evaluation region about the location in the patient's heart, the evaluation region encompassing a plurality of rods, wherein each rod of the plurality of rods is associated with a respective E-field loop having a respective maximum amplitude bipole axis and a respective minimum amplitude bipole axis, and wherein the rod is defined using the respective maximum amplitude bipole axis of the E-field loop; computing a rod orientation confidence score for the evaluation region; and when the rod orientation confidence score exceeds a preset rod orientation confidence threshold, computing a focus score for the evaluation region, wherein the focus score is indicative of rod orientation consistency within the evaluation region; and to output a graphical representation of the focus score map on a three-dimensional anatomical model.
Claims 1:
A method of mapping arrhythmic foci using electrophysiological measurements made by a multi-dimensional catheter, the method comprising: generating a focus score map by, for each location of a plurality of locations in a patient's heart at which an electrophysiology data point is collected using the multi-dimensional catheter: defining an evaluation region about the location in the patient's heart, the evaluation region encompassing a plurality of rods, wherein each rod of the plurality of rods is associated with a respective E-field loop having a respective maximum amplitude bipole axis and a respective minimum amplitude bipole axis, and wherein the rod is defined using the respective maximum amplitude bipole axis of the E-field loop; computing a rod orientation confidence score for the evaluation region; and when the rod orientation confidence score exceeds a preset rod orientation confidence threshold, computing a focus score for the evaluation region, wherein the focus score is indicative of rod orientation consistency within the evaluation region; and outputting a graphical representation of the focus score map on a three-dimensional anatomical model.
Claim 22:
The electroanatomical mapping system according to claim 15, wherein the evaluation region comprises a spherical region about the location in the patient’s heart.
Claim 2:
The method according to claim 1, wherein the step of defining an evaluation region about the location in the patient's heart comprises defining a spherical region about the location in the patient's heart.
Claim 18:
The electroanatomical mapping system according to claim 17, wherein the rod orientation confidence score for the evaluation region is computed using a subset of the plurality of rods having respective maximum amplitude bipole axis that exceed a preset threshold magnitude.
Claim 4:
The method according to claim 1, wherein the step of computing a rod orientation confidence score for the evaluation region comprises identifying a subset of the plurality of rods having associated respective maximum amplitude bipole axes that exceed a preset threshold magnitude.
Claim 19:
The electroanatomical mapping system according to claim 18, wherein the preset threshold magnitude is defined with reference to an electrogram noise floor.
Claim 5:
The method according to claim 4, wherein the preset threshold magnitude is defined with reference to an electrogram noise floor.
Claim 20:
The electroanatomical mapping system according to claim 19, wherein the preset threshold magnitude comprises twice the electrogram noise floor.
Claim 6:
The method according to claim 5, wherein the preset threshold magnitude comprises twice the electrogram noise floor.
Claim 21:
The electroanatomical mapping system according to claim 17, wherein the rod orientation confidence score for the evaluation region is computed using a subset of the plurality of rods having respective E-field loop eccentricities that exceeds a preset eccentricity threshold.
Claim 7:
The method according to claim 1, wherein the step of computing a rod orientation confidence score for the evaluation region comprises identifying a subset of the plurality of rods having associated respective E-field loop eccentricities in excess of a preset eccentricity threshold.
Claim 24:
The electroanatomical mapping system according to claim 15, wherein the focus score is computed by conducting a principal component analysis of antipodal points of the plurality of rods.
Claim 8:
The method according to claim 1, wherein the step of computing a focus score for the evaluation region comprises conducting a principal component analysis of antipodal points of the plurality of rods.
Claim 25:
The electroanatomical mapping system according to claim 15, wherein the focus score is computed by computing a mean pairwise dot product for the plurality of rods.
Claim 9:
The method according to claim 1, wherein the step of computing a focus score for the evaluation region comprises computing a mean pairwise dot product for the plurality of rods.
Claim 26:
The electroanatomical mapping system according to claim 15, wherein the focus score is computed by the electroanatomical mapping system: defining a plurality of directions; for each direction of the plurality of directions, computing a mean dot product of a plurality of dot products computed between (1) each rod of the plurality of rods and (2) a unit vector in the respective direction; and identifying a direction of the plurality of directions having a greatest computed mean dot product.
Claim 10:
The method according to claim 1, wherein the step of computing a focus score for the evaluation region comprises: defining a plurality of directions; for each direction of the plurality of directions, computing a mean dot product of a plurality of dot products computed between (1) each rod of the plurality of rods and (2) a unit vector in the respective direction; and identifying a direction of the plurality of directions having a greatest computed mean dot product.
Claim 27:
The electroanatomical mapping system according to claim 15, wherein the focus score is computed by, for each rod of the plurality of rods, the electroanatomical mapping system: defining a unit vector extending from a center of the evaluation region to a midpoint of the rod; and computing a dot product between the rod and the unit vector, thereby computing a plurality of dot products; and computing a mean of the plurality of dot products.
Claim 11:
The method according to claim 1, wherein computing a focus score for the evaluation region comprises: for each rod of the plurality of rods: defining a unit vector extending from a center of the evaluation region to a midpoint of the rod; and computing a dot product between the rod and the unit vector, thereby computing a plurality of dot products; and computing a mean of the plurality of dot products.
Allowable Subject Matter
Claim 23 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Claims 9-22 and 24-27 are rejected based on double patenting rejections. The allowable subject matter is described in the copending (now allowed) applications 11,793,442 and 11,134,879. Upon allowance a detailed notice of allowance will be provided.
Conclusion
THIS ACTION IS MADE FINAL. 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 PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796