DETAILED ACTION
This action is in response to amendments received on 5/4/2026. Claims 1-20 were previously pending with Claims 16-20 being withdrawn from consideration. Claims 8, 13 and 15 have been amended. A complete action on the merits of claims 1-15 follows below.
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 .
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 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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-15 in the reply filed on 1/16/2026 is acknowledged.
Claim Rejections - 35 USC § 102
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.
Claims 1-11 and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Margolis (US Pub. No. 2013/0289369).
Regarding Claim 1, Margolis teaches a system for facilitating an ablation (Fig. 16 and “This thermal neuromodulation may ablate the nerves 120” [0122]), the system comprising:
a catheter 220 including an electrode assembly (expandable structure 300-Figs. 12, 13, 16) having a plurality of spaced-apart electrodes 410 disposed on a plurality of splines 400 to generate an electric field, the splines configurable in an expanded position wherein the plurality of spaced-apart electrodes are in a selected spatial relationship (Figs. 12, 13), and wherein the splines are deformable relative to the expanded position when subjected to a force (Fig. 16); and
a controller (controller 310/processor 320) operably coupled to the electrode assembly (Fig. 5), the controller configured to:
measure an electrical signal received from an electrode of the plurality of spaced-apart electrodes in response to the electric field, the electrical signal indicative of a parameter of the electric field (“The application of force to the apex of the medial section 550 of the support arm 400 decreases the curvature of the support arm 400 resulting in a corresponding decrease in the distance D” [0094], “The at least one electrode 410 may be positioned on the medial section 550 of at least one of the support arms 400, thereby enabling the electrode 410 the sensor 420 to contact or approximate the vessel luminal wall. At least one electrode cable 560 connects each electrode 410 to the interface 240 and/or the thermal electric field generator 325” [0095], “The expandable structure 300 may include at least one ancillary sensor 575 thereon. As shown in FIG. 12, the ancillary sensor 575a may be positioned on an exterior surface of the inner body 490. In the alternative, at least one ancillary sensor 575b may be positioned on at least one support arm 400. Exemplary ancillary sensors 575 include, without limitation, ultrasonic sensors, flow sensors, thermal sensors, blood temperature sensors, electrical contact sensors, conductivity sensors, electromagnetic detectors, pressure sensors, chemical or hormonal sensors, pH sensors, and infrared sensors… The ancillary pressure sensor 575b may detect the pressure with which the proximate electrode 410 is contacting the vessel wall, thereby allowing the user to determine whether the electrode 410 is effectively contacting the vessel wall to ensure adequate energy transfer and neuromodulation” [0097], [0104], “In some embodiments, a single cable may convey thermal energy to the electrode 410 and convey data from the sensor 420” [0105], “Exemplary sensors 420 include, without limitation, ultrasonic sensors, flow sensors, thermal sensors, such as thermocouples, thermistors and infrared sensors, pressure sensors, electrical contact sensors, conductivity and/or impedance sensors, electromagnetic detectors, fluid flow sensors, electrical current sensors, tension sensors, chemical or hormonal sensors (capable of detecting the concentration or presence/absence of various gases, ions, enzymes, proteins, metabolic products, etc.), and pH sensors” [0106], “at least one sensor 420 may be positioned within or surrounding the electrode 410” [0107], [0108]-[0109], [0118]-[0122], [0128]-[0134]); and
determine a deformation of the splines relative to the expanded position based on the measured electrical signal (D4 vs. D5 in Fig. 16, [0070], [0094], “An apex of the medial section 550a of first support arm 400a is extended a first distance D4 from the guidewire lumen 510 while permitting an electrode 410a and a sensor 420a positioned thereon to remain in contact with the vessel wall 710a. The first distal tip 730a of the support arm 400a is positioned adjacent to or proximate to the first support arm retainer 540a within the retainer sleeve 530. A second support arm 400b has an apex that is positioned a second distance D5 from to the guidewire lumen 510 while permitting an electrode 410a and a sensor 420b positioned thereon to remain in contact with the vessel wall 710b, wherein the second distance D5 is smaller than the first distance D4. The second distal tip 730b of the second support arm 400b is positioned distally from the retainer 540b within the retainer sleeve 530. As a result, the electrodes 410a, 410b and the sensors 420a, 420b positioned on each of the support arms 400a, 400b remain in contact with the vessel wall 710 despite the disparity between distances D4 and D5” [0118], “the processor 320 may utilize the electrodes 410, the sensors 420, and/or any auxiliary sensors to sense baseline measurements of various cardiovascular and neurological characteristics of the vessel, including by way of non-limiting example, vessel wall temperature, vessel lumen temperature, the temperature of surrounding non-target tissue, vessel wall impedance and/or conductivity at the target site (i.e., at points of electrode contact with the vessel wall). For example, by emitting a low voltage pulse from the electrodes 410 through the vessel wall and measuring the electrical response, a baseline impedance for the vessel wall at a particular position may be established” [0120]; therefore, based on the measured electrical contact between the electrodes/sensors with the wall of the vessel in response to the electric field measurement received by each electrode/sensor, the processor evaluates a point of contact of each of the electrodes and as such insures contact remains between electrodes and the wall and therefore the deformation based on the differences between the distances to the central electrode/sensor such as D4 vs. D5 determines a deformation of the splines relative to the expanded position based on the electrical contact data received).
Regarding Claim 2, Margolis teaches wherein the catheter includes a shaft 510 having a distal region, and the plurality of splines 400 form a basket in the expanded position, wherein each of the plurality of splines includes a proximal end and a distal end, the basket coupled to the distal region wherein the distal ends of the splines form a distal tip region of the basket (Fig. 16).
Regarding Claim 3, Margolis teaches wherein the plurality of electrodes 410 includes a measurement electrode 575 disposed within the basket and configured to not contact tissue when the catheter is in the expanded position ([0128] and Fig. 16).
Regarding Claim 4, Margolis teaches wherein the measurement electrode 575 provides the electrical signal (“ancillary sensors 575 include, without limitation, ultrasonic sensors, flow sensors, thermal sensors, blood temperature sensors, electrical contact sensors, conductivity sensors, electromagnetic detectors, pressure sensors, chemical or hormonal sensors, pH sensors, and infrared sensors” [0097], [0118], [0128] and [0135]).
Regarding Claim 5, Margolis teaches wherein the plurality of electrodes 410 includes a distal indifferent electrode disposed within the basket and coupled to the distal tip region, and the controller is configured to determine a distance between the measurement electrode and the distal indifferent electrode (Figs. 12, 13 including equal distances from the electrodes 410/sensors 420 to 575 vs. Fig. 16 having different distances showing an amount of deformation of each spline based on a force exceeded on the spline by the tissue wall, [0094]-[0097], [0110], [0118] and [0135]).
Regarding Claim 6, Margolis teaches wherein the deformation of the splines is determined based on a determination, from the measured electrical signal, of a location of each of the plurality of electrodes (e.g., D4 vs. D5 in Fig. 16 and [0118], [0135]).
Regarding Claim 7, Margolis teaches wherein the determination of the deformation includes a determination of an amount of deformation of the splines relative to the expanded position (Figs. 12, 13 including equal distances from the electrodes 410/sensors 420 to 575 vs. Fig. 16 having different distances showing an amount of deformation of each spline based on a force exceeded on the spline by the tissue wall).
Regarding Claim 8, Margolis teaches wherein the controller is configured to determine an amount of the force applied to the splines based on the determination of an amount of deformation (“application of force to the apex of the medial section 550 of the support arm 400 decreases the curvature of the support arm 400 resulting in a corresponding decrease in the distance D” [0094] and “In another embodiment, the ancillary sensor 575b may comprise a pressure sensor positioned on the support arm 400 proximate to the electrode 410 and/or encircling the electrode 410. The ancillary pressure sensor 575b may detect the pressure with which the proximate electrode 410 is contacting the vessel wall, thereby allowing the user to determine whether the electrode 410 is effectively contacting the vessel wall to ensure adequate energy transfer and neuromodulation” [0097] and “when the expandable structure 300 is in a deployed and expanded state, the ability of the support arms 400 to move independently facilitates contact of each of the support arms 400 with the vessel wall without applying excessive force thereto, thereby decreasing or eliminating the likelihood of injury to the vessel. Maximizing contact of each of the support arms 400 with the vessel wall in turn maximizes contact of sensors 420 with the vessel wall, which can be important in some embodiments for obtaining accurate sensor readings” [0098] and [0118]-[0119]).
Regarding Claim 9, Margolis teaches wherein the controller is configured to generate a visualization based on the deformation ([0109]-[0111]).
Regarding Claim 10, Margolis teaches wherein the controller is configured to generate a visualization of a gradient based on the amount of deformation of the splines relative to the expanded position (Figs. 12, 13 vs. Fig. 16, [0109]-[0119]).
Regarding Claim 11, Margolis teaches wherein the controller is configured to (distinct) [highlight] a deformed spline of the plurality of splines (“individual support arms 400 may carry a distinctive pattern or shape of radiopaque markers 600 to enable the user to distinguish individual support arms in the image data gathered from the imaging apparatus 280 and/or external imaging” [0109]). Although Margolis does not specifically teach “highlight” a deformed spline of the plurality of splines since it does teach providing a radiopaque marker on each individual support arms and each arm deforms independent of another, examiner takes the position that each distinct pattern or shape of radiopaque markers on each arm provides an indication of that specific arm’s deformation and thus highlights the specific arm by its distinct marker in view of Marriam Webster dictionary “to cause (something, such as text or an icon) to be displayed in a way that stands out on an electronic screen (as of a computer or smartphone)”.
Regarding Claim 13, Margolis teaches an electroporation catheter for use with tissue ([0123], Fig. 1) , comprising:
an elongated shaft 510 having a distal region (Fig. 16); and
an electrode assembly (expandable structure 300-Figs. 12, 13, 16) operably coupled to the distal region, the electrode assembly having a plurality of spaced-apart electrodes 410 disposed on a plurality of splines 400 to generate an electric field, the splines configurable in an expanded position wherein the plurality of spaced-apart electrodes are in a selected spatial relationship (Figs. 12, 13), and wherein the splines are deformable relative to the expanded position when subjected to a force (Fig. 16);
wherein the plurality of splines 400 form a basket 300 (Fig. 16) defining a cavity in the expanded position, wherein each of the plurality of splines includes a proximal end and a distal end, the basket coupled to the distal region wherein the distal ends of the splines form a distal tip region of the basket, the shaft having a distal basket region extending into and terminating within the cavity (Figs. 12, 13, 16); and
wherein the plurality of electrodes 410 includes a measurement electrode 575 disposed within the basket on the distal basket region of the shaft, the measurement electrode configured to not contact the tissue when the splines are in the expanded position (Fig. 16).
Regarding Claim 14, Margolis teaches wherein the plurality of electrodes 410 includes a distal indifferent electrode disposed within the basket and coupled to the distal tip region, the distal indifferent electrode spaced-apart from the shaft and the measurement electrode ([0094], [0110], [0118] and [0135] and Fig. 16).
Regarding Claim 15, Margolis teaches wherein the plurality of electrodes includes a shaft electrode disposed on the distal region of the shaft and proximal to the basket (in light of the 112 rejection above, a shaft electrode is interpreted to be separate than the plurality of electrodes and since it is not tied to any specific functional limitation or coupled to a generator it is interpreted to be a conductive/metallic region on the distal end of the shaft, thus “radiopaque markers 270” in Fig. 16 is here interpreted to be a shaft electrode).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Margolis as applied above in view of Severino (US Pub. No. 2016/0183824).
Regarding Claim 12, Margolis teaches the use of radiopaque markers to visualize the path and ultimate position of the catheter within the vasculature of the patient in [0072], but does not specifically teach wherein the controller is configured to generate the visualization of the deformation on an electroanatomical map of a heart.
In the same field of invention, Severino teaches “the visualization of the electrode acquisition sequence includes images of the catheter and its electrodes, superimposed on a heart chamber map, wherein the visualization is dynamic and in real-time corresponding to movement of the catheter in the heart chamber and the heart chamber map is in 3-D and provides anatomical information, as well as any additional information currently available on the CARTO mapping system, such as LAT or voltage, if so desired by the physician” in [0095].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to superimpose the visualization basket/splines onto an electroanatomical map of a heart of a patient in real life in order to allow the user to correctly navigate and position the basket in the targeted area as well as visualize the basket including the deformation of each of the splines on the anatomical map to visualize the basket and provide anatomical information, as well as any additional information to the user during treatment.
Response to Arguments
Applicant's arguments filed 5/4/2026 have been fully considered but they are not persuasive.
Applicant argues that claim 1 requires a controller configured to "measure an electrical signal received from an electrode...in response to the electric field, the electrical signal indicative of a parameter of the electric field," and to use that measurement to "determine a deformation of the splines." The Office Action maps these features to paragraphs [0094]-[0097] and [0118]-[0120] of Margolis and to the D4/D5 distance comparison in Figure 16 of Margolis. Applicant submits that this mapping is incorrect. Margolis discloses that the difference between D4 and D5 in Figure 16 reflects the physical deformation of support arms contacting the vessel wall, and the imaging apparatus 280, which is an IVUS device, is what provides visualization of catheter position within the renal artery. The D4/D5 comparison is a geometric observation made through intravascular imaging, not a determination derived from measuring electrical signal parameters of the generated electric field. Margolis describes sensors 420 as thermal sensors, temperature sensors, impedance sensors, and pressure sensors used to monitor tissue characteristics and thermal energy delivery, none of which constitute measuring a parameter of the electric field generated by the electrode assembly to infer spline geometry.”
Given the broadest reasonable interpretation claim 1 requires “a plurality of spaced-apart electrodes disposed on a plurality of splines to generate an electric field, the splines configurable in an expanded position wherein the plurality of spaced-apart electrodes are in a selected spatial relationship, and wherein the splines are deformable relative to the expanded position when subjected to a force; and a controller operably coupled to the electrode assembly, the controller configured to: measure an electrical signal received from an electrode of the plurality of spaced-apart electrodes in response to the electric field, the electrical signal indicative of a parameter of the electric field; and determine a deformation of the splines relative to the expanded position based on the measured electrical signal”.
Margolis teaches a plurality of spaced-apart electrodes 410 disposed on a plurality of splines 400 to generate an electric field, the splines configurable in an expanded position (Figs. 6B and 12) wherein the plurality of spaced-apart electrodes 410 are in a selected spatial relationship (Figs. 13-14), and wherein the splines are deformable relative to the expanded position when subjected to a force “The application of force to the apex of the medial section 550 of the support arm 400 decreases the curvature of the support arm 400 resulting in a corresponding decrease in the distance D” [0094], “The at least one electrode 410 may be positioned on the medial section 550 of at least one of the support arms 400, thereby enabling the electrode 410 the sensor 420 to contact or approximate the vessel luminal wall. At least one electrode cable 560 connects each electrode 410 to the interface 240 and/or the thermal electric field generator 325” [0095], “The expandable structure 300 may include at least one ancillary sensor 575 thereon. As shown in FIG. 12, the ancillary sensor 575a may be positioned on an exterior surface of the inner body 490. In the alternative, at least one ancillary sensor 575b may be positioned on at least one support arm 400. Exemplary ancillary sensors 575 include, without limitation, ultrasonic sensors, flow sensors, thermal sensors, blood temperature sensors, electrical contact sensors, conductivity sensors, electromagnetic detectors, pressure sensors, chemical or hormonal sensors, pH sensors, and infrared sensors… The ancillary pressure sensor 575b may detect the pressure with which the proximate electrode 410 is contacting the vessel wall, thereby allowing the user to determine whether the electrode 410 is effectively contacting the vessel wall to ensure adequate energy transfer and neuromodulation” [0097], [0104], “In some embodiments, a single cable may convey thermal energy to the electrode 410 and convey data from the sensor 420” [0105], “Exemplary sensors 420 include, without limitation, ultrasonic sensors, flow sensors, thermal sensors, such as thermocouples, thermistors and infrared sensors, pressure sensors, electrical contact sensors, conductivity and/or impedance sensors, electromagnetic detectors, fluid flow sensors, electrical current sensors, tension sensors, chemical or hormonal sensors (capable of detecting the concentration or presence/absence of various gases, ions, enzymes, proteins, metabolic products, etc.), and pH sensors” [0106], “at least one sensor 420 may be positioned within or surrounding the electrode 410” [0107], [0108]-[0109], [0118]-[0122], [0128]-[0134]); and
determine a deformation of the splines relative to the expanded position based on the measured electrical signal (D4 vs. D5 in Fig. 16, [0070], [0094], “An apex of the medial section 550a of first support arm 400a is extended a first distance D4 from the guidewire lumen 510 while permitting an electrode 410a and a sensor 420a positioned thereon to remain in contact with the vessel wall 710a. The first distal tip 730a of the support arm 400a is positioned adjacent to or proximate to the first support arm retainer 540a within the retainer sleeve 530. A second support arm 400b has an apex that is positioned a second distance D5 from to the guidewire lumen 510 while permitting an electrode 410a and a sensor 420b positioned thereon to remain in contact with the vessel wall 710b, wherein the second distance D5 is smaller than the first distance D4. The second distal tip 730b of the second support arm 400b is positioned distally from the retainer 540b within the retainer sleeve 530. As a result, the electrodes 410a, 410b and the sensors 420a, 420b positioned on each of the support arms 400a, 400b remain in contact with the vessel wall 710 despite the disparity between distances D4 and D5” [0118], “the processor 320 may utilize the electrodes 410, the sensors 420, and/or any auxiliary sensors to sense baseline measurements of various cardiovascular and neurological characteristics of the vessel, including by way of non-limiting example, vessel wall temperature, vessel lumen temperature, the temperature of surrounding non-target tissue, vessel wall impedance and/or conductivity at the target site (i.e., at points of electrode contact with the vessel wall). For example, by emitting a low voltage pulse from the electrodes 410 through the vessel wall and measuring the electrical response, a baseline impedance for the vessel wall at a particular position may be established” [0120]; therefore, based on the measured electrical contact between the electrodes/sensors with the wall of the vessel in response to the electric field measurement received by each electrode/sensor, the processor evaluates a point of contact of each of the electrodes and as such insures contact remains between electrodes and the wall and therefore the deformation based on the differences between the distances to the central electrode/sensor such as D4 vs. D5 determines a deformation of the splines relative to the expanded position based on the electrical contact data received, thereby given the broadest reasonable interpretation, Margolis teaches the claimed invention and applicant’s arguments are not found persuasive.
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.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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