DETAILED ACTION
This action is in response to applicant’s election of group I directed to claims 1-15 on 1/16/2026. Claims 1-20 were originally pending. Claims 16-20 have been withdrawn from further consideration. 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 Objections
Claim 8 is objected to because of the following informalities: “clam” in line 1 of claim 8 should be amended to recite --claim--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 13 recites the limitation “a plurality of spaced-apart electrodes disposed on a plurality of splines” as well as “wherein the plurality of electrodes includes a measurement electrode 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”. It is at most unclear if all of the plurality of electrodes are “disposed on a plurality of splines” or not since it appears the measurement electrode is “disposed within the basket on the distal basket region of the shaft” and “the measurement electrode configured to not contact the tissue when the splines are in the expanded position”, which if it is disposed on a spline it would contact tissue. For analysis, the claim is interpreted to have “plurality of spaced-apart electrodes disposed on a plurality of splines” and an additional measurement electrode “disposed within the basket on the distal basket region of the shaft” such that “the measurement electrode configured to not contact the tissue when the splines are in the expanded position” and not “wherein the plurality of electrodes includes a measurement electrode”. Clarification and appropriate correction is required.
Claim 14 is rejected due to dependency over claim 13.
Claim 15 recites the limitation “the plurality of electrodes includes a shaft electrode disposed on the distal region of the shaft and proximal to the basket”. For the reasons states above, it is unclear how the shaft electrode can be “disposed on a plurality of splines” while at the same time being “disposed on the distal region of the shaft and proximal to the basket”. Clarification and appropriate correction is required.
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 ([0094]-[0097], [0104]-[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], [0118], [0120]).
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 ([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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794