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 .
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Gandionco et al (WO/2022/192522) in view of Goedeke et al (2018/0169414).
Referring to claim 1, Gandionco et al teaches an electroporation catheter for ablation of cardiac tissue, the electroporation catheter (paragraphs 0005, 0006 and 0223) comprising: an elongated shaft (1504) having a distal region (1506) and a deflection plane, the elongate shaft defining an axis (paragraph 0221); an electrode assembly operably coupled to the distal region and configured to generate an electric field, the electrode assembly having a plurality of splines (1522), wherein each spline supports an associated ablation electrode (1524) (paragraph 0222), the plurality of splines transitionable between a collapsed state and an expanded state; a deflector in the distal region (paragraph 0224), the deflector (1560 with 1526a/1526b) actuable in the expanded state to deflect the electrode assembly off axis towards a deflection direction in the deflection plane (paragraph 0229); wherein the electrode assembly in the expanded state includes a first set of the plurality of splines proximal the deflection direction and a second set of the plurality of splines distal the deflection direction (paragraph 0229); and an insulator (1528) disposed on the second set of splines so as to insulate at least a portion of the associated ablation electrode (paragraph 0222; Figures 34-35).
Gandionco et al fails to teach that the insulator is not disposed on the associated ablation electrodes on the first set of the plurality of splines. Goedeke et al teaches an analogous ablation catheter that teaches that an insulator is not disposed on the associated ablation electrodes (paragraphs 0943-0948). Goedeke et al teaches many different electrode configurations both with insulation (Figure 43B and 44B) and without insulation (43A and 44A). Goedeke et al teaches that if the electrode coupled to the spline has insulation then the energy is emitted from uninsulated areas which provides directional control (paragraphs 0945 and 0947). Goedeke et al teaches that if the electrode couple to the spline does not have insulation then the energy can be emitted in all directions (paragraphs 0944 and 0946). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes on the first set of the plurality of splines, as taught by Gandionco et al, to not have the insulator disposed thereon, as taught by Goedeke et al, in order to allow for the energy to be emitted in all directions. One of ordinary skill in the art before the effective filing date of the claimed invention would know how to choose whether an insulator is disposed to the electrodes in order to control the direction of energy as desired.
Referring to claim 2, Gandionco et al teaches that the plurality of splines form a basket defining a cavity in the expanded state, and the insulator directs the electric field from each ablation electrode associated with the second set of the plurality of splines towards the cavity (paragraph 0222; Figures 34-35).
Referring to claim 3, Gandionco et al teaches wherein the basket is steerable toward a treatment site via the deflector (1560 with 1526a/1526b) (paragraph 0229).
Referring to claim 4, Gandionco et al teaches wherein the electrode assembly is configured as one of a cathode and an anode to generate the electric field in a monopolar mode (paragraph 0222).
Referring to claim 5, Gandionco et al teaches wherein the shaft includes a lead conductor, and each of the associated ablation electrodes are electrically coupled to the lead conductor (paragraph 0226).
Referring to claim 6, Gandionco et al teaches wherein each ablation electrode associated with the second set of splines include a surface facing the deflection direction and a surface facing opposite the deflection direction, wherein the insulator is disposed on the surface facing opposite the deflection direction (paragraphs 0222-0229; Figures 34-35).
Referring to claim 7, Gandionco et al teaches wherein each ablation electrode associated with each of the splines include a surface facing the deflection direction and a surface facing the deflection direction, wherein the insulator is disposed on the surface facing opposite the deflection direction (paragraphs 0222-0229; Figures 34-35).
Referring to claim 8, Gandionco et al teaches wherein ablation electrodes associated with the first set of the plurality of splines are exposed (paragraph 0222; Figures 34-35).
Referring to claim 9, Gandionco et al teaches wherein each spine further includes a mapping electrode (paragraphs 0228 and 0241).
Claims 1-10, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sutermeister et al (2019/0350649) in view of Goedeke et al (2018/0169414).
Referring to claims 1 and 16 Sutermeister et al teaches an electroporation catheter and a method for making an electroporation catheter for ablation of cardiac tissue (paragraphs 0011 and 0071) , the apparatus and method comprising: providing an elongated shaft (205) having a distal region and a deflection plane, the elongate shaft defining an axis; coupling an electrode assembly (201/Figure 2A) to the distal region (paragraph 0041), the electrode assembly configured to generate an electric field, the electrode assembly having a plurality of splines (210), wherein each spline (210) supports an associated ablation electrode (211), the splines transitionable between a collapsed state and an expanded state (paragraph 0041); providing a deflector (steering wires) in the distal region, the deflector actuable in the expanded state to deflect the electrode assembly off axis towards a deflection direction in the deflection plane; wherein the electrode assembly in the expanded state includes a first set of the plurality of splines proximal the deflection direction and a second set of the plurality of splines distal the deflection direction (paragraphs 0037, 0049, 0077-0079) and depositing an insulator (pebax tubing) on the second set of the plurality of splines so as to insulate at least a portion of the associated electrode (paragraph 0045; Figures 1-2C).
Sutermeister et al fails to teach that the insulator is not disposed on the associated ablation electrodes on the first set of the plurality of splines. Goedeke et al teaches an analogous ablation catheter that teaches that an insulator is not disposed on the associated ablation electrodes (paragraphs 0943-0948). Goedeke et al teaches many different electrode configurations both with insulation (Figure 43B and 44B) and without insulation (43A and 44A). Goedeke et al teaches that if the electrode coupled to the spline has insulation then the energy is emitted from uninsulated areas which provides directional control (paragraphs 0945 and 0947). Goedeke et al teaches that if the electrode couple to the spline does not have insulation then the energy can be emitted in all directions (paragraphs 0944 and 0946). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes on the first set of the plurality of splines, as taught by Sutermeister et al, to not have the insulator disposed thereon, as taught by Goedeke et al, in order to allow for the energy to be emitted in all directions. One of ordinary skill in the art before the effective filing date of the claimed invention would know how to choose whether an insulator is disposed to the electrodes in order to control the direction of energy as desired.
Referring to claim 2, Sutermeister et al teaches that the plurality of splines form a basket defining a cavity in the expanded state, and the insulator directs the electric field from each ablation electrode associated with the second set of the plurality of splines towards the cavity (paragraphs 0041-0055; Figures 1-2C).
Referring to claim 3, Sutermeister et al teaches wherein the basket is steerable toward a treatment site via the deflector (paragraphs 0037, 0049, 0077-0079).
Referring to claim 4, Sutermeister et al teaches wherein the electrode assembly is configured as one of a cathode and an anode to generate the electric field in a monopolar mode (paragraph 0055; Figures 1-2C).
Referring to claims 5 and 17, Sutermeister et al teaches wherein the shaft includes a lead conductor, and each of the associated ablation electrodes are electrically coupled to the lead conductor (paragraph 0036; Figure 2).
Referring to claim 6, Sutermeister et al teaches wherein each ablation electrode associated with the second set of splines include a surface facing the deflection direction and a surface facing opposite the deflection direction, wherein the insulator is disposed on the surface facing opposite the deflection direction (paragraphs 0041-0055; Figures 1-2C).
Referring to claim 7, Sutermeister et al teaches wherein each ablation electrode associated with each of the splines include a surface facing the deflection direction and a surface facing the deflection direction, wherein the insulator is disposed on the surface facing opposite the deflection direction (paragraphs 0041-0055; Figures 1-2C).
Referring to claim 8, Sutermeister et al teaches wherein ablation electrodes associated with the first set of the plurality of splines are exposed (paragraphs 0041-0055; Figures 1-2C).
Referring to claims 9 and 10, Sutermeister et al teaches wherein each spline further includes a mapping electrode and wherein each spline includes a plurality of exposed mapping electrodes disposed along the spline (paragraphs 0035, 0045, 0047, 0052 and 0055; Figures 1-2C).
Response to Arguments
Applicant’s amendments and arguments, see pages 6-7, filed June 26, 2026, with respect to the pending claims have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Goedeke et al (2018/0169414) who teaches an analogous ablation catheter that teaches that an insulator is not disposed on the associated ablation electrodes (paragraphs 0943-0948). Goedeke et al teaches many different electrode configurations both with insulation (Figure 43B and 44B) and without insulation (43A and 44A). Goedeke et al teaches that if the electrode coupled to the spline has insulation then the energy is emitted from uninsulated areas which provides directional control (paragraphs 0945 and 0947). Goedeke et al teaches that if the electrode couple to the spline does not have insulation then the energy can be emitted in all directions (paragraphs 0944 and 0946). One of ordinary skill in the art before the effective filing date of the claimed invention would know how to choose whether an insulator is disposed to the electrodes in order to control the direction of energy as desired.
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 SAMANTHA M GOOD whose telephone number is (571)270-7480. The examiner can normally be reached Mon to Wed, 7am to 3pm.
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/SAMANTHA M GOOD/ Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/ Primary Examiner, Art Unit 3794
