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 .
Election/Restrictions
Applicant’s election without traverse of Species 1 in the reply filed on February 27, 2026 is acknowledged. Claim 11 recites “the electrode assembly having a plurality of elongated ablation electrodes configured as splines” in lines 6-7 of the claim. This claim reads on non-elected Species 2 as this embodiment teaches that the electrode is configured as the splines. Paragraph 0081 discusses Figure 3B (non-elected Species 2) and states that each spline 312B is formed from a longitudinally extending plate electrode. Elected Species 1 teaches that each spline supports an associated ablation electrode as described in paragraph 0074. Claim 18 recites “forming each of the splines from the associated ablation electrodes”, and is therefore similarly withdrawn. Claim 20 recites “the insulator is not deposited on the mapping electrodes”, which is described in paragraph 0085 with respect to non-elected Species 4 (Figure 3D) and is therefore withdrawn. Claims 11-15 and 18-20 are withdrawn.
Claim Objections
Claims 1-10, 16 and 17 are objected to because of the following informalities:
Claim 1 recites “off axis” in line 10, which does provide proper antecedence. Claim 1 in lines 3-4 recites “the elongate shaft defining an axis”. The recitation should read “off the axis” in order to provide proper antecedence.
Claim 16 recites “off axis” in line 10, which does provide proper antecedence. Claim 16 in line 4 recites “the elongate shaft defining an axis”. The recitation should read “off the axis” in order to provide proper antecedence.
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 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "each spline" in line 7 of the claim. There is insufficient antecedent basis for this limitation in the claim in light of the recitation of “a plurality of splines” in lines 6-7 of the claim. It is not clear if this is referring to another group of splines or if these splines are part of the previously recited plurality of splines.
Claim 1 recites the limitation "the splines" in line 7 of the claim. It is not clear if this recitation is referring to the recitation of “a plurality of splines” in line 6-7 or the recitation of “each spline” in line seven. Claim 7 recites “each of the splines” in line 2, claim 9 recites “each spine” in line 1 and claim 10 recites “each spline” in line one. These claims are rejected for the same reasons as described above. The same language needs to be consistently provided throughout the claims to provide proper antecedence. It is not clear if or how all these recitations are related.
Claim 2 recites the limitation "each ablation electrode" in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim in light of the recitation of “an associated ablation electrode” in line 7 of claim one. It is not clear how these recitations relate. The examiner suggests clearly claiming the ablation electrodes as part of the electrode assembly in order to provide antecedent basis. Claim 6 recites “each ablation electrode” in line 1, claim 7 recites “each ablation electrode” in line 1 and claim 8 recites “ablation electrodes” in line one. These claims are rejected for the same reasons as described above. The same language needs to be consistently provided throughout the claims to provide proper antecedence. It is not clear if or how all these recitations are related.
Claim 16 recites the limitation "each spline" in line 7 of the claim. There is insufficient antecedent basis for this limitation in the claim in light of the recitation of “a plurality of splines” in lines 6-7 of the claim. It is not clear if this is referring to another group of splines or if these splines are part of the previously recited plurality of splines.
Claim 16 recites the limitation "the splines" in lines 7-8 of the claim. It is not clear if this recitation is referring to the recitation of “a plurality of splines” in line 6-7 or the recitation of “each spline” in line seven. The same language needs to be consistently provided throughout the claims to provide proper antecedence. It is not clear if or how these recitations are related.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Gandionco et al (WO/2022/192522).
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 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).
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. 102(a)(1) and 102(a)(2) as being anticipated by Sutermeister et al (2019/0350649)
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).
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).
Conclusion
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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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/SAMANTHA M GOOD/Examiner, Art Unit 3794