DETAILED ACTION
Applicant's amendments and remarks, filed 7/1/26, are fully acknowledged by the Examiner. Currently, claims 1-22 and 26-28 are pending with claims 23-25 canceled, claims 1 and 26 amended. The following is a complete response to the 7/1/26 communication.
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 (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.
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.
Claim(s) 1-17, 19-22, and 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weinstein (US 6,102,046) in view of Greeley (US 2023/0039545), in view of Mickelson (US 2015/0182740).
Regarding claim 1, Weinstein teaches a method for tissue ablation comprising:
advancing an ablation catheter to a target tissue (Fig. 15), the ablation catheter comprising a tubular body having an inner surface (tubular body 276 with inner surface facing inward and defining 282 as in Fig. 15), an outer surface (outer surface of 276 facing 274), and a distal end (distal end facing 286), one or more inner electrodes disposed on the inner surface (inner electrode 270), and one or more outer electrodes disposed on the outer surface (outer electrode 272);
generating a first electric field having a first vector direction using a first voltage pattern for the one or more inner electrodes and the one or more outer electrodes (creating a first voltage pattern defined by 278).
Weinstein is silent regarding generating a second, different electric field having a second, different vector direction by switching the first voltage pattern for the one or more inner electrodes and the one or more outer electrodes to a second, different voltage pattern.
However, Greeley teaches a tubular multielectrode treatment device using bipolar and monopolar electrode selections to result in different treatment modalities (par. [0002], par. [0026]).
It would have been obvious to one of ordinary skill in the art to modify Weinstein with the modalities of Greeley, to allow for different treatment modalities on tissue (par. [0002]).Weinstein is not explicit regarding treating a cardia arrhythmia and ablating the target tissue comprises electroporation of the target tissue with the first and second electric fields.However, Mickelson teaches ablation for treating arrhythmia (par. [0148]), and treating a cardiac arrhythmia by ablating the target tissue comprises electroporation of the target tissue (par. [0160], unipolar or bipolar as in par. [0190]).
It would have been obvious to one of ordinary skill in the art to use the device of Weinstein to treat arrhythmia, to allow for a method of treating cardiac tissue. It would have been obvious to one of ordinary skill in the art at the time of invention to use the device of Weinstein for electroporation as an electrosurgical function that RF ablation catheters can deliver, allowing for treatment with reduced thermal transfer.
Regarding claim 2, Weinstein teaches bipolar treatment in the first pattern with wherein in the first voltage pattern (col. 28, lines 6-19), the one or more inner electrodes have a first polarity (270 as active electrode of bipolar device), and the one or more outer electrodes have a second polarity (272 as return electrode of bipolar device).
Regarding claim 3, Weinstein is silent wherein in the second voltage pattern, voltage is applied solely to the one or more outer electrodes.
However, Greeley teaches a tubular multielectrode treatment device using bipolar and monopolar electrode selections to result in different treatment modalities (par. [0026] with monopolar for cutting, par. [0027] voltage to outer electrode 12).
It would have been obvious to one of ordinary skill in the art to modify Weinstein with the monopolar modality of Greeley, to allow for different treatment modalities on tissue (par. [0002]).
Regarding claim 4, Weinstein teaches that the probe may include an array of electrode terminals rather than the annular electrode (col. 20 lines 52-67), but is not explicit wherein an outer electrode of the one or more outer electrodes has a first polarity, and another one of the one or more outer electrodes has a second polarity.
However, Greeley teaches switches to determine the polarity and other properties of given electrodes (par. [0149]).
It would have been obvious to one of ordinary skill in the art to modify Weinstein with the switching of the electrodes of Greeley, to allow for different treatment modalities on tissue (par. [0002]).
Regarding claim 5, Weinstein does not necessitate wherein the one or more outer electrodes comprises two outer electrodes, and wherein in the first voltage pattern, each of the two outer electrodes have a same polarity.
However, Weinstein teaches that the probe may include an array of electrode terminals rather than the annular electrode (col. 20 lines 52-67).
It would have been obvious to one of ordinary skill in the art to modify Weinstein such that the annular electrode is an array of electrodes, as a known alternative that is capable of treating tissue.
Regarding claim 6, Weinstein is not explicit wherein the one or more outer electrodes comprises two outer electrodes, and wherein in the second voltage pattern, the two outer electrodes have different polarities.
However, Weinstein teaches that the probe may include an array of electrode terminals rather than the annular electrode (col. 20 lines 52-67).
It would have been obvious to one of ordinary skill in the art to modify Weinstein such that the annular electrode is an array of electrodes, as a known alternative that is capable of treating tissue.
Regarding claim 7, Weinstein teaches wherein in the first voltage pattern, at least one inner
electrode of the one or more inner electrodes has a first polarity (bipolar treatment), but is not explicit regarding in the second voltage pattern, a voltage is not applied to the at least one inner electrode.
However, Greeley teaches a tubular multielectrode treatment device using bipolar and monopolar electrode selections to result in different treatment modalities (par. [0002], par. [0026]).
It would have been obvious to one of ordinary skill in the art to modify Weinstein with the modalities of Greeley, to allow for different treatment modalities on tissue (par. [0002]).
Regarding claim 8, Weinstein teaches wherein the first polarity is positive (active electrode 270).
Regarding claim 9, Weinstein is not explicit wherein in the first voltage pattern, a voltage is not applied to at least one electrode of the one or more outer electrodes and in the second voltage pattern the at least one electrode has a first polarity.
However, Greeley teaches a tubular multielectrode treatment device using bipolar and monopolar electrode selections to result in different treatment modalities (par. [0002], par. [0026]).
It would have been obvious to one of ordinary skill in the art to modify Weinstein with the modalities of Greeley, to allow for different treatment modalities on tissue (par. [0002]).
Regarding claim 10, Weinstein teaches wherein each of the one or more outer electrodes are offset from the distal end of the tubular body along a longitudinal axis of thereof (electrode 272 offset from distal end of 276).
Regarding claim 11, Weinstein teaches wherein each of the one or more inner electrodes are offset from the distal end of the tubular body along a longitudinal axis of thereof (inner electrodes 270 offset from the distal end of 280).
Regarding claim 12, Weinstein is not explicit wherein switching from the first voltage pattern to the second voltage pattern occurs without repositioning the ablation catheter.
However, Greeley teaches switching bipolar and monopolar without repositioning (par. [0037]).
It would have been obvious to one of ordinary skill in the art to modify Weinstein with the modalities of Greeley, to allow for different treatment modalities on tissue (par. [0002]).
Regarding claim 13, Weinstein is not explicit regarding further comprising switching from the second voltage pattern to a third voltage pattern to generate a third electric field different from the second electric field, the third electric field having a third vector direction.
However, Greeley teaches a tubular multielectrode treatment device using bipolar and monopolar electrode selections to result in different treatment modalities (par. [0038], monopolar and bipolar, but also a bipolar between different electrodes to reduce size and volume of tissue).
It would have been obvious to one of ordinary skill in the art to modify Weinstein with a third voltage pattern with a third vector direction, as in Greeley, as a way to produce multiple treatment modalities for different treatment cases.
Regarding claim 14, Weinstein is not explicit wherein in the first voltage pattern, a voltage is not applied to an outer electrode of the one or more outer electrodes, in the second voltage pattern the outer electrode has a first polarity, and in the third voltage pattern, the outer electrode has the first polarity.
However, Greeley teaches a tubular multielectrode treatment device using bipolar and monopolar electrode selections to result in different treatment modalities (par. [0038], monopolar and bipolar, but also a bipolar between different electrodes to reduce size and volume of tissue).
It would have been obvious to one of ordinary skill in the art to modify Weinstein with different voltage activations of different electrodes, as in Greeley, as a way to produce multiple treatment modalities for different treatment cases.
Regarding claim 15, Weinstein teaches wherein the first polarity is negative (270 as return electrode).
Regarding claim 16, Weinstein is not explicit regarding repeatedly switching between one or more of the first, second, or third voltage patterns.
However, Greeley teaches switching between different voltage patterns (par. [0037]).It would have been obvious to one of ordinary skill in the art to modify Weinstein with different voltage activations of different electrodes, as in Greeley, as a way to produce multiple treatment modalities for different treatment cases.
Regarding claim 17, Weinstein is not explicit wherein an angular difference between the first vector direction and the second vector direction is between about 1° to about 90°.
However, one of ordinary skill in the art would appreciate that in the combination, depending on vectors of the average electric field vector of the first treatment and second treatment, the difference may be at least one degree.
Regarding claim 19, Weinstein teaches wherein the tubular body comprises an electrically insulating material (insulator 276).
Regarding claim 20, Weinstein teaches wherein the one or more inner electrodes and the one or more outer electrodes are separated by the electrically insulating material (insulator 276 separates 270 from 272).
Regarding claim 21, Weinstein teaches wherein a current path between the one or more inner electrodes and the one or more outer electrodes bends around the distal end of the tubular body (Fig. 15 with current path 278 bending around the distal end of the tubular body).
Regarding claim 22, Weinstein is not explicit regarding the second voltage pattern, but teaches wherein setting the first voltage pattern and switching current is accomplished by a controller electrically coupled to the one or more inner electrodes and the one or more outer electrodes (col. 11, line 61 to col. 12 line 9).
It would have been obvious to one of ordinary skill in the art that switching to the second pattern would be controlled by a controller as in Weinstein as a device that controls voltage and treatment elements of the device.
Regarding claim 26, Weinstein is silent wherein the cardiac arrhythmia comprises atrial fibrillation.
However, Mickelson teaches ablation for treating arrhythmia (par. [0148], specifically atrial fibrillation as in par. [0003]).
It would have been obvious to one of ordinary skill in the art to use the device of Weinstein to treat arrhythmia, to allow for a method of treating cardiac tissue.
Regarding claim 27, Weinstein teaches wherein one or more of the first electric field or the second electric field has a symmetrical contour around the distal end of the tubular body (Fig. 15).
Regarding claim 28, Weinstein teaches wherein the ablation catheter is advanced intravascularly (at least col. 7, lines 3-4).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weinstein (US 6,102,046) in view of Greeley, in view of Mickelson, in further view of Cosman (US 2017/0049513).
Regarding claim 18, Weinstein is not explicit wherein switching between the first voltage pattern and the second voltage pattern occurs during a time period ranging from about 10 nanoseconds to about 1 second.
However, Cosman teaches switching modalities in different time periods, such as 1 millisecond (par. [0111]).
It would have been obvious to one of ordinary skill in the art to modify Weinstein with the switching time of Cosman, as known times for switching between treatments to occur.
Response to Arguments
Applicant's arguments filed 7/1/26 have been fully considered but they are not persuasive. Applicant argues that one of ordinary skill in the art would not modify Weinstein with the electroporation of Mickelsen, asserting that the mechanism of Weinstein uses a different modality to ablate tissue. However, Weinstein teaches the desire for different types of treatment, not just plasma (col. 7, lines 10-19 cutting, coagulating, ablation). Mickelsen teaches using a generator 700 to allow the device to deliver multiple treatment methods (par. [0130]). It would have been obvious to one of ordinary skill in the art to look to Mickelsen in the myriad ways of delivering energy to an electrode device to ablate or treat tissue, including using electroporation to ablate tissue (par. [0138]).
Applicant further argues that one of ordinary skill in the art would not look to Greeley for generating different voltage activations for electroporation to treat cardia arrhythmia. However, given that Mickelsen teaches unipolar and bipolar configurations for electroporation (par. [0159], [0190]), one of ordinary skill in the art would look to Greeley to be able to switch treatment patterns to deliver electroporation in a pattern desired by the user.
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 BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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