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 .
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.
Response to Amendment
Claims 1-17 are presently considered for examination. Claims 1, 2, 4, 5, 6, 9, 11, 12, 14, 15, and 16 are amended in the response filed 08/13/2026.
Response to Arguments
Applicant’s arguments, see Remarks page 5, filed 08/13/2026, with respect to the rejections of claims 1, 5-7, 9, and 16 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The amendments filed 08/13/2026 remedy the deficiencies of these claims in view of 35 U.S.C. 112b. Therefore, the rejection of these claims under 35 U.S.C. 112b has been withdrawn.
Applicant’s arguments, see Remarks page 5, filed 08/13/2026, with respect to the objections of claims 1, 2, 4, 14, and 15 have been fully considered and are persuasive. The amendments filed 08/13/2026 remedy the objections of these claims. Therefore, the objection of these claims has been withdrawn.
Applicant’s arguments, see Remarks pages 5-6, filed 08/13/2026, with respect to the rejection(s) of claim 1 under Byrd (US 2021/0121228) have been fully considered and are persuasive. Byrd does not teach the amended limitation “wherein the at least two separate electrical conductors are adapted to deliver a waveform with a peak voltage of at least 3000V”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Long (US Patent No. 10,342,598 B2).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Byrd (US 2021/0121228 A1), herein after “Byrd”, in view of Long (US Patent No. 10,342,598 B2), herein after “Long”.
Regarding claim 1, Byrd teaches
“A catheter for ablating tissue using pulsed-field (PF) energy from a high-voltage pulse generator configured to generate PF energy (Fig. 1, p.[0018] "the present disclosure relates to the electroporation systems and catheters for electroporation...", p.[0025]),”
“the catheter comprises at least two ablation electrodes, (Fig. 5, showing at least six ablation electrodes 304 as described in p.[0043] "First type catheter electrodes 304 are used by system 10 during electroporation."), configured for applying PF energy to the tissue (Fig. 5, p.[0043] "... First type catheter electrodes 304 are used by system 10 during electroporation...", note that electroporation is a type of PF energy)”,
“wherein the catheter is configured such that, in an ablation position of the catheter, the at least two ablation electrodes contact the tissue along a main axis of the catheter (Fig. 3-5 show electrodes were positioned along a main longitudinal axis, and therefore would contact tissue along a main longitudinal axis)”,
“wherein the catheter comprises at least two separate electrical conductors configured to connect said at least two ablation electrodes to said high-voltage pulse generator (Fig. 6, p.[0050] in particular, "… electrode wires 606 carry electrical current from a power source coupled to connector 208 to catheter electrodes 214... there are fifteen electrode wires. One electrode wire 606 is connected to all of first type catheter electrodes 304. The remaining fourteen electrodes 606 are connected to a different second type catheter electrode 306...")”.
Byrd does not explicitly “wherein the at least two separate electrical conductors are adapted to deliver a waveform with a peak voltage of at least 3000 V to said at least two ablation electrodes”. Byrd teaches that the electrosurgical generator can output a pulse of “peak magnitude of about between about negative one kilovolt (kV) and about negative two kV at the two hundred Joule output level” instead of the recited “peak voltage of at least 3000 V” as claimed by the invention. However, Long does in analogous pulsed waveform device. Long teaches “wherein the at least two separate electrical conductors are adapted to deliver a waveform with a peak voltage of at least 3000 V to said at least two ablation electrodes” in col. 14, lines 5-20 (where 6000 V is considered to be at least 3000 V). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Long in Byrd. As stated in Byrd p.[0026], “other embodiments may output any other suitable voltage, including a position voltage” and the use of a higher voltage output produces predictable results of delivering more energy to the desired tissue.
Regarding claim 2, the limitations of claim 1 are taught as described above. Byrd teaches “wherein the catheter is configured such that the tissue is ablated along a portion of the main axis, wherein the portion spans at least over a distance between the at least two ablation electrodes” in Figures 3-5 the orientation of electrodes 214, 304, 306, and 506 is over a portion of the main axis and spans a distance between ablation electrodes. The tissue would be ablated across the portion of the electrodes on the main axis (as further taught in p.[0003]), and therefore teaching the claimed limitation.
Regarding claim 3, the limitations of claim 1 are taught as described above. Byrd teaches “wherein the catheter is configured such that an elongated profile is ablated into the tissue” in Figures 3-5 the orientation of electrodes 214, 304, 306, and 506 is over a portion of the main axis and spans an elongated distance between ablation electrodes. The tissue would be ablated across the portion of the elongated profile of the electrodes on the main axis, and therefore teaches the claimed limitation.
Regarding claim 4, the limitations of claim 1 are taught as described above. Byrd teaches “wherein at least one of the at least two ablation electrodes is positioned at a sidewall of the catheter such that it is distanced to a tip of the catheter” in Figures 3-5 which show that the electrodes 214, 304, 306, and 506 are positioned on the side of the catheter at a distance from a tip of the catheter, therefore teaching the limitation as described.
Regarding claim 5, the limitations of claim 1 are taught as described above. Byrd teaches “wherein the at least two ablation electrodes are arranged as two or more pairs of ablation electrodes positioned along the main axis” in Figure 5, specifically the use of electrode pairs 214/304/506 positioned along the main axis and therefore teaches the claimed limitation. Note that any electrodes can be defined as pair and be selected for use individually or as a pair, as described in p.[0019].
Regarding claim 6, the limitations of claim 5 are taught as described above. Byrd does not explicitly teach "wherein the catheter is configured such that at least two of the two or more pairs of ablation electrodes simultaneously apply separate pulses of the electrical energy to the tissue in the ablation portion", but does suggest that the system is capable of such a configuration in p.[0019], which states "The first type catheter electrodes are all electrically connected together to a single connection in the catheter." The first type catheter electrodes, 214/304/506 are connected to a single connection and therefore could deliver electrical energy substantially simultaneously and separately, if desired (p.[0038, 0043]). Note that any electrodes can be defined as pair and be selected for use individually or as a pair, as described in p.[0019]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Byrd to arrive at the claimed invention. As stated in Byrd, it is known in the art of electroporation to deliver pulses of energy and such energy delivery produces predictable results of energy delivery (p.[0004,0020,0025]).
Regarding claim 7, the limitations of claim 5 are taught as described above. Byrd does not explicitly teach "wherein the two or more pairs of ablation electrodes are positioned along the main axis such that the application of the electrical energy in the ablation position causes a contiguous elongated profile without gaps ablated in the tissue", but does describe that the system is capable of achieving such a configuration. Byrd states in p.[0041-0044] that the first type electrodes "spacing may be developed to provide a targeted range of energy density to tissue, as well as provide sufficient electroporation coverage for different human anatomic geometries. In general, a sufficient number of electrodes 214 with appropriate lengths 310 and 312 are desired to provide substantially even and continuous coverage around the circumference of variable diameter loop 300". Note that any electrodes can be defined as pair and be selected for use individually or as a pair, as described in p.[0019]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Byrd to arrive at the claimed invention. As stated in Byrd (p.[0044]), different spaces and geometries may be developed to provide a targeted range of energy density to tissue, as well as to provide sufficient electroporation coverage for different human anatomic geometries and such a modification produces predictable results.
Regarding claim 8, the limitations of claim 1 are taught as described above. Byrd teaches the use of mapping electrodes for sensing the tissue in p.[0027, 0043], which in part (p.[0043]) states "A selection interface (discussed in more detail below), allows second type catheter electrodes 306 to be selectively used for electroporation and navigation/mapping" and teaches the limitation as described.
Regarding claim 9, the limitations of claim 8 are taught as described above. Byrd teaches that the catheter has a selection interface that allows for second type electrode catheters to act as either a mapping electrode or an ablation electrode, depending on the desired procedure of the device in p.[0043], whereas Figure 7 and p.[0053-0056] further describes how the selection interface performs this function. The selection interface allows for second type electrodes to function as either mapping or ablation electrodes to allow for electroporation and navigation/mapping without increasing the size of the shaft (p.[0045]).
Regarding claim 10, the limitations of claim 9 are taught as described above. Byrd does not explicitly teach the spacing between electrodes (either mapping nor ablation, where either first or second type electrodes can be ablation or mapping electrodes as detailed in p.[0043]), but does suggest that the system could be modified to arrive at the claimed range. Note that any electrodes can be defined as pair and be selected for use individually or as a pair, as described in p.[0019]. Byrd teaches in p.[0044] that "Diameter 400 and catheter electrode 214 spacing may be developed to provide a targeted range of energy density to tissue, as well as to provide sufficient electroporation coverage for different human anatomic geometries. In general, a sufficient number of electrodes 214 with appropriate lengths 310 and 312 are desired to provide substantially even and continuous coverage around the circumference of variable diameter loop 300, while still allowing enough flexibility to allow variable diameter loop 300 to expand and contract to vary diameter 400 to the desired extremes." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Byrd to arrive at the claimed invention. As stated in Byrd, modifying the spacing of the electrodes allows for a targeted range of energy density to tissue, to provide sufficient electroporation coverage for different human anatomic geometries (p.[0043]), with Byrd further recognizing that varying the length of diameter of electrodes (and therefore their spacing) may "help prevent arcing during electroporation operations" and produces predictable results.
Regarding claim 11, the limitations of claim 10 are taught as described above. Byrd does not explicitly teach the spacing between electrodes (either mapping nor ablation, where either first or second type electrodes can be assigned as pairs of ablation or mapping electrodes as detailed in p.[0043]), but does suggest that the system could be modified to arrive at the claimed inter-pair distance. Note that any electrodes can be defined as pairs and be selected for use individually or as a pair, as described in p.[0019]. Byrd teaches in p.[0044] that "Diameter 400 and catheter electrode 214 spacing may be developed to provide a targeted range of energy density to tissue, as well as to provide sufficient electroporation coverage for different human anatomic geometries. In general, a sufficient number of electrodes 214 with appropriate lengths 310 and 312 are desired to provide substantially even and continuous coverage around the circumference of variable diameter loop 300, while still allowing enough flexibility to allow variable diameter loop 300 to expand and contract to vary diameter 400 to the desired extremes." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Byrd to arrive at the claimed invention. As stated in Byrd, modifying the spacing of the electrodes allows for a targeted range of energy density to tissue, to provide sufficient electroporation coverage for different human anatomic geometries (p.[0043]), with Byrd further recognizing that varying the length of diameter of electrodes (and therefore their spacing) may "help prevent arcing during electroporation operations" and produces predictable results.
Regarding claim 12, the limitations of claim 11 are taught as described above. Byrd does not explicitly teach "wherein six of pairs of mapping electrodes are arranged on the catheter to function as three pairs of ablation electrodes", but does state that the second type electrodes 508 can become ablation electrodes (p.[0043,0045] and be selectively activated for ablation p.[0054-0057]). Note that any electrodes can be defined as pairs and be selected for use individually or as a pair, as described in p.[0019]. It is the Examiner's position that any six mapping electrodes arranged on the catheter could be selected to function as three pairs of ablation electrodes, given that there are a sufficient number of electrodes, and that the selection of specific electrodes does not provide any novelty or nonobvious results.
Regarding claim 13, the limitations of claim 8 are taught as described above. Byrd teaches “wherein the catheter comprises at least one pair of mapping electrodes and one pair of ablation electrodes”, “wherein the electrical conductors connected to the mapping electrodes are in a separate lumen of the catheter than the electrical conductors connected to the ablation electrodes”, and “wherein conductors connected to mapping and/or ablation electrodes of opposite polarity do not share a lumen” in Figure 5. Note that any electrodes can be defined as pairs and be selected for use individually or as a pair, as described in p.[0019]. Figure 5 shows at least a pair of mapping electrodes with second type electrodes 306 and at least a pair of ablation electrodes with first type electrodes 304, with each mapping electrode conductors and ablation electrode conductors having their own separate lumen within their own distinct wire, as taught in p.[0050] "Electrode wires 606 are isolated from one another and are not electrically connected to each other within catheter 200." The conductors do not share a lumen regardless of polarity as they are within their own distinct wire casings and therefore teaches the claimed limitation.
Regarding claim 14, the limitations of claim 8 are taught as described above. Byrd does not explicitly teach the spacing between electrodes (either mapping nor ablation, where either first or second type electrodes can be ablation or mapping electrodes as detailed in p.[0043]), but does suggest that the system could be modified to arrive at the claimed range. Note that any electrodes can be defined as pairs and be selected for use individually or as a pair, as described in p.[0019]. Byrd teaches in p.[0044] that "Diameter 400 and catheter electrode 214 spacing may be developed to provide a targeted range of energy density to tissue, as well as to provide sufficient electroporation coverage for different human anatomic geometries. In general, a sufficient number of electrodes 214 with appropriate lengths 310 and 312 are desired to provide substantially even and continuous coverage around the circumference of variable diameter loop 300, while still allowing enough flexibility to allow variable diameter loop 300 to expand and contract to vary diameter 400 to the desired extremes." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Byrd to arrive at the claimed invention. As stated in Byrd, modifying the spacing of the electrodes allows for a targeted range of energy density to tissue, to provide sufficient electroporation coverage for different human anatomic geometries (p.[0043]), with Byrd further recognizing that varying the length of diameter of electrodes (and therefore their spacing) may "help prevent arcing during electroporation operations" and produces predictable results.
Regarding claim 15, the limitations of claim 8 are taught as described above. Byrd does not explicitly teach the spacing between electrodes (either mapping nor ablation, where either first or second type electrodes can be ablation or mapping electrodes as detailed in p.[0043]), but does suggest that the system could be modified to arrive at the claimed range. Note that any electrodes can be defined as pairs and be selected for use individually or as a pair, as described in p.[0019]. Byrd teaches in p.[0044] that "Diameter 400 and catheter electrode 214 spacing may be developed to provide a targeted range of energy density to tissue, as well as to provide sufficient electroporation coverage for different human anatomic geometries. In general, a sufficient number of electrodes 214 with appropriate lengths 310 and 312 are desired to provide substantially even and continuous coverage around the circumference of variable diameter loop 300, while still allowing enough flexibility to allow variable diameter loop 300 to expand and contract to vary diameter 400 to the desired extremes." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Byrd to arrive at the claimed invention. As stated in Byrd, modifying the spacing of the electrodes allows for a targeted range of energy density to tissue, to provide sufficient electroporation coverage for different human anatomic geometries (p.[0043]), with Byrd further recognizing that varying the length of diameter of electrodes (and therefore their spacing) may "help prevent arcing during electroporation operations" and produces predictable results.
Regarding claim 16, the limitations of claim 1 are taught as described above. Byrd does not explicitly teach the spacing between electrodes (either mapping nor ablation, where either first or second type electrodes can be ablation or mapping electrodes as detailed in p.[0043]), but does suggest that the system could be modified to arrive at the claimed range. Note that any electrodes can be defined as pairs and be selected for use individually or as a pair, as described in p.[0019]. Byrd teaches in p.[0044] that "Diameter 400 and catheter electrode 214 spacing may be developed to provide a targeted range of energy density to tissue, as well as to provide sufficient electroporation coverage for different human anatomic geometries. In general, a sufficient number of electrodes 214 with appropriate lengths 310 and 312 are desired to provide substantially even and continuous coverage around the circumference of variable diameter loop 300, while still allowing enough flexibility to allow variable diameter loop 300 to expand and contract to vary diameter 400 to the desired extremes." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Byrd to arrive at the claimed invention. As stated in Byrd, it would have been obvious for one of ordinary skill in the art to try to modify the spacing of the electrodes to allow for a more targeted range of energy density to be applied to the tissue to provide sufficient electroporation coverage for different human anatomic geometries (p.[0043]), with Byrd further suggesting that varying the length of diameter of electrodes (and therefore their spacing) may "help prevent arcing during electroporation operations" and produces predictable results.
Regarding claim 17, the limitations of claim 1 are taught as described above. Byrd does not explicitly teach that the electric field inside cardiac tissue exceeds an intensity of 400 V/cm at a depth of 5mm when energized, but Byrd/Long does teach a system that is capable of achieving this range. It would have been obvious to one of ordinary skill of the art before the effective filing date of the art to use Byrd to arrive at the claimed invention, especially given that there is no criticality of the range expressed by the applicant. As stated in MPEP 2144.05, "In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)". Byrd/Long teaches a system that can achieve the range and therefore teaches the claimed invention.
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 Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/ Supervisory Patent Examiner, Art Unit 3794
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