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 .
Response to Amendment
Receipt is acknowledged of amendment filed 02/12/2026. Claims 1-20 are pending and an action on the merits is as follows.
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.
Claim(s) 1, 2, 4, 6-9, 11, 12, 14, 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Viswanathan (US 10,842,572).
Regarding claim 1, Viswanathan discloses a system for applying a series of pulse field ablation (PFA) pulse trains to tissue of a heart, the system comprising: energy-generating circuitry (waveform generator 130 or electric field generator 46); and a processor (42 with mapping system 140), configured to: using the energy-generating circuitry and a catheter in the heart (ablation device 110), apply one of the pulse trains in a series of pulse trains to be applied at a target location (Viswanathan discusses a target ablation zone which is considered to be a target location), store the target location of the catheter at which the one of the pulse trains is applied, track a position of the catheter following the application of the one of the pulse trains, based on the tracking, detect that the catheter is within a predefined distance from the location following a predefined minimum duration from a most recent one of the pulse trains, and in response to the detecting, apply another one of the pulse trains in the series of pulse trains at the target location using the energy-generating circuitry and the catheter (column 5, line 5- column 6, line 49; column 13, line 7-column 14, line 14, Viswanathan discloses a system which applies PFA to cardiac tissue with a mapping/position tracking system incorporated therein with a predefined distance between zones; column 17-18 also discusses the ablation zone creation where the position of the catheter is tracked and ablation pulses applied, the computation device evaluates the ablation zone or target location and decides whether to apply additional pulses or to move to better hit the target location within the ablation zone).
Regarding claim 2, Viswanathan discloses the system according to claim 1, wherein the processor is configured to detect that the catheter is within the predefined distance prior to a predefined maximum duration from the most recent one of the pulse trains (column 13, line 7-column 14, line 14).
Regarding claim 4, Viswanathan discloses the system according to claim 1, wherein the predefined distance is between 1 and 4 mm (column 13, line 55- column 14, line 6).
Regarding claim 6, Viswanathan discloses the system according to claim 1, wherein the processor is configured to apply the other one of the pulse trains upon the catheter being within the predefined distance (column 5, line 5- column 6, line 49; column 13, line 7-column 14, line 14).
Regarding claim 7, Viswanathan discloses the system according to claim 1, wherein the processor is configured to apply the other one of the pulse trains in response to the catheter reaching a minimum distance from the location (column 5, line 5- column 6, line 49; column 13, line 7-column 14, line 14).
Regarding claim 8, Viswanathan discloses the system according to claim 1, wherein the series is a first series and the target location is a first location, and wherein the processor is further configured to: apply a pulse train of a second series of PFA pulse trains using the energy-generating circuitry and the catheter in the heart, store a second location of the catheter at which the pulse train of the second series is applied, track the position of the catheter following the application of the pulse train of the second series, based on the tracking, ascertain that the catheter is not within the predefined distance from the second location following the predefined minimum duration, and prior to a predefined maximum duration, from a most recent pulse train of the second series, and in response to the ascertaining, output a warning (column 17, line 13- column 19, line 17).
Regarding claim 9, Viswanathan discloses the system according to claim 1, wherein the series is a first series and the target location is a first location, and wherein the processor is further configured to: apply a pulse train of a second series of PFA pulse trains using the catheter in the heart, store a second location of the catheter at which the pulse train of the second series is applied, track the position of the catheter following the application of the pulse train of the second series, based on the tracking, ascertain that the catheter is not within the predefined distance from the second location following the predefined minimum duration, and prior to a predefined maximum duration, from a most recent pulse train of the second series, and in response to the ascertaining, and in response to the catheter being at a third location within another predefined distance from the second location, select the third location for application of a third series of PFA pulse trains(column 17, line 13- column 19, line 17).
Regarding claim 11, Viswanathan discloses a method for applying a series of pulse field ablation (PFA)pulse trains to tissue of a heart, the method comprising: using a catheter in the heart, applying one of the pulse trains in a series of pulse trains to be applied at a target location; storing the target location of the catheter at which the one of the pulse trains is applied; tracking a position of the catheter following the application of the one of the pulse trains; based on the tracking, detecting that the catheter is within a predefined distance from the location following a predefined minimum duration from a most recent one of the pulse trains; and in response to the detecting, applying another one of the pulse trains in the series of pulse trains at the target location (column 5, line 5- column 6, line 49; column 13, line 7-column 14, line 14, Viswanathan discloses a system which applies PFA to cardiac tissue with a mapping/position tracking system incorporated therein with a predefined distance between zones; column 17-18 also discusses the ablation zone creation where the position of the catheter is tracked and ablation pulses applied, the computation device evaluates the ablation zone or target location and decides whether to apply additional pulses or to move to better hit the target location within the ablation zone).
Regarding claim 12, Viswanathan discloses the method according to claim 11, wherein the detecting comprises detecting that the catheter is within the predefined distance prior to a predefined maximum duration from the most recent one of the pulse trains (column 13, line 7-column 14, line 14).
Regarding claim 14, Viswanathan discloses the method according to claim 11, wherein the predefined distance is between 1 and 4 mm (column 13, line 55- column 14, line 6).
Regarding claim 16, Viswanathan discloses the method according to claim 11, wherein applying the other one of the pulse trains comprises applying the other one of the pulse trains upon the catheter being within the predefined distance (column 5, line 5- column 6, line 49; column 13, line 7-column 14, line 14).
Regarding claim 17, Viswanathan discloses the method according to claim 11, wherein applying the other one of the pulse trains comprises applying the other one of the pulse trains in response to the catheter reaching a minimum distance from the target location(column 5, line 5- column 6, line 49; column 13, line 7-column 14, line 14).
Regarding claim 18, Viswanathan discloses the method according to claim 11, wherein the series is a first series and the target location is a first location, and wherein the method further comprises: applying a pulse train of a second series of PFA pulse trains using the catheter in the heart; storing a second location of the catheter at which the pulse train of the second series is applied; tracking the position of the catheter following the application of the pulse train of the second series; based on the tracking, ascertaining that the catheter is not within the predefined distance from the second location following the predefined minimum duration, and prior to a predefined maximum duration, from a most recent pulse train of the second series; and in response to the ascertaining, outputting a warning (column 17, line 13- column 19, line 17).
Regarding claim 19, Viswanathan discloses the method according to claim 11, wherein the series is a first series and the target location is a first location, and wherein the method further comprises: applying a pulse train of a second series of PFA pulse trains using the catheter in the heart; storing a second location of the catheter at which the pulse train of the second series is applied; tracking the position of the catheter following the application of the pulse train of the second series; based on the tracking, ascertaining that the catheter is not within the predefined distance from the second location following the predefined minimum duration, and prior to a predefined maximum duration, from a most recent pulse train of the second series; and in response to the ascertaining, and in response to the catheter being at a third location within another predefined distance from the second location, selecting the third location for application of a third series of PFA pulse trains(column 17, line 13- column 19, line 17).
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.
Claim(s) 3, 5, 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan (US 10,842,572) in view of Francischelli (US 2010/0023004).
Regarding claims 3, 5, 13 and 15, Viswanathan discloses the system according to claims 1 and 2 and the method according to claims 11 and 12. While the processor/generator of Viswanathan would be capable of applying pulses at various times and durations with the corresponding mapping and evaluation of the application it fails to disclose wherein the predefined maximum duration is between 1 and 3 s and, wherein the predefined minimum duration is between 0.5 and 2 s. However, Francischelli discloses systems and method for cardiac tissue electroporation ablation with a pulse generator configured to apply pulses at various durations and ranges [Par 0031]. It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to have the system of Viswanathan operate at various pulse train times and durations as taught by Francischelli. Doing so allows for treating the cardiac tissue more effective especially through fatty areas of heart tissue and still minimize thermal damage.
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan (US 10,842,572) in view of Sliwa (US 2012/0265192).
Regarding claims 10 and 20, Viswanathan discloses the system according to claim 1 and the method according to claim 11, but fails to disclose wherein the processor is further configured to track a force applied to the catheter by the tissue, and wherein the processor is configured to apply each of the pulse trains in response to the force exceeding a predefined threshold. However, Sliwa discloses an RF ablation system with a contact force sensor incorporated into the catheter and the system is designed to apply pulses according to various measured parameters including force [Para 0058 and 0087]. It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to have the system of Viswanathan also utilize force as taught by Sliwa to control the output of pulse to target tissue. Doing so would allow for better evaluation of lesions within the cardiac tissue during pulse deployment.
Response to Arguments
Applicant's arguments filed 02/12/2026 have been fully considered but they are not persuasive. The applicant has argued that Viswanathan fails to disclose or suggest applying a series of pulse trains at a single target location or tracking a location of a catheter to ensure it has remained at the same location after a predetermined amount of time. The examiner respectfully disagrees. Within the description of Viswanathan, ablation zones are contemplated and these ablation zones are the targeted treatment area which is considered to be a target location. As discussed in columns 17 and 18 (not an exclusive recitation) the catheter position is tracked within these ablation zones and the treatment is evaluated. Ablation pulses can be repeated or moved within the target location or treatment zone and repeated. The current claim language does not require the catheter to be stationary and actually allows for a predetermined distance to be tracked. The examiner interprets the ablation zone as the predetermined distance allowed from Viswanathan. The cited prior art still anticipates the claimed apparatus and method.
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.
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/A.L.Z/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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