DETAILED ACTION
Applicant's amendments and remarks, filed 9/15/25, are fully acknowledged by the Examiner. Currently, claims 21-22, 24-40 are pending with claim 23 canceled, and claims 21 and 35 amended. The following is a complete response to the 9/15/25 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) 21-22, 25-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sliwa (US 2012/0265184) in view of Holmes (US 2018/0360531).
Regarding claim 21, Sliwa teaches a system comprising: a catheter for applying ablation energy to an ablation site (110), comprising: a proximal section (116); a distal section comprising a plurality of electrodes and a plurality of optical ports (114 with optical ports and electrodes 13a-b as in Fig. 2c and par. [0042]); an optical circuit configured to transmit an optical signal between the proximal section and the ablation site via the plurality of optical ports (optical circuit 128-130); and an electrical transmission medium coupling the plurality of electrodes and the proximal section (connection to 13a-b); a radio frequency (RF) source configured to provide an RF energy to the ablation site via the plurality of electrodes (120); a processing unit coupled to the catheter and configured to: analyze the optical signal returned from the ablation site via the optical circuit (par. [0044] polarized returned light with changes in polarization or bifringence); determine a structural change of the ablation site based on the optical signal (par. [0044)), and determine a condition of contact stability between the distal section and the ablation site by analyzing the optical signal (par. [0079)]).
Sliwa teaches an ablation energy source (120), but does not explicitly teach a pulsed field ablation energy source coupled to the catheter and configured to transmit pulsed electrical signals toa tissue sample.
However, Holmes teaches a catheter switching from RF energy to DC electroporation from a generator to tissue (par. [0049] switching from RF energy to DC electroporation to prevent thermal damage).
It would have been obvious to one of ordinary skill in the art to modify Sliwa with the switching sources from RF to electroporation of Holmes, as a known energy ablation mechanism that is capable of ablating tissue in the manner desired by Sliwa.
Regarding claim 22, Sliwa is silent regarding a control unit configured to choose between the RF source and the PFA source to couple to the catheter.
However, Holmes teaches switching from RF to DC electroporation (par. [0049] and par. [0072] with a controller).
It would have been obvious to one of ordinary skill in the art to modify Sliwa with the source being able to deliver RF and pulsed energy to tissue, as taught by Holmes, to allow for selective treatment of tissue.
Regarding claim 25, Sliwa teaches wherein the processing unit is further configured to monitor changes in a birefringence during delivery of the RF energy or the PFA energy to the ablation site (par. [0044] polarized returned light with changes in polarization or bifringence).
Regarding claim 26, Sliwa teaches wherein the processing unit is further configured to assess the ablation site in real time by comparing the structural change before and after the RF or PFA energy is applied to the ablation site (par. [0044] polarized returned light with changes in polarization or bifringence reflecting the changes in tissue structure).
Regarding claim 27, Sliwa teaches wherein the distal section comprises at least one of a helical, loop, radial, conical, cylindrical, or spherical structure (cylindrical, hemi-spherical distal tip as in at least Fig. 2c).
Regarding claim 28, Sliwa teaches a method for performing ablation in a patient, the method comprising: identifying contact between a distal end of a catheter inserted into vasculature of the patient and an ablation site (par. [0079]); determining a stability condition of the contact by measuring an optical signal applied through a plurality of optical ports on the distal end and returned from the ablation site (par. [0079] determining the condition of contact from the optical sensing); delivering an energy through the distal end to the ablation site from the energy source (par. [0044]); and assessing a lesion at the ablation site by measuring the optical signal (par. [0044)).
Sliwa teaches an ablation energy source (120), but does not explicitly teach a pulsed field ablation energy source coupled to the catheter and configured to transmit pulsed electrical signals toa tissue sample, selecting an energy source between a pulsed field ablation (PFA) energy source and a radio frequency (RF) energy source.
However, Holmes teaches a catheter switching from RF energy to DC electroporation from a generator to tissue (par. [0049] switching from RF energy to DC electroporation to prevent thermal damage).
It would have been obvious to one of ordinary skill in the art to modify Sliwa with the switching sources from RF to electroporation of Holmes, as a known energy ablation mechanism that is capable of ablating tissue in the manner desired by Sliwa.
Regarding claim 29, Sliwa teaches wherein assessing the lesion comprises measuring changes in polarization or phase retardation of the optical signal before and after delivering the energy to the ablation site (par. [0044] polarized returned light with changes in polarization or bifringence).
Regarding claim 30, Sliwa teaches wherein assessing the lesion comprises measuring changes in the optical signal in real time when delivering the energy to the ablation site (par. [0070] realtime assessment through light analyzer 130).
Regarding claim 31, Sliwa teaches wherein assessing the lesion comprises assessing a size of the lesion in realtime (par. [0070] realtime assessment through the light analyzer, par. [0072] lesion depth and volume).
Regarding claim 32, Sliwa teaches wherein assessing the lesion comprises assessing a depth of the lesion in real time (par. [0072] lesion depth and volume).
Regarding claim 33, Sliwa teaches wherein assessing the lesion comprises monitoring structural changes of the ablation site during delivering the energy to the ablation site (par. [0072)).
Regarding claim 34, Sliwa teaches further comprising continuing to determine the stability condition of the contact by measuring the optical signal while delivering energy to the ablation site (par. [0079] determining the condition of contact from the optical sensing).
Regarding claim 35, Sliwa teaches a catheter for ablating a tissue, the catheter comprising: a proximal section (116); a distal section (114); a shaft coupling the proximal section and the distal section (112); a plurality of electrodes disposed on the distal section and configured to deliver an energy to the
tissue (electrodes 12a-b as in Fig. 4); a plurality of optical ports positioned on the distal section and configured to transmit an optical signal to the tissue (13a-b act as windows to transmit optical signal to tissue); an electrical transmission medium disposed in the shaft and connecting the plurality of electrodes to an electrical connector on the proximal section (electrodes coupled to source 120 via the wires); and a plurality of optical fibers disposed in the shaft and coupled to the plurality of optical ports and an optical connector on the proximal section (14a-b in the shaft coupled to the ports and a connector to the source), wherein the optical connector is coupled to an external optical source and an external optical sensor (optical connector coupled to external source 130).
Sliwa is silent regarding wherein the electrical connector is connected to a radio frequency (RF) source and a pulse field ablation (PFA) source.
However, Holmes teaches a catheter switching from RF energy to DC electroporation from a generator to tissue (par. [0049] switching from RF energy to DC electroporation to prevent thermal damage).
It would have been obvious to one of ordinary skill in the art to modify Sliwa with the switching sources from RF to electroporation of Holmes, as a known energy ablation mechanism that is capable of ablating tissue in the manner desired by Sliwa.Sliwa further teaches the plurality of optical ports are separated from the plurality of electrodes (12a-b are separate from 13a-b).
Regarding claim 36, Sliwa is not explicit wherein the electrical connector is configured to switch between the RF source and the PFA source to couple to the electrical transmission medium.
However, Holmes teaches a catheter switching from RF energy to DC electroporation from a generator to tissue (par. [0049] switching from RF energy to DC electroporation to prevent thermal damage).
It would have been obvious to one of ordinary skill in the art to modify Sliwa with the switching sources from RF to electroporation of Holmes, as a known energy ablation mechanism that is capable of ablating tissue in the manner desired by Sliwa.
Regarding claim 37, Sliwa teaches wherein the distal section comprises a loop configuration (transmit and receive 14a-b form a loop as in Fig. 2c).
Regarding claim 39, Sliwa teaches wherein the distal section comprises a 3D spherical configuration extended from a surface of the distal section (13e as in Fig. 7).
Regarding claim 40, Sliwa teaches wherein each of the plurality of optical ports is positioned at a midpoint between a pair of the plurality of the electrodes (ports 13a-b are at a midpoint between the electrodes 12a-b).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sliwa in view of Holmes, in further view of Long (US 2014/0052126).
Regarding claim 24, Sliwa is not explicit wherein the PFA energy comprises a series of voltage pulses having peak-peak amplitudes between 500 Vpp to 1500 Vpp. However, Long teaches the generator configured to generate peak-peak voltage amplitudes of 200- 12,000 VAC (par. [0057]). It would have been obvious to one of ordinary skill in the art that the PFA energy comprises pulses with peak-peak amplitudes between 500-1500 Vpp, as a voltage that is capable of being provided by an electrosurgical generator.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sliwa in view of Holmes, in further view of Wittkampf (US 2017/0172654).
Regarding claim 38, Sliwa is not explicit wherein the distal section comprises a memory material. However, Wittkampf teaches the distal section of a similar probe device made of a memory shape material, allowing for different shapes to be assumed (par. [0023] 204 of a memory shape material). It would have been obvious to one of ordinary skill in the art to modify Sliwa with the memory shape material of Wittkampf as a way of adjusting the shape of the distal section to better position the device at the target area.
Response to Arguments
Applicant's arguments filed 9/15/25 have been fully considered but they are not persuasive. Applicant argues that Sliwa does not teach determining a stability condition of the contact, and that this . However, par. [0079] of Sliwa teaches that optical feedback varying as a function of tip application force and particularly how enwrapped, buried, or embedded the tip becomes in the tissue upon increasing force. That is, the optical feedback changes based on changing tissue contact, or a destability of the tissue contact.
Applicant further argues that the optical ports are separated from the electrodes. However, a new interpretation of Sliwa is being made looking to Fig. 4.
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