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 and Amendment Filed
Applicant’s response and amendment, filed June 3, 2026, has been entered and made of record.
Information Disclosure Statement
The information disclosure statement filed July 14, 2026 has been entered and the references cited therein have been considered by the examiner.
Previously Set Forth Interpretations and Rejections
The status of the interpretations and rejections set forth in the previous Office action (mailed March 3, 2026) is as follows:
The 35 USC 112(f) interpretation of the claims is hereby withdrawn.
The 35 USC 112(b) rejections of claims 8, 9, 18 and 19 have been overcome by amendments to those claims.
The 35 USC 102(a)(2) rejection of claims 1-20 are being anticipated by Callas et al. (U.S. Patent Application Publication No. 2013/0218157) is hereby withdrawn.
The following new grounds of rejection are set forth:
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) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gutbrod et al. (U.S. Patent Application Publication No. 2021/0369341).
In regard to claims 1-4, 8, 10-14, 18 and 20, Gutbrod et al. teach an electrophysiology system 50 comprised of an electroporation catheter system 60, an electro-anatomical mapping (EAM) system 70 which includes a localization field generator 80, a mapping and navigation controller 90 and a display 92 (see Fig. 1). Additional equipment such as a foot controller 96 allows an operator to control various aspects of the system 50 (see Fig. 1 and para. 0052). The electroporation catheter system 60 includes an electroporation catheter 105 and an electroporation console 130 where the electroporation catheter system 60 is configured to generate, based on models of electric fields, graphical representations of the electric fields that can be produced using the electroporation catheter 105 and to overlay, on the display 92, the graphical representations of the electric fields on an anatomical map of the patient’s heart (see para. 0054). The electroporation catheter system 60 is configured to generate graphical representations of the electric fields based on characteristics of the electroporation catheter 105 and the position of the catheter 105 in the patient 20 and the characteristics of the tissue surrounding the catheter 105 (see para. 0054). The electroporation console 130 is configured to control functional aspects of the system 60 by modeling the electric fields that can be generated by the catheter 105, which often includes consideration of the physical characteristics of the catheter 105 including the electrodes and spatial relationship of the electrodes on the catheter 105 (see para. 0055). The electroporation console 130 includes one or more controllers, microprocessors and/or computers that execute code out of memory to control and/or perform the functional aspects of the system 60 (see para. 0056). One electroporation catheter 300 includes a first group of electrodes 314 and a second group of electrodes 316 that are operably connected to the console 130 where the console is configured to provide electric pulses to the electrodes 314, 316 and to produce electric fields that can ablate cardiac tissue (see paras. 0078-0079). Figure 5 outlines a method of planning ablation that includes step 500: determining the location of the electrodes 314, 316 in the patient in relation to cardiac tissue 302; step 502, determining characteristics of the cardiac tissue 302 near or surrounding the catheter in the patient; step 504, modeling electric fields that can be generated by different combinations of the electrodes 314, 316 and selecting electrodes 314, 316 best suited for ablating the targeted cardiac tissue 302 (see para. 0107). This step includes providing user inputs like voltage amplitude (see para. 0107). Step 506 includes determining the surface area and depth of the cardiac tissue that would be affected by an electric field, determining electric pulses for producing the electric fields between the electrodes 314, 316 and determining dosing parameters for the electric fields, such as electric field strengths and the length of time that the electric field is applied to the cardiac tissue (see para. 0108 and Fig. 5). Step 508 includes generating by the console 130 and based on the models of the electric fields, graphical representations of the electrode fields that can be produced using selected electrodes and generating graphical representations of the electric fields based on the characteristics of the catheter 300 in the patient and characteristics of the cardiac tissue 302 surrounding the catheter 300 in the patient (see Fig. 5 and para 0109). Step 510 includes displaying on display 92 the graphical representations of the electric fields and the anatomical map of the patient which can be used to aid in the planning of the ablation and the graphical representations can be dynamically changed changes of position of the catheter, changes in the catheter changes in pulse parameters and changes in measured impedance values (see paras. 0110-0112 and Fig. 5). Figure 4C shows a predicted zone of reversible electroporation 420 and a predicted zone of irreversible electroporation 422 that are determined based on models of the electric fields that will or could be generated using selected electrodes of the electrodes 314, 316 where the area and depth of the predicted zones 420, 422 change depending on different pulse parameters of the electric pulses applied to the electrodes 314, 316 (see para. 0099). In regard to claims 5 and 15, see para. 0086. In regard to claims 6, 7, 16 and 17, see para. 0090. In regard to claims 9 and 19, see paras. 0075-0078.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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