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 January 20, 2026, has been entered and made of record. Accordingly, the status of the claims is as follows: Claims 1-8, 11-16 and 18-20 are amended; claims 9, 10 and 17 are canceled; claims 21-23 are newly added.
Previously Set Forth Objections and Rejections
The status of the objections and rejections as set forth in the previous Office action (mailed October 17, 2025) is as follows:
The objection to claim 8 has been overcome by amendments to claim 8;
The 35 USC 112(b) rejection of claims 1-20 is hereby withdrawn;
The 35 USC 112(b) rejection of claim 14 has been overcome by amendments to claim 14;
The 35 USC 103 rejection of claims 1-20 is hereby withdrawn.
The following new grounds of rejection are set forth:
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) 1-8, 11-16 and 18-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dahlen et al. (PCT Publication No. WO 2024/182595).
In regard to claims 1, 3, 4, 6, 11, 12, 14, 19 and 21-23, Dahlen et al. teach a system 10 for irreversible electroporation (IRE) where electric current is delivered as a pulsed electric field in the form of short duration pulses (see Fig. 1 and paras. 0021 and 0022). The system 10 includes a catheter electrode assembly 12 on the distal end of a catheter 14 for treatment of cardiac tissue 16 where the electrode assembly 12 includes one or more electrodes, a navigation system 30 and a computer system 32 including an electronic control unit 50 and data-storage memory 52 (see Fig. 1 and paras. 0027-0028). An electroporation generator 26 is configured to energize the electrode elements and electric fields are applied between pairs of electrodes on electrode assembly in a bipolar approach (see paras. 0028 and 0030). Dahlen et al. teach that to reduce the potential for phrenic impact, a physician may avoid ablating areas near the phrenic nerve or use a lower dosage when ablating near the phrenic nerve (see para. 0068). Thus, Dahlen et al. teach methods for automatic phrenic nerve monitoring involving measuring diaphragm movement using one or more sensors placed on the patient’s body (see Fig. 5 and para. 0069). The one or more sensors may include impedance sensors, magnetic sensors, fiber-optic sensors, accelerometers and/or any other sensor suitable for sensing diaphragm movement (see para. 0069). At block 504, the catheter 14 is positioned at or proximate to a target tissue and at block 506, pulses are delivered sequentially to the electrodes of electrode assembly 12 (see Fig. 5 and para. 0073-0074). Also at block 506, diaphragm movement is measured where the measurements coincide with delivering of the pacing pulses and the diaphragm movement may be continually monitored as the pacing pulses are delivered sequentially to each pair of electrodes of the electrode assembly 12 (see para. 0078). Measurements taken while pacing pulses are delivered are compared to baseline diaphragm movement and if phrenic nerve capture is detected, the method proceeds to block 510 which determines which electrode pairs were determined to have captured the phrenic nerve (see Fig. 5 and paras. 0079-0080). Then, at block 512, a phrenic nerve safe ablation therapy may be performed that may include modifying the pulse parameters or disabling electrodes determined to have caused phrenic nerve capture (see Fig. 5 and paras. 0081-0082). Dahlen et al. also teach determining one or more capture thresholds (the minimum amount of electrical current necessary to stimulate the phrenic nerve) (see para. 0086). Dahlen et al. do not specifically teach that the degrees of spasm of the diaphragm are determined. However, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention that the device and method of Dahlen et al. could be used to measure the degrees of spasm of the diaphragm as it is designed to measure diaphragm movement. In regard to claims 2 and 18, since Dahlen et al. teach the use of one or more motion sensors and the sensors are specifically designed to sense diaphragm movement, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to place the motion sensors of Dahlen et al. at a first location on the left side of the diaphragm and at a second location on the right side of the diaphragm. In regard to claims 5 and 13, since Dahlen et al. teach the use of any suitable motion sensor (see para. 0069), it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilize wireless sensors as the motion sensors in Dahlen et al. With further respect to claims 6 and 14 and in regard to claims 7, 8, 15, 16 and 20, at block 510, electrode pairs which were determined to have captured the phrenic nerve and pacing pulses output by those pairs of electrodes are logged or recorded (see para. 0080). The information is sent to the localization and navigation system 30 of system 10 which uses the information to determine phrenic nerve capture locations and visually identify phrenic nerve capture locations on a 3D map displayed on the user interface of display 34B (see para. 0080). The phrenic nerve capture location may be visually identified in relation to catheter 14 and/or the target tissue and the user may use this information to select phrenic safe ablation levels and/or to disable specific electrodes (see para. 0083). As such, the 3D map is created by adding additional tissue locations where phrenic nerve capture is detected.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8, 11-16 and 18-23 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