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 .
Information Disclosure Statement
The information disclosure statement filed April 15, 2026 has been entered and the references cited therein have been considered by the examiner.
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) 1-10 and 13-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stewart et al. (PCT Publication No. 2019/022816).
In regard to claims 1-5, 8 and 11-18, Stewart et al. teach a system 10 to perform electroporation comprised of a catheter 12 with an expandable element 30 having a plurality of electrodes 18 where the catheter 12 is adapted to position the electrodes 18 in contact with target tissue (see Figs. 1-4 and page 10, line 3 to page 11, line 16). An energy generator 14 is in electrical communication with a control unit 42 (see page 14, lines 15-16). The electrodes 18 are configured to record impedance measurements from tissue and/or fluids (blood) surrounding and/or in contact with the electrodes 18 in order to monitor the proximity to target tissues and quality of contact with an area of targe tissues CEDS 16 (see page 14, line 31 to page 15, line 2). The electrodes 18 may be configured to record impedance measurements from tissue before, during and/or after the delivery of electroporation energy (see page 15, lines 2-4). Thus, Stewart et al. teach the delivery of pre-pulse signals to the electrodes 18. See also page 18, lines 5-12 and 24-32. The generator 14 may be configured to receive impedance measurements from the electrodes 18 and use the impedance measurement to activate an electrode from the electrodes 18 or deactivate an electrode from the electrodes 18 and electrodes 18 may be activated based upon the impedance measurements during ablation (see page 15, lines 8-12). When targeted tissue is identified with the impedance measurement, energy can be delivered to those electrodes in close proximity or in contact with specified tissue and electrodes 18 that are in contact with blood or tissue that is not desirable may be deactivated based upon a specific impedance measurement (see page 15, lines 13-17). The CEDS 16 may include high-speed relays to disconnect/reconnect specified electrodes 18 from/to the generator 14 during an energy delivery procedure (see page 15, lines 17-19). See also page 4, line 27 to page 5, line 11 for disclosure of a method. In regard to claims 6 and 7, Stewart et al. teach that each electrode 18 may include a temperature sensor, pressure sensor or other sensor and the sensor(s) may be in communication with the generator 14 and/or the CEDS 16 for initiating or triggering one or more alerts and/or therapeutic delivery modifications during operation of the catheter 12 (see page 15, lines 23-30). In regard to claims 9 and 10, see page 17, line 25 to page 18, line 3. In regard to claims 19 and 20, see page 4, lines 20-26.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following prior art references teach devices that determine the contact status of electrodes to target tissue: Govari et al., U.S. Patent Application Publication No. 2022/0192736 and Govari, EP 3785656.
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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