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 March 5, 2026, has been entered and made of record.
Previously Set Forth Rejections
The 35 USC 102(a)(2) rejection of claims 1-8 as being anticipated by Byrd et al. (U.S. Patent Application Publication No. 2021/0161582), as set forth in the previous Office action (mailed December 12, 2025), is hereby withdrawn.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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 4-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Byrd et al. (U.S. Patent Application Publication No. 2021/0161582) in view of Viswanathan et al. (PCT Publication No. WO 2017/119934).
In regard to claims 1, 4, 5, 7 and 8, Byrd et al. teach a system 10 for irreversible electroporation comprised of a catheter14 with an electrode assembly 12 comprised of a plurality of electrodes, return electrodes 18, 20, 21 and a generator 26 (see paras. 0023, 0026 and 0027 and Fig. 1). Figure 1 shows that the generator 26 is connected to both the catheter 14 and the return electrodes 18, 20, 21. System 10 further includes a computer system 32 that controls the generator 26 and is configured to run an algorithm that identifies and/or selects which electrodes or electrode pairs of electrode assembly 12 to energize (see para. 0029). Generator 26 is configured to energize the electrode elements in accordance with an electroporation energization strategy, which may be predetermined or user selectable (see para. 0051). The electrodes of electrode assembly 12 may be energized sequentially, such as a first pair of electrodes may be energized according to the electroporation energization strategy and subsequently, a second pair of electrodes may be energized according to the electroporation energization strategy (see para. 0052). The generator 26 may be a biphasic electroporation generator configured to generate a series of DC pulses with alternating polarities (see para. 0053). Figure 7 shows a pulse signal 700 that is a biphasic pulse signal including a first phase 702 having a first voltage amplitude 704 with a first polarity (positive) and a second phase 708 having a second voltage amplitude 710 with a second polarity opposite to the first polarity (negative) (see paras. 0057-0058). When the pairs of electrodes are activated sequentially, this pattern of pulse signals would be repeated. Byrd et al. are silent as to each pair of electrodes including three or more electrodes. However, Viswanathan teaches a similar system comprised of a pulse waveform generator and an ablation device coupled to the pulse waveform generator (see para. 0019) comprised of a catheter 15 with a plurality of electrodes 17 disposed along its shaft (see Fig. 1). Viswanathan teaches a timing sequence 632 of electrode activation where a hierarchical ablation waveform is applied to electrode sets and each set comprises at least one anode and at least one cathode (see Fig. 8 and para. 0050). Viswanathan also teaches that a complete sequence of electrode sets can also be subdivided into smaller subsequences of electrode sets/electrode subsets (see para. 0053). Viswanathan thus demonstrates that applying sequential power to electrode pairs where the pairs may have more than three electrodes (or a subset with more than three electrodes) is well known in the art for the purpose of optimizing the delivery of pulses. Furthermore, it is well settled that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Byrd et al. with electrode sets having more than 3 electrodes or to create subsets from the electrode sets disclosed by Byrd et al. such as each electrode set has more than three electrodes, in the manner disclosed by Viswanathan, in order to optimize the delivery of pulses. In regard to claim 6, Byrd et al. teach a basket electrode assembly 400 that includes a basket 402 coupled to a catheter body 404 by a suitable proximal connector 406 where basket 402 has a plurality of splines 408 and a distal coupler 410 at which each of splines 408 terminates (see Fig. 4 and para. 0035). Each of the plurality of splines 408 includes at least one electrode 414 and the splines are formed in a curved shape (see Fig. 4 and para. 0035). With further respect to claim 8, see claims 14-20 of Byrd et al.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 4-8 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. The newly applied reference of Viswanathan addresses applicant’s arguments regarding Byrd et al. failing to teach electrode groups with more than three electrodes (see pages 5-6 of the response filed 3/5/26).
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