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 23, 2026, has been entered and made of record.
Previously Set Forth Objections and Rejections
The status of the objections and rejections set forth in the previous Office action (mailed March 23, 2026) is as follows:
The objections to the drawings have been overcome by amendments to the specification and the filing of replacement drawing sheets.
The objection to the specification has been overcome by amendments to the specification.
The objection to claim 12 has been overcome by amendments to claim 12.
The 35 USC 103 rejection of claims 1-20 are being unpatentable over Gandionco et al. (PCT Publication No. WO 2022/192522) in view of Govari et al. (EP973903) is hereby withdrawn.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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gandionco et al. (PCT Publication No. WO 2022/192522) in view of Hagstrom et al. (U.S. Patent Application Publication No. 2024/0341842).
The applied reference of Hagstrom et al. has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). Hagstrom et al. has an effective filing date of April 14, 2023, which predates the effective filing date of August 24, 2023 of the instant application.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
In regard to claims 1, 2, 16 and 17, Gandionco et al. teach a tissue modification system 100 for treating conditions of the heart using irreversible electroporation (see paras. 0005 and 00119) comprised of a treatment catheter 1502 having a shaft 1504 with a proximal portion and a distal end 1506 and an energy delivery body 1522 extending from the distal end 1506 of the shaft 1504 (see Fig. 24 and para. 00221). The energy delivery body 1522 comprises a plurality of conductive splines 1524 that each have a proximal portion secured to the distal end 1506 of the shaft 1504 and an opposite distal portion (see Fig. 34). The splines 1524 have a support member proximal portion coupled to the shaft distal end 1506 at shaft plug 1532 (see Fig. 35) and a distal portion terminating in a support member distal end at tip inner 1534 (see Figs. 34 and 35) where each of the splines 1524 are operable as a first ablation electrode configured to generate an electric field when a pulsed waveform is delivered to each spline 1524 as each of the splines 1524 are connected to a conductive wire that extends through the shaft 1504 for connection with the energy generator (see para. 00226). Gandionco et al. also teach that the splines 1524 are partially covered by insulative material 1528 located on the proximal side of the energy delivery body 1522 so that energy is directed through the uninsulated portions of the splines 1524 (see para. 00222 and Figs. 34-35). Tip Inner 1534 (distal retainer) is mechanically engaged with the distal portions of the splines 1524 and a shaft plug 1532 (proximal retainer) is mechanically engaged with the proximal portions of the splines 1524 and the tip inner 1534 mechanically couples all of the spline distal portions together (see Figs. 34 and 35). Gandionco et al. are silent as to a plurality of sensing electrodes disposed along the insulative material 1528. However, Hagstrom et al. teach an electroporation catheter 200 with an electrode assembly 210 having splines 216 with a dielectric (insulating) upper later 286A to which a sensing electrode 250 is affixed (see Fig. 2E and paras 0086-0087). Hagstrom et al. thus demonstrate that placing sensing electrodes on the insulative material on a spline is well known in the art. 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 Gandionco et al. with sensing electrodes on the insulative material, in the manner disclosed by Hagstrom et al., in order to provide the device with the ability to sense cardiac signals. In regard to claims 3, 5-7 and 18-19, Gandionco et al. teach that tip inner 1534 (proximal first piece) connects to distal tip electrode 1526 (second distal piece) and that distal tip electrode 1526 and the distal portions of splines 1524 form a smooth distal face for positioning against target tissue (see Figs. 34 and 35 and para. 00226). Figures 34 and 35 show that distal tip electrode 1526 is a conductive ball. In regard to claim 4, Gandionco et al. teach that distal tip electrode 1526 is used to detect areas of active cardiac tissue that are still needing to be treated or to record data (both sensing capabilities) (see para. 00223). In regard to claims 8 and 10-12, see para. 00222 of Gandionco et al. In regard to claim 9, Gandionco et al. teach electrodes 1542, 1544 disposed along the shaft 1504 (see Fig. 34 and para. 00227). In regard to claim 13, Figure 38 shows that shaft plug 1532 is mechanically abutted against the proximal portions of the splines 1524 and serves to space apart the proximal portions of the splines 1524. In regard to claims 14, 15 and 20, see Figure 35 of Gandionco et al.
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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