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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 23, 2026 has been entered.
Previously Set Forth Rejections
All of the previous rejection as set forth in the final rejection mailed November 6, 2025 are hereby withdrawn.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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 6, 7, 20 and 21 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Govari et al. (U.S. Patent Application Publication No. 2023/0190366 – hereinafter Govari ‘366).
The applied reference has a common assignee and inventor 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). This rejection under 35 U.S.C. 102(a)(2) 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) if the same invention is not being claimed; 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 in the reference 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.
In regard to claims 1-3, 6, 7, 20 and 21, Govari ‘366 teaches a system 20 used in IRE ablation procedures comprised of a catheter 22 with a deployable basket assembly 40 at the distal end of the catheter 22 (see Fig. 2A and para. 0041). The basket assembly 40 comprises multiple resilient spines 44 with electrodes 42 disposed on the spines 44 (see Fig. 2A and para. 0047). Each electrode 42 comprises a metal body 46 (substrate) where the metal body 46 contains a lumen that fits over the spine 44 and has an asymmetrical profile protruding outward away from the center of basket assembly 40 (see Fig. 2B and para. 0049). A thin ceramic film 48 (catalytic material) is deposited over the outer surface of metal body 46 and the film can comprise iridium oxide in a thickness between 100 and 10,000 nm (10,000 nm equals 0.003937 inches) (see para. 0050). Govari ‘366 also teaches that the metal body 46 comprises a suitable biocompatible metal such as gold or platinum that could be considered either conductive or non-conductive (see para. 0049). Govari ‘366 teaches performing IRE, which typically involves high voltages, and specifically state that the amplitude is at least 200V (see para. 0043).
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) 5, 8, 9, 11-14 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (U.S. Patent Application Publication No. 2023/0190366 – hereinafter Govari ‘366) in view of Govari et al. (U.S. Patent Application Publication No. 2023/0190363 – hereinafter Govari ‘363).
In regard to claim 5, Govari ‘336 teaches that the metal body 46 is formed from a suitable biocompatible metal such as gold or platinum (see para. 0050). Govari ‘363 teaches expandable superelastic elements 46 formed from nitinol (see para. 0019), which is similarly a biocompatible metal. It would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to form the metal body 46 of Govari ‘366 from nitinol as Govari ‘363 teaches that the use of nitinol is well known in the art. In regard to claim 8, see the above rejection for claim 1. With further respect to claim 8, Govari ‘366 is silent as to a polymer tube coupled to the spine 44 such that the spine extends through the polymer tube and the electrodes 42 are disposed on the polymer tube. However, Govari ‘363 teaches a similar system 20 for performing IRE with spines 36 formed from expandable superelastic elements 46 (nitinol) (see para. 0019) where spines 36 also include polymeric elements 48 that are sleeves 54 that cover the superelastic elements 46 (see Fig. 0037). The electrodes 40 are coupled to the sleeves so that the sleeves insulate the superelastic elements from the electrodes (see para. 0039). Govari ‘363 thus demonstrates that a polymer tube coupled to the spine such that the spine extends through the polymer tube and the electrodes are disposed on the polymer tube is well known in the art for the purpose of insulating the spine from the electrode. 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 spines 44 of Govari ‘366 with the polymeric sleeves 54 taught by Govari ‘363 where the electrodes 42 are disposed on the polymeric sleeves 54 in order to insulate the spines 44 from the electrodes 42. In regard to claim 9, as noted above, Govari ‘366 teaches that the thin ceramic film 48 is comprised of titanium nitride or iridium oxide but that other conductive materials may be used (see para. 0050). Given this broad disclosure, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to form the ceramic film 48 of Govari ‘366 from a platinum material as it would also be a conductive material (see also para. 0050 of Govari ‘366 which teaches the use of platinum. In regard to claim 11, Govari ‘366 teaches that the metal body 46 can comprise gold (see para. 0049). In regard to claim 12, Govari ‘363 teaches that the polymeric elements 48 are formed from polyethylene terephthalate (PET), which is a thermoplastic polymer (see para. 0037). In regard to claims 13 and 14, Figure 2A od Govari ‘366 shows that the spines 44 are formed from a planar sheet of material are Govari ‘363 teaches that the spines 36 formed from expandable superelastic elements 46 (nitinol) (see para. 0019). In regard to claims 16-18, Figure 2A of Govari ‘366 shows that the expandable basket 44 is positioned at the distal end of insertion tube 25, that each spine 44 includes a respective proximal end connected to the distal end of the insertion tube 25 and that the distal ends of the spines 44 converge at a central spine intersection proximately coincident with the longitudinal axis.
Claim(s) 15 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (U.S. Patent Application Publication No. 2023/0190366 – hereinafter Govari ‘366) in view of Govari et al. (U.S. Patent Application Publication No. 2023/0190363 – hereinafter Govari ‘363) and further in view of Okarski et al. (U.S. Patent Application Publication No. 2023/0225790).
In regard to claim 15, both Govari ‘366 and Govari ‘363 are silent as to the use of cobalt chromium to form the spines. However, Okarski et al. teach a similar medical system 20 with a basket assembly 38 with a plurality of spines 214 having struts 413 that may be formed from cobalt chromium (see para. 0019, Fig. 2A and paras. 0110-0111). Okarski et al. thus demonstrate that the use of cobalt chromium materials to form the spines or struts of an expandable member 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 form the spines of Govari ‘366 from the cobalt chromium disclosed by Okarski et al. In regard to claim 19, both Govari ‘366 and Govari ‘363 are silent as to the central spine intersection including one or more cutouts. However, as shown in Figures 2A and 3B, Okarski et al. teach one or more cutouts on the central spine intersection 211. Okarski et al. thus demonstrate that the use of cutouts is well known in the art to aid in the deployment of the expandable basket. 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 basket 40 of Govari ‘366 with the cutouts disclosed by Okarski et al. in order to aid in the deployment of the expandable basket.
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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