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 July 9, 2025 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- and 12-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hill, III et al. (U.S. Patent No. 6,746,446).
In regard to claims 1 and 4, Hill, III et al. teach an ablation catheter (Fig. 2, 3 (40)) comprising: an elongated structure (Fig. 2, 3 (42) configured to be at least partially inserted into a patient (Fig. 5A, 5B (40)), the elongated structure comprising a metallic element (Fig. 3 (50, 76)), the metallic element comprising a plurality of electrically conductive metallic wires (Fig. 3 (76)) comprising a polymer coated portion (Fig. 3 (78, 86)) and an exposed metallic portion (Fig. 2, 3 (50), col. 7, lines 43-43); and a plurality of electrodes (other more distal electrodes 50 in Figs, 2, 3) disposed at a distal portion of the elongated structure, wherein at least one of the plurality of electrodes and the exposed metallic portion are configured to provide a current path for at least one of pulsed field ablation or sensing (col. 3, lines 26-43). In regard to claims 12 and 15, Hill, III et al. teach providing an elongated structure (Fig. 2, 3 (42)) comprising a metallic element (Fig. 3 (50, 76)), the metallic element comprising a plurality of electrically conductive metallic wires (Fig. 3 (76)) having a polymer coating disposed thereon (Fig. 3 (78, 86)); removing at least a portion of the polymer coating from a portion of the plurality of electrically conductive metallic wires to create a polymer coated portion (Fig. 3 (78, 86)) and an exposed metallic portion (Fig. 2, 3 (50), col. 7, lines 34-43); and disposing a plurality of electrodes at a distal portion of the elongated structure (other more distal electrodes 50 in Figs. 2, 3), wherein at least one of the plurality of electrodes and the exposed metallic portion are configured to provide a current path for at least one of pulsed field ablation or sensing (col. 3, lines 26-43). In regard to claims 2 and 13, see col. 4, lines 15-16. In regard to claims 3 and 14, see col. 7, lines 44-46. In regard to claim 5, see col. 7, lines 22-26. In regard to claim 6, see Figs. 2 and 3. In regard to claims 7 and 16, see Figs. 2 and 3 and col. 7, lines 60-62. In regard to claim 8, see col. 4, lines 38-40 and col. 7, lines 60-62. In regard to claim 9, see col. 4, lines 38-40.
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) 10, 11, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill, III et al. (U.S. Patent No. 6,746,446) in view of Moisa (U.S. Patent Application Publication No. 2020/0022653).
In regard to claims 10, 11, 19 and 20, Hill, III et al. are silent as to an expandable structure on a distal portion of the elongated structure on which the distal electrodes 50 are disposed. However, Moisa teaches a catheter 206 with an elongated shaft member 214 and a structure 218 attached to the distal end of the shaft member 214 where transducers 220 are disposed on the structure 218 (see Fig. 2). Moisa thus demonstrates that expandable structure on a distal portion of the elongated structure on which the distal electrodes are disposed is well known in the art so that the electrodes/transducers can be selectively deployed. 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 elongated structure of Hill, III et al. with the expandable structure of Moisa, so that the distal electrodes 50 can be selectively deployed.
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill, III et al. (U.S. Patent No. 6,746,446) in view of Arnholt et al. (PCT Publication No. WO 2023/137008).
In regard to claims 17 and 18, Hill, III et al. are silent as to how the electrodes 50 are formed. However, Arnholt et al. teach various techniques that can be used to make electrodes, such as using a ribbon wire and laser cutting of a walled tube (see page 19, lines 24-32). Arnholt et al. thus demonstrate that using a ribbon wire and laser cutting a walled tube to form an electrode 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 electrodes 50 of Hill, III et al. using a ribbon wire or laser cutting a walled tube, in the manner disclosed by Arnholt et al.
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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