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 Statements
The information disclosure statements filed January 8, 2025 and July 10, 2025 have been entered and the references cited therein have been considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: At para. 0051, spline 1004 should be spline 254; at para. 0065, resistive loads 430, 432 should be resistive loads 432, 434.
Appropriate correction is required.
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) 1-4, 6, 8, 12-15, 17 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harlev et al. (U.S. Patent Application Publication No. 2020/0360079).
In regard to claims 1, 6, 8, 12 and 17, Harlev et al. teach an ablation system 100 comprised of a catheter 104 having at least one ablation electrode 112, a plurality of return electrodes 106 and a generator 110 configured to apply energy between the ablation electrode 112 and the plurality of return electrodes 106 to generate a lesion at the ablation electrode 112 (see Fig. 1 and paras. 0017-0019). Figure 6 shows at least one resistor 142 (impedance load) positioned between the generator 110 and the plurality of return electrodes 106 (see also paras. 0039-0040). In regard to claims 2-4 and 13-15, Figure 1 shows that the return electrodes 106 are external patch electrodes (see also para. 0017). With further respect to claim 12, see Fig. 8 and paras. 0047-0052. In regard to claim 19, see paras. 0025 and 0043-0044.
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, 7, 9-11, 16, 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlev et al. (U.S. Patent Application Publication No. 2020/0360079) in view of Byrd et al. (PCT Publication WO 2021/113463).
In regard to claims 5 and 16, Harlev et al. are silent as to at least some of the return electrodes 106 being located on the catheter 104. However, Byrd et al. teach a similar ablation system comprised of return electrodes 18, 20 and 21, that may be catheter electrodes (see Fig. 1 and para. 0027). Byrd et al. thus demonstrate that it is well known in the art to provide return electrodes on an ablation catheter in lieu of providing return electrodes that are external. 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 ablation catheter system 100 of Harlev et al. with a return electrode that is positioned on the catheter 104 as an art-recognized alternative placement for return electrodes. In regard to claims 9-11 and 20, Harlev et al. are silent as to the type of catheter that catheter 104 is. However, Byrd et al. teach catheters with loop structures, basket structures and paddle structures (see Figs. 2-5). Byrd et al. thus demonstrate that the art is well aware of various shaped structures for catheters carrying electrodes. 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 catheter 104 of Harlev et al. in any of the various shapes (loop, basket or paddle) disclosed by Byrd et al. In regard to claims 7 and 18, Harlev et al. are silent as to whether the generator 110 applies a monophasic or a biphasic pulse to the electrodes (see para. 0019). However, Byrd et al. teach an ablation device using a pulse signal 700 generated by a generator 26 where the pulse signal can be biphasic or monophasic (see Fig. 7 and paras. 0057-0058). Byrd et al. thus demonstrate that generators providing both biphasic and monophasic pulses are 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 with ablation system of Harlev et al. with a generator that can provide both biphasic and monophasic pulses, in the manner disclosed by Byrd 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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