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 September 20, 2024 has been entered and the references cited therein have been considered by the examiner.
Preliminary Amendment
Applicant’s preliminary amendment, filed June 20, 2024, has been entered and made of record.
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, 4, 9, 10, 11, 13-15 and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tran et al. (U.S. Patent Application Publication No. 2019/0117302).
In regard to claims 1, 2 and 14, Tran et al. teach a therapeutic system 100 comprised of a neuromodulation catheter 102 having an elongate shaft 108 with a proximal end portion 108a, a distal end portion 108b and an intermediate portion 108c (see Fig. 1 and para. 0024). A neuromodulation element 112 is operably connected to the distal end portion 108b of the shaft 108 (see Fig. 1). At the proximal end portion 108a and extending distally through a majority of the intermediate portion 108c is a proximal hypotube segment 128, a proximal jacket 130, a first electrically insulative tube 132 and a guide-wire tube 134 where the first electrically insulative tube 132 and the guide-wire tube 134 can be disposed side by side within the proximal hypotube segment 128 (within its lumen) (see para. 0027). The first electrically insulative tube 132 can be configured to carry electrical leads to electrically insulate the electrical leads from the proximal hypotube segment 128 and the proximal hypotube segment 128 can include a distal skive 138 at its distal end (see Fig. 2 and para. 0027). The first electrically insulative tube 132 can extend distally beyond the distal skive 138 and the first electrically insulative tube 132 extends proximally beyond a proximal end of the proximal hypotube segment 128 (as it serves to electrically insulate the electrical leads from the proximal hypotube segment 128) (see Figs. 2 and 3 and para. 0028). In regard to claims 4 and 15, Tran et al. teach a proximal stem 136 at the proximal end of proximal hypotube segment 128 and proximal jacket 130 constitutes a second lumen where the proximal hypotube segment 128 terminates within the proximal jacket 130 (see Fig. 7 and para. 0032). In regard to claims 9 and 13, see para. 0029 of Tran et al. In regard to claim 10, Tran et al. teach that the intermediate tube 140 in intermediate portion 108c has a metal braid 140b that is formed from stainless steel (see para. 0029). With further respect to claim 15 and in regard to claims 11 and 20, see paras. 0040-0041 and Fig. 21 of Tran et al.
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) 3, 5, 12, 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (U.S. Patent Application Publication No. 2019/0117302) in view of Welch et al. (U.S. Patent Application Publication No. 2019/0117240).
In regard to claims 3, 5, 12 and 16, Tran et al. are silent as to the attachment between the first electrically insulative tube 132 and the distal skive 138 (the distal portion of the proximal hypotube segment 128). However, Welch et al. teach a similar catheter with multiple layers that can be attached by thermal polymer heat shrinking or reflow (see para. 0029). Welch et al. thus demonstrate that the use of reflowed polymers to attach the layers of a catheter structure 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 use the reflowed polymer disclosed by Welch et al. in order to attach the first electrically insulative tube 132 and the distal skive 138 of Tran et al. In regard to claim 17, since first electrically insulative tube 132 resides within the proximal hypotube segment 128, the reflowed polymer disclosed by Welch et al. would necessarily attach the electrically insulative tube 132 to the inner diameter of the proximal hypotube segment 128.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (U.S. Patent Application Publication No. 2019/0117302) in view of Kunis (U.S. Patent Application Publication No. 2013/0204311).
In regard to claim 6, Tran et al. are silent as to the attachment between the first electrically insulative tube 132 and the distal skive 138 (the distal portion of the proximal hypotube segment 128). However, Kunis teaches that it is well known in the art to use a friction fit to attach two elements (see para. 0188). Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to use the friction fit disclosed by Kunis in order to attach the first electrically insulative tube 132 and the distal skive 138 of Tran et al. Since first electrically insulative tube 132 resides within the proximal hypotube segment 128, the friction fit disclosed by Kunis would necessarily attach the electrically insulative tube 132 to the inner diameter of the proximal hypotube segment 128.
Claim(s) 7 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (U.S. Patent Application Publication No. 2019/0117302) in view of Grovender et al. (U.S. Patent No. 9,687,634).
In regard to claims 7 and 18, Tran et al. are silent as to the attachment between the first electrically insulative tube 132 and the distal skive 138 (the distal portion of the proximal hypotube segment 128). However, Grovender et al. teach a similar catheter with a skived tubular member 30 that uses a melting process to attach a polymer tube to the skived tubular member (see col. 2, line 45 to col. 3, line 2). Grovender et al. thus demonstrate that the use of a melting process to attach a tubular member and a skived segment 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 use the melting process disclosed by Grovender et al. in order to attach the first electrically insulative tube 132 and the distal skive 138 of Tran et al. Since first electrically insulative tube 132 resides within the proximal hypotube segment 128, the melting process disclosed by Grovender et al. would necessarily attach the electrically insulative tube 132 to the inner diameter of the proximal hypotube segment 128.
Claim(s) 8 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (U.S. Patent Application Publication No. 2019/0117302) in view of Beasley et al. (U.S. Patent No. 10,548,663).
In regard to claims 8 and 19, Tran et al. are silent as to the attachment between the first electrically insulative tube 132 and the distal skive 138 (the distal portion of the proximal hypotube segment 128). However, Beasley et al. teach a similar catheter with a skived tubular member 30 that uses an adhesive to attach a distal end portion 108b to a proximal portion 120a (see col. 6, lines 18-34). Beasley et al. thus demonstrate that the use of an adhesive to attach two tubular members 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 use the adhesive disclosed by Beasley et al. in order to attach the first electrically insulative tube 132 and the distal skive 138 of Tran et al. Since first electrically insulative tube 132 resides within the proximal hypotube segment 128, the adhesive disclosed by Beasley et al. would necessarily attach the electrically insulative tube 132 to the inner diameter of the proximal hypotube segment 128.
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