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 December 27, 2023 has been entered and the references cited therein have been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 15 recites the limitations "the recess." There is insufficient antecedent basis for this limitation in the claim. As claims 16-20 depend from claim 15, they are likewise rejected.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sliwa et al. (U.S. Patent No. 11,439,460) in view of Just et al. (U.S. Patent Application Publication No. 2015/0327923).
In regard to claims 1, 7-9, 15, Sliwa et al. teach a medical device comprised of a catheter body 414 with an electrode basket 400 (expansion body) arranged at the distal end 238 (see Fig. 3). The electrode basket 400 is affixed to the proximal end of catheter body 414 via proximal hub 412 (see Fig. 3). Electrode basket 400 also includes four electrically active splines 402, 404, 406, 408 each connected to a distal hub 410 as well as proximal hub 412 (see Fig. 3). Electrode basket 400 also includes an elongated catheter body 414 through which a pulling wire 413 runs and connects to distal hub 410 where pulling wire 413 can be used to expand and contract the electrode basket 400 into different configurations before, during and after an ablation procedure (see col. 8, lines 10-15). Also running through catheter body 414 are electrical wires 416, 418, 420 and 422 that are electrically connected to electrically active splines 402, 404, 406, 408, respectively (see col. 8, lines 15-22). Electrically active splines 402, 404, 406, 408 each include ablation electrodes 424, 426, 428, 430 where they are each insulated from the other electrodes and can act independently and without short circuits or other electrical interference problems (see Fig. 3 and col. 8, lines 36-52). Figure 3 shows that the electrodes 424, 426, 428, 430 are disposed at different positions in an axial direction of the catheter body 414. Sliwa et al. do not specifically teach a contact portion that connects the electrical wires 416, 418, 420 and 422 and the electrodes 424, 426, 428, 430. However, Just et al. teach a similar catheter system 10 with a basket 110 having a plurality of splines 116 with electrodes thereon (see Figs. 6 and 7). Each spline 116 has a flexible circuit 68 coupled with at least one electrode 62, 64 (see para. 0043 and Figs. 2-3). The flexible circuit 68 may include one or more electrical pads (contact portions) that provide an electrical connection with electrical traces 70a, 70b, 70c, 70d (see Fig. 2 and para. 0030). Both distally located pads 74 and proximally located pads 76 are provided (see Fig. 2) and the electrode 62 can be attached to the flexible circuit 68 using a variety of techniques in order to prevent relative movement (see para. 0033). Just et al. thus demonstrate that the art is well aware of providing electrical contact portions for connection between an electrical wire and an electrode and to prevent relative movement of 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 device of Sliwa et al. with the pads 74, 76 of Just et al. in order to equip the device of Sliwa et al. with a connection between the electrical wires 416, 418, 420 and 422 and the electrodes 424, 426, 428, 430 in order to prevent relative movement of the electrode. In regard to claims 2, 3, 10, 11, 16 and 17, Sliwa et al. teach that one or more pairs of electrically active splines may be sequentially stimulated (see col. 8, lines 53-67). As Sliwa et al. teach placing of the electrodes at axially different positions (see above), this would include disposing electrode pairs at positions different from each other in an axial direction (see also col. 8, lines 53-67 of Sliwa et al. which teaches that two adjacent or opposed electrically active splines may be used as a bipolar pair). In regard to claims 4, 12 and 18, Sliwa et al. teach that the electrodes 424, 426, 428, 430 are electrically insulated (see col. 8, lines 45-52). With further respect to claim 15, Sliwa et al. do not specifically state that the device is used to form a shunt in an oval fossa or is inserted from an inferior vena cava into the right atrium and into a hole formed in the oval fossa. However, this recitation is considered an intended use recitation that is given little patentable weight. Moreover, the structure recited by Sliwa et al. does not include any structural limitations that would preclude its use for forming a shunt in an oval fossa. Thus, the device taught by Sliwa et al. is capable of being used to form a shunt in an oval fossa and one of ordinary skill in the art at the effective filing date of the invention would have been motivated to utilize the device in such a manner. Finally, it should be noted that it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Also, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004). In regard to claims 5, 13 and 19, Just et al. teach that the catheter assembly can include a liner tube 88 and an outer covering 90 where the flexible circuit 68 is sandwiched between the liner tube 88 and the outer covering 90 (see Fig. 3 and paras. 0034-0036). The liner tube 88 functions to isolate the electrodes from other catheter components (see para. 0034) and the outer covering 90 provides protection for the overall catheter during use (see paras. 0036-0037). Just et al. thus demonstrate that the use of a multi-walled catheter tube with the electrical contacts embedded therein 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 Sliwa et al. with the multi-walled tube (liner tube 88 and outer covering 90) of Just et al. in order to provide the device with the ability to both isolate the electrodes from other catheter components provides protection for the overall catheter during use. In regard to claims 6, 14 and 20, Sliwa et al. teach that the catheter shaft 234 is flexible and can be steered or guided (see col. 6, lines 9-24).
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