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 February 21, 2024 has been entered and the references cited therein have been considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-3, 7-14, 20-24, 26, 28 and 30-32) in the reply filed on January 6, 2026 is acknowledged. The traversal is on the ground(s) that there is substantial overlap in the subject matter of claims 37 and 38 of Group II and the claims of Group I and therefore it would not be a substantial examination burden to examine these claims together. This is found persuasive and accordingly, the restriction requirement is withdrawn. Claims 1-3, 7-14, 20-24, 26, 28, 30-32 and 37-38 have thus been examined.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include multiple reference character(s) not mentioned in the description. The following reference numbers appear in the drawings but are not mentioned in the specification: 138 (Fig. 2); 345, 460, 462, 463 (Fig. 5E); 82, 101, 102 (Fig. 6); 243 (Fig. 7A); and 605 (Fig. 11B). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are also objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “135” has been used to designate both the distal gap in Fig. 2 and the middle gap in Fig. 5A. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are also objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the braided wire layer 511 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: In para. 0127, Figure 67B should be Figure 7B and Figure 67A should be Figure 7A.
Appropriate correction is required.
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) 1-3, 7-14, 37 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kume et al. (U.S. Patent Application Publication No. 2021/0228847).
In regard to claims 1, 37 and 38, Kume et al. teach an access system 200 for establishing access to a carotid artery to treat coronary, peripheral and neurovascular disease states or for introducing an interventional device into an artery (see paras. 0012 and 0016). The access system 200 includes an access sheath 220 comprised of an elongated sheath body 222 that can have a length of between 80 and 110 cm when used from a femoral access site (see Fig. 2 and para. 0040). The access system 200 also includes a sheath dilator 260 or a kit with two or more tapered dilators 260A, 260B with distal sections that extend beyond the distal end of the sheath body 222 (see paras. 0060 and 0063 and Figs. 15 and 16). Kume et al. are silent as to the extent to which the dilators 260A, 260B extend beyond the distal end of the sheath body 222. However, since Kume et al. teach that the sheath body 222 can have a length of between 80 and 110 cm and since Kume et al. clearly show the dilators 260A, 260B extended beyond the distal end of the sheath body 222, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilize the device of Kume et al. such that the dilators 260A, 260B extend beyond the distal end of the sheath body 222 in a range of 10 cm to 30 cm. Furthermore, while Kume et al. do not specifically teach that at least one of the dilators 260A, 260B is configured to be inserted into the azygos vein from a vena cava, since Kume et al. does teach venous (arterial) access, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention that the device of Kume et al. is capable of use where at least one of the dilators 260A, 260B is inserted into the azygos vein from the vena cava. It should also 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 2 and 3, Kume et al. teach that the distal 2 to 5 cm of the sheath dilator 260 may be 20 to 50% more flexible than the proximal portion of the sheath dilator 260 (see para. 0060). Kume et al. also teach that the distal section of the first dilator 260A has a bending stiffness in the range of 50-100 N-mm2 and the distal section of the second dilator 260B has a bending stiffness in the range of 5 to 15 N-mm2 (see para. 0063). Kume et al. also teach that the sheath body 222 has a distalmost section that has a flexural stiffness in the range of 50-300 N-mm2 thus making the stiffness of the distal sections of each of the first dilator 260A and the second dilator 260B less than the stiffness of the distalmost section of the sheath body 222 (see para. 0047). In regard to claim 7, see Fig. 2 and para. 0060 of Kume et al. which demonstrate that the first dilator 260A and the second dilator 260B each have a proximal end, a distal end, and a working length between the proximal and distal ends, a central lumen for passage of guide wire 300 (see also para, 0084) and a distally decreasing outer diameter (see para. 0060) that ends in a tapered distal tip. In regard to claim 8, Kume et al. are silent as to the length of the working section of first dilator 260A and second dilator 260B. However, since Kume et al. teach that the elongated sheath body 222 that can have a length of between 80 and 110 cm, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to make the working section of the first dilator 260A and the second dilator 260B in a length between 60 cm and 145 cm in order to properly place the dilators within the sheath body 222 with the distal portions of the dilators extending from the distal end of sheath body 222 (as shown in Figs. 15 and 16). In regard to claims 9, 10 and 15, see para. 0061 of Kume et al. which teaches that the distal sections of the dilators are 2 to 5 cm. In regard to claims 11 and 12, Kume et al. teach that a dilator that has an angled tip 276 that is bent or angled relative to the longitudinal axis of the dilator for better direction into a branch of the venous structure (see Fig. 16 and para. 0070). Kume et al. also teach that the dilator may have a coil or braid reinforcement layer (see para. 0070) and that the sheath body 222 may assume an angled or curved shape (preformed) (see para. 0052). Since Kume et al. teach that the dilator can have an angled tip and that the sheath body 222 can be curved, it would have been obvious for one of ordinary skill in art at the effective filing date of the invention to make the angled tip 276 of the dilator in a preformed curve shape with an angle in the range of 90 degrees to 120 degrees and a radius of curvature in a range of 7 mm to 11 mm for the purpose of creating better direction into a branch of the venous structure. In regard to claim 13, Figure 16 of Kume et al. shows that the angled tip 176 has a straight section distal to the angle. It would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to make this straight distal section in a length between 5 mm to 10 mm given the overall length dimensions of the device. With further respect to claims 37 and 38, see para. 0067 of Kume et al.
Claim(s) 20-24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kume et al. (U.S. Patent Application Publication No. 2021/0228847) in view of Al-Jadda et al. (U.S. Patent Application Publication No. 2019/0298460).
In regard to claim 20, Figure 2 of Kume et al. shows that sheath body 222 has a proximal end, a distal end and a lumen therebetween as well as a tubular structure and that the distalmost end of the sheath 222 is most flexible (see para. 0047). Kume et al. teach that the sheath body 222 may vary in flexibility over its length and this change in flexibility may be achieved by various methods, such as changing a reinforcement structure or materials (see para. 0047). Al-Jadda et al. teach a medical instrument 100 with an elongated shaft 106 that comprises a plurality of bending stiffness zones and an outer layer 146 that can comprise a braided jacket having a jacket material 154 and braid 152 (see para. 0164 and Fig. 16D). The mechanical properties of the braided jacket can be modulated by adjusting the grand 152 geometry and the braid pic count (see para. 0165). Al-Jadda et al. thus demonstrate that utilizing a braided structure to change the flexibility of an elongated medical instrument 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 utilize the jacket material 154 and braid 152 of Al-Jadda et al. in the sheath 222 of Kume et al. to achieve the variance in flexibility of the sheath 222 over its length such that the stiffness of the sheath 222 decreases towards the distalmost portion of the sheath 222 in order to provide the method to change the flexibility over the length taught by Kume et al. In regard to claim 21, it follows that the braid 152 density would decrease towards the distal end of the sheath 222 and it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention that the structure of Kume et al. in view of Al-Jadda et al. would include a braid density decrease from 80 PPI to 40 PPI from proximal to distal end (see also para. 0047 of Kume et al.). In regard to claims 22-24 and 26, Al-Jadda et al. teach first bending stiffness zone 122, second bending stiffness zone 126, third bending stiffness zone 130 and fourth bending stiffness zone 134 (see para. 0167). Al-Jadda et al. thus demonstrate that multiple bending stiffness zones on an elongated medical instrument were well known in the art for the purpose of more precise operation of the instrument. 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 Kume et al. with three sections of different stiffness, all having the same inner diameter and wall thickness, in the manner disclosed by Al-Jadda et al., for the purpose of more precise operation of the instrument. With further respect to claim 23, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention that the structure of Kume et al. in view of Al-Jadda et al. would include a braid density decrease from 80 PPI to 60 PPI to 40 PPI from proximal to distal end (see also para. 0047 of Kume et al.). Al-Jadda et al. also teach that the jacket material 154 can include Pebax which is available in a range of durometers from 25-72D (see para. 0165).
Claim(s) 28 and 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kume et al. (U.S. Patent Application Publication No. 2021/0228847) in view of Panescu et al. (U.S. Patent No. 2019/0183569).
The applied reference has a common assignee 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. 103 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); 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 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. See generally MPEP § 717.02.
In regard to claims 28 and 30-32, see the above rejections for claim 1. With further respect to claim 28, Kume et al. are silent as to an ablation catheter that is configured to extend from the sheath 222 to the azygos vein at a level between T7 and T11. However, Panescu et al. teach a method and device for ablating a thoracic splanchnic nerve or nerve root (see para. 0014) by delivering an ablation catheter through a venous system of the patient and positioning the energy delivery device of the ablation catheter inside a vein selected from T9, T10 and T11 intercostal veins (see para. 0046). Panescu et al. thus demonstrate that it was well known in the art to provide an ablation catheter that extends from a delivery device to the azygos vein at a level between T7 and T11. Furthermore, as noted above, Kume et al. teach introducing an interventional device into an artery (see paras. 0012 and 0016). 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 system of Kume et al. with the ablation catheter taught by Panescu et al. and to extend the ablation catheter from the sheath 222 of Kume et al. to the azygos vein at a level between T7 and T11, in the manner disclosed by Panescu et al., in order to introduce an interventional device.
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