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 March 20, 2026 and June 15, 2026 have been entered and the references cited therein have been considered by the examiner.
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) 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maisano et al. (U.S. Patent No. 9,545,265) in view of Urbanski (U.S. Patent Application Publication No. 2023/0040020).
In regard to claim 12, Maisano et al. teach penetration apparatus 34 comprised of a sheath 12 with a lumen through with a catheter 38 is disposed where the catheter 38 extends distally relative to the sheath 12 (see Fig. 1C). Catheter 38 has flexible longitudinal members 14 (end effector) disposed at the distal end (see Figs. 1C, 3B and 3C). Flexible longitudinal members 14 are deployed from catheter 38 such that they transition from a first configuration with a first diameter to a second, atraumatic configuration with a second diameter greater than the first diameter (see Figs. 3A-3C). A dilator body 50 is slidaby disposed within the lumen of the catheter 38 and extends distally relative to the catheter 38 and the dilator body 50 contains within its lumen 51 a puncturing element 32 (see col. 20, lines 54-56 and col. 24, lines 20-28). Puncturing element 32 is used to puncture the fossa ovalis (see Figs. 3D-3E and col. 24, lines 48-50). Maisano et al. are silent as to the puncturing element 32 being able to deliver RF to puncture the fossa ovalis. However, Urbanski teaches a similar device for creating a puncture in tissue, specifically in a transseptal procedure (see para. 0076), with a puncture device 110 that comprises a flexible RF guidewire 10 that has a distal electrode tip 10d for delivering RF energy in order to puncture tissue (see Fig. 1A and para. 0094). Urbanski thus demonstrates that the use of RF guidewires for puncturing tissue, specifically in transseptal procedures, 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 RF guidewire taught by Urbanski as the puncturing element 32 in Maisano et al. in order to deliver RF energy to puncture the fossa ovalis. In regard to claim 13, see col. 23, lines 22-37 of Maisano et al. In regard to claim 14, Maisano et al. teach that the flexible longitudinal members 14 are radiopaque and that ultrasound imaging of the flexible longitudinal members 14 may be used (see col. 232, lines 58-67). It follows that it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to make the flexible longitudinal member 14 echogenic so that they would be viewed on ultrasound. In regard to claim 15, see col. 22, lines 62-67 and Figs. 8A-8E showing mesh 94. In regard to claim 16, Maisano et al. are silent as to the structure of the dilator body 50. However, Urbanski teaches that the dilator includes a shapeable hypotube (a dilator shaft 32 extends along the proximal portion 31 and comprises the reinforcing member 34 which can be a hypotube) (see para. 0105). Urbanski thus demonstrates that dilators formed from hypotubes 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 form the dilator body 50 of Maisano et al. with the reinforcing member 34 of Urbanski so that the dilator body 50 has a shapeable hypotube.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maisano et al. (U.S. Patent No. 9,545,265) in view of Urbanski (U.S. Patent Application Publication No. 2023/0040020) and further in view of Salaheih et al. (U.S. Patent Application Publication No. 2008/01188928).
In regard to claim 17, Maisano et al. are silent as to the distal end portion of the sheath 12 having a lower durometer than a portion of the sheath proximal to the distal portion. However, Salaheih et al. teach a sheath for use with catheters (see para. 0002) where the distal end portion of the sheath is more compliant than other portions of the sheath to reduce compression and strain forces imparted to the sheath (see para. 0055). Salaheih et al. thus demonstrate that sheath having distal portions that are more compliant (and thus of a lower durometer) 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 form the sheath 12 of Maisano et al. with a more compliant distal end in order to reduce compression and strain forces.
Allowable Subject Matter
Claims 1-11 and 21-26 are allowed.
Claims 18-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not teach or fairly suggest the invention as recited in claims 1-11 and 21-26 of the instant application. Specifically, the prior art does not teach an apparatus with an outermost sheath and a dilator where the sheath has a distal end portion with an inner diameter that is less than a maximum outer diameter of the dilator when a portion of the dilator having the maximum outer diameter is disposed proximal to or distal to the distal end portion of the sheath (independent claim 1) or a sheath that has a distal end portion having a lower durometer than a portion of the sheath proximal to the distal end portion such that an inner diameter of the distal portion of the sheath is configured to expand and contract laterally according to an outer diameter of the dilator (independent claim 21). These features are shown in, e.g., Figs. 24A and 24B of the instant application. The prior art is only aware of tubular, consistent diameter outermost sheaths (such as Maisano et al., applied above). More flexible distal portions are known, as in Urbanski (applied above), but specific diameters and lateral expansion and contraction are not taught by the prior art.
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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