DETAILED ACTION
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 .
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.
Election/Restrictions
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/17/2026.
Groups I and II are directed to two different inventions with different technical features that solve different technical problems, and therefore the restriction is maintained and deemed final.
Claim Rejections - 35 USC § 102
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.
Claims 1-6, 9, 11-12, 14-15, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Urbanski (WO 2021/161149), herein after “Urbanski”.
Regarding claim 1, Urbanski teaches “An apparatus (Fig. 3D, p.[074]) for transseptal catheterization (Fig. 4C-D, p.[077]), comprising a dilator (Fig. 3D, 102; p.[074]) having a proximal end, a distal end (Fig. 3D), and a lumen extending between the proximal end and the distal end (Fig. 3D, 110) and an energy delivery element (Fig. 3D, 104) attached to the distal end of the dilator (Fig. 3D) and configured to deliver sufficient energy to a tissue adjacent the distal end of the dilator to permit the dilator to penetrate the tissue (p.[076] "The cautery device 104 is configured for non-coring puncture of tissue.")”.
Regarding claim 2, the limitations of claim 1 are taught as described above. Urbanski teaches “wherein the energy delivery element comprises an electrode (p.[042] "The cautery device 104 (such as an electrode)")”.
Regarding claim 3, the limitations of claim 1 are taught as described above. Urbanski teaches “wherein the energy delivery element comprises a hollow cylindrical element inserted into the lumen at the distal end of the dilator (Fig. 3D-G)”.
Regarding claim 4, the limitations of claim 3 are taught as described above. Urbanski teaches “wherein an interior-facing energy-emitting surface of the energy delivery element is covered with an energy-inhibiting material (p.[070,076])” and “wherein at least a portion of a distal-facing energy-emitting surface of the energy delivery element is exposed.(Fig. 3D-G, p.[076])”.
Regarding claim 5, the limitations of claim 4 are taught as described above. Urbanski teaches “wherein between one-quarter and three-quarters of the distal-facing energy-emitting surface of the energy delivery element is exposed (Fig. 3F-G)”.
Regarding claim 6, the limitations of claim 1 are taught as described above. Urbanski teaches “further comprising a guidewire configured to be inserted through the lumen of the dilator (Fig. 4A-B, guidewire 908)”.
Regarding claim 9, the limitations of claim 1 are taught as described above. Urbanski teaches “further comprising an introducer sheath having a distal end, a proximal end, and a lumen extending therebetween (Fig. 1B, sheath 200)” and “wherein the dilator is configured to be inserted through the lumen of the introducer sheath. (p.[044])”.
Regarding claim 11, the limitations of claim 1 are taught as described above. Urbanski teaches “wherein the lumen comprises: a main lumen (Fig. 3D, lumen 110); and at least one secondary lumen (lumen for conductor 111).”
Regarding claim 12, the limitations of claim 11 are taught as described above. Urbanski teaches “wherein the at least one secondary lumen comprises a conductor lumen configured to accommodate an electrical conductor that is conductively coupled to the energy delivery element (Fig. 3D, lumen for conductor 111, p.[041] "The cautery device 104 is electrically coupled, via an elongated electrical conductor 111 (conductor) aligned along a length of the elongated medical dilator 102, to the proximal terminal")”.
Regarding claim 14, Urbanski teaches “An apparatus (Fig. 3D, p.[074]) for transseptal catheterization (Fig. 4C-D, p.[077]), comprising a dilator (Fig. 3D, 102; p.[074]) having a proximal end, a distal end (Fig. 3D), and a lumen extending therebetween” “and a guidewire configured to be inserted through the lumen of the dilator (Fig. 4A-B, guidewire 908) and having a distal end (Fig. 4A-B)”, “wherein at least one of the distal end of the dilator and the distal end of the guidewire comprises an energy delivery element (Fig. 3D, 104) configured to deliver sufficient energy to an adjacent tissue to permit penetration of the adjacent tissue (p.[076] ”The cautery device 104 is configured for non-coring puncture of tissue”)”.
Regarding claim 15, the limitations of claim 14 are taught as described above. Urbanski teaches “wherein the energy delivery element comprises an electrode attached to the distal end of the dilator. (p.[042] "The cautery device 104 (such as an electrode)")”.
Regarding claim 17, the limitations of claim 14 are taught as described above. Urbanski teaches “further comprising an introducer sheath having a distal end, a proximal end, and a lumen extending therebetween (Fig. 1B, sheath 200)” and “wherein the dilator is configured to be inserted through the lumen of the introducer sheath. (p.[044])”.
Claim Rejections - 35 USC § 103
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Urbanski in view of Hartmann (WO 2013/101632), herein after “Hartmann”.
Regarding claim 7, the limitations of claim 6 are taught as described above. Urbanski does not teach the limitation "wherein the lumen of the dilator further comprises a central lumen terminating at an opening in the distal end of the dilator and a side lumen terminating at a side port through a wall of the dilator proximate the distal end of the dilator" and "wherein the guidewire is configured to be inserted through the side lumen" but Hartmann does in an analogous transeptal device. Hartmann teaches "wherein the lumen of the dilator further comprises a central lumen terminating at an opening in the distal end of the dilator and a side lumen terminating at a side port through a wall of the dilator proximate the distal end of the dilator (Fig. 8A)" and "wherein the guidewire (110) is configured to be inserted through the side lumen (515)" in Fig. 8A. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the configuration of Hartmann in Urbanski. The use of a side lumen for the guidewire allows the system to deliver both the dilator and the guidewire through a single puncture to prevent against inadvertent injury to neighboring tissues and produces predictable results of reducing trauma to undesired tissues (page 21, lines 11-23).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Urbanski in view of Eyster (US 2021/0393327), herein after “Eyster”.
Regarding claim 8, the limitations of claim 1 are taught as described above. Urbanski does not teach the use of "further comprising a magnetic localization element carried by the dilator proximate the distal end", but Eyster does in an analogous biomedical device. Eyster teaches "further comprising a magnetic localization element carried by the dialtor proximate the distal end" in p.[0472] which states "magnetic sensors in the catheter". It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to use a magnetic localization element in the system of Urbanski as taught in Eyster. As stated in Eyster, the use of magnetic sensors allows for the user to understand where the device is within the human body and produces predictable results of tracking the device within the human body.
Claims 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski in view of Schuler (US 2021/0353354), herein after “Schuler”.
Regarding claim 10, the limitations of claim 1 are taught as described. Urbanski teaches “wherein the dilator further comprises a hypotube, wherein the hypotube defines the lumen, (Fig. 5A-C, p.[088])”, and “wherein the hypotube further comprises at least one of: a plurality of slots cut into a wall of the hypotube, wherein each slot of the plurality of slots extends at least partially around a perimeter of the hypotube and least partially through the wall of the hypotube (p.[088] "A hypotube is a long metal tube with micro-engineered features along its length")”. Urbanski does not teach the use of an additional coil in the apparatus, but Schuler does in an analogous dilator device. Schuler teaches in p.[0032] that " Distal region 106 comprises a softer polymer material with an optional embedded braid or coil". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a coil, as taught in Schuler, in Urbanski. As stated in Urbanski, the use of a coil is predictable "so that it is pliable and atraumatic when advanced through vasculature" and produces predictable results of a more controllable device through the vasculature of a patient during use.
Regarding claim 16, the limitations of claim 14 are taught as described above. Urbanski does not teach "wherein the energy delivery element comprises an exposed conductive distal end of the guidewire" but Schuler does in an analogous transseptal treatment device. Schuler teaches the use of an exposed conductive distal end of the guidewire as an energy delivery element in Fig. 4A-5C and p.[046,47,56]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a guidewire as an energy delivery element as taught in Schuler in Urbanski. The use of the guidewire as an energy delivery element allows for a single hole to be used to treat tissue and produces predictable results of limiting adjacent tissue damage.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Urbanski in view of Valley (US 2001/0016725), herein after “Valley”.
Regarding claim 13, the limitations of claim 11 are taught as described above. Urbanski does not teach " wherein the at least one secondary lumen comprises a pressure-measuring lumen having an open distal end" but Valley does in an analogous dilator device. Valley teaches " wherein the at least one secondary lumen comprises a pressure-measuring lumen having an open distal end" in Fig.5A and p.[0135]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Valley in the system of Urbanski. As stated in Valley, the use of the pressure-measuring lumen allows for desired pressure signal transmission to produce predictable results of adequate pressure for puncturing tissue via the device.
Conclusion
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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