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.
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.
Claim(s) 1-3, 5, 8, 13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al., (US 20110257722; hereinafter Wilson) in view of Girourard et al., (US 20030069606; hereinafter Girourard) Redmond et al., (US 20020006429; hereinafter Redmond), and Brenneman et al., (US 6371974; hereinafter Brenneman).
Regarding claim 1, Wilson (Figures 7A-9B) discloses a stent delivery system comprising: a stent (10); and a vascular penetration catheter (31) having a tip (32), wherein the stent (10) is coupled to one (proximal) side of the vascular penetration catheter (31), and the tip (32) is bent toward the other (distal) side opposite to the one (proximal) side ([0104]-[0105], [0111]-[0112]). Wilson fails to disclose that the stent has an electrode. However, Girouard (Figures 2-3A) teaches a stent delivery system in which the stent (110) has electrodes (111) thereon ([0016]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wilson to include electrodes on the stent, as taught by Girouard, because the modification would enable treatment through the application of electrical energy through the electrodes at a desired target, as required (Girouard; [0016]).
Wilson/Girouard fails to teach that the vascular penetration catheter is configured to directly contact a blood vessel wall. However, Redmond (Figures 1-5) teaches a stent delivery system in which a vascular penetration catheter is inserted percutaneously in order to directly contact a blood vessel wall ([0048]-[0054]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wilson/Girouard to include percutaneous access of the target site to directly contact a blood vessel wall, as taught by Redmond, because the modification would enable direct access of a vein or artery through a percutaneous tissue track (Redmond; [0003]).
Wilson/Girouard/Redmond fails to teach a hemostatic component located at the tip of the vascular penetration catheter and configured to provide hemostasis by covering and occluding avascular penetration area upon deployment of the stent; wherein, upon deployment, the stent is configured to secure the vascular penetration catheter and the hemostatic component against the blood vessel wall, enabling selectable positioning and orientation for vascular access. However, Brenneman (Figures 3-3A) teaches a device for promoting hemostasis in a puncture, employed with an introducer that accesses the puncture through an incision, comprising a hemostatic component (74) located at the tip of the vascular penetration catheter (34) and configured to directly contact a blood vessel wall and provide hemostasis by covering and occluding a vascular penetration area upon deployment of the device; wherein, upon deployment, the device is configured to secure the vascular penetration catheter (34) and the hemostatic component (74) against the blood vessel wall, enabling selectable positioning and orientation for vascular access (Col. 7, lines 46-67). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wilson/Girouard/Redmond to include a hemostatic component, as taught by Brenneman, because the modification would effect local hemostasis in a target are as desired (Brenneman; Col. 7, lines 46-67).
Regarding claim 2, Wilson/Girouard/Redmond/Brenneman further teaches wherein the stent (Wilson; 10) comprises a plurality of electrodes (Girouard; 111) coupled with each other, and at least one of the plurality of electrodes (111) is configured to directly contact a blood vessel wall upon deployment of the stent (10), (Wilson; [0104]-[0105], [0111]-[0112]; (Girouard; [0016]).
Regarding claim 3, Wilson (Figures 7A-9B) further discloses a ballon catheter (31), wherein the stent (10) is provided on a balloon of the balloon catheter (31), ([0104]-[0105], [0112]).
Regarding claim 5, Wilson (Figures 7A-9B) further discloses wherein the vascular penetration catheter (31) further includes a support (41B) facing in an opposite direction to the tip (31) and configured to contact a side of the blood vessel wall which is opposite to the tip (32) when the stent is deployed ([0104]-[0105], [0112]).
Regarding claim 8, Wilson (Figures 7A-9B) further discloses at least one radiopaque marker attached to the stent (10) or the vascular penetration catheter (31), ([0121]).
Regarding claim 13, Wilson (Figures 7A-9B) further discloses a directional adjustment cannula (41A) inserted into the vascular penetration catheter (31), ([0107]).
Regarding claim 15, Wilson/Girouard/Redmond/Brenneman further teaches a device comprising the stent delivery system according to claim 1, as explained in the rejection of claim 1.
Claim(s) 6-7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson/Girouard/Redmond/Brenneman, as applied to claim 1 above, and further in view of Fischell et al., (US 20180279894; hereinafter Fischell).
Regarding claims 6-7 and 10, Wilson/Girouard/Redmond/Brenneman fails to teach an electrode wire capable of being positioned outside blood vessel through the vascular penetration catheter, wherein the electrode wire is a directional electrode having an electrode at its tip, wherein the electrode wire has a separable distal end. However, Fischell (Figures 1-2) teaches a treatment device comprising an electrode wire (30) capable of being positioned outside blood vessel through the vascular penetration catheter, wherein the electrode wire (30) is a directional electrode having an electrode (20) at its tip, wherein the electrode wire (30) has a separable distal end (20), ([0047]-[0052]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wilson/Girouard/Redmond/Brenneman to include an electrode wire capable of being positioned outside blood vessel through the vascular penetration catheter, wherein the electrode wire is a directional electrode having an electrode at its tip, wherein the electrode wire has a separable distal end, as taught by Fischell, because the modification would provide an integrated ablation and sensing system, which may also have major advantages over other technologies by allowing highly efficient, and reproducible circumferential ablation (Fischell; [0028]).
Claim(s) 9, 11-12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson/Girouard/Redmond/Brenneman, as applied to claim 1 above, and further in view of Wilson et al., (US 20050043779; hereinafter W2).
Regarding claim 9, Wilson/Girouard/Redmond/Brenneman fails to teach a stent deployment microcatheter configured to provide a passage for the vascular penetration catheter to which the stent is attached. However, W2 (Figures 8-9) teaches a stent delivery system including a stent deployment microcatheter (28) configured to provide a passage for a vascular penetration catheter (12) to which a stent (18) is attached ([0036]-[0040]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wilson/Girouard/Redmond/Brenneman to include a stent deployment microcatheter configured to provide a passage for the vascular penetration catheter to which the stent is attached, as taught by W2, because the modification would provide a low-profile configuration for the device during delivery into the target area (W2; [0038]).
Regarding claim 11, Wilson/Girouard/Redmond/Brenneman fails to teach a microarray tube into which the vascular penetration catheter is inserted. However, W2 (Figures 8-9) teaches a stent delivery system including a microarray tube (28) into which a vascular penetration catheter (12) is inserted ([0036]-[0040]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wilson/Girouard/Redmond/Brenneman to include a microarray tube into which the vascular penetration catheter is inserted, as taught by W2, because the modification would provide a low-profile configuration for the device during delivery into the target area (W2; [0038]).
Regarding claim 12, Wilson/Girouard/Redmond/Brenneman fails to teach a microarray tube configured to provide a passage for an insertion of an electrode wire, a penetration wire, and/or a directional adjustment cannula inside the vascular penetration catheter. However, W2 (Figures 8-9) teaches a stent delivery system including a microarray tube (28) configured to provide a passage for an insertion of a vascular penetration catheter (12) ([0036]-[0040]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wilson/Girouard/Redmond/Brenneman to include a microarray tube into configured to provide a passage for an insertion of the vascular penetration catheter, as taught by W2, because the modification would provide a low-profile configuration for the device during delivery into the target area (W2; [0038]). Furthermore, the catheter would carry a penetration wire (41B). Therefore, the microarray tube of the modified device would provide a passage for the penetration wire through the vascular penetration catheter.
Regarding claim 14, Wilson (Figures 7A-9B) further discloses a directional adjustment cannula (41A) inserted into the microarray tube through catheter (31), ([0107]).
Response to Arguments
Applicant’s arguments filed 11/14/2025, with regard to the newly amended claim limitations, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art reference Redmond and Brenneman. Redmond teaches a stent delivery system, wherein the vascular penetration catheter is inserted percutaneously. Brenneman teaches a hemostatic component located at the distal tip of the catheter. In combination with Wilson/Girouard/Redmond/Brenneman, the modified device teaches the invention as recited at least in the amended set of claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794