DETAILED ACTION
This action is in response to applicant's amendments filed 11/20/24.
The examiner acknowledges the amendments to the claims, specification, and abstract.
Claims 1-6 are pending in this application.
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 .
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Mori (U.S. Pub. No. 2008/0125726) in view of Bonnette et al., hereinafter “Bonnette” (U.S. Pub. No. 2008/0188831).
Regarding claim 1, Mori disclose a thrombus suction catheter (see abstract) comprising:
a suction tube 1 (Figures 1-3) including a suction lumen 11 ([0035]) configured to suction a thrombus within a blood vessel;
a guide wire insertion tube 13 (Figure 3) including a guide wire lumen (within tube) configured to allow a guide wire to be inserted; and
a distal tip (see distal tip portion of device including suction port 12; Figures 2-3) attached to distal ends of the suction tube 1 and the guide wire insertion tube 13 (Id.), the distal tip including a distal lumen (near suction port 12) communicating with the suction lumen 11 of the suction tube ([0036], [0040]).
However, Mori does not disclose a tube mounting groove extending in an axial direction provided on an outer peripheral surface of the distal tip, and the guide wire insertion tube separate from the distal tip is inserted into the tube mounting groove and fixed to the distal tip.
Bonnette teaches in Figures 16-17, 19 a catheter for removing a thrombus including a distal tip portion 154 of tube 146 including a guide wire insertion tube 155 ([0095]) and a tube mounting groove (rounded slot 188; [0093]) extending in an axial direction provided on an outer peripheral surface of the distal tip (see guidewire tube 155 positioned in slot 188 in Figure 19), and the guide wire insertion tube separate from the distal tip is inserted into the tube mounting groove (Id.) and fixed to the distal tip ([0093]; guidewire tube 155 can be secured to slot 188 by an adhesive or other suitable attachment methods).
It would have been obvious to one of ordinary skill before the effective filing date to modify Mori with a tube mounting groove as claimed, as taught by Bonnette, in order to maintain a “desired minimal catheter profile” (Bonnette; [0095]) when the guide wire insertion tube is attached to the distal tip. Also, Mori acknowledges in [0042] that the guide wire insertion tube is connected with the distal tip in a manner that reduces the outer diameter of the catheter body, which improves the “crossability” and facilitates advancement through tortuous vasculature. Since Bonnette teaches a known technique for connecting a guide wire insertion tube within a catheter tip in a low-profile manner, it would have been obvious to one of ordinary skill before the effective filing date to modify the distal tip of Mori with a mounting groove with the guide wire insertion tube inserted into the tube mounting groove as claimed, since doing so would yield predictable results, namely minimizing the profile of the catheter for improved trackability through vasculature. See MPEP 2143.
Regarding claim 2, Mori as modified teaches the distal lumen includes a suction opening part opening (suction port 12; Figure 3 of Mori) to a lateral side on the outer peripheral surface of the distal tip (Id.), and an obstruction wall face (see annotated Figure 3 of Mori below) obstructing a distal side of the distal lumen is provided on the distal side of the suction opening part of the distal tip, and the tube mounting groove is arranged at a position away from the suction opening part in a circumferential direction of the distal tip (guidewire tube 13 in Mori is arranged at a position away from the suction opening part 12 in a circumferential direction of the distal tip [see Figure 3], and in combination with Bonnette, the tube mounting groove 188 that holds the guidewire tube would also be positioned away from the suction opening part in a circumferential direction).
FIGURE 3 of MORI
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Regarding claim 3, Mori as modified teaches a distal end portion of the distal tip comprises a small-diameter part including a tapered part (see annotated Figure 3 of Mori above), while a proximal end portion of the distal tip comprises a large-diameter part (Id.) having a circular cylinder shape (Figures 3-4 of Mori) with a diameter larger than that of the small-diameter part, and the suction opening part opens on the large-diameter part (Id.).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mori (U.S. Pub. No. 2008/0125726) in view of Bonnette (U.S. Pub. No. 2008/0188831), as applied to claim 2 above, and further in view of Itou et al., hereinafter “Itou” (U.S. Pub. No. 2006/0069381) and Masubuchi et al., hereinafter “Masubuchi” (U.S. Pub. No. 2019/0000500).
Regarding claim 4, Mori as modified teaches the claimed invention, as discussed above, including an X-ray transmission hole (inside distal tip, and exposed by suction port 12 in Mori, Figures 3-4) being formed at a position that overlaps with the suction opening part in a diametrical direction of the distal tip (Id.), except for the distal tip being formed of a resin material mixed with an X-ray opaque material, and the X-ray transmission hole penetrating a bottom wall of the tube mounting groove.
Itou teaches a thrombus suction catheter with a distal tip 22 (Figure 3) being formed of a resin material mixed with an X-ray opaque material ([0029]) so that the operator can confirm the distal end portion of the catheter.
It would have been obvious to one of ordinary skill before the effective filing date to modify the distal tip to be formed with a resin and X-ray opaque material, as taught by Itou, in order to facilitate visualization of a leading distal tip during advancement through vasculature.
Furthermore, Masubuchi teaches an X-ray transmission hole (lumen of tube 50; Figures 2, 5-6) that penetrates a bottom wall of a tube mounting groove 58 (the lumen of the tube 50 penetrates or extends into slit 58 of the tube, wherein a guide wire insertion tube 40 is inserted into or mounted on the slit; [0053]).
It would have been obvious to one of ordinary skill before the effective filing date to modify the distal tip of Mori as modified such that the X-ray transmission hole penetrates a bottom wall of the tube mounting groove, as taught by Masubuchi, since doing so would be substituting one known tube mounting groove for another, which would have yielded predictable results, namely securely mounting a guide wire tube within the catheter. See MPEP 2143.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Mori (U.S. Pub. No. 2008/0125726) in view of Bonnette (U.S. Pub. No. 2008/0188831), as applied to claim 2 above, and further in view of Simpson (U.S. Patent No. 4,979,951) and Makino et al., hereinafter “Makino” (U.S. Pub. No. 2013/0053763).
Regarding claim 5, Mori as modified teaches the claimed invention, as discussed above, except for a distal side wall face of the suction opening part has an inclination angle with respect to the axial direction of the distal tip larger than that of a proximal side wall face of the suction opening part.
Simpson teaches a catheter for removing a thrombus including a distal tip 12 with a suction opening part 14 opening to a lateral side (Figure 1A) with a distal side wall face 17 having an inclination angle with respect to an axial direction of the distal tip and a proximal side wall face 18 also having an inclination angle with respect to the axial direction of the distal tip (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the suction opening part of Mori as modified such that there are distal and proximal side wall faces that are inclined, as taught by Simpon, which will ensure that a substantial portion of a thrombus can fit within the suction opening part (Simpson; col. 5, lines 39-40 and see Figure 2B that fits atheroma 93 within the suction opening part).
However, Simpson does not teach that the distal side wall face inclination angle is larger than that of the proximal side wall face.
Makino teaches a catheter used in vasculature ([0012]), pertinent to the particular problem of removing material from a blood vessel, with a distal tip “side hole” used to remove the material from the blood vessel and is analogous to a suction opening part. The side hole 23 (Figure 16) has a distal side wall face 24 having an inclination angle with respect to an axial direction of the distal tip, and a proximal side wall face 25 having an inclination angle with respect to the axial direction of the distal tip, wherein the distal side wall face inclination angle is larger than that of the proximal side wall face ([0078]; the distal inclination angle may be approximately 33 degrees while the proximal inclination is set to approximately 28 degrees, for example). Makino teaches that the inclination angles may be set at values such that the side wall is unlikely to catch on the blood vessel when the catheter is inserted or withdrawn, making it easier to move the catheter within the vessel ([0064]), wherein the angles do not necessarily have to be equal ([0078]).
It would have been obvious to one of ordinary skill before the effective filing date to modify Mori as modified with Simpson such that the distal side wall face inclination angle is larger than that of the proximal side wall face, as taught by Makino, since doing so would be obvious to try with a reasonable expectation of success, and doing so would yield predicable results, namely preventing the catheter from catching onto a blood vessel wall during insertion and withdrawal. See MPEP 2143.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mori (U.S. Pub. No. 2008/0125726) in view of Bonnette (U.S. Pub. No. 2008/0188831), as applied to claim 1 above, and further in view of Laub (U.S. Pub. No. 2017/0043066).
Regarding claim 6, Mori as modified teaches the claimed invention, as discussed above, except for a control mechanism configured to induce curving deformation of the distal ends of the suction tube and the guide wire insertion tube by exerting operating force from an outside. Mori does acknowledge the relevance of the suction catheter being able to curve in order to enhance “crossability” and flexibility through sharp bends and tortuous vasculature (Figure 8; [0050]).
Laub teaches a suction catheter with a control mechanism 220 (Figure 2, [0032]) configured to induce curving deformation of a distal end 210 of a suction tube of the catheter by exerting operating force from an outside (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify Mori as modified with a control mechanism as claimed, as taught by Laub, in order to help steer and advance the catheter through a patient’s vasculature.
Conclusion
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/DIANE D YABUT/Primary Examiner, Art Unit 3771