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 .
Specification
The amendments to the Specification filed 12/22/2025 overcome the objection set forth in the last Office Action and are acceptable.
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.
Claims 1 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Mortier et al. (US Pat 6,193,705) in view of Weldon (US Pat 5,195,990).
Re claim 1, Mortier discloses a neurovascular catheter 40 (Fig 3A), comprising: an elongate flexible tubular body 18 (Fig 7), having a proximal end (to the left in Fig 7), an inclined distal end 80 and a side wall defining a central lumen (claim 12); a distal leading tip (labeled in Fig A below) on a first side (facing upward in Fig 7) of the inclined distal end (as seen in Fig 7); and a preset curve (Col 7, Lines 17-22) in a distal zone of the tubular body (as seen in Fig 7); wherein the distal leading tip lies on a concave side of the curve (as seen in Fig 7). Mortier does not explicitly disclose that the distal zone is configured to twist about a longitudinal axis of the elongate flexible tubular body in both clockwise and counterclockwise directions to self-orient within a vasculature of a patient without requiring rotation of the proximal end of the elongate flexible tubular body.
Weldon, however, teaches a catheter 10 (Fig 1) comprising an elongate flexible tubular body 12 (Fig 1) comprising a distal zone 20 (Fig 1) and a distal leading tip (at the distal-most end of zone 20, as seen in Fig 1) that is configured to twist about a longitudinal axis of the elongate flexible tubular body in both clockwise and counterclockwise directions to self-orient within a vasculature of a patient without requiring rotation of the proximal end of the elongate flexible tubular body (Col 5, Line 67 – Col 6, Line 4; Col 6, Lines 23-27; Col 6, Lines 36-44; Col 6, Lines 47-52; Col 6, Line 60 – Col 7, Line 3; Col 7, Lines 22-26) for the purpose of automatically adjusting the position of the distal leading tip to compensate if the catheter is mis-positioned (Col 6, Lines 32-36 and 44-46). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Mortier to include the elongate flexible tubular body such that its distal zone is configured to twist about a longitudinal axis of the elongate flexible tubular body in both clockwise and counterclockwise directions to self-orient within a vasculature of a patient without requiring rotation of the proximal end of the elongate flexible tubular body, as taught by Weldon, for the purpose of automatically adjusting the position of the distal leading tip to compensate if the catheter is mis-positioned (Col 6, Lines 32-36 and 44-46).
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Re claim 21, Mortier discloses that an entire length of the distal zone is curved so that the preset curve extends continuously from a proximal transition (labeled in Fig B below) of the distal zone to the distal leading tip (as seen in Fig 7 and annotated Fig B below, the convex side of the curve extends continuously from the proximal transition to the distal leading tip).
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Claims 2-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mortier et al. (US Pat 6,193,705)/Weldon (US Pat 5,195,990) in view of Yang et al. (PG PUB 2019/0336727).
Re claims 2 and 7-13, Mortier/Weldon discloses all the claimed features except a tubular radiopaque marker embedded in the sidewall that includes a proximal face and a distal face that inclines at an angle within a range of from about 45 degrees to about 80 degrees relative to a longitudinal axis of the central lumen (as required by claim 2), wherein the distal face of the radiopaque marker inclines at the angle within the range of from about 55 degrees to about 65 degrees relative to the longitudinal axis of the central lumen (as required claim 7), wherein the proximal face on the radiopaque marker is approximately perpendicular to the longitudinal axis (as required in claim 8), wherein the distal end of the tubular body is spaced apart from the distal face of the radiopaque marker to form an advance segment of the tubular body (as required by claim 9), wherein the advance segment has an axial length within a range of from about 0.1 mm to about 5 mm (as required by claim 10), wherein an axial length of the advance segment on a leading edge side of the tubular body is greater – specifically, at least about 20% longer – than the axial length of the advance segment on a trailing edge side of the tubular body (as required by claims 11 and 12), and wherein the radiopaque marker comprises at least one axial slit (as required by claim 13). Yang, however, teaches a catheter 3000 (Fig 31A) comprising an elongate flexible tubular body 3112 (Fig 31D) having an inclined distal end (to the left in Fig 31D) and a tubular radiopaque marker 3116 (Fig 31D) embedded in a side wall 3120+3124 (Fig 31D) of the tubular body (as seen in Fig 31D), the tubular radiopaque marker comprising a proximal face (to the right in Fig 31D; Para 243) and a distal face 3136, wherein the distal face of the radiopaque marker inclines at an angle within a range of from about 45 degrees to about 80 degrees relative to a longitudinal axis (extending horizontally in Fig 31D) of the central lumen (Para 11; Para 243 sets forth that the distal face 3136 is parallel to the distal surface 3126 and Para 242 sets forth that the distal surface is angled about 45 to about 80 degrees from the longitudinal axis), wherein the distal face of the radiopaque marker inclines at the angle within the range of from about 55 degrees to about 65 degrees relative to the longitudinal axis of the central lumen (Para 11; Para 243 sets forth that the distal face 3136 is parallel to the distal surface 3126 and Para 242 set forth that the distal surface is angled about 55 to about 65 degrees from the longitudinal axis), wherein the proximal face on the radiopaque marker is approximately perpendicular to the longitudinal axis (as seen in Fig 31D; Para 13,243), wherein the distal end is spaced apart from the distal face of the radiopaque marker to form an advance segment of the tubular body (as seen in Fig 31D, wherein the advance segment extends between face 3136 and surface 3126 and includes wall portions 3128,3134), wherein the advance segment has an axial length within a range of from about 0.1 mm to about 5 mm (Para 13,241), wherein an axial length of the advance segment on a leading edge side (facing upward in Fig 31D, possessing wall portion 3128) of the tubular body is at least about 20% longer than the axial length of the advance segment on a trailing edge side (facing downward in Fig 31D, possessing wall portion 3134) of the tubular body (Para 13,241), and wherein the radiopaque marker comprises at least one axial slit (not shown, but described in Para 244); Yang teaches that providing such a radiopaque marker aids in monitoring the positioning of the distal end of the catheter, compliments the angle of the inclined distal end (Para 220) and provides desired performance (Para 241,244). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Mortier/Weldon to include a radiopaque marker as claimed and to locate that radiopaque marker as claimed, as taught by Yang, for the purpose of aiding in monitoring the positioning of the distal end of the catheter, complimenting the angle of the inclined distal end (Para 220) and providing desired performance (Para 241,244).
Re claims 3-6, Mortier/Weldon discloses all the claimed features but does not explicitly disclose that the catheter comprises a distal port having an elliptical opening comprising an area that is at least about 105% – more specifically, at least about 110% and, even more specifically, within a range from about 110% to about 125% – of a cross-sectional area of the central lumen (as required by claims 3-5), wherein the elliptical opening inclines at an angle within a range of from about 55 degrees to about 65 degrees relative to a longitudinal axis of the central lumen (as required by claim 6). Yang, however, teaches a catheter 3000 (Fig 31A) comprising an elongate flexible tubular body 3112 (Fig 31D) having an inclined distal end (to the left in Fig 31D) with a distal port (at face 3126, as seen in Fig 31D) having an elliptical opening (as a result of the angled distal surface 3126, as seen in Fig 31D; Para 12) comprising an area that is from about 110% to about 125% of a cross-sectional area of the central lumen (Para 12,242), wherein the elliptical opening inclines at an angle within a range of from about 55 degrees to about 65 degrees relative to a longitudinal axis of the central lumen (Para 12,242); Yang teaches that having such an elliptical opening enhances clot aspiration or retention (Para 242). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Mortier/Weldon to include an elliptical opening having an area that is from about 110% to about 125% of a cross-sectional area of the central lumen and inclines at an angle within a range of from about 55 degrees to about 65 degrees relative to the longitudinal axis of the lumen, as taught by Yang, for the purpose of enhancing clot aspiration or retention (Para 242).
Claims 1-13 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (PG PUB 2019/0336727) in view of Mortier et al. (US Pat 6,193,705) and Weldon (US Pat 5,195,990).
Re claim 1, Yang discloses a neurovascular catheter 3000 (Fig 31A; wherein all reference numbers cited below refer to Fig 31D unless otherwise noted), comprising: an elongate flexible tubular body 3112, having a proximal end (to the left in Fig 31D), an inclined distal end (to the right in Fig 31D) and a side wall 3120+3124 defining a central lumen 3001 (Fig 31C, as seen in Fig 31D); and a distal leading tip 3132 on a first side (facing upward in Fig 31D) of the inclined distal end. Yang does not disclose that the tubular body possesses a preset curve in a distal zone thereof such that the distal leading tip lies on a concave side of the curve and does not explicitly disclose that the distal zone is configured to twist about a longitudinal axis of the elongate flexible tubular body in both clockwise and counterclockwise directions to self-orient within a vasculature of a patient without requiring rotation of the proximal end of the elongate flexible tubular body.
Mortier, however, teaches a catheter 40 (Fig 3A) comprising an elongate flexible tubular body 18 (Fig 7) having a inclined distal end 80 (Fig 7), wherein, the inclined distal end has a distal leading tip (labeled in annotated Fig A above; comparable to distal leading tip 3132 on a first side (facing upward in Fig 7), and the tubular body possesses a preset curve in a distal zone thereof (Col 7, Lines 17-22) such that the distal leading tip lies on a concave side of the curve (as seen in Fig 7) for the purpose of improving tracking of the distal end by preventing the distal end from diving into an outer radius of a vessel bend as it approaches the bend and by increasing pressure drag within the vessel (Col7, Lines 22-41). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Yang to include the tubular body with a preset curve in a distal zone thereof such that the distal leading tip lies on a concave side of the curve, as taught by Mortier, for the purpose of improving tracking of the distal end by preventing the distal end from diving into an outer radius of a vessel bend as it approaches the bend and by increasing pressure drag within the vessel (Col7, Lines 22-41). Mortier does not explicitly disclose that the distal zone is configured to twist about a longitudinal axis of the elongate flexible tubular body in both clockwise and counterclockwise directions to self-orient within a vasculature of a patient without requiring rotation of the proximal end of the elongate flexible tubular body.
Weldon, however, teaches a catheter 10 (Fig 1) comprising an elongate flexible tubular body 12 (Fig 1) comprising a distal zone 20 (Fig 1) and a distal leading tip (at the distal-most end of zone 20, as seen in Fig 1) that is configured to twist about a longitudinal axis of the elongate flexible tubular body in both clockwise and counterclockwise directions to self-orient within a vasculature of a patient without requiring rotation of the proximal end of the elongate flexible tubular body (Col 5, Line 67 – Col 6, Line 4; Col 6, Lines 23-27; Col 6, Lines 36-44; Col 6, Lines 47-52; Col 6, Line 60 – Col 7, Line 3; Col 7, Lines 22-26) for the purpose of automatically adjusting the position of the distal leading tip to compensate if the catheter is mis-positioned (Col 6, Lines 32-36 and 44-46). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Mortier to include the elongate flexible tubular body such that its distal zone is configured to twist about a longitudinal axis of the elongate flexible tubular body in both clockwise and counterclockwise directions to self-orient within a vasculature of a patient without requiring rotation of the proximal end of the elongate flexible tubular body, as taught by Weldon, for the purpose of automatically adjusting the position of the distal leading tip to compensate if the catheter is mis-positioned (Col 6, Lines 32-36 and 44-46).
Re claim 2, Yang discloses a tubular radiopaque marker 3116 embedded in the side wall (as seen in Fig 31D), the tubular radiopaque marker comprising a proximal face (to the right in Fig 31D; Para 243) and a distal face 3136, wherein the distal face of the radiopaque marker inclines at an angle within a range of from about 45 degrees to about 80 degrees relative to a longitudinal axis (extending horizontally in Fig 31D) of the central lumen (Para 11; Para 243 sets forth that the distal face 3136 is parallel to the distal surface 3126 and Para 242 sets forth that the distal surface is angled about 45 to about 80 degrees from the longitudinal axis).
Re claim 3, Yang discloses a distal port (at face 3126, as seen in Fig 31D) having an elliptical opening (as a result of the angled distal surface 3126, as seen in Fig 31D; Para 12), and wherein the elliptical opening comprises an area that is at least about 105% of a cross-sectional area of the central lumen (Para 12,242).
Re claim 4, Yang discloses that the area of the elliptical opening is at least about 110% of the cross-sectional area of the central lumen (Para 12,242).
Re claim 5, Yang discloses that the area of the elliptical opening is within a range of from about 110% to about 125% of the cross-sectional area of the central lumen (Para 12,242).
Re claim 6, Yang discloses that the elliptical opening inclines at an angle within a range of from about 55 degrees to about 65 degrees relative to a longitudinal axis of the central lumen (Para 12,242).
Re claim 7, Yang discloses that the distal face of the radiopaque marker inclines at the angle within the range of from about 55 degrees to about 65 degrees relative to the longitudinal axis of the central lumen (Para 11; Para 243 sets forth that the distal face 3136 is parallel to the distal surface 3126 and Para 242 set forth that the distal surface is angled about 55 to about 65 degrees from the longitudinal axis).
Re claim 8, Yang discloses that the proximal face on the radiopaque marker is approximately perpendicular to the longitudinal axis (as seen in Fig 31D; Para 13,243).
Re claim 9, Yang discloses that the distal end is spaced apart from the distal face of the radiopaque marker to form an advance segment of the tubular body (as seen in Fig 31D, wherein the advance segment extends between face 3136 and surface 3126 and includes wall portions 3128,3134).
Re claim 10, Yang discloses that the advance segment has an axial length within a range of from about 0.1 mm to about 5 mm (Para 13,241).
Re claim 11, Yang discloses that an axial length of the advance segment on a leading edge side (facing upward in Fig 31D, possessing wall portion 3128) of the tubular body is greater than the axial length of the advance segment on a trailing edge side (facing downward in Fig 31D, possessing wall portion 3134) of the tubular body (Para 13,241).
Re claim 12, Yang discloses that the axial length of the advance segment on the leading edge side of the tubular body is at least about 20% longer than the axial length of the advance segment on the trailing edge side of the tubular body (Para 241).
Re claim 13, Yang discloses that the radiopaque marker comprises at least one axial slit (not shown, but described in Para 244).
Re claim 21, Yang as modified by Mortier in the rejection of claim 1 above discloses all the claimed features with Mortier teaching that an entire length of the distal zone is curved so that the preset curve extends continuously from a proximal transition (labeled in Fig B above) of the distal zone to the distal leading tip (as seen in Fig 7 and annotated Fig B above, the convex side of the curve extends continuously from the proximal transition to the distal leading tip). The motivation cited in the rejection of claim 1 above also applies to this claim.
Response to Arguments
Applicant’s arguments filed 12/22/2025 have been considered but are moot in view of the present rejections that utilize the newly-cited Weldon reference to teach the amended limitation of claim 1.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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