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 .
Response to Arguments
Applicant's arguments, filed 08/27/2026, with respect to the claim objection of claim 13 has been fully considered and is persuasive. The claim objection of claim 13 has been withdrawn.
Applicant's arguments, filed 02/19/2026, with respect to the 35 U.S.C 103 rejection of claims 1-20 have been fully considered and are persuasive. Applicant’s argument that Ryan in view of Huemann fails to disclose or suggest “a wire with a distal segment interwoven into, and in contact with, the reinforcement braid” and instead teaches a straight wire opposed to a pull wire is persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mixter et al. (US PG Pub No. 2020/0061340 A1).
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) 1-8, 10-13, 15-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan (U.S Patent No 10,327,927) in view of Mixter et al. (US PG Pub No. 2020/0061340 A1).
Regarding claim 1, Ryan discloses a reinforced cardiovascular sheath and wire assembly comprising: an inner tube with an external surface extending between a proximal end and a distal end (Figs. 11 and 12, inner tube 101); a reinforcement braid in contact with the external surface of the inner tube (Col 6, lines 20-24, Figs 11 and 12, braid 100, PTFE inner tube 101); a wire (38) with a distal segment (21) and a proximal segment (107) extending proximally from the proximal end of the inner tube out of contact with the reinforcement braid ( Col 6, line 28-32, Fig 11, inner tube 101, braid 100); and an outer tube receiving, and in contact with, the reinforcement braid and the inner tube (Col 6, lines 20-24, Figs 11 and 12, braid 100, polymer outer tube 102, inner tube 101); and wherein the distal segment (21) of the wire (38) is located on one side of a plane that contains a centerline of the outer tube (Figs. 11-12, outer tube 102).
Ryan discloses the distal segment (21) of the wire (38) being attached to the reinforcement braid (100) in a number of ways (see col. 6, lines 11-13), but fails to disclose the attachment includes the distal segment (21) of the wire (38) being interwoven into, and in contact with, the reinforcement braid. Mixter also discloses a reinforced cardiovascular sheath and wire assembly (Fig. 54A, elongate inner body 110) comprising pull wires (Fig. 54A, tensioning elements 111 and 112) attached to a reinforcement braid (Paragraph [0291], “braided material in elongate inner body 110”). Mixter teaches the distal segment (Fig. 54A, distal region 115) of the wire (111 and 112) is interwoven into and in contact with the reinforcement braid (Paragraph [0291], “111 and 112 interwoven with braided material of 110, see Fig. 54A where 111 and 112 are each on one side of the elongate member and wrapping is optional as indicated by the phrase “can be” and as disclosed in paragraph [0032]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the distal segment of Ryan’s wire interwoven into, and in contact with, the reinforcement braid, as taught by Mixter, in order to secure the pull wires to the braided material (Paragraph [0291]).
Regarding claim 2, Ryan in view of Mixter discloses wherein the inner tube (Fig. 11, inner tube 101) has length that is about equal to a length of the outer tube (Fig. 11, outer tube 102); and the reinforcement braid (Fig. 11, braid 100) has length that is shorter than both the inner tube and the outer tube (Fig. 11).
Regarding claim 3, Ryan in view of Mixter discloses wherein the proximal segment (majority segment 19) of the wire (pull 38) is longer than the distal segment (Col 6, lines 1-4, distal attachment segment 21, stating the distal segment constitutes a minority length of the pull).
Regarding claim 4, Ryan in view of Mixter discloses wherein the inner tube is PTFE (Col 6, lines 18- 21, inner tube 101); the outer tube is a polymer jacket (Col 6, lines 18- 21, outer tube 102); and the wire is metallic (Col 1, lines 62-64).
Regarding claim 5, Ryan in view of Mixter discloses wherein the inner tube (Fig. 11, inner tube 101) has length that is longer than the distal segment (Fig. 11, distal attachment segment 21) of the wire (Fig. 11, pull 38).
Regarding claim 6, Ryan in view of Mixter discloses wherein the wire (38) has a cross section with a width (Fig. 14, width 103) that is greater than a thickness (Fig. 14, Col 5, lines 65-66, thickness 104).
Regarding claim 7, Ryan in view of Mixter discloses wherein the wire (38) has a curved cross section (Fig. 14, Col. 3, lines 40-41) with a concave side (Fig. 14, concave side 47) that is opposite to a convex side (Fig. 14, Col 6, lines 49-51, convex side 48).
Regarding claim 8, Ryan in view of Mixter discloses wherein a proximal segment (majority segment 19) of the wire (38) extends proximally beyond the proximal end of the reinforcement braid (Fig. 11, pull wire 38 (majority segment 19) extends proximally beyond braid 100), and is laminated between the inner tube (inner tube 101) and the outer tube (Fig. 11, Col 6, lines 20-23, outer tube 102).
Regarding claim 10, Ryan in view of Mixter discloses wherein different strand segments of the reinforcement braid (braid 100) are in contact with an inner surface and an outer surface, respectively, of the distal segment (21) of the wire (38) due to the interweaving taught by Mixter (Paragraph [0291]).
Regarding claim 11, Ryan in view of Mixter discloses wherein the distal segment of the wire has a curved cross section (Col 6, lines 49-57, Fig. 7, Fig. 14) with a curvature that matches a curvature of the reinforcement braid (Col. 6, lines 16-23, Fig 11, shows braid is laminated between the inner and outer tube showing the braid is tubular itself, which leads to the curvature).
Regarding claim 12, Ryan discloses a vascular intervention device delivery system (Fig. 1) comprising: a handle (Col 1, lines 48-50, Col 2, line 62, handle 61); a catheter with a proximal end attached to the handle (Col 1, lines 48-50, Col 3, lines 2-3, inner catheter 30, proximal end 31, handle 61), and a distal carrier segment for mounting a vascular intervention device thereon (Col 1, lines 50-51, Col 3, lines 4-6, distal carrier segment 32), and defining a longitudinal axis (Col 1, lines 51-52, Col 6, lines 55-57, longitudinal axis 36); a retractable sheath that includes a reinforcement braid (Col 6, lines 36-39, Fig 11, braid 100, retractable sheath 37) and is movable from a first position covering the distal carrier segment to a second position retracted proximally uncovering the distal carrier segment (Col 3, lines 14-18, distal carrier segment 32); a pull wire attached to, the reinforcement braid of, the retractable sheath (Col 3, lines 31-35, Fig 11, pull 38, retractable sheath 37, attachment 39, braid 100) and extending proximally from the retractable sheath toward the handle (Col 1, lines 55-57, pull 38, retractable sheath 37, handle 61).
Ryan discloses the pull wire (38) being attached to the reinforcement braid (100) in a number of ways (see col. 6, lines 11-13), but fails to disclose the pull wire mechanically attached to, and in interwoven contact with the reinforcement braid.
Mixter also discloses a reinforced cardiovascular sheath and wire assembly (Fig. 54A, elongate inner body 110) comprising pull wires (Fig. 54A, tensioning elements 111 and 112) attached to a reinforcement braid (Paragraph [0291], “braided material in elongate inner body 110”). Mixter teaches the distal segment (Fig. 54A, distal region 115) of the wire (111 and 112) is interwoven into and in contact with the reinforcement braid (Paragraph [0291], “111 and 112 interwoven with braided material of 110, see Fig. 54A where 111 and 112 are each on one side of the elongate and wrapping is optional as indicated by the phrase “can be” and as disclosed in paragraph [0032]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the distal segment of Ryan’s wire interwoven into, and in contact with, the reinforcement braid, as taught by Mixter, in order to secure the pull wires to the braided material (Paragraph [0291.
Regarding claim 13, Ryan in view of Mixter discloses wherein the distal segment (21) of the wire (38) is interwoven into the reinforcement braid (see rejection above) and the interwoven distal segment (21) is located on one side of a plane that contains a centerline of the outer tube (Figs. 11-12, outer tube 102).
Regarding claim 15, Ryan in view of Mixter discloses wherein reinforcement braid (braid 100) is laminated between an inner PTFE liner tube (inner tube 101) and an outer polymer tube (Col 6, lines 20-23, outer tube 102), and the reinforcement braid is metallic (Col 3, lines 34-35); and the pull wire is metallic (Col 3, lines 40-41, pull 38).
Regarding claim 16, Ryan in view of Mixter discloses including a thumbwheel rotatably mounted in the handle (Col 3, line 1, thumbwheel 65, handle 61) and connected to a proximal end of the pull wire (Fig 10, proximal end 24, spool 67, thumbwheel 65, Abstract “pull is attached to the retractable sheath and extends proximally”, Col 3, lines 60-67).
Regarding claim 17, Ryan in view of Mixter discloses wherein the pull wire has a curved cross section (Col 6, lines 49-57, Fig. 7, Fig. 14) with a curvature that matches a curvature of the reinforcement braid (Col. 6, lines 16-23, Fig 11, shows braid is laminated between the inner and outer tube showing the braid is tubular itself, which leads to the curvature).
Regarding claim 18, Ryan in view of Mixter discloses wherein a proximal segment of a polymer tube (outer tube 102 has the same proximal ending of the braid 100) of the retractable sheath covers a segment of the pull wire (38) that is proximal to a proximal end of the reinforcement braid (Claim 2, Fig. 11)
Regarding claim 20, Ryan in view of Mixter discloses wherein different strand segments of the reinforcement braid (braid 100) are in contact with an inner surface and an outer surface, respectively, of a distal segment (21) of the pull wire (Col 6, lines 13-23) due to the interweaving taught by Mixter (Paragraph [0291]).
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan (U.S Patent No 10,327,927) in view of Mixter et al. (US PG Pub No. 2020/0061340 A1) as applied to claims 1 and 12 above, and further in view of Fulton, III (U.S Patent No 9,277,935).
Regarding claim 9, Ryan as modified by Mixter fails to disclose wherein the distal segment of the wire includes a plurality of side notches that each receive a respective strand of the reinforcement braid. Fulton also discloses a reinforced cardiovascular sheath and wire assembly (Fig. 22, temporary scaffold) comprising a wire (Fig. 24, scoring wires 200) and reinforcement braid (Fig. 24, supportive wires 201). Fulton teaches wherein the wire includes a plurality of side notches (Fig. 22, notches 203) that each receive a respective strand of the reinforcement braid (Fig. 24, supportive wires 201). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal segment of Ryan’s in view of Mixter wire to include a plurality of side notches that each receive a respective strand of the reinforcement braid, as taught by Fulton, in order to limit the tension on the sheath (Col. 25, lines 1-6).
Regarding claim 19, Ryan as modified by Mixter fails to disclose a distal segment of the pull wire includes a plurality of side notches that each receive a respective strand of the reinforcement braid. Fulton also discloses a reinforced cardiovascular sheath and wire assembly (Fig. 22, temporary scaffold) comprising a wire (Fig. 24, scoring wires 200) and reinforcement braid (Fig. 24, supportive wires 201). Fulton teaches wherein the wire includes a plurality of side notches (Fig. 22, notches 203) that each receive a respective strand of the reinforcement braid (Fig. 24, supportive wires 201). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal segment of Ryan’s in view of Mixter pull wire to include a plurality of side notches that each receive a respective strand of the reinforcement braid, as taught by Fulton, in order to limit the tension on the sheath (Col. 25, lines 1-6).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ryan (U.S Patent No 10,327,927) in view of Mixter et al. (US PG Pub No. 2020/0061340 A1)as applied to claim 12 above, and further in view of Dorn et al. (US Patent No 9,687,370 B2).
Regarding claim 14, Ryan in view of Mixter discloses a stability sheath (stability sheath 42) that receives at least a portion of each of the pull wire (38), the catheter (inner catheter 30, outer catheter 33) and retractable sheath (Col. 3, lines 42-53, Figs. 2 and 3, retractable sheath 37); and a self-expanding stent (self-expanding stent 45) mounted about the distal carrier segment of the catheter (Col 3, lines 54-58, Figs. 2 and 3, distal carrier segment 32). Ryan fails to disclose the self-expanding stent being 5 Fr.
Dorn also discloses a self-expanding stent (10) mounted about a catheter (24). Dorn teaches the self-expanding stent being 5 Fr. (Col. 15, lines 49-56). Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Ryan’s self-expanding stent to be 5 Fr. as taught by Dorn since it “is a powerful technical advantage” for stent delivery systems of smaller passing diameters (Col. 1, lines 37-49).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sutermeister et al (US PG Pub No. 2015/0174363 A1) also discloses a reinforced cardiovascular sheath and wire assembly (Figs. 1-3, guide catheter 100) comprising an inner tube (Figs. 1-3, tubular member 102, inner layer 106), an outer tube (Figs. 1-3, tubular member 102, outer layer 110) a reinforcement braid (Figs. 1-3, reinforcing braid 108), a wire (Figs. 1-3, steering wire 114) interwoven and in contact with the braid (Paragraph [0030]) located on one side of a plane (Fig. 3).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARI L COCHRAN whose telephone number is (571)272-9637. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.L.C./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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