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 02/19/2026, with respect to the drawings, specification, and claim objections have been fully considered and are persuasive. The objections of the drawings, the specification, and claims have been withdrawn.
Applicant's arguments, filed 02/19/2026, with respect to the nonstatutory double patenting rejection for claims 12 and 15 have been fully considered and are persuasive. The nonstatutory double patenting rejection for claims 12 and 15 has been withdrawn.
Applicant's arguments, filed 02/19/2026, with respect to the 35 U.S.C 103 rejection of claims 1, 3-8, 10, and 11 have been fully considered but they are not persuasive. Applicant argues Ryan in view of Mixter fails to disclose or suggest “the interwoven distal segment of the wire is located on one side of a plane that contains a centerline of the outer tube” as now recited in amended claim 1. However, it is the examiner’s position that Ryan in view of Mixter discloses or suggests the interwoven distal segment (distal attachment segment 21) of the wire (Fig. 11-12, pull wire 38) is located on one side of a plane that contains a centerline of the outer tube (Figs. 11-12, outer tube 102) as now recited in amended claim 1 (see rejection below for further details).
Applicant's arguments filed 02/19/2026, with respect to the 35 USC 102 rejections of claims 12, 15-18, and 20 have been fully considered and are persuasive. Examiner agrees that Ryan fails to disclose the pull wire is “in interwoven contact with the reinforcement braid” as now recited in amended claim 12 Therefore, the 35 U.S.C. 102(a)(1) rejection of claims 12, 15-18, and 20 by Ryan (US Patent No. 10,327,927) has been withdrawn. However, upon further consideration, a new ground(s) of rejection of claims 12, 15-18, and 20 is made in view of Ryan (US Patent No. 10,327,927) and Mixter (US Patent No. 11,497,889).
Claim Objections
Claim 13 is objected to because of the following informalities: In line 4, “wherein an interwoven distal segment” is assumed to be a typo. The examiner suggests amending this informality to be “wherein the interwoven distal segment” and has been examined as such. Appropriate correction is required.
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, 10-11, 12, 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 (U. S Patent No 11,497,889).
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) in contact with the reinforcement braid (Col 6, lines 13-16, Figs 13 and 14, braid 100) 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 the reinforcement braid. Mixter also discloses a reinforced cardiovascular sheath and wire assembly (Fig. 2 and 7E) comprising a wire (pull wire 1104 and 1104’) attached to a reinforcement braid (braid wires 1250). Mixter teaches the distal segment of the wire is interwoven into the reinforcement braid (Col 14, lines 8-12, Fig 7E, pull wires 1104 and 1104’, distal pull wire lumen 1253, braid wires 1250, distal shaft 1222). 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 substituted the attachment of Mixter having the distal segment of the wire interwoven into the reinforcement braid for the attachment of Ryan having welds with a reasonable expectation of success for yielding the wire securely attached to the reinforcement braid.
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 (Col. 14, lines 8-12, Fig. 7E).
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. 2 and 7E) comprising a wire (pull wire 1104 and 1104’) and reinforcement braid (braid wires 1250). Mixter teaches the pull wire mechanically attached to (Col. 14, lines 8-12, Fig. 7E), and in interwoven contact with the reinforcement braid (Col 14, lines 8-12, Fig 7E, pull wires 1104 and 1104’, distal pull wire lumen 1253, braid wires 1250, distal shaft 1222). 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 substituted the attachment of Mixter having the pull wire mechanically attached to, and in interwoven contact with the reinforcement braid for the attachment of Ryan having welds with a reasonable expectation of success for yielding the pull wire securely attached to the reinforcement braid.
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 (Col. 14, lines 8-12, Fig. 7E).
Claim(s) 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 (U. S Patent No 11,497,889) 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 (U. S Patent No 11,497,889) 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
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 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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/KARI L COCHRAN/Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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