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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 0331/2026 has been entered.
Status of Claims
This office action is responsive to the amendment filed 31 March 2026.
Claims 1-8, 10, and 12 are canceled.
Claims 9 and 14 are amended.
Claims 9 and 11, 13, and 14 are presently pending in this application.
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 9, 11, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou in view of Okajima (US Patent No. 5538513 A).
Zhou teaches a support catheter (Zhou: Fig. 1, guide extension catheter 14) for use with a therapeutic catheter (para. 0021) for treating a treatment site (para. 0021) and a guiding catheter (Fig. 1, guide catheter 10) for receiving insertion of the therapeutic catheter (treatment catheter advances through guide catheter 10; para. 0023) and guiding the therapeutic catheter in a blood vessel (para. 0021), the support catheter (Zhou: Fig. 1, guide extension catheter 14) being long enough to project out of a distal end opening (Fig. 1, distal end 12) of the guiding catheter (Fig. 1, extension catheter 14 extends beyond distal end 12 of guide catheter 10; para. 0023) when inserted into the guiding catheter (Fig. 1, guide catheter 10) through a proximal end opening of the guiding catheter (in order for the extension catheter 14 to be inserted into guiding catheter 10 and extend beyond distal end opening, a proximal end opening must exist on the opposing side of the guiding catheter 10. Examiner interprets the extension catheter 14 to be inserted into a proximal end opening of the guiding catheter 10), the support catheter (Zhou: Fig. 1, guide extension catheter 14) being adapted to guide a distal portion of the therapeutic catheter to the treatment site (para. 0022 and 0026), the support catheter (Zhou: Fig. 1, guide extension catheter 14) comprising: a distal shaft (Fig. 2A-2C, distal sheath 110) shaped as a tube (distal sheath 110 is a tube; para. 0026) into which the therapeutic catheter is insertable (para. 0026), the distal shaft (Fig. 2A-2C, distal sheath 110) including an inner layer (Fig. 2A-2C, inner layer 119) and a reinforcing layer (Fig. 2A-2C, reinforcing member 116), the reinforcing layer (Fig. 2A-2C, reinforcing member 116) being shaped as a tubular mesh (para. 0028-0029) including metal wires (wires may be made of metal; para. 0028-0029) wound in first and second opposite directions (Fig. 2A-2C, wires are wound in first and second opposite directions; para. 0029); and a proximal shaft (Fig. 2A-2C, proximal shaft 102) connected to the distal shaft (para. 0027), and one end portion (Fig. 2A and 2C, attachment region 108) of the proximal shaft (Fig. 2A-2C, proximal shaft 102) is welded (attachment region 108 is welded to the reinforcing member 116; para. 0035) to a portion at two or more of axially aligned intersections (Zhou: Fig. 2A and 2C, crossover points 118) of the metal wires wound in the first and second directions (Zhou: Fig. 2A, the attachment region 108 is welded to two crossover points 118).
Zhou does not expressly disclose that the reinforcing layer includes two short pitch portions in which a pitch of the wound metal wires is a first value and a long pitch portion in which the pitch of the wound metal wires is a second value greater than the first value, and the long pitch portion is located between the two short pitch portions, and one end portion of the proximal shaft is fixed to the long pitch portion.
Okajima teaches a reinforcing layer (Okajima: Fig. 3 and 4, essential portion 22) that includes two short pitch portions (Fig. 3 and 4, any of regions 221-223) in which a pitch of the wound metal wires (Fig. 3 and 4, filamentous element 51, which is what the essential portion is comprised of, can be metal wire; col 7, ln 52 – col 8, ln 10) is a first value (Fig. 4, lattice point interval a2) and a long pitch portion (Fig. 3 and 4, third region 223) in which the pitch of the wound metal wires (Fig. 3 and 4, filamentous element 51) is a second value (Fig. 4, lattice point interval a3) greater than the first value (a3 is larger than a2; col 7, ln 20-22), and one end portion (Fig. 1, base end 21) of a proximal shaft (Fig. 1, hub 7) is fixed to the long pitch portion (Fig. 1, base end 21 is fixed to the third region 223). Examiner interprets that the first, second, and third regions 221-223 of Okajima can be arranged such that regions 221 and 223 have shorter pitch values (lattice point intervals a1-a3) than the long pitch region 222 (col 8, ln 39-48 and col 10, ln 59 – col 11, ln 4). Examiner also interprets that, if the reinforcing layer (Fig. 2A-2C, reinforcing member 116) of Zhou is modified by the reinforcing layer (Okajima: Fig. 3 and 4, essential portion 22) of Okajima, the proximal shaft (Zhou: Fig. 2A-2C, proximal shaft 102) would be connected to the long pitch region 222 between the short pitch regions 221 and 223 of Okajima.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Zhou such that the reinforcing layer includes a short pitch portion in which a pitch of the wound metal wires is a first value and a long pitch portion in which the pitch of the wound metal wires is a second value greater than the first value, and one end portion of the proximal shaft is fixed to the long pitch portion as taught by Okajima in order to decrease rigidity towards the tip portion of the catheter (col 6, ln 39-53) and to allow for any catheter design for various objects and various cases of diseases (col 10, ln 59 – col 11, ln 4).
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the support catheter of Zhou to include a long pitch portion as taught by Okajima in order to decrease rigidity towards the tip portion of the catheter (col 6, ln 39-53). Examiner interprets that, if the long pitch portion of Okajima were to be combined with the end portion of the proximal shaft of Zhou, the two or more axially aligned intersections of the metal wires, wound in the first and second directions of the long pitch portion of Okajima, would be welded to the attachment region of Zhou—in the same way that the attachment region of Zhou is welded to its own reinforcement member (Fig. 2A and 2C, the attachment region 108 is welded to two crossover points 118).
Regarding claim 11, Zhou in view of Okajima disclose the support catheter above, wherein the reinforcing layer (Okajima: Fig. 3 and 4, essential portion 22) includes a pitch-changing portion (Fig. 3, region between second region 222 and third region 223 which changes inclination direction theta 3) between at least one of the short pitch portions (Fig. 3, second region 222) and the long pitch portion (Fig. 3, third region 223), and in the pitch-changing portion (Fig. 3, region between second region 222 and third region 223 which changes inclination direction theta 3), the pitch of the wound metal wires (Fig. 3, theta 3) decreases in a direction from the long pitch portion (Fig. 3, third region 223) to the at least one of the two short pitch portions (Fig. 3, inclination angle decreases from third region 223 to second region 222; col 6, ln 21-54).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the reinforcing layer of Zhou such that the reinforcing layer includes a pitch-changing portion between the short pitch portion and the long pitch portion, and in the pitch-changing portion, the pitch of the wound metal wires decreases in a direction from the long pitch portion to the short pitch portion as taught by Okajima in order to gradually decrease rigidity towards the tip portion of the catheter (col 6, ln 39-53).
Regarding claim 13, Zhou in view of Okajima discloses the support catheter above, wherein when the support catheter (Okajima: Fig. 3 and 4, catheter tube 2) is in a normal state, an acute angle (Fig. 3, theta 3 is 35 to 40 degrees) between the wound metal wire of the long pitch portion (Fig. 3 and 4, third region 223) and a straight line perpendicular (theta 3 angle is in relation to axis of the catheter tube 2; col 6, ln 33-38) to a longitudinal direction of the inner layer is from 25 degrees to 70 degrees (Fig. 3, theta 3 angle is from 35-40 degrees).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter of Zhou such that, when the support catheter is in a normal state, an acute angle between the wound metal wire of the long pitch portion and a straight line perpendicular to a longitudinal direction of the inner layer is from 25 to 70 degrees as taught by Okajima in order to adjust the rigidity of the catheter tube (Okajima: col 7, ln 36-51).
Regarding claim 14, Zhou discloses a tube (Zhou: Fig. 2A-2C, catheter 100) comprising: a tubular inner layer (Fig. 2A-2C, inner layer 119); a reinforcing layer (Fig. 2A-2C, reinforcing member 116) located on an outer surface of the inner layer (Fig. 2A-2C, reinforcing member 116 is located outside inner layer 119; para. 0027) and shaped as a tubular mesh (para. 0028) including metal wires (wires may be made of metal; para. 0028-0029) wound in first and second opposite directions (Fig. 2A-2C, wires are wound in first and second opposite directions; para. 0029); and a fixed member (Fig. 2A and 2C, attachment portion 108) fixed to a portion of the reinforcing layer (Fig. 2A and 2C, attachment portion 108 is attached to reinforcing member 116; para. 0031).
Zhou does not expressly disclose that the reinforcing layer includes two short pitch portions in which a pitch of the wound metal wires is a first value and a long pitch portion in which the pitch of the wound metal wires is a second value greater than the first value, and the long pitch portion is located between the two short pitch portions, and that the fixed member is fixed to the long pitch portion.
Okajima teaches a reinforcing layer (Okajima: Fig. 3 and 4, essential portion 22) that includes a short pitch portion (Fig. 3 and 4, any of regions 221-223) in which a pitch of the wound metal wires (Fig. 3 and 4, filamentous element 51, which is what the essential portion is comprised of, can be metal wire; col 7, ln 52 – col 8, ln 10) is a first value (Fig. 4, lattice point interval a2) and a long pitch portion (Fig. 3 and 4, third region 223) in which the pitch of the wound metal wires (Fig. 3 and 4, filamentous element 51) is a second value (Fig. 4, lattice point interval a3) greater than the first value (a3 is larger than a2; col 7, ln 20-22), and one end portion (Fig. 1, base end 21) of a proximal shaft (Fig. 1, hub 7) is fixed to the long pitch portion (Fig. 1, base end 21 is fixed to the third region 223). Examiner interprets that the attachment portion 108 of Zhou would be fixed to the third region 223 of Okajima. Examiner interprets that the first, second, and third regions 221-223 of Okajima can be arranged such that regions 221 and 223 have shorter pitch values (lattice point intervals a1-a3) than the long pitch region 222 (col 8, ln 39-48 and col 10, ln 59 – col 11, ln 4). Examiner also interprets that, if the reinforcing layer (Fig. 2A-2C, reinforcing member 116) of Zhou is modified by the reinforcing layer (Okajima: Fig. 3 and 4, essential portion 22) of Okajima, the proximal shaft (Zhou: Fig. 2A-2C, proximal shaft 102) would be connected to the long pitch region 222 between the short pitch regions 221 and 223 of Okajima.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the reinforcing layer of Zhou such that the reinforcing layer includes a short pitch portion in which a pitch of the wound metal wires is a first value and a long pitch portion in which the pitch of the wound metal wires is a second value greater than the first value, and that the fixed member is fixed to the long pitch portion as taught by Okajima in order to decrease rigidity towards the tip portion of the catheter (col 6, ln 39-53) and to allow for any catheter design for various objects and various cases of diseases (col 10, ln 59 – col 11, ln 4).
Response to Arguments
Applicant's arguments filed 31 March 2026 have been fully considered but they are not persuasive.
Applicant argues that the attachment region 108 of Zhou is not welded to the crossover points 118, and, therefore, the one end portion of the proximal shaft of Zhou is not welded to the long pitch portion at two or more of axially aligned intersections of the metal wires wound in the first and second directions.
The attachment region 108 of Zhou is welded to the reinforcing member 116 (para. 0027). Fig. 2A of Zhou shows the crossover points 118 of the reinforcing member 116 are attached to the attachment region 108. Therefore, the crossover points 118 are welded to the attachment region 108. Accordingly, the rejection is maintained.
Conclusion
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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