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 .
Status of Claims
This office action is responsive to the amendment filed 16 September 2025.
Claims 1-8 and 10 are canceled.
Claims 9, 11, 13, and 14 are amended.
Claims 9 and 11-14 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 and 11-14 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).
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).
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 12, Zhou in view of Okajima disclose the support catheter above, wherein the one end portion (Zhou: 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 the long pitch portion (Okajima: Fig. 3 and 4, third region 223) 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).
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, it would be such that 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 similar to the 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 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, see page 6, filed 16 September 2025, with respect to the objection to the drawings have been fully considered and are persuasive. The objection to the drawings has been withdrawn.
Applicant's arguments, see pages 6-10, filed 16 September 2025, with respect to the rejections of claims 9 and 11-14 under 35 USC 103 have been fully considered but they are not persuasive.
Regarding claim 9 and 14, applicant argues:
“Okajima does not disclose any component equivalent to a proximal shaft recited in Applicant's claim 9 (…) However, in Okajima, the base end 21 is the base end of the catheter body 2, not the base end of the hub 7. See Okajima, col. 4, 11. 27-29 ("The catheter assembly 1 . . . is composed of a catheter tube 2, and a hub 7 attached to a based end 21 of the catheter tube 2"). Moreover, Fig. 1 of Okajima does not show that one end of the hub 7 is connected to the third region 223. Instead, Fig. 1 of Okajima shows that one end of the hub 7 is connected to the catheter tube 2, and the catheter tube 2 is located between the third region 223 of the essential portion 22 and the hub 7.”
This is not persuasive, as Fig. 1 of Okajima directly shows that the base end 21 is at an end of both catheter body 2 and hub 7, connecting the two. Furthermore, the catheter tube 2 comprises each of the regions 221-223, as shown in Fig. 1, 3, and 4, where region 223 extends with tube 2. Essential portion 22 also encompasses regions 221-223 and extends proximally with tube 2.
Applicant also argues:
“The problem to be solved by the present invention is not described in any of the cited references. If a proximal shaft were to be connected to the catheter assembly 1 of Okajima, the manipulability of the catheter assembly 1 would be impaired compared to its current state.”
This is not persuasive, as the increase in manipulability, pushing, torque transmission, and kink-resistance, as disclosed by Okajima (col 2, ln 1-4), would inevitably result in load suppression.
Applicant also argues:
“Furthermore, since the catheter assembly 1 of Okajima has a hub 7 that functions as a gripping portion as described in col. 4, 1. 38, a person skilled in the art would not have any motivation to provide two gripping portions.”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., two gripping portions) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant also argues:
“However, in the present invention, the long pitch portion is positioned between two short pitch portions in order to ensure flexibility of the distal shaft and prevent it from breaking (…) Because Okajima does not disclose a proximal shaft with one end portion connected to a long pitch portion located between two short pitch portions, Okajima does not address the technical issue that is described in Applicant's invention. Therefore, even if in Okajima, the lattice point spacing or interval is adjusted to an arbitrary value, this adjustment merely considers the overall rigidity of the catheter tube 2, and still does not address the technical problem that is addressed by the present invention.”
This is not persuasive, as the increase in manipulability, pushing, torque transmission, and kink-resistance, as disclosed by Okajima (col 2, ln 1-4), would inevitably result in an increase in flexibility. Furthermore, as previously cited, hub 7 via base end 21 connects to regions 221-223. Therefore, the rejection is maintained.
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 LEI GONZALEZ whose telephone number is (703)756-5908. The examiner can normally be reached 7:30am - 4:00pm (CT).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783