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 Amendment
In response to amendment filed December 29, 2025, claims 1, 5, 7, and 11 are amended. Claims 4 and 10 are cancelled. New claims 13-17 are added. Claims 1-3, 5-9 and 11-17 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed December 29, 2025, with respect to rejection of claims 5 and 11 under 35 U.S.C 112b have been fully considered and are persuasive in view of the amendments. The rejection of claims 5 and 11 have been withdrawn.
Applicant’s arguments, see Remarks, filed December 29, 2025, with respect to the rejections of claims 1-2, 5-8 and 11-12 under 35 U.S.C 102 and claims 3-4 and 9-10 under 35 U.S.C 103 have been fully considered and are persuasive in view of the amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Maruyama (US 20230302260 A1).
Applicant’s arguments, see Remarks, filed December 29, 2025, with respect to newly added claim 13 has been fully considered and is not persuasive. Applicant argues on p. 8, that the prior art of record does not teach that there is a resin part that covers the outer peripheral surface of the distal end side joint part and the outer peripheral surface of the coil body, however Examiner respectfully disagrees. Miyata teaches in [0053]-[0054] that the bulged portion #5 which is part of bonding portion #6 interpreted to be the distal end side joint part can be formed using a resin material where the tip portion of #2c is covered and further teaches in [0070]-[0071] that the entire circumference surface of the bonding portion #6 is coated with resin and the entire circumference of the coiled body #3 is coated with resin. This is interpreted to teach the claimed limitations.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-9 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Miyata (US 20120197159 A1; previously cited by applicant) in view of Maruyama (US 20230302260 A1) and Lind (US 5067489 A; previously cited by applicant).
With respect to claim 1, Miyata discloses a guide wire (see Fig. 1, guidewire #1) comprising:
a core shaft (see Fig. 1 and paragraph 0039-0040, core shaft 2b and 2c);
a coil body that covers an outer periphery of the core shaft (see Fig. 1, coil body #3);
a distal end side joint part that joins a distal end portion of the coil body with a distal end portion of the core shaft (see paragraph 0044, bonding portion #6 on distal end joins distal end portion of coil body #3 to distal end of core shaft #2c), the distal end side joint part comprising a resin material (see paragraph 0053, the bulged portion #5 which is part of bonding portion #6 can be formed using a resin material); and
a fixation part (see Fig. 1, middle bonding portion #7) comprising a metal material that joins the coil body with the core shaft on a proximal end side of the distal end side joint part (see Fig. 1, #7 joins coil body #3 with core shaft #2C on proximal side of the distal end side joint #6; and see paragraph 0067, materials for the middle bonding portion #7 are not limited and can include a metal solder).
Miyata further teaches wherein the core shaft has an outer diameter that is constant along the distal end portion of the core shaft (see Fig. 1, #2c small-diameter portion of core shaft #2 on the distal end portion has a constant outer diameter) and the portion of the core shaft joined to the fixation part (see Fig. 1, #2c small-diameter portion of core shaft #2 on the distal end portion has a constant outer diameter as it passes the middle bonding portion #7). However Miyata does not specifically teach that the entirely of the small diameter portion #2c has a constant outer diameter as it includes a bulged portion at the distal tip portion #5 seen in Fig. 1. Further, Miyata does not specifically disclose wherein the distal end side joint part and the fixation part are continuously arranged in an axial direction of the guide wire.
Maruyama teaches a core shaft (see Fig. 1 and paragraph 0037, first core member #11) that has an outer diameter constant along the distal end portion of the core shaft (see Fig. 1 and paragraph 0037-0038, #11 has first constant outer diameter portion #11b) and the portion of the core shaft joined to a fixation part (see Fig. 1 and paragraph 0037-0038, first bonding portion #11a is part of where first constant outer diameter portion is where the outer diameters are constant throughout the length of #11b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miyata with the teachings of Maruyama to have constant diameter along a distal end portion of a core shaft and where a core shaft is joined to a fixation part because it would have resulted in the predictable result of preventing stress from when a guidewire is bent from concentrating on a fixation part (Maruyama: see [0037]-[0039]) to allow guidewire to move without limitation
Miyata and Maruyama do not specifically teach wherein the distal end side joint part and the fixation part are continuously arranged in an axial direction of the guide wire.
Lind teaches a guidewire (see Figs 1, #10) wherein the distal end side joint part (see Fig. 1, #28) and the fixation part (see Fig. 1, bonding agent #22) are continuously arranged in an axial direction of the guidewire (see Fig. 1, #22 and #28 are placed adjacent with no gap).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miyata and Maruyama with the teachings of Lind to have placed a fixation part and distal end joint part next to each other because it would have resulted in the predictable result of hardening the distal end of a guidewire (Lind: see col 3 lines 30-53) for greater tensile strength.
With respect to claim 2, all limitations of claim 1 apply in which Miyata further discloses wherein the distal end side joint part comprises an elastomer material (see paragraph 0053, the bulged portion #5 which is part of bonding portion #6 can be formed using a resin material which include various elastomer materials).
With respect to claim 3, all limitations of claim 1 apply in which Miyata does not specifically disclose wherein a gap between the distal end side joint part and the fixation part in an axial direction of the guide wire is smaller than a length of the distal end side joint part in the axial direction.
Lind teaches a guidewire (see Fig. 1, #10) wherein a gap between the distal end side joint part (see Fig. 1, #28) and the fixation part (see Fig. 1, #22) is smaller than a length of the distal side joint part in the axial direction (see Fig. 1, there is no gap between #22 and #28 therefore the gap between the two is smaller than the length of #28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miyata with the teachings of Lind to have a smaller gap between a fixation part and distal end joint part because it would have resulted in the predictable result of hardening the distal end of a guidewire (Lind: see col 3 lines 30-53) for greater tensile strength.
With respect to claim 5, all limitations of claim 1 apply in which Miyata further discloses wherein a length of the distal end side joint part in an axial direction of the guide wire is twice to 10 times an outer diameter of the coil body (Miyata: see Fig. 1, the length of distal end side joint part #6 is smaller than the outer diameter of the coil body #3).
With respect to claim 6, all limitations of claim 1 apply in which Miyata further discloses
a resin film that covers an outer surface of the distal end side joint part and an outer peripheral surface of the coil body and comprises one or more resin materials (see paragraph 0070, the entire circumferential surface of guidewire or a part of its length may be coated with resin and hydrophobic or hydrophilic lubricant); and
the resin material for the distal end side joint part is the same as at least one of the one or more resin materials for the resin film (see paragraph 0070, the entire circumferential surface of guidewire or a part of its length may be coated with resin and hydrophobic or hydrophilic lubricant which is the same resin material).
With respect to claim 7, Miyata discloses a guide wire (see Fig. 1, guidewire #1) comprising:
a core shaft (see Fig. 1 and paragraph 00390040, core shaft 2b and 2c);
a coil body that covers an outer periphery of the core shaft (see Fig. 1, coil body #3);
a distal end side joint part that joins a distal end portion of the coil body with a distal end portion of the core shaft (see paragraph 0044, bonding portion #6 on distal end joins distal end portion of coil body #3 to distal end of core shaft #2c) and a fixation part (see Fig. 1, middle bonding portion #7) that joins the coil body with the core shaft on a proximal end side of the distal end side joint part (see Fig. 1, #7 joins coil body #3 with core shaft #2C on proximal side of the distal end side joint #6).
Miyata further teaches wherein the core shaft has an outer diameter that is constant along the distal end portion of the core shaft (see Fig. 1, #2c small-diameter portion of core shaft #2 on the distal end portion has a constant outer diameter) and the portion of the core shaft joined to the fixation part (see Fig. 1, #2c small-diameter portion of core shaft #2 on the distal end portion has a constant outer diameter as it passes the middle bonding portion #7). However Miyata does not specifically teach that the entirely of the small diameter portion #2c has a constant outer diameter as it includes a bulged portion at the distal tip portion #5 seen in Fig. 1. Further, Miyata does not specifically disclose wherein the distal end side joint part and the fixation part are continuously arranged in an axial direction of the guide wire.
Maruyama teaches a core shaft (see Fig. 1 and paragraph 0037, first core member #11) that has an outer diameter constant along the distal end portion of the core shaft (see Fig. 1 and paragraph 0037-0038, #11 has first constant outer diameter portion #11b) and the portion of the core shaft joined to a fixation part (see Fig. 1 and paragraph 0037-0038, first bonding portion #11a is part of where first constant outer diameter portion is where the outer diameters are constant throughout the length of #11b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miyata with the teachings of Maruyama to have constant diameter along a distal end portion of a core shaft and where a core shaft is joined to a fixation part because it would have resulted in the predictable result of preventing stress from when a guidewire is bent from concentrating on a fixation part (Maruyama: see [0037]-[0039]) to allow guidewire to move without limitation
Miyata and Maruyama do not specifically teach wherein the distal end side joint part and the fixation part are continuously arranged in an axial direction of the guide wire.
Lind teaches a guidewire (see Figs 1, #10) wherein the distal end side joint part (see Fig. 1, #28) and the fixation part (see Fig. 1, bonding agent #22) are continuously arranged in an axial direction of the guidewire (see Fig. 1, #22 and #28 are placed adjacent with no gap).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miyata and Maruyama with the teachings of Lind to have placed a fixation part and distal end joint part next to each other because it would have resulted in the predictable result of hardening the distal end of a guidewire (Lind: see col 3 lines 30-53) for greater tensile strength.
With respect to claim 8, all limitations of claim 7 apply in which Miyata further discloses wherein the distal end side joint part comprises an elastomer material (see paragraph 0053, the bulged portion #5 which is part of bonding portion #6 can be formed using a resin material which include various elastomer materials).
With respect to claim 9, all limitations of claim 7 apply in which Miyata does not specifically disclose wherein a gap between the distal end side joint part and the fixation part in an axial direction of the guide wire is smaller than a length of the distal end side joint part in the axial direction.
Lind teaches a guidewire (see Fig. 1, #10) wherein a gap between the distal end side joint part (see Fig. 1, #28) and the fixation part (see Fig. 1, #22) is smaller than a length of the distal side joint part in the axial direction (see Fig. 1, there is no gap between #22 and #28 therefore the gap between the two is smaller than the length of #28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miyata with the teachings of Lind to have a smaller gap between a fixation part and distal end joint part because it would have resulted in the predictable result of hardening the distal end of a guidewire (Lind: see col 3 lines 30-53) for greater tensile strength.
With respect to claim 11, all limitations of claim 7 apply in which Miyata further discloses wherein a length of the distal end side joint part in an axial direction of the guide wire is twice to 10 times an outer diameter of the coil body (Miyata: see Fig. 1, the length of distal end side joint part #6 is smaller than the outer diameter of the coil body #3).
With respect to claim 12, all limitations of claim 7 apply in which Miyata further discloses wherein the distal end side joint part comprises a first material (see paragraph 0053, the bulged portion #5 which is part of bonding portion #6 can be formed using a resin material including various elastomeric materials), and the fixation part comprises second metal material that is different from the first material (see Fig. 1, #7 joins coil body #3 with core shaft #2C on proximal side of the distal end side joint #6; and see paragraph 0067, materials for the middle bonding portion #7 are not limited and can include a metal solder).
Claims 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Miyata (US 20120197159 A1; previously cited by applicant) in view of Lind (US 5067489 A; previously cited by applicant).
With respect to claim 13, Miyata discloses a guide wire (see Fig. 1, guidewire #1) comprising:
a core shaft (see Fig. 1 and paragraph 0039-0040, core shaft 2b and 2c);
a coil body that covers an outer periphery of the core shaft (see Fig. 1, coil body #3), the coil body having an outer peripheral surface (see Fig. 1, the coil body #3 has an outer peripheral surface);
a distal end side joint part that joins a distal end portion of the coil body with a distal end portion of the core shaft (see paragraph 0044, bonding portion #6 on distal end joins distal end portion of coil body #3 to distal end of core shaft #2c), the distal end side joint part having an outer peripheral surface (see Fig. 1, the bonding portion #6 has an outer peripheral surface that where it is not covered by coils on the end);
a fixation part (see Fig. 1, middle bonding portion #7) that joins the coil body with the core shaft on a proximal end side of the distal end side joint part (see Fig. 1, #7 joins coil body #3 with core shaft #2C on proximal side of the distal end side joint #6); and
a resin part that covers the outer peripheral surface of the distal end side joint part (see paragraph 0053-0054, the bulged portion #5 which is part of bonding portion #6 can be formed using a resin material where the tip portion of #2c is covered; and see paragraph 0071, the entire circumference surface of the bonding portion #6 is coated with resin) and the outer peripheral surface of the coil body (see paragraph 0070-0071, the entire surface of guidewire #1 can be coated with resin including the coil body #3 and specifically the entire circumference surface of the coiled body #3 is coated with resin); and
wherein the resin part has an outer diameter that is greater than an outer diameter of the fixation part (see Fig. 1, the outer diameter of the resin coated on bonding portion #6 on the distal end of #2c is greater than the outer diameter of the middle bonding portion #7).
Miyata does not specifically disclose wherein the distal end side joint part and the fixation part are continuously arranged in an axial direction of the guide wire.
Lind teaches a guidewire (see Figs 1, #10) wherein the distal end side joint part (see Fig. 1, #28) and the fixation part (see Fig. 1, bonding agent #22) are continuously arranged in an axial direction of the guidewire (see Fig. 1, #22 and #28 are placed adjacent with no gap).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miyata with the teachings of Lind to have placed a fixation part and distal end joint part next to each other because it would have resulted in the predictable result of hardening the distal end of a guidewire (Lind: see col 3 lines 30-53) for greater tensile strength.
With respect to claim 14, all limitations of claim 13 apply in which Miyata further discloses wherein the distal end side joint part comprises an elastomer material (see paragraph 0053, the bulged portion #5 which is part of bonding portion #6 can be formed using a resin material which include various elastomer materials).
With respect to claim 15, all limitations of claim 13 apply in which Miyata does not specifically disclose wherein a gap between the distal end side joint part and the fixation part in an axial direction of the guide wire is smaller than a length of the distal end side joint part in the axial direction.
Lind teaches a guidewire (see Fig. 1, #10) wherein a gap between the distal end side joint part (see Fig. 1, #28) and the fixation part (see Fig. 1, #22) is smaller than a length of the distal side joint part in the axial direction (see Fig. 1, there is no gap between #22 and #28 therefore the gap between the two is smaller than the length of #28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miyata with the teachings of Lind to have a smaller gap between a fixation part and distal end joint part because it would have resulted in the predictable result of hardening the distal end of a guidewire (Lind: see col 3 lines 30-53) for greater tensile strength.
With respect to claim 16, all limitations of claim 13 apply in which Miyata further discloses wherein a length of the distal end side joint part in an axial direction of the guide wire is twice to 10 times an outer diameter of the coil body (Miyata: see Fig. 1, the length of distal end side joint part #6 is smaller than the outer diameter of the coil body #3).
With respect to claim 17, all limitations of claim 13 apply in which Miyata further discloses wherein the distal end side joint part comprises a first material (see paragraph 0053, the bulged portion #5 which is part of bonding portion #6 can be formed using a resin material including various elastomeric materials), and the fixation part comprises second metal material that is different from the first material (see Fig. 1, #7 joins coil body #3 with core shaft #2C on proximal side of the distal end side joint #6; and see paragraph 0067, materials for the middle bonding portion #7 are not limited and can include a metal solder).
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.
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/N.N.P./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791