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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 28, 2026 has been entered.
Response to Amendment
In response to amendment filed April 28, 2026, claims 1, 5, 7, 9, and 11 are amended. No new claims are added and claims 4, 10 and 13-17 have been canceled. Claims 1-3, 5-9 and 11-12 are pending.
Response to Arguments
Applicant's arguments filed April 28, 2026 with respect to the newly added limitation “wherein the core shaft has an outer diameter that is constant along a portion of the core shaft jointed to the fixation part and the distal end side joint part” have been fully considered but they are not persuasive.
Miyata teaches in [0052]-[0058] that the bulged part 5 is a separate piece attached to core shaft #2c which therefore is interpreted to mean that the core shaft joined the fixation part and the distal end side joint part has a constant outer diameter which meets the claimed limitation.
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 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 a portion of the core shaft joined to the fixation part and the distal end side joint (see paragraph 0052-0058: the bulged part 5 is a separate piece attached to core shaft 2c, which has a constant outer diameter).
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 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 the 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 a portion of the core shaft joined to the fixation part and the distal end side joint (see paragraph 0052-0058: the bulged part 5 is a separate piece attached to core shaft 2c, which has a constant outer diameter).
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.
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 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 the 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 the 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).
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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