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 8, 2025, claim 1 is amended. No claims are cancelled. New claims 26-28 are added. Claims 5-6, 10-11, 15-16 and 19-20 are withdrawn from consideration as being drawn to a nonelected invention and species as identified in a previous office action. Claims 1-4, 7-9, 12-14, 17-18 and 21-28 are pending.
Response to Arguments
Applicant's arguments, see Remarks, filed December 8, 2025, with respect to the newly added limitation “the covering member is disposed more proximally than the coil body and is not covered by anything other than a coating layer” have been fully considered but they are not persuasive. Applicant argues that the prior art Uchino and Satou do not teach this limitation, Examiner respectfully disagrees. Uchino teaches in Fig. 5 that the joining member #13 interpreted to be the covering member is disposed more proximally than the coil body #31 and further teaches in Fig. 5 that the solder #14 covers the joining member as a coating layer. This teaches the claimed limitation.
In response to applicant’s argument on p. 11 that there is no teaching, suggestion, or motivation to combine the references of Uchino and Satou, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, 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 Uchino with the teachings of Satou to combine prior art elements according to known methods to yield predictable results of having equal rigidity between two sides of two different wires respectively that are connected (Satou: see [0098]) in order to secure flexibility and resilience against bending at a boundary portion between two wires and to obtain a high joint strength (Satou: see [0099]-[0100]).
Applicant’s arguments, see Remarks, filed December 8, 2025, with respect to the newly added limitation “wherein the coating layer is a hydrophobic resin, a hydrophilic resin, or a combination thereof” have been fully considered and are persuasive in view of the amendments. Therefore, the rejection of claims 1-4, 7-9, 12-14, 17-18, 21 and 23-24 under 35 U.S.C 103 in view of Uchino and Satou has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Murayama (US 20040039308 A1; previously cited by applicant).
Further Examiner notes that Applicant did not expressly argue the combination of Uchino, Murayama and Satou. Murayama teaches a coating layer wherein the coating layer is a hydrophobic resin in [0094]-[0099] as the cover layer #5 is made from resins and the cover layer #5 covers the joining region of first wire #2 and second wire #3 and in [0113] specifies that it is hydrophobic resin that forms cover layer #5.
Claim Warning
Applicant is advised that should claim 25 be found allowable, claim 28 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims 1-4, 7-9, 12-14, 17-18, and 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Uchino (JP H1157014 A; previously cited by applicant; citations refer to machine translation provided with Office Action mailed November 27, 2024) in view of Murayama (US 20040039308 A1; previously cited by applicant) and Satou (US 20080183182 A1; previously cited by applicant).
With respect to claim 1, Uchino discloses
A guide wire (see Fig. 5, guidewire #30) comprising:
a first core shaft disposed on a distal end side of the guide wire and having a first large-diameter portion and a first small-diameter portion with a diameter smaller than that of the first large-diameter portion (see Fig. 5, first wire #11 has multiple sections with varying diameters where the diameter of where 11b is pointing is smaller than where 11 is pointing);
a second core shaft disposed on a proximal end side of the guide wire and having a second large-diameter portion and a second small-diameter portion with a diameter smaller than that of the second large-diameter portion (see Fig. 5, second wire #12 has two parts with 12a having a smaller diameter than where 12 is pointing);
a contact portion where the first small-diameter portion is arranged opposite to the second small-diameter portion (see Fig. 5, contact portion is in the middle of guidewire #30 where #18 is pointing);
a covering member (see Fig. 5, joining member #13) that covers the contact portion and at least a part of each of the first small-diameter portion and the second small-diameter portion, the parts being adjacent to the contact portion (see Fig. 5 #13 covers where 11b and 12a are pointing and is at the contact portion);
a coil body that covers a distal end portion of the first core shaft (see Fig. 5, coil body #31 covers the distal end portion of first wire #11); and
a joint layer (see Fig. 5, solder #14) that joins the covering member (see Fig. 5, #14 joins #13) with the first small-diameter portion and the second small-diameter portion inside the covering member (see Fig. 5, the parts that 11b and 12a are pointing at are inside #13), and
the covering member is disposed more proximally than the coil body (see Fig. 5, the joining member #13 is disposed more proximally than coil body #31) and is not covered by anything other than a coating layer (see Fig. 5, solder #14 covers the joining member #13 as a coating layer).
Uchino does not disclose wherein the coating layer is a hydrophobic resin, a hydrophilic resin, or a combination thereof. Uchino further does not disclose wherein a length in the axial direction of the covering member is i) shorter than a length in the axial direction of the second small diameter portion and ii) longer than a length in the axial direction of the first small diameter portion.
Murayama teaches a coating layer wherein the coating layer is a hydrophobic resin (see paragraph 0094-0099, cover layer #5 which is made from resins where the cover layer #5 covers the joining region of first wire #2 and second wire #3; and see paragraph 0113, hydrophobic resin for forming cover layer #5).
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 Uchino with the teachings of Murayama to have added a coating layer that is made of a resin material because it would have resulted in the predictable result of reducing a friction of a guidewire against an inner wall of a catheter to improve sliding performance thereby enhancing operationality of guidewire particularly in a vicinity of a welded portion (Murayama: see [0094]-[0099], [0113]).
Uchino and Murayama do not specifically teach wherein a length in the axial direction of the covering member is i) shorter than a length in the axial direction of the second small diameter portion and ii) longer than a length in the axial direction of the first small diameter portion.
Satou teaches a guidewire (see Fig. 4, #1C) with a first core shaft (see Fig. 4 and paragraph 0093, first wire #2) that has a first small diameter portion and a first large diameter portion (see Fig. 4 and paragraph 0097, proximal side portion #223 is interpreted to be a first small diameter portion as it is smaller in outer diameter than the distal side portion #222 which is interpreted to be a first large diameter portion; where are both #223 and #222 are on the first wire #2); a second core shaft (see Fig. 4 and paragraph 0093, second wire #3) that has a second small diameter portion and a second large diameter portion (see Fig. 4 and paragraph 0098, constant outer diameter portion #32 is interpreted to be a second small diameter portion; and see paragraph 0040, tapered portion #33 that has an outer diameter that gradually increases from the constant outer diameter portion #32 where the tapered portion #33 is interpreted to be a second large diameter portion; where both #32 and #33 are on the second wire #3); and a covering member (see Fig. 4 and paragraph 0092, connecting member #6). Satou teaches wherein a length in the axial direction of the covering member is shorter than a length in the axial direction of the second small diameter portion (see Fig. 4, length of connecting member #6 is shorter than length of constant outer diameter portion #32) and further teaches wherein a length in the axial direction of the covering member is also longer than a length in the axial direction of the first small diameter portion (see Fig. 4, length of connecting member #6 is longer than length of proximal side portion #223).
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 Uchino and Murayama with the teachings of Satou to combine prior art elements according to known methods to yield predictable results of having equal rigidity between two sides of two different wires respectively that are connected (Satou: see [0098]) in order to secure flexibility and resilience against bending at a boundary portion between two wires and to obtain a high joint strength (Satou: see [0099]-[0100]).
With respect to claim 2, all limitations of claim 1 apply in which Uchino discloses wherein the length of the first small-diameter portion in the axial direction is shorter than the length in the axial direction of the second small-diameter portion (see Fig. 5 and page 7, in order to form the space the outside diameter of the second wire #12 is larger than the insider diameter of #13 by 0.01 to 0.07 mm), and a bending rigidity of a material for forming the first core shaft is lower than a bending rigidity of a material for forming the second core shaft (see page 2, first wire is formed of superelastic metal and second wire is formed of stainless steel where the bending rigidity of stainless steel is higher than superelastic metal as taught on page 5).
With respect to claim 3, all limitations of claim 2 apply in which Uchino further discloses wherein the first core shaft includes a superelastic material (see Page 2, first wire is formed of a superelastic metal).
With respect to claim 4, all limitations of claim 1 apply in which Uchino further discloses wherein one end of the covering member is arranged at a boundary between the first large-diameter portion and the first small-diameter portion (see Fig. 5, one end of #13 is at a boundary between where 11b and 11 transition), and the joint layer joins at least the contact portion, the first small-diameter portion, and the second small-diameter portion together inside the covering member (see Fig. 5, #14 joins #13 and where 11b and 12a point).
With respect to claim 7, all limitations of claim 1 apply in which Uchino further discloses wherein an outer diameter of the covering member is substantially equal to a diameter of the first large-diameter portion (see page 5, outer diameter of first wire #11 is equal to outer diameter of wire #11 with #13).
With respect to claim 8, all limitations of claim 1 apply in which Uchino further discloses wherein the covering member is a tubular member having a tubular shape (see page 6, #13 is tubular) and includes a superelastic material (see page 6, material of #13 is not limited and can be a superelastic material).
With respect to claim 9, all limitations of claim 2 apply in which Uchino further discloses wherein one end of the covering member is arranged at a boundary between the first large-diameter portion and the first small-diameter portion (see Fig. 5, one end of #13 is at a boundary between where 11b and 11 transition), and the joint layer joins at least the contact portion, the first small-diameter portion, and the second small-diameter portion together inside the covering member (see Fig. 5, #14 joins #13 and where 11b and 12a point).
With respect to claim 12, all limitations of claim 2 apply in which Uchino further discloses wherein an outer diameter of the covering member is substantially equal to a diameter of the first large-diameter portion (see page 5, outer diameter of first wire #11 is equal to outer diameter of wire #11 with #13).
With respect to claim 13, all limitations of claim 2 apply in which Uchino further discloses wherein the covering member is a tubular member having a tubular shape (see page 6, #13 is tubular) and includes a superelastic material (see page 6, material of #13 is not limited and can be a superelastic material).
With respect to claim 14, all limitations of claim 3 apply in which Uchino further discloses wherein one end of the covering member is arranged at a boundary between the first large-diameter portion and the first small-diameter portion (see Fig. 5, one end of #13 is at a boundary between where 11b and 11 transition), and the joint layer joins at least the contact portion, the first small-diameter portion, and the second small-diameter portion together inside the covering member (see Fig. 5, #14 joins #13 and where 11b and 12a point).
With respect to claim 17, all limitations of claim 3 apply in which Uchino further discloses wherein an outer diameter of the covering member is substantially equal to a diameter of the first large-diameter portion (see page 5, outer diameter of first wire #11 is equal to outer diameter of wire #11 with #13).
With respect to claim 18, all limitations of claim 3 apply in which Uchino further discloses wherein the covering member is a tubular member having a tubular shape (see page 6, #13 is tubular) and includes a superelastic material (see page 6, material of #13 is not limited and can be a superelastic material).
With respect to claim 21, all limitations of claim 1 apply in which Uchino further teaches that the first core shaft is formed of a superelastic metal and the covering member is made of stainless steel (see page 3). Uchino does not specifically disclose wherein the first core shaft and the covering member contain the same metallic material.
Satou teaches a first core shaft (see Fig. 4 and paragraph 0093, first wire #2) and a covering member (see Fig. 4 and paragraph 0092, connecting member #6) where both contain the same metallic material (see paragraph 0095, it is preferable that the connecting member #6 includes the same Ni-Ti alloy that constitutes the first wire #2).
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 Uchino with the teachings of Satou to have made both a first core shaft and a covering member to contain the same metallic material because it would have resulted in the predictable result of reducing the manufacturing cost of a guidewire as the number of constituent materials to be used is reduced (Satou: see [0051]).
With respect to claim 22, all limitations of claim 1 apply in which Uchino further teaches that the joint layer is a solder (see p. 4, brazing filler or solder #14) and Satou also teaches a joint layer that is made of a solder or adhesive (see paragraph 0093-0094 and Fig. 4, fixing material #19) however Uchino and Satou does not specifically teach wherein the joint layer is made of a resin material.
Murayama teaches a joint layer that is made of a resin material (see paragraph 0094-0099, cover layer #5 which is made from resins where the cover layer #5 covers the joining region of first wire #2 and second wire #3).
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 Uchino with the teachings of Murayama to have created a joint layer that is made of a resin material because it would have resulted in the predictable result of reducing a friction of a guidewire against an inner wall of a catheter to improve sliding performance thereby enhancing operationality of guidewire particularly in a vicinity of a welded portion (Murayama: see [0094]-[0099]).
With respect to claim 23, all limitations of claim 1 apply in which Uchino further discloses wherein the contact portion joins the first core shaft to the second core shaft (see Fig. 5, contact portion is in the middle of guidewire #30 where #18 is pointing where first wire #11 and second wire #12 are connected)
With respect to claim 24, all limitations of claim 1 apply in which Satou further teaches wherein one end of the covering member is arranged at a boundary between the first large- diameter portion and the first small-diameter portion (see Fig. 4 and paragraph 0097, proximal side portion #223 is interpreted to be a first small diameter portion as it is smaller in outer diameter than the distal side portion #222 which is interpreted to be a first large diameter portion; where are both #223 and #222 are on the first wire #2; further see Fig. 4 and paragraph 0092, connecting member #6 is arranged at a boundary between which #222 and #223 is located), and in the axial direction, a distance between a proximal end of the first large-diameter portion and the one end of the covering member is shorter than a distance between a distal end of the second large-diameter portion and another end of the covering member (see Fig. 4, the distal side portion #222 is interpreted to be a first large diameter portion and the tapered portion #33 is interpreted to be a second large diameter portion; it is interpreted that the distance between the proximal end of #222 and one end of covering member #6 is shorter than between a distal end of #33 and other end of covering member #6).
With respect to claim 25, all limitations of claim 1 apply in which Uchino does not specifically disclose that the covering member has an exposed surface.
Murayama teaches a covering member (see Fig. 1 and paragraph 0064 and 0094-0095, cover layer #5) is exposed wherein the covering member has an exposed surface (see paragraph 0094-0095, cover layer #5 is on the outer peripheral surface of wire #10).
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 Uchino with the teachings of Murayama to have an covering member with an exposed surface because it would have resulted in the predictable result of reducing friction of a guidewire for improving sliding performance and enhancing operationality of the guidewire (Murayama: see [0094]-[0095]).
With respect to claim 26, all limitations of claim 1 apply in which Uchino and Murayama do not specifically teach a proximal end-side fixation portion that fixes a proximal end of the coil body to the first core shaft.
Satou teaches a guidewire (see Fig. 4, #1C) with a first core shaft (see Fig. 4 and paragraph 0093, first wire #2) and a coil body (see Fig. 4, coil #4b) and a proximal end-side fixation portion that fixes a proximal end of the coil body to the first core shaft (see Fig. 4 and paragraph 0099, fixing material #19 is present to fix first wire #2 and coil #4b on the proximal side of first wire #2c).
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 Uchino and Murayama with the teachings of Satou to have added a proximal end fixation portion because it would have resulted the predicable result of reinforcing strength of the joint area of a guidewire (Satou: see [0099], [0105]) and to improve torque transmission performance of a guidewire (Satou: see [0131]).
With respect to claim 27, all limitations of claim 1 apply in which Uchino further discloses wherein inside the covering member and throughout an entire region from a distal end to a proximal end of the covering member, the joint layer is disposed (see Fig. 5, solder #14 is disposed through the entire length of the joining member #13 from the distal end to the proximal end).
With respect to claim 28, all limitations of claim 1 apply in which Uchino does not specifically disclose that the covering member has an exposed surface.
Murayama teaches a covering member (see Fig. 1 and paragraph 0064 and 0094-0095, cover layer #5) is exposed wherein the covering member has an exposed surface (see paragraph 0094-0095, cover layer #5 is on the outer peripheral surface of wire #10).
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 Uchino with the teachings of Murayama to have an covering member with an exposed surface because it would have resulted in the predictable result of reducing friction of a guidewire for improving sliding performance and enhancing operationality of the guidewire (Murayama: see [0094]-[0095]).
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