DETAILED ACTION
This actions is responsive to the “RESPONSE TO NON-FINAL OFFICE ACTION” filed 28 October 2025. The Examiner acknowledges the amendments to claims 1, 3, 8, 12, 15-16, and 19, and the cancelation of claim 6. Claims 1-5 and 7-20 are pending.
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 .
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 112
Examiner’s Note Regarding Subjective and Relative Terminology: the Examiner’s note previously presented regarding sufficient support for the recitation of language that is considered subjective and relative in the Non-Final Rejection dated 28 July 2025 is maintained.
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.
Claim(s) 1-5 and 7-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Douk (US-6183420-B1, previously presented) in view of de Toledo (US-4932419-A, cited by Applicant) and Nabeshima (US-20160375226-A1, previously presented).
Regarding claim 1, Douk teaches
An elongate medical device adapted to provide adjustable flexibility, the elongate medical device comprising:
an inner coil having one or more inner coil filars extending in a first helical direction and at an inner coil angle, the inner coil having an outer diameter [inner spring 168 (Douk Fig. 10)];
an outer coil having one or more outer coil filars extending in a second helical direction, and at an outer coil angle, the outer coil having an inner diameter [outer spring 170 (Douk Fig. 10)], where the inner diameter of the outer coil is substantially equal to the outer diameter of the inner coil and the inner coil angle is substantially equal to the outer coil angle [Douk Fig. 10];
a hypotube extending proximally from the inner coil and the outer coil, where a proximal end of the inner coil and a proximal end of the outer coil are secured to a distal end of the hypotube [hypotube 164 (Douk Fig. 10); The intermediate spring 48 is then run over the uncovered portion of the core wire projecting outwardly from the distal tip of the hypotube and attached to the annular shoulder 46 with a suitable adhesive (Douk Col 5:21-23); With particular reference to FIG. 10, the guidewire 160 incorporates many of the structural features of the first two embodiments (Douk Col 8:1-3), wherein the Examiner notes that as depicted in Fig. 10, the inner coil spring and outer coil spring are depicted as being coupled to the hypotube 164];
a cable extending through the inner coil and through the hypotube [a core wire 162 slidably disposed coaxially within a tubular shaft or hypotube 164 and having a portion 166 that extends axially from the hypotube distal end (Douk Col 8:3-6, Fig. 10)], where a distal end of the cable, a distal end of the inner coil and a distal end of the outer coil are all secured together at a distal end of the elongate medical device [The respective distal ends of the core wire 162 and inner spring 168 terminate in a distal joint 172 that also attaches to a portion of the outer spring 170 (Douk Col 8:11-16)];
wherein applying a tensile force to the cable, relative to the hypotube, causes the inner coil and outer coil in combination to increase in stiffness [the guide wire 160 according to the fifth embodiment incorporates the inner stiffening spring 168 to complement the variable stiffening characteristics of the outer spring 170. This enables further control by the operator over the stiffness capabilities of the guide wire (Douk Col 8:32-36); During tracking, the operator can adjust the support provided by the guide wire for the catheter by pulling the core wire proximally to compress the inner stiffening element. This provides proximal and intermediate firmness to successfully track the catheter along the entire length of the guide wire (Douk Col 8:23-25, Fig. 10)].
However, Douk fails to explicitly disclose wherein the second helical direction is opposite the first helical direction.
de Toledo discloses an elongate medical device adapted to provide adjustable flexibility, wherein the device comprises an inner coil and an outer coil, wherein the inner coil has one or more inner coil filars extending in a first helical direction and at an inner coil angle, wherein the outer coil has one or more outer coil filars extending in a second helical direction, wherein the second helical direction is opposite the first helical direction [The first, inner coil 16 is bifilar, formed of two flat wires 28, 30, e.g., 0.003 inch by 0.010 inch, closely wound at a pitch ratio of about 2:1. The outer coil is quadrifilar, formed of four circular cross-section wires 32, 34, 36, 38, of 0.025 inch diameter wire, which are similarly closely wound thereabout, but in a direction opposite to the winding direction of the first, inner coil and with a ratio of 4:1. The resulting assembly provides a coil body portion of high axial pull strength, e.g., permitting safe use of a medical device without a core fixed to the distal tip or a safety wire (de Toledo Col 3:3-13, Fig. 5); Thus there is provided an elongated spring coil medical device of improved design, consisting of multi-filar, cross-wound coils and resulting in improved torque response and steerability, tip design freedom, high axial pull strength and improved patient safety, and an open-ended lumen for adaptability of design (de Toledo Col 2:25-31)].
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 the device of Douk to employ wherein the second helical direction is opposite the first helical direction, so as to improve torque response and steerability, and would also amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [improve rotation/torque transmission capabilities] [MPEP § 2143(I)(D)].
However, Douk in view of de Toledo fails to explicitly disclose wherein the distal end of the cable, the distal end of the inner coil, and the distal end of the outer coil are all secured at a weldment together at a distalmost end of the elongate medical device.
Nabeshima discloses an elongate medical device with variable stiffness, wherein Nabeshima discloses an inner coil, an outer coil, and a cable extending through the inner coil and outer coil, wherein the distal end of the cable, the distal end of the inner coil, and the distal end of the outer coil are all secured at a weldment together at a distalmost end of the elongate medical device [In the embodiment depicted in FIG. 3, a distal portion of an inner coil 4 is fixed to a small-diameter portion 21 of a wire main body 2 through a fixation material 11 along with a distal portion of an outer coil 3. In this manner, the fixation material 11 fixes both of the inner coil 4 and the outer coil 3 in this embodiment (Nabeshima ¶0078, Fig. 3); An operator moves the guidewire 1 into the state shown in FIG. 2 by pressing the operation member 5 distally relative to the wire main body 2 in an arrow direction in FIG. 2. The pressing force is transmitted the inner coil 4. Accordingly, the inner coil 4 reliably contracts (is compressed) and the interval p is reduced. In addition, an operator may increase the interval p by pulling the operation member 5 with respect to the wire main body 2 in a direction opposite to the arrow direction (i.e., causing the operation member 5 to move proximally relative to the wire main body 2). The pulling force is thus transmitted to the inner coil 4 to stretch/elongate the inner coil 4 reliably stretches (i.e., the interval p is increased) (Nabeshima ¶0066), wherein based on Nabeshima ¶0077, the embodiment of Fig. 3 is considered to operate similar to the embodiment described in at least Nabeshima ¶0066].
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 the device of Douk in view of de Toledo to employ wherein the distal end of the cable, the distal end of the inner coil, and the distal end of the outer coil are all secured at a weldment together at a distalmost end of the elongate medical device, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [allow for variable stiffness to be applied to a distal end of the device] [MPEP § 2143(I)(D)].
Regarding claim 2, Douk in view of de Toledo and Nabeshima teaches
The elongate medical device of claim 1.
However, while Fig. 10 of Douk depicts the wherein the one or more inner coil filars have a wire size and the one or more outer coil filars have a wire size that is substantially the same, Douk in view of de Toledo and Nabeshima fails to explicitly disclose wherein the one or more inner coil filars have a wire size and the one or more outer coil filars have the same wire size.
Nabeshima discloses an inner coil with one or more inner coil filars and an outer coil with one or more outer coil filars, wherein the one or more inner coil filars have a wire size and the one or more outer coil filars have the same wire size [The wire diameters of the wire rods 41 are preferably the same as or larger (i.e., greater in diameter) than those of the wire rods 31 (Nabeshima ¶0061)], wherein Nabeshima discloses that the wire size may affect the rigidity of the coil [For example, wire rods 41 have the same diameters from a distal side to a proximal side. However, a guidewire may have a configuration in which the diameters of the wire rods are gradually increased or decreased from the distal side over the proximal side (i.e., tapered). The above-described configuration can provide variation in the change of rigidity of the distal portion (Nabeshima ¶0079)]. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454 456, 105 USPQ 233 235 (CCPA 1955); MPEP § 2144.05(II) [wherein the “range” is considered to be defined as the wire size of the one or more inner coil filars]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the wire size of the outer coil filars to reach a desired level of stiffness.
“The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims… [I]n such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). Nothing in the specification leads one of ordinary skill in the art to understand that the range(s) recited in claim 2 is/are somehow ‘critical’ or lead to unexpected results [In some cases, each of the one or more filars 32 forming the inner coil 28 has a filar diameter, or filar wire size, and each of the one or more filars 34 forming the outer coil 30 has the same filar diameter, or filar wire size (Applicant’s Specification ¶0042)].
Regarding claim 3, Douk in view of de Toledo and Nabeshima teaches
The elongate medical device of claim 1, wherein the one or more inner coil filars of the inner coil comprise the same number of filars as the one or more outer coil filars of the outer coil [wherein each of the inner spring 168 and outer spring 170 being defined as individual springs is considered to define of the inner spring 168 and the outer spring 170 as each comprising a singular filar].
Regarding claim 4, Douk in view of de Toledo and Nabeshima teaches
The elongate medical device of claim 1.
However, Douk in view of de Toledo and Nabeshima as presently modified fails to explicitly disclose wherein the inner diameter of the outer coil is within approximately five percent of the outer diameter of the inner coil.
de Toledo discloses wherein the outer coil that has an inner diameter that is within approximately five percent of an outer diameter of the inner coil [Referring to FIG. 5, in which an alternate embodiment of the device is shown, consisting of cross-wound multi-filar coils of circular cross-section wires, the coils 62, 64 are each manufactured by winding four round cross-section wires of size about 0.004 inch diameter, so that D.sub.0 is about 0.032 inch, D.sub.1 is about 0.024 inch, d.sub.0 is about 0.024 inch and d.sub.1 is about 0.016 inch… To form inner coil 64, four individual round wires (or two flat wires in the embodiments of FIGS. 1-4) are simultaneously wound around a mandrel of about 0.016 inch outer diameter. The free ends of this coil are fixed, and then, to form the second coil 62 thereabout, four wires are wound in opposite hand directly over coil 64. The wires are wound under moderate tension, of about 22.5 gm/wire. After winding, the coils are released (de Toledo Col 4:7-13, 21-28, Fig. 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 the device of Douk in view of de Toledo and Nabeshima to employ wherein the inner diameter of the outer coil is within approximately five percent of the outer diameter of the inner coil, so as to improve torque response and steerability [de Toledo Col 2:25-31].
Regarding claim 5, Douk in view of de Toledo and Nabeshima teaches
The elongate medical device of claim 1.
However, Douk in view of de Toledo and Nabeshima as presently modified fails to explicitly disclose wherein the inner diameter of the outer coil is within approximately one percent of the outer diameter of the inner coil.
de Toledo discloses wherein the outer coil that has an inner diameter that is within approximately one percent of an outer diameter of the inner coil [de Toledo Col 4:7-13, 21-28, Fig. 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 the device of Douk in view of de Toledo and Nabeshima to employ wherein the inner diameter of the outer coil is within approximately one percent of the outer diameter of the inner coil, so as to improve torque response and steerability [de Toledo Col 2:25-31].
Regarding claim 7, Douk in view of de Toledo and Nabeshima teaches
The elongate medical device of claim 1.
However, while Douk discloses the use of soldering to fix the distal end of the inner coil, the distal end of the outer coil and the distal end of the cable together [The distal joint 38 is then formed at the tip of the core wire 30 to confine the intermediate spring therearound with a globule of solder material or the like (Douk Col 5:24-26); Douk Col 8:1-3], Douk in view of de Toledo and Nabeshima as presently modified fails to explicitly disclose wherein the proximal end of the inner coil and the proximal end of the outer coil are welded together and are welded to the distal end of the hypotube.
Nabeshima discloses known methods for fixating elements of a guidewire together includes welding [Examples of fixation methods include a method performed through fitting, a method performed through engagement, a method performed through adhesion (adhesion using an adhesive or a solvent), a method performed through fusion (heat-welding, high-frequency fusion, ultrasonic fusion, or the like), a method using a fixation material such as solder (brazing material), and a method in which these methods are combined (Nabeshima ¶0045)].
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 the elongate medical device of Douk in view of de Toledo and Nabeshima to employ wherein the proximal end of the inner coil and the proximal end of the outer coil are welded together and are welded to the distal end of the hypotube, as this modification would amount to merely applying a known technique [welding] to a known device ready for improvement to yield predictable results [couple elements together] [MPEP § 2143(I)(D)].
Regarding claim 8, Douk teaches
An elongate medical device, comprising:
a distal segment adapted to provide adjustable flexibility [the guide wire 160 according to the fifth embodiment incorporates the inner stiffening spring 168 to complement the variable stiffening characteristics of the outer spring 170. This enables further control by the operator over the stiffness capabilities of the guide wire (Douk Col 8:32-36)], the distal segment including:
an inner coil having one or more inner coil filars extending in a first helical direction and at an inner coil angle [inner spring 168 (Douk Fig. 10)];
an outer coil having one or more outer coil filars extending in a second helical direction, and an outer coil angle, where the inner coil angle is substantially equal to the outer coil angle [outer spring 170 (Douk Fig. 10)];
a cable extending through the inner coil and extending proximally therefrom [a core wire 162 slidably disposed coaxially within a tubular shaft or hypotube 164 and having a portion 166 that extends axially from the hypotube distal end (Douk Col 8:3-6, Fig. 10)], a distal end of the cable welded together with a distal end of the inner coil and a distal end of the outer coil [The respective distal ends of the core wire 162 and inner spring 168 terminate in a distal joint 172 that also attaches to a portion of the outer spring 170 (Douk Col 8:11-16)]; and
a proximal segment defining an elongate shaft, a distal end of the elongate shaft coupled to a proximal end of the inner coil and a proximal end of the outer coil [hypotube 164 (Douk Fig. 10); The intermediate spring 48 is then run over the uncovered portion of the core wire projecting outwardly from the distal tip of the hypotube and attached to the annular shoulder 46 with a suitable adhesive (Douk Col 5:21-23); With particular reference to FIG. 10, the guidewire 160 incorporates many of the structural features of the first two embodiments (Douk Col 8:1-3), wherein the Examiner notes that as depicted in Fig. 10, the inner coil spring and outer coil spring are depicted as being coupled to the hypotube 164];
wherein the distal segment is adapted to increase in stiffness when a tensile force is applied to the cable [the guide wire 160 according to the fifth embodiment incorporates the inner stiffening spring 168 to complement the variable stiffening characteristics of the outer spring 170. This enables further control by the operator over the stiffness capabilities of the guide wire (Douk Col 8:32-36); During tracking, the operator can adjust the support provided by the guide wire for the catheter by pulling the core wire proximally to compress the inner stiffening element. This provides proximal and intermediate firmness to successfully track the catheter along the entire length of the guide wire (Douk Col 8:23-25, Fig. 10)].
However, Douk fails to explicitly disclose wherein the second helical direction is opposite the first helical direction.
de Toledo discloses an elongate medical device adapted to provide adjustable flexibility, wherein the device comprises an inner coil and an outer coil, wherein the inner coil has one or more inner coil filars extending in a first helical direction and at an inner coil angle, wherein the outer coil has one or more outer coil filars extending in a second helical direction, wherein the second helical direction is opposite the first helical direction [The first, inner coil 16 is bifilar, formed of two flat wires 28, 30, e.g., 0.003 inch by 0.010 inch, closely wound at a pitch ratio of about 2:1. The outer coil is quadrifilar, formed of four circular cross-section wires 32, 34, 36, 38, of 0.025 inch diameter wire, which are similarly closely wound thereabout, but in a direction opposite to the winding direction of the first, inner coil and with a ratio of 4:1. The resulting assembly provides a coil body portion of high axial pull strength, e.g., permitting safe use of a medical device without a core fixed to the distal tip or a safety wire (de Toledo Col 3:3-13, Fig. 5); Thus there is provided an elongated spring coil medical device of improved design, consisting of multi-filar, cross-wound coils and resulting in improved torque response and steerability, tip design freedom, high axial pull strength and improved patient safety, and an open-ended lumen for adaptability of design (de Toledo Col 2:25-31)].
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 the device of Douk to employ wherein the second helical direction is opposite the first helical direction, so as to improve torque response and steerability, and would also amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [improve rotation/torque transmission capabilities] [MPEP § 2143(I)(D)].
However, Douk in view of de Toledo fails to explicitly disclose wherein a distalmost end of the cable welded together with a distalmost end of the inner coil and a distalmost end of the outer coil.
Nabeshima discloses an elongate medical device with variable stiffness, wherein Nabeshima discloses an inner coil, an outer coil, and a cable extending through the inner coil and outer coil, wherein the distal end of the cable, the distal end of the inner coil, and the distal end of the outer coil are all secured at a weldment together at a distalmost end of the elongate medical device [In the embodiment depicted in FIG. 3, a distal portion of an inner coil 4 is fixed to a small-diameter portion 21 of a wire main body 2 through a fixation material 11 along with a distal portion of an outer coil 3. In this manner, the fixation material 11 fixes both of the inner coil 4 and the outer coil 3 in this embodiment (Nabeshima ¶0078, Fig. 3); An operator moves the guidewire 1 into the state shown in FIG. 2 by pressing the operation member 5 distally relative to the wire main body 2 in an arrow direction in FIG. 2. The pressing force is transmitted the inner coil 4. Accordingly, the inner coil 4 reliably contracts (is compressed) and the interval p is reduced. In addition, an operator may increase the interval p by pulling the operation member 5 with respect to the wire main body 2 in a direction opposite to the arrow direction (i.e., causing the operation member 5 to move proximally relative to the wire main body 2). The pulling force is thus transmitted to the inner coil 4 to stretch/elongate the inner coil 4 reliably stretches (i.e., the interval p is increased) (Nabeshima ¶0066), wherein based on Nabeshima ¶0077, the embodiment of Fig. 3 is considered to operate similar to the embodiment described in at least Nabeshima ¶0066].
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 the device of Douk in view of de Toledo to employ wherein a distalmost end of the cable welded together with a distalmost end of the inner coil and a distalmost end of the outer coil, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [allow for variable stiffness to be applied to a distal end of the device] [MPEP § 2143(I)(D)].
Regarding claim 9, Douk in view of de Toledo and Nabeshima teaches
The elongate medical device of claim 8, wherein the inner coil has an outer diameter and the outer coil has an inner diameter that is about equal to the outer diameter of the inner coil [Douk Fig. 10].
Regarding claim 10, Douk in view of de Toledo and Nabeshima teaches
The elongate medical device of claim 9.
However, Douk in view of de Toledo and Nabeshima as presently modified fails to explicitly disclose wherein the outer diameter of the inner coil is within approximately five percent of the inner diameter of the outer coil.
de Toledo discloses wherein the outer coil that has an inner diameter that is within approximately five percent of an outer diameter of the inner coil [de Toledo Col 4:7-13, 21-28, Fig. 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 the device of Douk in view of de Toledo and Nabeshima to employ wherein the outer diameter of the inner coil is within approximately five percent of the inner diameter of the outer coil, so as to improve torque response and steerability [de Toledo Col 2:25-31].
Regarding claim 11, Douk in view of de Toledo and Nabeshima teaches
The elongate medical device of claim 9.
However, Douk in view of de Toledo and Nabeshima as presently modified fails to explicitly disclose wherein the outer diameter of the inner coil is within approximately one percent of the inner diameter of the outer coil.
de Toledo discloses wherein the outer coil that has an inner diameter that is within approximately one percent of an outer diameter of the inner coil [de Toledo Col 4:7-13, 21-28, Fig. 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 the device of Douk in view of de Toledo and Nabeshima to employ wherein the outer diameter of the inner coil is within approximately one percent of the inner diameter of the outer coil, so as to improve torque response and steerability [de Toledo Col 2:25-31].
Regarding claim 12, Douk in view of de Toledo and Nabeshima teaches
The elongate medical device of claim 8, wherein the one or more inner coil filars of the inner coil comprise the same number of filars as the one or more outer coil filars of the outer coil [wherein each of the inner spring 168 and outer spring 170 being defined as individual springs is considered to define of the inner spring 168 and the outer spring 170 as each comprising a singular filar].
Regarding claim 13, Douk in view of de Toledo and Nabeshima teaches
The elongate medical device of claim 8.
However, while Fig. 10 of Douk depicts the wherein the one or more inner coil filars have a wire diameter and the one or more outer coil filars have a wire diameter that is substantially the same, Douk in view of de Toledo and Nabeshima as presently modified fails to explicitly disclose wherein each of the one or more inner coil filars has a wire diameter, and each of the one or more outer coil filars has the same wire diameter.
Nabeshima discloses an inner coil with one or more inner coil filars and an outer coil with one or more outer coil filars, wherein the one or more inner coil filars have a wire size and the one or more outer coil filars have the same wire size [Nabeshima ¶0061], wherein Nabeshima discloses that the wire size may affect the rigidity of the coil [Nabeshima ¶0079]. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454 456, 105 USPQ 233 235 (CCPA 1955); MPEP § 2144.05(II) [wherein the “range” is considered to be defined as the wire size of the one or more inner coil filars]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the wire size of the outer coil filars to reach a desired level of stiffness.
“The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims… [I]n such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). Nothing in the specification leads one of ordinary skill in the art to understand that the range(s) recited in claim 2 is/are somehow ‘critical’ or lead to unexpected results [In some cases, each of the one or more filars 32 forming the inner coil 28 has a filar diameter, or filar wire size, and each of the one or more filars 34 forming the outer coil 30 has the same filar diameter, or filar wire size (Applicant’s Specification ¶0042)].
Regarding claim 14, Douk in view of de Toledo and Nabeshima teaches
The elongate medical device of claim 8, wherein the elongate shaft comprises a hypotube [hypotube 164 (Douk Fig. 10)].
Regarding claim 15, Douk teaches
A guidewire, comprising:
a coil assembly including an inner coil having one or more inner coil filars extending in a first helical direction [inner spring 168 (Douk Fig. 10)] and an outer coil having one or more outer coil filars extending in a second helical direction [outer spring 170 (Douk Fig. 10)], the inner coil having an outer diameter that is substantially equal to an inner diameter of the outer coil [Douk Fig. 10]; and
a cable having an attachment point at a distal end that is secured together with both a distal end of the inner coil and a distal end of the outer coil, the cable extending freely in a proximal direction from the attachment point [The respective distal ends of the core wire 162 and inner spring 168 terminate in a distal joint 172 that also attaches to a portion of the outer spring 170 (Douk Col 8:11-16, Fig. 10)); a core wire 162 slidably disposed coaxially within a tubular shaft or hypotube 164 and having a portion 166 that extends axially from the hypotube distal end (Douk Col 8:3-6, Fig. 10)];
wherein the cable is adapted to provide a compressive force to the coil assembly, thereby temporarily increasing a stiffness of the coil assembly [the guide wire 160 according to the fifth embodiment incorporates the inner stiffening spring 168 to complement the variable stiffening characteristics of the outer spring 170. This enables further control by the operator over the stiffness capabilities of the guide wire (Douk Col 8:32-36); During tracking, the operator can adjust the support provided by the guide wire for the catheter by pulling the core wire proximally to compress the inner stiffening element. This provides proximal and intermediate firmness to successfully track the catheter along the entire length of the guide wire (Douk Col 8:23-25, Fig. 10)].
However, Douk fails to explicitly disclose wherein the second helical direction is opposite the first helical direction.
de Toledo discloses an elongate medical device adapted to provide adjustable flexibility, wherein the device comprises an inner coil and an outer coil, wherein the inner coil has one or more inner coil filars extending in a first helical direction and at an inner coil angle, wherein the outer coil has one or more outer coil filars extending in a second helical direction, wherein the second helical direction is opposite the first helical direction [The first, inner coil 16 is bifilar, formed of two flat wires 28, 30, e.g., 0.003 inch by 0.010 inch, closely wound at a pitch ratio of about 2:1. The outer coil is quadrifilar, formed of four circular cross-section wires 32, 34, 36, 38, of 0.025 inch diameter wire, which are similarly closely wound thereabout, but in a direction opposite to the winding direction of the first, inner coil and with a ratio of 4:1. The resulting assembly provides a coil body portion of high axial pull strength, e.g., permitting safe use of a medical device without a core fixed to the distal tip or a safety wire (de Toledo Col 3:3-13, Fig. 5); Thus there is provided an elongated spring coil medical device of improved design, consisting of multi-filar, cross-wound coils and resulting in improved torque response and steerability, tip design freedom, high axial pull strength and improved patient safety, and an open-ended lumen for adaptability of design (de Toledo Col 2:25-31)].
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 the device of Douk to employ wherein the second helical direction is opposite the first helical direction, so as to improve torque response and steerability, and would also amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [improve rotation/torque transmission capabilities] [MPEP § 2143(I)(D)].
However, Douk in view of de Toledo fails to explicitly disclose wherein the attachment point of the cable is at a distalmost extent thereof that is secured together with both a distalmost end of the inner coil and a distalmost end of the outer coil.
Nabeshima discloses an elongate medical device with variable stiffness, wherein Nabeshima discloses an inner coil, an outer coil, and a cable extending through the inner coil and outer coil, wherein the distal end of the cable, the distal end of the inner coil, and the distal end of the outer coil are all secured at a weldment together at a distalmost end of the elongate medical device [In the embodiment depicted in FIG. 3, a distal portion of an inner coil 4 is fixed to a small-diameter portion 21 of a wire main body 2 through a fixation material 11 along with a distal portion of an outer coil 3. In this manner, the fixation material 11 fixes both of the inner coil 4 and the outer coil 3 in this embodiment (Nabeshima ¶0078, Fig. 3); An operator moves the guidewire 1 into the state shown in FIG. 2 by pressing the operation member 5 distally relative to the wire main body 2 in an arrow direction in FIG. 2. The pressing force is transmitted the inner coil 4. Accordingly, the inner coil 4 reliably contracts (is compressed) and the interval p is reduced. In addition, an operator may increase the interval p by pulling the operation member 5 with respect to the wire main body 2 in a direction opposite to the arrow direction (i.e., causing the operation member 5 to move proximally relative to the wire main body 2). The pulling force is thus transmitted to the inner coil 4 to stretch/elongate the inner coil 4 reliably stretches (i.e., the interval p is increased) (Nabeshima ¶0066), wherein based on Nabeshima ¶0077, the embodiment of Fig. 3 is considered to operate similar to the embodiment described in at least Nabeshima ¶0066].
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 the device of Douk in view of de Toledo to employ wherein the attachment point of the cable is at a distalmost extent thereof that is secured together with both a distalmost end of the inner coil and a distalmost end of the outer coil, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [allow for variable stiffness to be applied to a distal end of the device] [MPEP § 2143(I)(D)].
Regarding claim 16, Douk in view of de Toledo and Nabeshima teaches
The elongate medical device of claim 15.
However, Douk in view de Toledo and Nabeshima as presently modified fails to explicitly disclose wherein the one or more inner coil filars extend at a coil angle and the one or more outer coil filars extend at the same coil angle.
Nabeshima discloses an inner coil with one or more inner coil filars and an outer coil with one or more outer coil filars, wherein the one or more inner coil filers extend at a coil angle and the one or more outer coil filers extend at the same coil angle and wherein the coil angle is considered to affect resistance to deformation by bending stress [The winding direction (i.e., pitch angle) of the wire rods 41 may be the same as or different from the winding direction of the wire rods 31. If the winding direction of the wire rods 41 is the same as that of the wire rods 31 (as shown in FIGS. 1-3), the guidewire has a structure which is more easily deformed by bending stress compared to when the winding direction of the wire rods 41 is different from that of the wire rods 31. In contrast, if the winding direction of the wire rods 41 is different from the winding direction of the wire rods 31 (i.e., the pitch angle of the wire rods 41 is oriented in the opposite direction as the pitch angle of the wire rods 31), there is an advantage in that the guidewire has a structure which is more resistant to deformation by bending stress (Nabeshima ¶0046)]. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454 456, 105 USPQ 233 235 (CCPA 1955); MPEP § 2144.05(II) [wherein the “range” is considered to be defined as the coil angle of the one or more inner coil filars]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the coil angle of the outer coil filars to reach a desired level of resistance to deformation by bending stress.
“The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims… [I]n such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). Nothing in the specification leads one of ordinary skill in the art to understand that the range(s) recited in claim 16 is/are somehow ‘critical’ or lead to unexpected results [Applicant’s Specification ¶0059].
Regarding claim 17, Douk in view of de Toledo and Nabeshima teaches
The elongate medical device of claim 15.
However, Douk in view of de Toledo and Nabeshima as presently modified fails to explicitly disclose wherein the outer diameter of the inner coil is within approximately five percent of the inner diameter of the outer coil.
de Toledo discloses wherein the outer coil that has an inner diameter that is within approximately five percent of an outer diameter of the inner coil [de Toledo Col 4:7-13, 21-28, Fig. 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 the device of Douk in view of de Toledo and Nabeshima to employ wherein the outer diameter of the inner coil is within approximately five percent of the inner diameter of the outer coil, so as to improve torque response and steerability [de Toledo Col 2:25-31].
Regarding claim 18, Douk in view of de Toledo and Nabeshima teaches
The elongate medical device of claim 15.
However, Douk in view of de Toledo and Nabeshima as presently modified fails to explicitly disclose wherein the outer diameter of the inner coil is within approximately one percent of the inner diameter of the outer coil.
de Toledo discloses wherein the outer coil that has an inner diameter that is within approximately one percent of an outer diameter of the inner coil [de Toledo Col 4:7-13, 21-28, Fig. 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 the device of Douk in view of de Toledo and Nabeshima to employ wherein the outer diameter of the inner coil is within approximately one percent of the inner diameter of the outer coil, so as to improve torque response and steerability [de Toledo Col 2:25-31].
Regarding claim 19, Douk in view of de Toledo and Nabeshima teaches
The elongate medical device of claim 15, wherein the one or more inner coil filars of the inner coil comprise the same number of filars as the one or more outer coil filars of the outer coil [wherein each of the inner spring 168 and outer spring 170 being defined as individual springs is considered to define of the inner spring 168 and the outer spring 170 as each comprising a singular filar].
Regarding claim 20, Douk in view of de Toledo and Nabeshima teaches
The elongate medical device of claim 15.
However, while Fig. 10 of Douk depicts the wherein the one or more inner coil filars have a wire diameter and the one or more outer coil filars have a wire diameter that is substantially the same, Douk in view of de Toledo and Nabeshima as presently modified fails to explicitly disclose wherein each of the one or more inner coil filars has a wire diameter, and each of the one or more outer coil filars has the same wire diameter.
Nabeshima discloses an inner coil with one or more inner coil filars and an outer coil with one or more outer coil filars, wherein the one or more inner coil filars have a wire size and the one or more outer coil filars have the same wire size [Nabeshima ¶0061], wherein Nabeshima discloses that the wire size may affect the rigidity of the coil [Nabeshima ¶0079]. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454 456, 105 USPQ 233 235 (CCPA 1955); MPEP § 2144.05(II) [wherein the “range” is considered to be defined as the wire size of the one or more inner coil filars]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the wire size of the outer coil filars to reach a desired level of stiffness.
“The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims… [I]n such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). Nothing in the specification leads one of ordinary skill in the art to understand that the range(s) recited in claim 2 is/are somehow ‘critical’ or lead to unexpected results [In some cases, each of the one or more filars 32 forming the inner coil 28 has a filar diameter, or filar wire size, and each of the one or more filars 34 forming the outer coil 30 has the same filar diameter, or filar wire size (Applicant’s Specification ¶0042)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 6, filed 28 October 2025, with respect to the previously presented claim objections have been fully considered and are persuasive. The objections to claims 1-2 and 15-16 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 6, with respect to the previously applied rejections under § 112(b) have been fully considered and are persuasive. The rejections under § 112(b) of claims 3, 12, and 19 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 6-9, with respect to the rejection(s) of claim(s) 1, 15, and those dependent therefrom under § 102 [and § 103 for claims dependent therefrom] have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Douk (US-6183420-B1, previously presented) in view of de Toledo (US-4932419-Aand Nabeshima (US-20160375226-A1, previously presented).
Regarding claim 1, the Applicant asserts that Douk fails to teach the amended limitation of “an outer coil having one or more outer coil filars extending in a second helical direction, opposite the first helical direction”, as based on Douk Fig. 10, Douk fails to teach or suggest the inner spring 168 and the outer spring 170 extending in opposite helical directions.
Regarding claim 1, the Applicant further asserts that Douk fails to teach the amended limitation wherein “a distal end of the inner coils and a distal end of the outer coil are all secured together at a weldment at a distalmost end of the elongate medical device”, wherein the Applicant notes that Douk depicts in Fig. 10 that the distal joint 172, that attaches to both the inner spring 168 and the outer spring 170, is not at a distalmost end of the guidewire and expressly states “A distal portion 174 of the guidewire projects axially from the distal joint and is constructed substantially similar to the three previously described embodiments”.
Regarding claim 15, the Applicant asserts similar arguments to claim 1, and further asserts that Douk fails to teach the amended configuration of claim 15 of “a cable having an attachment point at a distalmost extent thereof that is secured together with both a distal most end of the inner coil and a distalmost end of the outer coil”, wherein the Applicant notes that in Fig. 10 of Douk, a distal portion of outer spring 170 extends distal of the distal joint 172, to form a distal portion 174 of the guidewire, and that the distal joint 172 is not secured to the distalmost end of the outer spring 170.
Regarding claims 1 and 15, the Applicant asserts that as Nabeshima discloses a mechanism that works by changing the spacing between coil windings [Nabeshima ¶0048], Nabeshima’s teachings cannot bridge the alleged structural gap between Douk’s configuration and the amended limitations. The Applicant further asserts that as Fleischhacker is directed towards the radial relationship between concentric coils [Fleischhacker Col 6:22-26, 15:62], but does not address the structural requirement of the securement location of the ends of the coils, Fleischhacker does not remedy an alleged structural incompatibility with Douk.
However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1 and 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Douk (US-6183420-B1, previously presented) is presently modified in view of de Toledo (US-4932419-Aand Nabeshima (US-20160375226-A1, previously presented), wherein the Examiner notes that de Toledo discloses an elongate medical device having variable stiffness comprising an inner coil and an outer coil, wherein the inner coil has one or more inner coil filars extending in a first helical direction and at an inner coil angle, wherein the outer coil has one or more outer coil filars extending in a second helical direction, wherein the second helical direction is opposite the first helical direction while maintaining [de Toledo Col 2:25-31, 3:3-13, Fig. 5]; and wherein Nabeshima discloses an embodiment of an elongate medical device with variable stiffness, wherein Nabeshima discloses an inner coil, an outer coil, and a cable extending through the inner coil and outer coil, wherein the distal end of the cable, the distal end of the inner coil, and the distal end of the outer coil are all secured at a weldment together at a distalmost end of the elongate medical device [Nabeshima ¶0078, Fig. 3].
Applicant’s arguments, see Applicant’s Remarks p. 6-10, with respect to the rejection(s) of claim(s) 8 and those dependent therefrom under § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Douk (US-6183420-B1, previously presented) in view of de Toledo (US-4932419-Aand Nabeshima (US-20160375226-A1, previously presented).
Regarding claim 8, the Applicant asserts that similar arguments to claim 1 as presented above regarding Douk and Nabeshima failing to teach, alone or in combination, the amended subject matter regarding the first and second helical directions, and the welding between the cable, inner coil, and outer coil. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1 and 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Douk (US-6183420-B1, previously presented) is presently modified in view of de Toledo (US-4932419-Aand Nabeshima (US-20160375226-A1, previously presented), wherein the Examiner notes that de Toledo discloses an elongate medical device having variable stiffness comprising an inner coil and an outer coil, wherein the inner coil has one or more inner coil filars extending in a first helical direction and at an inner coil angle, wherein the outer coil has one or more outer coil filars extending in a second helical direction, wherein the second helical direction is opposite the first helical direction while maintaining [de Toledo Col 2:25-31, 3:3-13, Fig. 5]. Furthermore, the Examiner disagrees with the Applicant’s argument that Nabeshima fails to teach subject matter regarding the welding between the cable, inner coil, and outer coil, as Nabeshima is considered to disclose an embodiment wherein a distal end of a cable, a distal end of an inner coil, and a distal end of an outer coil are all secured at a weldment together at a distalmost end of an elongate medical device [Nabeshima ¶0078, Fig. 3].
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 SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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