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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/2/2025 has been entered.
Response to Amendment
The amendment filed on 5/2/2025 has been entered. Claims 1-6 are pending in the application. The amendments to the claims overcome each and every 112(a) rejection previously set forth in the Final Office Action mailed on 2/27/2025.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Tsunezumi (US 2012/0253321 A1) in view of Crank (US 2005/0049523 A1).
Regarding claim 1, Tsunezumi discloses a guidewire (guidewire 1B, see Fig. 4), comprising:
an elongated core member (linear core shaft 2) having a proximal core section (proximal section of linear core shaft 2), a distal core section (distal section of linear core shaft 2), the distal core section (distal section of linear core shaft 2) having a tapered segment (linear core shaft 2 has a taper between proximal/distal ends) tapering from a larger diameter to a smaller diameter moving from the proximal core section (proximal section of linear core shaft 2) and extending along the distal core section (distal section of linear core shaft 2) (see Fig. 4, par. [0019] and [0026], linear core shaft 2 of Fig. 4 has the same shape as that of core shaft 2 in Fig. 2A), and the elongated core member (linear core shaft 2) having a proximal end (proximal end of linear core shaft 2) configured to remain outside a body of a patient and a distal end (distal end of linear core shaft 2) configured to be advanced into a vascular system of the patient (see par. [0024] and [0026], the user holds the proximal end of guidewire 1B and inserts guidewire 1B into the vasculature);
a single continuous inner wire coil (inner coil body 15) having a distal end (distal end of inner coil body 15) and a proximal end (proximal end of inner coil body 15) and being disposed over, but not touching, the tapered segment of the distal core section (distal section of linear core shaft 2) of the elongated core member (linear core shaft 2) (see Fig. 4, par. [0027], inner coil body 15 does not directly contact linear core shaft 2);
an outer wire coil (coil body 3) having a distal end (distal end of coil body 3) and a proximal end (proximal end of coil body 3) and being disposed over, but not touching, the inner wire coil (inner coil body 15) and the tapered segment of the distal core section (distal section of linear core shaft 2) of the elongated core member (linear core shaft 2) (see Fig. 4, par. [0027], coil body 3 does not directly contact inner coil body 15 or linear core shaft 2);
the distal end (distal end of inner coil body 15) of the inner wire coil (inner coil body 15) being permanently attached to the distal end (distal end of coil body 3) of the outer wire coil (coil body 3) by only a solder joint (tip portion 5) at the distal end (distal end of linear core shaft 2) of the elongated core member (linear core shaft 2) (see Fig. 4, par. [0022] and [0026]-[0027]);
the proximal end (proximal end of inner coil body 15) of the inner wire coil (inner coil body 15) being permanently attached to the elongated core member (linear core shaft 2) (see Fig. 4, par. [0022] and [0026]-[0027], via securing portion 17).
However, Tsunezumi fails to explicitly state wherein the inner wire coil has an I-beam cross-sectional shape and a linear torsional stiffness of the I-beam cross-sectional shape being more than about 4.545 times greater than a bending stiffness of the I-beam cross-sectional shape.
Crank teaches a guidewire (elongate medical device 100 is a guidewire – see par. [0039], Figs. 1 and 6) wherein the wire coil (coil 110/600) has an I-beam cross-sectional shape (see par. [0037] and [0062]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner wire coil of the guidewire of Tsunezumi to have an I-beam cross-sectional shape, as taught by Crank, in order to achieve a desired flexibility of the guidewire (see Crank par. [0037]).
However, modified Tsunezumi still fails to explicitly state a linear torsional stiffness of the l-beam cross-sectional shape being more than about 4.545 times greater than a bending stiffness of the l-beam cross-sectional shape.
Modified Tsunezumi teaches that the shape, dimensions, and relationship between torque, moment of inertia, and flexibility (bending) of the inner wire coil need to be optimized to achieve desired characteristics of the guidewire to be able to navigate through the anatomy of the patient (see Crank par. [0002], [0037], and [0069]). As such, the value by which the linear torsional stiffness of the l-beam cross-sectional shape is greater than the bending stiffness of the l-beam cross-sectional shape is a result effective variable in that changing the relationship between the linear torsional stiffness and the bending stiffness changes the flexibility and steering ability of the guidewire. Further, it appears that a person of ordinary skill in the art would have had a reasonable expectation of success in modifying the guidewire of modified Tsunezumi to include the claimed relationship between the linear torsional stiffness and the bending stiffness, as it involves only adjusting material properties of a component disclosed to allow adjustment. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of modified Tsunezumi to include that a linear torsional stiffness of the I-beam cross-sectional shape is more than about 4.545 times greater than a bending stiffness of the I-beam cross-sectional shape as a matter of routine optimization since it has been held that “where 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). Further, Applicant appears to place no criticality on the claimed relationship (see Response to Arguments below).
Regarding claim 2, modified Tsunezumi teaches the guidewire of claim 1 substantially as claimed. Tsunezumi further teaches wherein a first solder joint (securing portion 17) permanently attaches the proximal end (proximal end of inner coil body 15) of the inner wire coil (inner coil body 15) to the elongated core member (linear core shaft 2) (see Fig. 4, par. [0022] and [0026]-[0027]).
Regarding claim 4, modified Tsunezumi teaches the guidewire of claim 1 substantially as claimed. Tsunezumi further teaches wherein the inner wire coil (inner coil body 15) is formed from a multifilar coil of wire (see par. [0027]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Tsunezumi (US 2012/0253321 A1) in view of Crank (US 2005/0049523 A1), as applied to claim 1 above, and further in view of Sharrow (US 2007/0083132 A1).
Regarding claim 5, modified Tsunezumi teaches the guidewire of claim 1 substantially as claimed. However, modified Tsunezumi fails to explicitly state wherein the inner wire coil is formed from a radiopaque material taken from a group of radiopaque materials including: platinum, palladium, iridium, tungsten, tantalum, rhenium and gold.
Sharrow teaches a guidewire (guidewire 200, see Fig. 2) wherein the inner wire coil (inner coil 220) is formed from a radiopaque material such as gold, platinum, palladium, tungsten alloy, and tantalum (see par. [0035]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the inner wire coil of modified Tsunezumi to be a radiopaque material, as taught by Sharrow, in order to aid the user of the guidewire in determining its location during a medical procedure (see Sharrow par. [0035]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tsunezumi (US 2012/0253321 A1) in view of Crank (US 2005/0049523 A1), as applied to claim 1 above, and further in view of Roseke (What is the Torsion Constant?, December 5, 2013, Project Engineer).
Regarding claim 6, modified Tsunezumi teaches the guidewire of claim 1 substantially as claimed. However, modified Tsunezumi fails to explicitly state wherein the linear torsional stiffness of the l-beam cross-sectional shape is in a range from 0.1 moment (N.m) to 0.6 moment (N.m) when subjected to an applied torque in the range from 15 degrees to 90 degrees.
Roseke teaches the following equation for an angle of twist:
PNG
media_image1.png
54
132
media_image1.png
Greyscale
Where:
θ = Angle of Twist
T = Applied Torque (N·m or lb·ft)
L = Length of Beam (mm or in)
J = Torsional Constant (mm4 or in4)
G = Modulus of Rigidity (GPa or psi)
Torsional stiffness, τ, is known to be equal to applied torque, T, divided by the angle of twist, θ. The above equation can be manipulated to solve for torsional stiffness, t, such that:
τ
=
T
θ
=
J
*
G
L
Known parameters can be inserted into the above equation to solve for the torsional stiffness, yielding a predictable result. These parameters can be altered to achieve a desired torsional stiffness. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the known parameters to be within the claimed range as such a modification would behave according to the above equation. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the linear torsional stiffness of the l-beam cross-sectional shape of modified Tsunezumi to be in a range from 0.1 moment (N.m) to 0.6 moment (N.m) when subjected to an applied torque in the range from 15 degrees to 90 degrees as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, itis 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).
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Maki (US 2012/0265100 A1) in view of Crank (US 2005/0049523 A1).
Regarding claim 1, Maki discloses a guidewire (medical guidewire 1A, see Fig. 1), comprising:
an elongated core member (core shaft 2) having a proximal core section (proximal section of core shaft 2), a distal core section (distal section of core shaft 2), the distal core section (distal section of core shaft 2) having a tapered segment tapering from a larger diameter to a smaller diameter moving from the proximal core section (proximal section of core shaft 2) and extending along the distal core section (distal section of core shaft 2) (see Fig. 1, par. [0032]), and the elongated core member (core shaft 2) having a proximal end (proximal end of core shaft 2) configured to remain outside a body of a patient and a distal end (distal end of core shaft 2) configured to be advanced into a vascular system of the patient (see par. [0003], the user holds the proximal end of guidewire 1A and inserts guidewire 1A into the vasculature);
a single continuous inner wire coil (inner coiled body 10) having a distal end (distal end of inner coiled body 10) and a proximal end (proximal end of inner coiled body 10) being disposed over, but not touching, the tapered segment of the distal core section (distal section of core shaft 2) of the elongated core member (core shaft 2) (see Fig. 1, par. [0034], inner coiled body 10 does not directly contact core shaft 2);
an outer wire coil (outer coiled body 3) having a distal end (distal end of outer coiled body 3) and a proximal end (proximal end of outer coiled body 3) and being disposed over, but not touching, the inner wire coil (inner coiled body 10) and the tapered segment of the distal core section (distal section of core shaft 2) of the elongated core member (core shaft 2) (see Fig. 1, par. [0033]-[0034], outer coiled body 3 does not directly contact inner coiled body 10 or core shaft 2);
the distal end (distal end of inner coiled body 10) of the inner wire coil (inner coiled body 10) being permanently attached to the distal end (distal end of outer coiled body 3) of the outer wire coil (outer coiled body 3) by only a solder joint (most distal portion 4) at the distal end (distal end of core shaft 2) of the elongated core member (core shaft 2) (see Fig. 1, par. [0033]-[0034]);
the proximal end (proximal end of inner coiled body 10) of the inner wire coil (inner coiled body 10) being permanently attached to the elongated core member (core shaft 2) (see Fig. 1, par. [0034], via second fixing portion 12).
However, Maki fails to explicitly state wherein the inner wire coil has an l-beam cross-sectional shape and a linear torsional stiffness of the l-beam cross-sectional shape being more than about 4.545 times greater than a bending stiffness of the l-beam cross-sectional shape.
Crank teaches a guidewire (elongate medical device 100 is a guidewire – see par. [0039], Figs. 1 and 6) wherein the wire coil (coil 110/600) has an I-beam cross-sectional shape (see par. [0037] and [0062]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner wire coil of the guidewire of Maki to have an I-beam cross-sectional shape, as taught by Crank, in order to achieve a desired flexibility of the guidewire (see Crank par. [0037]).
However, modified Maki still fails to explicitly state a linear torsional stiffness of the l-beam cross-sectional shape being more than about 4.545 times greater than a bending stiffness of the l-beam cross-sectional shape.
Modified Maki teaches that the shape, dimensions, and relationship between torque, moment of inertia, and flexibility (bending) of the inner wire coil need to be optimized to achieve desired characteristics of the guidewire to be able to navigate through the anatomy of the patient (see Crank par. [0002], [0037], and [0069]). As such, the value by which the linear torsional stiffness of the l-beam cross-sectional shape is greater than the bending stiffness of the l-beam cross-sectional shape is a result effective variable in that changing the relationship between the linear torsional stiffness and the bending stiffness changes the flexibility and steering ability of the guidewire. Further, it appears that a person of ordinary skill in the art would have had a reasonable expectation of success in modifying the guidewire of modified Maki to include the claimed relationship between the linear torsional stiffness and the bending stiffness, as it involves only adjusting material properties of a component disclosed to allow adjustment. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of modified Maki to include that a linear torsional stiffness of the I-beam cross-sectional shape is more than about 4.545 times greater than a bending stiffness of the I-beam cross-sectional shape as a matter of routine optimization since it has been held that “where 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). Further, Applicant appears to place no criticality on the claimed relationship (see Response to Arguments below).
Regarding claim 2, modified Maki teaches the guidewire of claim 1 substantially as claimed. Maki further teaches wherein a first solder joint (second fixing portion 12) permanently attaches the proximal end (proximal end of inner coiled body 10) of the inner wire coil (inner coiled body 10) to the elongated core member (core shaft 2) (see Fig. 1, par. [0034]).
Regarding claim 3, modified Maki teaches the guidewire of claim 1 substantially as claimed. Maki further teaches wherein the inner wire coil (inner coiled body 10) is formed from a single strand of wire (see par. [0034}]).
Regarding claim 4, modified Maki teaches the guidewire of claim 1 substantially as claimed. However, modified Maki, in the embodiment of Maki Fig. 1, fails to state wherein the inner wire coil is formed from a multifilar coil of wire.
Maki teaches an alternative embodiment of a guidewire (medical guidewire 1C, see Fig. 3), wherein the inner wire coil (inner coiled body 14) is formed from a multifilar coil of wire (see par. [0046]-[0047]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner wire coil of the modified embodiment of Maki Fig. 1 to be formed from a multifilar coil of wire, as taught by the embodiment of Maki Fig. 3, in order to improve the robustness of the guidewire (see Maki par. [0046]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Maki (US 2012/0265100 A1) in view of Crank (US 2005/0049523 A1), as applied to claim 1 above, and further in view of Sharrow (US 2007/0083132 A1).
Regarding claim 5, modified Maki teaches the guidewire of claim 1 substantially as claimed. However, modified Maki fails to explicitly state wherein the inner wire coil is formed from a radiopaque material taken from a group of radiopaque materials including: platinum, palladium, iridium, tungsten, tantalum, rhenium and gold.
Sharrow teaches a guidewire (guidewire 200, see Fig. 2) wherein the inner wire coil (inner coil 220) is formed from a radiopaque material such as gold, platinum, palladium, tungsten alloy, and tantalum (see par. [0035]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the inner wire coil of modified Maki to be a radiopaque material, as taught by Sharrow, in order to aid the user of the guidewire in determining its location during a medical procedure (see Sharrow par. [0035]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Maki (US 2012/0265100 A1) in view of Crank (US 2005/0049523 A1), as applied to claim 1 above, and further in view of Roseke (What is the Torsion Constant?, December 5, 2013, Project Engineer).
Regarding claim 6, modified Maki teaches the guidewire of claim 1 substantially as claimed. However, modified Maki fails to explicitly state wherein the linear torsional stiffness of the l-beam cross-sectional shape is in a range from 0.1 moment (N.m) to 0.6 moment (N.m) when subjected to an applied torque in the range from 15 degrees to 90 degrees.
Roseke teaches the following equation for an angle of twist:
PNG
media_image1.png
54
132
media_image1.png
Greyscale
Where:
θ = Angle of Twist
T = Applied Torque (N·m or lb·ft)
L = Length of Beam (mm or in)
J = Torsional Constant (mm4 or in4)
G = Modulus of Rigidity (GPa or psi)
Torsional stiffness, τ, is known to be equal to applied torque, T, divided by the angle of twist, θ. The above equation can be manipulated to solve for torsional stiffness, t, such that:
τ
=
T
θ
=
J
*
G
L
Known parameters can be inserted into the above equation to solve for the torsional stiffness, yielding a predictable result. These parameters can be altered to achieve a desired torsional stiffness. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the known parameters to be within the claimed range as such a modification would behave according to the above equation. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the linear torsional stiffness of the l-beam cross-sectional shape of modified Maki to be in a range from 0.1 moment (N.m) to 0.6 moment (N.m) when subjected to an applied torque in the range from 15 degrees to 90 degrees as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, itis 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).
Response to Arguments
Applicant’s arguments filed 5/2/2025 have been fully considered. Applicant’s arguments with regards to the Hilmersson reference are persuasive (see Remarks pages 5-6). However, the Examiner maintains that Tsunezumi in view of Crank (and similarly Maki in view of Crank) still teaches each and every limitation of amended claim 1 for the reasons described in the rejection of claim 1 above.
Applicant’s arguments with regards to the criticality on the claimed 4.545 value are not persuasive. Though the Specification provides support for the 4.545 value, this is not supported as a critical value in the Specification. It is not clear what the value of 4.545 specifically provides that is critical. In other words, the Specification does not support that the value of 4.545 produces a new and unexpected result relative to what is taught by the state of the prior art (see MPEP 2144.05(III)(A)). The Specification describes, particularly in paragraphs [0089] and [0091], that there is a direct relationship between torque response and bending stiffness. The drawings, particularly Figures. 24-25, further establish that the linear torsional stiffness of the I-beam is more than about 4.545 times greater than a bending stiffness of the I-beam, but this does not show or describe that the value is critical.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783