DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
2. Claim 14 is objected to because of the following informalities:
in line 11, “and” is a typographical/grammatical error since there is an “and” in line 13, and should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
3. 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.
4. 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.
5. 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.
6. Claims 1-9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lemon et al., U.S. Patent Application Publication No. 2018/0169389 A1 (“Lemon”), in view of Imig et al., U.S. 2018/0297936 A1 (“Imig”), and further in view of Labelle et al., W.O. 2017/147041 A1 (“Labelle”).
As to Claim 1, Lemon teaches the following:
A stylet (“stylet”) 30 (see “A stylet for use in guiding a distal tip of a catheter to a predetermined location within the body of a patient.” in Abstract, and see fig. 2), comprising:
a core member (“core wire”) 131 formed of … steel (see “The core wire 131 defines an elongate configuration and is composed of a suitable stylet material including stainless steel or a memory material such as nitinol in one embodiment.” in para. [0060]) having a uniform cross-section (see “core wire 131” in fig. 6A) between a proximal end (“proximal portion of the core wire”) 130A and a distal tip (“distal portion of the core wire”) 132 (see “As shown, the distal segment 132 includes a distal portion of the core wire 131 defining a diameter D2 that is reduced with respect to the diameter D1 of the more proximal portion of the core wire.” in para. [0066]),
the core member 131 configured to transmit an electrical signal (see “Once the catheter has been introduced into the patient vasculature and is advanced toward the patient's heart, the distal portion of the core wire 131, being electrically conductive, begins to detect the electrical impulses produced by the SA node or other suitable node of the patient's heart. The distal coil 152 is included about the core wire distal tip 131B to increase the relative surface area of the core wire distal portion so as to improve reception of the electrical impulses from the SA node. Note that other structures could be provided to provide the same functionality. As such, the ECG sensor assembly 150 serves as a sensor or electrode for detecting the ECG heart signals. The elongate core wire 131 proximal to the core wire distal segment serves as a conductive pathway to convey the electrical impulses produced by the SA node and received by the ECG sensor assembly 150 away from the distal segment 132 of the stylet 130 to the tether 135.” in para. [0072]); and
a magnetic element (“magnetic assembly”) 160 disposed about the core member 131 (see “In the present embodiment of FIG. 5, the distal segment 132 of the stylet 130 further includes a magnetic assembly, generally designated at 160.” in para. [0074]), …
Lemon does not teach the following:
the magnetic element comprising a plurality of straight wires disposed parallel to a longitudinal axis of the core member.
However, Imig teaches the following:
a magnetic element (“magnetic sensor assembly”) 200 (see “FIG. 4 is a diagram illustrating a side view of the magnetic sensor assembly 200, according to embodiments described in the disclosure.” in para. [0072]) comprising a plurality of straight wires (“sensor lead wires”) 204, 206 disposed parallel to a longitudinal axis (“longitudinal axis”) Cx2 of a core member (“magnetic core”) 210 (see “Each of the two sensor lead wires 204 and 206 includes a straight portion 204a and 206a that is situated adjacent the magnetic sensor coil 208, at least from the coil distal end 214 to the coil proximal end 212. Also, the sensor coil 208 has a longitudinal axis Cx2 and each of the straight portions 204a and 206a is parallel to the longitudinal axis Cx2 of the sensor coil 208 from the coil proximal end 212 to the coil distal end 214.” in para. [0076]).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Lemon’s magnetic element (“magnetic assembly”) 160 to comprise Imig’s plurality of straight wires (“sensor lead wires”) 204, 206 disposed parallel to a longitudinal axis (“longitudinal axis”) Cx2 of a core member (“magnetic core”) 210, in order to “improv[e] lead tensile strength and reducing sensor signal noise” (see Imig, para. [0067]).
In addition, Lemon in view of Imig does not teach the following:
a core member formed of A228 carbon steel …
However, Labelle teaches the following:
a core member formed of A228 carbon steel (see “FIG. 4 is a table identifying five different bundled wire system prototype designs A to E. Each prototype design used steel music wire (ASTM 228), 0.015 inch” in para. [0086]; and see “As shown in FIG. 24A, the tubular body 221 includes a longitudinally extending flexible core 225, such as may include one or more wires, fibers, or similar elements. In certain embodiments, the flexible core 225 comprises an electrically conductive material (e.g., including one or more metal-containing wires) to enable resistive heating of the tubular body 221 to permit softening of the tubular body 221 to affect its stiffness properties.” in para. [0105]).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Lemon’s core member (“core wire”) 131 to be formed of A228 carbon steel, as taught Labelle, in order to control the flexibility of the core by conductive heating. Furthermore, Lemon and Labelle are analogous art as they both are directed to steerable catheter assemblies.
As to Claim 2, Lemon teaches the following:
wherein a material of the magnetic element includes copper (see “The EM coil 172 is depicted in the present embodiment as a winding of conductive wire, such as insulated copper wire, wound about a portion of the distal core wire 131 in the air gap 148 within the sleeve 142.” in para. [0084]).
As to Claim 3, Lemon teaches the following:
an outer sleeve (“sleeve”) 42 disposed over the plurality of straight wires (see “A tubing sleeve 42 is slid over the reduced diameter stylet core wire along the distal segment 32 and is sized to substantially match the diameter D1 of the proximal portion of the stylet core wire, though it can be sized differently, if desired.” in para. [0045]).
As to Claim 4, Imig teaches the following:
wherein the plurality of straight wires (“sensor lead wires”) 204, 206 are arranged about the core member 210 in a plurality of layers (see Imig, fig. 4, which shows “sensor lead wires 204 and 206” are in different layers).
As to Claim 5, Lemon teaches the following:
a plurality of curved wires (“electromagnetic (“EM”) coil”) 172 disposed about the core member 131, the plurality of curved wires 172 extending from a distal end of the plurality of straight wires (see “FIG. 7 depicts an example of one such alternative, wherein an electromagnetic (“EM”) coil 172 is employed in the magnetic assembly 160 of the stylet distal segment 132. The EM coil 172 is depicted in the present embodiment as a winding of conductive wire, such as insulated copper wire, wound about a portion of the distal core wire 131 in the air gap 148 within the sleeve 142.” in para. [0084]; and fig. 8).
As to Claim 6, Lemon teaches the following:
wherein the plurality of curved wires comprise a configuration selected from the group consisting of a coiled configuration (see “FIG. 7 depicts an example of one such alternative, wherein an electromagnetic (“EM”) coil 172 is employed in the magnetic assembly 160 of the stylet distal segment 132. The EM coil 172 is depicted in the present embodiment as a winding of conductive wire, such as insulated copper wire, wound about a portion of the distal core wire 131 in the air gap 148 within the sleeve 142.” in para. [0084]; and fig. 8), a braided configuration, a twisted configuration, and combinations thereof.
As to Claim 7, Lemon teaches the following:
wherein the plurality of straight wires and the plurality of curved wires repeat along a length of the core member, wherein the plurality of curved wires join adjacent sets of the plurality of straight wires (see “FIG. 7 depicts an example of one such alternative, wherein an electromagnetic (“EM”) coil 172 is employed in the magnetic assembly 160 of the stylet distal segment 132. The EM coil 172 is depicted in the present embodiment as a winding of conductive wire, such as insulated copper wire, wound about a portion of the distal core wire 131 in the air gap 148 within the sleeve 142.” in para. [0084]; and fig. 8).
As to Claim 8, Imig teaches the following:
wherein the plurality of straight wires 204, 206 of each set of the adjacent sets of the plurality of straight wires have a uniform longitudinal length (see lengths of “sensor lead wires 204 and 206” in fig. 4).
As to Claim 9, Imig teaches the following:
wherein one or more wire of the plurality of straight wires 204, 206 extends distally further along a length of the core member 210 than a remainder of the plurality of straight wires (see lengths of “sensor lead wires 204 and 206” in fig. 4).
As to Claim 13, Lemon teaches the following:
a handle (“handle”) 134 coupled to the proximal end of the core member 131 (see “As shown in FIG. 4B, the stylet 130 as removed from the catheter 112 defines a proximal end 130A and a distal end 130B and generally includes a core wire 131, a handle 134, and a tether 135.” in para. [0059]; and see fig. 4A).
Allowable Subject Matter
7. Claims 10-12 and 20-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
8. Claims 14-19 are allowed.
9. The following is a statement of reasons for the indication of allowable subject matter:
As to Claim 10-12, neither Lemon, Imig, Labelle, nor the prior art of record teaches the stylet of base claim 1, including the following, in combination with all other limitations of the base claim:
wherein plurality of straight wires comprises:
a first plurality of straight wires defining a first stiffness characteristic, each wire of the first plurality of straight wires having a first diameter; and
a second plurality of straight wires defining a second stiffness characteristic, each wire of the second plurality of straight wires having a second diameter less than the first diameter.
As to Claim 14, Lemon teaches the following:
A stylet (“stylet”) 30 (see “A stylet for use in guiding a distal tip of a catheter to a predetermined location within the body of a patient.” in Abstract, and see fig. 2), comprising:
a core member (“core wire”) 131 formed of … steel (see “The core wire 131 defines an elongate configuration and is composed of a suitable stylet material including stainless steel or a memory material such as nitinol in one embodiment.” in para. [0060]) having a uniform cross-section (see “core wire 131” in fig. 6A) between a proximal end (“proximal portion of the core wire”) 130A and a distal tip (“distal portion of the core wire”) 132 (see “As shown, the distal segment 132 includes a distal portion of the core wire 131 defining a diameter D2 that is reduced with respect to the diameter D1 of the more proximal portion of the core wire.” in para. [0066]),
the core member 131 configured to transmit an electrical signal (see “Once the catheter has been introduced into the patient vasculature and is advanced toward the patient's heart, the distal portion of the core wire 131, being electrically conductive, begins to detect the electrical impulses produced by the SA node or other suitable node of the patient's heart. The distal coil 152 is included about the core wire distal tip 131B to increase the relative surface area of the core wire distal portion so as to improve reception of the electrical impulses from the SA node. Note that other structures could be provided to provide the same functionality. As such, the ECG sensor assembly 150 serves as a sensor or electrode for detecting the ECG heart signals. The elongate core wire 131 proximal to the core wire distal segment serves as a conductive pathway to convey the electrical impulses produced by the SA node and received by the ECG sensor assembly 150 away from the distal segment 132 of the stylet 130 to the tether 135.” in para. [0072]); and
a magnetic element (“magnetic assembly”) 160 disposed about the core member 131 (see “In the present embodiment of FIG. 5, the distal segment 132 of the stylet 130 further includes a magnetic assembly, generally designated at 160.” in para. [0074]), the magnetic element comprising:
…
an outer sleeve (“sleeve”) 42 surrounding the core member 131 and the magnetic element 160 (see “A tubing sleeve 42 is slid over the reduced diameter stylet core wire along the distal segment 32 and is sized to substantially match the diameter D1 of the proximal portion of the stylet core wire, though it can be sized differently, if desired.” in para. [0045]).
Lemon does not teach the following:
the magnetic element comprising:
a first set of straight wires disposed parallel to a longitudinal axis of the core member; …
However, Imig teaches the following:
a magnetic element (“magnetic sensor assembly”) 200 (see “FIG. 4 is a diagram illustrating a side view of the magnetic sensor assembly 200, according to embodiments described in the disclosure.” in para. [0072]) comprising a first set of straight wires (“sensor lead wires”) 204, 206 disposed parallel to a longitudinal axis (“longitudinal axis”) Cx2 of a core member (“magnetic core”) 210 (see “Each of the two sensor lead wires 204 and 206 includes a straight portion 204a and 206a that is situated adjacent the magnetic sensor coil 208, at least from the coil distal end 214 to the coil proximal end 212. Also, the sensor coil 208 has a longitudinal axis Cx2 and each of the straight portions 204a and 206a is parallel to the longitudinal axis Cx2 of the sensor coil 208 from the coil proximal end 212 to the coil distal end 214.” in para. [0076]).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Lemon’s magnetic element (“magnetic assembly”) 160 to comprise Imig’s plurality of straight wires (“sensor lead wires”) 204, 206 disposed parallel to a longitudinal axis (“longitudinal axis”) Cx2 of a core member (“magnetic core”) 210, in order to “improv[e] lead tensile strength and reducing sensor signal noise” (see Imig, para. [0067]).
In addition, Lemon in view of Imig does not teach the following:
a core member formed of A228 carbon steel …
However, Labelle teaches the following:
a core member formed of A228 carbon steel (see “FIG. 4 is a table identifying five different bundled wire system prototype designs A to E. Each prototype design used steel music wire (ASTM 228), 0.015 inch” in para. [0086]; and see “As shown in FIG. 24A, the tubular body 221 includes a longitudinally extending flexible core 225, such as may include one or more wires, fibers, or similar elements. In certain embodiments, the flexible core 225 comprises an electrically conductive material (e.g., including one or more metal-containing wires) to enable resistive heating of the tubular body 221 to permit softening of the tubular body 221 to affect its stiffness properties.” in para. [0105]).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Lemon’s core member (“core wire”) 131 to be formed of A228 carbon steel, as taught Labelle, in order to control the flexibility of the core by conductive heating. Furthermore, Lemon and Labelle are analogous art as they both are directed to steerable catheter assemblies.
As to Claim 14-19, neither Lemon, Imig, Labelle, nor the prior art of record teaches the stylet of base claim 14, including the following, in combination with all other limitations of the base claim:
a second set of straight wires disposed parallel to the longitudinal axis of the core member, the second set of straight wires separated from the first set of straight wires;
a first set of curved wires connecting the first set of straight wires to the second set of straight wires; and …
As to Claims 20-22, neither Lemon, Imig, Labelle, nor the prior art of record teaches the stylet of base claim 1, including the following, in combination with all other limitations of the base claim:
wherein:
the first set of straight wires defines a first stiffness characteristic, each wire of the first set of straight wires having a first diameter; and
the second set of straight wires defines a second stiffness characteristic, each wire of the second set of straight wires having a second diameter less than the first diameter.
Conclusion
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 09/16/2026
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