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 .
2. 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.
Continued Examination Under 37 CFR 1.114
3. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/30/2025 has been entered.
Response to Arguments
4. Applicant’s arguments, see Applicant’s Arguments, filed 9/30/2025, with respect to the rejection(s) of the presently cancelled Claim 3, whose language is now incorporated into independent Claim 1, has 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 Therefore, the rejection has been withdrawn.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 newly found prior art references. This can be found in the present office action below.
Claim Rejections - 35 USC § 103
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1, 2, 5, and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hoar U.S. 6,032,063 (herein referred to as “Hoar”) and in view of Karmarkar U.S. 2006/0106303 (herein referred to as “Karmarkar”).
7. Regarding Claim 1, Hoar teaches an electrocardiograph cable (Fig. 1, ref num 10) for reducing heat induced by pulsating radio frequency waves applied by a magnetic resonance imaging (MRI) scanner (Col. 2, lines 42-47), comprising:
a. a cable jacket (Fig. 1, ref num 25); and
b. a plurality of lead wires (Fig. 1, ref num 12) extending through the cable jacket (Fig. 1 and 4, ref nums 12 extend through ref num 25), wherein each of the plurality of lead wires comprises:
b.1 a first end segment (Fig. 1, ref num 16) configured to be coupled to a monitoring electrode (Fig. 1, ref num 18; Col. 3, line 66),
b.2 a second end segment (Fig. 1, ref num 26 on the right side) configured to be coupled to a monitoring device (Fig. 1, ref num 30; Col. 4, lines 8-16),
b.3 an electrically insulating core (Fig. 2, ref num 14) extending from the first end segment to the second end segment (Col. 3, lines 38-40; Claims 1 and 5, “insulating fibrous core”),
b.4 an electrically conductive wire (Figs. 2 and 3, ref num 13) comprising a metal alloy-based material that is non-magnetic (Col. 3, line 37, “nichrome conductor wire”, known to be non-magnetic); and the electrically conductive wire having a plurality of turns wound around the electrically insulating core from the first end segment to the second end segment (see Fig. 3, ref num 13 is helically wound around ref num 14; Col. 3, lines 37-40 and Col. 4, lines 17-20), and
b.5 an electrically insulating sleeve (Fig. 2, ref num 22) covering the electrically conductive wire wound around the electrically insulating core (Col. 4, lines 2-3);
c. wherein a pitch defined as a distance between a point on one of the turns of the electrically conductive wire to a corresponding point of an adjacent turn of the electrically conductive wire remains substantially uniform along a longitudinal axis of the electrically insulating core (Col. 2, lines 50-57, “by using a high resistance nichrome conductor which is helically wound around a fiber core, the exact resistance per foot of finished wire can be very tightly controlled by the number of turns of the conductor per linear foot of finished wire stock. As a result, the resistance is distributed evenly and uniformly from one end of the wire to the other, which results in even heating of the wire from one end to the other, with no spots of high concentrated heat”).
Hoar fails to teach (c) the pitch is in a range from about 0.00138 inches to about 0.00026 inches.
Karmarkar teaches a cable of analogous art (Figs. 1A and 3B) comprising an electrically conductive wire comprising a metal alloy-based material that is non-magnetic (Fig. 1A, ref num 122 para 0041, “the loop wire 122 may be made of a non-magnetic conductive wire”) and an electrically insulating core (Fig. 1A, ref num 115; para 0040, “polymeric flexible tubing 115”). In one embodiment the electrically conductive wire has a plurality of turns wound around the electrically insulating core (see Fig. 1A and Fig. 3B; Fig. 3B and 3C, ref num 125 is wound around ref num 315). The electrically conductive wire has a pitch (para 0041, “the loop coil has… a pitch 140 (distance between each turn of the coil) of about 0.05 to 10 mm”). While the specific range of the pitch is not taught by Karmarkar, the desired pitch is chosen in order to maximize RF flux impinging on the wire, and may be even smaller than the recited pitch (para 0050). Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoar to have the pitch of the electrically conductive wire have a pitch within the desired range in order to maximize RF flux impinging on the wire. It also would have been obvious to one having ordinary skill in the art at the time the invention was made to have this range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
8. Regarding Claim 2, Hoar teaches the electrically conductive wire comprises a metal alloy-based material having a resistance in a range from about 650 ohm-cir-mil/foot to about 850 ohm-cir-mil/foot (Col. 3, line 37, “nichrome conductor wire”).
9. Regarding Claim 5, Hoar teaches the electrically insulating core comprises a glass fiber-based material (ref num 14; Col. 3, lines 38-40; Claims 1 and 5, “insulating fibrous core”).
10. Regarding Claim 8, Hoar teaches the electrically insulative sleeve (ref num 22) comprises an elastomer-based material (Col. 4, lines 2-4).
11. Regarding Claim 9, Hoar teaches each of the lead wires has a distributed resistance of about 10,000 ohms/foot (Col. 3, lines 56-57).
12. Regarding Claim 10, Hoar teaches the plurality of lead wires are twisted together along an internal passage of the cable jacket (Col. 4, lines 17-22).
13. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hoar and Karmarkar, and further in view of Tanigawa U.S. 6,259,030 (herein referred to as “Tanigawa”).
14. Regarding Claim 6, Hoar fails to teach the electrically insulating core comprises a diameter in a range from about 0.250 inches to about 0.035 inches.
Tanigawa teaches a cable of analogous art (Fig. 2) comprising a insulative core (Fig. 2, ref num 12), wherein the insulative core has a diameter from about 0.250 to 0.035 inches (Col. 3, lines 29-38, “tubular core portion 12 is prepared so as to have a diameter of about 1.3 mm”; 1.3 mm is approximately 0.0511 inches). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the diameter of the insulative core be about 0.250 to 0.035 inches, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
15. Claims 7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hoar and Karmarkar, and further in view of Schmidt U.S. 2021/0011099 (herein referred to as “Schmidt”).
16. Regarding Claim 7, Hoar fails to teach each of the lead wires is configured to maintain an outer surface of the electrically insulating sleeve at a temperature in a range from about 26 oC to about 15 oC when subjected to a time-varying magnetic field having a magnetic flux density in a range from about 3 Tesla to about 10 Tesla.
Schmidt teaches a cable of analogous art (Figs. 3A-3C), wherein the wires of the cable are configured to maintain an outer surface temperature in a range from about 26 oC to 15 oC (Fig. 14D) when subjected to a time-varying magnetic field having a magnetic flux density in a range from 3 to 10 Tesla (para 0040-0041). This prevents a rise in temperature of the cables and the tissues surrounding the catheter (abstract). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the lead wires maintain an outer surface at a temperature in a range from about 26 oC to about 15 oC when subjected to a time-varying magnetic field having a magnetic flux density in a range from about 3 Tesla to about 10 Tesla, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
17. Regarding Claim 20, Hoar teaches a method for controlling a temperature of a lead wire in an electrocardiograph cable during a magnetic resonance imaging procedure, comprising:
a. providing an electrically insulating core of the lead wire (Fig. 2, ref num 14);
b. providing an electrically conductive wire (Figs. 2 and 3, ref num 13) comprising a metal alloy-based material that is non-magnetic (Col. 3, line 37, “nichrome conductor wire”, known to be non-magnetic) with a resistance in a range from about 650 ohm-cir-mil/foot to about 850 ohm-cir-mil/foot (Col. 3, line 37, “nichrome conductor wire”),
c. winding the electrically conductive wire into a plurality of turns around the electrically insulating core from a first end segment to a second end segment of the lead wire (see Fig. 3, ref num 13 is helically wound around ref num 14; Col. 3, lines 37-40 and Col. 4, lines 17-20), and
d. maintaining a pitch defined as a distance between a point on one of the turns of the electrically conductive wire to a corresponding point of an adjacent turn of the electrically conductive wire, wherein the pitch of the turns of the electrically conductive wire remains substantially uniform (Col. 2, lines 50-57, “by using a high resistance nichrome conductor which is helically wound around a fiber core, the exact resistance per foot of finished wire can be very tightly controlled by the number of turns of the conductor per linear foot of finished wire stock. As a result, the resistance is distributed evenly and uniformly from one end of the wire to the other, which results in even heating of the wire from one end to the other, with no spots of high concentrated heat”); and,
e. covering the electrically conductive wire around the electrically insulating core with an electrically insulating sleeve (Fig. 2, ref num 22; Col. 4, lines 2-3).
Hoar fails to teach (d) the pitch is in a range from about 0.00138 inches to about 0.00026 inches; (f) subjecting the lead wire to a pulsating radio frequency waves and a time-varying magnetic field having a magnetic flux density in a range from about 3 Tesla to about 10 Tesla; and (g) dissipating heat away from the electrically conductive wire to maintain an outer surface of the electrically insulating sleeve at a temperature in a range from about 26 oC to about 15 oC.
Karmarkar teaches a cable of analogous art (Figs. 1A and 3B) comprising an electrically conductive wire comprising a metal alloy-based material that is non-magnetic (Fig. 1A, ref num 122 para 0041, “the loop wire 122 may be made of a non-magnetic conductive wire”) and an electrically insulating core (Fig. 1A, ref num 115; para 0040, “polymeric flexible tubing 115”). In one embodiment the electrically conductive wire has a plurality of turns wound around the electrically insulating core (see Fig. 1A and Fig. 3B; Fig. 3B and 3C, ref num 125 is wound around ref num 315). The electrically conductive wire has a pitch (para 0041, “the loop coil has… a pitch 140 (distance between each turn of the coil) of about 0.05 to 10 mm”). While the specific range of the pitch is not taught by Karmarkar, the desired pitch is chosen in order to maximize RF flux impinging on the wire, and may be even smaller than the recited pitch (para 0050). Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoar to have the pitch of the electrically conductive wire have a pitch within the desired range in order to maximize RF flux impinging on the wire. It also would have been obvious to one having ordinary skill in the art at the time the invention was made to have this range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Schmidt teaches a cable of analogous art (Figs. 3A-3C), wherein the wires of the cable are configured to maintain an outer surface temperature in a range from about 26 oC to 15 oC (Fig. 14D) when subjected to a time-varying magnetic field having a magnetic flux density in a range from 3 to 10 Tesla (para 0040-0041). This prevents a rise in temperature of the cables and the tissues surrounding the catheter (abstract). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the lead wires maintain an outer surface at a temperature in a range from about 26 oC to about 15 oC when subjected to a time-varying magnetic field having a magnetic flux density in a range from about 3 Tesla to about 10 Tesla, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
18. Claims 11, 14, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Hoar and in view of Karmarkar, Tanigawa, Schmidt, and Kassab U.S. 2018/0019039 (herein referred to as “Kassab”).
19. Regarding Claim 11, Hoar teaches a lead wire in an electrocardiograph cable for reducing heat induced by pulsating radio frequency waves applied by a magnetic resonance imaging (MRI) scanner, (Col. 2, lines 42-47; Fig. 1, ref num 12) comprising:
a. a first end segment (Fig. 1, ref num 16) configured to be coupled to a monitoring electrode (Fig. 1, ref num 18; Col. 3, line 66),
b. a second end segment (Fig. 1, ref num 26 on the right side) configured to be coupled to a monitoring device (Fig. 1, ref num 30; Col. 4, lines 8-16),
c. an electrically insulating core (Fig. 2, ref num 14) extending from the first end segment to the second end segment (Col. 3, lines 38-40; Claims 1 and 5, “insulating fibrous core”),
d. an electrically conductive wire (Figs. 2 and 3, ref num 13) comprising a metal alloy-based material that is non-magnetic (Col. 3, line 37, “nichrome conductor wire”, known to be non-magnetic), and having a plurality of turns wound around the electrically insulating core from the first end segment to the second end segment (see Fig. 3, ref num 13 is helically wound around ref num 14; Col. 3, lines 37-40 and Col. 4, lines 17-20);
e. an electrically insulating sleeve (Fig. 2, ref num 22) covering the electrically conductive wire wound around the electrically insulating core (Col. 4, lines 2-3); and
h. wherein a pitch defined as a distance between a point on one of the turns of the electrically conductive wire to a corresponding point of an adjacent turn of the electrically conductive wire remains substantially uniform along a longitudinal axis of the electrically insulating core (Col. 2, lines 50-57, “by using a high resistance nichrome conductor which is helically wound around a fiber core, the exact resistance per foot of finished wire can be very tightly controlled by the number of turns of the conductor per linear foot of finished wire stock. As a result, the resistance is distributed evenly and uniformly from one end of the wire to the other, which results in even heating of the wire from one end to the other, with no spots of high concentrated heat”).
Hoar fails to teach (c) the electrically insulating core comprises a diameter in a range from about 0.250 inches to about 0.035 inches; (f) the electrically conductive wire comprises a heat capacity configured to maintain an outer surface of the electrically insulating sleeve at a temperature in a range from about 26 oC to about 15 oC when subjected to a time-varying magnetic field having a magnetic flux density in a range from about 3 Tesla to about 10 Tesla (h) the pitch is in a range from about 0.00138 inches to about 0.00026 inches.
Karmarkar teaches a cable of analogous art (Figs. 1A and 3B) comprising an electrically conductive wire comprising a metal alloy-based material that is non-magnetic (Fig. 1A, ref num 122 para 0041, “the loop wire 122 may be made of a non-magnetic conductive wire”) and an electrically insulating core (Fig. 1A, ref num 115; para 0040, “polymeric flexible tubing 115”). In one embodiment the electrically conductive wire has a plurality of turns wound around the electrically insulating core (see Fig. 1A and Fig. 3B; Fig. 3B and 3C, ref num 125 is wound around ref num 315). The electrically conductive wire has a pitch (para 0041, “the loop coil has… a pitch 140 (distance between each turn of the coil) of about 0.05 to 10 mm”). While the specific range of the pitch is not taught by Karmarkar, the desired pitch is chosen in order to maximize RF flux impinging on the wire, and may be even smaller than the recited pitch (para 0050). Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoar to have the pitch of the electrically conductive wire have a pitch within the desired range in order to maximize RF flux impinging on the wire. It also would have been obvious to one having ordinary skill in the art at the time the invention was made to have this range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Tanigawa teaches a cable of analogous art (Fig. 2) comprising a insulative core (Fig. 2, ref num 12), wherein the insulative core has a diameter from about 0.250 to 0.035 inches (Col. 3, lines 29-38, “tubular core portion 12 is prepared so as to have a diameter of about 1.3 mm”; 1.3 mm is approximately 0.0511 inches). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the diameter of the insulative core be about 0.250 to 0.035 inches, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Schmidt teaches a cable of analogous art (Figs. 3A-3C), wherein the wires of the cable are configured to maintain an outer surface temperature in a range from about 26 oC to 15 oC (Fig. 14D) when subjected to a time-varying magnetic field having a magnetic flux density in a range from 3 to 10 Tesla (para 0040-0041). This prevents a rise in temperature of the cables and the tissues surrounding the catheter (abstract). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the lead wires maintain an outer surface at a temperature in a range from about 26 oC to about 15 oC when subjected to a time-varying magnetic field having a magnetic flux density in a range from about 3 Tesla to about 10 Tesla, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Kassab teaches a lead wire of analogous art (Fig. 23 and Fig. 26A), wherein the lead wire comprising an electrically conductive wire (Fig. 26A, ref num 110). The electrically conductive wire comprises a diameter in a range from about 0.00176 inches to about 0.00250 inches (para 0253, “conductor wires 110 would have a diameter at or between 0.0015″ to 0.003″…”). The resistance of the electrically conductive wire is directly related to its diameter (para 0239). The diameter of the electrically conductive wire then directly correlates to the degradation of the lead wire and the overall electrical performance (para 0250). Therefore, 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 Hoar to have the electrically conductive wire comprise a diameter in a range from 0.00176 inches to about 0.00250 inches.
20. Regarding Claim 14, Hoar teaches the electrically conductive wire comprises a metal alloy-based material having a resistance in a range from about 650 ohm-cir-mil/foot to about 850 ohm-cir-mil/foot (Col. 3, line 37, “nichrome conductor wire”).
21. Regarding Claim 17, Hoar teaches the electrically insulating core comprises a glass fiber-based material (ref num 14; Col. 3, lines 38-40; Claims 1 and 5, “insulating fibrous core”).
22. Regarding Claim 18, Hoar teaches the electrically insulative sleeve (ref num 22) comprises an elastomer-based material (Col. 4, lines 2-4).
23. Regarding Claim 19, Hoar teaches each of the lead wires has a distributed resistance of about 10,000 ohms/foot (Col. 3, lines 56-57).
Conclusion
24. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794