DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1-32 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Boggs (US 20100152808) in view of Glukhovsky et al. (US 20090326602), both cited previously.
Regarding claim 1, Boggs discloses a method comprising: placing an electrode of a coiled-wire percutaneous lead 12 within tissue in electrical proximity to but spaced from a peripheral nerve innervating a targeted region (Fig. 10, section 0124, 0128, the one or more leads 12(B) with its electrode 14(B) in the targeted muscle in electrical proximity to but spaced away from the targeted nerve of passage. In a percutaneous system, an electrode lead 12, such as a coiled fine wire electrode lead may be used because it is minimally-invasive and well suited for placement in proximity to a nerve of passage), wherein the tissue is outside of the targeted region (Fig. 10, section 0124, the one or more leads 12(B) with its electrode 14(B) in the targeted muscle in electrical proximity to but spaced away from the targeted nerve of passage), wherein the coiled-wire percutaneous lead comprises insulation formed from a biocompatible polymer film (section 0132, The wire can be insulated, e.g., with a biocompatible polymer film, such as polyfluorocarbon, polyimide, or parylene) and wherein the electrode is formed at a distal end of the coiled-wire percutaneous lead free of the biocompatible polymer film (Section 0134, The conduction location or electrode 14 may comprise a de-insulated area of an otherwise insulated conductor that runs the length of an entirely insulated electrode); attaching a proximal end of the coiled-wire percutaneous lead 12, 16 extending from skin of a patient to an electrical stimulation device 28 (Fig. 11C, section 0133, Each of the conduction locations may be connected to one or more conductors that run the length of the lead and lead extension 16 (see FIG. 11C), proving electrical continuity from the conduction location through the lead 12 to an external pulse generator or stimulator 28); attaching a surface electrode 14 to the patient (Fig. 11C, section 0141, the exposed conduction surfaces of the electrode 14, which is placed in th muscle of a patient shown in Fig. 10); applying electrical stimulation via the electrical stimulation device to the peripheral nerve (section 0150, Electrical stimulation may be applied to the targeted nerve of passage during and after placement of the electrode to determine whether stimulation of the targeted nerve of passage can generate comfortable sensations or paresthesia that overlap with the region of pain and/or reduce pain); and evoking an area of paresthesia without functional nerve stimulation at a motor point (section 0126, If electrical stimulation activates the target nerve of passage sufficiently at the correct intensity, then the patient will feel a comfortable tingling sensation called a paresthesia in the same region as their pain, which overlap with the region of pain and/or otherwise reduce pain. Page 14, claim 2, provide therapeutic nerve stimulation to alleviate pain in the painful region without functional nerve stimulation at a motor point) and without damaging the peripheral nerve (Section 0215, minimizing risk and/or damage to the patient nerve or tissue during placement of the lead).
However, Boggs does not specifically disclose a method to alleviate pain post limb joint replacement surgery, applying electrical stimulation via the electrical stimulation device to the peripheral nerve after a limb joint replacement surgery. Glukhovsky discloses applying stimulation percutaneously (section 0087, 0100), a method to alleviate pain post limb joint replacement surgery and applying electrical stimulation via the electrical stimulation device to the peripheral nerve (section 0048) after a limb joint replacement surgery (section 0049, a stimulation system can be used in conjunction with a joint replacement procedure (for example, knee replacement or hip replacement) to condition the muscles before the surgery, reduce the post-procedure pain, enhance the post-operative recovery and/or reduce or prevent some of the side effects associated with a joint replacement procedure). This allows for reducing post-procedure pain, enhance recovery, or prevent side-effects post procedure. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Boggs by adding applying electrical stimulation via the electrical stimulation device to the peripheral nerve after a limb joint replacement surgery as taught by Glukhovsky in order to facilitate reducing post-procedure pain, enhance recovery, or prevent side-effects post procedure.
Regarding claim 2, Boggs discloses the coiled-wire percutaneous lead 12 is configured to withstand mechanical forces and resist migration (section 0128, The lead can be sized and configured to withstand mechanical forces and resist migration during long-term use).
Regarding claim 3, Boggs discloses the electrode comprises a surface area of 0.001 to 200 mm2 (section 0196, The electrode contact surface area may be 0.1-20 mm2, 0.01-40 mm2, or 0.001-200 mm2).
Regarding claim 4, Boggs discloses the electrical stimulation comprises an intensity of 0.01 mA to 200 mA (Section 0166, 0188, The external pulse generator 28 may be programmed to 4 mA. The external or implantable pulse generator may use passive charge recovery to generate the stimulation waveform, regulated voltage (e.g., 10 mV to 20 V), and/or regulated current e.g., about 10 µA to about 50 mA).
Regarding claim 5, Boggs discloses the electrical stimulation comprises a pulse duration of between 1 µ sec and 10,000 µsec (section 0166, the external pulse generator 28 may be programmed to 4 mA, 100 µ sec, 100 Hz, and an on-off duty cycle of 0.25 sec).
Regarding claim 6, Boggs discloses the electrical stimulation comprises an intensity of 10 mA to 50 mA (Section 0188, The external or implantable pulse generator may use passive charge recovery to generate the stimulation waveform, regulated voltage (e.g., 10 mV to 20 V), and/or regulated current e.g., about 10 µA to about 50 mA).
Regarding claim 7, Boggs discloses the electrical stimulation comprises a stimulation frequency of 1 Hz to 300 Hz (section 0166, the external pulse generator 28 may be programmed to 4 mA, 100 µ sec, 100 Hz, and an on-off duty cycle of 0.25 sec).
Regarding claim 8, Boggs discloses the electrical stimulation comprises an intensity of between 1 mA and 2 mA (section 0167, a predetermined stimulus amplitude e.g., 1 mA).
Regarding claim 9, Boggs discloses the electrical stimulation comprises an intensity of between 0.1 mA and 40 mA (section 0167, a predetermined stimulus amplitude e.g., 1 mA).
Regarding claim 10, Boggs discloses the electrical stimulation comprises a pulse duration of between 100 µ sec and 300 µ sec (section 0166, the external pulse generator 28 may be programmed to 4 mA, 100 µ sec, 100 Hz, and an on-off duty cycle of 0.25 sec).
Regarding claim 11, Boggs discloses the electrical stimulation comprises a pulse duration of between 40 µ sec and 1000 µ sec (section 0166, the external pulse generator 28 may be programmed to 4 mA, 100 µ sec, 100 Hz, and an on-off duty cycle of 0.25 sec).
Regarding claim 12, Boggs discloses the electrode is spaced at 1mm to 100mm from the peripheral nerve (Section 0192, activate the targeted nerve of passage at some distance e.g. 1 mm away from the targeted nerve of passage).
Regarding claim 13, Boggs discloses the electrode is spaced at 1mm to 50mm from the peripheral nerve (Section 0192, activate the targeted nerve of passage at some distance e.g. 1 mm away from the targeted nerve of passage).
Regarding claim 14, Boggs discloses the electrode comprises a surface area of 0.1mm2 to 20 mm2 (section 0196, The electrode contact surface area may be 0.1-20 mm2, 0.01-40 mm2, or 0.001-200 mm2).
Regarding claim 15, Boggs discloses the electrode comprises a surface area of 0.01 mm2 to 40 mm2 (section 0196, The electrode contact surface area may be 0.1-20 mm2, 0.01-40 mm2, or 0.001-200 mm2).
Regarding claim 16, Boggs discloses placing an electrode of a coiled-wire percutaneous lead within tissue in electrical proximity to but spaced from a peripheral nerve innervating a targeted region (Fig. 10, section 0128, In a percutaneous system, an electrode lead 12, such as a coiled fine wire electrode lead may be used because it is minimally-invasive and well suited for placement in proximity to a nerve of passage), wherein the tissue is outside of the targeted region (Fig. 10, section 0124, the one or more leads 12(B) with its electrode 14(B) in the targeted muscle in electrical proximity to but spaced away from the targeted nerve of passage), wherein the coiled-wire percutaneous lead comprises insulation formed from a biocompatible polymer film (section 0132, The wire can be insulated, e.g., with a biocompatible polymer film, such as polyfluorocarbon, polyimide, or parylene) and wherein the electrode is formed at a distal end of the coiled-wire percutaneous lead free of the biocompatible polymer film (Section 0134, The conduction location or electrode 14 may comprise a de-insulated area of an otherwise insulated conductor that runs the length of an entirely insulated electrode); attaching a proximal end 16 of the coiled-wire percutaneous lead 12 extending from skin of a patient to an electrical stimulation device 28 (Fig. 11C, section 0133, Each of the conduction locations may be connected to one or more conductors that run the length of the lead and lead extension 16 (see FIG. 11C), proving electrical continuity from the conduction location through the lead 12 to an external pulse generator or stimulator 28); attaching a surface electrode 14 to the patient (Fig. 11C, section 0141, the exposed conduction surfaces of the electrode 14, which is placed in th muscle of a patient shown in Fig. 10); applying electrical stimulation via the electrical stimulation device to the peripheral nerve (section 0150, Electrical stimulation may be applied to the targeted nerve of passage during and after placement of the electrode to determine whether stimulation of the targeted nerve of passage can generate comfortable sensations or paresthesia that overlap with the region of pain and/or reduce pain); and evoking an area of paresthesia without functional nerve stimulation at a motor point (section 0126, If electrical stimulation activates the target nerve of passage sufficiently at the correct intensity, then the patient will feel a comfortable tingling sensation called a paresthesia in the same region as their pain, which overlap with the region of pain and/or otherwise reduce pain. Page 14, claim 2, provide therapeutic nerve stimulation to alleviate pain in the painful region without functional nerve stimulation at a motor point) and without damaging the peripheral nerve (Section 0215, minimizing risk and/or damage to the patient nerve or tissue during placement of the lead).
However, Boggs does not specifically disclose a method to alleviate pain post limb joint replacement surgery, applying electrical stimulation via the electrical stimulation device to the peripheral nerve after a limb joint replacement surgery. Glukhovsky discloses applying stimulation percutaneously (section 0087, 0100), a method to alleviate pain post limb joint replacement surgery and applying electrical stimulation via the electrical stimulation device to the peripheral nerve (section 0048) after a limb joint replacement surgery (section 0049, a stimulation system can be used in conjunction with a joint replacement procedure (for example, knee replacement or hip replacement) to condition the muscles before the surgery, reduce the post-procedure pain, enhance the post-operative recovery and/or reduce or prevent some of the side effects associated with a joint replacement procedure). This allows for reducing post-procedure pain, enhance recovery, or prevent side-effects post procedure. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Boggs by adding applying electrical stimulation via the electrical stimulation device to the peripheral nerve after a limb joint replacement surgery as taught by Glukhovsky in order to facilitate reducing post-procedure pain, enhance recovery, or prevent side-effects post procedure.
Regarding claim 17, Boggs in view of Glukhovsky, specfically Glukhovsky discloses the limb joint replacement surgery comprises total knee arthroplasty (section 0049, 0053, a stimulation system can be used in conjunction with a joint replacement procedure for example, knee replacement or knee arthroplasty). This allows for reducing post-procedure pain, enhance recovery, or prevent side-effects post procedure.
Regarding claim 18, Boggs discloses the peripheral nerve comprises a femoral nerve (Figs. 16A-C, 18A-B, section 0181, the targeted nerve of passage includes the femoral nerve).
Regarding claim 19, Boggs discloses the coiled-wire percutaneous lead 12 is configured to withstand mechanical forces and resist migration (section 0128, The lead can be sized and configured to withstand mechanical forces and resist migration during long-term use).
Regarding claim 20, Boggs discloses the electrode comprises a surface area of 0.001 to 200 mm2 (section 0196, The electrode contact surface area may be 0.1-20 mm2, 0.01-40 mm2, or 0.001-200 mm2).
Regarding claim 21, Boggs discloses the electrical stimulation comprises an intensity of 0.01 mA to 200 mA (Section 0166, 0188, The external pulse generator 28 may be programmed to 4 mA. The external or implantable pulse generator may use passive charge recovery to generate the stimulation waveform, regulated voltage (e.g., 10 mV to 20 V), and/or regulated current e.g., about 10 µA to about 50 mA).
Regarding claim 22, Boggs discloses the electrical stimulation comprises a pulse duration of between 1 µ sec and 10,000 µsec (section 0166, the external pulse generator 28 may be programmed to 4 mA, 100 µ sec, 100 Hz, and an on-off duty cycle of 0.25 sec).
Regarding claim 23, Boggs discloses the electrical stimulation comprises an intensity of 10 mA to 50 mA (Section 0188, The external or implantable pulse generator may use passive charge recovery to generate the stimulation waveform, regulated voltage (e.g., 10 mV to 20 V), and/or regulated current e.g., about 10 µA to about 50 mA).
Regarding claim 24, Boggs discloses the electrical stimulation comprises a stimulation frequency of 1 Hz to 300 Hz (section 0166, the external pulse generator 28 may be programmed to 4 mA, 100 µ sec, 100 Hz, and an on-off duty cycle of 0.25 sec).
Regarding claim 25, Boggs discloses the electrical stimulation comprises an intensity of between 1 mA and 2 mA (section 0167, a predetermined stimulus amplitude e.g., 1 mA).
Regarding claim 26, Boggs discloses the electrical stimulation comprises an intensity of between 0.1 mA and 40 mA (section 0167, a predetermined stimulus amplitude e.g., 1 mA).
Regarding claim 27, Boggs discloses the electrical stimulation comprises a pulse duration of between 100 µ sec and 300 µ sec (section 0166, the external pulse generator 28 may be programmed to 4 mA, 100 µ sec, 100 Hz, and an on-off duty cycle of 0.25 sec).
Regarding claim 28, Boggs discloses the electrical stimulation comprises a pulse duration of between 40 µ sec and 1000 µ sec (section 0166, the external pulse generator 28 may be programmed to 4 mA, 100 µ sec, 100 Hz, and an on-off duty cycle of 0.25 sec).
Regarding claim 29, Boggs discloses the electrode is spaced at 1mm to 100mm from the peripheral nerve (Section 0192, activate the targeted nerve of passage at some distance e.g. 1 mm away from the targeted nerve of passage).
Regarding claim 30, Boggs discloses the electrode is spaced at 1mm to 50mm from the peripheral nerve (Section 0192, activate the targeted nerve of passage at some distance e.g. 1 mm away from the targeted nerve of passage).
Regarding claim 31, Boggs discloses the electrode comprises a surface area of 0.1mm2 to 20 mm2 (section 0196, The electrode contact surface area may be 0.1-20 mm2, 0.01-40 mm2, or 0.001-200 mm2).
Regarding claim 32, Boggs discloses the electrode comprises a surface area of 0.01 mm2 to 40 mm2 (section 0196, The electrode contact surface area may be 0.1-20 mm2, 0.01-40 mm2, or 0.001-200 mm2).
Response to Arguments
Applicant's arguments filed 6/16/2026 have been fully considered but they are not persuasive. Examiner finds that Glukhovsky discloses applying stimulation percutaneously (section 0087, 0100), a method to alleviate pain post limb joint replacement surgery and applying electrical stimulation via the electrical stimulation device to the peripheral nerve (section 0048) after a limb joint replacement surgery (section 0049, a stimulation system can be used in conjunction with a joint replacement procedure (for example, knee replacement or hip replacement) to condition the muscles before the surgery, reduce the post-procedure pain, enhance the post-operative recovery and/or reduce or prevent some of the side effects associated with a joint replacement procedure). This allows for reducing post-procedure pain, enhance recovery, or prevent side-effects post procedure.
Conclusion
THIS ACTION IS MADE FINAL. 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 JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/ Primary Examiner, Art Unit 3796
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