DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 8965516. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and the US Patent claim percutaneous lead within tissue in electrical proximity to but spaced from a peripheral nerve innervating a targeted region, attaching to a stimulator and surface electrode, applying stimulation after limb joint replacement and evoking paresthesia without motor-point activation or nerve damage. The coiled wire and polymer-film insulation of the current application claims are obvious variants and not patentably distinct features shown in the US Patent specification.
Claims 1 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14, and 23 of U.S. Patent No. 11116971. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and the US Patent claim percutaneous lead within tissue in electrical proximity to but spaced from a peripheral nerve innervating a targeted region, attaching to a stimulator and surface electrode, applying stimulation after limb joint replacement and evoking paresthesia without motor-point activation or nerve damage. The coiled wire and polymer-film insulation of the current application claims are obvious variants and not patentably distinct features shown in the US Patent specification.
Claims 1 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 20 of U.S. Patent No. 12036407. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and the US Patent claim percutaneous lead within tissue in electrical proximity to but spaced from a peripheral nerve innervating a targeted region, attaching to a stimulator and surface electrode, applying stimulation after limb joint replacement and evoking paresthesia without motor-point activation or nerve damage. The coiled wire and polymer-film insulation of the current application claims are obvious variants and not patentably distinct features shown in the US Patent specification.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-15 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Boggs (US 20100152808).
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); 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).
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).
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 16-32 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).
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 applying electrical stimulation via the electrical stimulation device to the peripheral nerve after a limb joint replacement surgery. Glukhovsky discloses applying electrical stimulation via the electrical stimulation device to the peripheral nerve 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).
Conclusion
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