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 .
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.
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.
Claim 1, 2, 3, 4, 5, 7, 8, 9, 11, 14, 15, and 20 is rejected under 35 U.S.C. 103 as being unpatentable over Thacker et al (US 2013/0261695 A1, hereinafter “Thacker”) in view of Heruth et al (US 7,890,166 B2, hereinafter “Heruth”).
Regarding claim 1, Thacker discloses a method for selectively and reversibly modulating targeted neural- and non-neural tissue of a nervous system structure with electrical stimulation to treat a medical condition of a patient (par 0026), the method comprising: identifying a targeted nervous system structure (par 0033, 0056, 0063, 0074); positioning an electrical stimulation device at a treatment site proximate the targeted neural- and non-neural tissue of the nervous system structure (pars 0025-0026), the electrical stimulation device comprising an electrode that provides an electrical stimulation to the treatment site, the electrode having an elongated body with a proximal and distal electrical contacts positioned thereon (par 0025), the distal electrical contact sized and configured to interface with the targeted neural and non-neural tissue of the nervous system structure, the proximal contact sized and configured to be positioned in subcutaneous tissue (par 0025, 0121, where the lead includes multiple electrodes positioned in subcutaneous tissue and interface with the targeted tissue of the nervous system structure); delivering an electrical stimulation to the treatment site via the electrode (pars 0025-0029); wherein the application of the electrical stimulation to the treatment site selectively modulates the targeted neural- and non-neural tissue of the nervous system structure inhibiting pain and preserving other sensory and motor function, and proprioception (pars 0025-0026, 0047); wherein the application of the electrical stimulation to the treatment site selectively modulates the targeted neural- and non-neural tissue and results in subsequent inhibition of pain (pars 0025-0026).
Thacker discloses the claimed invention (as cited above) including at least one electrode to provide electrical stimulation (par 0025), but does not explicitly disclose the electrical stimulation device comprises a first electrode positioned on a first lead and a second electrode positioned on a second lead, such that electrical stimulation is delivered via the first electrode and second electrode. Heruth is analogous art in regard to associated method for treating pain via neurostimulation (abstract, col 9, ln 33-col 10, lnl 3). Heruth discloses it was known in the art to provide an electrical stimulation device comprising a first electrode positioned on a first lead and a second electrode positioned on a second lead (col 8, ln 15-col 9, ln 32 which details the lead arrangement for the stimulation system), such that electrical stimulation is delivered via the first electrode and second electrode (col 8, ln 15-col 10, ln 60 which details the lead arrangement for the stimulation system further used to provide therapeutic stimulation for pain relief). Applied to the invention of Thacker, the features of Heruth would provide an electrical stimulation device comprises a first electrode positioned on a first lead and a second electrode positioned on a second lead, such that electrical stimulation is delivered via the first electrode and second electrode as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the features of Heruth in the invention of Thacker, since such a modification would provide the predictable results of application to a broader region, while allowing finer control of the cells to be stimulated with greater efficacy, thereby reducing potential undesired effects.
Regarding claim 2, Thacker discloses the nervous system structure comprises at least one of a peripheral nerve, a cranial nerve, a ganglia, an autonomic nerve, or autonomic ganglia (pars 0023, 0036, 0065).
Regarding claim 3, Thacker discloses the application of the electrical stimulation to the treatment site selectively modulates the targeted neural- and non-neural tissue inhibiting nerve signal transmission through nerve fibers that are responsible for the transmission of pain, wherein nerve signal transmission through nerve fibers responsible for other sensory and motor function, and proprioception is preserved, wherein other sensory function includes at least one of touch, vision, audition, gustation, olfaction, or balance (par 0047).
Regarding claim 4, Thacker discloses the pain comprises at least one of acute pain, surgical pain, post-surgical pain, trauma pain, neuropathic pain, chronic pain, or head-and-face pain (pars 0039, 0058).
Regarding claim 5, Thacker discloses the pain is acute pain, wherein the electrical stimulation is applied at least one of immediately prior to a surgical procedure, intraoperatively, and/or immediately following a surgical procedure or trauma (par 0120).
Regarding claim 7, Thacker discloses that when the pain is post-surgical acute pain following a knee arthroplasty procedure, the electrical stimulation is applied to the femoral nerve, the sciatic nerve, the obturator nerve, or the lateral cutaneous nerve and nerve branches, or a combination thereof (par 0120).
Regarding claim 8, Thacker discloses the pain is neuropathic pain or chronic pain (par 0025), the electrical stimulation is used to provide an on-demand bolus of therapeutic treatment (par 0027).
Regarding claim 9, Thacker discloses the step of positioning the electrical stimulation device proximate the treatment site comprises: positioning the electrode percutaneously through an opening in the patient's skin such that the distal electrical contact is adjacent the nervous system structure (par 0003).
Thacker discloses the claimed invention (see rejection of claim 1 above) including at least one electrode to provide electrical stimulation (par 0025, which Examiner interprets to read on a single electrode [could be either of the first or second electrodes] as required in the instant claim), but does not explicitly disclose positioning of both the first and/or second electrodes percutaneously. Heruth is analogous art in regard to associated method for treating pain via neurostimulation (abstract, col 9, ln 33-col 10, ln 3). Heruth discloses it was known in the art to provide first and second electrode/leads percutaneously (col 10, ln 63-col 11, ln 30). Applied to the invention of Thacker, the features of Heruth would provide means for positioning the first and/or second electrodes percutaneously through an opening in the patient’s skin such that the distal electrical contact is adjacent the nervous system structure known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the features of Heruth in the invention of Thacker, since such a modification would provide the predictable results of application to a broader region, while allowing finer control of the cells to be stimulated with greater efficacy, thereby reducing potential undesired effects.
Regarding claim 11, Thacker discloses adjusting at least one parameter of the electrical stimulation to selectively inhibit nerve signal transmission through the targeted neural- and non-neural tissue, wherein the at least one parameter is selected from the group consisting of a waveform shape, a waveform frequency, a waveform amplitude, waveform envelope duration, an electrical field strength generated at the electrode, a waveform DC offset, a waveform duty cycle, a tissue temperature, a cooling mechanism parameter, and a treatment duration (par 0031).
Thacker discloses the claimed invention (see rejection of claim 1 above) including at least one electrode to provide electrical stimulation (par 0025, which Examiner interprets to read on a single electrode [could be either of the first or second electrodes] as required in the instant claim), but does not explicitly disclose the electrical field strength is generated at the first and second electrodes. Heruth is analogous art in regard to associated method for treating pain via neurostimulation (abstract, col 9, ln 33-col 10, ln 3). Heruth discloses it was known in the art to provide first and second electrode/leads to generate stimulation via an electrical field (col 9, ln 33-col 10, ln 60). Applied to the invention of Thacker, the features of Heruth would provide means for generating therapeutic electrical fields at the first and second electrodes known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the features of Heruth in the invention of Thacker, since such a modification would provide the predictable results of application to a broader region, while allowing finer control of the cells to be stimulated with greater efficacy, thereby reducing potential undesired effects.
Regarding claim 14, Thacker discloses slowly ramping a stimulation amplitude of the electrical stimulation to an amplitude plateau (par 0079).
Regarding claim 15, Thacker discloses adjusting the controller to vary the electrical stimulation based on a measured feedback selected from the group consisting of: measured inhibition of nerve signal transmission, measured temperature, input from the patient, a feedback corresponding to at least one of the adjustable parameters, a treatment setting associated with a time-course of recovery, electrode contact impedance, electric field generated in the tissue, patient physiological response, and a combination thereof (par 0031).
Regarding claim 20, Thacker discloses the distal electrical contact is adjacent a distal end of the elongated body of the electrode and the proximal electrical contact is located along the elongated body at a location between the distal electrical contact and a proximal end of the electrode (pars 0036-0037, figure 1B), wherein the distal end of the elongated body includes a bend such that a distal tip portion of the elongated body extends at a predefined non-zero degree angle with respect to a longitudinal axis of the elongated body (pars 0036-0037, figure 1B), wherein the distal electrical contact is provided along the elongated body between the distal tip portion and the proximal end of the electrode (pars 0036-0037, figure 1B).
Thacker discloses the claimed invention (as cited above) including at least one electrode to provide electrical stimulation (par 0025), but does not explicitly disclose the electrical stimulation device comprises an arrangement requiring a first and a second electrode with corresponding leads arranged as explained above. Heruth is analogous art in regard to associated method for treating pain via neurostimulation (abstract, col 9, ln 33-col 10, lnl 3). Heruth discloses it was known in the art to provide an electrical stimulation device comprising a first electrode positioned on a first lead and a second electrode positioned on a second lead (col 8, ln 15-col 9, ln 32 which details the lead arrangement for the stimulation system), such that electrical stimulation is delivered via the first electrode and second electrode (col 8, ln 15-col 10, ln 60 which details the lead arrangement for the stimulation system further used to provide therapeutic stimulation for pain relief). Applied to the invention of Thacker, the features of Heruth would provide an electrical stimulation device comprises a first electrode positioned on a first lead and a second electrode positioned on a second lead, such each distal electrical contact is adjacent a distal end of the elongated body of the respective electrode and each proximal electrical contact is located along the elongated body at a location between the distal electrical contact and a proximal end of the respective electrode, wherein the distal end of the elongated body includes a bend such that a distal tip portion of the elongated body extends at a predefined non-zero degree angle with respect to a longitudinal axis of the elongated body, wherein each distal electrical contact is provided along the elongated body between the distal tip portion and the proximal end of the respective electrode as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the features of Heruth in the invention of Thacker, since such a modification would provide the predictable results of application to a broader region, while allowing finer control of the cells to be stimulated with greater efficacy, thereby reducing potential undesired effects.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Thacker in view of Heruth, further in view of Barolat (US 2012/0232615 A1, hereinafter “Barolat”).
Regarding claim 6, Thacker in view of Heruth discloses the claimed invention (see rejection of claim 1 above), but does not explicitly disclose the electrical stimulation is delivered to the treatment site more than 24 hours prior to a surgical procedure. Barolat is analogous art in regard to known methods for operating neurostimulators (par 0052-0053). Barolat discloses it was known in the art to deliver electrical stimulation to a treatment site more than 24 hours prior to a surgical procedure (pars 0053-0056). Applied to the invention of Thacker in view of Heruth, the features of Barolat would provide electrical stimulation delivered to a treatment site more than 24 hours prior to a surgical procedure as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the features of Barolat in the invention of Thacker in view of Heruth, since such a modification would provide the predictable results of improved certainty in the outcome and high cost of implantation procedures, increasing access and audience of neurostimulators to patients as known in the art.
Allowable Subject Matter
Claims 10, 12, 13, 16, 17, 18, and 19 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9,11,14-15 and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Lindsey G Wehrheim whose telephone number is (571)270-5181. The examiner can normally be reached Monday - Friday 9 a.m. - 5 p.m. EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lindsey G Wehrheim
Primary Examiner
Art Unit 3799
/LINDSEY G WEHRHEIM/Primary Examiner, Art Unit 3799 4/14/2026