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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/14/2026 has been entered.
Remarks
This action is in response to the remarks filed 05/14/2026.
Claims 1, 2, and 4-23 are pending and are under consideration.
Response to Arguments
Applicant’s arguments, see pages 7-11, filed 05/14/2026, with respect to the rejection of claims 1, 2, 4-9, and 11-20 under 35 U.S.C. 102(a)(1) and claims 10 and 21-23 under 35 U.S.C. 103 have been fully considered and are persuasive. Independent claims 1, 11, and 16 have been amended to more specifically recite that the stimulation is provided before and during the amputation surgery and confirming greater than 50% paresthesia. Applicant argues that Boggs or Boggs in view of Bialer does not disclose the amended limitations. Examiner agrees. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made, as explained in the office action below.
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.
Claims 1, 2, 4-9, and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Boggs II et al. (US Patent Application Publication 2013/0238066 – of record), hereinafter Boggs, and further in view of Barolat et al. (US Patent Application Publication 2012/0232615), hereinafter Barolat.
Regarding claim 1, Boggs discloses a method to alleviate pain following an amputation surgery (e.g. Abstract; Par. [0041]: post-surgery pain treatment; Par. [0035]: treatment of amputee pain, that is, pain after amputation surgery has taken place), the method comprising:
inserting a coiled wire lead with at least one electrode percutaneously into a body within a therapeutically effective distance from at least one nerve to be transected (e.g. Fig. 11A-C: electrode lead 12 inserted into the muscle; Par. [0162]: lead 12 is placed percutaneously in the muscle; Par. [0166]: lead is coiled metal wire; Pars. [0178]-[0186]: placing lead in electrical proximity to but spaced away from a nerve of passage);
applying electrical stimulation through the at least one electrode to the nerve to be transected (e.g. Par. [0030]: stimulating peripheral nerves after transection; Par. [0161]: inducing paresthesia), thereby activating nerve fibers that innervate a region of pain expected from the amputation surgery and causing an area of tingling sensations in the body (e.g. Par. [0038]; Par. 0184]; Figs. 11A, C, D: stimulator 28), wherein the electrical stimulation does not block motor or sensory function of the nerve fibers, said area of tingling sensations being compared with an area affected by the at least one nerve innervating the region of pain expected from the amputation surgery until the stimulation- evoked tingling sensation overlaps greater than or equal to 50% of the identified region of pain expected from the amputation surgery (e.g. Pars. [0160]-[0161]: the invention evokes paresthesia, which does not block motor or sensory function of nerve fibers; Par. [0208]; Par. [0262]; Par. [0272]; Par. [0276]) and wherein the electrical stimulation is provided to the nerve to be transected after said nerve is transected during the amputation surgery (e.g. Par. [0245]: post-amputation pain can be treated; Par. [0041]: post-surgery pain treatment; Par. [0035]: treatment of amputee pain, that is, pain after amputation surgery has taken place).
However, Boggs fails to specifically disclose before the amputation surgery, receiving from a patient an identification of a region of pain expected from the amputation surgery, retaining the coiled wire lead within the body during the amputation surgery, applying electrical stimulation in advance of the amputation surgery and during the amputation surgery through the at least one electrode while the coiled wire lead is retained within the body.
Barolat, in a similar field of endeavor, is directed towards nerve stimulation. Barolat discloses receiving an identification of a region of pain expected from the amputation surgery before the surgery, retaining the coiled wire lead within the body during the amputation surgery, applying electrical stimulation in advance of the amputation surgery and during the amputation surgery through the at least one electrode while the coiled wire lead is retained within the body (e.g. Pars. [0012]-[0013]: implanting a stimulation system in advance of the amputation surgery and providing stimulation during the surgery to relieve nociceptive pain).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Boggs to include providing stimulation before and during amputation surgery as taught by Barolat because doing so would relieve nociceptive pain in the patient (e.g. Barolat, par. [0012]).
Regarding claim 2, Boggs further discloses wherein the at least one electrode comprises a pair of electrodes formed on the lead, wherein the pair of electrodes are spaced apart with an insulated portion of the lead positioned therebetween (e.g. Fig. 13B, 14B: electrodes 14 are separated by a segment; Pars. [0166]-[0168]: insulated section; Par. [0172]).
Regarding claim 4, Boggs further discloses wherein the electrical stimulation includes a first parameter selected from a group consisting of: frequency, pulse duration, amplitude, duty cycle, pattern of stimulus pulses, polarity, a predetermined number of phases, and waveform shape (e.g. Par. [0200]: parameter may be frequency, pulse duration, or duty cycle).
Regarding claim 5, Boggs further discloses wherein the electrical stimulation includes a second parameter selected from a group consisting of: frequency, pulse duration, amplitude, duty cycle, pattern of stimulus pulses, polarity, a predetermined number of phases, and waveform shape (e.g. Par. [0200]: parameter may be frequency, pulse duration, or duty cycle).
Regarding claim 6, Boggs further discloses wherein the first and second parameters are identical (e.g. Pars. [0228]-[0229]: “the duty cycle may be regular and repeatable from one intermittent burst to the next”, that is, the bursts of stimulation may vary in a repeatable pattern, which refers to a first parameter, that is, a frequency at a constant level, and then the system turns off, and then the system stimulates again with a second parameter, that is, with a second frequency at the same constant level).
Regarding claim 7, Boggs further discloses wherein the electrical stimulation does not damage the at least one nerve that will be transected or cut (e.g. Par. [0283]: the system is set not to damage neural tissue, which would include not damaging the at least one nerve that will be transected or cut).
Regarding claim 8, Boggs further discloses wherein the at least one nerve is a peripheral nerve (e.g. Par. [0030]).
Regarding claim 9, Boggs further discloses wherein the at least one nerve that will be transected or cut is selected from a group consisting of a femoral nerve, a sciatic nerve, lateral femoral cutaneous nerve, an obturator nerve, median nerve, radial nerve, ulnar nerve, axillary nerve, musculocutaneous nerve, brachial plexus, lumbar plexus, sacral plexus, intercostal nerve, ilioinguinal nerve, iliohypogastric nerve, and intercostobrachial nerve (e.g. Par. [0245]).
Regarding claim 11, Boggs discloses a method to alleviate pain following surgical amputation or removal of an extremity, limb, body part, or body tissue (e.g. Abstract; Par. [0041]: post-surgery pain treatment; Par. [0035]: treatment of amputee pain, that is, pain after amputation surgery has taken place), the method comprising:
percutaneously inserting a coiled wire lead having a thickness and a diameter into a portion of a body that is proximal to or will become part of a residual limb or extremity following surgical amputation (e.g. Fig. 11A-C: electrode lead 12 inserted into the muscle; Par. [0162]: lead 12 is placed percutaneously in the muscle; Par. [0166]: lead is coiled metal wire);
positioning a plurality of electrodes i) inside the body, and ii) at a therapeutically effective distance from a portion of at least one nerve that will be transected or cut during the surgical amputation (e.g. Fig. 11A-C: electrode lead 12 inserted into the muscle; Par. [0162]: lead 12 is placed percutaneously in the muscle; Par. [0166]: lead is coiled metal wire; Pars. [0178]-[0186]: placing lead in electrical proximity to but spaced away from a nerve of passage); and
applying electrical stimulation through an electrical stimulation device operatively coupled to the lead after the surgical amputation through the plurality of electrodes to the at least one nerve that will be transected or cut, to create tingling sensations in a region of residual or phantom pain until the tingling sensation overlaps greater than or equal to 50% of the identified region of residual or phantom pain expected from amputation surgery, wherein the electrical stimulation does not block motor or sensory function of the at least one nerve (e.g. Par. [0184]; Figs. 11A, C, D: stimulator 28 coupled to the lead; Pars. [0160]-[0161]: the invention evokes paresthesia, which does not block motor or sensory function of nerve fibers; Par. [0030]: stimulating peripheral nerves after transection; Par. [0245]: post-amputation pain can be treated; Par. [0041]: post-surgery pain treatment; Par. [0035]: treatment of amputee pain, that is, pain after amputation surgery has taken place; Par. [0208]; Par. [0262]; Par. [0272]; Par. [0276]); and
applying electrical stimulation through the electrical stimulation device operatively coupled to the lead after the surgical amputation, wherein the electrical stimulation after the surgical amputation is delivered through the plurality of electrodes while the coiled wire lead is retained within the body (e.g. Par. [0030]: stimulating peripheral nerves after transection; Par. [0245]: post-amputation pain can be treated; Par. [0041]: post-surgery pain treatment; Par. [0035]: treatment of amputee pain, that is, pain after amputation surgery has taken place).
However, Boggs fails to specifically disclose before the surgical amputation, receiving from a patient an identification of a region of residual or phantom pain expected following the surgical amputation, retaining the coiled wire lead within the body during the amputation surgery, and applying electrical stimulation in advance of the amputation surgery.
Barolat, in a similar field of endeavor, is directed towards nerve stimulation. Barolat discloses receiving an identification of a region of pain expected from the amputation surgery before the surgery, retaining the coiled wire lead within the body during the amputation surgery, and applying electrical stimulation in advance of the amputation surgery (e.g. Pars. [0012]-[0013]: implanting a stimulation system in advance of the amputation surgery and providing stimulation during the surgery to relieve nociceptive pain).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Boggs to include providing stimulation before amputation surgery as taught by Barolat because doing so would relieve nociceptive pain in the patient (e.g. Barolat, par. [0012]).
Regarding claim 12, Boggs further discloses wherein each of the electrodes are formed integrally on the lead (e.g. Par. [0168]: in some embodiments the electrode may comprise a de-insulated area of an otherwise insulated conductor that runs the length of an insulated electrode; that is, integrally formed).
Regarding claim 13, Boggs further discloses wherein the electrodes are spaced apart from one another with an insulated portion positioned between at least two of the plurality of electrodes (e.g. Fig. 13B, 14B: electrodes 14 are separated by a segment; Pars. [0166]-[0168]: insulated section; Par. [0172]).
Regarding claim 14, Boggs further discloses wherein the region of residual or phantom pain is at or distal to a location of the surgical amputation, said location selected from a group consisting of: above knee, at knee, below knee, at ankle, foot, toe, above shoulder, at shoulder, above elbow, at elbow, below elbow, at wrist, hand, finger, and breast (e.g. Par. [0245]).
Regarding claim 15, Boggs further discloses wherein the region of phantom pain is associated with amputation of appendages or extremities (e.g. Par. [0245]).
Regarding claim 16, Boggs discloses a method for treatment of pain from amputation surgery (e.g. Abstract; Par. [0041]: post-surgery pain treatment; Par. [0035]: treatment of amputee pain, that is, pain after amputation surgery has taken place), the method comprising:
providing a needle configured to be inserted into an animal body tissue, inserting a percutaneous lead into the needle, inserting the needle and percutaneous lead into an insertion point of the animal body tissue, removing the needle from the animal body tissue while retaining the percutaneous lead within the animal body tissue (e.g. Par. [0164]: needle introducer with a percutaneous lead inserted in it);
placing at least one electrode remote to but within a therapeutically effective distance from a peripheral nerve innervating a targeted region of pain resulting from the amputation surgery (e.g. Fig. 11A-C: electrode lead 12 inserted into the muscle; Par. [0162]: lead 12 is placed percutaneously in the muscle; Par. [0166]: lead is coiled metal wire; Pars. [0178]-[0186]: placing lead in electrical proximity to but spaced away from a nerve of passage);
delivering a test electrical stimulation through the at least one electrode by an electrical stimulation device, wherein the electrical stimulation is delivered to the peripheral nerve in the targeted region of pain, wherein the electrical stimulation does not block motor or sensory function of the peripheral nerve, and confirming, based on a stimulation-evoked tingling sensation perceived by the patient, that the stimulation-evoked tingling sensation overlaps greater than or equal to 50% of the identified targeted region of pain resulting from the amputation surgery (e.g. Par. [0184]; Figs. 11A, C, D: stimulator 28 coupled to the lead; Pars. [0160]-[0161]: the invention evokes paresthesia, which does not block motor or sensory function of nerve fibers; Par. [0030]: stimulating peripheral nerves after transection; Par. [0245]: post-amputation pain can be treated; Par. [0041]: post-surgery pain treatment; Par. [0035]: treatment of amputee pain, that is, pain after amputation surgery has taken place; Par. [0208]; Par. [0262]; Par. [0272]; Par. [0276]); and
delivering a treatment electrical stimulation through the at least one electrode by the electrical stimulation device after the amputation surgery (e.g. Par. [0184]; Figs. 11A, C, D: stimulator 28 coupled to the lead; Pars. [0160]-[0161]: the invention evokes paresthesia, which does not block motor or sensory function of nerve fibers; Par. [0030]: stimulating peripheral nerves after transection; Par. [0245]: post-amputation pain can be treated; Par. [0041]: post-surgery pain treatment; Par. [0035]: treatment of amputee pain, that is, pain after amputation surgery has taken place).
However, Boggs fails to specifically disclose before the amputation surgery, receiving from a patient an identification of a targeted region of pain resulting from the amputation surgery, retaining the percutaneous lead and the at least one electrode within the animal body tissue during the amputation surgery, and delivering electrical stimulation in advance of the amputation surgery.
Barolat, in a similar field of endeavor, is directed towards nerve stimulation. Barolat discloses receiving an identification of a region of pain expected from the amputation surgery before the surgery, retaining the percutaneous lead and the at least one electrode within the animal body tissue during the amputation surgery, and delivering electrical stimulation in advance of the amputation surgery (e.g. Pars. [0012]-[0013]: implanting a stimulation system in advance of the amputation surgery and providing stimulation during the surgery to relieve nociceptive pain).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Boggs to include providing stimulation before amputation surgery as taught by Barolat because doing so would relieve nociceptive pain in the patient (e.g. Barolat, par. [0012]).
Regarding claim 17, Boggs further discloses causing an area of tingling sensations through the electrical stimulation (e.g. Par. [0160]; Par. [0201]).
Regarding claim 18, Boggs further discloses comparing the area of tingling sensations with the region of expected pain from the amputation surgery (e.g. Par. [0040]; Par. [0184]).
Regarding claim 19, Boggs further discloses wherein the needle is an introducer needle (e.g. Par. [0164]).
Regarding claim 20, Boggs further discloses wherein the amputation surgery is selected from a group consisting of: limb amputation above knee, limb amputation at knee, limb amputation below knee, limb amputation at ankle, full or partial foot amputation, full or partial toe amputation, limb amputation above shoulder, limb amputation at shoulder, limb amputation above elbow, limb amputation at elbow, limb amputation below elbow, limb amputation at wrist, full or partial hand amputation, full or partial finger amputation, and mastectomy or breast amputation (e.g. Pars. [0243]-[0245]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Boggs II et al. (US Patent Application Publication 2013/0238066 – of record), hereinafter Boggs, and further in view of Barolat et al. (US Patent Application Publication 2012/0232615), hereinafter Barolat, as applied to claim 1 above.
Regarding claim 10, Boggs further discloses therapy for treating the pain resulting from the transection of one of a variety of nerves (e.g. Par. [0245]). However, Boggs fails to explicitly disclose wherein the at least one nerve is selected from a group that includes at least one distal branch of the selected nerve or nerves. However, it may be considered that any branch of a nerve beyond a nerve plexus constitutes a distal branch, and Boggs does teach stimulation of these branches (e.g. Pars. [0157], [0255], [0271]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Boggs in view of Barolat to have at least one nerve selected from the group include at least one distal branch of the selected nerve or nerves in order to stimulate the nerves at the extremities of the body that are most likely to be amputated and require this pain treatment.
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Boggs II et al. (US Patent Application Publication 2013/0238066 – of record), hereinafter Boggs, and further in view of Barolat et al. (US Patent Application Publication 2012/0232615), hereinafter Barolat, as applied to claims 1, 11, and 16 above, and further in view of Bialer et al. (US Patent Application Publication 2009/0182048 – of record), hereinafter Bialer.
Regarding claims 21-23, Boggs fails to disclose providing an anesthetic block to the nerve that was transected during the amputation surgery after the amputation surgery. Bialer is directed towards preparing medication for pain relief. Bialer discloses providing an anesthetic block to the nerve that was transected during the amputation surgery after the amputation surgery (e.g. Par. [0004]: use of neural blocks to treat nerve pain after surgery; Par. [0127]: nerve pain can also be an issue with amputation surgery).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Boggs in view of Barolat to include the anesthetic block as taught by Bialer because nerve blocks are a common and effective method of pain relief, and following surgery, more than one method of pain relief might be needed in order to make the patient comfortable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hofius et al. (US 2020/0246621) is directed towards pain management and discloses preemptive analgesia (e.g. par. [0011]).
Gross et al. (US 2013/0066393) is directed towards tibial nerve stimulation.
Saab (US 2013/0066394) is directed towards pain management.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796
