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 .
Response to Arguments
The Applicant filed Amendments to the Abstract, Amendments to the Claims, and Remarks on April 27, 2026 in response to the Examiner’s Non-Final Office Action, mailed January 26, 2026.
Amendments to the Claims
At this time, claims 1-4, 6-9, 12-18, and 20-22 are pending. Claims 1, 9, 12, and 18 have been amended. Claims 5, 10, 11, and 19 have been cancelled. The Applicant has added new claims 21 and 22. The Applicant asserts that no new matter is added. Claims 1 and 12 are in independent form. (Remarks, pg. 5)
Specification Objections
The Abstract was previously objected under due to not having proper language and format. The Applicant has submitted an amended Abstract in response. (Remarks, pg. 5)
Applicant’s arguments with respect to the Abstract have been fully considered and are persuasive. The objection of January 26, 2026 has been withdrawn.
Claim Rejections - 35 U.S.C. § 112
Claims 9 and 18 were previously rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement. The claims have been amended in response. (Remarks, pg. 5)
Applicant’s arguments with respect to claims 9 and 18 have been fully considered and are persuasive. The 35 U.S.C. 112(a) rejection of January 26, 2026 has been withdrawn.
Claims 5, 10, 11, and 19 were previously rejected under 35 U.S.C. 112(b) as being indefinite. The claims have been cancelled in response. (Remarks, pg. 6)
The 35 U.S.C. 112(b) rejection of January 26, 2026 is moot due to the cancellation of the claims.
Claim Rejections - 35 U.S.C. § 102
Claims 1-8, 10-17, and 19-20 were previously rejected under 35 U.S.C. 102(a)(2). The Applicant argues that that Kilgore (previously cited) does not teach each and every aspect of amended, independent claims 1 and 12, specifically, that the electrical waveform is applied to “a patient's nerve having a diameter of 3 mm or more”. (Remarks, pg. 6)
Due to claim amendments, the 35 U.S.C. 102(a)(2) rejection of January 26, 2026 is withdrawn.
Claim Rejections - 35 U.S.C. § 103
Claims 9 and 18 were previously rejected under 35 U.S.C. 103 over Kilgore in view of Donders (previously cited). The Applicant argues that the combination of Kilgore in view of Donders does not suggest all the features recited in the claims, including dependent claims 9 and 18. (Remarks, pg. 6-7)
Due to claim amendments, the 35 U.S.C. 103 rejection of January 26, 2026 is withdrawn.
Claim Rejections - 35 USC § 103
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.
Claims 1-4, 6-9, 12-18, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Kilgore et al. (US 2010/0241190, hereinafter referred to as Kilgore) (cited previously).
Regarding amended, independent claim 1, Kilgore discloses a method of blocking signal transmission through a nerve with reduced onset activity includes applying an HFAC to an axon of a nerve to block the transmission of signals through the axon. Kilgore further discloses a method of treating phantom limb pain in a patient ([0007]: “This application concerns apparatus, systems, and methods for blocking signal transmission through a nerve without generating activity in the nerve outside of the system.”), the method comprising:
administering an electrical waveform ([0025], Figs. 5-10 disclose a “HFAC waveform” or “high-frequency alternating current” waveform.) to the patient’s nerve for an interval sufficient to relieve the phantom limb pain ([0034]: “FIG. 2 illustrates an apparatus 30 used, for example, to block neuroma pain, pain associated with a missing appendage, pain associated with a damaged appendage, and so on.”), wherein the patient’s nerve has a diameter of 3 mm or greater ([0034]: “Apparatus 30 may, therefore, produce a median nerve block. Apparatus 30 comprises an HFAC blocking electrode 32 and an implantable controller 34. The blocking electrode 32 may be positioned adjacent to a nerve proximal to a neuroma. In this application, the nerve block can be delivered continuously, can be triggered using an external signal device 36, and so on.”), the electrical waveform configured to block conduction of an action potential in the patient’s nerve and not generate an action potential in the patient’s nerve ([0044]: “FIG. 10 illustrates another waveform 1010 for producing a nerve block. …An HFAC waveform is started after a period where the ramped direct current is applied. The HFAC waveform has its amplitude increased until it reaches a block threshold. At this point, the DC offset is ramped down until the whole waveform is charge-balanced, thus allowing the HFAC block to be established without onset action potentials.”), wherein the electrical waveform is characterized as having a frequency between 5 kHz to 50 kHz ([0031]: “"High-frequency", as used herein with reference to alternating current (e.g., HFAC), refers to frequencies above approximately 1 kiloHertz. In some examples, high-frequency refers more specifically to 5 to 50 kiloHertz.”), and wherein the electrical waveform has a voltage between 4 V peak-to-peak (Vpp) to 20 Vpp ([0029]: “Eliminating the undesired onset entirely involves eliminating both phases of the onset response. The repetitive phase can be reduced by adjusting amplitude and frequency. For example, a 30 kilohertz, 10 volts peak-to-peak sinusoidal waveform may eliminate the repetitive phase.”; [0050]: “In one example, the first amplitude and the third amplitude are in the range of 4 volts peak-to-peak to 10 volts peak-to-peak.”) or a current between 4 mA peak-to-peak (mApp) to 26 mApp.
Regarding the claim limitation of “the patient’s nerve [having] a diameter of 3 mm or greater”, Kilgore teaches to a median nerve block. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention that the median nerve in the hand, on average for an adult human patient, would have a diameter of 3 mm or greater.
Regarding claim 2, Kilgore discloses that the electrical waveform is applied to the patient’s nerve at a site proximal to a neuroma ([0034]: “The blocking electrode 32 may be positioned adjacent to a nerve proximal to a neuroma.”; see Fig. 2 below, showing treatment to a “missing” or “damaged” appendage.).
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Regarding claim 3, Kilgore discloses that the electrical waveform is applied to the patient’s sciatic or tibial nerve ([0032]: “Examples described herein may have application in areas including motor nerve block, sensory nerve block, and autonomic block.”; Note that the sciatic and tibial nerve(s) are motor and sensory nerves, thus a motor nerve block or sensory nerve block would affect these nerves.).
Regarding claim 4, Kilgore discloses that the electrical waveform is administered by an electrode implanted in the patient (blocking electrode 32 in Fig. 2; [0034]: “Apparatus 30 comprises an HFAC blocking electrode 32 and an implantable controller 34. The blocking electrode 32 may be positioned adjacent to a nerve proximal to a neuroma.”).
Regarding claim 6, Kilgore discloses that the electrical waveform is a sinusoidal waveform ([0029]: “For example, a 30 kilohertz, 10 volts peak-to-peak sinusoidal waveform may eliminate the repetitive phase.”).
Regarding claim 7, Kilgore discloses that the electrical waveform is applied to the patient’s nerve via a plurality of electrodes ([0039]: “…in one example the DC electrodes and the HFAC electrodes may be combined into a single five-pole nerve cuff electrode. This five-pole nerve cuff electrode may include two outer electrodes for direct current and three inner electrodes for HFAC. A further form of the electrode may utilize a three-pole nerve cuff electrode in which the DC and HFAC are superimposed on the outer electrodes.”).
Regarding claim 8, Kilgore discloses the plurality of electrodes are part of a nerve cuff wrapped around the patient’s nerve ([0039]: “…in one example the DC electrodes and the HFAC electrodes may be combined into a single five-pole nerve cuff electrode. This five-pole nerve cuff electrode may include two outer electrodes for direct current and three inner electrodes for HFAC. A further form of the electrode may utilize a three-pole nerve cuff electrode in which the DC and HFAC are superimposed on the outer electrodes.”).
Regarding amended claim 9, Kilgore discloses repeating administration of the electrical waveform on demand to provide pain relief in the patient ([0034]: “…the nerve block can be delivered continuously, can be triggered using an external signal device 36, and so on.”).
Regarding amended, independent claim 12, Kilgore discloses a method for treating phantom limb pain in a patient ([0007]: “This application concerns apparatus, systems, and methods for blocking signal transmission through a nerve without generating activity in the nerve outside of the system.”), the method comprising:
administering an electrical waveform ([0025], Figs. 5-10 disclose a “HFAC waveform” or “high-frequency alternating current” waveform.) to the patient’s nerve for an interval sufficient to relieve the phantom limb pain ([0034]: “FIG. 2 illustrates an apparatus 30 used, for example, to block neuroma pain, pain associated with a missing appendage, pain associated with a damaged appendage, and so on.”), wherein the patient’s nerve has a diameter of 3 mm or greater ([0034]: “Apparatus 30 may, therefore, produce a median nerve block. Apparatus 30 comprises an HFAC blocking electrode 32 and an implantable controller 34. The blocking electrode 32 may be positioned adjacent to a nerve proximal to a neuroma. In this application, the nerve block can be delivered continuously, can be triggered using an external signal device 36, and so on.”), the electrical waveform applied via an electrode that is in contact with the patient’s nerve (blocking electrode 32 in Fig. 2; [0034]: “Apparatus 30 comprises an HFAC blocking electrode 32 and an implantable controller 34. The blocking electrode 32 may be positioned adjacent to a nerve proximal to a neuroma.”), wherein the electrical waveform is configured to block conduction of an action potential in the patient’s nerve and not generate an action potential in the patient’s nerve ([0044]: “FIG. 10 illustrates another waveform 1010 for producing a nerve block. …An HFAC waveform is started after a period where the ramped direct current is applied. The HFAC waveform has its amplitude increased until it reaches a block threshold. At this point, the DC offset is ramped down until the whole waveform is charge-balanced, thus allowing the HFAC block to be established without onset action potentials.”), wherein the electrical waveform is characterized as having a frequency between 5 kHz to 50 kHz ([0031]: “"High-frequency", as used herein with reference to alternating current (e.g., HFAC), refers to frequencies above approximately 1 kiloHertz. In some examples, high-frequency refers more specifically to 5 to 50 kiloHertz.”), and wherein the electrical waveform has a voltage between 4 V peak-to-peak (Vpp) to 20 Vpp ([0029]: “Eliminating the undesired onset entirely involves eliminating both phases of the onset response. The repetitive phase can be reduced by adjusting amplitude and frequency. For example, a 30 kilohertz, 10 volts peak-to-peak sinusoidal waveform may eliminate the repetitive phase.”; [0050]: “In one example, the first amplitude and the third amplitude are in the range of 4 volts peak-to-peak to 10 volts peak-to-peak.”) or a current between 4 mA peak-to-peak (mApp) to 26 mApp.
Regarding the claim limitation of “the patient’s nerve [having] a diameter of 3 mm or greater”, Kilgore teaches to a median nerve block. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention that the median nerve in the hand, on average for an adult human patient, would have a diameter of 3 mm or greater.
Regarding claim 13, Kilgore discloses that the electrical waveform is applied to the patient’s sciatic or tibial nerve ([0032]: “Examples described herein may have application in areas including motor nerve block, sensory nerve block, and autonomic block.”; Note that the sciatic and tibial nerve(s) are motor and sensory nerves, thus a motor nerve block or sensory nerve block would affect these nerves.).
Regarding claim 14, Kilgore discloses that the electrical waveform is applied to a neuroma ([0034]: “The blocking electrode 32 may be positioned adjacent to a nerve proximal to a neuroma.”; Fig. 2).
Regarding claim 15, Kilgore discloses that the electrode is a cuff electrode that is wrapped around the patient’s nerve ([0039]: “…in one example the DC electrodes and the HFAC electrodes may be combined into a single five-pole nerve cuff electrode. This five-pole nerve cuff electrode may include two outer electrodes for direct current and three inner electrodes for HFAC. A further form of the electrode may utilize a three-pole nerve cuff electrode in which the DC and HFAC are superimposed on the outer electrodes.”).
Regarding claim 16, Kilgore discloses that the electrode has multiple conductive contact points that contact the patient’s nerve ([0039]: “…in one example the DC electrodes and the HFAC electrodes may be combined into a single five-pole nerve cuff electrode. This five-pole nerve cuff electrode may include two outer electrodes for direct current and three inner electrodes for HFAC. A further form of the electrode may utilize a three-pole nerve cuff electrode in which the DC and HFAC are superimposed on the outer electrodes.”).
Regarding claim 17, Kilgore discloses that the electrical waveform is generated by an external waveform generator ([0034]: “In this application, the nerve block can be delivered continuously, can be triggered using an external signal device 36, and so on.”).
Regarding amended claim 18, Kilgore discloses repeating administration of the electrical waveform on demand to provide pain relief in the patient ([0034]: “…the nerve block can be delivered continuously, can be triggered using an external signal device 36, and so on.”).
Regarding claim 20, Kilgore discloses that the electrical waveform is a sinusoidal waveform ([0029]: “For example, a 30 kilohertz, 10 volts peak-to-peak sinusoidal waveform may eliminate the repetitive phase.”).
Regarding new claim 21, Kilgore discloses that the patient's nerve is a trunk of a sensory peripheral nerve ([0032]: “…sensory nerve block…”; [0050]).
Regarding new claim 22, Kilgore discloses that the patient's nerve is a trunk of a sensory peripheral nerve ([0032]: “…sensory nerve block…”; [0050]).
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 MARY G SCHLUETER whose telephone number is (703)756-4601. The examiner can normally be reached M-F 9:00am-5:30pm EST.
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/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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