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 Amendment
The amendment filed 15 April 2026 has been entered. Claims 1, 7-8, 38, and 44 are currently amended. Claims 13-18, 21-32, 34-35, 39-43, and 45-53 were previously canceled, and claims 33 and 36-37 were previously withdrawn. Claims 1-12, 19-20, 33, and 36-38, and 44 are pending in the application. Applicant’s amendments to the claims have overcome each and every rejection under 35 U.S.C. 112(b) previously set forth in the Non-Final Office Action mailed 15 January 2026.
Claim Objections
Claim 7 is objected to because of the following informalities: in line 2, “dependent of” should read --dependent on--. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4, and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Fang et al. (US PGPub No. 2021/0220642) in view of Bhadra et al. (US PGPub No. 2017/0050024), hereinafter Bhadra.
Regarding claim 1, Fang teaches a method for selective nerve fiber conduction block using a neuromodulation device (par. 0011: "these methods and apparatuses may be useful to set (e.g., optimize) the dosing parameters used by an implanted neuromodulator to provide relief from pain using high-frequency nerve block"), the method comprising:
applying a hybrid waveform comprising a kilohertz frequency (KHF) component and a direct current (DC) component to a target nerve fiber or set of nerve fibers (par. 0065: "A neuromodulation dose may include a variety of dose parameters for treating pain. In general, a set of dose parameters may include [...] dose frequency (e.g., treatment frequency; in high-frequency never block variations the frequency may be greater than 1 KHz, such as between 1-100 KHz). Other dose parameters may include the initial (e.g., starting) voltage, which may be, e.g., zero, or may be an offset (e.g., voltage offset) voltage. In some variations, the therapeutic dose parameters may include [...] DC offset level");
wherein the hybrid waveform achieves reversible conduction block in the target nerve fiber or set of nerve fibers (par. 0013: "These methods may be applied to, but are not limited to, the use with neuromodulation to provide a high-frequency block of a nerve or bundle of nerves;" par. 0060: “One therapy involves reversibly blocking peripheral nerves by applying high frequency alternating current directly on a nerve trunk”).
Fang teaches an offset initial voltage and a DC offset level (par. 0065) but is silent with respect to charge balance and does not explicitly teach wherein the hybrid waveform comprises a net charge imbalance per unit time during phases of the KHF component without becoming charge-balanced.
However, in an analogous art, Bhadra teaches that charge-balanced and charge-imbalanced high-frequency waveforms for achieving reversible nerve conduction block are obvious alternatives of one another (par. 0094: “charge balanced or imbalanced HFAC waveforms (voltage controlled or current controlled) can be used to produce a rapidly-induced and rapidly-reversible nerve conduction block”) and that waveforms do not need to be entirely charge balanced in order to obtain beneficial effects (par. 0086: “beneficial effects can be obtained even if the total net charge is not completely balanced”). In light of Bhadra’s teaching, the substitution of one known element (a charge-imbalanced waveform as taught in Bhadra) for another (unspecified waveform as taught in Fang) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, since the substitution of the charge-imbalanced waveform shown in Bhadra would have yielded predictable results, namely, a nerve conduction block with similar beneficial effects to a charge-balanced waveform, as taught by Bhadra.
Regarding claim 2, the combination teaches the method of claim 1 as described previously. Fang further teaches wherein the KHF component comprises a biphasic alternating current waveform (par. 0025: “the pulse waveform may be biphasic”).
Regarding claim 4, the combination teaches the method of claim 1 as described previously. Fang further teaches wherein the DC component comprises a DC offset superimposed on the KHF component (par. 0065: “Other dose parameters may include […] DC offset level”).
Regarding claim 6, the combination teaches the method of claim 1 as described previously. Fang further teaches wherein the hybrid waveform is repeated at a frequency of about 1 kHz to about 200 kHz (par. 0065: “in high-frequency nerve block variations the frequency may be greater than 1 KHz, such as between 1-100 KHz”).
Regarding claims 7-8, the combination teaches the method of claim 1 as described previously. Bhadra further teaches wherein the net charge imbalance per unit time is amplitude-dependent or frequency-dependent on the DC or KHF component, and wherein the net charge imbalance is obtained by adjusting the amplitude of a DC offset superimposed on the KHF component (Figs. 12-17: charge imbalance of waveform over time depending on amplitude of DC component over time). Examiner notes that as the limitations of these claims are listed in the alternative, the claims are considered to be met when only one of the conditions is met.
Regarding claim 9, the combination teaches the method of claim 1 as described previously. Bhadra further teaches wherein the method further comprises adjusting polarity of a DC component (par. 0086: “A method of further extending the total plateau time over which the DC can be safely delivered is to use a “pre-charge” pulse, as shown in FIG. 13. The pre-charge pulse comprises delivering a DC wave of opposite polarity from desired block effect for a length of time up to the maximum charge capacity of the electrode contact. The DC polarity is then reversed to produce the block effect”).
Regarding claim 10, the combination teaches the method of claim 1 as described previously. Fang further teaches wherein the hybrid waveform blocks conduction in the target nerve fiber or set of nerve fibers but does not block conduction in a reference nerve fiber or set of nerve fibers (par. 0013: “these methods may be applied to, but are not limited to, the use with neuromodulation to provide a high-frequency block of a nerve or bundle of nerves. For example, these methods and apparatuses may be used to set and/or optimize therapy treatment dosing for a high-frequency block of a nerve such as the sciatic nerve, dorsal root ganglion (DRG), etc”). Examiner notes that as Fang’s method does not teach blocking conduction in all nerve fibers or sets of nerve fibers in a body, this limitation is considered to be met because conduction is blocked in a target nerve fiber and not blocked in any number of potential reference nerve fibers in the rest of the body.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Bhadra and further in view of Zhang et al. (US PGPub No. 2020/0061380), hereinafter Zhang.
Fang in view of Bhadra teaches the method of claim 1 as described previously. The combination does not explicitly teach wherein the KHF component comprises a waveform with more than two phases. However, in an analogous art, Zhang teaches using a triphasic waveform for nerve stimulation/block (Fig. 8: phases 102a1, 102a2, and 102b), which can reduce voltages that may cause electrochemical reactions at the electrode/tissue interface (par. 0112). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of the combined reference by using triphasic waveforms, as taught by Zhang, in order to reduce voltages that may cause electrochemical reactions at the electrode/tissue interface, as taught by Zhang.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Bhadra and further in view of Prochazka (US PGPub No. 2010/0016929).
Fang in view of Bhadra teaches the method of claim 1. Bhadra teaches an imbalanced KHF waveform (par. 0094) but does not explicitly teach wherein the imbalance comprises unequal phase durations, unequal phase amplitudes, and/or unequal phase shapes in the KHF component. However, in an analogous art, Prochazka teaches wherein a DC component for an imbalanced KHF waveform (that is, an offset resulting in an overall charge imbalance) comprises unequal phase durations, unequal phase amplitudes, and/or unequal phase shapes in the KHF component as a known example of an imbalanced high-frequency waveform (par. 0135: “delivering charge imbalanced time varying current or charge imbalanced pulsatile current. For example, pulses of current in one direction only, or biphasic pulses in which the charge delivered in one phase exceeds that in the other phase might be used”). The substitution of one known element (imbalanced high-frequency waveform having unequal phase amplitudes, as shown in Prochazka) for another (unspecific imbalanced high-frequency waveform as shown in Bhadra) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, since the substitution would have yielded predictable results, namely, a nerve conduction block using an imbalanced high-frequency waveform with similar beneficial effects to a charge-balanced waveform, as taught by Bhadra (par. 0086).
Claims 11-12, 19-20, 38, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Bhadra and further in view of Ayal et al. (US PGPub No. 2006/0106441), hereinafter Ayal.
Regarding claims 11-12 and 19-20, Fang in view of Bhadra teaches the method of claim 10 as described previously. Fang teaches that the nerve treatment may be applied to relatively large diameter nerves such as the sciatic nerve (par. 0060) but does not explicitly teach wherein the target nerve fiber or set of nerve fibers comprises a diameter that is smaller or larger than the reference nerve fiber, and wherein either smaller diameter is from about 0.2 µm to about 19.5 µm, and either larger diameter is from about 0.5 µm to about 20.0 µm. However, in an analogous art, Ayal teaches selectively blocking nerves based on diameter (par. 0067: “the electrode assembly is configured to selectively stimulate fibers of the nerve having certain diameters;” par. 0060: “the stimulation/block threshold of fibers is inversely proportional to their radius. Thus, to stimulate only small fibers, all fibers are stimulated using a large cathodic current, and the large fibers are then blocked using a smaller anodal current, the net effect being action potential propagation in the small fibers only”), and wherein a typical nerve fiber targeted for blocking or stimulation may have a diameter in the range of 1-20 µm (par. 0167: “The system is configured to selectively activate only A-delta fibers, while not activating A fibers;” examiner notes that A-delta fibers typically have a diameter around 1-5 µm, and A fibers typically have a diameter around 13-20 µm). Given that the claimed diameter ranges of 0.2 to 19.5 µm and 0.5 to 20.0 µm encompass the normal diameters of most myelinated and unmyelinated nerve fibers (which range from about 0.2 µm at the thinnest C-type fibers to about 20 µm at the thickest A-type fibers), along with the teachings of Ayal, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select target and reference nerve fibers within the claimed diameter ranges as appropriate for the specific application of nerve conduction blocking, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 38, Fang teaches a method for obtaining nerve fiber conduction block using a neuromodulation device (par. 0011: "these methods and apparatuses may be useful to set (e.g., optimize) the dosing parameters used by an implanted neuromodulator to provide relief from pain using high-frequency nerve block"), the method comprising:
applying a hybrid waveform comprising a kilohertz frequency (KHF) component and a direct current (DC) component to a target nerve fiber or set of nerve fibers (par. 0065: "A neuromodulation dose may include a variety of dose parameters for treating pain. In general, a set of dose parameters may include [...] dose frequency (e.g., treatment frequency; in high-frequency never block variations the frequency may be greater than 1 KHz, such as between 1-100 KHz). Other dose parameters may include the initial (e.g., starting) voltage, which may be, e.g., zero, or may be an offset (e.g., voltage offset) voltage. In some variations, the therapeutic dose parameters may include [...] DC offset level");
wherein the hybrid waveform achieves reversible conduction block in the target nerve fiber or set of nerve fibers (par. 0013: "These methods may be applied to, but are not limited to, the use with neuromodulation to provide a high-frequency block of a nerve or bundle of nerves;" par. 0060: “One therapy involves reversibly blocking peripheral nerves by applying high frequency alternating current directly on a nerve trunk”).
Fang teaches an offset initial voltage and a DC offset level (par. 0065) but is silent with respect to charge balance and does not explicitly teach wherein the hybrid waveform comprises a net charge imbalance per unit time during the phases of the KHF component without becoming charge-balanced. However, for the same reasons set forth previously in the rejection of claim 1, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Fang in view of Bhadra to include these limitations.
The combination does not explicitly teach wherein the hybrid waveform achieves a conduction block in a unidirectional manner. However, Ayal teaches achieving a conduction block in a unidirectional manner (par. 0143: “the electrode assembly is configured to apply unidirectional stimulation to the nerve, such as by using techniques described in one or more of the patent applications incorporated by reference hereinbelow. For example, control unit 40 may drive anode 42 to apply an inhibiting current capable of inhibiting device-induced action potentials traveling in a non-therapeutic direction in nerve 30”) so that organs at only one end of the nerve receive signals (par. 0005). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of the combined reference by obtaining unidirectional nerve fiber conduction block, as taught by Ayal, so that organs at only one of the nerves receive signals, as taught by Ayal.
Regarding claim 44, the combination teaches the method of claim 38 as described previously. These limitations are rejected in view of Bhadra for the same reasons laid out previously in the rejection of claim 8.
Response to Arguments
Applicant’s arguments, filed 15 April 2026, with respect to the rejection(s) of claim(s) 1 and 38 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claims, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bhadra. As described previously, Bhadra teaches a charge-imbalanced waveform in the context of a reversible conduction block.
Applicant’s arguments with respect to the combination of Fang and Prochazka 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Schepis et al. (US PGPub No. 2017/0224989) teaches that high frequency alternating current waveforms have a monotonic relationship between frequency and blocking thresholds for C-fibers and a non-monotonic relationship between frequency and blocking thresholds for A-fibers (par. 0005).
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 DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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