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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 28 August 2025 has been entered. Claim(s) 1, 7, and 38 are currently amended. Claims 33 and 36-37 were previously withdrawn. Claims 1-12, 19-20, 33, 36-38, and 44 are pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12, 19-20, 38, and 44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 38 both recite the limitation “the phases of the KHF component.” There is insufficient antecedent basis for this limitation in the claim. Dependent claims 2-12, 19-20, and 44 are necessarily rejected as depending on rejected base claims.
Claim 7 recites the limitation “amplitude-dependent or frequency-dependent” in line 2. It is unclear from the claim language which amplitude or frequency is being recited, such that the scope of the claim is indefinite because it is unclear upon which amplitude or frequency the net charge imbalance depends. For examination purposes, this limitation will be read as wherein the net charge imbalance depends upon the amplitude or frequency of the DC or KHF component.
In claims 8 and 44, the following limitations lack sufficient antecedent basis:
“the DC offset” (recited only in dependent claim 4)
“the amplitude of the DC offset”
“the magnitude of the difference in the phase durations”
“the magnitude of the difference in the amplitudes of the phases”
“the shapes of the phases”
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 1-2, 4-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Fang et al. (US PGPub No. 2021/0220642) in view of Prochazka (US PGPub No. 2010/0016929).
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 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").
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, in an analogous art, Prochazka teaches applying charge-imbalanced high frequency current to a target nerve without becoming charge-balanced, in order to deliver a sufficient net charge to cause controlled ablation (pars. 0038-0039: "The invention also broadly provides a method of treating a subject having unwanted or overactive nerve activity, comprising: (a) applying one or more of direct current and charge imbalanced time varying current to a target nerve; and (b) controlling the amplitude and the duration of the current such that there is a net charge delivered to the target nerve at a sufficient current density to cause controlled ablation of the target nerve until unwanted or overactive nerve activity is reduced in one or both of the target nerve and a target body tissue innervated by the target nerve").
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 claims 5 and 7-8, the combination teaches the method of claim 1 as described previously. Prochazka further teaches wherein the DC component (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, and wherein the net charge imbalance per unit time is amplitude-dependent or frequency-dependent, and wherein the net charge imbalance is obtained by adjusting the magnitude of the difference in the amplitudes of the phases of the KHF component (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”). Examiner interprets a charge imbalance resulting from unequal amplitudes as amplitude-dependent, and notes that as the limitations of claim 8 are listed in the alternative, the claim is considered to be met when only one of the conditions is met.
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 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 Prochazka and further in view of Zhang et al. (US PGPub No. 2020/0061380), hereinafter Zhang.
Fang in view of Prochazka 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 9 is rejected under 35 U.S.C. 103 as being unpatentable under 35 U.S.C. 103 over Fang in view of Prochazka and further in view of Bhadra et al. (US PGPub No. 2017/0050024), hereinafter Bhadra.
Fang in view of Prochazka teaches the method of claim 1 as described previously but does not explicitly teach wherein the method further comprises adjusting polarity of the DC component. However, in a related nerve conduction blocking art, Bhadra teaches a method of blocking nerve conduction that 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”), which allows the block to be applied for a longer time (par. 0086: “the block can now be delivered longer (e.g., twice as long) because the electrode contact has been “pre-charged” to an opposite polarity”). 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 reversing polarity of the DC component, as taught by Bhadra, so that the block can be applied for a longer time, as taught by Bhadra.
Claims 11-12, 19-20, 38, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Prochazka 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 Prochazka 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 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").
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 Prochazka 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 Prochazka for the same reasons laid out previously in the rejection of claim 8.
Response to Arguments
Applicant’s arguments, filed 28 August 2025, with respect to the rejection(s) of claim(s) 1 and 38 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 103, respectively, 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 Fang and Prochazka. As described previously, Prochazka teaches a net charge imbalance without becoming charge-balanced during nerve conduction block with a high frequency waveform.
Conclusion
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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LINDA C DVORAK can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794