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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 7, 2026 has been entered.
Response to Amendment
The amendment filed December 30, 2025 has been entered. Claims 1-2, 10, 21 have been amended. Claims 13, 15 are canceled. Currently, claims 1-12, 14, 16-22 are pending for examination.
Response to Arguments
Applicant’s arguments, see pages 9-12, filed December 30, 2025, with respect to the rejection(s) of claim(s) 1-12, 14, 16-22 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of De Ridder (US 2016/0074663).
Terminal Disclaimer
The terminal disclaimer filed on December 30, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 19/184,337 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Interpretation
It is noted that claim 1’s amended, “assigning a subset of discrete frequency bands… to a corresponding section of the electrode array” (lines 9-11) does not currently require assigning the subset of discrete frequency bands to a randomly selected electrical configuration as recited in lines 4-8. The “corresponding section of the electrode array” is not currently associated with any electrodes that have been randomly selected as an electrode configuration.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 has been amended to recite, “determining a period of time to cause depletion of a mitochondrial energy store of corresponding nerve cells of the patient and a subsequent period of time to rebuild the mitochondrial energy store”. These determination steps are not described in the specification in such a way as to provide adequate support for the new limitations. Paragraph [0122] of the published application describes an electrical stimulation signal may have a frequency range which, when delivered to a nerve, “causes the nerve cell to run out of its mitochondrial stores of energy. In other words, such an electrical stimulation signal may fatigue the nerve, so that it essentially becomes tired and is unable to fire.” The paragraph then states, “As such, the electrical stimulation system 400 is able to deliver the signal to the patient for a period (e.g., five minutes), turn the stimulation off for an extended period (e.g., several days) while the nerve cells rebuild their mitochondrial stores, and again deliver the signal to the patient to again fatigue the nerve and deplete the stores.” This statement does not support the active step of determining “a period of time to cause depletion of a mitochondrial energy store of corresponding nerve cells of the patient” or “a subsequent period of time to rebuild the mitochondrial energy store”. The “five minutes” and “several days” appear to be arbitrary examples of periods of time to deliver or turn off the stimulation, with no observation/sensing steps disclosed to reach these values such that they can be interpreted as a “determining” step in the method claim.
Claim 21 recites, “delivering… the electrical stimulation signal to the patient… for the period of time determined to cause depletion of a mitochondrial energy store of corresponding nerve cells of the patient” (lines 5-7). Looking at the same paragraph [0122], sufficient support is not provided for the claimed limitation of causing depletion of the mitochondrial energy store as a result of stimulation being delivered for a period of time. The duration of stimulation does not directly affect the mitochondrial energy store.
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, 14, 16-22 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.
Claim 1 recites the limitation "a frequency range of the electrical stimulation signal" in lines 9-10. There is insufficient antecedent basis for this limitation in the claim. An electrical stimulation signal has not yet been introduced in claim 1. Line 12 recites, “an electrical stimulation signal” but there is no current tie-in to what is recited in lines 9-10.
Claims 2-12, 14, 16-22 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 1.
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.
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.
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.
Claim(s) 1, 7-12, 14, 16, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Molnar et al. (US 2022/0080200) as evidenced by Zhang et al. (US 2020/0139127) and in view of De Ridder (US 2016/0074663).
Regarding claim 1, Molnar et al. discloses a method of delivering spatially random electrical stimulation to a patient through an electrical lead that includes an electrode array (fig. 1a-d), wherein the electrode array includes a plurality of electrodes ([0041-0043]), the method comprising: randomly selecting, by an electrical stimulation system (“IPG” [0059]), an electrical configuration from the plurality of electrodes from the electrode array, wherein randomly selecting the electrical configuration comprises randomly selecting a first set of electrodes of the plurality of electrodes to function as anodes and a second set of electrodes of the plurality of electrodes, different from the first set of electrodes, to function as cathodes (“select a different pair of electrodes along the lead to effective shift or field steer the electrical field to a new location… random designation of cathode and anode pairs” [0070]); and delivering, by the electrical stimulation system, an electrical stimulation signal to the patient via the randomly selected electrical configuration ([0070]).
Molnar et al. does not expressly disclose that the selected electrodes to function as anodes are electrical sources and the selected electrodes to function as cathodes are electrical sinks. However Zhang et al. teaches it is known in the art that anodic electrodes are regarded in the art as sourcing current, and cathodic electrodes are sinking current ([0094]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to consider Molnar et al. as selecting electrical sources and sinks as described in Zhang et al., with these specific limitations are not regarded as patentable over the prior art.
Molnar et al. does not expressly disclose assigning a subset of discrete frequency bands of a frequency range of the electrical stimulation signal to a corresponding section of the electrode array, wherein the section of the electrode array is associated with a corresponding anatomical region of the patient. De Ridder teaches it is known in the art to deliver nested stimulation to nerve tissue of interest, such as spinal cord tissue ([0006], [0079]) which is analogous to Molnar et al.’s disclosed method. De Ridder teaches a nested stimulation signal comprises discrete frequency bands ([0080-0081]) that are delivered to a corresponding section of an electrode array (“The nested stimulation waveforms 902-912 may be delivered from multiple electrode combinations along the lead.” [0089]), wherein the section of the electrode array is associated with a corresponding anatomical region of the patient (“IMD delivers a nested stimulation waveform to the select electrode combination within the array of electrodes located proximate to nervous tissue of interest.” [0095]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Molnar et al. to try the technique of delivering nested stimulation to the neuronal tissue of the spinal cord, where a subset of discrete frequency bands of a frequency range of the nested stimulation is assigned to a corresponding section of the electrode array that is associated with a corresponding anatomical region of the patient, as taught by De Ridder in order to provide a stimulation waveform that can incorporate the high-frequency physiological neural oscillations associated with the nerve tissue of interest ([0011]), and since such a technique is known in the art to yield the predictable result of treating spinal cord tissue.
Regarding claims 7-9, Molnar et al. further discloses randomly selecting, by the electrical stimulation system, a new electrical configuration from the plurality of electrodes of the electrode array in response to a determination that a threshold period of time has been met, the threshold defined as a predefined period of time elapsed since randomly selecting the electrical configuration, wherein the threshold is associated with one or more characteristics of the spatially random electrical stimulation being delivered to the patient (“the neuromodulation field is defined by the electrode position, spacing, designation as anode or cathode, and ratio of activation” [0079]; “the designated cathode and related anode pair and generated spherical electrical field, may be designated in a… random designation of cathode and anode pairs” [0070]; “after a period of time, the desired patient and performance outcomes may be sustained, or improved or minimally diminished by again varying from a current waveform to a new waveform” [0081]; “In another embodiment, a sensing window is used, wherein a predetermined time of sensed electrical information is received by sensing electrodes 20 of the first electrode 10 and such pattern is then delivered in a repeating fashion to the stimulating electrodes 22 of the second lead 10′ for either a predetermined period of time at which time the process repeats with a new sensing time frame for new stimulation pattern creation” [0098]).
Regarding claim 10, Molnar et al. in view of De Ridder discloses wherein to deliver the electrical stimulation signal to the patient via the randomly selected respective electrical configuration comprises to direct a set of frequency components ([0080-0081]) of the electrical stimulation signal to pass through a subset of the first set of electrodes and a subset of the second set of electrodes (“For each electrode combination (e.g., the defined polarity of at least two electrodes having at least one cathode and at least one anode)” [0146]).
Regarding claim 11, Molnar et al. in view of De Ridder discloses wherein the electrical stimulation signal comprises a pulse waveform ([0089-0092]).
Regarding claim 12, Molnar et al. discloses wherein the electrical stimulation signal comprises a periodic waveform 902, 904, 906, 908 (fig. 9).
Regarding claim 14, Molnar et al. discloses wherein each electrode of the plurality of electrodes is spatially separated from each other electrode of the plurality of electrodes down a length of the electrical lead (fig. 2a-d).
Regarding claim 16, Molnar et al. discloses the first set of electrodes comprises a first number of electrodes and the second set of electrodes comprises a second number of electrodes different from the first number (“a single cathode, e.g., electrode 4 designated as cathode 16 in FIG. 2a may be coupled with two anodes 14, both adjacent designated cathode 16” [0070]).
Regarding claim 19, Molnar et al. discloses wherein randomly selecting the first set of electrodes comprises to randomly selecting a number of electrodes in the first set of electrodes; and wherein to randomly selecting the second set of electrodes comprises randomly selecting a number of electrodes in the second set of electrodes ([0070]).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Molnar et al. (US 2022/0080200) as evidenced by Zhang et al. (US 2020/0139127) and in view of De Ridder (US 2016/0074663) and further in view of Torgerson (US 2020/0054879).
Regarding claim 17, Molnar et al. in view of De Ridder discloses delivering high-frequency components of the electrical signal (“the nested stimulation waveform may be comprised of waveform components associated with waves or frequency bands that are separated from one another, along the frequency spectrum… high-frequency waveform component” [0080]) but does not expressly disclose delivering the high-frequency signal components of the electrical stimulation signal through only the distal section of the electrode array. Torgerson teaches delivering stimulation through sets of electrodes, where low frequency is delivered only through one set of electrodes and delivering a high frequency to the other set of electrodes ([0127]). Given that it is known in the art to program different sets of electrodes with different frequency parameters, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Molnar et al. to try delivering a high frequency component to a set of electrodes at a distal section of the electrode array as taught by Torgerson et al. in order to allow for two different target areas of the patient to be stimulated at the same time and because high frequency therapy as compared to low frequency therapy may be delivered more frequently, requiring its own dedicated set of electrodes ([0127]), the specific location (distal vs proximal) for low and high frequency signals being a matter of design choice and lacking any particular criticality (see applicant’s specification [0113]).
Regarding claim 18, Molnar et al. does not expressly disclose wherein to deliver the electrical stimulation signal to the patient via the randomly selected electrical configuration comprises to amplify signals transmitted through the distal section at a different weight from signals transmitted through the proximal section. Torgerson teaches delivering stimulation through sets of electrodes, where low frequency is delivered only through one set of electrodes and delivering a high frequency to the other set of electrodes ([0127]), pulses with the lower frequency being weighted with a higher amplitude as compared to pulses with a higher frequency ([0087]). Given that it is known in the art to program different sets of electrodes with different frequency parameters, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Molnar et al. to try delivering different amplification of signal to a set of electrodes at a distal section of the electrode array as compared to a different weight of signals transmitted to a set of electrodes at a proximal section of the electrode array as taught by Torgerson et al. in order to allow for two different target areas of the patient to be stimulated at the same time and to allow for a better controlled and potentially faster technique to set the stimulation amplitude for different pulses ([0088]), the specific location (distal vs proximal) for amplified signals being a matter of design choice and lacking any particular criticality (see applicant’s specification [0114]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Molnar et al. (US 2022/0080200) ) as evidenced by Zhang et al. (US 2020/0139127) and in view of De Ridder (US 2016/0074663) and further in view of Zhu (US 2020/0078593).
Regarding claim 20, Molnar et al. does not expressly disclose wherein the frequency range of the electrical stimulation signal is 0.05 Hz to 2 kHz to block action potential of the patient’s nerve cells from firing. Zhu teaches it is known in the art to deliver an electrical stimulation signal in the range claimed by the applicant (“1.5 KHz-50 KHz”) stating this is an attractive frequency range for pain management as it blocks naturally occurring action potentials within neural fibers ([0009]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Molnar et al. to try applying an electrical stimulation signal within the ranges as taught by Zhu as it is a known technique for a known and similar device and the results of such a modification would have been reasonably predictable, such a modification would better block action potentials within the nerve fibers in neuromodulation for pain management ([0009]).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Molnar et al. (US 2022/0080200) as evidenced by Zhang et al. (US 2020/0139127) and in view of De Ridder (US 2016/0074663) and further in view of Christopherson et al. (US 2020/0230404).
Regarding claim 22, Molnar et al. does not expressly disclose changing a variable of the electrical stimulation signal as a function of a determined migration of the electrical lead in the patient; and delivering, by the electrical stimulation system, the electrical stimulation signal to the patient based on the changed variable. Christopherson et al. teaches it is known in the art to adjust therapy parameters in an event that a stimulation lead migrates from its original placement. For example, a variable of an electrical stimulation signal can change as a function of the determined migration of the electrical lead in the patient by selecting one combination of electrodes to a different combination based on the overall position of the lead ([0115]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Molnar et al. change a variable of the electrical stimulation signal as a function of a determined migration of the electrical lead in the patient and use the changed variable to deliver subsequent electrical stimulation as taught by Christopherson et al. in order to better account for lead migration from its original placement, such a modification being reasonably predictable and would not have altered the overall operation of the device.
Statement regarding prior art
Claim 2 recites, “partitioning, by the electrical stimulation system, the frequency range of the electrical stimulation signal into the discrete frequency bands, each of the discrete frequency bands having a corresponding bandwidth; and adjusting, by the electrical stimulation system, an amplitude of one or more of a voltage or current of the electrical stimulation signal within a selected frequency band of the discrete frequency bands to generate an adjusted electrical signal based on feedback received from the patient; wherein delivering the electrical stimulation signal to the patient comprises delivering the adjusted electrical signal to the patient via the randomly selected electrical configuration”. The closest prior art disclosing discrete frequency bands of a frequency range of the electrical stimulation signal (claim 1) is De Ridder (US 2021/0299447) describing nested stimulation that is created from delivering stimulation of discrete frequency bands. However given the discrete frequency bands are initially separated from one another ([0080]) when selected for delivery to create the nested stimulation, it would not be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the method step of partitioning the created nested stimulation signal back into discrete frequency bands for adjusting the amplitude and delivering the adjusted amplitude signal. De Ridder discloses changing the amplitude of the stimulation waveform ([0109]) but does not disclose this amplitude adjustment is within a selected frequency band of the discrete frequency bands.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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/ERICA S LEE/Primary Examiner, Art Unit 3796