FDETAILED 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 .
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 2, 3, 4, 5, 6, 10 and 17 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.
In re claim 2, there is insufficient antecedent basis for the limitation “the neurophysiological effect”. For the purposes of examination, the first instance of the limitation “the neurophysiological effect” will be read as “a neurophysiological effect”.
In re claim 3, see above (In re claim 2).
In re claim 4, see above (In re claim 2).
In re claim 5, there is insufficient antecedent basis for the limitation “the side effect”. For the purposes of examination, the first instance of the limitation “the side effect” will be read as “a side effect”.
In re claim 6, the limitation, “wherein generating the modified neurostimulation sequence comprises: maximizing the quiescence time of the neurostimulation sequence under one or both of a first constraint and a second constraint, wherein the first constraint comprises that the determined neurophysiologic effect strength remains above a preconfigured threshold for the neurophysiologic effect strength, and wherein the second constraint comprises that the determined side effect strength remains below a preconfigured threshold for the side effect strength”, is unclear. Specifically, the latter part of the limitation “wherein the first constraint comprises that the determined neurophysiologic effect strength remains above a preconfigured threshold for the neurophysiologic effect strength, and wherein the second constraint comprises that the determined side effect strength remains below a preconfigured threshold for the side effect strength” implies that both a first and second constraint are required. This contradicts the first part of the limitation “maximizing the quiescence time of the neurostimulation sequence under one or both of a first constraint and a second constraint”, which states that only one of the “first constraint” or “second constraint” is required.
For examination purposes, claim 6 will be interpreted as follows:
The method of claim 1 wherein generating the modified neurostimulation sequence comprises: maximizing the quiescence time of the neurostimulation sequence under one or both of
a first constraint, wherein the first constraint comprises that the determined neurophysiologic effect strength remains above a preconfigured threshold for the neurophysiologic effect strength, and
a second constraint wherein the second constraint comprises that the determined side effect strength remains below a preconfigured threshold for the side effect strength.
In re claim 10, there is insufficient antecedent basis for the limitation “the parameter”. For examination purposes, the limitation “the parameter” will be read as “a parameter”.
In re claim 17, see above (In re claim 2).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1-17 are rejected under 35 U.S.C 101 because the claimed invention is directed to an abstract idea (mental process of generating a modified neurostimulation sequence) without significantly more.
STEP 1
In re claim 1, the claim is directed to statutory subject matter as it recites a method. (STEP 1. YES)
STEP 2A PRONG 1:
In re claim 1, the limitations (“determining…effect strength”, “generating…a modified neurostimulation sequence”, “storing…the modified neurostimulation sequence”) are processes capable of being performed in the human mind (including observation, judgement, evaluation, and opinion) under the broadest reasonable standard. As discussed in MPEP 21106.04(a)(2), the courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. These limitations are nothing more than a clinician using a computer to calculate and use specific parameters to generate an updated stimulation sequence for a patient. (STEP 2A PRONG 1: YES)
STEP 2A PRONG 2:
In re claim 1, the judicial exception is not integrated into application. Specifically claim 1 recites the following additional elements: “neurostimulation device”, “applying…a neurostimulation sequence”, “including…quiescence periods”, “increasing…a pulse frequency”, “increasing…a pulse amplitude”, “increasing… a pulse width” and “a non-transitory computer readable medium”. The additional element “a non-transitory computer readable medium” does nothing more than invoke a computer as a tool to perform an existing process. The additional elements, “including…quiescence periods”, “increasing…a pulse frequency”, “increasing…a pulse amplitude”, and “increasing… a pulse width” and “applying…a neurostimulation sequence”, are examples of linking the judicial exception to a particular technological environment of field of use. See MPEP 2106.05(h). As illustrated above, these elements do not impose any meaningful limits on practicing the abstract idea and therefore do not integrate the abstract idea into practical application. See MPEP 2106.05 (f). (STEP 2A PRONG 2: NO)
STEP 2B:
In re claim 1, the claim does not include any additional elements that are sufficient to amount to more than the judicial exception. As discussed above in “STEP 2A PRONG 2”, the additional elements amount to no more than invoking a computer as a tool to perform an existing process, or generally linking the user of a judicial exception to a particular technological environment. Additionally, viewing the limitations in combination show that they fail to ensure the claims amount to significantly more than the abstract idea. When considered as an ordered combination, the additional elements of the claims add nothing that is not already present when considered separately. (STEP 2B: NO)
In re claims 2-16, the dependent claims are either directed to 1) steps that are also abstract 2) additional data output that is well-understood, routine, and previously known to the industry or 3) further recite additional elements at a high level of generality which are conventional in the art.
In re claim 17, Examiner asserts that the limitation, “applying the modified stimulation sequence”, would integrate the abstract idea into practical application. Therefore, claim 17 is not rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed 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.
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 1-6, and 17 are rejected under 35 U.S.C. 102(a)(1)/103 as being unpatentable over Grill et al. (US, 11,013,922).
In re claim 1, Grill discloses a method comprising (FIG. 1, FIG. 10):
applying, using a neurostimulation device (104; col. 9, lines 11-16: “SCS Device 650” shown in greater detail in FIG. 6A), a neurostimulation sequence comprising a plurality of stimulation pulses, to a nervous system of a person (104: “delivers stimulation”; Examples of potential stimulation patterns delivered are shown in FIG. 5A: where each row, i.e. “organism”, represents a potential stimulation pattern; col. 12, lines 6-12);
determining one or both of
a neurophysiologic effect strength caused by the neurostimulation sequence (106: “efficacy”; where the “efficacy” can be determined in several ways as described in: col. 3, lines 17-20 and col. 3, lines 21-28) and
a side effect strength associated with the neurostimulation sequence (106: “side effect parameters”; where the “side effect parameters” can be determined in several ways described in col. 3, lines 34-37 and col. 3, lines 45-47 ); and
generating, based on determining one or both of the neurophysiologic effect strength and the side effect strength, a modified neurostimulation sequence (112, 114: “offspring”; Examples of modified neurostimulation patterns (also called “subsequent generations”) are shown in FIG. 5B: where each row i.e., “organism” represents a modified stimulation pattern) having an increased quiescence time (FIGS. 5A-5B; For example modified stimulation pattern 10 (organism 10) from FIG. 5B has increased quiescence time compared to stimulation pattern 12 (organism 12) from FIG. 5A).
wherein generating the modified neurostimulation sequence comprises
reducing a number of stimulation pulses of the neurostimulation sequence (FIGS. 5A-5B);
by including one or more quiescence periods into the neurostimulation sequence (FIGS. 5A-5B; For example, modified stimulation pattern 10 (organism 10) from FIG. 5B has more quiescent periods compared to stimulation pattern 12 (organism 12) from FIG. 5A), or
by removing stimulation pulses from the neurostimulation sequence (FIGS. 5A-5B; For example, modified stimulation pattern 7 (organism 7) from FIG. 5B has fewer pulses than stimulation pattern 20 (organism 20) from FIG. 5A),
or by doing both (see preceding square bullets); and
increasing one or more of
a pulse frequency,
a pulse amplitude (col. 5, lines 27-29) and
a pulse width (col. 5, lines 27-29: “pulse duration”)
of the neurostimulation sequence to increase a charge injected into the nervous system (apparent as increasing either a pulse amplitude or width would cause the amount of charge injected into the nervous system to increase) and
storing the modified neurostimulation sequence in a non-transitory computer- readable memory medium (116).
It appears Grill discloses an algorithm that at least produces a modified neurostimulation sequence with increased quiescence time. This is evidenced by comparing neurostimulation sequences shown FIG 5A to modified stimulation sequences shown in FIG. 5B. As discussed above, a majority of the modified stimulation patterns have increased quiescence time (when compared to sequences in FIG. 5A) after only a single iteration (col. 12, lines 13-19: “subsequent generation”). However, in so far as this is not explicitly stated, claim 1 is alternatively rejected under 35 U.S.C. 103 as follows:
It would have been obvious to one of ordinary skill in the art to produce a modified neurostimulation sequence with increased quiescence time because introducing more quiescence has been shown reduce power consumption and promote efficiency (col. 8, lines 16-22, col. 7 lines 56-66).
In re claim 2, Grill discloses
wherein determining the neurophysiologic effect strength comprises measuring, via a sensor device, a physiologic parameter of the person indicating the neurophysiologic effect strength; and/or
wherein the *neurophysiologic effect comprises a reduction of a neurologic disorder (col. 3, lines 17-20: “reduction of neural activity…”; col. 1, lines 29-30: where the neurological disorder is “chronic pain”).
* Examiner notes that “the neurophysiologic effect” is being interpreted as any perceived effect caused by the stimulation. In this case the perceived effect is a reduction in chronic pain.
In re claim 3, Grill discloses
wherein determining the neurophysiologic effect strength comprises receiving a feedback signal (col. 15, lines 4-8: a user adjusted “absolute value of A” ; Examiner notes that “A” is the weighting term of the cost function that represents efficacy as described in col. 15, lines 63-66) from the person indicating the neurophysiologic effect strength; and/or
wherein the neurophysiologic effect comprises one or more artificial sensations elicited by the neurostimulation sequence (col. 14, lines 31-36: where the perceived effect is “whether side effects are experienced” or improved/worsened “pain symptoms”).
In re claim 4, Grill discloses
wherein determining the neurophysiologic effect strength comprises one or more of:
measuring a parameter indicating a degree of successful execution of a behavior task by the person supported by the neurophysiologic effect;
measuring neuronal activity of the person associated with the neurophysiologic effect (col. 3, lines 17-20: “reduction of neural activity…”);
measuring a parameter indicating a psychological state of the person affected by the neurophysiologic effect; and
determining a performance metric of a computer brain interface of the person using the neurophysiologic effect.
In re claim 5, Grill discloses
wherein determining the side effect strength associated with the neurostimulation sequence comprises one or more of:
measuring a parameter indicating a degree of successful execution of a behavior task by the person affected by the side effect;
measuring neuronal activity of the person associated with the side effect (col. 3, lines 34-37: “determining…firing rate of neurons”);
measuring a parameter indicating a psychological state of the person affected by the side effect; and
determining a performance metric of a computer brain interface of the person affected by the side effect.
In re claim 6, Grill discloses
wherein generating the modified neurostimulation sequence comprises:
maximizing the quiescence time (col. 11, lines 28-39: “better efficiency (increase B)”; col. 8, lines 14-20: Examiner notes that efficiency is increased by “reducing stimulation frequency”, which introduces more quiescence time) of the neurostimulation sequence under one or both of a first constraint (col. 11, lines 28-39: “better efficacy (increase A)” ) and a second constraint (col. 11, lines 28-39: “significant paresthesia reduction (increase C)”),
wherein the first constraint comprises that the determined neurophysiologic effect strength remains above a preconfigured threshold for the neurophysiologic effect strength (apparent see *below), and
wherein the second constraint comprises that the determined side effect strength remains below a preconfigured threshold for the side effect strength (apparent see *below).
*It is apparent that algorithm of Grill (col. 11, lines 28-29: “Equation 1”) has implicit thresholds bounding the neurophysiological effect strength and side effect strength. For example, it is apparent that the neurophysiological effect strength is required to remain above a preconfigured threshold of at least zero because otherwise the device would have no neurophysiological effect on the patient. Similarly, it is apparent that the side effect strength is bound by an upper threshold as there is a limit to the strength or severity of a side effect that a patient would be willing to endure.
In re claim 17, further comprising applying the modified stimulation sequence to the nervous system of the person to cause the neurophysiologic effect (104; Examiner notes that a modified stimulation pattern is applied at block 104 after a single iteration).
Claim Rejections - 35 USC § 102
Claim 1, 6, 7, 8, 10, 13, 14 and 17are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strother et al. (US 10,688,306).
In re claim 1, Strother discloses method (FIG. 8) comprising:
applying, using a neurostimulation device (FIG. 1: 100; col. 5, lines 46-48: “deep brain stimulation (DBS) system”; col. 13, lines 50-54), a neurostimulation sequence comprising a plurality of stimulation pulses to a nervous system of a person (138; col. 14, line 64- col. 15, line 1: “stimulation” that both achieves “symptom reduction” and is “below the level creating side effects”);
determining one or both of
a neurophysiologic effect strength (col. 14, line 64-col. 15, line 1: “to achieve symptom reduction”) caused by the neurostimulation sequence (138) and
a side effect strength (col. 14, line 64-col. 15, line 1: “level creating side effects”) associated with the neurostimulation sequence (138); and
generating, based on determining one or both of the neurophysiologic effect strength and the side effect strength, a modified neurostimulation sequence having an *increased quiescence time (142, 144);
wherein generating the modified neurostimulation sequence comprises:
reducing a number of stimulation pulses of the neurostimulation sequence (142: “Adjusting the TOPS Factor”; col. 15, lines 17-23; col. 15, lines 55-66: “lower average frequency”)
by including one or more quiescence periods into the neurostimulation sequence (col. 15, lines 55-66: “lower average frequency”; Examiner notes that fewer stimulation pulses would result in more quiescent periods.), or
by removing stimulation pulses from the neurostimulation sequence, or
by doing both; and
increasing one or more of a pulse frequency , a pulse amplitude (144: “Readjust amplitude”) and a pulse width of the neurostimulation sequence to increase a charge injected into the nervous system (144; apparent as increasing the pulse amplitude increases the total charge delivered especially if the stimulation pattern is unchanged); and
storing the modified neurostimulation sequence in a non-transitory computer- readable memory medium (col. 8, lines 52-59: “allow…programmed stimulus patterns to be saved”).
Examiner notes that step 142 involves choosing the smallest TOPS Factor (i.e., number that represent stimulation pattern (col. 15, lines 18-28) that continues to produce a significant reduction in symptoms. As shown in FIG. 9- FIG. 11 stimulation patterns associated with the smallest TOPS factors have more quiescence time when compared to their higher counterparts (FIG. 12-14).
In re claim 6, Strother discloses
wherein generating the modified neurostimulation sequence comprises:
maximizing the quiescence time of the neurostimulation sequence (142; “adjusting the TOPS factor”) under one or both of a first constraint (142: “reduction of symptoms”) and a second constraint,
wherein the first constraint comprises that the determined neurophysiologic effect strength remains above a preconfigured threshold for the neurophysiologic effect strength (142: “reduction of symptoms”), and
wherein the second constraint comprises that the determined side effect strength remains below a preconfigured threshold for the side effect strength.
In re claim 7, Strother discloses
wherein generating the modified neurostimulation sequence comprises:
reducing the number of stimulation pulses
until the determined neurophysiologic effect strength falls below the preconfigured threshold for the neurophysiologic effect strength (142: “adjusting the TOPS” until there is not a “significant reduction of symptoms”), or
until the determined side effect strength raises above the preconfigured threshold for the side effect strength, or
both; and
increasing the charge injected by the neurostimulation sequence into the nervous system (144: “Readjust amplitude”)
until the determined neurophysiologic effect strength raises above the preconfigured threshold for the neurophysiologic effect strength (144: until “amplitude no longer produces a corresponding reduction of symptoms”), or
until the determined side effect strength falls below the preconfigured threshold for the side effect strength,
or both.
In re claim 8, Strother discloses
wherein the number of stimulation pulses is iteratively reduced by including one or more quiescence periods of increasing length into the neurostimulation process (FIG. 9-FIG. 14)
Examiner notes that as a user adjusts the TOPS patterns from most efficient (shown in FIG. 14) to least efficient (shown in FIG. 9), the number of stimulation pulses (“Stimulus Patterns”) is iteratively (i.e., with each adjustment) reduced. Additionally, it can be seen by looking at the change in the stimulus pattern from FIG. 14 to FIG. 9 each adjustment adds an additional period of quiescence.
In re claim 10, Strother discloses
wherein generating the modified neurostimulation sequence comprises
repeating said reducing the number of stimulation pulses (FIG. 8; where the “repeating is represented by arrow coming into the left side of box 142) and
increasing the charge injected by the neurostimulation sequence into the nervous system (144: “Readjust the amplitude”)
until the quiescence time of the neurostimulation sequence is above a preconfigured threshold for the quiescence time or until the quiescence time is maximized (FIG. 8: “done” extending from the second “Adequate treatment” box; Examiner notes that Strother specifies that if a user determines that the treatment is still not adequate (at the second “Adequate treatment box”), the user can return to an earlier step in the sequence (e.g., 142, or 144); col. 15, lines 37-43) .
In re claim 13, Strother discloses
wherein generating the modified neurostimulation sequence comprises modifying a pulse shape of one or more stimulation pulses of the neurostimulation sequence (col. 14, lines 35-37: “waveform…can be monophasic, biphasic, or multiphasic”).
In re claim 14, see above (In re claim 1)
wherein increasing one or more of the pulse frequency, the pulse amplitude (144: “Readjust amplitude”) or the pulse width of the neurostimulation sequence maintains or increases the charge injected by the modified neurostimulation sequence into the nervous system (apparent as increasing the pulse amplitude increases the total charge delivered especially if the stimulation pattern is unchanged, as described in FIG. 8: 144)
In re claim 17, Strother discloses further comprising:
applying the modified stimulation sequence to the nervous system of the person to cause the neurophysiologic effect (FIG. 8: “Adequate treatment”; col. 15, lines 37-38).
Claim Rejections - 35 USC § 103
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Strother et al. (US 10,688,306) in view of Mishra et al. (US 2019/0001139).
In re claim 9, Strother does not disclose
wherein the number of stimulation pulses is iteratively reduced by randomly or pseudo-randomly removing stimulation pulses from the neurostimulation sequence based on an iteratively increasing stimulation pulse removal probability.
Mishra also discloses a method for providing a modified neurostimulation sequence (abstract). Mishra further discloses adjusting the neurostimulation sequence by randomly removing pulses based on a probability distribution [0052]. Mishra additionally discloses adjusting the probability distribution based on patient feedback, patient comfort, treatment efficacy, and assessment of paresthesia [0061].
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 Strother, to include wherein the number of stimulation pulses is reduced by randomly removing stimulation pulses based on a probability, as disclosed by Mishra. One would have been motivated to make this modification to create an unbiased removal process, ensuring that each pulse has a fair chance of being removed.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Strother et al. (US 10,688,306) in view of Grill, Jr. et al (US 9,242,095).
In re claim 11, Strother discloses
measuring a parameter indicating the neurophysiological effect strength (142: “Significant Reduction of Symptoms”)
Strother lacks:
wherein the parameter indicating the neurophysiologic effect strength is measured via one or more of: an accelerometer attached to a body part of the person; an imaging system; a neural activity sensor; and a behavioral task.
Grill Jr. discloses a similar method for generating a modified neural stimulation sequence using a cost function (abstract, title). Grill Jr. discloses using the cost function to generate neurostimulation sequences with a lower average frequency (col. 9, lines 47-59). Grill Jr. further discloses applying a modified neural stimulation sequence to a subject’s wrist (col. 15, lines 56-61) and measuring the subjects response using an accelerometer (col. 16, lines 8-10). Grill Jr. additionally discloses quantifying the subject’s response by calculating a power spectral density, using output signals from the accelerometer (col. 16, lines 12-23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Strother to include, wherein the parameter indicating the neurophysiological effect strength is measured via an accelerometer, as taught by Grill Jr. One would have been motivated to make this modification because using an accelerometer is a known way to measure the effects of electrical stimulation. Moreover, one of ordinary skill in the art would have the ability to choose a measurement technique that would best meet their needs.
In re claim 12, the proposed combination yields (all mapping directed to Grill Jr.)
wherein the parameter indicating the neurophysiologic effect strength is based on a power spectral density of an output signal of one or more of the accelerometer (col. 16, lines 12-23), the imaging system, or the neural activity sensor.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Strother et al. (US 10,688,306) in view of Lee et al. (US 2012/0004707).
In re claim 15, Strother discloses
wherein the modified stimulation sequence comprises multi-phasic stimulation pulses (col. 14, lines 35-37),
Strother lacks:
wherein each multi-phasic stimulation pulse comprises a stimulation phase and one or more active charge balancing phases, and
wherein generating the modified stimulation sequence further comprises: modifying the shape of the one or more active charge balancing phases of at least a subset of the multi-phasic stimulation pulses.
Lee discloses a method for providing electrical stimulation therapy to a patient (abstract) involving delivering stimulation pulses to a patient and adjusting characteristics of the electrical stimulation therapy. Lee further discloses adjusting characteristics of the electrical stimulation therapy by changing the shape of the stimulation pulses [0007]. In addition to changing the shape of stimulation pulses, Lee discloses optionally using multipolar stimulation pulses. As shown in FIG.7, multipolar stimulation pulses include both a stimulation phase (p) and an active charge balancing phase (n). Multipolar stimulation pulses are believed to enable improved discrimination between fiber types [0053]. Lee discloses modifying the shape of the charge balancing phase (FIG. 11), as it is believed to produced paresthesia differences in the same manner as modifying the shape of the stimulation phase [0055]. Lee further discloses modifying the shape of the charge balancing phase by adjusting pulse amplitude, pulse duration, and pulse rate [0055, 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 the multi-phasic stimulation pulse of Strother to include a stimulation phase and one or more active charge balancing phases, and to further comprise modifying the shape of the one or more active charge balancing phases, as taught by Lee. One would have been motivated to make this modification to be able to differentiate between fiber types [0053] and have an additional parameter that can be used to modify the patients side effects ([0055]: “modifying the shape of a recharge pulse will produce paresthesia differences”).
In re claim 16, the proposed combination yields (all mapping directed to Lee)
wherein modifying the shape of the active charge balancing phase of some or all of the multi-phasic stimulation pulses comprises (FIG. 11; [0053]: charge balancing phase is “modified in the same manner” as the stimulation phase):
reducing an amplitude of the active charge balancing phase [0009]and
increasing a duration of the active charge balancing phase [0009].
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Stubbs et al. (US 2019/0076657) discloses a method for identifying parameter settings on a neurostimulation device that prioritizes both treatment and minimizing side effects (abstract, [0008]).
Moffitt et al. (US 2021/0046316) discloses a method for identifying an optimal stimulation field set that satisfies one or more optimization criteria (abstract). Moffitt discloses the optimization criteria including effect level and side effect level [0100].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796