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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 15th, 2024 is being considered by the examiner.
Priority
Acknowledgment is made of applicant’s claim for priority. The certified copy has been filed in parent Application No. 17680034, filed on February 24th, 2024 and claims benefit of provisional application 63/153,775, filed on February 25th, 2021. Examiner acknowledges the applicant’s claim for priority.
Status of Claims
In the response dated August 12th, 2026, Applicant amended claims 1, 3, 5, 6, 21, and 23-25. Claims 1-10 and 21-30 are pending.
Response to Arguments
In response to the argument put forward in the amendment, Examiner will address them in the order they were presented.
112 Rejection
Regarding page 6, Applicant’s arguments have been considered and are persuasive. Examiner withdraws rejections under 35 U.S.C. 112(b).
102 Rejection
Regarding pages 6-7, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that the amended claims recite language of an initial period which is at least one month in duration and is not taught by the prior art because this duration avoids detrimental effects of memory or cognitive ability for the users. First, Applicant does not claim any therapeutic benefit of memory. Furthermore, Examiner maintains that Flaherty teaches the structure and functions provided in the claims and thus necessarily provides the therapeutic benefit of the nerve stimulation. Finally, Flaherty explicitly teaches “The improved treatment can correspond with a therapeutic benefit such as a desired memory recall with the patient” in [0157]. This explicit teaching further supports that if the memory recall benefit is a therapeutic benefit that inherently arises from this stimulation method, this claim limitation is taught by Flaherty.
Regarding pages 6-7, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that the specification at [0154] “states nothing about the timeframe over which the stimulation parameters are altered.” Flaherty states that [0154] “stimulation parameters 105 can be … continuous increase in stimulation energy level, such as a stepped or continuous increase of a stimulating voltage”. This is not merely continuously applying a stimulation over a period of time. A continuous adjustment of stimulation parameter voltage comprises a rate of change which can be tuned to adjust a voltage differential over time and requires further detail as to the scope of duration. Flaherty’s description of details continues to indicate the duration of adjustments in further paragraphs, as indicated by Examiner, to further clarify the duration of this continuous amplitude adjustment. ([0122] “System 10 can be constructed and arranged to provide stimulation continuously … for a chronic period of time of at least 1 month”). This indicates that the duration of change can occur over the month timeframe. Under broadest reasonable interpretation, Examiner maintains that the prior art of record teaches Applicant’s claim language.
102 Rejection
Regarding pages 7-8, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that Nelson fails to teach wherein the processor is further configured, during the initial stimulation period, to not deliver the electrical stimulation during periods in which a cognitive load is expected for the patient. Nelson describes [0101] “processor 40 may control stimulation generator 42 to … reduce the magnitude of electrical stimulation delivered when patient 12 is asleep in order to induce a relatively low arousal state of brain 14” where processer deems the user’s cognitive load sufficient for the level of arousal needed. This indicates that the system’s stimulation is dynamic based on the brain activity and utilizes different stimulation settings to adjust the level of stimulation based on a patient’s activity. Upon this level of cognitive load, the system measures that the patient does not require further stimulation and thus does not deliver stimulation during a cognitive load. Nelson continues to describe that “IMD 16 controls delivery of electrical stimulation by … deactivating electrical stimulation…or decreasing the intensity of electrical stimulation delivered to brain 14 based on the arousal state of brain” in [0044]. Nelson teaches that the measured arousal state determines the level of stimulation needed. When there is a high cognitive load, a stimulation may not be required for a user because overstimulation would fatigue a patient and cause safety risks for a user. Thus, Nelson also will not deliver a stimulation during these cognitive loads. Nelson furthermore sets thresholds as a safety precaution which avoid overstimulation during these cognitive loads. The stimulation system can deliver a single stimulation pulse and thus avoids the delivery of a pulse during a cognitive load. When this pulsatile stimulation occurs, the system also does not deliver a load. Finally, Nelson depicts that the stimulation signals can be predetermined based on the time of the day. When a patient receives a cognitive load, like may be the case when answering a work call late at night, the setting can provide no stimulation to avoid excessive arousal based on the time of day. Thus, under broadest reasonable interpretation, Examiner maintains that Nelson teaches to not deliver the electrical stimulation during periods in which a cognitive load is expected for the patient.
Claim Interpretation
Claim 1 and 21 recite the amended claim language “the increase of the level of the electrical stimulation comprises an increase over time of at least one of a daily duration of stimulation or an amplitude of the electrical stimulation from an initial value at the start of the initial period to a final value at the end of the initial period. This leaves uncertainty as to whether the duration of a stimulation is daily and the amplitude has a varying time period or whether the amplitude also is expected to be a daily time period. At page 25, line 1 to page 26, line 15, the present patent application describes that this relatively long period for increase of stimulation amplitude or daily duration is to reduce or avoid
detrimental effects to memory. This phrasing, repeated in the Applicant’s arguments, appears to indicate that the duration of stimulation is daily and the stimulation amplitude is not limited to this daily adjustment. Claims 5, 6, 21, 24 and 25 recite the same phrasing of “at least one of the daily duration or the amplitude from the initial value to the final value”. These claims recite alternative limitation that either require a daily duration or an amplitude from an initial value to the final value. Examiner interprets the amplitude length to comprise any amplitude voltages that vary over any time period.
Claim Rejections - 35 USC § 102
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.
Claims 1- 5, 9, 21- 24, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated over Flaherty et al. (US20170151436).
Regarding claim 1, Flaherty teaches a system for stimulation of a nucleus basalis of Meynert (NBM) of a patient, the system comprising ([0124] “System 10 can be constructed and arranged to modulate… nucleus basalis of Meynert”): an implantable electrical stimulation lead comprising a plurality of electrodes ([0120] “stimulation element 150 comprises up to four implanted stimulation electrodes”) and configured for implantation of at least one of the electrodes adjacent to or within the NBM of the patient ([0124] “System 10 can modulate memory circuits in brain B via electrical or other stimulation means… to stimulate brain tissue selected from… nucleus basalis of Meynert”); and an implantable pulse generator coupleable to the implantable electrical stimulation lead ([0124] “lead with conductors can be electromechanically attached to stimulator 100”) and configured for delivering electrical stimulation to the NBM through at least one of the electrodes of the implantable electrical stimulation lead ([0124] “System 10 can modulate memory circuits in brain B via electrical or other stimulation means… to stimulate brain tissue selected from… nucleus basalis of Meynert” and [0121] “ electrical stimulation configurations”), the implantable pulse generator comprising at least one processor configured to, upon user request ([0131] “stimulation parameters 105 can be made by an operator of system 10 using controller 200”), initially deliver a first level of electrical stimulation ([0012] “stimulation parameters can comprise a parameter with a lower value”) and to increase the level of electrical stimulation to a second level of stimulation during an initial period ([0154] “stimulation parameters 105 can be delivered to brain B (e.g. a stepped or continuous increase in stimulation energy level, such as a stepped or continuous increase of a stimulating voltage”), which is at least 1 month in duration and has a start and an end ([0122] “System 10 can be constructed and arranged to provide stimulation continuously and/or intermittently, such as for a chronic period of time of at least 1 month”), wherein the increase of the level of the electrical stimulation comprises an increase over time of at least one of a daily duration of stimulation or an amplitude of the electrical stimulation ([0154] “stimulation parameters 105 can be … stepped or continuous increase of a stimulation voltage) from an initial value at the start of the initial period to a final value at the end of the initial period. ([0156] “stimulator 100 stimulates brain B with a first set of test stimulation parameters 105 for a first time period and a second set of test stimulation parameters 105 for a second time period”)
Regarding claim 21, Flaherty teaches a method for stimulating a nucleus basalis of Meynert (NBM) of a patient ([0058] “a method of treating a patient is provided. The method comprises providing a stimulator for stimulating brain tissue” and [0124] “System 10 can be constructed and arranged to modulate… nucleus basalis of Meynert”), the method comprising: implanting an electrical stimulation lead in a brain of the patient ([0121] “stimulator 100 are implanted in the patient”), wherein the electrical stimulation lead comprises a plurality of electrodes ([0120] “stimulation element 150 comprises up to four implanted stimulation electrodes”) and at least one of the electrodes is disposed adjacent to or within the NBM of the patient ([0124] “System 10 can modulate memory circuits in brain B via electrical or other stimulation means… to stimulate brain tissue selected from… nucleus basalis of Meynert”); and delivering electrical stimulation to the NBM through at least one of the electrodes by initially delivering a first level of electrical stimulation ([0012] “stimulation parameters can comprise a parameter with a lower value”) and increasing the level of the electrical stimulation to a second level of electrical stimulation during an initial period ([0154] “stimulation parameters 105 can be delivered to brain B (e.g. a stepped or continuous increase in stimulation energy level, such as a stepped or continuous increase of a stimulating voltage”), which is least 1 month in duration and has a start and an end ([0122] “System 10 can be constructed and arranged to provide stimulation continuously and/or intermittently, such as for a chronic period of time of at least 1 month”), by increasing over time at least one of a daily duration of electrical stimulation or an amplitude of the electrical stimulation ([0154] “stimulation parameters 105 can be … stepped or continuous increase of a stimulation voltage) from an initial value at the start of the initial period to a final value at the end of the initial period. ([0156] “stimulator 100 stimulates brain B with a first set of test stimulation parameters 105 for a first time period and a second set of test stimulation parameters 105 for a second time period”)
Regarding claim 2 and 22, Flaherty teaches all of the limitations of claim 1 and 21’s system and method. Flaherty also teaches wherein the processor is configured to deliver the electrical stimulation during the initial stimulation period with the increase of the amplitude of the electrical stimulation over time. ([0154] “stimulation parameters 105 can be … stepped or continuous increase of a stimulation voltage”)
Regarding claim 3 and 23, Flaherty teaches all of the limitations of claim 1 and 21’s system and method. Flaherty also teaches wherein the processor is configured to deliver the electrical stimulation during the initial stimulation period ([0180] “In some embodiments, repeated stimulation with initial and adjusted stimulation parameters includes incremental increases”) with the increase of the daily duration [i.e., pulse width] of the electrical stimulation over time ([0087] “stimulation parameters 105a deliver a different form of stimulation energy than the stimulation energy delivered using stimulation parameters 105b… The difference in energy delivered can comprise a difference in… signal pulse width”).
Regarding claim 4, Flaherty teaches all of the limitations of claim 3. Flaherty also teaches wherein the processor is configured to deliver the electrical stimulation during the initial stimulation period with the increase of the amplitude of the electrical stimulation over time. ([0154] “stimulation parameters 105 can be … stepped or continuous increase of a stimulation voltage”)
Regarding claim 5 and 24, Flaherty teaches all of the limitations of claim 1 and 21’s system and method. Flaherty also teaches wherein the increase over time of the at least one of the daily duration or the amplitude comprises increasing the at least one of the daily duration or the amplitude from the initial value to the final value according to a linear ramp ([0180] “repeated stimulation with initial and adjusted stimulation parameters includes incremental increases or decreases of a test stimulation parameter such as… sequentially increasing the voltage (e.g. in 0.1, 0.2, 0.3, 0.4 or 0.5 Volt increments)” is linear ramping).
Regarding claim 9 and 29, Flaherty teaches all of the limitations of claim 1 and 21’s system and method. Flaherty also teaches further comprising a sensor selected from a blood flow sensor, an electroencephalography (EEG) sensor ([0095] “EEG sensor”), a movement sensor ([0095] “eye movement sensor”), a chemical concentration sensor ([0095] “neurochemical sensor” and/or “blood gas sensor”), or any combination thereof ([0095]“combinations of these”) wherein the sensor is configured for monitoring response of the patient to the electrical stimulation ([0095] “transitioning to the second mode of stimulation can be triggered by an event… detected by sensor 109 or another sensor of system 10”)
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.
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 6-8, 10, 25-28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US20170151436) in view of Nelson et al. (US20120116475) as applied to claims 1 and 21 above.
Regarding claim 6 and 25, Flaherty teaches all of the limitations of claim 1 and 21’s system and method. Flaherty also teaches wherein the increase over time of at least one of the duration or the amplitude comprises increasing the at least one of the daily duration or the amplitude from the initial value to the final value. However, Flaherty fails to disclose an increase according to a non-linear ramp. Nelson discloses this increase according to a non-linear ramp ([0076] “incremental steps in amplitude can be of a fixed size or may vary, e.g., according to an exponential, logarithmic or other algorithmic change”). Flaherty and Nelson are both in the same field of deep brain stimulation and disclose features for the purposes of “shifting the delivery of stimulation signals between two therapy programs” [0076]. It would have been obvious to one having ordinary skill in the at before the effective filing date of the claimed invention to modify Flaherty’s system to adjust stimulation with a non-linear ramp, as taught and suggested by Nelson, with a reasonable expectation of success. This would allow for shifting the delivery of stimulation signals between two therapy programs seamlessly.
Regarding claim 7 and 26, Flaherty teaches all of the limitations of claim 1 and 21’s system and method. However, Flaherty fails to disclose, as taught by Nelson wherein the processor is further configured, during the initial stimulation period, to not deliver the electrical stimulation during periods in which a cognitive load is expected for the patient. ([0101] “processor 40 may control stimulation generator 42 to terminate delivery of electrical stimulation or reduce the magnitude of electrical stimulation delivered when patient 12 is asleep in order to induce a relatively low arousal state of brain 14” where processer deems the user’s cognitive load sufficient for the level of arousal needed)
It would have been obvious to one having ordinary skill in the at before the effective filing date of the claimed invention to modify Flaherty’s system to not overstimulate a patient ramp during when a low cognitive load is desired, as taught and suggested by Nelson, with a reasonable expectation of success. This would allow for shifting the delivery of stimulation signals between two therapy programs seamlessly and “reduce the magnitude of electrical stimulation delivered when patient is asleep in order to induce a relatively low arousal state of brain”[0101].
Regarding claim 8, 27, and 28, Flaherty-Nelson as a combination teaches all of the limitations of claim 7 and 26. Nelson also teaches wherein the processor is further configured to indicate to a user at least one of i) electrical stimulation is being delivered or ii) electrical stimulation is soon to be delivered, ([0062] “Programmer 22 may also provide an indication to patient 12 when therapy is being delivered”) wherein the processor is further configured to provide a control for the user to postpone the delivery of the electrical stimulation and, upon actuation of the control, to postpone the delivery [i.e., adjust therapy parameters] of the electrical stimulation. ([0061] “programmer 22 may allow patient 12 to adjust values for certain therapy parameters or set an available range of values for a particular therapy parameter.” i.e., adjust time delivery parameters). It would have been obvious to one having ordinary skill in the at before the effective filing date of the claimed invention to modify Flaherty’s system to communicate and adjust a stimulation delivery timing, as taught and suggested by Nelson, with a reasonable expectation of success. This control of timed delivery could “reduce the magnitude of electrical stimulation delivered when patient is asleep in order to induce a relatively low arousal state of brain”[0101].
Regarding claim 10 and 30, Flaherty-Nelson teaches all of the limitations of claim 9 and 29’s system and method. Nelson also teaches wherein the processor is configured to monitor alpha wave brain activity of the patient using the EEG or ECoG sensor. ([0051] “monitored bioelectrical brain signals include, but are not limited to, an electroencephalogram (EEG) signal, an electrocorticogram (ECoG) signal”; see also [Table 1] where alpha wave brain signals are measured and stimulated in the patients). It would have been obvious to one having ordinary skill in the at before the effective filing date of the claimed invention to modify Flaherty’s system to explicitly monitor alpha waves using EEG or ECoG, as taught and suggested by Nelson, with a reasonable expectation of success. This “may be used to characterize the arousal state of brain” [0052] and “reduce the magnitude of electrical stimulation delivered when patient is asleep in order to induce a relatively low arousal state of brain”[0101].
Conclusion
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found on PTO-892 of the prior office action.
Hincapie Ordonez et al. (US20110313483) teaches vagus nerve stimulation, that checks whether the stimulation that listens for “evoked responses,” meaning signals that appear after each stimulation pulse if the nerve has been captured.
THIS ACTION IS MADE FINAL. 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 ROBERT ANTHONY SKROBARCZYK whose telephone number is (571)272-3301. The examiner can normally be reached Monday thru Friday 7:30AM -5PM CST.
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/R.A.S/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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