DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 14, and 24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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)(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.
Claim(s) 1-4, 6, 8, 10-17, 19, 21, 23, and 24 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hageman et al (US 2023/0166111) hereinafter Hageman.
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 1 and 14, Hageman discloses a system for closed-loop therapy (Fig. 2), the system comprising:
memory (memory 212) configured to store a first set of one or more parameters for a first set of one or more therapeutic electrical stimulation signals [0121]; and
processing circuitry (processing circuitry 210) coupled to the memory ([0121] Processing circuitry 210 may control stimulation generation circuitry 202 according to therapy programs stored in memory 212) and configured to:
determine one or more local field potential (LFP) measurements of an LFP ([0133] processing circuitry 210 may determine a plurality of LFP measurements of an LFP),
wherein the LFP is of a first signal type that is intrinsically generated by a signal source within a brain of the patient ([0029] the LFP is intrinsically generated by a signal source within the brain of the patient);
cause delivery of one or more electrical stimulation signals ([0184] processing circuitry may control stimulation generation circuitry 202 to deliver a plurality of electrical stimulation signals via the determined one or more electrodes (804));
determine one or more evoked signals that are evoked by delivery of respective ones of the one or more electrical stimulation signals ([0185] For respective ones of the plurality of electrical stimulation signals, the processing circuitry may determine respective evoked signals (806)),
wherein the one or more evoked signals are of a second signal type that is different than the first signal type of the LFP ([0185] processing circuitry may determine respective ERNA signals such as those illustrated in FIGS. 7A and 7B);
determine a second set of one or more parameters for a second set of one or more therapeutic electrical stimulation signals based on the one or more evoked signals having the second signal type and the one or more LFP measurements of the LFP having the first signal type ([0190] processing circuitry may determine at least one parameter for the therapeutic electrical stimulation signal based on the respective evoked signals (808); Examiner notes that the newly determined parameter in step 808 would also be determined based off of the measured LFPs since the electrode configuration used to deliver the stimulation was chosen based off of the measured LFPs),
wherein the second set of one or more parameters are updates to the first set of one or more parameters ([0192] processing circuitry may be configured to determine parameters for the therapeutic electrical stimulation signal based on the determined parameters of the determined electrical stimulation signal); and
cause delivery of the second set of the one or more therapeutic electrical stimulation signals ([0193] processing circuitry may be configured to control stimulation generation circuitry 202 to deliver the therapeutic electrical stimulation signal based on the determined at least one parameter).
Regarding claims 2 and 15, Hageman discloses wherein to determine the one or more LFP measurements, the processing circuitry is configured to determine that there is a change in the LFP measurements ([0183] processing circuitry may be configured to determine an LFP measurement from the plurality of LFP measurements having a highest powered signal, and determine the one or more electrodes based on the LFP), and
wherein to determine the one or more evoked signals, the processing circuitry is configured to determine the one or more evoked signals responsive to the determination that there is the change in the LFP measurements ([0183-0185]] processing circuitry may be configured to determine one or more electrodes based on the LFP measurements (802), control stimulation generation circuitry 202 to deliver a plurality of electrical stimulation signals via the determined one or more electrodes (804), and determine respective evoked signals (806)).
Regarding claims 3 and 16, Hageman discloses wherein the processing circuitry is configured to determine that there is the change in the LFP measurements during an instance where there is no delivery of therapeutic electrical stimulation signals ([0182] ach of the LFP measurements is measured with different electrodes 116, 118 on lead 114A, 114B and the LFP is intrinsically generated by a signal source within brain 120 of patient 122).
Regarding claims 4 and 17, Hageman discloses wherein to determine the one or more LFP measurements, the processing circuitry is configured to determine that there is no change in the LFP measurements for a period of time ([0167] Processing circuitry 210 may set one of the electrodes on lead 506B (e.g., electrode 504A) and determine LFP measurements between respective electrodes 502 at different levels and reference electrode 504A), and
wherein to determine the one or more evoked signals, the processing circuitry is configured to determine the one or more evoked signals responsive to the determination that there is no change in the LFP measurements for the period of time ([0173] processing circuitry 210 may utilize the evoked signals to confirm that the electrodes selected using the LFP measurements are the correct electrodes to use for stimulation).
Regarding claims 6 and 19, Hageman discloses wherein the processing circuitry is configured to determine that the one or more LFP measurements include artifacts [0149], and
wherein to determine the one or more evoked signals, the processing circuitry is configured to determine the one or more evoked signals responsive to the determination that the one or more LFP measurements include artifacts ([0149] processing circuitry 210 may use ERNA signals for determining which electrodes to use for stimulation, and for determining parameters for therapeutic electrical stimulation signals, such as when there is too much noise on the LFP measurements (e.g., due to excessive ECG artifacts)).
Regarding claims 8 and 21, Hageman discloses sensing circuitry configured to sense the one or more LFP measurements during delivery of the first set of the one or more therapeutic electrical stimulation signals ([0159] LFP sensing circuitry 400 may be configured to continuously determine LFP measurements, periodically determine LFP measurements, or determine LFP measurements in accordance with a schedule irrespective of when stimulation generation circuitry 202 is configured to deliver the stimulation).
Regarding claim 10, Hageman discloses an implantable medical device (IMD) (IMD 106), wherein the IMD includes the processing circuitry ([0116] IMD 106 includes processing circuitry 210).
Regarding claim 11, Hageman discloses a programmer (programmer 104), wherein the programmer includes the processing circuitry ([0150] programmer 104 may include processing circuitry 310).
Regarding claim 12, Hageman discloses an implantable medical device (IMD) ([0056] IMD 106) and a programmer ([0056] programmer 104), and wherein the processing circuitry is part of the IMD ([0116] IMD 106 includes processing circuitry 210), the programmer ([0150] programmer 104 may include processing circuitry 310), or both the IMD and the programmer.
Regarding claims 13 and 23, Hageman discloses wherein the one or more evoked signals are one or more evoked resonant neural activity signals ([0078] evoked signals (e.g., evoked potential signals and/or ERNA signals)).
Regarding claim 24, Hageman discloses a non-transitory computer-readable storage medium storing instructions [0116] thereon that when executed cause one or more processors to:
store a first set of one or more parameters for a first set of one or more therapeutic electrical stimulation signals ([0121] therapy programs stored in memory 212);
determine one or more local field potential (LFP) measurements of an LFP ([0133] processing circuitry 210 may determine a plurality of LFP measurements of an LFP),
wherein the LFP is of a first signal type that is intrinsically generated by a signal source within a brain of the patient ([0029] the LFP is intrinsically generated by a signal source within the brain of the patient);
cause delivery of one or more electrical stimulation signals ([0184] processing circuitry may control stimulation generation circuitry 202 to deliver a plurality of electrical stimulation signals via the determined one or more electrodes (804));
determine one or more evoked resonant neural activity (ERNA) signals that are evoked by delivery of respective ones of the one or more electrical stimulation signals ([0185] For respective ones of the plurality of electrical stimulation signals, the processing circuitry may determine respective evoked signals (806); [0078] evoked signals (e.g., evoked potential signals and/or ERNA signals)),
wherein the ERNA signals are of a second type that is different than the first signal type of the LFP ([0185] processing circuitry may determine respective ERNA signals such as those illustrated in FIGS. 7A and 7B);
determine a second set of one or more parameters for a second set of one or more therapeutic electrical stimulation signals based on the one or more evoked signals having the second signal type and the one or more LFP measurements of the LFP having the first signal type ([0190] processing circuitry may determine at least one parameter for the therapeutic electrical stimulation signal based on the respective evoked signals (808); Examiner notes that the newly determined parameter in step 808 would also be determined based off of the measured LFPs since the electrode configuration used to deliver the stimulation was chosen based off of the measured LFPs),
wherein the second set of one or more parameters are updates to the first set of one or more parameters ([0192] processing circuitry may be configured to determine parameters for the therapeutic electrical stimulation signal based on the determined parameters of the determined electrical stimulation signal); and
cause delivery of the second set of the one or more therapeutic electrical stimulation signals ([0193] processing circuitry may be configured to control stimulation generation circuitry 202 to deliver the therapeutic electrical stimulation signal based on the determined at least one parameter).
Allowable Subject Matter
Claims 5, 7, 9, 18, 20, and 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Examiner has not found any prior art that teaches or suggests in combination, the limitations recited in claims 5, 7, 9, 18, 20, and 22.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792