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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/09/2026 has been entered.
Response to Arguments
Applicant’s arguments filed 01/27/2026 have been fully considered but are not persuasive.
Applicant argues, “Referring to Arlotti ([0087]), the IPG device may be further configured to extract the neural activity signal records in a specific frequency band and adapts the set of stimulation parameters based on a linear relationship. That means, the linear relationship is for adapting the stimulation parameters, not for determining whether the subject has abnormal beta band oscillation.”
Examiner respectfully states that under broadest reasonable interpretation, the limitation, “analyze the LFP data to determine presence of abnormal beta band oscillation in real-time”, is interpreted as being directed to a real-time determination of any unusual beta band oscillation, for instance, the beta band oscillation being too high or low. Arlotti teaches that a patient’s neural activity signal records [0044] and are recorded, communicated, and analyzed in real-time [0044], so that stimulation parameters are changed in real-time [0044, 0087]. Further, Arlotti teaches that neural activity signal records with higher beta power values may need higher stimulation amplitudes [0087] due to worse clinical states [0087]. Thus, Arlotti teaches the above recited limitations.
Applicant argues, “Moreover, Arlotti ([0087]) further discloses that such a linear relationship, when quantitatively implemented in the IPG device may require, however, to be calibrated in a patient-specific fashion. Such calibration procedure is not required for determining presence of abnormal beta band oscillation in the technical solution proposed in the present application.”
Examiner respectfully states that the claim does not require determining a presence of abnormal beta band oscillation without such calibration procedure. As stated above, Arlotti teaches the recited limitation.
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, 4-6, 8, 10, 12-16 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arlotti et al. (US 2022/0016415).
In re claim 1, Arlotti discloses closed-loop neurostimulation system ([0012]: continuous implantable neurostimulation system; [0043-0044]) for regulating motor symptoms of a subject ([0095]: treats Parkinson’s symptoms; [0098]), comprising:
one or more neural electrodes [0087] for being implanted [0076, 0087] in a group of deep brain nuclei of the subject ([0105]: left and right subthalamic nucleus are considered part of deep brain nuclei) to
record local filed potential (LFP) signals [0105] generated in the deep brain nuclei [0087, 0104-0105] and
deliver deep brain stimulation (DBS) pulses to the deep brain nuclei [0104-0105]; and
a closed-loop stimulation generator ([0044]: stimulation parameters are adapted in real-time for efficient adaptive deep brain stimulation; [0012]) in communication with the neural electrodes [0087] and including:
a data acquisition unit (fig. 1: combination of processor 102, memory 103 and electrodes [0087]) in communication with the neural electrodes ([0049]: receives neural activity signals; [0087]: neural activity signals recorded from electrodes; [0020]) and configured to:
receive the LFP signals transmitted from the neural electrodes [0087]; and
convert the LFP signals to LFP data [0087];
a processing unit ([0049]: part of processor 102 which processes neural activity signal records; (102)) in communication with the data acquisition unit (fig. 1; [0047]) and configured to:
receive the LFP data from the data acquisition unit [0047, 0049];
analyze the LFP data to determine presence of abnormal beta band oscillation ([0087]: linear correlation between beta band oscillation and worse clinical states i.e. high beta band oscillations are abnormal) in real-time ([0044]: real-time analysis of neural activity signal records; [0087]: stimulation parameters are changed in real-time, such as increasing stimulation amplitudes based on real-time presence of abnormal beta band oscillation); and
generate a DBS signal upon determining presence of abnormal beta band oscillation ([0087]: higher beta band oscillations require higher stimulation amplitudes; [0047]); and
a pulse generation unit ([0047]: part of implantable device which provides DBS via probe extensions i.e. the electrodes [0087]; [0089]) in communication with
the processing unit [0047, 0049] and
the neural electrodes [0047, 0087] and
configured to:
receive the DBS signal from the processing unit [0047, 0049, 0087]; and
generate, in response to the DBS signal, the DBS pulses to the deep brain nuclei through the neural electrodes [0049, 0087];
wherein the processing unit is further configured to:
calculate an averaged LFP power ([0017]: second average value of spectral features within frequency band is calculated; [0021]: second average include maximum beta frequency band power) based on the received LFP data ([0088]: IPG modifies stimulation based on LFP i.e. neural activity signals);
compare the averaged LFP power against a reference LFP power ([0087]: linear relationship i.e. a reference LFP power is determined so that the higher the averaged LFP measured, the higher the stimulation amplitude will be); and
determine that the subject has abnormal beta band oscillation if the average beta band LPF power is higher than the reference LFP power ([0087]: higher beta power values imply worse clinical states and will need higher stimulation amplitudes, therefore, any high beta band oscillation will be considered abnormal beta band oscillation when compared to normal beta band oscillations).
In re claim 4, Arlotti discloses wherein the averaged LFP power is calculated from a beta band LFP power spectrum in a range from 13 to 40 Hz [0088].
In re claim 5, Arlotti discloses wherein the averaged LFP power is calculated from a low beta band LFP power spectrum in a range from 13 to 20 Hz [0088].
In re claim 6, Arlotti discloses wherein the averaged LFP power is calculated from a low beta band LFP power spectrum in a range from 20 to 40 Hz [0088].
In re claim 8, Arlotti discloses wherein the neural electrodes communicate with the processing unit via a wired network ([0071]: probes 302 have probe extension 304 and are connected to IPG 314; fig. 3A: 302).
In re claim 10, Arlotti discloses wherein the data acquisition unit comprises a local memory (fig. 1: memory 103 is part of implantable device 101; [0050]) for storing [0047-0050] and queuing up the packaged LFP data [0047-0050, 0086].
In re claim 12, Arlotti discloses a method [0002, 0012] for regulating motor symptoms of a subject [0095], comprising:
implanting one or more neural electrodes in a group of deep brain nuclei of the subject (see in re claim 1 above);
sensing, by the neural electrodes, local filed potential (LFP) signals generated in the deep brain nuclei of the subject (see in re claim 1 above);
acquiring and converting, by a data acquisition unit, the detected LFP signals to LFP data; (see in re claim 1 above)
packaging, by the data acquisition unit, the LFP data into data packets ([0047]: implantable device 101 records set of neural activity signal records);
queueing, by the data acquisition unit, the data packets in a memory (fig. 1: memory is either 103 or 113; [0047]: neural activity signal records are stored in the memory; [0049-0051]);
receiving, by a processing unit, the queued data packets from the memory ([0047-0049]: memory contains code to cause processor to retrieve the neural activity signal records);
unpacking, by the processing unit, the data packets to retrieve the LFP data ([0049]: implantable device retrieves the LFP data i.e. the neural activity signal records that were stored; [0047]);
Regarding the limitations,
“analyzing, by the processing unit, the retrieved LFP data to determine presence of abnormal beta band oscillation;
commanding, by the processing unit, a pulse generation unit to generate DBS pulses to the neural electrodes upon presence of abnormal beta band oscillation; and
applying, by the neural electrodes, deep brain stimulation (DBS) pulses to the deep brain nuclei of the subject;
wherein the retrieved LFP data is analyzed to determine presence of abnormal beta band oscillation in real-time by:
calculating an averaged LFP power based on the received LFP data;
comparing the averaged LFP power against a reference LFP power; and
determining that the subject has abnormal beta band oscillation if the average beta band LPF power is higher than the reference LFP power,”
see in re claim 1 above.
In re claim 14, regarding the limitation “wherein the averaged LFP power is calculated from a beta band LFP power spectrum in a range from 13 to 40 Hz”, see in re claim 4 above.
In re claim 15, regarding the limitation “wherein the averaged LFP power is calculated from a low beta band LFP power spectrum in a range from 13 to 20 Hz”, see in re claim 5 above.
In re claim 16, regarding the limitation “wherein the averaged LFP power is calculated from a low beta band LFP power spectrum in a range from 20 to 40 Hz”, see in re claim 6 above.
In re claim 18, Arlotti discloses wherein the memory a local storage in the data acquisition unit (fig. 1: memory 103 is part of implantable device 101; [0050]).
In re claim 19, Arlotti discloses wherein the memory is a remote data-store (fig. 1: memory 133 is part of programmer device 133 i.e. a remote data-store; [0056]).
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.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Arlotti et al. (US 2022/0016415) in view of Jackson et al. (US 2022/0266033).
In re claim 2, Arlotti fails to disclose wherein the processing unit is implemented with a field-programmable gate array.
Jackson teaches a system for providing deep brain electrical stimulation therapy [0029] and teaches wherein a processing unit (fig. 2: 210) includes a field-programmable gate array [0066].
Jackson further teaches that the processing unit may comprise of several processing circuitry, such as the field-programmable gate array [0066].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the closed-loop neurostimulation system taught by Arlotti, to provide wherein the processing unit is implemented with a field-programmable gate array, as taught by Jackson, because the processing unit may comprise of several processing circuitry, such as the field-programmable gate array.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Arlotti et al. (US 2022/0016415) in view of Nambu et al. (US 2015/0223718).
In re claim 11, Arlotti fails to disclose wherein the group of deep brain nuclei is Putamen.
Nambu teaches a system for applying electrical stimulation to a brain site [0056-0058] and teaches
providing stimulation to deep brain nuclei [0111],
wherein the group of deep brain nuclei is Putamen [0111].
Nambu further teaches that stimulation may be provided to various sites [0111] such as the Putamen, which is used to effectively treat basal ganglia dysfunctions such as Parkinson’s disease [0111].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the closed-loop neurostimulation system taught by Arlotti, to provide wherein the group of deep brain nuclei is Putamen, as taught by Nambu, because stimulation may be provided to various sites such as the Putamen, which is used to effectively treat basal ganglia dysfunctions such as Parkinson’s disease.
Claims 7, 9, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Arlotti et al. (US 2022/0016415) in view of Ma et al. (US 2020/0406031).
In re claim 7, Arlotti fails to disclose wherein the neural electrodes communicate with the processing unit via a wireless network.
Ma teaches a neurostimulation system [0055] and teaches wherein neural electrodes (fig. 1: 104) communicate with a processing unit (108) via a wireless network [0075].
Ma further teaches that the processor may be in wired or wireless communication with the neural electrode [0075].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the closed-loop neurostimulation system taught by Arlotti, to provide wherein the neural electrodes communicate with the processing unit via a wireless network, as taught by Ma, because the processor may be in wired or wireless communication with the neural electrode.
In re claim 9, Arlotti discloses wherein the data acquisition unit is further configured to
package the LFP data ([0047]: implantable device 101 records set of neural activity signal records) and
transmitted packaged LFP data the processing unit ([0047-0050]: processor receives packaged LFP data from the memory).
Arlotti fails to disclose wherein the data acquisition unit is further configured to package the LFP data using user datagram protocol (UDP)…
Ma teaches a data acquisition unit (106) that packages EMG signal [0102] using datagram protocol ([0102]: UDP).
Ma further teaches that using UPD allows for signals to be streamed to a processor at 100Hz [0102] so that the EMG signal can be analyzed and delivered as a DBS signal [0102].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the closed-loop neurostimulation system taught by Arlotti, to provide wherein the data acquisition unit is further configured to package the LFP data using user datagram protocol (UDP), as taught by the EMG signal in Ma, because using UPD allows for signals to be streamed to a processor at 100Hz so that the signal can be analyzed and delivered as a DBS signal.
In re claim 20, regarding the limitation “wherein the group of deep brain nuclei is Putamen”, see in re claim 11 above.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Arlotti et al. (US 2022/0016415) in view of Dzirasa et al. (US 2019/0143119).
In re claim 17, Arlotti fails to disclose wherein the LFP data are packaged in real-time using a sliding window method.
Dzirasa teaches a system [0061] that provides stimuli to a brain region [0061] and teaches wherein LFP data [0059] are packaged in real-time [0245] using a sliding window method [0245].
Dzirasa further teaches that the sliding window is updated in real time every 15 milliseconds [0245] and allows for various inflection points in the LFP to be extracted [0245].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the closed-loop neurostimulation system taught by Arlotti, to provide wherein the LFP data are packaged in real-time using a sliding window method, as taught by Dzirasa, because the sliding window is updated in real time every 15 milliseconds and allows for various inflection points in the LFP to be extracted.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Schnell et al. (US 2021/0196964) discloses sensing LFP signals [0045] in real-time [0162-0163, 0181], wherein an abnormal beta magnitude of a patient ([0115]: beta magnitude is abnormal when it falls below a lower bound) is used to adjust stimulation magnitude accordingly [0115].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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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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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796