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 Amendment
This Office Action is responsive to the amendment filed on 15 May 2026. As directed by the amendment: claims 1, 4, 9-10, 13, 16, 21-22, and 25 have been amended, no claims have been canceled, and no claims have been added. Thus, claims 1-25 are presently pending in this application.
Response to Arguments
Claim Objections
Applicant’s arguments, see Remarks, filed 14 May 2026, with respect to the objections to the claims have been fully considered and are persuasive in light of the claim amendments. The objections to the claims have been withdrawn.
However, new objections are made below, as necessitated by the claim amendments.
§ 112 Rejection
Applicant’s arguments, see Remarks, filed 14 May 2026, with respect to the rejections of the claims under 35 U.S.C. 112 have been fully considered and are persuasive in light of the claim amendments. The rejections of the claims under 35 U.S.C. 112 have been withdrawn.
§ 102 Rejection
Applicant’s arguments, see Remarks, filed 14 May 2026, with respect to the rejections of claims 1, 13, and 25 under 35 U.S.C. 102 have been fully considered and are persuasive in light of the claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Baker et al. (US 20250025698 A1, previously cited), hereinafter Baker, and Acerbo et al. (US 20240399143 A1), hereinafter Acerbo, as explained in further detail below.
Claim Objections
Claims 1, 13, and 25 are objected to because of the following informalities:
Claim 1: the semicolon after “wherein” in line 20 should be replaced with a colon
Claim 13: the semicolon after “wherein” on page 6, line 7 should be replaced with a colon
Claim 25: the semicolon after “wherein” in line 22 should be replaced with a colon
Appropriate correction is required.
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.
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.
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, 3-13, and 15-25 are rejected under 35 U.S.C. 103 as being unpatentable over Baker et al. (US 20250025698 A1, previously cited), hereinafter Baker, in view of Acerbo et al. (US 20240399143 A1), hereinafter Acerbo.
Regarding claim 1, Baker discloses a method comprising:
accessing subject data of the subject (Fig. 4B, paragraph [0056], "step 42 may include obtaining data related to the one or more tasks");
determining a predicted condition for the subject based on the subject data (paragraph [0056], medical condition of the patient);
sending, to a user device of a subject (Fig. 1, paragraph [0034], input output device 19), first software code that is configured to present, at a user interface of the user device, one or more tasks to be performed by the subject using the user device (paragraph [0057], "the system 10, the controller 12, and/or the like may output the instruction related to the one or more tasks (e.g., motor tasks, vocal tasks, cognitive tasks, and/or the like) by the one or more input output devices 19, an audio output device, a video device and/or the like"), wherein the one or more tasks are based on the predicted condition (Fig. 4B, paragraph [0056], "the one or more motor tasks may be chosen from predefined listing of motor tasks based on the medical condition of the patient");
obtaining, based on the tasks performed by the subject, information regarding an instantaneous user characteristic of the subject with respect to the predicted condition (Fig. 4B, paragraph [0058], step 44);
sending, to a base station (Fig. 1, paragraph [0030], controller 12) that is communicatively coupled to one or more implantable devices implanted in one or more regions of the subject (Fig. 1, paragraph [0030], neurostimulator 14), based on the instantaneous user characteristic of the subject, second software code (Fig. 4B, paragraph [0061], step 48), wherein:
the second software code includes an instruction to cause the one or more implantable devices to execute a set of stimulation protocols of a plurality of stimulation protocols (Fig. 4B, paragraph [0061], step 48, determines whether to apply DBS), and
the one or more implantable devices are configured to generate an electrical signal, according to the set of stimulation protocols, to stimulate the one or more regions of the subject (paragraph [0042], "The system 10 may be used to configure a DBS system 200 to stimulate a cerebellar pathway connecting to a brainstem, a diencephalon, a cerebrum, or other location in the brain of a patient to treat a neurological disorder in the patient");
the set of stimulation protocols are configured such that the electrical signals stimulate the one or more regions of the subject (paragraph [0042], "The system 10 may be used to configure a DBS system 200 to stimulate a cerebellar pathway connecting to a brainstem, a diencephalon, a cerebrum, or other location in the brain of a patient to treat a neurological disorder in the patient"; paragraph [0043], "The DBS system 200 may include one or more implanted DBS electrodes 15 that may be placed in areas of the brain of the patient");
receiving, from the user device and the base station, a communication that represents one or more inputs (paragraph [0046], "The receiver 26 may receive data from the internal portion 13, the external portion 16, the task component 18, the one or more input output devices 19 and/or the like. The receiver 26 may receive signals from the internal portion 13 and the external portion 16 that include internal data (e.g., electrophysiology data) and external data (e.g., EEG data). In some instances, the receiver 26 may also receive data from the task component 18, such as information related to one or more mechanical properties of performing a task that the user has been instructed to perform. In some aspects, the one or more input output devices 19 may receive input from the clinician such as limits, constraints, and/or the like for operation of the controller 12"; Fig. 4B, paragraph [0060], step 44, "neurophysiology activity data may be received by the data acquisition platform"), wherein:
the one or more inputs were detected at the user interface while or after the electrical signal was applied to the subject (paragraph [0058], "internal data (e.g., electrophysiology data used in Step 44) and/or external data (e.g., electroencephalography (EEG) data used in Step 46) can be recorded by appropriate electrodes and received (by controller 12) ... the task component 18 of FIG. 1 that can also record data related to the motor task"; paragraph [0031], "the received data may include data received in response to a patient performing a motor task with a task component 18"), and
the one or more inputs indicate a degree to which the instantaneous user characteristic is affected while or after the electrical signal was applied to the subject (paragraph [0056], "step 42 may include obtaining data relating to evaluation of how stimulation impacts spontaneous neural data as a distinct option from task-related changes");
the communication includes performance information associated with the one or more inputs received at the user interface corresponding to the one or more tasks (paragraph [0056], "step 42 may include obtaining data related to the one or more tasks. ... step 42 may include obtaining behavior data. This data may be received from one or more devices and/or from the clinician through the one or more input output devices 19"; paragraph [0058], "the task (e.g., motor task, vocal task, cognitive task, and/or the like) can be aided by the task component 18 of FIG. 1 that can also record data related to the motor task"), and
the performance information represents a performance on the one or more tasks performed by the subject on the user interface (paragraph [0041], "the task component 18 may provide a mechanical or digitized measurement of movement and may include a dynameter, a digital plate, articulated lever, a robotic arm, other mechanical measurement device, a digitized measurement device. This measurement of movement may include, for example, displacement/velocity/acceleration of an extremity or body part, dexterity, strength, resistance (rigidity or spasticity), electromyography, etc., of an extremity or body part. In certain aspects, the task component 18 may measure the movement and provide data regarding the movement to the system 10, the controller 12, and/or the like");
determining a treatment recommendation for the subject based on the communication (paragraph [0065], "the algorithm may utilize any of the input signals to determine how to apply the DBS by the DBS system 200. In other words, the stimulation parameters for application of the DBS by the DBS system 200"); and
outputting the treatment recommendation for the subject (paragraph [0035], "The one or more input output devices 19 can be configured to provide outputs from the system 10, the DBS system 200, the controller 12, and/or the like via a graphical user interface, including visual information"; paragraph [0047]).
Baker does not explicitly disclose that the electrical signals constructively interfere with each other.
However, Acerbo teaches a deep brain stimulation system (Abstract) wherein the set of stimulation protocols are configured such that the electrical signals constructively interfere with each other to stimulate the one or more regions of the subject (paragraph [0061], "FIG. 4 shows the creation of envelopes by signals interfering constructively"; paragraph [0084], "In order to avoid to modulate unwanted nodes in the brains or neighboring nerves in the case of peripheral nerve stimulation, the number of stimulating pairs is increased to improve the focality of stimulation, namely the ability to modulate a targeted area without disturbing the surrounding area").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baker with the teachings of Acerbo so that the set of stimulation protocols are configured such that the electrical signals constructively interfere with each other to stimulate the one or more regions of the subject, because doing so targets smaller points in space, reduces the necessary applied current from individual stimulation electrodes, and evokes activity at depth with lower applied electric fields compared to conventional DBS (Acerbo, paragraph [0020]).
Regarding claim 3, the method of claim 1 is obvious over Baker and Acerbo, as explained above. Baker further discloses that the base station includes:
a magnetic field generator (paragraph [0039], "the controller 12 may communicate with the neurostimulator 14 that is implanted in an internal portion 13 to the patient's body according to a near field wireless communication means"); and
a magnetic transceiver (paragraph [0093], Bluetooth).
Regarding claim 4, the method of claim 1 is obvious over Baker and Acerbo, as explained above. Baker further discloses:
receiving an additional communication from one or more sensors that are physically or wirelessly connected to the base station (paragraph [0041], "the task component 18 may provide a mechanical or digitized measurement of movement and may include a dynameter, a digital plate, articulated lever, a robotic arm, other mechanical measurement device, a digitized measurement device. ... the task component 18 may measure the movement and provide data regarding the movement to the system 10, the controller 12, and/or the like"; paragraph [0049], "The at least one peripheral signal 33 may include, but is not limited to, an output from an electromyography (EMG), a single or multi-unit activity, a heart rate, a heart rate variability, a muscle response, measure of speech performance, such as phonation, gait kinematics, and/or any other physiological aspect of the patient"), or from the one or more implantable devices (paragraph [0030], "The controller 12 may be configured to receive data from an internal portion 13 of the patient. In certain aspects, the data from the internal portion 13 may be obtained and/or recorded by the one or more DBS electrodes 15. The controller 12 may be configured to receive data from a neurostimulator 14. The neurostimulator 14 may be internal to the body of a patient and/or external to the body of the patient") during an execution of the first software code and the second software code (paragraph [0046], "The receiver 26 may receive signals from the internal portion 13 and the external portion 16 that include internal data (e.g., electrophysiology data) and external data (e.g., EEG data). In some instances, the receiver 26 may also receive data from the task component 18, such as information related to one or more mechanical properties of performing a task that the user has been instructed to perform"; paragraph [0063], "The algorithm may be trained to identify criteria that reflect any other relevant benchmark from the input signals for applying the DBS, such as a frequency, phase, or single-unit or multi-unit activity of the input neural or peripheral signal"); and
determining the treatment recommendation for the subject based on the additional communication (paragraph [0061], "The processed signals and their assigned weights may be input into a trained algorithm to determine the outcome of whether to apply the DBS, whether not apply the DBS, when to apply the DBS, and/or how to apply the DBS in step 48").
Regarding claim 5, the method of claim 1 is obvious over Baker and Acerbo, as explained above. Baker further discloses:
generating, by the base station, an additional communication by recording one or more stimulation times at which the one or more implantable devices deliver the electrical signal to the one or more regions (paragraph [0066], "the algorithm may determine the timing of when to apply the DBS relative to a specific neural signal, relative to a specific motor task, vocal task, or cognitive task, relative to a pulse wave, relative to a recent DBS application, and the like");
predicting, based on the communication and the additional communication, whether or the degree to which the set of implant stimulation protocols are resulting in a target effect for the instantaneous user characteristic (paragraphs [0063]-[0065], "The algorithm may be trained to identify criteria that reflect any other relevant benchmark from the input signals for applying the DBS, such as a frequency, phase, or single-unit or multi-unit activity of the input neural or peripheral signal. ... The algorithm may also be trained using a sample dataset from a single patient to differentiate relevant biomarker benchmarks (i.e., whether a patient's eyes are open or closed, whether a patient is awake or asleep, etc.) to determine criteria as to whether to apply the DBS, when to apply the DBS, and/or how to apply the DBS. ... the algorithm may utilize any of the input signals to determine how to apply the DBS by the DBS system 200. In other words, the stimulation parameters for application of the DBS by the DBS system 200"); and
modifying the second software code based on the prediction (paragraph [0052], "the system 10, the controller 12, the signal processing 35, and/or the like may generate stimulation parameters 38. Thereafter, the system 10 will proceed by applying the DBS 39 based on the stimulation parameters 38").
Regarding claim 6, the method of claim 5 is obvious over Baker and Acerbo, as explained above. Baker further discloses that modifying the second software code includes:
determining a subset of the one or more implantable devices that are associated with delivering the electrical signal that results in the target effect (paragraph [0055], "an initial monopolar review (or electrical stimulation) can occur to determine any electrode(s) and/or stimulation parameters that cause undesirable side effects"); and
modifying the second software code to cause the subset of the one or more implantable devices to deliver the electrical signal while remaining implantable devices are inactive (paragraph [0055], "These electrode(s) and/or stimulation patterns may be excluded from the further steps of the closed-loop deep brain stimulation method 40").
Regarding claim 7, the method of claim 1 is obvious over Baker and Acerbo, as explained above. Baker further discloses:
generating, by the base station, an additional communication by recording one or more stimulation times at which the one or more implantable devices deliver the electrical signal to the one or more regions (paragraph [0066], "the algorithm may determine the timing of when to apply the DBS relative to a specific neural signal, relative to a specific motor task, vocal task, or cognitive task, relative to a pulse wave, relative to a recent DBS application, and the like");
predicting, based on the communication and the additional communication, whether or the degree to which the set of implant stimulation protocols are resulting in a target effect for the instantaneous user characteristic (paragraphs [0063]-[0065], "The algorithm may be trained to identify criteria that reflect any other relevant benchmark from the input signals for applying the DBS, such as a frequency, phase, or single-unit or multi-unit activity of the input neural or peripheral signal. ... The algorithm may also be trained using a sample dataset from a single patient to differentiate relevant biomarker benchmarks (i.e., whether a patient's eyes are open or closed, whether a patient is awake or asleep, etc.) to determine criteria as to whether to apply the DBS, when to apply the DBS, and/or how to apply the DBS. ... the algorithm may utilize any of the input signals to determine how to apply the DBS by the DBS system 200. In other words, the stimulation parameters for application of the DBS by the DBS system 200"); and
determining the treatment recommendation based on the prediction (paragraph [0061], "The processed signals and their assigned weights may be input into a trained algorithm to determine the outcome of whether to apply the DBS, whether not apply the DBS, when to apply the DBS, and/or how to apply the DBS in step 48").
Regarding claim 8, the method of claim 1 is obvious over Baker and Acerbo, as explained above. Baker further discloses that determining the treatment recommendation includes:
generating, by the base station, an additional communication by recording one or more stimulation times at which the one or more implantable devices deliver the electrical signal to the one or more regions (paragraph [0066], "the algorithm may determine the timing of when to apply the DBS relative to a specific neural signal, relative to a specific motor task, vocal task, or cognitive task, relative to a pulse wave, relative to a recent DBS application, and the like");
determining, based on the communication and the additional communication, a subset of the one or more implantable devices that are associated with delivering the electrical signal that results in a target effect for the instantaneous user characteristic (paragraph [0055], "an initial monopolar review (or electrical stimulation) can occur to determine any electrode(s) and/or stimulation parameters that cause undesirable side effects"); and
generating the treatment recommendation to cause the subset of the one or more implantable devices to deliver the electrical signal while remaining implantable devices are inactive (paragraph [0055], "These electrode(s) and/or stimulation patterns may be excluded from the further steps of the closed-loop deep brain stimulation method 40").
Regarding claim 9, the method of claim 1 is obvious over Baker and Acerbo, as explained above. Baker further discloses:
selecting the first software code and the second software code based on the predicted condition (Fig. 4B, paragraph [0056], "the one or more motor tasks may be chosen from predefined listing of motor tasks based on the medical condition of the patient"; paragraph [0066], "the algorithm may determine the timing of when to apply the DBS relative to a specific neural signal, relative to a specific motor task, vocal task, or cognitive task, relative to a pulse wave, relative to a recent DBS application, and the like").
Regarding claim 10, the method of claim 1 is obvious over Baker and Acerbo, as explained above. Baker further discloses:
receiving an additional communication from a facial recognition device during the execution of the first software code and the second software code (paragraph [0025], "Analysis of a patient's...mood (measured by autonomic indicators, facial features or other measures)...may indicate time points when the patient's brain is most receptive to rehabilitative efforts"); and
determining the treatment recommendation for the subject based on the additional communication (paragraph [0025], "Examples include adjusting the timing of stimulation relative to phases of motor planning, adjusting the timing of stimulation relative to phases of motor execution, and/or adjusting the timing of recordings of neural activity").
Regarding claim 11, the method of claim 1 is obvious over Baker and Acerbo, as explained above. Baker further discloses that determining the treatment recommendation includes inputting the communication into a machine-learning model (paragraph [0062], "The algorithm may be implemented with artificial intelligence"; paragraph [0097], "artificial intelligence and/or machine learning").
Regarding claim 12, the method of claim 1 is obvious over Baker and Acerbo, as explained above. Baker further discloses that the treatment recommendation comprises a modification to an amplitude, a frequency, and/or a timing of the electrical signal delivered by the one or more implantable devices (paragraph [0024], "Examples of the stimulation parameters may include, but are not limited to, an amplitude, a pulse width, a frequency or frequencies, a burst rate, a burst count, a phase orientation, a voltage, a current, an on time period, an off time period, a number of pulses, and/or any combination thereof"; paragraph [0025], "Examples include adjusting the timing of stimulation relative to phases of motor planning, adjusting the timing of stimulation relative to phases of motor execution, and/or adjusting the timing of recordings of neural activity").
Regarding claim 13, Baker discloses a system comprising:
one or more data processors (Fig. 2, paragraph [0047], processor 24); and
a non-transitory computer readable storage medium containing instructions which, when executed on the one or more data processors, cause the one or more data processors to perform a set of actions (Fig. 2, paragraph [0045], memory 22) including:
accessing subject data of the subject (Fig. 4B, paragraph [0056], "step 42 may include obtaining data related to the one or more tasks");
determining a predicted condition for the subject based on the subject data (paragraph [0056], medical condition of the patient);
sending, to a user device of a subject (Fig. 1, paragraph [0034], input output device 19), first software code that is configured to present, at a user interface of the user device, one or more tasks to be performed by the subject using the user device (paragraph [0057], "the system 10, the controller 12, and/or the like may output the instruction related to the one or more tasks (e.g., motor tasks, vocal tasks, cognitive tasks, and/or the like) by the one or more input output devices 19, an audio output device, a video device and/or the like"), wherein the one or more tasks are based on the predicted condition (Fig. 4B, paragraph [0056], "the one or more motor tasks may be chosen from predefined listing of motor tasks based on the medical condition of the patient");
obtaining, based on the tasks performed by the subject, information regarding an instantaneous user characteristic of the subject with respect to the predicted condition (Fig. 4B, paragraph [0058], step 44);
sending, to a base station (Fig. 1, paragraph [0030], controller 12) that is communicatively coupled to one or more implantable devices implanted in one or more regions of the subject (Fig. 1, paragraph [0030], neurostimulator 14), based on the instantaneous user characteristic of the subject, second software code (Fig. 4B, paragraph [0061], step 48), wherein:
the second software code includes an instruction to cause the one or more implantable devices to execute a set of stimulation protocols of a plurality of stimulation protocols (Fig. 4B, paragraph [0061], step 48, determines whether to apply DBS), and
the one or more implantable devices are configured to generate an electrical signal, according to the set of stimulation protocols, to stimulate the one or more regions of the subject (paragraph [0042], "The system 10 may be used to configure a DBS system 200 to stimulate a cerebellar pathway connecting to a brainstem, a diencephalon, a cerebrum, or other location in the brain of a patient to treat a neurological disorder in the patient");
the set of stimulation protocols are configured such that the electrical signals stimulate the one or more regions of the subject (paragraph [0042], "The system 10 may be used to configure a DBS system 200 to stimulate a cerebellar pathway connecting to a brainstem, a diencephalon, a cerebrum, or other location in the brain of a patient to treat a neurological disorder in the patient"; paragraph [0043], "The DBS system 200 may include one or more implanted DBS electrodes 15 that may be placed in areas of the brain of the patient");
receiving, from the user device and the base station, a communication that represents one or more inputs (Fig. 4B, paragraph [0060], step 44, "neurophysiology activity data may be received by the data acquisition platform"), wherein:
the one or more inputs were detected at the user interface while or after the electrical signal was applied to the subject (paragraph [0058], "internal data (e.g., electrophysiology data used in Step 44) and/or external data (e.g., electroencephalography (EEG) data used in Step 46) can be recorded by appropriate electrodes and received (by controller 12) ... the task component 18 of FIG. 1 that can also record data related to the motor task"; paragraph [0031], "the received data may include data received in response to a patient performing a motor task with a task component 18"),
the one or more inputs indicate a degree to which the instantaneous user characteristic is affected while or after the electrical signal was applied to the subject (paragraph [0056], "step 42 may include obtaining data relating to evaluation of how stimulation impacts spontaneous neural data as a distinct option from task-related changes"),
the communication includes performance information associated with the one or more inputs received at the user interface corresponding to the one or more tasks (paragraph [0056], "step 42 may include obtaining data related to the one or more tasks. ... step 42 may include obtaining behavior data. This data may be received from one or more devices and/or from the clinician through the one or more input output devices 19"; paragraph [0058], "the task (e.g., motor task, vocal task, cognitive task, and/or the like) can be aided by the task component 18 of FIG. 1 that can also record data related to the motor task"), and
the performance information represents a performance on the one or more tasks performed by the subject on the user interface (paragraph [0041], "the task component 18 may provide a mechanical or digitized measurement of movement and may include a dynameter, a digital plate, articulated lever, a robotic arm, other mechanical measurement device, a digitized measurement device. This measurement of movement may include, for example, displacement/velocity/acceleration of an extremity or body part, dexterity, strength, resistance (rigidity or spasticity), electromyography, etc., of an extremity or body part. In certain aspects, the task component 18 may measure the movement and provide data regarding the movement to the system 10, the controller 12, and/or the like");
determining a treatment recommendation for the subject based on the communication (paragraph [0065], "the algorithm may utilize any of the input signals to determine how to apply the DBS by the DBS system 200. In other words, the stimulation parameters for application of the DBS by the DBS system 200"); and
outputting the treatment recommendation for the subject (paragraph [0035], "The one or more input output devices 19 can be configured to provide outputs from the system 10, the DBS system 200, the controller 12, and/or the like via a graphical user interface, including visual information."; paragraph [0047]).
Baker does not explicitly disclose that the electrical signals constructively interfere with each other.
However, Acerbo teaches a deep brain stimulation system (Abstract) wherein the set of stimulation protocols are configured such that the electrical signals constructively interfere with each other to stimulate the one or more regions of the subject (paragraph [0061], "FIG. 4 shows the creation of envelopes by signals interfering constructively"; paragraph [0084], "In order to avoid to modulate unwanted nodes in the brains or neighboring nerves in the case of peripheral nerve stimulation, the number of stimulating pairs is increased to improve the focality of stimulation, namely the ability to modulate a targeted area without disturbing the surrounding area").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baker with the teachings of Acerbo so that the set of stimulation protocols are configured such that the electrical signals constructively interfere with each other to stimulate the one or more regions of the subject, because doing so targets smaller points in space, reduces the necessary applied current from individual stimulation electrodes, and evokes activity at depth with lower applied electric fields compared to conventional DBS (Acerbo, paragraph [0020]).
Regarding claim 15, the system of claim 13 is obvious over Baker and Acerbo, as explained above. Baker further discloses that the base station includes:
a magnetic field generator (paragraph [0039], "the controller 12 may communicate with the neurostimulator 14 that is implanted in an internal portion 13 to the patient's body according to a near field wireless communication means"); and
a magnetic transceiver (paragraph [0093], Bluetooth).
Regarding claim 16, the system of claim 13 is obvious over Baker and Acerbo, as explained above. Baker further discloses that the set of actions further includes:
receiving an additional communication from one or more sensors that are physically or wirelessly connected to the base station (paragraph [0041], "the task component 18 may provide a mechanical or digitized measurement of movement and may include a dynameter, a digital plate, articulated lever, a robotic arm, other mechanical measurement device, a digitized measurement device. ... the task component 18 may measure the movement and provide data regarding the movement to the system 10, the controller 12, and/or the like"; paragraph [0049], "The at least one peripheral signal 33 may include, but is not limited to, an output from an electromyography (EMG), a single or multi-unit activity, a heart rate, a heart rate variability, a muscle response, measure of speech performance, such as phonation, gait kinematics, and/or any other physiological aspect of the patient"), or from the one or more implantable devices (paragraph [0030], "The controller 12 may be configured to receive data from an internal portion 13 of the patient. In certain aspects, the data from the internal portion 13 may be obtained and/or recorded by the one or more DBS electrodes 15. The controller 12 may be configured to receive data from a neurostimulator 14. The neurostimulator 14 may be internal to the body of a patient and/or external to the body of the patient") during an execution of the first software code and the second software code (paragraph [0046], "The receiver 26 may receive signals from the internal portion 13 and the external portion 16 that include internal data (e.g., electrophysiology data) and external data (e.g., EEG data). In some instances, the receiver 26 may also receive data from the task component 18, such as information related to one or more mechanical properties of performing a task that the user has been instructed to perform"; paragraph [0063], "The algorithm may be trained to identify criteria that reflect any other relevant benchmark from the input signals for applying the DBS, such as a frequency, phase, or single-unit or multi-unit activity of the input neural or peripheral signal"); and
determining the treatment recommendation for the subject based on the additional communication (paragraph [0061], "The processed signals and their assigned weights may be input into a trained algorithm to determine the outcome of whether to apply the DBS, whether not apply the DBS, when to apply the DBS, and/or how to apply the DBS in step 48").
Regarding claim 17, the system of claim 13 is obvious over Baker and Acerbo, as explained above. Baker further discloses that the set of actions further includes:
generating, by the base station, an additional communication by recording one or more stimulation times at which the one or more implantable devices deliver the electrical signal to the one or more regions (paragraph [0066], "the algorithm may determine the timing of when to apply the DBS relative to a specific neural signal, relative to a specific motor task, vocal task, or cognitive task, relative to a pulse wave, relative to a recent DBS application, and the like");
predicting, based on the communication and the additional communication, whether or the degree to which the set of implant stimulation protocols are resulting in a target effect for the instantaneous user characteristic (paragraphs [0063]-[0065], "The algorithm may be trained to identify criteria that reflect any other relevant benchmark from the input signals for applying the DBS, such as a frequency, phase, or single-unit or multi-unit activity of the input neural or peripheral signal. ... The algorithm may also be trained using a sample dataset from a single patient to differentiate relevant biomarker benchmarks (i.e., whether a patient's eyes are open or closed, whether a patient is awake or asleep, etc.) to determine criteria as to whether to apply the DBS, when to apply the DBS, and/or how to apply the DBS. ... the algorithm may utilize any of the input signals to determine how to apply the DBS by the DBS system 200. In other words, the stimulation parameters for application of the DBS by the DBS system 200"); and
modifying the second software code based on the prediction (paragraph [0052], "the system 10, the controller 12, the signal processing 35, and/or the like may generate stimulation parameters 38. Thereafter, the system 10 will proceed by applying the DBS 39 based on the stimulation parameters 38").
Regarding claim 18, the system of claim 17 is obvious over Baker and Acerbo, as explained above. Baker further discloses that modifying the second software code includes:
determining a subset of the one or more implantable devices that are associated with delivering the electrical signal that results in the target effect (paragraph [0055], "an initial monopolar review (or electrical stimulation) can occur to determine any electrode(s) and/or stimulation parameters that cause undesirable side effects"); and
modifying the second software code to cause the subset of the one or more implantable devices to deliver the electrical signal while remaining implantable devices are inactive (paragraph [0055], "These electrode(s) and/or stimulation patterns may be excluded from the further steps of the closed-loop deep brain stimulation method 40").
Regarding claim 19, the system of claim 13 is obvious over Baker and Acerbo, as explained above. Baker further discloses that the set of actions further includes:
generating, by the base station, an additional communication by recording one or more stimulation times at which the one or more implantable devices deliver the electrical signal to the one or more regions (paragraph [0066], "the algorithm may determine the timing of when to apply the DBS relative to a specific neural signal, relative to a specific motor task, vocal task, or cognitive task, relative to a pulse wave, relative to a recent DBS application, and the like");
predicting, based on the communication and the additional communication, whether or the degree to which the set of implant stimulation protocols are resulting in a target effect for the instantaneous user characteristic (paragraphs [0063]-[0065], "The algorithm may be trained to identify criteria that reflect any other relevant benchmark from the input signals for applying the DBS, such as a frequency, phase, or single-unit or multi-unit activity of the input neural or peripheral signal. ... The algorithm may also be trained using a sample dataset from a single patient to differentiate relevant biomarker benchmarks (i.e., whether a patient's eyes are open or closed, whether a patient is awake or asleep, etc.) to determine criteria as to whether to apply the DBS, when to apply the DBS, and/or how to apply the DBS. ... the algorithm may utilize any of the input signals to determine how to apply the DBS by the DBS system 200. In other words, the stimulation parameters for application of the DBS by the DBS system 200"); and
determining the treatment recommendation based on the prediction (paragraph [0061], "The processed signals and their assigned weights may be input into a trained algorithm to determine the outcome of whether to apply the DBS, whether not apply the DBS, when to apply the DBS, and/or how to apply the DBS in step 48").
Regarding claim 20, the system of claim 13 is obvious over Baker and Acerbo, as explained above. Baker further discloses that determining the treatment recommendation includes:
generating, by the base station, an additional communication by recording one or more stimulation times at which the one or more implantable devices deliver the electrical signal to the one or more regions (paragraph [0066], "the algorithm may determine the timing of when to apply the DBS relative to a specific neural signal, relative to a specific motor task, vocal task, or cognitive task, relative to a pulse wave, relative to a recent DBS application, and the like");
determining, based on the communication and the additional communication, a subset of the one or more implantable devices that are associated with delivering the electrical signal that results in a target effect for the instantaneous user characteristic (paragraph [0055], "an initial monopolar review (or electrical stimulation) can occur to determine any electrode(s) and/or stimulation parameters that cause undesirable side effects"); and
generating the treatment recommendation to cause the subset of the one or more implantable devices to deliver the electrical signal while remaining implantable devices are inactive (paragraph [0055], "These electrode(s) and/or stimulation patterns may be excluded from the further steps of the closed-loop deep brain stimulation method 40").
Regarding claim 21, the system of claim 13 is obvious over Baker and Acerbo, as explained above. Baker further discloses that the set of actions further includes:
selecting the first software code and the second software code based on the predicted condition (Fig. 4B, paragraph [0056], "the one or more motor tasks may be chosen from predefined listing of motor tasks based on the medical condition of the patient"; paragraph [0066], "the algorithm may determine the timing of when to apply the DBS relative to a specific neural signal, relative to a specific motor task, vocal task, or cognitive task, relative to a pulse wave, relative to a recent DBS application, and the like").
Regarding claim 22, the system of claim 13 is obvious over Baker and Acerbo, as explained above. Baker further discloses that the set of actions further includes:
receiving an additional communication from a facial recognition device during the execution of the first software code and the second software code (paragraph [0025], "Analysis of a patient's...mood (measured by autonomic indicators, facial features or other measures)...may indicate time points when the patient's brain is most receptive to rehabilitative efforts"); and
determining the treatment recommendation for the subject based on the additional communication (paragraph [0025], "Examples include adjusting the timing of stimulation relative to phases of motor planning, adjusting the timing of stimulation relative to phases of motor execution, and/or adjusting the timing of recordings of neural activity").
Regarding claim 23, the system of claim 13 is obvious over Baker and Acerbo, as explained above. Baker further discloses that determining the treatment recommendation includes inputting the communication into a machine-learning model (paragraph [0062], "The algorithm may be implemented with artificial intelligence"; paragraph [0097], "artificial intelligence and/or machine learning").
Regarding claim 24, the system of claim 13 is obvious over Baker and Acerbo, as explained above. Baker further discloses that the treatment recommendation comprises a modification to an amplitude, a frequency, and/or a timing of the electrical signal delivered by the one or more implantable devices (paragraph [0024], "Examples of the stimulation parameters may include, but are not limited to, an amplitude, a pulse width, a frequency or frequencies, a burst rate, a burst count, a phase orientation, a voltage, a current, an on time period, an off time period, a number of pulses, and/or any combination thereof"; paragraph [0025], "Examples include adjusting the timing of stimulation relative to phases of motor planning, adjusting the timing of stimulation relative to phases of motor execution, and/or adjusting the timing of recordings of neural activity").
Regarding claim 25, Baker discloses a computer-program product tangibly embodied in a non-transitory machine-readable storage medium that includes instructions configured to cause one or more data processors to perform a set of actions (Fig. 2, paragraph [0045], memory 22) including:
accessing subject data of the subject (Fig. 4B, paragraph [0056], "step 42 may include obtaining data related to the one or more tasks");
determining a predicted condition for the subject based on the subject data (paragraph [0056], medical condition of the patient);
sending, to a user device of a subject (Fig. 1, paragraph [0034], input output device 19), first software code that is configured to present, at a user interface of the user device, one or more tasks to be performed by the subject using the user device (paragraph [0057], "the system 10, the controller 12, and/or the like may output the instruction related to the one or more tasks (e.g., motor tasks, vocal tasks, cognitive tasks, and/or the like) by the one or more input output devices 19, an audio output device, a video device and/or the like"), wherein the one or more tasks are based on the predicted condition (Fig. 4B, paragraph [0056], "the one or more motor tasks may be chosen from predefined listing of motor tasks based on the medical condition of the patient");
obtaining, based on the tasks performed by the subject, information regarding an instantaneous user characteristic of the subject with respect to the predicted condition (Fig. 4B, paragraph [0058], step 44);
sending, to a base station (Fig. 1, paragraph [0030], controller 12) that is communicatively coupled to one or more implantable devices implanted in one or more regions of the subject (Fig. 1, paragraph [0030], neurostimulator 14), based on the instantaneous user characteristic of the subject, second software code (Fig. 4B, paragraph [0061], step 48), wherein:
the second software code includes an instruction to cause the one or more implantable devices to execute a set of stimulation protocols of a plurality of stimulation protocols (Fig. 4B, paragraph [0061], step 48, determines whether to apply DBS), and
the one or more implantable devices are configured to generate an electrical signal, according to the set of stimulation protocols, to stimulate the one or more regions of the subject (paragraph [0042], "The system 10 may be used to configure a DBS system 200 to stimulate a cerebellar pathway connecting to a brainstem, a diencephalon, a cerebrum, or other location in the brain of a patient to treat a neurological disorder in the patient");
the set of stimulation protocols are configured such that the electrical signals stimulate the one or more regions of the subject (paragraph [0042], "The system 10 may be used to configure a DBS system 200 to stimulate a cerebellar pathway connecting to a brainstem, a diencephalon, a cerebrum, or other location in the brain of a patient to treat a neurological disorder in the patient"; paragraph [0043], "The DBS system 200 may include one or more implanted DBS electrodes 15 that may be placed in areas of the brain of the patient");
receiving, from the user device and the base station, a communication that represents one or more inputs (Fig. 4B, paragraph [0060], step 44, "neurophysiology activity data may be received by the data acquisition platform"), wherein:
the one or more inputs were detected at the user interface while or after the electrical signal was applied to the subject (paragraph [0058], "internal data (e.g., electrophysiology data used in Step 44) and/or external data (e.g., electroencephalography (EEG) data used in Step 46) can be recorded by appropriate electrodes and received (by controller 12) ... the task component 18 of FIG. 1 that can also record data related to the motor task"; paragraph [0031], "the received data may include data received in response to a patient performing a motor task with a task component 18"), and
the one or more inputs indicate a degree to which the instantaneous user characteristic is affected while or after the electrical signal was applied to the subject (paragraph [0056], "step 42 may include obtaining data relating to evaluation of how stimulation impacts spontaneous neural data as a distinct option from task-related changes");
the communication includes performance information associated with the one or more inputs received at the user interface corresponding to the one or more tasks (paragraph [0056], "step 42 may include obtaining data related to the one or more tasks. ... step 42 may include obtaining behavior data. This data may be received from one or more devices and/or from the clinician through the one or more input output devices 19"; paragraph [0058], "the task (e.g., motor task, vocal task, cognitive task, and/or the like) can be aided by the task component 18 of FIG. 1 that can also record data related to the motor task"), and
the performance information represents a performance on the one or more tasks performed by the subject on the user interface (paragraph [0041], "the task component 18 may provide a mechanical or digitized measurement of movement and may include a dynameter, a digital plate, articulated lever, a robotic arm, other mechanical measurement device, a digitized measurement device. This measurement of movement may include, for example, displacement/velocity/acceleration of an extremity or body part, dexterity, strength, resistance (rigidity or spasticity), electromyography, etc., of an extremity or body part. In certain aspects, the task component 18 may measure the movement and provide data regarding the movement to the system 10, the controller 12, and/or the like");
determining a treatment recommendation for the subject based on the communication (paragraph [0065], "the algorithm may utilize any of the input signals to determine how to apply the DBS by the DBS system 200. In other words, the stimulation parameters for application of the DBS by the DBS system 200"); and
outputting the treatment recommendation for the subject (paragraph [0035], "The one or more input output devices 19 can be configured to provide outputs from the system 10, the DBS system 200, the controller 12, and/or the like via a graphical user interface, including visual information."; paragraph [0047]).
Baker does not explicitly disclose that the electrical signals constructively interfere with each other.
However, Acerbo teaches a deep brain stimulation system (Abstract) wherein the set of stimulation protocols are configured such that the electrical signals constructively interfere with each other to stimulate the one or more regions of the subject (paragraph [0061], "FIG. 4 shows the creation of envelopes by signals interfering constructively"; paragraph [0084], "In order to avoid to modulate unwanted nodes in the brains or neighboring nerves in the case of peripheral nerve stimulation, the number of stimulating pairs is increased to improve the focality of stimulation, namely the ability to modulate a targeted area without disturbing the surrounding area").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baker with the teachings of Acerbo so that the set of stimulation protocols are configured such that the electrical signals constructively interfere with each other to stimulate the one or more regions of the subject, because doing so targets smaller points in space, reduces the necessary applied current from individual stimulation electrodes, and evokes activity at depth with lower applied electric fields compared to conventional DBS (Acerbo, paragraph [0020]).
Claims 2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Baker et al. (US 20250025698 A1, previously cited), hereinafter Baker, in view of Acerbo et al. (US 20240399143 A1), hereinafter Acerbo, and further in view of Sun et al. (US Publication No. 20200144480 A1, previously cited), hereinafter Sun.
Regarding claim 2, the method of claim 1 is obvious over Baker and Acerbo, as explained above. Baker further discloses that at least one of the one or more implantable devices includes one or more electrodes (Fig. 1, paragraph [0036], DBS electrodes 15), but does not disclose that the one or more implantable devices includes a magnetoelectric film and an electrical circuit coupled to the magnetoelectric film.
However, Sun discloses an implantable system for recording and manipulating neural activity (paragraph [0009]) wherein the implantable system includes:
a magnetoelectric film (Fig. 4A, paragraph [0058], "The ME antenna 102 may be an ME thin-film heterostructure 400, comprising thin-film piezoelectric elements 402 (e.g., 500 nm thick aluminum nitride (AlN)), and a thin-film magnetorestrictive element 404 (500 nm thick FeGaB)."); and
an electrical circuit coupled to the magnetoelectric film (Fig. 1A, paragraph [0052], implantable system 100 comprises ME antenna 102 and integrated circuit 104; Fig. 1B, paragraphs [0066]-[0067]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baker and Acerbo with the teachings of Sun to include a magnetic field generator because doing so allows wireless power transfer to the implantable device (Sun, paragraph [0050]), which eliminates the need for a battery (Sun, paragraph [0052]), and allows data transfer from the implantable device to the base station (Sun, paragraph [0066]).
Regarding claim 14, the system of claim 13 is obvious over Baker and Acerbo, as explained above. Baker further discloses that at least one of the one or more implantable devices includes one or more electrodes (Fig. 1, paragraph [0036], DBS electrodes 15), but does not disclose that the one or more implantable devices includes a magnetoelectric film and an electrical circuit coupled to the magnetoelectric film.
However, Sun discloses an implantable system for recording and manipulating neural activity (paragraph [0009]) wherein the implantable system includes:
a magnetoelectric film (Fig. 4A, paragraph [0058], "The ME antenna 102 may be an ME thin-film heterostructure 400, comprising thin-film piezoelectric elements 402 (e.g., 500 nm thick aluminum nitride (AlN)), and a thin-film magnetorestrictive element 404 (500 nm thick FeGaB)."); and
an electrical circuit coupled to the magnetoelectric film (Fig. 1A, paragraph [0052], implantable system 100 comprises ME antenna 102 and integrated circuit 104; Fig. 1B, paragraphs [0066]-[0067]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baker and Acerbo with the teachings of Sun to include a magnetic field generator because doing so allows wireless power transfer to the implantable device (Sun, paragraph [0050]), which eliminates the need for a battery (Sun, paragraph [0052]), and allows data transfer from the implantable device to the base station (Sun, paragraph [0066]).
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.
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/CHRISTINE SISON/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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