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 .
Priority
The present application is a continuation of PCT International Application No. PCT/US2024/17059, filed February 23, 2024, which is based upon and claims priority to U.S. Provisional Application No. 63/447,996, filed February 23, 2023.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/03/2025 has been entered.
Response to Amendment
The amendments under 37 CFR 1.132 filed 12/03/2025 is sufficient to overcome the rejection of claims 21-26 and 32-43 based upon Howard (1) (US 20210263589 A1) in view of Shepard (US 20180185656 A1) and Howard (2) (US 20210138249 A1) failing to teach all aspects of the amended claims.
Newly added claims 63 and 64 are acknowledged. Claims 21-37 and 39-43, and 61-64 are currently pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed 12/03/2025, with respect to the rejection(s) of claim(s) 21-26 and 32-43 under 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 U.S.C. 103 as being unpatentable by Howard (1) (US 20210263589 A1) in view of Shepard (US 20180185656 A1), further in view of Donoghue (US 20210267523 A1).
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.
Claim(s) 21-37, 39-43, and 61-63 is/are rejected under 35 U.S.C. 103 as being unpatentable by Howard (US 20210263589 A1) in view of Shepard (US 20180185656 A1), further in view of Donoghue (US 20210267523 A1).
Regarding claim 21, Howard teaches a system for local amplification [0329] This analog electrical signal may be passed than through a Signal Conditioning Unit 2108, which may perform filtering and amplification on the analog electrical signal), multiplexing (Fig 20; [0326] Optical Multiplexing Unit 2008) and analog-to-digital conversion of signals ([fig 21; [0329] The processed analog electrical signal may then be input into Analog to Digital Converter (ADC) 2110) sensed from deep brain regions, comprising: a neural probe configured for placement within a brain ([0210] an implantable, miniaturized, for example, smaller than a pea, low-power, wireless probe with induction charging that may be used, for example, for treating neurodegenerative diseases like Parkinson's and Alzheimer through continual neuromodulation); at least one signal lead extending from the neural probe ([0270] Conventional thin film probes can fit hundreds of leads into one penetrating shank); and a sensing assembly included on the neural probe (Fig 23; [0334] the architecture may include a plurality of sense channels 2302) ([0149] CNTs serve as electrochemical and optical sensors as well as measurement/stimulation electrodes), where the sensing assembly includes: a plurality of electrodes positioned on the neural probe, wherein one or more of the plurality of electrodes are configured to sense electrical signals generated by one or more neurons in the brain ([0297] the CNTs 1502 may connect to the electrodes 1504 through which the neuron stimulation and reading will be performed, as shown in FIG. 15); at least one amplifier, the at least one amplifier being configured to generate at least one amplification signal based on the sensed electrical signals generated by the one or more neurons ([0329] This analog electrical signal may be passed than through a Signal Conditioning Unit 2108, which may perform filtering and amplification on the analog electrical signal); and at least one multiplexer configured to multiplex at least two amplified signals based on the sensed electrical signals generated by the one or more neurons (fig 98; [0228] analog signal multiplexer 9804) to provide a multiplexed sense sign ([0228] Multiplexed channels 9806); an externally located processing assembly with electrical components for analogue to digital conversion of signals ([0228] Multiplexed channels 9806 may be input to multiple channels of analog-to-digital converter circuitry (ADC) 9808, which may convert the analog signal to digital signals representative of the analog signals and may transmit 9810 the multiplexed digitized signals, for example, using a protocol such as Simple Peripheral Interface (SPI) to a gateway processor 9812. Gateway processor 9812 may process and compress the multiplexed digitized signals and may transmit 9814 them to a computer system 9816 for analysis using), a signal generator ([0320] The SWCNT fibers may each be connected to a preamplifier 1904, which may convert the weak electrical signal coming from the neurons into an output signal that is strong enough to be noise-tolerant and processing ready) ([0231] Further, gateway processor 10004 may perform real-time spike detection on the multiplexed digitized signals, probe calibration, and control of probes, such as probe channel selection, generation of stimulation signals) ([0366] Neuronal modulation or stimulation circuitry 3304 may include circuitry, such as that described above, for generating and transmitting electrical and/or optical stimulation signals to neurons 3318), a power source ([0246] A passive inductive power unit and the BCCS earbud amplifier will be used external to the cranium, allowing the implant device to be small, low power and of low energy consumption), and electronic circuitry enabling wireless transfer of data and wireless charging of power ([0251] The implant device, on the other hand, is wireless and inductively powered, and so is implantable anywhere in the brain with a subdural transceiver, to allow reading of neurons both at the surface and in 3D).
Howard fails to fully teach a neural probe configured for placement within a deep brain nucleus within a brain; wherein one or more of the plurality of electrodes are configured to sense from a position within the deep brain nucleus electrical signals generated by one or more neurons in the deep brain nucleus; at least one amplifier local to the sensing assembly included on the neural probe; electrical signals generated by the one or more neurons in the deep brain nucleus; wherein the at least one signal lead extending from the neural probe is configured to carry the multiplexed sense signal from the neural probe to a location outside a skull housing of the brain.
However, Shepard teaches at least one amplifier local to the sensing assembly included on the neural probe ([abstract] Disclosed systems can include a flexible probe adapted for insertion into a portion of a brain of the subject, the flexible probe comprising a tail portion and a head portion. The tail portion can include a plurality of electrodes configured to be coupled to the brain and a plurality of front-end amplifiers. Each of the plurality of front-end amplifiers can be configured to amplify a signal received from a corresponding electrode of the plurality of electrodes). It would have been obvious to one having ordinary skill in the art at before the effective filling date to have modified the invention of Howard (1) to include at least one amplifier local to the sensing assembly included on the neural probe. Doing so would improve the signal that is recorded and transmitted from the probe to the external device.
Further, Donoghue teaches a neural probe configured for placement within a deep brain nucleus within a brain ([0114] In some embodiments, sensor 160 is configured to deliver a pharmaceutical drug or other agent to the patient (e.g. an agent to treat epilepsy or other brain condition). Energy (e.g. stimulation energy) can be delivered to various tissue locations of the patient, such as brain tissue (e.g. cortex of the brain, deep brain nuclei) and other nerve tissue (e.g. vagal nerve tissue)); wherein one or more of the plurality of electrodes are configured to sense from a position within the deep brain nucleus electrical signals generated by one or more neurons in the deep brain nucleus ([0114] In these embodiments, sensor 160 can also be configured as a sensor, such as when sensor 160 comprises one or more electrodes configured to record electrical activity in tissue, and deliver electrical energy to tissue) ([0202] Implantable device 100 can be configured to record electrical activity and/or deliver electrical energy, via one or more electrode-based sensors 160, in a monopolar or multipolar (e.g. bipolar) arrangement. In some embodiments, all or a portion of housing 101 comprises a conductive portion, such as common electrode 111 shown, which can function as a return path for recorded signals and/or delivered energy); electrical signals generated by the one or more neurons in the deep brain nucleus ([0114]); wherein the at least one signal lead extending from the neural probe is configured to carry the multiplexed sense signal from the neural probe to a location outside a skull housing of the brain ([[0200] System 10 further includes external device 200 which can be positioned proximate implantable device 100 (e.g. close to the skin proximate the implantation site of ITX 110) such that a receiver, ETX 210 can receive wireless transmissions of information from ITX 110. In some embodiments, ETX 210 can transfer information and/or power to ITX 110 and/or another component of system 10. External device 200 can also include EPU unit 220, user interface 230, and/or ESA 240, each as described hereabove in reference to FIG. 1) (Fig 12; [0213] hub 155 can comprise an electronics assembly, such as an electronics assembly that applies signal processing to signals recorded by sensors 160 (e.g. digitizing, multiplexing, electronic switching, amplifying, noise reducing, and the like). In some embodiments, hub 155 comprises an electronics assembly that reduces the number of wires needed in conduit 152 (e.g. including switches or multiplexing functions that avoid conduit 152 having an individual wire, or individual wire pairs, for each sensor 160)). It would have been obvious to one having ordinary skill in the art at before the effective filling date to have modified the invention of Howard to include a neural probe configured for placement within a deep brain nucleus within a brain; wherein one or more of the plurality of electrodes are configured to sense from a position within the deep brain nucleus electrical signals generated by one or more neurons in the deep brain nucleus; electrical signals generated by the one or more neurons in the deep brain nucleus; wherein the at least one signal lead extending from the neural probe is configured to carry the multiplexed sense signal from the neural probe to a location outside a skull housing of the brain. Doing so allows for deep brain stimulation while just the probe is to be inserted while not overcrowding the implantation site with processing means.
Regarding claim 22, Howard teaches the system of claim 21, wherein one or more of the plurality of electrodes are configured to stimulate one or more neurons in the brain ([0337] neural tissue may be stimulated using one or more of several techniques, such as Optical Stimulation (Optogenetics), Electrophysiological Stimulation, and Electrochemical Stimulation). Howard fails to fully teach one or more neurons in the deep brain nucleus from a location within the deep brain nucleus.
However, Donoghue teaches one or more neurons in the deep brain nucleus from a location within the deep brain nucleus ([0114] In some embodiments, sensor 160 is configured to deliver a pharmaceutical drug or other agent to the patient (e.g. an agent to treat epilepsy or other brain condition). Energy (e.g. stimulation energy) can be delivered to various tissue locations of the patient, such as brain tissue (e.g. cortex of the brain, deep brain nuclei) and other nerve tissue (e.g. vagal nerve tissue)). It would have been obvious to one having ordinary skill in the art at before the effective filling date to have modified the invention of Howard to include one or more neurons in the deep brain nucleus from a location within the deep brain nucleus. Doing so allows for recording of signals in the deep brain for treatments of a specific outcome.
Regarding claim 23, Howard teaches the system of claim 21, wherein the plurality of electrodes includes one or more dual-role electrodes selectively configurable to stimulate one or more neurons in the brain or to sense electrical signals generated by one or more neurons in the brain ([0347] neurons may be stimulated optically, and interrogated electrically. The ROIC may include CCD or CMOS photodiodes or other imaging cells, to receive optical signals, electrical receiving circuitry, to receive electrical signals, light outputting circuitry, such as LED or lasers, to output optical signals, and electrical transmitting circuitry, to transmit electrical signals).
Howard fails to fully teach wherein the plurality of electrodes includes one or more dual-role electrodes selectively configurable to stimulate from a location within the deep brain nucleus one or more neurons in the at least one deep brain nucleus or to sense from a location within the deep brain nucleus electrical signals generated by one or more neurons in the at least one deep brain nucleus.
However, Donoghue teaches wherein the plurality of electrodes includes one or more dual-role electrodes selectively configurable to stimulate from a location within the deep brain nucleus one or more neurons in the at least one deep brain nucleus ([0114] In some embodiments, sensor 160 is configured to deliver a pharmaceutical drug or other agent to the patient (e.g. an agent to treat epilepsy or other brain condition). Energy (e.g. stimulation energy) can be delivered to various tissue locations of the patient, such as brain tissue (e.g. cortex of the brain, deep brain nuclei) and other nerve tissue (e.g. vagal nerve tissue)) or to sense from a location within the deep brain nucleus electrical signals generated by one or more neurons in the at least one deep brain nucleus ([0114] In these embodiments, sensor 160 can also be configured as a sensor, such as when sensor 160 comprises one or more electrodes configured to record electrical activity in tissue, and deliver electrical energy to tissue) ([0202] Implantable device 100 can be configured to record electrical activity and/or deliver electrical energy, via one or more electrode-based sensors 160, in a monopolar or multipolar (e.g. bipolar) arrangement. In some embodiments, all or a portion of housing 101 comprises a conductive portion, such as common electrode 111 shown, which can function as a return path for recorded signals and/or delivered energy). It would have been obvious to one having ordinary skill in the art at before the effective filling date to have modified the invention of Howard to include wherein the plurality of electrodes includes one or more dual-role electrodes selectively configurable to stimulate from a location within the deep brain nucleus one or more neurons in the at least one deep brain nucleus or to sense from a location within the deep brain nucleus electrical signals generated by one or more neurons in the at least one deep brain nucleus. Doing so allows for recording of signals in the deep brain for treatments of a specific outcome.
Regarding claim 24, Howard teaches the system of claim 21, wherein the system further includes at least one processor, located outside the brain (Fig 67; representing external processing), to cause transmission of one or more stimulation signals (Fig 101, 127, 129; Processor receives signals and transmits stimulation signals). Howard (1) fails to fully teach and also being configured to receive the multiplexed sense.
However, Donoghue teaches at least one processor, configured for location outside the skull housing of the brain ([[0200] System 10 further includes external device 200 which can be positioned proximate implantable device 100 (e.g. close to the skin proximate the implantation site of ITX 110) such that a receiver, ETX 210 can receive wireless transmissions of information from ITX 110. In some embodiments, ETX 210 can transfer information and/or power to ITX 110 and/or another component of system 10. External device 200 can also include EPU unit 220, user interface 230, and/or ESA 240, each as described hereabove in reference to FIG. 1), and also being configured to receive the multiplexed sense (Fig 12; [0213] hub 155 can comprise an electronics assembly, such as an electronics assembly that applies signal processing to signals recorded by sensors 160 (e.g. digitizing, multiplexing, electronic switching, amplifying, noise reducing, and the like). In some embodiments, hub 155 comprises an electronics assembly that reduces the number of wires needed in conduit 152 (e.g. including switches or multiplexing functions that avoid conduit 152 having an individual wire, or individual wire pairs, for each sensor 160)). It would have been obvious to one having ordinary skill in the art at before the effective filling date to have modified the invention of Howard to include at least one processor, configured for location outside the skull housing of the brain, and also being configured to receive the multiplexed sense. Doing so keeps the implantation site from overcrowding and can allow the signal to be transmitted to an external source.
Regarding claim 25, Howard teaches the system of claim 24, wherein the at least one external processor is configured to identify one or more of the plurality of electrodes to receive a transmission of the one or more stimulation signals based on at least one detected characteristic of the multiplexed sense ([0349] Processing circuitry 2902 may encode stimulation commands for modulation of optical signal. For example, such commands may be 5 bits, for up to 32 different modulation commands. Processing circuitry 2902 may send one of the 32 possible commands and the data identifying the channel to be stimulated. Each command may be mapped into a wavelength and a light intensity, which may be encoded digitally and sent to optical processor 2904 on its digital in/out port, together with the channel on which the light may be transmitted).
Regarding claim 26, Howard teaches The system of claim 21, wherein the at least one signal lead includes one or more electrical conductors ([0270] this design allows for potentially extremely dense architectures, as by combining several of these probes into a 10×10 array of 1 cm.sup.2, an implant using this technology could potentially deploy several tens of thousands of leads in a multielectrode array, and could be conceivably combined with optical fibers for stimulation within an electronic-photonic microarray implant).
Regarding claim 27, Howard teaches the system of claim 21, wherein the at least one signal lead has a length of at least 40 millimeters ([0295] The brain cells may be in the range of 10-50 micrometers in diameter) ([0296] The brain cells 1202 have been represented as circles 30 microns in diameter and 50 microns apart (distance between centers). The centers of the optrodes have been represented as squares 25 microns apart). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the length of the leads, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 28, Howard teaches the system of claim 21, wherein the at least one signal lead has a length of at least 50 millimeters ([0295] The brain cells may be in the range of 10-50 micrometers in diameter) ([0296] The brain cells 1202 have been represented as circles 30 microns in diameter and 50 microns apart (distance between centers). The centers of the optrodes have been represented as squares 25 microns apart). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the length of the leads, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 29, Howard teaches the system of claim 21, wherein the at least one signal lead has a length of at least 60 millimeters ([0295] The brain cells may be in the range of 10-50 micrometers in diameter) ([0296] The brain cells 1202 have been represented as circles 30 microns in diameter and 50 microns apart (distance between centers). The centers of the optrodes have been represented as squares 25 microns apart). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the length of the leads, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 30, Howard teaches the system of claim 21, wherein the at least one signal lead has a length of at least 70 millimeters ([0295] The brain cells may be in the range of 10-50 micrometers in diameter) ([0296] The brain cells 1202 have been represented as circles 30 microns in diameter and 50 microns apart (distance between centers). The centers of the optrodes have been represented as squares 25 microns apart). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the length of the leads, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 31, Howard teaches the system of claim 21, wherein the at least one signal lead has a length of at least 80 millimeters ([0295] The brain cells may be in the range of 10-50 micrometers in diameter) ([0296] The brain cells 1202 have been represented as circles 30 microns in diameter and 50 microns apart (distance between centers). The centers of the optrodes have been represented as squares 25 microns apart). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the length of the leads, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 32, Howard teaches the system of claim 21, wherein the at least one amplifier includes at least one of a low-noise operational transconductance amplifier, a Miller operational transconductance amplifier, a current mirror operational transconductance amplifier, or a differential self-biased operational transconductance amplifier ([0583] the First Amplifier Stage may include a differential input fixed gain instrumentation amplifier 9102. This design, while not adding much complexity, may be characterized by a low noise figure and a high common mode rejection ratio).
Regarding claim 33, Howard teaches the system of claim 21, wherein the one or more of the plurality of electrodes are configured to sense electrical signals from individual neurons, or a plurality of neurons within a 200-micron radius from an area of the neural probe on which the one or more of the plurality of electrodes are located ([0148] Once the chip reaches the target location it expands and attaches to the walls of the blood vessel to read the activity of the nearby neurons) ([0165] While optical stimulation is able to target specific neurons very precisely, electrical stimulation implies current dissipation in the surrounding area. CNTs connected to nanoelectrodes implanted directly in the brain parenchyma can achieve electrophysiological stimulation) ([0254] The implant device may be a microfabricated carbon nanotube neural implant that may provide, for example, reading from >1,000,000 neurons, writing to >100,000 neurons, and reading and writing simultaneously to >1,000 neurons) ([0305] The new design distributes the electrical current uniformly over a wider area (up to a radius of about 50 micrometers—the size of a typical neural microcircuit).
Howard fails to fully teach configured to sense from a location within the deep brain nucleus.
However, Donoghue teaches configured to sense from a location within the deep brain nucleus ([0114] In some embodiments, sensor 160 is configured to deliver a pharmaceutical drug or other agent to the patient (e.g. an agent to treat epilepsy or other brain condition). Energy (e.g. stimulation energy) can be delivered to various tissue locations of the patient, such as brain tissue (e.g. cortex of the brain, deep brain nuclei) and other nerve tissue (e.g. vagal nerve tissue)). It would have been obvious to one having ordinary skill in the art at before the effective filling date to have modified the invention of Howard to include configured to sense from a location within the deep brain nucleus. Doing so allows for recording of the deep brain nucleus for a specific treatment.
Regarding claim 34, Howard teaches the system of claim 21, wherein the at least one amplifier is configured to vary a gain associated with the at least one amplification signal based on at least one characteristic of the sensed electrical signals ([0583] the signal from the multiplexer may be amplified using a Gain Block 9100, such as the example shown in FIG. 91, before being input to the ADC sampling unit. In embodiments, the First Amplifier Stage may include a differential input fixed gain instrumentation amplifier 9102).
Regarding claim 35, Howard teaches the system of claim 21, wherein the at least one amplifier is configured to generate the at least one amplification signal for the at least one electrode based on a magnitude of a signal received at the at least one electrode ([0361] The analog electrical signal may be amplified by Signal Conditioning Unit 3106, to provide the proper amplitude signal. From Signal Conditioning Unit 3106, the signal may be input into an electrical Demultiplexing Unit (DEMUX) 3108. Based on the signal that comes from processing circuitry 3102 on Select Line 3112, the DEMUX 3108 may transmit the stimulation signal to the corresponding CNTs 3110, which will stimulate the neurons in their vicinity).
Regarding claim 36, Howard teaches the system of claim 21, wherein the at least one amplifier is configured to generate the at least one amplification signal for the at least one electrode based on a position of the at least one electrode on the neural probe ([0361] Based on the signal that comes from processing circuitry 3102 on Select Line 3112, the DEMUX 3108 may transmit the stimulation signal to the corresponding CNTs 3110, which will stimulate the neurons in their vicinity) ([0363] Neuro stimulation signals 3208 may then be transmitted to zone selection/controller circuitry 3206, which may route each neuro stimulation signal 3208 to an appropriate electrical stimulation electrode or optical stimulation optrode) ([0364]).
Regarding claim 37, Howard teaches the system of claim 21, wherein the sensing assembly further comprises at least one filter configured to condition the sensed electrical signals or the at least one amplification signal ([0334] Each recording pipeline 2306A-M may handle a plurality of sense channels 2302 and may include a plurality of instances of recording pipeline circuitry. Each instance of recording pipeline circuitry may include signal conditioning circuitry 2312, such amplifiers, filters, variable gain stages, etc.).
Regarding claim 39, Howard teaches the system of claim 21, wherein the external processing assembly is configured to convert a plurality of analog signals into digital signals to enable read-out of the data on a computer interface ([0321] From MUX 1906, the selected signal goes into Analog to Digital Converter (ADC) 1908, which converts the received analog value into a digital value, for example, 8, 10 or 12 bits, which is then passed along to processing circuitry 1910. Processing circuitry 1910 may include digital processing circuitry, such as one or more microprocessors, microcontrollers, digital signal processors (DSPs), custom or semi-custom circuitry, such as application specific integrated circuits (ASICs), field programmable circuitry, such as field programmable gate arrays (FPGAs), etc., or any other digital processing circuitry) ([0555] the UI for the patients may be focused on data visualization. They may be able to see real time activity as it comes in from the implant device). Howard fails to teach wherein the system further includes an external processing assembly configured for location outside the skull housing of the brain.
However, Donoghue teaches wherein the system further includes an external processing assembly configured for location outside the skull housing of the brain ([[0200] System 10 further includes external device 200 which can be positioned proximate implantable device 100 (e.g. close to the skin proximate the implantation site of ITX 110) such that a receiver, ETX 210 can receive wireless transmissions of information from ITX 110. In some embodiments, ETX 210 can transfer information and/or power to ITX 110 and/or another component of system 10. External device 200 can also include EPU unit 220, user interface 230, and/or ESA 240, each as described hereabove in reference to FIG. 1) (Fig 12; [0213] hub 155 can comprise an electronics assembly, such as an electronics assembly that applies signal processing to signals recorded by sensors 160 (e.g. digitizing, multiplexing, electronic switching, amplifying, noise reducing, and the like). In some embodiments, hub 155 comprises an electronics assembly that reduces the number of wires needed in conduit 152 (e.g. including switches or multiplexing functions that avoid conduit 152 having an individual wire, or individual wire pairs, for each sensor 160)). It would have been obvious to one having ordinary skill in the art at before the effective filling date to have modified the invention of Howard to include wherein the system further includes an external processing assembly configured for location outside the skull housing of the brain. Doing so allows for just the probe to be inserted while not overcrowding the implantation site.
Regarding claim 40, Howard teaches the system of claim 21, wherein the neural probe and the sensing assembly form integrated device having a complementary metal- oxide semiconductor (CMOS) fabrication structure ([0293] Depending on their chirality—the geometric orientation of the carbon atoms network—the electrical properties of the CNTs may change—they may behave either as conductors or semiconductors. In an electronic device this may allow both the active devices and interconnects to be made of CNTs) ([0292] Furthermore, the boundary (tip) of the CNT may be modified by functional groups, metal nanoparticles, polymers, and metal oxides to increase the selectivity of the detectors built based on them, adding filtering capabilities to it) ([0609] The computer readable storage medium may be, for example, but is not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the foregoing).
Regarding claim 41, Howard teaches the system of claim 21, further comprising a data processing assembly configured to be located on a skull of the brain and to transmit digital data via a wireless or wired connection ([0270] A design of an implantable electrode system may be a 3D electrode array attached to a platform on the cortical surface. Said platform would be used for signal processing and wireless communication). Howard fails to fully teach processing assembly configured to be located on a skull outside of the brain and to transmit digital data associated with the multiplexed sense signal via a wireless or wired connection.
However, Donoghue teaches processing assembly configured to be located on a skull outside of the brain and to transmit digital data associated with the multiplexed sense signal via a wireless or wired connection ([0121] As described hereabove, ITX 110 is configured to wirelessly transmit information through the skin to ETX 210 of external device 200. For example, ITX 110 can transmit information as recorded by lead assembly 150, and/or information that is derived from the recorded information (e.g. as processed by IPU 120 described herebelow). In some embodiments, ITX 110 is configured to wirelessly transmit information to other components of system 10, as described herein). It would have been obvious to one having ordinary skill in the art at before the effective filling date to have modified the invention of Howard to include processing assembly configured to be located on a skull outside of the brain and to transmit digital data associated with the multiplexed sense signal via a wireless or wired connection. Doing so allows for just the probe to be inserted while not overcrowding the implantation site. and can allow the signal to be transmitted to an external source.
Regarding claim 42, Howard teaches the system of claim 21, further comprising a power assembly configured to be located on a skull of the brain and to provide power to the sensing assembly located inside the brain (Fig 97; [0227] implant device 9702 may be directly powered by inductive power system 9704, which connects to induction coil 9706 and powers implant device 9702 directly using magnetic induction 9708. In embodiments, implant device 9702 may be directly powered by RF power system 9710, which connects to RF antenna 9712 and powers implant device 9702 directly using RF waves 9714).
Regarding claim 43, Howard teaches the system of claim 42, wherein the power assembly is configured to be charged via electrodynamic wireless power transmission, inductive power transmission, or resonant power coupling (Fig 97; [0227] implant device 9702 may be directly powered by inductive power system 9704, which connects to induction coil 9706 and powers implant device 9702 directly using magnetic induction 9708. In embodiments, implant device 9702 may be directly powered by RF power system 9710, which connects to RF antenna 9712 and powers implant device 9702 directly using RF waves 9714).
Regarding claim 61, Howard teaches the system of claim 21, wherein the neural probe further comprises an analog-to-digital converter for digitizing the multiplexed sense signal ([0321] From MUX 1906, the selected signal goes into Analog to Digital Converter (ADC) 1908, which converts the received analog value into a digital value) ([0229] Gateway processor 9904 may process and compress the multiplexed digitized signals 9912 and may transmit 9914 them to a computer system 9908).
Regarding claim 62, Howard teaches the system of claim 25, wherein the one or more of the plurality of electrodes is spatially distributed relative to the neural probe and wherein the set of stimulation electrodes is selected based on a target stimulation location ([0361] Processing circuitry 3102 may send one of the 32 possible commands and the data identifying the channel to be stimulated) ([0363] Neuro stimulation signals 3208 may then be transmitted to zone selection/controller circuitry 3206, which may route each neuro stimulation signal 3208 to an appropriate electrical stimulation electrode or optical stimulation optrode).
Regarding claim 63, Howard teaches the system of claim 21, but fails to teach wherein the deep brain nucleus comprises at least one of a diencephalon, a hypothalamus, a thalamic nucleus, a subthalamic nucleus, a mesencephalon, a midbrain, a tectum, a rhombencephalon, a pons, a cerebellum, a basal ganglia, or a part of a limbic system.
However, Donoghue teaches wherein the deep brain nucleus comprises at least one of a diencephalon, a hypothalamus, a thalamic nucleus, a subthalamic nucleus, a mesencephalon, a midbrain, a tectum, a rhombencephalon, a pons, a cerebellum, a basal ganglia, or a part of a limbic system ([0197] In some embodiments, stimulated tissue includes, but is not limited to, tissue of the: motor cortex; nucleus accumbens; subthalamic nucleus (STN); and/or globus pallidus internal (e.g. for a Parkinson's Disease patient)). It would have been obvious to one having ordinary skill in the art at before the effective filling date to have modified the invention of Howard to include wherein the deep brain nucleus comprises at least one of a diencephalon, a hypothalamus, a thalamic nucleus, a subthalamic nucleus, a mesencephalon, a midbrain, a tectum, a rhombencephalon, a pons, a cerebellum, a basal ganglia, or a part of a limbic system. Doing so records signals from the deep brain used for a specific treatment.
Claim(s) 64 is/are rejected under 35 U.S.C. 103 as being unpatentable by Howard (1) (US 20210263589 A1) in view of Shepard (US 20180185656 A1), further in view of Donoghue (US 20210267523 A1), further in view of Swanson (US 7266885 B1).
Regarding claim 64, Howard teaches the system of claim 21, but fails to fully teach wherein each electrode of the plurality of electrodes comprises a conductor having a surface area between 25 and 400 square microns.
However, Swanson teaches wherein each electrode of the plurality of electrodes comprises a conductor having a surface area between 25 and 400 square microns ([23] In the embodiment of FIG. 6, electrodes 17 are from 12.56 square microns to 300 microns in surface area. In one preferred embodiment electrodes 17 are 176 have a surface area of 176 square microns). It would have been obvious to one having ordinary skill in the art at before the effective filling date to have modified the invention of Howard to include wherein each electrode of the plurality of electrodes comprises a conductor having a surface area between 25 and 400 square microns. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein each electrode of the plurality of electrodes comprises a conductor having a surface area between 25 and 400 square microns, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794