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 .
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 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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 7, 21, 26, 29, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Leyde (US 20130046358) in view of Llinas (US 20040133118) and Fowler et al., (US 20090182391; hereinafter Fowler), Kaplan et al., (US 20150202351; hereinafter Kaplan), and Ghaffari et al., (US 20100298895; hereinafter Ghaffari).
Regarding claim 1, Leyde discloses (Figures 6-7) an implant device (24) adapted to be entirely implanted within a body of a person for interacting with brain tissue ([0064]), the implant device comprising: a plurality of electrodes (A-H/I-P as shown in arrays 9/11) adapted to be directly implanted in the brain tissue ([0041]), and to connect to and directly receive electrical signals from electrophysiological neural signals of the brain tissue and to transmit electrical signals to provide electrophysiological stimulation of the brain tissue ([0063]-[0064]), the electrodes (A-H/I-P) electrically coupled to at least one readout integrated circuit ([0072]); and at least one readout integrated circuit comprising a plurality of cells of circuitry (the signal connection between each electrode to the A/D converter), each cell electrically coupled to at least one electrode, each cell of circuitry comprising: circuitry adapted to receive the electrical neural signals from the plurality of electrodes and to process the electrical neural signals to form digital data representing the neural signals (which is performed by the A/D converter), and circuitry adapted to transmit electrical neural signals through the plurality of electrodes ([0046]: the sensing and stimulation may be performed by the same electrodes) so as to provide electrophysiological stimulation of the brain tissue ([0063]-[0064], [0069]-[0074], [0092]-[0094]).
Leyde fails to disclose that the electrodes are electrically conductive carbon nanotubes adapted to directly receive electrical signals. However, Llinas teaches an implant device adapted to be implanted within a body of a person for interacting with brain tissue comprising carbon nanotubes as electrodes ([0037]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the electrodes disclosed by Leyde with the electrically conductive carbon nanotubes taught by Llinas because both electrodes perform the same function of transmitting electrical signals, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Leyde/Llinas fails to teach that the plurality of electrically conductive carbon nanotubes are adapted to directly receive electrical signals from electrophysiological neural signals of a plurality of pyramidal layers of the brain tissue. However, Fowler teaches a system for interacting with living tissue wherein a device is adapted to receive electrical signals from pyramidal layers within a brain cortical structure ([0060]-[0064]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Leyde/Llinas to such that the plurality of electrically conductive carbon nanotubes are adapted to directly receive electrical signals from electrophysiological neural signals of a plurality of pyramidal layers of the brain tissue, as taught by Fowler, because the modification would provide specific electrical signal measurement with a desired brain cortical structure as desired for treatment (Fowler; [0060]).
Leyde/Llinas/Fowler fails to teach a gel membrane entirely surrounding the implant device and the plurality of electrically conductive carbon nanotubes adapted to ensure upright position of the plurality of electrically conductive carbon nanotubes and to attract neurons to the plurality of electrically conductive carbon nanotubes when implanted. However, Kaplan teaches an implant device comprising a silk gel membrane entirely surrounding electrodes of an implant device ([0112], [0180]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Leyde/Llinas/Fowler to include a gel membrane entirely surrounding the implant device and the electrodes (plurality of electrically conductive carbon nanotubes), as taught by Kaplan, because the modification would improve long-term functionality of the implant device (Kaplan; [0023]). Furthermore, since the gel membrane taught by Kaplan may provide sufficient mechanical stiffness (Kaplan; [0057]) and improve gel-tissue interfaces (Kaplan; [0180]), the gel membrane of the modified device would be adapted to ensure upright position of the plurality of electrically conductive carbon nanotubes and to attract neurons to the plurality of electrically conductive carbon nanotubes when implanted.
Leyde/Llinas/Fowler/Kaplan fails to teach that implant device has an oblate spheroid shape, wherein the plurality of electrically conductive carbon nanotubes radially stem from the oblate spheroid implant device. However, Ghaffari teaches a method using an implant device (200), which may be shaped as an oblate spheroid ([0079], [0188]). It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Leyde/Llinas/Fowler/Kaplan to include the implant device shaped as an oblate spheroid, as taught by Ghaffari, since applicant has not disclosed that having the implant device shaped as an oblate spheroid solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the implant device shaped as an oblate spheroid, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. Accordingly, the modified device would include the plurality of electrically conductive carbon nanotubes radially stemming from the oblate spheroid implant device.
Regarding claim 3, Leyde further discloses (Figures 6-7) a multiplexer (42), coupled to a plurality of cells of circuitry (signal paths) adapted to receive and process the electrical neural signals ([0072]-[0074]), adapted to select at least one of the electrical neural signals from the plurality of fibers ([0084]); and an analog-to-digital converter (34), coupled to the multiplexer, adapted to form digital data representing the electrical neural signals ([0069]).
Regarding claim 7, Leyde further discloses (Figures 6-7) a digital-to analog converter, coupled to a multiplexer (42), adapted to form an analog electrical signal based on digital data representing a stimulation signal; and a multiplexer (42), coupled to the circuitry adapted to transmit electrical neural signals, adapted to select at least one of the plurality of fibers to receive the analog electrical signal ([0074]: the device “may optionally comprise dedicated circuitry of a digital or analog or combined digital/analog nature, ASIC, DSP and/or a fast microprocessor,” therefore, there would need to be a digital-to-analog converter coupled to a multiplexer to turn the digital data into an analog electrical signal for use; [0084]: the device is adapted to select at least one of the different signals).
Regarding claim 21, Leyde discloses (Figures 6-7) a brain-machine interface device (24) adapted to be entirely implanted within a body of a person for interacting with brain tissue ([0064]) comprising an electrode array comprising a plurality of electrodes adapted to be directly implanted in the brain tissue and adapted to provide high-density neural connections ([0041], [0063]-[0064], [0069]-[0074], [0092]-[0094]). Leyde fails to disclose that the electrode array is a carbon nanotube fiber based electrode array comprising a plurality of electrically conductive carbon nanotubes adapted to provide direct high-density neural connections, wherein the neural connections are non-destructive to living neural tissue. However, Llinas teaches a brain-machine interface device comprising carbon nanotube fibers as electrodes adapted to provide direct high-density neural connections ([0037]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the electrodes disclosed by Leyde with the carbon nanotubes fibers taught by Llinas because both electrodes perform the same function of transmitting electrical signals, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B). Furthermore, in the modified device, the electrode array would be a carbon nanotube based electrode array and the neural connections would be non-destructive to living neural tissue.
Leyde/Llinas fails to teach that the electrode array is adapted to provide direct high-density neural connections with pyramidal layers of brain tissue. However, Fowler teaches a system for interacting with living tissue wherein a device is adapted to receive electrical signals from pyramidal layers within a brain cortical structure ([0060]-[0064]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Leyde/Llinas to such that the electrode array is adapted to provide direct high-density neural connections with pyramidal layers of brain tissue, as taught by Fowler, because the modification would provide specific electrical signal measurement with a desired brain cortical structure as desired for treatment (Fowler; [0060]).
Leyde/Llinas/Fowler fails to teach a gel membrane entirely surrounding the brain-machine interface device and the carbon nanotube fibers adapted to ensure upright position of the carbon nanotube fibers and to attract neurons to the carbon nanotube fibers when implanted. However, Kaplan teaches an implant device comprising a silk gel membrane entirely surrounding electrodes of an implant device ([0112], [0180]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Leyde/Llinas/Fowler to include a gel membrane entirely surrounding the brain-machine interface device and the electrodes (carbon nanotube fibers), as taught by Kaplan, because the modification would improve long-term functionality of the implant device (Kaplan; [0023]). Furthermore, since the gel membrane taught by Kaplan may provide sufficient mechanical stiffness (Kaplan; [0057]) and improve gel-tissue interfaces (Kaplan; [0180]), the gel membrane of the modified device would be adapted to ensure upright position of the carbon nanotube fibers and to attract neurons to the carbon nanotube fibers when implanted.
Leyde/Llinas/Fowler/Kaplan fails to teach that the brain-machine interface device has an oblate spheroid shape. However, Ghaffari teaches a method using a brain-machine interface device (200), which may be shaped as an oblate spheroid ([0079], [0188]). It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Leyde/Llinas/Fowler/Kaplan to include the brain-machine interface device shaped as an oblate spheroid, as taught by Ghaffari, since applicant has not disclosed that having the brain-machine interface device shaped as an oblate spheroid solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the brain-machine interface device shaped as an oblate spheroid, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 26, the Leyde/Llinas/Fowler/Kaplan combination further teaches that there are greater than ten carbon nanotube based electrodes (Leyde discloses that there are greater than ten electrodes, [0043]; the electrodes of the modified device are carbon nanotube based).
Regarding claim 29, the Leyde/Llinas/Fowler/Kaplan combination further discloses that the device comprises at least one electrode array having at least ten electrodes (Leyde; [0043]) with carbon nanotube based electrodes attached to a first side of the device and metal contacts (contacts required for signal transmission) formed on a second side of the device.
Regarding claim 32, the Leyde/Llinas/Fowler/Kaplan combination teaches the device of claim 21, but fails to teach that the gel is adapted to be solid at about 250 C and a liquid at about 370 C. However, the temperature at which the gel is adapted to be solid and the temperature at which the gel is adapted to be liquid are simply result effective variables that optimize when the gel remains solid on the implant, and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. MPEP 2144.05(II)(B).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Leyde/Llinas/Fowler/Kaplan/Ghaffari, as applied to claim 3, and further in view of Sridhar et al., (US 20160120432; hereinafter Sridhar).
Regarding claim 4, the Leyde/Llinas/Fowler/Kaplan/Ghaffari combination teaches the device of claim 3, but fails to teach that the analog-to-digital converter has a resolution of up to 24 bits per sample. However, Sridhar teaches a neural implant system using an analog-to-digital converter having a resolution of up to 24 bits per sample ([0059]-[0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the analog-to-digital converter disclosed by Leyde with the analog-to-digital converter taught by Sridhar because both analog-to-digital converters perform the same function of forming digital data representing electrical signals, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Leyde/Llinas/Fowler/Kaplan/Ghaffari, as applied to claim 3, and further in view of Jackson et al., (US 20170164852; hereinafter Jackson).
Regarding claim 5, the Leyde/Llinas/Fowler/Kaplan/Ghaffari combination teaches the device of claim 3, but fails to teach that the analog-to-digital converter has a resolution of from 8 bits per sample to 12 bits per sample. However, Jackson teaches a system for a brain-computer interface using an analog-to-digital converter which has a resolution of from 8 bits per sample to 12 bits per sample ([0055]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the analog-to-digital converter disclosed by Leyde with the analog-to-digital converter taught by Jackson because both analog-to-digital converters perform the same function of forming digital data representing electrical signals, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Regarding claim 6, the Leyde/Llinas/Fowler/Kaplan/Ghaffari combination teaches the device of claim 3, but fails to teach that the analog-to-digital converter has a variable resolution of from 8 bits per sample to 12 bits per sample. However, Jackson teaches a system for a brain-computer interface using an analog-to-digital converter which has a variable resolution of from 8 bits per sample to 12 bits per sample ([0055]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the analog-to-digital converter disclosed by Leyde with the analog-to-digital converter taught by Jackson because both analog-to-digital converters perform the same function of forming digital data representing electrical signals, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over in view of Leyde in view of Park et al., (US 20130237906; hereinafter Park), Kaplan, and Ghaffari.
Regarding claims 8-9, Leyde discloses (Figures 6-7) an implant device (24) adapted to be entirely implanted within a body of a person for interacting with brain tissue ([0064]) comprising: a plurality of electrodes ([0063]-[0064]: A-H/I-P as shown in arrays 9/11) adapted to be directly implanted in the brain tissue ([0041]), to connect to and receive signals from electrophysiological neural signals of the brain tissue and to transmit signals to provide electrophysiological stimulation of the brain tissue, the electrodes (A-H/I-P) coupled to at least one readout integrated circuit ([0072]); and at least one readout integrated circuit comprising a plurality of cells of circuitry (the signal connection between each electrode to the A/D converter), each cell electrically coupled to at least one electrode, each cell of circuitry comprising: circuitry adapted to receive the signals from the plurality of electrodes and to process the signals to form digital data representing the neural signals (which is performed by the A/D converter); and circuitry adapted to transmit signals through the plurality of electrodes ([0046]: the sensing and stimulation may be performed by the same electrodes) so as to provide electrophysiological stimulation of the brain tissue ([0063]-[0064], [0069]-[0074], [0092]-[0094]).
Leyde fails to disclose that the plurality of electrodes are a plurality of optically conductive fibers comprising optical fibers adapted to receive optical signals from electrophysiological neural signals of brain tissue and to transmit optical signals to provide electrophysiological stimulation of the brain tissue, the fibers optically coupled to at least one readout integrated circuit. However, Park teaches (Figure 1) an implant device adapted to be implanted within a body of a person for interacting with brain tissue in which the electrodes are electro-optrode fibers (10, 40) comprising an optical fiber (10) adapted to receive optical signals from electrophysiological neural signals of brain tissue and to transmit optical signals to provide electrophysiological stimulation of the brain tissue ([0046]-[0051]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the electrodes disclosed by Leyde with the electro-optrode fibers taught by Park because both electrodes perform the same function of transmitting signals, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B). Furthermore, the modification would enable electrode design in which an optical technique for recording a neural signal without an artifact signal and an electrode technique for electrically recording a neural signal are embodied on a single electrode (Park; [0036]). In the modified device, the optical fibers would be adapted to receive optical signals from electrophysiological neural signals of brain tissue and to transmit optical signals to provide electrophysiological stimulation of the brain tissue, the fibers optically coupled to at least one readout integrated circuit.
Leyde/Park fails to teach a gel membrane entirely surrounding the implant device and the plurality of optically conductive fibers adapted to ensure upright position of the plurality of optically conductive fibers and to attract neurons to the plurality of optically conductive fibers when implanted. However, Kaplan teaches an implant device comprising a silk gel membrane entirely surrounding electrodes of an implant device ([0112], [0180]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Leyde/Park to include a gel membrane entirely surrounding the implant device and the electrodes (plurality of optically conductive fibers), as taught by Kaplan, because the modification would improve long-term functionality of the implant device (Kaplan; [0023]). Furthermore, since the gel membrane taught by Kaplan may provide sufficient mechanical stiffness (Kaplan; [0057]) and improve gel-tissue interfaces (Kaplan; [0180]), the gel membrane of the modified device would be adapted to ensure upright position of the plurality of optically conductive fibers and to attract neurons to the plurality of optically conductive fibers when implanted.
Leyde/Park/Kaplan fails to teach that implant device has an oblate spheroid shape, wherein the plurality of electrically conductive carbon nanotubes radially stem from the oblate spheroid implant device. However, Ghaffari teaches a method using an implant device (200), which may be shaped as an oblate spheroid ([0079], [0188]). It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Leyde/Park/Kaplan to include the implant device shaped as an oblate spheroid, as taught by Ghaffari, since applicant has not disclosed that having the implant device shaped as an oblate spheroid solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the implant device shaped as an oblate spheroid, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. Accordingly, the modified device would include the plurality of electrically conductive carbon nanotubes radially stemming from the oblate spheroid implant device.
Regarding claim 10, the Leyde/Park/Kaplan/Ghaffari combination further teaches an optical multiplexer (the multiplexer 42 in Figure 7 of Leyde would be an optical multiplexer in the modified device), coupled to the circuitry adapted to receive and process the optical signals ([0072]-[0074]: the signals in Leyde would be optical signals in the modified device), adapted to select at least one of the optical signals from the plurality of fibers ([0084]: the signals in Leyde would be optical signals in the modified device); circuitry, coupled to the multiplexer, adapted to convert the optical signals to analog electrical signals; and an analog-to-digital converter, coupled to the circuitry adapted to convert the optical signals to analog electrical signals, adapted to form digital data representing the analog electrical signals ([0069]: the modified device would include signal processors to convert the optical signals to analog signals for transmission).
Regarding claim 11, the Leyde/Park/Kaplan/Ghaffari combination further teaches circuitry, coupled to a multiplexer (42), adapted to form an analog electrical signal based on digital data representing a stimulation signal; and a multiplexer (42), coupled to the circuitry adapted to transmit the optical signals, adapted to select at least one of the plurality of fibers to receive the optical signal ([0074]: the device “may optionally comprise dedicated circuitry of a digital or analog or combined digital/analog nature, ASIC, DSP and/or a fast microprocessor,” therefore, there would need to be a digital-to-analog converter coupled to a multiplexer to turn the digital data into an analog electrical signal for use; [0084]: the device is adapted to select at least one of the different signals).
Claims 12-20 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Leyde, Park, Kaplan, and Ghaffari.
Regarding claims 12 and 14-15, Leyde discloses (Figures 6-7) an implant device (24) adapted to be entirely implanted within a body of a person for interacting with brain tissue ([0064]) comprising: a plurality of fibers ([0063]-[0064]: electrodes), adapted to be directly implanted in the brain tissue ([0041]), to connect to and receive electrical signals from electrophysiological neural signals of the brain tissue and to transmit the signals to provide electrophysiological stimulation of the brain tissue, the fibers electrically and optically coupled to at least one readout integrated circuit ([0063]-[0064], [0069]-[0074], [0092]-[0094).
Leyde fails to disclose that the plurality of electrodes are a plurality of optically conductive fibers comprising optical fibers adapted to receive optical signals from electrophysiological neural signals of brain tissue and to transmit optical signals to provide electrophysiological stimulation of the brain tissue, the fibers optically coupled to at least one readout integrated circuit. However, Park teaches (Figure 1) an implant device adapted to be implanted within a body of a person for interacting with brain tissue in which the electrodes are electro-optrode fibers (10, 40) comprising an optical fiber (10) adapted to receive optical signals from electrophysiological neural signals of brain tissue and to transmit optical signals to provide electrophysiological stimulation of the brain tissue ([0046]-[0051]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the electrodes disclosed by Leyde with the electro-optrode fibers taught by Park because both electrodes perform the same function of transmitting signals, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B). Furthermore, the modification would enable electrode design in which an optical technique for recording a neural signal without an artifact signal and an electrode technique for electrically recording a neural signal are embodied on a single electrode (Park; [0036]). In the modified device, the optical fibers would be adapted to receive optical signals from electrophysiological neural signals of brain tissue and to transmit optical signals to provide electrophysiological stimulation of the brain tissue, the fibers optically coupled to at least one readout integrated circuit.
Leyde/Park fails to teach a gel membrane entirely surrounding the implant device and the plurality of fibers adapted to ensure upright position of the plurality of fibers and to attract neurons to the plurality of fibers when implanted. However, Kaplan teaches an implant device comprising a silk gel membrane entirely surrounding electrodes of an implant device ([0112], [0180]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Leyde/Park to include a gel membrane entirely surrounding the implant device and the electrodes (plurality of fibers), as taught by Kaplan, because the modification would improve long-term functionality of the implant device (Kaplan; [0023]). Furthermore, since the gel membrane taught by Kaplan may provide sufficient mechanical stiffness (Kaplan; [0057]) and improve gel-tissue interfaces (Kaplan; [0180]), the gel membrane of the modified device would be adapted to ensure upright position of the plurality of fibers and to attract neurons to the plurality of fibers when implanted.
Leyde/Park/Kaplan fails to teach that implant device has an oblate spheroid shape, wherein the plurality of electrically conductive carbon nanotubes radially stem from the oblate spheroid implant device. However, Ghaffari teaches a method using an implant device (200), which may be shaped as an oblate spheroid ([0079], [0188]). It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Leyde/Park/Kaplan to include the implant device shaped as an oblate spheroid, as taught by Ghaffari, since applicant has not disclosed that having the implant device shaped as an oblate spheroid solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the implant device shaped as an oblate spheroid, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. Accordingly, the modified device would include the plurality of electrically conductive carbon nanotubes radially stemming from the oblate spheroid implant device.
Regarding claim 13, Leyde further discloses (Figures 6-7) at least one readout integrated circuit ([0074]) comprising a plurality of cells of circuitry (signal path), each cell electrically and optically coupled to at least one fiber (each signal processing and transmission path is electrically coupled to a particular electrode; in the modified device, each cell is optically coupled to a respective fiber as well).
Regarding claim 16, the Leyde/Park/Kaplan/Ghaffari combination further teaches that each cell (signal path) of the at least one readout integrated circuit comprises: circuitry adapted to receive the electrical neural signals from the plurality of carbon nanotubes (in the modified device, the electrodes would comprise optical fibers coated with carbon nanotubes) and to process the electrical neural signals to form digital data representing the neural signals; circuitry adapted to transmit electrical neural signals through the plurality of carbon nanotubes so as to provide electrophysiological stimulation of the brain tissue; circuitry adapted to receive the optical signals from the plurality of optical fibers and to process the optical signals to form digital data representing the optical signals; and circuitry adapted to transmit optical signals through the plurality of optical fibers so as to provide electrophysiological stimulation of the brain tissue ([0046], [0063]-[0064], [0069]-[0074], [0092]-[0094]).
Regarding claim 17, Leyde further discloses (Figures 6-7) a multiplexer (42), coupled to the circuitry adapted to receive and process the electrical neural signals ([0072]-[0074]), adapted to select at least one of the electrical neural signals from the plurality of carbon fibers ([0084]: the electrodes comprises carbon fibers in the modified device); and an analog-to-digital converter (34), coupled to the multiplexer (42), adapted to form digital data representing the electrical neural signals ([0069]).
Regarding claim 18, Leyde further discloses (Figures 6-7) an digital-to analog converter, coupled to a multiplexer (42), adapted to form an analog electrical signal based on digital data representing a stimulation signal; and a multiplexer (42), coupled to the circuitry adapted to transmit the electrical neural signals, adapted to select at least one of the plurality of carbon fibers to receive the analog electrical signal ([0074]: the device “may optionally comprise dedicated circuitry of a digital or analog or combined digital/analog nature, ASIC, DSP and/or a fast microprocessor,” therefore, there would need to be a digital-to-analog converter coupled to a multiplexer to turn the digital data into an analog electrical signal for use; [0084]: the device is adapted to select at least one of the different signals).
Regarding claim 19, the Leyde/Park/Kaplan/Ghaffari combination further teaches an optical multiplexer, coupled to the circuitry adapted to receive and process the optical signals, adapted to select at least one of the optical signals from the plurality of fibers; circuitry, coupled to the multiplexer, adapted to convert the optical signals to analog electrical signals; and an analog-to-digital converter, coupled to the circuitry adapted to convert the optical signals to analog electrical signals, adapted to form digital data representing the analog electrical signals ([0074]: the device “may optionally comprise dedicated circuitry of a digital or analog or combined digital/analog nature, ASIC, DSP and/or a fast microprocessor,” therefore, there would need to be an optical multiplexer processing optical signals in the same way as the other multiplexer processes the other signals, and an analog-to-digital converter coupled to the multiplexer to turn form digital data representing the analog electrical signals for use; [0084]: the device is adapted to select at least one of the different signals).
Regarding claim 20, the Leyde/Park/Kaplan/Ghaffari combination further teaches circuitry, coupled to a multiplexer (46), adapted to form an analog electrical signal based on digital data representing a stimulation signal; and a multiplexer (42), coupled to the circuitry adapted to transmit the optical signals, adapted to select at least one of the plurality of carbon fibers to receive the optical signal ([0046], [0063]-[0064], [0069]-[0074], [0092]-[0094]; in the modified device, the signal is the optical signal from the plurality of carbon fibers).
Regarding claim 30, the Leyde/Park/Kaplan/Ghaffari combination further teaches that the device comprises at least one electrode array having at least ten electrodes (Leyde; [0043]) with metal contacts formed on both sides of the device (metal contacts on both sides are required for signal transmission).
Claims 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Leyde/Llinas/Fowler/Kaplan/Ghaffari, as applied to claim 21, and further in view of Mori et al., (US 20140146211; hereinafter Mori).
Regarding claims 22-25, the Leyde/Llinas/Fowler/Kaplan/Ghaffari combination teaches the device of claim 21, but fails to teach that the carbon nanotube based electrodes are integrated with solid-state imager readout circuitry, the solid-state imager readout circuitry has pixel densities on a micron pitch scale, the carbon nanotube based electrodes and the solid- state imager readout circuitry are adapted to provide single neuron readout, and the solid-state imager readout circuitry comprises carbon nanotube based electrodes adapted to readout an electrical potential from individual neurons and light-emitting diodes for optical stimulation of individual neurons. However, Mori teaches solid-state imager readout circuitry, the solid-state imager readout circuitry has pixel densities on a micron pitch scale ([0004], [0142]-[0147]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Leyde/Llinas/Fowler/Kaplan/Ghaffari combination to include solid-state imager readout circuitry, the solid-state imager readout circuitry has pixel densities on a micron pitch scale, as taught by Mori, because the modification would provide low power consumption from the readout circuitry (Mori; [0049]). Furthermore, in the modified device, the carbon nanotube based electrodes would be integrated with the solid-state imager readout circuitry, the carbon nanotube based electrodes and the solid-state imager readout circuitry adapted to provide single neuron readout (since the electrodes in Leyde are configured for single neuron readout as well, [0036]), and the solid-state imager readout circuitry comprising carbon nanotube based electrodes adapted to readout an electrical potential from individual neurons and light-emitting diodes (photo diodes in Mori) for optical stimulation of individual neurons (since the electrodes in Leyde are configured for single neuron readout and stimulation as well).
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Leyde/Llinas/Fowler/Kaplan/Ghaffari, as applied to claim 21, and further in view of Wei et al., (US 20080007154; hereinafter Wei).
Regarding claim 27, the Leyde/Llinas/Fowler/Kaplan/Ghaffari combination teaches the device of claim 21, but fails to teach that the device comprises: a micro-channel glass array substrate; a plurality of carbon nanotube based electrodes attached to a first side of the micro- channel glass array substrate; a plurality of metal wires formed through channels in the micro-channel glass array substrate, each metal wire in electrical contact with one carbon nanotube based electrode; and a plurality of metal contacts formed on a second side of the micro-channel glass array substrate, each metal contact in electrical contact with one metal wire. However, Wei teaches (Figures 2-5) a carbon nanotube based array which comprises a micro-channel glass array substrate (101); a plurality of carbon nanotube based electrodes (104) attached to a first side of the micro- channel glass array substrate (101); a plurality of metal wires (103) formed through channels in the micro-channel glass array substrate (101), each metal wire in electrical contact with one carbon nanotube based electrode (104); and a plurality of metal contacts (102) formed on a second side of the micro-channel glass array substrate (101), each metal contact (102) in electrical contact with one metal wire (103), ([0023]-[0024]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Leyde/Llinas/Fowler/Kaplan/Ghaffari combination to include a micro-channel glass array substrate; a plurality of carbon nanotube based electrodes attached to a first side of the micro- channel glass array substrate; a plurality of metal wires formed through channels in the micro-channel glass array substrate, each metal wire in electrical contact with one carbon nanotube based electrode; and a plurality of metal contacts formed on a second side of the micro-channel glass array substrate, each metal contact in electrical contact with one metal wire, as taught by Wei, because the modification would provide a device that is simple in structure and easy to be produced and assembled (Wei; [0011]).
Regarding claim 28, the Leyde/Llinas/Fowler/Kaplan//Ghaffari/Wei combination teaches the device of claim 27, but fails to teach that the micro-channel glass array substrate is about one millimeter in thickness. However, the thickness of the substrate is simply a result-effective variable which optimizes the size of the structure, and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. MPEP 2144.05(II)(B).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Leyde/Llinas/Fowler/Kaplan/Ghaffari, as applied to claim 21, and further in view of Aubourg et al., (US 20050032219; hereinafter Aubourg).
Regarding claim 31, the Leyde/Llinas/Fowler/Kaplan/Ghaffari combination teaches the device of claim 21, but fails to teach a virus vector carried on tips of the carbon nanotube based electrodes. However, Aubourg teaches a system to deliver a virus vector to neurons ([0016]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Leyde/Llinas/Fowler/Kaplan/Ghaffari combination to carry a virus vector for delivery to neurons, as taught by Aubourg, because the modification would allow the treatment of many neurological disorders, especially motor neuron disorders and disorders characterized by neurodegeneration within specific connected neuron populations (Aubourg; [0017]). Furthermore, in order for the virus vector to be delivered to the neurons in the modified device, it would need to be carried on the carbon nanotube based electrodes, including the tips.
Response to Arguments
Applicant’s arguments, filed 12/09/2025, regarding the newly amended claim limitations, have been fully considered and are persuasive. Therefore, the rejection(s) has/have been withdrawn. However, upon further consideration, a new ground(s) of rejection is/are made in view of newly found prior art reference Ghaffari, which teaches an implant device, which may be shaped as an oblate spheroid. In combination with Leyde/Llinas/Fowler/Kaplan, the modified device teaches the invention as recited at least in amended independent claims 1 and 21. In combination with Leyde/Park/Kaplan, the modified device teaches the invention as recited at least in amended independent claims 8 and 12.
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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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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