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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruffini et al., (US 20110190846; hereinafter Ruffini) in view of Ghaffari et al., (US 20100298895; hereinafter Ghaffari), Arumugam et al., (US 20150250421; hereinafter Arumugam), Roukes et al., (US 20160150963; hereinafter Roukes), Flaherty et al., (US 20050273890; hereinafter Flaherty), and Llinas (US 20040133118).
Regarding claim 1, Ruffini (Figure 1) discloses a system to provide self-guided, self-directed diagnostics and treatment of neural conditions ([0024], [0049]) comprising: a processor (PDPU+SR), memory (storage of the processor) accessible by the processor (PDPU+SR), and program instructions and data (stimulation/monitoring application) stored in the memory; a plurality of stimulation devices (E1-En) comprising electrical stimulation devices connected to signal output circuitry (communications module) interfacing the processor (PDPU+SR) with the plurality of stimulation devices (E1-En), wherein the program instructions and data stored in the memory are configured so that the processor (PDPU+SR) generates and transmits stimulation signals to the plurality of stimulation devices (E1-En); and a plurality of sensing devices (S1-Sn) comprising electrical sensing devices connected to signal input circuitry (communications module) interfacing the processor (PDPU+SR) with the plurality of sensing devices (S1-Sn), the electrical sensing devices (S1-Sn) comprising electrical terminals ([0031]: the sensing devices may be the electrophysiological sensors described in patent application ES2289948, which include electrical terminals capable of sensing voltage and current between the electrical terminals), wherein the program instructions and data stored in the memory are further configured so that the processor (PDPU+SR) receives sensed signals from the plurality of sensing devices (S1-Sn), the sensed signals comprising voltage and current between the electrical terminals so as to determine flow of electrons and positive ions through the brain ([0031]: as explained above, the electrophysiological sensors described in patent application ES2289948 include electrical terminals capable of sensing voltage and current between the electrical terminals so as to determine flow of electrons and positive ions through the brain); wherein the program instructions and data stored in the memory are further configured so that the processor (PDPU+SR) performs real-time dynamic closed loop feedback of the stimulation signals comprising adjusting stimulation signal intensity, frequency, and location, based on the received sensed signals to provide self-guided, self-directed diagnostics and treatment of neural conditions using at least one recipe for a treatment strategy guided by artificial intelligence ([0034]-[0037], [0074]-[0085]).
Ruffini fails to disclose that the plurality of stimulation devices comprises chemical and optical stimulation devices in addition to the electrical stimulation devices; and the plurality of sensing devices comprise chemical and optical sensing devices in addition to the electrical sensing devices, wherein the chemical sensing devices comprise carbon nanotubes. However, Ghaffari (Figures 1 and 7A) teaches a plurality of multifunction pixels (1010B) which may comprise stimulation devices and sensing devices. Each multifunction pixel (1010B) is a unit comprising electrical sensing devices (respective electrical sensors), chemical sensing devices (respective chemical sensors), optical sensing devices (respective optical sensors), electrical stimulation devices (respective electrical actuators), chemical stimulation devices (respective chemical actuators), and optical stimulation devices (respective optical actuators), ([0114], [0119]-[0128], [0131]-[0134]), wherein the chemical sensing devices comprise carbon nanotubes ([0107], [0233]: sensing devices may be based on semiconductor technology, which may include carbon nanotubes). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ruffini to include the plurality of stimulation devices comprising chemical and optical stimulation devices in addition to the electrical stimulation devices, and the plurality of sensing devices comprising chemical and optical sensing devices in addition to the electrical sensing devices, as taught by Ghaffari, because the modification would provide a dynamically configurable system ([0012], [0043]) with multiple sensing and stimulation modalities for enhanced performance.
Ruffini/Ghaffari fails to teach wherein the chemical sensing devices utilize fast-scan cyclic voltammetry. However, Arumugam teaches a chemical sensing device utilizing fast-scan cyclic voltammetry ([0063], [0124]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ruffini/Ghaffari to include chemical sensing devices utilizing fast-scan cyclic voltammetry because the modification would provide sensors which afford a superior combination of temporal and chemical resolution compared to other electro-analytical techniques (Arumugam; [0010]).
Ruffini/Ghaffari/Arumugam fails to teach wherein the optical sensing devices are small enough to identify neurons involved in specific chemical interactions. However, Roukes teaches a sensing system in which the optical sensing devices (optical detectors) are small enough to identify neurons involved in specific chemical interactions ([0006], [0055], [0061]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ruffini/Ghaffari/Arumugam to include the optical sensing devices small enough to identify neurons involved in specific chemical interactions, as taught by Roukes, because the modification would permit simultaneous recording from millions of neurons, at arbitrary positions and depths in the brain, to unveil dynamics of complete neural networks—with single-cell resolution and cell-type specificity (Roukes; [0006]).
Ruffini/Ghaffari/Arumugam/Roukes fails to teach wherein the plurality of stimulation devices utilize optic fibers coated with single wall carbon nanotubes to deliver at least one electrical signal and at least one optical signal to living brain tissue; wherein the plurality of sensing devices include the optic fibers coated with single wall carbon nanotubes to receive at least one second electrical signal and at least one second optical signal from the living brain tissue. However, Flaherty teaches an apparatus for interacting with brain tissue, comprising a plurality of optically conductive fibers comprising optic fibers as active elements ([0031], [0048], [0092]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ruffini/Ghaffari/Arumugam/Roukes to include a plurality of optic fibers, as taught by Flaherty, because the modification would provide other means of transmitting data and/or power, which may be used in combination with other active elements to transmit information between different components of the apparatus (Flaherty; [0048]). Furthermore, Llinas teaches an implant device adapted to be implanted within a body of a person for interacting with brain tissue comprising a plurality of fibers coated with carbon nanotubes as active elements ([0037]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a carbon nanotube coating, as taught by Llinas, because the modification would allow the interface to be removed without violating the integrity of the brain (Llinas; [0019]). Accordingly, in the modified device, the plurality of stimulation devices utilize optic fibers would be coated with single wall carbon nanotubes to deliver at least one electrical signal and at least one optical signal to living brain tissue; wherein the plurality of sensing devices would include the optic fibers coated with single wall carbon nanotubes to receive at least one second electrical signal and at least one second optical signal from the living brain tissue.
Regarding claim 2, Ruffini (Figure 1) further discloses that the plurality of stimulation devices (E1-En) comprises at least one of a Transcranial Direct Current Stimulation (tDCS) device, a Transcranial Alternating Current Stimulation (tACS), a Transcranial Photobiomodulation (tPBM), an implanted device providing electrical stimulation, an implanted device providing optical stimulation, and an implanted device providing both electrical and optical stimulation ([0026]).
Regarding claim 3, Ruffini (Figure 1) further discloses that the plurality of sensing devices (S1-Sn) comprises at least one of an Electro Encephalogram (EEG) device, an implanted device providing electrical sensing, an implanted device providing optical sensing, and an implanted device providing both electrical and optical sensing ([0031], [0047]).
Regarding claim 4, Ruffini (Figure 1) further discloses that the program instructions and data stored in the memory are configured so that the processor performs: applying stimulation based on a first version of stimulation parameters ([0036]); sensing results of the applied stimulation to form patient treatment results data; modifying the first version of stimulation parameters using the patient treatment results data to form a second version of stimulation parameters; and applying stimulation based on the second version of stimulation parameters ([0024], [0037], [0049]).
Regarding claim 5, Ruffini (Figure 1) further discloses that the program instructions and data stored in the memory are configured so that the processor performs: applying stimulation based on a version of stimulation parameters ([0036]); sensing results of the applied stimulation to form patient treatment results data; modifying the version of stimulation parameters using the patient treatment results data to form a modified version of stimulation parameters; and repeating the applying, sensing, and modifying using each modified version of stimulation parameters ([0024], [0037], [0049]).
Regarding claim 6, Ruffini (Figure 1) discloses a method of providing self-guided, self-directed diagnostics and treatment of neural conditions ([0024], [0049]) comprising: applying stimulation using a plurality of stimulation devices (E1-En) comprising electrical stimulation devices connected to signal output circuitry (communications module) interfacing a processor (PDPU+SR) with the plurality of stimulation devices (E1-En), wherein the processor (PDPU+SR), is communicably connected to accessible memory (storage of the processor), and the memory stores program instructions and data (stimulation/monitoring application), and wherein the program instructions and data stored in the memory are configured so that the processor (PDPU+SR) generates and transmits stimulation signals to the stimulation devices (E1-En); sensing results of the applied stimulation using a plurality of sensing devices (S1-Sn) comprising electrical sensing devices, the electrical sensing devices (S1-Sn) comprising electrical terminals ([0031]: the sensing devices may be the electrophysiological sensors described in patent application ES2289948, which include electrical terminals capable of sensing voltage and current between the electrical terminals) connected to signal input circuitry (communications module) interfacing the processor (PDPU+SR) with the sensing devices (S1-Sn) wherein the program instructions and data stored in the memory are further configured so that the processor (PDPU+SR) receives sensed signals from the sensing devices (S1-Sn) and uses the sensed signals, the sensed signals comprising voltage and current between the electrical terminals so as to determine flow of electrons and positive ions through the brain ([0031]: as explained above, the electrophysiological sensors described in patent application ES2289948 include electrical terminals capable of sensing voltage and current between the electrical terminals so as to determine flow of electrons and positive ions through the brain), to form patient treatment results data; and performing real-time dynamic closed loop feedback of the stimulation signals comprising adjusting stimulation signal intensity, frequency, and location, based on the received sensed signals to provide self-guided, self-directed diagnostics and treatment of neural conditions using at least one recipe for a treatment strategy guided by artificial intelligence ([0011]-[0015], [0028], [0103]-[0107], [0132]-[0133]).
Ruffini fails to disclose that the plurality of stimulation devices comprise chemical and optical stimulation devices in addition to the electrical stimulation devices; and the plurality of sensing devices comprise chemical and optical sensing devices in addition to the electrical sensing devices, wherein the chemical sensing devices comprise carbon nanotubes. However, Ghaffari (Figures 1 and 7A) teaches a plurality of multifunction pixels (1010B) which may comprise stimulation devices and sensing devices. Each multifunction pixel (1010B) is a unit comprising electrical sensing devices (respective electrical sensors), chemical sensing devices (respective chemical sensors), optical sensing devices (respective optical sensors), electrical stimulation devices (respective electrical actuators), chemical stimulation devices (respective chemical actuators), and optical stimulation devices (respective optical actuators), ([0114], [0119]-[0128], [0131]-[0134]), wherein the chemical sensing devices comprise carbon nanotubes ([0107], [0233]: sensing devices may be based on semiconductor technology, which may include carbon nanotubes). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ruffini to include the plurality of stimulation devices comprising chemical and optical stimulation devices in addition to the electrical stimulation devices, and the plurality of sensing devices comprising chemical and optical sensing devices in addition to the electrical sensing devices, as taught by Ghaffari, because the modification would provide a dynamically configurable system ([0012], [0043]) with multiple sensing and stimulation modalities for enhanced performance.
Ruffini/Ghaffari fails to teach wherein the chemical sensing devices utilize fast-scan cyclic voltammetry. However, Arumugam teaches a chemical sensing device utilizing fast-scan cyclic voltammetry ([0063], [0124]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ruffini/Ghaffari to include chemical sensing devices utilizing fast-scan cyclic voltammetry because the modification would provide sensors which afford a superior combination of temporal and chemical resolution compared to other electro-analytical techniques (Arumugam; [0010]).
Ruffini/Ghaffari/Arumugam fails to teach wherein the optical sensing devices are small enough to identify neurons involved in specific chemical interactions. However, Roukes teaches a sensing system in which the optical sensing devices (optical detectors) are small enough to identify neurons involved in specific chemical interactions ([0006], [0055], [0061]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ruffini/Ghaffari/Arumugam to include the optical sensing devices small enough to identify neurons involved in specific chemical interactions, as taught by Roukes, because the modification would permit simultaneous recording from millions of neurons, at arbitrary positions and depths in the brain, to unveil dynamics of complete neural networks—with single-cell resolution and cell-type specificity (Roukes; [0006]).
Ruffini/Ghaffari/Arumugam/Roukes fails to teach wherein the plurality of stimulation devices utilize optic fibers coated with single wall carbon nanotubes to deliver at least one electrical signal and at least one optical signal to living brain tissue; wherein the plurality of sensing devices include the optic fibers coated with single wall carbon nanotubes to receive at least one second electrical signal and at least one second optical signal from the living brain tissue. However, Flaherty teaches an apparatus for interacting with brain tissue, comprising a plurality of optically conductive fibers comprising optic fibers as active elements ([0031], [0048], [0092]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ruffini/Ghaffari/Arumugam/Roukes to include a plurality of optic fibers, as taught by Flaherty, because the modification would provide other means of transmitting data and/or power, which may be used in combination with other active elements to transmit information between different components of the apparatus (Flaherty; [0048]). Furthermore, Llinas teaches an implant device adapted to be implanted within a body of a person for interacting with brain tissue comprising a plurality of fibers coated with carbon nanotubes as active elements ([0037]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a carbon nanotube coating, as taught by Llinas, because the modification would allow the interface to be removed without violating the integrity of the brain (Llinas; [0019]). Accordingly, in the modified device, the plurality of stimulation devices utilize optic fibers would be coated with single wall carbon nanotubes to deliver at least one electrical signal and at least one optical signal to living brain tissue; wherein the plurality of sensing devices would include the optic fibers coated with single wall carbon nanotubes to receive at least one second electrical signal and at least one second optical signal from the living brain tissue.
Regarding claim 7, Ruffini (Figure 1) further discloses that the plurality of stimulation devices (effectors) comprises at least one of a Transcranial Direct Current Stimulation (tDCS) device, a Transcranial Alternating Current Stimulation (tACS), a Transcranial Photobiomodulation (tPBM), an implanted device providing electrical stimulation, an implanted device providing optical stimulation, and an implanted device providing both electrical and optical stimulation ([0026]).
Regarding claim 8, Ruffini (Figure 1) further discloses that the plurality of sensing devices (sensors) comprises at least one of an Electro Encephalogram (EEG) device, an implanted device providing electrical sensing, an implanted device providing optical sensing, and an implanted device providing both electrical and optical sensing ([0031]-[0047]).
Regarding claim 9, Ruffini (Figure 1) further discloses applying stimulation based on a first version of stimulation parameters ([0036]); sensing results of the applied stimulation to form patient treatment results data; modifying the first version of stimulation parameters using the patient treatment results data to form a second version of stimulation parameters; and applying stimulation based on the second version of stimulation parameters ([0024], [0037], [0049]).
Regarding claim 10, Ruffini (Figure 1) further discloses applying stimulation based on a version of stimulation parameters ([0036]); sensing results of the applied stimulation to form patient treatment results data; modifying the version of stimulation parameters using the patient treatment results data to form a modified version of stimulation parameters; and repeating the applying, sensing, and modifying using each modified version of stimulation parameters ([0024], [0037], [0049]).
Response to Arguments
Applicant’s arguments, filed 12/12/2025, with regard to the newly filed claim amendments, 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 in view of newly found prior art references Flaherty and Llinas, which in combination teach the plurality of stimulation devices utilize optic fibers being coated with single wall carbon nanotubes to deliver at least one electrical signal and at least one optical signal to living brain tissue; wherein the plurality of sensing devices include the optic fibers coated with single wall carbon nanotubes to receive at least one second electrical signal and at least one second optical signal from the living brain tissue. Therefore, the Ruffini/Ghaffari/Arumugam/Roukes/Flaherty/Llinas combination teaches the invention as recited in the newly amended set of claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE PREMRAJ whose telephone number is (571)272-8013. The examiner can normally be reached Monday - Friday: 8:00 AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794