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 (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.
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) 1-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leyde, (US 20130046358) in view of Lim, (US 20180015301; hereinafter Lim), Kagan et al., (US 20120143568; hereinafter Kagan), and Hagedorn, (US 20140350431).
Regarding claim 1, Leyde (Figures 1-2 and 6-7) discloses a device (20), ([0063]-[0064]) comprising: an apparatus (11) configured to apply Transcranial Direct Current Stimulation (tDCS) to a person ([0047], [0094]); an apparatus (9) configured to obtain Electro Encephalogram (EEG) signals from the person ([0041], [0047]); an apparatus (memory 38) configured to store a plurality of stimulation recipes defined using an apparatus (separate device comprising the observer algorithm) configured to provide the capability to define the plurality of stimulation recipes ([0054], [0056], [0062], [0087]-[0088]), and an apparatus (24) configured to perform dynamic closed loop feedback of the tDCS using one of the plurality of defined recipes and based on the obtained EEG signals ([0059], [0074], [0088], [0091]-[0092]). Leyde fails to disclose an apparatus configured to apply Transcranial Photobiomodulation (tPBM) to the person, wherein the apparatus is configured to perform dynamic closed loop feedback of the tPBM in addition to the tDCS based on the obtained EEG signals. However, Lim (Figures 20-25) teaches a neurostimulation system including an apparatus (100) configured to apply tPBM to the person ([0007], [0230]-[0232], [0241]). 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 to include an apparatus configured to apply tPBM to the person, as taught by Lim, because the modification would provide a great potential to treat a wide range of medical conditions ([0012]). Furthermore, the therapeutic effects of brain-absorbed light energy are not accompanied by any substantive complications or major side effects (Lim; [0017]). In the modified device, the apparatus would still be configured to perform dynamic closed loop feedback of the neuromodulation signals based on the obtained EEG signals. The neuromodulation would be performed by the tBPM in addition to the tDCS in the modified device. Therefore, feedback control apparatus would be configured to perform dynamic closed loop feedback of the tPBM and the tDCS based on the obtained EEG signals in the modified device.
Leyde/Lim fails to teach wherein the closed loop feedback is performed using machine learning techniques to compute an optic and electric response that minimizes the difference between current and desired neural activity. However, Kagan (Figure 1) teaches a sensor-effector system (110), wherein closed loop feedback of the system is performed using machine learning techniques to compute an optic and electric response that minimizes the difference between current and desired neural activity ([0010]-[0011], [0015], [0017]-[0019], [0025]). 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/Lim such that the closed loop feedback is performed using machine learning techniques to compute an optic and electric response that minimizes the difference between current and desired neural activity, as taught by Kagan, because the modification would provide a scalable, self-adaptive brain computer interface (BCI) platform to explore the architecture and operation of multi-scale, functional brain networks (Kagan; [0010]).
Leyde/Lim/Kagan fails to teach wherein the apparatus further comprises a visor configured to display multimedia information. However, Hagedorn (Figure 4) teaches a brain-computer interface system ([0050]) comprising a visor (460) configured to display multimedia information ([0051]). 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/Lim/Kagan to include a visor configured to display multimedia information, as taught by Hagedorn, because the modification would provide optical stimulation and facilitate various types of operations, including clinical use applications, personal data collection or bio-hacking operations, gaming operations, amongst others (Hagedorn; [0016]).
Regarding claim 2, Leyde/Lim/Kagan/Hagedorn further teaches wherein the apparatus configured to apply tPBM (Lim; [00230]-[0232]; element 100) comprises: at least one LED (Lim; [0241]; element 122) configured to be mounted in a nostril of the person; a plurality of LEDs (Lim; [0241], elements 108, 110, 112, 114) configured to be mounted on a head of the person; and circuitry (106) configured to control an on/off state of the LEDs and an intensity of the LEDs (Lim; [0133], [0333]-[0334]).
Regarding claim 3, Leyde/Lim/Kagan/Hagedorn further teaches wherein the circuitry (Lim; 106) configured to control an on/off state of the LEDs (Lim; 108, 110, 112, 114) and an intensity of the LEDs (Lim; 108, 110, 112, 114) is further configured to control the on/off state of the plurality of LEDs (Lim; 108, 110, 112, 114) in a range of 10-40Hz (Lim; [0181], [0254]) and to control the intensity of the LEDs configured to be mounted on a head of the person in a range of 20 mW/cm2 to 60 mW/cm2. Leyde/Lim/Kagan fails to teach that said intensity is controlled in a range of 75mW/cm2 to 150mW/cm2. However, 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/Lim/Kagan/Hagedorn such that said intensity is controlled in a range of 75mW/cm2 to 150mW/cm2 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. MPEP 2144.05(I).
Regarding claim 4, Leyde/Lim/Kagan/Hagedorn further teaches wherein the circuitry (Lim; 106) configured to control an on/off state of the LEDs (Lim; 108, 110, 112, 114) and an intensity of the LEDs (Lim; 108, 110, 112, 114) is further configured to control the intensity of the at least one LED (Lim; 122) configured to be mounted in a nostril of the person to be approximately 25mW/cm2 (Lim; [0254]).
Regarding claim 5, Leyde further discloses wherein the apparatus (11) configured to apply tDCS comprises: a plurality of electrodes (I-P) configured to be mounted on a head of the person ([0046]); and circuitry (8) configured to control a current of the plurality of electrodes ([0094]).
Regarding claim 6, Leyde further discloses wherein the circuitry (8) configured to control the current of plurality of electrodes (11) is further configured to control the current of the electrodes (11) in a range of 1 to 4 mA ([0006]).
Regarding claim 7, Leyde further discloses wherein the circuitry (8) configured to control the current of the plurality of electrodes (11) is further configured to apply Transcranial Alternating Current Stimulation (tACS), ([0094]).
Regarding claim 8, Leyde further discloses wherein the circuitry (8) configured to control the current of the plurality of electrodes (11) is further configured to apply tACS in a current range ±0.5 to ±2mA and a frequency range of 2 to 100 Hz ([0006]).
Regarding claim 9, Leyde (Figures 1-2 and 6-7) discloses a device (20), ([0063]-[0064]) comprising: a processor (4, 42), memory (38) accessible by the processor, and program instructions and data stored in the memory (38), ([0073]-[0074], [0091]); a plurality of electrodes (11) connected to signal output circuitry interfacing the processor (4, 42) with the electrodes (11), wherein the program instructions and data stored in the memory (38) are further configured so that the processor (4, 42) generates and transmits Transcranial Direct Current Stimulation (tDCS) signals to the plurality of electrodes (11), ([0047], [0094]); and a plurality of electrodes (9) connected to signal input circuitry interfacing the processor (4, 42) with the plurality of electrodes (9), wherein the program instructions and data stored in the memory (38) are further configured so that the processor (4, 42) receives Electro Encephalogram (EEG) signals from the electrodes (9), ([0041], [0047]); wherein the program instructions and data stored in the memory (38) are further configured to store a plurality of stimulation recipes defined using an apparatus (separate device comprising the observer algorithm) configured to provide the capability to define the plurality of stimulation recipes ([0054], [0056], [0062], [0087]-[0088]) and are further configured so that the processor (4, 42) performs dynamic closed loop feedback of the tDCS signals based on the received EEG signals ([0059], [0074], [0088]).
Leyde fails to disclose a plurality of LEDs connected to signal output circuitry interfacing the processor with the plurality of LEDs, wherein the program instructions and data stored in the memory are configured so that the processor generates and transmits Transcranial Photobiomodulation (tPBM) signals to the LEDs; wherein the program instructions and data stored in the memory are further configured so that the processor performs dynamic closed loop feedback of the tPBM signals in addition to the tDCS signals based on the received EEG signals. However, Lim (Figures 20-25) teaches a neurostimulation system including an apparatus (100) comprising a plurality of LEDs configured to apply tPBM to the person ([0007], [0230]-[0232], [0241]). 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 to include a plurality of LEDs configured to apply tPBM to the person, as taught by Lim, because the modification would provide a great potential to treat a wide range of medical conditions ([0012]). Furthermore, the therapeutic effects of brain-absorbed light energy are not accompanied by any substantive complications or major side effects (Lim; [0017]). In the modified device, the processor would still be configured to perform dynamic closed loop feedback of the neuromodulation signals based on the obtained EEG signals. The neuromodulation would be performed by the tBPM in addition to the tDCS in the modified device. Therefore, the modified device would include a plurality of LEDs connected to signal output circuitry interfacing the processor with the LEDs, wherein the program instructions and data stored in the memory are configured so that the processor generates and transmits tPBM signals to the LEDs; wherein the program instructions and data stored in the memory are further configured so that the processor performs dynamic closed loop feedback of the tPBM signals and the tDCS signals based on the received EEG signals.
Leyde/Lim fails to teach wherein the closed loop feedback is performed using machine learning techniques to compute an optic and electric response that minimizes the difference between current and desired neural activity. However, Kagan (Figure 1) teaches a sensor-effector system (110), wherein closed loop feedback of the system is performed using machine learning techniques to compute an optic and electric response that minimizes the difference between current and desired neural activity ([0010]-[0011], [0015], [0017]-[0019], [0025]). 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/Lim such that the closed loop feedback is performed using machine learning techniques to compute an optic and electric response that minimizes the difference between current and desired neural activity, as taught by Kagan, because the modification would provide a scalable, self-adaptive brain computer interface (BCI) platform to explore the architecture and operation of multi-scale, functional brain networks (Kagan; [0010]).
Leyde/Lim/Kagan fails to teach wherein the apparatus further comprises a visor configured to display multimedia information. However, Hagedorn (Figure 4) teaches a brain-computer interface system ([0050]) comprising a visor (460) configured to display multimedia information ([0051]). 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/Lim/Kagan to include a visor configured to display multimedia information, as taught by Hagedorn, because the modification would provide optical stimulation and facilitate various types of operations, including clinical use applications, personal data collection or bio-hacking operations, gaming operations, amongst others (Hagedorn; [0016]).
Regarding claim 10, Leyde/Lim/Kagan/Hagedorn further teaches wherein the plurality of LEDs (Lim; [0241]; elements 108, 110, 112, 114, 122) comprises: at least one LED (Lim; 122) configured to be mounted in a nostril of the person; and a plurality of LEDs (Lim; 108, 110, 112, 114) configured to be mounted on a head of the person (Lim; [0230]-[0232], [0241]).
Regarding claim 11, Leyde/Lim/Kagan/Hagedorn further teaches wherein the program instructions and data to generate and transmit tPBM signals are further configured to control an on/off state of the LEDs and an intensity of the LEDs (Lim; [0133], [0333]-[0334]).
Regarding claim 12, Leyde/Lim/Kagan/Hagedorn further teaches wherein the program instructions and data to generate and transmit tPBM signals are further configured to control the on/off state of the plurality of LEDs in a range of 10-40Hz (Lim; [0181], [0254]) and to control the intensity of the LEDs configured to be mounted on a head of the person in a range of 20 mW/cm2 to 60 mW/cm2. Leyde/Lim/Kagan fails to teach that said intensity is controlled in a range of 75mW/cm2 to 150mW/cm2. However, 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/Lim/Kagan/Hagedorn such that said intensity is controlled in a range of 75mW/cm2 to 150mW/cm2 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. MPEP 2144.05(I).
Regarding claim 13, Leyde/Lim/Kagan/Hagedorn further teaches wherein the program instructions and data to generate and transmit tPBM signals are further configured to control the intensity of the at least one LED (Lim; 122) configured to be mounted in a nostril of the person to be approximately 25mW/cm2 (Lim; [0254]).
Regarding claim 14, Leyde further discloses wherein the plurality of electrodes (11) connected to signal output circuitry comprises a plurality of electrodes (I-P) configured to be mounted on a head of the person ([0094]).
Regarding claim 15, Leyde further discloses wherein the program instructions and data to generate and transmit tDCS signals are further configured to control the current of the plurality of electrodes connected to the signal output circuitry (11) in a range of 1 to4 mA ([0006]).
Regarding claim 16, Leyde further discloses wherein the program instructions and data further comprises program instructions and data configured so that the processor generates and transmits Transcranial Alternating Current Stimulation (tACS) signals to the plurality of electrodes connected to the signal output circuitry (11), ([0094]).
Regarding claim 17, Leyde further discloses wherein the program instructions and data to generate and transmit tACS signals are further configured to control the current of the plurality of electrodes connected to the signal output circuitry (11) to apply tACS in a current range ±0.5 to ±2mA and a frequency range of 2 to 100 Hz ([0006]).
Response to Arguments
Applicant’s arguments, filed 10/15/2025, with respect to the rejection(s) of claim(s) 1-17 under 35 U.S.C 103 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 made in view of newly found prior art reference Hagedorn, which teaches a brain-computer interface system comprising a visor configured to display multimedia information. Therefore, in combination with Layde/Lim/Kagan, the modified device teaches the invention as recited at least in newly amended independent claims 1 and 9.
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