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 .
DETAILED ACTION
Response to Amendment
This office action is responsive to the amendment filed on 1/20/2026. As directed by the amendment, the status of the claim(s) are:
Claim(s) 1, 11, 13-14, 19, 23, 38, 44-45, 50-52 has/have been amended;
Claim(s) 2, 4-9, 16-18, 20-22, 24-26, 28-37, 39-41, 43, 47-49, 53-60 is/are cancelled;
Claim(s) 61 is/are new;
Claim(s) 1, 3, 10-15, 19, 23, 27, 38, 42, 44-46, 50-52, 61 is/are presently pending;
Claim(s) 52 is/are withdrawn;
Claim(s) 1, 3, 10-15, 19, 23, 27, 38, 42, 44-46, 50-51, 61 is/are examined on the merits.
The amendment(s) to the claim(s) is sufficient to overcome the 35 U.S.C. 112 rejection(s) from the previous office action.
Response to Arguments
Applicant argues on p. 13-14 of remarks that the prior art of record does not teach the recited limitation/features of “a source of electromagnetic measurement radiation arranged on the central microchip” and “an optical sensor arranged on the central microchip” of independent claim 1 because primary reference Akbari has source and detection fibers positioned on separate “legs” to the main body via hinges. After review, this is not persuasive. Akbari teaches the main body has processor along with LED’s and photodetectors (which are all understood in the art to be semiconductor chips) and that the legs are movable and retractable as needed to reach into tissue to a desired depth (Fig. 1A-1C; Fig. 6C-6D; Fig. 12-14; [0074]; [0077]). This means that the “source” is within the main body and is connected to the tissue via the “legs” through wires or optical fibers. This would read on at least instant claim 1 because claim 1 is open-ended reciting “comprises”; MPEP 2111.03 and so would not preclude having the addition of optical fibers to direct light from source within main body to tissue.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
Claim 1 recites “configured to detect of one or more of neurovascular activity or behavior” in lines 1-2 which is grammatically incorrect; a suggested edit is “configured to detect .
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 11-15, 23, 38, 46, 61 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Akbari (US 20200367761 A1; 11/23/2020; cited in IDS; cited in previous office action).
Regarding claim 1, Akbari teaches a microchip system that is configured to detect of one or more of neurovascular activity or behavior in subject; that is attachable to a skull of the subject (Fig. 1A; Fig. 9; Fig. 12), and that comprises:
a central microchip (Fig. 1A; Fig. 6C; [0062] “microprocessor”; [0137] “microcontroller”);
a source of electromagnetic measurement radiation arranged on the central microchip such that, with the microchip system attached to the skull, at least a portion of the electromagnetic radiation from the source one or more of reflects off of neural tissue or triggers fluorescence from a portion of neural tissue that includes one or more fluorescent molecules underlying the skull (Fig. 1A-1C; Fig. 6C-6D; Fig. 12-14; [0074]; the “legs” of the device are retractable and the source is within the device body and so reads on the instant limitation of “arranged on the central microchip”); and
an optical sensor arranged on the central microchip such that, with the microchip system attached to the skull, the optical sensor is configured to sense a portion of one or more of the reflected electromagnetic radiation off of the neural tissue or the fluorescence from the portion of the neural tissue (Fig. 6C-6D; Fig. 12-14; [0074]; the “legs” of the device are retractable and the sensor is within the device body and so reads on the instant limitation of “arranged on the central microchip”);
wherein changes in the one or more of the reflected electromagnetic radiation or the fluorescence correlate with the one or more of neurovascular activity or behavior (Fig. 1B; Fig. 14); and
wherein the microchip system is configured to receive signal from the optical sensor and transmit an electrical signal corresponding to at least one property of the changes (Fig. 1A-1C; Fig. 7A-7B; Fig. 12-14; [0063]).
Regarding claim 3, Akbari teaches wherein the source of electromagnetic radiation comprises a light emitting diode ([0046]).
Regarding claim 11, Akbari teaches wherein the optical sensor transmits measurements to a microcontroller or processor (Fig. 1A-1C; Fig. 7A-7B; Fig. 12-14; [0062] “microprocessor”; [0063]).
Regarding claim 12, Akbari teaches wherein said optical sensor measures intensity to detect said changes (Fig. 5A-6D; [0014] “photodetector”; [0067]).
Regarding claim 13, Akbari teaches wherein the microchip system further comprises a source of electromagnetic stimulus radiation (Fig. 10, “EM stimulation”; [0041]; [0080]; [0104] “EM stimulation”);
the source of electromagnetic stimulus radiation is arranged on the central microchip such that, with the microchip system attached to the skull, the source of electromagnetic stimulus radiation is configured to emit electromagnetic stimulus radiation towards neural tissue underlying the skull (Fig. 6C-6D; Fig. 10; Fig. 12-14; [0074]; the “legs” of the device are retractable and the source is within the device body and so reads on the instant limitation of “arranged on the central microchip”); and
the electromagnetic stimulus radiation induces a response in said subject (Fig. 10, “EM stimulation”; [0041]; [0080] [0104] “EM stimulation”).
Regarding claim 14, Akbari inherently teaches wherein said subject is a subject expressing opsin, or a fluorescent molecule, or said subject neural tissue comprising a fluorescent molecule. For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The instant claim recitation does not change the structure of the claimed invention and the prior art is capable of meeting the instant limitation(s).
Regarding claim 15, Akbari teaches wherein said source of electromagnetic stimulus radiation comprises a light emitting diode (Fig. 6B; [0013]; [0014]; [0015]; [0072]; claim 13).
Regarding claim 23, Akbari teaches one or more of a wireless transmitter configured to transmit measurements, or a connector configured to form a wired connection between said microchip system and a recording device ([0014]; [0063]).
Regarding claim 38, Akbari teaches a system for the detection of neurovascular activity and/or behavior in a subject comprising:
one or more microchip systems according to claim 1 (see claim 1 above),
b) a recording system in communication with the one or more microchip system, wherein each microchip system independently transmits measurements from each sensor to the recording system ([0014]; [0063]).
Regarding claim 46, Akbari teaches a method for the detection of neurovascular activity in a subject having a microchip system according to claim 1 (see claim 1 above), attached to the skull of said subject (Fig. 1A; Fig. 9; Fig. 12), comprising:
a) emitting electromagnetic measurement radiation from said source of electromagnetic measurement radiation (Fig. 1A-1C; Fig. 12-14); and
b) measuring the reflected or fluoresced electromagnetic measurement radiation with said optical sensor (Fig. 1A-1C; Fig. 12-14);
wherein changes in the reflected or fluoresced electromagnetic radiation correlate with said neurovascular activity (Fig. 1B; Fig. 14).
Regarding claim 61, Akbari teaches a microchip system that is configured to detect of one or more of neurovascular activity or behavior in a subject; that is attachable to a skull of the subject (Fig. 1A; Fig. 9; Fig. 12), and that comprises:
a source of electromagnetic measurement radiation arranged such that, with the microchip system attached to the skull, at least a portion of the electromagnetic radiation from the source one or more of reflects off of neural tissue or triggers fluorescence from a portion of neural tissue that includes one or more fluorescent molecules underlying the skull (Fig. 1A-1C; Fig. 6C-6D; Fig. 12-14; [0074]; the “legs” of the device are retractable and the source is within the device body and so reads on the instant limitation) and
an optical sensor arranged such that, with the microchip system attached to the skull, the optical sensor is configured to sense a portion of one or more of the reflected electromagnetic radiation off of the neural tissue or the fluorescence from the portion of the neural tissue (Fig. 6C-6D; Fig. 12-14; [0074]; the “legs” of the device are retractable and the sensor is within the device body and so reads on the instant limitation);
wherein the microchip system is configured to:
determine a correlation between a signal from the optical sensor to one or more of a heart rate or a breathing of the subject (Fig. 1B, blood flow reads on “heart rate”; Fig. 14; [0076] “respiratory impairment”);
determine one or more of neurovascular activity or behavior of the subject based on the signal and the correlation (Fig. 1B; Fig. 14; [0076]); and
transmit an electrical signal corresponding to the one or more of neurovascular activity or behavior of the subject (Fig. 1A-1C; Fig. 7A-7B; Fig. 12-14; [0063]; [0076]).
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Akbari as applied to claim 1 above.
Regarding claim 10, Akbari does not teach wherein said optical sensor has a sample rate of less than 20 kHz. However, in another embodiment, Akbari teaches said optical sensor has a sample rate of less than 20 kHz (Fig. 15; [0135] “60 Hz”; [0137] “~14 Hz”) and that this is a result effective variable ([0166] “sampling frequency”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Akbari to include this feature as taught by Akbari because this is a result effective variable to obtain the measurement as needed ([0166]); MPEP 2144.05.
Claim(s) 19, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Akbari as applied to claim 1 above, in view of Wentz (US 20120123508 A1; 5/17/2012; cited in previous office action).
Regarding claim 19, Akbari does not teach wherein said microchip system further comprises one or more of a motion sensor, a thermal sensor configured to measure skull surface temperature ([0016]-[0017]; [0077]; [0088]), a pressure sensor configured to measure intracranial pressure or a heat source.
However, Wentz teaches in the same field of endeavor (Fig. 3A) one or more of a motion sensor, a thermal sensor configured to measure skull surface temperature, a pressure sensor configured to measure intracranial pressure or a heat source
Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Akbari to include this feature as taught by Wentz because this enables safe control of the device by temperature feedback (([0016]-[0017]; [0088]).
Regarding claim 27, Akbari does not teach wherein said microchip system has a weight of less than 10 g. However, Wentz teaches in the same field of endeavor (Fig. 3A) wherein said microchip system has a weight of less than 10 g ([0007]; [0022]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Akbari to include this feature as taught by Wentz because this is a suitable weight for neural device ([0007]; [0022]); MPEP 2144.04 change in size; MPEP 2144.07 art recognized suitability for an intended purpose.
Claim(s) 42, 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Akbari as applied to claim 38 above, in view of Shyu (US 20200108271 A1; 4/9/2020; cited in previous office action).
Regarding claim 42, Akbari does not teach wherein said system further comprises an enclosure for said subject. However, Shyu teaches in the same field of endeavor (Abstract) wherein said system further comprises an enclosure for said subject (Fig. 1A; Fig. 3B). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Akbari to include this feature as taught by Shyu because this enables wireless powering of brain device ([0002]; [0014]).
Regarding claim 50, the combination of Akbari and Shyu teaches a method for the detection of neurovascular activity and behavior in one or more subjects comprising:
a) placing each of said one or more subjects into an enclosure in one or more system according to claim 42 (see claim 42 above), wherein each of said one or more subjects has a respective one of the one or more microchip systems affixed to the skull of said subject (Akbari Fig. 1A; Fig. 9; Fig. 12);
b) emitting electromagnetic radiation from each source of electromagnetic measurement radiation on each microchip system to reflect off of or fluoresce from neural tissue underlying the skull of each of said subject (Akbari Fig. 1A-1C; Fig. 12-14); and
c) measuring reflected or fluoresced radiation in the optical sensor from each of said microchip systems (Akbari Fig. 1A-1C; Fig. 12-14);
wherein changes in the reflected electromagnetic radiation correlate with said neurovascular activity (Akbari Fig. 1B; Fig. 14).
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Akbari and Shyu as applied to claim 42 above, in view of Hamner (US 20220233860 A1; Filed 3/6/2020; cited in previous office action).
Regarding claim 44, in the combination of Akbari and Shyu, Akbari teaches wherein said system further comprises a microcontroller (Fig. 1A-1C; Fig. 7A-7B; Fig. 12-14; [0062] “microprocessor”; [0063]).
The combination of Akbari and Shyu does not teach and a camera, said one or more microchip system comprises a motion sensor, and
said microcontroller is configured to identify awake and sleep cycles of said subject based on measurements transmitted thereto from one or more of said motion sensor or said camera.
However, Hamner teaches in the same field of endeavor ([0010] “optogenetic”) a camera, said one or more microchip system comprises a motion sensor ([0217] “detect sleep wake cycles, such as accelerometry, video-based…to detect motion”), and
said microcontroller is configured to identify awake and sleep cycles of said subject based on measurements transmitted thereto from one or more of said motion sensor or said camera ([0217] “detect sleep wake cycles”).
Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Akbari and Shyu to include these features as taught by Hamner because this enables delivering stimulation at specific phases of sleep wake cycle ([0217]).
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Akbari, Shyu, and Hamner as applied to claim 44 above, and further in view of Bermudez Contreras (US 20200383299 A1; 12/10/2020; cited in previous office action).
Regarding claim 45, the combination of Akbari, Shyu, and Hamner does not teach a vibration system attached to the enclosure. However, Bermudez Contreras teaches in the same field of endeavor (Abstract; [0002]) a vibration system attached to the enclosure ([0141] “vibration sensors”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Akbari, Shyu, and Hamner to include this feature as taught by Bermudez Contreras because this enables monitoring within enclosure without disturbing subject ([0007]).
Claim(s) 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Akbari and Shyu as applied to claim 50 above, and further in view of Lawrenson (US 20160262625 A1; 9/15/2016; cited in previous office action).
Regarding claim 51, the combination of Akbari and Shyu does not teach wherein said emitting and measuring occur over more than 5 sleep-wake cycles of each subject. However, Lawrenson teaches in the same field of endeavor ([0016]) wherein said emitting and measuring occur over more than 5 sleep-wake cycles of each subject ([0097]; [0106] “multiple sleep cycles of the patient 10 (e.g. one week)”; one week is known to be 7 days and so would be over more than the recited 5 sleep-wake cycles). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Akbari and Shyu to include this feature as taught by Lawrenson because this can identify a trend ([0097]; [0106]).
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 Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792