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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/10/2025 has been entered.
Response to Arguments
Applicant’s amendment and arguments filed 11/25/2025, with respect to the rejections set forth on the Final Rejection dated 9/11/2025 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 Therefore, the rejection has been withdrawn.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 Brown et al. (2021/0246185). Particularly, Brown discloses various viral vectors (specifically CAG-Flex viral vectors) can be used to express specific proteins such as ChR2, Chrimson, etc. (see Table 1; par. [0066]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Chung et al. “Optogenetic activation of SST-positive interneurons restores hippocampal theta oscillation impairment induced by soluble amyloid beta oligomers in vivo”, herein “Chung”, in view of Guru et al. “Making Sense of Optogenetics”, herein “Guru”, further in view of Brown et al. (2021/0246185).
Regarding Claims 1 and 5, Chung discloses a method for restoring brainwave impairment using optogenetic technology, comprising preparing an animal model in which the CRE gene is expressed in inhibitory neurons (SST-CRE or PV-CRE mice, see Abstract and p. 6); injecting a viral vector comprising a photoreceptor gene designed to target inhibitory neurons when the CRE gene is expressed into the animal model and expressing the viral vector (injecting ABO and adeno-associated virus (AAV) for expressing floxed channelrhodopsin-2 (ChR2) into the hippocampus, see Abstract and pg. 3); inserting an electrode and optical fiber into the animal model into which the viral vector has been injected (inserting an electrode probe for recordings and optical fiber for optogenetic stimulation, see pp. 7-8); and restoring brainwave impairment by transmitting optical stimulation to the designed photoreceptor gene to be selectively expressed only in the target neurons through the electrode and the optical fiber (optogenetic stimulation selectively restored ABO-induced impairment of hippocampal theta oscillations and aided in resynchronizing theta spike phases of CA1 pyramidal neurons in mice (Abstract; pp. 21-22 under “Discussion”). Chung is silent regarding the use of other opsins such as C1V1 and Chrimson and is therefore silent regarding using 565nm light (used for activating C1V1) or 590 nm light (used for activating Chrimson) and is silent regarding the use of CAG-Flex viral vectors.
However, Guru discloses the field of Optogenetic commonly involves viral vector targeting systems that allows tight control over spatial localization of opsin expression by injecting an engineered virus into the brain region of interest, see p. 5, “How are Neurons Engineered to Express Opsins?” (as described in detail in the Chung reference). Guru further discloses there are a vast array of known Optogenetic tools that have been extensively developed over the years and “include a vast array of proteins that allow control of neural activity over a range of timescales, control of biochemical activity within the cell, control of multiple neural channels in parallel, and, most recently, control of neural activity in parallel with optical monitoring of neural activity”, see p. 2, col. 1. One category of actuators commonly used in optogenetics are Channelrhodopsins (ChRs) and in particular ChR2 (col. 3 under “Channelrhodopsins”), which is the actuator relied upon by Chung as well. Guru further discloses that other actuators such as C1V1 and Chrimson could be selected as well. C1V1 provides the benefit of providing shifted excitation spectra that allows independent optical control of different populations of neurons, see p. 4, “Spectrally Shifted Excitatory Opsins”. Chrimson was developed as an improvement to C1V1 in that it provides peak excitation for red-shifted wavelengths of light while avoiding residual absorption of blue light, see p. 4, “Spectrally Shifted Excitatory Opsins”. Therefore it would have been obvious to one of ordinary skill in the art before the effective foiling date of the claimed invention to modify the device in the Chung reference to include opsins such as C1V1 or Chrimson (and therefore the application of red-shifted light in the range of 565-590 nm light, which are known activation wavelengths for C1V1 and Chrimson), as taught and suggested by Guru, for the purpose of providing one of shifted excitation spectra that allows independent optical control of different populations of neurons; or providing peak excitation for red-shifted wavelengths of light while avoiding residual absorption of blue light .
Additionally, the Examiner notes C1V1 and Chrimson are known actuators in optogenetics (and their light activation spectra are also well-known), as illustrated by Guru, and that selecting one particular opsin of a known set of opsins commonly used in optogenetics would involve routine design choice given the design constrains and goals of the treatment and the known responses these otpogenetic tools provide.
Lastly, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to try C1V1 or Chrimson as the particular actuator (and their associated light activation spectra) given that there are a finite number of identified, predictable solutions, each having a reasonable expectation of success (see the finite number of known actuators in optogenetics detailed by Guru).
The Examiner notes Applicant’s specification indicates likewise that any known photoceptor can be used and include in this treatment “In addition, all types of photoreceptors that can activate neurons can be used as the photoreceptor of the step 2).” Applicant only named a few, well-known types of actuators without any assertion of criticality or unexpected results with any particular one (see par. [0044] of PGPUB 2022/0249864, which is the publication of the present application).
With respect to the particular viral vector used to express Chr2, C1V1, Chrimson, etc., Brownn discloses using CAG-Flex viruses (Table 1) for the purpose of promoting enhanced local spread in the tissue (par. [0082]). These viruses provide the ability to modify membrane topology to enable targeted manipulation of activity in specific populations of cells (par. [0006]). 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 the device in the Chung and Guru combination to include a CAG-Flex viral vector, as taught and suggested by Brown, for the purpose of promoting enhanced local spread in the tissue and enabling targeted manipulation of activity in specific populations of cells.
In regards to Claim 2, Chung discloses the detected result of improved brainwave function is determined after the function is restored (see pp. 13-21 under “Results”), which would appear true for any condition improvement. An improvement cannot be detected unless the improvement has previously occurred; otherwise improvement would not be observable.
Regarding Claim 3, Chung discloses the inhibitory neurons are neurons expressing parvalbumin (parvalbumin-positive, PV+) or somatostatin (somatostatin-positive, SST+), see Abstract.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLEN PORTER whose telephone number is (571)270-5419. The examiner can normally be reached Mon - Fri 9:00-6:00 EST.
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, Carl Layno can be reached at 571-272-4949. 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.
/ALLEN PORTER/Primary Examiner, Art Unit 3796