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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/08/2025 has been entered.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed 08/01/2023 has been considered by the Examiner.
Response to Arguments
Rejections under 35 USC 112
In regards to Applicant’s response filed 03/04/2026, the amended claims have overcome the previously presented rejection(s) under 35 USC 112, and are hereby withdrawn.
Rejections under 35 USC 102/35 USC 103
Applicant's arguments filed 03/04/2026 with respect to claims 1-6, 24, 26, 27, 31, 34, 36, and 38-43 have been fully considered but they are not persuasive.
In the Remarks received 03/04/2026, Applicant argues that the prior art of Hayano cited in the most recent Office Action dated 01/08/2026 fails to disclose all of the limitations of claims 1-6, 24, 26, and 36-38.
Applicant argues that Hayano does not identically disclose the limitations of the claimed invention. Regarding independent claims 1 and 24, Applicant argues that Hayano fails to disclose a combination of 1) the specific frequency range of about 55 to 65 Hz; with 2) use of this range in a method of improving cognitive function or treating/preventing schizophrenia, anxiety, bipolar disorder, and/or depression.
Examiner disagrees and offers the following reasoning:
Regarding the specific frequency range of about 55 to 65 Hz, Applicant and Examiner both cite Hayano [0053] where Hayano discloses the generation of a 60 Hz wave in the occipital lobe and the frontal lobe as a result of irradiation with a light having a blinking frequency of 60 Hz. Hayano in paragraph [0050] teaches that gamma waves have a frequency of approximately 30 Hz or higher, and page 3 of the specification of the instant application teaches that inducing high gamma frequency neuronal oscillations in the range of about 50 to 70 Hz promotes neuronal plasticity. Therefore, Hayano must necessarily produce the induction of synchronized gamma oscillations in at least one region of the brain because Hayano discloses that the application of light having a blinking frequency of 60 Hz induces a corresponding brain wave at 60 Hz.
Examiner notes that the claim as currently presented limits the frequency range to ‘about 55 to about 65 Hz,’ but does not further disclose in the specification a margin for ‘about.’ Therefore, while Examiner maintains the use of Hayano, which teaches a frequency within the definitive range, it should be noted that this range may reasonably be expanded upon to include additional frequencies greater than 65 or less than 55.
Examiner would also note that in the case of claims 1 and 24, the respective preambles ‘a method for promoting cognitive function’ and ‘a method for treating or preventing schizophrenia, anxiety, bipolar disorder, and/or depression in a subject’ merely state the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations. Therefore, the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02(II). Examiner still maintains that although not required based on the claim construction, Hayano still teaches the purpose/intended use as recited in the preambles, as stated in Hayano paragraphs [0020-0022] and [0052].
Applicant’s arguments rely on language solely recited in preamble recitations in claims 1 and 24 When reading the preamble in the context of the entire claim, the recitation ‘a method for promoting cognitive function’ and ‘a method for treating or preventing schizophrenia, anxiety, bipolar disorder, and/or depression in a subject’ is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Regarding claims 2, 31, and 34 Applicant argues that Hayano does not disclose a system ‘configured to promote neuronal plasticity by induction of in vivo synchronized gamma oscillations and removal of the perineuronal net.’ Applicant disagrees with the identification of the above limitation as functional or intended use and argues that the claims recite a system with specific structural and operational requirements: a light source configured to emit flashing light at about 55 to 65 Hz, and a device configured to induce synchronized gamma oscillations at that specific frequency range.
Examiner disagrees and maintains that the device of Hayano teaches the structural and operational requirements as outlined by the Applicant. Hayano teaches a light source configured to emit flashing light at about 55 to 65 Hz, configured to induce synchronized gamma oscillations at that specific frequency range. In paragraph [0053], Hayano describes using the device to emit a flashing light at 60 Hz, and that the result of said irradiance was the generation of a corresponding 60 Hz brain wave in the occipital lobe and the frontal lobe.
Additionally, Applicant argues that Hayano does not disclose a system that may promote neuronal plasticity by removal of the perineuronal net and that the assertion that this feature is inherently disclosed rests on speculation rather than evidence.
Examiner disagrees and points to MPEP 2112.02, which states that ‘Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324.’ It can be appreciated that the prior art device of Hayano operating in a normal fashion, emitting a flashing light at 60 Hz, would necessarily perform the method claimed. In paragraph [0053], Hayano teaches the generation of a 60 Hz wave in the occipital lobe and the frontal lobe as a result of irradiance of light at a blinking frequency of 60 Hz. Hayano does not have to specifically mention the induction of neuronal plasticity or removal of the perineuronal net because it would be an inherent result of the normal and usual operation of the prior art device.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the cited references, Hayano and Malchano, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, there is a motivation to combine, because although Malchano is focused of the use of applying visual stimulus for the treatment of Alzheimer’s, it would be obvious to one of ordinary skill in the art to use the visual stimulus for the treatment of other neural conditions such as cognitive function, schizophrenia, anxiety, bipolar disorder, and/or depression. This can be demonstrated by Hayano, where a multitude of uses for generating brain waves is disclosed including Alzheimer’s, cognitive function, schizophrenia, anxiety, bipolar disorder, depression and many others (Hayano [0052]).
In summary, Applicant’s arguments hinge on the assertion that the prior art teaches away from stimulation in the claimed range and therefore does not disclose the claimed invention. Examiner emphasizes that the prior art device of Hayano discloses a blinking frequency at 60Hz, which is within the claimed range, and that the visual stimulus results in the generation of gamma brain waves, also at 60 Hz, in the brain. Therefore, although there may be other frequencies which are used for their therapeutic effects, it can be appreciated that the prior art device, in its normal and usual operation, would necessarily perform the method claimed.
Applicant’s arguments, see Remarks filed 03/04/2026, with respect to the rejection of claims 33 and 35 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, new ground of rejection of claim 35 is made in view of Hayano and Malchano, and claim 33 in view of Hayano and LaVine et al (US 20200108270 A1).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 24, 26, 31, 34, and 36-38 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hayano et al (US 20210308481 A1).
Regarding claim 1, Hayano teaches a method for promoting cognitive function in a subject (see [0020-0022]; using a light blinking at a specific frequency for the improvement, prevention, or increase in brain function/improvement of cognitive function),
comprising inducing synchronized gamma oscillations in at least one brain region of the subject (see [0050-0051]; it is possible to produce brain waves in the subject that are substantially the same frequency as the frequency of a blinking light, blinking frequency of 60 Hz is associated with gamma oscillations) by applying a visual stimulus comprising a flashing light (see [0048]; irradiating light having a specific wavelength onto a subject using a specific blinking frequency) at about 55 to about 65 Hz to the subject (see Figs. 2B and 3B, [0053]; irradiation of violet light at a blinking frequency of 60 Hz).
Regarding claim 2, Hayano teaches the method according to claim 1, wherein the synchronized gamma oscillations induce neuronal plasticity and/or removal of the perineuronal net in the subject (see [0004]; it has been found that when the synchronization of gamma wave vibration is restored in the brain, the amyloid beta protein accumulated in the brain is removed, [0051]; a blinking frequency of 60 Hz was used to promote the production of gamma brain waves of the same frequency).
Regarding claim 3, Hayano teaches the method according to claim 1, wherein the visual stimulus comprises a flashing light at about 57 to about 63 Hz (see Figs. 2B and 3B, [0053]; irradiation of violet light at a blinking frequency of 60 Hz).
Regarding claim 4, Hayano teaches the method according to claim 1, wherein the cognitive function comprises learning, attention, or memory (see [0052]; inducing brain waves of a frequency are to affect mental and physical conditions including memory, concentration, motivation, and awakening).
Regarding claim 5, Hayano teaches the method according to claim 1, wherein the subject is a normal subject and/or the method is non-therapeutic (see [0012]; the light irradiation can be used for the prevention of depression, stress, or degenerative diseases, where the method can be considered to be non-therapeutic as it is not actively treating a current ailment of the subject).
Regarding claim 6, Hayano teaches the method according to claim 1, wherein the subject is experiencing stress (see [0012]; using a light blinking at a specific frequency to suppress or prevent stress).
Regarding claim 24, Hayano teaches a method for treating or preventing schizophrenia, anxiety, bipolar disorder, and/or depression in a subject (see [0052]; inducing brain waves which can affect various mental and physical actions, including treatment effects, for schizophrenia, bipolar disorder, depression); the method comprising
inducing synchronized gamma oscillations in at least one brain region of the subject (see [0050-0051]; it is possible to produce brain waves in the subject that are substantially the same frequency as the frequency of a blinking light, blinking frequency of 60 Hz is associated with gamma oscillations) by applying a visual stimulus comprising a flashing light (see [0048]; irradiating light having a specific wavelength onto a subject using a specific blinking frequency) at about 55 to about 65 Hz to the subject (see Figs. 2B and 3B, [0053]; irradiation of violet light at a blinking frequency of 60 Hz).
Regarding claim 26, Hayano teaches the method according to claim 24, wherein the visual stimulus is applied to the subject for less than one hour daily (see [0056]; subjects were irradiated for five minutes with a blinking light).
Regarding claim 31, Hayano teaches a system for promoting neuronal plasticity in at least one brain region of a subject (see Figs. 2B and 3B), the system comprising:
(i) a stimulus-emitting device configured to promote neuronal plasticity by induction of in vivo synchronized gamma oscillations and removal of the perineuronal net in at least one brain region of a subject (see [0020-0022]; a device comprising a light blinking at a specific frequency to produce specific brain waves in the subject that are substantially the same frequency as the light),
wherein the device comprises a light source configured to emit flashing light at a frequency of about 55 to about 65 Hz (see Figs. 2B and 3B, [0053]; irradiation of violet light at a blinking frequency of 60 Hz); and
wherein the device is configured to induce synchronized gamma oscillations of a frequency of about 55 to about 65 Hz in the brain region of the subject by means of the flashing light (see [0050-0051]; it is possible to produce brain waves in the subject that are substantially the same frequency as the frequency of a blinking light, blinking frequency of 60 Hz is associated with gamma oscillations).
The limitation of a stimulus-emitting device ‘configured to promote neuronal plasticity by induction of in vivo synchronized gamma oscillations and removal of the perineuronal net in at least one brain region of a subject,’ has been identified as functional language/a statement of intended use. Hayano teaches a device that is capable of inducing synchronized gamma oscillations of a frequency of about 55 to 65 Hz (Hayano [0050-0051]). It has been found that when the synchronization of gamma wave vibration is restored in the brain, the amyloid beta protein accumulated in the brain is removed (Hayano [0004]), which may promote neuronal plasticity and the removal of perineuronal nets in at least one region of the brain. Therefore, the system as taught by Hayano is capable of promoting neuronal plasticity by induction of in vivo synchronized gamma oscillations and removal of the perineuronal net in at least one brain region of a subject.
Regarding claim 34, Hayano teaches the system according to claim 31, further comprising a monitoring device for monitoring synchronized gamma oscillations in the brain region of the subject, wherein the monitoring device is an electroencephalogram (EEG) apparatus (see [0056]; brain waves were measured by an electroencephalograph).
Regarding claim 36, Hayano teaches the method according to claim 6, wherein the stress is chronic stress (see [0022]; to prevent or suppress stress, [0052]; post-traumatic stress disorder).
Regarding claim 37, Hayano teaches the method according to claim 24, wherein the neuropsychiatric disorder is selected from schizophrenia, anxiety, bipolar disorder, and/or depression (see [0052]; inducing brain waves which can affect various mental and physical actions, including treatment effects, for schizophrenia, bipolar disorder, depression).
Regarding claim 38, Hayano teaches the method according to claim 24, wherein the visual stimulus is applied to the subject for 1 to 30 minutes daily (see [0056]; subjects were irradiated for five minutes with a blinking light).
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by LaVine et al (US 20200108270 A1).
Regarding claim 1, LaVine teaches a method for promoting cognitive function in a subject, comprising inducing synchronized gamma oscillations in at least one brain region of the subject by applying a visual stimulus comprising a flashing light at about 55 to about 65 Hz to the subject (see LaVine [0023]; non-invasive stroboscopic stimulation in the 20-60 Hz range to combat the buildup of amyloid proteins in the brain by improving gamma oscillations in the brain).
Regarding claim 2, LaVine teaches the method according to claim 1, wherein the synchronized gamma oscillations induce neuronal plasticity (see LaVine [0023]; non-invasive stroboscopic stimulation in the 20-60 Hz range to combat the buildup of amyloid proteins in the brain by improving gamma oscillations in the brain).
Regarding claim 3, LaVine teaches the method according to claim 1, wherein the visual stimulus comprises a flashing light at about 57 to about 63 Hz (see LaVine [0023]; non-invasive stroboscopic stimulation in the 20-60 Hz range).
Regarding claim 4, LaVine teaches the method according to claim 1, wherein the cognitive function comprises learning, attention, or memory (see LaVine [0027]; prophylactic use of the device before an individual shows signs of early onset memory loss is recommended as stroboscopic research has demonstrated enhanced cognitive processing skills through “temporal-occlusion training”).
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.
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.
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) 27, 35, and 39-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayano et al (US 20210308481 A1) in view of Malchano et al (US 20210121713 A1).
Regarding claim 27, Hayano teaches the method according to claim 24. Hayano is silent regarding wherein the visual stimulus is applied to the subject during mental or cognitive challenges or exercises, monocular deprivation, fear extinction training, psychosocial therapy, learning and relearning, psychotherapy, behavioural therapy, trauma therapy, or exposure and response prevention (ERP) therapy.
Malchano teaches a system for neural stimulation using a visual stimulus to trigger neural activity at a frequency corresponding to the particular frequency of the stimulus, wherein the visual stimulus is applied to the subject during mental or cognitive challenges or exercise, learning and relearning, or behavioral therapy (see Malchano [0927]; additional therapeutic regimens include cognitive or physical therapeutic regimen).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Hayano’s method for promoting cognitive function by applying the visual stimulus during a therapy session as taught by Malchano. One of ordinary skill in the art would have been motivated to make this modification in order to increase the effectiveness of both the stimulus therapy and cognitive or physical therapy in treatment or prevention of the targeted disease or disorder (Malchano [0925]).
Regarding claim 35, Hayano teaches the system of claim 31. Hayano is silent regarding wherein the device further comprises a sound source configured to promote the induction of synchronized gamma oscillations at a frequency of about 55 to about 65 Hz in the subject's brain.
Malchano teaches wherein the device further comprises a sound source (905) configured to promote the induction of synchronized gamma oscillations (see Malchano [0401]; the modulation frequency of the acoustic wave can correspond to a desired stimulation frequency of neural oscillations) at a frequency of about 55 to about 65 Hz in the subject's brain (see Malchano [0401]; the modulation frequency can be set to 60 Hz).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Hayano’s system for visual stimulation with auditory stimulation as taught by Malchano. One of ordinary skill in the art would have been motivated to make this modification in order to elicit advantageous brain wave effects via multi-modal stimulation for improvement of the cognitive state of a subject (Malchano [0665]).
Regarding claims 39-41, Hayano teaches the method according to claim 24. Hayano is silent regarding wherein the method further comprises administering to the subject a pharmaceutical composition comprising an active agent comprising an antidepressant, an anxiolytic, a psychedelic, an antipsychotic, or a neuroleptic drug;
wherein the active agent is selected from the group consisting of selective serotonin reuptake inhibitors (SSRIs), serotonin- norepinephrine reuptake inhibitors (SNRIs), serotonin antagonist and reuptake inhibitors (SARIs), serotonin modulator and stimulators (SMSs), norepinephrine reuptake inhibitors (NRIs), norepinephrine-dopamine reuptake inhibitors (NDRIs), tricyclic antidepressants (TCAs), tetracyclic antidepressants (TeCAs), monoamine oxidase inhibitors (MAOIs), barbiturates, benzodiazepines, carbamates, antihistamines, opioids, psychedelics, typical antipsychotics, and atypical antipsychotics;
wherein the active agent is selected from the group consisting of fluoxetine, sertraline, citalopram, escitalopram, fluvoxamine, paroxetine, venlafaxine, desvenlafaxine, duloxetine, milnacipran, levomilnacipran, trazodone, nefazodone, vortioxetine, vilazodone, reboxetine, atomoxetine, teniloxazine, viloxazine, bupropion, amitriptyline, amoxapine, desipramine, doxepine ,imipramine, nortriptyline, protriptyline, trimipramine, clomipramine, maprotiline, mirtazapine, amoxapine, maprotiline, mianserin, setiptiline, isocarboxazid, phenelzine, selegiline, tranylcypromine, rasagiline, agomelatine, ketamine, esketamine, lithium, buspirone, modafinil, lamotrigine, haloperidol, loxapine, thioridazone, molindone, thiothixene, fluphenazine, mesoridazine, trifluoperazine, perphenazine, chlorprothixene, pimozide, prochlorperazine, acetophenazine, triflupromazine, aripiprazole, brexpiprazole, olanzapine, quetiapine, risperidone, lurasidone, amisulpride, clozapine, ziprasidone and cariprazine, phenobarbital, alprazolam, bromazepam, chlordiazepoxide, clonazepam, clorazepate, diazepam, flurazepam, lorazepam, oxazepam, temazepam, triazolam, bromdihydrochlorphenylbenzodiazepine, meprobamate, carisoprodol, tybamate, lorbamate, hydroxyzine, chlorpheniramine and diphenhydramine, hydrocodone, fentanyl, buprenorphine, lysergic acid diethylamide (LSD), psilocybin, cannabis, ayahuasca, ololiuqui, 3,4-methylenedioxymethamphetamine (MDMA), mescaline, ibogaine, salvinorin A, 2,5-dimethoxy-4-methylamphetamine (DOM), 2,5-dimethoxy- 4-bromophenethylamine (2C-B), 25I-NBOMe (2-(4-iodo-2,5-dimethoxyphenyl)-N-[(2- methoxyphenyl)methyl]-ethanamine), and extracts/derivatives and pharmaceutically acceptable salts thereof.
Malchano teaches the method further comprising administering to the subject a pharmaceutical composition comprising an active agent comprising an anxiolytic (see Malchano [0928]; a pharmacological agent is administered in conjunction with the therapy, the agent including alprazolam, chlordiazepoxide, clonazepam, clorazepate, diazepam, lorazepam, oxazepam);
wherein the active agent is selected from the group consisting of barbiturates, benzodiazepines (see Malchano [0928]; a pharmacological agent is administered in conjunction with the therapeutic methods, the pharmacological agents can be barbiturates, benzodiazepines);
wherein the active agent is selected from the group consisting of ketamine, phenobarbital, alprazolam, chlordiazepoxide, clonazepam, clorazepate, diazepam, flurazepam, lorazepam, oxazepam, temazepam, or triazolam (see Malchano [0928]; the pharmacological agent can be ketamine, phenobarbital, alprazolam, chlordiazepoxide, clonazepam, clorazepate, diazepam, flurazepam, lorazepam, oxazepam, temazepam, or triazolam).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method taught by Hayano with the administration of an active agent as taught by Malchano. One of ordinary skill in the art would have been motivated to make this modification as the methods of the therapy involving stimulation may facilitate the use of a lower dosage of pharmacological agents to treat the targeted disorders.
Regarding claim 42, Hayano and Malchano teach the method according to claim 39. Hayano is silent regarding wherein the visual stimulus is applied to the subject at intervals between treatments with the active agent, thereby prolonging or sustaining a response to the active agent.
Malchano further teaches, wherein the visual stimulus is applied to the subject at intervals between treatments with the active agent, thereby prolonging or sustaining a response to the active agent (see Malchano [0048]; the system can administer a pharmacological agent to the subject prior to, simultaneous to, or subsequent to the administration of the stimulus).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method taught by Hayano with the administration of an active agent at intervals between treatments as taught by Malchano. One of ordinary skill in the art would have been motivated to make this modification in order to best prepare the subject for the therapeutic treatment, including inducing a relaxed state, inducing a heightened state of awareness, or modulating neuronal and/or synaptic activity (Malchano [0928-0930]).
Regarding claim 43, Hayano teaches the system according to claim 31. Hayano is silent regarding the system further comprising:
(ii) a monitoring device for monitoring synchronized gamma oscillations in the brain region of the subject; and
(iii) a processor configured to modulate a duration, a frequency, and/or an intensity of the flashing light emitted by the light source in response to detection of synchronized gamma oscillations of a frequency of about 55 to about 65 Hz by the monitoring device.
Malchano teaches the system comprising:
(ii) a monitoring device (700) for monitoring synchronized gamma oscillations in the brain region of the subject (see [0244]; the visual neural stimulation system 105 can include one or more hardware interfaces 700, [0296]; the feedback monitor 135 receives feedback from a feedback sensor 160 which may be a brain wave sensor or EEG probe); and
(iii) a processor (721) configured to modulate a duration, a frequency, and/or an intensity of the flashing light emitted by the light source in response to detection of synchronized gamma oscillations of a frequency of about 55 to about 65 Hz by the monitoring device (see [0033-0034]; the system applies a neural stimulation, which may be in the form of a visual stimulation, to a subject and measure the response of the subject to the stimulus and based on the response to the stimulus, modify the stimulus applied to the subject including the intensity of the stimulation).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Hayano’s visual stimulation system with the monitoring device and processing capabilities of Malchano. One of ordinary skill in the art would have been motivated to make this modification in order to determine the effectiveness of the delivered stimuli and adjust the stimuli based on the neural response of the subject (Malchano [0034-0037]).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayano et al (US 20210308481 A1) in view of LaVine et al (US 20200108270 A1).
Regarding claim 33, Hayano teaches the system of claim 31. Hayano is silent regarding the system further comprising a monitoring device for monitoring synchronized gamma oscillations in the brain region of the subject, the system further comprising a user interface for displaying brain activity detected by the monitoring device to a user.
LaVine teaches a system for stroboscopic light therapy to promote cognitive function in a subject using non-invasive stroboscopic stimulation in the 20-60 Hz range (LaVine, Abstract), comprising a monitoring device (202) for monitoring synchronized gamma oscillations in the brain region of the subject, the system further comprising a user interface for displaying brain activity detected by the monitoring device to a user (see LaVine [0014]; the device is designed to transmit data to a smartphone based mobile application, [0094-0097]; the eyewear device may record and transmit data representing responsive brain activity to the control device).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Hayano’s system with the monitoring device as taught by LaVine. One of ordinary skill in the art would have been motivated to make this modification in order to provide wireless or remote instantaneous access to healthcare professionals so they can access treatment plans, care management, and monitoring of progress as measured, for example, by neurological activity (LaVine [0097]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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