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 .
Preliminary Amendment
Preliminary Amendment dated 07/22/2024 has been formally entered and claims 51-73 submitted with Preliminary Amendment dated 07/22/2024 are being examined on the merits.
Information Disclosure Statement
The listing of references in the specification as-filed page 46 lines 34 (Lehman et al., 1987) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Abstract
The abstract of the disclosure is objected to because it reads like a claim. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives. Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps. Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Drawings
The drawings are objected to because fig. 6A is blurry.
Figures 4, 6A, 6B, 7, 8, 9, should be designated by a legend such as --Prior Art-- because only that which is old is illustrated as evidenced in instant application specification as-file page 26 lines 5-11, page 28 line 33-34, page 44 lines 7-9. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
“…short term…” in at least page 20 line 29 needs to be corrected. A suggested correction is –short-term--.
“…long term…” in at least page 21 line 2 needs to be corrected. A suggested correction is –long-term--.
“that optionally generates the maximal muscle twitch of a subject fingers” in at least page 43 lines 20-21 needs to be corrected. A suggested correction is -- that optionally generates the maximal muscle twitch of a [[subject]] subject’s fingers--.
“a time period between 1 minute and 60 minute” in page 44 line 34 needs to be corrected. A suggested correction is -- a time period between 1 minute and 60 minutes--.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Following claims are objected to because of the following informalities:
Claim 51 “determining an acute effect … an intermediate effect of the TMS protocol on a brain state of the patient based on a change in values of the one or more EEG parameters” needs to be corrected. A suggested correction is -- determining an acute effect … an intermediate effect of the TMS protocol on a brain state of the patient based on a change in the values of the one or more EEG parameters—in light of antecedent for the term “values” in claim 51 line 5.
In each of claims 54-68 line 1 “A system” needs to be corrected. A suggested correction is – [[A]] The system – in light of its antecedent in claim 51 line 1 “A system”.
In each of claims 70-71 line 1 “A method” needs to be corrected. A suggested correction is – [[A]] The method – in light of its antecedent in claim 69 line 1 “A method”.
Claim 73 line 1 “A method” needs to be corrected. A suggested correction is – [[A]] The method – in light of its antecedent in claim 73 line 1 “A method”.
Claim 55 “wherein the control circuitry signals the user interface to generate a human detectable indication with instructions to modify at least one parameter of the TMS protocol or to replace the TMS protocol with a different TMS protocol, if the determined efficacy is lower than a desired efficacy” needs to be corrected. A suggested correction is -- wherein the control circuitry signals the user interface to generate a human detectable indication with instructions to modify at least one parameter of the TMS protocol or to replace the TMS protocol with a different TMS protocol, [[if]] based on the determined efficacy [[is]] being lower than a desired efficacy -- to avoid conditional/contingent limitation recitation which would raise question as to whether the limitations resulting from the conditional clause is even required (see MPEP 2111.04) and also raises question as to what occurs when the condition is not met.
Claim 56 “wherein the control circuitry signals the user interface to generate a human detectable indication with instructions to stop the TMS treatment or to extend a length of an interval between two consecutive treatment sessions of the TMS treatment, if the determined efficacy is a desired efficacy or is larger than a desired efficacy” needs to be corrected. A suggested correction is -- wherein the control circuitry signals the user interface to generate a human detectable indication with instructions to stop the TMS treatment or to extend a length of an interval between two consecutive treatment sessions of the TMS treatment, [[if]] based on the determined efficacy [[is]] being a desired efficacy or is larger than a desired efficacy-- to avoid conditional/contingent limitation recitation which would raise question as to whether the limitations resulting from the conditional clause is even required (see MPEP 2111.04) and also raises question as to what occurs when the condition is not met.
Claim 69 “analyzing the recorded EEG signals to generate values of one or more EEG parameters; determining an acute effect and an intermediate effect of the TMS protocol on a brain state of the patient based on a change in values of the one or more EEG parameters; determining an efficacy of the TMS protocol based on the determined acute effect and the intermediate effect” needs to be corrected. A suggested correction is – analyzing via a control circuitry the recorded EEG signals to generate values of one or more EEG parameters; determining via the control circuitry an acute effect and an intermediate effect of the TMS protocol on a brain state of the patient based on a change in values of the one or more EEG parameters; determining via the control circuitry an efficacy of the TMS protocol based on the determined acute effect and the intermediate effect—to avoid any potential 35 U.S.C 101 subject-matter ineligibility issues that may arise under MPEP Patent Subject Matter Eligibility sections 2106.04(a) , 2106.04(d), 2106.05 i.e. claim as recited lends itself as a whole to a broad yet reasonable interpretation under MPEP 2111 as reciting a judicial exception when claim limitations individually and in combination are deemed as reciting for example abstract idea without reciting additional elements that integrate the judicial exception into a practical application of the judicial exception with the additional elements also not amounting to significant more than the judicial exception.
Claim 69 “analyzing the recorded EEG signals to generate values of one or more EEG parameters; determining an acute effect of the TMS protocol on a brain state of the patient based on values of the one or more EEG parameters; performing a cognitive examination of the patient using at least one cognitive exam, after completing the treatment session to determine an intermediate effect of the TMS protocol, and determining an efficacy of the TMS protocol based on the determined acute effect and the determined intermediate effect” needs to be corrected. A suggested correction is – analyzing via a control circuitry the recorded EEG signals to generate values of one or more EEG parameters; determining via the control circuitry an acute effect of the TMS protocol on a brain state of the patient based on values of the one or more EEG parameters; performing a cognitive examination of the patient using at least one cognitive exam, after completing the treatment session to determine an intermediate effect of the TMS protocol, and determining via the control circuitry an efficacy of the TMS protocol based on the determined acute effect and the determined intermediate effect—to avoid any potential 35 U.S.C 101 subject-matter ineligibility issues that may arise under MPEP Patent Subject Matter Eligibility sections 2106.04(a) , 2106.04(d), 2106.05 i.e. claim as recited lends itself as a whole to a broad yet reasonable interpretation under MPEP 2111 as reciting a judicial exception when claim limitations individually and in combination are deemed as reciting for example abstract idea without reciting additional elements that integrate the judicial exception into a practical application of the judicial exception with the additional elements also not amounting to significant more than the judicial exception.
Claim 59 “at least one EEG electrode attached to a head of the patient, configured to record said EEG signals” needs to be corrected needs to avoid potential interpretation as falling under 35 U.S.C. 101 and section 33(a) of the America Invents Act (Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism) and thus as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). A suggested correction is -- at least one EEG electrode configured to be attached to a head of the patient, wherein the EEG electrode records said EEG signals--.
Claim 69 “determining an acute effect and an intermediate effect of the TMS protocol on a brain state of the patient based on a change in values of the one or more EEG parameters” needs to be corrected. A suggested correction is -- determining an acute effect and an intermediate effect of the TMS protocol on a brain state of the patient based on a change in the values of the one or more EEG parameters—in light of antecedent for the term “values” in claim 69 lines 7-8.
Claim 72 “determining an acute effect of the TMS protocol on a brain state of the patient based on values of the one or more EEG parameters” needs to be corrected. A suggested correction is -- determining an acute effect of the TMS protocol on a brain state of the patient based on the values of the one or more EEG parameters—in light of antecedent for the term “values” in claim 72 line 6.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 51-73 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 58 in lines 1-2 recite the limitation " the one or more EEG microstates parameter". There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear as to which one among the “one or more EEG microstates parameters” in claim 57 line 2 is being referenced by claim 58 lines 1-2" the one or more EEG microstates parameter".
Claim 59 recite the limitation "the at least one TMS protocol". There is insufficient antecedent basis for this limitation in the claim.
Claim 51 in line 10 recites “a TMS protocol” which render this claim unclear. More specifically, it is unclear as to whether claim 51 line 10 “a TMS protocol” is the same as, different than or in addition to that in claim 51 lines 1-2 and if different in what way the two differ.
Claims 52, 53, 55, 60-62, 64-65, each recite “the TMS protocol” which render this claim unclear. More specifically, it is unclear as to whether in each of claims “the TMS protocol” is referencing “that in claim 51 line 2 and/or “a TMS protocol” in claim 51 line 10.
Claim 59 recite “said TMS treatment protocol” which render this claim unclear. More specifically, it is unclear as to whether claim 59 “said TMS treatment protocol” is referencing “that in claim 51 line 2 and/or “a TMS protocol” in claim 51 line 10.
Each of claims 51, 57, 62 recites ”acute effect” and “determining an acute effect” and/or “determine the acute effect” which renders each of these claims unclear. More specifically, it is unclear as to what is meant by the term “acute effect” in the context used, how is acute effect actually determined, what objective/subjective parameters are used to determine “acute effect”.
Claim 51 in line 10-11 recites “determining an efficacy of a TMS protocol used in the TMS treatment based on the determined acute effect and the determined intermediate effect” (emphasis added) which renders this claim unclear in the context of claim 51 line 6 which recites “determining an acute effect and/or an intermediate effect of the TMS protocol” (emphasis added). More specifically, a broad yet reasonable interpretation of claim 51 line 6 requires either “determining an acute effect” or “determining an acute effect intermediate effect” while claim 51 lines 10-11 goes on to require that both acute effect and intermediate need to be determined in order to determine an efficacy of a TMS protocol used in the TMS treatment.
Claim 69 recites ”acute effect” and “determining an acute effect” which renders these claims unclear. More specifically, unclear as to what is meant by the term “acute effect” in the context used, how is acute effect actually determined, what objective/subjective parameters are used to determine “acute effect”.
Claim 72 recites ”acute effect” and “determining an acute effect” which renders these claims unclear. More specifically, unclear as to what is meant by the term “acute effect” in the context used, how is acute effect actually determined, what objective/subjective parameters are used to determine “acute effect”.
Claim 57 recites “determine the acute effect and the intermediate effect based on a change in the calculated values of the extracted one or more EEG microstates parameters” which renders this claim unclear and indistinguishable. As recited the difference between “acute effect” and “intermediate effect” is unclear as both are recited as being determined based on a change in the calculated values of the extracted one or more EEG microstates parameters.
Claim 62 recites “an intermediate effect” and “an efficacy of the TMS protocol” which renders this claim unclear. More specifically, it is unclear as to whether claim 61 “an intermediate effect” and “an efficacy of the TMS protocol” are the same as, different than or in addition to the corresponding terms “an intermediate effect” and “an efficacy of the TMS protocol” recited in claim 51 and if different in what way the two differ.
Claim 70 recites “the acute effect and the intermediate effect are determined based on the measured values or the central tendency of the one or more EEG microstates parameters” which renders this claim unclear and indistinguishable. As recited the difference between “acute effect” and “intermediate effect” is unclear as both are recited as being determined based on the measured values or the central tendency of the one or more EEG microstates parameters.
Claim 69 in line 6 recites “recording EEG signals after completion of the treatment session” which renders this claim unclear in the context of claim 69 line 4-5 “recording EEG signals … after the delivering …the treatment session”. More specifically, it is unclear as to whether claim 69 line 6 “recording EEG signals after completion of the treatment session” is the same as, different than or in addition to that recited in claim 69 line 6 “recording EEG signals after completion of the treatment session” as the two as recited are indistinguishable one from the other.
Claim 69 in lines 4-5 recites “recording EEG signals before and after the delivering during the treatment session” which renders this claim unclear. More specifically, it is unclear as to whether EEG signals are recorded before and after the delivering the treatment session or whether EEG signals are recorded during the delivering of the treatment session. It is unclear as to how EEG signals can be simultaneously recorded before and after the delivering as well as during the treatment session i.e. are they two independent, mutually exclusive or sequential sessions. In the interest of furthering prosecution, claim 69 lines 4-5 is being interpreted as if reciting --recording EEG signals before and after the delivering [[during]] of the treatment session--.
Claim 71 in lines 1-2 recite the limitation "the measured one or more EEG microstates parameter". There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear as to which one among the “one or more EEG microstates parameters” in claim 70 lines 1-2 and/or lines 4-5 is being referenced by Claim 71 in lines 1-2 " the measured one or more EEG microstates parameter ".
Claim 72 in lines 4-5 recites “recording EEG signals before and after the delivering during the treatment session” which renders this claim unclear. More specifically, it is unclear as to whether EEG signals are recorded before and after the delivering the treatment session or whether EEG signals are recorded during the delivering of the treatment session. It is unclear as to how EEG signals can be simultaneously recorded before and after the delivering as well as during the treatment session i.e. are they two independent, mutually exclusive or sequential sessions. In the interest of furthering prosecution, claim 69 lines 4-5 is being interpreted as if reciting --recording EEG signals before and after the delivering [[during]] of the treatment session--.
Dependent claims 52-67, 70-71, and 73 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 52-67, 70-71, and 73 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification as-filed at least page 16 line 15 through page 19 line 2, page 28 lines 32-34, page 44 lines 7-9, page 45 lines 15-16, page 46 lines 12-14, page 52 line 12 through page 54 line 4.
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
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 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.
Claims 51-66. 69-73 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glik et al. (Pub. No.: US 20200237247 A1, hereinafter referred to as “Glik”).
As per independent Claim 51, Glik discloses a system for determining an efficacy of a transcranial magnetic stimulation (TMS) treatment protocol (Glik in at least abstract, fig. 1-5, [0060-0093], [0127-0156], [0194], [0200], [0202], [0247-0248], [0273-0285], [0310-0317] ,[0329-0331], [0357-0358], [0360], [0365-0372], [0374], [0494], [0497], [0501], [0508], [0515], [0529-0543] for example discloses relevant subject-matter. More pertinently, see Glik in at least abstract, fig. 5A,[0081-0083], [0247-0248], [0281], [0374]. See at least [0374] “TMS protocol is …modified at 518… based on the determined TMS treatment effect, for example treatment efficacy or treatment side effects…TMS protocol modifications are adjusted to increase the TMS treatment efficacy”), comprising:
a control circuitry (Glik, fig. 4, 412, 420), wherein the control circuitry is configured to:
analyzing EEG signals recorded during a TMS treatment delivered to a patient, to generate values of one or more EEG parameters (Glik, [0369-0371]: “during the TMS treatment an electric field is applied through … electrode or the magnetic coil are attached to the scalp of the patient…during the TMS treatment session… EEG parameters are measured and microstate parameters values are extracted … EEG parameters are measured after the completion of the TMS treatment session…the microstate parameters values that were extracted after the TMS application are compared … microstate parameters values of the same patient that were determined before the treatment or the treatment session”);
determining an acute effect and/or an intermediate effect of the TMS protocol on a brain state of the patient based on a change in values of the one or more EEG parameters (Glik, [0370-0371]: comparison of parameters measured before, during and/or after TMS treatment/stimulation; [0494], [0497]: cognitive tests performed before, during, and/or after; Also see [0501], [0515]: repeating testing before and after treatment); and
determining an efficacy of a TMS protocol used in the TMS treatment based on the determined acute effect and the determined intermediate effect (Glik in at least fig. 5A, [0372]: “the TMS treatment efficacy is determined based on the comparison between the post-treatment microstate parameters values to the pre-treatment microstate parameters values”; [0515]: “Repeated testing…may be performed periodically (e.g., on a time scale of 1-400 days… or intermediate time scales), before and/or in response to treatment … testing is repeated before and after treatment… in a short time period, for example, within 0.5-72 hours, for example, between 1 and 5 hours… patient is assessed at least once a week or 4 days or shorter or longer time periods.”; [0069] “comparing one or more microstate parameters values of an EEG signal that was measured after the treatment, to one or more microstate parameters values of an EEG signal that was measured before the treatment”; [0508], [0528]: “achieve a more stable change in microstate data, for example, as measured at a time which is delayed from an acute treatment …at some other delay (e.g., 1-10 days, weeks and/or months) which results in the measurement reflecting a longer term effect”).
As per dependent Claim 52, Glik further discloses system wherein said intermediate effect of the TMS protocol is determined based on a change in microstates parameter values between values calculated using EEG signals recorded after completion of a treatment session of said TMS treatment and values calculated using EEG signals recorded during said treatment session (Glik in at least fig. 5A, [0372]: “the TMS treatment efficacy is determined based on the comparison between the post-treatment microstate parameters values to the pre-treatment microstate parameters values”; [0393], [0068-0069] “comparing one or more microstate parameters values of an EEG signal that was measured after the treatment, to one or more microstate parameters values of an EEG signal that was measured before the treatment”).
As per dependent Claim 53, Glik further discloses system wherein said control circuitry is further configured to determine a long-term effect of the TMS protocol, wherein said long-term effect is determined based on microstates measurements performed at least 24 hours following the TMS treatment (Glik in at least [0393] “EEG signals are recorded one or more hours or one or more days or weeks following the treatment.”; [0508]: “achieve a more stable change in microstate data, for example, as measured at a time which is delayed from an acute treatment …at some other delay (e.g., 1-10 days, weeks and/or months)” ).
As per dependent Claim 54, Glik further discloses system comprising: a user interface operationally connected to the control circuitry, wherein the user interface is configured to generate a human detectable indication; and wherein the control circuitry signals the user interface to generate the human detectable indication according to the determined efficacy (Glik in at least [0373]: “a human-detectable indication is provided regarding the TMS treatment effect at 517”; [0329]).
As per dependent Claim 55, Glik further discloses a system wherein the control circuitry signals the user interface to generate a human detectable indication with instructions to modify at least one parameter of the TMS protocol or to replace the TMS protocol with a different TMS protocol, if the determined efficacy is lower than a desired efficacy (Glik in at least [0373]: “human-detectable indication includes the clinical and/or cognitive state of the patient and/or the microstate parameters values after the application of the TMS treatment… human-detectable indication includes at least one suggested modification to the TMS treatment protocol, for example at least one modification of TMS parameters”).
As per dependent Claim 56, Glik further discloses a system wherein the control circuitry signals the user interface to generate a human detectable indication with instructions to stop the TMS treatment or to extend a length of an interval between two consecutive treatment sessions of the TMS treatment, if the determined efficacy is a desired efficacy or is larger than a desired efficacy (Glik in at least [0247] “TMS … is used, an evaluation of the treatment effect on microstate parameters … guide treatment… if the microstate data shows improvement, the treatment is continued. Otherwise, one or more treatment parameter is changed”; [0331]: “treatment and/or the treatment protocol is modified based on the determined clinical and/or cognitive condition of the patient at 218… treatment parameters are modified, for example treatment duration and/or the intervals between two treatment sessions”; [0373]: “human-detectable indication includes the clinical and/or cognitive state of the patient and/or the microstate parameters values after the application of the TMS treatment… human-detectable indication includes at least one suggested modification to the TMS treatment protocol, for example at least one modification of TMS parameters”; [0374]: “TMS protocol modifications comprise modifying the duration of each TMS treatment session and/or the time interval between two consecutive treatment sessions”).
As per dependent Claim 57, Glik further discloses system wherein the one or more EEG parameters comprise one or more EEG microstates parameters (Glik in at least fig. 1B, [0310-0317]. See at least Glik [0310]:”extraction of microstate parameters values from EEG parameters”); and wherein the control circuitry is configured to extract the one or more EEG microstates parameters from the EEG signals (See at least Glik [0310]:”extraction of microstate parameters values from EEG parameters”) and to calculate values of the extracted one or more EEG parameters or central tendency thereof, during the analyzing (Glik in at least [0382]:” microstates parameter values are calculated …parameters values or mean values of resting state microstates are calculated…microstates parameters comprise duration or means duration of one or more microstates or the combined duration or mean duration of two or more microstates”; [0383]: “microstates parameters comprise one or more of microstate duration, microstate coverage, microstate frequency, number of transitions of each microstate or any combination of the microstates parameters for one or more or a combination of microstates”), and to determine the acute effect and the intermediate effect based on a change in the calculated values of the extracted one or more EEG microstates parameters (Glik in at least fig. 5A, [0372]: “the TMS treatment efficacy is determined based on the comparison between the post-treatment microstate parameters values to the pre-treatment microstate parameters values”; [0069] “comparing one or more microstate parameters values of an EEG signal that was measured after the treatment, to one or more microstate parameters values of an EEG signal that was measured before the treatment”; [0508], [0528]: “achieve a more stable change in microstate data, for example, as measured at a time which is delayed from an acute treatment …at some other delay (e.g., 1-10 days, weeks and/or months) which results in the measurement reflecting a longer term effect”).
As per dependent Claim 58, Glik further discloses system wherein the one or more EEG microstates parameter comprise at least one of, duration of at least one EEG microstate, frequency of at least one EEG microstate, coverage of at least one microstate and transitions between two or more EEG microstates (Glik in at least [0382]:” microstates parameter values are calculated …parameters values or mean values of resting state microstates are calculated…microstates parameters comprise duration or means duration of one or more microstates or the combined duration or mean duration of two or more microstates”; [0383]: “microstates parameters comprise one or more of microstate duration, microstate coverage, microstate frequency, number of transitions of each microstate or any combination of the microstates parameters for one or more or a combination of microstates”).
As per dependent Claim 59, Glik further discloses system further comprising: at least one magnetic coil configured to be positioned close to, or in contact with a head of the patient (Glik, [0369]: “the magnetic coil are attached to the scalp of the patient”); at least one EEG electrode attached to a head of the patient, configured to record said EEG signals (Glik, [0357]:”device 430 receives EEG signals from electrodes connected to a patient's head”); and a memory, wherein the memory stores at least one of said TMS treatment protocol (Glik [0357-0358]:” control circuitry 412 extracts microstate parameters values from the EEG signals, and signals pulse generator 424 to generate at least one pulse based on the microstate parameters values or based on other parameters stored in memory 416… control circuitry 412 determines pulse parameters according to a program stored in memory 416”; [0360]:” memory 416 stores at least one operation program of device 430 and/or microstate parameters values and/or EEG measurements and/or TMS parameters”), wherein said control circuitry is configured to deliver TMS to the patient using the at least one TMS protocol in at least one treatment session(Glik, [0369-0359]:” selected TMS protocol is applied at 508… during the TMS treatment an electric field is applied through … a magnetic coil…the magnetic coil are attached to the scalp of the patient”).
As per dependent Claim 60, Glik further discloses system wherein the determined efficacy comprises determining that the TMS protocol has low efficacy in improving a cognitive state of the patient, based on the intermediate effect (Glik, [0276]: “microstate parameters values measured after a treatment are compared to microstate parameters values of the same patient that were measured before the treatment, for example to determine the efficacy and/or the toxicity and/or side effects of the treatment…if the determined efficacy is not in a desired range, then the treatment is modified”;), and wherein the control circuitry is configured to modify the TMS treatment according to the determined efficacy (Glik, [0332]: “if the microstate parameters values following the treatment indicate, for example deterioration in the clinical and/or cognitive condition of the patient towards undesired microstate parameters values, then the TMS protocol is replaced or at least one parameter of the TMS protocol is modified.”; [0374]:” TMS protocol is modified based on the determined TMS treatment effect, for example treatment efficacy or treatment side effects… TMS protocol modifications comprise modifying pulse frequency, and/or number of pulses in a train of pulses and/or number of pulses in a treatment session and/or time of a treatment session…TMS protocol modifications comprise modifying the duration of each TMS treatment session and/or the time interval between two consecutive treatment sessions”. Also see [0330], [0372]).
As per dependent Claim 61, Glik further discloses system wherein the modifying comprises replacing the TMS protocol with a different TMS protocol, or modifying values of at least one parameter of the TMS protocol, based on the determined low efficacy (Glik, [0332]: “if the microstate parameters values following the treatment indicate, for example deterioration in the clinical and/or cognitive condition of the patient towards undesired microstate parameters values, then the TMS protocol is replaced or at least one parameter of the TMS protocol is modified.”; [0374]:” TMS protocol is modified based on the determined TMS treatment effect, for example treatment efficacy or treatment side effects… TMS protocol modifications comprise modifying pulse frequency, and/or number of pulses in a train of pulses and/or number of pulses in a treatment session and/or time of a treatment session…TMS protocol modifications comprise modifying the duration of each TMS treatment session and/or the time interval between two consecutive treatment sessions”).
As per dependent Claim 62, Glik further discloses a system wherein the control circuitry is further configured to: generate an indication to perform a cognitive examination of the patient using at least one cognitive exam, after completing the treatment session, to determine an intermediate effect of the at least one TMS treatment protocol, and determine an efficacy of the TMS protocol based on the determined acute effect and the determined intermediate effect (Glik [0497] “Repeated testing…may be performed periodically (e.g., on a time scale of 1-400 days, for example, between 1-10 days, between 10 and 50 days and/or between 50-400 days, or intermediate time scales), before and/or in response to treatment …and/or in response to a desired to change treatment … due to a side effect, perceived effectiveness and/or perceived ineffectiveness…testing is repeated before and after treatment… testing may be repeated during treatment … during breaks in a TMS sequence”; [0521-0522]:“ Testing may be repeated to detect an effect of treatment. For example, a TMS treatment may be considered successful if it changes (e.g., within 0-10 seconds, within 10-720 seconds, within 10-30 minutes, within 30-720 minutes or intermediate or greater times), microstate data values (e.g., classification results as in 2110) to more normal values, for example, sufficient to change the classification…treatment parameters are changed if classifier and/or classifying parameter values indicate an insufficient change in state… TMS … duration increased… when testing a plurality of treatments or possible treatment parameter settings, treatments and/or settings are changed in response to test results, for example, increase if the result is positive and/or changing treatment if no effective change is found.”).
As per dependent Claim 63, Glik further discloses system wherein the control circuitry is configured to: determine that a responsiveness of a brain of the patient to the delivered TMS is lower than a desired responsiveness level and/or that an effect of the TMS treatment has reached a maximal therapeutic effect after the treatment session, based on the determined efficacy; and modify the TMS treatment and/or the TMS treatment protocol according to the determined responsiveness and/or the determined TMS treatment effect (Glik, [0332]: “if the microstate parameters values following the treatment indicate, for example deterioration in the clinical and/or cognitive condition of the patient towards undesired microstate parameters values, then the TMS protocol is replaced or at least one parameter of the TMS protocol is modified.”;).
As per dependent Claim 64, Glik further discloses system wherein the modify the TMS treatment protocol by the control circuitry comprises replacing the TMS protocol with a different TMS protocol, or modifying values of at least one parameter of the TMS protocol (Glik, [0332]: “if the microstate parameters values following the treatment indicate, for example deterioration in the clinical and/or cognitive condition of the patient towards undesired microstate parameters values, then the TMS protocol is replaced or at least one parameter of the TMS protocol is modified.”).
As per dependent Claim 65, Glik further discloses system wherein the at least one parameter of the TMS protocol comprises at least one of, location of a magnetic coil on a head of the patient, intensity of a magnetic stimulation pulse, number of pulses per train of pulses, frequency of pulses during a train of pulses, and number of trains per treatment session(Glik in at least [0374]:TMS protocol is modified based on the determined TMS treatment effect, for example treatment efficacy or treatment side effects…TMS protocol modifications comprise modifying pulse frequency, and/or number of pulses in a train of pulses and/or number of pulses in a treatment session and/or time of a treatment session… TMS protocol include changing the location of the magnetic coil on the patient's head…TMS protocol modifications comprise modifying the duration of each TMS treatment session and/or the time interval between two consecutive treatment sessions”).
As per dependent Claim 66, Glik further discloses system wherein modifying by the control circuitry comprises extending an interval between two consecutive treatment sessions of the TMS treatment(Glik in at least [0374]:TMS protocol is modified based on the determined TMS treatment effect, for example treatment efficacy or treatment side effects… TMS protocol modifications comprise modifying … the time interval between two consecutive treatment sessions”).
As per dependent Claim 68, Glik further discloses system wherein said cognitive examination comprises at least one of, a mini-mental state exam (MMSE), a Montreal Cognitive Assessment (MoCA) and Rey's Auditory Verbal Learning Test (RAVLT) exam, Months backward test exam, Months forward test exam, Rey-Osterrieth Complex Figure Test (ROCFT) exam, Phonemic & Semantic Fluency exam, Digits span Forward & backwards exam, Stroop exam, Clock drawing exam, The Trail Making Test Part A and/or Part B, Functional Activities Questionnaire (FAQ), Quality of Life in Alzheimer's Disease (QOL-AD) Questionnaire, the Beck Depression Inventory (BDI, BDI-1A, BDI-II), the Beck Anxiety Inventory (BAI), and the Tablet-based Cognitive Assessment Tool (TabCAT) (Glik, [0379]).
As per independent Claim 69, Glik discloses a method for determining an efficacy of a transcranial magnetic stimulation (TMS) treatment (Glik in at least abstract, fig. 1-5, [0060-0093], [0127-0156], [0194], [0200], [0202], [0247-0248], [0273-0285], [0310-0317] ,[0329-0331], [0357-0358], [0360], [0365-0372], [0374], [0494], [0497], [0501], [0508], [0515], [0529-0543] for example discloses relevant subject-matter. More pertinently, fig. 5A, [0372] “the TMS treatment effect, for example the TMS treatment efficacy is determined based on the comparison between the post-treatment microstate parameters values to the pre-treatment microstate parameters values”), comprising:
delivering TMS to a patient using a TMS protocol in a TMS treatment session (Glik in at least fig. 5A, [0082] “delivering a TMS by at least one magnetic coil attached to the scalp”; [0247] “ TMS … an evaluation of the treatment effect on microstate parameters …to guide treatment”; [0369] “TMS protocol is applied at 508…during the TMS treatment an electric field is applied through an electrode or a magnetic coil”);
recording EEG signals before and after the delivering during the treatment session; recording EEG signals after completion of the treatment session (Glik in at least fig. 5A, [0281] “microstate parameters values are measured during and/or after a TMS treatment session, for example to determine the efficacy and/or one or more side effects of the treatment”; [0360] “memory 416 stores at least one operation program of device 430 and/or microstate parameters values and/or EEG measurements and/or TMS parameters”; [0370] “during the TMS treatment session… EEG parameters are measured and microstate parameters values are extracted at 510… EEG parameters are measured after the completion of the TMS treatment session”);
analyzing the recorded EEG signals to generate values of one or more EEG parameters (Glik, [0369-0371]: “during the TMS treatment an electric field is applied through … electrode or the magnetic coil are attached to the scalp of the patient…during the TMS treatment session… EEG parameters are measured and microstate parameters values are extracted … EEG parameters are measured after the completion of the TMS treatment session…the microstate parameters values that were extracted after the TMS application are compared … microstate parameters values of the same patient that were determined before the treatment or the treatment session”);
determining an acute effect and an intermediate effect of the TMS protocol on a brain state of the patient based on a change in values of the one or more EEG parameters (Glik, [0370-0371]: comparison of parameters measured before, during and/or after TMS treatment/stimulation; [0494], [0497]: cognitive tests performed before, during, and/or after; Also see [0501], [0515]: repeating testing before and after treatment);
determining an efficacy of the TMS protocol based on the determined acute effect and the intermediate effect (Glik in at least fig. 5A, [0372]: “the TMS treatment efficacy is determined based on the comparison between the post-treatment microstate parameters values to the pre-treatment microstate parameters values”; [0515]: “Repeated testing…may be performed periodically (e.g., on a time scale of 1-400 days… or intermediate time scales), before and/or in response to treatment … testing is repeated before and after treatment… in a short time period, for example, within 0.5-72 hours, for example, between 1 and 5 hours… patient is assessed at least once a week or 4 days or shorter or longer time periods.”; [0069] “comparing one or more microstate parameters values of an EEG signal that was measured after the treatment, to one or more microstate parameters values of an EEG signal that was measured before the treatment”; [0508], [0528]: “achieve a more stable change in microstate data, for example, as measured at a time which is delayed from an acute treatment …at some other delay (e.g., 1-10 days, weeks and/or months) which results in the measurement reflecting a longer term effect”).
As per dependent Claim 70, Glik further discloses a method wherein the one or more EEG parameters comprise one or more EEG microstates parameters(Glik in at least fig. 1B, [0310-0317]. See at least Glik [0310]:”extraction of microstate parameters values from EEG parameters”), and wherein the analyzing comprises extracting the one or more EEG microstates parameters from the recorded EEG signals (See at least Glik [0310]:”extraction of microstate parameters values from EEG parameters”) and measuring values of the one or more EEG microstates parameters or central tendency of the values (Glik in at least [0382]:” microstates parameter values are calculated …parameters values or mean values of resting state microstates are calculated…microstates parameters comprise duration or means duration of one or more microstates or the combined duration or mean duration of two or more microstates”; [0383]: “microstates parameters comprise one or more of microstate duration, microstate coverage, microstate frequency, number of transitions of each microstate or any combination of the microstates parameters for one or more or a combination of microstates”), and wherein the acute effect and the intermediate effect are determined based on the measured values or the central tendency of the one or more EEG microstates parameters (Glik in at least fig. 5A, [0372]: “the TMS treatment efficacy is determined based on the comparison between the post-treatment microstate parameters values to the pre-treatment microstate parameters values”; [0069] “comparing one or more microstate parameters values of an EEG signal that was measured after the treatment, to one or more microstate parameters values of an EEG signal that was measured before the treatment”; [0508], [0528]: “achieve a more stable change in microstate data, for example, as measured at a time which is delayed from an acute treatment …at some other delay (e.g., 1-10 days, weeks and/or months) which results in the measurement reflecting a longer term effect”).
As per dependent Claim 71, Glik further discloses method wherein the measured one or more EEG microstates parameter comprise duration of at least one EEG microstate (Glik in at least [0382]:” microstates parameter values are calculated …parameters values or mean values of resting state microstates are calculated…microstates parameters comprise duration or means duration of one or more microstates or the combined duration or mean duration of two or more microstates”; [0383]: “microstates parameters comprise one or more of microstate duration, microstate coverage, microstate frequency, number of transitions of each microstate or any combination of the microstates parameters for one or more or a combination of microstates”).
As per independent Claim 72, Glik discloses a method for determining an efficacy of a transcranial magnetic stimulation (TMS) treatment (Glik in at least abstract, fig. 1-5, [0060-0093], [0127-0156], [0194], [0200], [0202], [0247-0248], [0273-0285], [0310-0317] ,[0329-0331], [0357-0358], [0360], [0365-0372], [0374], [0494], [0497], [0501], [0508], [0515], [0529-0543] for example discloses relevant subject-matter. More pertinently, fig. 5A, [0372] “the TMS treatment effect, for example the TMS treatment efficacy is determined based on the comparison between the post-treatment microstate parameters values to the pre-treatment microstate parameters values”), comprising:
delivering TMS to a patient using a TMS protocol as part of a treatment session (Glik in at least fig. 5A, [0082] “delivering a TMS by at least one magnetic coil attached to the scalp”; [0247] “ TMS … an evaluation of the treatment effect on microstate parameters …to guide treatment”; [0369] “TMS protocol is applied at 508…during the TMS treatment an electric field is applied through an electrode or a magnetic coil”);
recording EEG signals before and after the delivering during the treatment session (Glik in at least fig. 5A, [0281] “microstate parameters values are measured during and/or after a TMS treatment session, for example to determine the efficacy and/or one or more side effects of the treatment”; [0360] “memory 416 stores at least one operation program of device 430 and/or microstate parameters values and/or EEG measurements and/or TMS parameters”; [0370] “during the TMS treatment session… EEG parameters are measured and microstate parameters values are extracted at 510… EEG parameters are measured after the completion of the TMS treatment session”);
analyzing the recorded EEG signals to generate values of one or more EEG parameters (Glik, [0369-0371]: “during the TMS treatment an electric field is applied through … electrode or the magnetic coil are attached to the scalp of the patient…during the TMS treatment session… EEG parameters are measured and microstate parameters values are extracted … EEG parameters are measured after the completion of the TMS treatment session…the microstate parameters values that were extracted after the TMS application are compared … microstate parameters values of the same patient that were determined before the treatment or the treatment session”);
determining an acute effect of the TMS protocol on a brain state of the patient based on values of the one or more EEG parameters (Glik, [0370-0371]: comparison of parameters measured before, during and/or after TMS treatment/stimulation; [0494], [0497]: cognitive tests performed before, during, and/or after; Also see [0501], [0515]: repeating testing before and after treatment);
performing a cognitive examination of the patient using at least one cognitive exam, after completing the treatment session to determine an intermediate effect of the TMS protocol(Glik [0497] “Repeated testing…may be performed periodically (e.g., on a time scale of 1-400 days, for example, between 1-10 days, between 10 and 50 days and/or between 50-400 days, or intermediate time scales), before and/or in response to treatment …and/or in response to a desired to change treatment … due to a side effect, perceived effectiveness and/or perceived ineffectiveness…testing is repeated before and after treatment… testing may be repeated during treatment … during breaks in a TMS sequence”; [0521-0522]:“ Testing may be repeated to detect an effect of treatment. For example, a TMS treatment may be considered successful if it changes (e.g., within 0-10 seconds, within 10-720 seconds, within 10-30 minutes, within 30-720 minutes or intermediate or greater times), microstate data values (e.g., classification results as in 2110) to more normal values, for example, sufficient to change the classification…treatment parameters are changed if classifier and/or classifying parameter values indicate an insufficient change in state… TMS … duration increased… when testing a plurality of treatments or possible treatment parameter settings, treatments and/or settings are changed in response to test results, for example, increase if the result is positive and/or changing treatment if no effective change is found.”), and
determining an efficacy of the TMS protocol based on the determined acute effect and the determined intermediate effect (Glik in at least fig. 5A, [0372]: “the TMS treatment efficacy is determined based on the comparison between the post-treatment microstate parameters values to the pre-treatment microstate parameters values”; [0515]: “Repeated testing…may be performed periodically (e.g., on a time scale of 1-400 days… or intermediate time scales), before and/or in response to treatment … testing is repeated before and after treatment… in a short time period, for example, within 0.5-72 hours, for example, between 1 and 5 hours… patient is assessed at least once a week or 4 days or shorter or longer time periods.”; [0069] “comparing one or more microstate parameters values of an EEG signal that was measured after the treatment, to one or more microstate parameters values of an EEG signal that was measured before the treatment”; [0508], [0528]: “achieve a more stable change in microstate data, for example, as measured at a time which is delayed from an acute treatment …at some other delay (e.g., 1-10 days, weeks and/or months) which results in the measurement reflecting a longer term effect”).
As per dependent Claim 73, Glik further discloses method wherein the at least one cognitive exam comprises at least one of, a mini-mental state exam (MMSE), a Montreal Cognitive Assessment (MoCA) and Rey's Auditory Verbal Learning Test (RAVLT) exam (Glik, [0379]).
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 of this title, 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 67 is rejected under 35 U.S.C. 103 as being unpatentable over Glik.
As per dependent Claim 67, Glik discloses system according to claim 51 (see claim 51 analysis above)
Glik does not necessarily require or explicitly disclose administer at least one drug before and/or after delivery of the TMS feature in the applied embodiment.
However, Glik discloses alternate embodiment combinations that make obvious modifying by the control circuitry comprises generating an indication by the control circuitry to administer at least one drug before and/or after delivery of the TMS (Glik in at least [0060-0062]:”evaluating a treatment for a brain condition…extracting one or more microstate parameter values from at least one EEG signal that was measured after the treatment; and…evaluating at least one parameter of the treatment based on the one or more microstate parameter values”; [0081]: “wherein the evaluating further comprises evaluating the efficacy and/or the efficiency of the treatment”; [0082] “delivering a TMS by at least one magnetic coil attached to the scalp, before the extracting”;[0089] “administering at least one drug to treat the brain condition”; [0248] “treatment may be, for example with TMS… in which case changes in microstate data may be used as an indicator that the treatment is correct and/or parameters thereof need to be changed. Similarly, drug treatment may be assessed/changed based on its effect on microstate parameters”; [0373]: “a human-detectable indication is provided regarding the TMS treatment effect at 517”; [0541]: “certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention…may also be provided separately or in any suitable subcombination”. Thus, applied art as a whole discloses the subject-matter as now explicitly, positively and specifically recited by the Applicants.).
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 system for determining the efficacy of a TMS treatment protocol as taught by Glik, by further administering at least one drug before and/or after delivery of the TMS feature, as made obvious by Glik. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, as such modifications would be apparent to a one of ordinary skill in the art before the effective filing date of the claimed invention as falling within the spirit and broad scope of the Glik (Glik, [0542]) for the advantage of effectively and efficaciously shifting microstates parameters values which correlate with a disease state to microstates parameters values which correlate with a healthy state (Glik, [0333]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
Prior art US 20240050763 A1 to Phillips et al. discloses systems for providing transcranial magnetic stimulation (TMS) therapy based on electroencephalogram (EEG) data similar to that disclosed. More specifically, Phillips discloses system for providing transcranial magnetic stimulation (TMS) based on analyzed electroencephalogram (EEG) data. The networked system interfaces with portable neuro-electroencephalogram synchronization therapy (NEST) devices for capturing EEG data from a patient. The network also may also include an electrophysiology database and customized TMS treatment system for receiving the EEG data from the portable NEST system. The electrophysiology database and customized TMS treatment system are configurable and operable to determine a TMS treatment based on the received EEG data. The portable NEST system also provides synchronized TMS based on the determined TMS treatment.
Prior art US 20210346710 A1 to Phillips et al. discloses methods and devices to modulate brain activity with repetitive transcranial magnetic stimulation (rTMS) wherein the rTMS pulse interval is variable similar to that disclosed. More specifically, methods, and devices for modulating the brain activity of a person by varying pulse interval of repetitive transcranial magnetic stimulation (rTMS). The pulse interval variation is chosen so that the interval frequency distribution of pulses for a treatment session approximates the EEG frequency distribution of the person.
Prior art US 20220211325 A1 to Malish discloses individualized transcranial magnetic stimulation to diagnose and treat particular disease states in neurology and mental health similar to that disclosed. More specifically, Malish discloses systems and methods for providing predictive diagnostics for mental health diagnosing by utilizing quantitative electroencephalography measurements of an individual to diagnose or assist in the diagnosis of a neurological or mental disease state for that individual. The diagnosed mental state can then be treated utilizing individualized transcranial magnetic stimulation. The individualized transcranial magnetic stimulation repairs these areas of the brain with customized protocols unique to the patient's brain based upon the quantitative electroencephalography measurements made during the diagnosis.
Prior art US 20040138578 A1 to Pineda et al. discloses the use of brain stimulation techniques using magnetic fields and characterization of bioelectric activity for producing real-time, adaptive changes in cognitive-emotive profiles similar to that disclosed. More specifically, Pineda discloses means and method for inducing a temporary physiological state-of-mind to effect persistent changes to the cognitive-emotive profile of an individual, which is adaptable for neurofeedback and "mental-state" therapeutic and non-therapeutic interventions. The system comprises an EEG Recording Module (ERM), a Neurodynamics Assessment Module ("NAM"), and a Transcranial Magnetic Stimulation module ("TMS") for acquiring and manipulating bioelectrical and/or EEG data, defining a cognitive-emotive profile, and mapping the cognitive-emotive profile to selectively control transcranial magnetic stimulation to drive therapeutic and non-therapeutic stimulus interventions. A bi-directional feedback feature is provided to further enhance the performance of the system to effect prolonged changes.
Prior art US 20200038417 A1 to Barbut et al. discloses methods of treating, preventing and/or delaying the onset or progression of cognitive impairment similar to that disclosed. More specifically, Barbut discloses methods of treating, preventing, and/or slowing the onset or progression of cognitive impairment and/or a cognitive impairment related symptom in a subject in need. The methods, which utilize a patient-specific “fixed dose” of an aminosterol, comprise administering a therapeutically effective dose of an aminosterol to a subject in need.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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