DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation "recommend the TMS" in line 5. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “recommend the sTMS treatment” and will be treated as such for examination purposes.
Claim Rejections - 35 USC § 101
Claims 1-7 and 9-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claims 1, 6, and 11 follows.
STEP 1
Regarding claims 1, 6, and 11, the claims recite a series of structural, including a system. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
the electrophysiology database and customized TMS treatment system is operable to classify the patient with a particular brain type based on the EEG data;
the electrophysiology database and customized TMS treatment system is operable to determine a synchronized transcranial magnetic stimulation (sTMS) treatment based on the classified brain type and the EEG data
the electrophysiology database and customized TMS treatment system is operable to analyze the EEG data to determine a brain health indication of the patient
the electrophysiology database and customized TMS treatment system is operable to determine synchronous TMS (sTMS) treatment based on the brain health indication and the EEG data;
the electrophysiology database and customized TMS treatment system is operable to analyze the EEG data to compute bursting EEG data analysis to determine a synchronous TMS (sTMS) treatment
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claims 1, 6, and 11 recites an electrophysiology database and customized TMS treatment system operable to access electroencephalogram (EEG) data for a patient and the electrophysiology database and customized TMS treatment system is operable to recommend the sTMS treatment, which is merely adding insignificant pre-solution and insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The recommended sTMS treatment does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the recommended sTMS treatment, nor does the method use a particular machine to perform the Abstract Idea.
Regarding claims 1, 6, and 11, the recited electrophysiology database and customized TMS treatment system are generic components configured to perform pre-solutional data gathering activity and insignificant extra-solution activity, and the recited electrophysiology database and customized TMS treatment system is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
an electrophysiology database and customized TMS treatment system operable to access electroencephalogram (EEG) data for a patient;
the electrophysiology database and customized TMS treatment system is operable to recommend the sTMS treatment.
The accessing and recommending steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the accessing and recommending steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity and insignificant extra-solution activity, e.g., mere data gathering and data outputting steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the accessing and recommending steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claims 1, 6, and 11 the system/electrophysiology database and customized TMS treatment system recited in the claim is a generic device comprising generic components (as evidenced by the non-patent literature of record: Sina Shirinpour et al 2020 J. Neural Eng. 17 046002; Atluri S, Frehlich M, Mei Y, Garcia Dominguez L, Rogasch NC, Wong W, Daskalakis ZJ and Farzan F (2016) TMSEEG: A MATLAB-Based Graphical User Interface for Processing Electrophysiological Signals during Transcranial Magnetic Stimulation. Front. Neural Circuits 10:78. doi: 10.3389/fncir.2016.00078; O. Romero, S. Chatterjee and S. Pequito, "Fractional-Order Model Predictive Control for Neurophysiological Cyber-Physical Systems: A Case Study using Transcranial Magnetic Stimulation," 2020 American Control Conference (ACC), Denver, CO, USA, 2020, pp. 4996-5001, doi: 10.23919/ACC45564.2020.9147545; Cook et al., Brain Activity and Clinical Outcomes in Adults With Depression Treated With Synchronized Transcranial Magnetic Stimulation: An Exploratory Study, Neuromodulation: Technology at the Neural Interface, Volume 22, Issue 8,2019, Pages 894-897 ISSN 1094-7159, https://doi.org/10.1111/ner.12914) configured to perform the abstract idea. The recited electrophysiology database and customized TMS treatment system are generic components configured to perform pre-solutional data gathering activity and insignificant extra-solution activity, and the recited electrophysiology database and customized TMS treatment system is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims. Claims 2, 5, 7, 10, 14-15 are directed to insignificant pre-solution activity and insignificant extra-solution activity, i.e. mere data gathering and data outputting steps necessary to perform the abstract idea. Claims 3-4, 9, 12-13, and 16-21 are directed to an abstract idea/Mental Processes (concepts performed in the human mind (including an observation, evaluation, judgment, opinion)). The dependent claims do not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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.
Claims 1-2, 6-7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hagedorn (US 20210393955 A1) in view of Philip (Philip et al., Predictors of response to synchronized transcranial magnetic stimulation for major depressive disorder. Depress Anxiety. 2019;36:278–285. https://doi.org/10.1002/da.22862)
Regarding claim 1, Hagedorn discloses a system for recommending transcranial magnetic stimulation (TMS) (“system ... electronically generating a treatment protocol”, Abstract, fig. 1, “programming of stimulation type (tDCS, tACS, tRNS, lt-TMS)”, para. [0059-0061, 0068], figs. 5 & 16 & 18) comprising: an electrophysiology database (“processing environment ... remote database”; “database ... EEG”, para. [0055, 0061, 0072]) and customized TMS treatment system (“joint brain electro-analysis and transcranial electrical stimulation system (tES)”, Abstract, para. [0055, 0064], figs. 3, 5, & 16) operable to access electroencephalogram (EEG) data for a patient (“collected EEG ... operative to receive the electrophysiology data”, para. [0071-0077, 0144-145], fig. 16), wherein the electrophysiology database and customized TMS treatment system is operable to classify the patient with a particular brain type based on the EEG data (“determining a brain malady and a severity value for the patent ... generating values predicting a cognitive category”; “classification task processes”, para. [0136-0139, 0150-0155, 0172], figs. 5 & 16), and the electrophysiology database and customized TMS treatment system is operable to determine a TMS treatment based on the classified brain type and the EEG data (“generating a treatment protocol for the patient based at least on the brain value measurements, the brain malady, and the severity value ... parameters for transcranial stimulation using an EEG ... TMS ... or any other suitable type of stimulation”, para. [0156-0157], figs. 5 & 16); and wherein the electrophysiology database and customized TMS treatment system is operable to recommend the TMS treatment (“report output ... graphical format ... report 504 may further include targeted brain stimulation protocol, functional training protocol with brain computer interface”; “recommended treatment protocols”, para. [0091, 0157], fig. 5 & 16).
Hagedorn further discloses that the treatment protocol further includes voltage strength and duration values, as well as location instructions for where to apply stimulation to the head of the patient (para. [0056]).
Hagedorn does not disclose that the electrophysiology database and customized TMS treatment system is operable to determine synchronous TMS (sTMS) treatment.
However, Philip directed to predictors of response to synchronized transcranial magnetic stimulation for major depressive disorder discloses determining synchronous TMS (sTMS) treatment based on EEG data (page 279, 2 2.3 sTMS device, “each participant's peak IAF was obtained using a short, single-channel EEG recording ... establish the sTMS sinusoidal wave periodicity used for all sub sequent treatments ... produce sinusoidal waveform magnetic fields with IAF periodicity” & page 280, Table 1, Participant Demographic and Clinical Characteristics & pag3 281, Table 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hagedorn such that the electrophysiology database and customized TMS treatment system is operable to determine a synchronized transcranial magnetic stimulation (sTMS) treatment based on the classified brain type and the EEG data, in view of the teachings of Philip, as this would aid in generating the treatment protocol by establishing an sTMS sinusoidal wave periodicity used for treatment to improve clinical efficacy.
Hagedorn, as modified by Philip hereinabove, discloses wherein the electrophysiology database and customized TMS treatment system is operable to recommend the sTMS treatment (Hagedorn, “report output ... graphical format ... report 504 may further include targeted brain stimulation protocol, functional training protocol with brain computer interface”; “recommended treatment protocols”, para. [0091, 0157, 0187], fig. 5 & 16 & Philip, page 279, 2 2.3 sTMS device, “establish the sTMS sinusoidal wave periodicity used for all sub sequent treatments ... produce sinusoidal waveform magnetic fields with IAF periodicity).
Regarding claim 2, Hagedorn, as modified by Philip hereinabove, discloses the system of claim 1, wherein the EEG data includes one or more EEGs from one or more of pre-treatments or post-treatments to provide diagnostic feedback and treatment feedback for the patient (“database of collected EEG ... pre and post measure of such electrophysiology”; “individual baseline data”; “pre-treatment brain malady condition”, para. [0061, 0083, 0192], fig. 16).
Regarding claim 6, Hagedorn discloses a system for recommending transcranial magnetic stimulation (TMS) (“system ... electronically generating a treatment protocol”, Abstract, fig. 1, “programming of stimulation type (tDCS, tACS, tRNS, lt-TMS)”, para. [0059-0061, 0068], figs. 5 & 16 & 18) comprising: an electrophysiology database (“processing environment ... remote database”; “database ... EEG”, para. [0055, 0061, 0072]) and customized TMS treatment system (“joint brain electro-analysis and transcranial electrical stimulation system (tES)”, Abstract, para. [0055, 0064], figs. 3, 5, & 16) operable to access electroencephalogram (EEG) data for a patient (“collected EEG ... operative to receive the electrophysiology data”, para. [0071-0077, 0144-145], fig. 16), wherein the electrophysiology database and customized TMS treatment system is operable to analyze the EEG data to determine a brain health indication of the patient (“EEG ... analyzed”; “quantified degree of severity from a normal health sample group”; “determining a brain malady and a severity value for the patent ... generating values predicting a cognitive category”, para. [0050, 0130, 0136-0139, 0150-0155, 0172], figs. 5 & 16), and the electrophysiology database and customized TMS treatment system is operable to determine TMS treatment based on the brain health indication and the EEG data (“generating a treatment protocol for the patient based at least on the brain value measurements, the brain malady, and the severity value ... parameters for transcranial stimulation using an EEG ... TMS ... or any other suitable type of stimulation”, para. [0156-0157], figs. 5 & 16); and wherein the electrophysiology database and customized TMS treatment system is operable to recommend the TMS treatment (“report output ... graphical format ... report 504 may further include targeted brain stimulation protocol, functional training protocol with brain computer interface”; “recommended treatment protocols”, para. [0091, 0157], fig. 5 & 16).
Hagedorn further discloses that the treatment protocol further includes voltage strength and duration values, as well as location instructions for where to apply stimulation to the head of the patient (para. [0056]).
Hagedorn does not disclose that the electrophysiology database and customized TMS treatment system is operable to determine synchronous TMS (sTMS) treatment.
However, Philip directed to predictors of response to synchronized transcranial magnetic stimulation for major depressive disorder discloses determining synchronous TMS (sTMS) treatment based on EEG data (page 279, 2 2.3 sTMS device, “each participant's peak IAF was obtained using a short, single-channel EEG recording ... establish the sTMS sinusoidal wave periodicity used for all sub sequent treatments ... produce sinusoidal waveform magnetic fields with IAF periodicity” & page 280, Table 1, Participant Demographic and Clinical Characteristics & pag3 281, Table 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hagedorn such that the electrophysiology database and customized TMS treatment system is operable to determine a synchronized transcranial magnetic stimulation (sTMS) treatment based on the brain health indication and the EEG data, in view of the teachings of Philip, as this would aid in generating the treatment protocol by establishing the sTMS sinusoidal wave periodicity used for treatment to improve clinical efficacy.
Hagedorn, as modified by Philip hereinabove, discloses wherein the electrophysiology database and customized TMS treatment system is operable to recommend the sTMS treatment (Hagedorn, “report output ... graphical format ... report 504 may further include targeted brain stimulation protocol, functional training protocol with brain computer interface”; “recommended treatment protocols”, para. [0091, 0157, 0187], fig. 5 & 16 & Philip, page 279, 2 2.3 sTMS device, “establish the sTMS sinusoidal wave periodicity used for all sub sequent treatments ... produce sinusoidal waveform magnetic fields with IAF periodicity).
Regarding claim 7, Hagedorn, as modified by Philip hereinabove, discloses the system of claim 6, wherein the EEG data includes one or more EEGs from one or more of pre-treatments or post-treatments to provide diagnostic feedback and treatment feedback for the patient (“database of collected EEG ... pre and post measure of such electrophysiology”; “individual baseline data”; “pre-treatment brain malady condition”, para. [0061, 0083, 0192], fig. 16).
Regarding claim 9, Hagedorn, as modified by Philip hereinabove, discloses the system of claim 6 wherein the electrophysiology database and customized TMS treatment system uses the brain health indication for diagnosing the patient (“generating values predicting a cognitive category, also referred to as the brain malady, with a diagnostic accuracy, also referred to as the severity value”, para. [0072, 0150-0156, 0186]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hagedorn in view of Philip, as applied to claim 1 above, and further in view of Jin (US 20170281035 A1).
Regarding claim 3, Hagedorn, as modified by Philip hereinabove, discloses the system of claim 1. Hagedorn further discloses that a brain malady may be dementia, depression, brain injury, or any other malady relating to the brain and that the method generates a treatment protocol directed to the brain malady type and tailored to the patient (para. [0007-0008]). Hagedorn, as modified by Philip hereinabove, does not disclose wherein the particular brain type is at least one of a highly rhythmic brain, a less rhythmic brain, a low energy brain, or a high energy brain.
However, Jin directed to systems for the diagnosis of specific mental disorders using neurometrics discloses wherein the particular brain type is at least one of a highly rhythmic brain, a less rhythmic brain, a low energy brain, or a high energy brain (“normally rhythmic ... energy ... distributed widely ... anxiety”; “lower energy ... highly rhythmic brain ... depression diagnosis”, para. [0072, 0074]). Jin further discloses that a key factor in treatment of mental disorders is proper diagnosis and system for the diagnosis of mental disorders that is based on measurable data (para. [0004]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hagedorn, as modified by Philip hereinabove, such that the particular brain type is at least one of a highly rhythmic brain, a less rhythmic brain, a low energy brain, or a high energy brain, in view of the teachings of Jin, as this would aid in diagnosing mental disorders based on measurable data (Abstract, para. [0006]) and would aid in generating the treatment protocol directed to the brain malady type tailored to the patient (Hagedorn, para. [0007-0008]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hagedorn in view of Philip, as applied to claim 1 above, and further in view of Zhao (WO 2018059177 A1 English Translation).
Regarding claim 4, Hagedorn, as modified by Philip hereinabove, discloses the system of claim 1. Hagedorn, as modified by Philip hereinabove, wherein the particular brain type is at least one of an absorber-type of personality or an emitter-type of personality.
However, Zhao directed to mobile epilepsy treatment device and epilepsy treatment system discloses the particular brain type is at least one of an absorber-type of personality or an emitter-type of personality (“a computer can obtain the following information ... personality (introverted, extroverted)”, para. [0033]). Zhao further discloses that the computer terminal can realize the function of patient database and provide epilepsy patients with convenient and fast diagnosis, treatment and follow-up procedures for screening and treatment, so as to realize accurate and complete data chain service for individual epilepsy patients and retain the data for life (para. [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hagedorn, as modified by Philip hereinabove, such that the particular brain type is at least one of an absorber-type of personality or an emitter-type of personality, in view of the teachings of Zhao, as this would aid in providing patients with convenient and fast diagnosis based on patient information of personality (Zhao, para. [0033]) and would aid in generating the treatment protocol directed to the brain malady type tailored to the patient (Hagedorn, para. [0007-0008]).
Claims 5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Hagedorn in view of Philip, as applied to claims 1 and 6 above, and further in view of Phillips (US 20110137104 A1).
Regarding claims 5 and 10, Hagedorn, as modified by Philip hereinabove, discloses the system of claim 1/the system of claim 6. Hagedorn, as modified by Philip hereinabove, does not expressly disclose a portable neuro-electroencephalogram synchronization therapy (NEST) system that is operable to capture the EEG data from the patient for access by the electrophysiology database and customized TMS treatment system, and wherein the portable NEST system is operable to recommend the sTMS treatment to the patient.
However, Phillips directed to systems and methods for depression treatment using neuro-EEG synchronization therapy discloses a portable neuro-electroencephalogram synchronization therapy (NEST) system (“Neuro-EEG Synchronization Therapy (NEST) device”; “patient can take the pMERT (NEST) device to his/her home to use the device in accordance with the therapy prescribed by the psychiatrist or the patient can be treated in the psychiatrist's office”, para. [0058, 0499, 0506]) that is operable to capture the EEG data from the patient for access by the electrophysiology database and customized TMS treatment system (“storing data in a device ... magnetic field ... database”, “database ... EEG”; “plug a pMERT (NEST) device ...PC ...NeoSync website”, para. [0107, 0121, 0151, 0504-0506]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hagedorn, as modified by Philip hereinabove, such that the system further comprises a portable neuro-electroencephalogram synchronization therapy (NEST) system that is operable to capture the EEG data from the patient for access by the electrophysiology database and customized TMS treatment system, in view of the teachings of Phillips, as this would aid in providing a small, generally cube-shaped device that can be used in home to apply transcranial magnetic stimulation therapy.
Upon the modification to incorporate the NEST device of Phillips, as described above, Hagedorn, as modified by Philip and Phillips hereinabove, further discloses wherein the portable NEST system is operable to recommend the sTMS treatment to the patient (Hagedorn, “report output ... graphical format ... report 504 may further include targeted brain stimulation protocol, functional training protocol with brain computer interface”; “recommended treatment protocols”, para. [0091, 0157], fig. 5 & 16 & Philip, page 279, 2 2.3 sTMS device, “establish the sTMS sinusoidal wave periodicity used for all sub sequent treatments ... produce sinusoidal waveform magnetic fields with IAF periodicity).
Claims 11-14 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Hagedorn in view of DiLorenzo (US 7974696 B1), and further in view of Philip.
Regarding claim 11, Hagedorn discloses a system for recommending transcranial magnetic stimulation (TMS) (“system ... electronically generating a treatment protocol”, Abstract, fig. 1, “programming of stimulation type (tDCS, tACS, tRNS, lt-TMS)”, para. [0059-0061, 0068], figs. 5 & 16 & 18) comprising: an electrophysiology database (“processing environment ... remote database”; “database ... EEG”, para. [0055, 0061, 0072]) and customized TMS treatment system (“joint brain electro-analysis and transcranial electrical stimulation system (tES)”, Abstract, para. [0055, 0064], figs. 3, 5, & 16) operable to access electroencephalogram (EEG) data for a patient (“collected EEG ... operative to receive the electrophysiology data”, para. [0071-0077, 0144-145], fig. 16), wherein the electrophysiology database and customized TMS treatment system is operable to analyze the EEG data (“EEG ... analyzed”; “ EEG or ERP measurements, an abnormality in a region of the brain is determined in step 230”; “quantified degree of severity from a normal health sample group”; “determining a brain malady and a severity value for the patent ... generating values predicting a cognitive category”, para. [0050, 0053, 0130, 0136-0139, 0150-0155, 0172], figs. 5 & 16) to compute EEG data analysis to determine a TMS treatment (“generating a treatment protocol for the patient based at least on the brain value measurements, the brain malady, and the severity value ... parameters for transcranial stimulation using an EEG ... TMS ... or any other suitable type of stimulation”, para. [0156-0157], figs. 5 & 16); and wherein the electrophysiology database and customized TMS treatment system is operable to recommend the TMS treatment (“report output ... graphical format ... report 504 may further include targeted brain stimulation protocol, functional training protocol with brain computer interface”; “recommended treatment protocols”, para. [0091, 0157], fig. 5 & 16).
Hagedorn does not expressly disclose that the electrophysiology database and customized TMS treatment system is operable to analyze the EEG data to compute bursting EEG data analysis to determine a synchronous TMS (sTMS) treatment.
However, DiLorenzo directed to a neurological control system for modulating activity of any component or structure of some or all of the nervous system discloses compute bursting EEG data analysis (“electrodes ... recording ... spike detector 85 ... spike characterizer 86 calculates parameters ... parameterization of recorded action potentials, also referred to as spikes, bursts of spikes, and overall neural activity patterns ... assessment and quantification of activity change, reflective of change in disease state”, col. 28 line 30 - col. 30 line 3) to determine an optimal set of stimulation parameters (“transcranial magnetic stimulation”; “automated determination of the optimum magnitude of treatment ... quantitative representation of the level or "state" of the disease is determined ... optimal set of stimulation parameters is converged upon”, col. 5 line 50 – col. 6 line 4 & col. 59 lines 53-53 & col. 41 lines 12-34 & col. 46 lines 6-17, figs . 3 & 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hagedorn such that the electrophysiology database and customized TMS treatment system is operable to analyze the EEG data to compute bursting EEG data analysis to determine an optimal set of stimulation parameters, in view of the teachings of DiLorenzo, as this would aid in determining an optimal set of stimulation parameters by measuring the disease state and response to therapy by incorporating the spike characterizer and analyzer of DiLorenzo to process the signals.
Hagedorn further discloses that the treatment protocol further includes voltage strength and duration values, as well as location instructions for where to apply stimulation to the head of the patient (para. [0056]).
Hagedorn, as modified by DiLorenzo hereinabove, does not disclose determining a synchronous TMS (sTMS) treatment.
However, Philip directed to predictors of response to synchronized transcranial magnetic stimulation for major depressive disorder discloses determining a synchronous TMS (sTMS) treatment based on EEG data (page 279, 2 2.3 sTMS device, “each participant's peak IAF was obtained using a short, single-channel EEG recording ... establish the sTMS sinusoidal wave periodicity used for all sub sequent treatments ... produce sinusoidal waveform magnetic fields with IAF periodicity” & page 280, Table 1, Participant Demographic and Clinical Characteristics & pag3 281, Table 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hagedorn, as modified by DiLorenzo hereinabove, such that the electrophysiology database and customized TMS treatment system is operable to determine a synchronized transcranial magnetic stimulation (sTMS) treatment, in view of the teachings of Philip, as this would aid in generating the treatment protocol by establishing the sTMS sinusoidal wave periodicity used for treatment to improve clinical efficacy.
Hagedorn, as modified by DiLorenzo and Philip hereinabove, discloses wherein the electrophysiology database and customized TMS treatment system is operable to recommend the sTMS treatment (Hagedorn, “report output ... graphical format ... report 504 may further include targeted brain stimulation protocol, functional training protocol with brain computer interface”; “recommended treatment protocols”, para. [0091, 0157, 0187], fig. 5 & 16 & Philip, page 279, 2 2.3 sTMS device, “establish the sTMS sinusoidal wave periodicity used for all sub sequent treatments ... produce sinusoidal waveform magnetic fields with IAF periodicity).
Regarding claim 12, Hagedorn, as modified by DiLorenzo and Philip hereinabove, discloses the system of claim 11 wherein the electrophysiology database and customized TMS treatment system is operable to provide a diagnosis for the patient using the bursting EEG data analysis (Hagedorn, “generating values predicting a cognitive category, also referred to as the brain malady, with a diagnostic accuracy, also referred to as the severity value”, para. [0072, 0150-0156, 0186] & DiLorenzo, “disease state estimator 88”, col. 28 line 30 - col. 30 line 3 & col. 46 lines 6-17, figs. 3 & 6).
Regarding claim 13, Hagedorn, as modified by DiLorenzo and Philip hereinabove, discloses the system of claim 11 wherein the electrophysiology database and customized TMS treatment system is operable to use the bursting EEG data analysis to determine one or more treatment parameters (Hagedorn, “EEG recordings ... processed ... generate brain malady typology and severity predictions ... determine improved treatment intervention protocols”, para. [0091-0092, 0148, 0186-0191], figs. 5 & 16 & 18; & DiLorenzo, “transcranial magnetic stimulation”; “determination ... quantitative representation of the level or "state" of the disease is determined ... optimal set of stimulation parameters is converged upon”, col. 59 lines 53-53 & col. 41 lines 12-34 & col. 46 lines 6-17, figs . 3 & 6), wherein the treatment parameters comprise one or more of a stimulation component position, a magnetic field characteristic, an output waveform, a magnetic field spatial distribution, a magnetic field strength gradient, a device compatibility, or a safety feature (“type of stimulation, location, amount, duration, etc.”; “voltage strength and duration values”, para. [0049, 0059, 0128, 0156]; & Philip, page 279, 2 2.3 sTMS device, “establish the sTMS sinusoidal wave periodicity used for all sub sequent treatments ... produce sinusoidal waveform magnetic fields with IAF periodicity”).
Regarding claim 14, Hagedorn, as modified by DiLorenzo and Philip hereinabove, discloses the system of claim 11 wherein the EEG data comprises one or more EEGs from one or more of pre-treatments or post-treatments to provide diagnostic feedback and treatment feedback for the patient. (“database of collected EEG ... pre and post measure of such electrophysiology”; “individual baseline data”; “pre-treatment brain malady condition”, para. [0061, 0083, 0192], fig. 16).
Regarding claim 16, Hagedorn, as modified by DiLorenzo and Philip hereinabove, discloses the system of claim 11, wherein the electrophysiology database and customized TMS treatment system comprises normative EEG data used to compute the bursting EEG data analysis (“database of known human population normative values ... determine a deviation ... EEG measures ... EEG and ERP analysis as part of the diagnostic process”, para. [0040, 0061, 0071-0072, 0148]).
Regarding claim 17, Hagedorn, as modified by DiLorenzo and Philip hereinabove, discloses the system of claim 11, wherein the electrophysiology database and customized TMS treatment system is operable to compute the bursting EEG data analysis using one or more of an artificial intelligence algorithm or a machine learning algorithm (“machine learning/deep learning operations ... generating and using data sets for estimating the brain malady”, para. [0138-0139, 0148, 0165, 0182-0183], figs. 16-18).
Regarding claim 18, Hagedorn, as modified by DiLorenzo and Philip hereinabove, discloses the system of claim 11, wherein the electrophysiology database and customized TMS treatment system comprises a treatment modeling system (“machine learning predictions ... generate measured improvements of the pre-treatment brain malady condition”, para. [0190-0192]) comprising one or more adjustable factors including electrode position, energy levels, or duration of treatment (“protocols define stimulation parameters ... type of stimulation, location, amount, duration”; “brain computer interface training location and frequency protocols ... scalp location, polarity at the sensor, and milliamp levels and duration at each location”; “ generate measured improvements of the pre-treatment brain malady condition”, para. [0049, 0086-0088, 0190-0192]).
Regarding claim 19, Hagedorn, as modified by DiLorenzo and Philip hereinabove, discloses the system of claim 11, wherein the electrophysiology database and customized TMS treatment system is operable to recommend the sTMS treatment based on a condition comprising one or more of post-traumatic stress disorder (PTSD), depression, anxiety, autism spectrum disorder, Alzheimer's, traumatic brain injury, or generalized anxiety disorder (“depression, Alzheimer's, ... traumatic brain injury ... generates a treatment protocol for treating or mitigating the brain malady”; “personalized treatment protocol in accordance with the patient's brain malady”, para. [0059, 0137-0143, 0157-0158], figs. 16 & 18).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hagedorn in view of DiLorenzo and Philip, as applied to claim 11 above, and further in view of Phillips.
Regarding claim 15, Hagedorn, as modified by DiLorenzo and Philip hereinabove, discloses the system 11. , Hagedorn, as modified by DiLorenzo and Philip hereinabove, does not expressly disclose a portable neuro-electroencephalogram synchronization therapy (NEST) system operable to capture the EEG data from the patient for access by the electrophysiology database and customized TMS treatment system, and wherein the portable NEST system is operable to recommend the TMS to the patient.
However, Phillips directed to systems and methods for depression treatment using neuro-EEG synchronization therapy discloses a portable neuro-electroencephalogram synchronization therapy (NEST) system (“Neuro-EEG Synchronization Therapy (NEST) device”; “patient can take the pMERT (NEST) device to his/her home to use the device in accordance with the therapy prescribed by the psychiatrist or the patient can be treated in the psychiatrist's office”, para. [0058, 0499, 0506]) that is operable to capture the EEG data from the patient for access by the electrophysiology database and customized TMS treatment system (“storing data in a device ... magnetic field ... database”, “database ... EEG”; “plug a pMERT (NEST) device ...PC ...NeoSync website”, para. [0107, 0121, 0151, 0504-0506]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hagedorn, as modified by DiLorenzo and Philip hereinabove, such that the system further comprises a portable neuro-electroencephalogram synchronization therapy (NEST) system operable to capture the EEG data from the patient for access by the electrophysiology database and customized TMS treatment system, in view of the teachings of Phillips, as this would aid in providing a small, generally cube-shaped device that can be used in home to apply transcranial magnetic stimulation therapy.
Upon the modification to incorporate the NEST device of Phillips, as described above, Hagedorn, as modified by Philip and Phillips hereinabove, further discloses wherein the portable NEST system is operable to recommend the sTMS treatment to the patient (Hagedorn, “report output ... graphical format ... report 504 may further include targeted brain stimulation protocol, functional training protocol with brain computer interface”; “recommended treatment protocols”, para. [0091, 0157], fig. 5 & 16 & Philip, page 279, 2 2.3 sTMS device, “establish the sTMS sinusoidal wave periodicity used for all sub sequent treatments ... produce sinusoidal waveform magnetic fields with IAF periodicity).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hagedorn in view of DiLorenzo and Philip, as applied to claim 11 above, and further in view of Phua (US 20220183611 A1).
Regarding claim 20, Hagedorn, as modified by DiLorenzo and Philip hereinabove, discloses the system of claim 11. Hagedorn, as modified by DiLorenzo and Philip hereinabove, does not disclose wherein the electrophysiology database and customized TMS treatment system is operable to recommend the sTMS treatment based on a neurotransmitter density change.
However, Phua directed to identifying and extracting pain-related electroencephalogram (EEG) signals discloses a system (“system”, para. [0076]) operable to recommend TMS treatment based on a neurotransmitter density change (“EEG data ... determine a current density for each of the one or more signals ... current density for a set of neural activity regions of interest ... mean and variance of changes in the EEG data”; “stimulation/feedback parameters in association with the brain-signal derived pain neuromatrix activation estimate”; “brain stimulation engine is used to determine the frequency, duration ... transcranial magnetic stimulation”, para. [0076, 0145, 0150-0156, 0296-0298]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hagedorn, as modified by DiLorenzo and Philip hereinabove, such that the electrophysiology database and customized TMS treatment system is operable to recommend the sTMS treatment based on a neurotransmitter density change, in view of the teachings of Phua, as this would aid in maximize the efficacy of the stimulation (Phua, para. [0298]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Hagedorn in view of DiLorenzo and Philip, as applied to claim 11 above, and further in view of Lee (US 20180368720 A1).
Regarding claim 21, Hagedorn, as modified by DiLorenzo and Philip hereinabove, discloses the system of claim 11. Hagedorn, as modified by DiLorenzo and Philip hereinabove, does not disclose wherein the electrophysiology database and customized TMS treatment system is operable to recommend the sTMS treatment based on a neuronal connectivity.
However, Lee directed to methods and systems for analyzing brain functional activity data discloses a system operable to recommend TMS treatment based on a neuronal connectivity (“functional activity data ... electroencephalography (EEG) ... generating the neuronal subtype-specific connectivity estimates”; “display results ... transcranial magnetic stimulation device ... based on the analysis of neural pathways contributing to the functional brain activity data ... determine ... a parameter for a therapy ... stimulus protocol”, para. [0007, 0059-0062, 0105-0107, 0115]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hagedorn, as modified by DiLorenzo and Philip hereinabove, such that the electrophysiology database and customized TMS treatment system is operable to recommend the sTMS treatment based on a neuronal connectivity, in view of the teachings of Lee, as this would aid in providing an appropriate stimulation to the relevant brain region that regulates the neural pathway by determining a stimulus protocol for transcranial magnetic stimulation based on neuronal subtype-specific connectivity estimates (Lee, para. [0105-0107, 0115]).
Conclusion
Aguilar (US 20150105837 A1) directed to a brain therapy system and method using noninvasive brain stimulation.
Zrenner et al., Real-time EEG-defined excitability states determine efficacy of TMS-induced plasticity in human motor cortex, Brain Stimulation, Volume 11, Issue 2, 2018, Pages 374-389, ISSN 1935-861X, https://doi.org/10.1016/j.brs.2017.11.016.
Zrenner et al., Brain oscillation-synchronized stimulation of the left dorsolateral prefrontal cortex in depression using real-time EEG-triggered TMS, Brain Stimulation, Volume 13, Issue 1, 2020, Pages 197-205, ISSN 1935-861X, https://doi.org/10.1016/j.brs.2019.10.007.
Philip (Philip et al., Synchronized transcranial magnetic stimulation for posttraumatic stress disorder and comorbid major depression, Brain Stimulation, Volume 12, Issue 5, 2019, Pages 1335-1337, ISSN 1935-861X, https://doi.org/10.1016/j.brs.2019.06.010).
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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