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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) is acknowledged.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 and 41-50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In particular, the scope of the claim includes any and all data types for embodying the “measurement data representative of a plurality of alpha bursts associated with the subject’s brain” of independent claims 1 and 10. The specification (page 4, third paragraph) teaches the data can be EEG, MRI image, Brain Score, EKG recording, SPECT scan, PET scan, x-ray, CT scan, Ultrasound, mammogram, fluoroscopy, arthrogram, myelogram, DEXA bone density scan, body temperature, respiratory rate, heart rate, blood pressure, blood oxygen saturation, Complete Blood Count, basic metabolic panel, comprehensive metabolic panel, lipid panel, liver panel, thyroid stimulating hormone, hemoglobin A1CProthrombin time, blood enzyme tests, blood clotting test, urinalysis, cultures, applanation tonometry, visual acuity testing, visual field test results, mental health assessment, behavioral health assessment, psychiatric assessment, athletic performance measurement, academic performance measurement, intelligence test result, self-assessment, demographics, and personality profile. However, the only data type disclosed that is recognized by one of ordinary skill for possibly measuring “the plurality of alpha bursts corresponding to successive bursts of activity in the subject’s brain between 8-13 Hz” as required by claims 1 and 10, is electroencephalography (EEG). The disclosure does not provide any details whatsoever about how any of the other data types listed could provide information on alpha bursts. As such, the scope of the claim is impermissibly broad to include data types other than EEG.
Further, the scope of the claim includes any and all stimulation types for embodying the “stimulation treatment at the stimulation frequency close to a head of the subject to influence at least one alpha burst parameter of the subject’s brain” of independent claims 1 and 10. In the specification, the disclosure provides for applying magnetic fields (page 10, last paragraph) by broadly applying a magnetic field to the entire surface of the subject’s head with a uniform distribution (page 12, last paragraph). The magnetic field could also be directed towards a specific portion of the subject’s head (page 12, last paragraph). The treatment modality could also be alternating magnetic field or pulsed magnetic field (page 10, last paragraph). The treatment modality could also be transcranial electrical stimulation, focused ultrasound, functional near infrared spectroscopy (fNIRS), or sensory stimulation including flashing light, sound, video, or touch (page 10, last paragraph; also page 6, second paragraph). The only modality with any detail whatsoever is that of application of the magnetic field, since US Patent No. 9,308,387 is incorporated by reference on page 6, first paragraph. In the 9,308,387 patent, details of repetitive transcranial magnetic stimulation (rTMS) are described for influencing the intrinsic Q-factor parameter of the brain, which includes alpha band wavelengths. However, nothing in the 9,308,387 relates specifically to the alpha burst parameter, e.g. alpha frequency variability (AFV) or alpha prevalence (AP). Patent 9,308,387 teaches there are many parameters of magnetic field generation that must be considered in a therapeutic device including a) intensity, b) frequency, c) amplitude, and d) phase (col. 25, lines 41-58). However, only the frequency parameter has been somewhat addressed by the instant disclosure. One is left wondering what settings for intensity, amplitude, phase, and even target treatment location would be sufficient to influence at least one alpha burst parameter as claimed. For the modalities included that are other than the rTMS technique (i.e. transcranial electrical stimulation, focused ultrasound, functional near infrared spectroscopy (fNIRS), or sensory stimulation), no direction is given at all. One of ordinary skill would not understand how to utilize these modalities to influence an alpha burst parameter without more direction. It does not appear that there is sufficient disclosure for any of the modalities and their corresponding stimulation parameters to show possession of “providing a stimulation treatment at the stimulation frequency close to a head of the subject to influence at least one alpha burst parameter of the subject’s brain”, as required by claims 1 and 10.
Additional evidence in the form of working examples is also lacking. Rather, a grandiose assertion of treating a wide variety of poorly-understood mental illnesses is made (Autism Spectrum Disorder, Alzheimer’s disease, ADHD, schizophrenia, anxiety, depression, coma, Parkinson’s disease, substance abuse, bipolar disorder, sleep disorder, eating disorder, tinnitus, traumatic brain injury, post-traumatic stress disorder, and fibromyalgia, page 11, second paragraph) as a result of the optimization of the alpha burst parameter, as in claim 2.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”).
Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
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.
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.
Claims 1-18, 41-50 are 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.
Regarding Claim 1, lines 2 and line 5, the scopes of each of “having obtained” and “having determined” respectively, are not understood, since they seem to be referring to steps that have already happened. Deleting these phrases would resolve the issue.
Further regarding Claim 1, two lines from the end “close to a head of the subject” is subjective and therefore indefinite. It is not understood what bounds to put on “close” because it has not been defined by the specification, thereby leaving up to subjective determination as to what is close enough to read on the claim.
The same issue exists in claim 10 as for claim 1 above, regarding “close to a head of the subject”.
Further regarding Claims 1 and 10, the scope cannot be determined of “providing a stimulation treatment at the stimulation frequency close to a head of the subject to influence at least one alpha burst parameter of the subject’s brain” due to the lack of disclosure for the treatment parameters (e.g. specific frequencies, phases, intensities, timing, target locations), target condition, disease/condition being treated, and treatment modalities. Examiner is unable to put reasonable bounds on the claim in light of the disclosure and is left guessing. See rejection under USC 112(a) above.
Claims 2-9, 11-18, 41-50 are rejected by virtue of their dependency on a rejected claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1-18, 41-50 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
Step 1: Statutory Category: YES - The claim 1 recites a method of treating a subject and, therefore, is a method. The claim 10 recites a system for providing treatment to a subject and, therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: YES – Claims 1 and 10 each recites the limitation of “determining or having determined a plurality of intrinsic frequencies of the subject’s brain based on the measurement data representative of the plurality of alpha bursts”. This limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers a naturally occurring phenomenon. That is, the “intrinsic frequencies of the subject’s brain” are a naturally occurring phenomenon, whether they are measured or not.
Step 2A, Prong 2, Integrated into Practical Application: No – Claims 1 and 10 each recites additional elements:
“obtaining or having obtained measurement data representative of a plurality of alpha bursts associated with the subject’s brain, the plurality of alpha bursts corresponding to successive bursts of activity in the subject’s brain between 8-13 Hz” and “selecting a stimulation frequency based on the plurality of intrinsic frequencies of the subject’s brain; and providing a stimulation treatment at the stimulation frequency close to a head of the subject to influence at least one alpha burst parameter of the subject’s brain”.
Per MPEP 2106.04(d)(2), one way to integrate the exception into a practical application is to effect a particular treatment for a disease or medical condition. However, while there is a “stimulation treatment” claimed, there is no particular treatment, disease, or medical condition specified in the claim. The stimulation treatment may be carried out in any way, as claimed. No treatment modality is specified, e.g. magnetic field, blinking light, touch tapping, etc. While claim 10 introduces a generic “stimulation source”, it is not specified. No target condition is specified. No specific disease or medical condition is being treated. No criteria for the selection of the stimulation frequency are claimed and it seems any arbitrary frequency reads on the claim “to influence at least one alpha burst parameter of the subject’s brain”, since brain frequencies naturally respond to their environment.
Further, the limitation of “obtaining the measurement data…” amounts to mere data gathering, which is a form of insignificant extra-solution activity. While claim 10 introduces a stimulation source, memory, and processor, they are recited at a high level of generality and merely automates the data collection and treatment steps. Each of the additional limitations is no more than mere instructions to apply the exception using a generic computer component (the processor, memory, and generic stimulation source).
The combination of these additional elements is no more than mere instructions to apply the exception using a generic computer component (the processor, memory, and generic stimulation source). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Claims 1 and 10 are therefore directed to the abstract idea.
Step 2B, Inventive Concept: No - As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component (for claim 10, no additional hardware elements exist in claim 1). The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B. Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B. Here, the initial data collecting step was considered to be extra-solution activity in Step 2A, and thus it is re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The background of the invention does not provide any indication that the processor and memory (claim 10) is anything other than a generic, off-the-shelf computer component, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here). Accordingly, a conclusion that the collecting step is well-understood, routine, conventional activity is supported under Berkheimer Option 2. For these reasons, there is no inventive concept in claims 1 and 10, and thus they are ineligible.
The dependent claims further describe an effect of the treatment stimulation, e.g. optimization (claim 2) to minimize the AFV (claim 3) and maximize the AP (claim 4) but they do not say how it is done or what disease or condition is being treated. As such, it does not qualify as “particular” treatment within the meaning of such from MPEP 2106.04(d)(2). The other dependent claims 6-9, 11-13, 15-18, 41-50 also do not mention any “particular” treatment.
Dependent claims 5 and 14 specifies the data measurement is done using an electroencephalogram (EEG). However, EEG is a well-understood, routine and conventional data collection source for alpha burst data. It also does not further integrate the determination of the intrinsic frequencies of the subject’s brain (the natural phenomenon) into a practical application, i.e. into a particular treatment.
As such, claims 1-18, 41-50 do not contain an inventive concept (i.e. significantly more than the judicial exception) and are therefore ineligible.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20220008728, 20230256250, 20250276181, 12138458 to Philips teach applying stimulation frequencies in response to determining intrinsic frequencies in an EEG.
US 10420953, 9308385 to Jin teaches utilizing rTMS to apply an optimized treatment frequency in response to determining information from an EEG.
US 20160228029, 20190307353, 10327662, 10827943 to Ware teach measuring brain waves including alpha prevalence (par. 0023) and applying biofeedback in response, in order to promote calmness.
US 20160045756, 20200315546, 10588576, 12376800 to Philips teach determination of the intrinsic alpha frequency using EEG.
US 8475354, 9308387, 20110112427, 20110118536, 20140179980, 20170120066, 20190070428, 20210146151, 8585568, 8870737, 9446259, 10065048, 10821293, 11975213 teach rTMS for tuning the brain to affect mood, focus, and cognition, in response to measured EEG parameters including alpha parameters.
US 20110137104, 8926490 to Philips teach rTMS for tuning the brain to affect symptoms of depression.
US 20110034822, 20140121446, 20180126184, 8465408, 9713729, 10357660 to Phillips teach rTMS for tuning the brain to affect symptoms of coma, PTSD, Parkinson’s disease, cognitive performance and amblyopia.
US 20040077967, 6985769 to Jordan teach determination of percent alpha variability, i.e. alpha frequency variability (AFV), and that it is associated with certain brain injuries.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/ Primary Examiner, Art Unit 3799