DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 13 April 2026 has been entered.
Response to Amendment
Claims 6-10 is currently pending. Claim 6 has been amended.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: EEG recording device in claim 6.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
“EEG recording device” is interpreted as an EEG that includes electrodes on an EEG cap or headband, as mentioned in Figs. 4 and 5 and [0082]-[0083] of the PGPUB.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 6-10 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 claim 6 follows.
STEP 1
Regarding claim 6, the claim recites a series of structural elements, including a device. 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
calculating a metric of the EEG at the stimulation frequency;
calculating the metric at the additional stimulation frequency;
calculating the metric at the additional stimulation frequency; and
determining the intrinsic frequency as equal to the additional stimulation frequency where the metric is optimized
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. Claim 6 recites an interface operable to present the intrinsic frequency to a user and the step of causing the device to provide a subsequent stimulus to the person at a pulse frequency that is based upon the intrinsic frequency, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The presenting of the intrinsic frequency and providing the subsequent stimulus 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 presented intrinsic frequency and the provided subsequent stimulus, nor does the machine use a particular machine to perform the Abstract Idea.
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:
a device operable to provide an initial stimulus to the person;
an EEG recording device, operable to record an EEG of the brain of the person;
recording, using the EEG recording device, the EEG when the initial stimulus is administered to the person at a stimulation frequency; and
recording, using the EEG recording device, an additional EEG when an additional stimulus is administered to the person at an additional stimulation frequency that is incremented or decremented from the stimulation frequency.
The providing and recording steps are well-understood, routine and conventional activities for those in the field of medical diagnostics (see Phillips et al. ‘756). Further, the providing and recording steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step 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 obtaining and comparing 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 claim 6, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited device and EEG recording device are generic sensors configured to perform pre-solutional data gathering activity, the interface is configured to perform insignificant extra-solution activity, and the processor 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 7-10 merely recite what the metric is, which does 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.
Claims 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Phillips et al. ‘756 (US Pub No. 2016/0045756 – previously cited) in view of Jin ‘083 (US Pub No. 2018/0056083).
Regarding claim 6, Phillips et al. ‘756 teaches a system for determining an intrinsic frequency of an electroencephalogram (EEG) band of a brain of a person (Title, Abstract), comprising:
a device operable to provide an initial stimulus to the person ([0027]; “NEST device”);
an EEG recording device operable to record an EEG of the brain of the person ([0033]; “receiving a first EEG recording obtained from an EEG sensor in a time domain”);
an interface operable to present the intrinsic frequency to a user ([0088]; “a display to send visual information to a user”);
a processor ([0036]; “digital processing device”) and a memory ([0036]; “memory”) having instructions ([0036]; “…executable instructions and a memory”) that, when executed by the processor, comprises
recording, using the EEG electrode device, the EEG when the initial stimulus is administered to the person at a stimulation frequency ([0031]; “a valid intrinsic alpha frequency (vIAF) is determined by quantitatively analyzing EEG records”),
calculating a metric of the EEG at the stimulation frequency ([0008]; “standard deviation”),
recording, using the EEG recording device, an additional EEG ([0007]; “a second EEG recording”),
calculating the metric at the additional stimulation frequency ([0007]; “second standard deviation (SD) of the N epoch IAF values”), and
determining the intrinsic frequency as equal to the additional stimulation frequency where the metric is optimized ([0017]; “…the second time domain EEG recording and the third time domain EEG recording is calculated and is set equal to the final intrinsic alpha frequency (fIAF).”), and
causing the device to provide the initial stimulus to the person at a pulse frequency that is based upon the intrinsic frequency ([0017], [0027]; “the device is configured to deliver low amplitude stimulation at an intrinsic alpha frequency that is the same as a patient’s intrinsic alpha frequency”).
Phillips et al. ‘756 teaches all of the elements of the current invention as mentioned above except for wherein the system is a system for providing a subsequent stimulus to a person following an initial stimulus, said subsequent stimulus comprising a pulse frequency calculated by determining an intrinsic frequency, comprising:
recording, using the EEG recording device, an additional EEG when an additional stimulus is administered to the person at an additional stimulation frequency that is incremented or decremented from the stimulation frequency, and
causing the device to provide a subsequent stimulus to the person at a pulse frequency that is based upon the intrinsic frequency.
Jin ‘083 teaches treating a person using repetitive Transcranial Magnetic Stimulation, which has a magnetic pulse frequency, comprising the following steps:
a) setting the magnetic pulse frequency to an initial pulse frequency value;
b) recording a baseline EEG of the person, which contains oscillations;
c) administering a magnetic field pulse train to a head of the person;
d) recording an EEG of the person following the magnetic field pulse train, which contains oscillations;
e) measuring the settling time of the EEG oscillations of the person;
f) adjusting the pulse frequency value; and
g) proceeding back to step (b) for a number of pulse trains over a treatment session in order to achieve an approximate global or local maximum settling time ([0040]-[0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Phillips et al. ‘756 to include providing a subsequent stimulus to a person following an initial stimulus, said subsequent stimulus comprising a pulse frequency calculated by determining an intrinsic frequency, comprising: recording, using the EEG recording device, an additional EEG when an additional stimulus is administered to the person at an additional stimulation frequency that is incremented or decremented from the stimulation frequency, and causing the device to provide a subsequent stimulus to the person at a pulse frequency that is based upon the intrinsic frequency as Jin ‘083 teaches that this will aid in achieving an approximate global or local maximum settling time.
Regarding claim 7, Phillips et al. ‘756 teaches wherein the metric is a maximum energy of the EEG of the brain of the person at the stimulation frequency across a subset of all EEG channels, and the metric is optimized when the metric is a maximum ([0040]; “peak IAF estimate”).
Regarding claim 8, Phillips et al. ‘756 teaches wherein the metric is an average energy of the EEG of the brain of the person at the stimulation frequency across a subset of all EEG channels, and the metric is optimized when the metric is a maximum ([0027], [0032]).
Regarding claim 9, Phillips et al. ‘756 teaches wherein the metric is an average of a bandwidth of the EEG of the brain of the person in an area around the stimulation frequency across a subset of all EEG channels, and the metric is optimized when the metric is a minimum ([0012]; “band between 8.0 Hz-13.0 Hz”).
Regarding claim 10, Phillips et al. ‘756 teaches wherein the metric is a standard deviation of a frequency corresponding to a peak magnitude of a Fast Fourier Transform (FFT) in a range around the stimulation frequency across all EEG channels, and the metric is optimized when the metric is a minimum ([0017]).
Response to Arguments
Applicant argues that claim 6 is not directed to a mental process. Examiner respectfully disagrees as the calculating and determining steps are mental processes. The recording steps are pre-solutional steps of data gathering and the providing steps are pre/post-solutional steps. There is no change being effected nor is there any transformation of the system. Furthermore, the recited structural elements are generic elements that are well-understood, routine, and conventional. Thus, Applicant’s arguments are not persuasive and the 35 U.S.C. 101 rejection has been maintained.
Applicant argues that the step of providing the subsequent stimulus at a pulse frequency provides a technological change. Examiner respectfully disagrees, as the providing step is a mere output of data. Furthermore, the device of claim 6 merely provides an initial stimulus to record EEG data, analyze the EEG data, and output a new (subsequent) stimulus. There is no change or transformation of the system. Section 2106.04(a)(2) of the MPEP recites: “a claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016).” Thus, Applicant’s arguments are not persuasive and the 35 U.S.C. 101 rejection has been maintained.
Applicant’s arguments with respect to the 35 U.S.C. 102(a)(1) rejection have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
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