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 .
Response to Amendment
Claims 6-10 are currently pending. Claims 1-5 and 11-20 have been cancelled. Claims 6-10 have been amended. Claim 7 has been amended to overcome the 35 U.S.C. 112(b) rejection set forth in the Non-Final Office Action mailed on 02 June 2025.
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 a 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 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. 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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Phillips et al. ‘756 (US Pub No. 2016/0045756 – cited by Applicant).
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 a 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 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”) when an additional stimulus is administered to the person at an additional stimulation frequency that is incremented or decremented from the stimulation frequency ([0007]; “decrementing N”),
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 a subsequent 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”).
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 the processor providing a subsequent stimulus to the person at a pulse frequency provides a technological change and thus, overcomes the 35 U.S.C. 101 rejection. Examiner respectfully disagrees, as the subsequent stimulus is outputted based off the determination of the intrinsic frequency. This is merely a data point (subsequent stimulus) is outputted based off another output of data (intrinsic frequency). Applicant mentions that Fig. 5 and [0083] of the PGPUB provides support for this. However, it is unclear to the Examiner if the technological change is transforming the stimulus since the stimulus is applied at repetitive stimulation frequencies. If this is true, Examiner suggests to amend the claim to clearly reflect that the stimulus is being transformed to optimize function to potentially overcome the 35 U.S.C. 101 rejection.
Applicant argues that the amendments overcome the 35 U.S.C. 102(a)(1) rejection. Examiner respectfully disagrees, as Phillips et al. ‘756 teaches decrementing signals ([0007]). As such, the 35 U.S.C. 102(a)(1) rejection has been maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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