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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10 June 2026 has been entered.
Response to Amendment
Claims 2, 8, 12, 19, and 23-32 are currently pending. Claims 2 and 12 have been amended.
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 2, 8, 12, 19, and 23-32 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 2 follows.
STEP 1
Regarding claim 2, the claim recites a series of steps or acts, including transmitting one or more time-domain signals from one or more EEG sensors worn by the living subject to a signal modulator of a digital processor. Thus, the claim is directed to a process, 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:
placing a headband comprising one or more EEG sensors on the subject;
transforming the one or more time-domain signals into a measurement acoustic signal resembling one or more of a vocal pattern and a vocal parameter of a human voice using the signal modulator;
audibly providing the human voice over one or more speakers;
accessing, via a user interface, a database comprising a plurality of comparison acoustic signals; and
comparing the measurement acoustic signal to the one or more of a plurality of comparison acoustic signals, each of the plurality of comparison acoustic signals resembling one or more of a vocal pattern and a vocal parameter of a human voice
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. The placing step is also a step of Organizing Human Activity, which is also an Abstract Idea. The transforming step is also a mathematical process, which is also an Abstract Idea. Furthermore, the providing and accessing step is also organizing human activity, which is also 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 2 recites detecting seizure activity when at least a volume of the human voice increase based on the comparison, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The detected seizure activity 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 detected seizure activity, nor does the method 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 the additional steps of including transmitting one or more time-domain signals from the one or more EEG sensors to a signal modulator of a digital processor, the one or more time-domain signals representing brain activity of the living subject and recording the one or more time-domain signals using the digital processor. Transmitting data (time-domain signals) is well-understood, routine and conventional (WURC) activity for those in the field of medical diagnostics as [0014] of Pless et al. ‘428 (US Pub No. 2003/0004428 – previously cited) teaches that it is typical to use EEG signals received from electrodes in a time-domain detection system. Further, the transmitting 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 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 step does 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)).
It is noted that the recited headband comprising one or more EEG sensors is also WURC and readily available, as supported by [0064] of Mershin et al. ‘324 (US Pub No. 2016/0235324). Column 3 Lines 34-48 of Clapp et al. ‘145 (US Patent No. 5,626,145) also provides support for the headband with EEG sensors to transmit data to a processor is WURC.
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.
The same rationale applies to claim 12.
Regarding claim 12, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited headband with one or more EEG sensors and recorder are generic sensors configured to perform the pre-solution activity of data gathering. The recited database and the recited memory are generic devices configured to perform WURC data storing and the one or more processors 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 23 and 24 are merely further defining the generic computer components as WURC components. Claims 25-32 recite what the vocal patterns of the transformed measurement acoustic signal and the transformed comparison acoustic signal are, which does not add anything significantly more to the abstract idea. However, it is noted that claims 8 and 19 recite “wherein the feedback therapy is based on the one or more audibly distinct variations of the transformed measurement acoustic signal.” This provides more detail as to when the feedback therapy or the determination of the activity of the organ is provided. However, it is unclear what exact criteria is needed for the one or more audibly distinct variations of the measurement acoustic signal in order to provide the therapy or the determination of the activity. Section 2106.04(d)(2) of the MPEP mentions that “treating a patient having a blood glucose over 250 mg/dl with insulin". The administration step is significantly related to the recited correlation between high blood glucose levels and the risk of ketoacidosis. Because insulin is also a "particular" treatment, this administration step integrates the law of nature into a practical application. Examiner suggests to amend claims 8 and 19 to include the exact criteria for the one or more audibly distinct variations of the measurement acoustic signal in order to provide the therapy or the determination of the activity.
Response to Arguments
Applicant argues that the transmitting step is carried out by using a signal modulator is not an Abstract Idea. However, it is noted that the transmitting step is analyzed in step 2B of the 35 U.S.C. 101 analysis, where it was found that the transmitting step is pre-solutional activity necessary to perform the Abstract Idea. Furthermore, the signal modulator of the digital processor was found to be WURC (see step 2B above). Applicant provides reasonings as to why the transmitting step is an improvement. However, the independent claims merely recite that the time-domain signals are transformed. There is no additional recitation as to what happens with the transformed signals. The independent claims merely recite that the measurement acoustic signals are compared to comparison acoustic signals and seizure activity is detected based on the comparison, which are Abstract Ideas. Examiner suggests to amend the transforming step to provide more detail as to what is exactly happening in the transforming step that would provide this improvement. It is noted that Figs. 2C, 2D, and [0092]-[0100] provides additional detail.
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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/AURELIE H TU/ Primary Examiner, Art Unit 3791
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