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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 1, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/31/19 has been considered by the examiner.
Amendment Entered
In response to the amendment filed on May 5, 2026, amended claims 1-7, 9-18, 20, 22 and 23 have been entered.
Response to Arguments
Applicant's remarks and amendments with respect to the rejections under
U.S.C. 101 have been fully considered. While Examiner agrees that the claimed invention does not explicitly recite mathematical calculations, after considering the amendments, Examiner argues that nothing from the claims, accompanying specification, and/or drawings suggest that the method steps cannot be practically performed mentally, or using pen/paper. Applicant argues the invention is not an abstract idea. Examiner notes that although the claims include EEG sensors, no physical aspect of the EEG sensors mentioned in the claims is novel. The claims merely recite data gathering/outputting steps. Applicant further argues the claims integrate into a practical application. Examiner notes that according to MPEP 2106.04(d)(2), the practical application consists of administering a specific medication in response to the collected data. Alternately, a practical application would consist of incorporating additional structure to the detection system. Lastly, Applicant argues the claims provide an inventive concept. Examiner notes the previously cited references teach all the components (i.e. EEG sensors, machine learning for detection of seizures, general computer components) of the present application. Therefore, as currently claimed, the invention is not an improvement in technology. Accordingly, Examiner maintains that the identified judicial exception recites a mental process that is not integrated into a practical application. As such, the 35 USC 101 rejections are maintained. Examiner suggests incorporating more structure to the claim or a medication administration step. Please see corresponding rejection heading below for more detailed analysis.
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 1-7, 9-18, 20, 22 and 23 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 1 follows.
Regarding claim 1, the claim recites a computer-implemented method for detecting a seizure. Thus, the claim is directed to a process, which is one of the statutory categories of invention
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
generating two-dimensional frames, wherein each of the two-dimensional frames comprises a first set of elements that stores the plurality of measurements and
a second set of elements that stores values calculated from the plurality of measurements
classifying the two-dimensional frames using a convolutional neural network- based model that is trained to accept the two-dimensional frames and to output a likelihood that a segment of data indicates the seizure
wherein the segment of data includes the plurality of measurements
These limitations 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.
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 1 recites determining that the subject experienced the seizure during a measurement interval, wherein the determining is based on the output of the convolutional neural network-based model, and controlling a treatment system to administer antiepileptic medications to an intravenous line associated with the subject, wherein the administering of the antiepileptic medications is based on the determining that the subject experienced the seizure, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The providing of a model for determining and administering antiepileptic medication does not provide an improvement to the technological field, the system does not effect a particular treatment or effect a particular change based on the model, nor does the method use a particular machine to perform the Abstract Idea. Examiner adds that administering antiepileptic medications is analogous to “administering a suitable medication to a patient”, which is further explained in MPEP 2106.04(d)(2).
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:
controlling an electroencephalograph receiver to sense a plurality of voltages to generate a plurality of measurements for a subject,
wherein the electroencephalograph receiver includes a plurality of electrodes to measure the plurality of voltages
treatment system
Additionally, claim 12 recites the additional elements
hardware processor
data formatter
classifier
interpreter
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
Independent claims 11 and 12 are also not patent eligible for substantially similar reasons
Dependent claims 2-7, 9, 10, 13-18, 20, 22, and 23 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea.
Therefore, claims 1-7, 9-18, 20, 22 and 23 are not patent eligible under 35 USC 101.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of publish
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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