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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/10/26 has been entered.
Response to Amendment
The Declaration under 37 CFR 1.132 filed 8/10/26 is insufficient to overcome the 101 rejection of claims 1-5, 7, 9, 11, 13-14, 16-18, 20-25 and 48 based upon the claims being directed toward and abstract idea as set forth in the last Office action because: the declaration is directed toward the non-conventional use of data and not the abstract idea of a generic off the shelf classification model that is trained using known mathematical algorithms to process known data. It is noted that a claim for an abstract idea is still an abstract idea.
Response to Arguments
Applicant's arguments regarding the 101 rejections filed 8/10/26 have been fully considered but they are not persuasive. The Applicant argues the claims utilize data in a non-conventional way. Therefore, the claims are not an abstract idea. The Examiner respectfully disagrees. The claims receive data and then process the data with a generic off the shelf classification model that is trained using known mathematical algorithms to process known data. It is noted that the claim is not directed to an implantable device, rather the claim is directed toward a method that receives data. The fact that the data came from an implantable electrode has no bearing on the claim as the claim is only directed toward how the data is received and manipulated. Therefore, the 101 rejections stand.
Applicant’s arguments, see Remarks and amendments, filed 8/10/26, with respect to the 103 rejections have been fully considered and are persuasive. The 103 rejections have been withdrawn.
Applicant’s amendments to the claims and cured the 112 rejections.
Claims 1-5,7,9,11,13-14,16-18,20-24 are pending.
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(s) 1-5,7,9,11,13-14,16-18,20-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1- Claim 1
Claim 1 and dependent claims 2-5,7,9,11,13-14,16-18,20-24 are drawn to a method and thus meet the requirements for step 1.
Step 2a (prong 1) - Claim 1
Claims 1 recites the step of “characterizing an epileptic seizure”, Under the broadest reasonable interpretation, this step covers a concept capable of being performed in the human mind, and thus falls within the mental processes grouping of abstract ideas. Other than reciting the method is “computer-implemented” in the preamble, nothing in the claim precludes the step from practically being performed in the mind.
Accordingly, claim 1 recites an abstract idea.
Step 2a (prong 2) – Claim 1
The judicial exception is not integrated into a practical application. Claim 1 recites the additional elements of:
Receiving, by at least one processor, interictal electroencephalographs is insignificant extra-solution activity (i.e., data gathering),
Inputting, by the at least one processor, the directional information flow values into a classification model, is insignificant extra-solution activity (i.e., data gathering), and
Receiving, by the at least one processor, an output from the classification model is recited at a high level of generality (i.e., as generic devices, a “computer-implemented” method, performing generic computer functions like sending, receiving, and visually displaying data) is insignificant extra-solution activity (i.e., data output).
Categorize the patient into a patient sub-population (i.e. gathering data/statistics).
Retrain the classification model based on the patient sub-population (e.g. gathering data/statistics).
A classification model trained to perform at least one of a first task and second task. The training algorithm is a SMOTE procedure (e.g. ¶172). When given their broadest reasonable interpretation in light of the background, the algorithm and gradient descent algorithm are mathematical calculations. The plain meaning of these terms are optimization algorithms, which compute neural network parameters using a series of mathematical calculations.
All of the steps are recited as being performed by a computer. The recited computer is recited at a high level of generality, i.e., as a generic computer performing generic computer functions.
Inputting the directional information flow values into the classification model. The claim does not provide any details about how the trained model operates or how the detection is made to indicate the location, and the plain meaning of “indicates” encompasses mental observations or evaluations, e.g., a computer programmer’s mental identification of an anomaly in a data set.
These steps do not integrate the abstract idea into a practical application because they are insignificant extra solution activity.
Step 2b- Claim 1
The additional elements when considered individually and in combination are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, providing a (output indicating the location of the seizure onset zone) is recited at a high level of generality (i.e., as generic devices, a “computer-implemented” method, performing generic computer functions like sending, receiving, and visually displaying data). Further, receiving by at least one processor interictal epileptiform discharges is considered data gathering.
The additional elements that were considered insignificant extra solution activity have been re-analyzed and do not amount to anything more than what is well-understood, routine and conventional when considered individually and in combination with evidence provided. Specifically:
Receiving, by at least one processor, interictal electroencephalographs is well understood, routine, and conventional (i.e., receiving data MPEP 2106.05(d)(II)).
Inputting, by the at least one processor, the directional information flow value(s) into a classification model is well-understood routine and conventional (i.e., gathering data/statistics MPEP 2106.05(d)(II)).
Receiving, by the at least one processor, an output from the classification model based on inputting the directional information flow value(s) into the classification model, wherein the output indicates the location of the seizure onset zone in the patient's cerebral cortex is considered to be well-understood, routine, and conventional (i.e., presenting data MPEP 2106.05(d)(II)).
Categorize the patient into a patient sub-population (i.e. gathering data/statistics MPEP 2106.05(d)(II)).
Retrain the classification model based on the patient sub-population (e.g. gathering data/statistics MPEP 2106.05(d)(II)).
As discussed in Step 2A, Prong Two above, the recitation of a computer to perform limitations amounts to no more than mere instructions to apply the exception using a generic computer component. Even when considered in combination, these additional elements represent mere instructions to implement an abstract idea or other exception on a computer and insignificant extra-solution activity, which do not provide an inventive concept.
Claims 2-5,7,9,11,13-14,16-18,20-24 depend from claim 1. The type of data analyzed as stated in claims 2-5 are considered extra solution activity. The type of classification models as listed in claims 7,9,11,13-14,16-18 are stated at a high level of generality in applicant’s specification (“a model”) and are merely used as a tool to carry out the data gathering. Claims 20-24 are directed to the extra solution activity of presenting the data. Thus, the dependent claim do not change the overall analysis that claims 2-5,7,9,11,13-14,16-18,20-24 are also directed to an abstract idea.
Claims 25
Independent claim 25 is directed to a system containing limitations similar to that for claim 1 and further includes a processor with memory. Analyzing the processor and memory of claim 25 under step 2a, prong 1, the processor and memory are recited at a high level of generality and merely use the computer elements (the processor and memory) as a tool. When analyzed under step 2a, prong 2, the processor and memory perform generic computer functions like storing and processing data. Further, when the analysis is extended to step 2b, the processor and memory are considered to use the computer elements as tools, MPEP 2106.05(d)(II). Thus, claim 25 is also considered to be patent ineligible subject matter.
Claims 48
Independent claim 48 is directed to a computer program product containing limitations similar to that for claim 1 and further includes a processor with memory. Analyzing the processor and memory of claim 48 under step 2a, prong 1, the processor and memory are recited at a high level of generality and merely use the computer elements (the processor and memory) as a tool. When analyzed under step 2a, prong 2, the processor and memory perform generic computer functions like storing and processing data. Further, when the analysis is extended to step 2b, the processor and memory are considered to use the computer elements as tools, MPEP 2106.05(d)(II). Thus, claim 48 is also considered to be patent ineligible subject matter.
Conclusion
Claims are rejected with a 101 rejection only.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Haeusser et al. (U.S. Pub. 2020/0345261) – discloses EEG system for characterizing epileptic seizures but fails to utilize interictal EEGs.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REX R HOLMES/Primary Examiner, Art Unit 3796
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