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 Arguments
Applicant's arguments filed 2/9/26 have been fully considered but they are not persuasive. The Applicant argues that the data that is received by the method came from electrodes that were implanted in a brain and therefore since the data came from a physical place the rejection is moot. 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.
The Applicant further argues that the 102 rejection is moot as Haeusser fails to teach using a Granger Causality analysis to determine the directional flow. The Examiner respectfully disagrees. Haeusser is directed toward finding directional flow values of EEG data and is modified by the Lin reference that states that it is well-known in the art to use Granger Causality analysis to determine directional flow. Since the Lin reference was previously presented and no arguments were set forth, the rejections stand. The rejections have been updated to include the Lin reference into the independent claims rejections. Further, The Applicant argues that Haeusser senses EEG which includes interictal EEGs. The Applicant argues that since Haeusser senses more than just interictal EEGs it does not read on the art. The Examiner respectfully disagrees. The claims are written in an open ended comprising fashion and therefore do not preclude the use of EEGs as long as the EEGs include the claimed interictal EEGs. It is noted that the claims do not state that they only sense interictal EEGs, just that the processor receives interictal EEGs. Therefore, a system that senses EEGs that include interictal EEGS reads on the claims.
Regarding the dependent claims directed toward classification models. They are moot as they lack antecedent basis, see the rejections below.
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).
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)).
Claim 1 is thus consider to be directed to an abstract idea without significantly more.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 recites the limitation "the classification model" in lines 22 and 23. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-5, 7, 9, 11, 13, 16-18, 20-24 are rejected for inheriting the same deficiencies as claim 1.
Claim 2 recites the limitation "the classification model" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the classification model" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the classification model" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the classification model" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the classification model" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "the classification model" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the classification model" in lines 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-2, 4-5, 11, 13-14, 22-23, 25 and 48 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haeusser et al. (U.S. Pub. 2020/0345261 hereinafter “Haeusser”) in view of Lin et al. (U.S. Pub. 2017/0340212 hereinafter “Lin”).
Regarding claims 1, 4-5, 25 and 48, Haeusser discloses a system and method for characterizing an epileptic seizure onset zone in a patient with epilepsy, the method comprising: receiving, by at least one processor, interictal electroencephalographs (e.g. ¶287,”computing device”; “EEG”, it is noted that all EEG can include interictal EEG data), optionally including interictal epileptiform discharges, from two or more points in a patient's cerebral cortex, wherein each of the two or more points represent an electrode of a plurality of electrodes; determining, by the at least one processor, directional information flow between the two or more points based on the interictal encephalographs by quantifying directional information flow value(s) at each electrode of the plurality of electrodes at a plurality of frequencies, wherein the directional information flow value(s) indicate(s) information flow to an electrode from one or more other electrodes and/or from a non-seizure onset zone to a seizure onset zone (e.g. ¶287; “Velocity Vectors”); inputting, by the at least one processor, the directional information flow value(s) into a classification model, wherein the classification model is trained to perform a first task and/or a second task, wherein the first task comprises locating the seizure onset zone in the patient's cerebral cortex based on the directional flow value(s), such as the inward directional flow value(s), e.g., a summation of information flow from all other electrodes to an electrode of interest, and quantifying directional information flow values, at an electrode of the plurality of electrodes, and wherein the second task comprises classifying the patient's predicted post-treatment seizure outcome after epilepsy treatment based on the directional information flow from the non-seizure onset zone to the seizure onset zone (e.g. ¶287); and 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 and/or the patient's predicted post-treatment seizure outcome after epilepsy treatment (e.g. ¶287; “reveal seizure location”). Haeusser discloses the claimed invention but fails to explicitly state that the system utilizes Granger Causality Analysis when analyzing the EEG data. However, Lin teaches that it is known to use Granger Causality Analysis as set forth in Paragraphs 67-68, 80 and 87 to provide a means for connections between epileptic and eloquent areas, the directed influences between them were identified to determine seizure origin. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Haeusser, with the use of Granger Causality Analysis as taught by Lin, since such a modification would provide the predictable results of identifying the connections and causal relationships between two sets of EEG data to determine seizure origin.
Regarding claim 2, meeting the limitations of claim 1 above, Haeusser further discloses wherein the classification model is trained to perform the first task and wherein the output from the classification model indicates the location of the seizure onset zone in the patient's cerebral cortex based on the directional information flow value(s), such as the inward directional flow value(s) (e.g. ¶287; “velocity vectors”).
Regarding claim 11, meeting the limitations of claim 1 above, Haeusser further discloses wherein the interictal electroencephalographs are in a range of 1 Hz to 1,000 Hz and/or the interictal electroencephalographs range from one second to thirty minutes in duration, including any increment therebetween (e.g. ¶¶287-288; “EEG”).
Regarding claim 13, meeting the limitations of claim 1 above, Haeusser further discloses wherein the classification model is a decision tree classification model (e.g. ¶¶272, 274, 283, 285, 289; “any known decision tree model”).
Regarding claim 14, meeting the limitations of claim 1 above, Haeusser further discloses wherein the decision tree classification model is a Random Forest model, and optionally a Balanced Random Forest model (e.g. ¶¶272, 274, 283, 285, 289; “any known decision tree model”).
Regarding claim 22, meeting the limitations of claim 1 above, Haeusser further discloses integrating brain imaging data with the output of the classification model, wherein the brain imaging data comprises brain images (e.g. ¶¶287-288).
Regarding claim 23, meeting the limitations of claim 1 above, Haeusser further discloses filtering the interictal electroencephalographs using a band-pass filer between 0.5 Hz and 1,000 Hz; and performing artifact rejection on the interictal electroencephalographs (e.g. ¶288).
Claim(s) 3, 18 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haeusser in view of Lin as applied to claims 1-2, 4-5, 11, 13-14, 22-23, 25 and 48 above, and further in view of Suffin (U.S. Pat. 6,622,036).
Regarding claims 3, 18, 20 and 24, Haeusser in view of Lin discloses the claimed invention including displaying the proposed treatment plan except for the system using the predicted treatment outcome when classifying and determining the treatment plan. However, Suffin teaches that it is known to use anticipated treatment response as set forth in Column 2, lines 9-14; Column 3, lines 12-35 and Col. 4, lines 7-11 to provide a means for utilizing the anticipated treatment response and outcome to classify and make more informed probabilistic treatment recommendations. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Haeusser in view of Lin, with predicted treatment outcome as taught by Suffin, since such a modification would provide the predictable results of providing a means for utilizing the anticipated treatment response and outcome to classify and make more informed probabilistic treatment recommendations.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haeusser in view of Lin as applied to claims 1-2, 4-5, 11, 13-14, 22-23, 25 and 48 above, and further in view of de Voir (U.S. Pub. 2008/0109041).
Regarding claims 7, Haeusser in view of Lin discloses the claimed invention but fails to explicitly state that the system inputs a 1/f power into the classification model. However, de Voir teaches that it is known to input a 1/f power into classification models as set forth in Paragraph 247 to provide a means for removing biological signal noise. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Haeusser in view of Lin, with an input into the classification model of a 1/f power as taught by de Voir, since such a modification would provide the predictable results of removing biological signal noise from the data.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haeusser in view of Lin as applied to claims 1-2, 4-5, 11, 13-14, 22-23, 25 and 48 above, and further in view of Weiss et al. (U.S. Pub. 22015/0099962 hereinafter “Weiss”).
Regarding claims 9, Haeusser in view of Lin discloses the claimed invention including displaying the proposed treatment plan except for the system using an Engel outcome score to classify the predicted seizure outcome. However, Weiss teaches that it is known to use anticipated treatment response using an Engel Score as set forth in Paragraphs 61 and 65-68 to provide a means for utilizing the anticipated treatment response and outcome to classify and make more informed probabilistic treatment recommendations. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Haeusser in view of Lin, with predicted treatment outcome using an Engel score as taught by Weiss, since such a modification would provide the predictable results of providing a means for utilizing the anticipated treatment response and Engel score outcome to classify and make more informed probabilistic treatment recommendations.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haeusser in view of Lin as applied to claims 1-2, 4-5, 11, 13-14, 22-23, 25 and 48 above, and further in view of Baker et al. (U.S. Pub. 2022/0308058 hereinafter “Baker”).
Regarding claims 16-17, Haeusser in view of Lin discloses the claimed invention but fails to explicitly state the explicit methods used in the machine learning models. However, Baker teaches that it is known to use non-biasing methods including synthetic minority over-sampling techniques as set forth in Paragraphs 24, 72 and 113 to provide a means for using known means including SMOTE to artificially mix the data to create ‘new’ samples to achieve a more balanced dataset. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Haeusser in view of Lin, with the use of non-biasing methods including synthetic minority over-sampling techniques as taught by Baker, since such a modification would provide the predictable results of using known means including SMOTE to artificially mix the data to create ‘new’ samples to achieve a more balanced dataset.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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