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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/9/2026 has been entered.
Response to Arguments
Applicant’s amendments merit new grounds for rejection under 35 U.S.C. § 103 as unpatentable over Crowder et al. (Pub. No.: US 2016/0228705 A1); hereinafter referred to as “Crowder”, in view of Leyde et al. (Pub. No.: US 2007/0150024 A1); hereinafter referred to as “Leyde”.
Leyde teaches it is known to use such a modification as set forth in [0101] to provide a weighted answer so as to further delineate within the pre-ictal state to further allow system 10 to provide a more specific output communication for the patient. For example, instead of a simple logical answer (e.g., pre-ictal or inter-ictal) it may be desirable to provide a weighted output in the form of a simplified neural state index (NSI) or other output that quantifies the patient's propensity, probability, likelihood or risk of a future seizure using some predetermined scale (e.g., scale of 1-10, with a "1" meaning "normal" and a "10" meaning seizure is imminent) (e.g. see [0101]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a weighted answer as taught by Leyde in the system/method of Crowder, since said modification would provide the predictable results of a weighted output in the form of a simplified neural state index (NSI) or other output that quantifies the patient's propensity, probability, likelihood or risk of a future seizure using some predetermined scale (e.g., scale of 1-10, with a "1" meaning "normal" and a "10" meaning seizure is imminent).
Applicant’s remarks filed 6/9/2026 with respect to Crowder are partially persuasive, as the examiner agrees that Crowder along does not teach “wherein the predicted seizure metric comprises an indicator of probability that the predicted seizure will occur”, newly added by amendment. Therefore, this limitation is taught in combination with Leyde, see rejection below for additional details.
However, Applicant further states that Crowder’s entire framework is built around detecting and classifying seizure onsets, alleging that PHOSITA would not view Crowder as teaching any techniques for predicting a future seizure before onset.
This is not found persuasive by the examiner because Crowder teaches in [0148] states “The therapeutic stimulator 512 is adapted to provide electrical stimulation signals appropriate for application to neurological tissue to terminate a present or predicted undesired neurological event, especially an epileptic seizure or its precursor.” In regards to the language “precursor” used by Crowder in [0148], the four seizure types disclosed in figures 8A-8D include sensing windows 812a-812d, that incorporate substantial sections before the seizures begin. These pre-seizure sections in the windows 812a-812d are precursors of seizures, and will read on the claim language of “predicted seizure” and “predicted seizure metric”.
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) 17-21 and 27-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crowder et al. (Pub. No.: US 2016/0228705 A1); hereinafter referred to as “Crowder”, in view of Leyde et al. (Pub. No.: US 2007/0150024 A1); hereinafter referred to as “Leyde”.
Regarding claim 17, Crowder discloses a method comprising: sending, by a signal processing device, instructions to administer a probing electrical stimulation pattern (e.g. see [0150], figure 5 element 516) to a subject through a plurality of electrodes (e.g. see [0152]); receiving, at the signal processing device, neuronal electrical activity signal data ([0092], [0096], [0097], and [0135]-[0137]) taken from the plurality of electrodes in response to the sent instructions to administer the probing electrical stimulation pattern (e.g. see figure 4 element 326, [0135], [0150], [0150] states “The excitability stimulator 518 and the refractoriness stimulator 520 both act under the control of the detection subsystem 326 to provide the stimulation signals used for the effective measurement of electrophysiological parameters in some embodiments”. Thus, elements 518 and 520 (and thus 516) “act under the control of the detection subsystem 326 to provide the stimulation signals used for the effective measurement of electrophysiological parameters in some embodiments”); analyzing, in the signal processing device, the received neuronal electrical activity signal data and, from the received neuronal electrical activity signal, generating a predicted seizure metric (e.g. see [0092], [0148]); and determining, in the signal processing device, from the predicted seizure metric whether to administer a treatment electrical stimulation pattern to prevent a predicted seizure (e.g. see [0096], [0097], [0148]. Crowder teaches in [0148] states “The therapeutic stimulator 512 is adapted to provide electrical stimulation signals appropriate for application to neurological tissue to terminate a present or predicted undesired neurological event, especially an epileptic seizure or its precursor.” In regards to the language “precursor” used by Crowder in [0148], the four seizure types disclosed in figures 8A-8D include sensing windows 812a-812d, that incorporate substantial sections before the seizures begin. These pre-seizure sections in the windows 812a-812d are precursors of seizures, and will read on the claim language of “predicted seizure” and “predicted seizure metric”.); and in response to a determination to administer a treatment electrical stimulation pattern, controlling at least one administration electrode to administer at least part of the electrical stimulation pattern (e.g. see [0096], [0097], [0148]).
Crowder discloses generating a predicted seizure metric (e.g. see [0148]) but does not explicitly disclose the predicted seizure metric comprises an indicator of probability that the predicted seizure will occur. Leyde teaches it is known to use such a modification as set forth in [0101] to provide a weighted answer so as to further delineate within the pre-ictal state to further allow system 10 to provide a more specific output communication for the patient. For example, instead of a simple logical answer (e.g., pre-ictal or inter-ictal) it may be desirable to provide a weighted output in the form of a simplified neural state index (NSI) or other output that quantifies the patient's propensity, probability, likelihood or risk of a future seizure using some predetermined scale (e.g., scale of 1-10, with a "1" meaning "normal" and a "10" meaning seizure is imminent) (e.g. see [0101]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a weighted answer as taught by Leyde in the system/method of Crowder, since said modification would provide the predictable results of a weighted output in the form of a simplified neural state index (NSI) or other output that quantifies the patient's propensity, probability, likelihood or risk of a future seizure using some predetermined scale (e.g., scale of 1-10, with a "1" meaning "normal" and a "10" meaning seizure is imminent).
Regarding claim 18, Crowder discloses the predicted seizure metric spans a plurality of value ranges each value range corresponding to a different seizure type; and the method further includes determining a type of the predicted seizure based on the value range of the predicted seizure metric (e.g. see figures 8A-8F, [0064]-[0089], [0097]).
Regarding claim 19, Crowder discloses the predicted seizure metric is a probability metric indicating a probability of a presence of a seizure type; and the method further includes determining a type of the predicted seizure based on the predicted seizure metric (e.g. see figures 8A-8F, [0064]-[0089], [0097]).
Regarding claim 20, Crowder discloses determining the treatment electrical stimulation pattern, wherein the treatment electrical stimulation pattern comprises at least one of: a brain location to stimulate; amplitude of the treatment electrical stimulation pattern; frequency of the treatment electrical stimulation pattern; duration of the treatment electrical stimulation pattern; or start time of the treatment electrical stimulation pattern (e.g. see [0150], [0152]).
Regarding claim 21, Crowder discloses the method further comprises: in response to the determination that the treatment electrical stimulation pattern will not be administered, sending a warning message to a smartphone of a subject indicating that no electrical stimulation will be administered to prevent an onset of the predicted seizure (e.g. see [0149]).
Regarding claim 27, Crowder discloses generating a predicted seizure metric (e.g. see [0092], [0148]) but does not explicitly disclose the predicted seizure metric comprises a probability distance. Leyde teaches it is known to use such a modification as set forth in [0101] to provide a weighted answer so as to further delineate within the pre-ictal state to further allow system 10 to provide a more specific output communication for the patient. For example, instead of a simple logical answer (e.g., pre-ictal or inter-ictal) it may be desirable to provide a weighted output in the form of a simplified neural state index (NSI) or other output that quantifies the patient's propensity, probability, likelihood or risk of a future seizure using some predetermined scale (e.g., scale of 1-10, with a "1" meaning "normal" and a "10" meaning seizure is imminent) (e.g. see [0101]) (Note: [0071] of the applicant’s printed publication disclose the “probability distance” is a measure to enable “a determination of if the patient is moving “closer to” or “farther away from” the predicted seizure”. This seems to be exactly what Leyde discloses in [0101]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a weighted answer as taught by Leyde in the system/method of Crowder, since said modification would provide the predictable results of a weighted output in the form of a simplified neural state index (NSI) or other output that quantifies the patient's propensity, probability, likelihood or risk of a future seizure using some predetermined scale (e.g., scale of 1-10, with a "1" meaning "normal" and a "10" meaning seizure is imminent).
Regarding claim 28, Crowder discloses generating a predicted seizure metric (e.g. see [0092], [0148]) but does not explicitly disclose the indicator of probability is numerical. Leyde teaches it is known to use such a modification as set forth in [0101] to provide a weighted answer so as to further delineate within the pre-ictal state to further allow system 10 to provide a more specific output communication for the patient. For example, instead of a simple logical answer (e.g., pre-ictal or inter-ictal) it may be desirable to provide a weighted output in the form of a simplified neural state index (NSI) or other output that quantifies the patient's propensity, probability, likelihood or risk of a future seizure using some predetermined scale (e.g., scale of 1-10, with a "1" meaning "normal" and a "10" meaning seizure is imminent). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a weighted answer as taught by Leyde in the system/method of Crowder, since said modification would provide the predictable results of a weighted output in the form of a simplified neural state index (NSI) or other output that quantifies the patient's propensity, probability, likelihood or risk of a future seizure using some predetermined scale (e.g., scale of 1-10, with a "1" meaning "normal" and a "10" meaning seizure is imminent).
Regarding claim 29, Crowder discloses administering the treatment electrical stimulation pattern; generating an interictal biomarker from a response to the treatment electrical stimulation pattern; and updating the predicted seizure metric based on the interictal biomarker (e.g. see [0092], [0096]-[0097], [0150]-[0152]).
Regarding claim 30, Crowder discloses identifying one or more seizure onset signal patterns in the received neuronal electrical activity signal data; and wherein the predicted seizure metric is generated based on a frequency and/or amplitude of the identified onset signal pattern (e.g. see figures 8A-8F, [0064]-[0089]).
Regarding claim 31, Crowder discloses determining a type of the predicted seizure based on the predicted seizure metric; administering the treatment electrical stimulation pattern to the subject through the plurality of electrodes; in response to administering the treatment electrical stimulation pattern to the subject through the plurality of electrodes, receiving, in the signal processing device, further neuronal electrical activity signal data taken from a plurality of electrodes; determining, in the signal processing device, an increase, decrease, or no change in the predicted seizure metric based on the further neuronal electrical activity signal data and generating an updated predicted seizure metric; and in response to the determination of the increase, decrease, or no change in the predicted seizure metric, changing the treatment electrical stimulation pattern to reduce likelihood of the predicted seizure (e.g. see [0092], [0096]-[0097], [0150]-[0152]).
Regarding claim 32, Crowder discloses the plurality of electrodes include at least one electrode configured to both: (1) administer at least part of the probing electrical stimulation pattern, and (ii) sense neuronal electrical activity (e.g. see [0116]).
Regarding claim 33, Crowder discloses the plurality of electrodes includes: (4) an administration electrode configured to administer at least part of the probing electrical stimulation pattern, but not configured to sense neuronal electrical activity; and (ii) a sensing electrode configured to sense the neuronal electrical activity, but not configured to administer the probing electrical stimulation pattern (e.g. see [0116]).
Regarding claim 34, Crowder discloses the plurality of electrodes are one or both of: (4) comprised in a therapeutic brain implant, or (ii) extracranial (e.g. see [0103]-[0105]).
Regarding claim 35, Crowder discloses determining a type of the predicted seizure based on the predicted seizure metric, wherein the type of the predicted seizure is one of: a supercritical Hopf bifurcation (SupH) bifurcation; a Saddle-Node on an Invariant Circle (SNIC) bifurcation; a Saddle-Node (SN) bifurcation; or a Subcritical Hopf (SubH) bifurcation (e.g. see figures 8A-8F, [0064]-[0089]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP C EDWARDS whose telephone number is (571)270-1804. The examiner can normally be reached Mon-Fri, 9:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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