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, see pp10-11, filed 11/5/2025, with respect to the rejection of claims 17-21 and 27-35 under 35 U.S.C. 101 have been fully considered and are persuasive. The rejection of claims 17-21 and 27-35 under 35 U.S.C. 101 has been withdrawn.
Applicant’s arguments, see p12, filed 11/5/2025, with respect to the rejection of claim 17 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claim 17 under 35 U.S.C. 112(b) has been withdrawn.
Applicant's arguments filed 11/5/2025 have been fully considered but they are not persuasive.
Applicant 1st argues on page 11 “That is, this paragraph in Crowder teaches that the therapeutic stimulator 512 shown in Figure 5 may provide electrical stimulation signals to terminate a predicted undesired neurological event. However, Crowder does not suggest that any prediction of a seizure would be made from the received neuronal electrical activity signal. Seizures may be predicted in many ways. Among many ways to predict seizures, examples include heart rate monitoring, movement monitoring, seizure diaries (on a smartphone, etc.), genetic and/or biomarker analysis, clinical observations, etc. Crowder's disclosure in paragraph 0148 of the therapeutic stimulator 512 in no way suggests that any prediction of a seizure would be made from the received neuronal electrical activity signal. Applicant respectfully submits that Crowder does not anticipate claim 17 for this first reason alone”.
The examiner is not persuaded. It is clear from [0092], [0096], [0097], and [0135]-[0137] that the data input for the detection subsystem 326 is a “received neuronal electrical activity signal”. Further, it is clear from Fig. 3, Fig. 5, and [0148] that the Detection Subsystem 326 feeds data into the Therapy Subsystem 328, and more specifically the Control Interface 510 in Figure 5. The Control Interface 510 is then used to control the Therapeutic Stimulator 512. [0148] then 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”. Thus, there is a direct link between the “received neuronal electrical activity signal” in element 326, which feeds to element 510, which controls element 512, which “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”.
Applicant 2nd argues on page 12 “Moreover, Crowder does not teach a specific functional relationship where neuronal electrical activity signal data taken in response to probing electrical stimulation is analyzed to generate a predicted seizure metric, which is then used to determine whether to administer treatment. While Crowder mentions diagnostic stimulation (para. 0150) and detection of seizure onsets (para. 0092), Crowder does not teach that responses to diagnostic/probing stimulation are analyzed to generate a metric that predicts future seizures. Applicant respectfully submits that Crowder does not anticipate claim 17 for this additional reason as well”.
The examiner is not persuaded. [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”. As stated above, element 326 feeds into element 510, which controls element 512, which “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”. Thus, there is a direct link between the probing signals in [0150] and the stimulation in [0148].
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 17-21 and 27-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crowder et al. (Pub. No.: US 2016/0228705 A1); hereinafter referred to as “Crowder”.
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 discloses in [0148] “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.”); 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]).
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 claims 27 and 28, Crowder discloses the predicted seizure metric comprises a probability distance and the predicted seizure metric comprises a numerical indicator of probability that the predicted seizure will occur (e.g. see figures 8A-8F, [0064]-[0089], [0097]).
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
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 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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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792