DETAILED ACTION
The amendment filed on 12/13/24 has been received and considered. By this amendment, no claims are amended, added, or cancelled. Claims 1-9 and 15-20 remain withdrawn.
Response to Arguments
Applicant's arguments filed 12/13/24 have been fully considered but they are not persuasive. Applicant argues no articulated reasoning with some rational underpinning was provided to demonstrate obviousness. Both Gordon (see par. 27) and Bukhman (see par. 9) are interested in indicators of epilepsy. Gordon does not disclose what happens after diagnostic analysis. Bukhman does (see par. 124). It would be obvious to treat an issue after detection.
Examiner identifies the 103 requirements here alongside the original rejection excerpt:
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“Gordon does not explicitly disclose applying an electrical stimulation to a neural target of the patient for treating the epileptic event [2]. Bukhman discloses a similar seizure detecting device [1] (see par. 9) wherein stimulation is applied to a neural target in response to an index being within a range (see par. 74 and 123). It would have been obvious to one of ordinary skill in the art at the time of the invention to stimulate based on an index with in a range because the comparison may suggest that an epilepsy event is occurring or impending [3 and 4] (see par. 124).”
Applicant further argues Gordon’s circular variance is not a phase locking index.
Paragraph 148 reproduced here:
[0148] Following this calculation of the time series of gamma (37 to 41 Hz) phase for each site, the phase synchrony across sites within various regions of interest is calculated at each sample point in time from -500 to 750 ms. Phase synchrony is defined to be the inverse of the circular variance of phase across sites. Circular variance is an index of the extent to which the sites are in phase or phase-locked with each other. Circular variance is a normalized measure that ranges from 0 to 1 and is completely independent of the amplitude of the responses. Like a correlation coefficient, it therefore has no associated units of measure. It can be thought of as similar to a coherence estimate, except that it is an index of the extent of phase-locking across many sites rather than just between two sites as with coherence. For ease of interpretation phase synchrony is calculated as the inverse of circular variance, or simply one minus the circular variance.
Regarding the previously applied rejection under 35 USC 112(a), the previous rejection is not overcome, as Applicant has not identified any sections or paragraphs from the Specification that describe sub-regions and phase-locking. In other words, if only regions and indexing are described, then only claim that. Simply stating that one of ordinary skill in the art would know and understand these aspects is not enough.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. “Sub-region” is not define in the Specification. Is “sub-region” simply “region” as defined in par. 64 of the Specification? Similarly, a “phase-locking index” is not described in the Specification.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 10-13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gordon (PG Pub. 2005/0273017) in view of Bukhman (PG Pub. 2010/0274303). The examiner considers the first instance of a range by the Applicant occurs in Application #13/280,178, which has a priority date of 10/24/11. Therefore, the range disclosed in Claim 10 (see line 10) is limited by 10/24/11. The depending claims, as a result, are also limited by this priority date.
Regarding Claim 10, Gordon discloses a medical device including one or more processors configured to perform a method, the method comprising:
detecting via one or more sensors a first electrical activity relating to a first epileptic activity in a first brain sub-region of a patient (see par. 52, 148, and 498);
detecting via the one or more sensors a second electrical activity relating to a second epileptic activity in a second brain sub-region of the patient (see par. 52, 148, and 498);
determining a phase-locking index between the first electrical activity and the second electrical activity (see circular variance; par. 148); and
determining an epileptic event based on the phase-locking index being within a range (see par. 148 and 182).
The examiner considers the two regions are chosen from the ones listed in par. 63-73. Gordon does not explicitly disclose applying an electrical stimulation to a neural target of the patient for treating the epileptic event.
Bukhman discloses a similar seizure detecting device (see par. 9) wherein stimulation is applied to a neural target in response to an index being within a range (see par. 74 and 123). It would have been obvious to one of ordinary skill in the art at the time of the invention to stimulate based on an index with in a range because the comparison may suggest that an epilepsy event is occurring or impending (see par. 124).
Regarding Claim 11, Bukhman further discloses where the method further includes:
receiving an efficacy body signal after applying the electrical stimulation to the neural target of the patient, wherein the efficacy body signal is selected from at least one of an autonomic signal, a neurologic signal, a metabolic signal, an endocrine signal, and a tissue stress marker signal (see par. 106);
determining whether the efficacy body signal indicates that the electrical stimulation to the neural target of the patient has an efficacious effect (see par. 103); and
terminating the application of the electrical stimulation to the neural target of the patient based on a determination that indicates that the electrical stimulation to the neural target of the patient has an efficacious effect. The examiner considers if the stimulation is not triggered (see par. 103 and 118), it means the stimulation was effective in getting rid of the heart rate index that indicates epilepsy and therefore, the stimulation is terminated. In other words, stimulation is provided as a responsive action to an analysis of whether there is an actual or impending epileptic seizure (see par. 113 and 114). If there is no epileptic seizure detected, there would be no need to continue stimulation.
Regarding Claim 12, Bukhman further discloses continuing the application of the electrical stimulation to the neural target of the patient based on a determination indicating that the first electrical stimulation to the neural target of the patient has not had an efficacious effect (see par. 103, 121; box 760; Fig. 6).
Regarding Claim 13, Bukhman discloses the method continues the electrical stimulation to the neural target of the patient for a predetermined duration (see on-time/off-time; par. 118).
Claim 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gordon (PG Pub. 2005/0273017) in view of Bukhman (PG Pub. 2010/0274303), and further in view of John (US Patent 6,463,328).
Regarding Claim 14, Gordon and Bukhman do not elaborate on safety constraints. John discloses a similar treatment of epilepsy (see col. 11, lines 1-4) comprising terminating the application of the first electrical stimulation to the neural target of the patient based on a safety duration constraint (see col. 23, line 67-col. 24, line 3). It would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate such safety constraints because John teaches it helps avoid unwanted side effects (see col. 24, lines 1-5).
Conclusion
THIS ACTION IS MADE FINAL. 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Carney et al. (US Patent 7433732) discloses neonatal seizure onset based on regularity statistics (PMRS).
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/N.P/Examiner, Art Unit 3792
/JAMES M KISH/Supervisory Patent Examiner, Art Unit 3792