DETAILED ACTION
The Examiner acknowledges the amendments received 20 June 2026. Claim 2 is cancelled; claims 12-14 are withdrawn; new claim 15 is entered; claims 1, 3-11 and 15 are pending.
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 20 June 2026 have been fully considered but they are not persuasive. Applicant argues (page 9, “Remarks”) “Applicants have search Osorio and are unable to find the verification function in Claim 1, which recites verifying the occurrence of the state change based upon the determination that the at least one heart beat complex shape fails to match the reference heart beat complex shape template.”
The Examiner draws attention to previously cited par. 0112, “Upon classifying the kinetic signal and detecting the possibility of the epileptic event based upon the patient's heart beat sequence, an output indicative of an epileptic event can be provided if the kinetic signal is classified as an epileptic event kinetic signal; and an output indicative of the non-occurrence of an epileptic event can be provided if the kinetic signal is classified as a nonepileptic event kinetic signal. This method can validate a cardiac-based seizure detection by use of kinetic signals.” This constitutes the limitation as claimed.
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.
Claims 1, 3-4, 6-11 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osorio (U.S. 2012/0083700). Osorio discloses (Figure 1) the implantable medical device including a first electrode (par. 0181) coupled to a first cranial nerve structure and a second electrode coupled to a second cranial nerve structure, the method comprising: obtaining data (par. 0052) relating to at least a portion of a heart beat complex from a patient, the obtained data further related to a heart rate variability (par. 0044; Table 1); comparing the at least the portion of the heart beat complex to stored data relating to the patient; indicating an occurrence of a state change based upon a determination of the comparison; providing a first electrical signal to the first cranial nerve structure of the patient; determining that at least one heart beat complex shape fails to match a reference heart beat complex shape template (par. 0074); verifying the occurrence of the state change based upon the determination that the at least one heart beat complex shape fails to match the reference heart beat complex shape template; and providing a second electrical signal to the second cranial nerve structure.
Regarding claim 3, Osorio discloses (par. 0112) the verification of the occurrence of the state change is based on a determination that a portion of data relating to the patient failed to match the portion of the heart beat complex.
Regarding claim 4, Osorio discloses (par. 0215) determining a reference heart rate derived shape from the time series of cardiac data where the reference heart rate derived shape comprises a characteristic selected from at least one phase relative to the reference heart rate derived shape; a number of positive phases relative to the reference heart rate derived shape; a number of negative phases relative to the reference heart rate derived shape; a number of extrema of the heart rate derivative; or an area under a curve of a phase.
Regarding claim 6, Osorio discloses (par. 0215) the data relating to the patient is further related to a heart rate.
Regarding claim 7, Osorio discloses (par. 0215) obtaining a time series of cardiac data from the patient; determining a reference heart rate derived shape from the time series of cardiac data where the reference heart rate derived shape comprises at least one characteristic selected from: a number of phases relative to the reference heart rate parameter; a number of extrema of a heart rate derivative; a number of directions of change of the heart rate derivative; an area under a first curve of a first phase; a number of positive phases; or a number of negative phases.
Regarding claim 8, Osorio discloses (Table 1) the data relating to the patient comprises at least one of: an amplitude of a P wave; a polarity of the P wave; an amplitude of an R wave; a polarity of a Q wave; a polarity of the R wave; an amplitude of an S wave; a polarity of the S wave; an amplitude of a T wave; a polarity of the T wave; an area under a curve of the P wave; an area under a curve of the Q wave; an area under a curve of the R wave; an area under a curve of the S wave; an area under a curve of the T wave; a width of the P wave; a width of the Q wave; a width of the R wave; a width of the S wave; a width of the T wave; a morphology of the P wave; a morphology of the Q wave; a morphology of the R wave; a morphology of the T wave; a magnitude of a change in a distance from the P wave to the Q wave; a magnitude of a change in a distance from the P wave to the R wave; a magnitude of a change in a distance from the Q wave to the R wave; a magnitude of a change in a distance from the R wave to the S wave; a magnitude of a change in a distance from the R wave to the T wave; a magnitude of a change in a distance from the S wave to the T wave; a magnitude of an S-T segment elevation; a magnitude of an S-T segment depression; a magnitude of a Q-T segment elevation; a magnitude of a Q-T segment depression; a P-R interval; an R-S interval; an S-T interval; an R-T interval; and a Q-T interval.
Regarding claim 9, Osorio discloses (par. 0052 and 0112) the identifying the occurrence of the state change is based upon a determination that there is no match between the heart beat complex and the reference heart beat complex relating to the patient.
Regarding claim 10, Osorio discloses (par. 0170) taking an action in response to the verification, wherein the action is at least one of: providing a warning of the seizure; logging a time of the seizure; computing one or more seizure indices; logging one or more computed seizure indices; providing at least one treatment of the seizure; and two or more thereof.
Regarding claim 11, Osorio discloses (par. 0112) the obtaining further comprises obtaining data relating to at least a portion of a plurality of heart beat complex shapes and the verification is based upon a determination that at least one heart beat complex shape of the plurality of heart beat complex shapes fails to match the reference heart beat complex shape template.
Regarding claim 15, Osorio discloses (par. 0174) in response to the determination that the at least one heart beat complex fails to match the reference heart beat complex shape template, the second electrical signal is provided to the first cranial nerve.
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
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