DETAILED ACTION
This action is pursuant to the claims filed on January 30, 2026. Claims 21-40 are pending. Claims 1-20 is/are canceled. A final action on the merits of claims 21-40 is as follows.
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 . 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 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.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21-22, 24, 29, 31-32, 34, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Ludvig et al. (hereinafter ‘Ludvig’, U.S. PGPub. No. 2009/0281446), in view of Leyde (U.S. PGPub. No. 2008/0183097), and further in view of Guillory et al. (hereinafter ‘Guillory’, U.S. PGPub. No. 2008/0091090).
In regards to independent claim 21, Ludvig discloses a computer implemented method for electroencephalogram (EEG) monitoring, the method comprising:
providing at least one wireless EEG sensor configured to be activated and placed on a scalp of a patient (EEG mindisc 505 in Fig. 5 and internal structures in Fig. 6d; [0017]), the at least one wireless EEG sensor comprising:
a transmitter (RF transceiver 550 and optical transceiver 545 in Fig. 6d);
a first electrode (first electrode 520);
a second electrode (second electrode 520), wherein the first electrode and the second electrode form a single bipolar channel (Fig. 7 explains the signals from the first and second electrode are amplified by an instrumentation amplifier, in which the output is a bipolar signal between the two electrodes);
continuously recording signal channel EEG data with the at least one wireless EEG sensor ([0017]: EEG signals produced before, during, and after the epileptic event is recorded);
transmitting, via the transmitter, the signal channel EEG data to a computing device ([0042]: the processing unit 530 may transfer the EEG data to a memory of the EEG minidisc 505 and/or transmit the EECG data as a wireless signal (e.g. optical, RF) to a remote computing device).
However, Ludvig does not disclose with the computing device, counting seizure events based on identifying epileptiform activity in a single channel EEG data; and with the computing device, providing an EEG activity report that comprises a count of seizure events.
Leyde teaches measuring a subject’s brain signal and analyze the signal to determine whether or not the subject has epilepsy, determine the type of epilepsy, determine the type of seizures, localize or lateralize one or more seizure foci or seizure networks, and assess seizure statics which include seizure count, frequency, duration, seizure patterns ([0074]). Given that Ludvig’s device is for detecting epileptiform activity, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the computer implemented method of Ludvig and incorporate providing an EEG activity report inherently performed by a seizure detection process that includes a count of seizure events as taught by Leyde as one of various seizure statistics to characterize epileptic event offline ([0074]).
However, Lang/Leyde combination does not disclose automatically counting seizure events in real-time or near real time based via a seizure detection process.
Guillory teaches a wearable monitoring device (monitoring device 10 in Fig. 1) configured to adhere to a subject’s skin ([0038]). Guillory further teaches the wearable monitoring device comprises one or more physiological sensors (sensors 12) configured for EEG ([0040]-[0041]), a signal processing unit or units (62 in Figs. 9 and 10) and other electronics within the monitoring device to process or analyze the physiological signals received from the sensors ([0043]). The signal processing units (62) analyzes the acquired signals by applying algorithms, computational techniques, or detection methods and so forth ([0044]) and generate a physiological condition index including generating an epileptiform activity index or a status epilepticus index ([0047], [0066]) and the same process can be performed by an external device such as a computer ([0032],[0113]). Given that Leyde teaches counting seizure events offline to determine epileptiform activity ([0074]-[0078]), it would have been obvious to one of ordinary skill in the art to modify the method step of offline seizure detection process as disclosed by Ludvig/Leyde combination so that the processing of seizure events is in real-time or near real time as taught by Guillory, as doing so involves routine skill in the art and predictable result of instantaneous indication of the epileptiform activity to a caregiver would ensue (abstract, [0007]-[0008]).
In regards to claim 22, Ludvig/Leyde/Guillory combination further discloses wherein transmitting the single channel EEG data to the computing device comprises continuously transmitting the single channel EEG data to the computing device ([0017]: EEG signals produced before, during, and after the epileptic event is recorded; [0042]: the processing unit 530 may transfer the EEG data to a memory of the EEG minidisc 505 and/or transmit the EEG data as a wireless signal (e.g. optical, RF) to a remote computing device).
In regards to claim 24, in view of the combination in claim 21 above, Leyde teaches wherein the epileptiform activity comprises interictal spikes ([0170]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the method steps of Leyde to determine one of various epileptiform activities such as interictal spikes ([0170]).
In regards to claim 29, Ludvig/Leyde/Guillory combination further discloses wherein the at least one wireless EEG sensor is further configured to be placed in a known location on the scalp of the patient associated with seizure activity (the examiner is in the position that the EEG mindisc 505 is capable of being positioned anywhere along the scalp which would include the location associated with seizure activity).
In regards to independent claim 31, Ludvig discloses a system for electroencephalogram (EEG) monitoring, the system comprising:
at least one wireless EEG sensor configured to be activated and placed on a scalp of a patient (EEG mindisc 505 in Fig. 5; internal structures are shown in Fig. 6d; [0017]:
EEG mindisc is activated or powered to record EEG signals before, during, and after the epileptic event);
a first electrode (first electrode 520);
a second electrode (second electrode 520), wherein the first electrode and the second electrode form a single bipolar channel (Fig. 7 explains the signals from the first and second electrode are amplified by an instrumentation amplifier, in which the output is a bipolar signal between the two electrodes);
a transmitter configured to transmit the single channel EEG data (RF transceiver 550 and optical transceiver 545 in Fig. 6d; [0017]: EEG signals produced before, during, and after the epileptic event is recorded and transmitted wirelessly to a remote computing device);
a non-transitory computer-readable memory storing instructions that, when executed by one or more processors, causes the one or more processors to:
receive the single channel EEG data 0042]: the processing unit 530 may transfer the EEG data to a memory of the EEG minidisc 505 and/or transmit the EEG data as a wireless signal (e.g. optical, RF) to a remote computing device).;
However, Ludvig does not disclose counting seizure events based on an epileptiform activity at the single bipolar channel; and provide an EEG activity report, wherein the EEG activity report that comprises a count of the seizure events.
Leyde teaches measuring a subject’s brain signal and analyze the signal to determine whether or not the subject has epilepsy, determine the type of epilepsy, determine the type of seizures, localize or lateralize one or more seizure foci or seizure networks, and assess seizure statics which include seizure count, frequency, duration, seizure patterns ([0074]). Given that Ludvig’s device is for detecting epileptiform activity, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the computer implemented method of Ludvig and incorporate providing an EEG activity report that includes a count of seizure events as taught by Leyde as one of various seizure statistics to characterize each epileptic event ([0074]).
However, Lang/Leyde combination does not disclose automatically counting seizure events in real-time or near real time based via a seizure detection process.
Guillory teaches a wearable monitoring device (monitoring device 10 in Fig. 1) configured to adhere to a subject’s skin ([0038]). Guillory further teaches the wearable monitoring device comprises one or more physiological sensors (sensors 12) configured for EEG ([0040]-[0041]), a signal processing unit or units (62 in Figs. 9 and 10) and other electronics within the monitoring device to process or analyze the physiological signals received from the sensors ([0043]). The signal processing units (62) analyzes the acquired signals by applying algorithms, computational techniques, or detection methods and so forth ([0044]) and generate a physiological condition index including generating an epileptiform activity index or a status epilepticus index ([0047], [0066]) and the same process can be performed by an external device such as a computer ([0032],[0113]). Given that Leyde teaches counting seizure events offline to determine epileptiform activity ([0074]-[0078]), it would have been obvious to one of ordinary skill in the art to modify the method step of offline seizure detection process as disclosed by Ludvig/Leyde combination so that the processing of seizure events is in real-time or near real time as taught by Guillory, as doing so involves routine skill in the art and predictable result of instantaneous indication of the epileptiform activity to a caregiver would ensue (abstract, [0007]-[0008]).
In regards to claim 32, Ludvig/Leyde/Guillory combination further discloses the transmitter is configured to continuously transmit the single channel EEG data ([0017]: EEG signals produced before, during, and after the epileptic event is recorded; [0042]: the processing unit 530 may transfer the EEG data to a memory of the EEG minidisc 505 and/or transmit the EEG data as a wireless signal (e.g. optical, RF) to a remote computing device).
In regards to claim 34, in view of the combination in claim 21 above, Leyde teaches wherein the epileptiform activity comprises interictal spikes ([0170]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the method steps of Leyde to determine one of various epileptiform activities such as interictal spikes ([0170]).
In regards to claim 39, Ludvig/Leyde combination further discloses wherein the at least one wireless EEG sensor is further configured to be placed in a known location on the scalp of the patient associated with seizure activity (the examiner is in the position that the EEG mindisc 505 is capable of being positioned anywhere along the scalp which would include the location associated with seizure activity).
Claims 23 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Ludvig, Leyde and Guillory as applied to claim 1 above, and further in view of Fischell et al. (hereinafter ‘Fischell’, U.S. Pat. No. 6,230,049).
In regard to claims 23 and 33, Ludvig/Leyde/Guillory combination discloses the invention substantially as claimed in claim 21 and 31, respectively and discussed above.
However, Ludvig/Leyde/Guillory combination does not necessarily disclose wherein transmitting the single channel EEG data to the computing device comprising: receiving, via the transmitter, a request; and transmitting the single channel EEG data to the computing device in response to the request.
Fischell generally teaches transmitting, via a transmitter, EEG data from specific site of an epileptic focus during brain mapping, after receiving, via the transmitter, a request from a computing device (EEG analysis workstation 60 and workstation electronic module 40 activates patient electronic module 20 via a wireless link 30 to gather EEG data based upon the physician’s directives; col. 4, ln. 8-49). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Ludvig/Leyde/Guillory combination and incorporate receiving a request from the computing device and transmitting the single channel EEG data to the computing device in response to the request as taught by Fischell, as doing so would record and transmit data only when it is activated or directed by a physician for diagnostic or brain mapping purposes (col. 4, ln. 8-49).
Claims 26-28 and 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Ludvig, Leyde and Guillory as applied to claim 1 above, and further in view of Puttilli et al. (hereinafter ‘Puttilli’, WO 2017/055354).
In regard to claims 26-28 and 36-38, Ludvig/Leyde/Guillory combination discloses the invention substantially as claimed in claim 21 and claim 31, respectively and discussed above.
However, Ludvig/Leyde combination does not disclose wherein the at least one wireless EEG sensor further comprises at least one Hall-effect sensor configured to activate the at least one wireless EEG sensor, wherein the method further comprises causing the at least one wireless EEG sensor to be activated responsive to a detection of a change in a magnetic field monitored by the at least one Hall-effect sensor.
Puttilli teaches generally the use of accelerometer such as Hall effect sensor to detect seizures and in turn power a sensor device (pg. 15, ln. 15-21). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Ludvig/Leyde/Guillory combination and incorporate a step of activating the at least one wireless EEG sensor for recording EEG signal, which inherently requires a switch circuitry, based upon detection of seizure by Hall effect sensor, as doing so allows the sensor to record during seizures which reduces the overall power consumption.
Claims 25 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Ludvig, Leyde and Guillory as applied to claim 21 and 31, respectively, and further in view of Bibian et al. (hereinafter ‘Bibian’, U.S. PGPub. No. 2017/0112408).
In regard to claims 25 and 35, Ludvig/Leyde/Guillory combination discloses the invention substantially as claimed in claim 21 and claim 31, respectively and discussed above.
However, Ludvig/Leyde/Guillory combination does not disclose monitoring at least one of: a quality or an impedance of the single channel EEG.
Bibian teaches measuring electrode impedance for guaranteeing an optimal signal quality and determining whether the electrode is of a good quality (e.g. aged electrodes or poorly shelved electrodes), see col. 19, ln. 18-31. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the Ludvig/Leyde/Guillory combination and incorporate monitoring impedance of each of the electrodes to determine the quality of the electrodes (col. 18, ln. 59-67).
Claims 30 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Ludvig, Leyde and Guillory as applied to claim 21 and 31, respectively, and further in view of Lang (hereinafter ‘Lang’, U.S. PGPub. No. 2014/0206975).
In regards to claims 30 and 40, Ludvig/Leyde/Guillory combination discloses the invention substantially as claimed in claim 21 and claim 31, respectively and discussed above.
Lang teaches providing a housing which sealably encloses a wireless EEG sensor (housing 600 encloses neural activity recording apparatus (not shown) in Fig. 6, [0038]-[0039]). Therefore, it would have been obvious to one of to one of ordinary skill in the art before the effective filing date of the invention to modify the Ludvig/Leyde/Guillory combination and enclose in a housing as taught by Lang, to thereby seal the wireless EEG sensor ([0038]-[0039]).
Response to Arguments
Applicant’s arguments, see Remarks, filed on January 30, 2016, with respect to the rejection(s) of claim(s) 21, 22, 24, 29, 31, 32, 34 and 39 under 35 U.S.C. 103 as being unpatentable over Ludvig in view of Leyde has been considered and is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Guillory et al. (U.S. PGPub. No. 2008/0091090). Guillory teaches a wearable monitoring device (monitoring device 10 in Fig. 1) similar to that of Ludvig and Leyde configured for EEG monitoring and determining an epileptiform activity ([0040]-[0041], [0047], [0066]). Specifically, Guillory teaches that the entire determining of the epileptiform activity can be performed in real-time within the wearable monitoring device ([0044]) and an external device ([0032], [0113]) for instantaneous indication of the patient’s condition. Therefore, the concept of real-time determination of epileptiform activity is already known in the art and modifying the step of offline epileptiform determination of Ludvig/Leyde combination to a real-time determination of epileptiform activity as taught by Guillory involves routine skill in the art and predictable result of instantaneous indication of the epileptiform activity to a caregiver would ensue (abstract, [0007]-[0008]). The examiner notes that the particular algorithm or process of counting seizure events based on identifying epileptiform activity via a seizure detection process is taught by Leyde and the method step of automatically, in real-time or near real time implementing a generic algorithm or process for identifying epileptiform activity is taught by Guillory.
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 EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 3/18/2026