DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 21-24, 27, 30-34, 37, 39, and 40-42 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wu et al.’556 (US Pub No. 2009/0192556 – previously cited) in view of Yamamori et al.’720 (US Pub No. 2013/0172720 – previously cited) further in view of Nathan et al.’696 (US Pub No. 2009/0062696 – previously cited).
Regarding claims 21-23, and 27, Wu et al.’556 discloses a system (Figure 1), the system comprising: processing circuitry (Figure 5, processing circuitry 70) configured to: receive information representative of a bioelectric brain signal sensed from a patient (section [0127]), wherein the bioelectrical brain signal is representative of local field potentials sensed via at least one electrode implanted within a brain of the patient (sections [0061], [0097], [0169], and [0147-0175]; Figure 1 shows at least one electrode 22A and 22B implanted within a brain of the patient); determine a power level of a beta frequency band of the bioelectrical brain signal from the information representative of the bioelectrical brain signal (power levels of a beta band as discussed in sections [0152], [0161], and [0175]); compare the power level to a plurality of threshold values (see description of Figure 7 in sections [0151-0157], particularly steps 92 and 94, and sections [0127], [0106], [0161], and [0175]; section [0106] specifically teaches using a plurality of threshold values that are each indicative of a particular sleep stage); and control a display to present a graphical user interface (sections [0074] and [0126]).
Wu et al.’556 discloses all of the elements of the current invention, as discussed above, except for the processing circuitry being configured to control the display to present a power level of the beta frequency band of the bioelectric brain signal over time. Yamamori et al.’720 teaches processing circuitry configured to control a display to present a graphical user interface comprising measurements of an acquired physiological signal over time with respect to at least one threshold. Yamamori et al.’720 teaches that providing such a graphical user interface allows a medical person to easily recognize in a visual manner when a measurement exceeds a threshold, thus making it possible to immediately check a condition of a patient (section [0047]). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the processing circuitry of Wu et al.’556 to be configured to control the display to present a graphical user interface comprising a power level of the beta frequency band of the bioelectric brain signal over time with respect to the plurality of threshold values, as Yamamori et al.’720 teaches that this would allow a medical person to easily recognize in a visual manner that the power level of the beta frequency band of the bioelectrical brain signal has exceeded any of the plurality of threshold values. It is noted that as modified by Yamamori et al.’720, a graphical user interface resembling Figures 11 and 12A-12D of Wu et al.’556 would be generated, with threshold lines showing the borders between different sleep stages.
Wu et al.’556 in view of Yamamori et al.’720 discloses all of the elements of the current invention, as discussed above, except for the processing circuitry being configured to receive, via the graphical user interface, user input selecting the plurality of threshold values. It is noted that section [0106] of Wu et al.’556 teaches the use of patient-specific thresholds. Nathan et al.’696 teaches allowing a user to manually input levels of a tolerance range (threshold levels) in order for the tolerance range to be patient-specific (section [0045]). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the processing circuitry of Wu et al.’556 in view of Yamamori et al.’720 to be configured to allow a user to input the plurality of threshold values using the graphical user interface, as this would allow patient-specific thresholds to be set for the patient.
In the system of Wu e tal.’556 in view of Yamamori et al.’720 further in view of Nathan et al.’696, because the power level of the beta frequency band is displayed over time with respect to the plurality of threshold values, the processing circuitry is configured to control the display to present the selected plurality of threshold values. Any two thresholds defining a sleep stage are capable of being considered a “tolerance range” (including “zero” and one other threshold value). It is noted that the claims do not require the processing circuitry to determine a tolerance range associated with a level of symptoms that the patient can tolerate. The user is capable of determining each tolerance range based on their assessment of a level of symptoms that the patient can tolerate, and then inputting each threshold value into the system to set the user-specific threshold values.
Regarding claim 24, sections [0106] and [0152] of Wu et al.’556 disclose that the plurality of threshold values comprises two thresholds at different values associated with the bioelectric brain signal.
Regarding claim 30, as the processing circuitry of Wu et al.’556 in view of Yamamori et al.’720 further in view of Nathan et al.’696 generates a graphical user interface comprising power levels of a beta frequency band of the bioelectric brain signal over time with respect to the at least one threshold, it is also configured to correlate the power levels with a time associated with measurement of the bioelectric brain signal (note, Figures 11 and 12A-12D of Wu et al.’556 graph amplitude/power vs. time). Furthermore, Official notice is being taken that it is well known in the medical diagnostic art to timestamp (and date stamp) any data/measurements obtained during physiological signal acquisition.
Regarding claim 40, sections [0016], [0083], and [0125] of Wu et al.’556 disclose a non-transitory computer readable medium comprising instructions that, when executed, cause the processing circuitry to perform the method steps discussed above.
Regarding claim 41, Wu et al.’556 discloses that the processing circuitry is configured to determine that a biomarker is detected in response to determining that the power level of the frequency band of the bioelectrical signal is outside of the tolerance range (sections [0151-0152]).
Regarding claims 31-34, 37, 39, and 42, the sections of Wu et al.’556 cited above, as modified by Yamamori et al.’720 and Nathan et al.’696, disclose a method comprising the steps set forth in the claims.
Claims 28, 29, and 38 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wu et al.’556 in view of Yamamori et al.’720 further in view of Nathan et al.’696, as applied to claims 21 and 31, further in view of Fasciano’703 (US Pub No. 2009/0005703 – previously cited).
Regarding claims 28, 29, and 38, Wu et al.’556 in view of Yamamori et al.’720 further in view of Nathan et al.’696 discloses all of the elements of the current invention, as discussed in paragraph 3 above, except for the processing circuitry being configured to control the graphical user interface to present information related to stimulation therapy delivered to the patient, or a time the patient received medication. It is noted that Wu et al.’556 teaches treating the patient with both electrical stimulation therapy and drug therapy based on analyzing the acquired bioelectric brain signal (sections [0238-0240]). Fasciano’703 teaches displaying time-marked event markers on a graphical user interface, the event markers being displayed along with a measured parameter and a threshold line (see Figure 5, which shows event marker 520, measured signal 502, threshold line 506, and a time bar at the bottom of the display). Fasciano’703 teaches that the delivery of a therapy to a patient is one type of event marker capable of being displayed, and that displaying such an event marker enables a caregiver to correlate events to a change in a patient’s condition as manifested by a measured physiological parameter (see ABSTRACT, and sections [0031-0032]). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the processing circuitry of Wu et al.’556 in view of Yamamori et al.’720 further in view of Nathan et al.’696 to be configured to control the graphical user interface to present information related to stimulation therapy delivered to the patient (the time the stimulation therapy was delivered) and information representative of a time the patient received medication, as Fasciano’703 teaches that this would enable a caregiver to correlate therapy delivery to a change in the patient’s condition as manifested by the measured power levels.
Response to Arguments
Applicant's arguments filed 23 June 2026 have been fully considered.
Applicant argues on pages 6-8 of the Remarks that (1) “Although not specifically acknowledged, the Office did not allege that Wu or Yamamori disclose or suggest a tolerance range of powers of a bioelectrical brain signal, the tolerance range being associated with a level of symptoms that the patient can tolerate.” and that (2) Nathan “does not disclose or suggest ‘a tolerance range of powers of [a] bioelectrical brain signal, the tolerance range being associated with a level of symptoms that the patient can tolerate’”. Applicant further provides arguments regarding the specific thresholds of Nelson and how the thresholds of Nelson would not be used to identify different sleep stages of Wu.
Applicant’s arguments are not persuasive.
Regarding the first argument, the Office provided the following explanation in paragraph 3 of the Non-Final Rejection mailed out on 23 March 2026 (and again in paragraph 3 above) as to why Wu in view of Yamamori further in view of Nathan reads on the limitation in question:
“In the system of Wu e tal.’556 in view of Yamamori et al.’720 further in view of Nathan et al.’696, because the power level of the beta frequency band is displayed over time with respect to the plurality of threshold values, the processing circuitry is configured to control the display to present the selected plurality of threshold values. Any two thresholds defining a sleep stage are capable of being considered a “tolerance range” (including “zero” and one other threshold value). It is noted that the claims do not require the processing circuitry to determine a tolerance range associated with a level of symptoms that the patient can tolerate. The user is capable of determining each tolerance range based on their assessment of a level of symptoms that the patient can tolerate, and then inputting each threshold value into the system to set the user-specific threshold values.” (emphasis added).
Regarding argument (1), as previously mentioned, the claims do not require that the system itself determines a tolerance range associated with a level of symptoms that the patient can tolerate. An operator of the system, who, as taught by Nathan, manually inputs each tolerance range for the various sleep stages determined by Wu, is capable of mentally determining the upper and lower limits of each sleep stage’s tolerance range based on their personal assessment of a level of symptoms that the patient can tolerate.
Regarding argument (2), the specific thresholds of Nelson were not relied upon to modify Wu in view of Yamamori. Nathan was merely relied upon to teach having an operator manually input specific threshold values. The tolerance ranges are taught by Wu alone (each sleep stage shown in Figure 11 – Awake, Stage 1, Stage 2 and Deep Sleep, REM – comprises an upper and lower limit; the upper and lower limits define a tolerance range). (It is noted that the previous example of “zero” as a tolerance range boundary was just that, an example. The Examiner was not indicating that Wu teaches “zero” as a threshold.) As modified by Nathan, an operator of the system determines and inputs the upper and lower limits for each tolerance range; the upper and lower limits are capable of being determined by the operator based on the operator’s assessment of a level of symptoms the patient can tolerate.
Applicant argues on page 9 of the Remarks that “even if one of ordinary skill in the art would have modified the Wu system to enable a user to select a threshold for each sleep stage, such a modification would still fail to arrive at ‘a tolerance range of powers of the bioelectrical brain signal, the tolerance range being associated with a level of symptoms that the patient can tolerate’”. As noted above, this argument is not persuasive as the claims do not require the system to determine the tolerance range; the operator of the system is capable of determining each tolerance range based on a level of symptoms that the patient can tolerate.
Applicant further argues on page 9 that modifying Wu to display a tolerance range associated with a level of symptoms that the patient can tolerate would change the principle of operation of the Wu system. This argument is not persuasive as Applicant does not state why or how the modification would change the principle of operation of the Wu system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Virag et al.’954 (US Pub No. 2007/0249954 – previously cited) teaches displaying the amplitudes of a bioelectric brain signal over time, and comparing the amplitudes to a threshold. Carlson et al.’153 (US Pub No. 2010/0100153 – previously cited) teaches comparing a power level of a beta band of a bioelectrical brain signal to a threshold. Panken et al.’829 (US Pub No. 2009/0082829 – previously cited) teaches comparing an amplitude of a bioelectric brain signal to a threshold.
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.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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