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 § 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.
Claims 1, 3-7, 9-17, 19, 21, and 22 are 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.
Claim 1 calls for a processor to be configured to use an identified current state, determined signatures, an indication of at least one of a characteristic of a patient, and an indication of at least one drug administered to the patient in a model selected based on the indications to identify a predicted future state of the patient. The Specification fails to provide any discussion or guidance related to a model that uses a current state, determined signatures, and the claimed indications, let alone a model that uses all three parameters to identify a predicted future state of a patient. At best, section [0083] of the published version of the originally filed Specification states that drug administration information, in conjunction with "the above-described EEG data" may be acquired and used to estimate and predict future patient states, and section [0251] states that “A mathematical model that parametrically relates anesthetic infusion dynamics to the burst suppression probability is provided”. Neither of these sections teaches using a current state, determined signatures, and the recited indications in a model to determine a predicted future state of the patient. The Specification states throughout its disclosure that a predicted future state is estimated using determined signature profiles and the indications, but (1) there is no mention of using an identified current state in combination with the signature profiles and indications to identify the predicted future state, and (2) there is no description of a model into which all three parameters are input.
Claim 11 calls for a processor to be configured to predict a future state of a patient using a model and an identified current state. As noted above, the specification fails to provide any written description for a model that uses an identified current state of a patient to predict a future state of the patient.
Claim 12 calls for a processor to be configured to predict a future state of a patient using a drug-specific model and an identified current state. As noted above, the specification fails to provide any written description for a model that uses an identified current state of a patient to predict a future state of the patient.
Response to Arguments
Applicant's arguments filed 06 July 2026 have been fully considered.
Regarding the rejections of the claims under 35 U.S.C. 101, Applicant’s amendments to the claims have overcome the rejection.
Regarding the rejections of the claims under 35 U.S.C. 112(a), while the amendments have overcome the previous rejection, as discussed in paragraph 3 above, they have warranted a new rejection under 35 U.S.C. 112(a).
Regarding the rejections of the claims in view of previously cited prior art, Applicant’s amendments have overcome the previous prior art rejections.
Examiner’s Note
The following is a statement of reasons for the lack of prior art rejections:
Regarding claim 1, none of the prior art discloses or suggests, either alone or in combination, a patient state monitoring and control system comprising at least one processor, the at least one processor configured to use an identified current state, determined signatures, and indications of at least one characteristic of a patient and of at least one drug administered to the patient in a model to identify a predicted future state of the patient, in combination with the other claimed elements.
Regarding claim 11, none of the prior art discloses or suggests, either alone or in combination, a method wherein a processor is configured to predict a future state of patient using a model and an identified current state of the patient, the model being selected based on the claimed indications, in combination with the other claimed steps.
Regarding claim 19, none of the prior art discloses or suggests, either alone or in combination, a system comprising at least one processor, wherein the at least one processor is configured to predict a future state of patient using a drug-specific model and an identified current state of the patient, the drug-specific model being selected based on identified signatures, in combination with the other claimed elements.
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.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
