DETAILED ACTION
Applicant' s arguments, filed 04/29/2026 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 01/26/2024, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-6 and 8-9 are the current claims hereby under examination.
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 .
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 and 8-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “adjusting a dose of anesthetic administered to the patient based on the first parameter” but the claimed method is a “computer-implemented” method and it is thus unclear what element or component of the computer or if some device attached thereto carries out this step. It is unclear how a computer alone could serve to adjust the dose of the anesthetic administered to the patient. For the purposes of this examination, the limitation is interpreted as the computer actuating or controlling another device to perform the adjustment.
Claims 2-6 and 8-9 are rejected by virtue of their dependence on claim 1.
Claim 6 recites the limitation "the total number of coefficients of the artifact projection" in lines 12-13. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the absolute value of a n-th coefficient of the artifact projection at level m" in lines 13-14. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 112(a)
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 1 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.
Claim 1 recites “adjusting a dose of anesthetic administered to the patient based on the first parameter” however the specification does not describe such a process. Paragraphs 0010, 0012, 0022, and 0024 are the only paragraphs that reference the dose of the anesthetic and none of these paragraphs describe how the first parameter may be used to adjust such a dose. Additionally, the claimed method is a “computer-implemented method” and the specification does not describe any component of a computer or any device which may be attached thereto which carries out the claimed adjustment. It would appear from Applicant’s specification that the adjustment is intended to be carried out by an anesthesiologist after the first parameter is displayed to them. Thus it would seem that the adjustment of the dose based on the first parameter is not part of the “computer-implemented” method. Additionally, paragraphs 0051, 0115, and 0130 recite that a minimum quantity of anesthetic to maintain the subject’s sedation may be calculated from the first parameter but no method of calculation is provided.
Prior Art
The closest prior art of record is considered to be:
Cartailler “Alpha rhythm collapse predicts iso-electric suppressions during anesthesia” published by Communications Biology, 09/02/2019, pages 1-11 hereinafter Cartailler. Cartailler teaches a that EEG traces may be used to predict anesthetic over-doses during general anesthesia (Abstract). Cartailler teaches a system and method for receiving EEG signals and detecting alpha suppressions therein (Page 2: Results first paragraph). The method involved using a sliding time window on the received EEG signal to calculate parameters related to alpha band suppressions in the EEG signal (Page 2 Results paragraph 3). The power spectrum of the sliding window is calculated (Fig. 1b: the power spectrum; Page 6: Discussion paragraph 6). Cartailler further teaches the calculation of time metrics related to alpha suppressions such as the time at which the first alpha suppression occurs after loss of consciousness (Page 2: Results paragraphs 2-3). The time at which the first alpha suppression occurs is noted by Cartailler (Page 3 Fig. 1f: the distribution of first occurrence times of alpha suppression).
US Patent Application Publication Number US 2016/0331307 A1 hereinafter Purdon teaches a system and method for monitoring and/or controlling a state of consciousness of a subject experiencing anesthesia are provided. In some aspects, the system includes a plurality of sensors placed about the subject and configured to acquire electroencephalogram (“EEG”} data therefrom while the subject is receiving anesthesia, and at least one processor configured to receive the EEG data from the plurality of sensors, and perform a phase-amplitude coupling analysis using the received EEG data to determine a phase-amplitude frequency distribution. The at least one processor is also configured to identify a state of consciousness of the subject using the determined phase-amplitude frequency distribution, and generate a report indicative of the state of consciousness of the subject (Abstract). Purdon teaches that beta power increases before loss of consciousness (LOC) and that LOC is followed by a sustained increase in low frequency activity (LFA) and a frontally organized alpha rhythm throughout unconsciousness. At LOC the alpha amplitude was largest. LOC coincides with a major increase in low-frequency EEG power (Paragraphs 0065-0066; Fig. 5c).
US Patent Application Publication Number US 2014/0187973 A1 hereinafter Brown teaches a method and system for determining the state of a patient’s brain under anesthesia. The present invention recognizes that anesthesia compounds induce different signatures in physiological characteristics of the patient under anesthesia and aids interpretation of physiological characteristics and signatures therein based on a selected anesthesia compound. The present invention aids the monitoring and/or interpreting of the physiological characteristics to a state of the patient's brain (Abstract). Brown teaches the analysis of EEG signals based on the anesthetic compound introduced to the patient (Paragraph 0007). Brown indicates that phase-amplitude information of the EEG signals can serve as reliable predictors for current and probable future patient states. The peak-max modulation of the signal can be used as a target for maintenance of surgical levels of anesthesia while avoiding burst-suppression (Paragraph 0056)
None of Cartailler, Purdon, and/or Brown either alone or in combination teach the method including “determining a reference time instant, tref, by curve fitting fmax(t) using a curve fitting function, tref being the time instant when the curve fitting function reaches an intermediate value such that the difference between the intermediate value and a minimum value of the curve fitting function is equal to 5% of a range of values of the curve fitting function, so that the maximum power frequency as a function of time fmax(t) takes higher values before the reference time instant than after; and adjusting a dose of anesthetic administered to the patient based on the first parameter” in combination with the other claimed method steps.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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