DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on October 2, 2025 were received and fully considered. Claims 1-5 and 22-26 were amended. Claims 28 and 29 are new. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5 and 21-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a system for an EEG-based anesthetic monitoring device for age-compensated monitoring of a patient experiencing an administration of at least one drug having anesthetic properties. Thus, the claim is directed to a product, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“process, in real time... the EEG data from the plurality of EEG sensors to determine signal markers; determine... a patient age by comparing signal markers from the EEG data with signal markers or signatures associated with reference EEG data, and generate, in real time... a report including at least the EEG data adjusted for the patient age based on at least one of the signal markers, wherein the EEG data is adjusted for at least one of an amplifier gain and a scale, and a regimen for anesthetic care, post-anesthesia care, or intensive care based on the EEG data adjusted for the patient age.”
These limitations describe a mental process as the skilled artisan is capable of analyzing EEG data and making a mental assessment thereafter. Furthermore, nothing from the claims and/or accompanying specification suggest that the identified judicial exception cannot be practically performed mentally, or using simple pen/paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“...a plurality of EEG sensors configured to acquire EEG data from the patient while receiving the at least one drug having anesthetic properties; at least one processor configured to: acquire EEG data from the plurality of EEG sensors...”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., mere data gathering steps necessary to perform the mental process.
Furthermore, the additional limitations do not add significantly more to the judicial exception as they pertain to widely known techniques in prior patient monitoring systems. For instance, the limitation “a plurality of EEG sensors” amounts to a conventional and widely known means for obtaining EEG data.
Independent claims 28 and 29 are also not patent eligible for substantially similar reasons.
Dependent claims 2-5 and 21-27 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea and/or recite additional limitations that do not integrate the identified judicial exception into a practical application for substantially similar reasons set forth above.
Therefore, claims 1-5 and 21-29 are not patent eligible under 35 USC 101.
Response to Arguments
Applicant's arguments filed with respect to the 35 USC 101 rejections raised in the previous office action have been fully considered, but they are not persuasive. Applicant appears to raise the following main arguments:
The claimed invention pertains to an improvement over prior anesthetic monitoring devices by providing EEG data adjusted for patient age, resulting in improved accuracy and efficiency (remarks, pgs. 7-8);
The alleged judicial exception is implemented with a particular machine (EEG-based anesthetic monitoring device) and, thus, is integrated into a practical application (remarks, pg. 9); and
The claims recite significantly more and thus, the claims are patent eligible (remarks, pgs. 9-10).
Examiner respectfully disagrees.
Examiner argues that the purported improvement (alleged improved accuracy and efficiency) lies within the identified abstract idea itself1. Moreover, there is no improvement to the processor, as the processor is merely being utilized as a tool. Furthermore, applicant’s “particular machine” argument is also not persuasive as “EEG-based anesthetic monitoring device… plurality of EEG sensors, and at least one processor” are recited at a high level of generality. See also MPEP 2106.05(b), which sets forth examples of what constitutes a particular machine2. As the additional limitations are recited at a high level of generality and/or are conventional, they accordingly fail to integrate the claims into a practical application; and do not recite significantly more.
For at least these reasons, the 35 USC 101 rejections are maintained. Please see corresponding rejection heading above for more detail.
Conclusion
No claim is allowed.
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 PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 MPEP 2106.05a: It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.
2 MPEP 2106.05(b) Particular Machine… The claim recited the particular type of antenna and included details as to the shape of the antenna and the conductors, particularly the length and angle at which they were arranged… a Fourdrinier machine (which was understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a series of rolls) arranged in a particular way to optimize the speed of the machine while maintaining quality of the formed paper web