DETAILED ACTION
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
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 19 and 29 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. The originally filed specification fails to provide support for a multi-channel feature extraction module comprising more than one random forest model. Figures 8 and 9 both show multi-channel feature extraction modules that comprise one boosted random forest model (elements 836 and 904, respectively).
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, 7, 9-15, 17, 19-27, 29, 30, and 34-37 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 series of steps or acts, including obtaining data, dividing the data into segments, extracting features from the segmented data, and determining whether a subject is experiencing delirium based on a combined output. Thus, the claim is directed to a process, 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 step of determining whether a subject is experiencing delirium based on a combination of extracted single channel features and extracted multichannel features sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. The determination of whether the subject is experiencing delirium does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the determination, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of obtaining EEG signals, dividing the EEG signals into segments, and extracting single channel features and multichannel features from the EEG signal segments. The obtaining, dividing, and extracting steps are each recited at a high level of generality such that they amount to insignificant presolution activity, e.g., mere data gathering steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes them from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 25, the device recited in the claim is a generic device comprising generic components configured to perform the Abstract Idea. The claim recites modules of computer system configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps/functions pertaining to data gathering (e.g., length of time windows/epochs, location of EEG signal acquisition) or other steps/functions capable of being performed mentally and/or by hand (classifying segments, determining a delirium score, providing a trace of a delirium score over time, determining a trendline of the trace). The obtaining, dividing, and extracting steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Response to Arguments
Applicant’s amendments to the claims have overcome some of the rejections made in the Non-Final Rejection mailed out 11 August 2025.
While the previous rejections of the claims under 35 U.S.C. 112(a) and 35 U.S.C. 112(b) have been overcome, as discussed in paragraph 3 above, the amendments have warranted a new rejection under 35 U.S.C. 112(a).
Regarding the rejection of the claims under 35 U.S.C. 101, Applicant’s arguments are not persuasive. The incorporation of subject matter not taught by the prior art does not automatically overcome a rejection under 35 U.S.C. 101 (see MPEP section 2106.05 I.: “Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting "the Government’s invitation to substitute §§ 102, 103, and 112 inquiries for the better established inquiry under § 101 "). As made clear by the courts, the "‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter." Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9). See also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) ("a claim for a new abstract idea is still an abstract idea. The search for a § 101 inventive concept is thus distinct from demonstrating § 102 novelty."). In addition, the search for an inventive concept is different from an obviousness analysis under 35 U.S.C. 103. See, e.g., BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016) ("The inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art. . . . [A]n inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces."). Specifically, lack of novelty under 35 U.S.C. 102 or obviousness under 35 U.S.C. 103 of a claimed invention does not necessarily indicate that additional elements are well-understood, routine, conventional elements. Because they are separate and distinct requirements from eligibility, patentability of the claimed invention under 35 U.S.C. 102 and 103 with respect to the prior art is neither required for, nor a guarantee of, patent eligibility under 35 U.S.C. 101. The distinction between eligibility (under 35 U.S.C. 101 ) and patentability over the art (under 35 U.S.C. 102 and/or 103 ) is further discussed in MPEP § 2106.05(d)”). Furthermore, Applicant asserts that the novel and non-obvious subject matter provides “a meaningful limitation resulting in an improvement over known methods and systems for detecting delirium”, but fails to provide details or evidence of the improvement.
Applicant’s arguments regarding the rejections of the claims in view of the previously cited prior art are persuasive.
Examiner’s Note
Regarding claims 1 and 25, none of the prior art teaches or suggests, either alone or in combination, a method for detecting delirium, wherein an output of a single-channel feature extraction module is combined with an output of a multi-channel feature extraction feature module to determine whether a subject is experiencing delirium, in combination with the other claimed steps.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Shinozaki’446 (WO 2020/206446 – previously cited) in view of Jain et al.’788 (US Pub No. 2018/0317788 – previously cited), as discussed in the Non-Final rejection mailed out 11 August 2025, is the closest prior art of record. It discloses all elements of claim 1 with the exception of combining an output of a single-channel feature extraction module and an output of a multi-channel feature extraction module to determine whether a subject is experiencing delirium. Sameni et al.’727 (US Pub No. 2010/0137727 – previously cited) teaches that signal quality for a bioelectrical signal can be determined using either time-domain multichannel features or frequency-domain multichannel features (section [0037]). Kamousi et al.’809 (USPN 10,743,809 – previously cited) teaches performing classification of EEG signals using any of a k nearest neighbors model, a random forest model, and a support vector machines model (col. 12, line 61 – col. 13, line 42). Greenhut et al.’220 (US Pub No. 2007/0239220 – previously cited) teaches determining signal quality of a bioelectric signal by extracting multichannel features (section [0057]). Wang et al.’664 (US Pub No. 2016/0242664 – previously cited) teaches determining signal quality of a bioelectric signal by extracting multichannel features (section [0016]). Naber et al.’299 (US Pub No. 2021/0030299 – previously cited) teaches removing noise from an EEG data segment based on a multichannel feature (section [0087]). Fickling et al. (Good data?... – previously cited) teaches different quality metrics for EEG segments. Faul et al.’401 (US Pub No. 2012/0101401 – previously cited) teaches classifying each of a plurality of EEG segments as condition positive or condition negative (sections [0169-0183]). Etemadi et al.’695 (US Pub No. 2023/0363695 – previously cited) teaches providing a physiological classification as one of positive, negative, or uncertain (section [0072]). Remmers et al.’692 (US Pub No. 2017/0181692 – previously cited) teaches providing a physiological classification as one of positive, negative, or uncertain (section [0009]), and further teaches that adding an “uncertain” category as a classification category increases the prediction accuracy of a classifier. Wall et al.’509 (US Pub No. 2021/0133509 – previously cited) teaches providing a physiological classification as one of positive, negative, or uncertain (section [0181]). Abbas et al.’030 (US Pub No. 2022/0344030 – previously cited) teaches providing a physiological classification as one of positive, negative, uncertain, or at risk for/having another disorder (section [0050]). Groth et al.’889 (USPN 6,443,889 – previously cited) teaches providing a physiological classification as one of positive, negative, or uncertain (description of Figure 1b). Bosl et al.’436 (US Pub No. 2015/0216436 – previously cited) teaches performing classification of EEG signals using any of a k nearest neighbors model, a random forest model, and a support vector machines model (section [0107]). Abrahami et al.’045 (US Pub No. 2017/0039045 – previously cited) teaches that it is well known in the art to attach EEG electrodes to a subject by using EEG electrodes incorporated into a headband (section [0035]). Greenwald et al.’821 (US Pub No. 2003/0181821 – previously cited) teaches that EEG signal classification for the purpose of diagnosing delirium may be performed using both extracted time-domain features and extracted frequency-domain features (ABSTRACT and section [0001]). Hunter et al. (Delirium screening… – previously cited) discloses detecting delirium using QEEG analysis. Mulkey et al. (Rapid Hand-held Continuous… – previously cited) teaches detecting delirium by analyzing and classifying EEG signals. van der Kooi et al. (Delirium Detection Using EEG… – previously cited) teaches analyzing delirium by analyzing EEG signals. Mulkey et al. (Methods of Identifying Neurological Delirium Study… – previously cited) teaches detecting delirium by analyzing and classifying EEG signals. Sun et al. (Automated tracking of level of consciousness… – previously cited) teaches classifying EEG signals to detect delirium, but makes note that no features are extracted from the EEG signals to perform the classification. Hasnain et al.’138 (WO 2021/195138 – previously cited) discloses determining a delirium score, level, or probability for a patient.
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 ETSUB D BERHANU whose telephone number is (571)270-5410. The examiner can normally be reached Mon-Fri 9:00am-5:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791