ADETAILED 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 .
Response to Amendment
The amendment filed 19 May 2026 has been entered. Claim(s) 1-10 and 12-20 remain pending in the application. Applicant’s amendments to the drawings and claims have overcome each and every objection to the drawings and claims, and each and every rejection under 35 U.S.C. 112(b) and 35 U.S.C. 102/103 previously set forth in the Office Action mailed 19 February 2026. The objection to claim 11 has been withdrawn in light of the claim’s cancellation.
Claim Objections
Claim 1 objected to because of the following informalities:
Claim 1 recites the limitation “the feature data” in line in line 17 of the claim. The limitation should be amended to “the at least one feature data” in accordance with earlier limitations.
Claim 14 recites the limitation “the feature data” in line in line 20 of the claim. The limitation should be amended to “the at least one feature data” in accordance with earlier limitations.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: communication unit in claims 14 and 15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Accordingly, “communication unit” is interpreted according to paragraph 0125 and 0135 of the instant specification “The communication unit 120 is connected to the user mobile device 200, the medical staff device 300, and the brain wave measuring device 400 using wired/wireless communication to transmit and receive various data”.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Utilizing the two step process adopted by the Supreme Court (Alice Corp vs CLS Bank Int'l, US
Supreme Court, 110 USPQ2d 1976 (2014) and the recent 101 guideline Federal Register Vol. 84, No., Jan
2019)), determination of the subject matter eligibility under the 35 U.S.C. 101 is as follows: Specifically, the Step 1 requires claim belongs to one of the four statutory categories (process, machine, manufacture, or composition of matter). If Step 1 is satisfied, then in the first part of Step 2A (Prong One), identification of any judicial recognized exceptions in the claim is made. If any limitation in the claim is identified as judicial recognized exception, then in the second part of Step 2A (Prong Two), determination is made whether the identified judicial exception is being integrated into practical application. If the identified judicial exception is not integrated into a practical application, then in Step 2B, the claim is further evaluated to see if the additional elements, individually and in combination provide "inventive concept" that would amount to significantly more than the judicial exception. If the element and combination of elements do not amount to significantly more than the judicial recognized exception itself, then the claim is ineligible under the 35 U.S.C. 101.
Claims 1-10 and 12-20 are rejected under 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. The claim recite(s) "determining whether the subject has the major depressive disorder on the basis of the at least one feature data, by using a classification model trained to output whether the subject has the major depressive disorder on the basis of the at least one feature data as an input, wherein the subject is a subject suspected of suffering from the major depressive disorder without having a history of drug use" and “wherein the determining of whether the subject has a major depressive disorder further includes determining whether the subject has a major depressive disorder using the classification model, based on the feature data for each of the brain wave data and the brain activity data”. This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 1 satisfies Step 1, namely the claim is directed to one of the four statutory classes, method. Following Step 2A Prong one, any judicial exceptions are identified in the claims. In claim 1, the limitations "determining whether the subject has the major depressive disorder on the basis of the at least one feature data, by using a classification model trained to output whether the subject has the major depressive disorder on the basis of the at least one feature data as an input, wherein the subject is a subject suspected of suffering from the major depressive disorder without having a history of drug use" and “wherein the determining of whether the subject has a major depressive disorder further includes determining whether the subject has a major depressive disorder using the classification model, based on the feature data for each of the brain wave data and the brain activity data” are abstract ideas as they are directed to a mental process or mathematical concept. With the identification of an abstract idea, the next phase is to proceed Step 2A, Prong Two, wherewith additional elements and taken as a whole, evaluation occurs of whether the identified abstract idea is integrated into a practical application.
In Step 2A, Prong Two, the claim does not recite any additional elements or evidence that amounts to significantly more than the judicial exception. Besides the abstract idea, the claim recites the additional elements “being implemented by a processor, comprising: receiving brain wave data of a subject measured from a plurality of electrode channels; extracting at least one feature data of power spectrum densities (PSDs), a functional connectivity, and a network index with respect to the brain wave data based on a plurality of frequency bands selected from low-alpha, high-alpha, low-beta, high-beta, gamma, delta, and theta of the brain wave data measured from the plurality of electrode channels”. However, these components may be seen as the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application. The measurement step leads to the final limitation of “determining” such that the end result of use of the system is only the generic determination which may be any generic output, or no output at all. As this determination is not defined as requiring any further action, such as a form of prophylaxis or treatment or an improvement to a computer or other technology, the claim limitations constitute mere generation of data, in this case the measurement of brain wave data and extraction of feature data from the brain wave data, such that the claim does not integrate the judicial exception into any practical application. Regarding “being implemented by a processor”, the limitation amounts to nothing more than an instruction to apply the abstract idea using a generic computer, which does not render an abstract idea eligible. The steps performed by the processor are, as claimed, capable of being performed in the human mind similar to the examples given in MPEP 2106.04(a)(2)(III)(A)-(C), wherein it is described that “a claim to ‘collecting information, analyzing it, and displaying certain results of the collection and analysis’ where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind” recites a mental process and that claims which merely use a computer as a tool to perform a mental process are not eligible when “there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper” such as “mental processes of parsing and comparing data” when the steps are recited at a high level of generality and a computer is used merely as a tool to perform the processes. Under the broadest reasonable interpretation, the claim elements are recited with a high level of generality (as written, each claimed step of the process may be performed by a person in an undefined manner) that there are no meaningful limitations to the abstract idea. Consequently, with the identified abstract idea not being integrated into a practical application, the next step is Step 2B, evaluating whether the additional elements provide "inventive concept" that would amount to significantly more than the abstract idea.
In Step 2B, claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The limitation of “being implemented by a processor, comprising: receiving brain wave data of a subject; extracting at least one feature data of power spectrum densities (PSDs), a functional connectivity, and a network index with respect to the brain wave data” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic processor which Sun (“Graph Theory Analysis of Functional Connectivity…”) describes as well-understood, routine, or conventional as it describes processing being performed using a commercially available tool (Matlab R2017a) which is utilized in conjunction with a generic computer (Page 431, section II part B--Data
processing tool was Matlab R2017a). It is additionally noted that “receiving brain wave data” implies the data is received from some brain wave sensor, such as an EEG including a plurality of electrodes. Per Sun, the use of EEG signals to determine major depressive disorder is well-understood, routine, or conventional in the art (see Table I—previous studies reporting abnormalities of resting state EEG functional brain networks in MDD, which describes six previous studies utilizing EEG signals including a plurality of channels for this purpose and Page 431, section II, part B—128 channel HydroCel Geodesic Sensor Net with a Cz reference, which were positioned according to the standard international 10/20 system). As discussed above with respect to integration of the abstract idea into a practical application, the present elements amount to no more than mere indications to apply the exception.
In Summary, claim 1 recites abstract idea without being integrated into a practical application, and does not provide additional elements that would amount to significantly more. As such, taken as a whole, the claim and is ineligible under the 35 U.S.C. 101.
Claims 2-10 and 12-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. As each of these claims depends from claim 1, which was rejected under 35 U.S.C. 101 in paragraph 9 of this action, these claims must be evaluated on whether they sufficiently add to the practical application of claim 1, or comprise significantly more than the limitations of claim 1.
Besides the abstract idea of claim 1: claims 2-10 and 12-13 recites the limitation recite further limitations of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application. The claim element of claim 1 of a method for providing information on a major depressive disorder is recited with a high level of generality (as written, the actions of the processor may be carried out by a person alone or with a generic computer in any undefined manner). This limitation provides no practical application, nor does it provide meaningful limitations to the abstract idea.
Claim 14 is rejected for similar reasons to claim 1 as described in paragraph 9 of this action above. In addition to a processor as described in the rejection of claim 1, in Step 2B, claim 14 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The limitation of “a communication unit configured to receive brain wave data of a subject” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic transmitter which Sun (“Graph Theory Analysis of Functional Connectivity…”) implicitly discloses as well-understood, routine, or conventional in its description of previous studies of analyzing EEG data to identify MDD in patients such that the collection of said EEG data to a computer to be analyzed is known in the art (see Table I—previous studies reporting abnormalities of resting state EEG functional brain networks in MDD, which describes six previous studies utilizing EEG signals including a plurality of channels for this purpose) and additionally in its description of using commercially available sensors and processing tools to analyze the sensor data (Page 431, section II part B—128 channel HydroCel Geodesic Sensor Net with a Cz reference, which were positioned according to the standard international 10/20 system…Data processing tool was Matlab R2017a). As discussed above with respect to integration of the abstract idea into a practical application, the present elements amount to no more than mere indications to apply the exception.
Claims 15-20 are additionally rejected under 35 U.S.C. 101 for similar reasons to claims 2-10 and 12-13.
Response to Arguments
Applicant’s arguments, see pages 6-7 of the applicant's remarks, filed 19 May 2026, with respect to the rejection of the claims under 35 U.S.C. 102/103 have been fully considered and are persuasive. The rejection of claims under 35 U.S.C. 102/103 has been withdrawn.
As a result, claims 1-10 and 12-20 are not currently rejected under 35 U.S.C. 102/103.
Regarding claims 1 and 14, the most pertinent prior art of the record, Shim (”Altered cortical functional network…”—previously cited), fails to disclose and/or fairly suggest extracting the at least one feature data for each of the brain wave data and the brain activity data. Each of Shim, Sun (“Graph Theory Analysis of Functional Connectivity…”—previously cited), and Mumtaz (“Electroencephalogram (EEG)-based computer-aided technique…”—previously cited) discloses some means of generating brain activity data based on the brain wave data by processing EEG data to remove noises and artifacts which may reflect non-brain activity (see Shim Page 1001, section 2.3 EEG recordings and pre-processing; Sun Page 431, Section II, part B; Mumtaz Page 110, section 2.3 Noise removal from the EEG data). However, each of these references teaches away from extracting features for each of the brain wave data and the brain activity data as the generation of brain activity data was performed to remove sources of inaccuracy that were present in the brain wave data and thus the unprocessed data was not utilized for the extraction of feature data. Claim 12 depends from claim 11 and thus is untaught.
Applicant's arguments filed 19 May 2026 regarding the rejection of the claims under 35 U.S.C. 101 have been fully considered but they are not persuasive.
The applicant argues that extracting data across specific, high-dimensional frequency bands is “physically and practically impossible for a human mind” and that the claims do not fall within an enumerated category of abstract ideas.
However, the relevant limitations are considered extra-solution activity as the limiting of frequency bands serves merely as the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application. The identified abstract idea of "determining whether the subject has the major depressive disorder on the basis of the at least one feature data, by using a classification model trained to output whether the subject has the major depressive disorder on the basis of the at least one feature data as an input, wherein the subject is a subject suspected of suffering from the major depressive disorder without having a history of drug use" and “wherein the determining of whether the subject has a major depressive disorder further includes determining whether the subject has a major depressive disorder using the classification model, based on the feature data for each of the brain wave data and the brain activity data” is practically possible for the human mind to perform using the gathered data, as simple classification models exist which can be used mentally or with the aid of pen and paper.
The applicant additionally argues that the claims are integrated into a practical application, citing Example 48 of the July 2024 AI Guidance Update to suggest that the claim limitations are directed to an improvement to another technology or technical field based upon the claimed classification model being constrained by specific frequency-band filtering.
However, as noted previously in the office action dated 19 February 2026, the extraction of data from particular frequency bands of interest is well-understood, routine, or conventional using a band-pass function to isolate standard frequency bands as described by Sun, Shim, and Lee (“Neurophysiological correlates…”—previously cited) and the current claim language appears to allow for the selection of a plurality of frequency bands from the group consisting of low-alpha, high-alpha, low-beta, high-beta, gamma, delta, and theta, such that the “plurality of frequency bands” does not need to include all of the claimed frequency bands, but merely some selection of more than one frequency band from the identified group of frequency bands. Additionally, while the applicant refers to Example 48 in support, the independent claims differ from claim 3 of Example 48 which was described as being eligible as being directed to an improvement because the example claim recites details of how a DNN trained on source separation aids in aids in the cluster assignments to correspond to the sources identified in the mixed speech signal, which are then converted into separate speech signals in the time domain to generate a sequence of words from the spectral features, thereby making individual transcription of each separated speech signal possible, as the current claim language does not limit how the feature data is extracted, how the classification model is trained or used, or how the brain activity data is generated, nor does it limit to a particular selection of frequency bands such that the current claim language does not appear to reflect the argued technological improvement.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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/ANNA ROBERTS/ Examiner, Art Unit 3791
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