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 .
Response to Amendment
Claims 1, 3, and 5-16 are currently pending. Claims 1, 3, and 5-7 have been amended. Claims 2 and 4 have been cancelled. Claims 8-16 has been added. Claim 3 has been amended to overcome the 35 U.S.C. 112(b) rejections set forth in the Non-Final Office Action mailed on 24 October 2025. The cancellation of claim 4 have rendered the 35 U.S.C. 112(b) rejections moot.
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, 3, and 5-16 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.
STEP 1
Regarding claim 1, the claim recites a series of structural elements, including an electroencephalography signal detector. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of determining a depressive symptom in the subject on a basis of a correlation between the frequency components of the electroencephalography signal of the determination target subject detected by the electroencephalography signal detector and each of the plurality of reference data 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.
STEP 2A, PRONG TWO
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. Claim 1 recites determining a depressive symptom in the subject on a basis of a correlation between the frequency components of the electroencephalography signal of the determination target subject detected by the electroencephalography signal detector and each of the plurality of reference data, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The determining of the depressive symptom 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 determined depressive symptom, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
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 detecting one or a plurality of frequency components of an electroencephalography signal in a certain brain area of a subject and a generator for generating a plurality of reference data corresponding to a plurality of subjects, the reference data being data in which frequency components of an electroencephalography signal of a subject are associated with an evaluation regarding a depressive symptom of the subject. Obtaining data (one or a plurality of frequency components) and generating a plurality of reference data are well-understood, routine and conventional activities for those in the field of medical diagnostics. The electroencephalography signal detector, generator, and depressive symptom determinator are also well-understood, routine, and conventional components configured to perform the Abstract Idea (see 35 U.S.C. 103 rejection below). Further, the detecting step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step 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 it from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
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.
The same rationale applies to claim 7.
Regarding claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited electroencephalography signal detector and the generator are generic sensors configured to perform pre-solutional data gathering activity and the depressive symptom determinator is 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. Claims 3, 5, 6, 8, 10, and 11 recite steps that add to the Abstract Idea as the claims generally recite mental processing steps. Claims 9 and 12-16 recite additional elements that are not significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 7, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Jin ‘030 (US Pub No. 2017/0281030 – previously cited) in view of Grin-Yatsenko et al. (“EEG Power Spectra at Early Stages of Depressive Disorders” – 2009).
Regarding claim 1, Jin ‘030 teaches a symptom determination apparatus (Title, Abstract) comprising:
an electroencephalography signal detector for detecting one or a plurality of frequency components of an electroencephalography signal in a certain brain area of a subject (Fig. 4 step 401 and [0082]); and
a depressive symptom determinator for determining a depressive symptom in a determination target subject on a basis of a correlation between the frequency components of the electroencephalography signal of the determination target subject detected by the electroencephalography signal detector and each of the plurality of reference data (Fig. 4 steps 403-407 and [0082]).
Jin ‘030 teaches all of the elements of the current invention as mentioned above except for a generator for generating a plurality of reference data corresponding to a plurality of subjects, the reference data being data in which frequency components of an electroencephalography signal of a subject are associated with an evaluation regarding a depressive symptom of the subject.
Grin-Yatsenko et al. teaches that EEG parameters, or power spectra, obtained in the early stages of depression is compared with age-matched healthy controls (Abstract, pg. 1, 2nd column 5th paragraph). It was found that the main differences were associated with increased theta, alpha, and beta EEG power in depressed patients compared with norms at parietal and occipital sites, both in eyes closed and open conditions (pg. 5, 2nd column, 1st paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the symptom determination apparatus of Jin ‘030 to include a generator for generating a plurality of reference data corresponding to a plurality of subjects, the reference data being data in which frequency components of an electroencephalography signal of a subject are associated with an evaluation regarding a depressive symptom of the subject as Grin-Yatsenko et al. teaches that this will aid in determining if a patient has depression based on the theta, alpha, and beta EEG power.
Regarding claim 3, as best understood by the Examiner, Jin ‘030 teaches wherein the electroencephalography signal detector detects the plurality of frequency components of the electroencephalography signal ([0020]; “EEG signals”), and
wherein the depressive symptom determinator determines the depressive symptom while giving priority, as a determination reference, to a correlation of a frequency component at a certain frequency, among the plurality of frequency components of the electroencephalography signal detected by the electroencephalography signal detector, over correlations of frequency components at other frequencies by weighting the frequency component at the certain frequency (Fig. 1 steps 403, 408 and [0082]).
Regarding claim 7, Jin ‘030, as modified by Grin-Yatsenko et al. teaches a non-transitory storage medium encoded with a computer-readable program that controls a processor of a computer to execute processes, as claim 7 is analogous to claim 1.
Regarding claim 13, Jin ‘030 teaches wherein the correlation between the frequency components of the electroencephalography signal of the determination target subject detected by the electroencephalography signal detector and each of the plurality of reference data is a comparison of the plurality of frequency components of the electroencephalography signal of the determination target subject detected by the electroencephalography signal detector and each of the plurality of reference data ([0085], [0087]).
Regarding claim 14, Jin ‘030 teaches wherein the comparison of the plurality of frequency components of the electroencephalography signal of the determination target subject detected by the electroencephalography signal detector and each of the plurality of reference data is relative to a threshold (Fig. 4 step 403 and [0082]).
Regarding claim 15, Jin ‘030 teaches wherein the correlation between the frequency components of the electroencephalography signal of the determination target subject detected by the electroencephalography signal detector and each of the plurality of reference data is a relationship of intensity indicated by power spectra (Fig. 4 “alpha power” and [0039], [0082]).
Regarding claim 16, Jin ‘030 teaches wherein the correlation between the frequency components of the electroencephalography signal of the determination target subject detected by the electroencephalography signal detector and each of the plurality of reference data is a relationship of intensity indicated by power spectra (Fig. 4 “alpha power” and [0039], [0082]).
Claims 5, 6, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Jin ‘030 in view of Greenwald et al. ‘821 (US Pub No. 2003/0181821 – previously cited).
Regarding claim 5, Jin ‘030 teaches all of the elements of the current invention as mentioned above except for wherein the evaluation regarding the depressive symptom of the subject, in the reference data, includes an evaluation as to whether the subject suffers from depression and an evaluation regarding a level of severity of the depressive symptom if the subject suffers from depression, and
wherein the depressive symptom determinator determines the level of severity of the depressive symptom in the determination target subject by using the reference data.
Greenwald et al. ‘821 teaches assessing the severity of depression based on the EEG bispectral density array ([0070]) that is calculated using frequency domain (Fourier transform) methods ([0021]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the evaluation regarding the depressive symptom of the subject of Jin ‘030 to include an evaluation as to whether the subject suffers from depression and an evaluation regarding a level of severity of the depressive symptom if the subject suffers from depression and the depressive symptom determinator of Jin ‘030 to include determining the level of severity of the depressive symptom in the determination target subject by using the reference data as Greenwald et al. ‘821 teaches that this will aid in indicating the progression of a disease or condition ([0010]).
Regarding claim 6, Jin ‘030 teaches all of the elements of the current invention as mentioned above except for wherein the depressive symptom determinator corrects, if the determination target subject takes a medicine, a determination reference for determining the depressive symptom in the determination target subject on a basis of an effect of the medicine taken by the determination target subject.
Greenwald et al. ‘921 teaches generating an index that predicts the efficacy of drug treatment or measures the state of a disease or condition. Such indices that assess the level of depression or use pre-treatment EEG data to predict the response of patients with depression to pharmacological treatment will now be described ([0067]-[0068]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the depressive symptom determinator of Jin ‘030 to include correcting, if the determination target subject takes a medicine, a determination reference for determining the depressive symptom in the determination target subject on a basis of an effect of the medicine taken by the determination target subject as Greenwald et al. ‘921 teaches that this will aid in predicting the efficacy of drug treatment.
Regarding claim 10, Jin ‘030 teaches wherein the evaluation regarding the depressive symptom of the subject, in the reference data, includes an evaluation as to whether the subject is a normal person not suffering from depression or suffers from depression and an evaluation regarding a level of severity of the depressive symptom if the subject suffers from depression ([0067]).
Jin ‘030 teaches all of the elements of the current invention as mentioned above except for wherein the depressive symptom determinator determines, if the subject suffers from depression, the level of severity of the depressive symptom in the determination target subject by using the reference data.
Greenwald et al. ‘921 teaches generating an index that predicts the efficacy of drug treatment or measures the state of a disease or condition. Such indices that assess the level of depression or use pre-treatment EEG data to predict the response of patients with depression to pharmacological treatment ([0067]-[0068]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the depressive symptom determinator of Jin ‘030 to include determining if the subject suffers from depression, the level of severity of the depressive symptom in the determination target subject by using the reference data as Greenwald et al. ’921 teaches that this will aid in predicting the response of patients with depression to pharmacological treatment.
Claims 8, 9, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Jin ‘030 in view of Greenwald et al. ‘821 further in view of Fedor et al. ‘143 (US Pub No. 2019/0117143).
Regarding claims 8 and 9, Jin ‘030 in view of Greenwald et al. ‘821 teaches all of the elements of the current invention as mentioned above except for wherein the evaluation regarding a level of severity of the depressive symptom if the subject suffers from depression comprises assigning the subject to one of four levels of severity of the depressive symptom (claim 8);
wherein the four levels of severity of the depressive symptom are mild, moderate, severe, and most severe (claim 9).
Greenwald et al. ‘821 teaches a change in theta power as a percent of the total power has been shown to distinguish between mild, moderate and severe dementia, as well as controls ([0005]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the evaluation regarding a level of severity of the depressive symptom if the subject suffers from depression of Jin ‘030 in view of Greenwald et al.’ 821 to include assigning the subject to one of three levels of severity of the depressive symptom as Greenwald et al. ‘821 teaches that this will aid in determining the severity of depression based on the change in theta power of the EEG power spectra ([0005]).
Jin ‘030 in view of Greenwald et al. ‘821 teaches all of the elements of the current invention as mentioned above except for wherein the four levels of severity of the depressive symptom are mild, moderate, severe, and most severe.
Fedor et al. ‘143 teaches that mild, moderate, severe, and very severe depression can be estimated or predicted ([0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the levels of severity of depressive symptoms of Jin ‘030 in view of Greenwald et al. ‘821 to include mild, moderate, severe, and most severe as Fedor et al. ‘143 teaches that four levels of depression can be predicted.
Regarding claims 11 and 12, Jin ‘030 in view of Greenwald et al. ‘821 teaches all of the elements of the current invention as mentioned above except for wherein the evaluation regarding a level of severity of the depressive symptom if the subject suffers from depression comprises assigning the subject to one of four levels of severity of the depressive symptom (claim 11);
wherein the four levels of severity of the depressive symptom are mild, moderate, severe, and most severe (claim 12).
Greenwald et al. ‘821 teaches a change in theta power as a percent of the total power has been shown to distinguish between mild, moderate and severe dementia, as well as controls ([0005]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the evaluation regarding a level of severity of the depressive symptom if the subject suffers from depression of Jin ‘030 in view of Greenwald et al.’ 821 to include assigning the subject to one of three levels of severity of the depressive symptom as Greenwald et al. ‘821 teaches that this will aid in determining the severity of depression based on the change in theta power of the EEG power spectra ([0005]).
Jin ‘030 in view of Greenwald et al. ‘821 teaches all of the elements of the current invention as mentioned above except for wherein the four levels of severity of the depressive symptom are mild, moderate, severe, and most severe.
Fedor et al. ‘143 teaches that mild, moderate, severe, and very severe depression can be estimated or predicted ([0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the levels of severity of depressive symptoms of Jin ‘030 in view of Greenwald et al. ‘821 to include mild, moderate, severe, and most severe as Fedor et al. ‘143 teaches that four levels of depression can be predicted.
Response to Arguments
Applicant argues that the amendments overcome the 35 U.S.C. 101 rejection. Examiner respectfully disagrees, as the generator is a generic computer component used to perform pre-solution activity. Furthermore, the claim recites steps directed to abstract ideas. The claim merely recites detecting frequency components, generating reference data, and determining a depressive symptom based on the correlation between the frequency components and reference data. There is no technological improvement mentioned in the claims and thus the claim is seen as merely reciting collecting data and analyzing it. Section 2106.05(h) of the MPEP recites that “limiting the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis to data related to the electric power grid, because limiting application of the abstract idea to power-grid monitoring is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016).” As such, the 35 U.S.C. 101 rejection has been maintained.
Applicant’s arguments with respect to the 35 U.S.C. 102(a)(1) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
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