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 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 1-14 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.
In particular, Claim 1 (and its respective dependents) fail to set forth structure for the mental disorder determination device besides the “processing circuitry.” Extracted data is mentioned, yet there is no structing for providing magnetic stimulation, nor is there structure provided to collect the data. Examiner notes that merely functions and intended uses of the processing circuitry are claimed, therefore it is unclear what structures are carrying out the claimed functions of the device claim set.
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 1-14, and 16-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 1-14, and 16-18 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1-14, and 16-18 recites at least one step or instruction for mathematical calculations, which is grouped as a mathematical concept under the 2019 PEG. The claimed limitation involves a generic computer carrying out mathematical calculations without demonstrating the computer into a practical application. Accordingly, each of Claims 1-14, and 16-18 recites an abstract idea.
Specifically, Claim 1 recites:
Processing circuitry to
extract a feature amount that represents a feature of a brain wave of a subject from the brain wave measured when a magnetic stimulation is applied to a brain of the subject (mathematical calculations, which is grouped as a mathematical concept under the 2019 PEG); and
determine whether or not the subject has a predetermined mental disorder based on a feature amount variation that is a differential value between a feature amount extracted from a brain wave measured immediately before the magnetic stimulation and a feature amount extracted from a brain wave measured immediately after the magnetic stimulation (mathematical calculations, which is grouped as a mathematical concept under the 2019 PEG).
Claim 17 provides parallel limitations.
Claim 16 recites:
A classifier, to:
receive a feature amount variation that is a differential value between a feature amount extracted from a brain wave measured immediately before a magnetic stimulation to a brain of a subject and a feature amount extracted from a brain wave measured immediately after the magnetic stimulation (mathematical calculations, which is grouped as a mathematical concept under the 2019 PEG); and
output a result of determining whether or not the subject has a predetermined mental disorder (mathematical calculations, which is grouped as a mathematical concept under the 2019 PEG).
Claim 18 recites:
A non-transitory computer-readable recording medium storing a program,
the program causing a computer to function as
a feature amount extractor that extracts a feature amount representing a feature of a brain wave of a subject from the brain wave measured when a magnetic stimulation is applied to a brain of the subject (mathematical calculations, which is grouped as a mathematical concept under the 2019 PEG), and
a mental disorder determiner that determines whether or not the subject has a predetermined mental disorder based on a feature amount variation that is a differential value between a feature amount extracted from a brain wave measured immediately before the magnetic stimulation and a feature amount extracted from a brain wave measured immediately after the magnetic stimulation (mathematical calculations, which is grouped as a mathematical concept under the 2019 PEG).
Examiner notes that claim limitations refer to brain wave data being measured after magnetic stimulation is applied to the brain. However, it is further noted that claims 1-14, and 16-18 are related to data processing of data without claiming any structural elements or corresponding steps to collect the brain wave data.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Further, dependent Claims 2-14 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 1 and 16-18 (and their respective dependents) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claim 1, 16, and 18), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. Examiner notes that claim 17 fails to positively claim additional elements. More specifically, the additional elements of: processing circuitry, classifier, non-transitory computer-readable recording medium, and program are generically recited computer elements in independent Claims 1, 16, and 18 (and their respective dependents) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 1 and 16-18 (and their respective dependents) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mathematical concepts) using rules (e.g., a program) executed by a computer (e.g., processing circuitry as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1 and 16-18 (and their respective dependents) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1, 16, and 18 (and their respective dependents) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1 and 16-18 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: processing circuitry, as recited in independent Claim 1, a classifier in Claim 16, and non-transitory computer-readable recording medium and program in Claim 18.
Per Applicant’s specification, the term “processing circuitry” is described as being responsible for carrying out the feature extraction and mental disorder determination [see in ¶ 0007] and acquiring brain data to transmit and display the result of mental disorder determination [see in ¶ 0021], and only further mentioned to detail its intended functions; the term “classifier” is described as a conceivable protected form [see in ¶ 0135] and is a classifier in which data is input and a result is output [see in ¶ 0136]; “non-transitory recording medium” is described to store a program and allows a computer to function as intended by the program [see in ¶ 0135]; “a program” is described to allow the controller to execute various processes [see in ¶ 0034] and is stored by a non-transitory recording medium to allow a computer to function as intended [see in ¶ 0135].
Accordingly, in light of Applicant’s specification, the claimed term “processing circuitry”, “classifier”, “non-transitory recording medium”, and “program” are reasonably construed as a generic computing device elements. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the processing circuitry. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1, 16, and 18 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the device and system of claims 1-14 and 16-18 are directed to applying an abstract idea (e.g., mathematical concept) on a general purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR). In other words, none of Claims 1-14 and 16-18 provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1, 16, and 18 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-14 and 16-18 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-14 and 16-18 amounts to significantly more than the abstract idea itself.
Accordingly, Claims 1-14 and 16-18 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5, 6, 8-14, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ide et al. (US 20190239794 A1 – Cited by Applicant), hereinafter Ide.
Regarding claim 1, and substantially similar limitations in claim 17, Ide discloses a mental disorder determination device, comprising:
processing circuitry to
extract a feature amount that represents a feature of a brain wave of a subject from the brain wave measured when a magnetic stimulation is applied to a brain of the subject [a program causes a computer to … detect electroencephalograms in a plurality of regions of the brain using a plurality of electrodes disposed on the brain to which the electromagnetic stimulus was applied, see in ¶ 0022], and
determine whether or not the subject has a predetermined mental disorder based on a feature amount variation that is a differential value between a feature amount extracted from a brain wave measured immediately before the magnetic stimulation and a feature amount extracted from a brain wave measured immediately after the magnetic stimulation [evaluate pathological conditions of neuropsychiatric disorders by evaluating a correlation between regions on the basis of reactions of a plurality of regions of a brain with respect to an electromagnetic stimulus applied to a prescribed region of the brain, see in ¶ 0023; the PLV for each subject was first calculated and the PLV at each time point for manipulation periods was compared with the averaged PLV for baseline periods (i.e., ITI), which means manipulation periods when magnetic stimulation is applied are compared to baseline values, see in ¶ 0063; see also in ¶ 0066].
Regarding claim 2, Ide discloses the mental disorder determination device according to claim 1, wherein the magnetic stimulation is consecutively applied to the brain of the subject, and the feature amount variation is a differential value between a feature amount extracted from a brain wave measured immediately before a second or later magnetic stimulation and a feature amount extracted from a brain wave measured immediately after the second or later magnetic stimulation [three evenly spaced TMS pulses delivered during each trial, see in ¶ 0055].
Regarding claim 3, Ide discloses the mental disorder determination device according to claim 1, wherein the brain waves are brain waves at a plurality of measurement spots of the subject, and the feature amount includes at least one of a frequency power value of at least one of α, β, γ, θ, and δ waves of each brain wave at the measurement spots, a phase synchronization value of at least one of α, β, γ, θ, and δ waves of each brain wave between the measurement spots, or a phase-amplitude coupling value in at least one combination of a plurality of combinations of a phase of an α, θ, or δ wave and an amplitude of a β or γ wave of a brain wave at a specific measurement spot [see in ¶ 0046 and ¶ 0066].
Regarding claim 5, Ide discloses the mental disorder determination device according to claim 1, wherein the mental disorder is major depressive disorder or treatment-resistant depression [see in ¶ 0042 – ¶ 0043].
Regarding claim 6, Ide discloses the mental disorder determination device according to claim 1, wherein the brain waves are brain waves at a plurality of measurement spots on a forehead of the subject, the brain waves being measured through a plurality of electrodes placed on the forehead of the subject [see in Fig. 2; Examiner notes that the cap and electrodes can be configured to measure EEGs at the forehead].
Regarding claim 8, Ide discloses the mental disorder determination device according to claim 1, wherein the processing circuitry determines whether or not the subject has the mental disorder based on the feature amount variation and on a feature amount extracted from a brain wave measured in quiet wakefulness [Examiner notes that EEG measurements are used in Ide’s device (see in ¶ 0058) and program and those of ordinary skill in the art would know that an environment of quiet wakefulness is ideal to minimize noise interference].
Regarding claim 14, and substantially similar limitations in claims 9-13, Ide discloses the mental disorder determination device according to claim 1, wherein the processing circuitry determines whether or not the subject has the mental disorder based on the feature amount variation, on a feature amount extracted from a brain wave measured in quiet wakefulness, on a feature amount extracted from a brain wave measured immediately before the magnetic stimulation, and on a feature amount extracted from a brain wave measured immediately after the magnetic stimulation [evaluate pathological conditions of neuropsychiatric disorders by evaluating a correlation between regions on the basis of reactions of a plurality of regions of a brain with respect to an electromagnetic stimulus applied to a prescribed region of the brain, see in ¶ 0023; the PLV for each subject was first calculated and the PLV at each time point for manipulation periods was compared with the averaged PLV for baseline periods (i.e., ITI), which means manipulation periods when magnetic stimulation is applied are compared to baseline values, see in ¶ 0063; see also in ¶ 0066;Examiner notes that EEG measurements are used in Ide’s device (see in ¶ 0058) and program and those of ordinary skill in the art would know that an environment of quiet wakefulness is ideal to minimize noise interference].
Regarding claim 16, Ide discloses a classifier, to: receive a feature amount variation that is a differential value between a feature amount extracted from a brain wave measured immediately before a magnetic stimulation to a brain of a subject and a feature amount extracted from a brain wave measured immediately after the magnetic stimulation; and output a result of determining whether or not the subject has a predetermined mental disorder [see in ¶ 0038].
Regarding claim 18, Ide discloses a non-transitory computer-readable recording medium storing a program,
the program causing a computer to function as a feature amount extractor that extracts a feature amount representing a feature of a brain wave of a subject from the brain wave measured when a magnetic stimulation is applied to a brain of the subject, and a mental disorder determiner that determines whether or not the subject has a predetermined mental disorder based on a feature amount variation that is a differential value between a feature amount extracted from a brain wave measured immediately before the magnetic stimulation and a feature amount extracted from a brain wave measured immediately after the magnetic stimulation [Examiner notes that the non-transitory computer-readable recording medium is storing information, therefore the program needs to be resident on the non-transitory computer-readable recording medium. As such, the processing component (CPU) of Ide (disclosed in ¶ 0022 and ¶ 0041) is able to store and execute a program/software and anticipate the claim details of claim 18 as written].
Claim 15 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (US 20220151540 A1), hereinafter Kim.
Regarding claim 15, Kim discloses a terminal device, comprising:
processing circuitry to acquire brain wave data indicating a brain wave of a subject, the brain wave being measured when a magnetic stimulation is applied to the brain of the subject, transmit the acquired brain wave data to a server, and cause a display to display a result of determining whether or not the subject has a predetermined mental disorder, the result being determined, by the server, based on a feature amount variation that is a differential value between a feature amount extracted from a brain wave measured immediately before the magnetic stimulation and a feature amount extracted from a brain wave measured immediately after the magnetic stimulation [see in Figs. 6 and 7, ¶ 0162, ¶ 0163, and ¶ 0165; Examiner notes that weight is given to the functions actually being performed by the processor, which are to acquire, transmit, and display, rather than what the remote server may do with the data before sending back a report/result. As such, Examiner considers Kim to anticipate the claim details as written].
Claim Rejections - 35 USC § 103
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ide (US 20190239794 A1 – Cited by Applicant) in view of Kim (US 20220151540 A1).
Regarding claim 7, Ide discloses the mental disorder determination device according to claim 1, wherein the processing circuitry determines whether or not the subject has the mental disorder and feature amount variation is input to the device to output a result of determining whether or not the subject has the mental disorder [see above in claim 1].
Ide fails to disclose that a learned model is used to determine the presence or lack of presence of mental disorder in a subject.
However, Kim discloses an artificial intelligence system to provide a diagnostic result of mental diseases using brain wave features [see in ¶ 0002, ¶ 0011, and ¶ 0163].
Ide and Kim are both analogous to the claimed invention because they are in the same field of using magnetic stimulation in diagnosing mental illness. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Ide to incorporate the teachings of Kim to include the use of a learning model in determining the diagnostic result of a mental illness in a subject, as a more accurate means to detect mental illness related biomarkers in brainwave data.
Conclusion
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/HY KHANH DOAN/Examiner, Art Unit 3791