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 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:
First measurement unit in claims 1 see [0020] (using PG Pub for paragraph numbers) “an electroencephalography (EEG) or a magnetoencephalography (MEG)”
Second measurement unit in claims 1 see [0023] “an electro dermal activity (EDA) sensor”, [0024] “a pulse wave sensor that detects pulse wave information”, [0025] “a camera that detects pupil reflection”
First analysis unit in claims 1 see [0028] “The control unit 14 includes a first analysis unit 21, a second analysis unit 22, a determination unit 23, and a processing unit 24. . . . For example, the control unit 14 reads and executes a program (software) from the storage unit 13 to implement the first analysis unit 21, the second analysis unit 22, the determination unit 23, and the processing unit 24, and executes these processes. Note that the control unit 14 may execute these processes by one CPU, or may include a plurality of CPUs and execute the processes by the plurality of CPUs.”
Second analysis unit in claims 1 see [0028]
Processing unit in claim 1 see [0028]
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.
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 § 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 1-11 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.
Claims 1, 10 and 11 both recite “estimate a second range” however the specification only provides support for a set predetermined relationship/look up table see [0031] “estimating the source of the intracerebral signal by the second analysis unit 22 will be described with reference to FIG. 2 .” which in view of MPEP 2163(II)(A)(3)(a)(ii) does not provide sufficient disclosure as it is does not represent a representative number species to satisfy a sufficient description. The MPEP definition of a “[a] "representative number of species" means that the species which are adequately described are representative of the entire genus”. A look up table or predefined set of relationships between the part of the brain (estimated “second range”) to the response/measurement sensor, see Fig. 2. “Estimating” based on the defined lookup table/predefined relationship seems to be the only species disclosed. While the claims recite the genus of a “estimate” which is extremely broad encompassing a variety of ways to perform the range estimate including regression, neural networks etc. Thus the specification does not provide support for enough species to fulfill the written description for the breadth of the genus term “estimate”. In view of this discussion Examiner would recommend amending the claim to recite a “lookup table”. The claims depending from these claims share this issue and are likewise rejected.
Claims 10 and 11 both recite “measuring a biological reaction” however the specification only provides support for “autonomic nerve reaction is detected by the pulse wave meter”, “sweating is detected by the electro dermal activity sensor” or “pupil reflection is detected by the camera” which in view of MPEP 2163(II)(A)(3)(a)(ii) does not provide sufficient disclosure as it is does not represent a representative number species to satisfy a sufficient description. The MPEP definition of a “[a] "representative number of species" means that the species which are adequately described are representative of the entire genus”. A pulse wave/PPG, EDA or camera sensor appear to be the only species disclosed. While the claims recite the genus of a “a biological reaction” which is extremely broad encompassing a variety of responses (and their respective sensor modalities) including thyroid changes from a blood draw, changes in heart rate from a ECG, etc. Thus the specification does not provide support for enough species to fulfill the written description for the breadth of the genus term “a biological reaction”. In view of this discussion Examiner would recommend amending the claim to recite one or more of the responses disclosed instead of the “biological reaction”. Examiner notes that this does not apply to claim 1 and its dependents because claim 1 is interpreted under 112f.
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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract, specifically a mental process and/or mathematical abstract idea, idea without significantly more.
Step 1
The claimed invention in claim 1, 10-11 is directed to statutory subject matter as the claimed recite an apparatus, method or CRM.
Step 2A, Prong 1
Regarding Claims 1, 10-11, the claims recite variations of “a first analysis unit configured to estimate a first range indicating a range of a source of the intracerebral signal based on measurement data by the first measurement unit; a second analysis unit configured to estimate a second range indicating the range of the source of the intracerebral signal based on the measurement data by the second measurement unit; and a processing unit configured to calculate an estimated position of the source of the intracerebral signal based on the first range and the second range, and output information regarding the calculated estimated position.” which is directed to a mental process of performing concepts in the human mind (including by a human using the aid of pen and paper) and/or the application of a mathematical relationships. For example, this limitation simply amounts to the mental process of a clinician reading a data printout mentally reviewing (or applying mathematical applications) the ECG data to determine an estimated region based on the data, using a reading from a “second measurement unit” to determine if there was a response the personal mentally using known relationships between changes in readings (for example pupil light reflex and midbrain) and a change in a particular area of the brain thus providing an estimate of that range of the brain, and making a mental determination based on the two as to the most likely and outputting it; and/or, the steps discussed previously can include applying mathematical relationships (such as comparisons, mathematical process using the data to determine the range based on the EEG data etc.).
Step 2A, Prong 2
Regarding Claims 1, 10-11, the judicial exception is not integrated into a practical application. The claims include the additional elements of “a first measurement unit configured to measure an intracerebral signal based on a state of a brain; a second measurement unit configured to measure a biological reaction signal generated in a body site other than the brain in association with brain activity;” (claims 10-11 recite this as “measuring . . .”). The steps of “configured to measure . . .” (or claims 10-11 “measuring . . .”) amounts to insignificant, extra-solution activity in that the it is data gathering; while the steps of “output . . .” (or claims 10-11 “outputting . . .”) amounts to insignificant, extra-solution activity in that the it is outputting a result. The processor (i.e., “processor”, “computer processor”, “cloud-computing device”, “mobile device”; see applicants [0028] using Pg Pub for paragraph numbers) in computing steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of determining outputs from inputs) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B
Regarding Claims 1, 10-11, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As with step 2A, Prong 2 above the claims include the additional elements of “a first measurement unit configured to measure an intracerebral signal based on a state of a brain; a second measurement unit configured to measure a biological reaction signal generated in a body site other than the brain in association with brain activity;” (claims 10-11 recite this as “measuring . . .”). The steps of “configured to measure . . .” (or claims 10-11 “measuring . . .”) amounts to insignificant, extra-solution activity in that the it is data gathering; while the steps of “output . . .” (or claims 10-11 “outputting . . .”) amounts to insignificant, extra-solution activity in that the it is outputting a result. The processor (i.e., “processor”, “computer processor”, “cloud-computing device”, “mobile device”; see applicants [0028] using Pg Pub for paragraph numbers) in computing steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of determining outputs from inputs) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Additionally, per the Berkheimer requirement, MEG or EEG; and, PPG or EDA/SCR/GSR or Camera data being sensed for analysis by computer processors are well-known, routine and conventional (WRC). Per references: (1) US 20160007921 see [0032]-[0034], Figs. 1A-2; (2) US 20140347265 see [0043], [0050], [0056]-[0057], [0086]-[0087]; (3) US 20180353084 see [0074]-[0077], Figs. 1-2 . As such elements (1) and (2) are shown to be WRC.
The claim limitations when viewed individually and in combination therefore do not amount to significantly more than the abstract idea itself. The claims are therefore ineligible.
Claims 2-10 only further define the decisions made with the gathered data (i.e., only further define the mental process or mathematical concept; decisions based on overlapping or sperate of the “estimated” ranges) or the output (insignificant, extra-solution activity) or. Therefore, the claims do not include any additional elements that show integration into a practical application and do not include any additional elements that amount to significantly more than the abstract idea. The claims are ineligible.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Saburo Homma et al., Intracerebral source localization of mental process-related potentials elicited prior to mental sweating response in humans, Neuroscience Letters, Volume 247, Issue 1, 1998, Pages 25-28, ISSN 0304-3940, https://doi.org/10.1016/S0304-3940(98)00274-2.https://www.sciencedirect.com/science/article/pii/S0304394098002742?via%3Dihub – among other things discusses determining brain locations using EEG data, see Figs. 2-3
Filip Sobczak et al. (2021) Decoding the brain state-dependent relationship between pupil dynamics and resting state fMRI signal fluctuation eLife 10:e68980. https://doi.org/10.7554/eLife.68980, viewed on 8/7/26
US 20210113141 (cited in IDS dated 7/29/24)
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/James Moss/Examiner, Art Unit 3792