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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims, 1, 9, and 13 are objected to because of the following informalities:
Claim 1, line 5-6 “a reference electrode that is arranged on a measurement-target living body” should be “a reference electrode that is configured to be arranged on a measurement-target living body”.
Claim 1, line 7 “a measurement electrode that is arranged on the living body” should be “a measurement electrode that is configured to be arranged on a measurement-target living body”.
Claim 9, line 3-4 “a reference electrode that is arranged on a measurement-target living body” should be “a reference electrode that is configured to be arranged on a measurement-target living body”.
Claim 9, line 5 “a measurement electrode that is arranged on the living body” should be “a measurement electrode that is configured to be arranged on a measurement-target living body”.
Claim 13, line 7-8 “a reference electrode that is arranged on a measurement-target living body” should be “a reference electrode that is configured to be arranged on a measurement-target living body”.
Claim 13, line 9 “a measurement electrode that is arranged on the living body” should be “a measurement electrode that is configured to be arranged on a measurement-target living body”.
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 section in claim 10.
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.
The limitation is thus interpreted according to paragraphs 0029-0031 of the instant specification.
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 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 5-7 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.
Claim 5 recites the limitation “the second signal processor calculates the second feature amount by performing signal averaging on the reference feature amount and each of the first feature amounts respectively calculated by the potential measurement sections other than the potential measurement section calculating the first feature amount set to be the reference feature amount”. It is unclear whether this limitation refers to averaging each first feature amount with the reference feature amount to produce a plurality of second feature amounts or if it refers to averaging all of the first feature amounts except the reference feature amount, with the reference feature amount to produce a single second feature amount. The limitation is currently interpreted as referring to averaging all of the first feature amounts except the reference feature amount, with the reference feature amount to produce a single second feature amount as the preceding claims refer only to “a second feature amount” calculated based on the plurality of first feature amounts rather than multiple second feature amounts.
Claim 6 recites the limitation “the second signal processor calculates the second feature amount by subtracting the reference feature amount from each of the first feature amounts respectively calculated by the potential measurement sections other than the potential measurement section calculating the first feature amount set to be the reference feature amount”. It is not clear if the limitation is intended to refer to subtracting the reference feature amount from each of the first feature amounts before some additional step is performed to form a single second feature amount, or if the limitation refers to producing a plurality of second feature amounts by subtracting the reference feature amount from each of the first feature amounts. The limitation is currently interpreted as referring to producing a single second feature amount as the preceding claims refer only to “a second feature amount” calculated based on the plurality of first feature amounts rather than multiple second feature amounts.
Claim 7 recites the limitation “the second signal processor calculates an intermediate feature amount by performing signal averaging on the powers for each frequency that are respectively calculated by the plurality of potential measurement sections, and the second signal processor normalizes the intermediate feature amount using an integrated intensity in a specified frequency interval to calculate the second feature amount for a normalized intensity”. It is not clear if the limitation is intended to refer to calculating an intermediate feature amount for each frequency by signal averaging the powers for that frequency, producing a plurality of intermediate feature amounts to be used in calculating a plurality of second feature amounts, or if the limitation instead refers to calculating an intermediate feature amount by averaging the powers across each frequency to produce a single intermediate feature amount which is used to calculate a single second feature amount. The limitation is currently interpreted as referring to producing a single second feature amount as the preceding claims refer only to “a second feature amount” calculated based on the plurality of first feature amounts rather than multiple second feature amounts.
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 1-13 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) "calculates a first feature amount using the digitally converted biological signal" and “calculating a second feature amount used to estimate a state of the living body, using the first feature amounts respectively calculated by the first signal processors respectively included in the plurality of potential measurement sections”. 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, machine. Following Step 2A Prong one, any judicial exceptions are identified in the claims. In (CLAIM X), the limitations "calculates a first feature amount using the digitally converted biological signal" and “calculating a second feature amount used to estimate a state of the living body, using the first feature amounts respectively calculated by the first signal processors respectively included in the plurality of potential measurement sections” are abstract ideas as they are directed to a mental process or mathematical concept as the limitation constitutes receiving data and generally transforming the data to be used in making a judgment, where the transforming of the data may comprise a mental process or a mathematical concept such as seeking out a maximum or minimum value in the data, performing a mathematical transform of the data, or performing basic statistical analysis of the data such as finding an average value, all of which may be performed in the human mind mentally or with the aid of pen and paper and/or which may be performed using basic mathematical concepts for the same reasons. 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 “a plurality of potential measurement sections; and a second signal processor, each of the plurality of potential measurement sections including a reference electrode that is arranged on a measurement-target living body, a measurement electrode that is arranged on the living body, a biological signal generator that generates a biological signal from a difference between a potential of the reference electrode and a potential of the measurement electrode, an analog-digital converter that digitally converts the biological signal, and a first signal processor”. 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 “calculating” such that the end result of use of the system is only the generic determined calculation which may include 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 data to generate a biological signal from a difference between potentials of electrodes, such that the claim does not integrate the judicial exception into any practical application. Regarding “a first processor” and “a second processor” performing the calculations of feature amounts, 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 processors 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 processors may be performed by a person in an undefined manner including extracting a peak value from a signal for each section and averaging the value of each of those peaks, for example) 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 “a plurality of potential measurement sections; and a second signal processor, each of the plurality of potential measurement sections including a reference electrode that is arranged on a measurement-target living body, a measurement electrode that is arranged on the living body, a biological signal generator that generates a biological signal from a difference between a potential of the reference electrode and a potential of the measurement electrode, an analog-digital converter that digitally converts the biological signal, and a first signal processor” 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 generic electrodes and processors which Nelson (US 20140358024 A1) describes as well-understood, routine, or conventional in its description of sensing devices and processing circuits known in the prior art for physiological signal monitoring and treatment (Paragraph 0003, 0098) as well as descriptions of brain wave electrodes in known arts such as EEG (Paragraph 0063, 0166) and generic computing components and forms of processors which are commercially available and known in the art to be used with such brain wave electrodes, including the use of multiple processors together (Paragraph 0070, 0080, 0093, 0105, 0167-0170). 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 9, 11, and 13 are rejected under 35 U.S.C. 101 for similar reasons.
Claims 2-8 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 11 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: claim 2 recites an additional abstract idea (estimating a state of a living body on a basis of the second feature amount) which is itself directed to a mental process, wherein the “state estimator” amounts to nothing more than an instruction to apply the abstract idea using a generic computer, which does not render an abstract idea eligible and wherein the “state estimator” is similarly seen as well-understood, routine, or conventional according to the disclosure of Nelson relating to processors; claims 3-7 recite additional details of the abstract idea of claim 1 which are themselves directed to further mental processes or mathematical concepts as they merely describe additional calculations performed on the received data which are capable of being performed in the human mind and thus cannot be seen to integrate the abstract idea of claim 1 into a practical application; claim 8 recites an additional element which 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, where the bias electrode may be seen as well-understood, routine, or conventional in view of Nelson (US 20140358024 A1) in its description of sensing devices and processing circuits known in the prior art for physiological signal monitoring and treatment (Paragraph 0003, 0098) as well as descriptions of brain wave electrodes in known arts such as EEG (Paragraph 0063, 0166) including bias electrodes (paragraphs 0091, 0096).
The claim element of claim 1 of a biological information acquiring system is recited with a high level of generality (as written, the actions of the processors 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 10 is additionally 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 9, which was rejected under 35 U.S.C. 101 in paragraph 11-12 of this action, these claims must be evaluated on whether they sufficiently add to the practical application of claim 9, or comprise significantly more than the limitations of claim 1.
Besides the abstract idea of claim 9: claim 10 recites an additional element which 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, where the communication section may be seen as well-understood, routine, or conventional in view of Nelson (US 20140358024 A1) in its description of communication means which are known in the art and commercially available (Paragraph 0074, 0101-0103).
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(s) 1-2, 4, and 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi (US 20040077966 A1) in view of Nelson (US 20140358024 A1).
Regarding claim 1, Yamaguchi teaches a biological information acquiring system (Fig. 1) comprising:
a plurality of potential measurement sections (electrodes G1, G2, T5, T6, amplifiers, input 11, phase analysis portion 12, and feature parameter calculating portion 13 in Fig. 1); and
a second signal processor (Mahalanobis distance calculating portion 16),
each of the plurality of potential measurement sections including
a reference electrode that is arranged on a measurement-target living body (reference electrodes G1 and G2),
a measurement electrode that is arranged on the living body (measuring electrodes T5 and T6),
a biological signal generator (Amplifiers) that generates a biological signal from a difference between a potential of the reference electrode and a potential of the measurement electrode (Paragraph 0070-- Cerebral evoked potential obtained from two channels between a measuring electrode T5 and its reference electrode G1 and between a measuring electrode T6 and its reference electrode G2 is supplied to an input portion 11), and
a first signal processor (Elements 11-13) that calculates a first feature amount using the digitally converted biological signal (Paragraph 0056-0060—using aspect ratio, v-axis maximum value, the ratio of the sub/total number of revolutions, and the RL/UB distribution ratio derived from phase space analysis arc as feature parameters…),
the second signal processor (Mahalanobis distance calculating portion 16) calculating a second feature amount used to estimate a state of the living body, using the first feature amounts respectively calculated by the first signal processors respectively included in the plurality of potential measurement sections (Paragraph 0056-0060, 0073—distribution of Mahalanobis distances of the normal electroencephalographic samples and epileptic…).
However, Yamaguchi does not explicitly disclose an analog-digital converter that digitally converts the biological signal.
Nelson, in the same field of endeavor of a system for determining a biological state of a user based on analysis of a potential difference between electrodes arranged on the user, discloses the system includes an analog-digital converter that digitally converts the biological signal (Paragraph 0100).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Yamaguchi to include an analog to digital converter as described by Nelson in order to predictably improve the device by ensuring that the signal obtained by the electrodes may be processed and analyzed by a digital processor (see Nelson, paragraph 0093).
Regarding claim 2, the combination of Yamaguchi and Nelson teaches the biological information acquiring system according to claim 1. Yamaguchi additionally teaches further comprising a state estimator (Judgment portion 17) that estimates the state of the living body on a basis of the second feature amount (Paragraph 0074-- A judgment portion 17 judges normality/abnormality of the discrimination-target electroencephalogram in accordance with the Mahalanobis distance).
Regarding claim 4, the combination of Yamaguchi and Nelson teaches the biological information acquiring system according to claim 1. Yamaguchi additionally teaches wherein the second signal processor calculates the second feature amount by performing signal averaging on the first feature amounts respectively calculated by the plurality of potential measurement sections (Paragraph 0073-- Mahalanobis distance calculating portion 16 obtains a Mahalanobis distance in accordance with Expression 10 from the mean, the variance, and the inverse matrix of the correlation matrix of the reference learning electroencephalographic data set calculated as a reference space, and the feature parameters calculated form the electroencephalographic data to be discriminated).
Regarding claim 8, the combination of Yamaguchi and Nelson teaches the biological information acquiring system according to claim 1. Yamaguchi additionally teaches wherein each of the plurality of potential measurement sections further includes a bias electrode (Paragraph 0007—ground electrodes).
Regarding claim 9, Yamaguchi teaches a biological information acquiring apparatus (Fig. 1; paragraph 0069) comprising:
a plurality of potential measurement sections (electrodes G1, G2, T5, T6, amplifiers, input 11, phase analysis portion 12, and feature parameter calculating portion 13 in Fig. 1); each including
a reference electrode that is arranged on a measurement-target living body (reference electrodes G1 and G2),
a measurement electrode that is arranged on the living body (measuring electrodes T5 and T6),
a biological signal generator (Amplifiers) that generates a biological signal from a difference between a potential of the reference electrode and a potential of the measurement electrode (Paragraph 0070-- Cerebral evoked potential obtained from two channels between a measuring electrode T5 and its reference electrode G1 and between a measuring electrode T6 and its reference electrode G2 is supplied to an input portion 11), and
a first signal processor (Elements 11-13) that calculates a first feature amount using the digitally converted biological signal (Paragraph 0056-0060—using aspect ratio, v-axis maximum value, the ratio of the sub/total number of revolutions, and the RL/UB distribution ratio derived from phase space analysis arc as feature parameters…).
However, Yamaguchi does not explicitly disclose an analog-digital converter that digitally converts the biological signal.
Nelson, in the same field of endeavor of a system for determining a biological state of a user based on analysis of a potential difference between electrodes arranged on the user, discloses the system includes an analog-digital converter that digitally converts the biological signal (Paragraph 0100).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Yamaguchi to include an analog to digital converter as described by Nelson in order to predictably improve the device by ensuring that the signal obtained by the electrodes may be processed and analyzed by a digital processor (see Nelson, paragraph 0093).
Regarding claim 10, the combination of Yamaguchi and Nelson teaches a biological information acquiring apparatus according to claim 9. Yamaguchi additionally teaches herein each of the plurality of potential measurement sections further includes a communication section that transmits the first feature amount to an external apparatus (Paragraph 0014-- data is supplied to a diagnosis apparatus body by wire or by wireless).
Regarding claim 11, the combination of Yamaguchi and Nelson teaches a biological information acquiring apparatus according to claim 9. Yamaguchi additionally teaches further comprising a second signal processor (Mahalanobis distance calculating portion 16) that calculates a second feature amount used to estimate a state of the living body, using the first feature amounts respectively calculated by the first signal processors respectively included in the plurality of potential measurement sections (Paragraph 0056-0060, 0073—distribution of Mahalanobis distances of the normal electroencephalographic samples and epileptic…).
Regarding claim 12, the combination of Yamaguchi and Nelson teaches the biological information acquiring apparatus according to claim 11. Yamaguchi additionally teaches further comprising a state estimator (Judgment portion 17) that estimates the state of the living body on a basis of the second feature amount (Paragraph 0074-- A judgment portion 17 judges normality/abnormality of the discrimination-target electroencephalogram in accordance with the Mahalanobis distance).
Regarding claim 13, Yamaguchi teaches an information processing apparatus (Fig. 1) comprising: a second signal processor (Mahalanobis distance calculating portion 16) that calculates a second feature amount used to estimate a state of the living body, using the first feature amounts respectively calculated by the first signal processors respectively included in the plurality of potential measurement sections (Paragraph 0056-0060, 0073—distribution of Mahalanobis distances of the normal electroencephalographic samples and epileptic…),
Each of the plurality of potential measurement sections (electrodes G1, G2, T5, T6, amplifiers, input 11, phase analysis portion 12, and feature parameter calculating portion 13 in Fig. 1) including
a reference electrode that is arranged on a measurement-target living body (reference electrodes G1 and G2),
a measurement electrode that is arranged on the living body (measuring electrodes T5 and T6),
a biological signal generator (Amplifiers) that generates a biological signal from a difference between a potential of the reference electrode and a potential of the measurement electrode (Paragraph 0070-- Cerebral evoked potential obtained from two channels between a measuring electrode T5 and its reference electrode G1 and between a measuring electrode T6 and its reference electrode G2 is supplied to an input portion 11), and
a first signal processor (Elements 11-13) that calculates a first feature amount using the digitally converted biological signal (Paragraph 0056-0060—using aspect ratio, v-axis maximum value, the ratio of the sub/total number of revolutions, and the RL/UB distribution ratio derived from phase space analysis arc as feature parameters…).
However, Yamaguchi does not explicitly disclose an analog-digital converter that digitally converts the biological signal.
Nelson, in the same field of endeavor of a system for determining a biological state of a user based on analysis of a potential difference between electrodes arranged on the user, discloses the system includes an analog-digital converter that digitally converts the biological signal (Paragraph 0100).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Yamaguchi to include an analog to digital converter as described by Nelson in order to predictably improve the device by ensuring that the signal obtained by the electrodes may be processed and analyzed by a digital processor (see Nelson, paragraph 0093).
Claim(s) 1-4 and 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakae (US 20200178888 A1) in view of Nelson (US 20140358024 A1).
Regarding claim 1, Nakae teaches a biological information acquiring system (5100), comprising:
a plurality of potential measurement sections; and
a second signal processor (Brainwave feature extraction unit 5500),
each of the plurality of potential measurement sections (Paragraph 0076, 0106, 0110-0112-- brainwave data is preferably collected by a simple method, which can 1) use minimum number of electrodes (about 2), 2) avoid the scalp with hair as much as possible, and 3) record while sleeping, to carry out the invention. The number of electrodes can be increased as need (e.g., 3, 4, 5, or the like) ; It is noted that in this case, each combination of electrodes together with the other elements described below may serve as a potential measurement section) including
a reference electrode that is arranged on a measurement-target living body (Electroencephalograph 5220; paragraph 0076, 0106, 0110-0112),
a measurement electrode that is arranged on the living body (Electroencephalograph 5220; paragraph 0076, 0106, 0110-0112),
a biological signal generator (Brainwave recording sensor 5250) that generates a biological signal from a difference between a potential of the reference electrode and a potential of the measurement electrode (Paragraph 0038-- “brainwave” has the meaning that is commonly used in the art and refers to a current generated by a difference in potential due to neurological activity of the brain when a pair of electrodes is placed on the scalp. Brainwave encompasses electroencephalogram (EEG); paragraph 0106, 0112-- brainwave recording sensor 5250 measures electrical activity generated in the brain of an object being estimated with an electrode on the scalp),
a pre-processing unit that pre-processes the biological signal (Brainwave amplification unit 5270) and
a first signal processor that calculates a first feature amount using the digitally converted biological signal (Brainwave signal processing unit 5400; paragraph 0039-0041-- “brainwave data” is any data related to brainwaves (also referred to as “amount of brain activity”, “brain feature”, or the like), such as amplitude data (EEG amplitude, frequency property, or the like). “Analysis data” from analyzing such brainwave data can be used in the same manner as brainwave data, so that such data can be collectively referred to as “brainwave data or analysis data thereof” herein. Examples of analysis data include mean amplitude and peak amplitude (e.g., Fz, Cz, C3, C4), frequency power (e.g., Fz(δ), Fz(θ), Fz(α), Fz(β), Fz(γ), Cz(δ), Cz(θ), Cz(α), Cz(β), Cz(γ), C3(δ), C3(θ), C3(α), C3(β), C3(γ), C4(δ), C4(θ), C4(α), C4(β), and C4(γ)) and the like of brainwave data…; paragraph 0102--brainwave signals are processed at a brainwave signal processing unit 5400),
the second signal processor calculating a second feature amount used to estimate a state of the living body, using the first feature amounts respectively calculated by the first signal processors respectively included in the plurality of potential measurement sections (Paragraph 0082-0083--brainwave data obtained in step a is subjected to basic signal processing such as filtering, eye movement correction, or artifact removal and then associated with a condition parameter, and a signal of a corresponding portion is extracted to create a brainwave feature (S300). This includes a mean value (arithmetic mean or geometric mean), other representative value (median or mode), entropy, frequency power, wavelet, mean, single run event related potential component, and the like; paragraph 0102--a brainwave feature is extracted, sometimes amplified, at a brainwave feature extraction unit 5500 as needed; paragraph 0096, 0117-- brainwave data (e.g., amplitude data) can be fitted to the pleasantness/unpleasantness determination device or value with a mean value).
However, Nakae does not explicitly disclose an analog-digital converter that digitally converts the biological signal.
Nelson, in the same field of endeavor of a system for determining a biological state of a user based on analysis of a potential difference between electrodes arranged on the user, discloses the system includes an analog-digital converter that digitally converts the biological signal (Paragraph 0100).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Nakae to include an analog to digital converter as described by Nelson in order to predictably improve the device by ensuring that the signal obtained by the electrodes may be processed and analyzed by a digital processor (see Nelson, paragraph 0093).
Regarding claim 2, the combination of Nakae and Nelson teaches the biological information acquiring system according to claim 1. Nakae additionally teaches further comprising a state estimator (Pleasantness/unpleasantness determination unit 5600) that estimates the state of the living body on a basis of the second feature amount (Paragraph 0111, 0122-0124-- pleasantness/unpleasantness determination unit 5600 estimates or classifies the magnitude of pain from amplitudes of a plurality of brainwave data based on a pain classifier created by the pleasantness/unpleasantness determination value generation unit 3000 (see FIG. 16). Specifically, the pleasantness/unpleasantness determination unit 5600 estimates or classifies pain of an object from brainwave data based on a determination value).
Regarding claim 3, the combination of Nakae and Nelson teaches the biological information acquiring system according to claim 1. Nakae additionally teaches wherein the first signal processor included in each of the plurality of potential measurement sections calculates a power for each frequency from the digitally converted biological signal, and normalizes the power for each frequency using an integrated intensity in a specified frequency interval to calculate the first feature amount for a normalized intensity (Paragraph 0039-0041, 0075, 0082-0083, 0148--Frequency power can be calculated by extracting and calculating frequency components of a signal embedded in a signal…can normalize the output thereof and calculate the power spectrum density PSD or power spectrum, which is the measurement of source of power. PSD indicates how power of a time signal is distributed with respect to frequencies. The unit thereof is watt/Hz. Each point in PSD is integrated over the range of frequencies where the point is defined (i.e., over the resolution bandwidth of PSD) to calculate the power spectrum).
Regarding claim 4, the combination of Nakae and Nelson teaches the biological information acquiring system according to claim 1. Nakae additionally teaches wherein the second signal processor calculates the second feature amount by performing signal averaging on the first feature amounts respectively calculated by the plurality of potential measurement sections (Paragraph 0082-0083--…a mean value (arithmetic mean or geometric mean), other representative value (median or mode), entropy, frequency power, wavelet, mean, single run event related potential component, and the like; paragraph 0096, 0117-- brainwave data (e.g., amplitude data) can be fitted to the pleasantness/unpleasantness determination device or value with a mean value).
Regarding claim 8, the combination of Nakae and Nelson teaches the biological information acquiring system according to claim 1. Nakae additionally teaches wherein each of the plurality of potential measurement sections further includes a bias electrode (Paragraph 0164, 0187—reference electrodes).
Regarding claim 9, Nakae teaches a biological information acquiring apparatus (5200), comprising
a plurality of potential measurement sections (Paragraph 0076, 0106, 0110-0112-- brainwave data is preferably collected by a simple method, which can 1) use minimum number of electrodes (about 2), 2) avoid the scalp with hair as much as possible, and 3) record while sleeping, to carry out the invention. The number of electrodes can be increased as need (e.g., 3, 4, 5, or the like) ; It is noted that in this case, each combination of electrodes together with the other elements described below may serve as a potential measurement section) including
a reference electrode that is arranged on a measurement-target living body (Electroencephalograph 5220; paragraph 0076, 0106, 0110-0112) each including
a measurement electrode that is arranged on the living body (Electroencephalograph 5220; paragraph 0076, 0106, 0110-0112),
a biological signal generator (Brainwave recording sensor 5250) that generates a biological signal from a difference between a potential of the reference electrode and a potential of the measurement electrode (Paragraph 0038-- “brainwave” has the meaning that is commonly used in the art and refers to a current generated by a difference in potential due to neurological activity of the brain when a pair of electrodes is placed on the scalp. Brainwave encompasses electroencephalogram (EEG); paragraph 0106, 0112-- brainwave recording sensor 5250 measures electrical activity generated in the brain of an object being estimated with an electrode on the scalp),
a pre-processing unit that pre-processes the biological signal (Brainwave amplification unit 5270) and
a first signal processor that calculates a first feature amount using the digitally converted biological signal (Brainwave signal processing unit 5400; paragraph 0039-0041-- “brainwave data” is any data related to brainwaves (also referred to as “amount of brain activity”, “brain feature”, or the like), such as amplitude data (EEG amplitude, frequency property, or the like). “Analysis data” from analyzing such brainwave data can be used in the same manner as brainwave data, so that such data can be collectively referred to as “brainwave data or analysis data thereof” herein. Examples of analysis data include mean amplitude and peak amplitude (e.g., Fz, Cz, C3, C4), frequency power (e.g., Fz(δ), Fz(θ), Fz(α), Fz(β), Fz(γ), Cz(δ), Cz(θ), Cz(α), Cz(β), Cz(γ), C3(δ), C3(θ), C3(α), C3(β), C3(γ), C4(δ), C4(θ), C4(α), C4(β), and C4(γ)) and the like of brainwave data…; paragraph 0102--brainwave signals are processed at a brainwave signal processing unit 5400).
However, Nakae does not explicitly disclose an analog-digital converter that digitally converts the biological signal.
Nelson, in the same field of endeavor of a system for determining a biological state of a user based on analysis of a potential difference between electrodes arranged on the user, discloses the system includes an analog-digital converter that digitally converts the biological signal (Paragraph 0100).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Nakae to include an analog to digital converter as described by Nelson in order to predictably improve the device by ensuring that the signal obtained by the electrodes may be processed and analyzed by a digital processor (see Nelson, paragraph 0093).
Regarding claim 10, the combination of Nakae and Nelson teaches a biological information acquiring apparatus according to claim 9. Nakae additionally teaches wherein each of the plurality of potential measurement sections further includes a communication section that transmits the first feature amount to an external apparatus (Paragraph 0075, 0114, 0117, 0178-- Brainwave data can be obtained by measuring electrical signals of a brainwave and is displayed by potential (can be displayed by μV or the like) as amplitude data or the like…transmitted from the electroencephalograph 5220 to the measurement unit 5200, then a brainwave feature is created at the feature extraction unit 5500 and transmitted to the pleasantness/unpleasantness determination unit 5600… Such a series of processes can be materialized by a computer or mobile terminal comprising a processor and a memory, or a dedicated electrical circuit. A dedicated electrical circuit can be a single integrated circuit or a plurality of electrical circuits.).
Regarding claim 11, the combination of Nakae and Nelson teaches a biological information acquiring apparatus according to claim 9. Nakae additionally teaches a second signal processor (Brainwave feature extraction unit 5500) that calculates a second feature amount used to estimate a state of the living body, using the first feature amounts respectively calculated by the first signal processors respectively included in the plurality of potential measurement sections (Paragraph 0082-0083--brainwave data obtained in step a is subjected to basic signal processing such as filtering, eye movement correction, or artifact removal and then associated with a condition parameter, and a signal of a corresponding portion is extracted to create a brainwave feature (S300). This includes a mean value (arithmetic mean or geometric mean), other representative value (median or mode), entropy, frequency power, wavelet, mean, single run event related potential component, and the like; paragraph 0102--a brainwave feature is extracted, sometimes amplified, at a brainwave feature extraction unit 5500 as needed; paragraph 0096, 0117-- brainwave data (e.g., amplitude data) can be fitted to the pleasantness/unpleasantness determination device or value with a mean value).
Regarding claim 12, the combination of Nakae and Nelson teaches the biological information acquiring apparatus according to claim 11. Nakae additionally teaches further comprising a state estimator (Pleasantness/unpleasantness determination unit 5600) that estimates the state of the living body on a basis of the second feature amount (Paragraph 0111, 0122-0124-- pleasantness/unpleasantness determination unit 5600 estimates or classifies the magnitude of pain from amplitudes of a plurality of brainwave data based on a pain classifier created by the pleasantness/unpleasantness determination value generation unit 3000 (see FIG. 16). Specifically, the pleasantness/unpleasantness determination unit 5600 estimates or classifies pain of an object from brainwave data based on a determination value).
Regarding claim 13, Nakae teaches an information processing apparatus, comprising a second signal processor that calculates a second feature amount used to estimate a state of the living body, using first feature amounts respectively calculated by first signal processors respectively included in the plurality of potential measurement sections (Paragraph 0082-0083--brainwave data obtained in step a is subjected to basic signal processing such as filtering, eye movement correction, or artifact removal and then associated with a condition parameter, and a signal of a corresponding portion is extracted to create a brainwave feature (S300). This includes a mean value (arithmetic mean or geometric mean), other representative value (median or mode), entropy, frequency power, wavelet, mean, single run event related potential component, and the like; paragraph 0102--a brainwave feature is extracted, sometimes amplified, at a brainwave feature extraction unit 5500 as needed; paragraph 0096, 0117-- brainwave data (e.g., amplitude data) can be fitted to the pleasantness/unpleasantness determination device or value with a mean value), comprising:
a plurality of potential measurement sections; and
a second signal processor (Brainwave feature extraction unit 5500),
each of the plurality of potential measurement sections (Paragraph 0076, 0106, 0110-0112-- brainwave data is preferably collected by a simple method, which can 1) use minimum number of electrodes (about 2), 2) avoid the scalp with hair as much as possible, and 3) record while sleeping, to carry out the invention. The number of electrodes can be increased as need (e.g., 3, 4, 5, or the like) ; It is noted that in this case, each combination of electrodes together with the other elements described below may serve as a potential measurement section) including
a reference electrode that is arranged on a measurement-target living body (Electroencephalograph 5220; paragraph 0076, 0106, 0110-0112),
a measurement electrode that is arranged on the living body (Electroencephalograph 5220; paragraph 0076, 0106, 0110-0112),
a biological signal generator (Brainwave recording sensor 5250) that generates a biological signal from a difference between a potential of the reference electrode and a potential of the measurement electrode (Paragraph 0038-- “brainwave” has the meaning that is commonly used in the art and refers to a current generated by a difference in potential due to neurological activity of the brain when a pair of electrodes is placed on the scalp. Brainwave encompasses electroencephalogram (EEG); paragraph 0106, 0112-- brainwave recording sensor 5250 measures electrical activity generated in the brain of an object being estimated with an electrode on the scalp),
a pre-processing unit that pre-processes the biological signal (Brainwave amplification unit 5270) and
a first signal processor that calculates a first feature amount using the digitally converted biological signal (Brainwave signal processing unit 5400; paragraph 0039-0041-- “brainwave data” is any data related to brainwaves (also referred to as “amount of brain activity”, “brain feature”, or the like), such as amplitude data (EEG amplitude, frequency property, or the like). “Analysis data” from analyzing such brainwave data can be used in the same manner as brainwave data, so that such data can be collectively referred to as “brainwave data or analysis data thereof” herein. Examples of analysis data include mean amplitude and peak amplitude (e.g., Fz, Cz, C3, C4), frequency power (e.g., Fz(δ), Fz(θ), Fz(α), Fz(β), Fz(γ), Cz(δ), Cz(θ), Cz(α), Cz(β), Cz(γ), C3(δ), C3(θ), C3(α), C3(β), C3(γ), C4(δ), C4(θ), C4(α), C4(β), and C4(γ)) and the like of brainwave data…; paragraph 0102--brainwave signals are processed at a brainwave signal processing unit 5400).
However, Nakae does not explicitly disclose an analog-digital converter that digitally converts the biological signal.
Nelson, in the same field of endeavor of a system for determining a biological state of a user based on analysis of a potential difference between electrodes arranged on the user, discloses the system includes an analog-digital converter that digitally converts the biological signal (Paragraph 0100).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Nakae to include an analog to digital converter as described by Nelson in order to predictably improve the device by ensuring that the signal obtained by the electrodes may be processed and analyzed by a digital processor (see Nelson, paragraph 0093).
Conclusion
Claims 5, 6, and 7 are not currently rejected under 35 U.S.C. 102/103. None of the prior art of the record appears to disclose and/or fairly suggest, as recited in each respective claim, “from among the first feature amounts respectively calculated by the plurality of potential measurement sections, the second signal processor sets the first feature amount exhibiting a smallest value to be a reference feature amount, and the second signal processor calculates the second feature amount by performing signal averaging on the reference feature amount and each of the first feature amounts respectively calculated by the potential measurement sections other than the potential measurement section calculating the first feature amount set to be the reference feature amount”, “from among the first feature amounts respectively calculated by the plurality of potential measurement sections, the second signal processor sets the first feature amount exhibiting a smallest value to be a reference feature amount, and the second signal processor calculates the second feature amount by subtracting the reference feature amount from each of the first feature amounts respectively calculated by the potential measurement sections other than the potential measurement section calculating the first feature amount set to be the reference feature amount”, or “the second signal processor calculates an intermediate feature amount by performing signal averaging on the powers for each frequency that are respectively calculated by the plurality of potential measurement sections, and the second signal processor normalizes the intermediate feature amount using an integrated intensity in a specified frequency interval to calculate the second feature amount for a normalized intensity”.
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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