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 disclosure is objected to because of the following informalities:
In [0009], “the evaluating unit determines blood pressure classification including at least distinction between normotension and hypertension” should read “the evaluating unit determines blood pressure classification including at least a distinction between normotension and hypertension”.
In [0015] and [0017], “blood pressure classification including at least distinction between normotension and hypertension is determined” should read “blood pressure classification including at a least distinction between normotension and hypertension is determined”.
Appropriate correction is required.
Drawings
The drawings are objected to because they are low resolution and not reproducible for publication purposes. See MPEP 608.02(b). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 26-27, 29-30, 35-36, 39, and 41-42 are objected to because of the following informalities:
In Claim 26, “an analyzing unit that analyzes...” should read “an analyzing unit configured to analyze...”.
In Claim 26, “an evaluating unit that accesses...” should read “an evaluating unit configured to access...”.
In Claim 26, the fact that the analyzing unit analyzing the biological signal data is repeated twice in the claim.
In Claim 26, the Examiner strongly recommends switching the clause that beings with “an evaluating unit that accesses...” to come after the clause that begins with “wherein the analyzing unit analyzes the biological signal data...”.
In Claim 26, “finds a gradient between two points of inflection or a gradient of a tangent at a point of inflection” should read “finds a gradient between two points of inflection or a gradient of a tangent at a point of inflection of the quartic function”.
In Claim 27, “determines blood pressure classification including at least distinction between normotension and hypertension” should read “determines blood pressure classification including at least a distinction between normotension and hypertension”.
In Claim 29, “wherein the evaluating unit infers whether or not an autonomic nervous system is in disorder, based on whether or not analysis results of a plurality of biological signal data measured from the evaluation-target person at different times present a change conforming to a distribution trend of the correlation data” should read “wherein the evaluating unit infers whether or not an autonomic nervous system is in disorder[[,]] based on whether or not analysis results of a plurality of biological signal data measured from the evaluation-target person at different times present a change conforming to a distribution trend of the correlation data”.
In Claim 30, “wherein: whether or not the autonomic nervous system is in disorder is inferred, using the plurality of biological signal data measured before and after an exercise load” should read “wherein [[:]] the evaluating unit infers whether or not the autonomic nervous system is in disorder is inferred[[,]] using the plurality of biological signal data measured before and after an exercise load”.
In Claim 35, “finding a gradient between two points of inflection or a gradient of a tangent at a point of inflection depending on the number of extreme values in the quartic function” should read “finding a gradient between two points of inflection or a gradient of a tangent at a point of inflection of the quartic function depending on the number of extreme values in the quartic function”.
In Claim 36, “blood pressure classification including at least distinction between normotension and hypertension is determined” should read “blood pressure classification including at least a distinction between normotension and hypertension is determined”.
In Claim 39, “wherein: whether or not the autonomic nervous system is in disorder is inferred, using the plurality of biological signal data measured before and after an exercise load” should read “wherein [[:]] the evaluating unit infers whether or not the autonomic nervous system is in disorder is inferred[[,]] using the plurality of biological signal data measured before and after an exercise load”.
In Claim 41, “finding a gradient between two points of inflection or a gradient of a tangent at a point of inflection depending on the number of extreme values in the quartic function” should read “finding a gradient between two points of inflection or a gradient of a tangent at a point of inflection of the quartic function depending on the number of extreme values in the quartic function”.
In Claim 42, “blood pressure classification including at least distinction between normotension and hypertension is determined” should read “blood pressure classification including at least a distinction between normotension and hypertension is determined”.
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: “analyzing unit” and “evaluating unit” in Claim 26.
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 26 is being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “unit” for the apparatus performing the specified function
“unit” is linked with the transitional word “that” and modified by the functional language “analyzes biological signal data as sound/vibration information that is propagated from a surface of a body of a person through a three-dimensional knitted fabric of a biological signal detection sensor having the three-dimensional knitted fabric and a microphone” and “analyzes the biological signal data, finds an analyzed waveform regarding heart rate variability information to represent the analyzed waveform on log-log axes, sets a quartic function for the analyzed waveform, finds a gradient between two points of inflection or a gradient of a tangent at a point of inflection depending on the number of extreme values in the quartic function, and outputs one of the gradients as the analysis result”.
“unit” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on [0032] as a computer configured to perform the algorithm of Claim 5 and equivalents thereof.
Claim 26 is also being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “unit” for the apparatus performing the specified function
“unit” is linked with the transitional word “that” and modified by the functional language “accesses a database in which correlation data of analysis results found by the analyzing unit and blood pressure values found with a blood pressure monitor is constructed in advance, and collates an analysis result found by the analyzing unit regarding the biological signal data of an evaluation-target person with the correlation data to evaluate a biological state of the person in relation to a blood pressure”.
“unit” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on [0032] as a computer configured to access a database and equivalents thereof.
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 26-45 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 26 recites “an evaluating unit that accesses a database in which correlation data of analysis results found by the analyzing unit and blood pressure values found with a blood pressure monitor is constructed in advance, and collates an analysis result found by the analyzing unit regarding the biological signal data of an evaluation-target person with the correlation data to evaluate a biological state of the person in relation to a blood pressure”.
It is unclear what metric or event the database is constructed in advance of (e.g. time, before the biological signal detection, etc.).
Claim 26 recites “wherein the analyzing unit analyzes the biological signal data, finds an analyzed waveform regarding heart rate variability information to represent the analyzed waveform on log-log axes, sets a quartic function for the analyzed waveform, finds a gradient between two points of inflection or a gradient of a tangent at a point of inflection depending on the number of extreme values in the quartic function, and outputs one of the gradients as the analysis result”.
It is unclear whether the analysis result in “outputs one of the gradients as the analysis result” is the same analysis result as “collates an analysis result”, or a different analysis result.
It is unclear what the applicant means by the clause “wherein the analyzing unit analyzes the biological signal data, finds an analyzed waveform regarding heart rate variability information to represent the analyzed waveform on log-log axes”. What does the applicant mean by “finding an analyzed waveform...to represent the analyzed waveform”? For the purposes of substantive examination, the examiner is construing this claim limitation to refer to the algorithm of dependent Claim 34.
Claims 26, 28, 35, 37, 41, and 43 all recite the word “collate”.
There are multiple reasonable interpretations to the clause “collates an analysis result found by the analyzing unit regarding the biological signal data of an evaluation-target person with the correlation data”, and it is unclear what interpretation the applicant is claiming. For example, Merriam Webster defines the word “collate” as “to compare critically”, “to collect, compare carefully in order to verify, and often to integrate or arrange in order”, “to assemble in proper order (e.g., for binding)”, “to verify the order of”. See the attached definition. The specification states “The evaluating unit 300 collates the analysis result in the analyzing unit 200 regarding the biological signal data of an evaluation-target person with the correlation data recorded in the database 400 to evaluate a blood pressure-related biological state of the person” ([0046]); “Preferably, in the procedure for evaluating the biological state based on whether the analysis result of the biological signal data of the evaluation-target person corresponds to the gradient between the two points of inflection or to the gradient of the tangent at the point of inflection, blood pressure classification including at least distinction between normotension and hypertension is determined. Preferably, in the procedure for evaluating the biological state, a value of the gradient between the two points of inflection or the gradient of the tangent at the point of inflection that is the analysis result of the biological signal data of the evaluation target person is collated with the correlation data, and a blood pressure value is inferred.” ([0018]). It is unclear what definition of “collating” the applicant is claiming performed on the data. Are the gradient value and correlation data compared critically to note points of agreement and divergence? Are the gradient value and correlation data arranged in some predetermined order? Is a determined gradient value mapped to a blood pressure using a correlation equation/regression line (e.g., Fig. 8)? For the purposes of substantive examination, the examiner is interpreting the word “collate” to mean critical comparison such as mapping a determined gradient value to a regression line as shown in Fig. 8.
Claims 27-34 are rejected by virtue of dependence on Claim 26.
Claim 27 recites “wherein, based on whether the analysis result of the biological signal data of the evaluation-target person corresponds to the gradient between the two points of inflection or to the gradient of the tangent at the point of inflection, the evaluating unit determines blood pressure classification including at least distinction between normotension and hypertension”.
It is unclear whether “the analysis result” refers to the collated analysis result or the outputted gradient of parent Claim 26.
Claim 33 recites “the evaluating unit: evaluates the biological state as having a possibility of an overload state in a case where it is confirmed that heart rates or blood pressures obtained at a predetermined time interval have a predetermined difference or more, and evaluates the biological state as having a possibility of a physical condition sudden change in a case where it is confirmed that the heart rates and the blood pressures obtained at the predetermined time interval both have the predetermined difference or more”.
In the first clause, the evaluating unit evaluates the heart rate or blood pressure. In the second clause, the evaluating unit has evaluated the heart rate and the blood pressure. It is unclear whether one or both of these parameters is being evaluated. For clarity, the claim should recite “heart rates and/or blood pressures”.
In the clause “it is confirmed that heart rates or blood pressures obtained at a predetermined time interval have a predetermined difference or more”, it is unclear what the difference is being calculated from: a predetermined difference in heart rates, a predetermined difference in blood pressure, a predetermined difference in either parameter, or a predetermined difference in heart rate compared to blood pressure using a compound/combined unit.
Claim 34 recites “the analyzing unit finds, as the heart rate variability information, two peak-to- peak amplitudes from extreme values included in time phases of an atrial systole and a ventricular systole”.
It is unclear how peak-to-peak amplitudes from an atrial systole and a ventricular systole related to heart rate variability, as it is the timing of peaks that holds information on heart rate variability, not the amplitude.
Claim 34 recites “wherein the analyzing unit...extracts a frequency band where a slope of a regression line of the analyzed waveform is close to 1/f”.
The term “close” is a relative term which renders the claim indefinite. The term “close” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 35 recites “referring to correlation data, which is stored in a database in advance, of analysis results found through the execution of the analyzing procedure and blood pressure values found with a blood pressure monitor, and collating an analysis result of the biological signal data of an evaluation-target person with the correlation data to evaluate a biological state of the evaluation-target person in relation to a blood pressure”.
It is unclear what metric or event the database is constructed in advance of (e.g. time, before the biological signal detection, etc.).
In the clauses “outputting one of the gradients as an analysis result” and “collating an analysis result of the biological signal data of an evaluation-target person with the correlation data”, it is unclear if these analysis results are the same element or different elements of the claim.
It is unclear what the applicant means by the clause “finding an analyzed waveform regarding heart rate variability information to represent the analyzed waveform on log-log axes”. What does the applicant mean by “finding an analyzed waveform...to represent the analyzed waveform”?
Claim 36 recites “wherein, in evaluating the biological state, based on whether the analysis result of the biological signal data of the evaluation-target person corresponds to the gradient between the two points of inflection or to the gradient of the tangent at the point of inflection, blood pressure classification including at least distinction between normotension and hypertension is determined”.
It is unclear whether “the analysis result” refers to the collated analysis result or the outputted gradient of parent Claim 35.
Claims 36-40 are rejected by virtue of dependence on Claim 35.
Claim 40 recites “the biological state is evaluated as having a possibility of an overload state in a case where it is confirmed that heart rates or blood pressures obtained at a predetermined time interval have a predetermined difference or more, and the biological state is evaluated as having a possibility of a physical condition sudden change in a case where it is confirmed that the heart rates and the blood pressures obtained at the predetermined time interval both have the predetermined difference or more”.
In the first clause, the evaluating unit evaluates the heart rate or blood pressure. In the second clause, the evaluating unit has evaluated the heart rate and the blood pressure. It is unclear whether one or both of these parameters is being evaluated. For clarity, the claim should recite “heart rates and/or blood pressures”.
In the clause “it is confirmed that heart rates or blood pressures obtained at a predetermined time interval have a predetermined difference or more”, it is unclear what the difference is being calculated from: a predetermined difference in heart rates, a predetermined difference in blood pressure, a predetermined difference in either parameter, or a predetermined difference in heart rate compared to blood pressure using a compound/combined unit.
Claim 41 recites “a procedure for referring to correlation data, which is stored in a database in advance, of analysis results found through the execution of the analyzing procedure and blood pressure values found with a blood pressure monitor, and collating an analysis result of the biological signal data of an evaluation-target person with the correlation data to evaluate a biological state of the evaluation-target person in relation to a blood pressure”.
It is unclear what metric or event the database is constructed in advance of (e.g. time, before the biological signal detection, etc.).
In the clauses “outputting one of the gradients as an analysis result” and “collating an analysis result of the biological signal data of an evaluation-target person with the correlation data”, it is unclear if these analysis results are the same element or different elements of the claim.
It is unclear what the applicant means by the clause “finding an analyzed waveform regarding heart rate variability information to represent the analyzed waveform on log-log axes”. What does the applicant mean by “finding an analyzed waveform...to represent the analyzed waveform”? For the purposes of substantive examination, the examiner is construing this claim limitation to refer to the algorithm of dependent Claim 45.
Claims 42-45 are rejected by virtue of dependence on Claim 41.
Claim 45 recites “as the heart rate variability information, two peak-to-peak amplitudes are found from extreme values included in time phases of an atrial systole and a ventricular systole”.
It is unclear how peak-to-peak amplitudes from an atrial systole and a ventricular systole related to heart rate variability, as it is the timing of peaks that holds information on heart rate variability, not the amplitude.
Claim 45 recites “a frequency band where a slope of a regression line of the analyzed waveform is close to 1/f is extracted”.
The term “close” is a relative term which renders the claim indefinite. The term “close” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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 26-45 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding Claim 26, the claim recites a biological state evaluation device. Thus, the claim is directed to an apparatus, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
analyzes biological signal data as sound/vibration information that is propagated from a surface of a body of a person through a three-dimensional knitted fabric of a biological signal detection sensor having the three-dimensional knitted fabric and a microphone, to be detected by the microphone while the biological signal detection sensor is in contact with the body
accesses a database in which correlation data of analysis results found by the analyzing unit and blood pressure values found with a blood pressure monitor is constructed in advance, and collates an analysis result found by the analyzing unit regarding the biological signal data of an evaluation-target person with the correlation data to evaluate a biological state of the person in relation to a blood pressure
analyzes the biological signal data, finds an analyzed waveform regarding heart rate variability information to represent the analyzed waveform on log-log axes, sets a quartic function for the analyzed waveform, finds a gradient between two points of inflection or a gradient of a tangent at a point of inflection depending on the number of extreme values in the quartic function
These limitations describe a mathematical calculation and/or a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
The plain meaning of the limitation “analyzes biological signal data as sound/vibration information that is propagated from a surface of a body of a person through a three-dimensional knitted fabric of a biological signal detection sensor having the three-dimensional knitted fabric and a microphone, to be detected by the microphone while the biological signal detection sensor is in contact with the body” includes mental processes that can be performed in the human mind by observations, evaluations, judgments, and opinions, or by a human with the aid of a pen and paper, or using a generic computer as a tool to perform these mental process steps in real time.
The plain meaning of the limitation “accesses a database in which correlation data of analysis results found by the analyzing unit and blood pressure values found with a blood pressure monitor is constructed in advance, and collates an analysis result found by the analyzing unit regarding the biological signal data of an evaluation-target person with the correlation data to evaluate a biological state of the person in relation to a blood pressure” includes mental processes that can be performed in the human mind by observations, evaluations, judgments, and opinions, or by a human with the aid of a pen and paper, or using a generic computer as a tool to perform these mental process steps in real time.
The plain meaning of the limitation “analyzes the biological signal data, finds an analyzed waveform regarding heart rate variability information to represent the analyzed waveform on log-log axes, sets a quartic function for the analyzed waveform, finds a gradient between two points of inflection or a gradient of a tangent at a point of inflection depending on the number of extreme values in the quartic function” includes mathematical calculations that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations steps in real time.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering. See MPEP 2106.05(g).
biological signal data as sound/vibration information that is propagated from a surface of a body of a person through a three-dimensional knitted fabric of a biological signal detection sensor having the three-dimensional knitted fabric and a microphone, to be detected by the microphone while the biological signal detection sensor is in contact with the body
outputs one of the gradients as the analysis result
The following limitations amount to a recitation of the words "apply it" (or an equivalent) and/or nothing more than mere instructions to implement the abstract idea on a generic computer. See MPEP 2106.05(f).
an analyzing unit that...
an evaluating unit that...
wherein the analyzing unit...
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
biological signal data as sound/vibration information that is propagated from a surface of a body of a person through a three-dimensional knitted fabric of a biological signal detection sensor having the three-dimensional knitted fabric and a microphone, to be detected by the microphone while the biological signal detection sensor is in contact with the body
outputs one of the gradients as the analysis result
an analyzing unit that...
an evaluating unit that...
wherein the analyzing unit...
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The evaluating unit and analyzing unit are considered to be well-understood, routine, and conventional based on a statement from the applicant's specification filed 10/24/2024 (“The biological state evaluation device 100 is constituted by a computer (including a personal computer, a microcomputer incorporated in a device, and so on) and receives the biological signal data transmitted from the microphone 30 of the biological signal detection sensor 1. It has an analyzing unit 200 and an evaluating unit 300 which perform predetermined processing using the received biological signal data”, [0032]).
The biological signal detection sensor having three-dimensional knitted fabric and a microphone is considered to be well-understood, routine, and conventional based on the disclosure of the following references: JP 5553303 B2 (pages 6-7 of attached machine translation), WO 2021086963 A1 ([0018]), US 20170265760 A1 (Abstract).
Independent Claim 35 is also not patent eligible for substantially similar reasons as it recites the same abstract idea(s) and additional element(s) as Claim 26 but as a process-type claim.
Independent Claim 41 is also not patent eligible for substantially similar reasons as it recites the same abstract idea(s) and additional element(s) as Claim 26 but as a machine-type claim.
Dependent Claim 30, 36-40, and 42-45 also fail to add subject matter qualifying as significantly more to the abstract independent claims as they merely further limit the abstract idea(s).
Dependent Claims 27-29 and 31-34 also fail to add subject matter qualifying as significantly more to the abstract independent claims as they merely further limit the abstract idea(s), recite limitations that do not integrate the claims into a practical application, and do not recite significantly more than the identified abstract idea(s).
Dependent Claim 27-29 and 31-34 also fails to add subject qualifying as significantly more to the abstract independent claims as it recites limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above and does not recite significantly more than the identified abstract idea.
Therefore, Claims 26-45 are not patent eligible under 35 U.S.C. § 101.
Examiner’s Note
The examiner notes that Claims 26-45 are not currently rejected under prior art.
Regarding Claim 26, the closest prior art (Fujita et al, JP 2019122502 A, cited in applicant’s IDS), discloses a biological state evaluation device (Element 100, Fig. 2) comprising: an analyzing unit (Element 200) that analyzes biological signal data as sound/vibration information that is propagated from a surface of a body of a person (Fig. 8) through a three-dimensional knitted fabric (Element 11, Figs. 1a-1b) of a biological signal detection sensor (Element 10, Figs. 1a-1b) having the three-dimensional knitted fabric and a microphone (Element 14, Figs. 1a-1b), to be detected by the microphone (“A microphone sensor 14 is disposed between one of the three-dimensional knitted fabric 122 and the film 123 for detecting vibration (sound) due to a back body surface pulse wave. The sensor is not limited to the microphone sensor 14 as long as it can detect a back body surface pulse wave that is a weak vibration (sound), and another sensor may be used”, page 3 of the attached machine translation) while the biological signal detection sensor is in contact with the body (“When a person is seated on or lies on his/her back for bringing his/her back into contact with on a biological signal measurement device capable of measuring a biological signal unrestrictedly, the device being attached to any kind of a chair such as a vehicular seat, a chair for desk work, or a chair for furniture, or bedding such as a bed, a blood pressure can be estimated easily”, Abstract); and
an evaluating unit (Elements 232 and 240, Fig. 2) that accesses a database in which correlation data of analysis results found by the analyzing unit and blood pressure values found with a blood pressure monitor is constructed in advance (“Therefore, it is necessary to obtain the correlation data for blood pressure estimation (correlation equation for blood pressure estimation) in advance in correspondence with the upper arm blood pressure value and the fractal slope (FS) and to set the correlation data in the storage unit”, pages 7-8 of the attached machine translation), and collates an analysis result found by the analyzing unit regarding the biological signal data of an evaluation-target person with the correlation data (“That is, as described later, when estimating blood pressure, fractal slope (FS), which is a fluctuation index of a subject, is collated with blood pressure estimation correlation data”, page 7 of the attached machine translation) to evaluate a biological state of the person in relation to a blood pressure (“By using such a method, after the blood pressure estimation correlation data is created, a predetermined frequency band can be automatically set for each subject. The newly obtained data is accumulated as new teacher data, and the blood pressure estimation correlation data (correlation equation for blood pressure estimation) is obtained again including the new teacher data. The accuracy of estimation can be increased”, page 8 of the attached machine translation).
However, neither Fujita nor any other prior art reference nor obvious combination of references in the same field of invention disclose wherein the analyzing unit analyzes the biological signal data, finds an analyzed waveform regarding heart rate variability information to represent the analyzed waveform on log-log axes, sets a quartic function for the analyzed waveform, finds a gradient between two points of inflection or a gradient of a tangent at a point of inflection depending on the number of extreme values in the quartic function, and outputs one of the gradients as the analysis result in combination with the rest of the claimed limitations.
Claims 27-34 are not currently rejected under prior art by virtue of dependence on Claim 26.
Regarding Claim 35, for substantially similar reasons as Claim 26, there is no prior art reference or obvious combination of references in the same field of invention that discloses analyzing the biological signal data, finding an analyzed waveform regarding heart rate variability information to represent the analyzed waveform on log-log axes, setting a quartic function for the analyzed waveform, finding a gradient between two points of inflection or a gradient of a tangent at a point of inflection depending on the number of extreme values in the quartic function, and outputting one of the gradients as an analysis result in combination with the rest of the claimed limitations.
Claims 36-40 are not currently rejected under prior art by virtue of dependence on Claim 35.
Regarding Claim 41, for substantially similar reasons as Claim 26, there is no prior art reference or obvious combination of references in the same field of invention that discloses analyzing the biological signal data, finding an analyzed waveform regarding heart rate variability information to represent the analyzed waveform on log-log axes, setting a quartic function for the analyzed waveform, finding a gradient between two points of inflection or a gradient of a tangent at a point of inflection depending on the number of extreme values in the quartic function, and outputting one of the gradients as an analysis result in combination with the rest of the claimed limitations.
Claims 42-45 are not currently rejected under prior art by virtue of dependence on Claim 41.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Tanriover et al (US 20170265760 A1).
See Yazawa et al (JP 2008173160 A).
See Fujita et al (JP 5553303 B2).
See Fujita et al (WO 2020166260 A1).
See Chong et al (WO 2021086963 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN EPHRAIM COOPER whose telephone number is (571)272-2860. The examiner can normally be reached Monday-Friday 7:30AM-5:30PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights