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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/27/23 is being considered by the examiner.
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 use the word “means” or “step” and are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claims 32, 36, 37, and 44 include the limitation “frequency analyzing means.” The Examiner is interpreting the biological signal analysis device as performing this function based on ¶74 of the specification “the biological signal analysis device 100 can also be actualized using an electronic circuit having one recording circuit or more in which the computer program implementing the frequency analyzing means 110.”
Claims 32-37 include the limitation “means that finds a boundary frequency.” The Examiner is interpreting the biological signal analysis device as performing this function based on ¶74 of the specification “the biological signal analysis device 100 can also be actualized using an electronic circuit having one recording circuit or more in which the computer program implementing the frequency analyzing means 110 and the boundary frequency identifying means 120 is incorporated.”
Claims 33-34, 36, and 37 include the limitation “means that finds, in the result of the frequency analysis, a power spectrum sudden changing point.” The Examiner is interpreting the biological signal analysis device as performing this function based on ¶74 of the specification “the biological signal analysis device 100 can also be actualized using an electronic circuit having one recording circuit or more in which the computer program implementing the frequency analyzing means 110 and the boundary frequency identifying means 120 is incorporated.”
Claim 35 includes the limitation “means that represent, in log-log axes, a waveform.” The Examiner is interpreting the biological signal analysis device as performing this function based on ¶74 of the specification “the biological signal analysis device 100 can also be actualized using an electronic circuit having one recording circuit or more in which the computer program implementing the frequency analyzing means 110 and the boundary frequency identifying means 120 is incorporated.”
Claim 35 includes the limitation “means that finds a fluctuation changing point.” The Examiner is interpreting the biological signal analysis device as performing this function based on ¶74 of the specification “the biological signal analysis device 100 can also be actualized using an electronic circuit having one recording circuit or more in which the computer program implementing the frequency analyzing means 110 and the boundary frequency identifying means 120 is incorporated.”
Claim 37 includes the limitation “means that outputs the analysis result of the short time Fourier transform.” The Examiner is interpreting the biological signal analysis device as performing this function based on ¶74 of the specification “the biological signal analysis device 100 can also be actualized using an electronic circuit having one recording circuit or more in which the computer program implementing the frequency analyzing means 110.”
Claims 38-43 include the limitation “means that infers a measurement-time health condition.” The Examiner is interpreting the biological signal analysis device as performing this function based on ¶19 of the specification “the biological signal analysis device further includes: a correlation data storage unit in which correlation data relating to the boundary frequency is stored; and a measurement-time condition inferring means that infers a measurement-time health condition.”
Claim 39 includes the limitation “means that infers a measurement-time boundary frequency.” The Examiner is interpreting the biological signal analysis device to perform this function based on ¶19 of the specification “the biological signal analysis device further includes:…a measurement-time condition inferring means.”
Claim 40 includes the limitation “means that infers a measurement-time fluctuation characteristic of heart rate variability.” The Examiner is interpreting the biological signal analysis device to perform this function based on ¶80 of the specification “the biological signal analysis device 100 of this embodiment has:…a measurement-time condition inferring means 130.”
Claims 41-43 include the limitation “means that filters the biological signal data.” The Examiner is interpreting the computer to perform this function based on ¶31 of the specification “the computer is further caused to execute: a procedure that filters the biological signal data.”
Claims 41 and 43-44 include the limitation “means that classifies the waveform of the vibration.” The Examiner is interpreting the biological signal analysis device as performing this function based on ¶21 of the specification “the biological signal analysis device further includes: a cardiac apex beat waveform extracting means that filters the biological signal data, with an upper limit value being set to the boundary frequency identified by the boundary frequency identifying means, to find a waveform of the vibration generated by the cardiac apex beat; and a waveform classifying means that classifies the waveform of the vibration generated by the cardiac apex beat.”
Claims 41-42 include the limitation “means that causes the waveform classifying means to classify a measurement-time waveform of the vibration.” The Examiner is interpreting the biological signal analysis device as performing this function based on ¶21 of the specification “the biological signal analysis device further includes:… the measurement-time condition inferring means includes a means that causes the waveform classifying means to classify a measurement-time waveform of the vibration.”
Claim 43 includes the limitation “means that uses information on waveforms and the health conditions as training data.” The Examiner is interpreting the biological signal analysis device as performing this function based on ¶122 of the specification “as illustrated in FIG. 31, the biological signal analysis device 100 may further include a model creating means 180 that uses, as training data, the health conditions and the waveform information.”
Claim 43 includes the limitation “means that receives the information of the measurement-time waveform of the vibration.” The Examiner is interpreting the biological signal analysis device as performing this function based on ¶23 of the specification “the biological signal analysis device includes…the measurement-time condition inferring means includes a means that receives the information of the measurement-time waveform of the vibration generated by the cardiac apex beat of the measurement subject.”
Claim 44 includes the limitation “means that classifies the waveform by a mathematical approach using Fourier series expansion.” The Examiner is interpreting the biological signal analysis device as performing this function based on ¶115 of the specification “a biological signal analysis device 100 includes a cardiac apex beat waveform extracting means 160 and a waveform classifying means 170.”
Claim 44 includes the limitation “means that classifies the waveform based on a combination of one or two or more of the following data.” The Examiner is interpreting the biological signal analysis device as performing this function based on ¶115 of the specification “a biological signal analysis device 100 includes a cardiac apex beat waveform extracting means 160 and a waveform classifying means 170.”
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:
“storage unit” in claims 38 and 42.
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.
For the limitation of “storage unit” in claims 38 and 42, the specification recites “the storage unit (including not only a recording medium such as an internal hard disk as the computer (biological signal analysis device 100) but also various types of removable recording media and a recording medium of another computer connected through communication means)” in ¶74. Therefore, the Examiner is interpreting the storage unit to be not only a recording medium such as an internal hard disk as the computer (biological signal analysis device 100) but also various types of removable recording media and a recording medium of another computer connected through communication means.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 43 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
For the limitation of “create, by machine learning, an inference model for inferring the health condition” in claim 43, this is a computer implemented functional limitation “inferring the health condition is created from the waveform information by machine learning” according to ¶32 of the disclosure. ¶31 of the specification fails to disclose how the machine learning algorithm is used to infer the health condition. MPEP 2161.01(I) states the following:
Claims may lack written description when the claims define the invention in functional language
specifying a desired result but the specification does not sufficiently describe how the function is
performed or the result is achieved. For software, this can occur when the algorithm or
steps/procedure for performing the computer function are not explained at all or are not
explained in sufficient detail (simply restating the function recited in the claim is not necessarily
sufficient). In other words, the algorithm or steps/procedure taken to perform the function must
be described with sufficient detail so that one of ordinary skill in the art would understand how
the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection
IV.”
Applicant has claimed a black-box algorithm without any clear description of what is inside the box to determine the health condition. This is a functional result and the description is lacking information, for instance, how is the model trained, what are the inputs to the model, what is the order of the inputs into the model, and how are the weights determined for the model? Therefore, the claims with the limitation of “create, by machine learning, an inference model for inferring the health condition” are rejected under 112(a) for failing to meet the written description requirement.
Claims 38-44 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 38 and 41-44 recites “health condition”. The specification discloses:
“health conditions (the presence/absence of a disease such as a heart disease, the identification of a disease, whether or not the physical condition is good or not, and so on)” (¶35).
However, there is insufficient written description under 35 U.S.C. 112(a), due to only disclosing some of the many species that encompass the broad or large genus of any or all possible health conditions. MPEP 2163(II)(A)(3)(a)(ii) states:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").”
There is not a sufficient number of species disclosed to encompass the broad or large genus of any or all possible health conditions. High blood pressure, high cholesterol, and diabetes differ greatly from other species that could fall within the genus such as high blood pressure (hypertension) (see attached reference), high cholesterol (see attached reference), and diabetes (see attached reference).
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 43-44 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 43 recites the limitation "the health conditions" in lines 2 and 8-9. There is insufficient antecedent basis for this limitation in the claim.
In claim 44, the limitation of “one or two or more” for step (B) seems unclear. It remains unclear what is required by the claim. Therefore, the Examine is interpreting a minimum of one step of (1) to (4) to be required by the claim.
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 45-51 are rejected under 35 U.S.C. 101 as not falling within one of the four statutory categories of invention and thus fails as eligible subject matter. Claims 45-51 characterize the invention as a computer program.
MPEP 2106.03(I) recites:
Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations.
Claims 32-44 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically abstract idea without significantly more.
Step 1
The claimed invention in claims 32-44 are directed to statutory subject matter as the claims recite a biological signal analysis device and a computer program for processing biological signal data.
Step 2A, Prong One
Regarding claim 32, the recited steps are directed to mathematical concepts (see MPEP 2106.04(a)(2) subsection (I)).
Regarding claim 32, the limitations of “frequency-analyzes biological signal data and a boundary frequency identifying means that finds a boundary frequency between vibration generated by cardiac apex beat and vibration generated by heart sound in the biological signal data” are mathematical calculations of performing short time Fourier transform, addition averaging and log difference in order to process biological signal data.
Step 2A, Prong Two
For claim 32, the judicial exception is not integrated into a practical application. In particular, claim 32 recites “a biological signal detection sensor.” The sensor amounts to nothing more than pre-solution activity of data gathering. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into
a practical application, the additional element of a sensor amounts to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the sensor is well-understood, routine, and conventional activity as evidenced by US 20060047215 as cited in the IDS (¶30-an acoustic sensor, in this instance, a conventional microphone 60), US 20130324848 (¶116-the cardiac sound sensor 305a is a sensor for measuring a cardiac sound, and may be a conventional cardiac sound sensor), and US 20050033190 (¶20-the specific constructions of these electrode structures and sound sensors form no part of the present invention, may be quite conventional in construction). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)). In this case, elements of general computer are being used to implement the abstract idea.
Regarding dependent claims 33-44, the limitations of claim 32 further define the limitations already indicated as being directed to the abstract idea.
Claims 33-36, 38-42, and 44 further define the abstract idea.
Claims 37, 43, and 50 further defines the abstract idea and post-solution activity.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 32-33, 45-46, and 51 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Fujita ‘516 (JP 2016026516 filed on 9/7/14 as cited in the IDS, a copy relied upon is being furnished with this Office Action).
Regarding claim 32 and 45, Fujita ‘516 teaches a biological signal analysis device and a computer program, comprising: a frequency analyzing means that frequency-analyzes biological signal data obtained by a biological signal detection sensor through a body surface (¶8-analyze biological signals with higher accuracy, and further, low frequency sound / vibration information such as biological signals; ¶38-the loudest sound is produced at the apex, the microphone sensor 14 should be provided near this area); and a boundary frequency identifying means that finds a boundary frequency between vibration generated by cardiac apex beat and vibration generated by heart sound in the biological signal data, from a result of the frequency analysis of the biological signal data which result is obtained from the frequency analyzing means (¶38-the loudest sound is produced at the apex, the microphone sensor 14 should be provided near this area; ¶109-this quantification point performs FFT on the frequency slope time-series waveform, divides the logarithmically displayed waveform into three sections centered on 0.003 Hz, 0.01 Hz, and 0.015 Hz, and draws an approximation line; ¶81-the combined waveform of the power spectrum of 20 to 30 Hz of external vibration input and the sound and vibration information of the heart and vascular system and the APW obtained by processing it capture the cardiac cycle characteristics, and the power spectrum of the external vibration is APW).
Regarding claim 33, Fujita ‘516 teaches the biological signal analysis device according to claim 32, wherein the boundary frequency identifying means includes means that finds, in the result of the frequency analysis, a power spectrum sudden changing point which is a boundary between harmonic vibration and random vibration and identifies the boundary frequency based on the sudden changing point (¶81- from FIG. 30, the combined waveform of the power spectrum of 20 to 30 Hz of external vibration input and the sound and vibration information of the heart and vascular system and the APW obtained by processing it capture the cardiac cycle characteristics, and the power spectrum of the external vibration is APW. It can be seen that a superimposed and amplified output is obtained; ¶61).
Regarding claim 46, Fujita ‘516 teaches the computer program according to claim 45, wherein the procedure that identifies the boundary frequency finds, in the result of the frequency analysis, a power spectrum sudden changing point which is a boundary between harmonic vibration and random vibration, and identifies the boundary frequency based on the sudden changing point (¶81- from FIG. 30, the combined waveform of the power spectrum of 20 to 30 Hz of external vibration input and the sound and vibration information of the heart and vascular system and the APW obtained by processing it capture the cardiac cycle characteristics, and the power spectrum of the external vibration is APW. It can be seen that a superimposed and amplified output is obtained; ¶61).
Regarding claim 51, Fujita ‘516 teaches a recording medium in which the computer program according to claim 45 is recorded (¶57-each biological signal was recorded on a data logger for 5 minutes at a sampling frequency of 200 Hz).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 34 and 47 rejected under 35 U.S.C. 103 as being unpatentable over Fujita ‘516 in view of Fujita ‘141 (US 20150182141 filed on 5/30/13).
Regarding claim 34, Fujita ‘516 teaches the biological signal analysis device according to claim 33. However, Fujita ‘516 does not teach wherein the boundary frequency identifying means includes means that finds the power spectrum sudden changing point, in consideration of a result of a frequency analysis of heart sound data measured simultaneously.
Fujita ‘141 teaches wherein the boundary frequency identifying means includes means that finds the power spectrum sudden changing point (¶184-this period from 900 to 1800 seconds, the power value had a peak in a band with respect to 0.0055 Hz, and the maximum Lyapunov index had two peaks in a power spectrum at 0.0033 Hz and 0.0055 Hz), in consideration of a result of a frequency analysis of heart sound data measured simultaneously (¶165-the frequency analysis results of apex beat and heart sound indicate respiratory components that were confirmed by analyzing the frequency of a biological signal obtained simultaneously by the respiration sensor).
Fujita ‘141 relates to a biological state analyzer and a computer program that analyze the state of a human being using a biological signal extracted from an upper part of a human being (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Fujita ‘516 to include wherein the boundary frequency identifying means includes means that finds the power spectrum sudden changing point, in consideration of a result of a frequency analysis of heart sound data measured simultaneously of Fujita ‘141 in order to analyze the state of a human being using a biological signal extracted from an upper part of a human being (Fujita ‘141, ¶1).
Regarding claim 47, Fujita ‘516 teaches the computer program according to claim 46. However, Fujita ‘516 does not teach wherein the procedure that identifies the boundary frequency finds the power spectrum sudden changing point, in consideration of a result of a frequency analysis of heart sound data measured simultaneously.
Fujita ‘141 teaches wherein the procedure that identifies the boundary frequency finds the power spectrum sudden changing point (¶184-this period from 900 to 1800 seconds, the power value had a peak in a band with respect to 0.0055 Hz, and the maximum Lyapunov index had two peaks in a power spectrum at 0.0033 Hz and 0.0055 Hz), in consideration of a result of a frequency analysis of heart sound data measured simultaneously (¶165-the frequency analysis results of apex beat and heart sound indicate respiratory components that were confirmed by analyzing the frequency of a biological signal obtained simultaneously by the respiration sensor).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Fujita ‘516 to include wherein the procedure that identifies the boundary frequency finds the power spectrum sudden changing point, in consideration of a result of a frequency analysis of heart sound data measured simultaneously of Fujita ‘141 in order to analyze the state of a human being using a biological signal extracted from an upper part of a human being (Fujita ‘141, ¶1).
Claims 35 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Fujita ‘516 in view of Fujita ‘141 as applied to claims 34 and 47 above, and further in view of Fujita ‘603 (US 20140371603 filed on 11/15/12).
Regarding claim 35, the combination of Fujita ‘516 and Fujita ‘141 teaches the biological signal analysis device according to claim 34. However, the combination of Fujita ‘516 and Fujita ‘141 does not teach wherein the boundary frequency identifying means includes: a log-log plot means that represents, in log-log axes, a waveform resulting from addition averaging of the results of the frequency analyses of the biological signal data and the heart sound data, using a log difference method, and a sudden changing point identifying means that finds a fluctuation changing point from the waveform represented in log-log axes and identifies the fluctuation changing point as the power spectrum sudden changing point.
Fujita ‘603 teaches wherein the boundary frequency identifying means includes: a log-log plot means that represents, in log-log axes, a waveform resulting from addition averaging of the results of the frequency analyses of the biological signal data and the heart sound data, using a log difference method (¶428-the results are displayed in a log-log graph plotting the frequency on the horizontal axis and the power spectral density on the vertical axis; ¶46-outputs a time-series change in the average values of the frequencies obtained in the respective time windows as a frequency fluctuation time-series waveform, wherein the frequency analysis means is preferably a means that analyzes frequencies of the frequency fluctuation time-series waveform obtained by the frequency fluctuation computation means and outputs the fluctuation waveform as a log-log graph of frequency and power spectral density), and a sudden changing point identifying means that finds a fluctuation changing point from the waveform represented in log-log axes and identifies the fluctuation changing point as the power spectrum sudden changing point (¶45-outputs the fluctuation waveform as a log-log graph of frequency and power spectral density; ¶283-difference in the values of the power spectral density. This break point is a bifurcation phenomenon occurring in an irregular vibration system, and this phenomenon changes depending on a time width in which disturbance changes and appears when a fluctuation of the biological state changes; ¶13-digitizing a fluctuation waveform obtained through frequency analysis and determining whether main resonance indicating heart rate fluctuation obtained from the biological signal is a harmonic oscillation system or an irregular vibration system).
Fujita ‘603 relates to a technique of detecting biological signals including indices of an autonomic nervous system and reaction information of the autonomic nervous system to estimate a biological state (in particular, a normal fatigued state where fatigue accumulates due to activities, a function recovery state realized by a predetermined function recovery means, or a slump state) from a relative change in a sympathetic nerve function in relation to a predetermined state of a parasympathetic nerve function controlled by the sympathetic nerve function or a relative change in a sympathetic nerve function in relation to a predetermined state of a parasympathetic nerve function (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Fujita ‘516 to include wherein the boundary frequency identifying means includes: a log-log plot means that represents, in log-log axes, a waveform resulting from addition averaging of the results of the frequency analyses of the biological signal data and the heart sound data, using a log difference method, and a sudden changing point identifying means that finds a fluctuation changing point from the waveform represented in log-log axes and identifies the fluctuation changing point as the power spectrum sudden changing point of Fujita ‘603 in order to more accurately perceiving change in a person's status (Fujita ‘603, Abstract).
Regarding claim 48, the combination of Fujita ‘516 and Fujita ‘141 teaches the computer program according to claim 47. However, the combination of Fujita ‘516 and Fujita ‘141 does not teach wherein the procedure that identifies the boundary frequency represents, in log-log axes, a waveform resulting from addition averaging of the results of the frequency analyses of the biological signal data and the heart sound data, using a log difference method, finds a fluctuation changing point from the waveform represented in log-log axes, and identifies the fluctuation changing point as the power spectrum sudden changing point.
Fujita ‘603 teaches wherein the procedure that identifies the boundary frequency represents, in log-log axes, a waveform resulting from addition averaging of the results of the frequency analyses of the biological signal data and the heart sound data, using a log difference method (¶428-the results are displayed in a log-log graph plotting the frequency on the horizontal axis and the power spectral density on the vertical axis; ¶46-outputs a time-series change in the average values of the frequencies obtained in the respective time windows as a frequency fluctuation time-series waveform, wherein the frequency analysis means is preferably a means that analyzes frequencies of the frequency fluctuation time-series waveform obtained by the frequency fluctuation computation means and outputs the fluctuation waveform as a log-log graph of frequency and power spectral density), finds a fluctuation changing point from the waveform represented in log-log axes, and identifies the fluctuation changing point as the power spectrum sudden changing point (¶45-outputs the fluctuation waveform as a log-log graph of frequency and power spectral density; ¶283-difference in the values of the power spectral density. This break point is a bifurcation phenomenon occurring in an irregular vibration system, and this phenomenon changes depending on a time width in which disturbance changes and appears when a fluctuation of the biological state changes; ¶13-digitizing a fluctuation waveform obtained through frequency analysis and determining whether main resonance indicating heart rate fluctuation obtained from the biological signal is a harmonic oscillation system or an irregular vibration system).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Fujita ‘516 to include wherein the procedure that identifies the boundary frequency represents, in log-log axes, a waveform resulting from addition averaging of the results of the frequency analyses of the biological signal data and the heart sound data, using a log difference method, finds a fluctuation changing point from the waveform represented in log-log axes, and identifies the fluctuation changing point as the power spectrum sudden changing point of Fujita ‘603 in order to more accurately perceiving change in a person's status (Fujita ‘603, Abstract).
Claims 36-37 and 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over Fujita ‘516 in view of Kametani (US 20190051315 filed on 1/29/16).
Regarding claim 36, Fujita ‘516 teaches the biological signal analysis device according to claim 33. However, Fujita ‘516 does not teach wherein short time Fourier transform is employed as the frequency analyzing means, and wherein the boundary frequency identifying means includes means that finds the power spectrum sudden changing point from an analysis result of the short time Fourier transform.
Kametani teaches wherein short time Fourier transform is employed as the frequency analyzing means, and wherein the boundary frequency identifying means includes means that finds the power spectrum sudden changing point from an analysis result of the short time Fourier transform (¶94-when the time-axis waveform is time-frequency-analyzed to obtain the power spectrum, an N-point short-time Fourier transform and a logarithmic transformation may be firstly performed on a value x(n) at a time point n of the time-axis waveform in units of frames, each of which has a length N. By this, a time-frequency-analyzed waveform P Log [n,ω] is calculated).
Kametani relates to a biological sound analyzing apparatus and a biological sound analyzing method for analyzing biological sounds, which may include noise, such as, for example, continuous adventitious lung sounds, a computer program, and a recording medium (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Fujita ‘516 to include wherein short time Fourier transform is employed as the frequency analyzing means, and wherein the boundary frequency identifying means includes means that finds the power spectrum sudden changing point from an analysis result of the short time Fourier transform of Kametani in order to more accurately distinguish the continuous sounds (Kametani, ¶147).
Regarding claim 37, the combination of Fujita ‘516 and Kametani teaches the biological signal analysis device according to claim 36, wherein the frequency analyzing means includes means that outputs the analysis result of the short time Fourier transform as image data showing time, frequency, and a degree of power spectrum variation, and wherein the boundary frequency identifying means includes means that finds the power spectrum sudden changing point from the image data (Kametani, ¶89-display various information outputted from the processor 200 as image data; ¶94-when the time-axis waveform is time-frequency-analyzed to obtain the power spectrum, an N-point short-time Fourier transform and a logarithmic transformation may be firstly performed on a value x(n) at a time point n of the time-axis waveform in units of frames, each of which has a length N. By this, a time-frequency-analyzed waveform P Log [n,ω] is calculated; Figs. 20-21 and 23-24).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Fujita ‘516 to include wherein the frequency analyzing means includes means that outputs the analysis result of the short time Fourier transform as image data showing time, frequency, and a degree of power spectrum variation, and wherein the boundary frequency identifying means includes means that finds the power spectrum sudden changing point from the image data of Kametani in order to more accurately distinguish the continuous sounds (Kametani, ¶147).
Regarding claim 49, Fujita ‘516 teaches the computer program according to claim 46. However, Fujita ‘516 does not teach wherein in the frequency analyzing procedure, short time Fourier transform is employed, and wherein the procedure that identifies the boundary frequency finds the power spectrum sudden changing point from an analysis result of the short time Fourier transform.
Kametani teaches wherein in the frequency analyzing procedure, short time Fourier transform is employed, and wherein the procedure that identifies the boundary frequency finds the power spectrum sudden changing point from an analysis result of the short time Fourier transform (¶94-when the time-axis waveform is time-frequency-analyzed to obtain the power spectrum, an N-point short-time Fourier transform and a logarithmic transformation may be firstly performed on a value x(n) at a time point n of the time-axis waveform in units of frames, each of which has a length N. By this, a time-frequency-analyzed waveform P Log [n,ω] is calculated).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Fujita ‘516 to include wherein in the frequency analyzing procedure, short time Fourier transform is employed, and wherein the procedure that identifies the boundary frequency finds the power spectrum sudden changing point from an analysis result of the short time Fourier transform of Kametani in order to more accurately distinguish the continuous sounds (Kametani, ¶147).
Regarding claim 50, the combination of Fujita ‘516 and Kametani teaches the computer program according to claim 49, wherein the frequency analyzing procedure outputs the analysis result of the short time Fourier transform as image data showing time, frequency, and a degree of power spectrum variation, and wherein the procedure that identifies the boundary frequency finds the power spectrum sudden changing point from the image data (Kametani, ¶89-display various information outputted from the processor 200 as image data; ¶94-when the time-axis waveform is time-frequency-analyzed to obtain the power spectrum, an N-point short-time Fourier transform and a logarithmic transformation may be firstly performed on a value x(n) at a time point n of the time-axis waveform in units of frames, each of which has a length N. By this, a time-frequency-analyzed waveform P Log [n,ω] is calculated; Figs. 20-21 and 23-24).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Fujita ‘516 to include wherein the frequency analyzing procedure outputs the analysis result of the short time Fourier transform as image data showing time, frequency, and a degree of power spectrum variation, and wherein the procedure that identifies the boundary frequency finds the power spectrum sudden changing point from the image data of Kametani in order to more accurately distinguish the continuous sounds (Kametani, ¶147).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Fujita ‘516 in view of
Inami (WO 2012090361 filed on 10/4/11).
Regarding claim 38, Fujita ‘516 teaches the biological signal analysis device according to claim 32. However, Fujita ‘516 does not teach a correlation data storage unit in which correlation data relating to the boundary frequency is stored; and a measurement-time condition inferring means that infers a measurement-time health condition of a measurement subject, by referring to the correlation data.
Inami teaches a correlation data storage unit in which correlation data relating to the boundary frequency is stored (page 2, 2nd to last ¶-a feature amount storage unit for setting and saving a feature amount relating to an activity amount effective for obtaining a correlation between a user's activity amount and vital data based on the amount of activity and vital data in the vital data measurement device; page 7, 2nd to last ¶-high frequency component HF of the heart rate variation (R - R interval variation) and the low frequency component LF); and a measurement-time condition inferring means that infers a measurement-time health condition of a measurement subject, by referring to the correlation data (page 9, 2nd to last ¶-the measurement timing control apparatus of the present invention can be used for a health management system and the like, and is particularly useful when measuring the correlation between a user's activity state and life pattern and vital data effectively).
Inami relates to a device used in a health management system or the like for measuring vital data, and more particularly to a measurement timing control device for controlling measurement timing of vital data in a measuring instrument (page 1, ¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Fujita ‘516 to include a correlation data storage unit in which correlation data relating to the boundary frequency is stored; and a measurement-time condition inferring means that infers a measurement-time health condition of a measurement subject, by referring to the correlation data of Inami in order for performing user diagnosis and advising on daily life guidance (Inami, page 3, 2nd to last ¶).
Claims 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Fujita ‘516 in view of Inami as applied to claim 38 above, and further in view of Fujita ‘996 (JP 2018093996 filed on 12/9/16).
Regarding cl