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 November 22, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been 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 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 limitations use 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 limitations are: “pulse acquisition mechanism” in claims 1, 6, and 7, “pulse interval calculation mechanism” in claims 1, 6, and 7, “display mechanism” in claims 1-2, 6-7, and “sound output mechanism” in claims 17-18.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
[0068] describes that the “pulse acquisition mechanism” is a sensor unit.
The “pulse interval calculation mechanism” does not have any corresponding structure described in the specification.
[0012] and [0065] of describe that the “display mechanism” is an LCD or LED light.
[0065] describes that the “sound output mechanism” is a speaker.
If applicant does not intend to have this/these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-6 and 15-16 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 2 recites the limitation "the number of the regions" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the number of the plurality of display segments" in line 5. There is insufficient antecedent basis for this limitation in the claim.
The term “large” and the term “small” in claims 4 and 6 are relative terms which render the claims indefinite. The term “large” and the term “small” 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. Because the specification does not specify what is considered “large” and what is considered “small”, there is indefiniteness in the claim that introduces uncertainty as to when direct infringement would occur.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-18 are directed to biological information measurement devices using a computational algorithm, which is an abstract idea. Claims 1-18 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a machine.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] – “a pulse interval calculation mechanism configured to calculate, based on the pulse, a pulse interval between one beat and an immediately preceding beat”
This element [A1] of claim 1 is drawn to an abstract idea since it involves a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] – “a pulse acquisition mechanism configured to detect a pulse of a human body”;
[B2] – “a display mechanism configured to display a level indicator visually indicating the pulse interval”;
[C2] – “the level indicator indicates, per beat of the pulse detected, the pulse interval”.
These elements [A2]-[C2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the elements [A2-C2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering and display at a high level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “a pulse acquisition mechanism configured to detect a pulse of the human body” does not qualify as significantly more because this limitation is merely insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements or simply displaying the results of the algorithm that uses conventional, routine, and well-known elements. In particular, the pulse acquisition mechanism is merely a generic sensor unit that collects pulse data, which does not qualify as a particular machine.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 2-5 and 13-18 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claims 17-18: “a sound output mechanism”.
Each of these claim limitations does not integrate the exception into a practical application. In particular, the elements of claims 17-18 are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering and output of results at a high level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the sound output mechanism is nothing more than a generic speaker.
Also, this limitation from claims 17-18 is simply appending well-understood, routine and conventional activities previously known in 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 is, one of display) that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
The analysis of claim 6 is as follows:
Step 1: Claim 6 is drawn to a process.
Step 2A – Prong One: Claim 6 recites an abstract idea. In particular, claim 6 recites the following limitations:
[A1] – “a pulse interval calculation mechanism configured to calculate, based on the pulse, a pulse interval between one beat and an immediately preceding beat”.
These elements [A1] of claim 6 is drawn to an abstract idea since it involves a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 6 recites the following limitations that are beyond the judicial exception:
[A2] – “a pulse acquisition mechanism configured to detect a pulse of a human body”;
[B2] – “a display mechanism configured to display a level indicator visually indicating at least one of the pulse interval or an amount of change from another pulse interval immediately before the pulse interval”;
[C2] – “the level indicator is composed of a plurality of display segments and visually indicates, per beat of the pulse, the pulse interval or the amount of change depending on whether the number of the plurality of display segments in which display is activated is large or small”;
[D2] – “the display mechanism further displays a sub-indicator including a plurality of sub-display segments corresponding one-to-one to the plurality of display segments of the level indicator”;
[E2] – “the level indicator maintains activation of display of a peak level portion of one pulse interval or one amount of change from display of the one pulse interval or the one amount of change until display of a next pulse interval or a next amount of change”;
[F2] – “the sub-indicator activates, per beat, display of a sub-display segment of the plurality of sub-display segments that corresponds to the display of the peak level portion of the pulse interval or the amount of change indicated per beat by the level indicator and maintains display of each sub-display segment activated until the detection by the pulse acquisition mechanism is finished”.
These elements [A2]-[F2] of claim 6 do not integrate the exception into a practical application of the exception. In particular, the elements [A2-F2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering and display of data at a high level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 6 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “a pulse acquisition mechanism configured to detect a pulse of the human body” does not qualify as significantly more because this limitation is merely insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements or simply displaying the results of the algorithm that uses conventional, routine, and well-known elements. In particular, the pulse acquisition mechanism is merely a generic sensor unit that collects pulse data, which does not qualify as a particular machine.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
The analysis of claim 7 is as follows:
Step 1: Claim 7 is drawn to a machine.
Step 2A – Prong One: Claim 7 recites an abstract idea. In particular, claim 7 recites the following limitations:
[A1] – “a pulse interval calculation mechanism configured to calculate, based on the pulse, a pulse interval between one beat and an immediately preceding beat”.
This elements [A1] of claim 7 is drawn to an abstract idea since it involves a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 7 recites the following limitations that are beyond the judicial exception:
[A2] – “a pulse acquisition mechanism configured to detect a pulse of a human body”;
[B2] – “a display mechanism configured to display a level indicator visually indicating at least one of the pulse interval or an amount of change from another pulse interval immediately before the pulse interval”;
[C2] – “the level indicator is composed of a plurality of display segments”;
[D2] – “a display segment in which display is activated in the level indicator makes a transition”; and
[E2] – “the pulse interval or the amount of change is visually indicated per beat of the pulse by a length of a distance of the transition”.
These elements [A2]-[E2] of claim 7 do not integrate the exception into a practical application of the exception. In particular, the elements [A2-E2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering and display of data at a high level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 6 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “a pulse acquisition mechanism configured to detect a pulse of the human body” does not qualify as significantly more because this limitation is merely insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements or simply displaying the results of the algorithm that uses conventional, routine, and well-known elements. In particular, the pulse acquisition mechanism is merely a generic sensor unit that collects pulse data, which does not qualify as a particular machine.
Claims 8-12 depend from claim 7, and recite the same abstract idea as claim 7. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200405245 A1.
Regarding claim 1, Tezuka teaches a biological information measurement device ([0046] “vital information display apparatus 10”), comprising:
a pulse acquisition mechanism configured to detect a pulse of a human body ([0007] “acquiring vital information including information of a human pulse wave from the video data of the detection area and generates an information display picture to be used for performing heart rate variability biofeedback using the vital information”; [0053]);
a pulse interval calculation mechanism configured to calculate, based on the pulse, a pulse interval between one beat and an immediately preceding beat ([0061] “a heart rate can be calculated and vital information such as a heartbeat interval (RRI: R-R interval) can be extracted by performing the filtering processing and the waveform examination processing on a signal representing a skin color variation of the image taken”; [0066] “an RRI can be calculated from an interval between mountain peaks of the waveform of the variation component display 34 shown in the figure.”; [0082] “the vital information display apparatus 10 calculates a fluctuation of the RRI data recorded in the memory 15 and checks regularity (periodicity) of RRIs in a prescribed interval (S17).”); and
a display mechanism configured to display a level indicator visually indicating the pulse interval (Figs. 5A-5B, [0063] “The information display picture 30 may include a face image display 33 of a face detection area of the user and a display 34 of variation components including a pulse wave extracted from an image taken.”; Fig. 9; [0066] “an RRI can be calculated from an interval between mountain peaks of the waveform of the variation component display 34 shown in the figure.”; [0080]; [0086] “various kinds of image data such as a skin color average value acquired from an image taken of a user face portion, a heart rate (BR), history information of a heart rate variation (RRIs), various vital indices (CV-RR, SDNN, rMSSD, LF/HF, tone, entropy, etc.), and a Lorentz-plot curve can be displayed as the acquired data displays 39.”), wherein
the level indicator indicates, per beat of the pulse detected, the pulse interval ([0049] “an indicator indicating states of breathing and heart beats of the user (judgment results)”; [0063] “an indicator 32 indicating states of breathing and heart beats of the user, etc. The breathing pacer 31 and the indicator 32 are provided in a region in the vicinity of the longer side that is closest to the camera 11, in the information display picture 30.”; [0064] “The indicator 32 is an index display indicating feedback information of a result of judgment as to whether heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user. For example, if it is judged that heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user, the display of the indicator 32 elongates gradually.”; [0066] “an RRI can be calculated from an interval between mountain peaks of the waveform of the variation component display 34 shown in the figure.”; [0086]).
Regarding claim 2, Tezuka teaches the biological information measurement device according to claim 1, wherein
the level indicator visually indicates the pulse interval by using at least one of a length, an area, or an angle of a region in which display is activated at the display mechanism or the number of the regions (Figs. 5A-5B, [0063] “The information display picture 30 may include a face image display 33 of a face detection area of the user and a display 34 of variation components including a pulse wave extracted from an image taken.”; Fig. 9; [0064] “The indicator 32 is an index display indicating feedback information of a result of judgment as to whether heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user. For example, if it is judged that heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user, the display of the indicator 32 elongates gradually.”; [0066] “an RRI can be calculated from an interval between mountain peaks of the waveform of the variation component display 34 shown in the figure.”; [0080]).
Regarding claim 3, Tezuka teaches the biological information measurement device according to claim 2, wherein
the level indicator visually indicates the pulse interval by using a size indicated by a display region in which display is activated in the level indicator ([0064] “The indicator 32 is an index display indicating feedback information of a result of judgment as to whether heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user. For example, if it is judged that heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user, the display of the indicator 32 elongates gradually … The length of the bar is changed in such a manner that, for example, the bar is short in a state that the heart rate variation is unstable, is elongated as the heart rate variation becomes more stable, and is kept long in a state that the heart rate variation is stable.”).
Regarding claim 4, Tezuka teaches the biological information measurement device according to claim 3, wherein
the level indicator is composed of a plurality of display segments and represents the size of the display region depending on whether the number of the plurality of display segments in which display is activated is large or small ([0049] “an indicator indicating states of breathing and heart beats of the user (judgment results)”; [0063] “an indicator 32 indicating states of breathing and heart beats of the user, etc. The breathing pacer 31 and the indicator 32 are provided in a region in the vicinity of the longer side that is closest to the camera 11, in the information display picture 30.”; [0064] “The indicator 32 is an index display indicating feedback information of a result of judgment as to whether heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user. For example, if it is judged that heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user, the display of the indicator 32 elongates gradually … The length of the bar is changed in such a manner that, for example, the bar is short in a state that the heart rate variation is unstable, is elongated as the heart rate variation becomes more stable, and is kept long in a state that the heart rate variation is stable.”).
Regarding claim 5, Tezuka teaches the biological information measurement device according to claim 3, wherein
the level indicator maintains activation of display of a peak level portion of one pulse interval from display of the one pulse interval until display of a next pulse interval ([0063-0066]; Fig. 7; [0080] “At this step, the vital information display apparatus 10 measures a heart rate by measuring RRIs as vital information through calculation (S14). Then the vital information display apparatus 10 judges whether RRIs have been measured normally (S15). If RRIs have not been measured normally or updated, the vital information display apparatus 10 moves to end judgment processing (S21). If RRIs have been measured normally, the vital information display apparatus 10 records RRI data acquired sequentially in the memory 16 (S16).”; [0081] “DSP 14 updates the RRI sequentially at the timing of the maximum points (black circles).”).
Regarding claim 6, Tezuka teaches a biological information measurement device ([0046] “vital information display apparatus 10”), comprising:
a pulse acquisition mechanism configured to detect a pulse of a human body ([0007] “acquiring vital information including information of a human pulse wave from the video data of the detection area and generates an information display picture to be used for performing heart rate variability biofeedback using the vital information”; [0053]);
a pulse interval calculation mechanism configured to calculate, based on the pulse, a pulse interval between one beat and an immediately preceding beat ([0061] “a heart rate can be calculated and vital information such as a heartbeat interval (RRI: R-R interval) can be extracted by performing the filtering processing and the waveform examination processing on a signal representing a skin color variation of the image taken”; [0066] “an RRI can be calculated from an interval between mountain peaks of the waveform of the variation component display 34 shown in the figure.”; [0082] “the vital information display apparatus 10 calculates a fluctuation of the RRI data recorded in the memory 15 and checks regularity (periodicity) of RRIs in a prescribed interval (S17).”); and
a display mechanism configured to display a level indicator visually indicating at least one of the pulse interval or an amount of change from another pulse interval immediately before the pulse interval (Figs. 5A-5B, [0063] “The information display picture 30 may include a face image display 33 of a face detection area of the user and a display 34 of variation components including a pulse wave extracted from an image taken.”; Fig. 9; [0066] “an RRI can be calculated from an interval between mountain peaks of the waveform of the variation component display 34 shown in the figure.”; [0080]; [0086] “various kinds of image data such as a skin color average value acquired from an image taken of a user face portion, a heart rate (BR), history information of a heart rate variation (RRIs), various vital indices (CV-RR, SDNN, rMSSD, LF/HF, tone, entropy, etc.), and a Lorentz-plot curve can be displayed as the acquired data displays 39.”), wherein
the level indicator is composed of a plurality of display segments and visually indicates, per beat of the pulse, the pulse interval or the amount of change depending on whether the number of the plurality of display segments in which display is activated is large or small ([0049] “an indicator indicating states of breathing and heart beats of the user (judgment results)”; [0063] “an indicator 32 indicating states of breathing and heart beats of the user, etc. The breathing pacer 31 and the indicator 32 are provided in a region in the vicinity of the longer side that is closest to the camera 11, in the information display picture 30.”; [0064] “The indicator 32 is an index display indicating feedback information of a result of judgment as to whether heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user. For example, if it is judged that heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user, the display of the indicator 32 elongates gradually.”),
the display mechanism further displays a sub-indicator including a plurality of sub-display segments corresponding one-to-one to the plurality of display segments of the level indicator ([0082] “to produce a vital information judgment result, the vital information display apparatus 10 judges whether the RRIs match the breathing pacer in periodicity (S18). Whether the RRIs match the breathing pacer in periodicity is judged by, for example, judging whether the difference in, for example, cycle period or fluctuation, between the RRIs and the breathing pacer is smaller than or equal to a prescribed threshold value.”; [0083]; Fig. 6 – S18, S19, S20),
the level indicator maintains activation of display of a peak level portion of one pulse interval or one amount of change from display of the one pulse interval or the one amount of change until display of a next pulse interval or a next amount of change (Fig. 7, [0080] “At this step, the vital information display apparatus 10 measures a heart rate by measuring RRIs as vital information through calculation (S14). Then the vital information display apparatus 10 judges whether RRIs have been measured normally (S15). If RRIs have not been measured normally or updated, the vital information display apparatus 10 moves to end judgment processing (S21). If RRIs have been measured normally, the vital information display apparatus 10 records RRI data acquired sequentially in the memory 16 (S16).”; [0081] “DSP 14 updates the RRI sequentially at the timing of the maximum points (black circles).”), and
the sub-indicator activates, per beat, display of a sub-display segment of the plurality of sub-display segments that corresponds to the display of the peak level portion of the pulse interval or the amount of change indicated per beat by the level indicator and maintains display of each sub-display segment activated until the detection by the pulse acquisition mechanism is finished ([0081] “output an RRI when the signal waveform has a maximum value and each of points indicated by white circles and black circles indicates timing of making an RRI measurement judgment of S15 (see FIG. 6). The judgment result at step S15 is “yes” at each peak point (maximum point) indicated by a black circle of the signal waveform, and is “no” at each point indicated by a white circle because no RRI can be measured. In this case, the DSP 14 updates the RRI sequentially at the timing of the maximum points (black circles).”; Figs. 5A, 5B, 6, and 9).
Regarding claim 7, Tezuka teaches a biological information measurement device ([0046] “vital information display apparatus 10”), comprising:
a pulse acquisition mechanism configured to detect a pulse of a human body ([0007] “acquiring vital information including information of a human pulse wave from the video data of the detection area and generates an information display picture to be used for performing heart rate variability biofeedback using the vital information”; [0053]);
a pulse interval calculation mechanism configured to calculate, based on the pulse, a pulse interval between one beat and an immediately preceding beat ([0061] “a heart rate can be calculated and vital information such as a heartbeat interval (RRI: R-R interval) can be extracted by performing the filtering processing and the waveform examination processing on a signal representing a skin color variation of the image taken”; [0066] “an RRI can be calculated from an interval between mountain peaks of the waveform of the variation component display 34 shown in the figure.”; [0082] “the vital information display apparatus 10 calculates a fluctuation of the RRI data recorded in the memory 15 and checks regularity (periodicity) of RRIs in a prescribed interval (S17).”); and
a display mechanism configured to display a level indicator visually indicating at least one of the pulse interval or an amount of change from another pulse interval immediately before the pulse interval (Figs. 5A-5B, [0063] “The information display picture 30 may include a face image display 33 of a face detection area of the user and a display 34 of variation components including a pulse wave extracted from an image taken.”; Fig. 9; [0066] “an RRI can be calculated from an interval between mountain peaks of the waveform of the variation component display 34 shown in the figure.”; [0080]; [0086] “various kinds of image data such as a skin color average value acquired from an image taken of a user face portion, a heart rate (BR), history information of a heart rate variation (RRIs), various vital indices (CV-RR, SDNN, rMSSD, LF/HF, tone, entropy, etc.), and a Lorentz-plot curve can be displayed as the acquired data displays 39.”), wherein
the level indicator is composed of a plurality of display segments ([0049] “an indicator indicating states of breathing and heart beats of the user (judgment results)”; [0063] “an indicator 32 indicating states of breathing and heart beats of the user, etc. The breathing pacer 31 and the indicator 32 are provided in a region in the vicinity of the longer side that is closest to the camera 11, in the information display picture 30.”),
a display segment in which display is activated in the level indicator makes a transition ([0064] “The indicator 32 is an index display indicating feedback information of a result of judgment as to whether heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user. For example, if it is judged that heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user, the display of the indicator 32 elongates gradually.”), and
the pulse interval or the amount of change is visually indicated per beat of the pulse by a length of a distance of the transition ([0064] “The indicator 32 is an index display indicating feedback information of a result of judgment as to whether heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user. For example, if it is judged that heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user, the display of the indicator 32 elongates gradually.”).
Regarding claim 8, Tezuka teaches the biological information measurement device according to claim 7, wherein
the level indicator represents, per transition of the display segment indicating one pulse interval or one amount of change, a length of a distance of the transition by highlighting the display segment activated at a terminal end of the distance of the transition ([0064] “The indicator 32 is an index display indicating feedback information of a result of judgment as to whether heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user. For example, if it is judged that heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user, the display of the indicator 32 elongates gradually … The length of the bar is changed in such a manner that, for example, the bar is short in a state that the heart rate variation is unstable, is elongated as the heart rate variation becomes more stable, and is kept long in a state that the heart rate variation is stable.”).
Regarding claim 9, Tezuka teaches the biological information measurement device according to claim 8, wherein
the level indicator maintains, until display of the display segment indicating the terminal end of the transition of the display segment indicating the one pulse interval or the one amount of change is activated, activation of the display segment indicating the terminal end of the transition related to at least an immediately preceding pulse interval or an immediately preceding amount of change ([0064] “The indicator 32 is an index display indicating feedback information of a result of judgment as to whether heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user. For example, if it is judged that heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user, the display of the indicator 32 elongates gradually … The length of the bar is changed in such a manner that, for example, the bar is short in a state that the heart rate variation is unstable, is elongated as the heart rate variation becomes more stable, and is kept long in a state that the heart rate variation is stable.”; Fig. 7, [0080] “At this step, the vital information display apparatus 10 measures a heart rate by measuring RRIs as vital information through calculation (S14). Then the vital information display apparatus 10 judges whether RRIs have been measured normally (S15). If RRIs have not been measured normally or updated, the vital information display apparatus 10 moves to end judgment processing (S21). If RRIs have been measured normally, the vital information display apparatus 10 records RRI data acquired sequentially in the memory 16 (S16).”; [0081] “DSP 14 updates the RRI sequentially at the timing of the maximum points (black circles).”).
Regarding claim 10, Tezuka teaches the biological information measurement device according to claim 7, wherein
the level indicator has an entire display region configured in a ring shape ([0095] “a ring-shaped display region as in a clock”),
the display segment in which the display is activated in the level indicator repeats, per beat, a transition in a fixed direction ([0064] “The indicator 32 is an index display indicating feedback information of a result of judgment as to whether heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user. For example, if it is judged that heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user, the display of the indicator 32 elongates gradually”; [0095]), and
the pulse interval is indicated by the length of the distance of the transition ([0064] “The length of the bar is changed in such a manner that, for example, the bar is short in a state that the heart rate variation is unstable, is elongated as the heart rate variation becomes more stable, and is kept long in a state that the heart rate variation is stable”).
Regarding claim 11, Tezuka teaches the biological information measurement device according to claim 7, wherein
the level indicator has an entire display region configured in a band shape extending in a left-right direction (Figs. 8A and 9; [0086] “An information display picture 302 displayed on the monitor 12 is oblong (the longer sides are in the horizontal direction). In the information display picture 302, an oblong breathing pacer 31 and indicator 32 are disposed in a region in the vicinity of the longer side that is closest to the camera 11”),
the display segment in which the display is activated in the level indicator repeats, per beat, a transition in a fixed direction of the left-right direction (Fig. 8A; [0064] “The indicator 32 is an index display indicating feedback information of a result of judgment as to whether heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user. For example, if it is judged that heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user, the display of the indicator 32 elongates gradually”), and
the pulse interval is indicated by the length of the distance of the transition ([0064] “The length of the bar is changed in such a manner that, for example, the bar is short in a state that the heart rate variation is unstable, is elongated as the heart rate variation becomes more stable, and is kept long in a state that the heart rate variation is stable”).
Regarding claim 12, Tezuka teaches the biological information measurement device according to any one of claim 7, wherein
the level indicator has an entire display region configured in a band shape extending in an up-down direction (Fig. 8B, [0087] “In the information display picture 303, an vertically long breathing pacer 31 and indicator 32 are disposed in a region located in the vicinity of the shorter side that is closest to the camera 11,”; [0088]),
the display segment in which the display is activated in the level indicator repeats, per beat, a transition in a fixed direction of the up-down direction (Fig. 8B; [0064] “The indicator 32 is an index display indicating feedback information of a result of judgment as to whether heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user. For example, if it is judged that heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user, the display of the indicator 32 elongates gradually”), and
the pulse interval is indicated by the length of the distance of the transition ([0064] “The length of the bar is changed in such a manner that, for example, the bar is short in a state that the heart rate variation is unstable, is elongated as the heart rate variation becomes more stable, and is kept long in a state that the heart rate variation is stable”).
Regarding claim 13, Tezuka teaches the biological information measurement device according to claim 1, wherein
the level indicator has an entire display region configured in a shape including at least part of a circumference and a pointer extending from an inside of the circumference toward the circumference and visually indicates the pulse interval by using a position on the circumference, the position being indicated by the pointer ([0095] “a breathing pace and timing by moving an index such as a color band or mark along the circle in a ring-shaped display region as in a clock”).
Regarding claim 14, Tezuka teaches the biological information measurement device according to claim 1, wherein
the level indicator indicates the pulse interval in synchronization with a waveform of the pulse detected ([0064] “The indicator 32 is an index display indicating feedback information of a result of judgment as to whether heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user.”; [0082] “In doing so, to produce a vital information judgment result, the vital information display apparatus 10 judges whether the RRIs match the breathing pacer in periodicity (S18). Whether the RRIs match the breathing pacer in periodicity is judged by, for example, judging whether the difference in, for example, cycle period or fluctuation, between the RRIs and the breathing pacer is smaller than or equal to a prescribed threshold value.”; Figs. 5A-5B).
Regarding claim 15, Tezuka teaches the biological information measurement device according to claim 2, wherein
the length, the area, or the angle of the region in which the display is activated or the number of the regions in the level indicator linearly changes in accordance with the pulse interval ([0064] “The indicator 32 is an index display indicating feedback information of a result of judgment as to whether heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user. For example, if it is judged that heartbeats are occurring in proper rhythm in accordance with correlation between breathing and heartbeats of the user, the display of the indicator 32 elongates gradually … The length of the bar is changed in such a manner that, for example, the bar is short in a state that the heart rate variation is unstable, is elongated as the heart rate variation becomes more stable, and is kept long in a state that the heart rate variation is stable.”.
Regarding claim 16, Tezuka teaches the biological information measurement device according to claim 2, wherein
the length, the area, or the angle of the region in which the display is activated or the number of the regions in the level indicator changes in a monotonically increasing non-linear manner in accordance with the pulse interval ([0095] “The breathing pacer 315 shows breathing-in intervals by causing the index of the ring to move clockwise along the circle from time t0 to t3 and from time t0′ to t3′, and shows breathing-in intervals by causing the index of the ring to move clockwise along the circle from time t3 to t8 and from time t3′ to t8′.”).
Regarding claim 17, Tezuka teaches the biological information measurement device according to claim 1, further comprising:
a sound output mechanism configured to output, per beat of the pulse detected, a sound indicating the pulse interval in synchronization with display of the level indicator ([0074] “The breathing pacer may be configured in such a manner that the vital information display apparatus is provided with a sound generation unit such as a speaker and the user is given an instruction relating to breathing timing using a sound generated from the sound generation unit in addition to a display in the information display picture 30”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over US 20200405245 A1 (Tezuka et al.) in view of US 20040171947 A1 (Ogura et al.).
Regarding claim 18, Tezuka teaches the biological information measurement device according to claim 17.
Tezuka does not explicitly teach the sound output mechanism indicates a difference in the pulse interval depending on a difference in a pitch of an output sound.
However,
Ogura teaches the sound output mechanism indicates a difference in the pulse interval depending on a difference in a pitch of an output sound ([0010] “even if the magnitude of the pulse wave signal may be considerably small over its entire length, the medical person can accurately recognize the shape of the pulse wave, based on the change of pitch of the sound outputted from the sound outputting device.”; [0037-0038]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the device taught by Tezuka to include a speaker changing pitch of an output sound. One would have been motivated to make this modification because the change in pitch allows medical profession to accurately recognize the shape of the pulse wave based on the pitch of the sound to aid in diagnosis, as suggested by Ogura ([0010]).
Conclusion
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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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