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 .
Response to Arguments
Applicant’s amendments to the claims, filed 12/15/2025, hereby obviate the previous interpretation of Claims 1 and 3 under 35 U.S.C. § 112(f), as all terms interpreted under this statute have been deleted. The interpretation of Claims 1 and 3 under 35 U.S.C. § 112(f) has been withdrawn.
Applicant’s arguments, see pages 11-13, filed 12/15/2025, with respect to the rejection(s) of Claims 1 and 6 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Chuang, Diab, and Betchel to disclose the entirety of amended Claims 1 and 6. All other rejections have been updated accordingly.
Applicant's arguments filed 12/15/2025 with regards to the outstanding rejection under 35 U.S.C. § 101 have been fully considered but they are not persuasive.
35 U.S.C. § 101
Step 2A, Prong One
The Applicant has argued “A human cannot generate a signal based on received light by using a pen and paper nor display information on a display. In addition, a general computer cannot perform at least the following features of amended claim 1 without having a specific calibration table and a specific program/algorithm”. However, the limitations “a plurality of photodiodes configured to receive the red light, the infrared light, and the green light emitted by the light-emitting assembly, and generate a first light-receiving signal based on the red light, a second light-receiving signal based on the infrared light, and a third light-receiving signal based on the green light” and “a display configured to display biological information” are both insignificant extra-solution activity to the claimed judicial exception, as they recite mere data gathering and output steps.
Step 2A, Prong Two
The Applicant has also argued the claimed features performed by a processor “should be categorized as...[applying] the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)”. However, the Applicant provides no further argument other than reciting their Claim 1 and stating “Thus, claim 1 is clearly directed to a "machine," which is subject matter eligible under 35 U.S.C. § 101.” Integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more. Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See MPEP 2106.05(b).
In this case, the claimed “machine” (a processor”) is used in a data gathering step (“a processor configured to execute the program so as to… detect an intensity of the first light-receiving signal within the first pulsation band and an intensity of the second light-receiving signal within the first pulsation band [and] detect an intensity of the first light-receiving signal within the second pulsation band and an intensity of the second light-receiving signal within the second pulsation band”) and is otherwise claimed as merely an object on which the abstract idea operates, which does not integrate the exception into a practical application or provide significantly more.
Step 2B
The Applicant has also argued the claimed features performed by a processor “should be categorized as...[applying] or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e)”. However, the applicant provides no further argument other than stating “Even if claim 6 is considered to be directed to a judicial exception (such as the alleged mental process or simple data gathering, which Applicant does not concede), claim 6 recites additional elements that integrate the alleged judicial exception into a practical application”. It is not clear which additional elements the Applicant is referring to. Furthermore, all additional elements in the claims are used in a data gathering step and/or are claimed as merely a generic processing device on which the abstract idea operates, which does not integrate the exception into a practical application or provide significantly more.
For these reasons, the rejection of the claims under 35 U.S.C. § 101 is maintained.
Claim Rejections - 35 USC § 101
Claims 1 and 4-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding Claim 1, the claim recites a biological information measurement device. Thus, the claim is directed to an apparatus, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
the calibration table containing a relationship between a plurality of fluctuation component ratios and a plurality of oxygen saturation concentrations
perform a time-frequency analysis on the first light-receiving signal, the second light-receiving signal, and the third light-receiving signal
determine a first pulsation band including
calculate a first fluctuation component ratio of the plurality of fluctuation component ratios between a first red light transmitted amount and a first infrared light transmitted amount by using the intensity of the first light-receiving signal within the first pulsation band and the intensity of the second light-receiving signal within the first pulsation band
obtain a first oxygen saturation concentration of the plurality of oxygen saturation concentrations by referring the calibration table based on the first fluctuation component ratio
determine a second pulsation band including a second pulse wave frequency during a second elapsed time different from the first elapsed time by the time-frequency analysis on the third light-receiving signal
calculate a second fluctuation component ratio of the plurality of fluctuation component ratios between a second red light transmitted amount and a second infrared light transmitted amount by using the intensity of the first light- receiving signal within the second pulsation band and the intensity of the second light-receiving signal within the second pulsation band
obtain a second oxygen saturation concentration of the plurality of oxygen saturation concentrations by referring the calibration table based on the second fluctuation component ratio
These limitations describe a mathematical calculation and/or a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
The calibration table containing a relationship between a plurality of fluctuation component ratios and a plurality of oxygen saturation concentrations is a mathematical equation that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
Performing a time-frequency analysis on the first light-receiving signal, the second light-receiving signal, and the third light-receiving signal is a mathematical calculation that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
Calculating a first fluctuation component ratio of the plurality of fluctuation component ratios between a first red light transmitted amount and a first infrared light transmitted amount by using the intensity of the first light-receiving signal within the first pulsation band and the intensity of the second light-receiving signal within the first pulsation band is a mathematical calculation that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
determine a first pulsation band including is a mental process that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
obtain a first oxygen saturation concentration of the plurality of oxygen saturation concentrations by referring the calibration table based on the first fluctuation component ratio is a mental process that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
Determining a second pulsation band including a second pulse wave frequency during a second elapsed time different from the first elapsed time by the time-frequency analysis on the third light-receiving signal is a mental process that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
Calculating a second fluctuation component ratio of the plurality of fluctuation component ratios between a second red light transmitted amount and a second infrared light transmitted amount by using the intensity of the first light- receiving signal within the second pulsation band and the intensity of the second light-receiving signal within the second pulsation band is a mathematical calculation that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
Obtaining a second oxygen saturation concentration of the plurality of oxygen saturation concentrations by referring the calibration table based on the second fluctuation component ratio is a mental process that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering. See MPEP 2106.05(g).
a display configured to display biological information
a light-emitting assembly including a first light-emitting diode that emits red light, a second light-emitting diode that emits infrared light, and a third light-emitting diode that emits green light
a plurality of photodiodes configured to receive the red light, the infrared light, and the green light emitted by the light-emitting assembly, and generate a first light-receiving signal based on the red light, a second light-receiving signal based on the infrared light, and a third light-receiving signal based on the green light
a processor configured to execute the program so as to... detect an intensity of the first light-receiving signal within the first pulsation band and an intensity of the second light-receiving signal within the first pulsation band
a processor configured to execute the program so as to... detect an intensity of the first light-receiving signal within the second pulsation band and an intensity of the second light-receiving signal within the second pulsation band
a processor configured to execute the program so as to...cause the display to display the first oxygen saturation concentration and the second oxygen saturation concentration as the biological information
The following limitations amount to a recitation of the words "apply it" (or an equivalent)and/or nothing more than mere instructions to implement the abstract idea on a generic computer. See MPEP 2106.05(f).
a memory configured to store a program and a calibration table
a processor configured to execute the program so as to...
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
a display configured to display biological information
a light-emitting assembly including a first light-emitting diode that emits red light, a second light-emitting diode that emits infrared light, and a third light-emitting diode that emits green light
a plurality of photodiodes configured to receive the red light, the infrared light, and the green light emitted by the light-emitting assembly, and generate a first light-receiving signal based on the red light, a second light-receiving signal based on the infrared light, and a third light-receiving signal based on the green light
a processor configured to execute the program so as to... detect an intensity of the first light-receiving signal within the first pulsation band and an intensity of the second light-receiving signal within the first pulsation band
a processor configured to execute the program so as to... detect an intensity of the first light-receiving signal within the second pulsation band and an intensity of the second light-receiving signal within the second pulsation band
a processor configured to execute the program so as to...cause the display to display the first oxygen saturation concentration and the second oxygen saturation concentration as the biological information
a memory configured to store a program and a calibration table
a processor configured to execute the program so as to...
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The display is considered to be well-understood, routine, and conventional based on statement from the applicant's specification filed 11/08/2023 ([0064]).
The light emitting assembly is considered to be well-understood, routine, and conventional based on statement from the applicant's specification filed 11/08/2023 ([0028]).
The plurality of photodiodes is/are considered to be well-understood, routine, and conventional based on statement from the applicant's specification filed 11/08/2023 ([0033]).
The memory and processor are considered to be well-understood, routine, and conventional based on statement from the applicant's specification filed 11/08/2023 ([0045]; [0060]).
Independent Claim 6 is also not patent eligible for substantially similar reasons as it recites the same abstract idea(s) and additional element(s) as Claim 1 but as a process-type claim.
Dependent Claim 4 also fail to add subject matter qualifying as significantly more to the abstract independent claims as it merely further limits the abstract idea.
Dependent Claim 5 also fail to add subject qualifying as significantly more to the abstract independent claims as it recites limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above.
Dependent Claim 5 also fail to add subject matter integrating the judicial exception or qualifying as significantly more to the abstract independent claims as it does not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, Claims 1 and 4-6 are not patent eligible under 35 U.S.C. § 101.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Chuang et al (US 20160007929 A1, hereinafter Chuang) in view of Diab et al (US 20130274571 A1, hereinafter Diab), and further in view of Bechtel et al (US 20170303835 A1, hereinafter Bechtel).
Regarding Claim 1, Chuang discloses a biological information measurement device (Element 1, Fig. 1A) comprising:
a display (Element 108, Fig. 1A) configured to display biological information (“The indication unit 108 is configured to show the biometric characteristic through audio or images, e.g. including a speaker module or a display device”, [0026]);
a light-emitting assembly (Element 101, Fig. 1A) including a first light-emitting diode that emits red light, a second light-emitting diode that emits infrared light, and a third light-emitting diode that emits green light (See “G”, “R”, and “IR” elements in Fig. 1A; “the light source module 101 includes a green light source, a red light source and an infrared light source configured to emit green light, red light and infrared light, respectively”, [0027]);
a plurality of photodiodes (Element 103A, Fig. 1A; “The detection region 103A is, for example, a semiconductor detection region which includes a plurality of detection pixels each including at least one photodiode configured to convert optical energy to electric signals”, [0028]) configured to receive the red light, the infrared light, and the green light emitted by the light-emitting assembly, and generate a first light-receiving signal based on the red light, a second light-receiving signal based on the infrared light, and a third light-receiving signal based on the green light (“The detection region 103A is configured to detect penetrating light emitted from the light source module 101 for illuminating the skin surface S and passing through body tissues so as to correspondingly generate a green light signal, a red light signal and an infrared light signal, wherein the green light signal, the red light signal and the infrared light signal are referred to photoplethysmographic signals or PPG signals”, [0028]);
a processor (Element 106, Fig. 1A) configured to execute the program so as to:
perform a time-frequency analysis on the first light-receiving signal, the second light-receiving signal, and the third light-receiving signal (See Figs. 2A-2B; “the control module 106 converts the PPG signals to the frequency domain using, for example, Fourier transform, wavelet analysis or other algorithms”, [0030]);
determine a first pulsation band including a first pulse wave frequency during a first elapsed time by the time-frequency analysis on the third light-receiving signal (“When the biometric detection module 1 is adapted to a head accessory, a relative position between the biometric detection module 1 and the skin surface S may not be stable such that noises are generated in the detected signals (i.e. the PPG signals). Accordingly, in the present disclosure the green light signal is used to determine a filtering parameter configured to filter the red light signal and the infrared light signal”, [0029]; “As SPO.sub.2 has a higher absorption of the green light, the filtering parameter is determined according to a frequency domain green light signal (as FIG. 2B), e.g. the signal component at 1 Hz being served as a basic frequency herein, wherein the control module 106 converts the PPG signals to the frequency domain using, for example, Fourier transform, wavelet analysis or other algorithms”, [0030]; under broadest reasonable interpretation, the signals must be sampled within a closed period of time, which can be considered a first elapsed time; the sampled signals can also be considered a first pulsation band);
detect an intensity of the first light-receiving signal within the first pulsation band and an intensity of the second light-receiving signal within the first pulsation band (“The control module 106 then filters the red light signal and the infrared light signal with the filtering parameter so as to respectively generate a filtered red light signal and a filtered infrared light signal”, [0030]);
obtain a first oxygen saturation concentration (S45, Fig. 10);
cause the display to display the first oxygen saturation concentration as the biological information (“The indication unit 108 is configured to show the biometric characteristic through audio or images, e.g. including a speaker module or a display device”, [0026]).
Chuang discloses the claimed invention except for expressly disclosing a memory configured to store a program and a calibration table, the calibration table containing a relationship between a plurality of fluctuation component ratios and a plurality of oxygen saturation concentrations; and
the processor configured to execute the program so as to:
calculate a first fluctuation component ratio of the plurality of fluctuation component ratios between a first red light transmitted amount and a first infrared light transmitted amount by using the intensity of the first light-receiving signal within the first pulsation band and the intensity of the second light-receiving signal within the first pulsation band;
obtain a first oxygen saturation concentration of the plurality of oxygen saturation concentrations by referring the calibration table based on the first fluctuation component ratio;
determine a second pulsation band including a second pulse wave frequency during a second elapsed time different from the first elapsed time by the time-frequency analysis on the third light-receiving signal;
detect an intensity of the first light-receiving signal within the second pulsation band and an intensity of the second light-receiving signal within the second pulsation band;
calculate a second fluctuation component ratio of the plurality of fluctuation component ratios between a second red light transmitted amount and a second infrared light transmitted amount by using the intensity of the first light- receiving signal within the second pulsation band and the intensity of the second light-receiving signal within the second pulsation band;
obtain a second oxygen saturation concentration of the plurality of oxygen saturation concentrations by referring the calibration table based on the second fluctuation component ratio; and
cause the display to display the second oxygen saturation concentration as the biological information.
However Diab which also discloses calculating biological information (See Abstract), teaches a memory (Element 230, Fig. 2) configured to store a program and a calibration table (“The processor(s) 226 may also communicate with a memory 230 located on the sensor 106; such memory typically contains information related to the properties of the sensor that may be useful in processing the signals”, [0030]; See Fig. 3C; the ordered pairs of data that make the graphed curve can also be stored as a table, see [0008]), the calibration table containing a relationship between a plurality of fluctuation component ratios and a plurality of oxygen saturation concentrations (“It can be shown that the use of two distinct light sources, Red (R)=660 nm and Infrared (IR)=910 nm, a pulse oximeter can calculate the oxygen saturation noninvasively by relating a ratio=R (AC/DC)/IR (AC/DC) to the hemoglobin oxygen saturation through a typical pulse oximeter calibration curve shown in FIG. 3C”, [0045]; the examiner notes this formula corresponds exactly to the fluctuation component amplitude ratio described in Equation 1, [0052] of the applicant’s written description; Fig. 3C contains a plurality of relationships between different fluctuation component ratios and oxygen saturations); and
the processor configured to execute the program so as to ([0030]):
calculate a first fluctuation component ratio of the plurality of fluctuation component ratios between a first red light transmitted amount and a first infrared light transmitted amount by using the intensity of the first light-receiving signal within the first pulsation band and the intensity of the second light-receiving signal within the first pulsation band (“As explained in detail below, the ratio of red and infrared light signals absorbed at the measuring site is calculated (R/IR ratio).”, [0008]; “It can be shown that the use of two distinct light sources, Red (R)=660 nm and Infrared (IR)=910 nm, a pulse oximeter can calculate the oxygen saturation noninvasively by relating a ratio=R (AC/DC)/IR (AC/DC) to the hemoglobin oxygen saturation through a typical pulse oximeter calibration curve shown in FIG. 3C”, [0045]; the examiner notes this formula corresponds exactly to the fluctuation component amplitude ratio described in Equation 1, [0052] of the applicant’s written description; under broadest reasonable interpretation, the AC and DC infrared and red signals must be sampled within a closed period of time, which can also be considered a first pulsation band); and
obtain a first oxygen saturation concentration of the plurality of oxygen saturation concentrations by referring the calibration table based on the first fluctuation component ratio (“Oxygen saturation level is determined using a lookup table that is based on empirical formulas that convert the ratio of red and infrared absorption rates to a SpO.sub.2 value”, [0008]).
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 processor of Chuang with the calculations of Diab, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and Chuang teaches the derivation of blood oxygen in their invention to be by known methods (“the principle of detecting the heart rate, the blood oxygenation and the second derivative of photoplethysmogram according to PPG signals is known to the art and thus details thereof are not described herein”, [0026]). Therefore, one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Bechtel, which also discloses calculating biological information (See Abstract), teaches the advantage of determining oxygen saturation multiple times in a series of measurements (“The series of oximeter measurements can be for predictions of tissue parameters, such as values for oxygen saturation, values for relative oxygen saturation, or any calculated valued used by the oximeter probe for calculating a subsequent value, such as where the subsequent value is an oxygen saturation value or a relative oxygen saturation value on particular patient tissue) to one another”, [0097]); and wherein the processor (Element 116, Fig. 1) configured to execute the program so as to: cause the display (Element 115, Fig. 4A) to display a second oxygen saturation concentration (Element 200, Fig. 4A) as the biological information (See Fig. 4A).
One of ordinary skill in the art could have realized that by repeating the process of modified Chuang at least a second time (i.e. wherein the processor is configured to: calculate a second fluctuation component ratio of the plurality of fluctuation component ratios between a second red light transmitted amount and a second infrared light transmitted amount by using the intensity of the first light- receiving signal within the second pulsation band and the intensity of the second light-receiving signal within the second pulsation band; and obtain a second oxygen saturation concentration of the plurality of oxygen saturation concentrations by referring the calibration table based on the second fluctuation component ratio), the advantages of Betchel could be realized. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Chuang in view of Betchel to achieve the claimed limitations.
Regarding Claim 4, modified Chuang discloses the biological information measurement device according to claim 1. Modified Chuang discloses the claimed invention except for expressly disclosing wherein the processor is further configured to:
determine another oxygen saturation concentration of the plurality of oxygen saturation concentrations at a predetermined time interval;
calculate a moving average of the plurality of oxygen saturation concentrations determined at the predetermined time interval; and
cause the display to display the moving average of the plurality of oxygen saturation concentrations.
However, Bechtel, teaches wherein the processor is further configured to:
determine another oxygen saturation concentration of the plurality of oxygen saturation concentrations at a predetermined time interval Steps 420 and 425, Fig. 4H; also see “temporal series of oximeter measurements (e.g., three, four, five, six, or more oximeter measurements over a period of time when the measurements are made on tissue of a patient)”, [0097]);
calculate a moving average of the plurality of oxygen saturation concentrations determined at the predetermined time interval (“the quality value shown on the display may be a moving average value of multiple measurement samples of oxygen saturation or other values”, [0099]); and
cause the display to display the moving average of the plurality of oxygen saturation concentrations (“the quality value shown on the display may be a moving average value of multiple measurement samples of oxygen saturation or other values”, [0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the moving average display of Bechtel to the device of modified Chuang, because the moving average is a measure of measurement quality (“The more closely the sampled measurements are grouped together and are close to the moving average, this indicates a higher quality measurement. In contrast, the less tightly spaced the samples are, the less quality of the measurement”, [0099] of Bechtel).
Regarding Claim 5, modified Chuang discloses the biological information measurement device according to claim 1, wherein
the plurality of photodiodes is configured to receive the red light, the infrared light, and the green light reflected by a subject (“The detection region 103A is configured to detect penetrating light emitted from the light source module 101 for illuminating the skin surface S and passing through body tissues so as to correspondingly generate a green light signal, a red light signal and an infrared light signal, wherein the green light signal, the red light signal and the infrared light signal are referred to photoplethysmographic signals or PPG signals”, [0028]).
Regarding Claim 6, Chuang discloses a biological information measurement method (“Biometric Detection Module With Denoising Function And Biometric Detection Method Thereof”, Title) for causing a processor to execute a process, the biological information measurement method comprising executing on the processor the steps of:
emitting red light, infrared light, and green light to a subject (Step S41, Fig. 10; “the light source module 101 includes a green light source, a red light source and an infrared light source configured to emit green light, red light and infrared light, respectively”, [0027]);
receiving the red light, the infrared light, and the green light passing through the subject (Step S42, Fig. 10; “detecting, using a semiconductor detection region, penetrating light illuminating the skin surface and passing through body tissues…”, [0055]);
generating a first light-receiving signal based on the received red light, a second light-receiving signal based on the received infrared light, and a third light- receiving signal based on the received green light (“detecting, using a semiconductor detection region, penetrating light illuminating the skin surface and passing through body tissues to correspondingly generate a green light signal, a red light signal and an infrared light signal”, [0055]);
performing a time-frequency analysis on the first light-receiving signal, the second light-receiving signal, and the third light-receiving signal (“the control module 106 converts the PPG signals to the frequency domain using, for example, Fourier transform, wavelet analysis or other algorithms”, [0030]);
determining a first pulsation band (Step S43, Fig. 10) including a first pulse wave frequency during a first elapsed time by the time-frequency analysis on the third light-receiving signal (“As SPO.sub.2 has a higher absorption of the green light, the filtering parameter is determined according to a frequency domain green light signal (as FIG. 2B), e.g. the signal component at 1 Hz being served as a basic frequency herein, wherein the control module 106 converts the PPG signals to the frequency domain using, for example, Fourier transform, wavelet analysis or other algorithms”, [0030]; under broadest reasonable interpretation, the signals must be sampled within a closed period of time, which can also be considered a first pulsation band);
detecting an intensity of the first light-receiving signal within the first pulsation band and an intensity of the second light-receiving signal within the first pulsation band (Step S44, Fig. 10; “The control module 106 then filters the red light signal and the infrared light signal with the filtering parameter so as to respectively generate a filtered red light signal and a filtered infrared light signal”, [0030]);
obtaining a first oxygen saturation concentration (S45, Fig. 10);
causing a display to display the first oxygen saturation concentration as biological information (“The indication unit 108 is configured to show the biometric characteristic through audio or images, e.g. including a speaker module or a display device”, [0026]).
Chuang discloses the claimed invention except for expressly disclosing the method comprising executing on the processor the steps of:
preparing a calibration table, the calibration table containing a relationship between a plurality of fluctuation component ratios and a plurality of oxygen saturation concentrations;
calculating a first fluctuation component ratio of the plurality of fluctuation component ratios between a first red light transmitted amount and a first infrared light transmitted amount by using the intensity of the first light-receiving signal within the first pulsation band and the intensity of the second light- receiving signal intensity within the first pulsation band;
obtaining a first oxygen saturation concentration of the plurality of oxygen saturation concentrations by referring the calibration table based on the first fluctuation component ratio;
determining a second pulsation band including a second pulse wave frequency during a second elapsed time different from the first elapsed time by the time- frequency analysis on the third light-receiving signal;
detecting an intensity of the first light-receiving signal within the second pulsation band and an intensity of the second light-receiving signal within the second pulsation band;
calculating a second fluctuation component ratio of the plurality of fluctuation component ratios between a second red light transmitted amount and a second infrared light transmitted amount by using the intensity of the first light-receiving signal within the second pulsation band and the intensity of the second light-receiving signal within the second pulsation band;
obtaining a second oxygen saturation concentration of the plurality of oxygen saturation concentrations by referring the calibration table based on the second fluctuation component ratio; and
causing a display to display the second oxygen saturation concentration as biological information.
However, Diab, which also discloses calculating biological information (See Abstract), teaches method comprising executing on the processor ([0030]) the steps of:
preparing a calibration table (“The processor(s) 226 may also communicate with a memory 230 located on the sensor 106; such memory typically contains information related to the properties of the sensor that may be useful in processing the signals”, [0030]; See Fig. 3C; the ordered pairs of data that make the graphed curve can also be stored as a table, see [0008]), the calibration table containing a relationship between a plurality of fluctuation component ratios and a plurality of oxygen saturation concentrations (“It can be shown that the use of two distinct light sources, Red (R)=660 nm and Infrared (IR)=910 nm, a pulse oximeter can calculate the oxygen saturation noninvasively by relating a ratio=R (AC/DC)/IR (AC/DC) to the hemoglobin oxygen saturation through a typical pulse oximeter calibration curve shown in FIG. 3C”, [0045]; the examiner notes this formula corresponds exactly to the fluctuation component amplitude ratio described in Equation 1, [0052] of the applicant’s written description; Fig. 3C contains a plurality of relationships between different fluctuation component ratios and oxygen saturations);
calculating a first fluctuation component ratio of the plurality of fluctuation component ratios between a first red light transmitted amount and a first infrared light transmitted amount by using the intensity of the first light-receiving signal within the first pulsation band and the intensity of the second light- receiving signal intensity within the first pulsation band (“As explained in detail below, the ratio of red and infrared light signals absorbed at the measuring site is calculated (R/IR ratio).”, [0008]; “It can be shown that the use of two distinct light sources, Red (R)=660 nm and Infrared (IR)=910 nm, a pulse oximeter can calculate the oxygen saturation noninvasively by relating a ratio=R (AC/DC)/IR (AC/DC) to the hemoglobin oxygen saturation through a typical pulse oximeter calibration curve shown in FIG. 3C”, [0045]; the examiner notes this formula corresponds exactly to the fluctuation component amplitude ratio described in Equation 1, [0052] of the applicant’s written description; under broadest reasonable interpretation, the AC and DC infrared and red signals must be sampled within a closed period of time, which can also be considered a first pulsation band);
obtaining a first oxygen saturation concentration of the plurality of oxygen saturation concentrations by referring the calibration table based on the first fluctuation component ratio (“Oxygen saturation level is determined using a lookup table that is based on empirical formulas that convert the ratio of red and infrared absorption rates to a SpO.sub.2 value”, [0008]).
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 method of Chuang with the calculations of Diab, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and Chuang teaches the derivation of blood oxygen in their invention to be by known methods (“the principle of detecting the heart rate, the blood oxygenation and the second derivative of photoplethysmogram according to PPG signals is known to the art and thus details thereof are not described herein”, [0026]). Therefore, one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Bechtel, which also discloses calculating biological information (See Abstract), teaches the advantage of determining oxygen saturation multiple times in a series of measurements (“The series of oximeter measurements can be for predictions of tissue parameters, such as values for oxygen saturation, values for relative oxygen saturation, or any calculated valued used by the oximeter probe for calculating a subsequent value, such as where the subsequent value is an oxygen saturation value or a relative oxygen saturation value on particular patient tissue) to one another”, [0097]); and
causing a display (Element 115, Fig. 4A) to display a second oxygen saturation concentration (Element 200, Fig. 4A) as biological information (See Fig. 4A).
One of ordinary skill in the art could have realized that by repeating the process of modified Chuang at least a second time (i.e. the method comprising executing on the processor the steps of: determining a second pulsation band including a second pulse wave frequency during a second elapsed time different from the first elapsed time by the time- frequency analysis on the third light-receiving signal; detecting an intensity of the first light-receiving signal within the second pulsation band and an intensity of the second light-receiving signal within the second pulsation band; calculating a second fluctuation component ratio of the plurality of fluctuation component ratios between a second red light transmitted amount and a second infrared light transmitted amount by using the intensity of the first light-receiving signal within the second pulsation band and the intensity of the second light-receiving signal within the second pulsation band; obtaining a second oxygen saturation concentration of the plurality of oxygen saturation concentrations by referring the calibration table based on the second fluctuation component ratio), the advantages of Betchel could be realized. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Chuang in view of Betchel to achieve the claimed limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Kuhn et al (US 20120130208 A1), which also discloses the advantage of determining oxygen saturation multiple times in a series of measurements ([0069]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JONATHAN E. COOPER/ Examiner, Art Unit 3791
/JACQUELINE CHENG/ Supervisory Patent Examiner, Art Unit 3791