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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “light emitting element” in Claims 1, 6, and 8, “light-receiving unit” in Claims 1 and 8, and “communication unit” in Claim 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim 1 is being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “light emitting element” for the apparatus performing the specified function
“light emitting element” is linked with the transitional phrase “configured to” and modified by the functional language “emit red light”, “emit infrared light” and “emit green light”.
“light emitting element” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant [0034] as a bare chip type or a shell type light emitting diode and equivalents thereof.
Claim 1 is being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “light receiving unit” for the apparatus performing the specified function
“light receiving unit” is linked with the transitional phrase “configured to” and modified by the functional language “receive the red light, the infrared light, and the green light emitted by the light emitting unit”.
“light receiving unit” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant [0037] as one or a plurality of photodiodes and equivalents thereof.
Claim 1 is being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “communication unit” for the apparatus performing the specified function
“communication unit” is linked with the transitional phrase “configured to” and modified by the functional language “transmit the first light receiving signal, the second light receiving signal, and the third light receiving signal”.
“communication unit” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant [0093] as an interface circuit capable of performing communication according to predetermined protocols in a wired or wireless manner (e.g., a connection port or a wireless antenna) and equivalents thereof.
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 1-9 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:
measure a pulse wave and an oxygen saturation concentration based on the first light receiving signal, the second light receiving signal, and the third light receiving signal
a first mode of measuring the pulse wave using the third light receiving signal or in a second mode of measuring the pulse wave using the first light receiving signal or the second light receiving signal
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:
A human is capable of manually/mentally measuring a pulse wave and an oxygen saturation concentration based on the first light receiving signal, the second light receiving signal, and the third light receiving signal, either qualitatively or quantitatively 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.
A human is capable of manually/mentally utilizing a first mode of measuring the pulse wave using the third light receiving signal or utilizing a second mode of measuring the pulse wave using the first light receiving signal or the second light receiving signal, either qualitatively or quantitatively 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 light emitting unit including a first light emitting element configured to emit red light, a second light emitting element configured to emit infrared light, and a third light emitting element configured to emit green light
a light receiving unit configured to receive the red light, the infrared light, and the green light emitted by the light emitting unit, and to 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 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 controller configured to…
wherein the controller operates the light emitting unit and the light receiving unit in…
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 light emitting unit including a first light emitting element configured to emit red light, a second light emitting element configured to emit infrared light, and a third light emitting element configured to emit green light
a light receiving unit configured to receive the red light, the infrared light, and the green light emitted by the light emitting unit, and to 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 controller configured to…
wherein the controller operates the light emitting unit and the light receiving unit in…
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The light-emitting unit is considered to be well-understood, routine, and conventional based on statement from the applicant' s specification filed 12/06/2023 ([0034]).
The light-receiving unit is considered to be well-understood, routine, and conventional based on statement from the applicant' s specification filed 12/06/2023 ([0037]).
The controller is considered to be well-understood, routine, and conventional based on statement from the applicant' s specification filed 12/06/2023 ([0049]).
Dependent Claims 2-5 also fail to add subject matter qualifying as significantly more to the abstract independent claims as they merely further limit the abstract idea.
Dependent Claims 2 and 4-5 also fail to add subject qualifying as significantly more to the abstract independent claims as they recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above.
Dependent Claims 2 and 4-5 also fail to add subject matter integrating the judicial exception or qualifying as significantly more to the abstract independent claims as they do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Regarding Claim 6, the claim recites a biological information measurement method. Thus, the claim is directed to a process, 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:
operating in a second mode of measuring a pulse wave using the first light receiving signal or the second light receiving signal
operating by switching to a first mode of measuring the pulse wave using a third light receiving signal based on green light emitted by a third light emitting element when a switching signal is received
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:
A human is capable of manually/mentally measuring operating in a second mode of measuring a pulse wave using the first light receiving signal or the second light receiving signal, either qualitatively or quantitatively 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.
A human is capable of manually/mentally operating by switching to a first mode of measuring the pulse wave using a third light receiving signal based on green light emitted by a third light emitting element when a switching signal is received, e.g. by hearing verbal instructions and qualitatively or quantitatively switching to a first mode of measuring the pulse wave using a third light receiving signal based on green light emitted by a third light emitting element.
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).
causing a first light emitting element configured to emit red light and a second light emitting element configured to emit infrared light to emit light
generating a first light receiving signal based on the red light and a second light receiving signal based on the infrared light
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.
causing a first light emitting element configured to emit red light and a second light emitting element configured to emit infrared light to emit light
generating a first light receiving signal based on the red light and a second light receiving signal based on the infrared light
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The light-emitting element is considered to be well-understood, routine, and conventional based on statement from the applicant' s specification filed 12/06/2023 ([0034]).
Dependent Claim 7 also fails to add subject matter qualifying as significantly more to the abstract independent claims as it merely further limits the abstract idea.
Regarding Claim 8, the claim recites a biological information measurement system comprising a biological information measurement device and a control 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:
transmit the first light receiving signal, the second light receiving signal, and the third light receiving signal… receive the first light receiving signal, the second light receiving signal, and the third light receiving signal
calculate a pulse wave using any one of the first light receiving signal, the second light receiving signal, and the third light receiving signal
evaluate an irregular pulse
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:
A human is capable of manually/mentally transmitting the first light receiving signal, the second light receiving signal, and the third light receiving signal and receiving the first light receiving signal, the second light receiving signal, and the third light receiving signal, either audibly, 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.
A human is capable of manually/mentally calculating a pulse wave using any one of the first light receiving signal, the second light receiving signal, and the third light receiving signal, either qualitatively or quantitatively 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.
A human is capable of manually/mentally evaluating an irregular pulse, either qualitatively or quantitatively 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).
wherein the biological information measurement device includes a light emitting unit including a first light emitting element configured to emit red light, a second light emitting element configured to emit infrared light, and a third light emitting element configured to emit green light, a light receiving unit configured to receive the red light, the infrared light, and the green light emitted by the light emitting unit, and to 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 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 controller configured to operate the light emitting unit and the light receiving unit, and a communication unit configured to…
the control device includes a terminal communication circuit configured to…
a data controller configured to…
the controller operates the light emitting unit and the light receiving unit in a first mode of generating the third light receiving signal or in a second mode of generating the first light receiving signal and the second light receiving signal
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.
wherein the biological information measurement device includes a light emitting unit including a first light emitting element configured to emit red light, a second light emitting element configured to emit infrared light, and a third light emitting element configured to emit green light, a light receiving unit configured to receive the red light, the infrared light, and the green light emitted by the light emitting unit, and to 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 controller configured to operate the light emitting unit and the light receiving unit, and a communication unit configured to…
the control device includes a terminal communication circuit configured to…
a data controller configured to…
the controller operates the light emitting unit and the light receiving unit in a first mode of generating the third light receiving signal or in a second mode of generating the first light receiving signal and the second light receiving signal
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The light-emitting element is considered to be well-understood, routine, and conventional based on statement from the applicant' s specification filed 12/06/2023 ([0034]).
The light-receiving unit is considered to be well-understood, routine, and conventional based on statement from the applicant' s specification filed 12/06/2023 ([0037]).
The controller is considered to be well-understood, routine, and conventional based on statement from the applicant' s specification filed 12/06/2023 ([0049]).
The terminal communication circuit is considered to be well-understood, routine, and conventional based on statement from the applicant' s specification filed 12/06/2023 ([0034]).
The data controller is considered to be well-understood, routine, and conventional based on statement from the applicant' s specification filed 12/06/2023 ([0034]).
Dependent Claim 9 also fail to add subject matter qualifying as significantly more to the abstract independent claims as it merely further limits the abstract idea.
Therefore, Claims 1-9 are not patent eligible under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 5-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ye et al (CN 114073520 A, hereinafter Ye; a machine translation was relied upon for this rejection).
Regarding Claim 1, Ye discloses a biological information measurement device (Element 200, Fig. 1) comprising:
a light emitting unit including a first light emitting element configured to emit red light (Element 251, Fig. 3; “When the red light emitted by the red LED 251 irradiates human tissue…”, [0065]), a second light emitting element configured to emit infrared light (Element 252, Fig. 3; “When the infrared light emitted by the infrared LED 252 irradiates human tissue…”, [0065]), and a third light emitting element configured to emit green light (Element 253, Fig. 3; “When the green light emitted by the green LED 253 irradiates human tissue…”, [0065]);
a light receiving unit (Element 254, Fig. 3) configured to receive the red light (“When the red light emitted by the red LED 251 irradiates human tissue, part of it is absorbed by deoxyhemoglobin, and part of it is reflected back and received by the photodetector 254…”, [0065]), the infrared light (“When the infrared light emitted by the infrared LED252 irradiates human tissue, part of it is absorbed by oxyhemoglobin, and part of it is reflected back and received by the photodetector 254…”, [0065]), and the green light emitted by the light emitting unit (“When the green light emitted by the green LED 253 illuminates human tissue, part of it is absorbed by the blood, and part is reflected back and received by the photodetector 254…”, [0065]), and to generate a first light receiving signal based on the red light (“…which converts it into red light data”, [0065]), a second light receiving signal based on the infrared light (“…which converts it into infrared light data”, [0065]), and a third light receiving signal based on the green light (“…which converts it into green light data”, [0065]); and
a controller (Element 210, Fig. 2; also see [0067]-[0068]) configured to measure a pulse wave (See Figs. 7 and 11-12; these figures show a PPG signal waveform, which is a visual representation of the pulsatile changes in blood flow of the subject) and an oxygen saturation concentration (See the method of Fig 4, specifically Step 409, [0096]) based on the first light receiving signal, the second light receiving signal, and the third light receiving signal (“Controller 210 calculates blood oxygen saturation based on PPG signals that meet the blood oxygen detection conditions”, [0097]), wherein
the controller operates the light emitting unit and the light receiving unit in a first mode of measuring the pulse wave using the third light receiving signal (“Step 403, Fig. 4; “Specifically, the controller 210 in the watch 200 executes the blood oxygen detection algorithm in the green light detection mode, controlling the red LED 251, infrared LED 252 and green LED 253 in the PPG sensor 250 to light up in sequence”, [0083]; also see [0021], [0081]) or in a second mode of measuring the pulse wave using the first light receiving signal or the second light receiving signal (Step 406, Fig. 4; “Watch 200 enters non-green light detection mode, only turning on the red LED 251 and infrared LED 252 in PPG sensor 250 for blood oxygen detection”, [0089]).
Regarding Claim 2, Ye discloses the biological information measurement device according to claim 1, wherein the controller calculates signal quality data using the first light receiving signal and the second light receiving signal (See Step 408, Fig. 4; “The controller 210 of the watch 200 determines whether the quality of the PPG signal meets the blood oxygen detection conditions based on red light data and infrared light data”, [0093]),
operates the light emitting unit and the light receiving unit in the second mode when the signal quality data is equal to or larger than a predetermined threshold value (“It can be understood that the above relationship (9) can filter out PPG signals that do not meet the blood oxygen detection conditions, while retaining PPG signals that meet the blood oxygen detection conditions”, [0155]; “it can also be determined whether the PPG signal meets the blood oxygen detection conditions by judging whether the ratio of the number of single-hop AC signals that satisfy the above relationship (9) to the total number of AC signal hops in the red light and infrared light data within a certain time period is within the threshold range of the ratio and whether the number of single-hop AC signals exceeds the set threshold”, [0156]), and
operates the light emitting unit and the light receiving unit in the first mode (“it is understood that in some other embodiments, the blood oxygen detection mode of the watch 200 can also be preset to the green light detection mode by default”, [0079]) when the signal quality data is smaller than the threshold value (“It can be understood that the above relationship (9) can filter out PPG signals that do not meet the blood oxygen detection conditions, while retaining PPG signals that meet the blood oxygen detection conditions”, [0155]; “it can also be determined whether the PPG signal meets the blood oxygen detection conditions by judging whether the ratio of the number of single-hop AC signals that satisfy the above relationship (9) to the total number of AC signal hops in the red light and infrared light data within a certain time period is within the threshold range of the ratio and whether the number of single-hop AC signals exceeds the set threshold”, [0156]; if the default mode of the watch is green light detection mode and at least some PPG signals do not meet the blood oxygen detection conditions, then the controller operates the light emitting unit and the light receiving unit in the first mode when the signal quality data is smaller than the threshold value).
Regarding Claim 3, Ye discloses the biological information measurement device according to claim 2, wherein
the signal quality data is correlation data between the first light receiving signal and the second light receiving signal (Step 408, Fig. 4; “The fluctuation stability of the AC component in red light data and infrared light data can be determined by judging whether the ratio of the rise height to the fall height of the single-hop AC signal in red light data and the ratio of the fall height of the single-hop AC signal are within the ratio threshold range, and whether the ratio of the rise height to the fall height of the single-hop AC signal in infrared light data is within the ratio threshold range.”, [0147]), and
the threshold value is a correlation data threshold value (“It can be understood that the above relationship (9) can filter out PPG signals that do not meet the blood oxygen detection conditions, while retaining PPG signals that meet the blood oxygen detection conditions”, [0155]; “it can also be determined whether the PPG signal meets the blood oxygen detection conditions by judging whether the ratio of the number of single-hop AC signals that satisfy the above relationship (9) to the total number of AC signal hops in the red light and infrared light data within a certain time period is within the threshold range of the ratio and whether the number of single-hop AC signals exceeds the set threshold”, [0156]).
Regarding Claim 5, Ye discloses the biological information measurement device according to claim 1, wherein the controller turns off the third light emitting element when operating the light emitting unit and the light receiving unit in the second mode (Step 406, Fig. 4; “Watch 200 enters non-green light detection mode, only turning on the red LED 251 and infrared LED 252 in PPG sensor 250 for blood oxygen detection”, [0089]).
Regarding Claim 6, Ye biological information measurement method ([0001]) comprising:
causing a first light emitting element configured to emit red light (Element 251, Fig. 3; “When the red light emitted by the red LED 251 irradiates human tissue…”, [0065]) and a second light emitting element configured to emit infrared light to emit light (Element 252, Fig. 3; “When the infrared light emitted by the infrared LED 252 irradiates human tissue…”, [0065]);
generating a first light receiving signal based on the red light (“When the red light emitted by the red LED 251 irradiates human tissue, part of it is absorbed by deoxyhemoglobin, and part of it is reflected back and received by the photodetector 254, which converts it into red light data”, [0065]) and a second light receiving signal based on the infrared light (“When the red light emitted by the red LED 251 irradiates human tissue, part of it is absorbed by deoxyhemoglobin, and part of it is reflected back and received by the photodetector 254, which converts it into red light data”, [0065]);
operating in a second mode of measuring a pulse wave (See Figs. 7 and 11-12; these figures show a PPG signal waveform, which is a visual representation of the pulsatile changes in blood flow of the subject) using the first light receiving signal or the second light receiving signal (Step 406, Fig. 4; “Watch 200 enters non-green light detection mode, only turning on the red LED 251 and infrared LED 252 in PPG sensor 250 for blood oxygen detection”, [0089]); and
operating by switching to a first mode of measuring the pulse wave (Step 403, Fig. 4) using a third light receiving signal based on green light emitted by a third light emitting element (“When the green light emitted by the green LED 253 illuminates human tissue, part of it is absorbed by the blood, and part is reflected back and received by the photodetector 254, which converts it into green light data”, [0065]) when a switching signal is received (See all of [0078]; “If the user selects the green light detection mode, the system will enter error 403”, [0080]).
Regarding Claim 7, Ye discloses the biological information measurement method according to claim 6, further comprising:
measuring an oxygen saturation concentration (See the method of Fig 4, specifically Step 409, [0096]) using the first light receiving signal and the second light receiving signal (“Controller 210 calculates blood oxygen saturation based on PPG signals that meet the blood oxygen detection conditions”, [0097]) when operating in the second mode (Step 406, Fig. 4; “Watch 200 enters non-green light detection mode, only turning on the red LED 251 and infrared LED 252 in PPG sensor 250 for blood oxygen detection”, [0089]).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ye in view of Crowe et al (US 20090306487 A1, hereinafter Crowe).
Regarding Claim 4, Ye discloses the biological information measurement device according to claim 1. Ye discloses the claimed invention except for expressly disclosing wherein the controller turns off the first light emitting element and the second light emitting element when operating the light emitting unit and the light receiving unit in the first mode. However, Crowe, which also discloses a biological information measurement device (Abstract) teaches disclosing wherein the controller turns off the first light emitting element and the second light emitting element when operating the light emitting unit and the light receiving unit in the first mode (“The plethysmograph may operate in a transmission mode or a reflectance mode. When in a reflectance mode, the device may use the green part of the optical spectrum and may use polarising filters”, Abstract). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first mode of Ye with Crowe (such that the controller turns off the first light emitting element and the second light emitting element when operating the light emitting unit and the light receiving unit in the first mode in order to only use green light), because red/infrared reflectance sensors do not function well because light at red and infrared wavelengths is poorly absorbed by blood and green light reflectance sensors function better, as taught by Crowe ([0014]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ye in view of Addison et al (US 20190142274 A1, hereinafter Addison).
Regarding Claim 8, Ye discloses a biological information measurement system comprising a biological information measurement device (Element 200, Fig. 1) and a control device (Element 100, Fig. 1), wherein the biological information measurement device includes
a light emitting unit including a first light emitting element configured to emit red light (Element 251, Fig. 3; “When the red light emitted by the red LED 251 irradiates human tissue…”, [0065]), a second light emitting element configured to emit infrared light (Element 252, Fig. 3; “When the infrared light emitted by the infrared LED 252 irradiates human tissue…”, [0065]), and a third light emitting element configured to emit green light (Element 253, Fig. 3; “When the green light emitted by the green LED 253 irradiates human tissue…”, [0065]),
a light receiving unit (Element 254, Fig. 3) configured to receive the red light (“When the red light emitted by the red LED 251 irradiates human tissue, part of it is absorbed by deoxyhemoglobin, and part of it is reflected back and received by the photodetector 254…”, [0065]), the infrared light (“When the infrared light emitted by the infrared LED252 irradiates human tissue, part of it is absorbed by oxyhemoglobin, and part of it is reflected back and received by the photodetector 254…”, [0065]), and the green light emitted by the light emitting unit (“When the green light emitted by the green LED 253 illuminates human tissue, part of it is absorbed by the blood, and part is reflected back and received by the photodetector 254…”, [0065]), and to generate a first light receiving signal based on the red light (“…which converts it into red light data”, [0065]), a second light receiving signal based on the infrared light (“…which converts it into infrared light data”, [0065]), and a third light receiving signal based on the green light (“…which converts it into green light data”, [0065]),
a controller (Element 210, Fig. 2; also see [0067]-[0068]) configured to operate the light emitting unit and the light receiving unit ([0060]), and
a communication unit (Element 220, Fig. 2) configured to transmit the first light receiving signal, the second light receiving signal, and the third light receiving signal (“watch 200 sends a PPG signal containing green light data to mobile phone 100”, [0218]; “watch 200 sends PPG signals without green light data to mobile phone 100”, [0219]), the control device includes
a terminal communication circuit configured to receive the first light receiving signal, the second light receiving signal, and the third light receiving signal (“In the embodiment shown in Figure 14, after the watch 200 acquires the PPG signal, it sends the PPG signal to the mobile phone 100”, [0215]), and
a data controller (“Mobile phone 100 may include processor 110…”, [0247]; “The processor in mobile phone 100 performs the same calculation process as in process 409 above”, [0226]) configured to calculate a pulse wave (See Figs. 7 and 11-12; these figures show a PPG signal waveform, which is a visual representation of the pulsatile changes in blood flow of the subject) using any one of the first light receiving signal, the second light receiving signal, and the third light receiving signal (“In the embodiment shown in Figure 14, after the watch 200 acquires the PPG signal, it sends the PPG signal to the mobile phone 100, which then analyzes the quality of the PPG signal and calculates the blood oxygen saturation”, [0215]), and
the controller operates the light emitting unit and the light receiving unit in a first mode of generating the third light receiving signal (“Step 403, Fig. 4; “Specifically, the controller 210 in the watch 200 executes the blood oxygen detection algorithm in the green light detection mode, controlling the red LED 251, infrared LED 252 and green LED 253 in the PPG sensor 250 to light up in sequence”, [0083]; also see [0021], [0081]; “When the user selects the green light detection mode, the controller in watch 200 performs the same steps as process 403 described above”, [0218]) or in a second mode of generating the first light receiving signal and the second light receiving signal (Step 406, Fig. 4; “Watch 200 enters non-green light detection mode, only turning on the red LED 251 and infrared LED 252 in PPG sensor 250 for blood oxygen detection”, [0089]; “When the user selects a non-green light detection mode, the processor in the mobile phone 200 performs the same judgment process as the above process 408, the only difference being that the execution subject is the mobile phone 100”, [0225]).
Ye discloses the claimed invention except for expressly disclosing wherein the data controller is configured to evaluate an irregular pulse. However, Addison, which also discloses a biological information measurement system (See Abstract), teaches wherein the data controller (Element 315, Fig. 3) is configured to evaluate an irregular pulse (See Fig. 8; “In an embodiment, a pulse oximeter may be the sensor used, and an alarm condition may be triggered based on an irregular pulse measurement from the pulse oximeter”, [0077]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ye with Addison such that the data controller of Ye also evaluates an irregular pulse, because an irregular pulse can be an indicator that a patient is not well (See [0075] of Addison).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ye in view of Addison, and further in view of Papini et al (US 20210275090 A1, hereinafter Papini).
Regarding Claim 9, modified Ye discloses the biological information measurement system according to claim 8, wherein the data controller calculates an oxygen saturation concentration using the first light receiving signal and the second light receiving signal (“409: Controller 210 calculates blood oxygen saturation based on PPG signals that meet the blood oxygen detection conditions.”, [0097]; “1406: The processor in mobile phone 100 performs the same calculation process as in process 409 above, the only difference being that the execution subject is mobile phone 100”, [0226]). Modified Ye discloses the claimed invention except for expressly disclosing wherein the data controller evaluates a sleep apnea syndrome. However, Papini, which also discloses a biological information measurement system (See Abstract), teaches wherein the data controller (Element 20, Fig. 2) evaluates a sleep apnea syndrome (“A system for detecting sleep apnea uses a PPG sensor for generating a PPG signal”, Abstract). 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 Ye with Papini, wherein the data controller evaluates a sleep apnea syndrome, because under-diagnosis of sleep apnea is a large problem due to difficulties in testing ([0019] of Papini), and a PPG system such as taught by Ye can be used to effectively and easily test for sleep apnea ([0023] of Papini).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Scharf (US 5830137 A), relevant to Claim 4 (2:37-43).
See Shim et al (US 20190083034 A1).
See Shimzu (US 20200406000 A1), relevant to Claim 4 ([0062]).
See Gerhard (US 5517988 A), relevant to Claim 8 (Abstract).
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791