Prosecution Insights
Last updated: July 17, 2026
Application No. 18/504,361

Biological Information Measurement Device And Biological Information Measurement Method

Final Rejection §101§103
Filed
Nov 08, 2023
Priority
Nov 09, 2022 — JP 2022-179372
Examiner
COOPER, JONATHAN EPHRAIM
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Seiko Epson Corporation
OA Round
2 (Final)
48%
Grant Probability
Moderate
3-4
OA Rounds
11m
Est. Remaining
79%
With Interview

Examiner Intelligence

Grants 48% of resolved cases
48%
Career Allowance Rate
68 granted / 143 resolved
-22.4% vs TC avg
Strong +31% interview lift
Without
With
+31.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
36 currently pending
Career history
190
Total Applications
across all art units

Statute-Specific Performance

§101
7.0%
-33.0% vs TC avg
§103
87.4%
+47.4% vs TC avg
§102
2.0%
-38.0% vs TC avg
§112
3.1%
-36.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 143 resolved cases

Office Action

§101 §103
CTFR 18/504,361 CTFR 95453 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 arguments, see page 10, filed 03/25/2026, with respect to the objection to Claim 1 have been fully considered and are persuasive. The objection to Claim 1 has been withdrawn. 07-38-01 AIA Applicant’s arguments, see page 10 , filed 03/25/2026 , with respect to the interpretation of Claims 1 and 4-5 under 35 U.S.C. § 112(f) have been fully considered and are persuasive. The interpretation of Claims 1 and 4-5 under 35 U.S.C. § 112(f) has been withdrawn. Applicant’s arguments, see pages 13-15, filed 03/25/2026, with respect to the rejection(s) of Claims 1-6 and 9 under 35 U.S.C. § 102 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 Therefore, the rejection has been withdrawn.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 Chen, CrossValidated, and Betchel. All other prior art rejections have been updated accordingly. 07-37 AIA Applicant's arguments filed 03/25/2026 regarding the rejection of the claims under 35 U.S.C. § 101 have been fully considered but they are not persuasive. Step 2A, Prong Two The Applicant has argued that “ amended claim 1 recites what the controller (processor) is configured to perform in detail that amounts to significantly more than the alleged judicial exception and integrates the alleged abstract idea into a practical application, such as a wearable device on a user having a display ” (page 11). However, a wearable device on a user having a display amounts to mere data gathering and outputting, as it is merely determining a biomarker in blood and outputting the calculation . See MPEP 2106(g)(3). The applicant has also argued “ These features performed by a controller should be categorized as either (1) Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b), or (2) 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). Claim 1 is clearly directed to a "machine," which is subject matter eligible under 35 U.S.C. § 101. ” However, the Examiner notes that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine. 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. See MPEP 2106.05(b)(I). In addition, the Applicant provides no further argument to support their conclusion that the claim applies or uses 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. The applicant has also argued “ Even if claim 9 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 9 recites additional elements that integrate the alleged judicial exception into a practical application .” (page 12). However, the applicant does not further explain what these alleged "additional" elements are, while the 101 analysis below accounts for the judicial exception and all additional elements as either extra-solution activity, generic computer components, or a particular field of use. For these reasons, the rejection of the claims under 35 U.S.C. § 101 is maintained . Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-3 and 5-15 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 wearable on a user . 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: calculate the oxygen saturation concentration using the plurality of first light-receiving signals and the plurality of second light-receiving signals calculate correlation data using the plurality of first light-receiving signals and the plurality of second light-receiving signals, the correlation data corresponding to a correlation coefficient, the correlation coefficient indicating approximation between the plurality of first light-receiving signals and the plurality of second light-receiving signals based on a formula below: PNG media_image1.png 291 1429 media_image1.png Greyscale where r is the correlation coefficient, N is a number of the plurality of first light-receiving signals, X n is a value of one of the plurality of first light-receiving signals at one of the plurality of measurement times, n is an integer of 1 or more, X ave is an average value of the plurality of first light-receiving signals obtained within a predetermined period of time, Yn is a value of one of the plurality of second light- receiving signals at one of the plurality of measurement times, and Y ave is an average value of the plurality of second light-receiving signals obtained within the predetermined period of time determine a reliability of the oxygen saturation concentration based on the correlation coefficient These limitations describe a mathematical calculation and/or a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example: The plain meaning of the limitation “ calculate the oxygen saturation concentration using the plurality of first light-receiving signals and the plurality of second light-receiving signals ” includes mathematical calculations that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations steps in real time. The plain meaning of the limitation “ calculate correlation data using the plurality of first light-receiving signals and the plurality of second light-receiving signals, the correlation data corresponding to a correlation coefficient, the correlation coefficient indicating approximation between the plurality of first light-receiving signals and the plurality of second light-receiving signals ” includes mathematical calculations that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations steps in real time. The following formula is a mathematical calculations that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations steps in real time. PNG media_image1.png 291 1429 media_image1.png Greyscale The plain meaning of the limitation “ where r is the correlation coefficient, N is a number of the plurality of first light-receiving signals, X n is a value of one of the plurality of first light-receiving signals at one of the plurality of measurement times, n is an integer of 1 or more, X ave is an average value of the plurality of first light-receiving signals obtained within a predetermined period of time, Yn is a value of one of the plurality of second light- receiving signals at one of the plurality of measurement times, and Y ave is an average value of the plurality of second light-receiving signals obtained within the predetermined period of time ” includes mathematical calculations that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations steps in real time. The plain meaning of the limitation “ determine a reliability of the oxygen saturation concentration based on the correlation coefficient ” includes mental processes that can be performed in the human mind by observations, evaluations, judgments, and opinions, or by a human with the aid of a pen and paper, or using a generic computer as a tool to perform these mental process steps in real time. 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 diode that emits red light and a second diode that emits infrared light a light-receiving unit having a photodiode and an output circuit, the photodiode being configured to repeatedly receive the red light emitted from the first diode and the infrared light emitted from the second diode at a plurality of measurement times, the output circuit being configured to repeatedly generate a plurality of first light-receiving- signals based on the repeatedly received red light and a plurality of second light- receiving signals based on the repeatedly received infrared light cause a display to display the oxygen saturation concentration and the reliability of the oxygen saturation concentration 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 calculate an oxygen saturation concentration, wherein the controller is configured 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 light-emitting unit including a first diode that emits red light and a second diode that emits infrared light a light-receiving unit having a photodiode and an output circuit, the photodiode being configured to repeatedly receive the red light emitted from the first diode and the infrared light emitted from the second diode at a plurality of measurement times, the output circuit being configured to repeatedly generate a plurality of first light-receiving- signals based on the repeatedly received red light and a plurality of second light- receiving signals based on the repeatedly received infrared light a controller configured to calculate an oxygen saturation concentration, wherein the controller is configured to... cause a display to display the oxygen saturation concentration and the reliability of the oxygen saturation concentration 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 11/08/2023 ([0028]). The light-receiving unit is considered to be well-understood, routine, and conventional based on statement from the applicant' s specification filed 11/08/2023 ([0029]). The controller is considered to be well-understood, routine, and conventional based on statement from the applicant' s specification filed 11/08/2023 ([0040]). The display is considered to be well-understood, routine, and conventional based on statement from the applicant' s specification filed 11/08/2023 ([0075]). Independent Claim 9 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 Claims 2-3, 5-8, and 10-15 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 2-3, 5-8, and 10-15 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 2-3, 5-8, and 10-15 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. Therefore, Claims 1-3 and 5-15 are not patent eligible under 35 U.S.C. § 101 . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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 1-3, 6, 9-11, and 13 are rejected under 35 U.S.C. 103 as being obvious over Chen et al (CN 112932475 A, hereinafter Chen; an attached machine translation from the European Patent Organization was relied upon for this rejection) in view of Betchel et al (US 20170303835 A1, hereinafter Betchel) and the Non-Patent Literature (NPL) to CrossValidated (“Does Pearson population correlation(rho) formula differ from sample correlation formula?”, hereinafter CrossValidated). Regarding Claim 1 , Chen discloses a biological information measurement device wearable on a user (“Currently, measurements are generally taken using non-invasive pulse oximeters. These instruments typically include finger-mounted photoelectric sensors”, [0003]) , the biological information measurement device comprising: a light-emitting unit including a first diode that emits red light and a second diode that emits infrared light (“In its operation, the non-invasive pulse oximeter uses two light-emitting diodes to emit 660nm red light and 940nm infrared light”, [0068]) ; a light-receiving unit having a photodiode and an output circuit, the photodiode being configured to repeatedly receive the red light emitted from the first diode and the infrared light emitted from the second diode at a plurality of measurement times (“The phototube detects the intensity of the transmitted light and separates the signals of the two wavelengths, obtaining the DC and AC components corresponding to the two wavelengths.”, [0068]) , the output circuit being configured to repeatedly generate a plurality of first light-receiving signals based on the repeatedly received red light and a plurality of second light-receiving signals based on the repeatedly received infrared light (“In some embodiments, the signal value in the initial photoplethysmography signal may indicate the intensity of the reflected light, or it may indicate the voltage value corresponding to the intensity of the reflected light, without limitation. It is understandable that, for the intensity of reflected light, the voltage value corresponding to each intensity of reflected light can be calculated based on the preset relationship between the intensity of reflected light and voltage”, [0073]) ; and a controller (“The execution subject of this method can be a processing device, which can be a terminal or a server”, [0070]) configured to calculate an oxygen saturation concentration (“Figure 1 is a flowchart illustrating a method for calculating blood oxygen saturation provided in an embodiment of this application. For example, the terminal can be any one of a desktop computer, laptop computer, tablet computer, smartphone, blood oxygen saturation meter, smart wearable device (watch, bracelet, earphone)”, [0070]) , wherein the controller is configured to: calculate the oxygen saturation concentration (S104, Fig. 1; [0079]) using the plurality of first light-receiving signals and the plurality of second light-receiving signals (“The initial photoplethysmography (PPG) signal includes: the initial PPG signal corresponding to red light and the initial PPG signal corresponding to infrared light”, [0072]) ; calculate correlation data using the plurality of first light-receiving signals and the plurality of second light-receiving signals, the correlation data corresponding to a correlation coefficient (“Optionally, the correlation coefficient between the two signals can be calculated based on the formula for calculating the Pearson correlation coefficient, which ranges from -1 to 1, representing negative and positive correlations respectively. However, it should be noted that the actual calculation formula is not limited to this”, [0093]) , the correlation coefficient indicating approximation between the plurality of first light-receiving signals and the plurality of second light-receiving signals (“Specifically, the correlation coefficient between the processed red light photoplethysmography (PPG) signal and the infrared light photoplethysmography (PPG) signal can be calculated to further determine the signal quality of the processed PPG signal”, [0093]) ; determine a reliability of the oxygen saturation concentration based on the correlation coefficient (“After obtaining the correlation coefficient, the correlation coefficients of the photoplethysmography (PPG) signals corresponding to red light and infrared light can be compared with a preset threshold in each period of the PPG signal. Optionally, if the correlation coefficient of the two signals in a certain period is less than the preset threshold, it indicates that the correlation between the two signals in that period is poor, and the PPG signals in that period can be filtered out to obtain the filtered PPG signals”, [0097]) ; and cause a display to display the oxygen saturation concentration (“[The sensor] measures the light transmission intensity through the tissue bed, collects the subject's PPG signal, and calculates and displays the oxygen saturation (SO2) based on the subject's PPG signal”, [0003]) . Chen discloses the claimed invention except for expressly disclosing calculating the correlation coefficient based on a formula below: PNG media_image1.png 291 1429 media_image1.png Greyscale where r is the correlation coefficient, N is a number of the plurality of first light-receiving signals, X n is a value of one of the plurality of first light-receiving signals at one of the plurality of measurement times, n is an integer of 1 or more, X ave is an average value of the plurality of first light-receiving signals obtained within a predetermined period of time, Yn is a value of one of the plurality of second light- receiving signals at one of the plurality of measurement times, and Y ave is an average value of the plurality of second light-receiving signals obtained within the predetermined period of time; and wherein the controller is configured to cause a display to display the reliability of the oxygen saturation concentration. However, CrossValidated, which is directed towards calculating correlation coefficients, teaches calculating the correlation coefficient based on a formula (“The Pearson correlation can be calculated, with the same formula, on any dataset of paired numeric values or other types of values that might be considered numeric (e.g., ordinal)”, page 1) below: PNG media_image2.png 112 539 media_image2.png Greyscale Fig. A : CrossValidated equation 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 Pearson correlation coefficient calculation for the red light and infrared light signals of Chen with CrossValidated (i.e. where r is the correlation coefficient, N is a number of the plurality of first light-receiving signals, X n is a value of one of the plurality of first light-receiving signals at one of the plurality of measurement times, n is an integer of 1 or more, X ave is an average value of the plurality of first light-receiving signals obtained within a predetermined period of time, Yn is a value of one of the plurality of second light- receiving signals at one of the plurality of measurement times, and Y ave is an average value of the plurality of second light-receiving signals obtained within the predetermined period of time), because the CrossValidated equation is a known correlation for samples in particular. All of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and 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. Betchel, which is also directed towards calculating an oxygen saturation concentration (Abstract) , teaches wherein the controller (Element 116, Fig. 3) is configured to cause a display (Element 115, Fig. 1) to display the reliability of the oxygen saturation concentration (See Elements 210, 220, and 225, Figs. 4A-4E, “Quality” metric; “The quality value may also be referred to as a quality metric, a quality indicator, a quality index, a confidence indicator, a confidence value, a confidence metric, or a confidence index”, [0069]) . 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 reliability metric display to the controller configuration of Chen, because the quality indicator may be used to provide feedback to the instrument operator (See Betchel, [0072]) . Regarding Claim 2 , modified Chen discloses a biological information measurement device according to claim 1, further comprising: a memory (“The aforementioned software functional units are stored in a storage medium and include several instructions to cause a computer device (which may be a personal computer, server, or network device, etc.) or processor to execute some steps of the methods of the various embodiments of this application”, [0136]) configured to store a threshold for evaluating the correlation- coefficient (“After obtaining the correlation coefficient, the correlation coefficients of the photoplethysmography (PPG) signals corresponding to red light and infrared light can be compared with a preset threshold in each period of the PPG signal”, [0097]) , wherein the controller is configured to determine the reliability of the oxygen saturation concentration by comparing the correlation- coefficient with the threshold (“Optionally, if the correlation coefficient of the two signals in a certain period is less than the preset threshold, it indicates that the correlation between the two signals in that period is poor, and the PPG signals in that period can be filtered out to obtain the filtered PPG signals”, [0097]) . Regarding Claim 3 , modified Chen discloses the biological information measurement device according to claim 2, wherein the controller is further configured to: output the oxygen saturation concentration when the correlation-coefficient is larger than the threshold (“Calculate and obtain the blood oxygen saturation of the test subject based on the screened photoplethysmography (PPG) signals”, [0098]) ; and delete the oxygen saturation concentration when the correlation-coefficient is smaller than the threshold (“Optionally, if the correlation coefficient of the two signals in a certain period is less than the preset threshold, it indicates that the correlation between the two signals in that period is poor, and the PPG signals in that period can be filtered out to obtain the filtered PPG signals”, [0097]) . Regarding Claim 6 , modified Chen discloses the biological information measurement device according to claim 1, wherein the light-receiving unit includes a filter that extracts a fluctuation component, the filter is configured to extract a first fluctuation component from the repeatedly received red light and extract a second fluctuation component from the repeatedly received infrared light (“After passing through the skin tissue, the red and infrared light are reflected back to the photosensitive sensor in the pulse oximeter. The phototube detects the intensity of the transmitted light and separates the signals of the two wavelengths, obtaining the DC and AC components corresponding to the two wavelengths”, [0068]) , and the controller is configured to calculate the oxygen saturation concentration using the first fluctuation component and the second fluctuation component (“Therefore, the blood oxygen saturation can be calculated based on the DC and AC components corresponding to the red and infrared light, respectively.”, [0068]) . Regarding Claim 9 , Chen discloses a biological information measurement method (“Figure 1 is a flowchart illustrating a method for calculating blood oxygen saturation provided in an embodiment of this application”, [0070]) of a biological information measurement device wearable on a user (“Currently, measurements are generally taken using non-invasive pulse oximeters. These instruments typically include finger-mounted photoelectric sensors”, [0003]) , the biological information measurement method for causing a processor to execute a program stored in a memory, the biological information measurement method comprising executing on the processor the steps of (“the present invention provides an electronic device, comprising: a processor, a storage medium, and a bus, wherein the storage medium stores machine-readable instructions executable by the processor, and when the electronic device is running, the processor communicates with the storage medium via the bus, and the processor executes the machine-readable instructions to perform the steps of the blood oxygen saturation calculation method as described in any of the foregoing embodiments”, [0047]) : causing first and second diodes to emit red light and infrared light to a part of the user, respectively (“In its operation, the non-invasive pulse oximeter uses two light-emitting diodes to emit 660nm red light and 940nm infrared light”, [0068]) ; causing a photodiode to repeatedly receive the red light and the infrared light passing through the-subject part of the user (“The phototube detects the intensity of the transmitted light and separates the signals of the two wavelengths, obtaining the DC and AC components corresponding to the two wavelengths.”, [0068]) at a plurality of measurement times (“S101. Acquire the initial photoplethysmography (PPG) signal of the subject within a preset time period”, [0071]; “Depending on the actual application scenario, the above preset time period can be 1 minute, 2 minutes, 5 minutes, etc., and is not limited here”, [0073]) ; generating a plurality of first light-receiving-signal signals based on the repeatedly received red light and a plurality of second light-receiving-signal signals based on the repeatedly received infrared light (“In some embodiments, the signal value in the initial photoplethysmography signal may indicate the intensity of the reflected light, or it may indicate the voltage value corresponding to the intensity of the reflected light, without limitation. It is understandable that, for the intensity of reflected light, the voltage value corresponding to each intensity of reflected light can be calculated based on the preset relationship between the intensity of reflected light and voltage”, [0073]) ; calculating an oxygen saturation concentration using the plurality of first light- receiving-signal signals and the plurality of second light-receiving-signal signals (“S104. Calculate and obtain the blood oxygen saturation of the test subject based on the processed photoplethysmography signal”, [0079]; “The initial photoplethysmography (PPG) signal includes: the initial PPG signal corresponding to red light and the initial PPG signal corresponding to infrared light”, [0072]) ; calculating correlation data based on the plurality of first light-receiving-signal signals and the plurality of second light-receiving-signal;-and signals, the correlation data corresponding to a correlation coefficient (“Optionally, the correlation coefficient between the two signals can be calculated based on the formula for calculating the Pearson correlation coefficient, which ranges from -1 to 1, representing negative and positive correlations respectively. However, it should be noted that the actual calculation formula is not limited to this”, [0093]) , the correlation coefficient indicating approximation between the plurality of first light-receiving signals and the plurality of second light-receiving signals (“Specifically, the correlation coefficient between the processed red light photoplethysmography (PPG) signal and the infrared light photoplethysmography (PPG) signal can be calculated to further determine the signal quality of the processed PPG signal”, [0093]) ; determining a reliability of the oxygen saturation concentration based on the correlation-data coefficient (“After obtaining the correlation coefficient, the correlation coefficients of the photoplethysmography (PPG) signals corresponding to red light and infrared light can be compared with a preset threshold in each period of the PPG signal. Optionally, if the correlation coefficient of the two signals in a certain period is less than the preset threshold, it indicates that the correlation between the two signals in that period is poor, and the PPG signals in that period can be filtered out to obtain the filtered PPG signals”, [0097]) ; and causing a display to display the oxygen saturation concentration (“[The sensor] measures the light transmission intensity through the tissue bed, collects the subject's PPG signal, and calculates and displays the oxygen saturation (SO2) based on the subject's PPG signal”, [0003]) . Chen discloses the claimed invention except for expressly disclosing the correlation coefficient based on a formula below: PNG media_image1.png 291 1429 media_image1.png Greyscale where r is the correlation coefficient, N is a number of the plurality of first light-receiving signals, X n is a value of one of the plurality of first light-receiving signals at one of the plurality of measurement times, n is an integer of 1 or more, X ave is an average value of the plurality of first light-receiving signals obtained within a predetermined period of time, Y n is a value of one of the plurality of second light- receiving signals at one of the plurality of measurement times, and Y ave is an average value of the plurality of second light-receiving signals obtained within the predetermined period of time; causing a display to display the reliability of the oxygen saturation concentration. However, CrossValidated, which is directed towards calculating correlation coefficients, teaches calculating the correlation coefficient based on a formula (“The Pearson correlation can be calculated, with the same formula, on any dataset of paired numeric values or other types of values that might be considered numeric (e.g., ordinal)”, page 1) below: PNG media_image2.png 112 539 media_image2.png Greyscale Fig. B : CrossValidated equation 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 Pearson correlation coefficient calculation for the red light and infrared light signals of Chen with CrossValidated (i.e. where r is the correlation coefficient, N is a number of the plurality of first light-receiving signals, X n is a value of one of the plurality of first light-receiving signals at one of the plurality of measurement times, n is an integer of 1 or more, X ave is an average value of the plurality of first light-receiving signals obtained within a predetermined period of time, Y n is a value of one of the plurality of second light- receiving signals at one of the plurality of measurement times, and Y ave is an average value of the plurality of second light-receiving signals obtained within the predetermined period of time) because the CrossValidated equation is a known correlation for samples in particular. All of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and 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. Betchel, which is also directed towards calculating an oxygen saturation concentration (Abstract) , teaches causing a display (Element 115, Fig. 1) to display the reliability of the oxygen saturation concentration concentration (See Elements 210, 220, and 225, Figs. 4A-4E, “Quality” metric; “The quality value may also be referred to as a quality metric, a quality indicator, a quality index, a confidence indicator, a confidence value, a confidence metric, or a confidence index”, [0069]) . 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 reliability metric display to the method of Chen, because the quality indicator may be used to provide feedback to the instrument operator (See Betchel, [0072]) . Regarding Claim 10 , modified Chen discloses the biological information measurement method according to claim 9, wherein the memory is further configured to store a threshold for evaluating the correlation coefficient (“After obtaining the correlation coefficient, the correlation coefficients of the photoplethysmography (PPG) signals corresponding to red light and infrared light can be compared with a preset threshold in each period of the PPG signal”, [0097]) , and the processor is further configured to determine the reliability of the oxygen saturation concentration by comparing the correlation coefficient with the threshold (“Optionally, if the correlation coefficient of the two signals in a certain period is less than the preset threshold, it indicates that the correlation between the two signals in that period is poor, and the PPG signals in that period can be filtered out to obtain the filtered PPG signals”, [0097]) . Regarding Claim 11 , modified Chen discloses the biological information measurement method according to claim 10, wherein the processor is further configured to: output the oxygen saturation concentration when the correlation coefficient is larger than the threshold (“Calculate and obtain the blood oxygen saturation of the test subject based on the screened photoplethysmography (PPG) signals”, [0098]) ; and delete the oxygen saturation concentration when the correlation coefficient is smaller than the threshold (“Optionally, if the correlation coefficient of the two signals in a certain period is less than the preset threshold, it indicates that the correlation between the two signals in that period is poor, and the PPG signals in that period can be filtered out to obtain the filtered PPG signals”, [0097]) . Regarding Claim 13 , modified Chen discloses the biological information measurement method according to claim 9, further comprising: causing a filter to extract a fluctuation component, wherein the filter is configured to extract a first fluctuation component from the repeatedly received red light and extract a second fluctuation component from the repeatedly received infrared light (“After passing through the skin tissue, the red and infrared light are reflected back to the photosensitive sensor in the pulse oximeter. The phototube detects the intensity of the transmitted light and separates the signals of the two wavelengths, obtaining the DC and AC components corresponding to the two wavelengths”, [0068]) , and the processor is configured to calculate the oxygen saturation concentration using the first fluctuation component and the second fluctuation component (“Therefore, the blood oxygen saturation can be calculated based on the DC and AC components corresponding to the red and infrared light, respectively”, [0068]) . Claims 5 and 12 are rejected under 35 U.S.C. 103 as being obvious over Chen in view of Betchel and CrossValidated, further in view of Ye et al (CN 114073520 A, hereinafter Ye; a machine translation was relied upon for this rejection). Regarding Claim 5 , modified Chen discloses the biological information measurement device according to claim 1. Modified Chen discloses the claimed invention except for expressly disclosing wherein the light-emitting unit includes a third diode that emits green light, the light-receiving unit is configured to repeatedly receive the green light and generate a plurality of third light-receiving signals based on the repeatedly received green light, and the controller is configured to calculate the correlation data using the plurality of first light-receiving signals, the plurality of second light-receiving- signals, and the plurality of third light-receiving signals. However, Ye, which also discloses a biological information measurement device (Element 200, Fig. 1) , teaches wherein the light-emitting unit includes a third diode that emits green light (“For example, the watch may contain one or more PPG sensors, which may include one or more green LEDs and a photodetector”, [0007]) , the light-receiving unit is configured to repeatedly receive the green light and generate a plurality of third light-receiving signals based on the repeatedly received green light (“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]) , and the controller is configured to calculate the correlation data using the plurality of first light-receiving signals, the plurality of second light-receiving- signals, and the plurality of third light-receiving signals (“the quality of the PPG signal is determined by judging the correlation between the AC component in the detected red light data and the AC component in the green light data, the correlation between the AC component in the infrared light data and the AC component in the green light data, the PI variance of the green light data, and the PI ratio of the green light data to the red or infrared light data”, [0005]) . 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 green light diode to modified Chen and calculate correlation data using the green light, as taught by Ye, because green light can also help to determine whether the quality of the PPG signal detected by the PPG sensor meets the conditions for blood oxygen calculation (Ye, [0004]) . Regarding Claim 12 , modified Chen discloses the biological information measurement method according to claim 9. Modified Chen discloses the claimed invention except for expressly disclosing the method further comprising: causing a third diode to emit green light to the part of the user; causing the photodiode to repeatedly receive the green light and generate a plurality of third light-receiving signals based on the repeatedly received green light; and calculating the correlation data using the plurality of first light-receiving signals, the plurality of second light-receiving signals, and the plurality of third light- receiving signals. causing a third diode (“For example, the watch may contain one or more PPG sensors, which may include one or more green LEDs and a photodetector”, [0007]) to emit green light to the part of the user (“When the green light emitted by the green LED 253 illuminates human tissue...”, [0065]) ; However, Ye, which also discloses a biological information measurement method (See Fig. 4 and [0001]) , teaches causing the photodiode to repeatedly receive the green light and generate a plurality of third light-receiving signals based on the repeatedly received green light (“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]) ; and calculating the correlation data using the plurality of first light-receiving signals, the plurality of second light-receiving signals, and the plurality of third light- receiving signals (“the quality of the PPG signal is determined by judging the correlation between the AC component in the detected red light data and the AC component in the green light data, the correlation between the AC component in the infrared light data and the AC component in the green light data, the PI variance of the green light data, and the PI ratio of the green light data to the red or infrared light data”, [0005]) . 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 green light diode to modified Chen and calculate correlation data using the green light, as taught by Ye, because green light can also help to determine whether the quality of the PPG signal detected by the PPG sensor meets the conditions for blood oxygen calculation (Ye, [0004]) . Claims 7-8 and 14-15 are rejected under 35 U.S.C. 103 as being obvious over Chen in view of Betchel and CrossValidated, further in view of Hatch (US 20170049336 A1, hereinafter Hatch). Regarding Claim 7 , modified Chen discloses the biological information measurement device according to claim 1, wherein the controller is configured to calculate the correlation data ([0093]) and the oxygen saturation concentration (S104, Fig. 1; [0079]) . Modified Chen discloses the claimed invention except for expressly disclosing wherein the controller is configured to calculate the correlation data and the oxygen saturation concentration at a predetermined time interval. However, Hatch, which also discloses a biological information measurement device (Abstract) , teaches wherein the controller (“A suitable computing device may include a processor to perform logic and other computing operations, e.g., a stand-alone computer processing unit (“CPU”), or hard wired logic as in a microcontroller, or a combination of both, and may execute instructions according to its operating system and the instructions to perform the steps of the method, or elements of the process”, [0095]) is configured to calculate oxygen saturation at a predetermined time interval (“the actual signal-derived data used for calculation of SpO2 is obtained only at the two brief periods of the waveform at the inflection points. The present invention uses the R-wave-derived timing pulse to record the characteristic time intervals to these inflection points during the initialization of the system at the beginning of each application; then times the data sampling accordingly”, [0073]) . 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 Chen in view of Hatch (such that the controller is configured to calculate the correlation data and the oxygen saturation concentration at a predetermined time interval), because this saves power as the light-emitting units only need to be powered for brief periods to fully obtain valid data (See the last sentence in [0073] of Hatch) . Regarding Claim 8 , modified Chen discloses the biological information measurement device according to claim 7. Modified Chen discloses the claimed invention except for expressly disclosing wherein the controller is further configured to: calculate a frequency of a pulse wave from the plurality of first light- receiving signals or the plurality of second light-receiving signals; and determine the predetermined time interval including one or more pulse waves using the frequency. However, Hatch, which also discloses a biological information measurement device (Abstract) , teaches wherein the controller (“A suitable computing device may include a processor to perform logic and other computing operations, e.g., a stand-alone computer processing unit (“CPU”), or hard wired logic as in a microcontroller, or a combination of both, and may execute instructions according to its operating system and the instructions to perform the steps of the method, or elements of the process”, [0095]) is configured to: calculate a frequency of a pulse wave from the plurality of first light- receiving signals or the plurality of second light-receiving signals (“Thus, as stated, the raw signal of a PPG is a downward waveform of photocurrent, as depicted. The two points on this waveform that are recorded with each heart cycle and used to calculate the SpO2 occur at the “trough” (as it would be referred to in a pressure waveform, such as in FIG. 10C(4) and the following “peak” inflection. See, FIG. 10C(6) depicts the correlation of the R-wave timing trigger pulse to the “trough” and “peak” inflections of the PPG; defining the “trough” timing interval and the “peak” timing interval”, [0073]) ; and determine the predetermined time interval including one or more pulse waves using the frequency (“The present invention uses the R-wave-derived timing pulse to record the characteristic time intervals to these inflection points during the initialization of the system at the beginning of each application; then times the data sampling accordingly”, [0073]) . 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 Chen in view of Hatch, because this saves power as the light-emitting units only need to be powered for brief periods to fully obtain valid data (See the last sentence in [0073] of Hatch) . Regarding Claim 14 , modified Chen discloses the biological information measurement method according to claim 9, wherein the processor is configured to calculate the correlation data ([0093]) and the oxygen saturation concentration (S104, Fig. 1; [0079]) . Modified Chen discloses the claimed invention except for expressly disclosing wherein the processor is configured to calculate the correlation data and the oxygen saturation concentration at a predetermined time interval. However, Hatch, which also discloses a biological information measurement method (Abstract) , teaches wherein the processor (“A suitable computing device may include a processor to perform logic and other computing operations, e.g., a stand-alone computer processing unit (“CPU”), or hard wired logic as in a microcontroller, or a combination of both, and may execute instructions according to its operating system and the instructions to perform the steps of the method, or elements of the process”, [0095]) is configured to calculate oxygen saturation at a predetermined time interval (“the actual signal-derived data used for calculation of SpO2 is obtained only at the two brief periods of the waveform at the inflection points. The present invention uses the R-wave-derived timing pulse to record the characteristic time intervals to these inflection points during the initialization of the system at the beginning of each application; then times the data sampling accordingly”, [0073]) . 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 Chen in view of Hatch (such that the processor is configured to calculate the correlation data and the oxygen saturation concentration at a predetermined time interval), because this saves power as the light-emitting units only need to be powered for brief periods to fully obtain valid data (See the last sentence in [0073] of Hatch) . Regarding Claim 15 , modified Chen discloses the biological information measurement method according to claim 14. Modified Chen discloses the claimed invention except for expressly disclosing the method further comprising: calculating a frequency of a pulse wave from the plurality of first light-receiving signals or the plurality of second light-receiving signals; and determining the predetermined time interval including one or more pulse waves using the frequency. However, Hatch, which also discloses a biological information measurement method (Abstract) , teaches the method further comprising: calculating a frequency of a pulse wave from the plurality of first light-receiving signals or the plurality of second light-receiving signals (“Thus, as stated, the raw signal of a PPG is a downward waveform of photocurrent, as depicted. The two points on this waveform that are recorded with each heart cycle and used to calculate the SpO2 occur at the “trough” (as it would be referred to in a pressure waveform, such as in FIG. 10C(4) and the following “peak” inflection. See, FIG. 10C(6) depicts the correlation of the R-wave timing trigger pulse to the “trough” and “peak” inflections of the PPG; defining the “trough” timing interval and the “peak” timing interval”, [0073]) ; and determining the predetermined time interval including one or more pulse waves using the frequency (“The present invention uses the R-wave-derived timing pulse to record the characteristic time intervals to these inflection points during the initialization of the system at the beginning of each application; then times the data sampling accordingly”, [0073]) . 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 Chen in view of Hatch, because this saves power as the light-emitting units only need to be powered for brief periods to fully obtain valid data (See the last sentence in [0073] of Hatch) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Takahashi (US 20160120477 A1), relevant to Claims 1 and 9 (Abstract) . See Chang et al (CN 114532978 A), relevant to Claims 1 and 9. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN EPHRAIM COOPER whose telephone number is (571)272-2860. The examiner can normally be reached Monday-Friday 7:30AM-5:30PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JONATHAN E. COOPER/Examiner, Art Unit 3791 /JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791 Application/Control Number: 18/504,361 Page 2 Art Unit: 3791 Application/Control Number: 18/504,361 Page 3 Art Unit: 3791 Application/Control Number: 18/504,361 Page 4 Art Unit: 3791 Application/Control Number: 18/504,361 Page 5 Art Unit: 3791 Application/Control Number: 18/504,361 Page 6 Art Unit: 3791 Application/Control Number: 18/504,361 Page 7 Art Unit: 3791 Application/Control Number: 18/504,361 Page 8 Art Unit: 3791 Application/Control Number: 18/504,361 Page 9 Art Unit: 3791 Application/Control Number: 18/504,361 Page 10 Art Unit: 3791 Application/Control Number: 18/504,361 Page 11 Art Unit: 3791 Application/Control Number: 18/504,361 Page 12 Art Unit: 3791 Application/Control Number: 18/504,361 Page 13 Art Unit: 3791 Application/Control Number: 18/504,361 Page 14 Art Unit: 3791 Application/Control Number: 18/504,361 Page 15 Art Unit: 3791 Application/Control Number: 18/504,361 Page 16 Art Unit: 3791 Application/Control Number: 18/504,361 Page 17 Art Unit: 3791 Application/Control Number: 18/504,361 Page 18 Art Unit: 3791 Application/Control Number: 18/504,361 Page 19 Art Unit: 3791 Application/Control Number: 18/504,361 Page 20 Art Unit: 3791 Application/Control Number: 18/504,361 Page 21 Art Unit: 3791 Application/Control Number: 18/504,361 Page 22 Art Unit: 3791 Application/Control Number: 18/504,361 Page 23 Art Unit: 3791 Application/Control Number: 18/504,361 Page 24 Art Unit: 3791 Application/Control Number: 18/504,361 Page 25 Art Unit: 3791 Application/Control Number: 18/504,361 Page 26 Art Unit: 3791 Application/Control Number: 18/504,361 Page 27 Art Unit: 3791
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Prosecution Timeline

Nov 08, 2023
Application Filed
Jan 27, 2026
Non-Final Rejection mailed — §101, §103
Mar 25, 2026
Response Filed
Jun 02, 2026
Final Rejection mailed — §101, §103 (current)

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3-4
Expected OA Rounds
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79%
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3y 8m (~11m remaining)
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