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 .
Drawings
The subject matter of this application admits of illustration by a drawing to facilitate understanding of the invention. Applicant is required to furnish a drawing under 37 CFR 1.81(c). No new matter may be introduced in the required drawing. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d).
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 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Under the two-step 101 analysis, the claims fail to satisfy the
criteria for subject matter eligibility.
Step 1: Claims 1-16 are within at least one of the four statutory categories.
Claim 1 and dependent claims 2-12 disclose an apparatus.
Claim 13 discloses a method.
Claim 14 and dependent claim 15 disclose an apparatus.
Claim 16 discloses a method.
Step 2A, Prong One: The independent claims 1, 13, 14, and 16 recite limitations directed to an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
Mental Processes: Mental Processes can be practically performed in the human mind using mental steps, a pen and paper, or basic critical thinking/judgement -- types of activities that have been found by the courts to represent abstract ideas. See p. 7-8 of October 2019 Update: 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) for examples of ineligible claims that recite mental processes.
Claims 1, 13, 14, and 16 recite the follow abstract ideas:
“calculate [the] blood oxygen saturation”
[Claims 1 & 13 only] “discard the light signal measured by the one or more light detector if the motion signal detected by the motion sensor exceeds a predetermined threshold value”
[Claim 16 only] “discards the light signal measured by the at least one detector and/or issues a warning to the user, if the contact signal indicates that at least one light source and/or at least one detector have lost contact to said subject's tissue”
Calculating blood oxygen saturation can be performed through an individual' s mental process and judgement, which can be done mentally or with the aid of pen and paper, for example using a mathematical concept based on Lambert-Beer Law and/or calculating the slope of the attenuation of the light signal per the specification. Discarding the measured light signal based on motion sensor data and/or loss of contact can also be performed through an individual' s mental process and judgement, for example by comparing a value to a predetermined threshold per the specification.
Regarding the dependent claims, they are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine, and previously known to the industry:
Claim 2 further limits where the measurement is occurring
Claim 3 further limits specifications of the measured light signal
Claim 4 further limits measuring motion data
Claims 5-7 further limits discarding data based on motion data
Claim 8 further limits storing data
Claim 9 further limits determining breathing frequency
Claim 10 further limits issuing a warning
Claim 11 further limits positioning lights sources/detectors
Claim 12 further limits discarding data based light signal quality and motion data
Claim 15 further limits discarding data or issuing a warning based on the contact signal
The dependent claims further limit the abstract ideas of independent claims 1, 13, 14, and 16 and do not recite significantly more than the abstract ideas.
Step 2A, Prong Two: The judicial exceptions (abstract ideas) in claims 1-16 are not integrated into a practical application because:
The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for recording measurement data and calculating results merely invoke a computer as a tool.
The data-gathering step (receiving measurement data) and the data-output step of determining oxygen saturation do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II.
The claims recite a computer/processor that is used as a tool for recording measurement data and determining results.
The claims do not apply the abstract idea to affect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized for recording spectrophotometric data to provide the oxygen saturation.
The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computer/processor for recording measurement data and determining results.
The additional elements are identified as follows:
Claims 1-12, 14, 15 - spectrophotometric device and/or housing
Claims 1, 3, 5, 11, 13-16 – light detectors
Claims 1, 3, 11, 13-16 – light sources
Claims 1, 5, 6, 8-10, 12, 13-16 – electronic data processing unit
Claims 1, 4, 5, 9, 13, – motion sensor, accelerometer, and/or gyroscope
Claims 8 – electronic storage device
Claim 11 – adhesive patch
Claim 11 - clothing
Claim 14, 16 - contact sensor
Step 2B: Claims 1-16 do not include additional elements that are sufficient to provide for an inventive concept nor amount to significantly more than the judicial exception.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for recording measurement data and determining results as demonstrated by the specification. The applicant discloses nothing unique about the spectrophotometric device/housing/adhesive patch/clothing (Specification [0040-0045]), light sources/detectors (Specification [0021-0024]), electronic data processing unit or storage device (Specification [0050, 0063]), motion sensor, accelerometer, gyroscope, or contact sensor (Specification [0046, 0086]), configured to perform the generic computer functions (e.g., recording measurement data and determining oxygenation saturation) that are well-understood, routine, and conventional activities previously known to the pertinent industry. More particularly, Cho (https://doi.org/10.1155/2019/3924508) in 2019 described “most current wristband-type devices are equipped with the combination of accelerometer, optical sensor, and electrodes for their health functions, and continuously measured data are expanding the possibility of discovering new medical meanings” (Cho [Abstract]). Henriksen (https://doi.org/10.2196/jmir.9157) in 2018 described the broad movement of wearables combining accelerometers and gyroscopes for more accurate motion tracking and reduction of PPG signal noise (Henriksen pg 2, col 2 [3-4] and pg 3, col 1 [1]). Schmidt (https://doi.org/10.3390/s19194079) described in 2019 common methods of wearable-based affect recognition including the recording of electrodermal activity based on skin conductance at the wrist (Schmidt pg 9 [2]).
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3. Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum.
When considered in combination, the additional elements (i.e., the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of the spectrophotometric device, housing, light sources/detectors, electronic data processing unit, storage device, motion sensor, accelerometer, gyroscope, contact sensor, or any other technology. Their collective functions
merely provide conventional computer implementation.
Therefore, claims 1-16 are directed to patent ineligible subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 8, 11, and 13 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipate by Borremans (US 20200383628 A1).
Regarding claim 1, Borremans teaches a spectrophotometric device for measuring blood oxygen saturation in a subject's tissue ([0051] “Spectroscopy device 16 can provide for simultaneous measurement of multiple physiological parameters… blood oxygenation”) comprising:
one or more light sources for emitting a light signal into the subject's tissue ([0065] “Illumination source 20: One or more illumination sources 20 can contain one or more Light Emitting Diodes (LEDs) or Vertical Cavity Surface Emitting LEDs (VSCELs) covering the wavelengths of interest. They may also contain one or more LEDs with phosphor coatings to extend the spectral range of the LED. In an example the LEDs can contain a combination of wideband (phosphor-based) LEDs and narrow-band LEDs. Illumination source 20 can also include other light sources such as small halogen lamps.”),
one or more light detectors for detecting the light signal reflected by the subject's tissue ([0054] “Such a device can contain one or more monolithically integrated spectrometers 18 and/or one or one monolithically integrated illumination sources 20. In these embodiments a multicomponent spectroscopy device 16 allows for the collection a spatial spectral response from the skin area of interest over a plurality of wavelengths ranges.”),
an electronic data processing unit configured to calculate the blood oxygen saturation based on the light signal measured by the one or more light detectors ([0017] “a processor configured to process the outcome of the spectrometer” [0070] “Processor 106: In an example processor 106 processes and manages the collection of data acquired from spectrometer 18.” [0060] “Parameters measured, such as measures of blood oxygen saturation (SpO2)”), and
a motion sensor for detecting a motion signal indicative of motion of the one or more light sources and/or the one or more light detectors ([0071] “Other sensors 104: in addition to the optical sensor network containing an illumination source and a spectrometer, other sensors 104 can be present. Examples of such other sensors include EKG sensors, inertial measurement unit (IMU), electrical impedance sensor or any other sensor which can be used to obtain other sensory information to correlate to or complement collected spectral data.”),
wherein the electronic data processing unit is configured to discard the light signal measured by the one or more light detectors if the motion signal detected by the motion sensor exceeds a predetermined threshold value ([0076] “an accelerometer can be added to correlate motion to the spectroscopic data and to assist in the disregarding of invalid data, or correcting the captured data for motion artifacts.”).
Regarding claim 2, Borremans teaches the spectrophotometric device according to claim 1, wherein the spectrophotometric device is configured to measure blood oxygen saturation on a subject's abdomen ([0060] “Parameters measured, such as measures of blood oxygen saturation (SpO2), CO saturation (SpCO), tissue oxygenation (StO2), total hemoglobin index (THI), pulse rate (PR), pulse rate variability (PRV), tissue hydration, body fat percentage, etc. can then be based on measurements obtained from different locations on the body. In use, the device can be placed the desired locations, such as at an arm, e.g. at wrist, forearm or upper arm, at a finger, on the forehead, at an earlobe, in the ear, on the skull, on the chest, on the back, on a muscle, on a wound, a leg, a foot, animal skin, on an udder.”).
Regarding claim 3, Borremans teaches the spectrophotometric device according to claim 1, wherein the spectrophotometric device is configured to measure the attenuation of the light signal at two or more wavelengths ([0080] “a wideband Light Emitting Device (LED) (e.g. >50 nm) and a narrow-band Light Emitting Device (LED) (e.g. <50 nm) are placed together with a spectrometer 18 in a single device to provide for hybrid spectral measurement;” [0086] “The spectrometer 18 and illumination source 20, operating within the spectral range of 400 nm-1100 nm measure SpCO from the spectral responses, and may also measure SpO2” [0073] “example one or more narrow-band ranges may be used for heart-rate or SpO2 measurements.”) and/or at two or more light source to detector distances ([0096] “FIG. 9a shows a row configuration of one illumination source with 3 spectrometers, each at a predetermined distance from that illumination source. In use such configuration allows to capture irradiated light returning from different locations within the skin, optionally underlying tissue”).
Regarding claim 4, Borremans teaches the spectrophotometric device according to claim 1, wherein the motion sensor comprises a linear accelerometer configured to measure linear displacement ([0115] “an accelerometer may be added to correlate motion to the spectroscopic data”).
Regarding claim 5, Borremans teaches the spectrophotometric device according to claim 1, wherein the electronic data processing unit is configured to continuously sample measurement data of the one or more light detectors to calculate the blood oxygen saturation and to continuously sample the motion signal provided by the motion sensor ([0073] “Due to low power consumption, such a measurement can be used to provide long term and/or continuous monitoring of skin or tissue. In an example, spectral data is logged over time to obtain a time-varying response. In another example one or more narrow-band ranges may be used for heart-rate or SpO2 measurements.”), and wherein the electronic data processing unit is configured to discard the light signal if the motion signal detected by the motion sensor exceeds the predetermined threshold value ([0076] “In an example, other sensors types can be added to spectroscopy device 16 to improve the quality of the data. For example, an ECG sensor may be added to correlate ECG data to optical data. For example, an accelerometer can be added to correlate motion to the spectroscopic data and to assist in the disregarding of invalid data, or correcting the captured data for motion artifacts.”).
Regarding claim 8, Borremans teaches the spectrophotometric device according to claim 1, wherein the device further comprises an electronic storage device connected to the electronic data processing unit, which stores data identifying the spectrophotometric device and calibration data for the spectrophotometric device ([0067] “Memory 110: memory 110 can be included to store collected data and/or instructions. Depending on the type of apparatus in which one or more spectroscopy devices 16 is implemented, the memory can either be dedicated for spectroscopy device 16 or shared with other functionalities of the apparatus, e.g. a smartphone. In an embodiment, memory 110 can contain instructions for executing a chemometric algorithm for deriving one or more physiological parameters influencing the irradiated light. In another embodiment, the memory stores specific calibration parameters related to the spectrometer, such as, for example, its illumination or optics. In yet another embodiment, the memory stores specific biometric data of the user locally. The memory can of any type, including, but not limited to volatile memory, nonvolatile memory, etc.”).
Regarding claim 11, Borremans teaches the spectrophotometric device according to claim 1, wherein the one or more light sources and the one or more light detectors are positioned in a single housing ([0089] “The device used for such diffuse optical spectroscopy can be integrated into several apparatus having different form factors such as body wearables, e.g. watch, bracelet, patch, in-ear, over-ear, headset, nose clip, ring, anklet, textile, footwear, handheld devices, ingestibles, e.g. smart pills, instruments for internal examination like an endoscopy tip, headgear such as a head band, helmet or head strap, hearables such as ear phones or ear pods, wrist wearables such as a smartwatch, a bracelet or a tracker.” Fig. 8c, patch device) and the housing comprises an adhesive patch for attaching the housing to said subject's clothing ([0090] “The device can be brought into contact with the skin area of interest in different ways. Adhesive or straps can be present to keep a patch tight to the skin. The patch can also be integrated in gear or clothing which is contact with the skin, such as socks, T-shirts, gloves, underwear, bandage, shoe insoles, headgear, hearables, wrist wearables, finger wearable such as a ring.”).
Regarding claim 13, Borremans teaches a method for non-invasively measuring blood oxygen saturation in a subject's tissue ([0024] “the method can be set up such that the optical response is used to derive one or more physiological parameters using in-vivo spectroscopy on the skin.” [0025] “the optical response is used to extract heart rate, heart rate variability, maximum rate of oxygen consumption (VO.sub.2), blood oxygen saturation (SpO.sub.2)”), comprising:
using at least one light source to emit a light signal into said subject's tissue, using at least one light detector to detect the light signal reflected from said subject's tissue ([0054] “Such a device can contain one or more monolithically integrated spectrometers 18 and/or one or one monolithically integrated illumination sources 20. In these embodiments a multicomponent spectroscopy device 16 allows for the collection a spatial spectral response from the skin area of interest over a plurality of wavelengths ranges.”),
using an electronic data processing unit to calculate the blood oxygen saturation based on the light signal measured by the at least one light detector ([0017] “a processor configured to process the outcome of the spectrometer” [0070] “Processor 106: In an example processor 106 processes and manages the collection of data acquired from spectrometer 18.” [0060] “Parameters measured, such as measures of blood oxygen saturation (SpO2)”),
using a motion sensor to detect a motion signal indicative of motion of the at least one light source and/or the at least one light detector ([0071] “Other sensors 104: in addition to the optical sensor network containing an illumination source and a spectrometer, other sensors 104 can be present. Examples of such other sensors include EKG sensors, inertial measurement unit (IMU), electrical impedance sensor or any other sensor which can be used to obtain other sensory information to correlate to or complement collected spectral data.”),
wherein the electronic data processing unit discards the light signal measured by the at least one light detector if the motion signal detected by the motion sensor exceeds a predetermined threshold value ([0076] “an accelerometer can be added to correlate motion to the spectroscopic data and to assist in the disregarding of invalid data, or correcting the captured data for motion artifacts.”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borremans (US 20200383628 A1) in view of Margiott (US 20210212610 A1).
Regarding claim 6, Borremans teaches the spectrophotometric device according to claim 1, wherein the electronic data processing unit is configured to discard the light signal, as soon as the motion signal exceeds a predetermined first threshold value ([0076] “an accelerometer can be added to correlate motion to the spectroscopic data and to assist in the disregarding of invalid data, or correcting the captured data for motion artifacts.”). However, Borremans fails to disclose multiple thresholds.
Margiott teaches a device that determines an oxygen saturation off tissue and determines a quality value for the oxygen saturation based on accelerometer data reflecting movement of the oximeter device. Margiott disclose and to resume the processing of the light signal, as soon as the motion signal falls below a predetermined second threshold value ([0155] “indicate the quality of displayed oximetry measurements to thereby aid users in determining whether the displayed oximeter measurements are acceptable and reliable.” [0156] “More specifically, the quality metric provides an indication of the consistency of light detected between select detector structures or pairs of detector structures of the sensor probe (e.g., an oximetry probe).” [0198] “In an implementation, the processor does not recognize movement of the system unit if the signal generated by the accelerometer is below a first threshold value (e.g., a first threshold voltage or a first threshold current). The processor may apply a first correction to the quality metric value for accelerometer output values (e.g., output voltages) above the first threshold value and below a second threshold value.” [0199] “The processor may apply a second correction to the quality metric value for accelerometer output values (e.g., output voltages) above the second threshold value and below a third threshold value. The first and second corrections are different corrections where the second correction is larger than the first correction. … The device may use additional threshold levels for an increasing amount of corrections, such a sixth, a seventh, an eighth, a ninth, or higher number of threshold levels.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Borremans to include resuming the processing of the light signal as soon as the motion signal falls below a predetermined second threshold value as disclosed in Margiott to have different levels of data correction based on the severity of motion (Margiott [0199]).
Regarding claim 7, the combination of Borremans/Margiott discloses the spectrophotometric device according to claim 6, wherein the first threshold value is larger than the second threshold value (Margiott: [0198] “The processor may apply a first correction to the quality metric value for accelerometer output values (e.g., output voltages) above the first threshold value and below a second threshold value.” [0199] “The processor may apply a second correction to the quality metric value for accelerometer output values (e.g., output voltages) above the second threshold value and below a third threshold value. The first and second corrections are different corrections where the second correction is larger than the first correction.”).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borremans (US 20200383628 A1) in view of Babaeizadeh (US 20190282180 A1).
Regarding claim 9, Borremans teaches the spectrophotometric device according to claim 1. However, Borremans fails to disclose determining breathing frequency.
Babaeizadeh teaches a wearable device comprising one or more physiological sensors that determine respiratory information. Babaeizadeh discloses wherein the electronic data processing unit is configured to determine breathing frequency of said subject based on the motion signal provided by the motion sensor (Fig. 1, control unit 102; [0058] “an accelerometer signal processing algorithm (which may be any algorithm suitable for determining respiratory information from an accelerometer signal), a PPG signal processing algorithm (which may be any algorithm suitable for determining respiratory information from a PPG signal);” [0066] “The respiratory information that is determined for the subject may comprise at least one of a respiration waveform, a respiration rate for the subject and a breathing pattern for the subject. For example, the respiratory information may comprise a respiration waveform for the subject, a respiration rate for the subject, or a breathing pattern for the subject, or any combination of this respiratory information.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Borremans to include determining breathing frequency based on motion signals as disclosed in Babaeizadeh for accurate non-invasive monitoring of respiration that allow for determination of respiratory health with minimal disturbance to the subject (Babaeizadeh [0067, 0109]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borremans (US 20200383628 A1) in view of Liu (CN 103505193 A).
Regarding claim 10, Borremans teaches the spectrophotometric device according to claim 1. However, Borremans fails to disclose a warning if the motion signal exceeds a threshold.
Liu teaches a physiological information monitoring device using light and motion signals. Liu discloses wherein the electronic data processing unit is configured to issue a warning if the motion signal exceeds the predetermined threshold value ([0052] “alarm unit 35 is set on the device main body, which comprises an evaluation module 351 and alert module 352. wherein the evaluation module 351 for receiving position by a physiological signal processing unit 21 sends to the physiological information and/or motion information processing unit 32 sends the movement information and the physiological information and/or motion information corresponding to the normal threshold value, if the physiological information and/or motion information exceeds a corresponding normal value, judging the body condition of the person to be measured is in an abnormal state, then sending reminding signal to the alert module 352.” [0053] “The reminding signal sends the warning to the user, and prompt module 352 sends the warning to the user of the method comprising a sound, light and/or vibrating prompting module 352.” Fig. 3, motion signal detecting unit 31, a motion signal processing unit 32, alarm unit 35).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Borremans to include issuing a warning if the motion signal exceeds the predetermined threshold value as disclosed in Liu for identifying an abnormal body state for the user of the device (Liu [0052]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borremans (US 20200383628 A1) in view of Bezemer (WO 2016097271 A2).
Regarding claim 12, Borremans teaches the spectrophotometric device according to claim 1, wherein the electronic data processing unit is configured (Control unit 108). While Borremans describes data being invalid due to circumstances associated with a poor light signal, Bezemer is introduced to more specifically disclose the mechanism of determining whether a light signal is of sufficient quality.
Bezemer teaches an apparatus comprising a light source, a light sensor, and an accelerometer for measuring a physiological parameter of a subject. The combination of Borremans/Bezemer discloses to determine a quality of the light signal and to discard the light signal only if the quality of the light signal is insufficient (Bezemer: pg 16 line 30 -pg 17 line 6 “In step 105 the signal is analysed to determine if the signal meets a quality metric. This step can comprise determining the quality of the signal and comparing the quality to a quality metric, such as a threshold or other criteria (e.g. is the quality the maximum available value). The quality of the signal can be measured in different ways. In some embodiments, the Quality of the signal can be measured in terms of the amplitude or intensity of the measured light (e.g. the AC amplitude), and the signal can meet the quality metric if a peak amplitude or peak intensity is above a threshold value or a signal-to-noise ratio (SNR) is above a threshold value, or the signal can meet the quality metric if the maximum amplitude or intensity obtained at the current contact pressure is above the maximum amplitude or intensity obtained at other contact pressures (in other words the amplitude, intensity or SNR is an optimal/maximum value)”; Borremans: [0077] “features of the spectrum such as its derivatives can be analyzed in cases where a spectrum with sufficient resolution and quality is available. In yet another example, determination can be made as to whether a measurement is invalid e.g. in case of a bad contact, too much background light, the sensor not being connected to a person or a broken device. In an example, after a confidence assessment, features may be extracted from the spectral data obtained or another measurement is done.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Borremans to include determining whether a light signal is of sufficient quality as disclosed in Bezemer to improve the reliability and quality of the estimated physiological parameter (Bezemer []).
The combination of Borremans/Bezemer discloses and if the motion signal exceeds the predetermined threshold value (Borremans: [0076] “In an example, other sensors types can be added to spectroscopy device 16 to improve the quality of the data … an accelerometer can be added to correlate motion to the spectroscopic data and to assist in the disregarding of invalid data, or correcting the captured data for motion artifacts.”).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borremans (US 20200383628 A1) in view of Van Den Ende (US 20170347957 A1).
Regarding claim 14, Borremans teaches a spectrophotometric device for measuring blood oxygen saturation in a subject's tissue ([0051] “Spectroscopy device 16 can provide for simultaneous measurement of multiple physiological parameters… blood oxygenation”) comprising:
at least one light source for emitting a light signal into said subject's tissue, at least one detector for detecting the light signal reflected by said subject's tissue ([0054] “Such a device can contain one or more monolithically integrated spectrometers 18 and/or one or one monolithically integrated illumination sources 20. In these embodiments a multicomponent spectroscopy device 16 allows for the collection a spatial spectral response from the skin area of interest over a plurality of wavelengths ranges.”),
an electronic data processing unit configured to calculate the blood oxygen saturation taking into account the light signal measured by the at least one detector ([0017] “a processor configured to process the outcome of the spectrometer” [0070] “Processor 106: In an example processor 106 processes and manages the collection of data acquired from spectrometer 18.” [0060] “Parameters measured, such as measures of blood oxygen saturation (SpO2)”). While Borremans describes invalid spectroscopy measurements from bad contact in [0077], Borremans fails to disclose a distinct contact sensor.
Van Den Ende teaches a wearable sensor for maintaining contact between the wearable sensor and the user during measuring of a physiological parameter. Van Den Ende discloses, and a contact sensor for detecting a contact signal indicative of contact between said subject's tissue and the at least one light source and/or the at least one detector ([0062] “The feedback sensor 7 is arranged to detect relative movement of the physiological parameter sensor 3 with respect to the user's body 2. For example, the feedback sensor 7 may be a contact sensor arranged to detect if the physiological parameter unit is in contact with the subject. For example, the feedback sensor may be an optical sensor or a sensor for measuring electrical resistance. Alternatively, the feedback sensor may be a pressure sensor, arranged to measure the contact pressure between the physiological parameter sensor 3 and the user's body, since a change in the contact pressure indicates that the relative position of the physiological parameter sensor and the body has changed. The feedback sensor may be capable of measuring the distance between the physiological parameter sensor 3 and the user's body or for measuring displacement of the physiological parameter sensor 3 relative to the subject.” [0094] “The physiological parameter sensor 3 includes a housing 20 which is adapted to interface with a user's body, a light source 14 (e.g. an LED) and a sensor element 12 for measuring light.” Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Borremans to include a contact sensor as disclosed in Van Den Ende to obtain high quality data even if the subject moves during the measurement process (Van Den Ende [0040]).
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borremans (US 20200383628 A1) in view of Van Den Ende (US 20170347957 A1), and in further view of Kawano (US 20190336075 A1).
Regarding claim 15, the combination of Borremans/Van Den Ende discloses the spectrophotometric device according to claim 14, wherein the electronic data processing unit is configured to discard the light signal measured by the at least one detector if the contact signal indicates that at least one light source and/or at least one detector have lost contact to said subject's tissue (Borremans: [0077] “In yet another example, determination can be made as to whether a measurement is invalid e.g. in case of a bad contact, too much background light, the sensor not being connected to a person or a broken device.” Van Den Ende: [0062] “The feedback sensor 7 is arranged to detect relative movement of the physiological parameter sensor 3 with respect to the user's body 2. For example, the feedback sensor 7 may be a contact sensor arranged to detect if the physiological parameter unit is in contact with the subject.). However, the combination of Borremans/Van Den Ende fails to disclose issuing a warning with loss of contact with the subject’s tissue.
Kawano teaches a device for measuring biological information includes at least one light emitting element configured to emit light having predetermined wavelength, a light receiving element configured to receive returned light from a subject with respect to the emitted light, an attachment determination unit configured to determine whether the device is attached to the subject. Kawano discloses and/or to issue a warning if the contact signal indicates that at least one light source and/or at least one detector have lost contact to said subject's tissue ([0016] “The device 10 for measuring biological information (which may be referred to as a device 10 hereafter) is attached to a subject, e.g., the skin (point) of a human body, by close contact.” [0047] “ the controller 14 determines that the device 10 is not suitably attached to the subject. In such a manner, the controller 14 causes a display unit that is not illustrated in the figures to display a message or the like for requesting to attach to a subject again.” Device 10, light emitting element unit 11, light receiving unit 13).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Borremans/Van Den Ende to include issuing a warning when contact is lost as disclosed in Kawano to instruct the user to adjust the device for proper skin contact to perform higher quality measurements (Van Den Ende [0047, 0050]).
Regarding claim 16, Borremans teaches a method for non-invasively measuring blood oxygen saturation in a subject's tissue ([0024] “the method can be set up such that the optical response is used to derive one or more physiological parameters using in-vivo spectroscopy on the skin.” [0025] “the optical response is used to extract heart rate, heart rate variability, maximum rate of oxygen consumption (VO.sub.2), blood oxygen saturation (SpO.sub.2)”), comprising:
using at least one light source to emit a light signal into said subject's tissue, using at least one detector to detect the light signal reflected from said subject's tissue ([0054] “Such a device can contain one or more monolithically integrated spectrometers 18 and/or one or one monolithically integrated illumination sources 20. In these embodiments a multicomponent spectroscopy device 16 allows for the collection a spatial spectral response from the skin area of interest over a plurality of wavelengths ranges.”),
using an electronic data processing unit to calculate blood oxygen saturation based on the light signal measured by the one or more detector ([0017] “a processor configured to process the outcome of the spectrometer” [0070] “Processor 106: In an example processor 106 processes and manages the collection of data acquired from spectrometer 18.” [0060] “Parameters measured, such as measures of blood oxygen saturation (SpO2)”). While Borremans describes invalid spectroscopy measurements from bad contact in [0077], Borremans fails to disclose a distinct contact sensor.
Van Den Ende discloses using a contact sensor for detecting a contact signal indicative of contact between said subject's tissue and the at least one light source and/or the at least one detector ([0062] “The feedback sensor 7 is arranged to detect relative movement of the physiological parameter sensor 3 with respect to the user's body 2. For example, the feedback sensor 7 may be a contact sensor arranged to detect if the physiological parameter unit is in contact with the subject. For example, the feedback sensor may be an optical sensor or a sensor for measuring electrical resistance. Alternatively, the feedback sensor may be a pressure sensor, arranged to measure the contact pressure between the physiological parameter sensor 3 and the user's body, since a change in the contact pressure indicates that the relative position of the physiological parameter sensor and the body has changed. The feedback sensor may be capable of measuring the distance between the physiological parameter sensor 3 and the user's body or for measuring displacement of the physiological parameter sensor 3 relative to the subject.” [0094] “The physiological parameter sensor 3 includes a housing 20 which is adapted to interface with a user's body, a light source 14 (e.g. an LED) and a sensor element 12 for measuring light.” Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Borremans to include a contact sensor as disclosed in Van Den Ende to obtain high quality data even if the subject moves during the measurement process (Van Den Ende [0040]).
The combination of Borremans/Van Den Ende discloses wherein the electronic data processing unit discards the light signal measured by the at least one detector if the contact signal indicates that at least one light source and/or at least one detector have lost contact to said subject's tissue (Borremans: [0077] “In yet another example, determination can be made as to whether a measurement is invalid e.g. in case of a bad contact, too much background light, the sensor not being connected to a person or a broken device.” Van Den Ende: [0062] “The feedback sensor 7 is arranged to detect relative movement of the physiological parameter sensor 3 with respect to the user's body 2. For example, the feedback sensor 7 may be a contact sensor arranged to detect if the physiological parameter unit is in contact with the subject.). However, the combination of Borremans/Van Den Ende fails to disclose issuing a warning with loss of contact with the subject’s tissue.
Kawano discloses and/or issues a warning if the contact signal indicates that at least one light source and/or at least one detector have lost contact to said subject's tissue ([0016] “The device 10 for measuring biological information (which may be referred to as a device 10 hereafter) is attached to a subject, e.g., the skin (point) of a human body, by close contact.” [0047] “ the controller 14 determines that the device 10 is not suitably attached to the subject. In such a manner, the controller 14 causes a display unit that is not illustrated in the figures to display a message or the like for requesting to attach to a subject again.” Device 10, light emitting element unit 11, light receiving unit 13).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Borremans/Van Den Ende to include issuing a warning when contact is lost as disclosed in Kawano to instruct the user to adjust the device for proper skin contact to perform higher quality measurements (Van Den Ende [0047, 0050]).
Conclusion
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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