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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, “the light passing through a living body” lacks antecedent basis.
Regarding claim 7, “the light passing through the living body” lacks antecedent basis.
Regarding claim 8, “the light passing through a living body” lacks antecedent basis.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 7 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by (KR 20150042261).
(KR 20150042261) teaches optical systems for monitoring oxygen levels in tissue. The sensor subsystem 110 is further depicted in FIG. 2, which is a simplified block diagram of the sensor subsystem 110, in accordance with one embodiment. The sensor subsystem 110 may include one or more light sources 150 (e.g., two light sources), each light source including one or more light emitting diodes (LEDs), one or more lighting elements And 152a-152n (collectively referred to as illumination members 152). The sensor subsystem 110 includes a first set of optical devices 155 that collect light emitted from each light source 150 and emit light to the tissue 140. More specifically, an optical probe such as a compact and handheld oximeter, wherein the probe includes a light source and a detector at the sensor head of the optical probe. The sensor subsystem 110 may also include one or more temperature sensors 160, such as one or more thermistors configured to detect the temperature of the light sources 150. In one implementation, temperature sensors 160 are each coupled to light sources 150 and configured to measure the temperature of the light sources. The temperature sensors 160 may transmit temperature information for the light sources 150 to one or more of the sensor subsystem 110, the acquisition module 115, the measurement module 120, and the control signal may be a luminosity (E.g., a time-varying control signal) supplied to the light sources that control the light source (e.g., the light source). For example, LEDs, one of the light sources, can be heated and cooled to change the efficiency of the LEDs to change the brightness of the LEDs.
Regarding claims 1, 7 and 8, (KR 20150042261) teaches a light emitting unit including a light emitting element that emits light; a light receiving unit configured to receive the light passing through a living body and generate a detection signal; a temperature sensor configured to measure at least one of an environmental temperature and a body temperature of the living body and generate temperature data; and a controller configured to adjust a light emitting intensity of the light emitting element, wherein the controller is configured to calculate a temperature change rate using the temperature data, and adjust the light emitting intensity based on the temperature change rate and a communication unit configured to transmit the detection signal; and a control device including: a terminal communication circuit configured to receive the detection signal, and an analysis controller configured to analyze biological information of the living body using the detection signal.
Note figs 1-2 and the corresponding description. If the temperature of the illumination members 152 is varied by the amount of the threshold (varying the temperature with respect to a threshold is interpreted as the determination of a temperature change rate up or down relative to the set threshold) between two successive temperature measurements made by the temperature sensors 160, the illumination members 152 The divergent light intensity may be changed by the sensor subsystem 110, the acquisition module 115, the measurement module 120, or a combination thereof. Specifically, if the temperature change is at a threshold value or within a threshold, the brightness of the illumination members may not be changed (e.g., the duty signal of the time varying control signal remains constant). Alternatively, if the temperature change is greater than the threshold value, the brightness of the illumination members can be varied to maintain a substantially unchanged brightness (e.g., the duty cycle of the time varying control signal increases or decreases, It can be changed differently). Correlation may be included to correlate correction information for each photodetector 170 with each of the illumination members 152. That is, the correction information used by the tissue oximetry device 100 may include correction information for each photodetector that is calibrated for each light source. The intensity of each light source, the gain of each photodetector, or both can be corrected based on the correction information. the tissue oximetry device 100 includes a handheld device housing 105 (bold line in FIG. 1), a sensor subsystem 110, a learning module 115, a measurement module 120 ) (Sometimes also referred to as a calculation module), a display 125 (e.g., a selectively transmissive liquid crystal display screen), one or more input controls 130, and a power source 135. The handheld device housing 105 ("housing") is configured to receive one or more of the enumerated members. The sensor subsystem 110 and the acquisition module 115 may be communicatively coupled through a bus system and the acquisition module 115 and the measurement module 120 may also be coupled to communicate via a bus system have. The power supply 135 may be configured to provide DC power, modulated power, or both to the sensor subsystem 110, the acquisition module 115, and the measurement module 120.
Regarding claim 2, (KR 20150042261) teaches wherein when the temperature change rate is a negative value, the controller increases the light emitting intensity.
The temperature change rate appears to be directed to the use of the device or the device capability as opposed to an actual structural limitation. However, Note figs 1-2 and the corresponding description. Also note, it is the examiner’s interpretation that determining if the temperature is above or below a threshold is indicative of determining a positive or negative value of the temperature change relative to the threshold.
Regarding claim 3, (KR 20150042261) wherein when the temperature change rate is a positive value, the controller decreases the light emitting intensity.
The temperature change rate appears to be directed to the use of the device or the device capability as opposed to an actual structural limitation. However, Note figs 1-2 and the corresponding description. Also note, it is the examiner’s interpretation that determining if the temperature is above or below a threshold is indicative of determining a positive or negative value of the temperature change relative to the threshold.
Allowable Subject Matter
Claims 4-6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
The closest prior art of record teaches devices for determining blood oxygen saturation including emitters and detectors of varied wavelengths of red, infrared and/or green light as well as calculating the AC/DC component of the PPG signals and determining the ratio of AC/DC components of the red/infrared light to calculate the oxygen saturation. The effects of temperature on PPG signals for measuring blood oxygen saturation are well known and varying the light intensity as a function of a measured temperature with respect to a set threshold is also well known.
Note Khan et al. , Analyzing the effects of cold, normal, and warm digits on transmittance pulse oximetry, Biomedical Signal Processing and Control 26 (2016) 34–41 teaches Typical transmittance pulse oximeter probes consist of two high output RD and IR light emitting diodes (LEDs) and a sensitive photo-detector (PD). Light energy transmitted through tissue is detected by the PD, which generates the PPG signal. From the PPG signal, the slowly changing (DC) and rapidly changing (AC)signals are extracted. The DC signal predominantly captures the unchanging light scattering and absorption, whereas the AC signal predominantly captures the varying absorption due to pulsatile arterial blood and is synchronous with HR. By taking the appropriate AC/DC ratios and calibration, SpO2can be reliably estimated[5,6]. Hence, the quality of pulse oximeter SpO2estimation is directly dependent on the quality of detected PPG signals. Temperature is another, often overlooked, limiting factor for pulse oximetry. It is generally accepted that cold digits may provide inaccurate pulse oximeter readings. The AC portion of the raw IR and RD PPG signals were analyzed. This choice is based on the fact that PPGAC is the primary signal of interest in conventional pulse oximetry, dominates the signal-to-noise ratio (SNR), and is directly related to arterial blood flow. PPGAC is thus most affected by any temperature induced change in perfusion. PPGDC is filtered and therefore noise is filtered out. Additionally, no apparent changes were observed in the DC portion of the PPG in this study.
Weakly et al.( CN 109195510) teaches FIG. 3, FIG. 4A, FIG. 4B the process can receive the indication from the environment temperature or the activity monitoring device of the wearer skin temperature of the bio-sensor or an environmental sensor input. based on the change of the temperature value received from the sensors, the process can supply or removal of energy supply to different light source. Over time, different combinations can respond to changing environmental conditions, changing the skin temperature and the other conditions of monitoring device 100 on the user body movement or to change the signal intensity from the light source.
XUAN et al(CN 110236503) teaches a flexible wearable physiological sleep parameter detection method and device since existing sleep apnea detection is not combined with heart rate and blood oxygen detection. Temperature and humidity data reflecting red light and reflected infrared light data of the Bluetooth module transmits the collected heart rate blood oxygen detecting module, and temperature and humidity detected by the detecting module after the characteristic value updating is sent to the mobile phone terminal software; mobile phone terminal software by detecting the change of the characteristic value, obtaining temperature and humidity data, reflecting red light data and reflected infrared light data, when of reflected infrared light data obtained by the mobile phone terminal software of the corresponding light intensity is less than the threshold value, determining the heart rate blood oxygen detecting module is not pasted on the skin.
Regarding claims 4 and 6, The prior art of record does not teach alone or in combination the subject matter of the independent claims including where the controller calculates a signal ratio of an AC component to a DC component of the detection signal and then adjusts the light emitting intensity based on the calculated signal ratio or emitting light at first and second different wavelengths and calculating a correlation coefficient between the detected signals from the different wavelengths and adjusting the light emitting intensity based on the correlation coefficient.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sugawara (EP2000801) teaches According to the present invention, it is possible to efficiently stabilize light intensity of emitted light and early measure constituents of body fluids. Further, as stabilization of light intensity is performed on the basis of the ambient temperature, it is possible to avoid excessive driving of the light-emitting element and to reduce power consumption.
SOETA et al.( WO 2018147045) teaches the sensor module 1 includes a pair of light emitting units 11, a light receiving unit 12 provided between the pair of light emitting units 11, a control unit 30, a temperature measuring unit 20, and an input / output interface unit. The light emitting unit 11 includes a first light emitting element 11a1 that emits light including first near infrared light having an emission wavelength of 806 nm or more and 855 nm or less. In addition, the light emitting unit 11 may include a second light emitting element 11a2 that emits light including second near infrared light having an emission wavelength of 755 nm to 765 nm, preferably 758 nm to 762 nm. The light receiving unit 12 includes a light receiving element 12a that receives first near-infrared light that is emitted from the light emitting unit 11 and flows through the blood vessel of the subject and converts the light into an electrical signal. The light receiving element 12a is, for example, a photodiode. In the present embodiment, the light receiving element 12a has a sensitivity to receive not only the first near-infrared light but also the second near-infrared light and output an electrical signal corresponding to the amount of received light. The light receiving unit 12 includes a light receiving element 12a that receives first near-infrared light that is emitted from the light emitting unit 11 and flows through the blood vessel of the subject and converts the light into an electrical signal. The light receiving element 12a is, for example, a photodiode. In the present embodiment, the light receiving element 12a has a sensitivity to receive not only the first near-infrared light but also the second near-infrared light and output an electrical signal corresponding to the amount of received light.
Jia et al.( CN 114947765) teaches a wearable device for heating the target skin of the user; The target conditions include: the signal-to-noise ratio of the first photoelectric volume pulse wave tracing PPG signal is lower than the signal-to-noise ratio threshold, and the first temperature is lower than the first temperature threshold; the first PPG signal is obtained by the wearable device measuring the target skin the first temperature is the wearable device measuring temperature obtained by the target area skin the wearable device after stopping heating the target skin, measuring to obtain the second PPG signal; the second PPG signal is obtained by wearable device measuring the target skin the second PPG signal is used for processing to obtain one or more physiological indexes. The light intensity control module is further used for according to the need to improve the temperature difference (i.e., the output of the temperature monitoring module), generating heating scheme; according to the real-time signal fed back by the photoelectric receiver and the temperature sensor, dynamically adjusting the heating scheme. In one another possible implementation, the light intensity control module is further used for according to the signal-to-noise ratio difference (i.e., the output of the signal-to-noise ratio monitoring module) and the temperature difference (i.e., the output of the temperature monitoring module) to improve the heating scheme; according to the real-time signal fed back by the photoelectric receiver and the temperature sensor, dynamically adjusting the heating scheme. Illustratively, the heating scheme can include the wavelength of the light wave for heating the local skin and/or the LED of the emitted light wave.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
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