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 Objections
Claim 4 is objected to because of the following informalities: line 11, “a blood oxygen saturation” should be –the blood oxygen saturation—since claim 1, from which claim 4 depends already sets forth “a blood oxygen saturation” . Appropriate correction is required.
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.
Claim 7 is 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 7, lines 2-3, “when four optical sensors are used” is unclear, claim 5 only sets forth 3 optical sensors however claim 6 sets forth a fourth sensor.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to an abstract idea without significantly more.
With Respect to claim 1, the claim recites the following limitation(s):
Claim 1: a first optical sensor configured to detect light;
a second optical sensor provided adjacent to the first optical sensor and configured to detect light;
at first light source configured to emit light having a predetermined wavelength;
a second light source configured to emit light having a wavelength different from that of the light emitted by the first light source;
a controller configured to cause the first light source and the second light source to simultaneously emit the light; and
a signal processor configured to perform processing to obtain a blood oxygen saturation level based on a value detected by the first optical sensor and a value detected by the second optical sensor, wherein the first optical sensor and the second optical sensor are configured to detect light that has been reflected in a living body or transmitted through the living body.
Step 1- Claim 1 is directed to a detection device for measuring blood oxygen saturation.
Step 2a Prong 1 – The claimed invention is directed to non-statutory subject matter. The above limitations, under their broadest reasonable interpretation, fall within the “Certain
Mathematical concepts and mental processes grouping of abstract ideas, enumerated in MPEP
2106.04(a)(2)(II), in that they recite a series of mathematical calculations and mental steps which
produce a blood oxygenation concentration measurement. When given their BRI, the limitations are considered an abstract idea of being certain mathematical concepts and mental processes.
With respect to claim 1, “ a signal processor configured to perform processing to obtain a blood oxygen saturation level based on a value detected by the first optical sensor and a value detected by the second optical sensor “ Is considered to fall within the Mathematical concepts and mental processes grouping of abstract ideas.
Step 2a Prong 2 - The recitation of the additional elements of first and second optical sensors, first and second light sources, and a controller for emitting the light from the sources, merely invokes such additional element(s) as tools to perform the abstract idea. MPEP 2106.05(f).
Further, the recitation of these additional element(s) in the claim generally links the use of the abstract idea to a particular technological environment or field of use, i.e., a computerized environment. MPEP 2106.05(h).
As such, under Prong 2 of Step 2A, when considered both individually and as a whole, the limitations of claim 1 are not indicative of integration into a practical application (Prong 2, Step 2A: NO). MPEP 2106.04(d).
“As set forth in MPEP 2106.05(g) Another consideration when determining whether a claim integrates the judicial exception into a practical application in Step 2A Prong Two or recites significantly more in Step 2B is whether the additional elements add more than insignificant extra-solution activity to the judicial exception. The term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Extra-solution activity includes both pre-solution and post-solution activity.” Note: Determining the level of a biomarker in blood, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring data derived from an ultrasound scan, to be used in a diagnosis).
With respect to claim 1, first and second optical sensors, first and second light sources, and a controller for emitting the light from the sources merely recite elements that represent insignificant extra-solution data gathering.
Applicant’s specification only sets forth the additional elements in a high level and in a general sense and the thrust of the invention is directed to how the signals are processed once they are collected.
As such, these additional elements do not integrate the abstract idea into a practical application and therefore the claim is directed to the judicial exception.
Step 2B - The recitation of the additional elements is acknowledged, as identified above with respect to Prong 2 of Step 2A. These additional elements do not add significantly more to the abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
Even when considered as an ordered combination, the additional elements of claim 1 does not add anything that is not already present when they are considered individually. Therefore, under Step 2B, there are no meaningful limitations in claim 1 that transform the judicial exception into a patent eligible application such that the claim amounts to significantly more than the judicial exception itself (Step 2B: NO). MPEP 2106.05.
Accordingly, under the Subject Matter Eligibility test, claim 1 is ineligible.
Furthermore, the dependent claims, 2-8 do not add significantly more to the
abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kato et al.(US20210326623) hereinafter Kato et al.
Kato et al. teaches detection device according to an aspect includes: a sensor base; a plurality of photoelectric conversion elements that are provided in a detection area of the sensor base and are configured to receive light incident thereon and output signals corresponding to the received light; a plurality of switching elements provided in the respective photoelectric conversion elements; a plurality of gate lines that are coupled to the switching elements and extend in a first direction; a first light source configured to emit first light having a first maximum emission wavelength; and a second light source configured to emit second light having a second maximum emission wavelength.
Regarding claim 1, Kato et al. teaches a first optical sensor configured to detect light;
a second optical sensor provided adjacent to the first optical sensor and configured to detect light;
a first light source configured to emit light having a predetermined wavelength;
a second light source configured to emit light having a wavelength different from that of the light emitted by the first light source;
a controller configured to cause the first light source and the second light source to simultaneously emit the light; and
a signal processor configured to perform processing to obtain a blood oxygen saturation level based on a value detected by the first optical sensor and a value detected by the second optical sensor, wherein the first optical sensor and the second optical sensor are configured to detect light that has been reflected in a living body or transmitted through the living body.
Note figs. 1,3, 9, 12 and 18, and paragraphs 49,55,65, 117,124, 148-151, 175,176. [0049] The sensor 10 is an optical sensor including the photodiodes PD serving as photoelectric conversion elements. Each of the photodiodes PD included in the sensor 10 outputs an electrical signal corresponding to light emitted thereto as a detection signal Vdet to the signal line selection circuit 16. The sensor 10 performs the detection in response to a gate drive signal Vgcl supplied from the gate line drive circuit 15. [0117] FIG. 12 is an explanatory diagram for explaining a relation between the driving of the sensor and the lighting operations of the light sources according to a first modification of the first embodiment. In the first modification, the first light sources 61 and the second light sources 62 are caused to be on simultaneously. [0065] The gate line drive circuit 15 may perform different driving for each of detection modes including the detection of the fingerprint and the detection of different items of the biological information (such as the pulse wave, the pulsation, the blood vessel image, and the blood oxygen concentration). Note since the sensors are configured as an array/matrix between the light emitters(61,62) , therefore, the sensors are adjacent each other and it is the examiner’s interpretation a first sensor is located between an adjacent second sensor and a light source and a second sensor of the array/matrix is at a location between the first sensor and the second light source.
Regarding claim 2, Kato et al. teaches wherein the first optical sensor is provided at a location interposed between the second optical sensor and the first light source, and
the second optical sensor is provided at a location interposed between the first optical sensor and the second light source. Note figs. 1,3, 9, 12 and 18, and paragraphs 49,55,65, 117,124, 148-151, 175,176. Note since the sensors are configured as an array/matrix between the light emitters(61,62) , therefore, the sensors are adjacent each other and it is the examiner’s interpretation a first sensor is located between an adjacent second sensor and a light source and a second sensor of the array/matrix is at a location between the first sensor and the second light source.
Regarding claim 3, Kato et al. teaches wherein the second optical sensor is provided at a location interposed between the first optical sensor and the first light source, and the second optical sensor is provided at a location interposed between the first optical sensor and the second light source. Note figs. 1,3, 9, 12 and 18, and paragraphs 49,55,65, 117,124, 148-151, 175,176. Note since the sensors are configured as an array/matrix between the light emitters(61,62) , therefore, the sensors are adjacent each other and it is the examiner’s interpretation a first sensor is located between an adjacent second sensor and a light source and a second sensor of the array/matrix is at a location between the first sensor and the second light source.
Claim Rejections - 35 USC § 103
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 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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kato et al.(US20210326623) hereinafter Kato et al. in view of Fine et al.( EP 0957747) hereinafter Fine et al.
Regarding claim 4, Kato et al. teaches the claimed invention as set forth above including calculating a blood oxygen concentration. Note [0055] The signal processor 44 is a logic circuit that detects a predetermined physical quantity received by the sensor 10 based on an output signal of the detection circuit 48. When the finger Fg is in contact with or in proximity to a detection surface, the signal processor 44 can detect the asperities on the surface of the finger Fg or the palm based on the signal from the detection circuit 48. The signal processor 44 can also detect the biological information based on the signal from the detection circuit 48. The biological information is, for example, the blood vessel image, a pulse wave, the pulsation, and/or the blood oxygen concentration of the finger Fg or the palm.
Kato et al. does not specifically teach wherein, when: AC(Pix1) denotes an alternating-current component of the value detected by the first optical sensor;
DC(Pix1) denotes a direct-current component of the value detected by the first optical sensor;
AC(Pix2) denotes an alternating-current component of the value detected by the second optical sensor; and
DC(Pix2) denotes a direct-current component of the value detected by the second optical sensor,
the signal processor is configured to calculate a blood oxygen saturation level SpO2 using the following expression:SpO2 = b' - a'-R' where a' and b' are given coefficients determined in advance, and
R' = {AC(Pixl)/DC(Pixl)}/{AC(Pix2)/DC(Pix2)}.
Fine et al. teaches The present invention relates to a novel sensor for non-invasive optical blood oximetry, such as blood pulse oximetry effected on a blood perfused tissue; to a method of optical oximetry. In paragraphs [0072] – [0073] , Fine et al. sets forth (f) the microprocessor 98 performs digital extraction of DC and AC signal components and calculates the SaO.sub.2 according to the following algorithm: For each of the two wavelengths a characteristic AC of a pulsatile component of the signal is defined, namely AC1 for the first wavelength and AC2 for the second wavelength, each of AC1 and AC2 being the difference between the intensity ratios calculated, respectively, for the crest and nil points at that particular wavelength.
For each of the two wavelengths the characteristic DC of a constant component of the signal is computed, namely DC1 for the first wavelength and DC2 for the second wavelength, each of DC1 and DC2 being the average from two intensity ratios calculated, respectively, at the nil and crest points at a given wavelength.
The microprocessor then calculates:
(i) the ratios R1 and R2 for each of the wavelengths: R1 = AC1DC1 ; R2 =AC2DC2
(ii) the ratio γ =R1R2
(iii) the oxygen saturation SaO.sub.2 of arterial blood SaO2 = K1 x γ + K2
where K.sub.1, K.sub.2 are calibration constants.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Kato et al. where the processor determines the blood oxygen concentration using the algorithm of Fine et al. Applying a known algorithm for calculating blood oxygen concentration as set forth in Fine et al. in the pulse oximeter of Kato et al. would be a simple substitution of one know method of calculating blood oxygen concentration for another and would achieve equivalent or predictable results.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kato et al.(US20210326623) hereinafter Kato et al. in view of Ashe et al.( Us20130261415) hereinafter Ashe et al.
Regarding claim 8, Kato et al. teaches the claimed invention as set forth above including the use of photodiodes for optical detection but does not specifically teach wherein the first optical sensor and the second optical sensor are organic photodiodes.
Ashe et al. teaches in the same field of endeavor a monitoring device includes at least one sensor configured to monitor one or more physiological parameters of a subject and a processing unit operatively coupled to the sensor. The sensor comprises a plurality of radiation sources and detectors disposed on a flexible substrate in a designated physical arrangement. The processing unit is configured to dynamically configure an operational geometry of the sensor by controlling the intensity of one or more of the radiation sources and the gain of one or more of the detectors so as to satisfy at least one quality metric associated with one or more physiological parameters of the subject. Paragraph [0019] sets forth system and methods for non-intrusive monitoring one or more physiological parameters of a subject, for example a person. To that end, the physiological parameters, for example, include SpO2, one or more hemoglobin fractions, total hemoglobin concentration, HbCO concentration, methemoglobin concentration, and/or other parameters related to blood flow, blood volume and blood or tissue constituents. Paragraph [0020] sets forth the present system may include any other suitable monitoring device, such as a pulse oximeter. [0021] The system 100, for example, includes a wearable pulse oximeter device for continuous monitoring of SpO2 in the subject's blood. Paragraph [0027] teaches the detectors 110 may include photodetectors 110 such as a silicon photodiode, an organic photodiode, or any other suitable detection device sensitive to single wavelengths or broadband light.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device of Kato et al. to include an organic photodiode as taught by Ashe et al. as a substitution of one known type of photodiode for another with a reasonable expectation for obtaining predictable results for measuring blood oxygen concentration .
Allowable Subject Matter
Claims 5-7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record teaches the subject matter of claims 1-4 and 8 as set forth above including a detection device for measuring blood oxygen concentration having a first and second light source of differing wavelengths and plural sensors adjacent each other and arranged in a matrix between the light emitters. The prior art also teaches where the photodiodes may be an organic photodiode and algorithms for calculating the blood oxygen concentration based on determining the R value from the AC/DC components as the ratio of the average of the measured DC component and AC component.
Regarding claims 5-7, The prior art of record does not reasonable teach alone or in combination the subject matter of the independent claims including calculating blood oxygen concentration using the multiple sensors calculating the blood oxygen concentration between various pairs of the sensors using the ratio of AC/DC components and averaging the resulting blood oxygen concentration values to obtain an overall average of SPO2.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
JP 2019513035 teaches In some embodiments, the processor may determine the concentration of oxygen in the blood (SpO2) from the difference in absorption of the two different wavelengths of light. For example, blood oxygen concentration may be two wavelengths of light (eg, one wavelength is red (eg, 660 nanometers (nm)) and the other wavelength is infrared (eg, about 950 nm) May be measured as the ratio of the average of the measured DC component and AC component.
Edgar et al.( US 4714080) teaches A noninvasive optical oximeter for measuring oxygen saturation of arterial blood. A sample of blood is illuminated with light at two different wavelengths. Light reflected by the blood is sensed by a photodetector and an output signal is created in response thereto. The output signal is processed to form a quotient representing the AC components of the reflected light at each wavelength. The oxygen saturation of the blood is calculated by correlating this quotient with an oxygen saturation reference curve uniquely representative of the blood oxygen saturation characteristics of a particular individual. (14) The reflected light signal detected by the system comprises an alternating-current (AC) component and a direct-current (DC) component for each of the respective light sources. The AC components of each of the reflected signals is filtered from the output of the sensor and a voltage amplitude ratio is calculated. This ratio is then correlated with an oxygen saturation reference curve to obtain an indication of the oxygen saturation of the patient's arterial blood.
WANG( CN 201104882) teaches a measuring device for testing blood oxygen saturation, including blood oxygen saturation sensor, blood oxygen signal processor and display; “… said blood oxygen signal processor pre-processes the signal output from the blood oxygen saturation sensor, and through DC separation, fast Fourier transform, de-noise, and fast inverse Fourier transform, respectively calculates the blood oxygen saturation and pulse rate value of the time domain signal and frequency domain signal in two independent channels; the pulse amplitude calculator and averager, which is divided into a time domain pulse amplitude calculator and the averager and the fundamental wave pulse amplitude calculator and the averager, respectively scanning pulse in red light and infrared AC signal queue the waveform of the wave, and calculates the time domain and frequency domain in red light and infrared light pulse wave current amplitude, in the red light and infrared DC signal queue to obtain the red light and infrared DC amplitude, calculating the average value of each range, blood oxygen saturation calculator, which is divided into a time domain blood oxygen saturation calculator and fundamental wave blood oxygen saturation calculator, The blood oxygen saturation value of the front time domain and frequency domain scaling calculation in time and frequency domain red light and the AC amplitude and DC amplitude of the infrared light, which are time domain and frequency domain red light and infrared light of the AC/DC amplitude ratio of sum ratio calculation result evaluator…”
Silveira et al. (US 20150230743) teaches a medical sensor includes a first set of optical components configured to obtain a first set of signals for determining a first regional oxygen saturation measurement. The first set of optical components includes a first emitter, a first detector separated from the first emitter by a first distance along a first axis, and a second detector separated from the first emitter by a second distance along the first axis, wherein the second distance is greater than the first distance. The sensor also includes a second set of optical components configured to obtain a second set of signals for determining a second regional oxygen saturation measurement. The second set of optical components includes a second emitter and a third detector separated from the second emitter by a third distance along a second axis, different from the first axis.
SCHARF(20090326347) teaches The pulse oximeter system (10) has an array of sensors (12) and a multi-parameter patient monitor (26) which is capable of calculating estimated value of oxygen saturation of patient's blood from information received from the array of sensors.
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