DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 04/28/2023. Claims 1-18 are pending and examined below.
Claim Objections
Claims 2, 4, 6, 10, 11 are objected to because of the following informalities:
In claims 1 and 10, "the measurement value" lacks antecedent basis. For the purpose of this written opinion, as best understood "the measurement value" will be interpreted as "a measurement value" in order to restore antecedent basis.
In line 2 of claim 2 the phrase "variation is measurement" is interpreted as being a typographical error, and for the purposes of this opinion, will be interpreted as the phrase "variation in measurement".
In line 4 of claim 10, "a subject" lacks clarity in that is in unclear if the applicant intended to introduce a new second subject or refer to the previously introduced subject. For the purpose of this written opinion, as best understood, "a subject" has been interpreted to read "the subject" to restore clarity.
In line 2 of claim 6 the phrase "different that the visible light" is interpreted as being a typographical error, and for the purposes of this opinion, will be interpreted as the phrase "different than the visible light".
In line 6 of claim 10 the phrase "reflected of subject" is interpreted as being a typographical error, and for the purposes of this opinion, will be interpreted as the phrase "reflected off of subject".
In line 2 of claim 11 the phrase "variation is measurement" is interpreted as being a typographical error, and for the purposes of this opinion, will be interpreted as the phrase "variation in measurement".
Appropriate correction is required.
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 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20180317821 A1 (hereinafter referred to as “Arko”).
Regarding claim 1, Arko teaches a biometric parameter measurement system (a device which measures blood sugar levels (biometric parameter measurement system); abstract; paragraph [0061]; Figure 1) comprising:
at least one visible light illuminant configured to emit light substantially in the visible wavelength (a blue LED 3 (visible light illuminant) which emits light with a wavelength of 460 nm (visible wavelength); paragraph [0061]);
at least one infrared illuminant configured to emit light substantially in the infrared wavelength (an IR LED 4 (infrared illuminant) which emits radiation with a wavelength of 940 nm (infrared wavelength); figure 1; paragraph [0061]);
wherein each of the at least one infrared and visible light illuminates are configured to emit light at a subject (the IR LED 4 and blue LED 3 are in contact with the skin of a wearer (subject) and emit light at the wearer; paragraph [0061]);
a light measurement device configured to receive, on a light sensing portion thereof, light produced by each of the at least one infrared and visible light illuminates and has been reflected off of the subject and generate a response output signal in response thereto (a sensor unit (light measurement device) which measures, using a receiving photodiode 5 (light sensing portion) the blue light and IR radiation produced by the blue LED 3 and the IR LED 4 which has been reflected from the skin of the wearer and generates a signal (output signal) of resistance, electrical current, or voltage; paragraphs [0018], [0061]); and
one or more processors having a memory and configured to receive the output signal from the light measurement device based on each of the at least one infrared and visible light illuminants (a processing unit (one or more processors) having a memory to receive the signal from the sensor unit based on the reflected light from the blue LED 3 and the IR LED 4; paragraphs [0019-0020), [0023]); and
calculate a value correlated to a glucose value of the subject by filtering the signal for each of the at least one infrared and visible light illuminants to isolate an AC component of the measurement value (calculating a blood sugar level (value correlated to a glucose value of the subject) by using a frequency filtering set on the signal for each of the IR LED 4 and blue LED 3 to isolate the useful component (AC component) of a current value or voltage value (measurement value); paragraphs [0025], [0048-0052]).
Regarding claim 10, Arko teaches a method for determining at least one biometric parameter measurement of a subject (a method for measuring blood sugar level (biometric parameter measurement) of a user (subject) using a device; abstract; paragraph [0033]), the method comprising:
measuring, with a light measurement device, light emitted from at least one visible light illuminant and reflected off of the subject (measuring, using a sensor unit (light measurement device), light emitted from a blue light source (visible light illuminant) and reflected off of the. user's skin/tissue; paragraphs [0035-0036]);
measuring, with the light measurement device, light emitted from at least at least one infrared illuminant and reflected off of the subject and generate a response output signal in response thereto (measuring, using the sensor unit, IR radiation emitted from an IR radiation source (infrared illuminant) and reflected off of the user's skin/tissue and generates an electrical signal (output signal) as a response; paragraphs [0034], [0041]); and
calculating, using a processor configured by code executing therein, a value correlated to a glucose value of the subject by filtering the signal for each of the at least one infrared and visible light illuminants to isolate an AC component of a measurement value (a processing unit (processor) calculates a blood sugar level (glucose value) of the user by filtering the electrical signal of the IR radiation source and the blue light source to isolate searched values (AC component) of measured current or voltage (measurement value); paragraphs [0036-0038], [0041-0043], [0048]).
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.
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.
Claim(s) 2, 7, 11-13, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arko as applied to claims 1 and 10 above, and further in view of US 20110230744 A1 (hereinafter referred to as “Ripoll”).
Regarding claim 2, Arko does not explicitly teach wherein the AC component of the measurement value corresponds to a variation in measurement values associated with arterial blood volume of the subject.
However, Ripoll teaches wherein the AC component of the measurement value corresponds to a variation in measurement values associated with arterial blood volume of the subject (the physiological pulsed wave (AC component) of the PPG wave (measurement value) corresponds to changes in blood volume of arteries of the patient; paragraphs [0036], [0042]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arko, to include wherein the AC component of the measurement value corresponds to a variation in measurement values associated with arterial blood volume of the subject, as taught by Ripoll, to gain the advantage of accurately calculating a blood glucose value while taking into account the changes of blood volume caused by heartbeats (see Ripoll paragraph [0043]).
Regarding claim 7, Arko does not explicitly teach wherein calculating the glucose value includes calculating the following: x'(t) = Sir(t) - Sred(t) Where: sir(t) - is the value of input Infrared signal Sred (t) - is the value of input visible light signal x'(t)- is the input signal for glucose calculation t - is the number of input signal sample "equivalent of time".
However, Ripoll teaches wherein calculating the glucose value includes calculating the following: x'(t) = Sir(t) - Sred(t) Where: sir(t) - is the value of input Infrared signal Sred (t) - is the value of input visible light signal x'(t) - is the input signal for glucose calculation t - is the number of input signal sample "equivalent of time" (calculating the glucose concentration value (glucose value) includes calculating_ox (NIR)- _ox (R) o(x'(t) = sir(t) - Sred(t)); paragraph [0047]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arko, to use the formula x'(t) = Sir(t) - Sred(t), as taught by Ripoll, to gain the advantage of eliminating the effect of properties of the blood other than glucose in order to get a more accurate reading of glucose values.
Regarding claim 11, Arko does not explicitly teach not disclose wherein the AC component of the measurement value corresponds to a variation is measurement values associated with arterial blood volume of the subject.
However, Ripoll teaches wherein the AC component of the measurement value corresponds to a variation in measurement values associated with arterial blood volume of the subject (the physiological pulsed wave (AC component) of the PPG wave (measurement value) corresponds to changes in blood volume of arteries of the patient; paragraph [0036], [0042]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arko to include wherein the AC component of the measurement value corresponds to a variation in measurement values associated with arterial blood volume of the subject, as taught by Ripoll, to gain the advantage of accurately calculating a blood glucose value while taking into account the changes of blood volume caused by heartbeats (see Ripoll paragraph [0043]).
Regarding claim 12, Arko teaches further teaches wherein calculating the glucose value includes: providing a second filtering of the of the filtered at least one infrared and visible light illuminants (calculating the blood sugar level includes band pass filtering (second filtering) of the high pass filtered IR radiation and the amplified blue light; paragraphs [0038], [0043], [0045-0046]); and calculating glucose value for the subject based, at least in part, on a difference between the filtered at least one infrared and visible light illuminant signals (calculating the blood sugar level based for the user based partially on the difference between the filtered electrical signals; paragraphs [0046-0052]); but Arko does not explicitly teach wherein calculating the glucose value includes generating a heartbeat value using at least one infrared illuminant and at least one visible light illuminant.
However, Ripoll teaches wherein calculating the glucose value includes generating a heartbeat value using at least one infrared illuminant and at least one visible light illuminant (the estimation (calculating) of the glucose concentration value includes generating an AC component based on the heartbeat of the patient using light at infrared wavelengths and red (visible light) wavelengths; paragraphs [0032], [0036], [0047]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arko to include wherein calculating the glucose value includes generating a heartbeat value using at least one infrared illuminant and at least one visible light illuminant, as taught by Ripoll, to gain the advantage of reducing the estimation error by capturing all the parameters which affect the glucose levels of the user (see RIPOLL paragraphs [0032]-[0033]).
Regarding claim 13, Arko does not explicitly teach wherein the visible light illuminant is configured to emit light substantially in the red wavelength. However, RIPOLL teaches wherein the visible light illuminant is configured to emit light substantially in the red wavelength (the first source for illuminating the tissue (visible light illuminant) emits light in the red wavelength; paragraphs [0034], [0042]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arko to include wherein the visible light illuminant is configured to emit light substantially in the red wavelength, as taught by RIPOLL, to gain the advantage of measuring the blood volume by using a wavelength of light that passes through the main constituents of tissue (see RIPOLL paragraph [0037]).
Regarding claim 16, Arko does not explicitly teach wherein calculating the glucose value includes calculating the following: x'(t) = Sir(t) - Sred(t) Where: sir(t) - is the value of input Infrared signal Sred (t) - is the value of input visible light signal x'(t)- is the input signal for glucose calculation t - is the number of input signal sample "equivalent of time".
However, Ripoll teaches wherein calculating the glucose value includes calculating the following: x'(t) = Sir(t) - Sred(t) Where: sir(t) - is the value of input Infrared signal Sred (t) - is the value of input visible light signal x'(t) - is the input signal for glucose calculation t - is the number of input signal sample "equivalent of time" (calculating the glucose concentration value (glucose value) includes calculating_ox (NIR)- _ox (R) o(x'(t) = sir(t) - Sred(t)); paragraph [0047]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arko, to use the formula x'(t) = Sir(t) - Sred(t), as taught by Ripoll, to gain the advantage of eliminating the effect of properties of the blood other than glucose in order to get a more accurate reading of glucose values.
Claim(s) 3-4, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arko as applied to claim 1 above, and further in view of US 20190133471 A1 (hereinafter referred to as “Olson”).
Regarding claim 3, Arko teaches wherein the filtering of the signal for each of the at least one infrared and visible light illuminants each signal includes: providing a second filtering of the of the filtered at least one infrared and visible light illuminants (the frequency filtering set for the IR LED 4 and blue LED 3 provides a band pass filter (second filtering) of the high pass filtered IR LED 4 and blue LED 3; paragraph [0019]); and calculating glucose value for the subject based, at least in part on a difference between the filtered at least one infrared and visible light illuminant signals (calculating the blood sugar level for the wearer based partially on the difference between the filtered signal values of the IR LED 4 signal values and the blue LED 3 signal values; paragraphs [0046-0052]); but does not explicitly teach wherein the filtering of the signal for each of the at least one infrared and visible light illuminants each signal includes: generating a heartbeat value using at least one infrared illuminant and at least one visible light at least illuminant.
However, Olson teaches wherein the filtering of the signal for each of the at least one infrared and visible light illuminants each signal includes: generating a heartbeat value using at least one infrared illuminant and at least one visible light illuminant (applying a Bayesian filter (filtering) of the input signal from two LEDs (illuminants) emitting wavelengths of 550 nm (visible light) and 950 nm (infrared) to generate a heart rate of the user (heartbeat value) using the two LEDs emitting wavelengths of 550 nm and 950 nm; paragraphs [0029-0032], [0034]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arko to include wherein the filtering of the signal for each of the at least one infrared and visible light illuminants each signal includes: generating a heartbeat value using at least one infrared illuminant and at least one visible light illuminant, as taught by Olson, to gain the advantage of providing real time heart rate information which can allow the subject to have accurate, timely health information and provide accurate depictions of the subject's athletic performance (see Olson paragraph [0037]).
Regarding claim 4, Arko does not explicitly teach wherein the visible light illuminant is configured to emit light substantially in the red wavelength. However, Olson teaches wherein the visible light illuminant is configured to emit light substantially in the red wavelength (the light emitting components (visible light illuminant) emits light at a wavelength of about 650 nm (red wavelength; paragraph [0114]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arko to include wherein the visible light illuminant is configured to emit light substantially in the red wavelength, as taught by Olson, to gain the advantage of using light in the red wavelength for large separation between oxy- and deoxy hemoglobin which can also be used to determine blood oxygenation (see Olson paragraph pa [0114]).
Regarding claim 6, Arko does not explicitly teach further comprising at least one additional visible illuminant that is configured to generate a light in a wavelength different than the visible light illuminant.
However, Olson teaches further comprising at least one additional visible illuminant that is configured to generate a light in a wavelength different than the visible light illuminant (an additional light emitting component can generate light in a wavelength of about 550 nm, different from the wavelength of about 650 nm; paragraph [0114]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arko to include disclose further comprising at least one additional visible illuminant that is configured to generate a light in a wavelength different than the visible light illuminant, as taught by Olson, to gain the advantage of the ability to use wavelengths with different uses, such as wavelengths that are useful in high hemoglobin adsorption regions or wavelengths that are not as affected by melanin (see Olson paragraph [0114]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arko as applied to claims 1 above, and further in view of US 20130066172 A1 (hereinafter referred to as “Kulcke”).
Regarding claim 5, Akro does not explicitly teach wherein the visible and infrared light illuminants are a single broad-band illuminant.
However, KULCKE discloses disclose wherein the visible and infrared light illuminants are a single broad-band illuminant (the light source for light between 500 nm and 850 nm (visible) and the light source for light between 800 nm and 1200 nm (infrared) are single light sources which generate broadband light (single broad-band illuminant); paragraph [0062]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arko to include wherein the visible and infrared light illuminants are a single broad-band illuminant, as taught by Kulcke, to gain the advantage of the ability to output a wide range of wavelengths for different purposes, such as oxygen saturation measurements or blood sugar measurements (see Kulcke paragraph [0062]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arko, in view of Ripoll, as applied to claim 10 above, and further in view of Kulcke.
Regarding claim 14, Akro, in view of Ripoll does not explicitly teach wherein the visible and infrared light illuminants are a single broad-band illuminant.
However, Kulcke discloses disclose wherein the visible and infrared light illuminants are a single broad-band illuminant (the light source for light between 500 nm and 850 nm (visible) and the light source for light between 800 nm and 1200 nm (infrared) are single light sources which generate broadband light (single broad-band illuminant); paragraph [0062]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arko, in view of Ripoll, to include wherein the visible and infrared light illuminants are a single broad-band illuminant, as taught by Kulcke, to gain the advantage of the ability to output a wide range of wavelengths for different purposes, such as oxygen saturation measurements or blood sugar measurements (see Kulcke paragraph [0062]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arko, in view of Ripoll, as applied to claim 10 above, and further in view of Olson.
Regarding claim 15, Arko, in view of Ripoll, does not explicitly teach further comprising at least one additional visible illuminant that is configured to generate a light in a wavelength different than the visible light illuminant.
However, Olson teaches further comprising at least one additional visible illuminant that is configured to generate a light in a wavelength different than the visible light illuminant (an additional light emitting component can generate light in a wavelength of about 550 nm, different from the wavelength of about 650 nm; paragraph [0114]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arko, in view of Ripoll, to include disclose further comprising at least one additional visible illuminant that is configured to generate a light in a wavelength different than the visible light illuminant, as taught by Olson, to gain the advantage of the ability to use wavelengths with different uses, such as wavelengths that are useful in high hemoglobin adsorption regions or wavelengths that are not as affected by melanin (see Olson paragraph [0114]).
Allowable Subject Matter
Claims 8, 9, 17, 18, and claims dependent thereof, are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claims 8, 9, 17, and 18, the claims recite limitations not found in the prior art when combined with the limitations of the claims upon which they depend.
Conclusion
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/ABID A MUSTANSIR/Examiner, Art Unit 3791