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 drawings are objected to because reference character “900” is used twice to refer to the wearable computing device. The Examiner suggests omitting one of the instances of “900” in Fig. 9.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “700” in Fig. 7; “1010” in Fig. 10.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 5-6 and 8 objected to because of the following informalities:
The Examiner notes that the terms “the electric signal for the red light” and “the electric signal associated with the red light” are used interchangeably in claims 5 [lines 3-4] and 6 [lines 2-5]. The Examiner suggests amending each instance of either to only recite one or the other of “the electric signal for the red light” and “the electric signal associated with the red light”. The Examiner notes similar objections to “the electric signal for the infrared light” and “the electric signal associated with the infrared light” in claim 6 and additionally suggests maintaining the same language with respect to any limitation that refers to the electric signal for the green light.
Claim 8 reads “the estimated oxygen saturation level [lines 3-4], as such the Examiner notes that “the blood of the user” was not previously recited in claims 1 or 7.
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Interpretation of Claim 6: The Examiner notes that based on the Applicant’s Specification ¶¶0063-0064 [The wearable computing device can generate a dot product value for the red light 604 and the green light 602 time series data as the first dot product value], the dot product value between the red light signal and the green light signal is a dot product between the red light time series data and the green light series data, such that the dot product would be calculated as:
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wherein “n” is the number of values in the time series. However, the Examiner notes that as recited in claim 3 [“the respective electric signal for a particular wavelength of light representing the intensity of the wavelength of light at one or more times”, emphasis added], the respective red and green light signals may only contain one value representing intensity at one time, such that the dot product would be calculated as:
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The Examiner notes a similar interpretation is applied to the product value between the infrared light signal and the green light signal mutatis mutandis. For examination purposes, the Examiner notes that any prior art that teaches, discloses, or suggests the interpretation of generating a dot product as described above may be considered applicable under § 102 or § 103.
Claim Rejections - 35 USC § 112
Examiner’s Note Regarding Machine Learning: the claimed “machine-learned model” of claim(s) 8 was considered under § 112(a), wherein the Examiner notes that the disclosure of machine learning of the Applicant’s Specification [Applicant’s Specification ¶¶0072, 0077-0078] is considered to provide sufficient written description support for the machine-learned model as presently claimed for one of ordinary skill in the art to understand that the Applicant possessed the instant invention at the time of filing.
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(s) 1-2, 4-5, 10-11, 14-15, and those dependent therefrom is/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.
Claim 1 recites the limitations “a computing system” [lines 3, 5, 7; 3 separate instances], which is considered indefinite, as it is not clear whether the claimed method is meant to refer to using three different/separate computing systems or refer to the same computing system. The Examiner further notes that claim 1 later reads “the computing system” [lines 9, 11; 2 separate instances], which is considered indefinite based on the previous recitation of three possible computing systems, such that it is unclear if the recited computing system [lines 9, 11] is meant to refer to any of the previously defined computing systems or refer to a singular computing system. For examination purposes, the Examiner has interpreted the second and third instance of “a computing system” [lines 5, 7] to refer to the same computing system as defined in line 3, and the later instances of “the computing system” [lines 9, 11] in claim 1, as well as any dependent claims, to refer to the same singular computing system.
Claim 1 recites the limitations “a skin of a user” [lines 4, 6, 8; 3 separate instances], which is considered indefinite, as it is not clear whether each instance of “a user” is meant to refer to a separate user or refer to the same user as defined in the preamble of claim 1, as well as whether the second and third instance of “a skin of a user” [lines 6, 8] are meant to refer to a separate skin [or separate area of skin] of a separate user or refer to the same skin [or same area of skin] of the user as defined in line 4. The Examiner further notes that claim 1 later reads “the skin of a user”, which is considered similarly indefinite, as it is not clear whether the same user is being referred to as any of the previous instances of “a user” [lines 4, 6, 8] or whether the skin and the user is meant to refer to the same skin of the same user throughout. For examination purposes, the Examiner has interpreted the same skin of the same user to be referred to in each instance of “a skin of a user” and “the skin of a user”. The Examiner notes that claims 2 [lines 2-3], 14 [lines 8, 10, 12, 13-14], and 15 [lines 6, 8, 10, 11-12] recite similarly indefinite subject matter that is interpreted similarly to the interpretation of claim 1 noted above mutatis mutandis.
Claim 4 recites the limitation “wherein generating, by the computing system, an estimated oxygen saturation level” [lines 1-2], which is considered indefinite, as it is not clear whether the recited limitation is meant to further limit the previous limitation of claim 1 of “determining, by the computing system, an estimated oxygen saturation level” [line 11] or refer to a generation of a different/separate instance of an oxygen saturation level. For examination purposes, the Examiner has interpreted the indefinite limitation to further limit the previous limitation of claim 1 of “determining, by the computing system, an estimated oxygen saturation level” [line 11]. Based on the Examiner’s interpretations of claim 4, the Examiner notes that the recitation of “wherein determining, by the computing system, an estimated oxygen saturation level” [lines 1-2] of claim 5 is meant to further limit the generation/determination of the estimated oxygen saturation as recited in claim 4.
Claim 4 recites the limitations “a electric signal for the red light and an electric signal for the infrared light” [lines 3-4], which is considered indefinite, as it is not clear whether the recited electric signals for red light and infrared light are meant to refer to the previously defined “respective electric signal[s for red/infrared light]” of claim 3 [lines 2-4] or refer to a different/separate electric signal. For examination purposes, the Examiner has interpreted the indefinite limitation to refer to the previously defined “respective electric signal[s for red/infrared light]” of claim 3 [lines 2-4].
Claim 10 recites the limitation “a predetermined threshold” [lines 2-3], which is considered indefinite, as it is not clear whether the recited predetermined threshold is meant to refer to the previously defined predetermined threshold of claim 9 or define a different/separate predetermined threshold. For examination purposes, the Examiner has interpreted the indefinite limitation to read “[[a]] the predetermined threshold”. The Examiner notes that claim 11 recites similar subject matter that is interpreted similarly to the interpretation of claim 10 above mutatis mutandis.
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Each claim has been analyzed to determine whether it is directed to any judicial exceptions.
Representative claim(s) 14 [representing all independent claims] recite(s):
A wearable computing device, the wearable computing device comprising:
one or more processors; and
a computer-readable memory, wherein the computer-readable memory stores instructions that, when executed by the one or more processors, cause the wearable computing device to perform operations comprising:
emitting, by the wearable computing device using one or more green light sources, light towards a skin of a user at a green wavelength;
emitting, by the wearable computing device using one or more red light sources, light towards a skin of a user at a red wavelength;
emitting, by the wearable computing device using one or more infrared light sources, light towards a skin of a user at an infrared wavelength;
detecting an intensity of green light, red light, and infrared light emitted from the skin of a user; and
determining an estimated oxygen saturation level.
(Emphasis added: abstract idea, additional element)
Step 2A Prong 1
Representative claim(s) 14 recites the following abstract ideas, which may be performed in the mind or by hand with the assistance of pen and paper:
“determining an estimated oxygen saturation level” – may be performed by merely observing known or previously collected data [for at least a limited amount of data] and drawing mental conclusions therefrom using known or derived relationships [The wearable computing device can generate an initial estimate of the saturation of the blood of the user based on a comparison of the intensity or amount of light emitted in each wavelength range. Specifically, the wearable computing device can determine a ratio between measured intensity of light in the red light wavelength spectrum and of the measured intensity of light in the infrared wavelength spectrum (Applicant’s Specification ¶0023)]
If a claim, under BRI, covers performance of the limitations in the mind but for the mere recitation of extra-solutionary activity (and otherwise generic computer elements) then the claim falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Step 2A Prong 1 of the Mayo framework as set forth in the 2019 PEG.
No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
Alternatively or additionally, these steps describe the concept of using implicit mathematical formula(s) [i.e., “determining an estimated oxygen saturation level” (Applicant’s Specification ¶0023, determining a ratio)] to derive a conclusion based on input of data, which corresponds to concepts identified as abstract ideas by the courts [Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)]. The concept of the recited limitations identified as mathematical concepts above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
The dependent claims merely include limitations that either further define the abstract idea [e.g. limitations relating to the data gathered or particular steps which are entirely embodied in the mental process] and amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they are merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Thus, these concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data [Int. Ventures v. Cap One Financial], collecting information, analyzing it, and displaying certain results of the collection and analysis [Electric Power Group], collection, storage, and recognition of data [Smart Systems Innovations].
Step 2A Prong 2
The judicial exception is not integrated into a practical application.
Representative claim 14 only recites additional elements of extra-solutionary activity – in particular, extra-solution activity [generic computer function, data gathering] – without further sufficient detail that would tie the abstract portions of the claim into a specific practical application (2019 PEG p. 55 – the instant claim, for example does not tie into a particular machine, a sufficiently particular form of data or signal collection – via the claimed extra-solution activity identified above, or a sufficiently particular form of display or computing architecture/structure).
Dependent claim(s) 4-9 merely add detail to the abstract portions of the claim but do not otherwise encompass any additional elements which tie the claim(s) into a particular application/integration [the dependent claim(s) recite generic ‘units’ or ‘steps’ which encompass mere computer instructions to carry out an otherwise wholly abstract idea].
Dependent claim(s) 2-3 and 10-13 encounter substantially the same issues as the independent claim(s) from which they depend in that they encompass further generic extra-solutionary activity [generic data gathering] and/or generic computer elements [storage, memory per se].
Accordingly, the claim(s) are not integrated into a practical application under Step 2A Prong 2.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Independent claims 1 and 14-15 as individual wholes fail to amount to significantly more than the judicial exception at Step 2B. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of extra-solutionary activity [i.e., generic computer function, data gathering] and generic computer elements cannot amount to significantly more than an abstract idea [MPEP § 2106.05(f)] and is further considered to merely implement an abstract idea on a generic computer [MPEP § 2106.05(d)(II) establishes computer-based elements which are considered to be well understood, routine, and conventional when recited at a high level of generality].
For the independent claim portions and dependent claims which provide additional elements of extra-solutionary data gathering, MPEP § 2106.05(g) establishes that mere data gathering for determining a result does not amount to significantly more. The extra-solutionary activity of processor steps [acquiring, storing, filtering signals, etc.] as presently recited, cannot provide an inventive concept which amounts to significantly more than the recited abstract idea.
For the independent claims as well as the dependent claims merely reciting generic computer elements and functions [processor, memory, computing system, display, each recited at a high level of generality], MPEP § 2106.05(d)(II) establishes computer-based elements which are considered to be well understood, routine, and conventional when recited at a high level of generality.
Accordingly, the generic computer elements and functions therein, as presently limited, cannot provide an inventive concept since they fall under a generic structure and/or function that does not add a meaningful additional feature to the judicial exception(s) of the claim(s).
Claim(s) 1 and 14-15 recite “emitting… using one or more green light sources, light towards a skin of a user at a green wavelength”, “emitting… using one or more red light sources, light towards a skin of a user at a red wavelength”, “emitting… using one or more infrared light sources, light towards a skin of a user at an infrared wavelength”. Such a green light source, red light source, and infrared light source is considered well-understood, routine, and conventional, as known by at least:
Wu (US-10568525-B1, cited by Applicant) [FIG. 1 depicts six pairs of light sources 102, two secondary light sources 104, and one detector 106, but in other embodiments the monitoring device 100 may contain any number of pairs of light sources 102, secondary light sources 104, and detectors 106 (Wu Col 5:8-13); each pair of light sources 102 includes a red light source and an infrared light source (Wu Col 6:8-9); light sources 104 may be green light sources, such as green LEDs (Wu Col 7:2-3)]
Fraser (US-20150355604-A1) [The apparatus 100 can include a wrist worn device 110 configured to be worn on a wrist of a user. The apparatus 100 can include a light emitter 120 that can emit light 125 from a user side 150 of the wrist worn device 110 to a wrist of the user. The light emitter 120 can include one or more of different types of light emitters. For example, the light emitter 120 can include a red light emitter, an infrared light emitter, a green light emitter,,,, and/or any other light emitter that can be used to detect biometric information of a user. For example, a red light emitter and an infrared light emitter can be used to detect blood oxygen saturation, such as oxygen saturation of hemoglobin in a volume of intravascular blood of the user, heart rate, and other biometric information. Additionally, one, two, or more green light emitters can also be used to detect blood oxygen saturation, heart rate, and/or other biometric information. Furthermore, a combination of red, infrared, and green light emitters can be used to detect blood oxygen saturation, heart rate, and/or other biometric information. For example, red and infrared light emitters can be used to detect blood oxygen saturation and a green light emitter can be used to detect heart rate (Fraser ¶0015)]
Lafon (US-20200000441-A1) [The watch can also include an optical measurement sub-system 152, such as is illustrated in the example back view of the smart watch 150 illustrated in FIG. 1B. In this example, the optical measurement sub-system includes at least one optical emitter and at least one optical receiver. The emitter can emit light of one or more wavelengths that can be reflected from the surface of the user's skin, or diffusely reflected after traveling, under the surface, and detected by at least one of the emitters (Lafon ¶0018); The example device in FIG. 6 includes emitters 616 and detectors 618 capable of being used for obtaining optical photoplethsymogram (PPG) measurements… In some embodiments, a PPG device employs a single light source coupled to a single detector (i.e., a single light path). Alternatively, a PPG device may employ multiple light sources coupled to a single detector or multiple detectors (i.e., two or more light paths). In other embodiments, a PPG device employs multiple detectors coupled to a single light source or multiple light sources (i.e., two or more light paths). In some cases, the light source(s) may be configured to emit one or more of green, red, and/or infrared light (Lafon ¶0068); Although some embodiments are described with reference to HR or cardiac components of PPG signals, the techniques described herein may be extended to other types of physiological metrics described herein, such as may relate to SpO.sub.2, or other types of signals that can be extracted from the PPG signals to determine such physiological metrics (Lafon ¶0075)]
Claim(s) 1-3 and 14-15 recite “detecting… an intensity of green light, red light, and infrared light emitted from the skin of a user” [claim 1], “wherein one or more light sensors are used to detect an intensity of green light, red light, and infrared light emitted from the skin of a user” [claim 2], and “wherein the one or more light sensors generate, for each of green light, red light, and infrared light, a respective electric signal, the respective electric signal for a particular wavelength of light representing the intensity of the wavelength of light at one or more times” [claim 3]. Such a one or more light sensors is considered well-understood, routine, and conventional, as known by at least:
Wu [Col 5:8-13; Col 6:8-9; Col 7:2-3]; Fraser [¶0015]; Lafon [¶¶0018, 0068, 0075]
Claim 8 recites “a machine-learned model”. Such a machine-learned model is considered well-understood, routine, and conventional, as known by at least:
Hu (“Intelligent Sensor Networks”, NPL attached) [In supervised learning, the learner is provided with labeled input data. This data contains a sequence of input/output pairs of the form xi, yi, where xi is a possible input and yi is the correctly labeled output associated with it. The aim of the learner in supervised learning is to learn the mapping from inputs to outputs. The learning program is expected to learn a function f that accounts for the input/output pairs seen so far, f (xi) = yi, for all i. This function f is called a classifier if the output is discrete and a regression function if the output is continuous. The job of the classifier/regression function is to correctly predict the outputs of inputs it has not seen before (Hu, Page 5)]
Huang (“Kernel Based Algorithms for Mining Huge Data Sets”, NPL attached) [In supervised learning, the learner is provided with labeled input data. This data contains a sequence of input/output pairs of the form xi, yi, where xi is a possible input and yi is the correctly labeled output associated with it. The aim of the learner in supervised learning is to learn the mapping from inputs to outputs. The learning program is expected to learn a function f that accounts for the input/output pairs seen so far, f (xi) = yi, for all i. This function f is called a classifier if the output is discrete and a regression function if the output is continuous. The job of the classifier/regression function is to correctly predict the outputs of inputs it has not seen before (Huang, Page 1)]
Mitchell (“The Discipline of Machine Learning”, NPL attached) [For example, we now have a variety of algorithms for supervised learning of classification and regression functions; that is, for learning some initially unknown function f : X [Calibri font/0xE0] Y given a set of labeled training examples {xi; yi} of inputs xi and outputs yi = f(xi) (Mitchell, Pages 3-4)]
Claim 13 recites “wherein the computing system is a wearable computing device”. Such a wearable computing device is considered well-understood, routine, and conventional, as known by at least:
Applicant’s disclosure is not particular regarding the particular structure of the generically claimed wearable computing device, and recites the wearable computing device at a high level of generality [More specifically, a wearable computing device can include any computing device that is integrated into an object that is meant to be worn by a user. For example, wearable computing devices can include, but are not limited to smartwatches, fitness bands, computing devices integrated into jewelry such as smart rings or smart necklaces, computing devices integrated into items of clothing such as jackets, shoes, and pants, and wearable glasses with computing elements included therein (Applicant’s Specification ¶0026)]. This lack of disclosure is acceptable under 35 U.S.C. 112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the medical technology arts. Thus, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the field of wearable technology. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional element because it describes such an additional element in a manner that indicates that the additional element is sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a) [see Berkheimer memo from April 19, 2018, Page 3, (III)(A)(1), not attached]. Adding hardware that performs “well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible [TLI Communications].
Examiner’s Note Regarding Particular Treatment or Prophylaxis: Claim(s) 1, 12, and 14-15 recite subject matter regarding determining and displaying an estimated oxygen saturation level, which the Examiner notes is not considered to be a particular treatment or prophylaxis, as none of the identified claims positively recite or include language that is considered to be a particular treatment or prophylaxis as an additional element to integrate the judicial exception into a practical application or allow the identified claims to amount to significantly more than the judicial exception [MPEP § 2106.04(d)(2)].
Accordingly, the claim(s) as whole(s) fail amount to significantly more than the judicial exception under Step 2B.
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.
Claim(s) 1-3, 5, 7, and 12-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu (US-10568525-B1, cited by Applicant).
Regarding claim 1, Wu teaches
A computer-implemented method for measuring blood oxygen saturation in a user [a computer system 900 upon which an embodiment may be implemented. Computer system 900 includes a bus 902 or other communication mechanism for communicating information, and a hardware processor 904 coupled with bus 902 for processing information. Hardware processor 904 may be, for example, a general purpose microprocessor (Wu Col 15:56-62)], the method comprising:
emitting, by a computing system with one or more processors using one or more green light sources, light towards a skin of a user at a green wavelength [the light sources 102, 104 are positioned to permit the detector 106 to detect reflected light that is emitted from the light sources toward the skin and therefore the light sources and detector may be closely located on a miniature substrate within a housing, band or other protective elements of the monitoring device 100 (Wu Col 4:28-33); light sources 104 may be green light sources, such as green LEDs. The green light sources may be configured to emit light with wavelengths in the range of 495 nm to 570 nm. For example, a particular green light source may emit light with a wavelength of 528 nm (Wu Col 7:2-6)];
emitting, by a computing system using one or more red light sources, light towards a skin of a user at a red wavelength [each pair of light sources 102 includes a red light source and an infrared light source. The light sources 102 may emit light with peak wavelengths typically in the range of 650 nm to 940 nm. For example, in various embodiments a particular red light source may emit light with a peak wavelength of 660 nm. The infrared light source may emit light with peak wavelengths in the range of 750 nm to 1700 nm (Wu Col 6:8-15)];
emitting, by a computing system using one or more infrared light sources, light towards a skin of a user at an infrared wavelength [Wu Col 6:8-15];
detecting, by the computing system, an intensity of green light, red light, and infrared light emitted from the skin of a user [Wu Col 4:28-33]; and
determining, by the computing system, an estimated oxygen saturation level [The first photodiode 180 is configured to receive PPG signals based upon emission of red and infrared light and is used to produce a SpO.sub.2 signal. The second and third photodiodes 182, 184 are configured to detect PPG signals based upon emission of green light and to generate a heart rate signal based on those PPG signals. The SpO.sub.2 signal and heart rate signal may be processed in the manner that is described herein, for example, with respect to the flow diagrams and other functional descriptions (Wu Col 8:14-23)].
Regarding claim 2, Wu teaches
The computer-implemented method of claim 1, wherein one or more light sensors are used to detect an intensity of green light, red light, and infrared light emitted from the skin of a user [Reflected light is detected using the detector 106 and PPG signals are formed using the detector 106 and gated or signaled for transient storage in memory within the monitoring device 100 (Wu Col 9:61-64), wherein it is well known that a photodiode provides a measurement of intensity of light].
Regarding claim 3, Wu teaches
The computer-implemented method of claim 2, wherein the one or more light sensors generate, for each of green light, red light, and infrared light, a respective electric signal, the respective electric signal for a particular wavelength of light representing the intensity of the wavelength of light at one or more times [Wu Col 9:61-64, wherein it is well known that a photodiode provides a measurement of intensity of light].
Regarding claim 5, Wu teaches
The computer-implemented method of claim 3, wherein determining, by the computing system, an estimated oxygen saturation level comprises:
filtering, by the computing system, the electric signal for the red light and the electric signal for the infrared light using the electric signal associated with the green light [At step 608, the noise components are removed from the one or more SpO.sub.2 datasets to produce one or more filtered SpO.sub.2 datasets, which can be performed by using an adaptive filter for which the one or more SpO.sub.2 datasets and a characteristic of the one or more PPG signals for characterizing a heart rate are inputs. For example, the SpO.sub.2 datasets formed at step 606 may be filtered based upon the signals received at step 604 to remove all or part of noise components from the SpO.sub.2 datasets to yield filtered SpO.sub.2 datasets. In one embodiment, the PPG signals obtained using infrared and red light sources typically are weaker than signals based upon green light sources (e.g., see FIG. 7); however, a heart rate signal determined using the green light source may be used to improve the PPG signals with an adaptive filter that uses the heart rate information detected using the green light sources to remove noise that are inconsistent with the heart rate frequency. In an embodiment, the PPG signals for SpO.sub.2 comprise primary inputs to an adaptive filter and the heart rate signal is the reference input (Wu Col 11:14-32)].
Regarding claim 7, Wu teaches
The computer-implemented method of claim 1, further comprising:
generating, by the computing system, feature data from the detected intensity of green light, red light, and infrared light [Wu Col 9:61-64, wherein the Examiner notes that the respective light intensity measured by the photodiode may be considered a “feature value”].
Regarding claim 12, Wu teaches
The computer-implemented method of claim 1, further comprising:
displaying, by the computing system, the estimated oxygen saturation level [Display 114 may be programmed or configured to display data, such as time, heart rate, and SpO.sub.2 levels of a user (Wu Col 4:42-44)].
Regarding claim 13, Wu teaches
The computer-implemented method of claim 1, wherein the computing system is a wearable computing device [Wu Col 4:28-33].
Regarding claim 14, Wu teaches
A wearable computing device, the wearable computing device comprising:
one or more processors [a computer system 900 upon which an embodiment may be implemented. Computer system 900 includes a bus 902 or other communication mechanism for communicating information, and a hardware processor 904 coupled with bus 902 for processing information. Hardware processor 904 may be, for example, a general purpose microprocessor (Wu Col 15:56-62)]; and
a computer-readable memory, wherein the computer-readable memory stores instructions that, when executed by the one or more processors, cause the wearable computing device to perform operations [Computer system 900 also includes a main memory 906, such as a random access memory (RAM) or other dynamic storage device, coupled to bus 902 for storing information and instructions to be executed by processor 904. Main memory 906 also may be used for storing temporary variables or other intermediate information during execution of instructions to be executed by processor 904. Such instructions, when stored in non-transitory storage media accessible to processor 904, render computer system 900 into a special-purpose machine that is customized to perform the operations specified in the instructions (Wu Col 15:63-16:6)] comprising:
emitting, by the wearable computing device using one or more green light sources, light towards a skin of a user at a green wavelength [the light sources 102, 104 are positioned to permit the detector 106 to detect reflected light that is emitted from the light sources toward the skin and therefore the light sources and detector may be closely located on a miniature substrate within a housing, band or other protective elements of the monitoring device 100 (Wu Col 4:28-33); light sources 104 may be green light sources, such as green LEDs. The green light sources may be configured to emit light with wavelengths in the range of 495 nm to 570 nm. For example, a particular green light source may emit light with a wavelength of 528 nm (Wu Col 7:2-6)];
emitting, by the wearable computing device using one or more red light sources, light towards a skin of a user at a red wavelength [each pair of light sources 102 includes a red light source and an infrared light source. The light sources 102 may emit light with peak wavelengths typically in the range of 650 nm to 940 nm. For example, in various embodiments a particular red light source may emit light with a peak wavelength of 660 nm. The infrared light source may emit light with peak wavelengths in the range of 750 nm to 1700 nm (Wu Col 6:8-15)];
emitting, by the wearable computing device using one or more infrared light sources, light towards a skin of a user at an infrared wavelength [Wu Col 6:8-15];
detecting an intensity of green light, red light, and infrared light emitted from the skin of a user [Reflected light is detected using the detector 106 and PPG signals are formed using the detector 106 and gated or signaled for transient storage in memory within the monitoring device 100 (Wu Col 9:61-64), wherein it is well known that a photodiode provides a measurement of intensity of light]; and
determining an estimated oxygen saturation level [The first photodiode 180 is configured to receive PPG signals based upon emission of red and infrared light and is used to produce a SpO.sub.2 signal. The second and third photodiodes 182, 184 are configured to detect PPG signals based upon emission of green light and to generate a heart rate signal based on those PPG signals. The SpO.sub.2 signal and heart rate signal may be processed in the manner that is described herein, for example, with respect to the flow diagrams and other functional descriptions (Wu Col 8:14-23)].
Regarding claim 15, Wu teaches
A computer-readable medium storing instructions that, when executed by a wearable computing device, cause the wearable computing device to operations [Computer system 900 also includes a main memory 906, such as a random access memory (RAM) or other dynamic storage device, coupled to bus 902 for storing information and instructions to be executed by processor 904. Main memory 906 also may be used for storing temporary variables or other intermediate information during execution of instructions to be executed by processor 904. Such instructions, when stored in non-transitory storage media accessible to processor 904, render computer system 900 into a special-purpose machine that is customized to perform the operations specified in the instructions (Wu Col 15:63-16:6)] comprising:
emitting, by the wearable computing device using one or more green light sources, light towards a skin of a user at a green wavelength [the light sources 102, 104 are positioned to permit the detector 106 to detect reflected light that is emitted from the light sources toward the skin and therefore the light sources and detector may be closely located on a miniature substrate within a housing, band or other protective elements of the monitoring device 100 (Wu Col 4:28-33); light sources 104 may be green light sources, such as green LEDs. The green light sources may be configured to emit light with wavelengths in the range of 495 nm to 570 nm. For example, a particular green light source may emit light with a wavelength of 528 nm (Wu Col 7:2-6)];
emitting, by the wearable computing device using one or more red light sources, light towards a skin of a user at a red wavelength [each pair of light sources 102 includes a red light source and an infrared light source. The light sources 102 may emit light with peak wavelengths typically in the range of 650 nm to 940 nm. For example, in various embodiments a particular red light source may emit light with a peak wavelength of 660 nm. The infrared light source may emit light with peak wavelengths in the range of 750 nm to 1700 nm (Wu Col 6:8-15)];
emitting, by the wearable computing device using one or more infrared light sources, light towards a skin of a user at an infrared wavelength [Wu Col 6:8-15];
detecting an intensity of green light, red light, and infrared light emitted from the skin of a user [Reflected light is detected using the detector 106 and PPG signals are formed using the detector 106 and gated or signaled for transient storage in memory within the monitoring device 100 (Wu Col 9:61-64), wherein it is well known that a photodiode provides a measurement of intensity of light]; and
determining an estimated oxygen saturation level [The first photodiode 180 is configured to receive PPG signals based upon emission of red and infrared light and is used to produce a SpO.sub.2 signal. The second and third photodiodes 182, 184 are configured to detect PPG signals based upon emission of green light and to generate a heart rate signal based on those PPG signals. The SpO.sub.2 signal and heart rate signal may be processed in the manner that is described herein, for example, with respect to the flow diagrams and other functional descriptions (Wu Col 8:14-23)].
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu, as applied to claim 3 above, in view of Song (US-20200187788-A1).
Regarding claim 4, Wu teaches
The computer-implemented method of claim 3.
However, Wu fails to explicitly disclose wherein generating, by the computing system, an estimated oxygen saturation level comprises: determining, by the computing system, a saturation ratio between a electric signal for the red light and an electric signal for the infrared light.
Song discloses systems and methods for determining blood oxygen saturation, wherein Song discloses estimating an oxygen saturation level by determining a saturation ratio between an electric signal for the red light and an electric signal for the infrared light [Determination of blood oxygen saturation may typically include calculating a first ratio of AC component to DC component for the PPG signal based on red light and a second ratio of AC component to DC component for the PPG signal based on IR light and then determining a ratio of the first ratio to the second ratio. Thus, determination of blood oxygen saturation may require detecting both an AC component and a DC component of a PPG signal (Song ¶0053)].
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 method of Wu to employ wherein generating, by the computing system, an estimated oxygen saturation level comprises: determining, by the computing system, a saturation ratio between a electric signal for the red light and an electric signal for the infrared light, as this modification would amount to merely applying a known technique to a known device (method, or product) ready for improvement to yield predictable results [MPEP § 2143(I)(D)].
Claim(s) 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu, as applied to claim 7 above, in view of Montgomery (US-20220031208-A1, effective filing date of 29 July 2020).
Regarding claim 8, Wu teaches
The computer-implemented method of claim 7.
However, Wu fails to explicitly disclose the method further comprising: determining, by the computing system using a machine-learned model with the feature data as input, a confidence level associated with the estimated oxygen saturation level of the blood of the user.
Montgomery discloses systems for assessing the correctness of sensor data, wherein Montgomery discloses inputting red light feature data, infrared light feature data, and other sensor feature data into a machine-learning model to output a confidence level associated with an estimated oxygen saturation level of a user [Training of the machine learning network 400 can use supervised learning or semi-supervised learning. More complex configurations can require a relatively large training data set size to converge on a set of weights through multiple training iterations. Training can use a combination of labeled and unlabeled data. Labeling of training data can assist the training process complete faster with fewer total samples needed. As part of training, a training data set containing many examples can be passed input into the machine learning network 400, and the machine learning network 400 can output results with confidence values indicating how well the input matches particular patterns. Results with confidence levels above a confidence threshold can be classified as most likely correct. Results with confidence levels below the confidence threshold may be classified as indeterminant. Although the example of FIG. 4 depicts three input nodes 402 and three output nodes 406, it will be understood that any number of input nodes 402 and output nodes 406 can be used depending upon the desired machine learning approach. For example, the input nodes 402 may receive SpO.sub.2 data, ratio data, co-oximeter data, red signal input, infrared signal input, derived data, and/or other sensor data… The output nodes 406 may indicate SpO.sub.2 value ranges, ratio data ranges, and/or various predictions/classifications with associated levels of confidence (Montgomery ¶0033)].
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 method of Wu to employ determining, by the computing system using a machine-learned model with the feature data as input, a confidence level associated with the estimated oxygen saturation level of the blood of the user, so as to determine whether the estimated oxygen saturation is correct or not.
Regarding claim 9, Wu in view of Montgomery teaches
The computer-implemented method of claim 8, further comprising:
determining, by the computing system, whether the confidence level exceeds a predetermined threshold [Montgomery ¶0033].
Regarding claim 10, Wu in view of Montgomery teaches
The computer-implemented method of claim 9.
However, while Wu discloses the storage of the estimated oxygen saturation level [the PPG signals that were received at step 602 are stored as SpO.sub.2 datasets in digital memory. A “dataset,” as used herein, may refer to a computer usable representation of data stored in computer memory. The dataset may be organized or otherwise structured to allow for a processor or program to access given elements of the datasets, such as an indexed (e.g., the Nth) sample of the PPG signal. In an example, the dataset may be stored in a buffer used for temporary processing or storing or in computer memory used for longer-term processing or storage (Wu Col 10:63-11:6)] and the modification of Wu in view of Montgomery is considered to disclose further comprising: in response to determining, by the computing system, that the confidence level exceeds a predetermined threshold, identifying that the estimated oxygen saturation level is likely correct [Montgomery ¶0033], the modification of Wu in view of Montgomery does not explicitly disclose storing, by the computing system, the estimated oxygen saturation level when the confidence level exceeds the predetermined threshold.
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 method of Wu in view of Montgomery to employ storing the estimated oxygen saturation level only when the confidence level exceeds the predetermined threshold, so as to only store estimated oxygen saturation levels that are considered correct.
Regarding claim 11, Wu in view of Montgomery teaches
The computer-implemented method of claim 9.
However, while Wu discloses the storage of the estimated oxygen saturation level [Wu Col 10:63-11:6] and the modification of Wu in view of Montgomery is considered to disclose further comprising: in response to determining, by the computing system, that the confidence level exceeds a predetermined threshold, identifying that the estimated oxygen saturation level is indeterminant [Montgomery ¶0033], the modification of Wu in view of Montgomery does not explicitly disclose discarding, by the computing system, the estimated oxygen saturation level when the confidence level does not exceed the predetermined threshold.
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 method of Wu in view of Montgomery to discarding the estimated oxygen saturation level when the confidence level does not exceed the predetermined threshold, so as to only store estimated oxygen saturation levels that are considered correct.
Subject Matter Not Taught By Prior Art
The Examiner notes that the closest prior art of record regarding claim 6 is Wu (US-10568525-B1, cited by Applicant), wherein Wu discloses filtering, by the computing system, the electric signal for the red light and the electric signal for the infrared light using the electric signal associated with the green light [At step 608, the noise components are removed from the one or more SpO.sub.2 datasets to produce one or more filtered SpO.sub.2 datasets, which can be performed by using an adaptive filter for which the one or more SpO.sub.2 datasets and a characteristic of the one or more PPG signals for characterizing a heart rate are inputs. For example, the SpO.sub.2 datasets formed at step 606 may be filtered based upon the signals received at step 604 to remove all or part of noise components from the SpO.sub.2 datasets to yield filtered SpO.sub.2 datasets. In one embodiment, the PPG signals obtained using infrared and red light sources typically are weaker than signals based upon green light sources (e.g., see FIG. 7); however, a heart rate signal determined using the green light source may be used to improve the PPG signals with an adaptive filter that uses the heart rate information detected using the green light sources to remove noise that are inconsistent with the heart rate frequency. In an embodiment, the PPG signals for SpO.sub.2 comprise primary inputs to an adaptive filter and the heart rate signal is the reference input (Wu Col 11:14-32)]. However, the Examiner notes that Wu fails to explicitly disclose, teach, or suggest “wherein filtering, by the computing system, the electric signal for the red light and the electric signal for the infrared light using the electric signal associated with the green light further comprises: generating, by the computing system, a dot product of the electric signal associated with the green light and the electric signal associated with the red light; and generating, by the computing system, a dot product of the electric signal associated with the green light and the electric signal associated with the infrared light”. It would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu to employ the subject matter of claim 6 without the benefit of hindsight. As such, claim 6 is considered to not be taught by any prior art reference.
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791