DETAILED ACTION
Claims 1-18 are hereby under examination.
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/08/2024 is being considered by the examiner.
Claim Objections
Claims 1 and 13 are objected to because of the following informalities:
Regarding claim 1, line 4 recites “the body”, however it appears it should read --a body-- (emphasis added).
Regarding claim 13, line 3 recites “the body”, however it appears it should read --a body-- (emphasis added).
Claim Interpretation- 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1: The claim limitation “using a light detection unit … to detect first to third derived lights …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “unit” coupled with functional language “to detect first to third derived lights …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “unit”.
Claim 13: The claim limitation “a light detection unit … to detect first to third derived lights …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “unit” coupled with functional language “to detect first to third derived lights …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “unit”.
Claim 13: The claim limitation “a computation unit that generates first and second ratio equations … calculates concentrations of glycated hemoglobin (HbA1c) and arterial blood oxygen saturation (SpO2) …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “unit” coupled with functional language “generates first and second ratio equations … calculates concentrations of glycated hemoglobin (HbA1c) and arterial blood oxygen saturation (SpO2) …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “unit”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Regarding a and b, the specification does not provide adequate structure, material or acts to support the claimed function. The specification recites in paras. [0061-0062], “the light detection unit may measure the intensity of light transmitted through blood in the human body or reflected by the human body … the light detection unit may perform an operation of detecting first to third derived lights derived from the first to third lights by passing through the measurement subject …”. For the purposes of examination, “light detection unit” is being interpreted as any structure capable of performing the claimed function.
Regarding c, the specification does not provide adequate structure, material or acts to support the claimed function. The specification recites in paras. [0064] and [0069-0070], “computation unit generates first and second ratio equations for each of the first and second derived light steps … calculates the concentrations of glycated hemoglobin … arterial blood oxygen saturation …”. For the purposes of examination, “computation unit” is being interpreted as any structure capable of performing the claimed function.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, but fails to provide the structure, material or acts to support the claimed function. As such, the claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim.
As discussed above, the claim limitations below are interpreted under 35 U.S.C. 112(f):
Claim 1: “using a light detection unit … to detect first to third derived lights …”;
Claim 13: “a light detection unit … to detect first to third derived lights …”; and
Claim 13: “a computation unit that generates first and second ratio equations … calculates concentrations of glycated hemoglobin (HbA1c) and arterial blood oxygen saturation (SpO2) …”
The specification merely discloses the functions performed by these limitations. However, one of ordinary skill in the art would not understand the specification, the drawings, and the original claims to disclose any particular structure that achieves the disclosed functionality.
The limitations fail to comply with the written description requirement as the limitations are unbound functional limitations which cover all ways of performing the respective functions and the inventor has not provided sufficient disclosure to show possession of such invention. The limitations therefore fail to comply with the written description requirement. See MPEP 2181.II.A.
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Rejections - 35 USC § 112(b)
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.
Regarding claims 1-18, claim limitations “light detection unit …” and “computation unit …”, as recited above, invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Regarding “light detection unit …” and “computation unit …”, as recited above, the specification does not provide adequate structure, material or acts to support the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The dependent claims of the above rejected claim are rejected due to their dependency.
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 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Analysis of independent claims 1 and 13:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a method, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Claim 13 is directed to a system, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1 and 13 recite an abstract idea. In particular, the claims recite the following:
Generating first and second ratio equations, respectively, for first and second derived light sets composed of two of the first to third derived lights; and
Calculating concentrations of glycated hemoglobin (HbA1c) and arterial blood oxygen saturation (SpO2) of the measurement subject by combining the first and second ratio equations.
These elements recited in claims 1 and 13 are drawn to an abstract idea since (1) they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations; and/or (2) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Generating first and second ratio equations is drawn to a mental process that can be practically performed in the human mind, with the aid of pen and paper. A person with ordinary skill in the art could reasonably generate ratio equations based on received data on a piece of paper. There is nothing to suggest an undue level of complexity. Additionally, generating the ratio equations is drawn to a mathematical concept and mathematical calculations of equation manipulation.
Calculating concentrations of glycated hemoglobin and arterial blood oxygen saturation of the measurement subject by combing the first and second ratio equations is drawn to a mental process that can be practically performed in the human mind, with the aid of pen and paper. A person with ordinary skill in the art could reasonably calculate the concentrations and measurements by combing the equations. There is nothing to suggest an undue level of complexity. Additionally, calculating the concentrations and measurements is drawn to a mathematical concept and mathematical calculations.
Prong Two: Claims 1 and 13 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “a computation unit” (claim 13)), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “LED modules” (claim 1 and claim 13), “light detection unit (claim 1 and claim 13)).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, “LED modules” and “light detection unit” are well-understood, routine, and conventional, as disclosed by Ting et al. (US 20130178724 A1) - para. [0033-0036].
Further, “a computation unit” does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)).
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 13 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to pre-solution steps/structure for necessary data gathering, which merely facilitate the abstract idea.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of the dependent claims:
Claims 2-12 and 14-18 depend from the independent claim. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“the generation comprises generating the first and second ratio equations using Photon-Diffusion Theory or Beer-Lambert Law” (claim 4), “the generation comprises generating an attribute equation for each wavelength of the first to third derived lights according to the Photon-Diffusion Theory, and generating the first and second ratio equations using the attribute equation for each derived light of the first and second derived light sets” (claim 5), “the generation comprises generating an equation for transmittance or reflectance including a total absorption coefficient and a scattering coefficient for each wavelength of the first to third derived lights as the attribute equation” (claim 6), “the generation comprises: applying the total absorption coefficient and scattering coefficient to spherical geometry to express the transmittance or reflectance of each of the first to third derived lights using a mathematical equation; generating a ratio for the transmittance or reflectance for each derived light of the first derived light set using the first ratio equation; and generating a ratio for the transmittance or reflectance for each derived light of the second derived light set using the second ratio equation” (claim 7), “the calculation comprises: generating first and second conversion formulas by applying the glycated hemoglobin (HbA1c) and the arterial blood oxygen saturation (SpO2) as unknown to each of the first and second ratio equations; applying coefficient values acquired corresponding to first to third wavelength ranges to each of the first and second conversion formulas; and combining the first and second conversion formulas to convert the concentrations of the glycated hemoglobin (HbA1c) and the arterial blood oxygen saturation (SpO2) into each functional formula regarding the first and second ratio equations” (claim 8), “the generation comprises applying attribute ratios regarding each derived light of each of the first and second derived light sets and the first to third derived lights measured by the light detection unit to the Beer-Lambert Law to generate the first and second ratio equations” (claim 9), “the generation comprises: generating the first ratio equation representing a ratio of absorbance for each derived light of the first derived light set by applying the Beer-Lambert Law; and generating the second ratio equation representing a ratio of absorbance for each derived light of the second derived light set by applying the Beer-Lambert Law” (claim 10), “the calculation comprises applying the first to third derived lights measured by the light detection unit to the first and second ratio equations to compute the concentrations of the glycated hemoglobin (HbA1c) and the arterial blood oxygen saturation (SpO2) of the measurement subject” (claim 11), “the calculation comprises: generating first and second conversion formulas by applying the glycated hemoglobin (HbA1c) and the arterial blood oxygen saturation (SpO2) as unknown to each of the first and second ratio equations; applying a molar extinction coefficient when applying first to third wavelengths to each of the first and second conversion formulas; and combining the first and second conversion formulas to convert the concentrations of the glycated hemoglobin (HbA1c) and the arterial blood oxygen saturation (SpO2) into each functional formula regarding the first and second ratio equations” (claim 12), “the computation unit generates the first and second ratio equations using Photon-Diffusion Theory or Beer-Lambert Law” (claim 16), “when using the Photon-Diffusion Theory, the computation unit calculates the concentration of the glycated hemoglobin using transmittance when the light detection unit is positioned at the opposite side, and calculates the concentration of the glycated hemoglobin using reflectance when the light detection unit is positioned on the same side surface” (claim 17), “the computation unit calculates the concentration of the glycated hemoglobin using the Beer-Lambert Law and using absorbance when the light detection unit is positioned at the opposite side” (claim 18)),
Further describe the pre-solution activity (or the structure used for such activity) (“the light detection unit is positioned at an opposite side or on the same side surface relative to positions of the first to third LED modules” (claim 2), “one side of the body of the measurement subject comprises a site where capillaries existing under the skin are able to be sensed, depending on a thickness of the skin” (claim 3), “the light detection unit is positioned at an opposite side or on the same side surface relative to positions of the first to third LED modules” (claim 14), “one side of the body of the measurement subject comprises a site where capillaries existing under the skin are able to be sensed, depending on a thickness of the skin” (claim 15)), and
Further describe the computer implementation (“computation unit” (claims 16-18)).
Further, a “computation unit” does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014).
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subjection matter. Claims 1-18 are rejected.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 13-18 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 13, lines 3-5 recite “first to third LED modules positioned on one side of the body of a measurement subject and respectively irradiating the measurement subject …”, and lines 6-8 recite “a light detection unit positioned … to detect first to third derived lights derived from the first to third lights by passing through the measurement subject”, which is directed to or encompasses a human organism. It is recommended to the Applicant to amend the claims to recite the LED modules and light detection unit are configured to performed the claimed actions.
The dependent claims of the above rejected claim are rejected due to their dependency.
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.
Claims 1-4, 9-16, and 18 rejected under 35 U.S.C. 103 as being unpatentable over Ting et al. (US 20130178724 A1), hereinafter referred to as Ting, in view of Robert Newberry (US 20170215793 A1), hereinafter referred to as Newberry.
The claims are generally directed towards a method for non-invasive measurement of glycated hemoglobin, the method comprising: irradiating a measurement subject with first to third lights having different wavelength values by means of first to third LED modules positioned on one side of the body of the measurement subject; using a light detection unit positioned corresponding to the first to third LED modules to detect first to third derived lights derived from the first to third lights by passing through the measurement subject; generating first and second ratio equations, respectively, for first and second derived light sets composed of two of the first to third derived lights; and calculating concentrations of glycated hemoglobin (HbA1c) and arterial blood oxygen saturation (SpO2) of the measurement subject by combining the first and second ratio equations.
Regarding claim 1, Ting discloses a method for non-invasive measurement of glycated hemoglobin (Abstract, “method for predicting a parameter in the blood stream … HbA1c …”, Fig. 2, para. [0010]), the method comprising:
irradiating a measurement subject with first to second lights having different wavelength values by means of first to second LED modules positioned on one side of the body of the measurement subject (Fig. 2, element 12, element 14, para. [0033-0037], “laser diode source comprises two laser diodes … produce infra-red radiation of a specific wavelength …”, para. [0057]);
using a light detection unit positioned corresponding to the first to second LED modules to detect first to second derived lights derived from the first to second lights by passing through the measurement subject (Fig. 2, element 12, element 16, element 18, element 22, element 24, para. [0033-037], “optical receiver … first optical receiver is arranged to receive incident light of the two different wavelengths … second optical receiver is arranged to receive transmitted or diffuse reflected light of the two different wavelengths when a finger of a subject is present …”, para. [0057]);
generating first ratio equation, respectively, for first derived light sets composed of two of the first to second derived lights (para. [0018-0019], para. [0047-0057]); and
calculating concentrations of glycated hemoglobin (HbA1c) (para. [0018-0019], “parameter to be predicted is the level of glycated hemoglobin (HbA1c), para. [0047-0057]).
However, Ting does not explicitly disclose irradiating the measurement subject with a third light have a different wavelength values by means of a third LED module, using the light detection unit positioned corresponding to the third LED module to detect third derived lights from the third light, generating a second ratio equation, respectively, for second derived light sets composed of two of the first to third derived lights; and calculating concentrations of arterial blood oxygen concentration saturation (SpO2) of the measurement subject by combining the first and second ratio equations.
Newberry teaches an analogous method for non-invasive measurement of blood parameters (Abstract, para. [0057-0058]). Newberry further teaches irradiating a measurement subject with first to third lights have different wavelength values by means of first to third LED modules positioned on one side of a body of the measurement subject (Fig. 2, elements 122a-n, para. [0068-0069]), using a light detection unit positioned corresponding to the first to third LED modules to detect first to third derived lights derived from the first to third lights by passing through the measurement subject (Fig. 2, element 130a-n, para. [0070-0072]), generating a second ratio equation, respectively, for second derived light sets composed of two of the first to third derived lights (para. [0077-0089]), and calculating concentrations of arterial blood oxygen saturation (SpO2) of the measurement subject (para. [0077-0089], para. [0108], para. [0117]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify method disclosed by Ting to additionally include a third LED module, detected a third derived light from the third light, generate a second ratio equation, and calculation both a concentration of more than one substance, as taught by Newberry. This is because Newberry teaches multiple wavelengths can be used in combination with ratio equations to determine more than one substance within blood in a short measurement period (para. [0117-0118]).
Regarding claim 2, modified Ting discloses the method of claim 1, wherein the light detection unit is positioned at an opposite side or on the same side surface relative to positions of the first to third LED modules (Fig. 2, element 14, element 16, element 18, para. [0034-0035]).
Regarding claim 3, modified Ting discloses the method of claim 1, wherein one side of the body of the measurement subject comprises a site where capillaries existing under the skin are able to be sensed, depending on a thickness of the skin (Fig. 2, element 12, para. [0035], “desired part of the subject … a finger”).
Regarding claims 4 and 9, modified Ting discloses the method of claim 1.
However, modified Ting does not explicitly disclose wherein the generation comprises generating the first and second ratio equations using Photon-Diffusion Theory or Beer-Lambert Law (claim 4), wherein the generation comprises applying attribute ratios regarding each derived light of each of the first and second derived light sets and the first to third derived lights measured by the light detection unit to the Beer-Lambert Law to generate the first and second ratio equations (claim 9).
Newberry further teaches generating ratio equations using Beer-Lambert Law and applying attribute ratios regarding each derived light of each of the first and second derived light sets and the first to third derived lights measured by the light detection unit to the Beer-Lambert Law to generate the first and second ratio equations (para. [0012], para. [0078-0090], para. [0108], para. [0117], para. [0122-0131]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the generation to comprise generating the first and second ratio equations using Beer-Lambert Law, as taught by Newberry. This is because Newberry teaches Beer-Lambert law is a well-known method of obtaining various levels of substances in the blood (para. [0078]).
Regarding claim 10, modified Ting discloses the method of claim 9.
However, modified Ting does not explicitly disclose wherein the generation comprises: generating the first ratio equation representing a ratio of absorbance for each derived light of the first derived light set by applying the Beer-Lambert Law; and generating the second ratio equation representing a ratio of absorbance for each derived light of the second derived light set by applying the Beer-Lambert Law.
Newberry further teaches generating the first ratio equation representing a ratio of absorbance for each derived light of the first derived light set by applying the Beer-Lambert Law; and generating the second ratio equation representing a ratio of absorbance for each derived light of the second derived light set by applying the Beer-Lambert Law (para. [0012], para. [0078-0090], para. [0108], para. [0117-0118], para. [0122-0131]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to generate a ratio of absorbance of the first derived light set and the second derived light set by applying the Beer-Lambert Law, as taught by Newberry. This is because Newberry teaches Beer-Lambert law is a well-known method of obtaining various levels of substances in the blood (para. [0078]), allowing for multiple concentration measurements to be obtained within a short period (para. [0118]).
Regarding claim 11, modified Ting discloses the method of claim 10.
However, modified Ting does not explicitly disclose wherein the calculation comprises applying the first to third derived lights measured by the light detection unit to the first and second ratio equations to compute the concentrations of the glycated hemoglobin (HbA1c) and the arterial blood oxygen saturation (SpO2) of the measurement subject.
Newberry further teaches applying the first to third derived lights measured by the light detection unit to the first and second ratio equations to compute the concentrations of the glycated hemoglobin (HbA1c) and the arterial blood oxygen saturation (SpO2) of the measurement subject (para. [0012], para. [0078-0090], para. [0108], para. [0117-0118], para. [0122-0131]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to additionally applying the first to third derived lights measured by the light detection unit to the first and second ratio equations to compute the concentrations of the glycated hemoglobin, as taught by Newberry. This is because Newberry teaches Beer-Lambert law is a well-known method of obtaining various levels of substances in the blood (para. [0078]), allowing for multiple concentration measurements to be obtained within a short period (para. [0118]).
Regarding claim 12, modified Ting discloses the method of claim 11.
However, modified Ting does not explicitly disclose wherein the calculation comprises: generating first and second conversion formulas by applying the glycated hemoglobin (HbA1c) and the arterial blood oxygen saturation (SpO2) as unknown to each of the first and second ratio equations; applying a molar extinction coefficient when applying first to third wavelengths to each of the first and second conversion formulas; and combining the first and second conversion formulas to convert the concentrations of the glycated hemoglobin (HbA1c) and the arterial blood oxygen saturation (SpO2) into each functional formula regarding the first and second ratio equations.
Newberry further teaches generating first and second conversion formulas by applying the substances as unknown to each of the first and second ratio equations; applying a molar extinction coefficient when applying first to third wavelengths to each of the first and second conversion formulas; and combining the first and second conversion formulas to convert the concentrations of the substances into each functional formula regarding the first and second ratio equations (para. [0012], para. [0078-0089], para. [0101-0118], para. [0203]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to additionally generate the first and second conversion formulas by applying the substances as unknown to each of the first and second ratio equations; applying a molar extinction coefficient when applying first to third wavelengths to each of the first and second conversion formulas; and combining the first and second conversion formulas to convert the concentrations of the substances into each functional formula regarding the first and second ratio equations, as taught by Newberry. This is because Newberry teaches using extinction coefficients in combination with the Beer-Lambert Law allows for obtaining various levels of substances in the blood (para. [0078]), allowing for multiple concentration measurements to be obtained within a short period (para. [0118]).
Regarding claim 13, Ting discloses a system for non-invasive measurement of glycated hemoglobin (Abstract, “apparatus … for predicting a parameter in the blood stream … HbA1c …”, Fig. 2, para. [0010]), the system comprising:
first to second LED modules positioned on one side of the body of a measurement subject and respectively irradiating the measurement subject with first to second lights having different wavelength values (Fig. 2, element 12, element 14, para. [0033-0037], “laser diode source comprises two laser diodes … produce infra-red radiation of a specific wavelength …”, para. [0057]);
a light detection unit positioned corresponding to the first to second LED modules to detect first to second derived lights derived from the first to second lights by passing through the measurement subject (Fig. 2, element 12, element 16, element 18, element 22, element 24, para. [0033-037], “optical receiver … first optical receiver is arranged to receive incident light of the two different wavelengths … second optical receiver is arranged to receive transmitted or diffuse reflected light of the two different wavelengths when a finger of a subject is present …”, para. [0057]); and
a computation unit that generates first ratio equations, respectively, for first derived light sets composed of two of the first to second derived lights and calculates concentrations of glycated hemoglobin (HbA1c) (Fig. 2, element 20, para. [0018-0019], “parameter to be predicted is the level of glycated hemoglobin (HbA1c), para. [0047-0057]).
However, Ting does not explicitly disclose a third LED module respectively irradiating the measurement subject with a third light having a different wavelength, the light detection unit positioned corresponding to the third LED module to detect a third derived light from the third light; and generating a second ratio equation, respectively, for second derived light sets composed of two of the first to third derived lights and calculates concentrations of arterial blood oxygen saturation (SpO2) of the measurement subject by combining the first and second ratio equations.
Newberry teaches an analogous system for non-invasive measurement of blood parameters (Abstract, para. [0057-0058]). Newberry further teaches irradiating a measurement subject with first to third lights have different wavelength values by means of first to third LED modules positioned on one side of a body of the measurement subject (Fig. 2, elements 122a-n, para. [0068-0069]), using a light detection unit positioned corresponding to the first to third LED modules to detect first to third derived lights derived from the first to third lights by passing through the measurement subject (Fig. 2, element 130a-n, para. [0070-0072]), generating a second ratio equation, respectively, for second derived light sets composed of two of the first to third derived lights (para. [0077-0089]), and calculating concentrations of arterial blood oxygen saturation (SpO2) of the measurement subject (para. [0077-0089], para. [0108], para. [0117]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify system disclosed by Ting to additionally include a third LED module, detected a third derived light from the third light, generate a second ratio equation, and calculation both a concentration of more than one substance, as taught by Newberry. This is because Newberry teaches multiple wavelengths can be used in combination with ratio equations to determine more than one substance within blood in a short measurement period (para. [0117-0118]).
Regarding claim 14, modified Ting discloses the system of claim 13, wherein the light detection unit is positioned at an opposite side or on the same side surface relative to positions of the first to third LED modules (Fig. 2, element 14, element 16, element 18, para. [0034-0035]).
Regarding claim 15, modified Ting discloses the system of claim 13, wherein one side of the body of the measurement subject comprises a site where capillaries existing under the skin are able to be sensed, depending on a thickness of the skin (Fig. 2, element 12, para. [0035], “desired part of the subject … a finger”).
Regarding claim 16, modified Ting discloses the system of claim 14.
However, modified Ting does not explicitly disclose wherein the computation unit generates the first and second ratio equations using Photon-Diffusion Theory or Beer-Lambert Law.
Newberry further teaches generating ratio equations using Beer-Lambert Law (para. [0012], para. [0078-0090], para. [0108], para. [0117], para. [0122-0131]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the generation to comprise generating the first and second ratio equations using Beer-Lambert Law, as taught by Newberry. This is because Newberry teaches Beer-Lambert law is a well-known method of obtaining various levels of substances in the blood (para. [0078]).
Regarding claim 18, modified Ting discloses the system of claim 16,
However, modified Ting does not explicitly disclose wherein the computation unit calculates the concentration of the glycated hemoglobin using the Beer-Lambert Law and using absorbance when the light detection unit is positioned at the opposite side.
Newberry further teaches using Beer-Lambert Law to calculate concentrations of blood substances and using absorbance when the light detection unit is positioned at the opposite side (para. [0012], para. [0072], para. [0078-0090], para. [0108], para. [0117], para. [0122-0131]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by modified Ting to additionally use Beer-Lambert Law to calculate concentrations of blood substances and using absorbance when the light detection unit is positioned at the opposite side, as taught by Newberry. This is because Newberry teaches Beer-Lambert law is a well-known method of obtaining various levels of substances in the blood (para. [0078]), allowing for multiple concentration measurements to be obtained within a short period (para. [0118]), and transmissive absorption techniques or reflection techniques are known substitutions depending on the location of the photodetectors and/or the body part being measured (para. [0072]).
Claims 4-8 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ting et al. (US 20130178724 A1), hereinafter referred to as Ting, in view of Robert Newberry (US 20170215793 A1), hereinafter referred to as Newberry as applied to claim 1 and claim 14 above, and further in view of Heanue et al. (US 20120130257 A1), hereinafter referred to as Heanue.
Regarding claim 4, modified Ting discloses the method of claim 1.
However, modified Ting does not explicitly disclose wherein the generation comprises generating the first and second ratio equations using Photon-Diffusion Theory or Beer-Lambert Law.
Heanue teaches an analogous method for optical detection (Abstract, para. [0002], para. [0066], para. [0073]). Heanue further teaches light attenuation can be described either through Beer-Lambert Law (para. [0067]) or Photon-Diffusion Theory (para. [0071], [0088], [0127]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to explicitly use Photon-Diffusion Theory, as taught by Heanue. This is because Heanue teaches Photon-Diffusion Theory allows for the depth of a tissue to be accounted for when performing optical measurements (para. [0127]).
Regarding claim 5, modified Ting discloses the method of claim 4.
However, modified Ting does not explicitly disclose wherein the generation comprises generating an attribute equation for each wavelength of the first to third derived lights according to the Photon-Diffusion Theory, and generating the first and second ratio equations using the attribute equation for each derived light of the first and second derived light sets.
Heanue further teaches generating an attribute equation for each wavelength of the first to third derived lights according to the Photon-Diffusion Theory, and generating the first and second ratio equations using the attribute equation for each derived light of the first and second derived light sets (para. [0071], [0088], [0127]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to additionally generate an attribute equation for each wavelength of the first to third derived lights according to the Photon-Diffusion Theory, and generating the first and second ratio equations using the attribute equation for each derived light of the first and second derived light sets, as taught by Heanue. This is because Heanue teaches attribute equations according to the Photon-Diffusion Theory allows for the depth of a tissue to be accounted for when performing optical measurements (para. [0127]).
Regarding claim 6, modified Ting discloses the method of claim 5.
However, modified Ting does not explicitly disclose wherein the generation comprises generating an equation for transmittance or reflectance including a total absorption coefficient and a scattering coefficient for each wavelength of the first to third derived lights as the attribute equation.
Heanue further teaches generating an equation for transmittance or reflectance including a total absorption coefficient and a scattering coefficient for each wavelength of the first to third derived lights as the attribute equation (para. [0127]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to additionally generate an equation for transmittance or reflectance including a total absorption coefficient and a scattering coefficient for each wavelength of the first to third derived lights as the attribute equation, as taught by Heanue. This is because absorption coefficients and scattering coefficients allows for the depth of a tissue to be accounted for when performing optical measurements (para. [0127]).
Regarding claim 7, modified Ting discloses the method of claim 6.
However, modified Ting does not explicitly disclose wherein the generation comprises: applying the total absorption coefficient and scattering coefficient to geometry to express the transmittance or reflectance of each of the first to third derived lights using a mathematical equation; generating a ratio for the transmittance or reflectance for each derived light of the first derived light set using the first ratio equation; and generating a ratio for the transmittance or reflectance for each derived light of the second derived light set using the second ratio equation.
Heanue further teaches applying the total absorption coefficient and scattering coefficient to geometry to express the transmittance or reflectance of each of the first to third derived lights using a mathematical equation; generating a ratio for the transmittance or reflectance for each derived light of the first derived light set using the first ratio equation; and generating a ratio for the transmittance or reflectance for each derived light of the second derived light set using the second ratio equation (para. [0071], [0088], [0127]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to additionally apply the total absorption coefficient and scattering coefficient to geometry to express the transmittance or reflectance of each of the first to third derived lights using a mathematical equation; generating a ratio for the transmittance or reflectance for each derived light of the first derived light set using the first ratio equation; and generating a ratio for the transmittance or reflectance for each derived light of the second derived light set using the second ratio equation, as taught by Heanue. This is because Heanue teaches applying absorption coefficients and scattering coefficients allows for the depth of a tissue to be accounted for when performing optical measurements (para. [0127]).
However, modified Ting does not explicitly disclose spherical geometry.
Newberry further teaches absorption coefficients or adjustments can be made based on determined positions and/or determined characteristics of the underlying tissue (para. [0167]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the coefficients to spherical geometry, as taught by Newberry. This is because Newberry teaches adjustments can be made based on positions and/or underlying tissue to obtain more accurate results (para. [0167]).
Regarding claim 8, modified Ting discloses the method of claim 5.
However, modified Ting does not explicitly disclose wherein the calculation comprises: generating first and second conversion formulas by applying the glycated hemoglobin (HbA1c) and the arterial blood oxygen saturation (SpO2) as unknown to each of the first and second ratio equations; applying coefficient values acquired corresponding to first to third wavelength ranges to each of the first and second conversion formulas; and combining the first and second conversion formulas to convert the concentrations of the glycated hemoglobin (HbA1c) and the arterial blood oxygen saturation (SpO2) into each functional formula regarding the first and second ratio equations.
Newberry further teaches generating first and second conversion formulas by applying the substances as unknown to each of the first and second ratio equations; applying coefficient values acquired corresponding to first to third wavelength ranges to each of the first and second conversion formulas; and combining the first and second conversion formulas to convert the concentrations of the substances into each functional formula regarding the first and second ratio equations (para. [0012], para. [0078-0089], para. [0101-0118], para. [0203]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to additionally generate the first and second conversion formulas by applying the substances as unknown to each of the first and second ratio equations; applying coefficient values acquired corresponding to first to third wavelength ranges to each of the first and second conversion formulas; and combining the first and second conversion formulas to convert the concentrations of the substances into each functional formula regarding the first and second ratio equations, as taught by Newberry. This is because Newberry teaches using coefficients allows for obtaining various levels of substances in the blood (para. [0078]), allowing for multiple concentration measurements to be obtained within a short period (para. [0118]).
Regarding claim 16, modified Ting discloses the system of claim 14.
However, modified Ting does not explicitly disclose wherein the computation unit generates the first and second ratio equations using Photon-Diffusion Theory or Beer-Lambert Law.
Heanue teaches an analogous system for optical detection (Abstract, para. [0002], para. [0066], para. [0073]). Heanue further teaches light attenuation can be described either through Beer-Lambert Law (para. [0067]) or Photon-Diffusion Theory (para. [0071], [0088], [0127]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system to explicitly use Photon-Diffusion Theory, as taught by Heanue. This is because Heanue teaches Photon-Diffusion Theory allows for the depth of a tissue to be accounted for when performing optical measurements (para. [0127]).
Regarding claim 17, modified Ting discloses the system of claim 16.
However, modified Ting does not explicitly disclose when using the Photon-Diffusion Theory, the computation unit calculates the concentration of the glycated hemoglobin using transmittance when the light detection unit is positioned at the opposite side, and calculates the concentration of the glycated hemoglobin using reflectance when the light detection unit is positioned on the same side surface.
Newberry further teaches using transmittance or reflectance (para. [0072]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by modified Ting to additionally use transmittance or reflectance, as taught by Newberry. This is because Newberry teaches transmissive absorption techniques or reflection techniques are known substitutions depending on the location of the photodetectors and/or the body part being measured (para. [0072]).
Conclusion
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791