CTNF 18/419,785 CTNF 101892 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-30-03-h AIA Claim Interpretation 07-30-03 AIA 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. 07-30-05 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: “the apparatus to: A) radiate first emission light of a first wavelength and second emission light of a second wavelength toward an object to be measured; B) receive first reflected light of the first wavelength and second reflected light of the second wavelength reflected from the object to be measured; C) detect first light absorbance for the first reflected light and second light absorbance for the second reflected light; and D) determine oxygen saturation of the object to be measured based on a difference between the first light absorbance and the second light absorbance.” in claim 1; “The apparatus to radiate first emission light of a first wavelength and second emission light of a second wavelength toward an object to be measured”; The “apparatus” is a generic placeholder and a non-structural term that does not impose any specific structural limitation and is modified by functional language (“to radiate first emission light of a first wavelength and second emission light of a second wavelength toward an object to be measured”). The claim element is not further modified by sufficient structure, material, act for performing the claimed function. Accordingly, limitation A invokes 35 U.S.C 112(f). The specification discloses adequate structure, (Paragraph, 0034: “the first light source 111 and the second light source 112 may each be used as light emitting diodes that generate emission light of different wavelengths”) for performing the claimed function. which constitutes corresponding structure for performing the recited function. Therefore, corresponding structure is disclosed in the specification. “The apparatus to receive first reflected light of the first wavelength and second reflected light of the second wavelength reflected from the object to be measured”; The “apparatus” is a generic placeholder and a non-structural term that does not impose any specific structural limitation and is modified by functional language (“apparatus to receive first reflected light of the first wavelength and second reflected light of the second wavelength reflected from the object to be measured”). The claim element is not further modified by sufficient structure, material, act for performing the claimed function. Accordingly, limitation B invokes 35 U.S.C 112(f). The specification discloses adequate structure, (Paragraph, 0037: “The reflected light reception portion 120 includes a first light reception portion 121 and a second light reception portion 122. A Complementary Metal-Oxide Semiconductor (CMOS) image sensor may be used as the first light reception portion 121 and the second light reception portion 122, respectively.”) for performing the claimed function. which constitutes corresponding structure for performing the recited function. Therefore, corresponding structure is disclosed in the specification. “The apparatus to detect first light absorbance for the first reflected light and second light absorbance for the second reflected light”; The “apparatus” is a generic placeholder and a non-structural term that does not impose any specific structural limitation and is modified by functional language (“to detect first light absorbance for the first reflected light and second light absorbance for the second reflected light”). The claim element is not further modified by sufficient structure, material, act for performing the claimed function. Accordingly, limitation C invokes 35 U.S.C 112(f). The specification fails to provide adequate structure for performing the claimed function. See further rejection in 112(b) rejection section. 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. 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 07-30-02 AIA 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. [7.30.02] 07-34-01 Claim 1-8 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. In claim 1: The Claim limitation of “The apparatus to:… detect first light absorbance for the first reflected light and second light absorbance for the second reflected light” 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. 07-34-23 The claim limitation is not further modified by sufficient structure, material, act for performing the claimed function. Accordingly, although the limitation invokes 35 U.S.C 112(f), The specification fails to disclose corresponding structure, material or acts that are clearly linked or associated with the function of “to detect first light absorbance for the first reflected light and second light absorbance for the second reflected light”. 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. [7.34.23] Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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. Step 2A, Prong One: Regarding claim 1-16, the recited steps are directed to mental process and mathematical calculation, i.e., concepts that can be performed in a human mind (see MPEP 2106.04(a)(2) subsection (III)). The courts have found that concepts performed in a human mind falls within the judicial exceptions, often labelled as “abstract ideas”. Specifically, the following limitations recite mental process and/or mathematical concepts; Regarding claim 1 and 9, the limitations of “ determine oxygen saturation of the object to be measured based on a difference between the first light absorbance and the second light absorbance .”, Regarding claim 2 and 10, the limitations of “ determine a pulse rate of the object to be measured from a time interval of a change in the first light absorbance. ”, Regarding claim 4 and 12, the limitations of “to determine the oxygen saturation using a first statistical index of the first light absorbance and a second statistical index of the second light absorbance .” and “ the oxygen saturation is determined using a first statistical index of the first light absorbance and a second statistical index of the second light absorbance .” (mathematical or calculation), Regarding claim 5 and 13, the limitations of “ to determine the oxygen saturation based on a ratio between the first statistical index and the second statistical index .” and “the oxygen saturation is determined based on a ratio between the first statistical index and the second statistical index .” (mathematical or calculation), Regarding 6 and 14, the limitations of “ a first value obtained by dividing a standard deviation of a plurality of the first light absorbances by the average of the first light absorbance ;” and “ dividing a standard deviation of a plurality of the second light absorbances by the average of the second light absorbance .” (mathematical or calculation), and Regarding claim 7 and 15, the limitations of “ determined by an equation below: K1 - K2*[a1/a2], where K1 and K2 are constants, a1 is the first value, and a2 is the second value.” and “determined by an equation below: K1 - K2*[a1/a2], where K1 and K2 are constants, a1 is the first value, and a2 is the second value .” (mathematical or calculation). Regarding claim 8 and 16, the limitations of “the first wavelength is 660 nm and the second wavelength is 940 nm.” (further extra-solutionary data gathering and conventional wavelengths) and “the K1 is 110 and the K2 is 25.” (mathematical) Furthermore, the “determine” step reasonably encompasses a user manually calculating and combining those oxygen saturation values mentally or using pen and paper. Step 2A, Prong Two: The claims, including dependent claims, are analyzed as a whole to determine whether additional limitations are recited such that the claims amount to significantly more than the abstract idea. Regarding claim 1, the additional limitation of “one or more processors and “memory storing instructions that, when executed by the one or more processors” amount to mere instructions to implement the abstract idea on generic computer components. The additional limitations of “radiate first emission light of a first wavelength and second emission light of a second wavelength toward an object to be measured; receive first reflected light of the first wavelength and second reflected light of the second wavelength reflected from the object to be measured; detect first light absorbance for the first reflected light and second light absorbance for the second reflected light;” are mere insignificant extra-solution activity of data gathering. Regarding claim 2-5, the “one or more processors”, the additional limitation, amount to generic computer implementation and mere insignificant extra-solution activity similar to claim 1. Regarding claim 3, “detect the first light absorbance and the second light absorbance over time” amounts to mere insignificant extra-solution activity. Regarding claim 11, “the first light absorbance and the second light absorbance are each detected over time” amounts to mere insignificant extra-solution activity. Note: regarding the underlined limitations (aforementioned in Step 2A, Prong One), the applicant’s specification does not sufficiently describe a concrete technological improvement attributable to the claimed “determining oxygen saturation”. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception. Regarding Claim 1-16, the judicial exception is not integrated into a practical application. Step 2B: The claim 1-16 do not include additional elements that are sufficient to amount significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements, including “one or more processor” and “memory” are recited at a high level of generality and are used for extra-solution activity, such as data gathering necessary to perform the abstract idea as well as part of generic computer equipment used to perform extra-solution data delivery computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)). Therefore, these elements do not provide an inventive concept sufficient to transform the claimed abstract idea into patent eligible subject matter. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. (FP 7.08.aia) 07-15 AIA Claim s 1-3, and 8-11 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by “Newberry” (US 20210137464 A1) . Regarding claim 1, Newberry teaches an apparatus (a device) (Paragraph, 0022: “a device includes one or more processing circuits configured to receive a plurality of photoplethysmography (PPG) signals”) comprising: one or more processors; and memory storing instructions that, when executed by the one or more processors, cause the apparatus to: (Paragraph, 0059: “The biosensor 100 may include one or more processing circuits 102 communicatively coupled to a memory device 104”) radiate first emission light of a first wavelength and second emission light of a second wavelength toward an object to be measured; receive first reflected light of the first wavelength and second reflected light of the second wavelength reflected from the object to be measured; detect first light absorbance for the first reflected light and second light absorbance for the second reflected light; (Paragraph, 0023: “a first PPG signal is obtained from light at a first wavelength reflected from or transmitted through skin tissue of a patient and a second PPG signal is obtained from light at a second wavelength reflected from or transmitted through skin tissue of the patient,”, and Paragraph, 0017: “Pulse oximeters detect oxygen saturation of hemoglobin by using, e.g., spectrophotometry to determine spectral absorbencies”, and Paragraph, 0084: “The biosensor 100 detects the light (reflected from the skin or transmitted through the skin)”) and determine oxygen saturation of the object to be measured based on a difference between the first light absorbance and the second light absorbance. (Paragraph, 0017: “Pulse oximeters detect oxygen saturation of hemoglobin by using, e.g., spectrophotometry to determine spectral absorbencies and determining concentration levels of oxygen based on Beer-Lambert law principles.”, and Paragraph, 0017, “The pulse oximeter filters the absorbance of the pulsatile fraction of the blood, i.e. that due to arterial blood (AC components), from the constant absorbance by nonpulsatile venous or capillary blood and other tissue pigments (DC components), to eliminate the effect of tissue absorbance to measure the oxygen saturation of arterial blood. Such PPG techniques are heretofore been limited to determining oxygen saturation.”) Regarding claim 2, Newberry teaches the apparatus of claim 1 (See rejection of claim 1 above), Newberry teaches wherein the instructions, when executed by the one or more processors, cause the apparatus to determine a pulse rate of the object to be measured from a time interval of a change in the first light absorbance. (Paragraph, 0095: “The spectral responses are obtained around the plurality of wavelengths, including at least a first wavelength and a second wavelength at 502. The spectral responses may be measured over a predetermined period (such as 300 usec.) or at least over 2-3 cardiac cycles. This measurement process is repeated continuously, e.g., pulsing the light at 10-100 Hz and obtaining spectral responses over a desired measurement period, e.g. from 1-2 seconds to 1-2 minutes or from 2-3 hours to continuously over days or weeks.”, and Paragraph, 0207: “To estimate the pulse rate , the frequency spectrum of the PPG signal is obtained using a FFT algorithm over a predetermined period (hamming window). The pulse rate is estimated as the frequency that corresponds to the highest power in the estimated frequency spectrum. The frequency spectrum may be averaged or added over 5-10 second windows.”) Regarding claim 3, Newberry teaches the apparatus of claim 1 (See rejection of claim 1 above), Newberry teaches wherein the instructions, when executed by the one or more processors, cause the apparatus to detect the first light absorbance and the second light absorbance over time. (Paragraph, 0017: “The pulse oximeter filters the absorbance of the pulsatile fraction of the blood, i.e. that due to arterial blood (AC components), from the constant absorbance by nonpulsatile venous or capillary blood and other tissue pigments (DC components), to eliminate the effect of tissue absorbance to measure the oxygen saturation of arterial blood. Such PPG techniques are heretofore been limited to determining oxygen saturation.”) Regarding claim 8, Newberry teaches the apparatus of claim 1 (See rejection of claim 1 above), Newberry teaches wherein the first wavelength is 660 nm and the second wavelength is 940 nm. (Paragraph, 0017: “The subject's skin at a ‘measurement location’ is illuminated with two distinct wavelengths of light and the relative absorbance at each of the wavelengths is determined. For example, a wavelength in the visible red spectrum (for example, at 660 nm) has an extinction coefficient of hemoglobin that exceeds the extinction coefficient of oxyhemoglobin. At a wavelength in the near infrared spectrum (for example, at 940 nm), the extinction coefficient of oxyhemoglobin exceeds the extinction coefficient of hemoglobin.”) Regarding claim 9, Newberry teaches a method (Paragraph, 0022: “a first PPG signal is obtained from light at a first wavelength reflected from or transmitted through skin tissue of a patient and a second PPG signal is obtained from light at a second wavelength reflected from or transmitted through skin tissue of the patient”) comprising: radiating first emission light of a first wavelength and second emission light of a second wavelength toward an object to be measured; receiving first reflected light of the first wavelength and second reflected light of the second wavelength reflected from the object to be measured; detecting first light absorbance for the first reflected light and second light absorbance for the second reflected light; (Paragraph, 0023: “a first PPG signal is obtained from light at a first wavelength reflected from or transmitted through skin tissue of a patient and a second PPG signal is obtained from light at a second wavelength reflected from or transmitted through skin tissue of the patient,”, and Paragraph, 0017: “Pulse oximeters detect oxygen saturation of hemoglobin by using, e.g., spectrophotometry to determine spectral absorbencies”, and Paragraph, 0084: “The biosensor 100 detects the light (reflected from the skin or transmitted through the skin)”) and determining oxygen saturation of the object to be measured according to a difference between the first light absorbance and the second light absorbance. (Paragraph, 0017: “Pulse oximeters detect oxygen saturation of hemoglobin by using, e.g., spectrophotometry to determine spectral absorbencies and determining concentration levels of oxygen based on Beer-Lambert law principles.”, and Paragraph, 0017, “The pulse oximeter filters the absorbance of the pulsatile fraction of the blood, i.e. that due to arterial blood (AC components), from the constant absorbance by nonpulsatile venous or capillary blood and other tissue pigments (DC components), to eliminate the effect of tissue absorbance to measure the oxygen saturation of arterial blood. Such PPG techniques are heretofore been limited to determining oxygen saturation.”) Regarding claim 10, Newberry teaches the method of claim 9 (See rejection of claim 9 above), Newberry teaches further comprising determining a pulse rate of the object to be measured from a time interval of a change in the first light absorbance. (Paragraph, 0095: “The spectral responses are obtained around the plurality of wavelengths, including at least a first wavelength and a second wavelength at 502. The spectral responses may be measured over a predetermined period (such as 300 usec.) or at least over 2-3 cardiac cycles. This measurement process is repeated continuously, e.g., pulsing the light at 10-100 Hz and obtaining spectral responses over a desired measurement period, e.g. from 1-2 seconds to 1-2 minutes or from 2-3 hours to continuously over days or weeks.”, and Paragraph, 0207: “To estimate the pulse rate , the frequency spectrum of the PPG signal is obtained using a FFT algorithm over a predetermined period (hamming window). The pulse rate is estimated as the frequency that corresponds to the highest power in the estimated frequency spectrum. The frequency spectrum may be averaged or added over 5-10 second windows.”). Regarding claim 11, Newberry teaches the method of claim 9 (See rejection of claim 9 above), Newberry teaches wherein the first light absorbance and the second light absorbance are each detected over time. (Paragraph, 0017: “The pulse oximeter filters the absorbance of the pulsatile fraction of the blood, i.e. that due to arterial blood (AC components), from the constant absorbance by nonpulsatile venous or capillary blood and other tissue pigments (DC components), to eliminate the effect of tissue absorbance to measure the oxygen saturation of arterial blood. Such PPG techniques are heretofore been limited to determining oxygen saturation.”) Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim 4-7 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Newberry in view of DE HAAN (US 20150366492 A1) . Regarding claim 4, Newberry teaches the apparatus of claim 3(See rejection of claim 3 above), Newberry teaches wherein the instructions, when executed by the one or more processors, cause the apparatus to determine the oxygen saturation (Abstract: “A neural network processing device generates an input vector including the PPG input data and determines an output vector including health data, wherein the health data includes for example, an oxygen saturation level, a heart rate, or indication of a septic condition.”). However, Newberry does not teach using a first statistical index of the first light absorbance and a second statistical index of the second light absorbance. DE HAAN teaches using a first statistical index of the first light absorbance and a second statistical index of the second light absorbance (Equation 1 and Paragraph, 0043: “Particularly the ratio of the estimated AC amplitudes in the two difference signals is used, e.g. the ratio of the standard deviation (or a more robust amplitude estimate, like a median of peak-minus-valley-values, or yet another estimate) of the difference signals. For reducing the influence of motion said processing unit is configured to normalize said PPG signals, in particular by (individually) dividing the PPG signals by their respective temporal means (DC), before forming said difference signals.”, and Paragraph, 0002: “The present invention relates to a device, system and method for determining the concentration of a substance, such as the concentration of oxygen (oxygen saturation, SpO2), bilirubin, CO2, etc., in the blood of a subject, such as a person or animal.”) S p O 2 = C 1 - C 2 R I R Equation (1) With R = A C R e d D C R e d a n d I R = A C I R D C I R It would have been obvious to a person of ordinary skill in the art to modify Newberry with DE HAAN because Standard deviation and mean characterize signal fluctuation and baseline magnitude analogue to AC and DC components. Further, such an equation could measure without the effect of specular reflectance by correctly estimating the difference signals (Paragraph, 0073). Regarding claim 5, Newberry in view of DE HAAN teaches the apparatus of claim 4 (See rejection of claim 4 above), Newberry teach wherein the instructions, when executed by the one or more processors, cause the apparatus to determine the oxygen saturation (Paragraph, “Abstract: A neural network processing device generates an input vector including the PPG input data and determines an output vector including health data, wherein the health data includes for example, an oxygen saturation level, a heart rate, or indication of a septic condition.”). Newberry is silent on based on a ratio between the first statistical index and the second statistical index. DE HAAN teaches wherein the instructions, when executed by the one or more processors, cause the apparatus to determine the oxygen saturation based on a ratio between the first statistical index and the second statistical index. (Equation 1 and Paragraph, 0043: “Particularly the ratio of the estimated AC amplitudes in the two difference signals is used, e.g. the ratio of the standard deviation (or a more robust amplitude estimate, like a median of peak-minus-valley-values, or yet another estimate) of the difference signals. (0029) For reducing the influence of motion said processing unit is configured to normalize said PPG signals, in particular by (individually) dividing the PPG signals by their respective temporal means (DC), before forming said difference signals.”, and Paragraph, 0002: “The present invention relates to a device, system and method for determining the concentration of a substance, such as the concentration of oxygen (oxygen saturation, SpO2), bilirubin, CO2, etc., in the blood of a subject, such as a person or animal.”) S p O 2 = C 1 - C 2 R I R Equation (1) With R = A C R e d D C R e d a n d I R = A C I R D C I R It would have been obvious to a person of ordinary skill in the art to modify Newberry with DE HAAN because Standard deviation and mean characterize signal fluctuation and baseline magnitude analogue to AC and DC components. Further, such an equation could measure without the effect of specular reflectance by correctly estimating the difference signals (Paragraph, 0073). Regarding claim 6, Newberry in view of DE HAAN teaches the apparatus of claim 5 (See rejection of claim 5 above), Newberry does not teach wherein: the first statistical index is a first value obtained by dividing a standard deviation of a plurality of the first light absorbances by the average of the first light absorbance; and the second statistical index is a second value obtained by dividing a standard deviation of a plurality of the second light absorbances by the average of the second light absorbance. DE HAAN teaches teach wherein: the first statistical index is a first value obtained by dividing a standard deviation of a plurality of the first light absorbances by the average of the first light absorbance; and the second statistical index is a second value obtained by dividing a standard deviation of a plurality of the second light absorbances by the average of the second light absorbance. (Equation 1 and Paragraph, 0043: “Particularly the ratio of the estimated AC amplitudes in the two difference signals is used, e.g. the ratio of the standard deviation (or a more robust amplitude estimate, like a median of peak-minus-valley-values, or yet another estimate) of the difference signals. (0029) For reducing the influence of motion said processing unit is configured to normalize said PPG signals, in particular by (individually) dividing the PPG signals by their respective temporal means (DC), before forming said difference signals.”, and Paragraph, 0002: “The present invention relates to a device, system and method for determining the concentration of a substance, such as the concentration of oxygen (oxygen saturation, SpO2), bilirubin, CO2, etc., in the blood of a subject, such as a person or animal.”) S p O 2 = C 1 - C 2 R I R Equation (1) With R = A C R e d D C R e d a n d I R = A C I R D C I R It would have been obvious to a person of ordinary skill in the art to modify Newberry with DE HAAN because Standard deviation and mean characterize signal fluctuation and baseline magnitude analogue to AC and DC components. Further, such an equation could measure without the effect of specular reflectance by correctly estimating the difference signals (Paragraph, 0073). Regarding claim 7, Newberry in view of DE HAAN teaches the apparatus of claim 6 (See rejection of claim 6 above), Newberry does not teach wherein the oxygen saturation is determined by an equation below: K1 - K2*[a1/a2], where K1 and K2 are constants, a1 is the first value, and a2 is the second value. DE HAAN teach wherein the oxygen saturation is determined by an equation below: K1 - K2*[a1/a2], where K1 and K2 are constants, a1 is the first value, and a2 is the second value. (Equation 1 and Paragraph, 0043: “Particularly the ratio of the estimated AC amplitudes in the two difference signals is used, e.g. the ratio of the standard deviation (or a more robust amplitude estimate, like a median of peak-minus-valley-values, or yet another estimate) of the difference signals. (0029) For reducing the influence of motion said processing unit is configured to normalize said PPG signals, in particular by (individually) dividing the PPG signals by their respective temporal means (DC), before forming said difference signals.”, and Paragraph, 0002: “The present invention relates to a device, system and method for determining the concentration of a substance, such as the concentration of oxygen (oxygen saturation, SpO2), bilirubin, CO2, etc., in the blood of a subject, such as a person or animal.”) S p O 2 = C 1 - C 2 R I R Equation (1) With R = A C R e d D C R e d a n d I R = A C I R D C I R It would have been obvious to a person of ordinary skill in the art to modify Newberry with DE HAAN because Standard deviation and mean characterize signal fluctuation and baseline magnitude analogue to AC and DC components. Further, such an equation could measure without the effect of specular reflectance by correctly estimating the difference signals (Paragraph, 0073). Regarding claim 12, Newberry teaches the apparatus of claim 11(See rejection of claim 11 above), Newberry teaches teach wherein the oxygen saturation is determined (Abstract: “A neural network processing device generates an input vector including the PPG input data and determines an output vector including health data, wherein the health data includes for example, an oxygen saturation level, a heart rate, or indication of a septic condition.”). Newberry is silent on using a first statistical index of the first light absorbance and a second statistical index of the second light absorbance. DE HAAN teaches wherein the oxygen saturation is determined using a first statistical index of the first light absorbance and a second statistical index of the second light absorbance. (Equation 1 and Paragraph, 0043: “Particularly the ratio of the estimated AC amplitudes in the two difference signals is used, e.g. the ratio of the standard deviation (or a more robust amplitude estimate, like a median of peak-minus-valley-values, or yet another estimate) of the difference signals. (0029) For reducing the influence of motion said processing unit is configured to normalize said PPG signals, in particular by (individually) dividing the PPG signals by their respective temporal means (DC), before forming said difference signals.”, and Paragraph, 0002: “The present invention relates to a device, system and method for determining the concentration of a substance, such as the concentration of oxygen (oxygen saturation, SpO2), bilirubin, CO2, etc., in the blood of a subject, such as a person or animal.”) S p O 2 = C 1 - C 2 R I R Equation (1) With R = A C R e d D C R e d a n d I R = A C I R D C I R It would have been obvious to a person of ordinary skill in the art to modify Newberry with DE HAAN because Standard deviation and mean characterize signal fluctuation and baseline magnitude analogue to AC and DC components. Further, such an equation could measure without the effect of specular reflectance by correctly estimating the difference signals (Paragraph, 0073). Regarding claim 13, Newberry in view of DE HAAN teaches the apparatus of claim 12 (See rejection of claim 12 above), Newberry teaches wherein the oxygen saturation is determined (Abstract: “A neural network processing device generates an input vector including the PPG input data and determines an output vector including health data, wherein the health data includes for example, an oxygen saturation level, a heart rate, or indication of a septic condition.”). Newberry is silent on based on a ratio between the first statistical index and the second statistical index. DE HAAN teaches wherein the oxygen saturation is determined based on a ratio between the first statistical index and the second statistical index. (Equation 1 and Paragraph, 0043: “Particularly the ratio of the estimated AC amplitudes in the two difference signals is used, e.g. the ratio of the standard deviation (or a more robust amplitude estimate, like a median of peak-minus-valley-values, or yet another estimate) of the difference signals. (0029) For reducing the influence of motion said processing unit is configured to normalize said PPG signals, in particular by (individually) dividing the PPG signals by their respective temporal means (DC), before forming said difference signals.”, and Paragraph, 0002: “The present invention relates to a device, system and method for determining the concentration of a substance, such as the concentration of oxygen (oxygen saturation, SpO2), bilirubin, CO2, etc., in the blood of a subject, such as a person or animal.”) S p O 2 = C 1 - C 2 R I R Equation (1) With R = A C R e d D C R e d a n d I R = A C I R D C I R It would have been obvious to a person of ordinary skill in the art to modify Newberry with DE HAAN because Standard deviation and mean characterize signal fluctuation and baseline magnitude analogue to AC and DC components. Further, such an equation could measure without the effect of specular reflectance by correctly estimating the difference signals (Paragraph, 0073). Regarding claim 14, Newberry in view of DE HAAN teaches the apparatus of claim 13 (See rejection of claim 13 above), Newberry does not teach wherein: the first statistical index is a first value obtained by dividing a standard deviation of a plurality of the first light absorbances by the average of the first light absorbance; and the second statistical index is a second value obtained by dividing a standard deviation of a plurality of the second light absorbances by the average of the second light absorbance. DE HAAN teaches wherein: the first statistical index is a first value obtained by dividing a standard deviation of a plurality of the first light absorbances by the average of the first light absorbance; and the second statistical index is a second value obtained by dividing a standard deviation of a plurality of the second light absorbances by the average of the second light absorbance. (Equation 1 and Paragraph, 0043: “Particularly the ratio of the estimated AC amplitudes in the two difference signals is used, e.g. the ratio of the standard deviation (or a more robust amplitude estimate, like a median of peak-minus- valley-values, or yet another estimate) of the difference signals. (0029) For reducing the influence of motion said processing unit is configured to normalize said PPG signals, in particular by (individually) dividing the PPG signals by their respective temporal means (DC), before forming said difference signals.” and Paragraph, 0002: “The present invention relates to a device, system and method for determining the concentration of a substance, such as the concentration of oxygen (oxygen saturation, SpO2), bilirubin, CO2, etc., in the blood of a subject, such as a person or animal.”). S p O 2 = C 1 - C 2 R I R Equation (1) With R = A C R e d D C R e d a n d I R = A C I R D C I R It would have been obvious to a person of ordinary skill in the art to modify Newberry with DE HAAN because Standard deviation and mean characterize signal fluctuation and baseline magnitude analogue to AC and DC components. Further, such an equation could measure without the effect of specular reflectance by correctly estimating the difference signals (Paragraph, 0073). Regarding claim 15, Newberry in view of DE HAAN teaches the apparatus of claim 14 (See rejection of claim 14 above), Newberry does not teach wherein the oxygen saturation is determined by an equation below: K1 - K2*[a1/a2], where K1 and K2 are constants, a1 is the first value, and a2 is the second value. DE HANN teaches wherein the oxygen saturation is determined by an equation below: K1 - K2*[a1/a2], where K1 and K2 are constants, a1 is the first value, and a2 is the second value. (Equation 1 and Paragraph, 0043: “Particularly the ratio of the estimated AC amplitudes in the two difference signals is used, e.g. the ratio of the standard deviation (or a more robust amplitude estimate, like a median of peak-minus-valley-values, or yet another estimate) of the difference signals. (0029) For reducing the influence of motion said processing unit is configured to normalize said PPG signals, in particular by (individually) dividing the PPG signals by their respective temporal means (DC), before forming said difference signals.” and Paragraph, 0002: “The present invention relates to a device, system and method for determining the concentration of a substance, such as the concentration of oxygen (oxygen saturation, SpO2), bilirubin, CO2, etc., in the blood of a subject, such as a person or animal.”). S p O 2 = C 1 - C 2 R I R Equation (1) With R = A C R e d D C R e d a n d I R = A C I R D C I R It would have been obvious to a person of ordinary skill in the art to modify Newberry with DE HAAN because Standard deviation and mean characterize signal fluctuation and baseline magnitude analogue to AC and DC components. Further, such an equation could measure without the effect of specular reflectance by correctly estimating the difference signals (Paragraph, 0073). Regarding claim 16, Newberry in view of DE HAAN teaches the apparatus of claim 15 (See rejection of claim 15 above) Newberry does not teach wherein the K1 is 110 and the K2 is 25. DE HAAN teaches wherein the K1 is 123 and the K2 is 54. (Paragraph, 0060: “The constants C1 and C2 in the equation above are called the calibration parameters (or calibration constants)” and Paragraph, 0062: “The effect of specular reflectance can be shown with a simple computation as shown in the following table”: the table shows C1=123, C2=54”. It would have been obvious to a person of ordinary skill in the art to modify Newberry and DE HAAN to have K1 be 110 and K2 be 25 because the constants are calibration parameters and the applicant does not limit the range (The applicant’s specification, Paragraph, 0068: “Herein, K 1 and K 2 are proportionality constants and may be set to 110 and 25, respectively, without being limited thereto”). There is no evidence of record that establishes that changing the constant would result in a functional difference in the oxygen saturation measurement of the claimed invention, and therefore there appears to be no critically associated with the values or evidence that the claimed such produce an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the constants of the equation to have C1=110 (corresponding to K1) and C2=25 (corresponding to K2) (Paragraph, 0060) as an obvious matter of design choice within the ordinary skill of the art. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MORGAN S SHIM whose telephone number is (571)272-9032. The examiner can normally be reached Mon-Fri 7:30AM-4:30PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert(Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MORGAN SANGJO SHIM/Examiner, Art Unit 3791 /PATRICK FERNANDES/Primary Examiner, Art Unit 3791 Application/Control Number: 18/419,785 Page 2 Art Unit: 3791 Application/Control Number: 18/419,785 Page 3 Art Unit: 3791 Application/Control Number: 18/419,785 Page 4 Art Unit: 3791 Application/Control Number: 18/419,785 Page 5 Art Unit: 3791 Application/Control Number: 18/419,785 Page 6 Art Unit: 3791 Application/Control Number: 18/419,785 Page 7 Art Unit: 3791 Application/Control Number: 18/419,785 Page 8 Art Unit: 3791 Application/Control Number: 18/419,785 Page 9 Art Unit: 3791 Application/Control Number: 18/419,785 Page 10 Art Unit: 3791 Application/Control Number: 18/419,785 Page 11 Art Unit: 3791 Application/Control Number: 18/419,785 Page 12 Art Unit: 3791 Application/Control Number: 18/419,785 Page 13 Art Unit: 3791 Application/Control Number: 18/419,785 Page 14 Art Unit: 3791 Application/Control Number: 18/419,785 Page 15 Art Unit: 3791 Application/Control Number: 18/419,785 Page 16 Art Unit: 3791 Application/Control Number: 18/419,785 Page 17 Art Unit: 3791 Application/Control Number: 18/419,785 Page 18 Art Unit: 3791 Application/Control Number: 18/419,785 Page 19 Art Unit: 3791 Application/Control Number: 18/419,785 Page 20 Art Unit: 3791 Application/Control Number: 18/419,785 Page 21 Art Unit: 3791 Application/Control Number: 18/419,785 Page 22 Art Unit: 3791 Application/Control Number: 18/419,785 Page 23 Art Unit: 3791
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