DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on June 22, 2026 were received and fully considered. Claims 1, 9, 17-20 were amended. Please see below for more detail.
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 1-20 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.
Regarding Claim 1, the claim(s) recites “a first calculation portion configured to obtain, based on the detection signal, a first parameter and a second parameter, the first parameter being a temporal relative change amount from a certain timing of a quantity based on a degree of absorption of oxygenated hemoglobin, the first parameter depending on a concentration of oxygenated hemoglobin in blood and a volume of a blood vessel in an optical path, the second parameter being a temporal relative change amount from a certain timing of a quantity based on a degree of absorption of deoxygenated hemoglobin, the second parameter depending on a concentration of deoxygenated hemoglobin in blood and the volume of the blood vessel in the optical path;”
“a second calculation portion configured to obtain, based on the first parameter and the second parameter, at least one parameter among a third parameter regarding a concentration of oxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded and a fourth parameter regarding a concentration of deoxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded;”
“a third calculation portion configured to obtain the data regarding the degree of metabolism based on the at least one parameter;”
“wherein the second calculation portion obtains the at least one parameter by using a predetermined formula in which a variable relating to a fluctuation component of the volume of the blood vessel in the optical path is eliminated based on a predetermined relationship among the first parameter, the second parameter, a steady component of the concentration of oxygenated hemoglobin in blood, a steady component of the concentration of deoxygenated hemoglobin in blood, and the fluctuation component of the volume of the blood vessel in the optical path." which amounts to an abstract idea (mental process and mathematical concepts).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“a light source configured to output measurement light to be input to the living body;”
“a light detector configured to detect the measurement light propagating through the living body and generate a detection signal according to an intensity of the measurement light;”
“a processor configured to output data regarding the degree of metabolism based on the detection signal,”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, light sources and light detectors are general field of use and processors are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of determining temporal relative change parameters, absolute concentration values, and a degree of metabolism from the input data of oxygenated hemoglobin and deoxygenated hemoglobin and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 2-8 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
Regarding Claim 9, the claim(s) recites “performing a first calculation of obtaining, based on the detection signal, a first parameter and a second parameter, the first parameter being a temporal relative change amount from a certain timing of a quantity based on a degree of absorption of oxygenated hemoglobin, the first parameter depending on a concentration of oxygenated hemoglobin in blood and a volume of a blood vessel in an optical path, the second parameter being a temporal relative change amount from a certain timing of a quantity based on a degree of absorption of deoxygenated hemoglobin, the second parameter depending on a concentration of deoxygenated hemoglobin in blood and the volume of the blood vessel in the optical path;”
“performing a second calculation of obtaining, based on the first parameter and the second parameter, at least one parameter among a third parameter regarding a concentration of oxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded and a fourth parameter regarding a concentration of deoxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded;”
“performing a third calculation of obtaining data regarding the degree of metabolism based on the at least one parameter”
“wherein, in the second calculation, the at least one parameter is obtained by using a predetermined formula in which a variable relating to a fluctuation component of the volume of the blood vessel in the optical path is eliminated based on a predetermined relationship among the first parameter, the second parameter, a steady component of the concentration of oxygenated hemoglobin in blood, a steady component of the concentration of deoxygenated hemoglobin in blood, and the fluctuation component of the volume of the blood vessel in the optical path." which amounts to an abstract idea (mental process and mathematical concepts).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, there are no additional limitations to consider.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of determining temporal relative change parameters, absolute concentration values, and a degree of metabolism from the input data of oxygenated hemoglobin and deoxygenated hemoglobin and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 10-16 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
Regarding Claim 17, the claim(s) recites “performing a first calculation of obtaining a first parameter and a second parameter, the first parameter being a temporal relative change amount from a certain timing of a quantity based on a degree of absorption of oxygenated hemoglobin, the first parameter depending on a concentration of oxygenated hemoglobin in blood and a volume of a blood vessel in an optical path, the second parameter being a temporal relative change amount from a certain timing of a quantity based on a degree of absorption of deoxygenated hemoglobin, the second parameter depending on a concentration of deoxygenated hemoglobin in blood and the volume of the blood vessel in the optical path;”
“performing a second calculation of obtaining, based on the first parameter and the second parameter, at least one parameter among a third parameter regarding a concentration of oxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded and a fourth parameter regarding a concentration of deoxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded”
“performing a third calculation of obtaining data regarding the degree of metabolism based on the at least one parameter”
“wherein, in the second calculation, the at least one parameter is obtained by using a predetermined formula in which a variable relating to a fluctuation component of the volume of the blood vessel in the optical path is eliminated based on a predetermined relationship among the first parameter, the second parameter, a steady component of the concentration of oxygenated hemoglobin in blood, a steady component of the concentration of deoxygenated hemoglobin in blood, and the fluctuation component of the volume of the blood vessel in the optical path." which amounts to an abstract idea (mental process and mathematical concepts).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
Processors are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of determining temporal relative change parameters, absolute concentration values, and a degree of metabolism from the input data of oxygenated hemoglobin and deoxygenated hemoglobin and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 18-20 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
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.
Claim(s) 1-4, 7-12, and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dekker (US 2003/0163033) in view of Katsumura et al (US 2009/0018405) (“Katsumura”).
Regarding Claim 1, while Dekker teaches a measurement apparatus that measures a degree of oxygenation of a living body (Abstract, Fig. 1, [0028], [0031], [0039]), the measurement apparatus comprising:
a light source configured to output measurement light to be input to the living body (Fig. 1, [0031] light sources 12, 14, and/or 16 configured to output measurement light to be input to the living body);
a light detector configured to detect the measurement light propagating through the living body and generate a detection signal according to an intensity of the measurement light (Fig. 1, [0031] photodetector 18 configured to detect the measurement light propagating through the living body and generate a detection signal according to an intensity of the measurement light); and
a processor configured to output data based on the detection signal (Figs. 1-2, [0031], [0033] processor 21 which converts received data into digital output data),
wherein the processor includes:
a first calculation portion configured to obtain, based on the detection signal, a first parameter and a second parameter, the first parameter being a temporal relative change amount from a certain timing of a quantity based on a degree of absorption of oxygenated hemoglobin, the first parameter depending on a concentration of oxygenated hemoglobin in blood and a volume of a blood vessel in an optical path, the second parameter being a temporal relative change amount from a certain timing of a quantity based on a degree of absorption of deoxygenated hemoglobin, the second parameter depending on a concentration of deoxygenated hemoglobin in blood and the volume of the blood vessel in the optical path ([0052]-[0056] calculate a value R, the Ratio of Ratios, which is a ratio of the temporal relative change amount from a certain timing of a first wavelength quantity over the temporal relative change amount from a certain timing of a second wavelength quantity, where the intensity changes for these wavelength quantities are based on a degree of absorption of oxygenated hemoglobin and a degree of absorption of deoxygenated hemoglobin and is related to a volume of a blood vessel in an optical path as noted in Equation 1, [0041] and the Lambert-Beer law through the present terms of HbO2, Hb, and L);
a second calculation portion configured to obtain, based on the first parameter and the second parameter, at least one parameter among a third parameter regarding a concentration of oxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded and a fourth parameter regarding a concentration of deoxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded ([0052]-[0056] Equation 13 provides a parameter regarding a concentration of oxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded and a concentration of deoxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded, as the length term is cancelled out for the analyzed DC component); and
wherein the second calculation portion obtains the at least one parameter by using a predetermined formula in which a variable relating to a fluctuation component of the volume of the blood vessel in the optical path is eliminated based on a predetermined relationship among the first parameter, the second parameter, a steady component of the concentration of oxygenated hemoglobin in blood, a steady component of the concentration of deoxygenated hemoglobin in blood, and the fluctuation component of the volume of the blood vessel in the optical path ([0052]-[0056] Equation 13 is the predetermined formula based on predetermined relationship of wavelength-dependent intensity values, a steady component of the concentration of oxygenated hemoglobin in blood, a steady component of the concentration of deoxygenated hemoglobin in blood, and the fluctuation component of the volume of the blood vessel in the optical path where the length variable relating to a fluctuation component of the volume of the blood vessel in the optical path is eliminated as noted in [0052]).
Dekker fails to teach a metabolism measurement apparatus that measures a degree of metabolism of a living body; and
a third calculation portion configured to obtain the data regarding the degree of metabolism based on the at least one parameter.
However Katsumura teaches an exercise load measuring device (Abstract) based on optical measuring comprising a calculation of a degree of metabolism based on an least one parameter of a ratio of oxygenated hemoglobin and deoxygenated hemoglobin ([0020], [0041]-[0042] the metabolic ratio of the energy consumption can be calculated from the hemoglobin ratio between oxygenated hemoglobin and deoxygenated hemoglobin).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further recognize the determined degree of oxygenation found in Dekker as a parameter of a degree of metabolism as taught by Katsumura and to communicate this degree of metabolism to a user to increase the diagnostic utility of Dekker with already acquired data.
Regarding Claim 2, Dekker and Katsumura teach the metabolism measurement apparatus according to claim 1, and Dekker teaches wherein the second calculation portion obtains the at least one parameter assuming that the volume of the blood vessel in the optical path is constant (See Claim 1 Rejection, [0053]-[0055] by just analyzing the DC component of plethysmographic signals, only the unchanging portion of the volume of the blood vessel is being considered).
Regarding Claim 3, Dekker and Katsumura teach the metabolism measurement apparatus according to claim 1, and Dekker further teaches
fourth calculation portion configured to obtain a numerical value regarding a fluctuation component of the volume of the blood vessel in the optical path from the first parameter and the second parameter; and
wherein, in the third calculation, the data regarding the degree of metabolism is obtained based further on the numerical value regarding the fluctuation component of the volume of the blood vessel in the optical path obtained in the fourth calculation ([0015] the previous analysis may be applied to the AC component and thus only be applied to the fluctuation component of the volume of the blood vessel, See Claim 1 Rejection, Katsumura teaches the determined parameter of this analysis reflects a degree of metabolism).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further recognize the determined degree of oxygenation from fluctuation volume found in Dekker as a parameter of a degree of metabolism as taught by Katsumura for equivalent reasons as those given above, i.e., to communicate this degree of metabolism to a user to increase the diagnostic utility of Dekker with already acquired data. Here, we may identify how a degree of metabolism fluctuates for the subject over time.
Regarding Claim 4, Dekker and Katsumura teach the metabolism measurement apparatus according to claim 1, the apparatus further comprising:
a fourth calculation portion configured to extract steady components of the first parameter and the second parameter,
wherein the third calculation portion obtains the data regarding the degree of metabolism based further on the steady components of the first parameter and the second parameter obtained by the fourth calculation portion (See Claim 1 Rejection).
Regarding Claim 7, Dekker and Katsumura teach the metabolism measurement apparatus according to claim 1, and Dekker teaches wherein the second calculation portion extracts a quantity of predetermined feature from the at least one parameter, and the third calculation portion obtains the data regarding the degree of metabolism based on a pre-acquired relationship between the quantity of predetermined feature and the degree of metabolism (See Claim 1 Rejection, [0052], [0056] the first and second parameter represented by the Ratio of Ratios is calculated as an average which a predetermined feature, the at least one parameter than calculated from the constant values of extinction coefficient along with the averaged Ratio of Ratios, indicating the at least one parameter is also reflective of an average value).
Regarding Claim 8, Dekker and Katsumura teach the metabolism measurement apparatus according to claim 7, wherein the quantity of predetermined feature is at least one value selected from a group consisting of a maximum value, a time average value, a peak-to-peak value, and a time integration value, of the at least one parameter (See Claim 7 Rejection, a time averaged value).
Regarding Claim 9, while Dekker teaches a calculation method that calculates a degree of oxygenation of a living body (Abstract, Fig. 1, [0028], [0031], [0039]), the calculation method comprising:
outputting measurement light to be input to the living body (Fig. 1, [0031] light sources 12, 14, and/or 16 configured to output measurement light to be input to the living body);
detecting the measurement light propagating through the living body and generating a detection signal according to an intensity of the measurement light (Fig. 1, [0031] photodetector 18 configured to detect the measurement light propagating through the living body and generate a detection signal according to an intensity of the measurement light);
performing a first calculation of obtaining, based on the detection signal, a first parameter and a second parameter, the first parameter being a temporal relative change amount from a certain timing of a quantity based on a degree of absorption of oxygenated hemoglobin, the first parameter depending on a concentration of oxygenated hemoglobin in blood and a volume of a blood vessel in an optical path, the second parameter being a temporal relative change amount from a certain timing of a quantity based on a degree of absorption of deoxygenated hemoglobin, the second parameter depending on a concentration of deoxygenated hemoglobin in blood and the volume of the blood vessel in the optical path ([0052]-[0056] calculate a value R, the Ratio of Ratios, which is a ratio of the temporal relative change amount from a certain timing of a first wavelength quantity over the temporal relative change amount from a certain timing of a second wavelength quantity, where the intensity changes for these wavelength quantities are based on a degree of absorption of oxygenated hemoglobin and a degree of absorption of deoxygenated hemoglobin and is related to a volume of a blood vessel in an optical path as noted in Equation 1, [0041] and the Lambert-Beer law through the present terms of HbO2, Hb, and L);
performing a second calculation of obtaining, based on the first parameter and the second parameter, at least one parameter among a third parameter regarding a concentration of oxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded and a fourth parameter regarding a concentration of deoxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded ([0052]-[0056] Equation 13 provides a parameter regarding a concentration of oxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded and a concentration of deoxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded, as the length term is cancelled out for the analyzed DC component); and
wherein, in the second calculation, the at least one parameter is obtained by using a predetermined formula in which a variable relating to a fluctuation component of the volume of the blood vessel in the optical path is eliminated based on a predetermined relationship among the first parameter, the second parameter, a steady component of the concentration of oxygenated hemoglobin in blood, a steady component of the concentration of deoxygenated hemoglobin in blood, and the fluctuation component of the volume of the blood vessel in the optical path ([0052]-[0056] Equation 13 is the predetermined formula based on predetermined relationship of wavelength-dependent intensity values, a steady component of the concentration of oxygenated hemoglobin in blood, a steady component of the concentration of deoxygenated hemoglobin in blood, and the fluctuation component of the volume of the blood vessel in the optical path where the length variable relating to a fluctuation component of the volume of the blood vessel in the optical path is eliminated as noted in [0052]),
Dekker fails to teach a metabolism calculation method that calculates a degree of metabolism of a living body; and
Performing a third calculation portion of obtaining data regarding the degree of metabolism based on the at least one parameter.
However Katsumura teaches an exercise load measuring device (Abstract) based on optical measuring comprising a calculation of a degree of metabolism based on an least one parameter of a ratio of oxygenated hemoglobin and deoxygenated hemoglobin ([0020], [0041]-[0042] the metabolic ratio of the energy consumption can be calculated from the hemoglobin ratio between oxygenated hemoglobin and deoxygenated hemoglobin).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further recognize the determined degree of oxygenation found in Dekker as a parameter of a degree of metabolism as taught by Katsumura and to communicate this degree of metabolism to a user to increase the diagnostic utility of Dekker with already acquired data.
Regarding Claim 10, Dekker and Katsumura teach the metabolism calculation method according to claim 9, and Dekker teaches wherein, in the second calculation, the at least one parameter is obtained assuming that the volume of the blood vessel in the optical path is constant (See Claim 9 Rejection, [0053]-[0055] by just analyzing the DC component of plethysmographic signals, only the unchanging portion of the volume of the blood vessel is being considered).
Regarding Claim 11, Dekker and Katsumura teach the metabolism calculation method according to claim 9, and Dekker further teaches the method comprising, before the third calculation:
performing a fourth calculation of obtaining a numerical value regarding a fluctuation component of the volume of the blood vessel in the optical path from the first parameter and the second parameter,
wherein, in the third calculation, the data regarding the degree of metabolism is obtained based further on the numerical value regarding the fluctuation component of the volume of the blood vessel in the optical path obtained in the fourth calculation ([0015] the previous analysis may be applied to the AC component and thus only be applied to the fluctuation component of the volume of the blood vessel, See Claim 9 Rejection, Katsumura teaches the determined parameter of this analysis reflects a degree of metabolism).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further recognize the determined degree of oxygenation from fluctuation volume found in Dekker as a parameter of a degree of metabolism as taught by Katsumura for equivalent reasons as those given above, i.e., to communicate this degree of metabolism to a user to increase the diagnostic utility of Dekker with already acquired data. Here, we may identify how a degree of metabolism fluctuates for the subject over time.
Regarding Claim 12, Dekker and Katsumura teach the metabolism calculation method according to claim 9, further comprising, before the third calculation:
performing a fourth calculation of extracting steady components of the first parameter and the second parameter,
wherein, in the third calculation, the data regarding the degree of metabolism is obtained based further on the steady components of the first parameter and the second parameter obtained in the fourth calculation (See Claim 9 Rejection).
Regarding Claim 15, Dekker and Katsumura teach the metabolism calculation method according to claim 9, and Dekker teaches wherein, in the second calculation, a quantity of predetermined feature is extracted from the at least one parameter, and in the third calculation, the data regarding the degree of metabolism is obtained based on a pre-acquired relationship between the quantity of predetermined feature and the degree of metabolism (See Claim 9 Rejection, [0052], [0056] the first and second parameter represented by the Ratio of Ratios is calculated as an average which a predetermined feature, the at least one parameter than calculated from the constant values of extinction coefficient along with the averaged Ratio of Ratios, indicating the at least one parameter is also reflective of an average value).
Regarding Claim 16, Dekker and Katsumura teach the metabolism calculation method according to claim 15, wherein the quantity of predetermined feature is at least one value selected from a group consisting of a maximum value, a time average value, a peak-to-peak value, and a time integration value, of the at least one parameter (See Claim 15 Rejection, a time averaged value).
Regarding Claim 17, while Dekker teaches a non-transitory computer-readable storage medium storing a calculation program that calculates a degree of oxygenation of a living body (Abstract, Fig. 1, [0028], [0031], [0039], [0056] data is being processed according to instructions stored within processor, indicating a non-transitory computer-readable medium), the calculation program causing a computer to execute:
performing a first calculation of obtaining a first parameter and a second parameter, the first parameter being a temporal relative change amount from a certain timing of a quantity based on a degree of absorption of oxygenated hemoglobin, the first parameter depending on a concentration of oxygenated hemoglobin in blood and a volume of a blood vessel in an optical path, the second parameter being a temporal relative change amount from a certain timing of a quantity based on a degree of absorption of deoxygenated hemoglobin, the second parameter depending on a concentration of deoxygenated hemoglobin in blood and the volume of the blood vessel in the optical path ([0052]-[0056] calculate a value R, the Ratio of Ratios, which is a ratio of the temporal relative change amount from a certain timing of a first wavelength quantity over the temporal relative change amount from a certain timing of a second wavelength quantity, where the intensity changes for these wavelength quantities are based on a degree of absorption of oxygenated hemoglobin and a degree of absorption of deoxygenated hemoglobin and is related to a volume of a blood vessel in an optical path as noted in Equation 1, [0041] and the Lambert-Beer law through the present terms of HbO2, Hb, and L);
performing a second calculation of obtaining, based on the first parameter and the second parameter, at least one parameter among a third parameter regarding a concentration of oxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded and a fourth parameter regarding a concentration of deoxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded ([0052]-[0056] Equation 13 provides a parameter regarding a concentration of oxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded and a concentration of deoxygenated hemoglobin in blood from which an influence of the volume of the blood vessel in the optical path is excluded, as the length term is cancelled out for the analyzed DC component); and
wherein, in the second calculation, the at least one parameter is obtained by using a predetermined formula in which a variable relating to a fluctuation component of the volume of the blood vessel in the optical path is eliminated based on a predetermined relationship among the first parameter, the second parameter, a steady component of the concentration of oxygenated hemoglobin in blood, a steady component of the concentration of deoxygenated hemoglobin in blood, and the fluctuation component of the volume of the blood vessel in the optical path ([0052]-[0056] Equation 13 is the predetermined formula based on predetermined relationship of wavelength-dependent intensity values, a steady component of the concentration of oxygenated hemoglobin in blood, a steady component of the concentration of deoxygenated hemoglobin in blood, and the fluctuation component of the volume of the blood vessel in the optical path where the length variable relating to a fluctuation component of the volume of the blood vessel in the optical path is eliminated as noted in [0052]),
Dekker fails to teach a metabolism calculation program that calculates a degree of metabolism of a living body; and
Performing a third calculation portion of obtaining data regarding a degree of metabolism of the living body based on the at least one parameter.
However Katsumura teaches an exercise load measuring device (Abstract) based on optical measuring comprising a calculation of a degree of metabolism based on an least one parameter of a ratio of oxygenated hemoglobin and deoxygenated hemoglobin ([0020], [0041]-[0042] the metabolic ratio of the energy consumption can be calculated from the hemoglobin ratio between oxygenated hemoglobin and deoxygenated hemoglobin).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further recognize the determined degree of oxygenation found in Dekker as a parameter of a degree of metabolism as taught by Katsumura and to communicate this degree of metabolism to a user to increase the diagnostic utility of Dekker with already acquired data.
Regarding Claim 18, Dekker and Katsumura teach the metabolism calculation program according to claim 17, wherein, in the second calculation, the at least one parameter is obtained assuming that the volume of the blood vessel in the optical path is constant (See Claim 17 Rejection, [0053]-[0055] by just analyzing the DC component of plethysmographic signals, only the unchanging portion of the volume of the blood vessel is being considered).
Regarding Claim 19, Dekker and Katsumura teach the metabolism calculation program according to claim 17, and Dekker further teaches the program causing the computer to further execute, before the third calculation:
performing a fourth calculation of obtaining a numerical value regarding a fluctuation component of the volume of the blood vessel in the optical path from the first parameter and the second parameter,
wherein, in the third calculation, the data regarding the degree of metabolism is obtained based further on the numerical value regarding the fluctuation component of the volume of the blood vessel in the optical path obtained in the fourth calculation ([0015] the previous analysis may be applied to the AC component and thus only be applied to the fluctuation component of the volume of the blood vessel, Katsumura teaches the determined parameter of this analysis reflects a degree of metabolism (See Claim 17 Rejection).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further recognize the determined degree of oxygenation from fluctuation volume found in Dekker as a parameter of a degree of metabolism as taught by Katsumura for equivalent reasons as those given above, i.e., to communicate this degree of metabolism to a user to increase the diagnostic utility of Dekker with already acquired data. Here, we may identify how a degree of metabolism fluctuates for the subject over time.
Regarding Claim 20, Dekker and Katsumura teach the metabolism calculation program according to claim 17, causing the computer to further execute, before the third calculation:
performing a fourth calculation of extracting steady components of the first parameter and the second parameter,
wherein, in the third calculation, the data regarding the degree of metabolism is obtained based further on the steady components of the first parameter and the second parameter obtained in the fourth calculation (See Claim 17 Rejection).
Claim(s) 6 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dekker in view of Katsumura and further in view of Cho et al (US 2010/0222652) (“Cho”).
Regarding Claim 6, Dekker and Katsumura teach the metabolism measurement apparatus according to claim 1, their combined efforts fail to teach wherein the third calculation portion further obtains a blood glucose level of the living body based on a pre-acquired relationship between the degree of metabolism and the blood glucose level.
However Cho teaches an optical-based diagnostic sensor (Abstract, Fig. 1, [0014], [0038]) wherein, in the third calculation, a blood glucose level of the living body is further obtained based on a pre-acquired relationship between the degree of metabolism and the blood glucose level ([0014] the ratio of oxyhemoglobin and deoxyhemoglobin is a oxygen consumption, which can be used to find blood glucose, [0024] the predetermined relationship and how to calculate glucose from the degree of metabolism parameter).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further recognize the determined degree of oxygenation found in Dekker as a parameter of a degree of metabolism as taught by Katsumura and to communicate this degree of metabolism to a user to increase the diagnostic utility of Dekker with already acquired data.
Regarding Claim 14, while Dekker and Katsumura teach the metabolism calculation method according to claim 9, their combined efforts fail to teach wherein, in the third calculation, a blood glucose level of the living body is further obtained based on a pre-acquired relationship between the degree of metabolism and the blood glucose level.
However Cho teaches an optical-based diagnostic sensor (Abstract, Fig. 1, [0014], [0038]) wherein, in the third calculation, a blood glucose level of the living body is further obtained based on a pre-acquired relationship between the degree of metabolism and the blood glucose level ([0014] the ratio of oxyhemoglobin and deoxyhemoglobin is a oxygen consumption, which can be used to find blood glucose, [0024] the predetermined relationship and how to calculate glucose from the degree of metabolism parameter).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further recognize the determined degree of oxygenation found in Dekker as a parameter of a degree of metabolism as taught by Katsumura and to communicate this degree of metabolism to a user to increase the diagnostic utility of Dekker with already acquired data.
Allowable Subject Matter
No prior art rejection is applied to claims 5 and 13 because the prior art fails to teach the specifically cited equation. However, the claims are not allowed at this time due to the rejections under 101, as set forth above
Response to Arguments
Applicant’s amendments and arguments filed 6/22/2026 with respect to the 35 USC 101 rejections have been fully considered, but are not persuasive.
Applicant argues on page 11 of the Remarks that the claims are addressing a specific technical problem inherent in near-infrared spectroscopy measurement. That is, they are subject to fluctuations of the blood vessel volume and the metabolism of the body cannot be calculated using these value as-is with high accuracy. Examiner respectfully notes that these arguments are moot. Specifically, the claim language does not cite the use of near-infrared spectroscopy (NIRS) so the improvement of the claims cannot be predicated on this dataset. Furthermore, Applicant is framing the improvement in terms of NIRS monitoring as the claims overcome the fluctuations of volume present in NIRS which affects accuracy in a determination of a degree of metabolism, but that indicates an improvement in how useful NIRS data is for determining a degree of metabolism. The overall quality of NIRS data is not improved upon. To this point, on page 12, Applicant states that the claims overcome a measurement error in NIRS, but NIRS providing data with a DC component and AC component is an inherent characteristic of the sensing modality itself and therefore cannot be an error.
Applicant argues on pages 11-12 that the predetermined relationship cited improves the accuracy of a determined metabolism measurement. Examiner respectfully disagrees. The prior art taught similar determinations, with the volume magnitude obviated, as seen by Dekker, Craig et al (US 4,869, 253), and Cheng et al (US 6,597,931) for patient oxygenation values. While the particulars of the equation on claim 5 may be an improvement over this prior art, mathematical steps and mental processes cannot be the sole basis of an improvement over the prior art. And an improvement would be more persuasive if the output of a ‘degree of metabolism’ went beyond a generic display and the term was specifically defined. Examiner suggests amending the claim to provide a more specific ‘degree of metabolism’ values and to show how the claims as a whole (i.e. the extrasolution data gathering in combination with the judicial exception) amounts to significantly more than the abstract idea.
Applicant’s remaining argument on pages 12-13 reiterates an improvement in NIRS monitoring. Examiner respectfully disagrees for the reasons given above. Examiner suggests specifying how this conditions NIRS data to provide an accurate degree of metabolism parameter with non-invasive data, and further specifying how the particular of the equation are an improvement over similar prior art. Finally, how these steps are more than what is well-understood, routine, and conventional with respect to other optical-based hemoglobin data measurement systems that identify metabolic-related parameters. The rejection stands.
Applicant’s amendments and arguments filed 6/22/2026 with respect to the 35 USC 103 rejections of claims 1, 9, and 17 have been fully considered, but are not persuasive. The rejection(s) is/are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Dekker and Matsumura.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
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