DETAILED ACTION
Applicant’s arguments, filed on 10/03/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 1-13 and 15-25 are the current claims hereby under examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
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.
Claims 5 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 5, the claim recites the limitation “wherein said evaluation function corresponds to a logarithm of another function of said light intensities” in lines 1-2. It is unclear how the evaluation corresponds to another function of said light intensities, when it has been defined in claim 4, which claim 5 is dependent on, as being a function of the original function of light intensities. It is unclear how the evaluation function is both the function of the light intensities as well as another function of said light intensities. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as referring to the original function of said light intensities from claim 4.
Regarding claim 19, the claim recites the limitation “wherein said evaluation function corresponds to a logarithm of another function of said light intensities” in lines 1-2. It is unclear how the evaluation corresponds to another function of said light intensities, when it has been defined in claim 18, which claim 16 is dependent on, as being a function of the original function of light intensities. It is unclear how the evaluation function is both the function of the light intensities as well as another function of said light intensities. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as referring to the original function of said light intensities from claim 18.
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 1-13 and 15-25 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. Under the two-step 101 analysis, the claims fail to satisfy the criteria for subject matter eligibility.
Regarding Step 1, claims 1-25 are all within at least one of the four statutory categories.
Claim 1 and its dependent claims disclose a method.
Claim 12 and its dependent claims disclose an apparatus (machine).
Claim 15 discloses a storage medium (machine).
Regarding Step 2A, Prong One, the independent claims 1, 12, and 15 recite an abstract idea. In particular, the claims generally recite the following:
Obtaining an optical plethysmography signal measured at an investigated volume of said individual;
Obtaining light intensities acquired by optical plethysmography at two or more points in time along said optical plethysmography signal;
Obtaining an oxygen saturation estimate;
Obtaining calibration data;
Determining a compensation function from said oxygen saturation estimate and said calibration data; wherein said compensation function is a function of said oxygen saturation estimate;
Determining a ratio of a function of said light intensities and of said compensation function, thereby evaluating changes in arterial blood volume in said investigation volume between
said two or more points in time and hereby assessing the PAT of said individual.
These elements recited in claims 1, 12, and 15 are drawn to abstract ideas since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgement, and opinion and using pen and paper.
Obtaining an optical plethysmography signal measured at an investigated volume of said individual is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, or with the aid of pen and paper. A person of ordinary skill in the art could reasonably obtain the optical plethysmography signal on a piece of paper. There is nothing to suggest an undue level of complexity in obtaining an optical plethysmography signal measured at an investigated volume of said individual. The added limitation of “electronically” obtaining the information is simply a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry, therefore defining it as an abstract idea.
Obtaining light intensities acquired by optical plethysmography at two or more points in time along said optical plethysmography signal is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, or with the aid of pen and paper. A person of ordinary skill in the art could reasonably obtain the light intensities on a piece of paper. There is nothing to suggest an undue level of complexity in obtaining light intensities acquired by optical plethysmography at two or more points in time. The added limitation of “electronically” obtaining the information is simply a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry, therefore defining it as an abstract idea.
Obtaining an oxygen saturation estimate is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, or with the aid of pen and paper. A person of ordinary skill in the art could reasonably obtain the oxygen saturation estimate on a piece of paper. There is nothing to suggest an undue level of complexity in obtaining an oxygen saturation estimate. The added limitation of “electronically” obtaining the information is simply a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry, therefore defining it as an abstract idea.
Obtaining calibration data is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, or with the aid of pen and paper. A person of ordinary skill in the art could reasonably obtain calibration data on a piece of paper. There is nothing to suggest an undue level of complexity in obtaining calibration data. The added limitation of “electronically” obtaining the information is simply a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry, therefore defining it as an abstract idea.
Determining a compensation function from said oxygen saturation estimate and said calibration data; wherein said compensation function is a function of said oxygen saturation estimate is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, or with the aid of pen and paper. A person of ordinary skill in the art could reasonably determine a function based on the oxygen saturation estimate and calibration data mentally, or with the aid of pen and paper. These techniques are based on calculations and mathematical principles, which can be performed by hand. The mathematics of determining a compensation function are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas. There is nothing to suggest an undue level of complexity in determining a compensation function from said oxygen saturation estimate and said calibration data. The added limitation of “electronically” determining the information is simply a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry, therefore defining it as an abstract idea.
Determining a ratio of a function of said light intensities and of said compensation function, thereby evaluating changes in arterial blood volume in said investigation volume between said two or more points in time and hereby assessing PAT of said individual is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, or with the aid of pen and paper. A person of ordinary skill in the art could reasonably determine a ratio of a function of light intensities and the compensation function mentally, or with the aid of pen and paper. These techniques are based on calculations and mathematical principles, which can be performed by hand. The mathematics of determining a ratio and evaluating changes in blood volume are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas. There is nothing to suggest an undue level of complexity in determining a ratio of a function of said light intensities and of said compensation function, thereby evaluating changes in arterial blood volume in said investigation volume between said two or more points in time and hereby assessing PAT of said individual. The added limitation of “electronically” determining the information is simply a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry, therefore defining it as an abstract idea.
Regarding Step 2A, Prong Two, claims 1, 12, and 15 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are directed to the abstract idea. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “a processor” (claims 12), “a memory” (claim 12), “a computer-readable storage medium” (claim 15), and “a computer” (claim 15)).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Regarding Step 2B, claims 1, 12, and 15 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above.
The elements of a processor, a memory, a computer-readable storage medium, and a computer in claims 12 and 15 do not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above judicial exception. Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Regarding the dependent claims, claims 2-11 depend on claim 1 and claims 13 and 16-25 depend on claim 12. The dependent claims merely further define the abstract idea or are additional data output that is well-understood, routine, and previously known to the industry.
For example, the following are dependent claims reciting abstract ideas and can be performed in the human mind:
(Claim 2): “wherein said calibration data comprises predetermined calibration coefficients and/or predefined coefficients; and wherein: said determining said compensation function corresponds to deriving said compensation function from said predefined coefficients; or said determining said compensation function corresponds to determining said predetermined calibration coefficients by fitting said oxygen saturation estimate to a calibration ratio” is based in mathematical concept that van be performed mentally or with the aid of pen and paper. These techniques are based on calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 3): “wherein at least one of said points in time corresponds to the diastole in a cardiac cycle of said individual and/or wherein at least one of said points in time corresponds to the systole in a cardiac cycle of said individual” further defines the abstract idea since it further limits the points in time;
(Claim 4): “further comprising determining an evaluation function which is a function of said light intensities; and wherein said determining a ratio corresponds to determining a ratio of said evaluation function and said compensation function” is based in mathematical concept that van be performed mentally or with the aid of pen and paper. These techniques are based on calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 5): “wherein said evaluation function corresponds to a logarithm of a function of said light intensities” is based in mathematical concept that van be performed mentally or with the aid of pen and paper. These techniques are based on calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 6): “wherein said evaluation function corresponds to a logarithm of a ratio of said light intensities; and wherein said evaluation function depends on one or more of the following: an optical path length; a function of said oxygen saturation estimates; and said changes in arterial blood volume in said investigated volume” is based in mathematical concept that van be performed mentally or with the aid of pen and paper. These techniques are based on calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 7): “further comprising the steps of: providing a first light source configured to emit light at a first wavelength; providing a second light source configured to emit light at a second wavelength; providing a sensor; collecting, by optical plethysmography and on said sensor, propagated light corresponding to said light being transmitted or reflected when propagating in said investigated volume of said individual at said two or more points in time; for said first wavelength, determining first light intensities of said propagated light on said sensor at said two or more points in time; for said second wavelength, determining second light intensities of said propagated light on said sensor at said two or more points in time; determining a first ratio corresponding to a ratio of said first light intensities at said first wavelength; determining a second ratio corresponding to a ratio of said second light intensities at said second wavelength; determining said calibration ratio of a function of said first ratio and of a function of said second ratio; and fitting said oxygen saturation estimate to said calibration ratio thereby determining said predetermined calibration coefficients” is generic data-gathering steps.
The generic data-gathering steps are evidenced by:
Chinese Application No. 106999057 (Mena Benito) discloses conventional PPG sensors using multiple light sources at different wavelengths and a sensor for detecting light signal intensities ([0067]);
Chinese Application No. 105007816 (Bresch) discloses conventional plethysmography sensors with multiple light sources with different wavelengths for detecting light intensity ([0066]).
Additionally, the rest of the claim is based in mathematical concept that van be performed mentally or with the aid of pen and paper. These techniques are based on calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 8): “further comprising the steps of: collecting, by optical plethysmography and on said sensor, propagated light corresponding to light at said first wavelength or at said second wavelength being transmitted or reflected when propagating in said investigated volume of said individual at said two or more points in time; and determining said light intensities of said propagated light on said sensor at said two or more points in time” is generic data-gathering steps;
(Claim 9): “further comprising the step of determining said oxygen saturation estimate in the a vicinity of said investigated volume of said individual” is insignificant pre-solution activity;
(Claim 10): “wherein said evaluating said compensation function corresponds to determining a regression which maps said oxygen saturation estimate onto said predetermined calibration coefficients” is based in mathematical concept that van be performed mentally or with the aid of pen and paper. These techniques are based on calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 11): “further comprising the step of forcing that said regression to use a first-degree rational mapping when evaluating said compensation function” is based in mathematical concept that van be performed mentally or with the aid of pen and paper. These techniques are based on calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 13): “further comprising: a light source configured to emit light; and a sensor configured to collect by optical plethysmography propagated light corresponding to said light being transmitted or reflected when propagating in a distal end of a digit of said individual at said two or more points in time; and further configured to determine said light intensities of said propagated light at said two or more points in time” is generic data-gathering steps;
(Claim 16): “wherein said calibration data comprises predetermined calibration coefficients and/or predefined coefficients; and wherein: determine said compensation function, the apparatus is configured to derive said compensation function from said predefined coefficients; or determine said compensation function, the apparatus is configured to determine said predetermined calibration coefficients by fitting said oxygen saturation estimate to a calibration ratio” is based in mathematical concept that van be performed mentally or with the aid of pen and paper. These techniques are based on calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 17): “wherein at least one of said points in time correspond to the diastole in a cardiac cycle of said individual and/or wherein at least one of said points in time corresponds to the systole in a cardiac cycle of said individual” further defines the abstract idea since it further limits the points in time;
(Claim 18): “further configured to determine an evaluation function that is a function of said light intensities; and wherein to determine the ratio, the apparatus is configured to determine a ratio of said evaluation function and said compensation function” is based in mathematical concept that van be performed mentally or with the aid of pen and paper. These techniques are based on calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 19): “wherein said evaluation function corresponds to a logarithm of a function of said light intensities” is based in mathematical concept that van be performed mentally or with the aid of pen and paper. These techniques are based on calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 20): “wherein said evaluation function corresponds to a logarithm of a ratio of said light intensities; and wherein said evaluation function depends on one or more of the following: an optical path length; a function of said oxygen saturation estimate; and said changes in arterial blood volume in said investigated volume” is based in mathematical concept that van be performed mentally or with the aid of pen and paper. These techniques are based on calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 21): “further comprising: a first light source configured to emit light at a first wavelength; a second light source configured to emit light at a second wavelength; and a sensor; where the apparatus is configured to: collect, by optical plethysmography and on said sensor, propagated light corresponding to said light being transmitted or reflected when propagating in said investigated volume of said individual at said two or more points in time; for said first wavelength, determine first light intensities (106;107) of said propagated light on said sensor at said two or more points in time; for said second wavelength, determine second light intensities of said propagated light on said sensor at said two or more points in time; determine a first ratio corresponding to a ratio of said first light intensities at said first wavelength; determine a second ratio corresponding to a ratio of said second light intensities at said second wavelength; determine said calibration ratio of a function of said first ratio and of a function of said second ratio; and fit said oxygen saturation estimate to said calibration ratio thereby determine said predetermined calibration coefficients.” is generic data-gathering steps.
The generic data-gathering steps are evidenced by:
Chinese Application No. 106999057 (Mena Benito) discloses conventional PPG sensors using multiple light sources at different wavelengths and a sensor for detecting light signal intensities ([0067]);
Chinese Application No. 105007816 (Bresch) discloses conventional plethysmography sensors with multiple light sources with different wavelengths for detecting light intensity ([0066]).
Additionally, the rest of the claim is based in mathematical concept that van be performed mentally or with the aid of pen and paper. These techniques are based on calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 22): “further configured to: collect, by optical plethysmography and on said sensor, propagated light corresponding to light at said first wavelength or at said second wavelength being transmitted or reflected when propagating in said investigated volume of said individual at said two or more points in time; and determine said light intensities of said propagated light on said sensor at said two or more points in time”
(Claim 23): “further configured to determine said oxygen saturation estimate in a vicinity of said investigated volume of said individual” is insignificant pre-solution activity;
(Claim 24): “wherein to evaluate said compensation function the apparatus is configured to determine a regression which maps said oxygen saturation estimate onto said predetermined calibration coefficients” is based in mathematical concept that van be performed mentally or with the aid of pen and paper. These techniques are based on calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas;
(Claim 25): “further configured to force said regression to use a first-degree rational mapping when evaluating said compensation function” is based in mathematical concept that van be performed mentally or with the aid of pen and paper. These techniques are based on calculations and mathematical principles, which can be performed by hand. The mathematics are not overly complicated to perform using pen and paper given enough time, therefore these are defined as abstract ideas.
The dependent claims do not recite significantly more than the abstract ideas. Therefore, claims 1-13 and 15-25 are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-6, 12-13, 15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Goor (CN 1522660) in further view of Brumfield (US 20060009700), Yalamanchali (“Diagnosis of Obstructive Sleep Apnea by Peripheral Arterial Tonometry”), Jacques (US 20030109776) and Schnall (WO 2013076722). Citations to CN 1522660 will refer to the English Machine Translation that accompanies this Office Action.
Regarding independent claim 1, Goor teaches a computer-implemented method for assessing peripheral arterial tone, PAT, of an individual monitored by optical plethysmography (Abstract: “The invention claims a non-invasive detect the physiological state or health condition of the method and device. The method of the invention based on monitoring peripheral arterial tone changes and when detecting the specific change of a peripheral arterial tone determining status of the patient is changed to detect the response to myocardial ischemia or sleep apnea state or condition of a peripheral arterial tone to provide the state or condition of the indication”), wherein said method comprises:
electronically obtaining:
an optical plethysmography signal measured at an investigated volume of said individual ([0062]: “Changes in arterial blood volume can be determined using one or more parameters of plethysmography, such as the volume of the finger or optical density.”; [0056]: “Another existing method is to use a photographic volumetric recording device that includes a light transmitter and a light receiver placed on the opposite side of the fingertip”);
light acquired by optical plethysmography at two or more points in time along said optical plethysmography signal ([0212]: “the finger probe 2 is used to measure the volume change (as a function of time) at the tip of the monitored finger (or toe) in response to a blood pressure wave”; [0250]: “The processor 23 processes the measured changes in finger volume (or optical density) to produce a volume measurement output 24a and/or a volume measurement output 24b that varies with time”; [0062]: “Changes in arterial blood volume can be determined using one or more parameters of plethysmography, such as the volume of the finger or optical density.”; [0056]: “Another existing method is to use a photographic volumetric recording device that includes a light transmitter and a light receiver placed on the opposite side of the fingertip”).
However, Goor does not teach measuring the intensity of the light signals.
Brumfield discloses an apparatus and method for assessing peripheral circulation. Specifically, Brumfield teaches obtaining light intensities of the measurements ([0257]: “Analysis of the pulse volume (PV) 4020 of the pulsatile or alternating current (AC) component of the photoplethysmograph blood flow signal can also be used to determine blood flow characteristics. Normalized pulse volume (NPV) can be determined by dividing the AC component of the signal by the baseline transmitted light level (DC) as shown in equation (8). NPV=AC/DC (8) DNPV=(.DELTA.Vb/Vb) (9) NPV.about.=.DELTA.Vb (10) DNPV=NPV/ln(I/It)”). Goor and Brumfield are analogous arts as they are both related to determining parameters of peripheral circulation of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the measurement of the light intensities from Brumfield into the method from Goor as Goor is silent on the method used to determine blood volume from the photoplethysmography signals, and Brumfield discloses a suitable determination in an analogous device.
The Goor/Brumfield combination teaches obtaining an oxygen saturation estimate (Goor, [0289]: “each time apnea occurs, the output signal of the local ischemia recorder (labeled ISCH) exhibits a repetitive characteristic pattern with the time curve of oxygen saturation (SaO<sub>2</sub>”); and
calibration data (Goor, [0122]: “a method for calibrating a blood pressure measuring instrument is provided, comprising inducing and monitoring changes in static pressure within a measured artery by changing the vertical position of a measuring point relative to the heart, measuring corresponding quantities and other quantities associated with characteristics of the artery, and then plotting these measurements and the induced static pressure changes to generate compliance curves of the vessels”; [0132]-[0134]: “The fingers or toes are placed vertically in multiple vertical positions relative to the subject's heart; The static pressure superimposed on the blood pressure of the subject when the subject's fingers or toes are in each vertical position relative to the subject's heart; The predetermined external counterpressure and the static pressure measurement are used to calibrate the change in the measured amount of arterial blood pressure at the outer end of the subject's fingers or toes, and the change in the measured amount is converted into arterial blood pressure”).
However, the Goor/Brumfield combination does not teach the relation between oxygen saturation and peripheral arterial tone.
Yalamanchali discloses a relation between oxygen saturation and peripheral arterial tone (Page 3: “The WatchPAT (Figure 1) is a unique, wrist-worn ambulatory sleep study device that uses PAT in conjunction with pulse oximetry and actigraphy to assess respiratory disturbances. Given that obstruction-induced transient elevations of sympathetic tone have been associated with arousals from sleep,10- 16 the WatchPAT device indirectly detects apnea and hypopnea via selectively measuring peripheral arterial volume changes (mediated by α-adrenergic receptors of vascular smooth muscle) using a finger-mounted plethysmograph. The information is collated with pulse oximetry (detection of oxygen desaturation) in conjunction with heart rate and is further analyzed using a predeveloped automated algorithm. This algorithm associates arousals with measurement of oxygen desaturation levels to determine respiratory effort–related arousals. Furthermore, with the advantage of eliminating interscorer variability, this relatively novel approach has been proposed to offer an accurate, reproducible, and simple alternative to PSG. Multiple studies have demonstrated high correlation of sleep indexes measured by PAT, such as the respiratory disturbance index (RDI) or the apnea-hypopnea index (AHI), compared with the same indexes measured by formal PSG.”). Goor, Brumfield, and Yalamanchali are analogous arts as they are all related to the determination of peripheral circulation.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include oxygen saturation in the determination of peripheral arterial tone as it is shown to have an effect on PAT, therefore it is an important parameter to include in the determination.
However, the Goor/Brumfield/Yalamanchali combination does not teach determining a function in relation to the oxygen saturation.
Jacques discloses a method of determining arterial blood oxygen saturation with light transmitted through the tissue. Specifically, Jacques discloses obtaining determining a compensation function from said oxygen saturation estimate and said calibration data; wherein said compensation function is a function of said oxygen saturation estimate ([0145]: “The function getSaO2( ) uses the normalized light measurement data [mTred, mTir] to specify the blood volume fraction and mixed blood oxygen saturation values [fv, SmO2], which in turn specify a calibration curve for S.sub.aO.sub.2 as a function of R that has been summarized as a second-order polynomial. The polynomial is used to convert the pulsatile measurement mR into a predicted S.sub.aO.sub.2. The final answer is the predicted S.sub.aO.sub.2.”). Goor, Brumfield and Jacques are analogous arts as they are all related to determining health parameters of a user using light transmittance through tissue.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the compensation function from Jacques into the Goor/Brumfield/Yalamanchali combination as it allows the combination to include calibration information into the PAT determination, and the combination is silent on to how the calibration information is incorporated into the PAT determination.
However, the Goor/Brumfield/Yalamanchali/Jacques combination is silent on the relation between the light intensities and the compensation function.
Schnall discloses an apparatus for monitoring peripheral arterial tone in a user. Specifically, Schnall teaches electronically determining a ratio of a function of said light intensities and said compensation function (Page 1, lines 10-12: “The present invention relates to apparatus for monitoring arterial pulse waves in diagnosing various medical conditions. The invention is particularly useful in relation to the methods and apparatus for measuring the peripheral arterial tone of a subject”; Page 13, lines 10-17: “The quantitative analysis of incomplete arterial occlusion may be determined by measuring the absolute amplitude of detected arterial pulse signals, as indicated 700 in Fig. 17, or by dividing the amplitude of detected arterial pulse signals, as indicated at 705 in Fig. 17, during occlusion by the corresponding arterial pulse signals, as indicated at 706, or by for example the mean amplitude of the occluded side baseline arterial pulse signals amplitude as indicated at 701 or 704. The resulting ratios can thus provide relative indices of incomplete arterial occlusion, when their value exceeds a predetermined threshold value.”; Fig. 17. Oxygen saturation can be indicative of occlusion, therefore the ratio used by dividing pre-occlusion by post-occlusion teaches on the claimed ratio.). Goor, Brumfield, Yalamanchali, and Schnall are analogous arts as they are all related to determining parameters related to peripheral circulation.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the ratio from Schnall into the Goor/Brumfield/Yalamanchali/Jacques combination as the combination is silent on the relation, and Schnall discloses a suitable relation.
The Goor/Brumfield/Yalamanchali/Jacques/Schnall combination teaches thereby evaluating changes in arterial blood volume in said investigated volume between said two or more points in time and hereby assessing the PAT of said individual (Goor, [0062]: “Therefore, what is disclosed here are methods and devices for non-invasive monitoring of peripheral arterial tone. Although changes in peripheral arterial tone can be detected by monitoring various other hemodynamic parameters of any peripheral artery, such as changes in blood flow, blood volume, and the shape of the arterial pulse wave, it is best to detect changes in the pulsatility of arterial blood at that location by drawing a signal from the patient's finger or toe. Changes in arterial blood volume can be determined using one or more parameters of plethysmography, such as the volume of the finger or optical density”).
Regarding claim 3, the Goor/Brumfield/Yalamanchali/Jacques/Schnall combination teaches the method according to claim 1, wherein at least one of said points in time corresponds to the diastole in a cardiac cycle of said individual and/or wherein at least one of said points in time corresponds to the systole in a cardiac cycle of said individual (Goor, [0056]: “Another existing method is to use a photographic volumetric recording device that includes a light transmitter and a light receiver placed on the opposite side of the fingertip. The receiver records the changes in light transmission through the finger caused by changes in blood flow within the artery. The received signal is transmitted to a computer, which converts the receiver's output signal into systolic and diastolic blood pressure data”).
Regarding claim 4, the Goor/Brumfield/Yalamanchali/Jacques/Schnall combination teaches the method according to claim 1, further comprising determining an evaluation function which is said function of said light intensities, and wherein the ratio is a ratio of said evaluation function and said compensation function (Brumfield, [0257]: “Analysis of the pulse volume (PV) 4020 of the pulsatile or alternating current (AC) component of the photoplethysmograph blood flow signal can also be used to determine blood flow characteristics. Normalized pulse volume (NPV) can be determined by dividing the AC component of the signal by the baseline transmitted light level (DC) as shown in equation (8). NPV=AC/DC (8) DNPV=(.DELTA.Vb/Vb) (9) NPV.about.=.DELTA.Vb (10) DNPV=NPV/ln(I/It)”; Schnall, Page 1, lines 10-12: “The present invention relates to apparatus for monitoring arterial pulse waves in diagnosing various medical conditions. The invention is particularly useful in relation to the methods and apparatus for measuring the peripheral arterial tone of a subject”; Page 13, lines 10-17: “The quantitative analysis of incomplete arterial occlusion may be determined by measuring the absolute amplitude of detected arterial pulse signals, as indicated 700 in Fig. 17, or by dividing the amplitude of detected arterial pulse signals, as indicated at 705 in Fig. 17, during occlusion by the corresponding arterial pulse signals, as indicated at 706, or by for example the mean amplitude of the occluded side baseline arterial pulse signals amplitude as indicated at 701 or 704. The resulting ratios can thus provide relative indices of incomplete arterial occlusion, when their value exceeds a predetermined threshold value.”; Fig. 17. Oxygen saturation can be indicative of occlusion, therefore the ratio used by dividing pre-occlusion by post-occlusion teaches on the claimed ratio.).
Regarding claim 5, the Goor/Brumfield/Yalamanchali/Jacques/Schnall combination teaches the method according to claim 4, wherein said evaluation function corresponds to a logarithm of another function of said light intensities (Brumfield, [0257]: “Analysis of the pulse volume (PV) 4020 of the pulsatile or alternating current (AC) component of the photoplethysmograph blood flow signal can also be used to determine blood flow characteristics. Normalized pulse volume (NPV) can be determined by dividing the AC component of the signal by the baseline transmitted light level (DC) as shown in equation (8). NPV=AC/DC (8) DNPV=(.DELTA.Vb/Vb) (9) NPV.about.=.DELTA.Vb (10) DNPV=NPV/ln(I/It)”).
Regarding claim 6, the Goor/Brumfield/Yalamanchali/Jacques/Schnall combination teaches the method according to claim 4, wherein said evaluation function corresponds to a logarithm of a ratio of said light intensities, wherein said evaluation function depends on one or more of the following: an optical path length; said oxygen saturation estimate; and said changes in arterial blood volume in said investigated volume (Brumfield, [0257]: “Analysis of the pulse volume (PV) 4020 of the pulsatile or alternating current (AC) component of the photoplethysmograph blood flow signal can also be used to determine blood flow characteristics. Normalized pulse volume (NPV) can be determined by dividing the AC component of the signal by the baseline transmitted light level (DC) as shown in equation (8). NPV=AC/DC (8) DNPV=(.DELTA.Vb/Vb) (9) NPV.about.=.DELTA.Vb (10) DNPV=NPV/ln(I/It)”).
Regarding independent claim 12, Goor teaches an apparatus comprising at least one processor ([0093]: “A processor that receives signals from the probe and provides an output signal indicating changes in the tension of the peripheral arteries in the finger or toe, thereby indicating the patient's physiological state or health condition”) and at least one memory including computer program code ([0322]: “the curve shown in Figure 25 can be stored in the memory of the processor 23”), the at least one memory and computer program code configured to, with the at least one processor, control operation of the apparatus, (Abstract: “The invention claims a non-invasive detect the physiological state or health condition of the method and device. The method of the invention based on monitoring peripheral arterial tone changes and when detecting the specific change of a peripheral arterial tone determining status of the patient is changed to detect the response to myocardial ischemia or sleep apnea state or condition of a peripheral arterial tone to provide the state or condition of the indication”), wherein the apparatus is configured to:
electronically obtain:
an optical plethysmography signal measured at an investigated volume of an individual ([0062]: “Changes in arterial blood volume can be determined using one or more parameters of plethysmography, such as the volume of the finger or optical density.”; [0056]: “Another existing method is to use a photographic volumetric recording device that includes a light transmitter and a light receiver placed on the opposite side of the fingertip”);
light acquired by optical plethysmography at two or more points in time along said optical plethysmography signal ([0212]: “the finger probe 2 is used to measure the volume change (as a function of time) at the tip of the monitored finger (or toe) in response to a blood pressure wave”; [0250]: “The processor 23 processes the measured changes in finger volume (or optical density) to produce a volume measurement output 24a and/or a volume measurement output 24b that varies with time”; [0062]: “Changes in arterial blood volume can be determined using one or more parameters of plethysmography, such as the volume of the finger or optical density.”; [0056]: “Another existing method is to use a photographic volumetric recording device that includes a light transmitter and a light receiver placed on the opposite side of the fingertip”).
However, Goor does not teach measuring the intensity of the light signals.
Brumfield discloses an apparatus and method for assessing peripheral circulation. Specifically, Brumfield teaches obtaining light intensities of the measurements ([0257]: “Analysis of the pulse volume (PV) 4020 of the pulsatile or alternating current (AC) component of the photoplethysmograph blood flow signal can also be used to determine blood flow characteristics. Normalized pulse volume (NPV) can be determined by dividing the AC component of the signal by the baseline transmitted light level (DC) as shown in equation (8). NPV=AC/DC (8) DNPV=(.DELTA.Vb/Vb) (9) NPV.about.=.DELTA.Vb (10) DNPV=NPV/ln(I/It)”). Goor and Brumfield are analogous arts as they are both related to determining parameters of peripheral circulation of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the measurement of the light intensities from Brumfield into the apparatus from Goor as Goor is silent on the method used to determine blood volume from the photoplethysmography signals, and Brumfield discloses a suitable determination in an analogous device.
The Goor/Brumfield combination teaches obtaining an oxygen saturation estimate (Goor, [0289]: “each time apnea occurs, the output signal of the local ischemia recorder (labeled ISCH) exhibits a repetitive characteristic pattern with the time curve of oxygen saturation (SaO<sub>2</sub>”); and
calibration data (Goor, [0122]: “a method for calibrating a blood pressure measuring instrument is provided, comprising inducing and monitoring changes in static pressure within a measured artery by changing the vertical position of a measuring point relative to the heart, measuring corresponding quantities and other quantities associated with characteristics of the artery, and then plotting these measurements and the induced static pressure changes to generate compliance curves of the vessels”; [0132]-[0134]: “The fingers or toes are placed vertically in multiple vertical positions relative to the subject's heart; The static pressure superimposed on the blood pressure of the subject when the subject's fingers or toes are in each vertical position relative to the subject's heart; The predetermined external counterpressure and the static pressure measurement are used to calibrate the change in the measured amount of arterial blood pressure at the outer end of the subject's fingers or toes, and the change in the measured amount is converted into arterial blood pressure”).
However, the Goor/Brumfield combination does not teach the relation between oxygen saturation and peripheral arterial tone.
Yalamanchali discloses a relation between oxygen saturation and peripheral arterial tone (Page 3: “The WatchPAT (Figure 1) is a unique, wrist-worn ambulatory sleep study device that uses PAT in conjunction with pulse oximetry and actigraphy to assess respiratory disturbances. Given that obstruction-induced transient elevations of sympathetic tone have been associated with arousals from sleep,10- 16 the WatchPAT device indirectly detects apnea and hypopnea via selectively measuring peripheral arterial volume changes (mediated by α-adrenergic receptors of vascular smooth muscle) using a finger-mounted plethysmograph. The information is collated with pulse oximetry (detection of oxygen desaturation) in conjunction with heart rate and is further analyzed using a predeveloped automated algorithm. This algorithm associates arousals with measurement of oxygen desaturation levels to determine respiratory effort–related arousals. Furthermore, with the advantage of eliminating interscorer variability, this relatively novel approach has been proposed to offer an accurate, reproducible, and simple alternative to PSG. Multiple studies have demonstrated high correlation of sleep indexes measured by PAT, such as the respiratory disturbance index (RDI) or the apnea-hypopnea index (AHI), compared with the same indexes measured by formal PSG.”). Goor, Brumfield, and Yalamanchali are analogous arts as they are all related to the determination of peripheral circulation.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include oxygen saturation in the determination of peripheral arterial tone as it is shown to have an effect on PAT, therefore it is an important parameter to include in the determination.
However, the Goor/Brumfield/Yalamanchali combination does not teach determining a function in relation to the oxygen saturation.
Jacques discloses a method of determining arterial blood oxygen saturation with light transmitted through the tissue. Specifically, Jacques discloses obtaining determining a compensation function from said oxygen saturation estimate and said calibration data; wherein said compensation function is a function of said oxygen saturation estimate ([0145]: “The function getSaO2( ) uses the normalized light measurement data [mTred, mTir] to specify the blood volume fraction and mixed blood oxygen saturation values [fv, SmO2], which in turn specify a calibration curve for S.sub.aO.sub.2 as a function of R that has been summarized as a second-order polynomial. The polynomial is used to convert the pulsatile measurement mR into a predicted S.sub.aO.sub.2. The final answer is the predicted S.sub.aO.sub.2.”). Goor, Brumfield and Jacques are analogous arts as they are all related to determining health parameters of a user using light transmittance through tissue.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the compensation function from Jacques into the Goor/Brumfield/Yalamanchali combination as it allows the combination to include calibration information into the PAT determination, and the combination is silent on to how the calibration information is incorporated into the PAT determination.
However, the Goor/Brumfield/Yalamanchali/Jacques combination is silent on the relation between the light intensities and the compensation function.
Schnall discloses an apparatus for monitoring peripheral arterial tone in a user. Specifically, Schnall teaches electronically determining a ratio of a function of said light intensities and said compensation function (Page 1, lines 10-12: “The present invention relates to apparatus for monitoring arterial pulse waves in diagnosing various medical conditions. The invention is particularly useful in relation to the methods and apparatus for measuring the peripheral arterial tone of a subject”; Page 13, lines 10-17: “The quantitative analysis of incomplete arterial occlusion may be determined by measuring the absolute amplitude of detected arterial pulse signals, as indicated 700 in Fig. 17, or by dividing the amplitude of detected arterial pulse signals, as indicated at 705 in Fig. 17, during occlusion by the corresponding arterial pulse signals, as indicated at 706, or by for example the mean amplitude of the occluded side baseline arterial pulse signals amplitude as indicated at 701 or 704. The resulting ratios can thus provide relative indices of incomplete arterial occlusion, when their value exceeds a predetermined threshold value.”; Fig. 17. Oxygen saturation can be indicative of occlusion, therefore the ratio used by dividing pre-occlusion by post-occlusion teaches on the claimed ratio.). Goor, Brumfield, Yalamanchali, and Schnall are analogous arts as they are all related to determining parameters related to peripheral circulation.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the ratio from Schnall into the Goor/Brumfield/Yalamanchali/Jacques combination as the combination is silent on the relation, and Schnall discloses a suitable relation.
The Goor/Brumfield/Yalamanchali/Jacques/Schnall combination teaches thereby evaluating changes in arterial blood volume in said investigated volume between said two or more points in time and hereby assessing the peripheral arterial tone (PAT) of said individual (Goor, [0062]: “Therefore, what is disclosed here are methods and devices for non-invasive monitoring of peripheral arterial tone. Although changes in peripheral arterial tone can be detected by monitoring various other hemodynamic parameters of any peripheral artery, such as changes in blood flow, blood volume, and the shape of the arterial pulse wave, it is best to detect changes in the pulsatility of arterial blood at that location by drawing a signal from the patient's finger or toe. Changes in arterial blood volume can be determined using one or more parameters of plethysmography, such as the volume of the finger or optical density”).
Regarding claim 13, the Goor/Brumfield/Yalamanchali/Jacques/Schnall combination teaches a system comprising an apparatus according to claim 12, and further comprising:
a light source configured to emit light; and a sensor configured to collect by optical plethysmography propagated light corresponding to said light being transmitted or reflected when propagating in a distal end of a digit of said individual at said two or more points in time; and further configured to determine said light intensities of said propagated light at said two or more points in time (Goor, [0062]: “Changes in arterial blood volume can be determined using one or more parameters of plethysmography, such as the volume of the finger or optical density.”; [0056]: “Another existing method is to use a photographic volumetric recording device that includes a light transmitter and a light receiver placed on the opposite side of the fingertip”; [0212]: “the finger probe 2 is used to measure the volume change (as a function of time) at the tip of the monitored finger (or toe) in response to a blood pressure wave”; [0250]: “The processor 23 processes the measured changes in finger volume (or optical density) to produce a volume measurement output 24a and/or a volume measurement output 24b that varies with time”).
Regarding independent claim 15, Goor teaches a computer readable storage medium comprising computer-executable instructions for controlling operation of a computer, said computer-executable instructions comprising ([0093]: “A processor that receives signals from the probe and provides an output signal indicating changes in the tension of the peripheral arteries in the finger or toe, thereby indicating the patient's physiological state or health condition”; [0322]: “the curve shown in Figure 25 can be stored in the memory of the processor 23”):
instructions to electronically obtain:
an optical plethysmography signal measured at an investigated volume of an individual ([0062]: “Changes in arterial blood volume can be determined using one or more parameters of plethysmography, such as the volume of the finger or optical density.”; [0056]: “Another existing method is to use a photographic volumetric recording device that includes a light transmitter and a light receiver placed on the opposite side of the fingertip”);
light acquired by optical plethysmography at two or more points in time along said optical plethysmography signal ([0212]: “the finger probe 2 is used to measure the volume change (as a function of time) at the tip of the monitored finger (or toe) in response to a blood pressure wave”; [0250]: “The processor 23 processes the measured changes in finger volume (or optical density) to produce a volume measurement output 24a and/or a volume measurement output 24b that varies with time”; [0062]: “Changes in arterial blood volume can be determined using one or more parameters of plethysmography, such as the volume of the finger or optical density.”; [0056]: “Another existing method is to use a photographic volumetric recording device that includes a light transmitter and a light receiver placed on the opposite side of the fingertip”).
However, Goor does not teach measuring the intensity of the light signals.
Brumfield discloses an apparatus and method for assessing peripheral circulation. Specifically, Brumfield teaches obtaining light intensities of the measurements ([0257]: “Analysis of the pulse volume (PV) 4020 of the pulsatile or alternating current (AC) component of the photoplethysmograph blood flow signal can also be used to determine blood flow characteristics. Normalized pulse volume (NPV) can be determined by dividing the AC component of the signal by the baseline transmitted light level (DC) as shown in equation (8). NPV=AC/DC (8) DNPV=(.DELTA.Vb/Vb) (9) NPV.about.=.DELTA.Vb (10) DNPV=NPV/ln(I/It)”). Goor and Brumfield are analogous arts as they are both related to determining parameters of peripheral circulation of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the measurement of the light intensities from Brumfield into the apparatus from Goor as Goor is silent on the method used to determine blood volume from the photoplethysmography signals, and Brumfield discloses a suitable determination in an analogous device.
The Goor/Brumfield combination teaches obtaining an oxygen saturation estimate (Goor, [0289]: “each time apnea occurs, the output signal of the local ischemia recorder (labeled ISCH) exhibits a repetitive characteristic pattern with the time curve of oxygen saturation (SaO<sub>2</sub>”); and
calibration data (Goor, [0122]: “a method for calibrating a blood pressure measuring instrument is provided, comprising inducing and monitoring changes in static pressure within a measured artery by changing the vertical position of a measuring point relative to the heart, measuring corresponding quantities and other quantities associated with characteristics of the artery, and then plotting these measurements and the induced static pressure changes to generate compliance curves of the vessels”; [0132]-[0134]: “The fingers or toes are placed vertically in multiple vertical positions relative to the subject's heart; The static pressure superimposed on the blood pressure of the subject when the subject's fingers or toes are in each vertical position relative to the subject's heart; The predetermined external counterpressure and the static pressure measurement are used to calibrate the change in the measured amount of arterial blood pressure at the outer end of the subject's fingers or toes, and the change in the measured amount is converted into arterial blood pressure”).
However, the Goor/Brumfield combination does not teach the relation between oxygen saturation and peripheral arterial tone.
Yalamanchali discloses a relation between oxygen saturation and peripheral arterial tone (Page 3: “The WatchPAT (Figure 1) is a unique, wrist-worn ambulatory sleep study device that uses PAT in conjunction with pulse oximetry and actigraphy to assess respiratory disturbances. Given that obstruction-induced transient elevations of sympathetic tone have been associated with arousals from sleep,10- 16 the WatchPAT device indirectly detects apnea and hypopnea via selectively measuring peripheral arterial volume changes (mediated by α-adrenergic receptors of vascular smooth muscle) using a finger-mounted plethysmograph. The information is collated with pulse oximetry (detection of oxygen desaturation) in conjunction with heart rate and is further analyzed using a predeveloped automated algorithm. This algorithm associates arousals with measurement of oxygen desaturation levels to determine respiratory effort–related arousals. Furthermore, with the advantage of eliminating interscorer variability, this relatively novel approach has been proposed to offer an accurate, reproducible, and simple alternative to PSG. Multiple studies have demonstrated high correlation of sleep indexes measured by PAT, such as the respiratory disturbance index (RDI) or the apnea-hypopnea index (AHI), compared with the same indexes measured by formal PSG.”). Goor, Brumfield, and Yalamanchali are analogous arts as they are all related to the determination of peripheral circulation.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include oxygen saturation in the determination of peripheral arterial tone as it is shown to have an effect on PAT, therefore it is an important parameter to include in the determination.
However, the Goor/Brumfield/Yalamanchali combination does not teach determining a function in relation to the oxygen saturation.
Jacques discloses a method of determining arterial blood oxygen saturation with light transmitted through the tissue. Specifically, Jacques discloses instructions to electronically determine a compensation function from said oxygen saturation estimate and said calibration data; wherein said compensation function is a function of said oxygen saturation estimate ([0145]: “The function getSaO2( ) uses the normalized light measurement data [mTred, mTir] to specify the blood volume fraction and mixed blood oxygen saturation values [fv, SmO2], which in turn specify a calibration curve for S.sub.aO.sub.2 as a function of R that has been summarized as a second-order polynomial. The polynomial is used to convert the pulsatile measurement mR into a predicted S.sub.aO.sub.2. The final answer is the predicted S.sub.aO.sub.2.”). Goor, Brumfield and Jacques are analogous arts as they are all related to determining health parameters of a user using light transmittance through tissue.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the compensation function from Jacques into the Goor/Brumfield/Yalamanchali combination as it allows the combination to include calibration information into the PAT determination, and the combination is silent on to how the calibration information is incorporated into the PAT determination.
However, the Goor/Brumfield/Yalamanchali/Jacques combination is silent on the relation between the light intensities and the compensation function.
Schnall discloses an apparatus for monitoring peripheral arterial tone in a user. Specifically, Schnall teaches instructions to electronically determine a ratio of a function of said light intensities and said compensation function (Page 1, lines 10-12: “The present invention relates to apparatus for monitoring arterial pulse waves in diagnosing various medical conditions. The invention is particularly useful in relation to the methods and apparatus for measuring the peripheral arterial tone of a subject”; Page 13, lines 10-17: “The quantitative analysis of incomplete arterial occlusion may be determined by measuring the absolute amplitude of detected arterial pulse signals, as indicated 700 in Fig. 17, or by dividing the amplitude of detected arterial pulse signals, as indicated at 705 in Fig. 17, during occlusion by the corresponding arterial pulse signals, as indicated at 706, or by for example the mean amplitude of the occluded side baseline arterial pulse signals amplitude as indicated at 701 or 704. The resulting ratios can thus provide relative indices of incomplete arterial occlusion, when their value exceeds a predetermined threshold value.”; Fig. 17. Oxygen saturation can be indicative of occlusion, therefore the ratio used by dividing pre-occlusion by post-occlusion teaches on the claimed ratio.). Goor, Brumfield, Yalamanchali, and Schnall are analogous arts as they are all related to determining parameters related to peripheral circulation.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the ratio from Schnall into the Goor/Brumfield/Yalamanchali/Jacques combination as the combination is silent on the relation, and Schnall discloses a suitable relation.
The Goor/Brumfield/Yalamanchali/Jacques/Schnall combination teaches thereby evaluating changes in arterial blood volume in said investigated volume between said two or more points in time and hereby assessing the peripheral arterial tone (PAT) of said individual (Goor, [0062]: “Therefore, what is disclosed here are methods and devices for non-invasive monitoring of peripheral arterial tone. Although changes in peripheral arterial tone can be detected by monitoring various other hemodynamic parameters of any peripheral artery, such as changes in blood flow, blood volume, and the shape of the arterial pulse wave, it is best to detect changes in the pulsatility of arterial blood at that location by drawing a signal from the patient's finger or toe. Changes in arterial blood volume can be determined using one or more parameters of plethysmography, such as the volume of the finger or optical density”).
Regarding claim 17, the Goor/Brumfield/Yalamanchali/Jacques/Schnall combination teaches the apparatus according to claim 12, wherein at least one of said points in time corresponds to the diastole in a cardiac cycle of said individual and/or wherein at least one of said points in time corresponds to the systole in a cardiac cycle of said individual (Goor, [0056]: “Another existing method is to use a photographic volumetric recording device that includes a light transmitter and a light receiver placed on the opposite side of the fingertip. The receiver records the changes in light transmission through the finger caused by changes in blood flow within the artery. The received signal is transmitted to a computer, which converts the receiver's output signal into systolic and diastolic blood pressure data”).
Regarding claim 18, the Goor/Brumfield/Yalamanchali/Jacques/Schnall combination teaches the apparatus according to claim 12, further configured to determine an evaluation function which is said function of said light intensities, and wherein the ratio is a ratio of said evaluation function and said compensation function (Brumfield, [0257]: “Analysis of the pulse volume (PV) 4020 of the pulsatile or alternating current (AC) component of the photoplethysmograph blood flow signal can also be used to determine blood flow characteristics. Normalized pulse volume (NPV) can be determined by dividing the AC component of the signal by the baseline transmitted light level (DC) as shown in equation (8). NPV=AC/DC (8) DNPV=(.DELTA.Vb/Vb) (9) NPV.about.=.DELTA.Vb (10) DNPV=NPV/ln(I/It)”; Schnall, Page 1, lines 10-12: “The present invention relates to apparatus for monitoring arterial pulse waves in diagnosing various medical conditions. The invention is particularly useful in relation to the methods and apparatus for measuring the peripheral arterial tone of a subject”; Page 13, lines 10-17: “The quantitative analysis of incomplete arterial occlusion may be determined by measuring the absolute amplitude of detected arterial pulse signals, as indicated 700 in Fig. 17, or by dividing the amplitude of detected arterial pulse signals, as indicated at 705 in Fig. 17, during occlusion by the corresponding arterial pulse signals, as indicated at 706, or by for example the mean amplitude of the occluded side baseline arterial pulse signals amplitude as indicated at 701 or 704. The resulting ratios can thus provide relative indices of incomplete arterial occlusion, when their value exceeds a predetermined threshold value.”; Fig. 17. Oxygen saturation can be indicative of occlusion, therefore the ratio used by dividing pre-occlusion by post-occlusion teaches on the claimed ratio.).
Regarding claim 19, the Goor/Brumfield/Yalamanchali/Jacques/Schnall combination teaches the apparatus according to claim 18, wherein said evaluation function corresponds to a logarithm of another function of said light intensities (Brumfield, [0257]: “Analysis of the pulse volume (PV) 4020 of the pulsatile or alternating current (AC) component of the photoplethysmograph blood flow signal can also be used to determine blood flow characteristics. Normalized pulse volume (NPV) can be determined by dividing the AC component of the signal by the baseline transmitted light level (DC) as shown in equation (8). NPV=AC/DC (8) DNPV=(.DELTA.Vb/Vb) (9) NPV.about.=.DELTA.Vb (10) DNPV=NPV/ln(I/It)”).
Regarding claim 20, the Goor/Brumfield/Yalamanchali/Jacques/Schnall combination teaches the apparatus of claim 18, wherein said evaluation function corresponds to a logarithm of a ratio of said light intensities, wherein said evaluation function depends on one or more of the following: an optical path length; said oxygen saturation estimate; and said changes in arterial blood volume in said investigated volume (Brumfield, [0257]: “Analysis of the pulse volume (PV) 4020 of the pulsatile or alternating current (AC) component of the photoplethysmograph blood flow signal can also be used to determine blood flow characteristics. Normalized pulse volume (NPV) can be determined by dividing the AC component of the signal by the baseline transmitted light level (DC) as shown in equation (8). NPV=AC/DC (8) DNPV=(.DELTA.Vb/Vb) (9) NPV.about.=.DELTA.Vb (10) DNPV=NPV/ln(I/It)”).
Claims 2 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over the Goor/Brumfield/Yalamanchali/Jacques/Schnall combination as applied to claims 1 and 12 above, and further in view of Watson (US 20090326353).
Regarding claim 2, the Goor/Brumfield/Yalamanchali/Jacques/Schnall combination teaches the method according to claim 1.
However, the Goor/Brumfield/Yalamanchali/Jacques/Schnall does not teach wherein said calibration data comprises predetermined calibration coefficients and/or predefined coefficients; and wherein: said determining said compensation function corresponds to deriving said compensation function from said predefined coefficients; or said determining said compensation function corresponds to determining said predetermined calibration coefficients by fitting said oxygen saturation estimate to a calibration ratio.
Watson discloses a system to analyze changes in signals. Specifically, Watson teaches wherein said calibration data comprises predetermined calibration coefficients and/or predefined coefficients ([0057]: “this information may be used by monitor 14 to select appropriate algorithms, lookup tables and/or calibration coefficients stored in monitor 14 for calculating the patient's physiological parameters.”). Goor, Brumfield, Yalamanchali, Schnall, and Watson are analogous arts as they are all related to determining health parameters of a user using light transmittance through tissue.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the calibration coefficients in the evaluation as it allows the function to compensate for important factors, which can ensure the method is providing the most accurate result.
Therefore, the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson combination teaches wherein said calibration data comprises predetermined calibration coefficients and/or predefined coefficients (Watson, [0057]: “this information may be used by monitor 14 to select appropriate algorithms, lookup tables and/or calibration coefficients stored in monitor 14 for calculating the patient's physiological parameters.”); and wherein: said determining said compensation function corresponds to deriving said compensation function from said predefined coefficients (Jacques, ([0145]: “The function getSaO2( ) uses the normalized light measurement data [mTred, mTir] to specify the blood volume fraction and mixed blood oxygen saturation values [fv, SmO2], which in turn specify a calibration curve for S.sub.aO.sub.2 as a function of R that has been summarized as a second-order polynomial. The polynomial is used to convert the pulsatile measurement mR into a predicted S.sub.aO.sub.2. The final answer is the predicted S.sub.aO.sub.2.”); or said determining said compensation function corresponds to determining said predetermined calibration coefficients by fitting said oxygen saturation estimate to a calibration ratio.
Regarding claim 16, the Goor/Brumfield/Yalamanchali/Jacques/Schnall combination teaches the apparatus according to claim 12.
However, the Goor/Brumfield/Yalamanchali/Jacques/Schnall does not teach wherein said calibration data comprises predetermined calibration coefficients and/or predefined coefficients; and wherein: said determining said compensation function corresponds to deriving said compensation function from said predefined coefficients; or said determining said compensation function corresponds to determining said predetermined calibration coefficients by fitting said oxygen saturation estimate to a calibration ratio.
Watson discloses a system to analyze changes in signals. Specifically, Watson teaches wherein said calibration data comprises predetermined calibration coefficients and/or predefined coefficients ([0057]: “this information may be used by monitor 14 to select appropriate algorithms, lookup tables and/or calibration coefficients stored in monitor 14 for calculating the patient's physiological parameters.”). Goor, Brumfield, Yalamanchali, Schnall, and Watson are analogous arts as they are all related to determining health parameters of a user using light transmittance through tissue.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the calibration coefficients in the evaluation as it allows the function to compensate for important factors, which can ensure the method is providing the most accurate result.
Therefore, the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson combination teaches wherein said calibration data comprises predetermined calibration coefficients and/or predefined coefficients (Watson, [0057]: “this information may be used by monitor 14 to select appropriate algorithms, lookup tables and/or calibration coefficients stored in monitor 14 for calculating the patient's physiological parameters.”); and wherein: said determining said compensation function corresponds to deriving said compensation function from said predefined coefficients (Jacques, ([0145]: “The function getSaO2( ) uses the normalized light measurement data [mTred, mTir] to specify the blood volume fraction and mixed blood oxygen saturation values [fv, SmO2], which in turn specify a calibration curve for S.sub.aO.sub.2 as a function of R that has been summarized as a second-order polynomial. The polynomial is used to convert the pulsatile measurement mR into a predicted S.sub.aO.sub.2. The final answer is the predicted S.sub.aO.sub.2.”); or said determining said compensation function corresponds to determining said predetermined calibration coefficients by fitting said oxygen saturation estimate to a calibration ratio.
Claims 7-9 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson combination as applied to claims 2 and 16 above, and further in view of Morimoto (WO 2014073360). Citations to WO 2014073360 will refer to the English Machine Translation that accompanies this Office Action.
Regarding claim 7, the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson combination teaches the method according to claim 2, further comprising: providing a first light source configured to emit light at a first wavelength (Goor, [0056]: “Another existing method is to use a photographic volumetric recording device that includes a light transmitter and a light receiver placed on the opposite side of the fingertip”).
However, the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson combination does not disclose using multiple light sources at different wavelengths.
Morimoto discloses an endoscope that uses light intensity and blood oxygen saturation to analyze blood volume. Specifically, Morimoto teaches providing a first light source configured to emit light at a first wavelength (Page 11: “This first laser light is wavelength-converted to fluorescence having a wavelength range from green to red by the phosphor 50 (wavelength conversion member) disposed at the scope distal end portion 19 of the endoscope apparatus 12” ) and providing a second light source configured to emit light at a second wavelength (Page 11: “The laser light source LD2 emits a second laser beam having a center wavelength of 445 nm”). Goor, Brumfield, Jacques, and Morimoto are analogous arts as they are all related to determining health parameters of a user using light transmittance through tissue.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the multiple light sources at different wavelengths from Morimoto into the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson combination as it allows the device to measure multiple factors, which can provide more information to the device and create a more accurate result.
The Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson/Morimoto combination teaches providing a sensor (Goor, [0079]: “Figure 11 illustrates another embodiment of the finger detector of the present invention, wherein the detector includes an optical senso”); collecting, by optical plethysmography and on said sensor, propagated light corresponding to said light being transmitted or reflected when propagating in said investigated volume of said individual at said two or more points in time (Goor, [0062]: “Changes in arterial blood volume can be determined using one or more parameters of plethysmography, such as the volume of the finger or optical density.”; [0056]: “Another existing method is to use a photographic volumetric recording device that includes a light transmitter and a light receiver placed on the opposite side of the fingertip”; [0212]: “the finger probe 2 is used to measure the volume change (as a function of time) at the tip of the monitored finger (or toe) in response to a blood pressure wave”; [0250]: “The processor 23 processes the measured changes in finger volume (or optical density) to produce a volume measurement output 24a and/or a volume measurement output 24b that varies with time”); for said first wavelength, determining first light intensities of said propagated light on said sensor at said two or more points in time (Brumfield, [0257]: “Analysis of the pulse volume (PV) 4020 of the pulsatile or alternating current (AC) component of the photoplethysmograph blood flow signal can also be used to determine blood flow characteristics. Normalized pulse volume (NPV) can be determined by dividing the AC component of the signal by the baseline transmitted light level (DC) as shown in equation (8). NPV=AC/DC (8) DNPV=(.DELTA.Vb/Vb) (9) NPV.about.=.DELTA.Vb (10) DNPV=NPV/ln(I/It)”); for said second wavelength, determining second light intensities of said propagated light on said sensor at said two or more points in time (Goor, [0062]: “Changes in arterial blood volume can be determined using one or more parameters of plethysmography, such as the volume of the finger or optical density.”; [0056]: “Another existing method is to use a photographic volumetric recording device that includes a light transmitter and a light receiver placed on the opposite side of the fingertip”; [0212]: “the finger probe 2 is used to measure the volume change (as a function of time) at the tip of the monitored finger (or toe) in response to a blood pressure wave”; [0250]: “The processor 23 processes the measured changes in finger volume (or optical density) to produce a volume measurement output 24a and/or a volume measurement output 24b that varies with time”); determining a first ratio corresponding to a ratio of said first light intensities at said first wavelength; determining a second ratio corresponding to a ratio of said second light intensities at said second wavelength; determining said calibration ratio of a function of said first ratio and of a function of said second ratio; and fitting said oxygen saturation estimate to said calibration ratio thereby determining said predetermined calibration coefficients (Brumfield, [0257]: “Analysis of the pulse volume (PV) 4020 of the pulsatile or alternating current (AC) component of the photoplethysmograph blood flow signal can also be used to determine blood flow characteristics. Normalized pulse volume (NPV) can be determined by dividing the AC component of the signal by the baseline transmitted light level (DC) as shown in equation (8). NPV=AC/DC (8) DNPV=(.DELTA.Vb/Vb) (9) NPV.about.=.DELTA.Vb (10) DNPV=NPV/ln(I/It)”; Watson, [0057]: “this information may be used by monitor 14 to select appropriate algorithms, lookup tables and/or calibration coefficients stored in monitor 14 for calculating the patient's physiological parameters.”).
Regarding claim 8, the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson/Morimoto combination teaches the method according to claim 7, further comprising: collecting, by optical plethysmography and on said sensor, the propagated light corresponding to light at said first wavelength or at said second wavelength being transmitted or reflected when propagating in said investigated volume of said individual at said two or more points in time; and determining said light intensities of said propagated light on said sensor at said two or more points in time (Brumfield, [0257]: “Analysis of the pulse volume (PV) 4020 of the pulsatile or alternating current (AC) component of the photoplethysmograph blood flow signal can also be used to determine blood flow characteristics. Normalized pulse volume (NPV) can be determined by dividing the AC component of the signal by the baseline transmitted light level (DC) as shown in equation (8). NPV=AC/DC (8) DNPV=(.DELTA.Vb/Vb) (9) NPV.about.=.DELTA.Vb (10) DNPV=NPV/ln(I/It)”).
Regarding claim 9, the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson/Morimoto combination teaches the method according to claim 7, further comprising determining said oxygen saturation estimate in the a vicinity of said investigated volume of said individual (Goor, [0289]: “each time apnea occurs, the output signal of the local ischemia recorder (labeled ISCH) exhibits a repetitive characteristic pattern with the time curve of oxygen saturation (SaO<sub>2</sub>”).
Regarding claim 21, the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson combination teaches the apparatus according to claim 16, further comprising: a first light source configured to emit light at a first wavelength (Goor, [0056]: “Another existing method is to use a photographic volumetric recording device that includes a light transmitter and a light receiver placed on the opposite side of the fingertip”).
However, the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson combination does not disclose using multiple light sources at different wavelengths.
Morimoto discloses an endoscope that uses light intensity and blood oxygen saturation to analyze blood volume. Specifically, Morimoto teaches a first light source configured to emit light at a first wavelength (Page 11: “This first laser light is wavelength-converted to fluorescence having a wavelength range from green to red by the phosphor 50 (wavelength conversion member) disposed at the scope distal end portion 19 of the endoscope apparatus 12” ) and a second light source configured to emit light at a second wavelength (Page 11: “The laser light source LD2 emits a second laser beam having a center wavelength of 445 nm”). Goor, Brumfield, Jacques, and Morimoto are analogous arts as they are all related to determining health parameters of a user using light transmittance through tissue.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the multiple light sources at different wavelengths from Morimoto into the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson combination as it allows the device to measure multiple factors, which can provide more information to the device and create a more accurate result.
The Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson/Morimoto combination teaches a sensor (Goor, [0079]: “Figure 11 illustrates another embodiment of the finger detector of the present invention, wherein the detector includes an optical senso”); collect, by optical plethysmography and on said sensor, propagated light corresponding to said light being transmitted or reflected when propagating in said investigated volume of said individual at said two or more points in time (Goor, [0062]: “Changes in arterial blood volume can be determined using one or more parameters of plethysmography, such as the volume of the finger or optical density.”; [0056]: “Another existing method is to use a photographic volumetric recording device that includes a light transmitter and a light receiver placed on the opposite side of the fingertip”; [0212]: “the finger probe 2 is used to measure the volume change (as a function of time) at the tip of the monitored finger (or toe) in response to a blood pressure wave”; [0250]: “The processor 23 processes the measured changes in finger volume (or optical density) to produce a volume measurement output 24a and/or a volume measurement output 24b that varies with time”); for said first wavelength, determine first light intensities of said propagated light on said sensor at said two or more points in time (Brumfield, [0257]: “Analysis of the pulse volume (PV) 4020 of the pulsatile or alternating current (AC) component of the photoplethysmograph blood flow signal can also be used to determine blood flow characteristics. Normalized pulse volume (NPV) can be determined by dividing the AC component of the signal by the baseline transmitted light level (DC) as shown in equation (8). NPV=AC/DC (8) DNPV=(.DELTA.Vb/Vb) (9) NPV.about.=.DELTA.Vb (10) DNPV=NPV/ln(I/It)”); for said second wavelength, determine second light intensities of said propagated light on said sensor at said two or more points in time (Goor, [0062]: “Changes in arterial blood volume can be determined using one or more parameters of plethysmography, such as the volume of the finger or optical density.”; [0056]: “Another existing method is to use a photographic volumetric recording device that includes a light transmitter and a light receiver placed on the opposite side of the fingertip”; [0212]: “the finger probe 2 is used to measure the volume change (as a function of time) at the tip of the monitored finger (or toe) in response to a blood pressure wave”; [0250]: “The processor 23 processes the measured changes in finger volume (or optical density) to produce a volume measurement output 24a and/or a volume measurement output 24b that varies with time”); determine a first ratio corresponding to a ratio of said first light intensities at said first wavelength; determining a second ratio corresponding to a ratio of said second light intensities at said second wavelength; determine said calibration ratio of a function of said first ratio and of a function of said second ratio; and fit said oxygen saturation estimate to said calibration ratio thereby determining said predetermined calibration coefficients (Brumfield, [0257]: “Analysis of the pulse volume (PV) 4020 of the pulsatile or alternating current (AC) component of the photoplethysmograph blood flow signal can also be used to determine blood flow characteristics. Normalized pulse volume (NPV) can be determined by dividing the AC component of the signal by the baseline transmitted light level (DC) as shown in equation (8). NPV=AC/DC (8) DNPV=(.DELTA.Vb/Vb) (9) NPV.about.=.DELTA.Vb (10) DNPV=NPV/ln(I/It)”; Watson, [0057]: “this information may be used by monitor 14 to select appropriate algorithms, lookup tables and/or calibration coefficients stored in monitor 14 for calculating the patient's physiological parameters.”).
Regarding claim 22, the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson/Morimoto combination teaches the apparatus according to claim 21, further configured to: collect, by optical plethysmography and on said sensor, the propagated light corresponding to light at said first wavelength or at said second wavelength being transmitted or reflected when propagating in said investigated volume of said individual at said two or more points in time; and determine said light intensities of said propagated light on said sensor at said two or more points in time (Brumfield, [0257]: “Analysis of the pulse volume (PV) 4020 of the pulsatile or alternating current (AC) component of the photoplethysmograph blood flow signal can also be used to determine blood flow characteristics. Normalized pulse volume (NPV) can be determined by dividing the AC component of the signal by the baseline transmitted light level (DC) as shown in equation (8). NPV=AC/DC (8) DNPV=(.DELTA.Vb/Vb) (9) NPV.about.=.DELTA.Vb (10) DNPV=NPV/ln(I/It)”).
Regarding claim 23, the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson/Morimoto combination teaches the apparatus according to claim 21, further configured to determine said oxygen saturation estimate in the a vicinity of said investigated volume of said individual (Goor, [0289]: “each time apnea occurs, the output signal of the local ischemia recorder (labeled ISCH) exhibits a repetitive characteristic pattern with the time curve of oxygen saturation (SaO<sub>2</sub>”).
Claims 10-11 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson combination as applied to claims 2 and 16 above, and further in view of Benni (EP 2503935).
Regarding claim 10, the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson combination teaches the method according to claim 2.
However, the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson combination is silent on the calculations used to evaluate the compensation function.
Benni discloses an apparatus for monitoring blood oxygenation. Specifically, Benni teaches wherein said evaluating said compensation function corresponds to determining a regression which maps said oxygen saturation estimate onto said predetermined calibration coefficients ([0032]: “A calibrated NIRS sensor affords accurate measurement of total tissue oxygen saturation, StO.sub.2, by using regression techniques by correlation to mixed venous oxygen saturation SmvO.sub.2.”). Brumfield, Jacques, Morimoto, Watson, and Benni are analogous arts as they are all related to determining health parameters of a user using light transmittance through tissue.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the analysis techniques from Benni into the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson combination as the combination is silent on the analysis steps and Benni discloses a suitable analysis in an analogous device.
Regarding claim 11, the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson/Benni combination teaches the method according to claim 10, further comprising forcing said regression to use a first-degree rational mapping when evaluating said compensation function (Benni, [0032]: “A calibrated NIRS sensor affords accurate measurement of total tissue oxygen saturation, StO.sub.2, by using regression techniques by correlation to mixed venous oxygen saturation SmvO.sub.2.”; Watson, [0033]-[0046]).
Regarding claim 24, the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson combination teaches the apparatus according to claim 16.
However, the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson combination is silent on the calculations used to evaluate the compensation function.
Benni teaches wherein to evaluate said compensation function the apparatus is configured to determine a regression which maps said oxygen saturation estimate onto said predetermined calibration coefficients ([0032]: “A calibrated NIRS sensor affords accurate measurement of total tissue oxygen saturation, StO.sub.2, by using regression techniques by correlation to mixed venous oxygen saturation SmvO.sub.2.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the analysis techniques from Benni into the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson combination as the combination is silent on the analysis steps and Benni discloses a suitable analysis in an analogous device.
Regarding claim 25, the Goor/Brumfield/Yalamanchali/Jacques/Schnall/Watson/Benni combination teaches apparatus according to claim 24, further configured to force said regression to use a first-degree rational mapping when evaluating said compensation function (Benni, [0032]: “A calibrated NIRS sensor affords accurate measurement of total tissue oxygen saturation, StO.sub.2, by using regression techniques by correlation to mixed venous oxygen saturation SmvO.sub.2.”; Watson, [0033]-[0046]).
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant has amended claims 5 and 19 to overcome the 112(b) rejections, however the amendments have raised new 112(b) issues, therefore they are rejected under 112(b).
Applicant's arguments with regard to the 101 rejection have been fully considered but they are not persuasive. Applicant argues that the claimed limitation cannot be performed in the human mind, however as stated in the 101 rejection above, all the features of the claimed limitations can be performed mentally or with the aid of pen and paper. A person could easily obtain the different signals and data types on a piece of paper. The limitation merely claims obtaining the data, which can be obtained by a person being given the gathered data on a piece of paper. Additionally, a person of ordinary skill in the art could perform the analysis, evaluation, and calculations necessary to determine a compensation function based on the data and determine a ratio of the data and use the ratio to determine the PAT of the individual. These steps are merely evaluations and calculations that can be performed mentally or with the aid of pen and paper given enough time, therefore they are drawn to abstract ideas, and the additional limitations do not qualify as significantly more, as they are simply implementing the abstract idea on a computer or storing it in a memory, which is a well-known and conventional activity in the art.
Applicant also argues that the claimed invention improves the functioning of a computer, however simply determining a compensation function and a ratio is not an improved computer function and are basic mathematical concepts that are well known within the function of a computer.
With regards to the argument that the invention improves the technical area of optical plethysmography, all steps being performed can be accomplished with established equipment and methods that are previously known, and the invention as claimed fails to distinguish itself from such.
Applicant’s arguments with respect to the 103 rejections of claims 1-13 and 15-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 09/30/2025 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791