DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status Modifier
Claim(s) 32 is/are labeled as (previously presented). However, Claim 32 has amendments within the Claim. It is assumed that the Status Modifier of Claim 32 is incorrect and the correct Status Modifier would be (currently amended). If this assumption is incorrect or not, a clarification statement regarding the status of Claim 32 is required. The amendments of Claim 32 have been entered.
Claim Objections
Claim(s) 30 is/are objected to because of the following informalities: Claim 30 states, “thereof”. Previous citations of “thereof” have been removed. It is unclear whether or not the Applicant simply missed this “thereof” in a dependent claim. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 11-14, 18-26 & 29-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goor et al. (U.S. Patent 6,322,515 B1) and further in view of Brumfield et al. (U.S. Patent Application 2006/0009700 A1).
Claim 11: Goor teaches –
A method for assessing, with one or more processors [a processor which processes the signal] (Abstract), peripheral arterial tone (PAT) [method and apparatus for the non-invasive monitoring of peripheral arterial tone] (Col. 11, Line 10-11), of an individual monitored by optical plethysmography [plethysmography of one or more parameters, such as the finger's volume, optical density etc] (Col. 11,Line 20-21) and for detecting therefrom an occurrence of a sleep-related event of said individual [detecting and monitoring various physiological states and medical conditions, in addition to…sleep apnea syndrome] (Col. 11, Line 47-53), the method comprising:
obtaining an optical plethysmography signal measured [optical density or surface-reflectivity…may be measured using a light source and light collector] (Col. 23, Line 45-48) at an investigated volume of said individual [finger (or toe) or the skin in other areas of the body] (Col. 23, Line 45-48); and
light acquired by optical plethysmography at two or more points in time along said optical plethysmography signal [detected as changes in optical density by the light receiver 101] (Col. 24, Line 5-6);
Examiner’s Note: In order to detect a change in the optical density, two or more points in time would be required from the signal.
determining changes in arterial blood volume in said investigated volume between said two or more points in time [sensing pulsatile arterial blood volume changes in the finger] (Col. 29. Line 20-21) by determining a function approximation (See Examiner’s Note below), of a function of said light [peripheral arterial tone may be detected by monitoring changes in any of a number of hemodynamic parameters such as blood flow, blood volume…to detect changes in the pulsatile volume of arterial blood of such location. The changes in the amount of blood can be determined by plethysmography of one or more parameters, such as the…optical density] (Col. 11, Line 12-21),
Examiner’s Note: The prior art explains how PAT is not measured directly but through a function of other measured parameters (changes over time in blood flow, blood volume, etc.) in order to measure the PAT (Col. 11, Line 12-21).
thereby assessing PAT of said individual [peripheral arterial tone may be detected by monitoring] (Col. 11, Line 12-13); and
determining a drop in said PAT indicative for a vasoconstriction of arteries and arterioles in said investigated volume [a drop in the magnitude of the arterial pulse wave in such digit, would indicate a drop in the arterial blood volume in such digit indicating the presence of peripheral vasoconstriction, and therefore an increase in peripheral resistance] (Col. 14, Line 15-19),
thereby detecting occurrence of a sleep-related event of said individual [detecting and monitoring various physiological states and medical conditions, in addition to…sleep apnea syndrome] (Col. 11, Line 47-53) [output indicating changes in peripheral arterial tone from which the physiological state can be determined or determining the physiological state from changes in the peripheral arterial tone and providing an output indicating the physiological state] (Claim 26) [wherein the physiological state is a sleep disordered breathing condition] (Claim 36) [wherein the sleep disordered breathing condition is obstructive sleep apnea] (Claim 39 depends from Claim 36 & 26).
Goor fails to the details with respect to the light intensities acquired by optical plethysmography. However, Brumfield teaches light intensities acquired by optical plethysmography [measuring the intensity of light reflected from the surface of the skin] (Para 0077) in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optical plethysmography of Goor to include acquiring light intensities of Brumfield in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract).
Goor fails to teach the logarithm. However, Brumfield teaches determining changes in arterial blood volume [Changes in the peripheral arterial tone may be detected by monitoring changes in any number of hemodynamic parameters such blood flow, blood volume, and the shape of the arterial wave] (Para 0004) by determining a logarithm of a function of said light intensities [pulse volume can be determined by dividing the normalized pulse volume NPV by the natural logarithm of the baseline intensity of transmitted (or reflected) light (I) from a feature (including tissue and blood) divided by the intensity of light transmitted (or reflected) (It) from only the tissue in the feature (no blood/ischemic tissue)] (Para 0258), thereby assessing PAT [Changes in the peripheral arterial tone may be detected by monitoring changes in any number of hemodynamic parameters such blood flow, blood volume, and the shape of the arterial wave] (Para 0004) in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optical plethysmography of Goor to include acquiring light intensities of Brumfield in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract).
Claim 12/11: Goor fails to teach a ratio. However, Brumfield teaches wherein said function of said light intensities corresponds to a ratio of said light intensities [DNPV=NPV/ln(I/It)] (Para 0257 and Equation 11) in order to determine blood flow characteristics (Para 0255-0257) for monitoring and assessing peripheral circulation (Para 0002)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the function of Goor to include the ratio of Brumfield in order to determine blood flow characteristics (Para 0255-0257) for monitoring and assessing peripheral circulation (Para 0002).
Claim 13/11: Goor fails to teach the specifics regarding the function. However, Brumfield teaches wherein the function of said light intensities includes a first measure corresponding to the light intensity measured by a sensor [light detector] (Para 0101) of an optical plethysmography setup at a first point in time [baseline intensity of transmitted (or reflected) light (I) from a feature (including tissue and blood)] (Para 0258) and a second measure corresponding to the light intensity measured by the sensor [light detector] (Para 0101) of the optical plethysmography setup at a second point in time [the intensity of light transmitted (or reflected) (It) from only the tissue in the feature (no blood/ischemic tissue)] (Para 0258) in order to determine blood flow characteristics (Para 0255-0257) for monitoring and assessing peripheral circulation (Para 0002)
Examiner’s Note: In order to measure the baseline intensity and the intensity of the feature, the measurements would have to occur at different times as explained in Para 0258 force needs to be applied to stop blood flow into the feature.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the function of Goor to include the light intensity measurements as disclosed by Brumfield in order to determine blood flow characteristics (Para 0255-0257) for monitoring and assessing peripheral circulation (Para 0002).
Claim 14/12/11: Goor fails to teach the specifics regarding the function. However, Brumfield teaches wherein said function of said light intensities that corresponds to said ratio of said light intensities [DNPV=NPV/ln(I/It)] (Para 0257 and Equation 11) is the ratio of a first measure corresponding to the light intensity measured by a sensor of an optical plethysmography setup at a first point in time from a feature (including tissue and blood)] (Para 0258) and a second measure corresponding to the light intensity measured by the sensor of the optical plethysmography setup at a second point in time [the intensity of light transmitted (or reflected) (It) from only the tissue in the feature (no blood/ischemic tissue)] (Para 0258) in order to determine blood flow characteristics (Para 0255-0257) for monitoring and assessing peripheral circulation (Para 0002)
Examiner’s Note: In order to measure the baseline intensity and the intensity of the feature, the measurements would have to occur at different times as explained in Para 0258 force needs to be applied to stop blood flow into the feature.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the function of Goor to include the light intensity measurements as disclosed by Brumfield in order to determine blood flow characteristics (Para 0255-0257) for monitoring and assessing peripheral circulation (Para 0002)
Claim 18/11: Goor teaches further comprising:
operating a light source configured to emit light at a wavelength [light source] (Col. 24, Line 1-2);
operating a sensor to collect, by optical plethysmography, on the sensor, propagated light corresponding to light at said wavelength being transmitted or reflected when propagating in said investigated volume of said individual at said two or more points in time [light receiver] (Col. 24, Line 5-6); and
Goor fails to teach determining said light intensities. However, Brumfield teaches determining said light intensities of said propagated light on said sensor at said two or more points in time [measuring the intensity of light reflected from the surface of the skin] (Para 0077) in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optical plethysmography of Goor to include determining light intensities of Brumfield in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract).
Claim 19/11: Goor teaches further comprising:
detecting the occurrence, of the individual under monitoring, of the sleep-related event [detecting and monitoring various physiological states and medical conditions, in addition to…sleep apnea syndrome] (Col. 11, Line 47-53) [output indicating changes in peripheral arterial tone from which the physiological state can be determined or determining the physiological state from changes in the peripheral arterial tone and providing an output indicating the physiological state] (Claim 26) [wherein the physiological state is a sleep disordered breathing condition] (Claim 36) [wherein the sleep disordered breathing condition is obstructive sleep apnea] (Claim 39 depends from Claim 36 & 26) by determining a drop in value of the logarithm, or a function approximation thereof [a drop in the magnitude of the arterial pulse wave in such digit, would indicate a drop in the arterial blood volume in such digit indicating the presence of peripheral vasoconstriction, and therefore an increase in peripheral resistance] (Col. 14, Line 15-19), of the function of said light below a predetermined threshold value [an alarm 25 (e.g. audio or visual) may be actuated if this predetermined drop in measured volume occurs] (Col. 22, Line 23-25).
Goor fails to teach determining said light intensities. However, Brumfield teaches determining said light intensities of said propagated light on said sensor at said two or more points in time [measuring the intensity of light reflected from the surface of the skin] (Para 0077) in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optical plethysmography of Goor to include determining light intensities of Brumfield in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract).
Claim 20/19/11: Goor teaches wherein when the PAT is below the predetermined threshold value [an alarm 25 (e.g. audio or visual) may be actuated if this predetermined drop in measured volume occurs] (Col. 22, Line 23-25) a sleep-related event is detected [detecting and monitoring various physiological states and medical conditions, in addition to…sleep apnea syndrome] (Col. 11, Line 47-53) [output indicating changes in peripheral arterial tone from which the physiological state can be determined or determining the physiological state from changes in the peripheral arterial tone and providing an output indicating the physiological state] (Claim 26) [wherein the physiological state is a sleep disordered breathing condition] (Claim 36), and when the PAT is above the predetermined threshold value [an alarm 25 (e.g. audio or visual) may be actuated if this predetermined drop in measured volume occurs] (Col. 22, Line 23-25), no sleep-related event is detected [comprising a device for determining whether the patient is in…awake state] (Claim 29).
Claim 21/20/19/11: Goor teaches wherein the sleep-related event is sleep apnea [wherein the sleep disordered breathing condition is obstructive sleep apnea] (Claim 39).
Claim 22: Goor teaches –
A system [apparatus for non-invasively determining a physiological condition] (Abstract) comprising one or more processors [a processor which processes the signal] (Abstract) and memory [computer memory] (Col. 33, Line 4) including processor control instructions [a processing system for controlling the measurement process and collecting and processing the signals of the finger probe] (Col. 14, Line 66 – Col. 15, Line 1), wherein the one or more processors are configured, with the processor control instructions and memory, to:
obtain an optical plethysmography signal measured [optical density or surface-reflectivity…may be measured using a light source and light collector] (Col. 23, Line 45-48) at an investigated volume of said individual [finger (or toe) or the skin in other areas of the body] (Col. 23, Line 45-48), and
light acquired by optical plethysmography at two or more points in time along said optical plethysmography signal [detected as changes in optical density by the light receiver 101] (Col. 24, Line 5-6);
Examiner’s Note: In order to detect a change in the optical density, two or more points in time would be required from the signal.
determine changes in arterial blood volume in said investigated volume between said two or more points in time [sensing pulsatile arterial blood volume changes in the finger] (Col. 29. Line 20-21) by determining a function approximation (See Examiner’s Note below), of a function of said light [peripheral arterial tone may be detected by monitoring changes in any of a number of hemodynamic parameters such as blood flow, blood volume…to detect changes in the pulsatile volume of arterial blood of such location. The changes in the amount of blood can be determined by plethysmography of one or more parameters, such as the…optical density] (Col. 11, Line 12-21),
Examiner’s Note: The prior art explains how PAT is not measured directly but through a function of other measured parameters (changes over time in blood flow, blood volume, etc.) in order to measure the PAT (Col. 11, Line 12-21).
thereby assessing PAT of said individual [peripheral arterial tone may be detected by monitoring] (Col. 11, Line 12-13); and
determine a drop in said PAT indicative for a vasoconstriction of arteries and arterioles in said investigated volume [a drop in the magnitude of the arterial pulse wave in such digit, would indicate a drop in the arterial blood volume in such digit indicating the presence of peripheral vasoconstriction, and therefore an increase in peripheral resistance] (Col. 14, Line 15-19),
thereby detecting occurrence of a sleep-related event of said individual [detecting and monitoring various physiological states and medical conditions, in addition to…sleep apnea syndrome] (Col. 11, Line 47-53) [output indicating changes in peripheral arterial tone from which the physiological state can be determined or determining the physiological state from changes in the peripheral arterial tone and providing an output indicating the physiological state] (Claim 26) [wherein the physiological state is a sleep disordered breathing condition] (Claim 36) [wherein the sleep disordered breathing condition is obstructive sleep apnea] (Claim 39 depends from Claim 36 & 26).
Goor fails to the details with respect to the light intensities acquired by optical plethysmography. However, Brumfield teaches light intensities acquired by optical plethysmography [measuring the intensity of light reflected from the surface of the skin] (Para 0077) in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optical plethysmography of Goor to include acquiring light intensities of Brumfield in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract).
Goor fails to teach the logarithm. However, Brumfield teaches to determine changes in arterial blood volume [Changes in the peripheral arterial tone may be detected by monitoring changes in any number of hemodynamic parameters such blood flow, blood volume, and the shape of the arterial wave] (Para 0004) by determining a logarithm of a function of said light intensities [pulse volume can be determined by dividing the normalized pulse volume NPV by the natural logarithm of the baseline intensity of transmitted (or reflected) light (I) from a feature (including tissue and blood) divided by the intensity of light transmitted (or reflected) (It) from only the tissue in the feature (no blood/ischemic tissue)] (Para 0258), thereby assessing PAT [Changes in the peripheral arterial tone may be detected by monitoring changes in any number of hemodynamic parameters such blood flow, blood volume, and the shape of the arterial wave] (Para 0004) in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optical plethysmography of Goor to include acquiring light intensities of Brumfield in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract).
Claim 23/22: Goor teaches further comprising:
a light source configured to emit light [light source] (Col. 24, Line 1-2); and
a sensor configured to collect by optical plethysmography, 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 [light receiver] (Col. 24, Line 5-6); and
Goor fails to teach determining said light intensities. However, Brumfield teaches to determine said light intensities of said propagated light at said two or more points in time [measuring the intensity of light reflected from the surface of the skin] (Para 0077) in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optical plethysmography of Goor to include determining light intensities of Brumfield in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract).
Claim 24/22: Goor fails to teach a ratio. However, Brumfield teaches wherein said function of said light intensities corresponds to a ratio of said light intensities [DNPV=NPV/ln(I/It)] (Para 0257 and Equation 11) in order to determine blood flow characteristics (Para 0255-0257) for monitoring and assessing peripheral circulation (Para 0002)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the function of Goor to include the ratio of Brumfield in order to determine blood flow characteristics (Para 0255-0257) for monitoring and assessing peripheral circulation (Para 0002).
Claim 25/22: Goor fails to teach the specifics regarding the function. However, Brumfield teaches wherein the function of said light intensities includes a first measure corresponding to the light intensity measured by a sensor of an optical plethysmography setup at a first point in time [baseline intensity of transmitted (or reflected) light (I) from a feature (including tissue and blood)] (Para 0258) and a second measure corresponding to the light intensity measured by the sensor of the optical plethysmography setup at a second point in time [the intensity of light transmitted (or reflected) (It) from only the tissue in the feature (no blood/ischemic tissue)] (Para 0258) in order to determine blood flow characteristics (Para 0255-0257) for monitoring and assessing peripheral circulation (Para 0002)
Examiner’s Note: In order to measure the baseline intensity and the intensity of the feature, the measurements would have to occur at different times as explained in Para 0258 force needs to be applied to stop blood flow into the feature.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the function of Goor to include the light intensity measurements as disclosed by Brumfield in order to determine blood flow characteristics (Para 0255-0257) for monitoring and assessing peripheral circulation (Para 0002).
Claim 26/24/22: Goor fails to teach the specifics regarding the function. However, Brumfield teaches wherein said function of said light intensities that corresponds to said ratio of said light intensities [DNPV=NPV/ln(I/It)] (Para 0257 and Equation 11) is a ratio of a first measure corresponding to a light intensity measured by a sensor [light detector] (Para 0101) of an optical plethysmography setup at a first point in time [baseline intensity of transmitted (or reflected) light (I) from a feature (including tissue and blood)] (Para 0258) and a second measure corresponding to a light intensity measured by the sensor of the optical plethysmography setup at a second point in time [the intensity of light transmitted (or reflected) (It) from only the tissue in the feature (no blood/ischemic tissue)] (Para 0258) in order to determine blood flow characteristics (Para 0255-0257) for monitoring and assessing peripheral circulation (Para 0002)
Examiner’s Note: In order to measure the baseline intensity and the intensity of the feature, the measurements would have to occur at different times as explained in Para 0258 force needs to be applied to stop blood flow into the feature.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the function of Goor to include the light intensity measurements as disclosed by Brumfield in order to determine blood flow characteristics (Para 0255-0257) for monitoring and assessing peripheral circulation (Para 0002).
Claim 29/22: Goor teaches wherein the one or more processors are further configured, with the processor control instructions and memory, to:
operate a light source configured to emit light at a wavelength [light source] (Col. 24, Line 1-2);
operate a sensor to collect, by optical plethysmography, on the sensor, propagated light corresponding to light at said wavelength being transmitted or reflected when propagating in said investigated volume of said individual at said two or more points in time [light receiver] (Col. 24, Line 5-6); and
Goor fails to teach determining said light intensities. However, Brumfield teaches determine said light intensities of said propagated light on said sensor at said two or more points in time [measuring the intensity of light reflected from the surface of the skin] (Para 0077) in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optical plethysmography of Goor to include determining light intensities of Brumfield in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract).
Claim 30/22: Goor teaches further comprising:
detecting the occurrence at the individual under monitoring of the sleep-related event [detecting and monitoring various physiological states and medical conditions, in addition to…sleep apnea syndrome] (Col. 11, Line 47-53) [output indicating changes in peripheral arterial tone from which the physiological state can be determined or determining the physiological state from changes in the peripheral arterial tone and providing an output indicating the physiological state] (Claim 26) [wherein the physiological state is a sleep disordered breathing condition] (Claim 36) [wherein the sleep disordered breathing condition is obstructive sleep apnea] (Claim 39 depends from Claim 36 & 26) by determining a drop in value of the logarithm, or a function approximation thereof [a drop in the magnitude of the arterial pulse wave in such digit, would indicate a drop in the arterial blood volume in such digit indicating the presence of peripheral vasoconstriction, and therefore an increase in peripheral resistance] (Col. 14, Line 15-19), of the function of said light below a predetermined threshold value [an alarm 25 (e.g. audio or visual) may be actuated if this predetermined drop in measured volume occurs] (Col. 22, Line 23-25)
Goor fails to teach determining said light intensities. However, Brumfield teaches determining said light intensities of said propagated light on said sensor at said two or more points in time [measuring the intensity of light reflected from the surface of the skin] (Para 0077) in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optical plethysmography of Goor to include determining light intensities of Brumfield in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract).
Claim 31/30/22: Goor teaches wherein when the PAT is below the predetermined threshold value [an alarm 25 (e.g. audio or visual) may be actuated if this predetermined drop in measured volume occurs] (Col. 22, Line 23-25) a sleep-related event is detected [detecting and monitoring various physiological states and medical conditions, in addition to…sleep apnea syndrome] (Col. 11, Line 47-53) [output indicating changes in peripheral arterial tone from which the physiological state can be determined or determining the physiological state from changes in the peripheral arterial tone and providing an output indicating the physiological state] (Claim 26) [wherein the physiological state is a sleep disordered breathing condition] (Claim 36), and when the PAT is above the predetermined threshold value [an alarm 25 (e.g. audio or visual) may be actuated if this predetermined drop in measured volume occurs] (Col. 22, Line 23-25), no sleep-related event is detected [comprising a device for determining whether the patient is in…awake state] (Claim 29), wherein the sleep-related event is sleep apnea [wherein the sleep disordered breathing condition is obstructive sleep apnea] (Claim 39 depends from Claim 36 & 26).
Claim 32: Goor teaches –
A non-transitory computer readable storage medium [computer memory] (Col. 33, Line 4) comprising processor-executable instructions for performing a program when executed [a processing system for controlling the measurement process and collecting and processing the signals of the finger probe] (Col. 14, Line 66 – Col. 15, Line 1) on computing apparatus [a processor which processes the signal] (Abstract), the processor-executable instructions comprising:
instructions to obtain an optical plethysmography signal measured [optical density or surface-reflectivity…may be measured using a light source and light collector] (Col. 23, Line 45-48) at an investigated volume of an individual, and
light acquired by optical plethysmography at two or more points in time along said optical plethysmography signal [detected as changes in optical density by the light receiver 101] (Col. 24, Line 5-6);
Examiner’s Note: In order to detect a change in the optical density, two or more points in time would be required from the signal.
instructions to determine changes in arterial blood volume in said investigated volume between said two or more points in time [sensing pulsatile arterial blood volume changes in the finger] (Col. 29. Line 20-21) by determining a function approximation (See Examiner’s Note below), of a function of said light [peripheral arterial tone may be detected by monitoring changes in any of a number of hemodynamic parameters such as blood flow, blood volume…to detect changes in the pulsatile volume of arterial blood of such location. The changes in the amount of blood can be determined by plethysmography of one or more parameters, such as the…optical density] (Col. 11, Line 12-21),
Examiner’s Note: The prior art explains how PAT is not measured directly but through a function of other measured parameters (changes over time in blood flow, blood volume, etc.) in order to measure the PAT (Col. 11, Line 12-21).
thereby assessing PAT of said individual [peripheral arterial tone may be detected by monitoring] (Col. 11, Line 12-13); and
instructions to determine a drop in said PAT indicative for a vasoconstriction of arteries and arterioles in said investigated volume [a drop in the magnitude of the arterial pulse wave in such digit, would indicate a drop in the arterial blood volume in such digit indicating the presence of peripheral vasoconstriction, and therefore an increase in peripheral resistance] (Col. 14, Line 15-19),
thereby detecting occurrence of a sleep-related event at said individual [detecting and monitoring various physiological states and medical conditions, in addition to…sleep apnea syndrome] (Col. 11, Line 47-53) [output indicating changes in peripheral arterial tone from which the physiological state can be determined or determining the physiological state from changes in the peripheral arterial tone and providing an output indicating the physiological state] (Claim 26) [wherein the physiological state is a sleep disordered breathing condition] (Claim 36) [wherein the sleep disordered breathing condition is obstructive sleep apnea] (Claim 39 depends from Claim 36 & 26).
Goor fails to the details with respect to the light intensities acquired by optical plethysmography. However, Brumfield teaches light intensities acquired by optical plethysmography [measuring the intensity of light reflected from the surface of the skin] (Para 0077) in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optical plethysmography of Goor to include acquiring light intensities of Brumfield in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract)
Goor fails to teach the logarithm. However, Brumfield teaches to determine changes in arterial blood volume [Changes in the peripheral arterial tone may be detected by monitoring changes in any number of hemodynamic parameters such blood flow, blood volume, and the shape of the arterial wave] (Para 0004) by determining a logarithm of a function of said light intensities [pulse volume can be determined by dividing the normalized pulse volume NPV by the natural logarithm of the baseline intensity of transmitted (or reflected) light (I) from a feature (including tissue and blood) divided by the intensity of light transmitted (or reflected) (It) from only the tissue in the feature (no blood/ischemic tissue)] (Para 0258), thereby assessing PAT [Changes in the peripheral arterial tone may be detected by monitoring changes in any number of hemodynamic parameters such blood flow, blood volume, and the shape of the arterial wave] (Para 0004) in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optical plethysmography of Goor to include acquiring light intensities of Brumfield in order measure the hemodynamic parameters of a body (Para 0079) for diagnostic purposes and treatment (Abstract).
Claim(s) 15-17 & 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goor et al. (U.S. Patent 6,322,515 B1) and Brumfield et al. (U.S. Patent Application 2006/0009700 A1) and further in view of Pantelopoulos et al. (U.S. Patent Application 2017/0209055 A1)
Claim 15/14/12/11: Goor fails to teach the specifics regarding the function. However, Brumfield teaches (a) wherein the first point in time corresponds to the diastole in a first cardiac cycle and the second point in time corresponds to the systole in a second cardiac cycle different from the first cardiac cycle [averaging data across multiple pulse waveforms] (Para 0046), or (b) wherein the first point in time corresponds to the systole in a first cardiac cycle and the second point in time corresponds to the diastole in a second cardiac cycle different from the first cardiac cycle [The base of the waveform near zero corresponds to diastolic pressure. The height of the early systolic pressure (P1) relative to the diastolic pressure is labeled as “a” in the figure, which is also known as the pulse pressure. The height of the late systolic pressure (P2) relative to the diastolic pressure is labeled as “b” in the figure, which is also known as the augmentation pressure. The ratio b/a is known as the augmentation index, or peripheral augmentation index for a peripheral pulse wave] (Para 0108) in order to distinguish between the effects of different vasoactive medications in order to improve patient outcomes (Para 0108)
Examiner’s Note: Averaging the data from multiple waveforms means averaging the augmentation index, which would then include ratios from different cycles. The claim is open-ended and does not limit the claim interpretation to one ratio.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ratio of Goor in view of Brumfield to include the measurements of Pantelopoulos in order to distinguish between the effects of different vasoactive medications in order to improve patient outcomes (Para 0108)
Claim 16/14/12/11: Goor fails to teach the specifics regarding the function. However, Brumfield teaches (a) wherein the first point in time corresponds to the diastole in a cardiac cycle and the second point in time corresponds to the systole in the same cardiac cycle, or (b) the first point in time corresponds to the systole in a cardiac cycle and the second point in time corresponds to the diastole in the same cardiac cycle [The base of the waveform near zero corresponds to diastolic pressure. The height of the early systolic pressure (P1) relative to the diastolic pressure is labeled as “a” in the figure, which is also known as the pulse pressure. The height of the late systolic pressure (P2) relative to the diastolic pressure is labeled as “b” in the figure, which is also known as the augmentation pressure. The ratio b/a is known as the augmentation index, or peripheral augmentation index for a peripheral pulse wave] (Para 0108) in order to distinguish between the effects of different vasoactive medications in order to improve patient outcomes (Para 0108)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ratio of Goor in view of Brumfield to include the measurement points of Pantelopoulos in order to distinguish between the effects of different vasoactive medications in order to improve patient outcomes (Para 0108).
Claim 17/11: Goor fails to teach the specifics regarding the function. However, Brumfield teaches (a) wherein at least one of said points in time corresponds to the diastole in a cardiac cycle of said individual, and/or (b) at least one of said points in time corresponds to the systole in a cardiac cycle of said individual [The base of the waveform near zero corresponds to diastolic pressure. The height of the early systolic pressure (P1) relative to the diastolic pressure is labeled as “a” in the figure, which is also known as the pulse pressure. The height of the late systolic pressure (P2) relative to the diastolic pressure is labeled as “b” in the figure, which is also known as the augmentation pressure. The ratio b/a is known as the augmentation index, or peripheral augmentation index for a peripheral pulse wave] (Para 0108) in order to distinguish between the effects of different vasoactive medications in order to improve patient outcomes (Para 0108)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ratio of Goor in view of Brumfield to include the measurement points of Pantelopoulos in order to distinguish between the effects of different vasoactive medications in order to improve patient outcomes (Para 0108).
Claim 27/26/24/22: Goor fails to teach the specifics regarding the function. However, Brumfield teaches wherein (iii) the first point in time corresponds to the diastole in a cardiac cycle and the second point in time corresponds to the systole in the same cardiac cycle, or (iv) the first point in time corresponds to the systole in a cardiac cycle and the second point in time corresponds to the diastole in the same cardiac cycle [The base of the waveform near zero corresponds to diastolic pressure. The height of the early systolic pressure (P1) relative to the diastolic pressure is labeled as “a” in the figure, which is also known as the pulse pressure. The height of the late systolic pressure (P2) relative to the diastolic pressure is labeled as “b” in the figure, which is also known as the augmentation pressure. The ratio b/a is known as the augmentation index, or peripheral augmentation index for a peripheral pulse wave] (Para 0108) in order to distinguish between the effects of different vasoactive medications in order to improve patient outcomes (Para 0108)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ratio of Goor in view of Brumfield to include the measurement points of Pantelopoulos in order to distinguish between the effects of different vasoactive medications in order to improve patient outcomes (Para 0108).
Claim 28/22: Goor fails to teach the specifics regarding the function. However, Brumfield teaches 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 [The base of the waveform near zero corresponds to diastolic pressure. The height of the early systolic pressure (P1) relative to the diastolic pressure is labeled as “a” in the figure, which is also known as the pulse pressure. The height of the late systolic pressure (P2) relative to the diastolic pressure is labeled as “b” in the figure, which is also known as the augmentation pressure. The ratio b/a is known as the augmentation index, or peripheral augmentation index for a peripheral pulse wave] (Para 0108) in order to distinguish between the effects of different vasoactive medications in order to improve patient outcomes (Para 0108)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ratio of Goor in view of Brumfield to include the measurement points of Pantelopoulos in order to distinguish between the effects of different vasoactive medications in order to improve patient outcomes (Para 0108).
Response to Arguments
Applicant’s arguments, see Page 7, filed 01/20/2026, with respect to the Claim Objections have been fully considered and are persuasive. The Objections of the Claims have been withdrawn.
Applicant's arguments filed 01/20/2026 have been fully considered but they are not persuasive. The Applicant asserts that Goor cites no “function” let alone functions. The Applicant acknowledges that Goor teaches, “peripheral arterial tone may be detected by monitoring changes in any of a number of hemodynamic parameters such as blood flow, blood volume, and the shape of the arterial pulse wave”. The Examiner contends that Goor teaches a relationship between the peripheral arterial tone (PAT) and changes in hemodynamic parameters such as changes in blood volume. The Examiner acknowledges that the specific relationship is not disclosed but broadly a relationship between the PAT and changes in blood volume. Britannica discloses that the term, function, defines a relationship between one variable and another1. The Examiner contends that PAT is one variable and changes in blood volume is the other variable. The Examiner acknowledges that Goor fails to teach the specific rule or specific expression to define the relationship between the two variables. In other words, Goor fails to teach the specific function required but that functions are used broadly between the two vatiables. The rejection above relies on Brumfield for the specifics of the function between the two variables.
The Applicant contends that Brumfield fails to teach an assessment of PAT by the claimed functions for doing so. The Examiner respectfully disagrees. The claim limitation is directed to arterial blood volume by determining a logarithm of a function of light intensities, thereby assessing PAT. Brumfield teaches that PAT can be assessed by determining a change in blood volume (Para 0004) and blood/pulse volume [photoplethysmograph blood flow signal can include direct and alternating current components, normalized and double normalized pulse volume] (Para 0237) can be determining from the natural logarithm of light intensities (Para 0258). The Examiner contends that the claim limitation is open ended and thus additional steps or indirect steps can be disclosed in PAT assessing. The claim language is thus broad enough to be read on by the prior art of Goor in view of Brumfield as the specifics of the equation or algorithm are absent from the claim limitation. The arguments are unconvincing.
The rejection is deemed proper and is hereby maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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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/Helene Bor/Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
1 Britannica Editors. "function". Encyclopedia Britannica, 30 Apr. 2026, https://www.britannica.com/science/function-mathematics. Accessed 14 May 2026.
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