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 .
Information Disclosure Statement
The information disclosure statement filed 03/24/2026 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
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 1-11 are rejected under 35 USC § 101.
Regarding claim 1,
Step 1: Statutory category: Yes- A biometric system is disclosed, and therefore, is a device.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes- This claim recites the limitations
“detecting heart rate waveforms in the signals”, “extracting heart rate waveform features from the heart rate waveforms…”, “making one or more blood pressure estimations based…”.
This limitation, as drafted, according to its broadest reasonable interpretation,
recites a mental-process type abstract idea, which can practically be performed in the
mind and/or with the with the aid of pen and paper or with a generic computer, in a
computer environment, or merely using the generic computer as a tool to perform the
steps. One of ordinary skill in the art could ascertain a heart rate from a signal. A blood pressure estimation can be calculated with the aid of a pen and paper using values from the extracted heart rate. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- the claim recites the following additional elements of “a piezoelectric receiver” ,”a light source system configured for emitting a plurality of light pulses at a pulse repetition frequency between 10Hz and 1 MHz”, “control system configured for: controlling the light source system to emit a plurality of light pulses into biological tissue at the pulse repetition frequency, the biological tissue including blood and blood vessels at depths within the biological tissue; receiving signals from the piezoelectric receiver corresponding to acoustic waves emitted from portions of the biological tissue, the acoustic waves corresponding to photoacoustic emissions from the blood and the blood vessels caused by the plurality of light pulses”
Emitting and receiving light pulses is a form of data gathering that is a form of a pre-solution insignificant activity.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into
a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to
significantly more than the judicial exception. For these reasons, there is no inventive
concept in the claim. Further, use of a piezoelectric receiver and a control system are well-known in the art.
Accordingly, claim 1 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 2,
Step 1: Statutory category: Yes- A biometric system is disclosed, and therefore, is a device.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes- This claim is a part of the judicial exception as noted above in claim 1.
Step 2A, Prong 2, Integrated into Practical Application: No – The claim additionally recites “wherein receiving the signals from the piezoelectric receiver involves obtaining depth-discriminated signals by applying first through Nth acquisition time delays and receiving first through Nth signals during first through Nth acquisition time windows, each of the first through Nth acquisition time windows occurring after a corresponding one of the first through Nth acquisition time delays, wherein N is an integer greater than one”.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into
a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to
significantly more than the judicial exception. For these reasons, there is no inventive
concept in the claim.
Accordingly, claim 2 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claims 3,
Step 1: Statutory category: Yes- A biometric system is disclosed, and therefore, is a device.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes- This claim is a part of the judicial exception as noted above in claim 1.
Step 2A, Prong 2, Integrated into Practical Application: No – The claim additionally recites “wherein the control system is configured for receiving first signals from the piezoelectric receiver corresponding to acoustic waves emitted from the portions of the biological tissue while the biological tissue is at a first elevation relative to a user's heart and for receiving second signals from the piezoelectric receiver corresponding to acoustic waves emitted from the portions of the biological tissue while the biological tissue is at a second elevation relative to the user's heart”.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. The claim further recites a “control system”, which is a generic component that is well known in the art to be used for signal processing. For these reasons, there is no inventive concept in the claim.
Accordingly, claim 3 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 4,
Step 1: Statutory category: Yes- A biometric system is disclosed, and therefore, is a device.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes- This claim recites the limitation “determining a first subset of detected heart rate waveforms corresponding to vein heart rate waveforms”, and “determining a second subset of detected heart rate waveforms corresponding to artery heart rate waveforms”.
This limitation, as drafted, according to its broadest reasonable interpretation,
recites a mental-process type abstract idea, which can practically be performed in the
mind and/or with the with the aid of pen and paper or with a generic computer, in a
computer environment, or merely using the generic computer as a tool to perform the
steps. One of ordinary skill in the art could ascertain a heart rate from a signal. The determining steps involve grouping two subsets of waveforms as either artery heart waveforms or vein heart rate waveforms. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No – The claim does not
contain additional elements. Therefore, the claim does not integrate the judicial
exception into a practical application. The claim further recites a “control system”, which is a generic component that is well known in the art to be used for signal processing.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to
significantly more than the judicial exception. For these reasons, there is no inventive
concept in the claim. Further, use of a piezoelectric receiver and a control system are well-known in the art.
Accordingly, claim 4 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 5,
Step 1: Statutory category: Yes- A biometric system is disclosed, and therefore, is a device.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes- This claim recites the limitation “extracting a set of hemodynamic features from at least one of first subset of detected heart rate waveforms or the second subset of detected heart rate waveforms; and making a first blood pressure estimation based, at least in part, on the set of hemodynamic features”
This limitation, as drafted, according to its broadest reasonable interpretation,
recites a mental-process type abstract idea, which can practically be performed in the
mind and/or with the with the aid of pen and paper or with a generic computer, in a
computer environment, or merely using the generic computer as a tool to perform the
steps. The extracting step can take place by observing and grouping a subset of the heart waveforms for a set of hemodynamic features, which can then be used to calculated blood pressure.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No – The claim does not
contain additional elements. Therefore, the claim does not integrate the judicial
exception into a practical application.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to
significantly more than the judicial exception. For these reasons, there is no inventive
concept in the claim. Further, use a control system are well-known in the art.
Accordingly, claim 5 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 6,
Step 1: Statutory category: Yes- A biometric system is disclosed, and therefore, is a device.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes- This claim recites the limitation “d wherein extracting the set of hemodynamic features involves determining artery-vein phase shift (AVPS) data from the first subset of detected heart rate waveforms and the second subset of detected heart rate waveforms and wherein the control system is further configured for making the first blood pressure estimation based, at least in part, on the AVPS data.”
This limitation, as drafted, according to its broadest reasonable interpretation,
recites a mental-process type abstract idea, which can practically be performed in the
mind and/or with the with the aid of pen and paper or with a generic computer, in a
computer environment, or merely using the generic computer as a tool to perform the
steps. The AVPS data can be calculated with the aid of a pen and paper using the data from the first and second subset of heart rate wave forms, which can then be used to calculate the blood pressure. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to
significantly more than the judicial exception. For these reasons, there is no inventive
concept in the claim.
Accordingly, claim 6 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 7-11,
Step 1: Statutory category: Yes- A biometric system is disclosed, and therefore, is a device.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes- This claim recites the limitations “extracting one or more fiducial features from the extracted heart rate waveform features”, “making a second blood pressure estimation based, at least in part, on the one or more fiducial features”, “wherein the one or more fiducial features include one or more heart rate waveform peaks, one or more heart rate waveform valleys, one or more heart rate waveform portion widths. or combinations thereof”, “making a third blood pressure estimation based, at least in part, on the first blood pressure estimation and the second blood pressure estimation”, “wherein the third blood pressure estimation is an average of the first blood pressure estimation and the second blood pressure estimation”, “wherein the average is a weighted average”.
This limitation, as drafted, according to its broadest reasonable interpretation,
recites a mental-process type abstract idea, which can practically be performed in the
mind and/or with the with the aid of pen and paper or with a generic computer, in a
computer environment, or merely using the generic computer as a tool to perform the
steps. The steps require using different features of heart rate waveforms, and calculate multiple blood pressure estimations by taking weighted averages. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to
significantly more than the judicial exception. For these reasons, there is no inventive
concept in the claim.
Accordingly, claims 7-11 are directed to non-eligible patent subject matter and is therefore rejected.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US 20130190589 A1) in view of Lu (US 20190220642 A1).
Regarding claim 1,Chen teaches a biometric device (A photoacoustic system [0017], physiological monitoring system (abstract)), comprising:
a piezoelectric receiver (detector 18 may be a piezoelectric transducer [0045]);
a light source system (light source [0017]) configured for emitting a plurality of light pulses at a pulse repetition frequency (light source [0017])
a control system (time processing unit (TPU) [0050]) configured for:
controlling the light source system (control the activation of light source [0050]) to emit a plurality of light pulses into biological tissue at the pulse repetition frequency (characteristics of the light provided by the light source may be controlled in any suitable manner. In some embodiments, a pulsed light source may be used to provide relatively short-duration pulses (e.g., nano-second pulses) of light to the region of interest [0021]), the biological tissue including blood and blood vessels (tissue may include muscle, fat, blood, blood vessels, and/or any other suitable tissue types [0017]; Light source 402 may provide photonic signal 404 to subject tissue 470 including blood vessel 420 and blood vessel 450 [0063]; fig 4) at depths within the biological tissue (spatial location z (within the subject's tissue) of interest may be dependent upon the light source, the location itself (e.g., the depth) [0021]; fig. 4 reproduced below, with blood vessel 420 and blood vessel 450 at different depths with light source 402);
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Fig. 4 of Chen reproduced above
receiving signals from the piezoelectric receiver (detector 18 may be a piezoelectric transducer [0045]) corresponding to acoustic waves emitted from portions of the biological tissue (detect the acoustic response of tissue [0045]), the acoustic waves corresponding to photoacoustic emissions from the blood and the blood vessels (tissue may include muscle, fat, blood, blood vessels, and/or any other suitable tissue types [0017]) caused by the plurality of light pulses (light source…. light source [0017]; FIG. 5 is a plot of an illustrative photoacoustic signal, including peaks corresponding to blood vessels [0010]).
detecting heart rate waveforms in the signals (pumping of the subject's heart may cause a modulation of detected signals at the frequency of the heart rate [0079]; For example, sensor unit 12, monitor 14, or both, may be configured to determine blood oxygen saturation (e.g., arterial, venous, or both), pulse rate, blood pressure, hemoglobin concentration (e.g., oxygenated, deoxygenated, or total), any other suitable physiological parameters, or any combination thereof [0036]).
extracting heart rate waveform features from the heart rate waveforms, to produce extracted heart rate waveform features (calculate physiological parameters based at least in part on data relating to light emission and acoustic detection [0036]; system may identify peaks using their width, height, shape [0072]; pulse rate [0036] [0039] [0052]; pulse rate and heart rate are equivalent);; and
making one or more blood pressure estimations based blood pressure [0036] [0039] [0059]), at least in part, on the extracted heart rate waveform features (pulse rate [0036] [0039] [0052]; a pulse rate may be determined based on modulations of detected signals… an artery may be monitored, and the pumping of the subject's heart may cause a modulation of detected signals at the frequency of the heart rate [0079]; heart rate and blood pressure are related as well-understood in the art).
Chen, however, does not explicitly teach [a light source system configured for emitting a plurality of light pulses at a pulse repetition frequency] between 10Hz and 1 MHz.
Lu is considered analogous to the instant application as “Biometric system with photoacoustic imaging” is disclosed. Lu teaches a biometric system (biometric system [0005]) a light source system configured for emitting a plurality of light pulses at a pulse repetition frequency between 10Hz and 1 MHz (light source system may be capable of emitting a plurality of light pulses at a pulse frequency between about 1 MHz and about 100 MHz [0008]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chen include a light source system configured for emitting a plurality of light pulses at a pulse repetition frequency between 10Hz and 1 MHz, in order to have a pulse repetition frequency that is safe to use in medicine.
Regarding claim 2, modified Chen teaches the biometric device of claim 1, as discussed above.
Chen, however, does not teach wherein the signals from the piezoelectric receiver involves obtaining depth-discriminated signals by applying first through Nth acquisition time delays and receiving first through Nth signals during first through Nth acquisition time windows, each of the first through Nth acquisition time windows occurring after a corresponding one of the first through Nth acquisition time delays, wherein N is an integer greater than one
Lu, however, teaches, wherein the signals from the piezoelectric receiver involves obtaining depth-discriminated signals by applying first through Nth acquisition time delays and receiving first through Nth signals during first through Nth acquisition time windows, each of the first through Nth acquisition time windows occurring after a corresponding one of the first through Nth acquisition time delays, wherein N is an integer greater than one (the control system may be operatively configured to select second through Nth acquisition time delays and to acquire second through Nth ultrasonic image data during second through Nth acquisition time windows after the second through Nth acquisition time delays. Each of the second through Nth acquisition time delays may correspond to a second through an Nth depth inside the target object. In some such examples, the apparatus may include a display and the control system may be configured to control the display to depict a three-dimensional image that corresponds with at least a subset of the first through Nth ultrasonic image data [0023]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Chen include the signals from the piezoelectric receiver involves obtaining depth-discriminated signals by applying first through Nth acquisition time delays and receiving first through Nth signals during first through Nth acquisition time windows, each of the first through Nth acquisition time windows occurring after a corresponding one of the first through Nth acquisition time delays, wherein N is an integer greater than one, as taught by Lu, in order to have the ability to receive acoustic wave emissions from one or more corresponding distances from the ultrasonic sensor array, as suggested by Lu ([0025]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Chen (US 20130190589 A1, cited in IDS) in view of Lu (US 20190220642 A1 of record) and Baek et a. (US 20170231598 A1, hereinafter "Baek")
Regarding claim 3, modified Chen teaches the biometric device of claim 1, as discussed above. Chen, however, does not teach wherein the control system is configured for receiving first signals from the piezoelectric receiver corresponding to acoustic waves emitted from the portions of the biological tissue while the biological tissue is at a first elevation relative to a user's heart and for receiving second signals from the piezoelectric receiver corresponding to acoustic waves emitted from the portions of the biological tissue while the biological tissue is at a second elevation relative to the user's heart.
Baek is considered analogous to the instant application as “Ultrasound devices for estimating blood pressure and other cardiovascular properties” is disclosed. Baek teaches: wherein the control system is configured for receiving first signals from the piezoelectric receiver corresponding to acoustic waves emitted from the portions of the biological tissue while the biological tissue (The one or more sensors may include one or more ultrasonic sensors [0005]) is at a first elevation relative to a user's heart and for receiving second signals from the piezoelectric receiver corresponding to acoustic waves emitted from the portions of the biological tissue while the biological tissue is at a second elevation relative to the user's heart (at least two of the two or more measurements correspond to different measurement elevations of a subject's limb [0012]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Chen include herein the control system is configured for receiving first signals from the piezoelectric receiver corresponding to acoustic waves emitted from the portions of the biological tissue while the biological tissue is at a first elevation relative to a user's heart and for receiving second signals from the piezoelectric receiver corresponding to acoustic waves emitted from the portions of the biological tissue while the biological tissue is at a second elevation relative to the user's heart, as taught by Baek. Doing so would facilitate improved diagnoses of various cardiovascular issues, including hypertension, as suggested by Baek.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US 20130190589 A1, cited in IDS) in view of Lu (US 20190220642 A1 of record) and Theran et. al (US 20140058273 A1, hereinafter "Theran").
Regarding claim 4, modified Chen teaches the biometric device of claim 1, as discussed above.
Chen, however, does not teach wherein the control system is further configured for: determining a first subset of detected heart rate waveforms corresponding to vein heart rate waveforms; and determining a second subset of detected heart rate waveforms corresponding to artery heart rate waveforms.
Theran is considered analogous to the instant application as “Apparatus, Systems and Methods Analyzing Pressure and Volume Waveforms in the Vasculature” is disclosed (title). Theran teaches wherein the control system is further configured for:
determining a first subset of detected heart rate waveforms (each “subset” is the time between the peaks figures 6 and 7, further paragraph [0088] discloses that the PPG modulation is assumed to be at the cardiac frequency, i.e. heart rate, further paragraph [0012] discloses that the PPG wave form is related to cardiac stroke volume/cardiac output/heart rate/etc.) corresponding to vein heart rate waveforms (FIG. 6 depicts of an exemplary PG waveform overlaid with a venous pressure waveform, in the time domain, according to the present disclosure. Peaks, valleys and venous pulsations of the exemplary PG waveform are identified [0060]); and
determining a second subset of detected heart rate waveforms (each “subset” is the time between the peaks in figures 6 and 7, further paragraph [0088] discloses that the PPG modulation is assumed to be at the cardiac frequency, i.e. heart rate, further paragraph [0012] discloses that the PPG wave form is related to cardiac stroke volume/cardiac output/heart rate/etc.) corresponding to artery heart rate waveforms (FIG. 7 depicts arterial and venous components of the PG signal as represented in the frequency domain, according to the present disclosure [0061]).
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Table 1 of Theran reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Chen to include determining a first subset of detected heart rate waveforms corresponding to vein heart rate waveforms; and determining a second subset of detected heart rate waveforms corresponding to artery heart rate waveforms, as taught by Theran. This would allow to assess cardiac health and/or monitor relative compliance, as suggested by Theran ([0047]).
Regarding claim 5, modified Chen teaches the biometric system of claim 4, as discussed above. Chen further teaches the biometric system wherein the control system is configured for:
extracting a set of hemodynamic features from the second subset of detected heart rate waveforms (determine one or more physiological parameters, such as oxygen saturation, the concentration of hemoglobin (e.g., oxygenated, deoxygenated, and/or total hemoglobin), or both for blood vessels (e.g., arterial and venous) [0004]; the system may identify peaks using their width, height, shape [0072]; hemodynamic features and heart rate waveforms can implicitly be extracted and calculated through peak analysis) and
making a first blood pressure estimation based, at least in part, on the set of hemodynamic features (may be configured to determine … blood pressure [0036]; configured to display an estimate of, for example, a subject's blood oxygen saturation, blood pressure [0039]; blood pressure is implicitly influenced by hemodynamic features which is accounted for when calculating the estimate).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Chen (US 20130190589 A1, cited in IDS) in view of Lu (US 20190220642 A1 of record), Theran et. al (US 20140058273 A1), and Frimer et al. (WO 2017098503 A1,of record hereinafter Frimer).
Regarding claim 6, modified Chen teaches the biometric device of claim 5, s discussed above.
Chen, however, does not teach wherein extracting the set of hemodynamic features involves determining artery-vein phase shift (AVPS) data from the first subset of detected heart rate waveforms and the second subset of detected heart rate waveforms and wherein the control system is further configured for making the first blood pressure estimation based, at least in part, on the AVPS data.
Frimer is analogous to the instant application as photoacoustic imaging (Pg. 5 para.1) and blood pressure measurements (Pg. 4 para. 9) is disclosed.
Frimer teaches:
wherein extracting the set of hemodynamic features involves determining artery-vein phase shift (AVPS) data from the first subset of detected heart rate waveforms and the second subset of detected heart rate waveforms (Phase differences, pressure differences or both can be used to differentiate veins from arteries, Page 40 Paragraph 2) and wherein the control system is further configured for making the first blood pressure estimation based, at least in part, on the AVPS data (sensor information can be ….. heartbeat, heart rate, arterial blood pressure, venous blood pressure (Pg.43 para.3- pg.44 para. 1); phase differences are implicitly accounted for to distinguish between arterial and venous pressure).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the combined invention of Chen to include wherein extracting the set of hemodynamic features involves determining artery-vein phase shift (AVPS) data from the first subset of detected heart rate waveforms and the second subset of detected heart rate waveforms and wherein the control system is further configured for making the first blood pressure estimation based, at least in part, on the AVPS data, as taught by Frimer, in order to have the ability to determine adverse events, as suggested by Frimer (Image processing can also be used to identify body structures such as nerves, ligaments and blood vessels and to distinguish between arteries and veins. From blood movement, the heartbeat can be identified, so that the pulse rate can be determined and, from changes in the heartbeat and/or the pulse rate, adverse events can be determined. Adverse events can include, but are not limited to, cardiac events; increases in blood pressure: decreases in blood pressure … Pg. 23 Para. 2).
Claims 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US 20130190589 A1, cited in IDS) in view of Lu (US 20190220642 A1 of record), Theran et. al (US 20140058273 A1), Frimer et al. (WO 2017098503 A1,of record hereinafter Frimer), and Schmitt et al. (US 20200229716 A1, of record and previously cited, hereinafter "Schmitt").
Regarding claim 7, modified Chen teaches the biometric device of claim 6, as discussed above. Chen further teaches extracting one or more fiducial features from the extracted heart rate waveform features (calculate physiological parameters based at least in part on data relating to light emission and acoustic detection [0036]; system may identify peaks using their width, height, shape [0072]; pulse rate [0036] [0039] [0052]; pulse rate and heart rate are equivalent). Chen, however, does not teach making a second blood pressure estimation based, at least in part, on the one or more fiducial features.
Schmitt is considered analogous to the instant application as “Apparatus and method for determining blood pressure of a subject” is disclosed. Schmitt teaches the biometric method, further comprising:
making a second blood pressure estimation based, at least in part, on the one or more fiducial features (estimation unit is configured to determine the subject's blood pressure by taking a weighted average of some or all of said multiple blood pressure estimation values [0025]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Chen include making a second blood pressure estimation based, at least in part, on the one or more fiducial features, as taught by Schmitt, in order to increase accuracy of the blood pressure measurement.
Regarding claim 8, modified Chen teaches the biometric device of claim 7, as discussed above. Chen further teaches wherein the one or more fiducial features include one or more heart rate waveform peaks, one or more heart rate waveform valleys, one or more heart rate waveform portion widths, or combinations thereof (calculate physiological parameters based at least in part on data relating to light emission and acoustic detection [0036]; system may identify peaks using their width, height, shape [0072]; pulse rate [0036] [0039] [0052]; pulse rate and heart rate are equivalent).
Regarding claim 9, modified Chen teaches the biometric device of claim 7, as discussed above. Chen, however, does not teach wherein the control system is further configured for making a third blood pressure estimation based, at least in part, on the first blood pressure estimation and the second blood pressure estimation.
Schmitt, however, teaches wherein the control system is further configured for making a third blood pressure estimation based, at least in part, on the first blood pressure estimation and the second blood pressure estimation (estimation unit is configured to determine the subject's blood pressure by taking a weighted average of some or all of said multiple blood pressure estimation values [0025]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Chen include wherein the control system is further configured for making a third blood pressure estimation based, at least in part, on the first blood pressure estimation and the second blood pressure estimation., as taught by Schmitt, in order to increase accuracy of the blood pressure measurement.
Regarding claim 10, modified Chen teaches the biometric device of claim 9, as discussed above. Chen, however, does not teach wherein the third blood pressure estimation is an average of the first blood pressure estimation and the second blood pressure estimation.
Schmitt, however, teaches wherein the third blood pressure estimation is an average of the first blood pressure estimation and the second blood pressure estimation. (estimation unit is configured to determine the subject's blood pressure by taking a weighted average of some or all of said multiple blood pressure estimation values [0025]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Chen include wherein the third blood pressure estimation is an average of the first blood pressure estimation and the second blood pressure estimation, as taught by Schmitt, in order to increase accuracy of the blood pressure measurement.
Regarding claim 11, modified Chen teaches the biometric device of claim 9, as discussed above. Chen, however, does not teach wherein the average is a weighted average.
Schmitt, however, teaches wherein the average is a weighted average (estimation unit is configured to determine the subject's blood pressure by taking a weighted average of some or all of said multiple blood pressure estimation values [0025]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Chen include wherein the average is a weighted average, as taught by Schmitt, in order to increase accuracy of the blood pressure measurement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NESHAT BASET whose telephone number is (571)272-5478. The examiner can normally be reached M-F 8:30-17:30 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, PASCAL M. BUI-PHO can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.B./ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
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