DETAILED ACTION
This action is pursuant to claims filed on 10/20/2025. Claims 1-6 and 21-34 are pending. A first action on the merits of claims 1-6 and 21-34 is as follows.
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 .
Election/Restrictions
Claim 7-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-V, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/20/2025.
Claim Objections
Claims 1, 3-5, 28, 30, 32, and 34 are objected to because of the following informalities:
In claim 1, line 8, “cuff pressure waveform” should read “the cuff pressure waveform”
In claim 1, line 11, “brachial artery compliance” should read “the brachial artery compliance”
In claim 3, line 3, “brachial artery compliance” should read “the brachial artery compliance”
In claim 3, line 4, “the group” should read “a group”, as there is a lack of antecedent basis in the claim
In claim 4, lines 2-3, “the sub-diastolic pulse volume plethysmography (PVP) waveform” should read “a sub-diastolic pulse volume plethysmography (PVP) waveform”, as there is a lack of antecedent basis in the claim
In claim 5, line 2, “systolic and diastolic blood pressure values” should read “the systolic and diastolic blood pressure values”
In claim 5, line 2, “formula” should read “a formula”
In claim 28, line 3, “pulse pressure” should read “pulse pressure.”
In claim 30, line 13, “brachial artery compliance” should read “the brachial artery compliance”
In claim 32, line 2, “cardiac output” should read “the cardiac output”
In claim 34, line 2, “the slow cuff inflation” should read “a slow cuff inflation”, as there is a lack of antecedent basis in the claim
Appropriate correction is required.
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 6, 21-23, 26-27, and 34 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 6, the claim recites the limitation “wherein the cardiac output is computed based on the common feature value” in line 3. Claim 1 states that the cardiac output is computed based on the blood pressure waveform or the brachial artery compliance, therefore it is unclear if this limitation from claim 6 is intended to be an alternative form of computation for cardiac output, or is intended to somehow include the common feature value into the computation of cardiac output from claim 1. If it is meant to refer to an alternative form of computation, however, it is also unclear, as the claim references the cardiac output from claim 1 and not an alternative cardiac output. 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 either an alternative computation, or as incorporating the common feature value into the computation from claim 1.
Regarding claim 21, the claim recites the limitation “about 2 to about 3 mmHg/second” in line 2. It is unclear what constitutes as “about” 2 mmHg/second or “about” 3 mmHg/second, and how far away from these values will still constitute as teaching on this limitation. 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, any value that can be considered “about” 2 mmHg/second and “about” 3 mmHg/second will teach on this limitation.
Regarding claim 22, the claim recites the limitations “about 40 to about 60 mmHg” and “about 10 to about 30 seconds” in line 2. It is unclear what constitutes as “about” these values, and how far away from these values will still constitute as teaching on this limitation. 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, any value that can be considered “about” these values will teach on this limitation.
Regarding claim 23, the claim recites the limitations “about 2 to about 3 mmHg/second” in line 2, and “about 40 to about 60 mmHg” and “about 10 to about 30 seconds” in line 3. It is unclear what constitutes as “about” these values, and how far away from these values will still constitute as teaching on this limitation. 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, any value that can be considered “about” these values will teach on this limitation.
Regarding claim 26, the claim recites the limitation “the arterial compliance factor” in line 1. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if this limitation is meant to depend on claim 5, where the arterial compliance factor was introduced, or meant to introduce a new limitation of an arterial compliance factor. 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 reading as “an arterial compliance factor”.
Regarding claim 27, the claim recites the limitation “around or near a zero transmural pressure range” in lines 2-3. It is unclear what constitutes as “around or near” the range, and how close a value can be to the range to be considered as teaching on this limitation. 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, any value that can be considered around or near the range will teach on this limitation.
Regarding claim 34, the claim recites the limitation ““about 2 to about 3 mmHg/second” in line 2. It is unclear what constitutes as “about” 2 mmHg/second or “about” 3 mmHg/second, and how far away from these values will still constitute as teaching on this limitation. 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, any value that can be considered “about” 2 mmHg/second and “about” 3 mmHg/second will teach on this limitation.
Claims 1-18 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 1-6 and 21-34 are all within at least one of the four statutory categories.
Claim 1 and its dependent claims disclose a method (process).
Claim 30 and its dependent claims disclose a system (machine).
Regarding Step 2A, Prong One, the independent claims 1 and 30 recite an abstract idea. In particular, the claims generally recite the following:
computing systolic and diastolic blood pressure from the cuff pressure waveform using the cuff device;
constructing a blood pressure waveform from the systolic and diastolic blood pressure and cuff pressure waveform using the cuff device;
computing brachial artery compliance from the cuff pressure waveform;
computing the cardiac output from at least one of the blood pressure waveform and brachial artery compliance using the cuff device.
These elements recited in claims 1 and 30 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.
Computing systolic and diastolic blood pressure from the cuff pressure waveform using the cuff device 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 receive the measured cuff pressure waveform on a piece of paper and perform the computations to determine systolic and diastolic blood pressure mentally or with the aid of pen and paper. These techniques are based on evaluation, judgement, calculations, and mathematical principles, which can be performed by hand. The mathematics of computing systolic and diastolic blood pressure 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 computing systolic and diastolic blood pressure from the cuff pressure waveform using the cuff device.
Constructing a blood pressure waveform from the systolic and diastolic blood pressure and cuff pressure waveform using the cuff device 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 construct a blood pressure waveform using the systolic and diastolic blood pressure mentally or with the aid of pen and paper. These techniques are based on observations, evaluations, judgement, and calculations, which can be performed by hand. The mathematics of constructing a blood pressure waveform 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 constructing a blood pressure waveform from the systolic and diastolic blood pressure and cuff pressure waveform using the cuff device.
Computing brachial artery compliance from the cuff pressure waveform 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 compute the brachial artery compliance from the cuff pressure waveform mentally or with the aid of pen and paper. These techniques are based on evaluation, judgement, calculations, and mathematical principles, which can be performed by hand. The mathematics of computing brachial artery compliance 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 computing brachial artery compliance from the cuff pressure waveform.
Computing the cardiac output from at least one of the blood pressure waveform and brachial artery compliance using the cuff device 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 compute the cardiac output mentally or with the aid of pen and paper. These techniques are based on evaluation, judgement, calculations, and mathematical principles, which can be performed by hand. The mathematics of computing the cardiac output 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 computing the cardiac output from at least one of the blood pressure waveform and brachial artery compliance using the cuff device.
Regarding Step 2A, Prong Two, claims 1 and 30 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” in claim 30), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g., “a cuff device to measure a cuff pressure waveform” in claim 1 and 30)).
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 and 30 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.
Claim 1 and 30 do not recite additional elements that amount to significantly more than the judicial exception itself. In particular, a cuff device used to measure a cuff pressure waveform of a user does not qualify as significantly more because this limitation merely describes generic data gathering.
The data gathering step of a duff device to measure a cuff pressure waveform is nothing more than using a generic data gathering device. Such data gathering devices are evidenced by:
US Patent Application Publication No. 20080058614 (Banet) discloses a conventional blood pressure cuff to measure blood pressure waveforms ([0030]);
US Patent Application Publication No. 20110288420 (Mano) discloses a conventional blood pressure measurement device using a cuff to measure a pressure waveform ([0051]);
US Patent Application Publication No. 20180103856 (Murray) discloses a conventional cuff device to measure blood pressure waveforms ([0060]);
US Patent Application Publication No. 20180296104 (Qasem) discloses a conventional blood pressure cuff device measuring a pressure waveform ([0020]).
Further, the element of a processor in claim 30 does 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 2-6 and 21-29 depend on claim 1 and claims 31-34 depend on claim 30. 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 the cuff pressure waveform is measured during slow cuff inflation and/or deflation of the cuff device followed by maintaining a cuff pressure at a sub-diastolic level” further defines the abstract idea as it further defines when the measurement is taken;
(Claim 3): “wherein the computing the cardiac output is based on a formula that includes at least one of the blood pressure waveform, brachial artery compliance and additional information of the subject, wherein the additional information is selected from the group consisting of age, height, weight, gender of the subject, or combinations thereof” further defines the abstract idea as it is based on calculations and evaluations that can be performed mentally or with the aid of pen and paper;
(Claim 4): “wherein the brachial artery compliance is determined based on a ratio of peak-to-peak amplitude of the sub-diastolic pulse volume plethysmography (PVP) waveform to a pulse pressure or a ratio of peak-to-peak amplitude of the PVP waveform at a fixed transmural pressure to the pulse pressure” further defines the abstract idea as it is based on calculations and evaluations that can be performed mentally or with the aid of pen and paper;
(Claim 5): “wherein at least one of the additional information, systolic and diastolic blood pressure values, and formula to compute an arterial compliance factor from the brachial artery compliance is defined through training data” further defines the abstract idea as it is based on calculations and evaluations that can be performed mentally or with the aid of pen and paper;
(Claim 6): “further comprising estimating a common feature value from the constructed blood pressure waveform, and wherein the cardiac output is computed based on the common feature value” further defines the abstract idea as it is based on calculations and evaluations that can be performed mentally or with the aid of pen and paper;
(Claim 21): “wherein a rate of the slow cuff inflation and/or deflation is from about 2 to about 3 mmHg/second” further defines the abstract idea as it further defines when the measurement is taken;
(Claim 22): “wherein the cuff pressure at the sub-diastolic level is from about 40 to about 60 mmHg for about 10 to about 30 seconds” further defines the abstract idea as it further defines when the measurement is taken;
(Claim 23): “wherein a rate of the slow cuff inflation and/or deflation is from about 2 to about 3 mmHg/second, and wherein the cuff pressure at the sub-diastolic level is from about 40 to about 60 mmHg for about 10 to about 30 seconds” further defines the abstract idea as it further defines when the measurement is taken;
(Claim 24): “further comprising computing an ensemble-averaged beat of the blood pressure waveform from the cuff pressure waveform; and wherein the cardiac output is computed from the ensemble-averaged beat of the blood pressure waveform” further defines the abstract idea as it is based on calculations and evaluations that can be performed mentally or with the aid of pen and paper;
(Claim 25): “further comprising displaying information about the cardiac output of the patient on a graphical user interface” is insignificant post-solution activity;
(Claim 26): “wherein the arterial compliance factor is a function of the additional information” further defines the abstract idea as it is based on calculations and evaluations that can be performed mentally or with the aid of pen and paper;
(Claim 27): “wherein the ensemble-averaged beat is formed from beats in a low cuff pressure range or from beats around or near a zero transmural pressure range” further defines the abstract idea as it further defines when the measurement is taken;
(Claim 28): “wherein the brachial artery compliance is determined based on a ratio of peak-to-peak amplitude of a pulse volume plethysmography (PVP) waveform at a fixed transmural pressure to pulse pressure” further defines the abstract idea as it is based on calculations and evaluations that can be performed mentally or with the aid of pen and paper;
(Claim 29): “wherein the blood pressure waveform is constructed without maintaining a cuff pressure at a sub-diastolic level” further defines the abstract idea as it further defines when the measurement is taken;
(Claim 31): “wherein the processor is further configured to compute an ensemble-averaged beat of the blood pressure waveform from the cuff pressure waveform and wherein the computation of the cardiac output by the processor includes the ensemble-averaged beat of the blood pressure waveform” further defines the abstract idea as it is based on calculations and evaluations that can be performed mentally or with the aid of pen and paper;
(Claim 32): “further comprising a graphical user interface configured to display information about cardiac output of the patient” is insignificant post-solution activity;
(Claim 33): “wherein the sensor maintains a cuff pressure of the cuff device at a sub-diastolic level” further defines the abstract idea as it further defines when the measurement is taken;
(Claim 34): “wherein the cuff devices inflates and deflates at a rate of the slow cuff inflation and/or deflation is from about 2 to about 3 mmHg/second” further defines the abstract idea as it further defines when the measurement is taken.
The dependent claims do not recite significantly more than the abstract ideas. Therefore, claims 1-6 and 21-34 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, 3-5, 25-26, 30, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Bogatu (US 12408876) in further view of Liu (US 20180256045).
Regarding independent claim 1, Bogatu teaches a method for determining a cardiac output of a patient using a cuff device (Column 2, lines 50-53: “there is provided a method of estimating the reliability of cardiac output, CO, measurements for a subject obtained using an arterial waveform analysis, AWA, technique”) comprising:
measuring a cuff pressure waveform of a subject the patient during at least one of inflation and deflation of the cuff device (Column 2, lines 58-61: “initiating inflation of a cuff that is at a first location on the subject; (ii) obtaining a first cuff pressure signal comprising measurements of pressure inside the cuff during inflation”).
Bogatu discloses the relevance of systolic and diastolic blood pressure on the cardiac output value (Column 14, lines 52-64: “FIG. 7 also shows how arterial compliance information can be obtained over a wider range of transmural pressure values to allow the derivation of a relationship between blood pressure and arterial compliance. This is useful for obtaining more accurate CO estimates in the event that BP changes, since the C parameter in Equation (1) is dependent on BP. The cuff 4 applies external pressure on the arm 36 and the transmural pressure over the arterial wall (P.sub.tm) is defined as: P.sub.tm=P.sub.art−P.sub.cuff, where P.sub.art is arterial pressure varying between systolic and diastolic values and P.sub.cuff is pressure inside the cuff 4”), however Bogatu does not teach specifically computing systolic and diastolic blood pressure from the cuff pressure waveform using the cuff device.
Liu discloses a method for determining cuff blood pressure. Specifically, Liu teaches computing systolic and diastolic blood pressure from the cuff pressure waveform using the cuff device ([0005]: “Then, systolic and diastolic BP (SP and DP) are each estimated as the cuff pressure at which the oscillation amplitude is some fixed ratio of the maximal value”). Bogatu and Liu are analogous arts as they are both related to determining blood pressure using a blood pressure cuff.
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 computation of systolic and diastolic blood pressure form Liu into the method from Bogatu as it allows the method to determine the different components, which have important effects on the blood pressure and can be used for the computation of blood pressure waveform and cardiac output.
The Bogatu/Liu combination teaches constructing a blood pressure waveform from the cuff pressure waveform using the cuff device (Bogatu, Column 2, lines 61-64: “analyzing the first cuff pressure signal to derive a relationship between oscillations in arterial volume beneath the cuff and pressure in the arteries”), however the Bogatu/Liu combination does not teach constructing a blood pressure waveform from the systolic and diastolic blood pressure.
Liu discloses constructing a blood pressure waveform from the systolic and diastolic blood pressure ([0067]: “the signal processor 62 implements the steps of estimating the parameters of the mathematical model including systolic and diastolic blood pressures, constructing a blood volume waveform for the subject to within a scale factor, determining a blood pressure waveform for the subject”).
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 systolic and diastolic blood pressure into the blood pressure waveform as it allows the method to determine the different components of the measured pressure and incorporate the values into the blood pressure waveform, which can provide important and relevant information to be used in further analysis.
The Bogatu/Liu combination teaches computing brachial artery compliance from the cuff pressure waveform (Bogatu, Column 2, lines 64-66: “estimating a first arterial compliance of the arteries for a range of cuff pressures based on the determined relationship”); and
computing the cardiac output from at least one of the blood pressure waveform and brachial artery compliance using the cuff device (Bogatu, Column 2, line 66 – Column 3, line 5: “during a second time period that is after the first time period, repeating steps (i)-(iv) to estimate a second arterial compliance of the arteries; and (c) using a result of a comparison of the first arterial compliance and the second arterial compliance to determine a reliability of CO measurements obtained using the AWA technique during the second time period”).
Regarding claim 3, the Bogatu/Liu combination teaches the method of claim 1, wherein the computing the cardiac output is based on a formula that includes at least one of the blood pressure waveform, brachial artery compliance and additional information of the subject (Bogatu, Column 2, line 66 – Column 3, line 5: “during a second time period that is after the first time period, repeating steps (i)-(iv) to estimate a second arterial compliance of the arteries; and (c) using a result of a comparison of the first arterial compliance and the second arterial compliance to determine a reliability of CO measurements obtained using the AWA technique during the second time period”), wherein the additional information is selected from the group consisting of age, height, weight, gender of the subject, or combinations thereof (Bogatu, Column 14, lines 47-51: “The scaling of C can be a proportional increase or decrease, for example, to account for the entire length of the arterial tree, and/or taking into account other patient specific characteristics such as body-mass index (BMI) or body length (height)”).
Regarding claim 4, the Bogatu/Liu combination teaches the method of claim 1, wherein the brachial artery compliance is determined based on a ratio of peak-to-peak amplitude of the sub-diastolic pulse volume plethysmography (PVP) waveform to a pulse pressure or a ratio of peak-to-peak amplitude of the PVP waveform at a fixed transmural pressure to the pulse pressure (Bogatu, Column 16, lines 27-29: “the baseline arterial compliance is estimated by analyzing the cuff pressure signal obtained during the calibration procedure”; Column 16, lines 8-26: “steps 101 and 103 are performed as above, including obtaining a PPG signal during the calibration procedure. However, rather than determine PAT or PWV, the morphology of the PPG signal can be analyzed to provide a baseline morphology (i.e. a morphology corresponding to when the calibration procedure was performed). Aspects of the morphology that can be considered include decomposition in to forward and reflected waves, or using higher order derivatives, from which Pulse Transit Time (PTT) can be derived. Other aspects include, on a beat-to-beat basis, the ratio of the amplitude of PPG to arterial pulse pressure (PPG.sub.amp/PP, as relative vascular compliance) to total peripheral resistance (TPR) and Windkessel compliance (C.sub.wk) obtained from the Modelflow CO algorithm (as described in “The photoplethysmographic amplitude to pulse pressure ratio can track sudden changes in vascular compliance and resistance during liver graft reperfusion” by Wook-Jong Kim et al., in Medicine (Baltimore), 2 Jun. 2017; 96(22):e7045”; Column 17, lines 20-22: “AP measurements are obtained by the AP sensor 20 during the calibration procedure (step 101)”).
Regarding claim 5, the Bogatu/Liu combination teaches the method of claim 3.
However, the Bogatu/Liu combination does not teach wherein at least one of the additional information, systolic and diastolic blood pressure values, and formula to compute an arterial compliance factor from the brachial artery compliance is defined through training data.
Liu teaches wherein at least one of the additional information, systolic and diastolic blood pressure values, and formula to compute an arterial compliance factor from the brachial artery compliance is defined through training data ([0045]: “The measurement pairs from 57 of the patients were utilized as training data to refine the method”).
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 information being defined through training data from Liu into the Bogatu/Liu combination as it allows the device to refine the methods used to determine the measurements, and can allow for more accurate information.
Regarding claim 25, the Bogatu/Liu combination teaches the method of claim 1, further comprising displaying information about the cardiac output of the patient on a graphical user interface (Bogatu, Column 9, lines 3-10: “The apparatus 12 may be in the form of, or be part of, a computing device, such as a server, desktop computer, laptop, tablet computer, smartphone, smartwatch, etc., or other types of device typically found in clinical environments, such as a patient monitoring device (e.g. a monitoring device located at the bedside of a patient in a clinical environment) that is used to monitor (and optionally display) various physiological characteristics of a subject/patient”).
Regarding claim 26, the Bogatu/Liu combination teaches the method of claim 3, wherein the arterial compliance factor is a function of the additional information (Bogatu, Column 14, lines 47-51: “The scaling of C can be a proportional increase or decrease, for example, to account for the entire length of the arterial tree, and/or taking into account other patient specific characteristics such as body-mass index (BMI) or body length (height)”. The value of “C” is the arterial compliance factor.).
Regarding independent claim 30, Bogatu teaches a system for determining cardiac output of a patient (Column 6, lines 20-22: “there is provided a system for estimating the reliability of CO measurements for a subject obtained using an AWA technique”), comprising:
a cuff device configured to determine cardiac output (Abstract: “initiating inflation of a cuff that is at a location on the subject”), wherein the cuff device includes a sensor configured to measure a cuff pressure waveform of the patient during at least one of inflation and deflation of the cuff device (Column 2, lines 58-61: “initiating inflation of a cuff that is at a first location on the subject; (ii) obtaining a first cuff pressure signal comprising measurements of pressure inside the cuff during inflation”), and
a processor (Column 4, lines 26-32: “there is provided a computer program product comprising a computer readable medium having computer readable code embodied therein, the computer readable code being configured such that, on execution by a suitable computer or processor, the computer or processor is caused to perform the method according to the first aspect or any embodiment thereof”).
Bogatu discloses the relevance of systolic and diastolic blood pressure on the cardiac output value (Column 14, lines 52-64: “FIG. 7 also shows how arterial compliance information can be obtained over a wider range of transmural pressure values to allow the derivation of a relationship between blood pressure and arterial compliance. This is useful for obtaining more accurate CO estimates in the event that BP changes, since the C parameter in Equation (1) is dependent on BP. The cuff 4 applies external pressure on the arm 36 and the transmural pressure over the arterial wall (P.sub.tm) is defined as: P.sub.tm=P.sub.art−P.sub.cuff, where P.sub.art is arterial pressure varying between systolic and diastolic values and P.sub.cuff is pressure inside the cuff 4”), however Bogatu does not teach specifically computing systolic and diastolic blood pressure from the cuff pressure waveform using the cuff device.
Liu discloses a method for determining cuff blood pressure. Specifically, Liu teaches computing systolic and diastolic blood pressure from the cuff pressure waveform ([0005]: “Then, systolic and diastolic BP (SP and DP) are each estimated as the cuff pressure at which the oscillation amplitude is some fixed ratio of the maximal value”). Bogatu and Liu are analogous arts as they are both related to determining blood pressure using a blood pressure cuff.
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 computation of systolic and diastolic blood pressure form Liu into the method from Bogatu as it allows the system to determine the different components, which have important effects on the blood pressure and can be used for the computation of blood pressure waveform and cardiac output.
The Bogatu/Liu combination teaches constructing a blood pressure waveform from the systolic and diastolic blood pressure and cuff pressure waveform (Liu, [0067]: “the signal processor 62 implements the steps of estimating the parameters of the mathematical model including systolic and diastolic blood pressures, constructing a blood volume waveform for the subject to within a scale factor, determining a blood pressure waveform for the subject”; Bogatu, Column 2, lines 61-64: “analyzing the first cuff pressure signal to derive a relationship between oscillations in arterial volume beneath the cuff and pressure in the arteries”);
compute brachial artery compliance from the cuff pressure waveform (Bogatu, Column 2, lines 64-66: “estimating a first arterial compliance of the arteries for a range of cuff pressures based on the determined relationship”), and
compute the cardiac output from at least one of the blood pressure waveform and brachial artery compliance (Bogatu, Column 2, line 66 – Column 3, line 5: “during a second time period that is after the first time period, repeating steps (i)-(iv) to estimate a second arterial compliance of the arteries; and (c) using a result of a comparison of the first arterial compliance and the second arterial compliance to determine a reliability of CO measurements obtained using the AWA technique during the second time period”).
Regarding claim 32, the Bogatu/Liu combination teaches the system of claim 30, further comprising a graphical user interface configured to display information about cardiac output of the patient (Bogatu, Column 9, lines 3-10: “The apparatus 12 may be in the form of, or be part of, a computing device, such as a server, desktop computer, laptop, tablet computer, smartphone, smartwatch, etc., or other types of device typically found in clinical environments, such as a patient monitoring device (e.g. a monitoring device located at the bedside of a patient in a clinical environment) that is used to monitor (and optionally display) various physiological characteristics of a subject/patient”).
Regarding claim 33, the Bogatu/Liu combination teaches the system of claim 30, wherein the sensor maintains a cuff pressure of the cuff device at a sub-diastolic level (Bogatu, Column 15, lines 26-29: “If the AP waveform is recorded when the cuff pressure is held at a plateau (e.g. the cuff pressure=20 mmHg, causing a mean transmural pressure of 80 mmHg) then a different waveform will be obtained”).
Claims 2, 21, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over the Bogatu/Liu combination as applied to claims 1 and 30 above, and further in view of Inukai (US 6527725).
Regarding claim 2, the Bogatu/Liu combination teaches the method of claim 1.
However, the Bogatu/Liu combination is silent on the inflation and deflation steps.
Inukai discloses a blood pressure estimating apparatus. Specifically, Inukai teaches wherein the cuff pressure waveform is measured during slow cuff inflation and/or deflation of the cuff device (Column 11, lines 12-19: “according to a well-known oscillometric method, based on variation of respective amplitudes of pulses of the pulse wave represented by the pulse-wave signal SM1 obtained while the pressing pressure of the cuff 10 … is slowly decreased from the target value PCM, at the rate of about 3 mmHg/sec”). Bogatu, Liu, and Inukai are analogous arts as they are all related to methods and devices used to determine blood pressure 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 slow cuff inflation and/or deflation from Inukai into the Bogatu/Liu combination as the combination is silent on the inflation and deflation steps, and Inukai discloses a suitable step of slow inflation in an analogous device.
The Bogatu/Liu/Inukai combination teaches the step of the slow inflation followed by maintaining a cuff pressure at a sub-diastolic level (Bogatu, Column 15, lines 26-29: “If the AP waveform is recorded when the cuff pressure is held at a plateau (e.g. the cuff pressure=20 mmHg, causing a mean transmural pressure of 80 mmHg) then a different waveform will be obtained”).
Regarding claim 21, the Bogatu/Liu/Inukai combination teaches the method of claim 2, wherein a rate of the slow cuff inflation and/or deflation is from about 2 to about 3 mmHg/second (Inukai, Column 11, lines 12-19: “according to a well-known oscillometric method, based on variation of respective amplitudes of pulses of the pulse wave represented by the pulse-wave signal SM1 obtained while the pressing pressure of the cuff 10 … is slowly decreased from the target value PCM, at the rate of about 3 mmHg/sec”).
Regarding claim 34, the Bogatu/Liu combination teaches the system of claim 30.
However, the Bogatu/Liu combination is silent on the inflation and deflation steps.
Inukai discloses a blood pressure estimating apparatus. Specifically, Inukai teaches wherein the cuff devices inflates and deflates at a rate of the slow inflation and/or deflation is from about 2 to about 3 mmHg/second (Column 11, lines 12-19: “according to a well-known oscillometric method, based on variation of respective amplitudes of pulses of the pulse wave represented by the pulse-wave signal SM1 obtained while the pressing pressure of the cuff 10 … is slowly decreased from the target value PCM, at the rate of about 3 mmHg/sec”). Bogatu, Liu, and Inukai are analogous arts as they are all related to methods and devices used to determine blood pressure 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 slow cuff inflation and/or deflation from Inukai into the Bogatu/Liu combination as the combination is silent on the inflation and deflation steps, and Inukai discloses a suitable step of slow inflation in an analogous device.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over the Bogatu/Liu combination as applied to claim 1 above, and further in view of Sajgalik (WO 2018017542).
Regarding claim 6, the Bogatu/Liu combination teaches the method of claim 1.
However, the Bogatu/Liu combination does not teach further comprising estimating a common feature value from the constructed blood pressure waveform, and wherein the cardiac output is computed based on the common feature value.
Sajgalik discloses a method of measuring cardiac output of a user. Specifically, Sajgalik teaches the method further comprising estimating a common feature value from the constructed blood pressure waveform, and wherein the cardiac output is computed based on the common feature value (Claim 1: “determining an area under the average blood pressure pulse wave measurement curve; determining a maximal blood pressure of the average blood pressure pulse wave measurement curve; and determining the cardiac output of the patient, wherein the cardiac output equals the heart rate multiplied by the area under the average blood pressure pulse wave measurement curve and divided by the maximal blood pressure of the average blood pressure pulse wave measurement curve”). Bogatu, Liu, and Sajgalik are analogous arts as they are all related to methods and devices used to determine blood pressure 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 step of estimating a common feature value of the blood pressure waveform from Sajgalik into the Bogatu/Liu combination as the area under the curve of the blood pressure waveform can provide valuable information about factors affecting the cardiac output, therefore can be important parameters to include in the computation of cardiac output of the user.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over the Bogatu/Liu/Inukai combination as applied to claim 2 above, and further in view of Sajgalik.
Regarding claim 22, the Bogatu/Liu/Inukai combination teaches the method of claim 2, wherein the cuff pressure at the sub-diastolic level is from about 40 to about 60 mmHg (Bogatu, Column 15, lines 26-29: “If the AP waveform is recorded when the cuff pressure is held at a plateau (e.g. the cuff pressure=20 mmHg, causing a mean transmural pressure of 80 mmHg) then a different waveform will be obtained”).
However, the Bogatu/Liu/Inukai combination is silent on how long the cuff pressure is maintained.
Sajgalik discloses the cuff pressure being maintained for about 10 to about 30 seconds (Page 7, lines 8-10: “cuff 110 will be used to occlude the brachial artery for a period of time, without limitation, of between about 10 seconds and 30 seconds, or about 15 seconds and 25 seconds, or about 20 seconds and 30 seconds, or about 25 seconds and 35 seconds”).
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 duration of the pressure from Sajgalik into the Bogatu/Liu/Inukai combination as the combination is silent on the duration, and Sajgalik discloses a suitable duration in an analogous device.
Regarding claim 23, the Bogatu/Liu/Inukai combination teaches the method of claim 2, wherein a rate of the slow cuff inflation and/or deflation is from about 2 to about 3 mmHg/second (Inukai, Column 11, lines 12-19: “according to a well-known oscillometric method, based on variation of respective amplitudes of pulses of the pulse wave represented by the pulse-wave signal SM1 obtained while the pressing pressure of the cuff 10 … is slowly decreased from the target value PCM, at the rate of about 3 mmHg/sec”), and wherein the cuff pressure at the sub-diastolic level is from about 40 to about 60 mmHg (Bogatu, Column 15, lines 26-29: “If the AP waveform is recorded when the cuff pressure is held at a plateau (e.g. the cuff pressure=20 mmHg, causing a mean transmural pressure of 80 mmHg) then a different waveform will be obtained”).
However, the Bogatu/Liu/Inukai combination is silent on how long the cuff pressure is maintained.
Sajgalik discloses the cuff pressure being maintained for about 10 to about 30 seconds (Page 7, lines 8-10: “cuff 110 will be used to occlude the brachial artery for a period of time, without limitation, of between about 10 seconds and 30 seconds, or about 15 seconds and 25 seconds, or about 20 seconds and 30 seconds, or about 25 seconds and 35 seconds”).
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 duration of the pressure from Sajgalik into the Bogatu/Liu/Inukai combination as the combination is silent on the duration, and Sajgalik discloses a suitable duration in an analogous device.
Claims 24, 27-29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over the Bogatu/Liu combination as applied to claims 1 and 30 above, and further in view of Jang (EP 3753484).
Regarding claim 24, the Bogatu/Liu combination teaches the method of claim 1.
However, the Bogatu/Liu combination does not teach further comprising computing an ensemble-averaged beat of the blood pressure waveform from the cuff pressure waveform; and wherein the cardiac output is computed from the ensemble-averaged beat of the blood pressure waveform.
Jang discloses an apparatus and method for calibrating bio-information. Specifically, Jang teaches further comprising computing an ensemble-averaged beat of the blood pressure waveform from the cuff pressure waveform ([0060]: “a representative waveform may be detected by calculating an ensemble average of the waveform of the bio-signal in units of a predetermined number of bits”). Bogatu, Liu, and Jang are analogous as they are all related to methods and apparatus used to determine blood pressure 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 ensemble-averaged beat for the blood pressure waveform from Jang into the Bogatu/Liu combination as it allows the combination to use multiple measurements in the calculations, which can improve the determination accuracy.
The Bogatu/Liu/Jang combination teaches wherein the cardiac output is computed from the ensemble-averaged beat of the blood pressure waveform (Jang, [0060]: “a representative waveform may be detected by calculating an ensemble average of the waveform of the bio-signal in units of a predetermined number of bits”; Bogatu, Column 2, line 66 – Column 3, line 5: “during a second time period that is after the first time period, repeating steps (i)-(iv) to estimate a second arterial compliance of the arteries; and (c) using a result of a comparison of the first arterial compliance and the second arterial compliance to determine a reliability of CO measurements obtained using the AWA technique during the second time period”).
Regarding claim 27, the Bogatu/Liu/Jang combination teaches the method of claim 24.
However, the Bogatu/Liu/Jang combination is silent on the pressure ranges in which the ensemble-averaged beats are measured in.
Liu teaches wherein the measurements are from beats in a low cuff pressure range or from beats around or near a zero transmural pressure range (Claim 1: “estimating the parameters of the mathematical model by fitting the mathematical model to the oscillogram while constraining the parameters such that derivative of the blood volume-transmural pressure relationship with respect to transmural pressure is maximum near zero and right skewed about the maximum”).
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 pressure range from Liu into the Bogatu/Liu/Jang combination as the combination is silent on the pressure ranges measured, and Liu discloses a suitable pressure range in an analogous device.
Regarding claim 28, the Bogatu/Liu/Jang combination teaches the method of claim 24, wherein the brachial artery compliance is determined based on a ratio of peak-to-peak amplitude of a pulse volume plethysmography (PVP) waveform at a fixed transmural pressure to pulse pressure (Bogatu, Column 16, lines 27-29: “the baseline arterial compliance is estimated by analyzing the cuff pressure signal obtained during the calibration procedure”; Column 16, lines 8-26: “steps 101 and 103 are performed as above, including obtaining a PPG signal during the calibration procedure. However, rather than determine PAT or PWV, the morphology of the PPG signal can be analyzed to provide a baseline morphology (i.e. a morphology corresponding to when the calibration procedure was performed). Aspects of the morphology that can be considered include decomposition in to forward and reflected waves, or using higher order derivatives, from which Pulse Transit Time (PTT) can be derived. Other aspects include, on a beat-to-beat basis, the ratio of the amplitude of PPG to arterial pulse pressure (PPG.sub.amp/PP, as relative vascular compliance) to total peripheral resistance (TPR) and Windkessel compliance (C.sub.wk) obtained from the Modelflow CO algorithm (as described in “The photoplethysmographic amplitude to pulse pressure ratio can track sudden changes in vascular compliance and resistance during liver graft reperfusion” by Wook-Jong Kim et al., in Medicine (Baltimore), 2 Jun. 2017; 96(22):e7045”; Column 17, lines 20-22: “AP measurements are obtained by the AP sensor 20 during the calibration procedure (step 101)”; Column 18, lines 39-40: “an arterial compliance of the arteries is estimated for a range of cuff (transmural) pressures”).
Regarding claim 29, the Bogatu/Liu/Jang combination teaches the method of claim 24, wherein the blood pressure waveform is constructed without maintaining a cuff pressure at a sub-diastolic level (Bogatu, Column 15, lines 21-24: “using the AWA technique an unaltered (unprocessed) AP waveform is processed to estimate CO, e.g. at 100 mmHg mean arterial pressure, which causes a 100 mmHg mean transmural pressure across the arterial wall”).
Regarding claim 31, the Bogatu/Liu combination teaches the system of claim 30.
However, the Bogatu/Liu combination does not teach wherein the processor is further configured to compute an ensemble-averaged beat of the blood pressure waveform from the cuff pressure waveform; and wherein the computation of cardiac output by the processor includes the ensemble-averaged beat of the blood pressure waveform.
Jang discloses an apparatus and method for calibrating bio-information. Specifically, Jang teaches wherein the processor is further configured to compute an ensemble-averaged beat of the blood pressure waveform from the cuff pressure waveform ([0060]: “a representative waveform may be detected by calculating an ensemble average of the waveform of the bio-signal in units of a predetermined number of bits”). Bogatu, Liu, and Jang are analogous as they are all related to methods and apparatus used to determine blood pressure 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 ensemble-averaged beat for the blood pressure waveform from Jang into the Bogatu/Liu combination as it allows the combination to use multiple measurements in the calculations, which can improve the determination accuracy.
The Bogatu/Liu/Jang combination teaches wherein the computation of the cardiac output by the processor includes the ensemble-averaged beat of the blood pressure waveform (Jang, [0060]: “a representative waveform may be detected by calculating an ensemble average of the waveform of the bio-signal in units of a predetermined number of bits”; Bogatu, Column 2, line 66 – Column 3, line 5: “during a second time period that is after the first time period, repeating steps (i)-(iv) to estimate a second arterial compliance of the arteries; and (c) using a result of a comparison of the first arterial compliance and the second arterial compliance to determine a reliability of CO measurements obtained using the AWA technique during the second time period”).
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791