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 .
Status of Claims
The amendments and remarks filed on 29DEC2025 have been entered and considered.
Claims 1, 3-7, & 9-13 are currently pending.
Claims 1 & 7 have been amended.
Claims 10-13 have been added.
Claims 1, 3-7, & 9-13 are under examination.
Response to Arguments
Applicant's arguments filed 29DEC2025 regarding the rejections under 35 USC 101 have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Pages 8-9 of the Remarks):
Under recent USPTO guidance, namely the Advance notice of change to the MPEP in light of Ex Parte Desjardins (December 5, 2025), the memorandum "Best Practices for Submission of Rule 132 Subject Matter Eligibility Declarations (SMEDs)" (December 4, 2025), and "Reminders on evaluating subject matter eligibility of claims under 35 U.S.C. 101" (August 4, 2025), Applicant respectfully submits that the claims, at least as amended, recite patent eligible subject matter under Step 2A, Prong One and/or Step 2A, Prong Two.In particular, the USPTO has emphasized that the "mental process grouping is not without limits" and should not be expanded to encompass "claim limitations that cannot be practically performed in the human mind." Furthermore, although the present claims involve generating and applying certain mathematical concepts, these claims fall short of "reciting" (i.e., within the meaning of the USPTO's subject matter eligibility analysis applying case law) a mathematical relationship, calculation, formula, or equation. Additionally, under Step 2A, Prong Two, the USPTO has emphasized that each claim must be considered "as a whole" and that the "way in which the additional elements use or interact with the [alleged] exception may integrate the [alleged] judicial exception into a practical application." Unlike cases where the claims have merely applied a judicial exception on a generic computer, the present claims incorporate a detailed arrangement for a wearable device for monitoring heart health, and "Examiners are cautioned not to oversimplify claim limitations and expand the application of the 'apply it' consideration." The present application is also consistent with the decision in Ex Parte Desjardins and subsequent USPTO guidance, namely, the specification indicates improvements in the technology of non-invasive cardiac monitoring when compared with conventional methods that involve more expensive equipment and more invasive techniques, and these improvements are reflected in the limitations of the claims.
However, the examiner disagrees as the applicant has not provided an adequate amount of information to properly show what the improvements of the invention are. One would understand that using non-invasive devices is always a preferable improvement and cheaper. The mere claiming of these devices is not a technological improvement. As previously stated, a human could analyze (i.e. evaluate) the heart biomarkers using the technology listed, as well as calibrate the properties and derive corresponding biomarkers from the analysis in an iterative fashion. The claims amount to no more than generic processing tasks which do not provide sufficient details with which one could recreate the invention. Since the claims are lacking in details of the inventive concept and the specification does not specify a distinct technological improvement, the examiner is maintaining the rejection.
Applicant's arguments filed 29DEC2025 regarding the rejections under 35 USC 103 have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Pages 9-11 of the Remarks):
However, there is no suggestion in the proposed combination of Wiard and Du to selectively measure blood pressure using a blood pressure sensor at multiple locations along the sub-system; measure a pulse transit time at one or more of the plurality of distal sections of the sub-system; and measure a cardiac output (CO) of the larger cardiovascular system. Tang is cited at paragraph [0010] for constructing a patient-specific computational (FSI) model of the patient's heart. Tang describes a method for patient-specific, image-based computational modeling aimed at optimizing human heart surgery. This technique involves creating detailed computational models of a patient's heart using imaging data to simulate various surgical scenarios. Tang looks at the structure and fluid flow inside the heart's right and left ventricles. The data for the patient-specific heart model comes from 3D segmentation of MRI images of the patient's heart. In contrast, the claimed invention builds a patient-specific model, for example, of the arteries after the heart starting from aortic root to peripheral systemic arteries by numerically solving the FSI model using (a) blood pressure (BP) at multiple locations along the cardiovascular sub-system; (b) pulse transit time (PTT) measured at one or more of the distal sections of the sub-system; and (c) cardiac output (CO) of the larger cardiovascular system. There is no teaching how these claimed specific measured cardiovascular properties could be substituted in the Tang FSI model for the data from 3D segmentation of MRI images of the patient's heart to arrive at the claimed patient-specific model. Banet is cited for determining arterial diameter and estimating parameters such as LVET and PEP for use in a mathematical relationship to continuously estimate SV/CO/CP values. The Banet method does not use a blood pressure sensor to measure peripheral BP as claimed by the present invention. An algorithm is used in Banet relying on PTT and Pulse arrival time and vascular transit time, independently, to estimate SV and CO. There is no teaching of computing the dependency of CO on the measured PTT and BP at locations of the sub-system. Thus, the Banet disclosed method for data collection and processing has nothing to do with the claimed sensor configuration or method of computing the dependency of CO on the measured PTT and BP. Consequently, the prior art documents may teach general principles but fail to suggest the specific method steps of the claimed invention or how the disclosed steps in four prior patents could be modified to specifically combine and arrive at the claimed steps.
The arguments presented on Pg. 9 Lines 11-14 to Pg. 11 Line6 were addressed in the previous office action and are maintained.
Applicant states (see Pages 10-11 of the Remarks):
Applicant further observes that Wiard appears to describe measuring pulse travel time (PTT) at multiple locations (see T 0009), but does not actually disclose measuring blood pressure at multiple locations and, separately, measuring PTT at a distal location.
The examiner disagrees as ¶0009 of Wiard further discloses “The secondary sensors detects the blood pressure pulse travel time at the user's feet and hands, to determine differential characteristics of the user's arterial stiffness along different branches, and then provides an output characterizing the detected indications. “. This shows that the Pulse Transit Time is sensed at a distal location (the feet) and multiple locations (hands & feet). Therefore, the examiner maintains that the references teach the claim limitations.
Even if Wiard did teach this arrangement of measurement taking, there is no teaching in Tang or reasonable expectation of success in combining the Wiard and Tang which would lead a person of ordinary skill in the art to arrive at the claimed solution. That is, the Office's rationale uses impermissible hindsight to expansively render "models built and used based on cardiovascular properties such as blood pressure" obvious in light of the cited references.
The examiner disagrees as Wiard discussed cardiac system monitoring, which such as in ¶0078 “Measurements of both finger and foot allows the separation of both velocities, either directly (simple proportionality) or through the use of global or patient-specific models.” Idealizes the use of patient specific modeling. Tang discusses a cardiac system such as in the Abstract “wherein the quantitative analysis of the cardiac function provides an assessment for surgical options, optimizing surgical techniques, or predicting outcomes.”. One of ordinary skill in the art would view Wiard and think that the invention may be optimized by introducing an FSI model such as taught in Tang for the purposes of automating calculations and being able to review complex relationships of the cardiovascular system which may be hard to accomplish with Wiard alone. Therefore, the examiner maintains that the combination of references teaches the claim limitations.
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 1, 3-7, & 9-13 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 Claims 1 & 7:
Claims 1 & 7 recite the limitation " at least one of the electrocardiogram, photoplethysmogram, or ballistocardiogram " in Lines 10-11 & Lines 15-16 respectively. There is insufficient antecedent basis for this limitation in the claim.
Claims 3-6 & 10-11 are further rejected for depending upon the rejected claim 1.
Claims 9 & 12-13 are further rejected for depending upon the rejected claim 7.
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.
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject matter. The stepwise analysis for the instant claim is provided here.
Claims 1, 3-7, & 9-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Step 1: Statutory Categories
Claims 1 & 7 are directed to a method (i.e. process) and an apparatus (i.e. machine) respectively, and thus meets the step 1 requirements.
Step 2A: Prong 1; Judicial Exception
Regarding claims 1 & 7 the following claim limitations are an abstract idea:
“derives a central blood pressure of the patient based, at least in part, on the computed dependency of the CO on the further non-invasively measured PTT and BP and monitors heart health of the patient by continuously rederiving the central blood pressure in response to updated PTT and BP measurements BP”, “generating, with the wearable device, a patient-specific model by numerically solving the FSI model using the plurality of cardiovascular properties”, and “inputting a plurality of cardiovascular properties into a differential physics-based fluid structure interaction (FSI) model”, which is a mental process in addition to mathematical when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions, and mathematical concepts are considered laws of nature per MPEP 2106.04(a)(2)(II). In this case, a human could analyze (i.e. evaluate) the heart biomarkers using the technology listed. The presence of mathematical algorithms and concepts within claims 1 & 7, as well as dependent claims 3-6, & 8-9 are also considered a judicial exception as mathematical concepts are considered laws of nature per MPEP 2106.04(a)(2)(II). In this case, a human could also calibrate the properties and derive corresponding biomarkers from the analysis in an iterative fashion.
Step 2A: Prong 2; Additional Elements to Integrate J.E. Into A Practical Application
Regarding claims 1 & 7, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
“identifying a cardiovascular sub-system”, “proximal section”, “electrocardiogram”, “photoplethysmogram”, “ballistocardiogram”, “blood pressure sensor”, and “plurality of distal sections” is recited at a high level of generality and are generic cardiac monitoring components amounting to insignificant extra-solution activity in that they are merely data that is necessary to implement the abstract idea on a computer [MPEP 2106.05(g)]. Additionally, regarding claim 7, the abstract idea is not integrated into a practical application wherein “a wearable device”, “a plurality of sensors”; “a processor”, “ultrasound”, “and “software contained in a non-transitory storage medium containing instructions, that when executed by the processor” are recited at a high level of generality and are generic cardiac monitoring components amounting to insignificant extra-solution activity in that they are merely objects on which the functional limitations operate [MPEP 2106.05(b)].
Step 2B: Significantly More/Inventive Concept
The additional elements of claims 1 & 7, when considered separately and in
combination, do not add significantly more (i.e. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, identifying a cardiovascular sub-system containing a proximal section and a plurality of distal sections are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The additional elements are insignificant extra-solution activity and do not amount to more than what is well- understood, routine, and conventional.
Dependent claims 3-6, & 9-13 do not integrate the abstract idea into a practical application
and do not add significantly more to the abstract idea of claim 1,7 respectively. The dependent claim limitations are directed to specifying the sensors used (Claims 3 & 8), using principles of fluid and structure interaction to generate a calibrated model that can continuously reconstruct cardiovascular health biomarkers (Claim 4), using Windkessel properties of resistance and compliance of truncated arteries (Claim 5), Describing calibrated properties found from the arterial network (Claims 6), identifying the cardiovascular sub-system with reference to at least one of ultrasound images, MRI images, or CT scan images (Claim 9), identifying where biometrics are recorded on a user (Claims 10-13), and which are insignificant extra-solution activity and do not amount to more than what is well understood, routine, and conventional.
In summary, claims 1, 3-7, & 9-13 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
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 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.
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, 3-7, & 9-13 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wiard et al. (US Publication 20130310700; Previously Cited) in view of Du et al. (Du T, Hu D, Cai D. Outflow boundary conditions for blood flow in arterial trees. PLoS One. 2015 May 22;10(5):e0128597. doi: 10.1371/journal.pone.0128597. PMID: 26000782; PMCID: PMC4441455. ; Previously Cited), further in view of Tang et al. (US Publication 20080319308; Previously Cited), and further in view of Banet et al. (US Publication No. 20140249442; Previously Cited).
Regarding claim 1, Wiard discloses noninvasive monitoring of the circulatory system (Wiard ¶0063 “Various embodiments of the present disclosure are directed toward systems and methods for assessing an individual's cardiovascular risk by determining the individual's arterial stiffness/elasticity through pulse wave velocity measurements using noninvasive ballistocardiographic and photoplethysmographic methods.”), comprising: a plurality of distal sections (Wiard ¶0080 “Using the BCG timing as the start of the pulse wave, the peripheral and central vascular stiffness's are measured and an arterial pressure mismatch term is determined. The pressure amplification term is used in conjunction with a brachial blood pressure measurement, to determine the central blood pressure.” This quotation describes plural distal sections of focus for monitoring methods.), and the non-invasive BP measurements taken (Wiard ¶0015 “The system includes a device (e.g. an automated brachial blood pressure cuff, ambulatory blood pressure monitor, finger sphygmomanometer, etc.) to measure peripheral blood pressure.”, Figure 1B (Described in ¶0019) showing the sensors having multiple locations in the subsystem.), the PPT measurements taken at the one or more of the plurality of distal sections; and (Wiard Figures 1A,1B, 4 as described in ¶0018, ¶0019, ¶0022 respectively, showing the PTT at the most distal location of focus, within a plurality of measurements.), measuring cardiac output (CO) of the larger cardiovascular system (Wiard ¶0093 “The processor circuit generates output BCG signals over time to provide an indication of at least one of cardiac output and stroke volume for determining a treatment need for the user.”), obtaining non-invasive blood pressure (BP) measurements for the patient using a blood pressure sensor of the wearable device at multiple locations along the identified cardiovascular sub-system; obtaining non-invasive pulse transit time (PTT) measurements for the patient using at least one of the electrocardiogram, photoplethysmogram, or ballistocardiogram of the wearable device at one or more of the plurality of distal sections of the identified cardiovascular sub-system; obtaining further non-invasive BP measurements at the multiple locations along the identified cardiovascular sub-system using the blood pressure sensor and further non-invasive PTT diagnostic measurements using at least one of the electrocardiogram, photoplethysmogram, or ballistocardiogram at the one or more of the plurality of distal sections of the identified cardiovascular sub-system (Wiard ¶0008 “The secondary sensor detects the blood pressure pulse travel time at the user's feet, to determine a characteristic of the user's distal arterial stiffness, and then provides an output characterizing the detected indication.” Describes that utilization of distal measurement sensors for PTT and BP acquisition; ¶0009 “The system includes a BCG capture device, a plurality of secondary sensors and a processor circuit. The secondary sensors detects the blood pressure pulse travel time at the user's feet and hands, to determine differential characteristics of the user's arterial stiffness along different branches, and then provides an output characterizing the detected indications.”), deriving a central blood pressure of the patient based, at least in part, on the computed dependency of the CO on the further non-invasively measured PTT and BP (Wiard ¶0080 “Using the BCG timing as the start of the pulse wave, the peripheral and central vascular stiffness's are measured and an arterial pressure mismatch term is determined. The pressure amplification term is used in conjunction with a brachial blood pressure measurement, to determine the central blood pressure.”) and monitoring heart health of the patient by continuously rederiving the central pressure in response to updated PTT and BP measurements (Wiard ¶0008 “The secondary sensor detects the blood pressure pulse travel time at the user's feet, to determine a characteristic of the user's distal arterial stiffness, and then provides an output characterizing the detected indication.” Describes that utilization of distal measurement sensors for PTT and BP acquisition, and ¶0153 “Once both BCG I-wave and PPG foot timings are obtained, their difference (PPG-BCG) is computed to obtain the PTT” shows derivation happening to determine health biomarkers based on BP and PTT.).
Wiard does not disclose a plurality of truncated sections of the identified arterial sub-system of the individual wherein the plurality of cut-off sections separate the cardiovascular sub-system from other portions of a larger cardiovascular system of the patient.
Du teaches a plurality of truncated sections of the identified arterial sub-system of the individual wherein the plurality of cut-off sections separate the cardiovascular sub-system from other portions of a larger cardiovascular system of the patient (Du Abstract “In this work, we provide a systematic method to extract parameters of the three-element Windkessel model from the impedance of a truncated arterial tree or from experimental measurements of the blood pressure and flow rate at the inlet of the truncated arterial crown.”).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to configure a noninvasive system for monitoring the circulatory system by means of a plurality of distal sections used to obtain heart health biomarkers as taught by Wiard with a systematic method to extract parameters of the cardiovascular system as taught by Du. The motivation to integrate the technology of Wiard with Du was to configure a noninvasive system for monitoring the circulatory system using distal sections to acquire data and using mathematical techniques of Du to aid in calculating core heart health biomarkers from the data presented, as described in Du. This is helpful for the biomarker determination as it is easier to obtain distal information from a patient regardless of their physical location (i.e. not required to be in hospital), in a manner that facilitates home use by the patient. (Wiard ¶0043).
Neither Wiard nor Du teaches a system or method built for identifying a cardiovascular sub-system, comprising a single proximal section and inputting a plurality of cardiovascular properties into a differential physics-based fluid structure interaction (FSI) model to generate a patient-specific model by numerically solving the FSI model using the plurality of cardiovascular properties. Tang teaches an image based computational modeling technique for cardiovascular surgery optimization which includes identifying a cardiovascular sub-system of a patient, comprising a single proximal section and inputting a plurality of cardiovascular properties into a differential physics-based fluid structure interaction (FSI) model to generate a patient-specific model by numerically solving the FSI model using the plurality of cardiovascular properties (Tang ¶0010 “The model can include any one or combination of: fluid-structure interactions, valve mechanics, pulmonary regurgitation, fiber orientation and single-, double-, or multiple-layer anisotropic models, and an active contraction model. The method can also comprise validating the model with patient-specific data.” The ability to model pulmonary regurgitation indicates the use of the pulmonary system for heart biomarker evaluation. The pulmonary system is the proximal cardiovascular system that is associated with the heart and lungs.; ¶0055 “A 3D MRI-based RV-LV combination model with FSI was selected because a) it is based on clinically available patient-specific data (morphology, pressure, and flow); b) the FSI model makes it possible to combine fluid and structure models to analyze RV function with different patch designs and represents a starting point for many further improvements”; ¶0082; ¶0127).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to make a noninvasive system for monitoring the circulatory system by means of a plurality of distal sections used to obtain heart health biomarkers because Wiard discloses such a system. It would have been obvious to incorporate this system using a proximal section of a cardiovascular subsystem wherein this identified section is used to build and solve a patient specific FSI model of the identified system as disclosed by Tang. Therefore, one of ordinary skill in the art would recognize that the combination of these three technologies allows for a noninvasive way to detect and monitor cardiovascular conditions through distal data points and create a patient specific model that continuously calibrates to the patient (Wiard ¶0043). Therefore, the instant claim 1 is obvious over Wiard, Du, and Tang.
Neither Wiard, Du, nor Tang teaches determining the arterial diameter of the larger cardio cardiovascular system measured using an ultrasound of the wearable device, and run the patient-specific model in various iterations of CO, and computes a simulated PTT value corresponding to each iteration, until approaching the further non-invasively measured BP and PTT in order to compute a dependency of the CO on the further non-invasively measured PTT and BP. Banet teaches a body-worn system (Banet ¶0163 “In other embodiments, a set of body-worn monitors can continuously monitor a group of patients, wherein each patient in the group wears a body-worn monitor similar to those described herein.”) for continuous, noninvasive measurement of cardiac output, stroke volume, cardiac power, and blood pressure for determining the arterial diameter of the larger cardio cardiovascular system measured using an ultrasound of the wearable device (Banet ¶0016 “During a measurement, a microprocessor analyses both red and infrared radiation measured by the photodetector to determine time-dependent waveforms corresponding to the different wavelengths, each called a photoplethysmogram waveform (PPG). From these a SpO2 value is calculated Time-dependent features of the PPG waveform indicate both pulse rate and a volumetric absorbance change in an underlying artery (e.g., in the finger) caused by the propagating pressure pulse.” This information can be used to determine the arterial diameter.; ¶0091; ¶0129), and run the patient-specific model in various iterations of CO, and computes a simulated PTT value corresponding to each iteration, until approaching the further non-invasively measured BP and PTT in order to compute a dependency of the CO on the further non-invasively measured PTT and BP. (Banet ¶0020 “From these waveforms parameters such as LVET and PEP can be estimated and used in a mathematical relationship to continuously and accurately estimate SV/CO/CP values, as described in detail below. Once determined, they are combined with conventional vital signs, and wirelessly transmitted by the body-worn monitor to a central station to effectively monitor the patient.; ¶0092; ¶0102; ¶0146).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to make a noninvasive system for monitoring the circulatory system by means of a plurality of distal sections used to obtain heart health biomarkers because Wiard discloses such a system. It would have been obvious to incorporate this system with body-worn system for continuous, noninvasive measurement of cardiac output, stroke volume, cardiac power, and blood pressure for determining the arterial diameter of the larger cardio cardiovascular system using an ultrasound of the wearable device, and generating the patient-specific model using the plurality of cardiovascular properties; runs the patient-specific model in various iterations of CO, computes a simulated PTT value corresponding to each iteration, until approaching the further non-invasively measured BP and PTT in order to compute a dependency of the CO on the further non-invasively measured PTT and BP as taught by Banet, to the combined system disclosed and taught by Wiard, Du, and Tang. Therefore, one of ordinary skill in the art would recognize that the combination of these technologies allows for a noninvasive way to detect and monitor cardiovascular conditions through distal data points and create a patient specific model that continuously calibrates to the patient. Therefore, the instant claim 1 is obvious over Wiard, Du, Tang, and Banet.
Regarding claim 3, Claim 1 is obvious over the combinations of Wiard, Du, Tang, and Banet. Wiard further discloses deriving, with the wearable device at least one of central blood pressure (CBP) (Wiard ¶0080 “Using the BCG timing as the start of the pulse wave, the peripheral and central vascular stiffness's are measured and an arterial pressure mismatch term is determined. The pressure amplification term is used in conjunction with a brachial blood pressure measurement, to determine the central blood pressure.”),, cardiac output (CO) (Wiard ¶0114 “The BCG signal is used to provide a measure of changes in perfusion by estimating changes in cardiac output;”),, stroke volume (SV) (Wiard ¶0093 “The processor circuit generates output BCG signals over time to provide an indication of at least one of cardiac output and stroke volume for determining a treatment need for the user.”), and aortic compliance (AC) (Wiard ¶0053 “A measurement of the Carotid-Femoral Pulse Wave Velocity (cfPWV) can be used to quantify aortic stiffness.” Aortic stiffness is inversely related to aortic compliance, and can therefore be calculated). based, at least in part, on the computed dependency of the CO on the further non-invasively measured PTT and BP (Wiard ¶0080 “Using the BCG timing as the start of the pulse wave, the peripheral and central vascular stiffness's are measured and an arterial pressure mismatch term is determined. The pressure amplification term is used in conjunction with a brachial blood pressure measurement, to determine the central blood pressure.”). Therefore, it would have been obvious to combine device of claim 1, as detailed by Wiard, Du, and Tang, with the calculations of acquired data as disclosed by Wiard. The motivation for this combination is to obtain proximal heart health biomarkers through standard calculations based on distal heart monitoring data, as disclosed by Wiard in claim 3.
Regarding claim 4, Claim 1 is obvious over the combinations of Wiard, Du, Tang, and Banet. Wiard further discloses a model that can continuously reconstruct cardiovascular health biomarkers (Wiard ¶0124 “A micro-power op-amp is used with the bandwidth boosted by a composite amplifier design, facilitating desirable current consumption (e.g., about 3.9 micro-Amps), such that a battery could operate the device continuously for years.” Describes how biometrics could be recorded continuously by the power of a battery.)” However, none of Wiard, Du, or Banet specifically disclose a model that uses principles of fluid and structure interaction to generate a calibrated patient-specific arterial sub-system. Tang further teaches “a model that uses principles of fluid and structure interaction to generate a calibrated patient-specific arterial sub-system (Tang ¶0010 “The model can include any one or combination of: fluid-structure interactions, valve mechanics, pulmonary regurgitation, fiber orientation and single-, double-, or multiple-layer anisotropic models, and an active contraction model. The method can also comprise validating the model with patient-specific data.”; ¶0055 “A 3D MRI-based RV-LV combination model with FSI was selected because a) it is based on clinically available patient-specific data (morphology, pressure, and flow); b) the FSI model makes it possible to combine fluid and structure models to analyze RV function with different patch designs and represents a starting point for many further improvements”; ¶0082; ¶0127).”. It would have been obvious to one of ordinary skill of the art before the effective filing date of the claimed invention to combine the technologies of Tang with the combination of Wiard, Du, Tang, and Banet to create a device as described in claim 1 that is also capable of continuously reconstructing cardiovascular health biomarkers as disclosed by Wiard based on a model that uses the principles of fluid and structure interaction to generate a calibrated patient-specific arterial sub-system as taught by Tang. The combination is useful to create a self-sufficient system of acquisition that aids in patient use.
Regarding claim 5, Claim 1 is obvious over the combinations of Wiard, Du, Tang, and Banet. However, none of Wiard, Tang, or Banet specifically disclose using the plurality of cardiovascular properties to derive a plurality of calibrated properties, the plurality of calibrated properties comprising Windkessel properties of resistance, and compliance of each of the plurality of cut-off sections.
Du further teaches using the plurality of cardiovascular properties to derive a plurality of calibrated properties, the plurality of calibrated properties comprising Windkessel properties of resistance, and compliance of each of the plurality of cut-off sections. (Du Abstract “In this work, we provide a systematic method to extract parameters of the three-element Windkessel model from the impedance of a truncated arterial tree or from experimental measurements of the blood pressure and flow rate at the inlet of the truncated arterial crown.”).Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date of the claimed invention to use the calibrated properties of the boundary conditions such as Windkessel properties of resistance, and compliance of truncated arteries, as taught by Du, in addition to the acquired signals from the system of claim 1 disclosed by Wiard, Du, and Tang to more accurately determine a patient’s heart health.
Regarding claim 6, Claim 1 is obvious over the combinations of Wiard, Du, Tang, and Banet None of Wiard, Tang, or Banet specifically disclose using the plurality of cardiovascular properties to derive a plurality of calibrated properties, the plurality of calibrated properties comprising arterial compliance, speed of wave propagation and cross-sectional area of each arterial wall of the cardiovascular sub-system in absence of pressure. Du further teaches using the plurality of cardiovascular properties to derive a plurality of calibrated properties (Du Introduction “The capacitance is introduced to take into account the compliance of the downstream arterial walls.” ), the plurality of calibrated properties comprising arterial compliance (Du Introduction “The capacitance is introduced to take into account the compliance of the downstream arterial walls.” ), speed of wave propagation (Du Discussion “In our work, we have shown that the characteristic resistance can be estimated with the pulse wave speed or the area compliance”), and cross-sectional area of each arterial wall of the cardiovascular sub-system in absence of pressure (Du Mathematical Model “A0(x)=πr20 is the unstressed cross-sectional area of the vessel.”). Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date of the claimed invention to use the calibrated properties along with the calculations of wave propagation and arterial wall dimensions as taught by Du with the technology of claim 1 disclosed by Wiard, Du, and Tang in combination to generate data more accurately based on the patient’s cardiovascular signals.
Regarding claim 7, Wiard discloses noninvasive monitoring of the circulatory system (Wiard ¶0063 “Various embodiments of the present disclosure are directed toward systems and methods for assessing an individual's cardiovascular risk by determining the individual's arterial stiffness/elasticity through pulse wave velocity measurements using noninvasive ballistocardiographic and photoplethysmographic methods.”), the device comprising a blood pressure sensor (Wiard ¶0015 “The system includes a device (e.g. an automated brachial blood pressure cuff, ambulatory blood pressure monitor, finger sphygmomanometer, etc.) to measure peripheral blood pressure.”, Figure 1B (Described in ¶0019) showing the sensors having multiple locations in the subsystem.); at least one of an electrocardiogram (Wiard ¶0077 Consistent with various embodiments of the present disclosure, a BCG device, such as a modified bathroom scale, includes ECG electrodes.”, Mentions of ECG use are also seen in ¶0087-¶0091), photoplethysmogram (Wiard ¶0068 “embodiments of the present disclosure are directed toward the use of photoplethysmographic (PPG) measurements.”, Also Figure 1A as described in ¶0076), or ballistocardiogram (Wiard ¶0077 Consistent with various embodiments of the present disclosure, a BCG device, such as a modified bathroom scale, includes ECG electrodes.”, Mentions of ECG use are also seen in ¶0087-¶0091); an ultrasound (Wiard ¶0058 “Arterial pulse waves can be detected using pressure-sensitive transducers or sensors (piezoresistive, piezoelectric, capacitive), Doppler ultrasound, based on the principle that the pressure pulse and the flow pulse propagate at the same velocity, or applanation tonometry, where the pressure within a small micromanometer flattened against the artery equates to the pressure within the artery.” ); a processor (Wiard ¶0011 “A processor uses the second sensor signal to process the captured signal, such as to filter or gate (e.g., weight or eliminate aspects of) a captured BCG recording, and provide user diagnostics”); and software contained in a non-transitory storage medium containing instructions, that when executed by the processor (Wiard ¶0106 “As with other aspects of the present disclosure, the various functionalities can be implemented using combinations of general purpose computers configured by specialized software, programmable logic devices, discrete circuits/logic and combinations thereof.”) , comprising a plurality of distal sections (Wiard ¶0080 “Using the BCG timing as the start of the pulse wave, the peripheral and central vascular stiffness's are measured and an arterial pressure mismatch term is determined. The pressure amplification term is used in conjunction with a brachial blood pressure measurement, to determine the central blood pressure.” This quotation describes plural distal sections of focus for monitoring methods.) and the non-invasive BP measurements taken (Wiard ¶0015 “The system includes a device (e.g. an automated brachial blood pressure cuff, ambulatory blood pressure monitor, finger sphygmomanometer, etc.) to measure peripheral blood pressure.”, Figure 1B (Described in ¶0019) showing the sensors having multiple locations in the subsystem.), the PPT measurements taken at the one or more of the plurality of distal sections; and (Wiard Figures 1A,1B, 4 as described in ¶0018, ¶0019, ¶0022 respectively, showing the PTT at the most distal location of focus, within a plurality of measurements.)a cardiac output (CO) of the larger cardiovascular system (Wiard ¶0093 “The processor circuit generates output BCG signals over time to provide an indication of at least one of cardiac output and stroke volume for determining a treatment need for the user.”); derives a central blood pressure of the patient based, at least in part, on the computed dependency of the CO on the further non-invasively measured PTT and BP (Wiard ¶0080 “Using the BCG timing as the start of the pulse wave, the peripheral and central vascular stiffness's are measured and an arterial pressure mismatch term is determined. The pressure amplification term is used in conjunction with a brachial blood pressure measurement, to determine the central blood pressure.”), obtaining non-invasive blood pressure (BP) measurements for the patient using a blood pressure sensor of the wearable device at multiple locations along the identified cardiovascular sub-system; obtaining non-invasive pulse transit time (PTT) measurements for the patient using at least one of the electrocardiogram, photoplethysmogram, or ballistocardiogram of the wearable device at one or more of the plurality of distal sections of the identified cardiovascular sub-system; obtaining further non-invasive BP measurements at the multiple locations along the identified cardiovascular sub-system using the blood pressure sensor and further non-invasive PTT diagnostic measurements using at least one of the electrocardiogram, photoplethysmogram, or ballistocardiogram at the one or more of the plurality of distal sections of the identified cardiovascular sub-system (Wiard ¶0008 “The secondary sensor detects the blood pressure pulse travel time at the user's feet, to determine a characteristic of the user's distal arterial stiffness, and then provides an output characterizing the detected indication.” Describes that utilization of distal measurement sensors for PTT and BP acquisition; ¶0009 “The system includes a BCG capture device, a plurality of secondary sensors and a processor circuit. The secondary sensors detects the blood pressure pulse travel time at the user's feet and hands, to determine differential characteristics of the user's arterial stiffness along different branches, and then provides an output characterizing the detected indications.”), and monitors heart health of the patient by continuously rederiving the central blood pressure in response to updated PTT and BP measurements (Wiard ¶0008 “The secondary sensor detects the blood pressure pulse travel time at the user's feet, to determine a characteristic of the user's distal arterial stiffness, and then provides an output characterizing the detected indication.” Describes that utilization of distal measurement sensors for PTT and BP acquisition, and ¶0153 “Once both BCG I-wave and PPG foot timings are obtained, their difference (PPG-BCG) is computed to obtain the PTT” shows derivation happening to determine health biomarkers based on BP and PTT.).
Although Wiard discloses a device for noninvasive monitoring of the circulatory system comprising a device containing at least one of a plurality of sensors, a processor, software containing executable code, and a plurality of distal sections, operated by measuring the blood pressure (BP) at multiple locations along the sub-system, measuring pulse transit time (PTT) at a location of a distal section in a plurality of distal sections, measuring the cardiac output (CO) and determining the arterial diameter of the individual for deriving a proximal heart health biomarker corresponding to the distal PTT and BP diagnostic measurements as described above.
Wiard does not disclose the plurality of cut-off sections separate the cardiovascular sub-system from other portions of a larger cardiovascular system of the patient. Du teaches wherein the model contains a plurality of truncated sections of the identified arterial sub-system of the individual wherein the plurality of cut-off sections separate the cardiovascular sub-system from other portions of a larger cardiovascular system of the patient (Du Abstract “In this work, we provide a systematic method to extract parameters of the three-element Windkessel model from the impedance of a truncated arterial tree or from experimental measurements of the blood pressure and flow rate at the inlet of the truncated arterial crown.”).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to configure a wearable noninvasive system for monitoring the circulatory system by means of a plurality of distal sections used to obtain heart health biomarkers as disclosed by Wiard with a systematic method to extract parameters of the three-element Windkessel model from Outflow Boundary Conditions for Blood Flow in Arterial Trees as taught by Du. Therefore, it would have been obvious to use the wearable device as described by Wiard for applications in claim 7. The portability of the device aids in the device being non-invasive as instead of implantation it can be worn during use. The motivation to integrate the technology of Wiard with Du was to configure a wearable noninvasive system for monitoring the circulatory system using distal sections to acquire data and using mathematical techniques of Du to aid in calculating core heart health biomarkers from the data presented, as described in Du. This is helpful for the biomarker determination as it is easier to obtain distal information from a patient regardless of their physical location (i.e. not required to be in hospital), while also minimizing risk or harm to the patient.
Furthermore, neither Wiard nor Du teaches a proximal section of a cardiovascular subsystem, inputs a plurality of cardiovascular properties into a differential physics-based fluid structure interaction (FSI) model and generates a patient-specific model by numerically solving the FSI model using the plurality of cardiovascular properties. Tang teaches an image based computational modeling technique for cardiovascular surgery optimization which includes identifying a cardiovascular sub-system of a patient, the cardiovascular sub-system comprising a single proximal section containing an arterial network associated with the heart; inputs a plurality of cardiovascular properties into a differential physics-based fluid structure interaction (FSI) model, and generates a patient-specific model by numerically solving the FSI model using the plurality of cardiovascular properties (Tang ¶0010 “The model can include any one or combination of: fluid-structure interactions, valve mechanics, pulmonary regurgitation, fiber orientation and single-, double-, or multiple-layer anisotropic models, and an active contraction model. The method can also comprise validating the model with patient-specific data.” The ability to model pulmonary regurgitation indicates the use of the pulmonary system for heart biomarker evaluation. The pulmonary system is the proximal cardiovascular system that is associated with the heart and lungs; ¶0055 “A 3D MRI-based RV-LV combination model with FSI was selected because a) it is based on clinically available patient-specific data (morphology, pressure, and flow); b) the FSI model makes it possible to combine fluid and structure models to analyze RV function with different patch designs and represents a starting point for many further improvements”; ¶0082; ¶0127).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to make a noninvasive and wearable system for monitoring the circulatory system by means of a plurality of distal sections used to obtain heart health biomarkers because Wiard discloses such a system. It would have been obvious to incorporate this system with a systematic method to extract parameters of the three-element Windkessel model from Outflow Boundary Conditions for Blood Flow in Arterial Trees as taught by Du. Along with a system or method built to detect an arterial network based proximal section of a cardiovascular subsystem wherein this identified section is used to build a patient specific model of the identified system as disclosed by Tang. Therefore, one of ordinary skill in the art would recognize that the combination of these three technologies allows for a noninvasive way to detect and monitor cardiovascular conditions through distal data points and create a patient specific model that continuously calibrates to the patient.
Neither Wiard, Du, nor Tang teaches a body worn device for determining the arterial diameter of the larger cardio cardiovascular system measured using an ultrasound of the wearable device, and generating the patient-specific model using the plurality of cardiovascular properties; runs the patient-specific model in various iterations of CO and computes a simulated PTT value corresponding to each iteration until approaching the further non-invasively measured BP and PTT in order to compute a dependency of the CO on the further non-invasively measured PTT and BP. Banet teaches a body-worn system (Banet ¶0163 “In other embodiments, a set of body-worn monitors can continuously monitor a group of patients, wherein each patient in the group wears a body-worn monitor similar to those described herein.”) for continuous, noninvasive measurement of cardiac output , stroke volume, cardiac power, and blood pressure for determining the arterial diameter of the larger cardio cardiovascular system measured using an ultrasound of the wearable device (Banet ¶0016 “During a measurement, a microprocessor analyses both red and infrared radiation measured by the photodetector to determine time-dependent waveforms corresponding to the different wavelengths, each called a photoplethysmogram waveform (PPG). From these a SpO2 value is calculated Time-dependent features of the PPG waveform indicate both pulse rate and a volumetric absorbance change in an underlying artery (e.g., in the finger) caused by the propagating pressure pulse.” This information can be used to determine the arterial diameter.; ¶0091; ¶0129), and run the patient-specific model in various iterations of CO, and computes a simulated PTT value corresponding to each iteration, until approaching the further non-invasively measured BP and PTT in order to compute a dependency of the CO on the further non-invasively measured PTT and BP. (Banet ¶0020 “From these waveforms parameters such as LVET and PEP can be estimated and used in a mathematical relationship to continuously and accurately estimate SV/CO/CP values, as described in detail below. Once determined, they are combined with conventional vital signs, and wirelessly transmitted by the body-worn monitor to a central station to effectively monitor the patient.; ¶0092; ¶0102; ¶0146).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to make a noninvasive system for monitoring the circulatory system by means of a plurality of distal sections used to obtain heart health biomarkers because Wiard discloses such a system. It would have been obvious to incorporate this system with body-worn system for continuous, noninvasive measurement of cardiac output, stroke volume, cardiac power, and blood pressure for determining the arterial diameter of the larger cardio cardiovascular system measured using an ultrasound of the wearable device, and generating the patient-specific model using the plurality of cardiovascular properties; runs the patient-specific model in various iterations of CO until approaching the further non-invasively measured BP and PTT in order to compute a dependency of the CO on the further non-invasively measured PTT and BP as taught by Banet, to the combined system disclosed and taught by Wiard, Du, and Tang. Therefore, one of ordinary skill in the art would recognize that the combination of these technologies allows for a noninvasive way to detect and monitor cardiovascular conditions through distal data points and create a patient specific model that continuously calibrates to the patient to allow for a mobile monitoring device (Wiard ¶0043). Therefore, the instant claim 7 are obvious over Wiard, Du, Tang, and Banet.
Regarding claim 9, Claim 7 is obvious over the combinations of Wiard, Du, Tang, and Banet. Wiard further discloses wherein the wearable device is configured to identify the cardiovascular sub-system with reference to at least one of ultrasound images, MRI images, or CT scan images of the patient (Wiard ¶0058 “Arterial pulse waves can be detected using pressure-sensitive transducers or sensors (piezoresistive, piezoelectric, capacitive), Doppler ultrasound, based on the principle that the pressure pulse and the flow pulse propagate at the same velocity, or applanation tonometry, where the pressure within a small micromanometer flattened against the artery equates to the pressure within the artery”).
Regarding claim 10, Claim 1 is obvious over the combinations of Wiard, Du, Tang, and Banet Wiard further discloses wherein the multiple locations of the identified cardiovascular sub-system where the non-invasive BP measurements and the further non-invasive BP measurements of the patient are taken is selected from the following: an upper arm, a finger, and a brachial artery, (Wiard ¶0015 “The system uses the vascular stiffness measurements along the arterial track to determine the brachial and central pressure differences. The system includes a device (e.g. an automated brachial blood pressure cuff, ambulatory blood pressure monitor, finger sphygmomanometer, etc.) to measure peripheral blood pressure.”).
Regarding claim 11, Claim 1 is obvious over the combinations of Wiard, Du, Tang, and Banet. Wiard further discloses wherein the one or more of the plurality of distal sections of the identified cardiovascular sub-system where the non-invasive PTT measurements and the further non-invasive PPT measurements of the patient are taken is selected from the following: a finger (Wiard ¶0009 “The secondary sensors detects the blood pressure pulse travel time at the user's feet and hands,”).
Regarding claim 12, Claim 7 is obvious over the combinations of Wiard, Du, Tang, and Banet. Wiard further discloses wherein the multiple locations of the identified cardiovascular sub-system where the non-invasive BP measurements and the further non-invasive BP measurements of the patient are taken is selected from the following: an upper arm, a finger, and a brachial artery (Wiard ¶0015 “The system uses the vascular stiffness measurements along the arterial track to determine the brachial and central pressure differences. The system includes a device (e.g. an automated brachial blood pressure cuff, ambulatory blood pressure monitor, finger sphygmomanometer, etc.) to measure peripheral blood pressure.”).
Regarding claim 13, Claim 7 is obvious over the combinations of Wiard, Du, Tang, and Banet. Wiard further discloses wherein the one or more of the plurality of distal sections of the identified cardiovascular sub-system where the non-invasive PTT measurements and the further non-invasive PPT measurements of the patient are taken is selected from the following: a finger (Wiard ¶0009 “The secondary sensors detects the blood pressure pulse travel time at the user's feet and hands,”).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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