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
This action is a non-final rejection
Claims 1-20 are pending
Claims 1-20 are rejected under 35 USC § 101
Claims 1-20 are rejected under 35 USC § 103
Priority
Acknowledgement is made of Applicant’s claim for a domestic priority date of 12-13-2018
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10-22-2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are not patent eligible because the claimed invention is directed to an abstract idea without significantly more.
Analysis
First, claims are directed to one or more of the following statutory categories: a process, a machine, a manufacture, and a composition of matter. Regarding claims 1-20 the claims recite an abstract idea of detecting and monitoring oversedation to prevent harm to patients.
Independent Claims 1, 6 and 12 are rejected under 35 U.S.C 101 based on the following analysis.
-Step 1 (Does the claim fall within a statutory category? YES): claims 1, 6 and 12 recite a method and system of detecting and monitoring oversedation to prevent harm to patients.
-Step 2A Prong One (Does the claim fall within at least one of the groupings of abstract ideas?: YES): The claimed invention:
A system and method comprising:
storing a plurality of data aggregated in association with each of a plurality of patients, the plurality of data comprising:
a documentation data input by at least one healthcare professional in association with a patient in the plurality of patients;
at least one medication history record associated with the patient; and
at least one surgical history record associated with the patient;
extract a plurality of risk factor data, in the plurality of data, associated with at least one over sedation risk factor for the patient;
input the plurality of risk factor data into an over sedation risk model;
calculate, as output from the over sedation risk model, a risk score and a risk level for the patient;
responsive to the risk score exceeding a predetermined threshold, automatically generate an over sedation alert for the patient;
displaying a synchronized timeline and a first plurality of points indicating administration of a plurality of medications to the patient along the synchronized timeline;
displaying a second plurality of points, along the synchronized timeline, indicating the risk level for the patient at each of the first plurality of points and;
displaying a third plurality of points, along the synchronized timeline, indicating a sedation scale score for the patient. at each of the first plurality of points.
belonging to the grouping of mental processes under concepts performed in the human mind (including an observation, evaluation, judgement, opinion) as it recites “detecting and monitoring oversedation to prevent harm to patients”. Alternatively, the selected abstract idea belongs to the grouping of certain methods of organizing human activity under managing personal behavior or relationships or interactions between people as it recites “detecting and monitoring oversedation to prevent harm to patients”. (refer to MPP 2106.04(a)(2)). Accordingly this claim recites an abstract idea.
-Step 2A Prong Two (Are there additional elements in the claim that imposes a meaningful limit on the abstract idea? NO). Claims 1, 6 and 12 recite:
a data repository coupled to a computer network
a server, comprising at least one server hardware computing device coupled to the computer network and comprising at least one processor executing instructions within a memory which, when executed, cause the system to:
data repository;
Graphical User Interface (GUI) comprising:
a first GUI component
a second GUI component
a third GUI component
update the GUI responsive to an update to the data repository such that the GUI is synchronized with the data repository.
Amounting to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, these additional elements, when considered separately and as an ordered combination do not integrate the judicial exception/abstract idea into a “practical application” of the judicial exception because they do not impose any meaningful limit on practicing the judicial exception.
-Step 2B (Does the additional elements of the claim provide an inventive concept?: NO. As discussed previously with respect to Step 2A Prong Two, claim 1 recites:
a data repository coupled to a computer network
a server, comprising at least one server hardware computing device coupled to the computer network and comprising at least one processor executing instructions within a memory which, when executed, cause the system to:
data repository;
Graphical User Interface (GUI) comprising:
a first GUI component
a second GUI component
a third GUI component;
update the GUI responsive to an update to the data repository such that the GUI is synchronized with the data repository.
Amounting to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)) Accordingly, even when viewed as a whole the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
Dependent Claims:
Step 2A Prong One: The following dependent claims recites additional limitations that further define the abstract idea of detecting and monitoring oversedation to prevent harm to patients. The claim limitations include:
Claims 3 and 14: further comprising a content displayed.. comprising:
a notification of the over sedation alert;
the risk level for the patient;
the at least one over sedation risk factor; and
a recommendation, associated.. in the instructions with the risk level for the patient
Claims 4 and 15: further comprising a plurality of dots or dashes, displayed .. each of the plurality of dots or dashes representing the risk level for the patient along the synchronized timeline at a time that the risk level was determined.
Claims 5 and 16: wherein each of the plurality of dots or dashes is color- coded according to the risk level for the patient, wherein:
a low risk level is represented by a first color;
a moderate risk level is represented by a second color; and
a high risk level is represented by a third color.
Claim 7: further comprising the step of deriving, … the plurality of risk factors from a plurality of data aggregated … for each of a plurality of patients, the plurality of data comprising:
a documentation data input by at least one healthcare professional in association with the patient;
at least one medication history record associated with the patient; and
at least one surgical history record associated with the patient.
Claim 8: further comprising the step of identifying .. within the plurality of risk factor data, at least one dynamic risk factor comprising:
a surgical procedure performed on the patient;
an anesthesia time for the patient greater than 3 hours and less than 24 hours;
and a sedative administered to the patient within the previous 2 hours
Claim 9: further comprising the step of identifying .. within the plurality of risk factor data, at least one non-dynamic risk factor comprising:
a first determination whether the patient smokes;
a second determination whether the patient snores;
an obstructive sleep apnea diagnosis for the patient;
an age for the patient;
or a body mass index metric for the patient
Claim 10: wherein the sedation scale score comprises a Pasero Opioid-induced Sedation Scale score
Claim 11: wherein the sedation scale score comprises a Richmond Agitation-Sedation Scale score
Claim 17:
select the plurality of risk factor data or a plurality of additional data;
input the plurality of risk factor data or the plurality of additional data as input, determined factors, or parameters,;
receive, as output:
at least one adjustment to the predetermined threshold;
an identification of at least one false positive or at least one false negative;
or a dynamic adjustment to the risk model, the risk score, or the risk level for the patient
Claim 18: wherein the at least one over sedation risk factor includes:
at least one renal or kidney factor indicating whether a renal or kidney function for the patient is impaired;
at least one hepatic or liver factor indicating whether a hepatic or liver function is impaired;
or at least one indication of renal insufficiency in association with the patient
Claim 19: wherein …further includes a chronological and longitudinal display of at least one of:
a history of at least one medication administered;
at least one risk score associated with, and indicating an effect of, the at least one medication administered;
at least one trend
Step 2A Prong Two (Are there additional elements in the claim that imposes a meaningful limit on the abstract idea? NO). The following dependent claims recite mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, the claims as a whole do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims include:
Claims 2 & 13: comprising a GUI popup window generated responsive to the risk score exceeding the predetermined threshold, and displayed on a client computer operated by at least one healthcare professional
Claims 3 & 14: GUI popup window & data repository.
Claims 4 & 15: second GUI component.
Claim 7: server & data repository.
Claim 8: server
Claim 9: server
Claim 17: server is further configured to ; data repository & machine learning algorithm
Claim 19: GUI ; first GUI component; second GUI component & third GUI component
Claim 20: wherein the server is further configured to:
receive, from within an electronic medical record (EMR) software application, a first user input selecting a link to the GUI; and
display the GUI within an embedded display within the EMR software application
Step 2B (Does the additional elements of the claim provide an inventive concept?: NO). As discussed previously with respect to Step 2A Prong Two, the following dependent claims recite mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible. The claims include:
Claims 2 & 13: comprising a GUI popup window generated responsive to the risk score exceeding the predetermined threshold, and displayed on a client computer operated by at least one healthcare professional
Claims 3 & 14: GUI popup window & data repository.
Claims 4 & 15: second GUI component.
Claim 7: server & data repository.
Claim 8: server
Claim 9: server
Claim 17: server is further configured to ; data repository & machine learning algorithm
Claim 19: GUI ; first GUI component; second GUI component & third GUI component
Claim 20: wherein the server is further configured to:
receive, from within an electronic medical record (EMR) software application, a first user input selecting a link to the GUI; and
display the GUI within an embedded display within the EMR software application
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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
non-obviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being un-patentable by Garcia da Rocha et.al. (US 2016/0067220 A1) hereinafter “Garcia” in view of Amarasingham et.al (US 2017/0061093 A1) hereinafter “Amarasingham”
Regarding claims 1, 6 & 12 Garcia teaches:
A system comprising: (See at least [Abstract] via: “…providing sedation or analgesia to a pediatric patient by administering a dexmedetomidine infusion and optionally a loading dose. The dexmedetomidine can be administered before, during, or after surgery…”; in addition see at least [0289] via: “…UMSS is a simple observational tool that assesses the level of alertness on a 5-point scale ranging from 1 (wide awake) to 5 (unarousable with deep stimulation)…”)
a data (Data from all fully evaluable patients (those receiving at least 2 hours of dexmedetomidine infusion) were included in the analysis) repository coupled to a computer network and storing (recorded) a plurality of data aggregated in association with each of a plurality of patients, the plurality of data comprising: (in addition see at least [0286] via: “…The primary pharmacokinetic evaluation was to define the pharmacokinetics of increasing doses of dexmedetomidine administered as an IV bolus followed by a continuous IV infusion in infants who were postoperative from cardiac surgery. Data from all fully evaluable patients (those receiving at least 2 hours of dexmedetomidine infusion) were included in the analysis..”; in addition see at least [0287] via: “…The pharmacodynamic assessments monitored continuously every hour until 24 hours after the discontinuation of the infusion included heart rate, blood pressure, mean arterial blood pressure, cardiac rhythm, oxygen saturation, and respiratory rate. The Bispectral Index Scale (BIS, Aspect Medical Systems, Natick, Mass.) and the University of Michigan Sedation Scale (UMSS) were used to assess the level of sedation..”; in addition see at least [0288] via: “…The BIS monitor was applied to the patient's forehead prior to the bolus dose, and remained until the EOI. A member of the clinical team periodically did a sensor check to be sure signal quality and proper sensor application/adhesion were maintained. BIS values, with the exception of the Signal Quality Index (SQI) were blinded. Pre-stimulation BIS values were recorded for sedation assessments (or during non-stimulated times). The maximal BIS reading during stimulation was also recorded. … The maximum BIS readout and the corresponding SQI were recorded for each hour that the patient was on study. The BIS sensor was removed from the patient's head after the infusion had been discontinued, and the patient had been declared awake by the clinical care team…”; in addition see at least [0289] via: “…The UMSS is a simple, valid and reliable tool that facilitates rapid and frequent assessment and documentation of depth of sedation in children. The UMSS is a simple observational tool that assesses the level of alertness on a 5-point scale ranging from 1 (wide awake) to 5 (unarousable with deep stimulation). The UMSS score was assessed by the clinical nurse caring for the patient, and recorded every hour until the BIS sensor was removed…”; in addition see at least [0290] via: “…Adverse events were reported in a routine manner at scheduled times during the trial..”)
a documentation data (documentation of depth of sedation in children) input by at least one healthcare professional (clinical nurse) in association with a patient in the plurality of patients (children); (See at least [0284] via: “…The University of Michigan Sedation Score (UMSS) is a validated pediatric sedation scale and is used as a pharmacodynamic measurement for the Example 5 study. ..”; in addition see at least [0289] via: “…The UMSS is a simple, valid and reliable tool that facilitates rapid and frequent assessment and documentation of depth of sedation in children. The UMSS is a simple observational tool that assesses the level of alertness on a 5-point scale ranging from 1 (wide awake) to 5 (unarousable with deep stimulation). The UMSS score was assessed by the clinical nurse caring for the patient, and recorded every hour until the BIS sensor was removed…”)
at least one medication history record (primary PD variables assessed) associated with the patient; (See at least [0284] via: “…The primary PD variables assessed the level of sedation using BIS and the University of Michigan Sedation Scale Safety variables included exposure to study drug, adverse events (adverse effects), hepatotoxicity, DLT, laboratory results, vital signs, use of concomitant medication, and 12-lead electrocardiogram…
at least one surgical history record (Relevant medical history) associated with the patient (infants); (See at least [0286] via: “… The primary pharmacokinetic evaluation was to define the pharmacokinetics of increasing doses of dexmedetomidine administered as an IV bolus followed by a continuous IV infusion in infants who were postoperative from cardiac surgery. Data from all fully evaluable patients (those receiving at least 2 hours of dexmedetomidine infusion) were included in the analysis..”; in addition see at least [0291] via: “… Serious adverse effects that were expected because of the surgical procedure did not require expedited review and were reviewed bi-weekly…”; in addition see at least [0513] via: “…Relevant ongoing medical history included hypoplastic left heart syndrome and was post-surgery (cardiac catheterization, left pulmonary artery stenosis with balloon dilatation and aortopulmonary collaterals that required coil embolization)…”; in addition see at least [0514] via: “…Relevant medical history included transposition of the great arteries, pulmonary stenosis, and ventricular septal defect and was postoperative for open heart surgery for correction of these problems (Nikaidoh operation). This subject also received sufentanil IV and IV morphine, both one time each for pain during dexmedetomidine infusion which were protocol violations…”)
a server, comprising at least one server hardware computing device coupled to the computer network and comprising at least one processor executing instructions within a memory which, when executed, cause the system to:
extract, from the data repository, a plurality of risk factor data (adverse effect profile), in the plurality of data, associated with at least one over sedation risk factor for the patient (pediatric population and post-operative surgical patients); (See at least [0134] via: “…Dexmedetomidine was safe and well tolerated in both age groups and at all doses. The adverse effect profile observed is typical of the critically ill, high risk pediatric population and post-operative surgical patients….”; ….”; in addition see at least [0291] via: “…An adverse effect was defined as any untoward medical occurrence that presented itself during treatment or administration with a pharmaceutical product and which may or may not have a causal relationship with the treatment. A treatment-emergent adverse event (treatment-emergent adverse effect) was defined as any adverse effect with onset or worsening reported by a patient from the time that the first dose of study drug was administered until 24 hours had elapsed following discontinuation of study drug administration. … Adverse events were also classified by severity (mild, moderate, or severe)… An assessment of the risks to patients were made, and a recommendation to continue with the study or close the trial were made to the IRB for review. If a decision was made to continue with the trial, the modifications to the protocol, the updated assessment of risks and benefits, and a modified informed consent were to be submitted to the IRB….”)
input the plurality of risk factor data (covariates- weight and age) into an over sedation risk model (modeling); (See at least [0218] via: “…The relationship between the level of sedation and plasma concentration, supplemental sedation requirements, and impact of dexmedetomidine alone, and with co-administration of midazolam or fentanyl, on sedation, HR, and BP was analyzed. Subsequent pharmacokinetic and pharmacodynamic relationships and modeling were done to identify covariates that may further explain inter-individual variability in the pharmacokinetic and pharmacodynamic parameters…”; in addition see at least [0218] via: “…The relationship between the level of sedation and plasma concentration, supplemental sedation requirements, and impact of dexmedetomidine alone, and with co-administration of midazolam or fentanyl, on sedation, HR, and BP was analyzed. Subsequent pharmacokinetic and pharmacodynamic relationships and modeling were done to identify covariates that may further explain inter-individual variability in the pharmacokinetic and pharmacodynamic parameters…”; in addition see at least [0531] via: “…Population pharmacokinetic modeling was performed using the nonlinear mixed effects modeling (NONMEM®) computer program, Version 6.0, Level 2.0 on an Intel cluster with the Linux operating system….”; in addition see at least [0532] via: “…The first-order conditional estimation (FOCE) with interaction method was used at all stages of model development. The effects of both weight and age were included in the model considered the base structural model, given the range of weights and ages in this pediatric population and their likely impact on pharmacokinetic…”)
calculate, as output from the over sedation risk model, a risk score (dose limiting toxicity (DLT)- UMSS score) and a risk level (Adverse events -severity (mild, moderate, or severe) for the patient; (See at least [0287] via: “…The pharmacodynamic assessments monitored continuously every hour until 24 hours after the discontinuation of the infusion included heart rate, blood pressure, mean arterial blood pressure, cardiac rhythm, oxygen saturation, and respiratory rate. The Bispectral Index Scale (BIS, Aspect Medical Systems, Natick, Mass.) and the University of Michigan Sedation Scale (UMSS) were used to assess the level of sedation..”; in addition see at least [0291] via: “…Adverse events were also classified by severity (mild, moderate, or severe)…”; in addition see at least [0292] via: “…A dose limiting toxicity (DLT) was defined as any of the events that are possibly, probably, or definitely attributable to dexmedetomidine…”; in addition see at least [0299] via: “… oversedation deemed clinically relevant by the clinical care providers or requiring intervention. Clinical signs included difficulty arousing with moderate stimulation, bradypnea (respiratory rate ≦14), bradycardia, and hypotension and”; in addition see at least [0300] via: “… serious adverse event…”; in addition see at least [0529] via: “…A population pharmacokinetic evaluation of dexmedetomidine in pediatric subjects was completed, as described in Example 6…”; in addition see at least [0169] via: “…Prior to the start of drug infusion, a baseline score on the UMSS was obtained. The UMSS scale is given in Table 12 below. If a loading dose was administered, the UMSS score was obtained immediately before loading and at 5 and 10 minutes during the loading dose. If the loading dose occurred over 20 minutes, then the UMSS score was obtained at 15 minutes. If no loading dose was administered, the UMSS score was obtained at the start of the maintenance infusion and at 5, 10, 15, 30, and 60 minutes for the first hour. The UMSS score was obtained every 4 hours during the remainder of the maintenance infusion. IF rescue medication was administered, the UMSS score was measured immediately before and 5 minutes after the rescue medication was administered. The UMSS score was also obtained immediately before and 5 minutes after a non-pharmacological intervention, such as swaddling, cuddling, or rocking…
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in addition see at least [0197] via: “…The level of sedation was assessed first using the RSS and then the Richmond Agitation Sedation Scale (RASS) immediately after completion of the RSS. The RASS has been used and validated to quantify depth of anesthesia in adults in the ICU setting; however it has not been validated in infants and children. The purpose of using the RASS in this study was to evaluate the suitability of the RASS in children who were 2 years old to younger than 17 years old. The RASS scale is given in Table 20 below…
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in addition see at least [0337] via: “…A summary of the level of sedation, measured with the UMSS, at each time point during the treatment period for the enrolled population is presented in Table 40. Patients had deep sedation (UMSS 3-4) from pre-dose to 2 hours after infusion, and maintained a moderate level of sedation (UMSS 1-3) after 4 hours infusion through the end of infusion for all dose levels. There was a correlated relationship between plasma concentration and UMSS for low dose 30 minutes after start of infusion, moderate dose 8 hours after end of infusion, and high dose 30-15 minutes prior to end of infusion and 60 minutes after end of infusion. With the UMSS, fewer patients were categorized as “unarousable” at 1 hour post-infusion as compared with Pre-bolus/Baseline, for all three dexmedetomidine dose groups. After 1 hour of post-infusion of dexmedetomidine, the level of sedation had decreased for all dose groups. Patients became less sedated from the time of infusion to 6 hours post-infusion. This was apparent with all 3 doses of dexmedetomidine; the incidence of patients who were “unarousable” at Pre-bolus/Baseline was 91.7%, 91.7%, and 83.3% for the low, moderate, and high-dose dexmedetomidine groups, respectively. At six hours post-infusion, the incidence of patients who were “moderately sedated/somnolent” was 58.3%, 41.7%, and 50.0% for each of the dexmedetomidine dose groups.
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responsive (The PI was notified) to the risk score exceeding a predetermined threshold, automatically generate an over sedation alert (The UMSS is a … reliable tool that facilitates rapid and frequent assessment) for the patient (children); (See at least [0289] via: “…The UMSS is a simple, valid and reliable tool that facilitates rapid and frequent assessment and documentation of depth of sedation in children. The UMSS is a simple observational tool that assesses the level of alertness on a 5-point scale ranging from 1 (wide awake) to 5 (unarousable with deep stimulation). The UMSS score was assessed by the clinical nurse caring for the patient, and recorded every hour until the BIS sensor was removed…”; in addition see at least [0291] via: “…The PI was notified by pager or telephone of any serious adverse effects. All drug-related and previously undescribed toxicities were reviewed within 24 hours by the PI….”)
generate a Graphical User Interface (GUI) comprising: (See at least [0391] via: “… SAS Version 9.1 or later was used for data preparation, summary statistics, and graphical displays…”; in addition see at least [0393] via: “… A variety of graphs and tables were generated from the analysis dataset to understand the informational content of the data with respect to the anticipated model, to search for extreme values and/or potential outliers, to assess possible trends in the data, … Data visualization techniques were used to search for patterns and extreme values that may have caused significant bias during the analysis…”)
[a first GUI component] displaying a synchronized timeline (mean dexmedetomidine concentrations over time) and a first plurality of points indicating administration of a plurality of medications (variables included exposure to study drug- use of concomitant medication) to the patient along the synchronized timeline: (See at least [0051] via: “…FIG. 35 depicts a linear plot illustrating the mean dexmedetomidine concentrations over time…”; in addition see at least [0284] via: “… The primary PD variables assessed the level of sedation using BIS and the University of Michigan Sedation Scale Safety variables included exposure to study drug, adverse events (adverse effects), hepatotoxicity, DLT, laboratory results, vital signs, use of concomitant medication, and 12-lead electrocardiogram…”)
[a second GUI component] displaying a second plurality of points, along the synchronized timeline, indicating the risk level (Adverse events.. classified by severity (mild, moderate, or severe)) for the patient at each of the first plurality of points (monitored continuously every hour until 24 hours) and; (See at least [0287] via: “…The pharmacodynamic assessments monitored continuously every hour until 24 hours after the discontinuation of the infusion included heart rate, blood pressure, mean arterial blood pressure, cardiac rhythm, oxygen saturation, and respiratory rate. The Bispectral Index Scale (BIS, Aspect Medical Systems, Natick, Mass.) and the University of Michigan Sedation Scale (UMSS) were used to assess the level of sedation….”; in addition see at least [0291] via: “…Adverse events were also classified by severity (mild, moderate, or severe). A serious adverse effect was defined as any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, created persistent or significant disability/incapacity, or a congenital anomaly/birth defect…”)
[a third GUI component] displaying a third plurality of points, along the synchronized timeline, indicating a sedation scale score (The Bispectral Index Scale … and the University of Michigan Sedation Scale (UMSS) ..used to assess the level of sedation) for the patient at each of the first plurality of points; (See at least [0051] via: “…FIG. 35 depicts a linear plot illustrating the mean dexmedetomidine concentrations over time…”; in addition see at least [0287] via: “…The pharmacodynamic assessments monitored continuously every hour until 24 hours after the discontinuation of the infusion included heart rate, blood pressure, mean arterial blood pressure, cardiac rhythm, oxygen saturation, and respiratory rate. The Bispectral Index Scale (BIS, Aspect Medical Systems, Natick, Mass.) and the University of Michigan Sedation Scale (UMSS) were used to assess the level of sedation…”; in addition see at least [0291] via: “…Adverse events were also classified by severity (mild, moderate, or severe)…”)
However Garcia fails to specifically disclose Graphical User Interface (GUI) displaying patient data plotted against a timeline as taught by Amarasingham
Graphical User Interface (GUI) (dashboard user interface) displaying patient data (risk score) plotted against a timeline (FIG. 2 is a timeline diagram) (See at least [Abstract] via: “…A dashboard user interface method includes displaying a navigable list of patients each associated with a target disease with a calculated risk level, displaying historic and current data associated with a selected patient in the patient list identified as being associated with the target disease, displaying an identification of key factors in the selected patient's health data that contribute to the risk level for the selected patient with respect to the target disease, receiving and displaying care management notes for transitional care intervention for the selected patient, and displaying automatically-generated intervention and treatment recommendations…”; in addition see at least [0046] via: “… FIG. 2 is a timeline diagram … of a clinical predictive and monitoring system and method …. The timeline diagram is used to illustrate how the clinical predictive and monitoring system and method 10 may be applied to reduce hospital readmission rate relating to congestive heart failure as an example…”; in addition see at least [0047] via: “…system 10 calculates a risk score for congestive heart failure for this particular patient within 24 hours of admission. If this particular patient's risk score for congestive heart failure is above a certain risk threshold, then the patient is identified on a list of high-risk patients that is presented to an intervention coordination team…”; in addition see at least [0048] via: “…The clinical predictive and monitoring system and method 10 are operable to display, transmit, and otherwise present the list of high risk patients to the intervention coordination team, which may include physicians, physician assistants, case managers, patient navigators, nurses, social workers, family members, and other personnel or individuals involved with the patient's care…”)
It would have been obvious to one of ordinary skill in the art to add Amarasingham's GUI timeline to Garcia's method/system as the intervention coordination team may then prioritize intervention for the highest risk patients and provide targeted inpatient care and treatment. The clinical predictive and monitoring system and method may further automatically present a plan to include recommended intervention and treatment options - the plan may include clinical and social outpatient interventions and developing a post-discharge plan of care and support.
update the GUI responsive to an update to the data repository such that the GUI is synchronized with the data repository (See at least [0066] via: “…The dashboard user interface 44 allows interactive requesting of a variety of views, reports and presentations of extracted data and risk score calculations from an operational database within the system...”)
It would have been obvious to one of ordinary skill in the art to add Amarasingham's GUI timeline to Garcia's method/system as the intervention coordination team may then prioritize intervention for the highest risk patients and provide targeted inpatient care and treatment. The clinical predictive and monitoring system and method may further automatically present a plan to include recommended intervention and treatment options - the plan may include clinical and social outpatient interventions and developing a post-discharge plan of care and support.
Regarding claims 2 and 13: Garcia and Amarasingham teach the invention as claimed and detailed above with respect to claims 1 and 12 respectively. Garcia is silent the following claim that is taught by Amarasingham:
further comprising a GUI popup window generated responsive to the risk score exceeding the predetermined threshold, and displayed on a client computer operated by at least one healthcare professional. (See at least [0043] via: “… generate a list of patients that have the highest congestive heart failure risk scores, e.g., top n numbers or top x % -data may be transmitted, presented, and displayed to the clinician/user in the form of web pages, web-based message, tex1 files, video messages, multimedia messages, text messages, e-mail messages, and in a variety of suitable ways and formats..”)
It would have been obvious to one of ordinary skill in the art to add Amarasingham's GUI display to Garcia's method/system as the intervention coordination team may then prioritize intervention for the highest risk patients and provide targeted inpatient care and treatment. The clinical predictive and monitoring system and method may further automatically present a plan to include recommended intervention and treatment options - the plan may include clinical and social outpatient interventions and developing a post-discharge plan of care and support.
Regarding claims 3 and 14: Garcia and Amarasingham teach the invention as claimed and detailed above with respect to claims 1&2 and 12&13 respectively. Garcia is silent the following claim that is taught by Amarasingham:
further comprising a content displayed on the GUI popup window, comprising: a notification of the over sedation alert; the risk level for the patient; the at least one over sedation risk factor; and a recommendation, associated in the data repository or in the instructions with the risk level for the patient. (See at least [Abstract] via: “…dashboard user interface… displaying a navigable list of patients each associated with a target disease with a calculated risk level, displaying historic and current data associated with a selected patient in the patient list identified as being associated with the target disease, displaying an identification of key factors in the selected patient's health data that contribute to the risk level for the selected patient with respect to the target disease, receiving and displaying care management notes for transitional care intervention for the selected patient, and displaying automatically generated intervention and treatment recommendations…”; in addition see at least [0048] via: “…presentment may include e-mail, text messages, multimedia messages, voice messages, web pages, facsimile, audible or visual alerts, etc. delivered by a number of suitable electronic or portable computing devices…”; in addition see at least [0079] via: “…targeted conditions due to possible adverse event for surveillance may include: … trigger for narcotic (over-sedation), trigger for … unexpected death…”)
It would have been obvious to one of ordinary skill in the art to add Amarasingham's GUI display to Garcia's method/system as the intervention coordination team may then prioritize intervention for the highest risk patients and provide targeted inpatient care and treatment. The clinical predictive and monitoring system and method may further automatically present a plan to include recommended intervention and treatment options - the plan may include clinical and social outpatient interventions and developing a post-discharge plan of care and support.
Regarding claims 4 and 15: Garcia and Amarasingham teach the invention as claimed and detailed above with respect to claims 1 and 12 respectively. Garcia is silent the following claim that is taught by Amarasingham:
further comprising a plurality of dots or dashes, displayed within the second GUI component, each of the plurality of dots or dashes representing the risk level for the patient along the synchronized timeline at a time that the risk level was determined. (See at least [Abstract] via: “…dashboard user interface… displaying a navigable list of patients each associated with a target disease with a calculated risk level, displaying historic and current data associated with a selected patient in the patient list identified as being associated with the target disease, displaying an identification of key factors in the selected patient's health data that contribute to the risk level for the selected patient with respect to the target disease, receiving and displaying care management notes for transitional care intervention for the selected patient, and displaying automatically generated intervention and treatment recommendations…”; in addition see at least [0046] via: “… FIG. 2 is a timeline diagram of an exemplary embodiment of a clinical predictive and monitoring system and method…”; in addition see at least [0087] via: “…number of data items associated with each patient in a list are displayed, such as name, patient ID, gender, age, the admission or arrival date, working diagnosis, risk level (e.g., very high, high, medium, and low), status (enrollment in intensive intervention program), location, and comordities, The type of data displayed for each list of patients may vary and can be easily configured….”)
It would have been obvious to one of ordinary skill in the art to add Amarasingham's GUI display to Garcia's method/system as the intervention coordination team may then prioritize intervention for the highest risk patients and provide targeted inpatient care and treatment. The clinical predictive and monitoring system and method may further automatically present a plan to include recommended intervention and treatment options - the plan may include clinical and social outpatient interventions and developing a post-discharge plan of care and support.
Regarding claims 5 and 16: Garcia and Amarasingham teach the invention as claimed and detailed above with respect to claims 1&4 and 12&15 respectively. Garcia is silent the following claim that is taught by Amarasingham:
wherein each of the plurality of dots or dashes is color- coded according to the risk level for the patient, wherein: a low risk level is represented by a first color; a moderate risk level is represented by a second color; and a high risk level is represented by a third color. (See at least [0087] via: “…risk level (e.g., very high, high, medium, and low)…”; in addition see at least [0109] via: “…FIG. 28 is an exemplary screen shot of a dashboard user interface system and method showing an at-a-glance graphical representation of a patient survey according to the present disclosure. The at-a-glance graphic provides a summary of the total number of patients and the proportionate percentages of patients who are at very high (red), high (orange), medium (yellow), and low (green) risks. In FIG. 28, the risk bands … filled with the respective colors for the risk levels…”)
It would have been obvious to one of ordinary skill in the art to add Amarasingham's GUI display to Garcia's method/system as the intervention coordination team may then prioritize intervention for the highest risk patients and provide targeted inpatient care and treatment. The clinical predictive and monitoring system and method may further automatically present a plan to include recommended intervention and treatment options - the plan may include clinical and social outpatient interventions and developing a post-discharge plan of care and support.
Regarding claim 7: Garcia and Amarasingham teach the invention as claimed and detailed above with respect to claim 6. Garcia also teaches:
further comprising the step of deriving, by the server, the plurality of risk factors from a plurality of data aggregated within the data repository for each of a plurality of patients, the plurality of data comprising: a documentation data input by at least one healthcare professional in association with the patient; at least one medication history record associated with the patient; and at least one surgical history record associated with the patient. (See at least [0218] via: “…The relationship between the level of sedation and plasma concentration, supplemental sedation requirements, and impact of dexmedetomidine alone, and with co-administration of midazolam or fentanyl, on sedation, HR, and BP was analyzed. Subsequent pharmacokinetic and pharmacodynamic relationships and modeling were done to identify covariates that may further explain inter-individual variability in the pharmacokinetic and pharmacodynamic parameters…”; in addition see at least [0134] via: “…Dexmedetomidine ….. The adverse effect profile observed is typical of the critically ill, high risk pediatric population and post-operative surgical patients…”; in addition see at least [0284] via: “…The primary PD variables assessed the level of sedation using BIS and the University of Michigan Sedation Scale Safety variables included exposure to study drug, adverse events (adverse effects), hepatotoxicity, DLT, laboratory results, vital signs, use of concomitant medication, and 12-lead electrocardiogram…”; in addition see at least [0286] via: “… The primary pharmacokinetic evaluation was to define the pharmacokinetics of increasing doses of dexmedetomidine administered as an IV bolus followed by a continuous IV infusion in infants who were postoperative from cardiac surgery. Data from all fully evaluable patients (those receiving at least 2 hours of dexmedetomidine infusion) were included in the analysis..”; in addition see at least [0291] via: “… Serious adverse effects that were expected because of the surgical procedure did not require expedited review and were reviewed bi-weekly…”; in addition see at least [0513] via: “…Relevant ongoing medical history included hypoplastic left heart syndrome and was post-surgery (cardiac catheterization, left pulmonary artery stenosis with balloon dilatation and aortopulmonary collaterals that required coil embolization)…”; in addition see at least [0514] via: “…Relevant medical history included transposition of the great arteries, pulmonary stenosis, and ventricular septal defect and was postoperative for open heart surgery for correction of these problems (Nikaidoh operation). This subject also received sufentanil IV and IV morphine, both one time each for pain during dexmedetomidine infusion which were protocol violations…” in addition see at least [0289] via: “…The UMSS is a simple, valid and reliable tool that facilitates rapid and frequent assessment and documentation of depth of sedation in children. The UMSS is a simple observational tool that assesses the level of alertness on a 5-point scale ranging from 1 (wide awake) to 5 (unarousable with deep stimulation). The UMSS score was assessed by the clinical nurse caring for the patient, and recorded every hour until the BIS sensor was removed…”)
Regarding claim 8: Garcia and Amarasingham teach the invention as claimed and detailed above with respect to claim 6. Garcia is silent the following claim that is taught by Amarasingham:
further comprising the step of identifying, by the server, within the plurality of risk factor data, at least one dynamic risk factor comprising: a surgical procedure performed on the patient; an anesthesia time for the patient greater than 3 hours and less than 24 hours; and a sedative administered to the patient within the previous 2 hours. (See at least [0047] via: “…Within 24 hours of a patient's admission to the hospital, stored historical and real-time data related to the patients are analyzed by the clinical predictive and monitoring system and method 10 to identify specific diseases and conditions related to the patient…system 10 calculates a risk score for congestive heart failure…”; in addition see at least [0079] via: “…Targeted predictive readmission diseases may include: … trigger for narcotic (over-sedation),..”)
It would have been obvious to one of ordinary skill in the art to add Amarasingham's GUI display to Garcia's method/system as the intervention coordination team may then prioritize intervention for the highest risk patients and provide targeted inpatient care and treatment. The clinical predictive and monitoring system and method may further automatically present a plan to include recommended intervention and treatment options - the plan may include clinical and social outpatient interventions and developing a post-discharge plan of care and support.
Regarding claim 9: Garcia and Amarasingham teach the invention as claimed and detailed above with respect to claim 6. Garcia is silent the following claim that is taught by Amarasingham:
further comprising the step of identifying, by the server, within the plurality of risk factor data, at least one non-dynamic risk factor comprising: a first determination whether the patient smokes; a second determination whether the patient snores; an obstructive sleep apnea diagnosis for the patient; an age for the patient; or a body mass index metric for the patient. (See at least [0066] via: “…The dashboard user interface 44 allows interactive requesting of a variety of views, reports and presentations of extracted data and risk score calculations from an operational database within the system. including, … aggregation of the data into frequently used medical formulas to assist in care provision including … Child-Pugh-Turcot score, TIMI risk score, CHADS score, estimated creatinine clearance, Body Surface area, Body Mass Index, ….”)
It would have been obvious to one of ordinary skill in the art to add Amarasingham's GUI display to Garcia's method/system as the intervention coordination team may then prioritize intervention for the highest risk patients and provide targeted inpatient care and treatment. The clinical predictive and monitoring system and method may further automatically present a plan to include recommended intervention and treatment options - the plan may include clinical and social outpatient interventions and developing a post-discharge plan of care and support.
Regarding claim 10: Garcia and Amarasingham teach the invention as claimed and detailed above with respect to claim 6. Garcia also teaches:
wherein the sedation scale score comprises a Pasero Opioid-induced Sedatio