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 final rejection
Claims 1-3, 6-11, 17-19, 21-23, 27-29, 31 are pending
Claims 4-5, 12-16, 20, 24-26, 30 were cancelled
Claims 1, 19, 22-23, 27 was amended
Claim 31 was added
Claims 1-3, 6-11, 17-19, 21-23, 27-29, 31 are rejected under 35 USC § 101
Priority
Acknowledgement is made of Applicant’s claim for a domestic priority date of 7-26-2022
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1-24-2024 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 1-3, 6-11, 17-19, 21-23, 27-29, 31 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 1-3, 6-11, 17-19, 21-23, 27-29, 31 the claims recite an abstract idea of “identifying the risk of post-cardiotomy cardiogenic shock in patients”.
Independent Claim 1 is rejected under 35 U.S.C 101 based on the following analysis.
-Step 1 (Does the claim fall within a statutory category? YES): claim 1 recites a method for predicting whether a patient is likely to develop post-cardiotomy cardiogenic shock (PCCS).
-Step 2A Prong One (Does the claim fall within at least one of the groupings of abstract ideas?: YES):
receiving medical information for a patient;
extracting one or more features from the received medical information including left ventricle ejection fraction and/or total bilirubin level;
providing the one or more features as input to a model configured to output a risk assessment that the patient is likely to develop post-cardiotomy cardiogenic shock (PCCS); and
the trained model having been trained using training data including first patient medical information for a PCCS patient group and second patient medical information for a no PCCS patient group, wherein each of the first patient medical information and the second patient medical information includes left ventricle ejection fraction and/or total bilirubin level information
outputting an indication of the risk assessment , wherein outputting the indication of the risk assessment comprises displaying a visual indicator of the risk assessment in an health record of the patient.
belong to the grouping of mental processes under concepts performed in the human mind as it recites “identifying the risk of post-cardiotomy cardiogenic shock in 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 “identifying the risk of post-cardiotomy cardiogenic shock in 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).
Claim 1 recites:
trained classification model;
the trained classification model having been trained using training data.
electronic health record
Amounting to additional elements that are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. Support for this can be found in the specification, paragraphs [0009-0010]. [0039-0043]. (refer to MPEP 2106.05(f)). Accordingly, the claim as a whole does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
-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:
trained classification model;
the trained classification model having been trained using training data.
electronic health record.
Amount to additional elements that are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. Support for this can be found in the specification, paragraphs [0009-0010]. [0039-0043]. (refer to MPEP 2106.05(f)) Accordingly, even in combination the additional elements of the claim do not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
Independent Claim 19 is rejected under 35 U.S.C 101 based on the following analysis.
-Step 1 (Does the claim fall within a statutory category? YES): claim 19 recites a method of training a risk model to predict whether a patient is likely to develop post-cardiotomy cardiogenic shock (PCCS).
-Step 2A Prong One (Does the claim fall within at least one of the groupings of abstract ideas?: YES):
receiving a dataset of patient medical information;
selecting, from the dataset of patient medical information, training data based on PCCS criteria and defined data fields, wherein the training data includes first patient medical information for a PCCS patient group and second patient medical information for a no PCCS patient group, wherein each of the first patient medical information and the second patient medical information includes left ventricle ejection fraction and/or total bilirubin information;
using the selected training data; and
outputting.
belong to the grouping of mental processes under concepts performed in the human mind as it recites “identifying the risk of post-cardiotomy cardiogenic shock in 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 “identifying the risk of post-cardiotomy cardiogenic shock in 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).
Claim 19 recites:
training the neural network
trained neural network
Amounting to additional elements that are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. Support for this can be found in the specification, paragraphs [0009-0010]. [0039-0043]. (refer to MPEP 2106.05(f)). Accordingly, the claim as a whole does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
-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 19 recites:
training the neural network
trained neural network
Amount to additional elements that are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. Support for this can be found in the specification, paragraphs [0009-0010]. [0039-0043]. (refer to MPEP 2106.05(f)) Accordingly, even in combination the additional elements of the claim do not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
Independent Claim 29 is rejected under 35 U.S.C 101 based on the following analysis.
-Step 1 (Does the claim fall within a statutory category? YES): claim 29 recites computer-implemented system for simulating a likelihood that a patient will develop post-cardiotomy cardiogenic shock (PCCS).
-Step 2A Prong One (Does the claim fall within at least one of the groupings of abstract ideas?: YES):
extracting one or more features including left ventricle ejection fraction and/or total bilirubin level from medical information for the patient;
providing the one or more features as input to a model configured to output a risk assessment that the patient is likely to develop PCCS;
display values for at least some of the one or more features;
receiving user input ... to change one or more of the values displayed
simulating, using the ...classification model, a risk assessment that the patient will develop PCCS based, at least in part, on the changed one or more values, to generate a simulated risk assessment;
displaying, on the user interface, an indication of the simulated risk assessment;
belong to the grouping of mental processes under concepts performed in the human mind as it recites “identifying the risk of post-cardiotomy cardiogenic shock in 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 “identifying the risk of post-cardiotomy cardiogenic shock in 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).
Claim 29 recites:
a display
at least one hardware computer processor; and
at least one non-transitory computer readable medium encoded with a plurality of instructions that, when processed by the at least one hardware computer processor perform a method
providing, on the display, a user interface configured to display values;
user interface
trained classification model.
Amounting to additional elements that are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. Support for this can be found in the specification, paragraphs [0009-0010]. [0039-0043]. (refer to MPEP 2106.05(f)). Accordingly, the claim as a whole does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
-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 29 recites:
a display
at least one hardware computer processor; and
at least one non-transitory computer readable medium encoded with a plurality of instructions that, when processed by the at least one hardware computer processor perform a method
providing, on the display, a user interface configured to display values
user interface
trained classification model.
Amount to additional elements that are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. Support for this can be found in the specification, paragraphs [0009-0010]. [0039-0043]. (refer to MPEP 2106.05(f)) Accordingly, even in combination the additional elements of the claim do 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 recite additional limitations that further define the abstract idea of “identifying the risk of post-cardiotomy cardiogenic shock in patients”. These claim limitations include:
Claim 2: wherein the medical information for the patient includes one or more of an health record, a laboratory report, a medical procedure report, physician notes, and a medical imaging report;
Claim 3: wherein the medical information includes structured data and unstructured data;
Claim 6: receiving data indicating whether the patient developed PCCS;
Claim 7: wherein the risk assessment includes a numerical value, and outputting an indication of the risk assessment comprises displaying the numerical value and/or information based on the numerical value;
Claims 8: performing based on the numerical value, categorization of the patient into a risk group of a plurality of risk groups, wherein outputting the indication of the risk assessment comprises outputting an indication of the risk group for the patient;
Claims 9;
wherein performing categorization of the patient into a risk group comprises determining whether the numerical value is above a threshold value; and
classifying a high risk for PCCS when it is determined that the numerical value is above the threshold value.
Claims 10: wherein outputting an indication of the risk group for the patient comprises displaying a color coded indication of the risk group;
Claims 11: wherein the risk assessment is a categorization of the patient into a risk group of a plurality of risk groups, and outputting the indication of the risk assessment comprises outputting an indication of the risk group for the patient
Claims 17:
display values for the one or more features;
receiving user input to change one or more of the values for the one or more features;
simulating a risk assessment that the patient is likely to develop PCCS based, at least in part, on the changed one or more values, to generate a simulated risk assessment; and
displaying, the simulated risk assessment.
Claims 18: wherein outputting an indication of the risk assessment comprises outputting a cumulative score associated with the risk assessment;
Claims 20:
defining a plurality of PCCS criteria;
generating the at least two risk groups of patients based on the PCCS criteria;
Claims 21:
receiving input regarding the data fields to define; and
defining the data fields based, at least in part, on the received input.
Claims 22: validating the model using at least some patient medical information not used the model, wherein outputting the risk model comprises outputting the validated model.
Claims 23:
receiving an indication to update the risk model; and
receiving the indication to update the risk model
Claims 27: receiving additional medical information.
Claim 28: wherein the additional medical information includes medical information for a plurality of patients at a medical facility on which cardiac surgery was performed
Claim 31:
determining whether the risk assessment indicates that the patient is likely to develop PCCS; and
treating the patient by inserting a mechanical circulatory support device into a heart of the patient based, at least in part, on the risk assessment indicating that the patient is likely to develop PCCS
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 additional elements that are recited at a high-level of generality such that it amounts to no more than 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:
Claim 2:
electronic health record;
Claim 6:
retraining the trained classification model based, at least in part, on the received data;
Claim 7:
user interface;
Claim 10:
user interface
Claim 17:
user interface;
Claim 21:
user interface;
Claim 22:
trained neural network
train the neural network
Claim 23:
trained risk model;
retraining the risk model.
Claim 27:
retraining the trained neural network
Claim 31: circulatory support device
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 additional elements that are recited at a high-level of generality such that it amounts to no more than 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 in combination the additional elements of the claim do not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible. The claims include:
Claim 2:
electronic health record;
Claim 6:
retraining the trained classification model based, at least in part, on the received data;
Claim 7:
user interface;
Claim 10:
user interface
Claim 17:
user interface;
Claim 21:
user interface;
Claim 22:
trained neural network
train the neural network .
Claim 23:
trained risk model;
retraining the risk model.
Claim 27:
retraining the trained neural network
Claim 31: circulatory support device
Subject Matter Free of Prior Art
Closest prior art:
The reference Heldt, Parlikar, and Chen disclose as shown below:
Heldt (US 20170042483 A1) - SYSTEM AND METHODS TO PREDICT SERUM LACTATE LEVEL- teaches: A method to quantitatively predict a patient's serum lactate level, comprising measuring arterial blood pressure and heart rate from the patient, computing estimates of one or more cardiovascular parameters from the measured arterial blood pressure and heart rate, providing one or more classifiers that have been trained on a training data set including a reference set of arterial blood pressure, heart rate, and serum lactate levels and using the one or more classifiers to estimate the serum lactate level of the patient
Parlikar (US 20080287753 A1) - SYSTEM AND METHOD FOR PREDICTION AND DETECTION OF CIRCULATORY SHOCK – teaches: Systems and methods for prediction and detection of circulatory shock using estimates or measurements of arterial blood pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, cardiac ejection fraction, cardiac contractility and ventricular end-diastolic volume are provided. These estimates and measurements are used to determine a type of circulatory shock. In some embodiments, the type of circulatory shock is determined to be one of septic shock, hypovolemic shock, anaphylactic shock, hemorrhagic shock, and cardiogenic shock.
Chen (US 20200162412 A1) - AUTOMATED PREVENTION OF SENDING OBJECTIONABLE CONTENT THROUGH ELECTRONIC COMMUNICATIONS – teaches: A computer implemented method of pre-emptively blocking an electronic communication is provided. The computer implemented method includes inputting an electronic communication history, wherein the electronic communication history includes a plurality of electronic communications and a set of corresponding recipients for each of the plurality of electronic communications. The computer implemented method further includes normalizing the plurality of electronic communications, and extracting a topic from each of the plurality of electronic communications. The computer implemented method further includes clustering the plurality of electronic communications according to the extracted topics, and digesting the plurality of electronic communication to form a positive learning data set and a negative learning data set to train a neural network. The computer implemented method further includes training the neural network on the positive learning data set and the negative learning data set, and preparing a positive neutral network model and a negative neural network model
The closest prior art of record noted below fails to expressly teach or suggest, either alone or in combination, the features found within the independent claims (Claim 1 recited here as representative). In particular, the closest prior art of record fails to expressly teach or suggest the combination of:
A method comprising:
receiving medical information for a patient;
extracting one or more features including left ventricle ejection fraction and/or total bilirubin level from the received medical information;
providing the one or more features as input to a trained classification model configured to output a risk assessment that the patient is likely to develop post-cardiotomy cardiogenic shock (PCCS);
the trained classification model having been trained using training data including first patient medical information for a PCCS patient group and second patient medical information for a no PCCS patient group, wherein each of the first patient medical information and the second patient medical information includes left ventricle ejection fraction and/or total bilirubin level information;
outputting an indication of the risk assessment, wherein outputting the indication of the risk assessment comprises displaying a visual indicator of the risk assessment in an electronic health record of the patient.
Therefore, the claims of the instant application are novel and unobvious.
Foreign prior art and NPL search was conducted however no relevant prior art was found
Response to Arguments
Applicant's arguments filed 7-2-2026, have been fully considered but not found
persuasive.
Applicant amended independent claims 1, 19 and dependent claims 22-23, 27 and added claim 31 as posted in the above analysis with additions underlined and deletions
In response to applicant's arguments regarding claim rejection under 35 U.S.C § 101.
Several steps are taken in the analysis as to whether an invention is rejected under 101. The first step is to determine if the claim falls within a statutory category. In this claims 1, 19 & 29 recite a method, system of predicting whether a patient is likely to develop post-cardiotomy cardiogenic shock (PCCS).
The second step under 2A prong one is to determine if the claims recite an abstract idea, which would be the case if the invention can be grouped as either: a) mathematical concepts; (b) mental processes; or (c) certain methods of organizing human activity (encompassing (i) fundamental economic principles, (ii) commercial or legal interactions or (iii) managing personal behavior or relationships or interactions between people). The current invention is classified as an abstract idea since it may be grouped as a mental process as it recites “identifying the risk of post-cardiotomy cardiogenic shock in patients”. Alternatively, the selected abstract idea belongs to certain methods of organizing human activity under managing personal behavior or relationships or interactions between people as it recites “identifying the risk of post-cardiotomy cardiogenic shock in patients”.
The third step under 2A Prong Two is to determine if additional elements in the claim imposes a meaningful limit on the abstract idea in order to integrate it into a practical idea. The current invention does not represent a practical idea since the additional elements amount to mere instructions to implement an abstract idea on a computer, or merely use a generic computer as a tool to implement the abstract idea.
the fourth step under 2B is to determine if additional elements of the claim provide an inventive concept. An invention may be classified as an inventive concept if a computer-implemented processes is determined to be significantly more than an abstract idea (and thus eligible), where generic computer components are able in combination to perform functions that are not merely generic, and non-conventional even if generic computer operations on a generic computing device is used to implement the abstract idea. The current invention does not represent an inventive concept since the additional elements amount to mere instructions to implement an abstract idea on a computer, or merely use a generic computer as a tool to implement the abstract idea.
Step 2A Prong ONE
The Applicant argues that the claims are not directed to an abstract idea, yet fails to elaborate further the reasoning to support that argument.
The Examiner disagrees since the Applicant’s arguments are not persuasive. The method used to select the abstract idea, is to strip the additional elements from the claims. As seen below the recited boldened words constitute the abstract idea after stripping the un-boldened additional elements of amended limitation of claims 1, 19 and 29:
Claim 1:
receiving medical information for a patient;
extracting one or more features including left ventricle ejection fraction and/or total bilirubin level from the received medical information;
providing the one or more features as input to a trained classification model configured to output a risk assessment that the patient is likely to develop post-cardiotomy cardiogenic shock (PCCS);
the trained classification model having been trained using training data including first patient medical information for a PCCS patient group and second patient medical information for a no PCCS patient group, wherein each of the first patient medical information and the second patient medical information includes left ventricle ejection fraction and/or total bilirubin level information;
outputting an indication of the risk assessment, wherein outputting the indication of the risk assessment comprises displaying a visual indicator of the risk assessment in an electronic health record of the patient.
Claim 19:
receiving a dataset of patient medical information;
selecting, from the dataset of patient medical information, training data based on PCCS criteria and defined data fields, wherein the training data includes first patient medical information for a PCCS patient group and second patient medical information for a no PCCS patient group, wherein each of the first patient medical information and the second patient medical information includes left ventricle ejection fraction and/or total bilirubin information;
training the neural network using the selected training data; and
outputting the trained neural network .
Claim 29:
a display;
at least one hardware computer processor; and
at least one non-transitory computer readable medium encoded with a plurality of instructions that, when processed by the at least one hardware computer processor perform a method,
extracting one or more features including left ventricle ejection fraction and/or total bilirubin level from medical information for the patient;
providing the one or more features as input to a trained classification model configured to output a risk assessment that the patient is likely to develop PCCS;
providing, on the display, a user interface configured to display values for at least some of the one or more features
receiving user input via the user interface to change one or more of the values displayed on the user interface;
simulating, using the trained classification model, a risk assessment that the patient will develop PCCS based, at least in part, on the changed one or more values, to generate a simulated risk assessment; and
displaying, on the user interface, an indication of the simulated risk assessment;
The selected abstract idea (boldened limitations) of claims 1, 19, 29 can be implemented by pencil and paper and thus belong to the grouping of mental processes under concepts performed in the human mind (including an observation, evaluation, judgement, opinion) as it recites “identifying the risk of post-cardiotomy cardiogenic shock in patients”. Alternatively, the selected abstract idea belongs to certain methods of organizing human activity under managing personal behavior or relationships or interactions between people as it recites “identifying the risk of post-cardiotomy cardiogenic shock in patients”. (refer to MPP 2106.04(a)(2)). Accordingly this claim recites an abstract idea.
Step 2A Prong TWO
The Applicant argues that even if he claims recite an abstract idea the claimed subject matter is directed to a practical application based on the amendments.
Specifically the Applicant argues that the trained classification model recited in claim 1 is configured using a large amount of data related to patients having previously undergone cardiac surgeries and whether those patients developed or did not develop PCCS, which is a particular and often fatal type of cardiogenic shock that a patient may experience following cardiac surgery. The Applicant further argues that current assessment of a patient's risk of developing complications of cardiac surgery including PCCS varies among surgeons and often results in having to wait for symptoms of PCCS to appear before action is taken, resulting in significant risk to the patient's health. In the described and claimed improvement, the trained classification model is used to provide a more accurate prediction of whether a patient is likely to develop PCCS, which may guide healthcare providers to take preemptive actions, thereby improving patient outcomes.
The instant application describes that "it is unknown which patients are most susceptible [to develop PCCS], and surgeons and other healthcare providers are left to gestalt to anticipate the occurrence of PCCS or wait until it happens," and "patients that develop PCCS are at significantly increased risk of mortality and morbidity" (Instant Application, paragraph [0014]). To achieve an accurate classification model, the recited model is trained using a large sample size of cardiac surgery patients using particular types of data (e.g., a PCCS patient group and a no PCCS patient group) to generate a particular output for assessing a risk that a patient is likely to develop PCCS (Instant Application, paragraphs [0015], [0033] and [0035]).
The pending claims recite this described improvement stating, "providing the one or more features as input to a trained classification model configured to output a risk assessment that the patient is likely to develop post-cardiotomy cardiogenic shock (PCCS), the trained classification model having been trained using training data including first patient medical information for a PCCS patient group and second patient medical information for a no PCCS patient group, wherein each of the first patient medical information and the second patient medical information includes left ventricle ejection fraction and/or total bilirubin level information". Accordingly, the specification sets forth an improvement in technology and the claim itself reflects the disclosed improvement. As such, even if claim 1 is interpreted as including an alleged abstract idea, any such abstract idea is integrated into a practical application.
For at least these reasons, claims 1 and similarly claims 19 and 29 are directed to patent eligible subject matter, and it is respectfully requested that the rejection under 35 U.S.C. § 101 of claim 1 and all claims that depend therefrom be withdrawn
The Examiner disagrees since the Applicant’s arguments are not persuasive. Most of the added amendments constitute additional elements that do not impose a meaningful limit on the abstract idea.
The Applicant has recited the generic use of a trained classification model to implement the abstract idea. Although colloquially the invention represents a practical application, the Applicant has not demonstrated any specific technological improvement in the trained classification model
The Examiner restates that claims 1, 19 and 29 do not integrate the abstract idea into a practical application. Neither claims 1, 19 or 29 recite additional elements that impose a meaningful limit on the abstract idea:
Claim 1 recites the following additional elements:
trained classification model;
the trained classification model having been trained using training data.
electronic health record.
Claim 19 recites the following additional elements:
training the neural network;
trained neural network.
Claim 29 recites the following additional elements:
a display
at least one hardware computer processor; and
at least one non-transitory computer readable medium encoded with a plurality of instructions that, when processed by the at least one hardware computer processor perform a method
providing, on the display, a user interface configured to display values for at least some of the one or more features
user interface
trained classification model.
The additional elements as recited above for claims 1, 19 and 29 amount to additional elements that are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. Support for this can be found in the specification, paragraphs [0039-0041]. (refer to MPEP 2106.05(f)). Accordingly, the claim as a whole does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
In order to integrate the abstract idea into a practical idea the Applicant could demonstrate at least one of the conditions enumerated below applies:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo
The Applicant has not demonstrated any of the above listed conditions. As a result, the Examiner restates the rejection of the invention under 35 USC §101.
Step 2B
Similar to the analysis under Step 2A Prong Two, the additional elements amount to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. Support for this can be found in the specification, paragraphs [0039-0041] (refer to MPEP 2106.05(f)). The use of generic computer components, in combination, do not perform functions that are not merely generic, and non-conventional even if the generic computer operations on a generic computing device is used to implement the abstract idea. Accordingly, the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
In order evaluate whether the claim recites additional elements that amount to an inventive concept what could be shown is:
Adding a specific limitation (unconventional other than what is well-understood, routine, conventional (WURC) activity in the field - see MPEP 2106.05(d)
The Applicant has not demonstrated the above listed condition.
In response to applicant's arguments regarding claim rejection under 35 U.S.C § 103.
The Applicant argues that "post- cardiotomy cardiogenic shock (PCCS)" as recited in the pending independent claims is a specific type of cardiogenic shock that occurs following a cardiac surgery, and that claim 1 is directed to a technique for more accurately predicting whether a patient about to undergo cardiac surgery is likely to develop PCCS so that a preemptive intervention (e.g., insertion of a heart pump) can be used to reduce the risk of the patient developing PCCS, thereby improving patient outcomes.
The Applicant further argues that "cardiac shock" as mentioned in paragraph [0083] of Heldt describes the general inability of the heart to adequately pump blood, which is different from predicting PCCS as recited in the pending claims. Rather, Heldt describes determining serum lactate level for a patient, which "may be used to predict hypoperfusion, lung disease and cardiac shock" (Heldt, [0083]). Using serum lactate level to predict cardiac shock is not the same as using a trained classification model to output a risk assessment that a patient is likely to develop PCCS as recited in claims 1, 19 and 29. Hence Heldt in combination with Parlikar and Chen fail to teach the following limitations of claims 1, 19, 29:
“providing the one or more features as input to a model configured to output a risk assessment that the patient is likely to develop post-cardiotomy cardiogenic shock (PCCS); and
the trained model having been trained using training data including first patient medical information for a PCCS patient group and second patient medical information for a no PCCS patient group, wherein each of the first patient medical information and the second patient medical information includes left ventricle ejection fraction and/or total bilirubin level information
outputting an indication of the risk assessment , wherein outputting the indication of the risk assessment comprises displaying a visual indicator of the risk assessment in an health record of the patient
The Examiner agrees with the Applicant’s arguments. The closest prior art of record noted above under “closest prior art fails to expressly teach or suggest, either alone or in combination, the features found within the independent claims.
Therefore, the claims of the instant application are novel and unobvious. Furthermore, foreign prior art and NPL search was conducted however no relevant prior art was found
Hence the rejection under 35 U.S.C § 103 is withdrawn
For reasons of record and as set forth above, the examiner maintains the rejection of claims 1-3, 6-11, 17-19, 21-23, 27-29, 31 as being directed to a judicial exception without significantly more, and thereby being directed to non-statutory subject matter under 35 USC §101. In reaching this decision, the Examiner considered all evidence presented and all arguments actually made by Applicant.
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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE L MACCAGNO whose telephone number is (571)270-5408. The examiner can normally be reached M-F 8:00 to 5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at (571)270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PIERRE L MACCAGNO/Examiner, Art Unit 3687
/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687
