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 .
Claim Status: Claims 1-19, 39-41, 44, 45, 49, 50, 52, and 55-57 are pending.
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) a method.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04.
The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, Claim 1 is directed towards a method.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the judicial exception relied upon by the instantly claimed invention is an abstract idea, and the limitation that sets forth or describes the abstract idea is: “determining a baseline cardiac health status by applying a first set of decision engines with one or more subject health parameters of the first set of subject health parameters to determine i) an initial cardiac condition in the subject, and/or ii) an initial risk score for developing the initial cardiac condition by the subject; determining a subsequent cardiac health status by applying a second set of decision engines with one or more ambulatory monitoring parameters of the set of ambulatory monitoring parameters to determine i) a change in severity of the initial cardiac condition, ii) a change in the initial risk score, iii) a subsequent cardiac condition in the subject, and/or iv) a subsequent risk score for developing the subsequent cardiac condition by the subject; and identifying a change from the baseline cardiac health status to the subsequent cardiac health status.”
The reason that the above limitations are abstract idea is because they are directed to mental process (observation, evaluation, judgment, opinion) and mathematical concepts.
Please see the following analogous types of data manipulations that courts have found to be abstract ideas (all taken from MPEP § 2106.04):
collecting information, analyzing it, and displaying certain results of the collection and analysis, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016)
The steps of data collection and usage carried out in Applicant's claims are akin to a mental process because they are the type of calculations that could theoretically be carried out mentally, but are merely implemented using generic collection technology. The 2019 revised§ 101 guidance makes clear that the "mental process" category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing/collection technology.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, the claim recites “obtaining a first set of subject health parameters of the subject, wherein the first set of subject health parameters comprises i) electrocardiogram (ECG) data, ii) clinical biomarker data, iii) imaging data, and/or iv) clinical parameters; obtaining a set of ambulatory monitoring parameters of the subject, wherein the set of ambulatory monitoring parameters is obtained temporally subsequent to obtaining the first set of subject health parameters”; however, these additional elements do not integrate the judicial exception into a practical application, because obtaining data amounts to insignificant extra-solution activity.
The following are relevant examples of similar limitations which courts have found not to constitute improvements to computers or improvements to other technology or technical field:
Gathering and analyzing information using conventional techniques and displaying the result, TIJ Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48.
It is further noted that merely collecting the necessary data using known, generic sensors (or other data gathering components) only amounts to insignificant extrasolution activity; see MPEP § 2106.05(g). Applicant's claimed invention does not affect/change the functionality of the technology being used. Rather, Applicant's claimed invention uses the claimed technology for its standard, well-known purpose, e.g. known sensors are used to collect data which they are known to be capable of collecting, known generic processing circuitry is used to perform data calculations/ comparisons, etc. Applicant's invention does not result in improved performance of the sensors, the processing circuitry, etc.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, the claim recites additional elements “obtaining a first set of subject health parameters of the subject, wherein the first set of subject health parameters comprises i) electrocardiogram (ECG) data, ii) clinical biomarker data, iii) imaging data, and/or iv) clinical parameters; obtaining a set of ambulatory monitoring parameters of the subject, wherein the set of ambulatory monitoring parameters is obtained temporally subsequent to obtaining the first set of subject health parameters.” The additional elements do not amount to significantly more than the judicial exception, because it is simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (See MPEP 2106.05(d)).
The courts have recognized receiving or transmitting data over a network, e.g., using the Internet to gather data, as well-understood, routine, and conventional functions when they are claimed in a merely generic manner or as insignificant extra-solution activity: Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network). See MPEP 2106.05(d)II.
Therefore, the claim is not patent eligible.
With regards to the instantly rejected dependent claims 2-18, these claims when analyzed as a whole are also held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to a judicial exception and/or do not add significantly more to the judicial exception. Therefore, the claim(s) is/are not patent eligible.
Claims 39-41, 44, 45, 49, 50, 52, and 55-57 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) a system.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04.
The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, Claim 39 is directed towards a system.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the judicial exception relied upon by the instantly claimed invention is an abstract idea, and the limitation that sets forth or describes the abstract idea is: “determining a baseline cardiac health status by applying a first set of decision engines with one or more subject health parameters of the first set of subject health parameters to determine i) an initial cardiac condition in the subject, and/or ii) an initial risk score for developing the initial cardiac condition by the subject; determining a subsequent cardiac health status by applying a second set of decision engines with one or more ambulatory monitoring parameters of the set of ambulatory monitoring parameters to determine i) a change in severity of the initial cardiac condition, ii) a change in the initial risk score, iii) a subsequent cardiac condition in the subject, and/or iv) a subsequent risk score for developing the subsequent cardiac condition by the subject; and identifying a change from the baseline cardiac health status to the subsequent cardiac health status.”
The reason that the above limitations are abstract idea is because they are directed to mental process (observation, evaluation, judgment, opinion) and mathematical concepts.
Please see the following analogous types of data manipulations that courts have found to be abstract ideas (all taken from MPEP § 2106.04):
collecting information, analyzing it, and displaying certain results of the collection and analysis, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016)
The steps of data collection and usage carried out in Applicant's claims are akin to a mental process because they are the type of calculations that could theoretically be carried out mentally, but are merely implemented using generic collection technology. The 2019 revised§ 101 guidance makes clear that the "mental process" category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing/collection technology.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, the claim recites “one or more processors” which can be interpreted as a generic processor. The processors do not integrate the judicial exception into a practical application, because it is merely using a generic processor as a tool to perform an abstract idea (see MPEP 2106.05(f)).
The claim recites additional elements, “obtaining a first set of subject health parameters of the subject, wherein the first set of subject health parameters comprises i) electrocardiogram (ECG) data, ii) clinical biomarker data, iii) imaging data, and/or iv) clinical parameters; obtaining a set of ambulatory monitoring parameters of the subject, wherein the set of ambulatory monitoring parameters is obtained temporally subsequent to obtaining the first set of subject health parameters”; however, these additional elements do not integrate the judicial exception into a practical application, because obtaining data amounts to insignificant extra-solution activity.
The following are relevant examples of similar limitations which courts have found not to constitute improvements to computers or improvements to other technology or technical field:
Gathering and analyzing information using conventional techniques and displaying the result, TIJ Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48.
It is further noted that merely collecting the necessary data using known, generic sensors (or other data gathering components) only amounts to insignificant extrasolution activity; see MPEP § 2106.05(g). Applicant's claimed invention does not affect/change the functionality of the technology being used. Rather, Applicant's claimed invention uses the claimed technology for its standard, well-known purpose, e.g. known sensors are used to collect data which they are known to be capable of collecting, known generic processing circuitry is used to perform data calculations/ comparisons, etc. Applicant's invention does not result in improved performance of the sensors, the processing circuitry, etc.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, the claim recites additional elements “obtaining a first set of subject health parameters of the subject, wherein the first set of subject health parameters comprises i) electrocardiogram (ECG) data, ii) clinical biomarker data, iii) imaging data, and/or iv) clinical parameters; obtaining a set of ambulatory monitoring parameters of the subject, wherein the set of ambulatory monitoring parameters is obtained temporally subsequent to obtaining the first set of subject health parameters.” The additional elements do not amount to significantly more than the judicial exception, because it is simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (See MPEP 2106.05(d)).
The courts have recognized receiving or transmitting data over a network, e.g., using the Internet to gather data, as well-understood, routine, and conventional functions when they are claimed in a merely generic manner or as insignificant extra-solution activity: Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network). See MPEP 2106.05(d)II.
Therefore, the claim is not patent eligible.
With regards to the instantly rejected dependent claims 40-41, 44, 45, 49, 50, 52, and 55-57, these claims when analyzed as a whole are also held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to a judicial exception and/or do not add significantly more to the judicial exception. Therefore, the claim(s) is/are not patent eligible.
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 11 and 49 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.
Re Claims 11 and 49, the limitation, “the first set of subject health factors”, is indefinite, because it lacks antecedent basis.
Re Claims 11 and 49, the limitation, “one or more clinical parameters”, in line 4 is indefinite, because it is unclear whether it is referring to “one or more clinical parameters” in line 3 or a different one.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11, 13-19, 39-41, 44, 45, 49, 52, and 55-57 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Basu (US 2018/0203978A1).
Re Claim 1, Basu discloses a method for monitoring a cardiac health status for a subject, the method comprising:
a. obtaining a first set of subject health parameters of the subject, wherein the first set of subject health parameters comprises i) electrocardiogram (ECG) data (fig. 8, para. [0120], electrocardiogram sensors 832), ii) clinical biomarker data, iii) imaging data (para. [0058], echocardiogram results), and/or iv) clinical parameters (fig. 3, para. [0058], demographic information; para. [0059], dynamic data 330);
b. determining a baseline cardiac health status by applying a first set of decision engines with one or more subject health parameters of the first set of subject health parameters to determine i) an initial cardiac condition in the subject, and/or ii) an initial risk score for developing the initial cardiac condition by the subject (fig. 5, using a machine learning model, generate one or more initial risk factors based on the first set of data 520; para. [0088], As described with regard to FIG. 3, the first set of data may include patient demographic information, comorbidities, medications taken before, during, and after hospitalization, patient vital signs, patient lab results, patient weight change during hospitalization, echocardiogram results, etc.);
c. obtaining a set of ambulatory monitoring parameters of the subject, wherein the set of ambulatory monitoring parameters is obtained temporally subsequent to obtaining the first set of subject health parameters (fig. 5, receive from a wearable cardiovascular physiology monitor a second set of data for the user, the second set of data dynamically updating over time 530; para. [0090], The second set of data may include, for example, information regarding the user's pulse arrival time, pulse transit time, heart rate, heart rate variability, and pulse pressure wave morphology.);
d. determining a subsequent cardiac health status by applying a second set of decision engines with one or more ambulatory monitoring parameters of the set of ambulatory monitoring parameters to determine i) a change in severity of the initial cardiac condition, ii) a change in the initial risk score, iii) a subsequent cardiac condition in the subject, and/or iv) a subsequent risk score for developing the subsequent cardiac condition by the subject (fig. 5, using the machine learning model, evaluate the second set of data based on a set of trained dynamic data classifiers 540; para. [0091]); and
e. identifying a change from the baseline cardiac health status to the subsequent cardiac health status (fig. 5, para. [0094], at 550, method 500 includes indicating one or more aggregate risk scores for the user based on an evaluation of the second set of data against the dynamic data classifiers and the initial risk factors described with regard to 520; abstract, real-time data from wearable cardiovascular physiology monitors to provide an accurate and continuously updating risk of decompensated heart failure for a user.).
Re Claim 39, Claim 39 is rejected under substantially the same basis as claim 1. Basu discloses processors configured to execute software instructions (para. [0112]).
Re Claim 2, Basu discloses outputting an alert based on the identified change, wherein the change comprises i) an increase in the severity of the initial cardiac condition, ii) an increase in the initial risk score, iii) the subsequent cardiac condition in the subject, and/or iv) the subsequent risk score (para. [0028], Data may be presented to clinicians via clinical computing device 150 in the form of alerts and/or continuously varying data and risk scores; para. [0063], The clinician may receive an alert if a risk score increases above a threshold, thus indicating a user is at a heightened risk for decompensation within a set time interval. The clinician may receive an alert if a risk score changes by more than a threshold over a duration, thus indicating that a user may have experienced significant worsening of symptoms, and/or is not responding to treatment.).
Re Claim 3, Basu discloses repeating steps (c) to (e) a plurality of times for a prescribed duration, thereby providing monitoring of the cardiac health status of the subject for the prescribed duration (para. [0060], [0063], risk scores 340 may be determined and output for the user indicating the user's risk of decompensation within one or more of the next 12 hours, 24 hours, 48 hours, one week, 30 days, or other suitable time interval)
Re Claim 4, Basu discloses that the set of ambulatory monitoring parameters are obtained according to a temporal frequency during the prescribed duration (para. [0103], [0125], fig. 7, collecting, at a first frequency, from a wearable cardiovascular physiology monitor, a first set of data for the user comprising dynamically-updating data. At 720, method 700 includes indicating instructions to the user at a second frequency, less than the first frequency, to actively generate a second set of data comprising periodically-updating data).
Re Claim 5, Basu discloses that the temporal frequency is every hour, every 6 hours, every 12 hours, daily, every other day, weekly, bi-weekly, monthly, or bi-monthly (para. [0092], A machine-learning model may be configured as a discrete classifier that uses all of a user's first set of data as an input along with a fixed history (e.g., three days) of the user's second set of data; para. [0063], risk scores 340 may be determined and output for the user indicating the user's risk of decompensation within one or more of the next 12 hours, 24 hours, 48 hours, one week, 30 days, or other suitable time interval; para. [0103], [0125]).
Re Claim 6, Basu discloses that the set of ambulatory monitoring parameters is obtained temporally subsequent to determining the baseline cardiac health status (para. [0092], A machine-learning model may be configured as a discrete classifier that uses all of a user's first set of data as an input along with a fixed history (e.g., three days) of the user's second set of data; para. [0063], risk scores 340 may be determined and output for the user indicating the user's risk of decompensation within one or more of the next 12 hours, 24 hours, 48 hours, one week, 30 days, or other suitable time interval; para. [0103], [0125]).
Re Claim 7, Basu discloses that the set of ambulatory monitoring parameters comprises electrocardiogram (ECG) data and/or one or more clinical parameters (para. [0120], [0121], [0122], cardiovascular sensor suite may include wrist pulse sensor 830 and electrocardiogram sensors 832, fig. 8, para. [0090], second set of data; para. [0025], [0043], wearable electronic device 210, fig. 2).
Re Claim 8, Basu discloses that the one or more clinical parameters comprises the subject's age, sex, weight, body mass index, height, physiological data, exercise testing results, heart rate, activity levels, velocity, sleep data, or a combination thereof (para. [0059], [0097], activity level, step count, sleep time, sleep quality, posture; para. [0088], demographic information, patient weight change).
Re Claim 9, Basu discloses that the ECG data is obtained via ECG device, wherein the ECG device comprises a 12-lead device, a 6- lead device, a 1-lead device, or a 2-lead device (para. [0051], the left arm and right arm of a wearer comprise Lead 1 of an EKG).
Re Claim 10, Basu discloses that the ECG device comprises a wearable device (para. [0051], wearable electronic device 210 may thus function as a first electrode contacting a first measurement location on a wearer's skin. The left arm and right arm of a wearer comprise Lead 1 of an EKG).
Re Claim 11, Basu discloses that one or more subject health factors of the first set of subject health factors correspond to ECG data and/or one or more clinical parameters of the clinical parameters, wherein said ECG data and one or more clinical parameters are obtained via ambulatory measurement (para. [0103], a first set of data for the user comprises dynamically-updating data from a wearable cardiovascular physiology monitor; para. [0043], [0053], [0054], fig. 2, wearable electronic device 210 and its clinical measurements; para. [0050], Contacting multiple contact sensor modules may allow compute system 232 to determine an electrocardiogram (EKG) of the wearer; para. [0119], [0120], ECG sensors and other sensors; fig. 8, sensor and logic system).
Re Claim 13, Basu discloses that the imaging data comprises one or both of an echocardiogram image and a cardiac MRI (para. [0058], echocardiogram results).
Re Claim 14, Basu discloses that one or both of the first cardiac condition and the subsequent cardiac condition comprise a cardiac disease (para. [0023], continuous dynamic data from wearable physiological sensors to provide a continuous prediction of disease state and decompensation risk in heart failure patients).
Re Claim 15, Basu discloses that the first cardiac condition comprises cardiomyopathy, hypertrophic cardiomyopathy, pulmonary arterial hypertension, amyloid cardiomyopathy, reduced ejection fraction heart failure, arrhythmia (which can include atrial fibrillation), heart failure, heart attack, stroke, myocardial ischemia (including macrovascular and/or microvascular), left atrial myopathy, left atrial enlargement (LAE), diastolic dysfunction, or any combination thereof (para. [0023], continuous dynamic data from wearable physiological sensors to provide a continuous prediction of disease state and decompensation risk in heart failure patients; abstract).
Re Claim 16, Basu discloses that the subsequent cardiac condition comprises cardiomyopathy, hypertrophic cardiomyopathy, pulmonary arterial hypertension, amyloid cardiomyopathy, reduced ejection fraction heart failure, arrhythmia (which can include atrial fibrillation), heart failure, heart attack, stroke, myocardial ischemia (including macrovascular and/or microvascular), left atrial myopathy, diastolic dysfunction, or any combination thereof (para. [0023], continuous dynamic data from wearable physiological sensors to provide a continuous prediction of disease state and decompensation risk in heart failure patients; abstract).
Re Claim 17, Basu discloses that one or both of the first set of decision engines and the second set of decision engines comprise a trained model, a decision tree, an analytical expression, or a combination thereof (para. [0068], training machine-learning model).
Re Claim 18, Basu discloses that the first set of decision engines and the second set of decision engines each comprise one or more decision engines (fig. 5 shows using a machine learning model for both the first set and the second set).
Re Claim 19, Basu discloses that at least one decision engine is found in both the first set of decision engines and the second set of decision engines (para. [0098], A default set of dynamic data classifiers may be selected to evaluate the dynamically-updating data, the default set of classifiers representing an aggregate set of static and dynamic data for the user that is applicable during most user states).
Re Claim 40, Claim 40 is rejected under substantially the same basis as claim 2.
Re Claim 41, Claim 41 is rejected under substantially the same basis as claim 3.
Re Claim 44, Claim 44 is rejected under substantially the same basis as claim 6.
Re Claim 45, Claim 45 is rejected under substantially the same basis as claim 7.
Re Claim 49, Claim 49 is rejected under substantially the same basis as claim 11.
Re Claim 52, Claim 52 is rejected under substantially the same basis as claim 14.
Re Claim 55, Claim 55 is rejected under substantially the same basis as claim 17.
Re Claim 56, Claim 56 is rejected under substantially the same basis as claim 18.
Re Claim 57, Claim 57 is rejected under substantially the same basis as claim 19.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 12 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Basu (US 2018/0203978A1) in view of Osman (US 2020/0383584).
Re Claim 12, Basu discloses the claimed invention substantially as set forth in claim 1.
Basu is silent regarding the clinical biomarker data comprising data for one or more of B-type natriuretic peptide (BNP), N-terminal(NT)-pro hormone BNP (NT-proBNP), and cardiac troponin.
However, Osman discloses computing risk score for cardiac conditions (abstract) and teaches using clinical biomarker data comprising data for one or more of B-type natriuretic peptide (BNP), N-terminal(NT)-pro hormone BNP (NT-proBNP), and cardiac troponin to compute the risk score (para. [0184], [0188], [0197], It should also be noted that multiple risk scores, including those derived from third party tests such as biomarkers (e.g. Troponin, BNP, etc.), may be integrated together or included as a multiparametric analysis tool that may help evaluate diseases and management performance. For example, endocardial, midmyocardial, and epicardial risk scores calculated similar to Equation (2) in page 14 or the ratios discussed above may be combined or used in concert to identify diseases that have subtle differences in which fingerprinting for diagnosing the disease is improved with a plurality of features; para. [0011], risk scoring systems based on MRI Strain ENCoded (SENC) imaging that can generate risk scores to assess and/or quantify patient predisposition for developing heart failure and/or to assess a current status of the heart (from normal to one of several defined different stages of heart failure)).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Basu, by configuring the clinical biomarker data to comprise data for one or more of B-type natriuretic peptide (BNP), N-terminal(NT)-pro hormone BNP (NT-proBNP), and cardiac troponin, as taught by Osman, for the purpose of improving the diagnosis of different stages of heart failure (para. [0184], [0188], [0197]).
Re Claim 50, Claim 50 is rejected under substantially the same basis as claim 12.
Conclusion
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, March 25, 2026Examiner, Art Unit 3792