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 .
Application Status
This is the first non-final action on the merits. Claims 1-11 as originally filed on June 28, 2024 are currently pending and considered below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 28, 2024 is being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. an abstract idea) without significantly more.
Claims 1-9 recite a method for determining a degree of possibility of secondary hypertension, which is within the statutory category of a process. Claim 10 recites a system for determining a degree of possibility of secondary hypertension, which is within the statutory category of a machine. Claim 11 recites an apparatus for determining a degree of possibility of secondary hypertension, which is within the statutory category of a machine.
Step 2A - Prong One:
Regarding Prong One of Step 2A , the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they "recite" a judicial exception or in other words whether a judicial exception is "set forth" or "described" in the claims. An "abstract idea" judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes. Representative independent claim 1 includes limitations that recite at least one abstract idea.
Specifically, independent claim 1 recites: A method for determining a degree of possibility of secondary hypertension, the method
comprising causing one or more computers to execute
a step of acquiring user-related data including blood pressure value data indicating a blood pressure value measured and behavior record data indicating behavior performed by a user and
a step of determining, based on the user-related data acquired, an essential hypertension prediction model based on a behavior score indicating the behavior of the user, and a secondary hypertension prediction model, degrees of possibilities of essential hypertension and secondary hypertension.
The underlined limitations constitute concepts performed in the human mind and mathematical concepts. That is, other than reciting steps as performed by the generic computer components, nothing in the claim elements precludes the steps from practically being performed in the mind. The claim encompasses a mental process of acquiring user data. The identified abstract idea, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind except for the recitation of generic computer components. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind except for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Additionally, the claim encompasses an abstract idea that falls under the mathematical concepts grouping because determining an essential hypertension prediction model based on a behavior score, a secondary hypertension prediction model, and degrees of possibilities of essential hypertension and secondary hypertension, under its broadest reasonable interpretation, represent mathematical calculations and relationships (see MPEP 2106.04(a)(2)). The abstract idea for Claims 10 and 11 are identical as the abstract idea for Claim 1, because the only difference between Claim 1 and 10 is that Claim 1 recites a method, whereas Claim 10 recites a system, and because the only difference between Claims 1 and 11 is that Claim 1 recites a method, whereas Claim 11 recites an apparatus. Any limitations not identified above as part of the limitation in the mind or mathematical concepts, are deemed “additional elements” and will be discussed further in detail below. Accordingly, independent claims 1, 10 and 11 recite at least one abstract idea.
Similarly, dependent claims 2-7 further narrow the abstract idea described in the independent claims. Claim 2 further describes determining degrees of possibilities of essential hypertension and secondary hypertension. Claim 3 and 4 describe comparing the degree of possibility of secondary hypertension with the determined possibility of essential hypertension. Claim 5 describes the behavior score. Claims 6 and 7 describe the user data. Claim 4 partially narrows the abstract idea as described above and also introduces additional element(s) which will be discussed in Step 2A Prong 2 and Step 2B.
These limitations only serve to further limit the abstract idea and hence, are directed toward fundamentally the same abstract ideas as independent claims 1, 17 and 20.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As such, it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a "practical application."
In the present case, claims 1-11 as a whole do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea. The additional elements or combination of additional elements, beyond the above-noted at least one abstract idea will be described as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the “abstract idea(s)”).
Specifically, independent claim 1 recites: A method for determining a degree of possibility of secondary hypertension, the method
comprising causing one or more computers to execute
a step of acquiring user-related data including blood pressure value data indicating a blood pressure value measured and behavior record data indicating behavior performed by a user and
a step of determining, based on the user-related data acquired, an essential hypertension prediction model based on a behavior score indicating the behavior of the user, and a secondary hypertension prediction model, degrees of possibilities of essential hypertension and secondary hypertension.
The independent claims recite the additional elements of a computer, system and apparatus that implement the identified abstract idea. The computer, system and apparatus are not described by the applicant and are recited at a high-level of generality such that they amount to no more than mere instructions to apply the exception using a generic computer component.
The dependent claims 4, 8 and 9 recite additional element(s) beyond those already recited in the independent claims that implement the identified abstract idea. Claims 4 and 8 recite a terminal. Claim 9 recites a non-transitory computer-readable computer medium storing a computer program. However, these functions do not integrate a practical application more than the abstract idea because they represents mere instructions to apply the abstract idea on a computer (i.e., merely invoking the computer structure as a tool used to execute the limitations).
Claim 4 further recites the additional element of presenting information. Claim 8 further recites the additional element of transmitting information. Under practical application, presenting information and transmitting information are all forms of extra-solution activity. MPEP 2106.5(g) indicates the term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Therefore, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Accordingly, the claims as a whole do not integrate the abstract idea into a practical application as they do not impose any meaningful limits on practicing the abstract idea.
Step 2B
Regarding Step 2B, representative independent claim 1 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
When viewed as a whole, claims 1-11 do not include additional limitations that are sufficient to amount to significantly more than the judicial exception because the claims recite processes that are routine and well-known in the art and simply implements the process on a computer(s) is not enough to qualify as "significantly more."
As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a computer, system and apparatus to perform the noted steps amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
The dependent claims 4, 8 and 9 recite additional element(s) beyond those already recited in the independent claims that implement the identified abstract idea. Claims 4 and 8 recite a terminal. Claim 9 recites a non-transitory computer-readable computer medium storing a computer program. However, these functions are not deemed significantly more than the abstract idea because they represent mere instructions to apply the abstract idea on a computer (i.e., merely invoking the computer structure as a tool used to execute the limitations).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of presenting information and transmitting information (claims 4 and 8) were considered extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field. Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such, the claims also do not recite significantly more than the abstract idea and are not patent eligible.
Therefore, claims 1-11 are rejected under 35 USC §101 as being directed to non-statutory subject matter.
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.
Claims 1 and 3-11 are rejected under 35 U.S.C. 103 as being unpatentable over Reel (“Machine learning for classification of hypertension subtypes using multi-omics: A multi-centre, retrospective, data-driven study”, eBioMedicine, 2022) in further view of Fung (US 2011/0202486 A1).
Regarding claim 1, Reel teaches: A method for determining a degree of possibility of secondary hypertension (e.g. see pg. 2 “Methods”), the method
comprising causing one or more computers to execute a step of acquiring user-related data […] and (“The study used well-established computational packages and libraries”, e.g. see pg. 14 “Data sharing statement”; clinical data was collected from “487 male and female participants”, e.g. see pg. 4 “Patient details”)
a step of determining, based on the user-related data acquired, an essential hypertension prediction model […], and a secondary hypertension prediction model, (training specific machine learning classifiers to classify “primary hypertension (PHT)” (i.e. essential hypertension) and “endocrine hypertension (EHT)” (i.e. secondary hypertension), including subtypes of EHT like “primary aldosteronism (PA), pheochromocytoma/functional paraganglioma (PPGL) or Cushing syndrome (CS)”; training classifiers for “EHT (PA + PPGL + CS) vs PHT” and distinguishing among the secondary subtypes, e.g. see pg. 2 “Findings”, “Methods”, “Interpretation”)
degrees of possibilities of essential hypertension and secondary hypertension. (the classifiers output “decision value (prediction probability)” for each disease type (i.e. degrees of possibilities), e.g. see pgs. 8-9 “Performance metrics”; Fig. 2(b) illustrates the “Predicted disease type” and the “decision value (probability)” for both primary hypertension and secondary hypertension (EHT/PA/PPGL/CS))
Reel does not teach:
blood pressure value data indicating a blood pressure value measured and behavior record data indicating behavior performed by a user
a behavior score indicating the behavior of the user
However, Fung in the analogous art of a “framework for predicting development of a cardiovascular
condition” such as hypertension (e.g. see [0009], [0020]) teaches:
blood pressure value data indicating a blood pressure value measured and behavior record data indicating behavior performed by a user (the “system 101 retrieves patient data” including “clinic measurement data (e.g., heart-rate, systolic and diastolic blood pressures, mean arterial blood pressure, etc.)”, “patient habits (e.g., smoking status, exercise habits, etc.)” and “patient lifestyle data ( e.g., stress level),”, e.g. see [0029], [0032]-[0033])
a behavior score indicating the behavior of the user (“a risk score as a function of patient data”, which includes “patient habits” and “patient lifestyle data”, e.g. see [0009], [0032]-[0033])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Reel to include blood pressure value data indicating a blood pressure value measured and behavior record data indicating behavior performed by a user and a behavior score indicating the behavior of the user as taught by Fung, for the purposes of “classify[ing] patients (or subjects) into different risk categories, so as to facilitate formulation of more personalized preventive strategies” (Fung [0019]).
Regarding claim 3, Reel and Fung teach the method of claim 1 as described above.
Reel further teaches:
further causing the one or more computers to execute a step of determining a degree of possibility of secondary hypertension compared with the determined possibility of essential hypertension (Fig. 2(b) and 3 present the “decision value (probability)” for primary hypertension side-by-side with the probabilities for secondary hypertension (EHT/PA/PPGL/CS) (The system calculates the probability for essential hypertension (PHT) with secondary hypertension (EHT). By presenting them together, the system is determining the possibility of one compared with the other.))
Regarding claim 4, Reel and Fung teach the method of claim 3 as described above.
Reel teaches the degree of possibility of secondary hypertension compared with the determined possibility of essential hypertension as described above.
Reel does not teach:
a step of presenting, upon input of request operation to a terminal of the user or a medical service worker, information on the terminal
However, Fung in the analogous art teaches:
a step of presenting, upon input of request operation to a terminal of the user or a medical service worker, information on the terminal (provide decision support “at the point-of-care for patients considered at risk” (this is understood to require an input of request), e.g. see [0027]; presenting a “recommendation of the preventive strategy associated with the selected risk category” to the “the primary care physician or any other medical practitioner”, e.g. see [0052]-[0053]; the system may be a “desktop personal computer, a portable laptop computer, another portable device, a mini-computer, a mainframe computer, a server, a storage system, a dedicated digital appliance, or another device” with “various input devices 110 ( e.g., mouse or keyboard) via an input-output interface”, e.g. see [0021])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Reel to include step of presenting, upon input of request operation to a terminal of the user or a medical service worker, information on the terminal as taught by Fung, for the purposes of “facilitat[ing] interpretation, risk assessment and/or clinical decision support” (Fung [0009]).
Regarding claim 5, Reel and Fung teach the method of claim 1 as described above.
Reel further teaches:
the essential hypertension prediction model includes a term […], and the secondary hypertension prediction model includes no term […] (utilizing the “Boruta” algorithm for “feature selection” to identify the most relevant features for each classification, e.g. see pg. 5 “Classifiers”; primary hypertension is associated with risk factors, e.g. “socio-environmental risk factors including salt intake, obesity, alcohol consumption”, which are distinct from risk factors associated with secondary hypertension, e.g. “excess hormone production”, e.g. see pg. 3 “Introduction” (The feature selection algorithm for PHT would include terms causal to PHT, and the feature selection algorithm for EHT would prioritize causal terms to EHT and exclude those associated with PHT.))
Reel does not teach:
term related to the behavior score
However, Fung in the analogous art teaches:
term related to the behavior score (“a risk score as a function of patient data”, which includes “patient habits” and “patient lifestyle data”, e.g. see [0009], [0032]-[0033])
Regarding claim 6, Reel and Fung teach the method of claim 1 as described above.
Reel does not teach:
the behavior record data includes at least one of an amount of exercise, a weight, and an amount of salt intake of the user
However, Fung in the analogous art teaches:
the behavior record data includes at least one of an amount of exercise, a weight, and an amount of salt intake of the user (the “system 101 retrieves patient data” including “patient habits (e.g., smoking status, exercise habits, etc.)”, e.g. see [0029], [0032]-[0033])
Regarding claim 7, Reel and Fung teach the method of claim 1 as described above.
Reel does not teach:
the user-related data is acquired in a predetermined time period and includes two or more pieces of the blood pressure value data and two or more pieces of the behavior record data
However, Fung in the analogous art teaches:
the user-related data is acquired in a predetermined time period and includes two or more pieces of the blood pressure value data and two or more pieces of the behavior record data (“the patient data is stored in the form of one or more computerized patient records (CPRs), which are also known as electronic health records (EHRs )…An exemplary CPR (or EHR) includes information that is collected over the course of a patient's treatment, and typically draws from multiple data sources.”, e.g. see [0029]; patient data may include “patient medical history (e.g., prior history of hypertension…)” and “doctor progress notes, details about medical procedures and/or examinations (e.g., time between first examination and follow-up)”, e.g. see [0032])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Reel to include the user-related data is acquired in a predetermined time period and includes two or more pieces of the blood pressure value data and two or more pieces of the behavior record data as taught by Fung, for the purposes of “classify[ing] patients (or subjects) into different risk categories, so as to facilitate formulation of more personalized preventive strategies” (Fung [0019]).
Regarding claim 8, Reel and Fung teach the method of claim 1 as described above.
Reel does not teach:
the user-related data includes information indicating the blood pressure value and the behavior performed by the user and is transmitted by a terminal of the user, the information being input by the user to the terminal of the user
However, Fung in the analogous art teaches:
the user-related data includes information indicating the blood pressure value and the behavior performed by the user and is transmitted by a terminal of the user, the information being input by the user to the terminal of the user (patient data “may be collected by various methods, such as…questionnaire”, e.g. see [0030]; the system may be a “desktop personal computer, a portable laptop computer, another portable device, a mini-computer, a mainframe computer, a server, a storage system, a dedicated digital appliance, or another device” with “various input devices 110 ( e.g., mouse or keyboard) via an input-output interface”, e.g. see [0021]))
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Reel to include the user-related data includes information indicating the blood pressure value and the behavior performed by the user and is transmitted by a terminal of the user, the information being input by the user to the terminal of the user as taught by Fung, for the purposes of “classify[ing] patients (or subjects) into different risk categories, so as to facilitate formulation of more personalized preventive strategies” (Fung [0019]).
Regarding claim 9, Reel and Fung teach the method of claim 1 as described above.
Reel does not teach:
A non-transitory computer-readable computer medium storing a computer program for causing one or more computers to execute the method
However, Fung in the analogous art teaches:
A non-transitory computer-readable computer medium storing a computer program for causing one or more computers to execute the method (e.g. see claim 23)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Reel to include a non-transitory computer-readable computer medium storing a computer program for causing one or more computers to execute the method as taught by Fung, for the purposes of implementing the system (Fung [0019]).
Claims 10 and 11 recite substantially similar limitations as those already addressed in claim 1, and, as such are rejected for similar reasons as given above.
Claims 2 is rejected under 35 U.S.C. 103 as being unpatentable over Reel and Fung in further view of Trost (US 2005/0119534 A1).
Regarding claim 2, Reel and Fung teach the method of claim 1 as described above.
Reel teaches determining degrees of possibilities of essential hypertension and secondary hypertension, the essential hypertension prediction model and the secondary hypertension prediction model as described above.
Reel further teaches:
a step of determining, […] when hypertension is assumed to be essential hypertension and the […] when hypertension is assumed to be secondary hypertension, the degrees of possibilities of essential hypertension and secondary hypertension (the classifiers output “decision value (prediction probability)” for each disease type (i.e. degrees of possibilities); “High decision values highlighted the confidence of the classifier”, e.g. see pgs. 8-9 “Performance metrics”; Fig. 2(b) illustrates the “Predicted disease type” and the “decision value (probability)” for both primary hypertension and secondary hypertension (EHT/PA/PPGL/CS))
Reel and Fung do not teach:
calculating an error term in the prediction model
a step of calculating, based on the calculated error term in the prediction model, likelihood
However, Trost in the analogous art of “medical diagnosis and evaluation” (e.g. see [0003]) teaches:
calculating an error term in the prediction model (the regression model where “if an error value or residual R is the difference between an observed value Y and the expected value XB” (i.e. calculating an error term), e.g. see [0273], [0275]; “the residual analysis…which represents the distribution of the residuals over time, and the variance thereof V[Error].”, e.g. see [0368]; predicting the onset of a specific medical condition using the dynamic regression analysis, e.g. see [0286])
a step of calculating, based on the calculated error term in the prediction model, likelihood (calculating likelihoods and probabilities derived from the model parameters which include errors/residuals: unknown parameters of the model “can be estimated by any acceptable statistical estimation procedure” including “maximum likelihood estimation”, e.g. see [0281]; “confidence intervals calculated by the system provide a measure of the probability of the model fitting”, e.g. see [0292]; create probability distributions “By overlaying the proper curvilinear probability distribution…one can appreciate the high chance for false positives”, e.g. see [0008])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Reel and Fung to include calculating an error term in the prediction model and a step of calculating, based on the calculated error term in the prediction model, likelihoods as taught by Trost, for the purposes of quantifying the reliability of the prediction (Trost [0291]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Reference Shivpure (US 2022/0280121 A1) discloses non-invasive non-contact system and method for evaluating primary and secondary hypertension conditions using thermal imaging. Reference Diao (“An Application of Machine Learning to Etiological Diagnosis of Secondary Hypertension: Retrospective Study Using Electronic Medical Records”, JMIR Med Inform, 2021) discloses a study to develop and validate machine learning (ML) prediction models of common etiologies in patients with suspected secondary hypertension. Reference Zennaro (US 2024/0047065 A1) discloses identification of biomarkers for diagnosis and treatment of endocrine hypertension.
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/A.A./Examiner, Art Unit 3686
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681