DETAILED ACTION
This office action is based on the claim set filed on 07/20/2026.
Claims 22, 31, and 39 have been amended.
Claims 22, 24-29, 31, and 37-41 are currently pending and have been examined.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/20/2026 has been entered.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not
patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg,
140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d
2010 (Fed. Cir. 1993); In re Langi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van
Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
(CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR l.32I(c) or l.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717. 02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP
§ § 706.02(1)(1) - 706.02(1)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR l.32l(b).
The USPTO Internet website contains terminal disclaimer forms which may be used.
Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or
PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal
Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-inf o-1.js p.
Claims 39-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 and 17 of App. No. 18/739,226. The claims at issue are not identical and they are not patentably distinct from each other because both are directed toward addressing a similar scope. The table/chart below exhibits the similarity* between the independent claim(s) while claim 39 of the current application ‘099 discloses equivalent elements for as in claim 12 and 17 of the reference application ‘226.
*Similarities highlighted in BOLD
App. No. 18/873,099 (current application) Claim 39
App. No. 18/739,226 (reference patent) Claim 12
A method of operating a clinical decision support system for pulmonary hypertension, the method comprising
A method comprising
receiving, from a database via a communications interface, a first set of input variable data of a set of input variables
receiving, from a database, a first set of input variable data of a set of input variables
determining, via one or more pulmonary arterial hypertension risk algorithms executed by a processor, a first set of risk score values associated with a patient surviving within a given time period using the first set of input variable data, for one or more time instances,
wherein the one or more pulmonary arterial hypertension risk algorithms comprise an ensemble of multiple modules built separately, the multiple modules including a clinical data module and at least one of an imaging data module, an ECHO data module, or a genomic biomarker module, wherein each of the multiple modules comprises tree augmented Naive Bayes (TAN) networks configured to process missing data using an Expectation- Maximization (EM) algorithm, wherein weights of the multiple modules in the ensemble are determined through cross-validation
determining, via one or more pulmonary arterial hypertension risk algorithms, a first set of risk score values associated with a patient surviving within a given time period using electronic medical records from the first set input variable data for one or more time instances
outputting, via a visualization output of a graphical user interface associated with a user's device, the first set of risk score values associated with a patient surviving within the given time period in a plotted line;
wherein the visualization output further comprises a visual representation of a patient frequency index that provides a measure of rarity of the patient given the first set of input variable data to indicate a confidence of the one or more pulmonary arterial hypertension risk algorithms
outputting, via a visualization output of a graphical user interface associated with a user device, the first set of risk score values associated with the patient surviving within the given time period
presenting, via the graphical user interface, a set of input variables for a second set of input variable data, wherein the second set of input variable data includes a portion or all of the set of input variables
presenting, via the graphical user interface, a set of input variables for a second set of input variable data, wherein the second set of input variable data includes a portion or all of the first set of input variables;
receiving, from the user's device, a user modified second set of input variable data provided by the user through the graphical user interface;
receiving, from the user device, the second set of input variable data provided by a user through the graphical user interface to simulate a clinical scenario
determining, via the one or more pulmonary arterial hypertension risk algorithms, a second set of risk score values associated with the patient surviving within the given time period using the user modified second set of input variable data;
determining, via the one or more pulmonary arterial hypertension risk algorithms, a second set of risk score values associated with the patient surviving within the given time period using the second set of input variable data
outputting, via the visualization output of the graphical user interface, the second set of risk score values associated with a patient surviving within the given time period, wherein the second set of risk score values is concurrently presented with the first set of risk score values in the visualization output
outputting, via the visualization output of the graphical user interface, the second set of risk score values associated with a patient surviving within the given time period, wherein the second set of risk score values is concurrently presented with the first set of risk score values in the visualization output to provide a comparative risk assessment between the first set of input variable data and the simulated clinical scenario
As per the above chart, it shows the similarities in the reference application ‘226 and the current application ‘099 independent claim(s) which exhibits a broader and more generic than application ‘099.
Thus, this is a provisional nonstatutory double patenting rejection because the patentably indistinct claims are obvious variations of one another.
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.
Claim 22, 24-29, 31, and 37-41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 22, 24-29, 31, and 37-38 are drawn to a system and Claim 39-41 are drawn to a method, and each of which is within the four statutory categories (i.e., a machine and a process). Claims 22, 24-29, 31, and 37-41 are further directed to an abstract idea on the grounds set out in detail below.
Under Step 2A, Prong 1, the steps of the claim for the invention represents an abstract idea of a series of steps that recite a process for predicting health condition risk and evaluating survival rate. Collecting a patient data to estimate risk score for a period of time and measure survival rate for the time period are steps that could have been performed by a human mind but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for which both the instant claims and the abstract idea are defined as Metal Process that can be performed using human mind with the aid of pencil and paper.
Independent Claim 22 recites the steps of:
“a processor; a memory having instructions stored thereon; and
a means for input and output, wherein at least one set of input variable data are provided by the input means,
wherein execution of the instructions by the processor causes the processor to execute one or more pulmonary arterial hypertension risk algorithms configured to generate a risk score value associated with a patient surviving within a given time period,
wherein the one or more pulmonary arterial hypertension risk algorithms comprises an ensemble of multiple modules built separately, the multiple modules including a clinical data module and at least one of an imaging data module, an ECHO data module, or a genomic biomarker module, wherein each of the multiple modules comprises a tree augmented Naive Bayes (TAN) configured to process missing data using an Expectation-Maximization (ME) algorithm, wherein weights of the multiple modules in the ensemble are determined through cross-validation, and
wherein the clinical decision support system is configured to display a set of risk score values associated with a patient surviving within a given time period computed by the one or more pulmonary arterial hypertension risk algorithms associated with a first set of input variable data in a plotted line on a graphical user interface, and further configured to receive a user- modified second set of input variable data via the communication interface, determine a second set of risk score values using the second set of input variable data, and concurrently present the second set of risk score values as future risk score values alongside the set of risk score values from the first set as historical risk score values in a visualization output
wherein the visualization output further comprises a visual representation of a patient frequency index that provides a measure of rarity of the patient given the first set of input variable data to indicate a confidence of the one or more pulmonary arterial hypertension risk algorithms”.
Independent Claim 39 recites similar steps as in Claim 22:
“receiving, from a database, a first set of input variable data of a set of input variables;
determining, via one or more pulmonary arterial hypertension risk algorithms executed by a processor, a first set of risk score values associated with a patient surviving within a given time period using the first set of input variable data, for one or more time instances, wherein the one or more pulmonary arterial hypertension risk algorithms comprise an ensemble of multiple modules built separately, the multiple modules including a clinical data module and at least one of an imaging data module, an ECHO data module, or a genomic biomarker module, wherein each of the multiple modules comprises a tree augmented Naive Bayes (TAN) networks configured to process missing data using an Expectation- Maximization (EM) algorithm, wherein weights of the multiple modules in the ensemble are determined through cross-validation;
outputting, via a visualization output of a graphical user interface associated with a user's device, the first set of risk score values associated with a patient surviving within the given time period in a plotted line, wherein the visualization output further comprises a visual representation of a patient frequency index that provides a measure of rarity of the patient given the first set of input variable data to indicate a confidence of the one or more pulmonary arterial hypertension risk algorithms;
presenting, via the graphical user interface, a set of input variables for a second set of input variable data, wherein the second set of input variable data includes a portion or all of the set of input variables;
receiving, from the user's device, a user modified second set of input variable data provided by the user through the graphical user interface;
determining, via the one or more pulmonary arterial hypertension risk algorithms, a second set of risk score values associated with the patient surviving within the given time period using the user modified second set of input variable data; and
outputting, via the visualization output of the graphical user interface, the second set of risk score values associated with a patient surviving within the given time period,
wherein the second set of risk score values is concurrently presented with the first set of risk score values in the visualization output
These limitations, as drafted, given the broadest reasonable interpretation cover performance of the limitations by a human mind with aid of pen and paper reciting an abstract idea for Mental Process along with Organizing Human Activity and Mathematical concepts, but for the recitation of generic computer components. For example, using tree augmented Naive Bayes (TAN) networks and Expectation-Maximization (EM) algorithm is a mathematical and probabilistic concept. The limitations encompass a user the ability to collect a patient data to evaluate pulmonary arterial hypertension risk, compute risk score, determine survival rate and display outputs, which are steps that that could have been performed by a human to implement the abstract idea and are steps reciting mental process that could have been performed using a human mind with aid of pen and paper and mathematical concepts, but other than the mere nominal recitation of "processor, memory, user device", to implement the abstract idea for performing the steps of observing, evaluating, judgment and opinion which can be performed using a human mind with the aid of pencil and paper, MPEP § 2106.04(a)(2)(III) and Electric Power Group v. Alstom., S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016). Accordingly, the claim limitations (in BOLD) recite an abstract idea. Any limitations not identified above as part of the Mental Process are deemed "additional elements," and will be discussed in further detail below.
Under Step 2A, Prong 2, this judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas, linking the abstract idea to a particular technological environment. In particular, the claims recite the additional elements such as “processor, memory, clinical decision support system, communication interface, database, graphical user interface (GUI), user device, clinical data module, imaging data module, ECHO data module, genomic biomarker module” that iteratively takes input data and analyzes said data to determine an output to performing generic computer functions, e.g., display[ing] risk score and survival rate, such that it amounts no more than adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea, see MPEP 2106.05(f), generally linking the use of the judicial exception to a particular technological environment or field of use, see MPEP 2106.05(h), and a mere data gathering process that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.04(d). As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 "merely include[ing] instructions to implement an abstract idea on a computer" is an example of when an abstract idea has not been integrated into a practical application. Accordingly, looking at the claim as a whole, individually and in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Under step 2B, the claims do not include additional elements that are sufficient to amount to "significantly more" than the judicial exception because as mentioned above, the additional elements amount to no more than generic computing components, recited at a high level of generality, do not present improvements to another technology or technical field, nor do they affect an improvement to the functioning of the computer itself, that amount to no more than mere instruction to perform the abstract idea such that it amounts no more than adding the words "apply it" (or an equivalent) to apply the exception using generic computer component, see MPEP 2106.05(f). There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and mere instructions to apply an exception using a generic computer component cannot provide an inventive concept, See Alice, 573 U.S. at 223 ("mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention."). The claims are not patent eligible.
Dependent Claims 24-29, 31, 37-38, and 40-41 include all of the limitations of claim(s) 22 and 39, and therefore likewise incorporate the above-described abstract idea. While the depending claims add additional limitations, such as
As for claims 24-25, 28, 37-38, 40, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible.
As for claims 26-27, 29, 31, 41, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper, reciting an abstract idea for Mental Process. The claims recite additional elements “processor, decision system, processor, memory, database, Bayesian networks, GUI” that implement the identified abstract idea. These hardware components are recited at a high level of generality to perform the steps, e.g., “display[ing], store[ing]”, that amounts to no more than the words "apply it" with a computer because it appears to intend to do so, which would still amount to mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Additionally, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements amount to more than mere instruction to apply the exception using generic computer component and have been re-evaluated under the “significantly more” analysis. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
As for claims 29, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper, reciting an abstract idea for Mental Process along with mathematical calculations and relationships that constitute Mathematical Concepts but for the recitation of generic computer components. For example, calculating weights is/are Mathematical Concepts, but for the recitation of generic computer components. The claims recite additional elements “processor” that implement the identified abstract idea. These hardware components are recited at a high level of generality to perform the steps that amounts to no more than the words "apply it" with a computer because it appears to intend to do so, which would still amount to mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Additionally, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements amount to more than mere instruction to apply the exception using generic computer component and have been re-evaluated under the “significantly more” analysis. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
Subject Matter Free of Prior Art
Claims 22, 24-29, 31, and 37-41 have been found by the examiner to be free of prior art. A thorough search of the prior art was conducted and the examiner could not find a single reference or combination of references with adequate rationale to combine that would teach the claimed invention.
Specifically, the examiner finds that the language “wherein the one or more pulmonary arterial hypertension risk algorithms comprise an ensemble of multiple modules built separately, the multiple modules including a clinical data module and at least one of an imaging data module, an ECHO data module, or a genomic biomarker module, wherein each of the multiple modules comprises a tree augmented Naive Bayes (TAN) networks configured to process missing data using an Expectation- Maximization (EM) algorithm, wherein weights of the multiple modules in the ensemble are determined through cross-validation” to be free of prior art. In the examiner's search of prior art, the following references were found to be the closest prior art:
Kim et al. (US 2025/0253050) discloses using the different variables for calculating the probability of the patient risk to be cross validated via algorithm to predict critical event(s) projecting a trajectory over a time period and plotting trajectories on a visualization and analysis (VA) tool to display the probabilities associated with the predicted risk level trajectory over the projected time period and surviving probability based on the estimated risk. Kim also discloses the trajectories are estimated using a Bayesian multivariate linear mixed effects model (MLMM) and discloses the system memory includes other program modules, however, Kim does not expressly disclose multiple modules to include clinical data, imaging data (ECHO), genomic biomarker data and tree-augmented Naïve Bayes (TAN) associated with model(s) and associating with the different modules.
Ciolko et al. (“Intelligent Clinical Decision Support Systems Based on SNOMED CT” discloses a decision support system that learn the relationship between variables and diseases such as disease of lung, using plurality of Bayesian networks
Galie et al. (Guidelines for the diagnosis and treatment of pulmonary hypertension” discloses decision support system for evaluating a risk of a disease risk assessment score of pulmonary arterial hypertension (PAH) and patient survival over a period of time, e.g., 3-6 month based on biomedical information such as presence of the disease based on historical clinical data, lab test, etc., biomedical information such as presence of the disease based on imaging data or studies, using echocardiography, biomarker and developing diagnostics classifiers decision tree where based on the decision support system classifies patients in groups with pulmonary hypertension (PH) risk based specific characteristics where a patient group experiences a particular clinical event such as ventricular fibrillation/arrhythmias of the total diagnosis indicating the heterogeneity and rarity of the group conditions.
Duijnhouwer “The outcome of pulmonary hypertension and its association with pulmonary artery dilatation” discloses assessment of Pulmonary Arterial Hypertension where survival is related to the stage of the disease at the time of diagnosis.
Benza et al. “Predicting Survival in Pulmonary Arterial Hypertension” discloses assessment of Pulmonary Arterial Hypertension survival score over 12 month span.
Xiong “A modified risk score in one-year survival rate assessment of group 1 pulmonary arterial hypertension” discloses a modified Risk Assessment Score of PAH (mRASP).
It would not have been obvious to one of ordinary skill in the art at the time of filing to have employed the claimed invention because the references taken solely, or in combination, fail to provide the required limitations, and modification of any complementary combination of the references of record would be impermissible. While the prior art does recite features that are similar to the claimed invention, the examiner finds claims 22, 24-29, 31, and 37-41 as free of prior art.
Response to Amendment
Applicant's arguments filed 07/20/2026 have been fully considered by the Examiner and addressed as the following:
In the remarks, Applicant argues in substance that:
Applicant's arguments with respect to Double Patenting (DP) rejection on page 7.
In response to the Applicant argument that “Applicant does not agree but has filed a terminal disclaimer herewith to overcome the rejections”, Examiner affirms that up to the date of this OA, no terminal disclaimer was filed. In addition, Examiner, finds that the additional limitation as amended is/are further narrow the current application claims however the steps recites the similar concept as recited in the reference application, see claim 17 reference app. Therefore, Examiner remains the DP rejection.
Applicant's arguments with respect to the 35 U.S.C. § 101 rejection on page 7-8.
On page 7 of the remarks, the Applicant argues “Independent claims 22 and 39 have been amended to explicitly recite a multi-modular system architecture and a graphical user interface (GUI), ... These specific features tie the invention to a concrete technological implementation that improves the functioning of clinical decision support systems...”, Examiner respectfully disagree. The claim limitations, given their broadest reasonable interpretation, recite steps, i.e., receiving information of a user to evaluate and predict pulmonary arterial hypertension risk, computing risk score, and provide visualization outputs, which have been analyzed under Step 2A, Prong One reciting a process for obtaining/collecting, determining, comparing (analyzing) and predicting or provide an opinion, which are steps of observing, evaluating, judgment, and opinion that are citing a process for which can be performed using a human mind with the aid of pencil and paper for which both the instant claims and the abstract idea are defined as Mental Process. While the claim recites algorithms and recite a general-purpose computer processor executing such algorithms to implement the abstract idea as such claims can recite a mental process even if they are claimed as being performed on a computer “the Court concluded that the algorithm could be performed purely mentally even though the claimed procedures "can be carried out in existing computers long in use, no new machinery being necessary." 409 U.S at 67, 175 USPQ at 675, See also Mortgage Grader, and see MPEP § 2106.04(a)(2)(III)(C).
Moreover, as discussed above, the claims include additional elements identified above and recited at high level of generality such that the “GUI, clinical data module, imaging data module, ECHO data module, genomic biomarker module” which are recited as an additional element to perform the abstract steps, e.g., the user interface displaying results, as the court found that “collecting information, analyzing it, and displaying certain results of the collection and analysis”, has/have been analyzed under Step 2A, Prong Two as an additional element cited as a tool for implementing claim steps that amounts to no more than mere instructions to implement “apply” the exception using a generic computer component and no more than adding the words "apply it" (or an equivalent) with the judicial exception, see MPEP 2106.04(a)(2)(III)(A), and Electric Power Group v. Alstom. Furthermore, the amended step recited in independent claims such as utilizing a multi-modular system structure, a tree-augmented Naïve Bayes (TAN), and Expectation-Maximization (EM) algorithm which performs a mathematical process and in the present claims is to measure and assess the risk, where the court found “organizing information and manipulating information through mathematical correlations” is a mathematical concepts, Digitech Image Techs., LLC v. Electronics for Imaging, Inc.
Furthermore, the claim(s), as a whole, recites an abstract idea and nowhere the claims nor the specification recite a technical solution improving the functioning of a computer or improves another technology or technical field rather the claimed invention is describing a solution addressing an administrative activity facilitating a tool to support healthcare providers clinical decision that do not concern an improvement in computer capabilities, any improvement to another technology or technical field, or an improvement to the functioning of the computer itself, but instead relate to an alleged improvement in clinical decision, for which a computer is used as a tool in its ordinary capacity, which describes an improvement to for solving a health facility administrative and clinical issue for clinical decision.
On page 7 of the remarks, the Applicant argues “Moreover, the "patient frequency index" provides a specific, unconventional user interface improvement that enhances how model confidence is visualized to a user”, Examiner respectfully disagree. As discussed above, using a GUI to display data, where displaying the “patient frequency index” is considered data to display. There is no description of the alleged “the "patient frequency index" provides a specific, unconventional user interface improvement” is being unconventionally displayed or improving the user interface other than utilized the GUI to perform the function for displaying data.
Therefore, the Examiner has addressed the Applicant argument(s) and found this argument is not found to be persuasive. Hence, Examiner remains the 101 rejections of claims which have been updated to address Applicant's amendments.
Applicant's arguments with respect to the 35 U.S.C. § 102/103 rejection on page 7-8.
In response to the claim amendment and Applicant argues, Examiner withdraws to the prior art rejection as mentioned in the above section “Subject Matter Free of Prior Art”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAAELDIN ELSHAER whose telephone number is (571)272-8284. The examiner can normally be reached M-Th 8:30-5:30.
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687
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