DETAILED ACTION
This action is made in response to the amendments filed on October 10, 2025. This action is made final.
Claims 1, 3, 4, 6, 7, and 12 are pending. Claims 2, 5, and 8-11 have been cancelled. Claims 1, 3, 4, 6, and 7 have been amended. Claims 12 is newly added. Claims 1 and 12 are independent claims.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments filed October 10, 2025 have been fully considered. Applicant’s arguments with respect to the previous 102 rejection is moot in light of the new grounds of rejection.
Applicant argues the claims integrate the abstract idea into a practical application that determines and displays risk score values associated with the patient surviving within a given time period. However, the examiner respectfully disagrees.
Applicant has not identified, nor has the examiner found, any limitations which are indicative of integration into a practical application. Applicant’s assertion that all the claims integrate the abstract idea into a practical application that determines and displays risk score values associated with the patient surviving within a given time period is not persuasive. Determining and displaying risk score values associated with the patient surviving within a given time period is not a recognized consideration for limitations that are indicative of integrations into a practical application as per MPEP 2106.05. Notably, determining and display risk score values associated with the patient surviving within a given time period falls within the human interaction subgroup “managing personal behavior or relationships or interactions between people” which includes a series of steps a person would follow to determine and display risk score values associated with the patient. Furthermore, the October 2019 updated: Subject Matter Eligibility at Pg. 5 further states that certain activities between a person and a computer may fall within the “certain methods of organizing human activity” grouping. Under the broadest reasonable interpretation, the limitations of the claims can be performed by a person with or without the use of a computer. Accordingly, the claims are directed towards and abstract idea and the previous 101 rejection is maintained.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 4, 6, 7, and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 3, 4, 6, and 7 recite a system for generating a risk score, which is within the statutory category of a machine. Claim 12 recites a method for generating a risk score, which is within the statutory category of a machine.
Claims are eligible for patent protection under § 101 if they are in one of the four statutory categories and not directed to a judicial exception to patentability. Alice Corp. v. CLS Bank Int'l, 573 U.S. ___ (2014). Claims 1, 3, 4, 6, 7, and 12, each considered as a whole and as an ordered combination, are directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
MPEP 2106 Step 2A – Prong 1:
The bolded limitations of:
Claims 1 and 12 (claim 1 being representative)
a processor; a memory having instructions stored thereon; wherein execution of the instructions by the processor causes the processor to execute a method comprising: 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, 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 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 first set of input variables; receiving, from the user device, the second set of input variable data provided 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 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.
as presently drafted, under the broadest reasonable interpretation, covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for the recitation of generic computer components. For example, but for the noted computer elements, the claim encompasses a person following rules or instructions to collect and process data to calculate a patient’s risk score in the manner described in the abstract idea. The examiner further notes that “methods of organizing human activity” includes a person’s interaction with a computer (see October 2019 Update: Subject Matter Eligibility at Pg. 5). If the claim limitation, under its broadest reasonable interpretation, covers managing persona behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
MPEP 2106 Step 2A – Prong 2:
This judicial exception is not integrated into a practical application because there are no meaningful limitations that transform the exception into a patent eligible application. The additional elements merely amount to instructions to apply the exception using generic computer components (“processor”, “a memory”, “database”, “graphical user interface”, “user device” —all recited at a high level of generality). Although they have and execute instructions to perform the abstract idea itself, this also does not serve to integrate the abstract idea into a practical application as it merely amounts to instructions to "apply it." (See MPEP 2106.04(d)(I) indicating mere instructions to apply an abstract idea does not amount to integrating the abstract idea into a practical application). Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea. Therefore, the claims are directed to an abstract idea.
The ”electronic” medical records is not a generic computer component; however it is recited at a high levels of generality and similarly amount to generally linking the abstract idea to a particular technological environment. (See MPEP 2106.04(d)(I) indicating generally linking an abstract idea to a particular technological environment does not amount to integrating the abstract idea into a practical application).
The claims only manipulate abstract data elements into another form. They do not set forth improvements to another technological field or the functioning of the computer itself and instead use computer elements as tools in a conventional way to improve the functioning of the abstract idea identified above. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. 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. None of the additional elements recited "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Alice Corp., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)).
At the levels of abstraction described above, the claims do not readily lend themselves to a finding that they are directed to a nonabstract idea. Therefore, the analysis proceeds to step 2B. See BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1349 (Fed. Cir. 2016) ("The Enfish claims, understood in light of their specific limitations, were unambiguously directed to an improvement in computer capabilities. Here, in contrast, the claims and their specific limitations do not readily lend themselves to a step-one finding that they are directed to a nonabstract idea. We therefore defer our consideration of the specific claim limitations’ narrowing effect for step two.") (citations omitted).
MPEP 2106 Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the same reasons as presented in Step 2A Prong 2. Moreover, the additional elements recited are known and conventional generic computing elements (“processor”, “a memory”, “database”, “graphical user interface”, “user device” -- see Specification Fig. 1, [0045], [0194]-[0201] describing the various components as general purpose, common, standard, known to one of ordinary skill, and at a high level of generality, and in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy the statutory disclosure requirements). Therefore, these additional elements 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 that amounts to significantly more. See MPEP 2106.05(f).
Furthermore, as discussed above, the additional element of a “electronic” medical records is recited at high levels of generality and were determined to generally link the abstract idea into a particular technological environment or field of use. This additional element have been re-evaluated under step 2B and have also been found insufficient to provide significantly more. (See MPEP 2106.05(A) indicating generally linking an abstract idea to a particular technological environment does not amount to significantly more). Furthermore, the Background section of Applicant' s Specification (e.g., see [0109]) indicates that electronic health record integration is well-understood, routing, and conventional in the field. (See MPEP 2106.05(I)(A) indicating that well-understood, routine, and conventional activities cannot provide significantly more)
The Federal Circuit has recognized that "an invocation of already-available computers that are not themselves plausibly asserted to be an advance, for use in carrying out improved mathematical calculations, amounts to a recitation of what is 'well-understood, routine, [and] conventional.'" SAP Am., Inc. v. InvestPic, LLC, 890 F.3d 1016, 1023 (Fed. Cir. 2018) (alteration in original) (citing Mayo v. Prometheus, 566 U.S. 66, 73 (2012)). Apart from the instructions to implement the abstract idea, they only serve to perform well-understood functions (e.g., receiving, translating, and displaying data—see Specification above as well as Alice Corp.; Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307 (Fed. Cir. 2016); and Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334 (Fed. Cir. 2015) covering the well-known nature of these computer functions).
Dependent Claims
The limitations of dependent but for those addressed below merely set forth further refinements of the abstract idea without changing the analysis already presented. Claims 3, 4, 6 merely recites calculating a risk score with a chance of survival, different variable, and for different diseases, which covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions).
Claim 7 further refine the abstract idea described in the independent claim and merely recite the use of one or more neural networks. The use of an existing neural network model provides nothing more than mere instructions to implement the abstract idea on a generic computer (“apply it”) under both the practical application and significantly more analysis, supra. July 2024 Subject Matter Eligibility Examples, Example 47, Claim 2, discussion of item (c) at Pgs. 7-9. See MPEP 2106.05(f). MPEP 2106.05(f); July 2024 Subject Matter Eligibility Examples, Example 47, Claim 2, discussion of items (d) and (e) at Pgs. 8-9.
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.
Claim(s) 1, 3, 6, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (USPPN: 2025/0253050; hereinafter Kim) in further view of Covington et al. (USPPN: 2022/0285032; hereinafter Covington).
As to claim 1, Kim teaches A clinical decision support system (e.g., see Title, Abstract) comprising:
a processor (e.g., see Fig. 2);
a memory having instructions stored thereon (e.g., see Fig. 2); and
wherein execution of the instructions by the processor causes the processor to execute a method comprising:
receiving, from a database, a first set of input variable data of a set of input variables (e.g., see Figs. 3, 5, [0033], [0041], [0044] wherein data from a plurality of sources are retrieved);
determining, via one or more pulmonary arterial hypertension risk algorithms, a first set of risk score values associated with a patient within a given time period using electronic medical records from the first set of input variable data for one or more time instances (e.g., see Figs. 7-9, [0035], [0041], [0048], [0054], [0055] teaching one or more algorithms to make risk predictions on current and future health states based on the received data within a given time, including pulmonary arterial hypertension);
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 (e.g., see Figs. 7-9, [0054], [0055] teaching displaying the patient’s risk predictions within a given time period as a visualized graph);
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 of the first set of input variables (e.g., see Figs. 7-9, [0051]-[0052] wherein a user can filter the data to visualize the patient’s risk prediction based on a subset of the data, such as a reference population similar to the patient);
receiving, from the user device, the second set of input variable data provided through the graphical user interface (e.g., see Figs. 7-9, [0052] wherein a user can select the data through the displayed visualization);
determining, via the one or more pulmonary arterial hypertension risk algorithms, a second set of risk score values associated with the patient within the given time period using the second set of input variable data instances (e.g., see Figs. 7-9, [0035], [0041], [0048], [0051], [0054], [0055] teaching one or more algorithms to make risk predictions, such as for risk of pulmonary arterial hypertension, on current and future health states based on the received/inputted data within a given time, wherein the user can modify/filter the inputted 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 e.g., see Figs. 7-9, [0048], [0051]-[0052], [0054], [0055] teaching displaying the patient’s risk predictions within a given time period as a visualized graph, wherein a user can filter the data to visualize the patient’s risk prediction based on a subset of the data, such as a reference population similar to the patient, wherein the graphs can be concurrently displayed).
While Kim teaches determining and displaying a patient’s risk prediction for a disease, including pulmonary arterial hypertension, including critical events within a given time period, Kim fails to explicitly teach the risk score being associated with the patient surviving.
However, in the same field of endeavor of patient diagnosis, Covington teaches risk score associated with a patient surviving within a given time period (e.g., see Fig. 10, [0029], [0145]-[0150] describing various risk scores corresponding to different survival rates percentages over a span of 0-5 years).
Accordingly, it would have been obvious to modify Kim in view of Covington, before the effective filing date of the present invention, with a reasonable expectation of success. One would have been motivated to make the modification to aid in the determination of a risk score by factoring in survival rates (e.g., see [0002]-[0004] of Covington).
As to claim 3, the rejection of claim 2 is incorporated. Kim-Covington teach wherein the first and/or second risk score value is categorized into low risk (>95% chance of survival in 1 year), medium risk (%95-%90 chance of survival in 1 year), high risk (<90% chance of survival in 1 year) (e.g., see [0037], [0038], [0054] of Kim teaching various risk scores within a period of time, including various ranges for high/medium/low risk groups. See also Fig. 10, [0029], [0145]-[0150] of Covington describing various risk scores corresponding to different survival rates percentages over a span of 0-5 years. See also MPEP 2144.05 wherein where the claimed ranges overlap or lie within ranges disclosed by the prior art, a prima facie case of obviousness exists).
Accordingly, it would have been obvious to modify Kim in view of Covington with a reasonable expectation of success. One would have been motivated to make the modification to aid in the determination of a risk score by factoring in survival rates (e.g., see [0002]-[0004] of Covington).
As to claim 6, the rejection of claim 1 is incorporated. Kim further teaches further comprising calculating the influence of the set of input variable data on the associated risk score value (e.g., see Fig. 7, [0051] wherein a user can modify the input filters and the corresponding risk score value is updated based on the modified filters).
As to claim 8, the rejection of claim 1 is incorporated. Kim further teaches wherein the risk algorithm is one of a plurality of risk algorithms, each associated with a different disease area (e.g., see [0035], [0041], [0045] wherein one or more algorithms may be used to determine one or more diseases/conditions).
As to claim 12, the claim is directed to the method implemented on the system of claim 1 and is similarly rejected.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Covington, as applied above, and in further view of McNair (USPN: 12,020,814; hereinafter McNair).
As to claim 4, the rejection of claim 1 is incorporated. Kim-Covington fail to teach further comprising a lookup table of clinical treatment guidelines for the disease area
However, in the same field of endeavor of clinical support systems, McNair further teaches further comprising a lookup table of clinical treatment guidelines for the disease area (e.g., see 17:32-62 wherein recommended treatments for treating the at risk condition is maintained and determined).
Accordingly, it would have been obvious to modify Kim-Covington in view of McNair with a reasonable expectation of success. One would have been motivated to make the modification to help guide a physician develop a treatment plan (e.g., see [0002] of McNair).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Covington, as applied above, and in further view of Cheng et al. (“Comparing Bayesian Network Classifiers”; hereinafter Cheng).
As to claim 7, the rejection of claim 1 is incorporated. Kim further teaches wherein one of the risk algorithm comprises an ensemble of one or more Bayesian (neural) networks (e.g., see [0041] wherein the algorithms can include one or more neural networks, including a Bayesian model).
While Kim teaches the use of one or more neural networks, including Bayesian networks, McNair fails to explicitly teach wherein the one or more Bayesian networks are tree-augmented Naive Bayes (TAN) networks.
However, in the same field of endeavor of neural networks, Cheng teaches Bayesian networks are tree-augmented Naive Bayes (TAN) networks (e.g., see section 3.2: tree augmented naïve-bayes). Accordingly, it would have been obvious to modify Kim in view of Chen, before the effective filing date of the present invention, with a reasonable expectation of success. One would have been motivated to modify the neural network as taught in Kim with that taught in Cheng as a simple substitution of one known type of neural network for another yielding the predictable solution to improve prediction accuracy (e.g., see section 4.2: results of Cheng).
It is noted that any citation to specific pages, columns, lines, or figures in the prior art references and any interpretation of the references should not be considered to be limiting in any way. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). Further, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STELLA HIGGS whose telephone number is (571)270-5891. The examiner can normally be reached Monday-Friday: 9-5PM.
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/STELLA HIGGS/Primary Examiner, Art Unit 3681