DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This Office Action is responsive to the request for continued examination filed June 23, 2025.
Claims 8 and 19-22 have been canceled.
Claims 30-31 have been added.
Claims 2-3, 5-7, 12-13, 15-17 and 23-29 have been amended.
Claims 2-3, 5-7, 10, 12-13, 15-17, 23-31 are pending and have been examined below.
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 2-3, 5-7, 10, 12-13, 15-17, and 23-31 is/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.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a process (claim 23), a machine (claim 29), and an article of manufacture (claim 26) which are recited as methods, systems, and non-transitory computer readable media that perform the steps and/or functions of:
receiving, an artificial intelligence model, an input dataset comprising first data and second data, the second data comprising an initial set of covariate data for a causal effect relationship between at least one action and an outcome, wherein the input dataset comprises patient electronic medical records (EMRs);
executing, by an estimator analyzing the first and second data, an estimation so that a relevant subset of covariates is identified, the relevant subset comprising covariates relevant to the outcome and being smaller than an initial covariate set, wherein the estimator is a joint sparsity estimator comprising a plurality of regression engines;
generating, by the estimator, a modified dataset comprising the subset of relevant covariates and at least a portion of the first data, wherein the modified dataset does not include covariates in the initial set of covariates that are not in the relevant subset;
inputting the modified dataset to the estimator; and
receiving causal effect relationship estimates for causal effects between the at least one action and the outcome from the estimator, wherein the at least one action comprises one or more treatments for a medical condition that may be used to treat the medical condition, wherein the outcome is an effect of the corresponding treatment on a state of the medical condition, and wherein the subset of relevant covariates comprise covariates in the initial set of covariate data that are determined to have a connection to the outcome.
Step 2A: Prong 1
When taken individually and as a whole, the steps corresponds to concepts identified as abstract ideas by the courts, such as “mathematical concepts”, which are mathematical relationships, mathematical formulas or equations, and mathematical calculations (MPEP 2106.04(a)(2).I) and mental processes, which are concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (MPEP 2106.04(a)(2).III).
The claim is directed to a system to perform the process of generating causal effect relationship estimates for specifying causal effects between at least one action and an outcome, which is performed by the system performing the above underlined steps.
This series of steps describes using an estimator to estimate causal effects between an action and an outcome, which is determining a mathematical relationship between two sets of data using mathematical calculations or formulas (see dependent claims 6-7, which show that the broadest reasonable interpretation of the claims includes embodiments where the estimator comprises mathematical formulas and calculations).
Step 2A: Prong 2
The claims do not include additional elements that are sufficient to be considered a practical application because the additional elements amount to: insignificant extra-solution activity (MPEP 2106.05(g)), generally linking the application of the abstract idea to a particular field of use or technological environment (2106.05(h)), or mere instructions to apply it with a computer (MPEP 2106.05(f)), as discussed below.
Insignificant Extra-Solution Activity
The steps of ‘receiving, by an artificial intelligence model, an input data set comprising first and second data…. wherein the input dataset comprises patient electronic medical records (EMRs)’ and ‘inputting the modified dataset to the estimator’ are examples of mere data gathering, which is an insignificant extra-solution activity (MPEP 2106.5(g)).
The steps defining the first data as “comprising first and second data, the second data comprising an initial set of covariate data for a causal effect relationship between at least one action and an outcome” is an example of selecting by type or source the data to be manipulated, which is an insignificant extra-solution activity (MPEP 2106.05(g)).
Insignificant extra-solution activities are not sufficient to integrate the abstract idea into a practical application or cause the claim to amount to significantly more than the abstract idea (MPEP 2106.05(g))
Mere Instructions to Apply the Abstract Idea Using a Computer
The steps reciting the use of computer components, such as the method being “computer-implemented”, steps being performed “by an artificial intelligence model” and “wherein the estimator is a joint sparsity estimator comprising a plurality of regression engines” serve as mere instructions to apply the abstract idea using a computer. Mere instructions to apply the abstract idea using a computer are not sufficient to integrate the abstract idea into a practical application or amount to significantly more than the abstract idea (MPEP 2106.05(f)).
Step 2B
The claims also do not include additional elements that are sufficient to be considered a significantly more than the abstract idea because the additional elements amount to: insignificant extra-solution activity (MPEP 2106.05(g)), mere instructions to apply it with a computer (MPEP 2106.05(f)), generally linking the application of the abstract idea to a particular field of use or technological environment (MPEP 2106.05(h)), or a well-understood, routine, and conventional limitation (MPEP 2106.05(d)), as discussed below.
The steps addressed above in Step 2A: Prong 2, when considered again under Step 2B are not considered to make the claims amount to significantly more than the abstract idea because those steps, when considered additionally with regards to Step 2B, are still considered to be either insignificant extra-solution activity, mere instructions to apply an abstract idea with a computer, or generally linking the application of the abstract idea to a particular field of use or technological environment, which are types of limitations that are not sufficient to make the claims amount to significantly more than the abstract idea (MPEP 2106.05.I.A).
The steps recited as either being part of the abstract idea or insignificant extra-solution activity are all examples of at least one of: storing and retrieving data from a memory (receiving the input data if the data is accessed locally), sending and receiving data over a network (receiving the input data if the data is received from an external device), electronic recordkeeping, or performing repetitive calculations. All of those functions have been identified as well-understood, routine, and conventional functions of a generic computer that are not significantly more than the abstract idea when claimed broadly or as an extra-solution activity (MPEP 2106.05(d).II).
The recited computer components (e.g., at least one processor, at least one memory, and computer-readable storage medium) are all generically recited components (see specification, par. [0027]-[0031]). Commercially available components, generic computer components, and specially-programmed computer components performing the functions of a generic computer are not considered to be amount to significantly more than the abstract idea (MPEP 2106.05(b)).
When considered as a whole, the components do not provide anything that is not present when the component parts are considered individually. Using the broadest reasonable interpretation, the system as a whole is a general purpose computer system receiving data and analyzing the data using a mathematical model. This is a general purpose computer performing the abstract idea and insignificant extra-solution activities through these generically described devices performing well-understood, routine, and conventional functions of a generic computer (MPEP 2106.05(d).II).
Dependent Claim Analysis
Claims 2-3, 5-7, 10, and 24-25 are ultimately dependent from Claim(s) 23 and includes all the limitations of Claim(s) 23. Therefore, claim(s) 2-3, 5-7, 10, and 24-25 recite the same abstract idea as claim 23.
Claims 2-3, 5-7, and 24-25 all recite additional limitations that further describe the abstract idea by providing further details regarding the mathematical model used to generate the estimated causal relationship. Steps that are part of the abstract idea cannot be additional elements that are able to integrate the abstract idea into a practical application or amount to significantly more than the abstract idea (see MPEP 2106.04.II.A.2, 2106.05(a)
Claim 10 recites additional limitations that amount to necessary data outputting because they recite outputting the results of the estimator to another system for further processing, but there is no positive recitation of the other system being a part of the present system or a description of what that further processing would be beyond a broad recitation. Necessary data outputting is a type of insignificant extra-solution activity that is not sufficient to integrate the abstract idea into a practical application or amount to significantly more than the abstract idea (MPEP 2106.05(g)).
Claims 12-13, 15-17, and 27-28 are ultimately dependent from Claim(s) 26 and includes all the limitations of Claim(s) 26. Therefore, claim(s) 12-13, 15-17, and 27-28 recite the same abstract idea as claim 26.
Claims 12-13, 15-17, and 27-28 recite additional limitations that are the same or substantially similar to the limitations of claims 2-3, 5-7, and 24-25, respectively. Therefore, claims 12-13, 15-17, and 27-28 are rejected under 101 for the same reasons.
Claims 30-31 recite additional limitations that are the same or substantially similar to the limitations of claims 2-3 respectively. Therefore, claims 30-31 are rejected under 101 for the same reasons.
Response to Arguments
101 Rejections
Applicant's arguments filed June 23, 2025, have been fully considered but they are not persuasive.
With respect to the Applicant’s arguments that the claims are eligible under 35 USC 101, these arguments are not persuasive.
Firstly, the Applicant asserts that independent claims 23, 26 and 29, as amended do not recite a mental process because “receiving, by an artificial intelligence model, an input dataset”, and “executing, by an estimator analyzing the first and second data, and estimation” cannot be practically performed in the human mind outside of a technical environment, citing paragraph 37 of the specification.
Examiner disagrees. Per MPEP 2106.04(a)(2)(III), [t]he courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper” to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed “conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally,” i.e., “as a person would do it by head and hand.”); Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, “[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind.” Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").
The claimed steps are similar to a concept held by the courts as reciting a mental process: a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016)
Per MPEP 2106.04(a)(2)(III))(C), claims can recite a mental process even if they are claimed as being performed in a computer. The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea. 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.
In evaluating whether claim 23 requires a computer recites a mental process, the broadest reasonable interpretation of the claim in light of the specification has been considered to determine if the claimed invention is described as a concept that is performed in the human mind and applicant is merely claiming that concept performed 1) on a generic computer, or 2) in a computer environment, or 3) is merely using a computer as a tool to perform the concept.
The examiner finds this to be the case in claim 23, and as such, the claim is considered to recite a mental process. Claim 23 recites an input dataset that comprises electronic medical records that are received by an artificial intelligence model, and an estimator that comprises a plurality of regression engines. The medical records being electronic in nature and the AI model being used as the mechanism to receive the input dataset is mere confinement to a computer environment, and the estimator comprising regression engines (e.g., computer hardware or software per paragraph 24) is indicative of the computer being used as a tool.
Secondly, the Applicant argues that the amended claims integrate the alleged judicial exception into a practical application because the claimed invention set forth in claim 23 is directed to improving detection accuracy in the technical field of supervised models for machine learning, citing paragraphs 21, 22 and 37 of the specification.
Specifically, applicant argues that existing healthcare decision-making support computing tools do not provide sufficient solutions for handling the voluminous amount of data and large number of covariates, and as a result, either feature selection for identifying a subset of relevant covariates within large datasets is either not performed or only limited simple feature selection is performed. Applicant asserts that the claimed improved computing tool is able to intelligently identify the covariates that are actually relevant to a causal effect relationship and include in the information processed by causal effect estimates only those covariates that are determined to be relevant to the causal effect relationship, improving accuracy and performance of the causal effect estimator computing tools as a result.
Examiner disagrees. The volume and magnitude of data and covariates is not claimed, nor is it described in the specification as a challenge or problem that the claimed invention solves. Furthermore, the steps of “identifying the covariates relevant to a causal effect relationship” and “including in the information processed by causal effect estimates only those covariates that are determined to be relevant to the causal effect relationship” have been determined to be part of the abstract idea. The claimed improvement is within the abstract idea. These mathematical techniques are not a technical solution to a technical problem, nor do their use constitute an improvement to the functioning of the computer, computer/computing tool or any other technology.
Furthermore, with the regard to the additional elements of the claim, the claims do not articulate how the artificial intelligence model used to receive input datasets, the electronic medical records or regression engines themselves would integrate the identified abstract idea into a practical application. There is no improvement to the functioning of these elements themselves, or an improvement to technology or technical field as discussed in MPEP 2106.04(d)(1) and 2106.05(a), and does not apply or use the judicial exception in any meaningful way beyond generally linking the use of the judicial exception to a particular technological environment as discussed in MPEP 2106.05(e). Instead, the additional elements are utilized more akin to an “apply it” manner, adding insignificant extra-solution activity to the abstract idea and generally link the abstract idea to a particular technological environment or field of use, in line with MPEP 2106.05(f)-(h).
For at least the foregoing reasons, the arguments based on the assertion that the claims do not recite a judicial exception, and integrate the judicial exception into a practical application is not persuasive, and the 101 rejection will be sustained.
Conclusion
THIS ACTION IS MADE FINAL. 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 PETER H CHOI whose telephone number is (469)295-9171. The examiner can normally be reached M-F 930am-6pm.
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/PETER H CHOI/ Supervisory Patent Examiner, Art Unit 3681
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