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 .
DETAILED ACTION
In the Amendment dated 29 April 2026, the following occurred:
Claims 1, 6, 9, and 10 were amended.
Claims 8 and 11 were canceled.
Claims 1-7, 9, 10, and 12 are pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7, 9, 10, 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, 9, and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite a device, method, and storage medium for supporting selection of a treatment or examination suitable for a patient and therefore meet step 1.
Step 2A1
The limitations of (Claim 9 being representative) acquiring first data indicating a state of a patient before intervention of a medical procedure related to a predetermined disease, and second data indicating a state of the patient after intervention of the medical procedure; […]; …learn[ing] policies for the medical procedure based on the reward…; updating… through a learning of the policies; […] determining the medical procedure for intervention on a target patient based on third data indicating a state of the target patient before intervention of the medical procedure…; and outputting information based on the determined medical procedure…, the information based on determined medical procedure including a first medical procedure for which the value is maximized, and a second medical procedure for which the value is lower than that of the first medical procedure, as drafted, is a process that, under the broadest reasonable interpretation, falls in the grouping of certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions).
The limitations of calculating a reward based on a value obtained by subtracting a variation in the second data and a variation in the first data, wherein the variation in the first data and the variation in the second data are each calculated by estimating probability density functions of missing examination values in the first data and the second data from available examination values…; …learning at least a value function… based on the reward, the value function being a function that maps a state of the patient and a medical procedure to a value representing an expected outcome of the medical procedure, as drafted, is a process that, under the broadest reasonable interpretation, covers mathematical concepts but for recitation of generic computer components. The types of identified abstract ideas are considered together as a single abstract idea for analysis purposes.
That is, other than reciting a device, method, and storage medium, the claimed invention amounts to managing personal behavior or interaction between people and mathematical concepts. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people and/or covers mathematical calculations but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” and/or “mathematical concept” grouping(s) of abstract ideas. The types of identified abstract ideas are considered together as a single abstract idea for analysis purposes. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of a computer/processing circuitry (claims 1, 9, and 10) and a non-transitory storage medium (claim 10) that implement the identified abstract idea. The computing elements are not exclusively described by the applicant and are recited at a high-level of generality (i.e., generic computer components) such that it amounts to no more than mere instructions to apply the exception using a generic computer or components thereof.
The claim further recites the additional element of using a trained conversion model to estimate probability density functions. The Examiner notes that the trained conversion model is described in the Specification as encompassing a machine learning model, a statistical model, a rule-based model, or a combination thereof. The machine learning model may be a neural network, a support vector machine, a decision tree, a naive Bayes classifier, a random forest, or the like. This represents mere instructions to implement the abstract idea on a generic computer. Implementing an abstract idea using a generic computer or components thereof does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. See, e.g., Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437 at 10 (Fed. Cir. April 18, 2025) (finding that claims that do no more than apply established methods of machine learning to a new data environment are ineligible). Alternatively, or in addition, the implementation of the machine learning model to the medical data merely confines the use of the abstract idea (i.e., the trained model) to a particular technological environment or field of use (the noted types of ML) and thus fails to add an inventive concept to the claims.
The claims recite the additional element of an artificial intelligence (AI) model. The utilization of an artificial intelligence model represents an “apply it” step. MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application. Further, acquiring data is considered insignificant extra solution activity such as pre-solution activity e.g., data gathering (performed by receiving/transmitting/etc.) See MPEP 2106.05(g).
The claim further recites the additional element of an output interface. The output interface merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, 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.
Step 2B
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 element of using a computer to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component cannot provide an inventive concept (“significantly more”).
As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a trained conversion model and an artificial intelligence model were found to be “apply it.” This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP2106.05(I)(A) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide an inventive concept (“significantly more”).
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of an output interface was determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. As such, the claim is not patent eligible. Accordingly, even in combination, these additional elements do not provide significantly more. As such the claim is not patent eligible.
Claims 2-7 and 12 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim 2 merely describes the first data and the second data, which further defines the abstract idea.
Claim 3 merely describes estimating a first missing examination value and variation, and a second missing examination value and variation, which further defines the abstract idea.
Claims 4-7 merely describe calculating the reward, which further defines the abstract idea.
Claim 12 merely describes causing the value-based neural network to learn the value function, which further defines the abstract idea.
The value-based neural network is part of the artificial intelligence model, which was considered to “apply it” under both the practical application and significantly more analysis.
Response to Arguments
Rejection under 35 U.S.C. § 112
Regarding the indefiniteness rejection of Claim 6, the Applicant has amended the claim to overcome the basis of rejection. The rejection has been withdrawn.
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1-7, 9, 10, and 12, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons. Applicant argues:
The claimed invention… performs a specific transformation of incomplete medical data into probabilistic representations and derived statistical measures…
Regarding (a), the Examiner respectfully disagrees. MPEP 2106.04(d)(2) indicates that a practical application may be present where the claimed invention effects a transformation or reduction of a particular article to a different state or thing. MPEP 2106.05(c) thereafter describes that a transformation is present where a physical object or substance is transformed to a different state or thing. Notably, the mere manipulation of data has been deemed not to be a transformation within the meaning of the term “transformation.” See MPEP 2106.05(c): “mere manipulation of basic mathematical constructs i.e., the paradigmatic abstract idea, has not been deemed a transformation” (internal quotations omitted). Because no transformation is present in Applicant’s claimed invention, a practical application is not present.
…the claims do not recite a method of organizing human activity or a mental process. The claimed operations require probabilistic modeling, estimation of missing data, and statistical computation that cannot be practically performed in the human mind…
Regarding (b), the Examiner respectfully disagrees. Whether a claim or a portion of a claim can be performed mentally does not remove it from being characterized as Certain Methods of Organizing Human Activity (CMOHA). A mental step may be part of the rules or instructions that a person follows under CMOHA. However, the Examiner did not assert that any portion of the abstract idea was a mental process, so the Examiner is unclear what the Applicant is arguing. The Specification at Page 1, Line 18-20 describes the functions performed in the abstract idea as human activities. The claimed invention describes a series of rules or steps for a person to follow. Applicant's own Specification counters Applicant's argument.
Further, the Examiner determined in the previous Action that the identified abstract idea represents Mathematical Concepts, as necessitated by amendment. It is a series of mathematical calculations to “support[…] selection of a treatment or examination suitable for a patient.”
The claims… recite a specific architecture… [T]he claimed invention provides a technical improvement over conventional systems…
Regarding (c), the Examiner respectfully disagrees. Per Example 47, Claim 2, the training of a particular machine learning (“ML”) or artificial intelligence (“AI”) model (ANN in the case of Ex. 47) may fall under the abstract idea of a mathematical concept where, given the broadest reasonable interpretation in light of the Specification, the training merely represents mathematical calculations performed on data. Here, Applicant’s Specification describes the training of the model as calculating a gradient and learning parameters of a value function, which the Examiner interprets as merely performing mathematical calculations to arrive at a trained AI model.
The use of the trained ML/ANN model in Example 47, Cl. 2 thereafter represents the application of this abstract idea (“apply it”) on a generic computer. This is because the use of the trained ML/AI in the claims does not place any limits on how the trained ML/AI functions. Where “the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished” (see MPEP 2106. 05(f)). Put another way, where the use of trained ML/AI in a claim does not recite how its functions are actually performed and are merely recited at a high, non-inventive level, the ML/AI itself represents the application of a mathematical concept because no improvement to the ML/AI is claimed. Applicant’s argument that the claims recite a specific architecture is unpersuasive because the argued details, given the broadest reasonable interpretation in light of the Specification, represent generic ML/AI functionality. Applicant is also directed to Recentive Analytics, Inc. v. Fox Corp. which stated that non-specifically claimed training of an AI/ML algorithm is insufficient to provide a practical application or significantly more because it does not result in “improving the mathematical algorithm or making machine learning better.”
Finally, “a technical improvement over conventional systems” is not one of the tests for a practical application or significantly more. If it were, the claims at issue in the Alice Corp. decision would have been eligible.
…medical data often includes missing examination values, and the invention addresses this technical problem… This coordinated interaction between distinct models defines a specific technological implementation…
Regarding (d), the Examiner respectfully disagrees. MPEP 2106.04(d) states that one way in which a claimed abstract idea may be subject matter eligible under prong 2A2 is if the claimed invention solves a described technological problem. Example 42 is an illustration of this. The Specification of Example 42 describes a technical problem (i.e., a problem caused by the technology): the technological implementation of software formats made it difficult to share updated health information. The claimed invention then solved this problem (a technical solution) by providing a message and access to updated real-time data that has been converted to a standardized format, thus integrating the abstract idea into a practical application. Unlike Example 42, Applicant has not identified nor can the Examiner locate any technical problem that the claimed invention is solving. At best, the problem(s) described in the as-filed disclosure are medical problems.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Quan et al. (U.S. 2021/0280078) which discloses a method and system for remotely coaching a set of participants.
Fotsch et al. (U.S. 2019/0252049) which discloses methods and apparatuses for providing alternatives for preexisting prescribed medications.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAMRYN B LEWIS whose telephone number is (703)756-1807. The examiner can normally be reached Monday - Friday, 11:00 am - 8:00 pm EST.
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/CAMRYN B LEWIS/
Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
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