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 25 November 2025, the following occurred:
Claims 1-10 were amended.
Claims 11 and 12 were added.
Claims 1-12 are pending.
Subject Matter Free of Art
Claims 1-12 include subject matter that is free of prior art. The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within independent claims 1, 9, and 10. In particular, the cited prior art fails to expressly teach or suggest the combination of:
acquire 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;
calculate a reward based on at least a variation in the first data and a variation in the second data;
cause the artificial intelligence model to learn policies for the medical procedure based on the reward, wherein the artificial intelligence model is a reinforcement learning model, and the reinforcement learning model includes a value-based neural network or a combination of the value-based neural network and a policy-based neural network;
update the artificial intelligence model through a learning of the policies;
learn at least a value function of the artificial intelligence model based on the reward, the value function being a function representing a value when the medical procedure has been intervened under the state of the patient before intervention of the medical procedure; and
calculate the reward based on a value obtained by subtracting the variation in the second data from the variation in the first data.
The closest prior art Kim et al. (U.S. 2024/0221940) teaches 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; calculating a reward based on at least a variation in the first data and a variation in the second data; causing the artificial intelligence model to learn policies for the medical procedure based on the reward, wherein the artificial intelligence model is a reinforcement learning model, and the reinforcement learning model includes a value-based neural network or a combination of the value-based neural network and a policy-based neural network; updating the artificial intelligence model through a learning of the policies; learning at least a value function of the artificial intelligence model based on the reward, the value function being a function representing a value when the medical procedure has been intervened under the state of the patient before intervention of the medical procedure; and calculating the reward. However, Kim fails to teach calculating the reward based on a value obtained by subtracting the variation in the second data from the variation in the first data.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites, “calculate a reward based on at least a variation in the first data and a variation in the second data... and calculate the reward based on a value obtained by subtracting the variation in the second data from the variation in the first data.” It is unclear whether “the reward,” meaning singular, is calculated once or twice. For examination purposes, this is interpreted to be a single reward, and the latter limitation further defines the first. For this reason, the Examiner suggests changing it to “calculate a reward based on at least a variation in the first data and a variation in the second data, wherein the reward is calculated based on a value obtained by subtracting the variation in the second data from the variation in the first data…”
Claims 1, 9, and 10 recite, “the value function being a function representing a value when the medical procedure has been intervened under the state of the patient before intervention of the medical procedure.” It is unclear how the value function is a value that is simultaneously “before intervention” and “has been intervened upon.” One cannot determine something prior to an act occurring while also requiring the act to have occurred; at least not according the currently-accepted model of Physics. The portions of the Specification asserted to provide support (page 11, lines 17-25, page 15, lines 18-22, page 16, lines 14-20, and page 17, lines 18-21) does not provide clarity. The Examiner cannot provide a suggestion because she does not know what the Applicant is intending to state.
By virtue of their dependence from Claim 1, this basis of rejection also applies to dependent Claims 2-8, 11, and 12.
Claim 6 is further rejected because it is unclear and thus indefinite. Claim 6 recites, “a number of types of medical procedures.” The only mention of a medical procedure before this is in claim 1, which recites, “a medical procedure,” indicating a singular procedure. It is unclear what “a number of types of medical procedures” is referring to. For examination purposes, the number of types of medical procedures is interpreted to be one.
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 1-12 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; calculating a reward based on at least a variation in the first data and a variation in the second data; …learn[ing] policies for the medical procedure based on the reward…; updating… through a learning of the policies; …and calculating the reward based on a value obtained by subtracting the variation in the second data from the variation in the first data, 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 …learning at least a value function… based on the reward, the value function being a function representing a value when the medical procedure has been intervened under the state of the patient before intervention 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. 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.
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. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. 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).
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 element of an artificial intelligence model was 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”). Accordingly, even in combination, these additional elements do not provide significantly more. As such the claim is not patent eligible.
Claims 2-8, 11, 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 8 merely describes determining the medical procedure for intervention and outputs information, which further defines the abstract idea.
Claim 8 further recites an output interface, which is considered to “generally link” under both the practical application and significantly more analysis.
Claim 11 merely describes estimating a probability density function and calculating a variance, 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 not sufficiently amended the claim to overcome the rejection. It remains unclear what “a number of types of medical procedures is referring to when there is only one medical procedure. In the event that Applicant is attempting to claim all medical procedures in existence (which the examiner doubts), the claim would alternately be indefinite because that number changes minute-by-minute and is unascertainable. The rejection is maintained.
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1-12, 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:
…acquir[ing] pre and post intervention medical data, calculat[ing] a reward based on the data, and caus[ing] an artificial intelligence model… to learn policies for the medical procedure based on that reward… Such operations cannot reasonably be performed as mental steps and are not methods of organizing human interactions.
Regarding (a), 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. Applicant's own Specification counters Applicant's argument.
…learning at least a value function of the artificial intelligence model… Such operations cannot reasonably be performed as mental steps and are not methods of organizing human interactions.
Regarding (b), the Examiner has reconsidered the claims based on the present amendment and finds that the identified abstract idea now 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 claimed subject matter therefore integrates the alleged abstract idea into a practical application by requiring a particular machine-learning architecture and a particular manner of model training…
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 particular machine-learning architecture and a particular manner of model training is unpersuasive because the argued details, given the broadest reasonable interpretation in light of the Specification, represent generic 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.”
…the combination of features in independent claims 1, 9, and 10 amounts to significantly more under Step 2B… These steps collectively define a non-conventional and non-routine arrangement for training the claimed reinforcement learning model using the acquired medical data.
Regarding (d), the Examiner respectfully disagrees. MPEP 2106.05(d) states: “Another consideration when determining whether a claim recites significantly more than a judicial exception is whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry (emphasis added).” Further, MPEP 2106.05(I) states: “As made clear by the courts, the novelty of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter (internal quotations omitted, emphasis original).” As such, it is only the additional elements identified by the Examiner to not be part of the abstract idea that are analyzed to determine whether they represent well-understood, routine, conventional activities in the field of the invention.
In that regard, MPEP 2106.05(d)(I) indicates that in determining whether the additional elements represent are well-understood, routine, conventional activities, the Examiner should consider whether the additional elements (1) provide an improvement to the technological environment to which the claim is confined, (2) whether the additional elements are mere instructions to apply the judicial exception, or (3) whether the additional elements represent insignificant extra-solution activity. The additional elements of the claims do not provide significantly more based on this inquiry.
Taking these in turn, whether the additional elements of the claim provide an improvement was analyzed/addressed in the 2A2 analysis. The technological environment to which the claims are confined (a general-purpose computer performing generic computer functions) is recited at a high level of generality and has been found by the courts to be insufficient to provide a practical application (see MPEP 2106.05(d)(II); Alice Corp.).
Finally, none of the additional elements of the claim were found to represent extra-solution activity and thus no well-understood, routine, conventional analysis is required. MPEP 2106.07(a) states “At Step 2A Prong Two or Step 2B, there is no requirement for evidence to support a finding that the exception is not integrated into a practical application or that the additional elements do not amount to significantly more than the exception unless the examiner asserts that additional limitations are well-understood, routine, conventional activities in Step 2B.” This was not asserted. As such, when viewed either individually or as an ordered combination, the additional elements do not provide significantly more to the abstract idea and the claims are not subject matter eligible.
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:
Goldstein (U.S. 2021/0327569) which discloses a system and method for selection and distribution of dietary and nutritional supplements.
Hwang et al. (U.S. 2012/0265591) which discloses systems and methods for resource apportionment.
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 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