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 for the 18/323640 application is in response to the communications filed February 13, 2026.
Claims 1, 8, and 15 were amended February 13, 2026.
Claims 3, 10 and 17 were cancelled February 13, 2026.
Claims 1, 2, 4, 5, 7-9, 11, 12, 14-16, 18 and 19 are currently pending and considered 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 1, 2, 4, 5, 7-9, 11, 12, 14-16, 18 and 19 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.
As per claim 1,
Step 1: The claim recites subject matter within a statutory category as a process.
Step 2A is a two-prong inquiry, in which Prong 1 determines whether a claim recites a judicial exception. Prong 2 determines if the additional limitations of the claim integrates the recited judicial exception into a practical application. If the additional elements of the claim fail to integrate the judicial exception into a practical application, claim is directed to the recited judicial exception, see MPEP 2106.04(II)(A).
Step 2A Prong 1: The claim contains subject matter that recites an abstract idea, with the steps of a method of using a classification model to calculate a cumulant-based risk score corresponding to a disease risk via analysis of medical records from different domains to calculate continuous variables corresponding to disease risk for an individual in situations involving increasing amounts of testing and associated medical data, the method comprising: detecting multimodal input data associated with an individual, the multimodal input data spanning across a plurality of domains and involving higher dimension interactions, the multimodal input data comprising multi-modal binary, categorical and continuous variables; extracting interpretable variables from the detected multimodal input data, interpretable variables corresponding to any features extracted from the multimodal input data which may be related to a probability of the individual experiencing a specific disease or medical outcome; computing meta-features from the interpretable variables by identifying cumulant-based redescription groups, the cumulant-based redescription groups including higher-order cumulants providing additional information about shape and properties of distributions to identify observations in medical records of other patients that share similar distribution properties; calculating effect sizes for each of the computed meta-features with respect to a target medical outcome; and based on the calculated effect sizes for each of the computed meta-features, computing a summation of the effect sizes in a hold-out data set with cross-validation to generate a cumulant-based risk score corresponding to the target outcome for the individual, the cumulant-based risk score obtained by employing a classification model. These steps, as drafted, under the broadest reasonable interpretation are directed to:
certain methods of organizing human activity (e.g., fundamental economic principles or practices including: hedging; insurance; mitigating risk; etc., commercial or legal interactions including: agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations; etc., managing personal behavior or relationships or interactions between people including: social activities; teaching; following rules or instructions; etc.) but for recitation of generic computer components. That is, other than reciting steps as performed by the generic computer components, nothing in the claim element precludes the step from being directed to certain methods of organizing human activity. The identified abstract idea, law of nature, or natural phenomenon identified above, in the context of this claim, encompasses a certain method of organizing human activity, namely managing personal behavior or relationships or interactions between people. This is because each of the limitations of the abstract idea recite a list of rules or instructions that a human person can follow in the course of their personal behavior. If a claim limitation, under its broadest reasonable interpretation, covers at least the recited methods of organizing human activity above, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. See MPEP 2106.04(a).
Step 2A Prong 2: The claim does not recite additional elements that integrate the judicial exception into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception, see MPEP 2106.05(f), such as:
“computer-based”, “electronic”, “to improve an ability of computers”, “electronic medical records in”, and “self-assessing a confidence of the model to determine how well the calculated cumulant-based risk scores fit medical outcomes” which corresponds to merely using a computer as a tool to perform an abstract idea. Paragraph [0018] of the as-filed specification describes that the computer that implements the abstract idea amounts to a generic computer. Implementing an abstract idea on a generic computer, does not integrate the abstract idea into a practical application in Step 2A Prong Two or add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
add insignificant extra-solution activity to the abstract idea, see MPEP 2106.05(g), such as:
“displaying to a user the calculated cumulant-based risk scores related to medical outcomes in real-time” which corresponds to mere data gathering and/or output.
Accordingly, this claim is directed to an abstract idea.
Step 2B: The claim does not recite additional elements that amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, identified as insignificant extra-solution activity to the abstract idea, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as:
computer functions that have been identified by the courts as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity, see MPEP 2106.05(d)(II), such as:
“displaying to a user the calculated cumulant-based risk scores related to medical outcomes in real-time” which corresponds to receiving or transmitting data over a network.
Looking at the limitations of the claim 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 recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 2,
Claim 2 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“further comprising: calculating an area under a curve to calculate phenotypic variance explained by the cumulant-based risk scores with respect to the target medical outcome” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim 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 recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 4,
Claim 4 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 4 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“further comprising: generating a distribution which plots the cumulant-based risk scores against a population density variable” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim 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 recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 5,
Claim 5 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 5 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein extracting the interpretable variables from the detected multimodal input data further comprises: extracting the interpretable variable using at least one of a regression and a chi square distribution” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim 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 recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 7,
Claim 7 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 7 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the employed classification model is a logistic regression” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim 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 recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 8,
Claim 8 is substantially similar to claim 1. Accordingly, claim 8 is rejected for the same reasons as claim 1.
As per claim 9,
Claim 9 is substantially similar to claim 2. Accordingly, claim 9 is rejected for the same reasons as claim 2.
As per claim 11,
Claim 11 is substantially similar to claim 4. Accordingly, claim 11 is rejected for the same reasons as claim 4.
As per claim 12,
Claim 12 is substantially similar to claim 5. Accordingly, claim 12 is rejected for the same reasons as claim 5.
As per claim 14,
Claim 14 is substantially similar to claim 7. Accordingly, claim 14 is rejected for the same reasons as claim 7.
As per claim 15,
Claim 15 is substantially similar to claim 1. Accordingly, claim 15 is rejected for the same reasons as claim 1.
As per claim 16,
Claim 16 is substantially similar to claim 2. Accordingly, claim 16 is rejected for the same reasons as claim 2.
As per claim 18,
Claim 18 is substantially similar to claim 4. Accordingly, claim 18 is rejected for the same reasons as claim 4.
As per claim 19,
Claim 19 is substantially similar to claim 5. Accordingly, claim 19 is rejected for the same reasons as claim 5.
Subject Matter Free of Prior Art
Claims 1, 2, 4, 5, 7-9, 11, 12, 14-16, 18 and 19 contain subject matter that is free of prior art. The Examiner has conducted a thorough search of the prior art and could not find a single reference, or combination of references with suitable rationale to combine, to teach the limitation of “based on the calculated effect sizes for each of the computed meta-features, computing a summation of the effect sizes in a hold-out data set with cross-validation to generate a cumulant-based risk score corresponding to the target outcome for the individual” as taught by claim 1. Claims 8 and 15 recite similar limitations. The closest prior art that the Examiner was able to find was:
Bose et al. (US 2023/0132849; herein referred to as Bose): which teaches the generation of a cumulant-based continuous variable, detecting multimodal input data associated with an individual, extracting interpretable variables from the detected multimodal input data, computing meta-features from the interpretable variables by identifying cumulant-based redescription groups and calculating effect sizes for each of the computed meta-features with respect to a target outcome. However, Bose is deficient in teaching computing a summation of the effect sizes in a hold-out data set with cross-validation, based on the calculated effect sizes for each of the computed meta-features, to generate a cumulant-based risk score corresponding to the target outcome for the individual
Zamft et al. (US 2022/0301658; herein referred to as Zamft): which teaches a process of utilizing hold-out data sets with cross-validation in conjunction with effect sizes. However Zamft is deficient in teaching computing a summation of the effect sizes in a hold-out data set with cross-validation to generate a cumulant-based risk score corresponding to the target outcome for the individual.
Wipperman et al. (US 2024/0062906; herein referred to as Wipperman): which teaches a process of utilizing hold-out data sets with cross-validation in conjunction with effect sizes. However Wipperman is deficient in teaching computing a summation of the effect sizes in a hold-out data set with cross-validation to generate a cumulant-based risk score corresponding to the target outcome for the individual.
It can be seen that the best prior art the Examiner was able to find does not teach the limitations of claim 1 even in combination. Accordingly, claims 1, 2, 4, 5, 7-9, 11, 12, 14-16, 18 and 19 contain subject matter that is free of prior art.
Response to Arguments
Applicant's arguments filed February 13, 2026 have been fully considered.
Applicant’s arguments pertaining to rejections made under 35 U.S.C. 101 are not persuasive.
The Applicant argues that pursuant to the decision made in Ex Parte Desjardin, the pending claims are instructive in finding that they involve patent eligible subject matter, citing paragraph [0040] of the as-filed specification.
The Examiner respectfully disagrees. The Applicant has failed to clearly articulate what argument is being presented here. What elements in paragraph [0040] are relevant to patent-eligible subject matter and how does this finding relate to Ex Parte Desjardin? There is no reasoning presented in this argument. Accordingly, the Examiner is not persuaded by this argument.
The Applicant further argues that the MPEP specifically clarified that a "defined series of steps" is not "a method of organizing human activity", citing In re Marco Guldenaar.
The Examiner respectfully disagrees. Aside from a dubious application of the hypothetical situation the Court in Guldenaar was discussing, the MPEP did not state that a "defined series of steps" is not "a method of organizing human activity". The MPEP states that ""a defines series of steps for combining particular ingredients to create a drug formulation" is not a certain "method of organizing human activity"" (MPEP 2106.04(a)(II)). This difference may seem minute, however the MPEP also explicitly states that In re Marco Guldenaar was actually ineligible because the claims were directed to following rules or instructions which is specifically a certain method of organizing human activity. See MPEP 2106.04(a)(II)(C). This establishes that merely claiming "defined series of steps" does not connote patent eligibility.
The Applicant further argues that paragraphs [0032] and [0044] of the as-filed specification provide for an improvement to technology and therefore is eligible via a practical application of the abstract idea.
The Examiner respectfully disagrees. Looking to the cited paragraphs, it is clear that the argued improvement rests with "improved methods for using computers to calculate continuous variables" with data that is multimodal and involves higher dimension interactions. While "multimodal" and "higher dimension" may seem impressive, these terms are poorly defined as they are generally relative to an undefined standard. For example, "multimodal" can merely mean "multiple electronic medical records" as is discussed in paragraph [0002] of the as-filed specification. There is no discussion about the technical problem relating to multimodal data. Further, "higher dimension" is a poorly defined term in the as-filed specification that is merely shown in exemplary fashion as opposed to definitive. From what the Examiner can ascertain, this kind of data merely has additional data included in it that it otherwise would. Such a kind of data is still data nonetheless and is therefore still abstract. There is no discussion about how this multimodal data or higher dimension data interaction corresponds to what computational improvement. There is merely the assertion that some form of computational advantage is present in the disclosed invention. Accordingly, this is a bare assertion of improvement and such a bare assertion is not persuasive in establishing a definite clear improvement to technology. To provide for a practical application via a technical improvement, it must be clear to one of ordinary skill in the art that a specific aspect of technology is being improved. This is absent from the current discussion.
The Applicant further argues that the pending claims provide an improvement to the ability of a computer to calculate continuous variables.
The Examiner respectfully disagrees with this argument. The as-filed specification does not provide any technical detail about how calculations are allegedly improved. It merely states that they could be and leaves the discussion there. This is another bare assertion of improvement.
The Applicant further argues that the amendments to the pending claims provide more basis for understanding the practical application provided by the claims.
The Examiner respectfully disagrees. These amendments, while being more specific, do not reasonably provided a basis for a practical application of the identified abstract idea, given that the amended language is considered to be abstract in of itself.
The Applicant further argues that the claimed amendments provide a search for an inventive concept.
The Examiner respectfully disagrees. The Applicant has failed to articulate what inventive concept is present in the pending claims. They relate limitations of the pending claims to an inventive concept, but any discussion relating to identifying what technical problem is present and how a technical solution in the claim solves this technical problem.
The Applicant argues that the pending claims recite an improvement to technology, specifically citing paragraphs [0001], [0002], [0010]-[0013], [0032] and [0042] of the as-filed specification to support their position. Accordingly, the pending claims provide for a practical application and something significantly more than the abstract idea.
The Examiner respectfully disagrees. It is not clear to the Examiner what technological problem is being addressed by the disclosed invention. The as-filed specification cites that “the presently described embodiments have the capacity to improve the ability of computers to calculate continuous variables corresponding to a disease risk for an individual, even within environments containing data that is multimodal and involves higher dimension interactions.” This citation does not describe what technical difficulties are present here or how the limitations of the claimed invention address those difficulties. From what the Examiner can ascertain, the vague language of the specification such as “multimodal” and “higher dimension interactions” does not convey a reasonable basis to determine a technological capability. The Examiner is not convinced that such a high level of generality would have conveyed an improvement to technology to one of ordinary skill in the art. The Examiner finds that this level of description is a mere assertion of improvement that is not supported with technical details that describe how the asserted improvement is actualized. The aspect of "self-assessing" is not an inventive concept in the field of machine learning. Machine learning routinely used training sets and validation sets to self-assess the accuracy of a machine learning model at the time of filing. Applying this known technology to the claimed field does not inherently make the field improved. It merely applies the abstract idea to a particular field of technology; machine learning.
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 CHAD A NEWTON whose telephone number is (313)446-6604. The examiner can normally be reached M-F 8:00AM-4:00PM (EST).
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/CHAD A NEWTON/Primary Examiner, Art Unit 3681
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