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 18/856177 application is in response to the communications filed March 02, 2026.
Claims 1, 13 and 14 were amended March 02, 2026.
Claims 15-19 were added as new March 02, 2026.
Claim 12 was cancelled March 02, 2026.
Claims 1-11 and 13-19 are currently pending and considered below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “determining by a machine learning module” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-11 and 13-19 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 for assessing measurement results on a localized basis comprising: (a) receiving input data, the input data comprising individual-level data and population-level data, wherein the individual-level data and population-level data are validated, wherein validation of the individual-level data and population-level data comprises checking for missing values; ensuring that data values fall within a permitted range for a given measure; ensuring data are the correct data type; and combinations thereof; (b) normalizing the individual-level data and the population data by executing a normalization algorithm to ensure that the data values fall within a permitted range for a given measure; (c) transforming the individual-level data and the population-level data to a format useable by a machine learning module, transforming the individual-level data and the population-level data comprising algorithmically rescaling the data from 0 to 100 and ensuring all values are positive by multiplying negative values by -1, recentering the data and combinations thereof; (d) calculating first error parameters (first EPs) and first error statistical parameters (first ESPs) from individual-level data, wherein first EPs and first ESPs comprise a combination of (1) true positives, true negatives, false positives and false negatives from a set of individual-level data; (2) forecasted first EPs and first ESPs from previously calculated first EPs and first ESPs over time for a given set of individual-level data using time series analysis; and (3) prediction from properties of a population over time; (e) calculating second EPs and second ESPs from population-level data, wherein second EPs and second ESPs comprise a combination of (1) forecasted second EPs and second ESPs from previously calculated second EPs and second ESPs using time series analysis and calculating second EPs and second ESPs for separate demographic subgroups; and (2) prediction from properties of a population; (f) determining geographically specific statistical measure that a measurement result is correct or incorrect, the determining comprising inputting at least the first EPs, the second EPs, the first ESPs, and the second ESPs as feature inputs to generate a geographically specific likelihood; (g) generating an actionable validity report based on a pre-programmed threshold to determine if the measurement result should be accepted, repeated, or supplemented, the generating of the report comprising selecting a threshold based on false positives and/or false negatives. These steps, as drafted, under the broadest reasonable interpretation recite:
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”, “by a programmable processing unit”, “by the programmable processing unit”, “by a machine learning module”, “to a trained machine-learning model executed by the programmable processing unit” and “automatically” which corresponds to merely using a computer as a tool to perform an abstract idea. Paragraph [0047] of the as-filed specification describes that the hardware that implements the steps of the abstract idea amount to nothing more than 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:
“(h) reporting over a communications link the geographically localized likelihood that the measurement result is more likely to be true or false” 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:
“(h) reporting over a communications link the geographically localized likelihood that the measurement result is more likely to be true or false” 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:
“wherein the measurement comprises a laboratory test result or a diagnostic procedure.” 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 3,
Claim 3 depends from claim 2 and inherits all the limitations of the claim from which it depends. Claim 3 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 first EPs and the second EPs comprise sensitivity, specificity, prevalence, receiver-operator area under the curve (ROAUC), positive predictive value (PPV), negative predictive value (NPV), false discovery rate (FDR), false omission rate (FOR) and combinations thereof.” 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 2 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:
“wherein the first ESPs and the second ESPs comprise p-values, adjusted p-values, confidence intervals, sample sizes and combinations thereof.” 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 2 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:
“further comprising …using individual-level data and population-level data as inputs to learn whether the measurement result is likely to be true or false.” 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.
“executing the machine learning module” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to merely using a computer as a tool to perform 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 6,
Claim 6 depends from claim 2 and inherits all the limitations of the claim from which it depends. Claim 6 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein individual-level data comprise medical tests results; machine-learning predictions; medical triage algorithms; properties, attributes, metadata, or other information assigned to an individual person, object, or other unit of study; location; age; sex; ethnicity; socioeconomic factor; medical records data; habits; activities; occupation; and combinations thereof.” 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 2 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 medical test results comprise COVID-19 antibody and polymerase chain reaction test results.” 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 depends from claim 2 and inherits all the limitations of the claim from which it depends. Claim 8 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein population-level data comprise individual-level data summarized to the population-level; properties, attributes, metadata, or other information assigned to a population of people, groups of object, average laboratory result rate; average machine learning result; disease rates; unemployment rates; diagnosis rates; crime rates; environmental features; average distance to physical locations; and combinations thereof.” 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 9,
Claim 9 depends from claim 8 and inherits all the limitations of the claim from which it depends. Claim 9 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 population-level data is measured for one or more geographical levels, wherein the one or more geographical levels comprise national, subnational, state, county, census tract levels.” 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 10,
Claim 10 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 10 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 determination that the measurement result is more likely to be true or false is encoded by an encoding module into a format usable by electronic medical records systems, decision support systems, electronic formats comprising JSON, XML, or CSV,” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to merely using a computer as a tool to perform an abstract idea.
“wherein the likelihood that the measurement result is more likely to be true or false is transmitted over an Application Programming Interface (API).” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to mere data gathering and/or output and 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 11,
Claim 11 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 11 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 method is performed by one or more general purpose computers, customized computing hardware, local computer server, virtual machine, mobile device, tablet, cloud-based device or combinations thereof comprising a programmable processing unit, volatile memory comprising Random Access Memory, non-volatile memory comprising one or more hard disk drives or solid-state disk drives, and one or more network connections to other devices.” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to merely using a computer as a tool to perform 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 13,
Claim 13 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 13 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“calculating PPV for each day within a time period using Bayesian calculation based on first EPs and first ESPs; and thereafter forecasting PPV for future dates to predict how long the specific medical tests should be repeated, wherein forecasting PPV comprises statistical regression methods…, wherein a budget for performing test can be forecast based on predicted duration for which tests must be reported according to the forecasted PPV.” 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.
“and machine-learning methods” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to merely using a computer as a tool to perform 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 14,
Claim 14 depends from claim 13 and inherits all the limitations of the claim from which it depends. Claim 14 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein a neural network (ANN) comprises a sequential model with three dense interconnected neural network layers having 100, 8 and 1 node in each layer, respectively.” introduces additional elements that is insufficient to provide a practical application or significantly more:
Step 2A Prong 2: 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:
“wherein a neural network (ANN) comprises a sequential model with three dense interconnected neural network layers having 100, 8 and 1 node in each layer, respectively.” which corresponds to merely using a computer as a tool to perform an abstract idea. Paragraph [0047] of the as-filed specification describes that the hardware that implements the steps of the abstract idea amount to nothing more than 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.
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 15,
Claim 15 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 15 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 geographically-specific statistical measure is an odds ratio.” 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 16,
Claim 16 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 16 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 predetermined value is a threshold calculated … based on a localized Bayesian positive predictive value (PPV), and wherein … generates an alert to repeat the specific medical test only when the localized PPV falls below said threshold.” 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.
“by the programmable processing unit” and “the programmable processing unit” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to merely using a computer as a tool to perform 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 17,
Claim 17 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 17 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 input data further comprises localized environmental parameters including pollution levels and hospital proximity data; and wherein the determining of the localized likelihood comprises … calculation that utilizes bootstrap aggregating or Bayesian model averaging to combine outputs from a plurality of distinct statistical models, including at least a regression model and a neural network.” 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.
“executing an ensemble machine learning” introduces additional elements that is insufficient to provide a practical application or significantly more:
Step 2A Prong 2: 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:
“executing an ensemble machine learning” which corresponds to merely using a computer as a tool to perform an abstract idea. Paragraph [0047] of the as-filed specification describes that the hardware that implements the steps of the abstract idea amount to nothing more than 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.
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 18,
Claim 18 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 18 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 transforming of the data in step (c) further comprises discretizing continuous individual-level data … to dynamically generate feature categories prior to input into the machine learning module.” 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.
“into machine-learning derived clusters generated via an unsupervised clustering algorithm” introduces additional elements that is insufficient to provide a practical application or significantly more:
Step 2A Prong 2: 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:
“into machine-learning derived clusters generated via an unsupervised clustering algorithm” which corresponds to merely using a computer as a tool to perform an abstract idea. Paragraph [0047] of the as-filed specification describes that the hardware that implements the steps of the abstract idea amount to nothing more than 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.
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 19,
Claim 19 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 19 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein calculating the first EPs and first ESPs comprises a recursive time-series analysis, and wherein previously calculated EPs and ESPs from a historical time window are used as weighted inputs to predict the current real-time EPs and ESPs using an autoregressive integrated moving average (ARIMA) model.” 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.
Subject Matter Free of Prior Art
Claims 1-11 and 13-19 contain subject matter 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 adequate rationale to combine, to teach the limitation of “determining by a machine learning module geographically specific statistical measure that a measurement result is correct or incorrect, the determining comprising inputting at least the first EPs, the second EPs, the first ESPs, and the second ESPs as feature inputs to a trained machine-learning model executed by the programmable processing unit to generate a geographically specific likelihood” the closest prior art that the Examiner was able to find was:
Cohen et al. (US 2018/0068083; herein referred to as Cohen) which teaches "a positive predictive score," "a positive predictive value," or "PPV" refers to the likelihood that a score within a certain range on a biomarker test is a true positive result. It is defined as the number of true positive results divided by the number of total positive results. Data across the entire population (namely, the patients and controls) are sorted in ascending order based on the value of a single feature. Then, for each value for that feature, the true positive and false positive rates for the data are determined; sensitivities were determined for assessing a patient's likelihood of having cancer based on a single biomarker. However, this teaching merely describes an application of error rates with medical testing in a total population context without using error rates within a machine learning model to generate a geographically specific likelihood.
Bentley (Bentley, P.M. “Error Rates in SARS-CoV-2 Testing Examined with Bayes’ Theorem.” Heliyon, vol. 7, no. 4, Apr. 2021, p. e06905, https://doi.org/10.1016/j.heliyon.2021.e06905. Accessed 9 Aug. 2021.) which teaches using the same "black box" procedure, then they are unlikely to be stochastically independent and the errors in both tests are correlated; same is true in the effort to guard against false positives: if the test kits both come from the same batch, are processed by the same people, in the same facility, using the same "black box" procedure, then they are unlikely to be stochastically independent and the errors in both tests are correlated'; one sees that the confusion matrix is a table of test results that are true positive (), true negative (), false positive (), and false negative (). These numbers could be given as tallies of results; the "input" prior probability () for a subsequent test, because combining multiple scenarios with logical is simply multiplication; The lower upper two rows show Ai's reported data, the lower two rows convert these into rates. The ranges in parentheses correspond to the 95% confidence intervals. However, this teaching merely describes a general application of error rates with medical testing without using error rates within a machine learning model to generate a geographically specific likelihood.
As it can be seen, the prior art does not teach all of the limitations of the pending claims alone or in combination. Accordingly, claims 1-11 and 13-19 contain subject matter free of prior art.
Response to Arguments
Applicant's arguments filed March 02, 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 there is no conventionally known method of organizing human activity that involves transforming data to a format useable by a machine learning module.
The Examiner respectfully disagrees. Conventionality is not relevant to considering whether a claim recites an abstract idea. Transforming data in of itself is an inherently abstract process that humans are more than capable of performing. Data is inherently abstract, it follows that the mere transformation of data into different data is also abstract. Making that data useable by a machine learning model is not significant as all data that used by a machine learning model is by definition, machine learning model usable data. Human input valid data into machine learning models all the time. Accordingly, transforming data into a format useable by a machine learning module falls under “Certain Methods of Organizing Human Activity”.
The Applicant further argues that claim 1 recites additional elements that integrate the abstract idea into a practical application. Specifically, the limitations claimed provide functions as a reliable indicator in a decision making process that allows the user to avoid errors and save medical or monetary resources. The as-filed specification is clear that the predictive measures can indicate when medical tests need not be repeated, described in at least paragraph [0051] of the as-filed specification.
The Examiner respectfully disagrees. These business problem considerations are not relevant factors in determining whether a practical application exists in the pending claims. For relevant considerations for an additional element to an abstract idea providing a practical application of the abstract idea, please refer to MPEP 2106.04(d).
Applicant’s arguments pertaining to rejections made under 35 U.S.C. 103 are persuasive for the reasons indicated above.
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 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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