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 18/398406 application is in response to the communications filed December 29, 2025.
Claims 18 and 20 were amended December 29, 2025.
Claims 18-23 and 25-28 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 18-23 and 25-28 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 18,
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 generating a predictive model for a medication regimen change, comprising the steps of: receiving at least one intrinsic component data source for the patient, receiving at least one extrinsic component data source for the patient, receiving data directed to one or more targeted outcomes for the hypothetical medication modification; receiving data directed to the proposed medication modification for the patient; and generating the predictive model, wherein the predictive model includes a hypothetical risk profile for the proposed medication modification by correlating one or more of the data directed to the proposed medication modification, at least one intrinsic component data source, and the at least one extrinsic component data source against the one or more targeted outcomes for the hypothetical medication modification, wherein intrinsic components of the intrinsic component data source and/or extrinsic components of the extrinsic component data source include risk factors comprising: aACB score, Sedative burden, drug metabolism pathway, drug-drug interactions, drug-gene interactions, and published drug guidelines; and wherein the method further comprises weighting the risk factors. 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. For example, but for the additional element(s) of “a network linked computer program product comprising a non-transitory computer readable medium having program instructions stored in a memory device, the instructions executable by a processor to direct the performance of operations for the management of a regimen for a patient's use of prescribed medication, the program instructions comprising the steps of: initializing a hypothetical medication modification comprising the steps of:” and “at the memory device”, 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:
“at a network linked computer coupled to a memory device, initializing a hypothetical medication modification comprising the steps of:” which corresponds to merely using a computer as a tool to perform an abstract idea. Page 2 Lines 11-18 of the as-filed specification describes that the technology that implements the abstract idea is at a level comparable 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:
“at the memory device” 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:
“at the memory device” 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 19,
Claim 19 depends from claim 18 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 the correlation against the one or more targeted outcomes is weighted.” 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 20,
Claim 20 depends from claim 18 and inherits all the limitations of the claim from which it depends. Claim 20 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 receiving the current risk profile of the patient's medication regimen, and wherein the intrinsic component data source and/or the extrinsic component data source are analyzed against the projected impact of the proposed medication modification in relation to the current risk profile of the patient's medication regimen in the context of the intrinsic and/or extrinsic components.” 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 21,
Claim 21 depends from claim 18 and inherits all the limitations of the claim from which it depends. Claim 21 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein intrinsic components of the intrinsic component data source comprise: lab test results for the patient; concomitant medications prescribed to the patient; documented medication allergies for the patient; pharmacogenomic data for a particular medication(s) based on medication metabolizing isoenzymes and transporters and their impact; and/or medication adherence information for the patient.” 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 22,
Claim 22 depends from claim 18 and inherits all the limitations of the claim from which it depends. Claim 22 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein extrinsic components of the extrinsic component data source comprise: BEERS listed medications; medication name; START/STOPP criteria; black-box FDA warnings; GCN sequence number; RxCUID (RxNorm); NDC; CNS sedative burdens; and/or aggregated Anticholinergic Burden.” 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 23,
Claim 23 depends from claim 18 and inherits all the limitations of the claim from which it depends. Claim 23 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 targeted outcomes comprise: reductions in hospitalizations; reductions in falls; and reductions in medication misadventuring.” 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 25,
Claim 25 depends from claim 18 and inherits all the limitations of the claim from which it depends. Claim 25 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 published drug guidelines comprise one or more of: a Beers List indication for at least one medication in the proposed medication modification, and an FDA Black Box warning for at least one medication in the proposed medication modification.” 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 26,
Claim 26 depends from claim 18and inherits all the limitations of the claim from which it depends. Claim 26 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 aggregating the weighted risk factors to generate the hypothetical risk profile.” 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 27,
Claim 27 depends from claim 26 and inherits all the limitations of the claim from which it depends. Claim 27 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 hypothetical risk profile is a weighted risk profile including: each of the aggregated weighted risk factors, the number of medications being taken concurrently, duration of therapy of the existing medications, Anticholinergic Cognitive Burden Index, Creatine Clearance, interaction warnings; drug allergies, patient demographics, documented lab results and lab results trending.” 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 28,
Claim 28 depends from claim 27 and inherits all the limitations of the claim from which it depends. Claim 28 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 documented lab results and/or lab results trending include one or more of INR, CrCl, and BMI 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.
Subject Matter Free of Prior Art
Claims 18-23, and 25-28 have neem found to contain subject matter free of prior art. Claim 18 recites the limitation of “wherein intrinsic components of the intrinsic component data source and/or extrinsic components of the extrinsic component data source include risk factors comprising: aACB score, Sedative burden, drug metabolism pathway, drug-drug interactions, drug-gene interactions, and published drug guidelines; and wherein the method further comprises weighting the risk factors”. Similar to what was indicated in the Notice of Allowance for application 14/579,283, now Patent No. 10,720,241, the Examiner cannot find a single reference of a combination of references with adequate motivation to combine to teach this limitation. The closest prior art to teach this limitation would be the cited prior art above. Accordingly, claims 18-23, and 25-28 contain subject matter free of prior art.
Response to Arguments
Applicant's arguments filed December 29, 2025 have been fully considered.
Applicant’s arguments pertaining to the rejections made under 35 U.S.C. 101 are not persuasive.
The Applicant argues that the predictive model is not a method of organizing human activity because it is not management of personal behavior or relationships or interactions between people as alleged by the Examiner. Rather, the predictive model is rooted in a computer system.
The Examiner respectfully disagrees. Predictive models are fundamentally mathematical functions that are carried out to provide a probabilistic explanation of future events. Simply put, these models are specific mathematical formulas. All mathematics are a series of processes that a human person performs. Accordingly, conducting mathematical functions is fundamentally a human behavior. The pending claims merely take this human behavior and apply it to the computer environment claimed.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, PETER H CHOI can be reached on (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHAD A NEWTON/Primary Examiner, Art Unit 3686