DETAILED ACTION
This action is in reference to the communication filed on 9 MARCH 2026.
Applicant has elected Group III, consisting of claim 33.
Amendments to claims 12, 23, 33, 38, 39 have been entered, as has the cancellation of claims 1-11, 13-22, 24-32, 34-37, 40-44, and the addition of claims 45-59.
Claims 12, 23, 33, 38, 39, 45-59 are present and examined.
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 12, 23, 33, 38, 39, 45-59 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. As explained below, the claim(s) are directed to an abstract idea without significantly more.
Step One: Is the Claim directed to a process, machine, manufacture or composition of matter? YES
With respect to claim(s) 12, 23, 33, 38, 39, 45-59 the independent claim(s) 33, 45, 55 recite(s) each recite a statutory category of invention.
Step 2A – Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? YES
With respect to claim(s) 12, 23, 33, 38, 39, 45-59 the independent claim(s) (claims 33, 45, 55) is/are directed, in part, to:
(Exemplary claim 33) automatic classification of health risks in a medication regimen administered to a patient, the method comprising:
generating a risks-map data-structure wherein the risks-map is a data-structure comprising: i) a plurality of relevant health- items, each relevant health-item is a data object that represents a respective health condition which is identified as relevant to a medical status of the patient by at least one activator that includes medical data; and ii) at least one intervention that includes data that prescribes a change to a drug or a treatment that has been identified in the risks-map to be related to a respective health-risk to the patient;
determining the at least one intervention by:
processing a patient's health-journey that comprises historical personal medical data of the patient collected over a past period and generating a respective risks-maps-sequence comprising a plurality of risks-maps, each risks-map in the risks-maps-sequence is generated based on personal medical data which was available at a certain time point along the past period;
determining for each relevant health-item in each risks-map in the risks-maps-sequence a respective health-item risk-score;
generating at least one intervention that prescribes a change to a drug or a treatment that has been identified in the risks-map to be related to a health-risk to the patient, including: identifying one or more changes in a respective drug or treatment in the medication regimen observed along the patient's health-journey;
identifying one or more changes in health-item risk-scores of respective relevant health- items observed along the risks-maps-sequence;
identifying a correlation between a time of a change in a respective drug or treatment and a time of a change in health-item risk-score of a respective relevant health-item;
deducing based on the correlation that the change in the drug or treatment associated with the change of the health-item risk-score of the respective relevant health-item;
generating the at least one intervention dedicated to alleviating a health risk related to the respective drug or treatment.
With the exception of the elements of the claim excluded in the strikethroughs, these claim elements are considered to be abstract ideas because they are directed to a mental process, in that the claims ensconce concepts performed in the human mind including observation, evaluation, judgment, and opinion functions. Generating a risk map using health data, intervention data, determining an intervention by using health journey information, generating/identifying changes and responses, as well as correlations therein, are all examples of such concepts as identified above. If a claim limitation, under its broadest reasonable interpretation, covers a concept performed in the human mind, then it/they falls/ fall into the “mental processes” category.
Examiner also notes that the elements of the claims with regard to risk mapping and health risks are also examples of methods of organizing human activity which include fundamental economic principles or practices (including hedging, insurance, mitigating risk). The independent claims clearly discuss applicability to alleviating health risks related a respective drug or treatment as provided to a patient. If a claim limitation, under its broadest reasonable interpretation, mitigating risk, then it falls within the “method of organizing human activity” grouping of abstract ideas.
Accordingly, the claim recites an abstract idea.
Step 2A – Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? NO.
This judicial exception is not integrated into a practical application. In particular, the claim(s) recite(s) additional elements: claim 33 recites a “non-transitory computer readable storage medium tangibly embodying a program of instructions…executed by a computer cause computer to perform a method…” as identified above, claim 45 does not appear to recite any additional elements for consideration at this step, and claim 55 recites a computer system comprising processing circuitry. The computer readable storage medium/computer, and the computer system in claims 33, 55 are recited at a high-level of generality recited at a high level of generality and as such amount to no more than adding the words “apply it” to the judicial exception, or mere instructions to implement the abstract idea on a computer, or merely uses the computer as a tool to perform the abstract idea (see MPEP 2106.05f), or generally links the use of the judicial exception to a particular technological field of use/computing environment (see MPEP 2106.05h). Examiner finds no improvement to the functioning of the computer or any other technology or technical field in the identified above as claimed (see MPEP 2106.05a), nor any other application or use of the judicial exception in some meaningful way beyond a general link between the use of the judicial exception to a particular technological environment (see MPEP 2106.05e). In the interest of prosecution, Examiner notes that the storing of instructions on a computer readable medium is analogous to storing information, which is found to be adding insignificant extra solution activity to the judicial exception(s) identified (see MPEP 2106.05g).
Accordingly, this/these additional element(s) do(es) not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO.
The independent claim(s) is/are additionally directed to claim elements such as: claim 33 recites a “non-transitory computer readable storage medium tangibly embodying a program of instructions…executed by a computer cause computer to perform a method…” as identified above, claim 45 does not appear to recite any additional elements for consideration at this step, and claim 55 recites a computer system comprising processing circuitry. When considered individually, the above identified claim elements (i.e. the computers/computer readable storage medium) only contribute generic recitations of technical elements to the claims. It is readily apparent, for example, that the claim is not directed to any specific improvements of these elements. Examiner looks to Applicant’s specification in:
[0103] Unless specifically stated otherwise, as apparent from the following discussions, it is appreciated that throughout the specification discussions utilizing terms such as “obtaining”, “determining”, “generating”, “comparing”, “adding” or the like, include an action and/or processes of a computer that manipulate and/or transform data into other data, said data represented as physical quantities, e.g., such as electronic quantities, and/or said data representing the physical objects.
[0104] The terms computer/computer device/computerized system, or the like, should be expansively construed to include any kind of hardware-based electronic device with a processing circuitry (e.g., digital signal processor (DSP), a GPU, a TPU, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), microcontroller, microprocessor etc.). The processing circuitry can comprise for example, one or more processors operatively connected to computer memory, loaded with executable instructions for executing operations as further described below.
[0106] The operations in accordance with the teachings herein may be performed by a computer specially constructed for the desired purposes, or by a general-purpose computer specially configured for the desired purpose by a computer program stored in a computer readable storage medium.
These passages, as well as others, makes it clear that the invention is not directed to a technical improvement. The use of a computer and related elements are strictly to execute or apply the abstract idea to the technological element of processing. When the claims are considered individually and as a whole, the additional elements noted above, appear to merely apply the abstract concept to a technical environment in a very general sense – i.e. a generic computer receives information from another generic computer, processes the information and then sends information back. The most significant elements of the claims, that is the elements that really outline the inventive elements of the claims, are set forth in the elements identified as an abstract idea. The fact that the generic computing devices are facilitating the abstract concept is not enough to confer statutory subject matter eligibility.
As per dependent claims 12, 23, 38, 39, 46-54, 56-59:
Dependent claims 12, 23, 38, 39, 46-54, 56-59 are not directed any additional abstract ideas and are also not directed to any additional non-abstract claim elements. Rather, these claims offer further descriptive limitations of elements found in the independent claims and addressed above – such as the types of interventions, the changes made, and different actions based on the risk values and assorted thresholds. While these descriptive elements may provide further helpful context for the claimed invention these elements do not serve to confer subject matter eligibility to the invention since their individual and combined significance is still not heavier than the abstract concepts at the core of the claimed invention.
Prior Art
As currently written, claims 12, 23, 33, 38, 39, 45-59 are believed to be free of the prior art. The closest prior art is believed to be:
US 20170286221, to Cox, which teaches analyzing personal medical history of patients to determine appropriate risk mapping of a future intervention. This information is used to create a score which is compared to the general population to determine the specific risk of a given condition for that specific individual.
US 20200143946, to Lewis, discusses creating a patient based intervention module and applying the patient information to a risk prediction for a patient based on a survey procedure including medical history and any predicted future medical conditions suspected. The risks of the treatments of the potential future medical conditions are compared to the current risks associated with conditions of the user that are already diagnosed.
US 20230085062, to Zhou discusses the risks of making changes to a given patient’s routine or periodic treatment for a chronic illness. This risk considers additional medical issues or risk factors the patient already has to be pre-existing and the affect of a chronic treatment on other comorbidities.
US 11376361 to Ruchti, discloses minimizing or alleviating risks of an automated medication delivery to a patient for a condition, specifically to lower the risks of non-reactive dosing common in automated delivery including assuming a treatment is required to continue at the original dose (which may be causing potential side effects to the patient).
Morden et al discloses the effects and risks of changing a medication taken for a chronic condition due to the development of a new or worsening co existing disease – i.e. discontinuing a medication for a condition to preserve kidney function based on the overall risk to the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE KOLOSOWSKI-GAGER whose telephone number is (571)270-5920. The examiner can normally be reached Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at 571-270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687
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