DETAILED ACTION
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 the Claims
Claims 1-20 are currently pending and have been considered below. The status of the claims as of the response filed 4/2/2026 is as follows: Claims 1 and 4 are currently amended. Claims 2-3 and 5-20 are original. Claims 1-20 are currently pending in the application and have been considered below.
Response to Amendment
Objection to Claims
Claim 4 has been sufficiently amended to correct the minor informality objected to in the previous office action, and thus the corresponding objection is withdrawn.
Rejection Under 35 USC 101
The claims have been amended but the 35 USC 101 rejections for claims 1-20 are upheld.
Rejection Under 35 USC 102/103
The amendments made to claim 1 alters its scope such that it now requires the subject matter found to be free from prior art in the previous office action (see paras. 26-27 of the non-final rejection mailed 1/8/2026), and thus the corresponding 35 USC 102/103 rejections are withdrawn.
Response to Arguments
Rejection Under 35 USC 101
On page 9 of the response filed 4/2/2026 Applicant argues that “providing a medical treatment for a particular duration as particularly determined according to the recited features is not abstract,” and that “determining a particular target use duration for a medication for an effective patient treatment incorporates improvements to medical technology and safety aspects of administering medication” such that any recited abstract idea is integrated into a practical application. Applicant further submits that claim 1 has been amended to recite the specific medical treatment of insulin therapy, which Examiner presumes is an argument implying that the invention meets the ‘particular treatment or prophylaxis’ consideration.
Applicant’s arguments are fully considered, but are not persuasive. Examiner respectfully disagrees that determining a particular target use duration for a medication amounts to a practical application; calculating medication regimen durations or schedules is not a technology or technical field, and instead describes the abstract idea of making medication prescribing and dosing determinations that doctors and other medical professionals are routinely tasked with performing in the course of patient care. Improvements to the abstract idea itself do not provide “significantly more” than the abstract idea itself and thus do not confer eligibility (see MPEP 2106.05(a): “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.” See also 2106.05(a)(II): “it is important to keep in mind that an improvement in the abstract idea itself… is not an improvement in technology”).
Additionally, Examiner respectfully disagrees that providing a medical treatment for a particular calculated duration is not abstract; Examiner notes that “providing” a treatment could encompass a vast array of activities under the broadest reasonable interpretation, including abstract activities like communicating a recommendation to a patient that they take a particular medication or prescribing the patient a medication, nominal “apply it” level activities like handing the patient a prescribed medication, and positive administering activities like physically injecting or infusing a drug into a patient. Under this BRI, Examiner maintains that the claim language does not currently require that a treatment is positively administered to the patient, and may include the abstract step of a provider informing a patient of a recommended treatment.
Even if a treatment were to be positively recited, Examiner notes that it is not particular; claims 15 and 20 make no mention of the specific type of medication provided, while claim 1 as presently amended merely specifies an example medication type of insulin therapy. There is only one mention of insulin therapy in the specification in para. [0034], which makes it clear that the invention is intended to apply to “any medication therapy and type” with insulin merely being an example of a medication. There is no explanation of how the specific field of insulin therapy administration is specifically improved for the treatment of any particular disease or condition responsive to insulin; accordingly, this treatment is not considered to be particular as outlined in MPEP 2106.04(d)(2). Contrast the instant claim’s generality with claims 2-5 of Example 43, which recited administering specific types of medications to patients identified as having specific phenotypes responsive to those medications, with the aim of the invention outlined in the background being to provide improved methods of treating the specific condition of NAS-3 in patients not responsive to conventional glucocorticoid treatments. This particularity amounted to a particular treatment under the Step 2A – Prong 2 consideration, whereas the intended applicability of the instant claims’ treatment to be any type of treatment for any type of condition (with one nominally recited example treatment as being insulin therapy), combined with the lack of positively administering the treatment, does not amount to a particular treatment under this consideration.
For the reasons outlined above, the 35 USC 101 rejections are upheld for claims 1-20.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
In the instant case, claims 1-14 are directed to a method (i.e. a process), claims 15-19 are directed to a computer program product comprising a set of one or more computer readable storage media (i.e. a manufacture, in accordance with Applicant’s definition of “computer readable storage media” as excluding transitory signals per se in [0014] of the specification), and claim 20 is directed to a system (i.e. a machine). Thus, each of the claims falls within one of the four statutory categories. Nevertheless, the claims fall within the judicial exception of an abstract idea.
Step 2A – Prong 1
Independent claims 1, 15, and 20 recite steps that, under their broadest reasonable interpretations, cover certain methods of organizing human activity, e.g. managing personal behavior, relationships, or interactions between people. Specifically, claim 1 recites:
A computer-implemented method, comprising:
retrieving from a database, by a processor set, a data frame that includes at least covariates and medical outcome associated with subjects with usage history of a medication of interest including insulin therapy;
performing by the processor set, using a specified duration threshold, a data linkage assessment on the data frame to determine data linkage between the covariates and the medical outcome, and the specified duration threshold;
based on the data linkage, determining by the processor set a linkage measure value that determines strength of an effect of taking the medication of interest including the insulin therapy, on the medical outcome;
comparing by the processor set, the linkage measure value with a predefined risk assessment threshold;
determining that a difference between the linkage measure value and the predefined risk assessment threshold is greater than a predefined difference threshold;
filtering by the processor set, the data frame by excluding from the data frame, data associated with subjects with use history of the medication of interest including the insulin therapy for longer than the specified duration threshold;
specifying by the processor set, a different duration threshold as the specified duration threshold;
repeating by the processor set, the performing of the data linkage assessment, the determining of the linkage measure value, and the comparing of the linkage measure value with a predefined risk assessment threshold until a stop criterion is met; and
providing a treatment using the medication of interest including the insulin therapy for the specified duration threshold as a target use duration in treating a patient.
But for the recitation of generic computer components like a processor set, the italicized functions, when considered as a whole, describe mathematical concepts and a clinical data analysis operation that could be achieved by a human actor such as a clinician or researcher managing their personal behavior and/or interactions with others. For example, a clinician could retrieve a table representing patient covariates and clinical outcomes (i.e. a data frame in accordance with Applicant’s example in [0043] of the specification) from a repository and perform an assessment (e.g. via mathematical operations, use of their medical expertise, etc.) to determine linkages or relationships between the covariates and clinical outcomes representative of the strength of an effect of taking a certain medication (e.g. insulin therapy) for a given duration on a specific outcome. The clinician could then compare this measure with a risk threshold, and if the comparison shows that the measure is greater than the risk threshold by a given amount, they could filter out certain data from the initial table of data and re-perform the assessment and comparison steps for the filtered data with a new selected medication duration threshold until some stopping criteria is met. Once the clinician determines that the measure of strength of the effect of taking the medication for the given duration on the clinical outcome is within a certain range of the risk assessment threshold, the clinician can identify that duration threshold as a target for using the medication (e.g. insulin), and provide this treatment information to a patient, colleague, or other human actor for use in treating future patients with the medication. Accordingly, claim 1 recites an abstract idea in the form of a certain method of organizing human activity.
Similarly, claim 15 recites:
A computer program product comprising: a set of one or more computer readable storage media; and program instructions, collectively stored in the set of one or more storage media, for causing a processor set to perform the following computer operations:
retrieve from a database a data frame that includes at least covariates and medical outcome associated with subjects with usage history of a medication of interest;
perform, using a specified duration threshold, a data linkage assessment on the data frame to determine data linkage between the covariates and the medical outcome, and the specified duration threshold;
based on the data linkage, determine a linkage measure value that determines strength of an effect of taking the medication of interest, on the medical outcome;
compare the linkage measure value with a predefined risk assessment threshold;
responsive to determining that a difference between the linkage measure value and the predefined risk assessment threshold is greater than a predefined difference threshold:
filter the data frame by excluding from the data frame, data associated with subjects with use history of the medication of interest for longer than the specified duration threshold;
specify a different duration threshold as the specified duration threshold; and
repeat the performing of the data linkage assessment, the determining of the linkage measure value, and the comparing of the linkage measure value with a predefined risk assessment threshold;
responsive to determining that the difference between the linkage measure value and the predefined risk assessment threshold is not greater than the predefined difference threshold, identify the specified duration threshold as a target use duration of the medication of interest; and
provide a treatment using the medication of interest for the target use duration in treating a patient.
But for the recitation of generic computer components like a computer program product comprising computer readable storage media and program instructions executed by a processor set, the italicized functions, when considered as a whole, describe a clinical data analysis operation that could be achieved by a human actor such as a clinician or researcher managing their personal behavior and/or interactions with others. For example, a clinician could retrieve a table representing patient covariates and clinical outcomes (i.e. a data frame in accordance with Applicant’s example in [0043] of the specification) from a repository and perform an assessment (e.g. via mathematical operations, use of their medical expertise, etc.) to determine linkages or relationships between the covariates and clinical outcomes representative of the strength of an effect of taking a certain medication (e.g. insulin therapy) for a given duration on a specific outcome. The clinician could then compare this measure with a risk threshold, and if the comparison shows that the measure is greater than the risk threshold by a given amount, they could filter out certain data from the initial table of data and re-perform the assessment and comparison steps for the filtered data with a new selected medication duration threshold. Once the clinician determines that the measure of strength of the effect of taking the medication for the given duration on the clinical outcome is within a certain range of the risk assessment threshold, the clinician can identify that duration threshold as a target for using the medication, and provide this treatment information to a patient, colleague, or other human actor for use in treating future patients with the medication. Accordingly, claim 15 recites an abstract idea in the form of a certain method of organizing human activity. Claim 20 recites substantially similar subject matter as claim 15 and is also found to recite an abstract idea under the same analysis.
Dependent claims 2-14 and 16-19 inherit the limitations that recite an abstract idea from their dependence on claims 1 and 15, respectively, and thus these claims also recite an abstract idea under the Step 2A – Prong 1 analysis. In addition, claims 2-14 and 16-19 recite additional limitations that further describe the abstract idea identified in the independent claims. Specifically, claims 2 and 16 specify that the covariates include duration-based covariate data indicating prescriptions associated with durations, which are types of data that a clinician or researcher would be capable of retrieving and assessing in the manner explained above for the independent claims. Claims 3-4 and 17-18 specify that the data linkage assessment includes a regression algorithm or a causal inference technique, which are mathematical operations that a clinician or researcher would be capable of executing to assess linkages or relationships in data as explained above for the independent claims. Claims 5 and 19 specify that the linkage measure value includes an odds ratio value, which a is a mathematical value that a clinician or researcher would be capable of deriving from patient data. Claims 6-7 specify how the risk assessment threshold is mathematically expressed, each of which are types of mathematical values or indicators that a clinician or researcher would be capable of observing and comparing against another value as in the independent claims. Claims 8-9 specify that the different duration threshold is either higher or lower in value than a duration threshold being evaluated in a current iteration of the method, each of which are types of increments that a clinician or researcher would be capable of implementing in new iterations of the data analysis method of the independent claims. Claim 10 recites that covariates are split into subpopulations before being used separately in performing the data linkage assessments, which a clinician or researcher would be capable of doing when preparing the data in the table for the iterative analysis of the independent claims. Claims 11-14 specify various stopping criteria for stopping the iterative linkage assessment, linkage measure value determination, and comparison steps of the independent claims, each of which are types of stopping criteria that a clinician or researcher would be capable of evaluating and using as a basis for halting further data analysis when the criteria are met.
However, recitation of an abstract idea is not the end of the analysis. Each of the claims must be analyzed for additional elements that indicate the abstract idea is integrated into a practical application to determine whether the claim is considered to be “directed to” an abstract idea.
Step 2A – Prong 2
The judicial exception is not integrated into a practical application. In particular, independent claims 1, 15, and 20 do not include additional elements that integrate the abstract idea into a practical application. The additional elements of claim 1 include that the method is computer-implemented, and performance of the various steps by a processor set. Claim 15 similarly includes the additional element of a computer program product comprising a set of one or more computer readable storage media and program instructions collectively stored in the set of one or more storage media for causing a processor set to perform the steps as computer operations, while claim 20 also includes substantially similar additional elements of a processor set, computer-readable storage media, and program instructions. These additional elements, when considered in the context of each claim as a whole, merely serve to automate operations that could be performed as mathematical concepts and by and among human actors (as described above), and thus amount to instructions to “apply” the abstract idea using generic computer components (see MPEP 2106.05(f)). For example, a clinician or researcher can access a data repository including a table of patient data, perform various mathematical or other data analysis assessments and comparisons using the data, and iterate on the assessment and comparison steps with filtered datasets and different duration values until a stopping criterion is met so that a recommended treatment duration may be provided. The performance of such steps with a processor set executing computer program instructions merely serves to use computing elements as tools with which to automate and/or digitize these otherwise-abstract steps such that they occur in an electronic environment. Accordingly, claims 1, 15, and 20 as a whole are each directed to an abstract idea without integration into a practical application.
The judicial exception recited in dependent claims 2-14 and 16-19 is also not integrated into a practical application under a similar analysis as above. The functions of claims 2-14 and 16-19 are performed with the same additional elements introduced in the independent claims, without introducing any new additional elements of their own, and accordingly also amount to mere instructions to apply the abstract idea using these same additional elements.
Accordingly, the additional elements of claims 1-20 do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Claims 1-20 are directed to an abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a processor set executing computer program instructions stored in one or more computer-readable storage media to perform the retrieving, performing, determining, comparing, filtering, specifying, repeating, identifying, providing, etc. steps of the invention amount to mere instructions to apply the exception using generic computer components. As evidence of the generic nature of the above recited additional elements, Examiner notes paras. [0014]-[0018], where these computer elements are disclosed in terms of “known types of storage devices” and “computer processors of any type now known or to be developed in the future” with numerous generic examples, leading one of ordinary skill in the art to understand that they are well-known computing elements.
Analyzing these additional elements as an ordered combination adds nothing that is not already present when considering the elements individually; the overall effect of the computer implementation is to digitize and/or automate a mathematical clinical data analysis operation that could otherwise be achieved as a certain method of organizing human activity. Thus, when considered as a whole and in combination, claims 1-20 are not patent eligible.
Subject Matter Free from Prior Art
The following is a statement of reasons for the indication of subject matter free from prior art:
The prior art of record fails to expressly teach or suggest, either alone or in combination, each and every feature of the independent claims. In particular, the prior art fails to teach an iterative method of, responsive to determining that a difference between a linkage measure value and the predefined risk assessment threshold is greater than a predefined difference threshold: filtering a retrieved data frame by excluding data associated with subjects with a use history of a medication for longer than the specified duration threshold, specifying a different duration threshold as the specified duration threshold, and repeating the performing of the data linkage assessment, the determining of the linkage measure value, and the comparing of the linkage measure value with a predefined risk assessment threshold. See paras. 26-27 of the non-final rejection mailed 1/8/2026 for detailed explanation of most relevant prior art. Upon completion of an updated prior art search, Examiner discovered not additional references relevant to the instant invention.
Conclusion
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 KAREN A HRANEK whose telephone number is (571)272-1679. The examiner can normally be reached M-F 8:00-4:00 ET.
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/KAREN A HRANEK/ Primary Examiner, Art Unit 3684
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