DETAILED ACTION
This action is in response to the initial filing filed on September 22, 2025. Claims 1-12 have been examined and are currently pending.
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 .
Inventorship
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim Objections
Claim 7 is objected to because of the following informalities: Dependent claim 7 recites, “the first dimension” in line 2 lacks antecedent basis. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: Dependent claim 7 recites, “the second dimension” in lines 2-3 lacks antecedent basis. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: Dependent claim 8 recites, “the plurality of weights” in lines 1-2 lacks antecedent basis. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: Dependent claim 8 recites, “the same” in line 3 lacks antecedent basis. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: Dependent claim 9 recites, “the embedded plane” in line 2 lacks antecedent basis. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: Dependent claim 10 recites, “the embedded plane” in line 2 lacks antecedent basis. Appropriate correction is required.
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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
ALICE/ MAYO: TWO-PART ANALYSIS
2A. First, a determination whether the claim is directed to a judicial exception (i.e., abstract idea).
Prong 1: A determination whether the claim recites a judicial exception (i.e., abstract idea).
Groupings of abstract ideas enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Mathematical concepts- mathematical relationships, mathematical formulas or equations, mathematical calculations.
Certain methods of organizing human activity- fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions).
Mental processes- concepts performed in the human mind (including an observation, evaluation, judgement, opinion).
Prong 2: A determination whether the judicial exception (i.e., abstract idea) is integrated into a practical application.
Considerations indicative of integration into a practical application enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Improvement to the functioning of a computer, or an improvement to any other technology or technical field
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition
Applying the judicial exception with, or by use of a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception
Considerations that are not indicative of integration into a practical application enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea.
Adding insignificant extra-solution activity to the judicial exception.
Generally linking the use of the judicial exception to a particular technological environment or field of use.
2B. Second, a determination whether the claim provides an inventive concept (i.e., Whether the claim(s) include additional elements, or combinations of elements, that are sufficient to amount to significantly more than the judicial exception (i.e., abstract idea)).
Considerations indicative of an inventive concept (aka “significantly more”) enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Improvement to the functioning of a computer, or an improvement to any other technology or technical field
Applying the judicial exception with, or by use of a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception NOTE: The only consideration that does not overlap with the considerations indicative of integration into a practical application associated with step 2A: Prong 2.
Considerations that are not indicative of an inventive concept (aka “significantly more”) enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea.
Adding insignificant extra-solution activity to the judicial exception.
Generally linking the use of the judicial exception to a particular technological environment or field of use.
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. NOTE: The only consideration that does not overlap with the considerations that are not indicative of integration into a practical application associated with step 2A: Prong 2.
See also, 2019 Revised Patent Subject Matter Eligibility Guidance; Federal Register; Vol. 84, No. 4; Monday, January 7, 2019
Claims 1-12 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.
1: Statutory Category
Applicant’s claimed invention, as described in independent claim 1 is directed to a method.
2(A): The claim(s) are directed to a judicial exception (i.e., an abstract idea).
PRONG 1: The claim(s) recite a judicial exception (i.e., an abstract idea).
Mathematical Concepts
Independent claim 1 recites the limitations, “converting, the information set of a plurality of medication effects and medication side effects into a plurality of individual embedded values in an embedded domain of two dimension comprising a medication effect and a medication side effect; classifying, medications of the information set into one of a plurality of medication types based on a medication effect/side effect similarity of the plurality of individual embedded values determined based on at least one distance between the plurality of individual embedded values; positioning, the plurality of individual embedded values in the embedded domain; clustering, the individual embedded values into clusters; generating, a dense cluster of the plurality of individual embedded values in the clusters based on a clustering range; and determining, a prediction of a change of one of a plurality of effects or a plurality of side effects for the user specific combination of medications based on a concentration of the dense cluster being above a threshold concentration;” are directed to the abstract idea of mathematical concepts (mathematical relationships and mathematical calculations). In particular, mathematical calculations are performed in the steps of "converting, information set of a plurality of medication effects and medication side effects into a plurality of individual embedded values...", "generating a dense cluster of the plurality of individual embedded values in the clusters based on clustering range", and "determining a prediction of a change based on a concentration of the dense cluster being above a threshold concentration;" After mathematical calculations are performed, mathematical relationships are described to find patterns or trends associated with the data, for instance the generating prescription data for the user specific combination of medications based on the prediction.
Mental Processes
Independent claim 1 recites the limitations, “classifying, medications of the information set into one of a plurality of medication types based on a medication effect/side effect similarity of the plurality of individual embedded values determined based on at least one distance between the plurality of individual embedded values; preprocessing, the user-specific data set by grouping the user specific data set into a plurality of user specific data groups; determining, a prediction of a change of one of a plurality of effects or a plurality of side effects for the user specific combination of medications based on a concentration of the dense cluster being above a threshold concentration; and generating, each prescription data for the user specific combination of medications based on the prediction;” are directed to the abstract idea of mental processes. Specifically, the claim limitations above are directed to a user (e.g., a doctor or health professional) organizing, classifying, and analyzing data to predict combination of medications by observation, evaluation, and judgment of data.
PRONG 2: The judicial exception (i.e., an abstract idea) is not integrated into a practical application.
The applicant's limitations are not "integrated into a practical application" because they are adding words "apply it" with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea (see MPEP 2106.05(f)). The claim recites the elements of “prescription management device” and an “artificial intelligence engines” to perform the abstract idea. The claim does not include additional elements or limitations individually or in combination that are sufficient to amount to significantly more than the judicial exception. Specifically, the individual element of a prescription management device and artificial intelligence engines amount to no more than implementing an idea with a computerized system and they are adding words "apply it" with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea. The additional elements taken in combination add nothing more than what is present when the elements are considered individually.
The “obtaining” and “transmitting” steps are mere data gathering steps output recited at a high level of generality and are insignificant extra solution activity. MPEP 2106.05(g).
Therefore, based on the two-part Alice Corp. analysis, there are no meaningful limitations in the claims that transform the exception (i.e., abstract idea) into a patent eligible application.
Dependent claims 2-12 are rejected as ineligible subject matter under 35 U.S.C. 101 based on a rationale similar to the claims from which they depend. The following dependent claims: dependent claim 3 recites an artificial intelligence engines, default artificial intelligent engine and user optimized artificial intelligence engine and dependent claims 11-12 recite artificial intelligence engines. Dependent claims 3 and 11-12 do not recite additional elements that amount to significantly more than the judicial exception. Since the claim(s) recite a judicial exception and fails to integrate the judicial exception into a practical application, the claim(s) is/are "directed to" the judicial exception. Thus, the claim(s) must be reviewed under the second step of the Alice/ Mayo analysis to determine whether the abstract idea has been applied in an eligible manner.
2(B): The claims do not provide an inventive concept (i.e., The claim(s) do not include additional elements, or combinations of elements, that are sufficient to amount to significantly more than the judicial exception (i.e., abstract idea)). As discussed with respect to Step 2A Prong Two, the additional element(s) in the claim amounts to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
For these reasons, there is no invention concept in the claim, and thus the claim is ineligible.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
classifying, by the prescription management device, medications of the information set into one of a plurality of medication types based on a medication effect/side effect similarity of the plurality of individual embedded values determined based on at least one distance between the plurality of individual embedded values;
generating, by the prescription management device, a plurality of artificial intelligence engines, each of the plurality of artificial intelligence engines generated for a different one of the plurality of medication types;
positioning, by each of the plurality of artificial intelligence engines, the plurality of individual embedded values in the embedded domain;
clustering, by each of the plurality of artificial intelligence engines, the individual embedded values into clusters;
generating, by each of the plurality of artificial intelligence engines, a dense cluster of the plurality of individual embedded values in the clusters based on a clustering range;
determining, by each of the plurality of artificial intelligence engines, a prediction of a change of one of a plurality of effects or a plurality of side effects for the user specific combination of medications based on a concentration of the dense cluster being above a threshold concentration;
generating, by each of the plurality of artificial intelligence engines, each prescription data for the user specific combination of medications based on the prediction;
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shelly et al. US Publication 20220101975 A1 Methods and Systems for Performing Dose Titration
Shelly discloses a computer-implemented method for controlling a dose titration of a medicament to be provided to a subject for treating obstructive sleep apnea. The method includes obtaining a dose level of a previous dose of the medicament, the previous dose having been provided to the subject and obtaining a medicament efficacy measure based on a response of the subject to the previous dose. A dose titration for a future dose of the medicament is determined based on the medicament efficacy measure and the dose level of the previous dose.
Griffin et al. US Publication 20230178253 A1 Machine Learning Method for Identifying Drug Interactions
Griffin discloses a method for identifying drug interactions that occur between various drugs utilized to treat various morbidities. Each drug combination used to treat a morbidity has an efficacy that can be measured relative to a baseline real world efficacy. Differences between effective and ineffective drug combinations are identified and drug interactions are identified based on overlapping drugs in the effective and ineffective combinations.
Peyman et al. US Publication 20220093229 A1 Apparatus and Method for Calculating an Optimum Medication Dose
Peyman discloses an apparatus and method for calculating an optimum medication dose for a patient based on a multiplicity of factors that can affect the medical condition and thus the medication dose. The apparatus includes a trained machine learning based model that can calculate an optimum medication dose based on medication data, diagnostic data, biodata, and plurality of parameters affecting the medical condition. The apparatus can also include a dispenser for dispensing the calculated medication dose.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW L HAMILTON whose telephone number is (571)270-1837. The examiner can normally be reached Monday-Thursday 9:30-5:30 pm EST.
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/MATTHEW L HAMILTON/Primary Examiner, Art Unit 3682
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