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 .
In view of the Appeal Brief filed on August 02/19/2026, PROSECUTION IS HEREBY REOPENED. A new grounds of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686
Status of claims
Claims 1-15 have been 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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claim 1 recite(s) a method for generating a dosing protocol for an individual, which is within a statutory category (process). Claim 6 recite(s) a non-transitory medium which is within a statutory category (manufacture). Claim 11 recite(s) an apparatus which is within a statutory category (machine)
Step 2A - Prong One:
Regarding Prong One of Step 2A (MPEP2106.04-07), the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes.
The limitation of Independent claims 1-15 recites at least one abstract idea. Specifically, claim 1 recites the steps of
A method executed automatically on a processor for generating a dosing protocol for an individual subject, the method comprising:
receiving first data that indicates, for a dose response to a medicament, a non-linear mixed effects (NLME) model of a population with at least one distribution parameter characterizing variations in the population based on an observable property of individuals within the population wherein at least one of a structural model or a dynamical model of the NLME model is based on training weights of a universal approximator on a least a subset of the population;
evaluating for a candidate dose regimen an expected response by a subject based on the NLME model and one or more properties of the subject; and
when the expected response is therapeutic, causing the candidate dose regime of the medicament to be administered to the subject.
The limitations “receiving first data that indicates, for a dose response to a medicament, a non-linear mixed effects (NLME) model of a population with at least one distribution parameter characterizing variations in the population based on an observable property of individuals within the population wherein at least one of a structural model or a dynamical model of the NLME model is based on training weights of a universal approximator on a least a subset of the population” constitutes (b) certain methods of organizing human activity (e.g. fundamental economic principles or practice including hedging, insurance, mitigating risk; etc., commercial or legal interactions including agreements in the form of contracts, etc., managing personal behavior or relationships or interactions between people including social activities, teaching, following rules or instruction, etc.) because this limitation could be performed by the clinic professionals, the users to provide the medication model based on a dose response …. Accordingly, the claim is directed toward at least one abstract idea.
Furthermore, the abstract idea for claims 6, 11 is identical as the abstract idea from claim 1 because the only difference between claims 1, 6, 11 is that claim 1 recites a method, whereas claim 6 recites a non-transitory media, whereas claim 11 recites an apparatus.
Furthermore, the following depending claims further define the at least one abstract idea, and thus fail to make the abstract idea any less abstract.
Dependent claim 2-5. 7-10, 12-15 recite further the use of neural network, training fixed effect, linear or non-linear models, as being part of the abstract idea, and thus part of a certain organizing of human activity
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim, as a whole, integrates the abstract idea into a practical application. As noted in MEPE2106.04-06, it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
In the present case, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
Claim 1 recites
A method executed automatically on a processor for generating a dosing protocol for an individual subject, the method comprising:
receiving first data that indicates, for a dose response to a medicament, a non-linear mixed effects (NLME) model of a population with at least one distribution parameter characterizing variations in the population based on an observable property of individuals within the population wherein at least one of a structural model or a dynamical model of the NLME model is based on training weights of a universal approximator on a least a subset of the population;
evaluating for a candidate dose regimen an expected response by a subject based on the NLME model and one or more properties of the subject; and
when the expected response is therapeutic, causing the candidate dose regime of the medicament to be administered to the subject.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the limitation “receiving first data that indicates, for a dose response to a medicament, a non-linear mixed effects (NLME) model of a population with at least one distribution parameter characterizing variations in the population based on an observable property of individuals within the population wherein at least one of a structural model or a dynamical model of the NLME model is based on training weights of a universal approximator on a least a subset of the population”, this is a pre-solution activity. The examiner submits that this additional limitation merely adds insignificant extra-solution activity to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract (using a computer as tools to carry out the abstract idea as noted below, See MPEP 2106.05(f)).
Regarding the additional limitation of ” evaluating for a candidate dose regimen an expected response by a subject based on the NLME model and one or more properties of the subject; and
when the expected response is therapeutic, causing the candidate dose regime of the medicament to be administered to the subject”, this is a post-solution activity. The examiner submits that this additional limitation merely adds insignificant extra-solution activity of gathering data to the at least one abstract idea in a manner of post solution activity that does not meaningfully limit the at least one abstract idea ((merely data gathering steps as noted, see MPEP 2106.05(g))).
Particularly, the use of a processor in the preamble, the application on a non-linear mixed effects (NLME) model, Neural Network, etc.. such a high level of generality that it represents mere instructions to implement an abstract idea MPEP 2106.05(f).
Dependent claims 9, 16 recites, the use of neural network, non-linear model is not positively claimed in the claim as it defines the service but is claimed at such a high level of generality that it represents mere instructions to implement an abstract idea MPEP 2106.05(f)
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to implement and revise a wellbeing plan, a productivity, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use 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 not more than a drafting effort designed to monopolize the exception (see 2019 PEG and MPEP § 2106.05).
For these reasons, representative independent claims 1-15 do not recite additional elements that integrate the judicial exceptions into a practical application. (The Examiner notes the mere recitation of a processor, a non-linear mixed effects (NLME) model, neural network model does not take the claim out of the mental process grouping or organizing human activity. Thus the claim recites an abstract idea)
The remaining dependent claim limitations are not addressed above fail to integrate the abstract idea into a practical application
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Step 2B:
Regarding Step 2B, independent claims 1, 6, 11 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
For claims 1-15 limit the use of a computer device, a processor, a non-linear mixed effects (NLME) model, etc.... The specification merely describes the use of these computing components. The Examiner submits that these limitations amount to merely using these computer devices as well-understood, routine, conventional activity (Berkheimer v. HP, Inc., 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. 2018).), and MPEP 2106.05(d)(I)(2). Further the use of generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patient-ineligible abstract idea into a patent-eligible invention”).
For the reasons stated, the claims fail the Subject Matter Eligibility Test and are consequently rejected under 35 USC 101. Therefore, claims 1-33 are held ineligible under 35USC101.
Response to Arguments
Applicant’s arguments, see Appel Briefs, filed 01/30/2026, with respect to claim rejection under 35USC103 have been fully considered and are persuasive. The combined art Gobburu/Ashraf Hafez fails to disclose wherein at least one of a structural model or a dynamical model of the non-linear mixed model is an universal Approximator trained trained on at least a subset of the population. The claim rejection under 35USC103 has been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US6658396B1, Dec. 2, 2003; Tang et al.; Neural Network Drug Dosage Estimation.
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/HIEP V NGUYEN/Primary Examiner, Art Unit 3686
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