DETAILED ACTION
Status of Claims
This action is in reply to the communication filed on 10 February, 2026.
Claims 1, 10, 11, 14 and 18 have been amended.
Claims 2 and 19 have been cancelled.
Claims 1, 3 – 18 and 20 are currently pending and have been examined.
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1, 3 – 18 and 20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claims 1, 14, 18 and 20 recite:
“processing the initial patient data set with a neural network trained, using a set of training data comprising clinical trial criteria, diagnostic data, and/or electronic medical record data, to determine patient eligibility for the medical treatment for the medical condition based on a set of eligibility criteria, said set of eligibility criteria comprising associations between the characteristics and eligibility for the medical treatment, to make an initial provisional determination that the patient is eligible for the medical treatment”.
Examiner cannot determine the metes and bounds of the claim. The claims recite a neural network trained to determine eligibility using training data that includes “clinical trial criteria, diagnostic data, and/or electronic medical record data.” Patient eligibility is determined “based on eligibility criteria comprising associations between characteristics of the patient and eligibility for treatment.” However, the neural network is not trained on “eligibility criteria comprising associations between characteristics and eligibility”; rather the neural network is trained on other data. Examiner cannot determine how a model, trained on clinical trial criteria, diagnostic data, and/or electronic medical record data, can determine eligibility based on associations between characteristics and eligibility. The training data does not include these elements.
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.
The following rejection is formatted in accordance with MPEP 2106.
Claims 1, 3 – 18 and 20 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), and does not include additional elements that either: 1) integrate the abstract idea into a practical application, or 2) that provide an inventive concept – i.e. element that amount to significantly more than the abstract idea. The Claims are directed to an abstract idea because, when considered as a whole, the plain focus of the claims is on an abstract idea.
Claim 1 is representative. Claim 1 recites:
A computer-implemented method of determining a medical treatment of a medical condition for a patient, the method comprising:
obtaining, with data ingestion circuitry, an initial patient data set comprising a plurality of patient values indicative of characteristics of the patient;
processing the initial patient data set with a neural network trained, using a set of training data comprising clinical trial criteria, diagnostic data, and/or electronic medical record data, to determine patient eligibility for the medical treatment for the medical condition based on a set of eligibility criteria, said set of eligibility criteria comprising associations between the characteristics and eligibility for the medical treatment, to make an initial provisional determination that the patient is eligible for the medical treatment independent of the patient's diagnosis of the medical condition in the set of eligibility criteria;
obtaining, with the data ingestion circuitry and in response to a detection that a status of the patient data has changed in an electronic medical records system, an updated patient data set comprising one or more further patient values for the patient;
processing the updated patient data set with the neural network to make an updated provisional determination that the patient is eligible for the medical treatment independent of the patient's diagnosis of the medical condition in the set of eligibility criteria;
obtaining, with the data ingestion circuitry, in response to a detection that a status of diagnosis data has changed in the electronic medical records system, and (iii) subsequent to the updated provisional determination that the patient is eligible for the medical treatment, an indication of a diagnosis of the medical condition for the patient; and
based on the updated provisional determination that the patient is eligible for the medical treatment and (ii) the indication of the diagnosis of the medical condition for the patient, generating a notification of eligibility of the patient for the medical treatment and transmitting said notification through a user interface layer or through a network interface connection to: the patient; and/or a clinician associated with the patient.
Claim 20 recites medium with instructions executed by a processor that executes the steps of the method recited in Claim 1. Claim 14 recites similar limitations for a population of patients instead of a single patient. Claim 18 recites similar limitations specifying prompting for input.
STEP 1
The claims are directed to a method and non-transitory computer readable medium which are included in the statutory categories of invention.
STEP 2A PRONG ONE
The claims, as illustrated by Claim 1, recite limitations that encompass an abstract idea including:
A computer-implemented method of determining a medical treatment of a medical condition for a patient, the method comprising:
obtaining, an initial patient data set comprising a plurality of patient values indicative of characteristics of the patient;
processing the initial patient data set to determine patient eligibility for the medical treatment for the medical condition based on a set of eligibility criteria, said set of eligibility criteria comprising associations between the characteristics and eligibility for the medical treatment, to make an initial provisional determination that the patient is eligible for the medical treatment independent of the patient's diagnosis of the medical condition in the set of eligibility criteria;
obtaining in response to a detection that a status of the patient data has changed in an electronic medical records system, an updated patient data set comprising one or more further patient values for the patient;
processing the updated patient data set to make an updated provisional determination that the patient is eligible for the medical treatment independent of the patient's diagnosis of the medical condition in the set of eligibility criteria;
obtaining in response to a detection that a status of diagnosis data has changed in the electronic medical records system, and subsequent to the updated provisional determination that the patient is eligible for the medical treatment, an indication of a diagnosis of the medical condition for the patient; and
based on the updated provisional determination that the patient is eligible for the medical treatment and the indication of the diagnosis of the medical condition for the patient, generating a notification of eligibility of the patient for the medical treatment.
The claims, as illustrated by Claim 1, recite limitations that encompass an abstract idea within the “certain methods of organizing human activity” grouping
- 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.
The claims recite a process for determining a patient’s eligibility for a “medical treatment” by applying eligibility criteria to a data set of patient values. The eligibility criteria is reapplied in response to detecting changes in the patient data. A clinician is notified to provide the “treatment” to an eligible patient who has an indicated diagnosis. The claimed “medical treatment” is described in the specification broadly, such as : “a cancer treatment . . . treatment for sepsis, neurological conditions such as multiple sclerosis or Parkinson’s disease, dementia, and or cardiovascular disease”. “The medical treatment may comprise enrolment in a medical trial for a cancer treatment.” The broadest reasonable interpretation of the claims includes determining if a patient is eligible for a clinical trial by comparing the patient’s data with inclusion and/or exclusion criteria of the trial. This process is typical in medicine, where a doctor may determine if the patient is eligible for participation in a clinical trial. Repeatedly comparing patient data, as well as changes in patient data, to eligibility criteria is process that merely organizes this human activity. (See MPEP 2016.04 (a)(2) II C finding that “a mental process that a neurologist should follow when testing a patient for nervous system malfunctions” is a method of organizing human activity, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982). The specification describes how clinicians determine if patients could be eligible for a clinical trial and information the patient of their eligibility. (@ 0003) As such, the claims recite an abstract idea within the certain methods of organizing human activity grouping.
The claims, as illustrated by Claim 1, recite limitations that encompass an abstract idea within the “mental processes” grouping – concepts performed in the human mind including observation, evaluation, judgment and opinion. The broadest interpretation of the claims include applying (and reapplying) eligibility criteria to values in a patient’s data set to determine eligibility for enrolment in a clinical trial. The specification discloses that a “matching algorithm” may be employed to determine if eligibility criteria is met. (@ 0011) Comparing eligibility criteria, such as inclusion and/or exclusion criteria for a clinical trial, is a process that, except for generic computer implementation steps, can be performed in the human mind. For example, comparing eligibility criteria such as “age, biological sex, comorbidities, diagnosis, treatments to date, allergies, etc.” to values in a patient data set is a process that can be performed in the human mind. The claims collect (i.e. obtaining) and analyze information to obtain a result.
Collecting information, including when limited to particular content, is within the realm of abstract ideas, and analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, are mental processes within the abstract idea category (Electric Power Group v. Alstom S.A. (Fed Cir, 2015-1778, 8/1/2016).
As such, the claims recite an abstract idea within the mental process grouping.
STEP 2A PRONG TWO
The claims recite additional limitations having elements beyond those that encompass the abstract idea above including:
A computer-implemented method;
data ingestion circuitry;
a neural network trained, using a set of training data comprising clinical trial criteria, diagnostic data, and/or electronic medical record data;
transmitting said notification through a user interface layer or through a network interface connection to: the patient; and/or a clinician associated with the patient.
However, these additional elements do not integrate the abstract idea into a practical application of that idea in accordance with the MPEP. (see MPEP 2106.05)
The computer that implements the method, together with the associated data ingestion circuitry, and user interface/network interface are recited at a high level of generality such that it amounts to no more than instructions to apply the abstract idea using a generic computer components. These elements merely add instructions to implement the abstract idea on a computer, and generally link the abstract idea to a particular technological environment.
The claims further recite a neural network trained with training data. However, the claims replace the knowledge and experience of a clinician by applying established methods of machine learning to an abstract treatment eligibility (i.e. clinical trial eligibility) determining process in a new data environment – i.e. applying a trained model to compare the eligibility criteria to the patient data set. The specification teaches that the model may be trained to determine that the patient is eligible based on one or more eligibility criteria being met. (@ 0011, 0084, 0085). Machine learning limitations reciting broad, functionally described, well-known techniques executed by generic and conventional computing devices, as in the claims here, does not provide a practical application of the abstract diagnostic process. “Today we hold only that patents that do no more than claim the application of generic machine learning to new data environments, without disclosing improvements to the machine learning models to be applied, are patent ineligible under §101.” (Recentive Analytics, Inc. v. Fox Corp. (Fed. Cir. 2025)).
Similarly, transmitting and displaying the results of the abstract process does not improve the computer itself, or any other technology, nor does the display of results provide a meaningful limitation beyond generally linking the abstract idea to a particular technological environment.
Nothing in the claim recites specific limitations directed to an improved technological process. Similarly, the specification is silent with respect to these kinds of improvements. A general purpose computer that applies a judicial exception by use of conventional computer functions, as is the case here, does not qualify as a particular machine, nor does the recitation of a generic computer impose meaningful limits in the claimed process. (see Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17 (Fed. Cir. 2014)). As such, the additional elements recited in the claim do not integrate the abstract eligibility determination process into a practical application of that process.
STEP 2B
The additional elements identified above do not amount to significantly more than the abstract eligibility determination process. Obtaining information, for example over a network, is a well-understood, routine and conventional computer function – i.e. receiving or transmitting data over a network as in Symantec, TLI, OIP and buySAFE. The specification discloses obtaining the recited information from a conventional EMR over a network. Displaying the results of the abstract process is an ancillary part of the abstract process itself as in Electric Power Group.
The additional structural elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generic computer structure (i.e. a computer, data ingestion circuitry, user/network interface). Each of the above components are disclosed in the specification as being purely conventional and/or known in the industry. Because the specification describes these additional elements in general terms, without describing particulars, Examiner concludes that the claim limitations may be broadly, but reasonably construed, as reciting well-understood, routine and conventional computer components and techniques. The specification describes the elements in a manner that indicates that they are sufficiently well-known that the specification does not need to describe the particulars in order to satisfy U.S.C. 112. Considered as an ordered combination the limitations recited in the claims add nothing that is not already present when the steps are considered individually. As such, the additional elements recited in the claim do not provide significantly more than the abstract eligibility determination process, or an inventive concept.
The dependent claims add additional features including:
those that merely serve to further narrow the abstract idea above such as:
further limiting the type of treatment (Claim 4, 16);
further limiting the type of patient values (Claim 8, 17);
further limiting the how patient values are obtained (Claim 9 - 13);
those that recite additional abstract ideas such as:
continually monitoring patient status (Claim 3);
obtaining an outcome, adjusting treatment, adjusting eligibility criteria based on the outcome (Claim 5 - 7);
reapplying the model at various times (Claim 12).
The limitations recited in the dependent claims, in combination with those recited in the independent claims add nothing that integrates the abstract idea into a practical application, or that amounts to significantly more. As such, the additional element do not integrate the abstract idea into a practical application, or provide an inventive concept that transforms the claims into a patent eligible invention.
The apparatus claims are no different from the method claims in substance. “The equivalence of the method, system and media claims is readily apparent.” “The only difference between the claims is the form in which they were drafted.” (Bancorp). The method claims recite the abstract idea implemented on a generic computer, while the apparatus claims recite generic computer components configured to implement the same idea. Specifically, Claim 20 merely adds the generic hardware noted above that nearly every computer will include. The apparatus claim’s requirement that the same method be performed with a programmed computer does not alter the method’s patentability under U.S.C. 101 (In re Grams). Therefore, the claims are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
The Prior Art
The prior art does not disclose a system and method for using machine learning to determine patient eligibility for a treatment or clinical trial, where an initial provisional determination is made; and when patient data is updated an updated provisional determination is made, both independent of the patient’s diagnosis. An eligibility determination is made based on obtaining an indication of a diagnosis for the patient.
Response to Arguments
The U.S.C. §112 Rejection
Applicant’s amendment and arguments, with respect to the U.S.C. §112 rejection have been fully considered and are persuasive. The rejection has been withdrawn. However, the amended claims present additional issues under this Section, as shown above.
The U.S.C. §101 Rejection
Applicant asserts an improvement to medical treatment eligibility determination technology through use of a trained neural network – i.e. the claims enable accelerated eligibility determinations. The trained neural network is trained using clinical trial criteria comprising diagnostic data; however, what data elements comprise diagnostic data is not disclosed. Similarly, the neural network is trained using EMR data which has many elements disclosed in the specification; however, none of which are claimed. While the claims assert a particular machine learning model, they do not indicate specific input data elements used for training. The claims do not even positively recite training the neural network. Finally, the patient data (both initial and updated) is processed by the neural network; however, the neural network has not been trained using “patient values indicative of characteristics of the patient”, or even eligibility criteria. Using a neural network to accelerate eligibility determinations simply make the execution of the abstract process faster.
CONCLUSION
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US PGPUB 2020/0381087 A1 to Ozeran et al. discloses a system and method for managing a clinical trial, including matching patients eligible for a clinical trial and updating eligibility when patient data is updated (@ 0294).
“Clinical Trial Basics: Pre-Screening and Screening”; WithPower.com; discloses a system and method for pre-screening clinical trial candidates based on basic information about the candidate, and before any diagnostic procedures or tests are conducted.
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 extension fee 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 date of this final action.
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to John A. Pauls whose telephone number is (571) 270-5557. The Examiner can normally be reached on Mon. - Fri. 8:00 - 5:00 Eastern. If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773.
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/JOHN A PAULS/Primary Examiner, Art Unit 3683
Date: 17 March, 2026