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 Claims
This action is a final rejection
Claims 1-2, 4, 8, 11, 13, 18-19, 21, 23, 25, 27-28, 30, 35, 38-39, 42-44 are pending
Claims 3, 5-7, 9-10, 12, 14-17, 20, 22, 24, 26, 29, 31-34, 36-37, 40-41 were cancelled
Claims 1, 4, 11, 13, 18-19, 21, 23, 25, 27-28, 30, 38-39 were amended
Claims 42-44 were added
Claims 1-2, 4, 8, 11, 13, 18-19, 21, 23, 25, 27-28, 30, 35, 38-39, 42-44 are rejected under 35 USC § 101
Priority
Acknowledgement is made of Applicant’s claim for a foreign priority date of 10-24-2023
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6-9-2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-2, 4, 8, 11, 13, 18-19, 21, 23, 25, 27-28, 30, 35, 38-39, 42-44 are not patent eligible because the claimed invention is directed to an abstract idea without significantly more.
Analysis
First, claims are directed to one or more of the following statutory categories: a process, a machine, a manufacture, and a composition of matter. Regarding claims 1-2, 4, 8, 11, 13, 18-19, 21, 23, 25, 27-28, 30, 35, 38-39, 42-44 the claims recite an abstract idea of “performing a clinical assessment”.
Independent Claims 1, 39 and 44 are rejected under 35 U.S.C 101 based on the following analysis.
-Step 1 (Does the claim fall within a statutory category? YES): claims 1, 39 and 44 recite respectively a method and system of “performing a clinical assessment”.
-Step 2A Prong One (Does the claim fall within at least one of the groupings of abstract ideas?: YES): The claimed invention:
A method and system comprising:
providing a first input to an .. model, wherein the .. model is a .. model for automating instruction of one or more tasks of the clinical assessment, the first input comprising template data administering a part of the clinical assessment, the template data encoding information defining one or more of a structure of the clinical assessment, intended content of the clinical assessment, or instructions for administering the part of the clinical assessment;
receiving a real-time stream of assessment data during the clinical assessment, the assessment data comprising one or more of text, audio, video, or image data encoding a response of a participant in the clinical assessment to a task of the clinical assessment
inputting sequential sections of the assessment data as a second input to the
wherein the first input is provided to the map one or more of the sequential sections of the assessment data, in view of the template data, to usable to initiate an action to administer
wherein the action comprises one or more of: waiting for a further response from the participant; prompting the participant for more information; outputting a task or question based on the template data; initiating an external program or operation; or updating a persistent state of the .. model, the persistent state encoding a current position in the clinical assessment; and
using the output from the administer the clinical assessment in real time.
belonging to the grouping of mental processes under concepts performed in the human mind (including an observation, evaluation, judgement, opinion) as it recites “performing a clinical assessment”. Alternatively, the selected abstract idea belongs to the grouping of certain methods of organizing human activity under managing personal behavior or relationships or interactions between people as it recites “performing a clinical assessment”. (refer to MPP 2106.04(a)(2)). Accordingly this claim recites an abstract idea.
-Step 2A Prong Two (Are there additional elements in the claim that imposes a meaningful limit on the abstract idea? NO).
Claims 1, 39 and 44 recite:
administration model
machine learning model;
Claim 39 recites
a processor
Claim 44 recites:
computer
Amounting to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, these additional elements, when considered separately and as an ordered combination do not integrate the judicial exception/abstract idea into a “practical application” of the judicial exception because they do not impose any meaningful limit on practicing the judicial exception.
-Step 2B (Does the additional elements of the claim provide an inventive concept?: NO. As discussed previously with respect to Step 2A Prong Two,
Claims 1, 39 and 44 recite:
administration model
machine learning model;
Claim 39 recites
a processor
Claim 44 recites:
computer;
Amounting to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)) Accordingly, even when viewed as a whole the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
Dependent Claims:
Step 2A Prong One: The following dependent claims recites additional limitations that further define the abstract idea of “performing a clinical assessment”: claims 1-2, 4, 8, 11, 13, 18-19, 21, 23, 25, 27-28, 30, 35, 38-39, 42-44.
Step 2A Prong Two (Are there additional elements in the claim that imposes a meaningful limit on the abstract idea? NO). The following dependent claims 1-2, 4, 11, 13, 18, 21, 23, 25, 27-28, 30, 39, 44 amount to no more than mere instructions to apply the exception using a generic computer, or merely using a computer as a tool to implement the abstract idea as even in combination, these additional elements do not integrate the abstract idea into a practical application and do not amount to significantly more than the abstract idea itself. (refer to MPEP 2106.05(f)). Accordingly, the claims as a whole do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea:
Step 2B (Does the additional elements of the claim provide an inventive concept?: NO). As discussed previously with respect to Step 2A Prong Two, the following dependent claims 1-2, 4, 11, 13, 18, 21, 23, 25, 27-28, 30, 39, 44 amount to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, the additional elements alone, and in combination do not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure, and is listed in the attached form PTO-892 (Notice of References Cited). Unless expressly noted otherwise by the Examiner, all documents listed on form PTO-892 are cited in their entirety.
Nakasian (US 20250125007 A1) -- COMPUTING SYSTEM FOR CUSTOMIZING AND DEFINING PARAMETERS OF A MEDICAL-BASED ANALYSIS SYSTEM - teaches: receiving data from at least one health database, performing a large language model (LLM) routine to transform the data into structured data, generating a phenotype routine by selectively modifying at least one parameter of a selected template phenotype routine of the plurality of template phenotype routines, analyzing the structured data based on the phenotype routine to generate an output that defines a relationship model associated with the structured data, and transmitting a command to a user interface to generate a display corresponding to the output.
Irimia (US 20250104240 A1) - PERSONALIZED PROFILING OF FUTURE BRAIN TRAJECTORIES AND FUTURE DISEASE EVOLUTION USING GENERATIVE ARTIFICIAL INTELLIGENCE - teaches: conducting anatomically interpretable deep learning of brain age that captures domain-specific cognitive impairment. By performing personalized profiling of future brain trajectories using generative artificial intelligence, the system facilitates early identification of neuroanatomy changes to screen individuals according to risk of neurocognitive impairments. A system may implement a generative AI model and may receive a plurality of brain data sets, extract various maps of a subject brain, and determine a salience probability map of future brain trajectory or future brain disease biomarkers based thereon. Moreover, the generative AI model may compute a training objective and the model may update based on the training objective.
Garcia (WO 2024059869 A1) -MEDICAL VISIT RECORDING SYSTEM - teaches: A system for creating a recording of a consultation between a user and a subject, and for transmitting the recording to the subject or to a secure database. The system may be implemented on an application, such as an application for mobile devices or a web application. In a primary context, the consultation is a medical consultation between a medical practitioner and a patient. In this context, the details of a medical visit can be recorded for the patient to better retain and understand complex medical information, and for the physician to have a record to avoid later disputes. The system may be implemented as part of an electronic medical records database
Neumann (US 20240296348 A1) - ARTIFICIAL INTELLIGENCE ADVISORY SYSTEMS AND METHODS FOR BEHAVIORAL PATTERN MATCHING AND LANGUAGE GENERATION – teaches: An artificial intelligence system for behavioral pattern matching and language generation includes at least a server. The system includes a behavior modification module operating on the at least a server, wherein the behavior modification module is designed and configured to receive at least a request for a behavior modification and generate a behavior modification model as a function of the at least a request for behavior modification. The system includes an artificial intelligence advisor operating on the at least a server, wherein the artificial intelligence advisor is configured to receive at least a user input from a user client device, generate at least a textual output using the behavior modification model and the at least a user input, and transmit the at least a textual output to the user client device.
KATZMANN (EP 4462445 A1) - METHOD FOR PROVIDING MEDICAL IMAGING DECISION SUPPORT DATA - teaches: a computer-implemented method for providing medical imaging decision support data, the method comprising:- receiving natural language data, the natural language data comprising patient-specific clinical information,- generating structured information by applying a large language model onto the natural language data, the structured information comprising the patient-specific clinical information in a structured format,- calculating the medical imaging decision support data based on the structured information, and- providing the medical imaging decision support data.
Response to Arguments
Applicant's arguments filed 5-20-2026, have been fully considered but not found
persuasive.
Applicant amended independent claim 1, 39, 44 in addition to dependent claims 4, 11, 13, 18-19, 21, 23, 25, 27-28, 30, 38, cancelled claims 3, 5-7, 9-10, 12, 14-17, 20, 22, 24, 26, 29, 31-34, 36-37, 40-41, and added claim 42-44, as posted in the above analysis with additions underlined and deletions as .
In response to applicant's arguments regarding claim rejection under 35 U.S.C § 101.
Several steps are taken in the analysis as to whether an invention is rejected under 101. The first step is to determine if the claim falls within a statutory category. In this case it does for claims 1, 39, 44 since the claims recite “performing a clinical assessment”.
The second step under 2A prong one is to determine if the claims recite an abstract idea, which would be the case if the invention can be grouped as either: a) mathematical concepts; (b) mental processes; or (c) certain methods of organizing human activity (encompassing (i) fundamental economic principles, (ii) commercial or legal interactions or (iii) managing personal behavior or relationships or interactions between people). The current invention is classified as an abstract idea since it may be grouped as mental processes under concepts performed in the human mind (including an observation, evaluation, judgement, opinion) as it recites “performing a clinical assessment”. Alternatively, the selected abstract idea belongs to the grouping of certain methods of organizing human activity under managing personal behavior or relationships or interrelations between people as it recites “performing a clinical assessment”.
The third step under 2A Prong Two is to determine if additional elements in the claim imposes a meaningful limit on the abstract idea in order to integrate it into a practical idea. The current invention does not represent a practical idea since the additional elements amount to mere instructions to implement an abstract idea on a computer, or merely use a generic computer as a tool to implement the abstract idea.
the fourth step under 2B is to determine if additional elements of the claim provide an inventive concept. An invention may be classified as an inventive concept if a computer-implemented processes is determined to be significantly more than an abstract idea (and thus eligible), where generic computer components are able in combination to perform functions that are not merely generic, and non-conventional even if generic computer operations on a generic computing device is used to implement the abstract idea.
Step 2A Prong ONE
The Applicant argues that independent claim 1 is not an abstract idea since the steps of amended claim 1 are not practically performable in the human mind. While a human clinician may follow an assessment protocol and may decide how to continue an interview, a human mind cannot input sequential sections of a real-time stream of text, audio, video, or image data into a machine-learning administration model; condition that model using template data defining assessment structure, intended content, or administration instructions; map the sequential sections, in view of the template data, to outputs; and use those outputs to initiate computer-controlled administration actions in real time as in amended claim 1. These are machine data-processing and control operations, not mental observations. This ordered sequence of steps defines a real-time control loop for administering the assessment, rather than a purely mental clinical judgement.
The Examiner disagrees since the Applicant’s argument is not persuasive. The method to select the abstract idea is to strip the additional elements from the claims. The Arguments presented by the Applicant is one where additional elements are interspersed with the abstract idea, and for the sake of the analysis they need to be separated out as explained below.
As seen below the recited boldened words constitute the abstract idea after stripping the un-boldened additional elements of amended limitation of claim 1, 39, 44:
providing a first input to an administration model, wherein the administration model is a machine learning model for automating instruction of one or more tasks of the clinical assessment, the first input comprising template data for administering a part of the clinical assessment, the template data encoding information defining one or more of a structure of the clinical assessment, intended content of the clinical assessment, or instructions for administering the part of the clinical assessment;
receiving a real-time stream of assessment data during the clinical assessment, the assessment data comprising one or more of text, audio, video, or image data encoding a response of a participant in the clinical assessment to a task of the clinical assessment
inputting sequential sections of the assessment data as a second input to the administration model;
wherein the first input is provided to the administration model to condition the administration model to map one or more of the sequential sections of the assessment data, in view of the template data, to an output usable to initiate an action to administer the clinical assessment;
wherein the action comprises one or more of: waiting for a further response from the participant; prompting the participant for more information; outputting a task or question based on the template data; initiating an external program or operation; or updating a persistent state of the administration model, the persistent state encoding a current position in the clinical assessment; and
using the output from the administration model to administer the clinical assessment in real time
The selected abstract idea (boldened limitations) of claims 1, 39, 44 belong to the grouping of mental processes under concepts performed in the human mind (including an observation, evaluation, judgement, opinion) as it recites “performing a clinical assessment”. Alternatively, the selected abstract idea belongs to the grouping of certain methods of organizing human activity under managing personal behavior or relationships or interactions between people as it recites “performing a clinical assessment”. (refer to MPP 2106.04(a)(2)). Accordingly this claim recites an abstract idea.
Step 2A Prong TWO
The Applicant argues that even if the amended claims 1 recites an abstract idea, they recite additional elements that integrate the judicial exception into a practical application. The Applicant submits that claim 1, as a whole, is more than just including additional elements that are merely generic computer implementation. The Applicant argues that claim 1 is directed to a particular technological implementation for real-time, template-conditioned administration of a clinical assessment. Specifically the Amended claim 1 amended claim 1 integrates any alleged mental process into the practical application of reducing errors and inconsistencies in performing clinical assessments. Using a machine-learning administration model to control the progression of the clinical assessment in real time reduces these errors, increases consistency, and reduces the time needed to perform the clinical assessment. In addition, the template conditioning of amended claim 1 improves the administration model’s ability to interpret assessment data and generate outputs tailored to the assessment context. Amended claim 1 is patent eligible at least because it provides these technical improvements to the task of performing a clinical assessment. The other pending claims are patent eligible for at least the same reason
The Applicant concludes that amended claim 1 "as a whole integrates the judicial exception into a practical application such that the claim is not directed to the judicial exception."
The Examiner disagrees since the Applicant’s arguments are not persuasive. The Applicant cites the advantages of the invention, namely that the invention reduces errors and inconsistencies in performing clinical assessments, and the use of a machine-learning administration model controls the progression of the clinical assessment in real time reduces these errors, increases consistency, and reduces the time needed to perform the clinical assessment, in addition to improving the administration model’s ability to interpret assessment data and generate outputs tailored to the assessment context. These advantages may be described colloquially as a practical application. Nevertheless the claims describe how the additional elements implement the abstract idea without describing any technological improvement pertaining to these additional elements. In other words these additional elements are just generic as described in the claims which is not enough to determine that the invention is a practical application.
The Examiner restates that claims 1, 39, 44 do not integrate the abstract idea into a practical application. Specifically claims 1, 39, 44 do not recite additional elements that impose a meaningful limit on the abstract idea:
Claims 1, 39 and 44 recite:
administration model
machine learning model;
Claim 39 recites
a processor
Claim 44 recites:
computer
The additional elements as recited above amount to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, the claim as a whole does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
In order to integrate the abstract idea into a practical application the additional elements should be shown to impose a meaningful limit on the abstract idea which is not the case in this invention. A colloquial interpretation of a practical application is not enough.
In order to integrate the abstract idea into a practical idea the Applicant could demonstrate at least one of the conditions enumerated below applies:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
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 - see MPEP 2106.05(e) and Vanda Memo
The Applicant has not demonstrated any of the above listed conditions. As a result the Examiner restates the rejection of the invention under 35 USC §101.
Step 2B
Similar to the analysis under Step 2A Prong Two, the additional elements amount to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). The use of generic computer components, in combination, do not perform functions that are not merely generic, and non-conventional even if the generic computer operations on a generic computing device is used to implement the abstract idea. Accordingly, the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
In order evaluate whether the claim recites additional elements that amount to an inventive concept what could be shown is:
Adding a specific limitation (unconventional other than what is well-understood, routine, conventional (WURC) activity in the field - see MPEP 2106.05(d)
The Applicant has not demonstrated the above listed condition.
In response to applicant's arguments regarding claim rejection under 35 U.S.C § 103
The closest prior art of record noted above under “Prior Art Made of Record” fail to expressly teach or suggest, either alone or in combination, the features found within the independent claims (Claim 1 recited here as representative with the underlined sections representing the amendments). In particular, the closest prior art of record fails to expressly teach or suggest the combination of:
providing a first input to an administration model, wherein the administration model is a machine learning model for automating instruction of one or more tasks of the clinical assessment, the first input comprising template data for administering a part of the clinical assessment, the template data encoding information defining one or more of a structure of the clinical assessment, intended content of the clinical assessment, or instructions for administering the part of the clinical assessment;
receiving a real-time stream of assessment data during the clinical assessment, the assessment data comprising one or more of text, audio, video, or image data encoding a response of a participant in the clinical assessment to a task of the clinical assessment
inputting sequential sections of the assessment data as a second input to the administration model;
wherein the first input is provided to the administration model to condition the administration model to map one or more of the sequential sections of the assessment data, in view of the template data, to an output usable to initiate an action to administer the clinical assessment;
wherein the action comprises one or more of: waiting for a further response from the participant; prompting the participant for more information; outputting a task or question based on the template data; initiating an external program or operation; or updating a persistent state of the administration model, the persistent state encoding a current position in the clinical assessment; and
using the output from the administration model to administer the clinical assessment in real time.
Therefore, the claims of the instant application are novel and unobvious.
Foreign prior art and NPL search was conducted however no relevant prior art was found.
For reasons of record and as set forth above, the examiner maintains the rejection of claims 1-2, 4, 8, 11, 13, 18-19, 21, 23, 25, 27-28, 30, 35, 38-39, 42-44 as being directed to a judicial exception without significantly more, and thereby being directed to non-statutory subject matter under 35 USC §101. In reaching this decision, the Examiner considered all evidence presented and all arguments actually made by Applicant.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 PIERRE L MACCAGNO whose telephone number is (571)270-5408. The examiner can normally be reached M-F 8:00 to 5:00.
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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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/PIERRE L MACCAGNO/Examiner, Art Unit 3687
/WINSTON R FURTADO/Primary Examiner, Art Unit 3687
