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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/18/2026 has been entered.
Response to Arguments
Claim Objection:
Applicant's arguments filed 06/18/2026 have been fully considered.
Applicant argues that in light of the amendment the objection should be withdrawn. In light of the amendments, the objection is withdrawn.
Rejection Under 101:
Applicant's arguments filed 06/18/2026 have been fully considered.
Applicant argues that the claims recite a particular technical architecture through which information is structured, processed, and evaluated within the claimed system.
In response to Applicant’s arguments, any improvement is an improvement to the abstract idea. The additional elements (bolded below) amount to nothing more than merely invokes use of computer and other machinery as a tool to carry out the abstract idea. See the rejection below.
Applicant argues that claims recite specific LLM-agent architecture that imposes meaningful limits on the abstract idea and recites a practical application.
In response to Applicant’s arguments, as discussed in the claim interpretations the LLM agents are construed as software being carried out by a processor. “Merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection.” See MPEP 2106.05(b)(I). Thus the use of the LLM agents do not amount to a particular machine nor a practical application. Additionally, Applicant did not address the claim interpretation in the Remarks and therefore is understood to mean they do not disagree with the interpretation. See the updated rejection in light of the amendments.
Applicant argues that the claims recite an ordered combination of technical operations and components that impose meaningful limits on the claims and define a specific computerized architecture for ED patient flow processing. The claims do not merely apply the abstract idea on a generic computer but integrate the abstract idea into a practical application.
In response to Applicant’s arguments, the additional elements (bolded below) amount to nothing more than merely invokes use of computer and other machinery as a tool to carry out the abstract idea. As previously discussed, the specific agents are merely interpreted as software and a processor. The other additional elements are also recited at a high level of generality and used for their intended purposes. Thus the additional elements do not amount to a practical application. See the rejection below.
Applicant argues that the similar to Example 42, the claims integrate the abstract idea into a practical application through specific computer-implemented medical-information processing architecture.
In response to Applicant’s argument, as discussed above the additional elements amount to nothing more than merely invoking the use of computer and other machinery as a tool to carry out the abstract idea. For example, the LLM-agents are interpreted as software and a processor, which is being used for their intended use. Therefore due to this recited high level of generality the additional elements do not amount to a specific architecture or a practical application. See the updated rejection below for further clarification.
Applicant argues that the amended claims recite significantly more than the abstract idea. The ordered combination requires more than applying generic computer to an abstract patient management workflow. The claims require structured representations with a defined scheme and an evaluation LLM agent for reviewing the operation and output against defined objectives.
In response to Applicant’s argument, the additional elements (bolded below) amount to nothing more than merely invokes use of computer and other machinery as a tool to carry out the abstract idea. As previously discussed, the specific agents are merely interpreted as software and a processor. The other additional elements are also recited at a high level of generality and used for their intended purposes. Thus the additional elements do not amount to significantly more than the abstract idea. See the rejection below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Regarding Claim 48, 67-68 – The claim recites “background LLM-based agent, configured to provide queries...” See MPEP 2181. The claim limitation uses the term “background LLM-based agent.” The “background LLM-based agent” is modified by functional language “configured to provide queries….” The “background LLM-based agent” is not modified by sufficient structure, material or act for performing the claim. Therefore 112(f) is invoked. See Spec. pg. 14-15 describes the agent relates to software with a reasoning engine, which is construed as a processor shown in Fig. 1. For examination purposes the background LLM-based agent is construed to be software carried out by hardware such as a processor.
Regarding Claim 48, 67-68 – The claim recites “anamnesis LLM-based agent configured to provide queries related to complaint...” See MPEP 2181. The claim limitation uses the term “background LLM-based agent.” The “anamnesis LLM-based agent” is modified by functional language “configured to provide queries….” The “anamnesis LLM-based agent” is not modified by sufficient structure, material or act for performing the claim. Therefore 112(f) is invoked. See Spec. pg. 14-15 describes the agent relates to software with a reasoning engine, which is construed as a processor shown in Fig. 1. For examination purposes the anamnesis LLM-based agent is construed to be software carried out by hardware such as a processor.
Regarding Claim 48, 67-68 – The claim recites “generating potential diagnosis utilizing a diagnosis LLM-based agent...” See MPEP 2181. The claim limitation uses the term “diagnosis LLM-based agent.” The “diagnosis LLM-based agent” is modified by functional language “generating potential diagnosis….” The “diagnosis LLM-based agent” is not modified by sufficient structure, material or act for performing the claim. Therefore 112(f) is invoked. See Spec. pg. 14-15 describes the agent relates to software with a reasoning engine, which is construed as a processor shown in Fig. 1. For examination purposes the diagnosis LLM-based agent is construed to be software carried out by hardware such as a processor.
Regarding Claim 48, 67-68 – The claim recites “utilizing a test recommender LLM-based agent, said agent is configured to receive the generated potential diagnosis...” See MPEP 2181. The claim limitation uses the term “test recommender LLM-based agent.” The “test recommender LLM-based agent” is modified by functional language “configured to receive the generated….” The “test recommender LLM-based agent” is not modified by sufficient structure, material or act for performing the claim. Therefore 112(f) is invoked. See Spec. pg. 14-15 describes the agent relates to software with a reasoning engine, which is construed as a processor shown in Fig. 1. For examination purposes the test recommender LLM-based agent is construed to be software carried out by hardware such as a processor.
Regarding Claim 48, 67-68 – The claim recites “generating a summary utilizing a decision LLM-based agent based on the recommended medical examinations results...” See MPEP 2181. The claim limitation uses the term “decision LLM-based agent.” The “decision LLM-based agent” is modified by functional language “generating a summary utilizing….” The “decision LLM-based agent” is not modified by sufficient structure, material or act for performing the claim. Therefore 112(f) is invoked. See Spec. pg. 14-15 describes the agent relates to software with a reasoning engine, which is construed as a processor shown in Fig. 1. For examination purposes the decision LLM-based agent is construed to be software carried out by hardware such as a processor.
Regarding Claim 48, 67-68 – The claim recites “the collecting agents comprise one or more LLM-based agents… each collecting agent is configured to extract and summarize information...” See MPEP 2181. The claim limitation uses the term “collecting agents.” The “collecting agents” is modified by functional language “configured to extract and summarize information….” The “collecting agents” is not modified by sufficient structure, material or act for performing the claim. Therefore 112(f) is invoked. See Spec. pg. 14-15 describes the agent relates to software with a reasoning engine, which is construed as a processor shown in Fig. 1. For examination purposes the collecting agents which comprises an LLM-based agent is construed to be software carried out by hardware such as a processor.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 48, 51-64, 67-68 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1 of the Alice/Mayo Test
Claims 48, 51-64 are drawn to a computerized method, which is within the four statutory categories (i.e. process). Claim 67 is drawn to a computerized system, which is within the four statutory categories (i.e. apparatus). Claim 68 is drawn to a non-transitory computer-readable medium, which is within the four statutory categories (i.e. manufacture).
Step 2A of the Alice/Mayo Test - Prong One
The independent claims recite an abstract idea. For example, claim 48 (and substantially similar with independent claim 67, 68) recites:
A computerized method for full patient flow management through an emergency department process, the method comprising:
upon receiving an ID of a subject, extracting medical information of the subject from at least one medical information system;
generating and storing, in a database, a structured summarized medical history of the subject organized in accordance with a defined scheme by executing a pre-summary large language model (LLM)-based agent comprising a plurality of collecting agents, wherein:
(i) the collecting agents comprise at least one of:
one or more LLM-based agents;
one or more extracting agents;
(ii) each collecting agent is configured to extract and summarize information related to a defined subject-related parameter; and
(iii) the structured summarized medical history is generated based on the summaries provided by the collecting agents;
receiving results of preliminary measurements obtained from the subject patient in the emergency department;
preprocessing the structured summarized medical history together with the preliminary measurements results to identify medical information relevant to the preliminary measurements results;
interactively providing queries to the subject and generating a comprehensive anamnesis utilizing:
a background LLM-based agent, configured to provide queries related to the medical history of the subject and receive medical history related input from the subject; and
an anamnesis LLM-based agent configured to provide queries related to complaint(s) of the subject, and receive complaint related input from the subject;
wherein the comprehensive anamnesis is generated based on the complaint related input from the subject and the preliminary measurements;
generating potential diagnosis utilizing a diagnosis LLM-based agent, based on the comprehensive anamnesis;
outputting recommendations regarding one or more medical examinations, utilizing a test recommender LLM-based agent, said agent is configured to receive the generated potential diagnosis and output recommended medical examinations for confirming or ruling-out said potential diagnosis;
receiving results of one or more of the recommended medical examinations; and
generating a summary utilizing a decision LLM-based agent based on the recommended medical examinations results and the comprehensive anamnesis, wherein the summary comprises at least one of:
a differential diagnosis;
a recommendation regarding admission or discharge of the subject from the emergency department; and
reviewing one or more of the LLM-based agents operation and output and providing a score to the one or more LLM-based agents for said operation and output,
utilizing an evaluation LLM-based agent, wherein reviewing one or more LLM-based agents operation and output comprises evaluating the output of the respective LLM-based agent with respect to content structure and linguistic integration using guardrails implemented to ensure that the LLM-based agent operates safely, ethically and in accordance with the LLM-based agent's defined objectives.
These underlined elements recite an abstract idea that can be categorized, under its broadest reasonable interpretation, to cover the management of personal behavior or interactions (following rules or instructions), but for the recitation of generic computer components. For example, but for the computer, processing unit executing code instructions, non-transitory computer-readable medium storing instructions, processor, LLM-based agents, collecting agents, database, medical information system, the limitations in the context of this claim encompass following steps or rules to organize information and determine a diagnosis or a recommendation for a patient in an emergency department and ensuring accurate decision outputs. If a claim limitation, under its broadest reasonable interpretation, covers management of personal behavior or interactions but for the recitation of generic computer components, then the limitations fall within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a).
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 51-64 reciting particular aspects of the abstract idea).
Step 2A of the Alice/Mayo Test - Prong Two
For example, claim 48 (and substantially similar with independent claim 67, 68) recites:
A computerized (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) method for full patient flow management through an emergency department process, the method comprising:
upon receiving an ID of a subject, extracting medical information of the subject from at least one medical information system; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
generating and storing, in a database (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)), a structured summarized medical history of the subject organized in accordance with a defined scheme by executing a pre-summary large language model (LLM)-based agent comprising a plurality of collecting agents, wherein: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
(i) the collecting agents comprise at least one of: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
one or more LLM-based agents; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
one or more extracting agents; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
(ii) each collecting agent is configured to(merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) extract and summarize information related to a defined subject-related parameter; and
(iii) the structured summarized medical history is generated based on the summaries provided by the collecting agents;
receiving results of preliminary measurements obtained from the subject patient in the emergency department;
preprocessing the structured summarized medical history together with the preliminary measurements results to identify medical information relevant to the preliminary measurements results;
interactively providing queries to the subject and generating a comprehensive anamnesis utilizing:
a background LLM-based agent, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) configured to provide queries related to the medical history of the subject and receive medical history related input from the subject; and
an anamnesis LLM-based agent (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) configured to provide queries related to complaint(s) of the subject, and receive complaint related input from the subject;
wherein the comprehensive anamnesis is generated based on the complaint related input from the subject and the preliminary measurements;
generating potential diagnosis utilizing a diagnosis LLM-based agent (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)), based on the comprehensive anamnesis;
outputting recommendations regarding one or more medical examinations, utilizing a test recommender LLM-based agent, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) said agent is configured to receive the generated potential diagnosis and output recommended medical examinations for confirming or ruling-out said potential diagnosis;
receiving results of one or more of the recommended medical examinations; and
generating a summary utilizing a decision LLM-based agent (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) based on the recommended medical examinations results and the comprehensive anamnesis, wherein the summary comprises at least one of:
a. a differential diagnosis;
b. a recommendation regarding admission or discharge of the subject from the emergency department; and
reviewing one or more of the LLM-based agents operation and output and providing a score to the one or more LLM-based agents for said operation and output,
utilizing an evaluation LLM-based agent, wherein reviewing one or more LLM-based agents operation and output comprises evaluating the output of the respective LLM-based agent with respect to content structure and linguistic integration using guardrails implemented to ensure that the LLM-based agent operates safely, ethically and in accordance with the LLM-based agent's defined objectives.
The judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations, which:
amount to mere instructions to apply an exception (such as recitations of the computer, processing unit executing code instructions, non-transitory computer-readable medium storing instructions, processor, LLM-based agents, collecting agents, database, medical information system, thereby invoking computers as a tool to perform the abstract idea, see applicant’s specification pgs. 14-16, 20, 25, 38, 47-48, see MPEP 2106.05(f))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 51-64 recite additional limitations that further the abstract idea; claims 51, 55-56, recite additional limitations which amount to invoking computers as a tool to perform the abstract idea, and claims 51-64 recite additional limitations which generally link the abstract idea to a particular technological environment or field of use). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B of the Alice/Mayo Test for Claims
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 discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception. Additionally, the additional elements, other than the abstract idea per se, amount to no more than elements which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as using the computer, processing unit executing code instructions, non-transitory computer-readable medium storing instructions, processor, LLM-based agents, collecting agents, database, medical information system, e.g., Applicant’s spec describes the computer system with it being well-understood, routine, and conventional because it describes in a manner that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such elements to satisfy 112a. (See Applicant’s Spec. pgs. 14-16, 20, 25, 38, 47-48); using a computer, processing unit executing code instructions, non-transitory computer-readable medium storing instructions, processor, LLM-based agents, collecting agents, database, medical information system, e.g., merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2358-59, 110 USPQ2d 1976, 1983-84 (2014).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea and are generally linking the abstract idea to a particular field of environment. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. Therefore, the claims are not patent eligible, and are rejected under 35 U.S.C. § 101.
Subject Matter Free of Prior Art
Claims 48, 51-64, 67-68 are free of prior art over Williams et al., “Use of a Large Language Model to Assess Clinical Acuity of Adults in the Emergency Department,”(May 7, 2024) and Borgert et al. (US 2023/0005575). The references, or reasonable combination thereof, could not be found to disclose, or suggest all of the limitations found in the independent claims. The closest NPL is Williams et al. (May 7, 2024), which discloses using LLM to assess clinical acuity of adults in the emergency departments by looking at all adult ED visits during a period of time. The closest prior art is Borgert et al. (US 2023/0005575), which teaches recommending medical examinations based on patient information and clinical guidelines. The references taken solely, or in combination, fail to provide the required limitations, and modification of any complementary combination of the references of record would be impermissible hindsight and not provide any advantages over their present application. The dependent claims are also free of prior art due to their corresponding dependency of the independent claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Peresie et al. (US 2024/0331835) is considered pertinent for the scoring an output. See Peresie [0074].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA R COVINGTON whose telephone number is (303)297-4604. The examiner can normally be reached Monday - Friday, 10 - 5 MT.
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/AMANDA R. COVINGTON/Examiner, Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
