DETAILED ACTION
This office action is based on the claims filed on 11/26/2025.
Claims 7, 14, and 18 have been amended.
Claims 1-20 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 § 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.
Claim 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-6 and 18-20 are drawn to a system and Claims 7-17 are drawn to a method, which are within the four statutory categories (i.e., a machine and a process). Claims 1-20 are further directed to an abstract idea on the grounds set out in detail below.
Under Step 2A, Prong 1, the steps of the claim for the invention represents an abstract idea of a series of steps that recite a process for displaying treatment guidelines and recommendation for supporting decision. This abstract idea could have been performed by a human actor to implement the abstract idea for steps citing a process directed to a user input or interaction with a device and following rules to determine treatment guidelines and associated clinical markers, which both the instant claims and the abstract idea are defined as certain methods of organizing human activity.
Independent Claim 1 recites the steps for:
a display screen configured to display a patient medical path listing one or more of treatment guidelines and patient medical history, and additionally being configured to display abbreviated representations of at least one of the treatment guidelines and the patient medical history that can be reached directly from the displayed patient medical path, the patient medical history comprising clinical markers automatically identified from health records of the patient,
wherein automatically identifying the clinical markers comprises using a natural language processing pipeline to identify entities from the health records, identifying positive and negative assertions of the identified entities, identifying relationships between the identified entities, and recognizing and generating binary relationships between the identified entities;
wherein the abbreviated representations each display a limited list of data offered within the treatment guidelines and/or the patient medical history, each of the data in the list being selectable to launch the treatment guidelines and/or the patient medical history and enable the selected data to be seen, and
wherein the abbreviated representations are displayed while in an unlaunched state”
Independent Claim 7 recites the steps for:
“providing a user-interactive electronic form for a user to input rules for displaying a treatment path for a patient wherein the rules for displaying the treatment path include node names, node types, node display confirmation, node display visual effects, and node ordering constraints, and wherein the node ordering constraints are automatically filled by a processor matching the node names and/or the node types to a sequence shown in reference treatment guidelines based on the node names and/or the node types;
automatically acquiring, via the processor, health records of the patient and treatment guidelines corresponding to a condition of the patient, based on the input rules, and identifying, via the processor, clinical markers from the health records via a natural language processing pipeline, wherein identifying clinical markers from the health records via the natural language processing pipeline comprises:
identifying entities from the health records, identifying positive and negative assertions of the identified entities, identifying relationships between the identified entities, and recognizing and generating binary relationships between the identified entities;
wherein the identification of clinical markers includes entity recognition by a machine learning model trained to perform various steps upon parsing or scanning the health records of the patient, including identifying entities from text of the health records of the patient, including a type of a tumor, a position of the tumor, and a body part at which the tumor is located, wherein identified text is indicated in boxes while assignment/categorization of the identified text by the natural language processing pipeline is depicted;
matching the clinical markers to relevant sections of the treatment guidelines according to implementation of the input rules by the processor including identifying nodes of the treatment guidelines based on a set of guideline selection rules of the input rules and comparing entry markers and exit markers for each of the nodes with information from the clinical markers, wherein the entry markers and the exit markers are defined by a set of node traversal rules of the input rules, and wherein matching the clinical markers to the relevant sections of the treatment guidelines further comprises: determining, by the processor, satisfaction of the node exit markers by comparing information from the clinical markers against the node exit markers to enable progression to subsequent nodes; and clipping the relevant sections into segments based on the node exit markers determined to be satisfied; and
displaying, at a graphical user interface of a display device in real-time, the relevant sections of the treatment guidelines overlaid with summaries of the health records, the summaries correlated to the relevant sections based on the clinical markers, displayed as a graphical representation along a lane and spaced along the lane to align with a corresponding section of the treatment guidelines to provide treatment recommendations based on a path of the treatment guidelines.”
Independent Claim 18, similar to Claim 7, recites the steps for:
a display screen displaying the patient journey;
a guideline information collection form providing parameters for displaying a treatment path for a patient stored at a guideline database wherein the parameters include, for each node of a plurality of nodes, a node name, a node type, node display constraints, node entry markers, node exit markers, and node ordering constraints;
treatment guidelines corresponding to the treatment path for the patient stored at a memory of a processor; and
a set of modules also stored at the memory of the processor and implemented at the processor, the set of modules including with executable instructions that, when executed, cause the processor to:
process the parameters from the guideline information collection form to generate node traversal rules;
identify clinical markers from health records and the guideline information collection form via a natural language processing pipeline, wherein identifying the clinical markers from the guideline information collection form via the natural language processing pipeline comprises:
identifying entities from the health records, identifying positive and negative assertions of the identified entities,
identifying relationships between the identified entities, and recognizing and generating binary relationships between the identified entities;
identify the treatment path from the treatment guidelines based on the parameters;
wherein identifying the treatment path from the treatment guidelines based on the parameters comprises locating relevant sections of the treatment guidelines that match the identified clinical markers,
identifying nodes within the relevant sections of the treatment guidelines using the node traversal rules,
comparing the node entry markers and the node exit markers for each identified node with information of the identified clinical markers,
determining if the clinical markers satisfy the node exit markers, clipping the relevant sections into segments based on the node exit markers
determined to be satisfied, and ordering the segments according to a sequence of the treatment guidelines; and
display the treatment path at a display device along with corresponding summaries from medical records of the patient, the summaries correlated to the treatment path based on common clinical markers, the treatment path overlaid with a patient event timeline, the patient event timeline including segments of treatment guidelines ordered sequentially and connected by arrows”.
These limitations, as drafted, given the broadest reasonable interpretation, cover performance of the limitations by a human user/actor that constitute certain methods of organizing human activity. For example, the limitations encompass a user interacting with a displaying device to manually the ability inquire treatment path following input rules, identifying markers and treatment path to receive treatment guidelines to a patient condition and associated guidelines clinical markers to display on a device proving a recommendation and decision support of a human activity, which are steps that that could have been performed by a human actor interaction and a device to implement the abstract idea. These limitations encompass activity of a single person or multiple people and a computer, following rules or instructions to perform the steps of the claimed invention, e.g., interaction with devices and following rules and/or steps to determine treatment guideline(s) to be displayed for the subject following instruction(s), which constitutes Certain Methods of Organizing Human Activity. Accordingly, the claim limitations recite an abstract idea. Any limitations not identified above as part of the process are deemed "additional elements," and will be discussed in further detail below.
Under Step 2A, Prong 2, this judicial exception is not integrated into a practical application because the remaining elements amount to no more than a component programmed to perform the abstract ideas and linking the abstract idea to a particular technological environment. In particular, the claims recite the additional elements such as “processor, graphical user interface (GUI)/display device, database, memory, modules, natural language processing (NLP), machine learning (ML) model” that is/are disclosed at a high - level of generality and includes known hardware components to perform steps, i.e., input[ting], display[ing], , that iteratively takes input data and determine an output performing generic computer functions for displaying treatment guidelines and recommendations such that it amounts no more than adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea because the steps reciting additional elements that are mere data implemented using a general purpose computing components being used in ordinary capacity to perform the steps such that causing the computer system to perform the instructions, see MPEP 2106.05(f), and mere data gathering and outputting process that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.04(d).
For example, the machine learning (ML) model and NLP, is/are recited in the claims in a high level of generality and is in described in the specification in an arbitrary form without disclosing a specific algorithm and implementing the claimed invention for allowing the model to learn patterns and relationships within the data and implement these additional elements to perform the claimed function rather the trained ML model is recited at a high level of generality and describing a general concept of using a ML model to perform task(s) which is a mere in instruction(s) that may be performed by human that it amounts no more than adding the words "apply it" (or an equivalent). Implementing the abstract idea for displaying a treatment guideline on generic computer components is not a practical application of the abstract idea. As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 "merely include[ing] instructions to implement an abstract idea on a computer" is an example of when an abstract idea has not been integrated into a practical application, see (Applicant, PGPub 0065, 0067). Accordingly, looking at the claim as a whole, individually and in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Under step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not present improvements to another technology or technical field and the additional elements amount to no more than a generic computer components, recited at a high level of generality, that amounts to no more than adding the words "apply it" (or an equivalent) to apply the exception, e.g. “input, display”, using generic computer component, see MPEP 2106.05(f), mere data gathering that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.04(d). Their collective functions merely provide conventional computer implementation and mere instructions to apply an exception using a generic computer component to the abstract idea cannot provide an inventive concept, see Alice, 573 U.S. at 223 ("mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention"). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea
Dependent Claims 2-6, 8-17 and 19-20 include all of the limitations of claim(s) 1, 7, and 18, and therefore likewise incorporate the above-described abstract idea. While the depending claims add additional limitations, such as
As for claims 2-3, 5, 10-12 and 15-17, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human interaction but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
As for claims 4, 6, 8-9, 13-14, and 19-20, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human interaction but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. The claims recite additional elements “graphical user interface, clinical marker detection module, natural language processing, marker filter module, summary generation module, database” that implement the identified abstract idea and is/are recited in the claim(s) at a high level as a tool to apply the exceptions and perform the disclosed feature, e.g., “displaying, applying, store, interact with a cursor”. These components are recited at a high level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered by the Examiner and addressed as the following:
In the remarks, Applicant argues the substance:
Applicant's arguments with respect to the 35 U.S.C. § 101 rejection on page 10-12.
On page 11 of the remarks, the Applicant argues “For the reasons already of record, Applicant respectfully requests withdrawal of the rejection as the claims integrate any abstract idea into a practical application. Further, following Desjardins (see Ex parte Desjardins, Appeal 2024-000567 (ARP Sept. 26, 2025)), claim 7 is also allowable as it specifically utilizes a machine learning model in a non-conventional way to streamline the NLP approach”, Examiner respectfully disagree. The limitations recite the abstract idea of determining patient treatment guidelines based on selection rules of user’s input rules supporting decision making, for example claim 7, under BRI, recite steps performed by a user where a the user interact with a suer interactive electronic form providing input for displaying a treatment path while acquiring and analyzing the patient medical history and treatment guidelines where medical records is/are associated with clinical markers for identifying patient records and relationship of the records, and presenting treatment guidelines following rules as input by the user. These steps have been identified as steps that can be performed by a human user organizing data that falls in the course of human behavior which defines the identified abstract idea. The claim(s) recite additional elements, e.g., processor, graphical user interface (GUI)/display device, NLP, ML model”, recited at a high level of generality and as tool(s) to perform the steps of the identified abstract however striping the claim from these additional elements, the limitations recite the abstract idea as such implementing the abstract idea for displaying a treatment guideline on generic computer components is not a practical application of the abstract idea.
As for the Applicant argument that claim 7 is similar to Desjardins (see Ex parte Desjardins, Appeal 2024-000567 (ARP Sept. 26, 2025)), as it specifically utilizes a machine learning model in a non-conventional way to streamline the NLP approach, in which Examiner disagrees to such argument. The PTAB had found the Desjardins invention ineligible under Section 101 as being directed to an abstract idea however the Appeals Review Panel (ARP) found the claims to be directed to methods for training artificial intelligence/machine learning (AI) models and the claims improved the functioning of the computer itself by reducing storage requirements and preserving task performance across sequential training as such improves the operation of a machine learning system by enhancing its training efficiency or preserving prior learning, as such it is not “directed to” an abstract idea under Alice Step 1. In contrast and as mentioned above, the machine learning (ML) model and NLP, is/are recited in the claims in a high level of generality and is in described in the specification, (see PGPub 0065, 0067), in an arbitrary form without disclosing a specific algorithm and implementing the claimed invention for allowing the model to learn patterns and relationships within the data and implement these additional elements to perform the claimed function rather the trained ML model is recited at a high level of generality and describing a general concept of using a ML model to perform task(s) which is a mere in instruction(s) that may be performed by human that it amounts no more than adding the words "apply it" (or an equivalent).
On page 11 of the remarks, the Applicant argues “However, merely because a technical solution interacts with human inputs does not categorically mean that the method is unpatentably abstract. This is especially true here, where claim 7 illustrates substantial technical actions taken by the processor to efficiently extract clinical markers automatically in an efficient manner”, Examiner respectfully disagree. In the OA, Examiner identified the additional element(s) “i.e., processor” recited in the claim which has/have been analyzed under step 21 P2 and is/are not configured in a manner other than what any off-the-shelf, commercially available processor is capable of being programmed to do which is a tool applying the steps of the claim. The fact that the identified additional elements is/are applied in the area of displaying clinical treatment guidelines using known data does not change the claims to be patentable.
On page 11 of the remarks, the Applicant argues “Similarly, claim 18 sets forth an approach that enables a patient journey displayed at the display screen to directly reach, ... the clinical care pathway chart in real-time and with reduced processing of data. Thus, claim 18 is not a method of organizing human activity, but a system with an improved display that solves a real world technical problem related to efficient processing in order to accurately display the patient journey in real-time”, Examiner respectfully disagree. The amended claim 18 do not describe a solution to a technological problem rather the claims are directed to displaying clinical treatment path and patient treatment journey to healthcare provider and/or patient from treatment guidelines and medical records which is solving an administrative problem as described by the Applicant on page 10 of the remarks, and PGPub 0025.
Hence, Examiner remains the 101 rejections of claims which have been updated to address Applicant's amendments and remarks and to comply with the 2019 Revised Patent Subject Matter Eligibility Guidance in the above Office Action.
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 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.
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687