DETAILED ACTION
This office action is based on the claims filed on 08/14/2026.
Claims 1-2, 4, 7-8, 10-11, 13, 15, and 18-19 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 organizing clinical data and 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 treatment guidelines and patient medical history for a patient, and additionally being configured to display abbreviated representations 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 electronic health records of the patient, wherein automatically identifying the clinical markers comprises:
using a natural language processing pipeline to identify entities from the electronic health records,
identifying positive and negative assertions of the identified entities,
after identifying the positive and negative assertions of the identified entities identifying relationships between the identified entities,
recognizing and generating binary relationships between the identified entities and corresponding codes, and
recognizing and extracting the clinical markers from the identified entities, the positive and negative assertions of the identified entities, the identified relationships between the identified entities, and the binary relationships, based on a clinical marker list;
wherein the abbreviated representations each display a limited list of data offered within the treatment guidelines or the patient medical history, each of the data in the limited list of data being selectable to launch the treatment guidelines 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, and
wherein the abbreviated representations include summaries of the electronic health records, the summaries populated with filtered clinical markers, the filtered clinical markers generated by filtering the identified clinical markers to remove clinical markers unrelated to a diagnosis or treatment of the patient according to filtering rules, such that only clinical markers relevant to the diagnosis or treatment of the patient are included in the summaries”
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, for nodes of the treatment path, 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 reference sequence shown in reference treatment guidelines based on the node names and/or the node types, wherein the node ordering constrains are applied to adjust a node sequence of the nodes to adhere to the reference sequence shown in the reference treatment guidelines;
automatically acquiring, via the processor, electronic 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 electronic health records via a natural language processing pipeline, wherein identifying clinical markers from the electronic health records via the natural language processing pipeline comprises:
identifying entities from the electronic health records,
identifying positive and negative assertions of the identified entities,
after identifying the positive and negative assertions of the identified entities identifying relationships between the identified entities, and recognizing and generating binary relationships between the identified entities and standardized medical codes, and
recognizing and extracting the clinical markers from the identified entities, the positive and negative assertions of the identified entities, the identified relationships between the identified entities, and the binary relationships, based on a clinical marker list
wherein identifying the clinical markers includes entity recognition by a machine learning model trained to perform various steps upon parsing or scanning the electronic health records of the patient, including identifying entities from text of the electronic 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;
matching the clinical markers to relevant sections of the treatment guidelines according to implementation of the input rules by the processor including identifying the nodes 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 exit markers by comparing information from the clinical markers against the exit markers to enable progression to subsequent nodes; and clipping the relevant sections into segments based on the exit markers determined to be satisfied; and
filtering the clinical markers to remove clinical markers unrelated to a diagnosis or treatment of the patient according to filtering rules stored at a summary rules database, such that only the clinical markers relevant to the diagnosis or treatment of the patient are used to generate summaries of the electronic health records
displaying, at a graphical user interface of a display device in real-time, the relevant sections of the treatment guidelines overlaid with the summaries of the electronic health records generated using the filtered clinical markers, the summaries correlated to the relevant sections based on the filtered 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, wherein the node sequence of the nodes of the treatment path is independent of a chronology of the clinical markers in the electronic health records”
Independent Claim 18, similar to Claim 7, recites the steps for:
“a display screen displaying the patient journey;
guideline database storing parameters obtained via a guideline information collection form, the parameters for displaying a treatment path for a patient, 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;
the guideline database also storing treatment guidelines corresponding to the treatment path for the patient; and
a memory storing a set of modules and configured to be implemented at a processor, the set of modules including executable instructions that, when executed, cause the processor to:
process the parameters from the guideline information collection form to generate node traversal rules and node ordering rules;
identify clinical markers from electronic health records of the patient via a natural language processing pipeline, wherein identifying the clinical markers via the natural language processing pipeline comprises:
identifying entities from the electronic health records, identifying positive and negative assertions of the identified entities,
after identifying the positive and negative assertions of the identified entities identifying relationships between the identified entities, and recognizing and generating binary relationships between the identified entities and standardized medical codes, and recognizing and extracting the clinical markers from the identified entities, the positive and negative assertions of the identified entities, the identified relationships between the identified entities, and the binary relationships, based on a clinical marker list;
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 the electronic health 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, treatment path including segments of treatment guidelines ordered according to the node ordering rules and connected by arrows, the patient event timeline including the summaries, wherein clipping the relevant sections into the segments comprises selectively showing the segments at the display device”.
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 data gathering and processing/transformation by 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 for organizing/arranging clinical data and display it. 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” and subgrouping “managing personal behavior or relationships or interactions between people" include following rules or instructions. 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, electronic health records” 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 08/14/2026 and 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 13-18.
On page 14 of the remarks, the Applicant argues “Applicant respectfully disagrees. Claim 1 is not directed to a certain method of organizing human activity... Amended claim 1 instead requires that clinical markers be "automatically identified from electronic health records" through a specific, ordered sequence ... Nothing in the record establishes that a human could mentally or manually perform this specific ordered sequence directly on electronic health records... A human cannot review, annotate, or reorganize encrypted, access-restricted electronic records the way a person could sort a physical chart or paper notes”, Examiner respectfully disagree. The claim(s), given their broadest reasonable interpretation, recite limitations that are directed towards a process organizing workflow data and display it for determining treatment guidelines and decision making based on data gathering and transformation and inputted rules by a user interacting with a user interface 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 the rules inputted by the user. Such steps have been interpreted, under BRI, as a process for organizing clinical data for treatment steps and guideline to support decision making as such 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.
Additionally, the feature argued of “automatically” that is recited at a high degree of generality such that providing/configuring a machine to performs the claimed functions without manual operation even though a human may initiate or interrupt the process. Accordingly, looking at the claims as a whole, individually and in combination, such additional element(s) provide no integration of the abstract ideas into a practical application because they appear to merely automate a manual process, such that no meaningful limits on practicing the abstract idea are introduced and the computing elements are merely utilized as tools to perform the abstract ideas. Mere automation of manual processes, such as using a generic computer to process a generic function(s) may not be sufficient to show an improvement in computer-functionality, see MPEP § 2106.05 (a) and (g), Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017) and LendingTree, LLC v. Zillow, Inc., 656 Fed. App'x 991, 996-97 (Fed. Cir. 2016) (non-precedential). The claim as a whole is therefore directed to an abstract idea.
On page 15 of the remarks, the Applicant further argues “clinical markers are extracted through the ordered NLP pipeline described above, rather than through generic keyword search or an unspecified "apply a machine learning model" instruction ,..”, Examiner respectfully disagree. As described in the prior OA mailed 05/21/2026, the claim and specifications describe the process at a high level of generality and as tool(s) to perform the steps of the identified abstract steps that amount no more than adding the words "apply it" (or an equivalent). For example, the NPL and ML model in the claims and specification do not preclude the system from being implemented on a generic computer configured with a specific purpose with specific programming as their collective functions merely provide conventional computer implementation and mere instructions to apply an exception using a generic computer component to the abstract idea, see (Applicant [0067-0068] “The NLP pipeline 1100 may be a machine learning model implemented at the clinical marker detection module 506 and trained to perform various steps upon parsing or scanning the EHRs 1102..., [0104] “Creation of the patient journey, in some examples, may be aided by leveraging machine learning algorithms, such as NLP, to generate summaries and select treatment guideline segments displayed in the timeline.).
On page 15 of the remarks, the Applicant further argues “the abbreviated representations of treatment guidelines and patient medical history are displayed in an unlaunched state ... This is directly analogous to Core Wireless Licensing S.A.R.L. v. LG Electronics, Inc., 880 F.3d 1356 (Fed. Cir. 2018) ,..”, Examiner respectfully disagree. As described in the prior OA mailed 05/21/2026, the claim in Core Wireless described a specific technological solution to a technological problem, where the claim(s) contain precise language delimiting the type of data to be displayed and how to display it specifying a particular manner for accessing summary window and a data list being selectable to launch a respective application and enable the selected data to be seen within the respective application summary window displayed while the one or more applications are in an un-launched state, thus improving upon conventional user interfaces to increase the efficiency of using mobile devices. In contrast, and as mentioned above, the instant invention describes displaying an abbreviated representation however there no specific description of how the device captures the data to be abbreviated while in an unblanched state. Therefore, the claimed invention is not analogues to Core Wireless.
On page 15-16 of the remarks, the Applicant further argues “the clinical markers populating the summaries are filtered according to defined filtering rules ... This is not a generic instruction to "summarize data."... By filtering before rendering/displaying, the configuration of amended claim 1 limits the volume of data that is processed and displayed to generate each summary, which is a concrete technical benefit, not a restatement of the abstract idea”, Examiner respectfully disagree. As discussed in the above rejection, the claim limitation “i.e., filtering rules” recite the abstract idea of organizing clinical data for determining patient treatment guidelines based on selection rules of user’s input rules and filtered summaries for supporting decision making which are steps describing rules that collecting data (i.e., patient clinical events), manipulating or filtering it, and presenting the results on a display. Providing input for displaying a treatment path and presenting treatment guidelines following rules which recites a judicial exception for the abstract idea of Certain Methods of Organizing Human Activity and subgrouping “managing personal behavior or relationships or interactions between people" include following rules or instructions.
On page 16 of the remarks, the Applicant further argues “Additionally, amended claim 1 recites significantly more than any alleged abstract idea.”, Examiner respectfully disagree. The claims at issue do not require any nonconventional computer, network, or other components, or even a non-conventional and non-generic arrangement of known, conventional pieces but merely call for performance of the claimed functions on a set of generic computer components. The elements of the instant process, when taken alone, each execute in a manner conventionally expected of these elements. The elements of the instant underlying process, when taken in combination, together do not offer substantially more than the sum of the functions of the elements when each is taken alone. Limitations that the courts have found to qualify as "significantly more" when recited in a claim with a judicial exception include adding a specific limitation other than what is well-understood, routine, conventional activity in the field, or adding unconventional steps that confine the claim to a particular useful application, e.g., a non-conventional and non-generic arrangement of various computer components for filtering Internet content, as discussed in BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243 (Fed. Cir. 2016). Hence, the instant claim(s) steps and additional elements do not add anything significantly more than an abstract idea.
On page 17 of the remarks, the Applicant further argues “This ordered arrangement, not the presence of a processor or GUI in isolation, supplies the inventive concept”, Examiner respectfully disagree. As described in the above rejection, the steps of the claims, taken individually or as an ordered combination, have already been identified in the rejection above as corresponding to an abstract idea. The additional elements in the claims, “i.e., processor, graphical user interface (GUI)/display device, database, memory, modules, natural language processing (NLP), machine learning (ML) model, electronic health records”, to execute the claimed steps.
On page 17 of the remarks, the Applicant further argues “The Office has not identified a human method by which a person mentally cross references an arbitrary node name or node type against the full text ... That operation is a machine matching function performed against structured reference data, not a mental step. The technical result of this matching function is likewise concrete, not abstract”, Examiner respectfully disagree. The Applicant argued feature “match[ing]” alleging not a mental step, Examiner finds that the matching or comparing process is a step that encompass a human to perform manually. As discussed in the above rejection, the claim recites, under BRI, steps for collecting and analyzing clinical data for displaying which are steps recited in a claim directed to the judicial exception of an abstract idea, see MPEP 2106.04(a)(2), Electric Power Group v. Alstom, S.A., and Classen Immunotherapies, Inc. v. Biogen. The fact that the judicial exception, identified in the rejection above, relies upon gathering data through monitoring and analyzing user activity does not impart an improvement to any existing computer, or any other technology or technical field.
On page 18 of the remarks, the Applicant further argues “This is precisely the kind of rule based, specific solution to a defined problem, namely correctly ordering a display output to match a reference source rather than patient specific chronology that the Federal Circuit has found sufficient to avoid an abstract idea characterization when the claim recites a specific way of achieving a result rather than the result itself. See MPEP 2106.05(a); McRO, Inc. ...”, Examiner respectfully disagree. There is no evidence in Applicant's as-filed disclosure that Applicant's claimed invention is performing functions that previously only humans could perform as in McRO. The Examiner notes that in McRO the as-filed disclosure explicitly described that computers could not previously be programmed to perform the particular type of animation described and that only human animators were previously capable of such animation. Because the claimed invention in McRO solved this particular problem, the court found that the claimed invention was an improvement to computer technology. There is no such problem described in Applicant's disclosure.
On page 18 of the remarks, the Applicant further argues “amended claim 18 recites that a treatment path is displayed "overlaid with a patient event timeline,” where "clipping the relevant sections into the segments ... This is not a generic instruction to combine two data sets on a screen.”, Examiner respectfully disagree. As described in the above rejection, the claim(s), under BRI, recites steps for organizing clinical and patient data on a display while the steps such as overlaying and clipping data are process describing data manipulation and data-sorting task on a generic computer screen as such rules that collecting data (patient events), manipulating or filtering it (clipping relevant sections), and presenting the results (displaying segments) are long-standing human tasks. In addition, nowhere in the claim(s) or specification describes and clipping mechanism to improve computing components such as memory requirements, or if the overlay interface dynamically interacts with medical hardware in a novel way, see (Applicant [0104], [0109], [0119]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAAELDIN ELSHAER whose telephone number is (571)272-8284. The examiner can normally be reached M-Th 8:30-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MAMON OBEID can be reached at Mamon.Obeid@USPTO.GOV. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687
Prosecution Insights