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 .
Information Disclosure Statements
The information disclosure statements (IDS) submitted on October 15, 2024, are in compliance with the provisions of 37 CFR 1.97, and have been 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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. See MPEP § 2106 (hereinafter referred to as the “2019 Revised PEG”).
Step 1 of the 2019 Revised PEG
Following Step 1 of the 2019 Revised PEG, claims 1-5, 12, 13, and 15 are directed to a system for identifying and documenting patient co-morbidities and comorbid conditions, which is within one of the four statutory categories (i.e., a machine or apparatus). See MPEP § 2106.03. Claims 6-10, 14, and 16 are directed to a method for identifying and documenting patient co-morbidities and comorbid conditions, which is also within one of the four statutory categories (i.e., a process). See id. Claims 11 and 17 are directed to a non-transitory computer readable storage medium comprising a computer readable program for identifying and documenting patient co-morbidities and comorbid conditions, which is also within one of the four statutory categories (i.e., a manufacture). See id.
Step 2A of the 2109 Revised PEG – Prong One
Following Prong One of Step 2A of the 2019 Revised PEG, , the claim limitations are to be analyzed to determine whether they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. See MPEP §2106.04. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: (1) Mathematical Concepts; (2) Certain Methods of Organizing Human Activity, and (3) Mental Processes. See MPEP § 2106.04(a).
Claims 1-17 are rejected under 35 U.S.C. § 101, because the claimed invention is directed to an abstract idea without significantly more. Representative independent claims 1, 6, and 11 include limitations that recite an abstract idea. Note that independent claim 1 is a system claim, while claim 6 covers the matching method claim and claim 11 covers the matching non-transitory computer readable storage medium claim. Specifically, independent claim 1 recites the following limitations:
A system for identifying and documenting patient co-morbidities and comorbid conditions and thereby decreasing risk-adjusted mortality rates, the system comprising:
a hardware processor operatively coupled to a non-transitory computer-readable storage medium, the processor being configured for:
identifying, using natural language processing (NLP), patient co-morbidity-related clinical data for a patient by preprocessing input historical patient data in real time based on one or more rules, the one or more rules being customizable by tuning threshold values or ranges of one or more of the one or more rules to any of a plurality of user-specified values or ranges;
displaying the identified co-morbidity-related clinical data and the one or more rules using an interactive customizable graphical user interface (GUI) for validation;
accessing and displaying via the GUI the one or more rules on a smartphone device;
accessing further details regarding the rules to increase usability and readability of the system for smartphone devices;
verifying the identified co-morbidity-related clinical data via the GUI prior to storing any of the identified co-morbidity-related clinical data in a remote electronic health record (EHR);
automatically storing the verified results in the remote EHR for the patient;
identifying updated co-morbidity-related clinical data by postprocessing input updated patient data based on the one or more rules;
displaying and validating the updated co-morbidity-related clinical data using the GUI for the validating of the updated co-morbidity related clinical data; and
detecting changes to the updated and verified co-morbidity data in the remote EHR by the post processing;
iteratively updating the remote EHR in real time with the updated and verified comorbidity data by the postprocessing upon detection of the changes to the remote EHR, the iterative updating resulting in a reduction of processing requirements and an increase in speed in updating of the remote EHR;
wherein the step of iteratively updating the remote EHR in real time is completed during a patient visit in real time.
Similarly, claim 11 recites (and claim 6 substantially recites) the following limitations:
A non-transitory computer readable storage medium comprising a computer readable program for identifying and documenting patient co-morbidities and comorbid conditions and thereby decreasing risk-adjusted mortality rates, wherein the computer readable program when executed on a computer causes the computer to perform the steps of:
identifying, using natural language processing (NLP), patient co-morbidity-related clinical data for a patient by preprocessing input historical patient data in real time based on one or more rules, the one or more rules being customizable by tuning threshold values or ranges of one or more of the one or more rules to any of a plurality of user-specified values or ranges;
displaying the identified co-morbidity-related clinical data and the one or more rules using an interactive customizable graphical user interface (GUI) for validation;
accessing and displaying via the GUI the one or more rules on a smartphone device;
accessing further details regarding the rules to increase usability and readability of the system for smartphone devices;
in response to a user action on the smartphone device, displaying further details regarding the rules or the button as a pop-up window or on a new display screen to increase usability and readability of the system,
verifying the identified co-morbidity-related clinical data via the GUI prior to storing any of the identified co-morbidity-related clinical data in a remote electronic health record (EHR);
automatically storing, using a non-transitory computer-readable storage medium, verified results in the remote EHR for the patient;
displaying and validating the updated co-morbidity-related clinical data using the GUI for verifying of the updated co-morbidity related clinical data, the GUI being configured for improving usability of the system by being customized for readability on a smartphone device by presenting respective buttons on the GUI display directed only to accessing further information stored on a remote server regarding the relevant co-morbidities, clinical conditions, and corresponding rules from the updated verified co-morbidity-related clinical data;
detecting changes to the updated and verified co-morbidity data in the remote EHR by the post processing;
iteratively updating the remote EHR in real time with only the updated, verified comorbidity data by the postprocessing upon detection of the changes to the EHR based on the verifying the updated co-morbidity-related clinical data, the iterative updating resulting in a reduction of processing requirements and an increase in speed in updating of the remote EHR;
wherein the step of iteratively updating the remote EHR in real time is completed during a patient visit in real time.
However, the aforementioned limitations that are identified in underlined font comprise a process that, under its broadest reasonable interpretation, falls within the “Mental Processes” grouping of abstract ideas. See 2019 Revised PEG. The Mental Processes category covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper (including an observation, evaluation, judgment, or opinion) (i.e., identifying patient co-morbidity related data in patient data; verifying the identified co-morbidity-related clinical data; identifying updated co-morbidity-related clinical data; validating the updated co-morbidity-related clinical data; and detecting changes to the updated and verified co-morbidity data). That is, other than reciting some computer components and functions (the foregoing limitations in claim 1 which are not underlined), the context of claims 1, 6, and 11 encompass concepts that are capable of being performed in the human mind or encompasses a human performing the steps mentally with the aid of a pen and paper (including an observation, evaluation, judgment, and/or opinion) (i.e., identifying patient co-morbidity related data in patient data; verifying the identified co-morbidity-related clinical data; identifying updated co-morbidity-related clinical data; validating the updated co-morbidity-related clinical data; and detecting changes to the updated and verified co-morbidity data).
The aforementioned claim limitations described in claims 1, 6, and 11 are analogous to claim limitations directed toward concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, because they merely recite limitations which encompass a person mentally and/or manually: (1) identifying co-morbidity-related clinical data in patient data (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally identify co-morbidity-related clinical data in patient data by applying customizable rules to patient data); (2) verifying the identified co-morbidity-related clinical data (a type of observation, evaluation, judgment, and/or opinion where a person could mentally and/or manually verify the identified co-morbidity-related clinical data); (3) identifying updated co-morbidity-related clinical data (a type of observation, evaluation, judgment, and/or opinion where a person could mentally identify updated co-morbidity-related clinical data in patient data); (4) validating the updated co-morbidity-related clinical data (a type of observation, evaluation, judgment, and/or opinion where a person could mentally and/or manually validate the updated co-morbidity-related clinical data); and (5) detecting changes to the updated and verified co-morbidity data (a type of observation, evaluation, judgment, and/or opinion where a person could mentally detect changes to the updated and verified co-morbidity-related data). Medical professionals, such as physicians, commonly make these types of observations, evaluations, judgments, or opinions with their medical knowledge mentally and/or manually using a pen and paper, by applying rules to patient data in order to identify comorbidity data.
Further, Applicant’s claims are similar to claims which have been held to recite an abstract mental process. For example, the Federal Circuit held the a claim directed to “collecting information, analyzing it, and displaying certain results of the collection and analysis”, where the data analysis steps are recited at a high level of generality amounted to steps that could practically be performed in the human mind. See MPEP § 2106.04(a)(2)(III)(A) (citing Electric Power Group v. Alstom, S.A.). Similarly, Applicant’s claims recite steps for collecting information (i.e., the step directed to identifying the co-morbidity-related clinical data and updated co-morbidity-related clinical data, and detecting changes to the updated and verified co-morbidity data); analyzing the data (i.e., verifying the identified co-morbidity-related clinical data and validating the updated co-morbidity-related clinical data); and displaying certain results about the collection and analysis (i.e., displaying the validated updated co-morbidity-related clinical data and iteratively updating the remote EHR in real time with the updated and verified co-morbidity data), at a high level of generality. Therefore, the aforementioned underlined claim limitations may reasonably be interpreted as mental/manual observations, evaluations, judgments, and/or opinions made by a person, such as healthcare provider. If a claim limitation, under its broadest reasonable interpretation, covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. See 2019 Revised PEG. Accordingly, claims 1, 6, and 11 recite an abstract idea that falls within the Mental Processes category.
Examiner notes that: claims 2-5, 7-10, and 12-17 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below. Examiner also notes that dependent claims 2, 4, 7, 9, and 13-17 include limitations that are deemed to be additional elements, and require further analysis under Prong Two of Step 2A; and dependent claims 3, 5, 8, 10, and 12 do not provide any additional limitations that are deemed to be additional elements which require further analysis under Prong Two of Step 2A. For example, claims 3 and 8 describe further mental or manual steps directed to adjusting time search parameters to any of a plurality of time ranges. Next, claims 4 and 9 describe that input historical patient data is in a non-structured format, which is deemed to be part of the abstract mental process because it merely modifies the type of data that may be collected mentally and/or manually with the aid of pen and paper. Further, claims 5 and 10 describe further mental or manual steps of pulling the patient data from a structured report. Claim 12 describes further mental steps of monitoring and detecting updated co-morbidity data based on changes to the EHR. Claim 14 describes the mental or manual step of tuning (i.e., adjusting) the values or ranges of the one or more rules in real-time. These are all similar to features in the independent claims in that they are mental or manual steps that are applied on a computer. Claims 14-17 also merely repeat the additional elements from claims 6 and 11 directed to the GUI being customized for a smartphone device display based on a button press, where the button press accesses further details regarding the rules. These are additional elements, but they are not different from limitations that are already described in claims 6 and 11.
Step 2A of the 2019 Revised PEG – Prong Two
Regarding Prong Two of Step 2A of the 2019 Revised PEG, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted in the 2019 Revised PEG, it must be determined whether any additional elements in the claims are indicative of integrating the abstract idea into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” See MPEP §§ 2106.05 (f)-(h).
In the present case, for independent claim 1, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A system (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) for identifying and documenting patient co-morbidities and comorbid conditions and thereby decreasing risk-adjusted mortality rates, the system comprising (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)):
a hardware processor (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) operatively coupled to a non-transitory computer-readable storage medium (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)), the processor being configured for:
identifying, using natural language processing (NLP) (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)), patient co-morbidity-related clinical data for a patient by preprocessing input historical patient data in real time based on one or more rules, the one or more rules being customizable by tuning threshold values or ranges of one or more of the one or more rules to any of a plurality of user-specified values or ranges;
displaying the identified co-morbidity-related clinical data and the one or more rules using an interactive customizable graphical user interface (GUI) for validation (adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving or transmitting data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d));
accessing and displaying via the GUI the one or more rules (adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving or transmitting data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) on a smartphone device (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f));
accessing further details regarding the rules to increase usability and readability of the system for smartphone devices (adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving or transmitting data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d));
verifying the identified co-morbidity-related clinical data via the GUI prior to storing any of the identified co-morbidity-related clinical data in a remote electronic health record (EHR);
automatically storing the verified results in the remote EHR for the patient (adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of storing and retrieving information in memory and electronic recordkeeping, as evidenced by the Versata Dev. Group, Inc. v. SAP Am., Inc. and Alice Corp. Pty. Ltd. v. CLS Bank Int’l cases, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d));
identifying updated co-morbidity-related clinical data by postprocessing input updated patient data based on the one or more rules;
displaying and validating the updated co-morbidity-related clinical data using the GUI for the validating of the updated co-morbidity related clinical data (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)); and
detecting changes to the updated and verified co-morbidity data in the remote EHR by the post processing;
iteratively updating the remote EHR in real time with the updated and verified comorbidity data by the postprocessing upon detection of the changes to the remote EHR, the iterative updating resulting in a reduction of processing requirements and an increase in speed in updating of the remote EHR (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f));
wherein the step of iteratively updating the remote EHR in real time is completed during a patient visit in real time (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)).
Similarly, for claim 11 (and substantially similarly for claim 6), the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A non-transitory computer readable storage medium comprising a computer readable program (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) for identifying and documenting patient co-morbidities and comorbid conditions and thereby decreasing risk-adjusted mortality rates, wherein the computer readable program when executed on a computer causes the computer to perform the steps of (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)):
identifying, using natural language processing (NLP) (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)), patient co-morbidity-related clinical data for a patient by preprocessing input historical patient data in real time based on one or more rules, the one or more rules being customizable by tuning threshold values or ranges of one or more of the one or more rules to any of a plurality of user-specified values or ranges;
displaying the identified co-morbidity-related clinical data and the one or more rules using an interactive customizable graphical user interface (GUI) for validation (adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving or transmitting data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d));
accessing and displaying via the GUI the one or more rules (adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving or transmitting data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) on a smartphone device (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f));
accessing further details regarding the rules to increase usability and readability of the system for smartphone devices (adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving or transmitting data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d));
in response to a user action on the smartphone device, displaying further details regarding the rules or the button as a pop-up window or on a new display screen to increase usability and readability of the system (adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving or transmitting data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)),
verifying the identified co-morbidity-related clinical data via the GUI prior to storing any of the identified co-morbidity-related clinical data in a remote electronic health record (EHR);
automatically storing, using a non-transitory computer-readable storage medium, verified results in the remote EHR for the patient adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of storing and retrieving information in memory and electronic recordkeeping, as evidenced by the Versata Dev. Group, Inc. v. SAP Am., Inc. and Alice Corp. Pty. Ltd. v. CLS Bank Int’l cases, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d));
displaying and validating the updated co-morbidity-related clinical data using the GUI (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) for verifying of the updated co-morbidity related clinical data, the GUI being configured for improving usability of the system by being customized for readability on a smartphone device by presenting respective buttons on the GUI display directed only to accessing further information stored on a remote server regarding the relevant co-morbidities, clinical conditions, and corresponding rules from the updated verified co-morbidity-related clinical data (adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving or transmitting data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d));
detecting changes to the updated and verified co-morbidity data in the remote EHR by the post processing;
iteratively updating the remote EHR in real time with only the updated, verified comorbidity data by the postprocessing upon detection of the changes to the EHR based on the verifying the updated co-morbidity-related clinical data, the iterative updating resulting in a reduction of processing requirements and an increase in speed in updating of the remote EHR (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f));
wherein the step of iteratively updating the remote EHR in real time is completed during a patient visit in real time (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)).
However, the recitation of these limitations is made with a high-level of generality (i.e., using computer components and software to perform the abstract mental process of: identifying patient co-morbidity related data in patient data; verifying the identified co-morbidity-related clinical data; identifying updated co-morbidity-related clinical data; validating the updated co-morbidity-related clinical data; and detecting changes to the updated and verified co-morbidity data), such that it amounts to no more than: (1) adding the words “apply it” (or is the equivalent of) with the judicial exception; mere instructions to implement an abstract idea on a computer; or merely uses a computer as a tool to perform an abstract idea; (2) adding insignificant extra-solution activity to the judicial exception; and (3) generally linking the use of the judicial exception to a particular technological environment or field of use (i.e., merely linking the abstract mental process to the medical field of identifying co-morbidity data). See MPEP §§ 2106.05(f)-(h).
- The following are examples of court decisions that demonstrate merely applying instructions by reciting the computer structure as a tool to implement the claimed limitations (e.g., see MPEP § 2106.05(f)):
- Invoking computers or other machinery merely as a tool to perform an existing process, e.g. see, Affinity Labs v. DirecTV – similarly, the current invention invokes computers (i.e., the system, hardware processor, non-transitory computer-readable storage medium, computer readable program, computer, and interactive, customizable GUI) and other machinery to perform the existing process of identifying, displaying, and storing data (i.e., identifying, displaying, and storing the co-morbidity-related clinical data in the patient’s medical records); and
- Requiring the use of software to tailor information and provide it to the user on a generic computer, e.g. see, Intellectual Ventures I LLC v. Capital One Bank – similarly, the current invention merely requires the computer readable program and the computer components (i.e., the system, hardware processor, non-transitory computer-readable storage medium, computer, and interactive, customizable GUI) described in claims 1, 6, and 11 to ultimately perform the limitations identified in claims 1, 6, and 11 as being directed to the abstract idea; and the customizable GUI, described in claim 11, to provide the co-morbidities and clinical condition data on a smartphone.
- The following are examples of insignificant extra-solution activities (e.g., see MPEP § 2106.05(g)):
- Examples of Mere Data Gathering/Mere Data Outputting:
- Consulting and updating an activity log, e.g., see Ultramercial, Inc. v. Hulu, LLC – similarly, the limitation directed to: “automatically storing verified results in the remote EHR for the patient” (as described in claims 1, 6, and 11), are similarly deemed to be a necessary data gathering step (i.e., “storing” the data pertaining to verified co-morbidity-related clinical data is a necessary gathering step before the system is able to be updated with the updated co-morbidity related data in a later step described in claims 1, 6, and 11); and
- Printing or downloading generated menus, e.g., see Apple, Inc. v. Ameranth, Inc. – similarly, the limitations directed to: “displaying the identified co-morbidity-related clinical data and the one or more rules using an interactive customizable graphical user interface (GUI) for validation” (as described in claims 1, 6, and 11); “accessing and displaying via the GUI the one or more rules on a smartphone device” (as described in claim 1, 6, and 11); “accessing further details regarding the rules to increase usability and readability of the system for smartphone devices” (as described in claims 1, 6, and 11); and “displaying the updated co-morbidity-related clinical data using the GUI, the GUI being configured to improve usability of the system by being customized for readability on a smartphone device display by presenting only respective buttons on the GUI display directed to accessing further information stored on a remote server regarding the relevant comorbidities, clinical conditions, and corresponding rules from the updated co-morbidity-related clinical data, wherein a particular type of GUI button activation displays further details regarding the relevant co-morbidities, clinical conditions, and corresponding rules from the updated, verified co-morbidity-related clinical data as a pop-up window or on a new display screen to increase usability and readability of the system” (as described in claims 6 and 11), are similarly deemed to be necessary data outputting steps (i.e., “displaying” the first identified and updated co-morbidity-related clinical data are necessary outputting steps in order for a medical professional to view or receive such data after identifying the data).
- The following represent examples that courts have identified as generally linking the abstract idea to a particular technological environment (e.g., see MPEP § 2106.05(h)):
- Specifying that the abstract idea is executed in a computer environment, because this requirement merely limits the claims to a particular field, e.g., see FairWarning v. Iatric Sys. – similarly, the describing that the abstract idea is implemented with the aforementioned computer components and done in real-time, as described in claims 1, 6, and 11, merely limits the claims to a computer environment and does not provide any meaningful limits to the abstract mental process described in the claims; and
- Limiting the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis to data related to the electric power grid, because limiting application of the abstract idea to power-grid monitoring is simply an attempt to limit the use of the abstract idea to a particular technological environment, e.g., see Electric Power Group, LLC v. Alstom S.A. – similarly, the limitations directed to “displaying” and “storing” the identified and validated co-morbidity-related clinical data, described in claims 1, 6, and 11, merely limits the abstract idea to the co-morbidity-related data and does not provide any meaningful limits to the abstract mental process described in the claims.
Thus, the additional elements in independent claims 1, 6, and 11 are not indicative of integrating the judicial exception into a practical application. Similarly, dependent claims 3, 5, 8, 10, and 12 do not recite any additional elements outside of those identified as being directed to the abstract idea (or those additional elements which were already identified and analyzed in claims 1, 6, and 11), described above. Examiner notes that dependent claims 2, 4, 7, 9, and 13-17 recite the following additional elements (in bold font below):
wherein the GUI is customizable for interoperability with any of a plurality of types of electronic health record (EHR) systems (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) (as described in claims 2 and 7);
wherein the input historical patient data is in a non-structured format, the non-structured data being processed using a natural language processor (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) (as described in claims 4 and 9);
wherein multiple fields within the EHR are searchable with a single user action on the GUI, the single action being executable by an on-screen button push, a long press, or a short press with the results appearing in a pop-up window displayed in front of the GUI buttons on the display (as described in claim 13) (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f); insignificant extra-solution activity as noted above, see MPEP § 2106.05(g); and the Examiner further submits that such steps are not unconventional as they merely consist of receiving or transmitting data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d));
wherein GUI is configured for the tuning values or ranges of one or more of the one or more rules and the verification in real-time by an end user using one or more customizable GUI buttons (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) (as described in claim 14);
wherein the GUI is customized for readability on a smartphone device display by presenting respective graphical buttons on the GUI display directed only to accessing further information stored on a remote server regarding the relevant co-morbidities, clinical conditions, and corresponding rules from the updated co-morbidity-related clinical data, wherein a particular type of graphical button activation displays further details regarding the relevant co-morbidities, clinical conditions, and corresponding rules from the updated, verified co-morbidity-related clinical data as a pop-up window or on a new display screen to increase usability and readability of the system (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) (as described in claim 15); and
wherein the GUI is configured for accessing and displaying the one or more rules by a particular type of graphical button activation on a smartphone device, wherein the particular type of graphical button activation accesses further details regarding the rules or the button as a pop-up window or on a new display screen to increase usability and readability of the system (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) (as described in claims 16 and 17).
However, these additional elements in dependent claims 2, 4, 7, 9, and 13-17 are deemed to be no more than (1) adding the words “apply it” (or is the equivalent of) with the judicial exception; mere instructions to implement an abstract idea on a computer; or merely uses a computer as a tool to perform an abstract idea; (2) adding insignificant extra-solution activity to the judicial exception; and (3) generally linking the use of the judicial exception to a particular technological environment or field of use (i.e., merely linking the abstract mental process to the medical field of identifying co-morbidity data), for similar reasons as identified above. See analysis above; see also MPEP §§ 2106.05(f)-(h). As such, the additional elements in claims 1, 2, 4, 6, 7, 9, 11, and 13-17 are not indicative of integrating the judicial exception into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, unlike claims that have been held as a whole to be directed to an improvement or otherwise directed to something more than the abstract idea, claims 1-17: (1) are not directed to improvements to the functioning of a computer, or to any other technology or technical field similar to the Enfish, LLC v. Microsoft Corp. case (see MPEP § 2106.05(a)); (2) do not apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see MPEP § 2106.04(d)(2)); (3) do not apply the judicial exception with, or by use of, a particular machine (see MPEP § 2106.05(b)); (4) do not effect a transformation or reduction of a particular article to a different state or thing (see MPEP § 2106.05(c)); nor do they (5) apply or use 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 whole is more than a drafting effort designed to monopolize the exception (see MPEP § 2106.05(e) and MPEP § 2106.04(d)(2)). For these reasons, claims 1-17 do not recite additional elements that integrate the judicial exception into a practical application.
Step 2B of the 2019 Revised PEG
Regarding Step 2B of the 2019 Revised PEG, claims 1-17 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, with respect to whether the abstract idea is integrated into a practical application, the additional elements of claims 1, 2, 4, 6, 7, 9, 11, and 13 amount to no more than: (1) adding the words “apply it” (or is the equivalent of) with the judicial exception; mere instructions to implement an abstract idea on a computer; or merely uses a computer as a tool to perform an abstract idea; (2) adding insignificant extra-solution activity to the judicial exception; and (3) generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP §§ 2106.05(f)-(h). Further the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than limitations consistent with what the courts recognize, or those having ordinary skill in the art would recognize, to be well-understood, routine, and conventional computer components. See MPEP §§ 2106.05 (d).
Specifically, the Examiner submits that the additional elements of claims 1, 2, 4, 6, 7, 9, 11, and 13, as recited, the system; hardware processor; non-transitory computer-readable storage medium; natural language processing (NLP); computer readable program; computer; interactive, customizable GUI; smartphone device; and the steps of: “displaying the identified co-morbidity-related clinical data and the one or more rules using an interactive customizable graphical user interface (GUI) for validation”; “accessing and displaying via the GUI the one or more rules on a smartphone device”; “accessing further details regarding the rules to increase usability and readability of the system for smartphone devices”; “automatically storing the verified results in the remote EHR for the patient”; “displaying the updated co-morbidity-related clinical data using the GUI for the validating of the updated co-morbidity-related clinical data”; “displaying the updated co-morbidity-related clinical data using the GUI, the GUI being configured to improve usability of the system by being customized for readability on a smartphone device display by presenting only respective buttons on the GUI display directed to accessing further information stored on a remote server regarding the relevant comorbidities, clinical conditions, and corresponding rules from the updated co-morbidity-related clinical data, wherein a particular type of GUI button activation displays further details regarding the relevant co-morbidities, clinical conditions, and corresponding rules from the updated, verified co-morbidity-related clinical data as a pop-up window or on a new display screen to increase usability and readability of the system”; “iteratively updating the remote EHR in real time with the updated and verified comorbidity data by the postprocessing upon detection of the changes to the remote EHR, the iterative updating resulting in a reduction of processing requirements and an increase in speed in updating of the remote EHR”; “wherein the step of iteratively updating the remote EHR in real time is completed during a patient visit in real time”; “wherein the GUI is customizable for interoperability with any of a plurality of types of electronic health record (EHR) systems”; “the non-structured data being processed using a natural language processor”; and “wherein multiple fields within the EHR are searchable with a single user action on the GUI, the single action being executable by an onscreen button push, a long-press, or a short-press with the results appearing in a pop-up window displayed in front of the GUI buttons on the display”, are well-understood, routine, and conventional functions. See MPEP § 2106.05(d)(II).
- Regarding the system; hardware processor; non-transitory computer-readable storage medium; natural language processing (NLP); computer readable program; computer; interactive, customizable GUI; smartphone device; and the steps of: “the GUI is customizable for interoperability with any of a plurality of types of electronic health record (EHR) systems”; and “the non-structured data being processed using a natural language processor”, these additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than well-understood, routine, and conventional activities previously known to the industry, because:
- Applicant generally describes the system for performing the functions of claimed invention as being implemented by “computer program instructions which may be sent to a processor of any type of computing system (e.g., general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine).” See Applicant’s specification as filed on October 15, 2024, paragraph [0054]. This disclosure shows that the system and its components may be part of a general purpose computer. See Applicant’s specification, at paragraph [0054]. A general purpose computer is a well-understood, routine, and conventional computing device in the medical industry. Therefore, the disclosure in Applicant’s specification shows that the system; hardware processor; non-transitory computer-readable storage medium; natural language processing (NLP); computer readable program; computer; interactive, customizable GUI; smartphone device; and the steps of: “the GUI is customizable for interoperability with any of a plurality of types of electronic health record (EHR) systems”; and “the non-structured data being processed using a natural language processor”, are well-understood, routine, and conventional computer components that are previously known in the industry. See MPEP § 2106.05(d).
- The Examiner submits that these limitations amount to merely using a computer or other machinery as tools for performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f) and analysis of these limitations under Step 2A, Prong Two above).
- The Examiner submits that these limitations generally link the use of the judicial exception to a particular technological environment or field of use – for example, the limitations directed to: “the GUI is customizable for interoperability with any of a plurality of types of electronic health record (EHR) systems”; and “the non-structured data being processed using a natural language processor”, amount to limiting the abstract idea to the field of electron health record systems and natural language processing technology (see MPEP § 2106.05(h) and analysis of these limitations under Step 2A, Prong Two above).
Therefore, these limitations are also deemed to be well-understood, routine, and conventional under Step 2B for similar reasons since they are claimed in a generic manner.
- Regarding the steps and features of: “displaying the identified co-morbidity-related clinical data and the one or more rules using an interactive customizable graphical user interface (GUI) for validation”; “accessing and displaying via the GUI the one or more rules on a smartphone device”; “accessing further details regarding the rules to increase usability and readability of the system for smartphone devices”; “automatically storing the verified results in the remote EHR for the patient”; “displaying the updated co-morbidity-related clinical data using the GUI for the validating of the updated co-morbidity-related clinical data”; “displaying the updated co-morbidity-related clinical data using the GUI, the GUI being configured to improve usability of the system by being customized for readability on a smartphone device display by presenting only respective buttons on the GUI display directed to accessing further information stored on a remote server regarding the relevant comorbidities, clinical conditions, and corresponding rules from the updated co-morbidity-related clinical data, wherein a particular type of GUI button activation displays further details regarding the relevant co-morbidities, clinical conditions, and corresponding rules from the updated, verified co-morbidity-related clinical data as a pop-up window or on a new display screen to increase usability and readability of the system”; “iteratively updating the remote EHR in real time with the updated and verified comorbidity data by the postprocessing upon detection of the changes to the remote EHR, the iterative updating resulting in a reduction of processing requirements and an increase in speed in updating of the remote EHR”; “wherein the step of iteratively updating the remote EHR in real time is completed during a patient visit in real time”; and “wherein multiple fields within the EHR are searchable with a single user action on the GUI, the single action being executable by an onscreen button push, a long-press, or a short-press with the results appearing in a pop-up window displayed in front of the GUI buttons on the display” - The following represents examples that courts have identified to be well-understood, routine, and conventional activities (e.g.,