DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-20 were previously pending and subject to a non-final office action filed on October 1, 2025 (the “October 1, 2025 Non-Final Office Action”). On December 18, 2025, Applicant amended claim 13 in an amendment (the “December 18, 2025 Amendment”). As such, claims 1-20, as recited in the December 18, 2025 Amendment, are currently pending and subject to the final office action below.
Response to Applicant’s Remarks
Response to Applicant’s Remarks Concerning Claim Objections
Applicant’s arguments, see Applicant’s Remarks, p. 12, Objection to Claims 13-19 Section, filed December 18, 2025, with respect to the claim objections of claims 13-19 have been considered, but they are moot in light of Applicant’s amendments to independent claim 13. Specifically, Applicant amended claim 13 to delete a macron that was a typographical error identified in line 6 of claim 13. As such, the claim objections of claims 13-19 are no longer necessary and are hereby withdrawn.
Response to Applicant’s Remarks Concerning Rejections under 35 U.S.C. § 101
Applicant’s arguments, see Applicant’s Remarks, pp. 12-18, Rejections Under 35 U.S.C. § 101 Section, filed December 18, 2025, with respect to rejections of claim 1-20 under 35 U.S.C. § 101 have been fully considered, but they are not persuasive. Further, in light of the 2019 Revised Patent Subject Matter Eligibility Guidance (available at MPEP § 2106) (the “2019 Revised PEG”), the § 101 rejections of claims 1-20 are maintained in this final office action.
Applicant generally argues that the claims are not directed to an abstract idea, because the claims recite “a particular set of technical steps that operate within a computer environment to transform raw, unstructured patient input into structured, indexed data and use that data in real-time aggregate reporting”. Applicant’s Remarks, at p. 13. Specifically, Applicant provides support for this assertion by pointing to the limitations which provide “generating a genetic assessment for the patient based on the responses and the additional responses” and “periodically generating, based at least in part on the patient’s genetic assessment, an aggregate report… wherein the aggregate report is generated in the searchable structured data format to allow the healthcare provider to prioritize discussing at least one of health history, genetic testing, or genetic counseling”. Applicant’s Remarks, at p. 13. Examiner respectfully disagrees with this argument. While the claims recite generating an aggregate report that is in a searchable format and converting unstructured data into a structured format is not necessarily the equivalent of following rules or instructions, this is not the test for determining whether the claims recite an abstract method of organizing human activity. The managing personal behavior or relationships or interactions between people encompasses both activity of a single person (for example, a person following a set of instructions or a person signing a contract online) and activity that involves multiple people (such as a commercial interaction), and thus, certain activity between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within the “certain methods of organizing human activity” grouping. MPEP § 2106.04(a)(2)(II). The Court of Customs and Patent Appeals recognized this in In re Meyer, determining that a mental process that a neurologist should follow when testing a patient for nervous system malfunctions was an abstract idea. MPEP § 2106.04(a)(2)(II)(C).
Similarly, in the present case, the identified abstract method of organizing human activity involves at least certain activity between one person and a computer, namely, steps for scheduling medical appointments; transmitting data (the family history request forms) to patients after the appointments have been scheduled; collecting patient family history responses; and generating genetic risk assessments based on the responses. Under the broadest reasonable interpretation of the claims, these steps are rules and instructions for generating genetic risk assessments based on the user’s responses to family history questions. The fact that Applicant uses a computer to collect the responses and adds that they are unstructured initially, and converting into a structured, searchable format amounts to performing the abstract method of organizing the human activity in a generic computer environment. Therefore, the steps of perform structured data conversion and generating the genetic assessment are recited at a high level of generality, and amount to using a computer as a tool to perform an abstract method of organizing human activity. For these reasons, this argument is not persuasive.
Next, Applicant argues that the claims provide a technological improvement in the field of medical records management, because the claimed invention enables improved interoperability, searchability, and usefulness of patient data through automated computer processes. See Applicant’s Remarks, at pp. 14-15. Examiner respectfully disagrees with this assertion. The consideration of whether the claim as a whole includes an improvement to a computer or to a technological field requires an evaluation of the specification and the claim to ensure that a technical explanation of the asserted improvement is present in the specification, and that the claim reflects the asserted improvement. See MPEP § 2106.04(d)(1).
When evaluating whether claims recite an improvement to the functioning of a computer or a technical field, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. MPEP § 2106.05(a). The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Id. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art.
For example, in the McRO, Inc. v. Bandai Namco Games Am. Inc. case, the Federal Circuit relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea. Id. Conversely, the Federal Circuit has held claims which merely record, transmit, and archive data by use of conventional or generic technology in a nascent but well-known environment, without any assertion that the invention reflects an inventive solution to any problem may not be sufficient to show an improvement in computer-functionality. See MPEP § 2106.05(a) (citing the TLI Communications LLC v. AV Auto case). Further, gathering and analyzing information using conventional techniques, was also determined to be insufficient to show an improvement in computer-functionality. See MPEP § 2106.05(a) (also citing the TLI Communications case).
In the present case, Applicant’s claims do not describe an improvement to the functioning of a computer or any other technology or technical field. Similar to the TLI Communications case, Applicant’s claims merely implement conventional techniques, such as collecting data (i.e., receiving the bulk patient data secure file transfer indicating the patient has scheduled an appointment and receiving responses to the plurality of questions); analyzing the data (i.e., generating a genetic assessment for the patient based on the responses); and displaying certain results about the collection and analysis (i.e., presenting the genetic assessment in a graphical user interface) with greater speed through the use of existing computer technology. Applicant’s claims merely describe a conventional process of collecting data, analyzing the data, and displaying certain results of the analysis with a computer.
Applicant’s claims and specification do not describe details for how the system converts data from an unstructured format into a structured format that makes such an improvement of generated patient reports apparent to one of ordinary skill in the art. Rather, the preamble of claims 1, 13, and 20 merely state in a conclusory manner that the claimed method improves trackability and usefulness of stored patient data. Therefore, this argument is not persuasive and Applicant’s claims do not recite an improvement to a technological field.
Lastly, Applicant generally argues that claims provide significantly more than the exception under Step 2B. See Applicant’s Remarks, at pp. 16-18. Examiner respectfully disagrees with this argument. When making a determination whether the additional elements in a claim amount to significantly more than a judicial exception, the examiner should evaluate whether the elements define only well-understood, routine, conventional activity. MPEP § 2106.05(d). In this respect, the well-understood, routine, conventional consideration overlaps with other Step 2B considerations, particularly the improvement consideration (see MPEP § 2106.05(a)), the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)), and the insignificant extra-solution activity consideration (see MPEP § 2106.05(g)). Id. Thus, evaluation of those other considerations may assist examiners in making a determination of whether a particular element or combination of elements is well-understood, routine, conventional activity. Id.
In the present case, the additional elements recited in the claims represent well-understood, routine, and conventional activity. Courts have held computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). MPEP § 2106.05(d). Applicant’s claims were deemed to recite an abstract method of organizing human activity (see above). The action steps recited in the claims (namely, the steps directed to presenting the plurality of questions related to family history of the patient; generating the genetic assessment based on the user’s responses; and periodically generating the aggregate report of the patients) amounts to rules or instructions performed on a computer. As described in the amended rejections under the Claim Rejections – 35 U.S.C. § 101 Section below, the additional elements (the system; non-transitory computer-readable medium; smartphone; web server managed by an entity that provides genetic testing services; data share module, stored in memory of the web server; electronic health records system associated with a healthcare provider; patient engagement module, stored in the memory; web-based portal; response module, stored in the memory; genetic assessment module, stored in the memory; at least one processor/at least one processor configured to execute the data share module, the patient engagement module, and the genetic assessment module to the patient computing device; first graphical user interface of the web-based portal; and second graphical user interface of the web-based portal) represent generic component components and functions for performing the existing processes of: transmitting data (i.e., family history request forms) to patients after the appointments have been scheduled; collecting patient family history responses; generating genetic risk assessments based on the responses; and transmitting the genetic risk assessments to healthcare providers. The Federal Circuit has recognized the functions of retrieving/extracting data and presenting data as well-understood, routine, and conventional activity in particular fields. See MPEP § 2106.05(d) (citing Intellectual Ventures v. Symantec, TLI Communications LLC v. AV Auto. LLC, OIP Techs., Inc., v. Amazon.com, Inc., buySAFE, Inc. v. Google, Inc., DDR Holdings, LLC v. Hotels.com, L.P., and Content Extraction and Transmission, LLC v. Wells Fargo Bank). Therefore, this argument is not persuasive and Applicant’s claims do not provide significantly more than the exception under Step 2B.
As a result, the rejections of claims 1-20 under 35 U.S.C. § 101 are maintained in this office action. Please see the amended rejections under the Claim Rejections – 35 U.S.C. § 101 Section below, for further clarification and complete analysis.
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 1-20 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 Alice/Mayo Test
Following Step 1 of the 2019 Revised PEG, claims 1-12 are directed to a computer-implemented method, which is also within one of the four statutory categories (i.e., a process). See MPEP § 2106.03. Claims 13-19 are directed to a system, which is within one of the four statutory categories (i.e., a machine or apparatus). See id. Claim 20 is directed to a non-transitory computer-readable medium, which is also within one of the four statutory categories (i.e., an article of manufacture). See id.
Step 2A of the Alice/Mayo Test – Prong One
Following Prong One of Step 2A of the 2019 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 1-20 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, 13, and 20 include limitations that recite an abstract idea. Note that independent claim 13 is a system claim, while claim 1 covers the matching computer-implemented method claim and claim 20 covers the matching non-transitory computer-readable medium claim. Specifically, independent claim 13 recites (and claims 1 and 20 substantially recite the following limitations):
A system for improving trackability and usefulness of structured and unstructured patient data stored an electronic health record system by generating special data format, the system comprising:
a web server managed by an entity that provides genetic testing services;
a data share module, stored in memory of the web server, that initiates a first encrypted data exchange with a server of an electronic health records system associated with a healthcare provider to receive a bulk patient data secure file indicating that a patient has scheduled an appointment with the healthcare provider;
a patient engagement module, stored in the memory, that, (i) determines that the bulk patient data secure file transfer indicates the patient has the scheduled appointment, and generates a text message with a digital link configured to be selectable for access to a web-based portal of the web server, and a request to access and complete, in preparation for the scheduled appointment, an electronic family history form using the web-based portal, and transmits, using a Short Message Serve, to a smartphone of the patient, the text message with the digital link and the request, and (ii) in response to detecting selection of the digital link, serves the web-based portal to the smartphone;
a response module, stored in the memory, that presents, through the web-based portal being accessed using the smartphone, a first graphical user interface comprising questions related to a family history of the patient, and receives response to the questions through the web-based portal, being accessed using the smartphone, the web-based portal configured to dynamically update to present additional graphical elements corresponding to additional questions based on a first answer to a first question of the plurality of questions and receive additional responses via the additional graphical elements;
a genetic assessment module, stored in the memory, that automatically generates a genetic assessment for the patient based on the responses and the additional responses received through the web-based portal; and
at least one physical processor configured to execute the data share module, the patient engagement module, and the genetic assessment module;
wherein the web server is operable to:
present the genetic assessment in a second graphical user interface of the web-based portal being accessed using the smartphone;
generate a computer-searchable patient report with a structured data format, wherein generating the patient report comprises converting unstructured data format to the structured data format;
initiate a second encrypted data exchange with the server of the electronic health records system;
transmit, via the second encrypted data exchange, the patient report to the electronic health records system for storage in the electronic health records system and access by the healthcare provider, wherein the patient report is stored in the electronic health record system in the searchable structured data format, thereby improving trackability and usefulness of the stored patient report;
periodically generate, based at least in part on the patient’s genetic assessment, an aggregate report of a plurality of patients, including the patient, who have scheduled appointments with the healthcare provider; and
transmit the aggregate report to a provider device of the healthcare provider;
wherein the patients of the aggregate report comprise patients with similar genetic assessments having appointments with similar timeframes, and wherein the aggregate report is generated in the searchable structured data format to allow the healthcare provider to prioritize discussing at least one of health history, genetic testing, or genetic counseling.
However, the Examiner submits that the foregoing underlined limitations constitute a process that, under its broadest reasonable interpretation, falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See 2019 Revised PEG. The Certain Methods of Organizing Human Activity category covers concepts related to managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (i.e., scheduling medical appointments; transmitting data (i.e., family history request forms) to patients after the appointments have been scheduled; collecting patient family history responses; and generating genetic risk assessments based on the responses). See MPEP § 2106.04(a)(2)(II). 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, 13, and 20 encompasses concepts directed to managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (i.e., scheduling medical appointments; transmitting data (i.e., family history request forms) to patients after the appointments have been scheduled; collecting patient family history responses; and generating genetic risk assessments based on the responses).
The aforementioned claim limitations described in claims 1, 13, and 20 are analogous to claim limitations directed toward concepts of managing personal behavior or relationships or interactions between people, because they merely recite limitations for ultimately generating genetic assessment reports and sharing this genetic data between people (i.e., collecting family history data from patients and providing this information to healthcare providers who are providing genetic screening and counseling services in a report). If a claim limitation, under its broadest reasonable interpretation, covers the management of personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See 2019 Revised PEG. Accordingly, claims 1, 13, and 20 recite an abstract idea.
Furthermore, Examiner notes that dependent claims 2-12 and 14-19 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below. Examiner notes that: (1) dependent claims 8, 10, 11, and 14 include limitations that are deemed to be additional elements, and require further analysis under Prong Two of Step 2A; and (2) dependent claims 2-7, 9, 12, and 15-19 do not provide any limitations that are deemed to be additional elements which require further analysis under Prong Two of Step 2A. For example, claims 2-7, 12, and 15-19 merely recite further steps for providing recommendations and limiting the type of data that is contained in the generated aggregate report; and claim 9 merely recites steps for receiving information, aggregating the information, and analyzing the information to identify populations that are at risk for hereditary cancer (i.e., these steps are deemed to be cover the management of personal behavior or relationships or interactions between people, because they merely follow rules or instructions to modify the type of data that is used for the aggregated reports).
Step 2A of the Alice/Mayo Test – 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).
Following Prong Two of Step 2A of the 2019 Revised PEG, this judicial exception is not integrated into a practical application because they do not impose any meaningful limits on practicing the abstract idea. In the present case, for independent claim 13, 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 for improving trackability and usefulness of structured and unstructured patient data stored an electronic health record system by generating special data format, 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)) comprising:
a web server managed by an entity that provides genetic testing services (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 data share module, stored in memory of the web server, that initiates a first encrypted data exchange with a server of an electronic health records system associated with a healthcare provider to receive a bulk patient data secure file indicating that a patient has scheduled an appointment with the healthcare provider (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 patient engagement module, stored in the memory, that (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)), (i) determines that the bulk patient data secure file transfer indicates the patient has the scheduled appointment, and generates a text message with a digital link configured to be selectable for access to a web-based portal of the web server, and a request to access and complete, in preparation for the scheduled appointment, an electronic family history form using the web-based portal, and transmits, using a Short Message Serve, to a smartphone of the patient, the text message with the digital link and the request (the Examiner submits that this additional element amounts to insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); generally linking the abstract idea to a particular field of use, as noted below, see MPEP § 2106.05(e); 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)), and (ii) in response to detecting selection of the digital link, serves the web-based portal to the smartphone (the Examiner submits that this additional element amounts to insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); generally linking the abstract idea to a particular field of use, as noted below, see MPEP § 2106.05(e); 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));
a response module, stored in the memory, (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)) that presents, through the web-based portal being accessed using the smartphone, a first graphical user interface 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)) questions related to a family history of the patient, and receives response to the questions through the web-based portal, being accessed using the smartphone, the web-based portal configured to (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)) dynamically update to present additional graphical elements corresponding to additional questions based on a first answer to a first question of the plurality of questions and receive additional responses via the additional graphical elements;
a genetic assessment module, stored in the memory (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)), that automatically generates a genetic assessment for the patient based on the responses and the additional responses received through the web-based portal; and
at least one physical processor configured to execute the data share module, the patient engagement module, and the genetic assessment module (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 web server is operable to (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)):
present the genetic assessment in a second graphical user interface of the web-based portal being accessed using the smartphone (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));
generate a computer-searchable patient report with a structured data format, wherein generating the patient report comprises converting unstructured data format to the structured data format (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));
initiate a second encrypted data exchange with the server of the electronic health records 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));
transmit, via the second encrypted data exchange, the patient report to the electronic health records system for storage in the electronic health records system and access by the healthcare provider (the Examiner submits that this additional element amounts to insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); generally linking the abstract idea to a particular field of use, as noted below, see MPEP § 2106.05(e); 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 the patient report is stored in the electronic health record system in the searchable structured data format, thereby improving trackability and usefulness of the stored patient report (the Examiner submits that this additional element amounts to insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); and the Examiner further submits that such steps are not unconventional as they merely consist of storing and retrieving information in memory, as evidenced by the Versata Dev. Group, Inc. v. SAP Am., Inc. case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d));
periodically generate, based at least in part on the patient’s genetic assessment, an aggregate report of a plurality of patients, including the patient, who have scheduled appointments with the healthcare provider; and
transmit the aggregate report to a provider device of the healthcare provider (the Examiner submits that this additional element amounts to insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); generally linking the abstract idea to a particular field of use, as noted below, see MPEP § 2106.05(e); 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 the patients of the aggregate report comprise patients with similar genetic assessments having appointments with similar timeframes, and wherein the aggregate report is generated in the searchable structured data format to allow the healthcare provider to prioritize discussing at least one of health history, genetic testing, or genetic counseling;
a non-transitory computer-readable medium comprising one or more computer-executable instructions (as described in claim 20) (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 a computing device (as described in claims 1 and 20) (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 methods of organizing human activity directed to: transmitting data (i.e., family history request forms) to patients after the appointments have been scheduled; collecting patient family history responses; generating genetic risk assessments based on the responses; and transmitting the genetic risk assessments to healthcare providers), 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 a judicial exception to a particular technological environment or field of use. 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; non-transitory computer-readable medium; smartphone; web server managed by an entity that provides genetic testing services; data share module, stored in memory of the web server; electronic health records system associated with a healthcare provider; patient engagement module, stored in the memory; web-based portal; response module, stored in the memory; genetic assessment module, stored in the memory; at least one processor/at least one processor configured to execute the data share module, the patient engagement module, and the genetic assessment module to the patient computing device; first graphical user interface of the web-based portal; and second graphical user interface of the web-based portal, to perform the existing processes of: transmitting data (i.e., family history request forms) to patients after the appointments have been scheduled; collecting patient family history responses; generating genetic risk assessments based on the responses; and transmitting the genetic risk assessments to healthcare providers);
- Using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data), e.g. see, TLI Communications LLC v. AV Auto, LLC – similarly, the current invention invokes the system; non-transitory computer-readable medium; smartphone; web server; memory; processor; electronic health records system; first and second graphical user interfaces; and the various modules, as tools to execute the abstract idea; 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 at least one processor configured to execute the various modules (i.e., software – see paragraph [0087] in Applicant’s specification as filed on September 17, 2024) to be programmed to ultimately perform the limitations identified in claims 1, 13, and 20 as being directed to the abstract idea.
- The following are examples of insignificant extra-solution activities (e.g., see MPEP § 2106.05(g)):
- Examples of Mere Data Gathering/Mere Data Outputting:
- Performing clinical tests on individuals to obtain input for an equation, e.g., see In re Grams – similarly, the current invention merely utilizes the steps of “initiating the first and second encrypted data exchanges with the server” and “sending a digital family history request to the patient in preparation for the scheduled appointment”, described in claims 1, 13, and 20, as necessary data gathering/outputting steps for collecting the information that is used to generate the genetic risk assessment for the patient; and
- Obtaining information about transactions using the Internet to verify credit card transactions, e.g., see CyberSource v. Retail Decisions, Inc. – similarly, the limitations directed to: “generating a text message with a digital link configured to be selectable for access to a web-based portal of the web server, and a request to access and complete, in preparation for the scheduled appointment, an electronic family history form using the web-based portal, and transmits, using a Short Message Serve, to a smartphone of the patient, the text message with the digital link and the request”; “in response to detecting selection of the digital link, serving the web-based portal to the smartphone”; “generating a computer-searchable patient report with a structured data format, wherein generating the patient report comprises converting unstructured data format to the structured data format”; “transmitting the patient report to the electronic health records system for storage in the electronic health records system and access by the healthcare provider” and “transmitting the aggregate report to a provider device of the healthcare provider”, described in claims 1, 13, and 20, are similarly deemed to be a necessary data gathering/outputting steps (i.e., “transmitting an electronic message with a digital link is a necessary gathering/outputting step before the system is able to: (i) collect the patient’s responses; and (ii) generate the genetic risk assessments for the patient based on the patient’s responses; and “sending the genetic risk assessments to the patient and the patient reports to a health records system are necessary data outputting steps in order for the patients and healthcare providers to access the information.).
- An Example of Selecting a Particular Data Source or Type of Data to be Manipulated:
- Limiting a database index to XML tags, e.g., see Intellectual Ventures I LLC v. Erie Indem. Co. – similarly, the limitations directed to “wherein the patient report is stored in the electronic health record system in the searchable structured data format, thereby improving the trackability and usefulness of the stored patient report”, described in claims 1, 13, and 20, are similarly deemed to be the mere selection of a particular data source or type of data to be manipulated (i.e., selecting the searchable patient report for storage in an electronic storage device).
Thus, the additional elements in independent claims 1, 13, and 20 are not indicative of integrating the judicial exception into a practical application. Similarly, dependent claims 2-7, 9, 12, and 15-19 do not recite any additional elements outside of those identified as being directed to the abstract idea, described above. Examiner notes that dependent claims 8, 10, 11, and 14 recite the following additional elements (in bold font below):
wherein generating the aggregate report comprises periodically generating the aggregate report, each generated instance of the aggregate report being generated in connection with a successive time period; and transmitting the aggregate report comprises periodically transmitting the aggregate report (the Examiner submits that this additional element amounts to insignificant extra-solution activity as noted above, see MPEP § 2106.05(g); and insufficient to amount to significantly more than the judicial exception as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) (as described in claim 8);
wherein the web server is managed by an entity that provides genetic screening services (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 electronic health records system automatically transmits the bulk patient data secure file to the web server managed by the entity in response to determining that the patient has been scheduled for the scheduled appointment (the Examiner submits that this additional element amounts to insignificant extra-solution activity as noted above, see MPEP § 2106.05(g); and insufficient to amount to significantly more than the judicial exception as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) (as described in claim 10);
further comprising providing the patient with a personal report comprising at least one of: the patient’s genetic assessment; the patient’s responses to the electronic family history form; and educational information, wherein providing the patient with the personal report comprises at least one of: transmitting, to the smartphone of the patient, a second digital link to the personal report; and transmitting, to the smartphone of to the patient, an email that includes the personal report (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 insufficient to amount to significantly more than the judicial exception as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) (as described in claim 11); and
the system further comprising: a patient pedigree module, stored in the memory (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)), that generates a three-generation patient pedigree based on the genetic assessment for the patient, wherein the three-generation patient pedigree comprises determining at least one of: number of aunts / uncles related to the patient; number of brothers / sisters related to the patient; and number of sons / daughters related to the patient (as described in claim 14).
However, the additional elements in dependent claims 8, 10, 11, and 14 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; and (2) adding insignificant extra-solution activity to the judicial exception, for similar reasons as identified above. See analysis above; see also MPEP §§ 2106.05(f), (g). For example, the steps directed to: automatically sending the report to the healthcare provider, clinic, and server; and sending the patient the report in a link or email, as described in claims 8, 10, 11, and 14, are merely using common computer components and features to present the organized human activity (i.e., the generated assessment) to the persons in the claims.
As such, the additional elements in claims 1, 8, 10, 11, 13, 14, and 20 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 1-20: (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 1-20 do not recite additional elements that integrate the judicial exception into a practical application.
Step 2B of the Alice/Mayo Test for Claims
Regarding Step 2B of the 2019 Revised PEG, claims 1-20 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, 8, 10, 11, 13, 14, and 20 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 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, 8, 10, 11, 13, 14, and 20, as recited, the system; non-transitory computer-readable medium; smartphone; web server managed by an entity that provides genetic testing services; data share module, stored in memory of the web server; electronic health records system associated with a healthcare provider; patient engagement module, stored in the memory; web-based portal; response module, stored in the memory; genetic assessment module, stored in the memory; at least one processor/at least one processor configured to execute the data share module, the patient engagement module, and the genetic assessment module to the patient computing device; first graphical user interface of the web-based portal; and second graphical user interface of the web-based portal; and the steps of: “generating a text message with a digital link configured to be selectable for access to a web-based portal of the web server, and a request to access and complete, in preparation for the scheduled appointment, an electronic family history form using the web-based portal, and transmits, using a Short Message Serve, to a smartphone of the patient, the text message with the digital link and the request”; “in response to detecting selection of the digital link, serving the web-based portal to the smartphone”; “generating a computer-searchable patient report with a structured data format, wherein generating the patient report comprises converting unstructured data format to the structured data format”; “transmitting the patient report to the electronic health records system for storage in the electronic health records system and access by the healthcare provider”; “wherein the patient report is stored in the electronic health record system in the searchable structured data format, thereby improving the trackability and usefulness of the stored patient report”; “transmitting the aggregate report to a provider device of the healthcare provider”; “transmitting the aggregate report comprises periodically transmitting the aggregate report”; “automatically transmits the bulk patient data secure file to the web server managed by the entity in response to determining that the patient has been scheduled for the appointment”; “transmitting, to the smartphone of the patient, a second digital link to the personal report; and transmitting, to the smartphone of to the patient, an email that includes the personal report”; “ and “generating a three-generation patient pedigree module, stored in the memory, based on the genetic assessment for the patient”. See MPEP § 2106.05(d)(II).
- Regarding the system; non-transitory computer-readable medium; computing device; web server managed by an entity that provides genetic testing services; data share module, stored in memory of the web server; electronic health records system associated with a healthcare provider; patient engagement module, stored in the memory; web-based portal; response module, stored in the memory; genetic assessment module, stored in the memory; at least one processor/at least one processor configured to execute the data share module, the patient engagement module, and the genetic assessment module to the patient computing device; first graphical user interface of the web-based portal; and second graphical user interface of the web-based portal, and the steps directed to: “generating a computer-searchable patient report with a structured data format, wherein generating the patient report comprises converting unstructured data format to the structured data format” - 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’s disclosure supports this assertion – for example, Applicant generally describes the computer system as one that “broadly represents any single or multi-processor computing device or system capable of executing computer-readable instructions”, including, without limitation, “workstations, laptops, client-side terminals, servers, distributed computing systems, handheld devices, or any other computing system or device.” Applicant’s specification as filed on July 26, 2019, paragraph [0086]. Further, Applicant describes the processor as generally representing “any form of physical processing unit (e.g., a hardware-implemented central processing unit) capable of processing data or interpreting and executing instructions. Id. at paragraph [0087]. These components are described at a high level, and are the equivalent of generic computer components (i.e., generic computer processing devices). Therefore, this disclosure shows that the system; computing device; server; electronic health records system; and at least one processor, are generic computing devices. Such devices are old and well-known computing devices in the medical industry.
- Similarly, the specification discloses that the system memory generally “represents any type or form of volatile or nonvolatile storage device or medium capable of storing data and/or other computer-readable instructions. Examples of system memory 816 include, without limitation, Random Access Memory (RAM), Read Only Memory (ROM), flash memory, or any other suitable memory device.” Id. at paragraph [0088]. Paragraph [0088] also discloses that “the one more modules 102 from FIG. 1 [which include the data share module; request module; response module; and risk assessment module] may be loaded into the system memory.” Id. This disclosure shows that the memory and various modules may be embodied by generic computer components and software instructions. Likewise, these computer components and generic software instructions are old and well-known in the medical industry.
- Still further, the specification discloses that the I/O device may include and/or represent a user interface that facilitates human interaction with the computing system, such as a computer mouse, keyboard, monitor, printer, touchscreen device, and/or variations or combinations of the same and/or any other input/output device. Applicant’s specification as filed on July 26, 2019, paragraph [0095]. A user interface that facilitates human interaction with a computing system (i.e., such as a generic display monitor or touchscreen device) is old and well-known in the medical industry. Therefore, this disclosure shows that the first and second graphical user interfaces may be embodied by generic computer monitors and touchscreen interfaces.
- 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). 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.
- 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 “in response to detecting selection of the digital link, serves the web-based portal to the smartphone” amounts to limiting the abstract idea to the field of computers/computer 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 do not limit the claims meaningfully.
- Yet still further, prior art shows that formatting reports into structured and searchable formats are old and well-known computer functions. For example, Florin et al. (Pub. No. US 2017/0083665) teaches that well-known computer processors, memory units, storage devices, computer software, and other components may be used to: generate patient-specific structured report templates, creating a radiology structured reports, automatically review a free-form radiology reports (i.e., automatically searching reports indicates that the reports are in a searchable format); and automatically generating healthcare analytics using patient-specific structured report templates for radiology scans. See Florin, paragraph [0033]. This disclosure shows that it was old and well-known in the medical industry to create medical reports in a structured and searchable format. Therefore, the step of “automatically generating, based on response with an unstructured data format, a computer-searchable patient report with a structured data format, wherein generating the patient report comprises converting the unstructured data format to the structured data format”, as described in claims 1, 13, and 20, is also deemed to be a well-understood, routine, and conventional computer function in the medical industry.
Therefore, the disclosure in Applicant’s specification and prior art shows that the aforementioned computer components and functions are well-understood, routine, and conventional computer components and functions that are previously known in the industry. See MPEP § 2106.05(d).
- Regarding the steps and features directed to: “generating a text message with a digital link configured to be selectable for access to a web-based portal of the web server, and a request to access and complete, in preparation for the scheduled appointment, an electronic family history form using the web-based portal, and transmits, using a Short Message Serve, to a smartphone of the patient, the text message with the digital link and the request”; “in response to detecting selection of the digital link, serving the web-based portal to the smartphone”; “transmitting the patient report to the electronic health records system for storage in the electronic health records system and access by the healthcare provider”; “wherein the patient report is stored in the electronic health record system in the searchable structured data format, thereby improving the trackability and usefulness of the stored patient report”; “transmitting the aggregate report to a provider device of the healthcare provider”; “transmitting the aggregate report comprises periodically transmitting the aggregate report”; “automatically transmits the bulk patient data secure file to the web server managed by the entity in response to determining that the patient has been scheduled for the appointment”; “transmitting, to the smartphone of the patient, a second digital link to the personal report; and transmitting, to the smartphone of to the patient, an email that includes the personal report”; “ and “generating a three-generation patient pedigree module, stored in the memory, based on the genetic assessment for the patient” - The following represents an example that courts have identified to be well-understood, routine, and conventional activities (e.g., see MPEP § 2106.05(d)):
- Receiving or transmitting data over a network, e.g., see Intellectual Ventures v. Symantec – similarly, the limitations directed to: “generating a text message with a digital link configured to be selectable for access to a web-based portal of the web server, and a request to access and complete, in preparation for the scheduled appointment, an electronic family history form using the web-based portal, and transmits, using a Short Message Serve, to a smartphone of the patient, the text message with the digital link and the request”; “in response to detecting selection of the digital link, serving the web-based portal to the smartphone”; “transmitting the patient report to the electronic health records system for storage in the electronic health records system and access by the healthcare provider”; “transmitting the aggregate report to a provider device of the healthcare provider”; “transmitting the aggregate report comprises periodically transmitting the aggregate report”; “automatically transmits the bulk patient data secure file to the web server managed by the entity in response to determining that the patient has been scheduled for the appointment”; “transmitting, to the smartphone of the patient, a second digital link to the personal report; and transmitting, to the smartphone of to the patient, an email that includes the personal report”; “ and “generating a three-generation patient pedigree module, stored in the memory, based on the genetic assessment for the patient”, are also deemed to be well-understood, routine, and conventional activity in the medical field, because they also represent mere collection and transmission of data over a network (i.e., merely (i) sending medical information requests to a patient and; (ii) sending medical reports to the healthcare providers).
- Storing and retrieving information in memory, e.g., see Versata Dev. Group, Inc. v. SAP Am., Inc. – similarly, the limitations directed to “wherein the patient report is stored in the electronic health record system in the searchable structured data format, thereby improving the trackability and usefulness of the stored patient report”, are also deemed to be well-understood, routine, and conventional activity in the medical field, because they also represent generic storage of data in memory (i.e., this limitation is claimed with a high level of generality, because it merely requires that that the structured report is stored in a storage/memory device).
Therefore, the additional elements described in claims 1, 8, 10, 11, 13, 14, and 20 are deemed to be additional elements which do not amount to significantly more than the abstract idea identified above.
Thus, taken alone, the additional elements of claims 1, 8, 10, 11, 13, 14, and 20 do not amount to significantly more than the above-identified judicial exception (the abstract idea). Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functionality of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an ordered combination, claims 1, 8, 10, 11, 13, 14, and 20 are nonetheless rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Additionally, dependent claims 2-7, 9, 12, and 15-19 (which individually depend on claims 1 and 13 respectively); do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Examiner notes that claims 2-7, 9, 12, and 15-19 do not include any additional elements beyond those identified as well-understood, routine, and conventional components as described above in the subject matter eligibility rejections of independent claims 1 and 13. Dependent claims 2-7, 9, 12, and 15-19 merely add limitations that further narrow the abstract idea described in independent claims 1 and 13. Therefore, claims 1-20 are also nonetheless rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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/N.A.A./Examiner, Art Unit 3686
/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686