DETAILED ACTION
Notices to Applicant
This communication is a Final Office Action on the merits. Claims 1-2, 4-14 and 16-21 as filed 12/23/2025, are currently pending and have been considered below.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 4-14 and 16-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Claims 1-2, 4-9, and 21 are drawn to a system for notifying clinicians regarding tissue for donation in near-real time, which is within the four statutory categories (i.e. system).
Independent Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recites (additional elements bolded):
1. A system comprising: an electronic health information database; a medical condition information database; one or more processors configured to communicate with the database using network communications; and a non-transitory computer-readable storage media having computer-executable instructions embodied thereon that, when executed by the one or more processors, cause the processors to perform actions comprising:
querying the electronic health information database to access, via a network communication, an indication of expiration for an individual, wherein the indication is received by input into a remote computing device;
in response to receiving the indication of expiration, automatically triggering the system to determine whether the individual is a donor;
querying the electronic health information database to request and receive electronic health information associated with the individual from at least the database via a first database query;
receiving one or more exclusionary criteria for donor tissue associated with the individual from at least the database via a second database query, wherein the exclusionary criteria are programmed predetermined rules;
querying the medical condition information database to request and receive medical condition information;
integrating the electronic health information and the medical condition information received using FHIR, wherein the electronic health information has a first format that differs from the FHIR-formatted medical condition information;
identifying, by the one or more processors, a first ineligible tissue from the individual based on executing program rules that compare the integrated electronic health information and medical condition information to the exclusionary criteria;
identifying, by the one or more processors, a first likely eligible tissue from the individual based on executing the program rules that compare the integrated electronic health information and medical condition information to the exclusionary criteria;
generating, by the one or more processors, a structured donor alert that identifies the first ineligible tissue and the first likely eligible tissue, wherein the structured donor alert includes a blacklist indicator for the first ineligible tissue and a whitelist indicator for the first likely eligible tissue; and
providing a notification, via the network communication to the remote computing device, that causes the remote computing device to display, in a graphical user interface, without opening an entire chart, the structured donor alert that displays the blacklist indicator and the whitelist indicator as an overlay over the other content being displayed in the graphical user interface in real time with respect to the indication of expiration.
The above limitations, as drafted, is a system that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting the above bolded limitations, nothing in the claim precludes the step from practically being performed in the mind. For example, but for the above bolded limitations, determine whether the individual is a donor in response to receiving the indication of expiration; receiving one or more exclusionary criteria for donor tissue associated with the individual, wherein the exclusionary criteria are programmed predetermined rules; request and receive medical condition information; identifying a first ineligible tissue from the individual based on executing program rules that compare integrated electronic health information and medical condition information to the exclusionary criteria; identifying a first likely eligible tissue from the individual based on executing the program rules that compare the integrated electronic health information and the medical condition information to the exclusionary criteria in the context of this claim encompasses the observation, evaluation, judgment, and opinion of health data regarding eligibility of organs and tissue for donation. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Further, the above limitations are also directed to rules or instructions for managing personal behavior or interactions between people, which falls under the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements, for example “an electronic health information database; a medical condition information database; one or more processors configured to communicate with the database using network communications; and a non-transitory computer-readable storage media having computer-executable instructions embodied thereon that, when executed by the one or more processors, cause the processors” to perform the claim limitations. The above bolded additional elements in each of these steps are recited at a high-level of generality (i.e., a database; one or more processors configured to communicate with the database using network communications; and a non-transitory computer-readable storage media having computer-executable instructions embodied thereon that, when executed by the one or more processors, cause the processors to perform actions e.g. remote computing device communicative over a network, data stores and storage media with program components comprising rules and including data from one or more electronic medical records can include a tablet used by a medical professional to access displayed program components via a graphical user interface in a screen view as they relate to general purpose computer components (Application Specification [0019]-[0021], [0023], [0035], [0064], [0065])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer or other machinery in its ordinary capacity, or merely uses a computer or other machinery in its ordinary capacity as a tool to perform an abstract idea. See MPEP 2106.05(f)(2). This includes the additional elements of querying databases to access, request, and receive information via a communication network, and inputting information into a computing device, and integrating information that has different formats using general purpose computing components or other machinery in their ordinary capacity. See MPEP 2106.05(f)(2). Further, the additional elements of receiving data via a network, requesting and receiving data from a database via a query, and providing a notification alert via a network as well as the conversion of electronic health information to a health information standard format selected from HL7 or FHIR data structures and the displaying on a graphical user interface with indicators as an overlay amounts to adding insignificant extra-solution activity to the abstract idea. See MPEP 2106.05(g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the above bolded additional elements, for example “an electronic health information database; a medical condition information database; one or more processors configured to communicate with the database using network communications; and a non-transitory computer-readable storage media having computer-executable instructions embodied thereon that, when executed by the one or more processors, cause the processors” to perform the claim limitations amounts to no more than mere instructions to apply the exception using generic computer components (i.e., a remote computing device communicative over a network, data stores and storage media with program components comprising rules and including data from one or more electronic medical records can include a tablet used by a medical professional as they relate to general purpose computer components (Application Specification [0019]-[0021], [0064], [0065])). Mere instructions to apply an exception using a generic computer component or other machinery in its ordinary capacity cannot provide an inventive concept. See MPEP 2106.05(f)(2). The additional element of receiving data via a network and providing a notification via a network as well as the conversion of electronic health information to a health information standard format selected from HL7 or FHIR data structures amounts to adding insignificant extra-solution activity to the abstract idea and is well-understood, routine, and conventional activity. See MPEP 2106.05(g)(d) (Receiving or transmitting data over a network, OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network) (U.S. 2019/0034591 A1 discloses data from the different institutions may be in different data formats, due to lack of standardization in the industry, wherein the records are converted into the standardized data structure format such as the Fast Health Interoperability Resources (FHIR) format, a known format, see Mandel JC, et al., SMART on FHIR: a standards-based, interoperable apps platform for electronic health records. J Am Med Inform Assoc. 2016; 23(5):899-908). Further, the additional elements of displaying on a graphical user interface with indicators as an overlay amounts to adding insignificant extra-solution activity to the abstract idea and is well-understood, routine, and conventional activity. See MPEP 2106.05(g)(d) (U.S. Patent 2011/0306926 A1 discloses a user interface having an overlay of important patient data and/or patient related alerts [0038], [0070], Fig 7; U.S. 2019/0034591 A1 discloses a provider-facing interface including the display of key medical problem or conditions related to the alert and notes or excerpts thereof wherein the display includes applying an attention mechanism thereby drawing the attention of the provider to the most significant past medical events in the EHR [0016]))). The claim is not patent eligible.
Dependent claims 2, 4-9 and 21 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the health data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond collecting, analyzing, and displaying health data. Dependent claim 21 recites the additional element of “providing the notification that identifies the first ineligible tissue and the first likely eligible tissue triggers a display of a donor alert that shows the first ineligible tissue as blacklisted with a filled-in icon and shows the first likely eligible tissue as whitelisted with an open icon, wherein the blacklisting of the first ineligible tissue and the whitelisting of the first likely eligible tissue are shown in a single window of the donor alert, and wherein the donor alert is shown over other content in a graphical user interface.” This additional element, however, recites performing the step of displaying using a generic computer component (i.e. a graphical user interface such as using a computing device to access or view data. See Application Specification at [0019]), such that it amounts to performing the limitation as instructions to apply the abstract idea using a generic computer component cannot provide an inventive concept. See MPEP 2106.05(f). Further the additional elements receiving data via a network and providing a notification via a network amounts to well-understood, routine, and conventional activity. See MPEP 2106.05(g)(d) (Receiving or transmitting data over a network, OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network). Furthermore, the combination of elements does not indicate an improvement to the functioning of a computer or any other technology. Therefore, the dependent claims are rejected under 35 U.S.C. § 101.
Claims 10-14 are drawn to a method for notifying clinicians regarding tissue for donation in near-real time, which is within the four statutory categories (i.e. method).
Independent Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 10 recites (additional elements bolded):
A computerized method performed by a computerized system for determining a list of one or more tissues for donation in real-time, the method comprising:
querying an electronic health information database to access, via a network communication by the computerized system, first medical information about a patient;
identifying, by a processor of the computerized system, that the first medical information includes an indication of expiration for the patient;
automatically determining, by the computerized system, that the patient has registered to be a donor;
automatically querying the medical condition information database to request, by the computerized system based on the first medical information including the indication of expiration, second medical information about medical conditions of the patient from a database;
retrieving, via the network communication from a first data source, one or more programmed predetermined rules relating to potential tissue donation by the patient, wherein the rules include exclusionary criteria to determine an impact of one or more of the medical conditions of the patient to determine eligibility and ineligibility of tissues for donation from the patient, wherein the first medical information, the second medical information, and the exclusionary criteria have different data formats;
integrating the first medical information, the second medical information received using FHIR, wherein the first medical information has a first format that differs from the FHIR-formatted second medical information;
analyzing, by the processor, the integrated first medical information and second medical information based on executing the one or more rules and determining one or more eligible tissues for donation from the patient and determining one or more ineligible tissues for donation from the patient;
generating, by the processor, the structured donor alert that identified the one or more eligible tissues and the one or more ineligible tissues, wherein the structured donor alert includes a blacklist indicator for the one or more ineligible tissues and a whitelist indicator for the one or more eligible tissues; and
automatically generating and providing, via the network communication, an alert to one or more remote devices that causes the one or more remote devices to display, in a graphical user interface, the structured donor alert that displays the blacklist indicator and the whitelist indicator as an overlay over other content being displayed in the graphical use interface in real time with respect to the indication of expiration.
The above limitations, as drafted, is a method that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting the above bolded limitations, nothing in the claim precludes the step from practically being performed in the mind. For example, but for the above bolded limitations, access first medical information about a patient; identifying that the first medical information includes an indication of expiration for the patient; automatically determining that the patient has registered to be a donor; request, based on the first medical information including the indication of expiration, second medical information about medical conditions of the patient; retrieving one or more predetermined rules relating to potential tissue donation by the patient, wherein the rules include exclusionary criteria to determine an impact of one or more of the medical conditions of the patient to determine eligibility and ineligibility of tissues for donation from the patient, wherein the first medical information, the second medical information, and the exclusionary criteria have different data formats; analyzing the integrated first medical information and second medical information based on executing the one or more rules and determining one or more eligible tissues for donation from the patient and determining one or more ineligible tissues for donation from the patient in the context of this claim encompasses the observation, evaluation, judgment, and opinion of health data regarding eligibility of organs and tissue for donation. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Further, the above limitations are also directed to rules or instructions for managing personal behavior or interactions between people, which falls under the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements, for example “by a computerized system,” and “by a processor of the computerized system,” to perform the claim limitations. The above bolded additional elements in each of these steps are recited at a high-level of generality (i.e., a database; one or more processors configured to communicate with the database using network communications; and a non-transitory computer-readable storage media having computer-executable instructions embodied thereon that, when executed by the one or more processors, cause the processors to perform actions e.g. remote computing device communicative over a network, data stores and storage media with program components comprising rules and including data from one or more electronic medical records can include a tablet used by a medical professional to access displayed program components via a graphical user interface in a screen view as they relate to general purpose computer components (Application Specification [0019]-[0021], [0023], [0035], [0064], [0065])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer or other machinery in its ordinary capacity, or merely uses a computer or other machinery in its ordinary capacity as a tool to perform an abstract idea. See MPEP 2106.05(f)(2). This includes the additional elements of querying databases to access, request, and receive information via a communication network, and inputting information into a computing device, and integrating information that has different formats using general purpose computing components or other machinery in their ordinary capacity. See MPEP 2106.05(f)(2). Further, the additional elements of receiving data via a network, requesting and receiving data from a database via a query, and providing a notification alert via a network as well as the conversion of electronic health information to a health information standard format selected from HL7 or FHIR data structures and the displaying on a graphical user interface with indicators as an overlay amounts to adding insignificant extra-solution activity to the abstract idea. See MPEP 2106.05(g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the above bolded additional elements, for example “by a computerized system,” and “by a processor of the computerized system,” to perform the claim limitations amounts to no more than mere instructions to apply the exception using generic computer components. (i.e., a remote computing device communicative over a network, data stores and storage media and including data from one or more electronic medical records can include a tablet used by a medical professional as they relate to general purpose computer components (Application Specification [0019]-[0021], [0064], [0065])). Mere instructions to apply an exception using a generic computer component or other machinery in its ordinary capacity cannot provide an inventive concept. See MPEP 2106.05(f)(2). The additional element of receiving data via a network and providing a notification via a network as well as the conversion of electronic health information to a health information standard format selected from HL7 or FHIR data structures amounts to adding insignificant extra-solution activity to the abstract idea and is well-understood, routine, and conventional activity. See MPEP 2106.05(g)(d) (Receiving or transmitting data over a network, OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network) (U.S. 2019/0034591 A1 discloses data from the different institutions may be in different data formats, due to lack of standardization in the industry, wherein the records are converted into the standardized data structure format such as the Fast Health Interoperability Resources (FHIR) format, a known format, see Mandel JC, et al., SMART on FHIR: a standards-based, interoperable apps platform for electronic health records. J Am Med Inform Assoc. 2016; 23(5):899-908). Further, the additional elements of displaying on a graphical user interface with indicators as an overlay amounts to adding insignificant extra-solution activity to the abstract idea and is well-understood, routine, and conventional activity. See MPEP 2106.05(g)(d) (U.S. Patent 2011/0306926 A1 discloses a user interface having an overlay of important patient data and/or patient related alerts [0038], [0070], Fig 7; U.S. 2019/0034591 A1 discloses a provider-facing interface including the display of key medical problem or conditions related to the alert and notes or excerpts thereof wherein the display includes applying an attention mechanism thereby drawing the attention of the provider to the most significant past medical events in the EHR [0016]))). The claim is not patent eligible.
Dependent claims 11-14 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the medical data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond collecting, analyzing, and displaying medical data. Claim 11 recites the additional element of “a graphical user interface,” however, this is recited at a high level of generality such that it amounts to a generic computer component for applying the abstract idea. See (Application Specification at [0035], Fig. 2), MPEP 2106.05(f). Furthermore, the combination of elements does not indicate an improvement to the functioning of a computer or any other technology. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Claims 16-20 are drawn to a non-transitory computer-readable storage media for notifying clinicians regarding tissue for donation in near-real time, which is within the four statutory categories (i.e. manufacture).
Independent Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 16 recites (additional elements bolded):
16. A non-transitory computer-readable storage media having computer-executable instructions embodied thereon that, when executed by the one or more processors, cause the processors to perform actions comprising:
querying an electronic health information database to access electronic health information about an individual, wherein the electronic health information corresponds to one or more donor criteria;
determining from the electronic health information database an indication the individual is terminal or expired;
in response to determining the indication, automatically triggering the one or more processors to determine whether the individual is a donor;
receiving one or more exclusionary criteria for donor tissue from the one or more network-based data sources, wherein the exclusionary criteria are programmed predetermined rules;
integrating the electronic health information and the medical condition information received using FHIR, wherein the electronic health information has a first format that differs from the FHIR-formatted medical condition information;
generating and automatically providing a real-time notification to one or more remote computing devices associated with one or more clinicians, wherein the real-time notification graphically displays a donor-eligibility status for one or more tissues of the individual with a graphical blacklist indicator for one or more ineligible tissues that are ineligible for donation and a graphical whitelist indicator for one or more eligible tissues that are eligible for donation, wherein the real-time notification is real-time with respect to the indication the individual is terminal or expired;
wherein the donor-eligibility status is determined by at least: identifying the one or more ineligible tissues from the individual based on applying the one or more exclusionary criteria associated with the individual to the integrated electronic health information and the medical information; and
identifying one or more eligible tissues from the individual based on applying the one or more exclusionary criteria associated with the individual to the integrated electronic health information and medical condition information;
wherein the real-time notification notifies a clinician of the one or more eligible tissues for donation from the individual and the one or more ineligible tissues from the individual that is not for donation, wherein the real-time notification is provided without the one or more clinicians accessing one or more medical records for the individual.
The above limitations, as drafted, is a method that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting the above bolded limitations, nothing in the claim precludes the steps from practically being performed in the mind. For example, but for the above bolded limitations, access electronic health information about an individual, wherein the electronic health information corresponds to one or more donor criteria; determining an indication the individual is terminal or expired; in response to determining the indication, determine whether the individual is a donor; receiving one or more exclusionary criteria for donor tissue, wherein the exclusionary criteria are predetermined rules; wherein the donor-eligibility status is determined by at least: identifying the one or more ineligible tissues from the individual based on applying the one or more exclusionary criteria associated with the individual to the integrated electronic health information and the medical information; and identifying one or more eligible tissues from the individual based on applying the one or more exclusionary criteria associated with the individual to the integrated electronic health information and medical condition information in the context of this claim encompasses the observation, evaluation, judgment, and opinion of health data regarding eligibility of organs and tissue for donation. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Further, the above limitations are also directed to rules or instructions for managing personal behavior or interactions between people, which falls under the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements, for example “a non-transitory computer-readable storage media having computer-executable instructions embodied thereon that, when executed by the one or more processors, cause the processors to perform” to perform the claim limitations. The above bolded additional elements in each of these steps are recited at a high-level of generality (i.e., a database; one or more processors configured to communicate with the database using network communications; and a non-transitory computer-readable storage media having computer-executable instructions embodied thereon that, when executed by the one or more processors, cause the processors to perform actions e.g. remote computing device communicative over a network, data stores and storage media with program components comprising rules and including data from one or more electronic medical records can include a tablet used by a medical professional to access displayed program components via a graphical user interface in a screen view as they relate to general purpose computer components (Application Specification [0019]-[0021], [0023], [0035], [0064], [0065])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer or other machinery in its ordinary capacity, or merely uses a computer or other machinery in its ordinary capacity as a tool to perform an abstract idea. See MPEP 2106.05(f)(2). This includes the additional elements of querying databases to access, request, and receive information via a communication network, and inputting information into a computing device, and integrating information that has different formats using general purpose computing components or other machinery in their ordinary capacity. See MPEP 2106.05(f)(2). Further, the additional elements of receiving data via a network, requesting and receiving data from a database via a query, and providing a notification alert via a network as well as the conversion of electronic health information to a health information standard format selected from HL7 or FHIR data structures and the displaying on a graphical user interface with indicators as an overlay amounts to adding insignificant extra-solution activity to the abstract idea. See MPEP 2106.05(g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the above bolded additional elements, for example “a non-transitory computer-readable storage media having computer-executable instructions embodied thereon that, when executed by the one or more processors, cause the processors to perform” to perform the claim limitations amounts to no more than mere instructions to apply the exception using generic computer components. (i.e., a remote computing device communicative over a network, data stores and storage media with program components comprising rules and including data from one or more electronic medical records can include a tablet used by a medical professional as they relate to general purpose computer components (Application Specification [0019]-[0021], [0064], [0065])). Mere instructions to apply an exception using a generic computer component or other machinery in its ordinary capacity cannot provide an inventive concept. See MPEP 2106.05(f)(2). The additional element of receiving data via a network and providing a notification via a network as well as the conversion of electronic health information to a health information standard format selected from HL7 or FHIR data structures amounts to adding insignificant extra-solution activity to the abstract idea and is well-understood, routine, and conventional activity. See MPEP 2106.05(g)(d) (Receiving or transmitting data over a network, OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network) (U.S. 2019/0034591 A1 discloses data from the different institutions may be in different data formats, due to lack of standardization in the industry, wherein the records are converted into the standardized data structure format such as the Fast Health Interoperability Resources (FHIR) format, a known format, see Mandel JC, et al., SMART on FHIR: a standards-based, interoperable apps platform for electronic health records. J Am Med Inform Assoc. 2016; 23(5):899-908). Further, the additional elements of displaying on a graphical user interface with indicators as an overlay amounts to adding insignificant extra-solution activity to the abstract idea and is well-understood, routine, and conventional activity. See MPEP 2106.05(g)(d) (U.S. Patent 2011/0306926 A1 discloses a user interface having an overlay of important patient data and/or patient related alerts [0038], [0070], Fig 7; U.S. 2019/0034591 A1 discloses a provider-facing interface including the display of key medical problem or conditions related to the alert and notes or excerpts thereof wherein the display includes applying an attention mechanism thereby drawing the attention of the provider to the most significant past medical events in the EHR [0016]))). The claim is not patent eligible.
Dependent claims 17-20 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the patient health data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond collecting, analyzing, and displaying patient health data. Furthermore, the combination of elements does not indicate an improvement to the functioning of a computer or any other technology. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed herein below in the order in which they appear in the response filed on 12/23/2025.
In the remarks, Applicant argues in substance that:
Regarding the 112(a) rejection of claims 1-2, 4-14 and 16-21, Applicant argues the rejections are moot in light of the amendments;
Regarding the 112(b) rejection of claims 1-2, 4-14 and 16-21, Applicant argues the rejections are moot in light of the amendments; and
Regarding the 101 rejection of claims 1-2, 4-14 and 16-21, Applicant argues the claims recite patient eligible subject matter;
In response to Applicant’s argument that (a) regarding the 112(a) of claims 1-2, 4-14 and 16-21, Examiner is persuaded and has withdrawn the prior 112(a) rejection.
In response to Applicant’s argument that (b) regarding the 112(b) rejection of claims 1-2, 4-14 and 16-21 Examiner is persuaded and has withdrawn the prior 112(b) rejection.
In response to Applicant’s argument that (c) regarding the 101, Examiner respectfully disagrees.
Under Step 2A, Prong 1, the analysis for 101 provides identifying whether claim recites limitations of a judicial exception such as an abstract idea. Examiner respectfully submits that the claims are directed to the identified abstract idea because the limitations amount to Mental Processes of observation, evaluation, judgement, and opinion through, for example, the analyzing of health data regarding individuals and their determination of eligible or ineligible tissue donation against rules/criteria. Applicant argues that the claims do not recite a Mental Process because the steps performed in real-time cannot be practically performed in the mind; however, Examiner respectfully submits that but for the recitation of generic computer components to perform this element, the claim limitations are directed to a Mental Process. In view of the amendments to the claims, Examiner further has applied the abstract idea of Certain Methods of Organizing Human activity, as the claim limitations are also directed to rule or instructions for managing personal behavior or interactions between people but for the recitation of generic computer components. For example, the steps of accessing, requesting, and receiving information are rules or instructions for managing personal behavior or interactions between people for data collection, but for the recitation of the generic computer components (e.g. processor, database, network, etc.). As a result and in view of applicants arguments regarding recent USPTO Memos, the claims do not merely involve an abstract idea(s), but are directed to the abstract idea, but merely invoke the abstract idea to a computing environment. Accordingly, the claims recite an abstract idea(s).
Under Step 2A, Prong 2, Applicant argues the abstract idea is integrated into a practical application because the claims recite a technical solution to a technical problem through the real-time notification to remote devices where the underlying data for the notification exists across multiple or disparate sources. See Remarks at pg. 16. Examiner respectfully disagrees and submits that Applicant’s Remarks noting that “the specification explicitly states that “many donation opportunities are missed due to lack of notice and/or lack of screening ahead of time and/or in near real-time,” reflects not a technical problem, but rather, the problem invoked by the present Application Specification is one of time/efficiency of the abstract idea (i.e. donor eligibility determination and notification). Applicant’s arguments recite one potential area of a technical problem, that is, “tracking information is “not readily available and remotely-accessible by clinicians in near real-time,” and that there is need to notify clinicians using information from “multiple or disparate sources,” however, the instant claims do not provide an unconventional technical solution of disparate data sourcing. That is, the claims invoke additional elements of general purpose computing components for data gathering using processors/computing systems to request/send/receive data over a network from databases using these general purpose computing components in their ordinary capacity. See MPEP 2106.05(f)(2). Further, the additional element of integrating the collected electronic health information and medical condition information is recited at a high level of generality as using standardized FHIR standards. The limitation does not recite an improvement to data integration using FHIR and other non-FHIR formats that overcomes a problem of disparate source data integration. The claim merely states that integration occurs between two differing data times. This falls under an “apply it” step of using generic computer components to perform data integration and/or insignificant extra-solution activity (to be further analyzed under Step 2B under well-understood, routine and conventional activity). Applicant argues that the “apply it” and generic computing computer allegations are improper, however, as discussed above, the claims merely invoke using the general purpose computing components i.e. a processor for data processing/integration/determination, a network for sending data requested via a database query, and network for sending a notification, and an interface for displaying selective information based on the data analysis. The limitations amount to no more than mere instructions to implement an abstract idea on a computer or other machinery in its ordinary capacity, or merely uses a computer or other machinery in its ordinary capacity as a tool to perform an abstract idea. See MPEP 2106.05(f)(2). As a result, when viewing the additional elements as a whole, the claim does not recite a technical solution to a technical problem, but rather recites an alleged improvement to the abstract idea through invoking general purpose computing components to perform the claim limitations.
The analysis of these additional elements turns to Step 2B, wherein additional elements considered to be extra-solution activity are analyzed as to whether they are well-understood, routine, and conventional activity. Applicant agues in the remarks at pg. 20 that not evidentiary support has been provided to support the well-understood, routine, and conventional analysis. Examiner respectfully disagrees. Examiner respectfully submits that the additional elements of receiving data via a network and providing a notification via a network as well as the conversion of electronic health information to a health information standard format selected from HL7 or FHIR data structures amounts to adding insignificant extra-solution activity to the abstract idea and is well-understood, routine, and conventional activity. See MPEP 2106.05(g)(d) (Receiving or transmitting data over a network, OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network) (U.S. 2019/0034591 A1 discloses data from the different institutions may be in different data formats, due to lack of standardization in the industry, wherein the records are converted into the standardized data structure format such as the Fast Health Interoperability Resources (FHIR) format, a known format, see Mandel JC, et al., SMART on FHIR: a standards-based, interoperable apps platform for electronic health records. J Am Med Inform Assoc. 2016; 23(5):899-908). Further, the additional elements of displaying on a graphical user interface with indicators as an overlay amounts to adding insignificant extra-solution activity to the abstract idea and is well-understood, routine, and conventional activity. See MPEP 2106.05(g)(d) (U.S. Patent 2011/0306926 A1 discloses a user interface having an overlay of important patient data and/or patient related alerts [0038], [0070], Fig 7; U.S. 2019/0034591 A1 discloses a provider-facing interface including the display of key medical problem or conditions related to the alert and notes or excerpts thereof wherein the display includes applying an attention mechanism thereby drawing the attention of the provider to the most significant past medical events in the EHR [0016]))). The claim is not patent eligible.
Applicant argues that the claims recite an integration into a practical application in view of the Guidance Example 42. Examiner respectfully disagrees. The Example of the guidance given with the context of specifically laid out factual context. Example 42 sets out the factual basis that the background of the Example that prior art systems store medical records locally in a format that is dependent on the hardware and/or software platforms in use in the provider’s office such that it is difficult to share updated information a patient’s medical condition with other medical providers because of format inconsistences, different geographic locations of the information, and untimely sharing of information. The claims of Example 42 set forth additional elements are directed to and set forth a technical solution to this technical problem. That is not true in the instant Application, where the problem, as noted in Applicant’s Remarks on page 23 is ““real-time donor identification and notification” ([0016]-[0018])” The instant claims are directed to and set forth steps for donor eligibility based on comparing electronic health data and medical condition data to exclusionary rules. The claim recites well-understood, routine, and conventional activity for integrating data from disparate sources, as discussed above. In this way, when viewing the claim limitations individually and as a whole, the claim is not directed to overcoming a technical problem, but claiming an abstract idea within a general purpose computing environment to create a timely solution over a untimely manual application in a non-computer environment.
As a result, the combination of elements, when viewed as a whole, applies generic computer components to perform the abstract idea and recites limitations that are extra-solution activity that are well-known, routine, and conventional in the technical field that are then applied to the abstract idea of determining donor organs and tissues based on exclusionary criteria.
Accordingly, Examiner respectfully maintains the 101 rejection of claims 1-2, 4-14 and 16-21.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Pub. No. 2019/0350983 A1 teaches a review of the donor’s information and screening test results will deem either acceptable or not if the donor’s information, screening tests, and the delivery cultures are all negative, the donor is approved and the tissues specimen is designated as initially eligible [0042];
U.S. Patent Application Pub. No. 2005/0102161 A1 teaches organ and/or tissue donor identification and match notification [0054]);
U.S. Patent Application Pub. No. 2021/0174914 A1 teaches FHIR based APIs to access EHR data, with information related to the particulars of each donor (Abstract, [0008]); and
U.S. Patent Application Pub. No. 2015/0213079 A1 teaches a method and system associated with an organ donation matching score as a compatibility score ([0013]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.M.B./Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682