DETAILED ACTION
This action is in response to the filed 2-17-2026. Claims 1, 3-7, and 9-13 are pending and have been examined.
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, 3-7 and 9-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The analysis of the claims will follow 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (“2019 PEG”).
Claim 1
Step 1: The claim recites a device; therefore, it is directed to the statutory category of machine.
Step 2A Prong 1: The claim recites, inter alia:
[T]o add the at least one element from the standardized nomenclature to the medical knowledge model according to a selection of the user: This limitation could encompass a human mentally performing the task of adding an element from the standardized nomenclature with a pen and paper.
[T]o to validate a consistency of the medical knowledge model by at least one of checking for circular dependencies and checking for incomplete pathways: Validating the consistency of the medical knowledge model could be performed mentally.
[T]o add a digital signature to the medical knowledge model: This limitation could encompass a human mentally performing the task of adding a signature because it is indicating that the information in the model is authentic.
Step 2A Prong 2: This judicial exception is not granted into a practical application. The additional elements of the claim are:
[A] processing device, which is configured: Stating that the method is performed by a processing device is a mere instruction to apply the exception using a generic computer. MPEP § 2106.05(f).
[T]o provide at least one element from a standardized nomenclature for a user: This limitation recites insignificant extra-solution activity of mere data gathering and output. MPEP § 2106.05(g).
Wherein the at least one element comprises at least one medical element comprising patient medical data received from a patient medical device;
[T]o store logic or rule with regard to the at least one element concerning at least one element parameter according to a definition of the user, said at least one element parameter corresponds to a medical parameter;
To execute the logic or rule in a runtime engine based on the patient medical data This limitation recites insignificant extra-solution activity of mere data gathering. MPEP § 2106.05(g).
The claim further states that the signature is a digital signature and states that there’s interference that provides the model and receives an input, wherein a patient is therapy is created based on the medical knowledge model, via the one or more interfaces is mere instruction to apply the exception using a generic computer. MPEP § 2106.05(f).
Step 2B: The claim does not contain significantly more than the judicial exception. The recitation that the method is performed by a processing device is a mere instruction to apply the exception, as noted above. Upon reevaluation, the providing an element limitation is well-understood, routine, and conventional (“WURC”) because it is directed to receiving or transmitting data over a network. MPEP § 2106.05(d)(II); OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 U.S.P.Q.2d 1090, 1093 (Fed Cir. 2015) (sending messages over a network). The storing limitation is also WURC because it’s directed to storing and retrieving information in memory. MPEP § 2106.05(d)(II) Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015).
Claim 3
Step 1: A machine, as above.
Step 2A Prong 1: The claim recites that “the processing device is further configured to offer to the user at least one element, the at least one element comprising one or more physiological variables, settings, roles, mathematical and statistical operations, Boolean logic, an "if-then" case distinction and temporal criteria as the logic or rule.” A human can mentally solve the mathematical and statistical operation with a pen and paper.
Step 2A Prong 2: This judicial exception is not integrated into a practical application. Mere recitation that the judicial exception is to be performed using a generic computer programmed with a generic computer does not meaningfully integrate the judicial exception into a practical application. MPEP § 2106.05(f).
Step 2B: The claim does not contain significantly more than the judicial exception. The recitation that the method is performed by a processing device is a mere instruction to apply the exception, as noted above. Upon reevaluation, the offering an element limitation is well-understood, routine, and conventional (“WURC”) because it is directed to receiving or transmitting data over a network. MPEP § 2106.05(d)(II); OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 U.S.P.Q.2d 1090, 1093 (Fed Cir. 2015) (sending messages over a network).
Claim 4
Step 1: A machine, as above.
Step 2A Prong 1: The claim recites that “the patient medical data comprises a measurement of a vital parameter of a patient.” A human can mentally write the measurement of a vital parameter with a pen and paper.
Step 2A Prong 2: This judicial exception is not integrated into a practical application. Mere recitation that the judicial exception is to be performed using a generic computer programmed with a generic computer does not meaningfully integrate the judicial exception into a practical application. MPEP § 2106.05(f).
Step 2B: The claim does not contain significantly more than the judicial exception. Mere recitation that the judicial exception is to be performed using a generic computer programmed with a generic computer does not amount to significantly more than the judicial exception. MPEP § 2106.05(f).
Claim 5
The claim is directed to a system comprising a device; therefore, it is directed to the statutory category of a machine.
Step 2A Prong 1: The claim recites the same mental process as in claim 1
Step 2A Prong 2: This judicial exception is not granted into a practical application. The analysis of claim 5 at this step mirrors that of claim 1.
Claim 6
Step 1: A machine, as above.
Step 2A Prong 1: The claim recites, inter alia:
[T]he processing device is further configured to generate output information during the execution of the logic or rule: This limitation could encompass a human mentally forming the information and writing it with pen and paper.
Step 2A Prong 2: This judicial exception is not integrated into a practical application. The additional element is:
[T]he one or more interfaces are further configured to provide the output information: This limitation recites insignificant extra-solution activity of mere data gathering and output. MPEP § 2106.05(g).
Step 2B: The claim does not contain significantly more than the judicial exception. Mere recitation that the judicial exception is to be performed using a generic computer programmed with a generic computer does not amount to significantly more than the judicial exception. MPEP § 2106.05(f).
Claim 7
Step 1: The claim recites a process; therefore, it is directed to the statutory category of processes.
Step 2A Prong 1: The claim recites the same mental process as in claim 1
Step 2A Prong 2: This judicial exception is not granted into a practical application. The analysis of claim 7 at this step mirrors that of claim 1.
Claim 9
Step 1: A process, as above.
Step 2A Prong 1: The claim recites, inter alia:
[E]xpanding the medical knowledge model by at least one additional element from the standardized nomenclature: This limitation could encompass a human mentally performing the task of expanding an element from the standardized nomenclature with a pen and paper.
Step 2A Prong 2:
[E]xecuting the logic or of the rule with regard to the at least one element concerning the at least one element parameter from the standardized nomenclature: This limitation recites to execute on a generic computer which indicates a field of use or technological environment in which to apply a judicial exception. MPEP § 2106.05(f).
Step 2B: The claim does not contain significantly more than the judicial exception. The analysis of claim 5 at this step mirrors that of claim 1. The claim further recites “one or more interfaces that are configured to provide the medical knowledge model, to receive a user input and to provide the at least one element”. This states that there’s an interference that provides the model and receives an input is mere instruction to apply the exception using a generic computer. MPEP § 2106.05(f).
Claim 10
Step 1: A process, as above.
Step 2A Prong 1: The claim recites that “providing a computer program with a program code for carrying out at least one of the process steps upon executing the program code on a computer, on a processor or on a programmable hardware component”. At least one of the steps could be performed mentally.
Step 2A Prong 2: This judicial exception is not integrated into a practical application. Mere recitation that the judicial exception is to be performed using a generic computer programmed with a generic computer does not meaningfully integrate the judicial exception into a practical application. MPEP § 2106.05(f).
Step 2B: The claim does not contain significantly more than the judicial exception. Mere recitation that the judicial exception is to be performed using a generic computer programmed with a generic computer does not amount to significantly more than the judicial exception. MPEP § 2106.05(f).
Claim 11
Step 1: A process, as above.
Step 2A Prong 1: The claim recites that “providing a computer program with a program code for carrying out at least one of the process steps upon executing the program code on a computer, on a processor or on a programmable hardware component”. At least one of the steps could be performed mentally.
Step 2A Prong 2: This judicial exception is not integrated into a practical application. Mere recitation that the judicial exception is to be performed using a generic computer programmed with a generic computer does not meaningfully integrate the judicial exception into a practical application. MPEP § 2106.05(f).
Step 2B: The claim does not contain significantly more than the judicial exception. Mere recitation that the judicial exception is to be performed using a generic computer programmed with a generic computer does not amount to significantly more than the judicial exception. MPEP § 2106.05(f).
Claims 12-13
Step 1: Direct to a process and machine, as above.
Step 2A Prong 1: The claim recites the same mental process as in claim 4
Step 2A Prong 2: This judicial exception is not integrated into a practical application. The analysis of claims 12-13 at this step mirror that of claim 4.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 5-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over AHMED (WO-0150330-A1) in view of SOOK (KR-2010-0028776-A), GHOSH ET AL. (“GHOSH” US-20210375488-A1), GOTTHARDT (US-20110225114-A1) and NPL KLEHR (Joan Klehr, Jennifer Hafner, Leah Mylrea Spelz, Sara Steen, Kathy Weaver).
Regarding claim 1 AHMED teaches A device (page 48, claim 12, a computer apparatus) for generating a medical knowledge model, the device comprising: a processing device (page 48, claim 12, a computer comprising a processor), which is configured: to validate a consistency (page 16, line26-28 All the responses and evaluations are stored as a history for the user to reference upon return to the web site, and by the experts to validate the data set.); … and one or more interfaces (page 26, lines 37-38 an Input and Output interface ("Input/Output").) that are configured to provide (page 23, line 14 “The system provides health information and service on the Internet.” Page 23 lines 10-11 “The system is a medical/health self-assessment software application for consumers to use on the Internet.”), and to receive a user input, (page 26, lines 36-38 Figure 9 shows a basic computer model with a central processing unit ("CPU"), Hard Storage ("Hard Disk"), Soft Storage ("RAM"), and an Input and Output interface ("Input/Output").)
AHMED further teaches wherein the at least one element comprises at least one medical element comprising patient medical data received from a patient medical device (Pages 15 and 16, Figures 15-16 and 19; user inputs medical elements through device);
said at least one element parameter corresponds to a medical parameter(Pages 15 and 16, Figures 15-16 and 19; user inputs medical elements through device, entering medical parameters (i.e. pain);
to execute the logic or rule in a runtime engine based on the patient medical data (Pages 15 and 16, Figures 15-16 and 19; user inputs medical elements through device and rule based diagnosis);
wherein a patient therapy is created, based on the medical knowledge model, via the one or more interfaces (Page 13, Line 28-37; provides treatments, Page 19, Lines 29-34, Pages 15 and 16, Figures 15-16 and 19; therapy based on input);
Figure 16 shows a sample interview and diagnosis, as shown on a web page. A sample Interview or query set that may be asked of a user is as follows: How do you feel?; Where does it hurt?; Does it hurt when you move this way?; Let me examine you...; Where is it tender?; How tender it is it?; Ok, from what you have told me I think you have an [decision/diagnosis], Let me tell you more about it (i.e., treatment, home remedies, drugs, insurance, etc.). In preferred embodiments, the system is implemented as a full, interactive service, linking the diagnosis to "smart" information (see herein below) on treatment, causes, care, insurance, drags, specialists, etc. The ranked diagnoses are hyper-linked, allowing the user to "click" and obtain more information on particular diagnoses. Accordingly, users are led to additional windows where they can learn about cures, treatments, drags, home remedies, exercises, therapies, and other related information. Along with information the user also can access related health services, health insurance, physicians directory, appointments with specialists, and other related services (see Figures 10 and 5). Other features include, e.g., printing a coupon for a non-prescription drug for a local pharmacy, obtaining directions to that pharmacy, and interaction with an insurance-plan physician directly over a secure connection, allowing the physician to prescribe to the user online. Figure 5 schematically illustrates the "End Implementation" of the present invention. Using ELICIT™ and "Algorithm 42" (see Example 1 below) in emulating the physician decision-making process has resulted in accurate diagnoses of symptoms. ELICIT™ can be used in all medical and health specialties. The process is innovative and unique. There are layers of processes that have been standardized to allow efficient and rapid implementation of the invention and its content. These processes include gathering expert data, developing data concept standards within each specialty that will reflect adaptive uses of fuzzy logic. Additionally, other processes include the inputting, editing and testing of the expert data both through experimental prototypes and on the Web.
AHMED fails to teach for generating a medical knowledge model; to provide at least one element from a standardized nomenclature for a user; to add the at least one element from the standardized nomenclature to the medical knowledge model according to a selection of the user; to store logic or a rule with regard to the at least one element concerning at least one element parameter according to a definition of the user; to validate a consistency of the medical knowledge model; to add a digital signature to the medical knowledge model. However, SOOK teaches for generating a medical knowledge model; to validate a consistency of the medical knowledge model (page 4, lines 12-13 Knowledge Engine: an engine for implementing medical knowledge, a module with process and rule processing capabilities). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine AHMED with the medical knowledge model from SOOK because both references are used to improve medical diagnosis and SOOK’s medical knowledge model also includes medical guidelines and clinical protocols. The combination of AHMED with SOOK would allow the medical staff to have decreased workload and improve medical decision and diagnosis.
AHMED as modified fails to teach to validate the medical knowledge model by at least one of checking for circular dependencies and checking for incomplete pathways;
However, GHOSH teaches generating a medical knowledge graph/model (Paragraph 39); and validating the medical knowledge model by checking for missing (incomplete) pathways/linkage (Figure 5 and Paragraphs 13, 21 and 60).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine AHMED with the missing link functionality from GHOSH because both references are used to address medical evaluations. The combination of AHMED with GHOSH would allow the medical staff to have expanded medical relationship insight for improved medical decision and diagnosis.
AHMED as modified fails to teach to provide at least one element from a standardized nomenclature for a user; to add the at least one element from the standardized nomenclature to the medical knowledge model according to a selection of the user; and to store logic or rule with regard to the at least one element concerning at least one element parameter according to a definition of the user; to add a digital signature to the medical knowledge model. However, KLEHR teaches to provide at least one element from a standardized nomenclature for a user (Page 6, column 1 “The new care plan [element] format used the previously mentioned description fields to display [provide to the user] the label definition for the NANDA-I [standardized nomenclature] and the NOC.” Page 11, Column 1 “The charge was to do research and improve the electronic care plans using the NANDA, NIC, and NOC standardized nomenclatures.”) and to add the at least one element from the standardized nomenclature to the medical knowledge model according to a selection of the user (Page 7, column 1 “In addition, some diagnoses and outcomes that were appropriate for the hospitalized patient needed revisions to reflect current practice. New diagnoses and outcomes were developed, and revisions were submitted to the NANDA-I [standardized nomenclature] Diagnosis and Development Committee (DDC) committee as appropriate.” Page 11, Column 1 “The charge was to do research and improve the electronic care plans using the NANDA, NIC, and NOC standardized nomenclatures.” Page 1, column 2: “However, the records do include a free text description field where a user can individualize [add to the model according to user selection] the care plan [element] based on a patient’s particular needs or status.”). It would have been obvious to a person skilled in the art before the effective filing date of the claimed invention to combine modified AHMED with the standardized nomenclature from KLEHR to allow the medical knowledge model to provide and add elements from the standardized nomenclature according to the request from the user. Doing so would aid users to be informed and to keep the standardized nomenclature up to date when needed by the user.
AHMED as modified also fails to teach to store logic or rule with regard to the at least one element concerning at least one element parameter according to a definition of the user. However, GOTTHARDT teaches to store logic or rule with regard to the at least one element concerning at least one element parameter according to a definition of the user (page 40, P[0284] A user connected to the rule manager is able to create or modify a rule stored and managed by the rules engine 748. Page 40, P[0278] “A rule can be, for example, the computer-interpretable expression: ‘if gender=male and age>11 and age<23 and glucose level in blood<Xmg/ml [element parameter] and conditions Ca, Cb and Cd apply to the biomedical data values of a patient, then: clinical suspicion of Disease Y’.”) and to add a digital signature to the medical knowledge model (page 29, P[0195] “The digital signature is deposited into the database, associated with the data. This embodiment is particularly advantageous because the digital signature for the data allows authentication of the data. In this way the authorship of the data can be verified.”). It would have been obvious to a person skilled in the art before the effective filing date of the claimed invention to combine the modified AHMED with the rule manager and addition of a digital signature from GOTTHARDT. Doing so would allow the validation of the medical knowledge model and for a user to add or modify logic and rules with the element of if-then case distinction to improve the medical knowledge model.
AHMED, SOOK, GHOSH, KLEHR, and GOTTHARDT are considered to be analogous to the claimed invention because they are in the same field of medical data, validation, and diagnosis.
Regarding claim 5 AHMED teaches a medical knowledge model system for the formalized application of medical knowledge, the medical knowledge model system comprising a device (page 48, claim 12, a computer apparatus) for generating a medical knowledge model, the device comprising: a processing device (page 48, claim 12, a computer comprising a processor), which is configured: … and one or more interfaces (page 26, lines 37-38 an Input and Output interface ("Input/Output").) that are configured to provide (page 23, line 14 “The system provides health information and service on the Internet.” Page 23 lines 10-11 “The system is a medical/health self-assessment software application for consumers to use on the Internet.”), to validate a consistency (page 16, line26-28 All the responses and evaluations are stored as a history for the user to reference upon return to the web site, and by the experts to validate the data set.) to receive a user input and to provide the at least one element (page 26, lines 36-38 Figure 9 shows a basic computer model with a central processing unit ("CPU"), Hard Storage ("Hard Disk"), Soft Storage ("RAM"), and an Input and Output interface ("Input/Output").)
AHMED further teaches wherein the at least one element comprises at least one medical element comprising patient medical data received from a patient medical device(Pages 15 and 16, Figures 15-16 and 19; user inputs medical elements through device);
said at least one element parameter corresponds to a medical parameter(Pages 15 and 16, Figures 15-16 and 19; user inputs medical elements through device, entering medical parameters (i.e. pain);
to execute the logic or rule in a runtime engine(Pages 15 and 16, Figures 15-16 and 19; user inputs medical elements through device and rule based diagnosis);
wherein a patient therapy is created, based on the medical knowledge model, via the one or more interfaces
(Page 13, Line 28-37; provides treatments, Page 19, Lines 29-34, Pages 15 and 16, Figures 15-16 and 19; therapy based on input);
Figure 16 shows a sample interview and diagnosis, as shown on a web page. A sample Interview or query set that may be asked of a user is as follows: How do you feel?; Where does it hurt?; Does it hurt when you move this way?; Let me examine you...; Where is it tender?; How tender it is it?; Ok, from what you have told me I think you have an [decision/diagnosis], Let me tell you more about it (i.e., treatment, home remedies, drugs, insurance, etc.). In preferred embodiments, the system is implemented as a full, interactive service, linking the diagnosis to "smart" information (see herein below) on treatment, causes, care, insurance, drags, specialists, etc. The ranked diagnoses are hyper-linked, allowing the user to "click" and obtain more information on particular diagnoses. Accordingly, users are led to additional windows where they can learn about cures, treatments, drags, home remedies, exercises, therapies, and other related information. Along with information the user also can access related health services, health insurance, physicians directory, appointments with specialists, and other related services (see Figures 10 and 5). Other features include, e.g., printing a coupon for a non-prescription drug for a local pharmacy, obtaining directions to that pharmacy, and interaction with an insurance-plan physician directly over a secure connection, allowing the physician to prescribe to the user online. Figure 5 schematically illustrates the "End Implementation" of the present invention. Using ELICIT™ and "Algorithm 42" (see Example 1 below) in emulating the physician decision-making process has resulted in accurate diagnoses of symptoms. ELICIT™ can be used in all medical and health specialties. The process is innovative and unique. There are layers of processes that have been standardized to allow efficient and rapid implementation of the invention and its content. These processes include gathering expert data, developing data concept standards within each specialty that will reflect adaptive uses of fuzzy logic. Additionally, other processes include the inputting, editing and testing of the expert data both through experimental prototypes and on the Web.
AHMED fails to teach a medical knowledge model system for the formalized application of medical knowledge; to provide at least one element from a standardized nomenclature for a user; to add the at least one element from the standardized nomenclature to the medical knowledge model according to a selection of the user; to store logic or rule with regard to the at least one element concerning at least one element parameter according to a definition of the user; to validate a consistency of the medical knowledge model; to execute the logic or of the rule with regard to the at least one element concerning the at least one element parameter from the standardized nomenclature; and to expand the medical knowledge model by at least one additional element from the standardized nomenclature; and to add a digital signature to the medical knowledge model. However, SOOK teaches a medical knowledge model system for the formalized application of medical knowledge; to validate a consistency of the medical knowledge model (page 4, lines 12-13 “Knowledge Engine: an engine for implementing medical knowledge, a module with process and rule processing capabilities”), to execute the logic or of the rule with regard to the at least one element concerning the at least one element parameter from the standardized nomenclature (page 5, lines 45-48 “In addition, the clinical decision logic 121 including specific clinical judgment and medical measures may be defined by being divided into a process element 131 and a rule element 133. In other words, the clinical decision logic 121 is authored with the knowledge executed by the CDSS system. In the encoding region 130, knowledge authoring including the process element 131 and the rule element 133 is performed”. page 6, lines 6-7 “the rule element 133 is a rule for encoding as a decision element for clinical diagnosis.” page 6, lines 7-9 “For example, in the CDS service for severe sepsis, it refers to a decision-making element for clinical diagnosis such as a rule to determine the severe sepsis of the physician in the emergency room when the blood pressure [element parameter] reaches less than 90 mmHg when the emergency patient arrives.”), and to expand the medical knowledge model by at least one additional element from the standardized nomenclature (page 5, lines 16-19 “Developed guidelines, protocols and primary care routes should not be fixed but should be continually revised and improved based on the results of the implementation”). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine AHMED with the medical knowledge model from SOOK because both references are used to improve medical diagnosis and SOOK’s medical knowledge model also includes medical guidelines and clinical protocols along with the execution of rules and expansion of elements from the standardized nomenclature for medical diagnosis and decision support. The combination of AHMED with SOOK would allow the medical staff to have decreased workload and improve medical decision and diagnosis.
AHMED as modified fails to teach to validate the medical knowledge model by at least one of checking for circular dependencies and checking for incomplete pathways;
However, GHOSH teaches generating a medical knowledge graph/model (Paragraph 39); and validating the medical knowledge model by checking for missing (incomplete) pathways/linkage (Figure 5 and Paragraphs 13, 21 and 60).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine AHMED with the missing link functionality from GHOSH because both references are used to address medical evaluations. The combination of AHMED with GHOSH would allow the medical staff to have expanded medical relationship insight for improved medical decision and diagnosis.
AHMED as modified also fails to teach to provide at least one element from a standardized nomenclature for a user; to add the at least one element from the standardized nomenclature to the medical knowledge model according to a selection of the user; and to store logic or rule with regard to the at least one element concerning at least one element parameter according to a definition of the user; and to add a digital signature to the medical knowledge model. However, KLEHR teaches to provide at least one element from a standardized nomenclature for a user (Page 6, column 1 “The new care plan [element] format used the previously mentioned description fields to display [provide to the user] the label definition for the NANDA-I [standardized nomenclature] and the NOC.” Page 11, Column 1 “The charge was to do research and improve the electronic care plans using the NANDA, NIC, and NOC standardized nomenclatures.”) and to add the at least one element from the standardized nomenclature to the medical knowledge model according to a selection of the user (Page 7, column 1 “In addition, some diagnoses and outcomes that were appropriate for the hospitalized patient needed revisions to reflect current practice. New diagnoses and outcomes were developed, and revisions were submitted to the NANDA-I [standardized nomenclature] Diagnosis and Development Committee (DDC) committee as appropriate.” Page 11, Column 1 “The charge was to do research and improve the electronic care plans using the NANDA, NIC, and NOC standardized nomenclatures.” Page 1, column 2: “However, the records do include a free text description field where a user can individualize [add to the model according to user selection] the care plan [element] based on a patient’s particular needs or status.”). It would have been obvious to a person skilled in the art before the effective filing date of the claimed invention to combine modified AHMED with the standardized nomenclature from KLEHR to allow the medical knowledge model to provide and add elements from the standardized nomenclature according to the request from the user. Doing so would aid users to be informed and to keep the standardized nomenclature up to date when needed by the user.
AHMED as modified fails to teach to store logic or rule with regard to the at least one element concerning at least one element parameter according to a definition of the user. However, GOTTHARDT teaches to store logic or rule with regard to the at least one element concerning at least one element parameter according to a definition of the user (page 40, P[0284] “A user connected to the rule manager is able to create or modify a rule stored and managed by the rules engine 748.” Page 40, P[0278] “A rule can be, for example, the computer-interpretable expression: ‘if gender=male and age>11 and age<23 and glucose level in blood<Xmg/ml [element parameter] and conditions Ca, Cb and Cd apply to the biomedical data values of a patient, then: clinical suspicion of Disease Y’.”) and to add a digital signature to the medical knowledge model (page 29, P[0195] “The digital signature is deposited into the database, associated with the data. This embodiment is particularly advantageous because the digital signature for the data allows authentication of the data. In this way the authorship of the data can be verified.”). It would have been obvious to a person skilled in the art before the effective filing date of the claimed invention to combine modified AHMED with the rule manager and addition of a digital signature from GOTTHARDT. Doing so would allow the validation of the medical knowledge model and for a user to add or modify logic and rules with the element of if-then case distinction to improve the medical knowledge model.
AHMED, SOOK, GHOSH, KLEHR, and GOTTHARDT are considered to be analogous to the claimed invention because they are in the same field of medical data, validation, and diagnosis.
Regarding claim 6, AHMED teaches a medical knowledge model system in accordance with claim 5, wherein: the processing device (page 48, claim 12, a computer comprising a processor) is further configured to …; and the one or more interfaces are further configured to provide (page 23, line 14 “The system provides health information and service on the Internet.” Page 23 lines 10-11 “The system is a medical/health self-assessment software application for consumers to use on the Internet.”), the output information (page 26, lines 36-38 Figure 9 shows a basic computer model with a central processing unit ("CPU"), Hard Storage ("Hard Disk"), Soft Storage ("RAM"), and an Input and Output interface ("Input/Output").
AHMED fails to teach a medical knowledge model system in accordance with claim 5, is further configured to generate output information during the execution of the logic the rule. However, SOOK teaches a medical knowledge model system (page 4, lines 12-13 Knowledge Engine: an engine for implementing medical knowledge, a module with process and rule processing capabilities) in accordance with claim 5, is further configured to generate output information during the execution of the logic or of the rule (page 8, lines 30-32 The knowledge engine of the clinical decision support system processes rule elements and process elements of the plurality of medical treatment processes, and executes business logic in which an application of the electronic medical record system inputs and outputs on a screen of a user terminal.). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine AHMED with the medical knowledge model from SOOK because both references are used to improve medical diagnosis and SOOK’s medical knowledge model also includes medical guidelines and clinical protocols along with the execution of rules to determine medical diagnosis and help with decision support. The combination of AHMED with SOOK would allow the medical staff to have decreased workload and improve medical decision and diagnosis.
Claim 7 is similar in scope to claim 1 and therefore rejected under the same rationale.
Regarding claim 9, AHMED as modified by SOOK teaches a process (page 2, lines 31-33 Electronic processing using various well-known knowledge modeling and knowledge engines provided the basis for performing a series of procedures encoded according to specific clinical events.) further comprising providing a formalized application of medical knowledge (page 4, lines 12-13 Knowledge Engine: an engine for implementing medical knowledge, a module with process and rule processing capabilities), comprising: executing the logic or of the rule with regard to the at least one element concerning the at least one element parameter from the standardized nomenclature (page 5, lines 45-48 “In addition, the clinical decision logic 121 including specific clinical judgment and medical measures [element parameter] may be defined by being divided into a process element 131 and a rule element 133. In other words, the clinical decision logic 121 is authored with the knowledge executed by the CDSS system. In the encoding region 130, knowledge authoring including the process element 131 and the rule element 133 is performed”. page 6, lines 6-7 “the rule element 133 is a rule for encoding as a decision element for clinical diagnosis).
KLEHR teaches expanding the medical knowledge model by at least one additional element from the standardized nomenclature (page 7, column 1 “In addition, some diagnoses and outcomes that were appropriate for the hospitalized patient needed revisions to reflect current practice. New diagnoses [element] and outcomes were developed, and revisions were submitted [expanding] to the NANDA-I [standardized nomenclature] Diagnosis and Development Committee (DDC) committee as appropriate.” Page 11, Column 1 “The charge was to do research and improve the electronic care plans using the NANDA, NIC, and NOC standardized nomenclatures.”).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over AHMED (WO-0150330-A1) in view of SOOK (KR-2010-0028776-A), GHOSH ET AL. (“GHOSH” US-20210375488-A1), GOTTHARDT (US-20110225114-A1), and NPL KLEHR (Joan Klehr, Jennifer Hafner, Leah Mylrea Spelz, Sara Steen, Kathy Weaver) and further in view of KAWAMOTO (WO-2007030425-A2)
Regarding claim 3, AHMED teaches a device (page 48, claim 12, a computer apparatus) in accordance with claim 1, wherein the processing device (page 48, claim 12, a computer comprising a processor) is further configured to offer to the user (page 23, line 14 “The system provides health information and service on the Internet.” Page 23 lines 10-11 “The system is a medical/health self-assessment software application for consumers to use on the Internet.”) ....
AHMED fails to teach at least one element from the group comprising physiological variables, settings, roles, mathematical and statistical operations, Boolean logic, and temporal criteria as the logic or rule.
GOTTHARDT teaches Boolean logic (page 9, P[0025] The term ‘rule’ as used herein is a computer-interpretable statement with two parts: an if-clause and a then-clause, whereby the then clause is only executed in case the if-clause returns the Boolean value ‘true’.). It would have been obvious to a person skilled in the art before the effective filing date of the claimed invention to combine AHMED with the Boolean logic from GOTTHARDT because it allows the data entered to be checked to determine the diagnosis. Doing so would aid users with improved diagnosis and decision support.
SOOK teaches temporal criterial as the logic or rule, (page 5, lines 7-10 It is defined what kind of care will be provided to the covered patient / participant, in what order, at what time and for how long [temporal criteria]. In other words, tasks to be performed within a certain time or period are listed in sequence, and each task is linked to specific decisions or actions through preconditions and exception conditions.). It would have been obvious to a person skilled in the art before the effective filing date of the claimed invention to combine AHMED and GOTTHARDT with the temporal criteria from SOOK because it determines how long a care or task should take. Doing so would allow the users and medical staff to determine the time certain tasks should take, allowing them to plan accordingly.
AHMED as modified fails to teach settings. However, KAWAMOTO teaches settings (page 13, P[0095] The system framework allows the same knowledge modules to be re-used across diverse applications and care settings.). It would have been obvious to a person skilled in the art before the effective filing date of the claimed invention to combine the modified AHMED with the settings from KAWAMOTO. Doing so would allow the users to keep their medical or user settings according to their use case within the device and improve user efficiency.
Claims 4 and 12-13 is rejected under 35 U.S.C. 103 as being unpatentable over AHMED (WO-0150330-A1) in view of SOOK (KR-2010-0028776-A), GHOSH ET AL. (“GHOSH” US-20210375488-A1), GOTTHARDT (US-20110225114-A1), NPL KLEHR (Joan Klehr, Jennifer Hafner, Leah Mylrea Spelz, Sara Steen, Kathy Weaver), and NPL JALALI (JALALI A, BENDER D, REHMAN M, NADKANRI V, NATARAJ C. JALALI for outcome prediction in intensive care units. Conf Proc IEEE Eng Med Biol Soc. 2016; 2016: 2520-2524).
Regarding claim 4, AHMED teaches a device (page 48, claim 12, a computer apparatus) in accordance with claim 1, wherein the at least one element ….
AHMED fails to teach wherein the patient medical data comprises a measurement of a vital parameter of a patient. However, JALALI teaches wherein the at least one element comprises at least one medical element comprising a measurement of a vital parameter of a patient (page 1, column 1, line 32 Most of the clinically based studies have focused on providing simple scores that focus on the severity of disease or illness [3]. Basically, these scores add weights to the degree of abnormality of an organ or a disease based on the vital sign measurement [vital parameter], blood gas measurement or visual inspection of the patients, and attempt to identify patients at high risk.) It would have been obvious to a person skilled in the art before the effective filing date of the claimed invention to combine AHMED with the vital parameters from JALALI because it helps with determining the diagnosis for a patient. Doing so would aid the medical staff with patient diagnosis and decision support.
AHMED and JALALI are considered to be analogous to the claimed invention because they are in the same field of medical data to identify diseases.
Regarding Claims 12 and 13 they recite similar claim language as claim 4 and are therefore rejected under the same rationale utilizing AHMED as modified by JALALI.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over AHMED (WO-0150330-A1) in view of SOOK (KR-2010-0028776-A), GHOSH ET AL. (“GHOSH” US-20210375488-A1), GOTTHARDT (US-20110225114-A1) and NPL KLEHR (Joan Klehr, Jennifer Hafner, Leah Mylrea Spelz, Sara Steen, Kathy Weaver) and further in view of KAWAMOTO (WO-2007030425-A2),
Regarding Claim 10 which is similar in scope to claim 7 and KAWAMOTO teaches further comprising providing a computer program with a program code (page 2, P[0015] In a further aspect, the invention relates to a method for implementing the clinical decision support system as described, involving the programmatic coupling of the aforementioned network server with a plurality of executable knowledge modules that specify the data requirements for assessing a patient, the patient-specific conclusions that can be drawn from using that data, and the instructional logic utilized to generate the patient-specific conclusions using the specified data.) for carrying out at least one of the process steps upon executing the program code on a computer (page 9, P[0050] The present invention relates to a clinical decision support system and method for efficiently encoding, processing, and delivering machine-executable medical decision logic for use in medical software applications.).
It would have been obvious to a person skilled in the art before the effective filing date of the claimed invention to combine the modified AHMED with the program of KAWAMOTO. Doing so would allow efficient encoding, processing, and delivery of medical decision logic for use in medical software applications.
Regarding Claim 11 which is similar in scope to claims 7 and 9 and KAWAMOTO teaches further comprising providing a computer program with a program code (page 2, P[0015] In a further aspect, the invention relates to a method for implementing the clinical decision support system as described, involving the programmatic coupling of the aforementioned network server with a plurality of executable knowledge modules that specify the data requirements for assessing a patient, the patient-specific conclusions that can be drawn from using that data, and the instructional logic utilized to generate the patient-specific conclusions using the specified data.), for carrying out at least one of the process steps upon executing the program code on a computer (page 9, P[0050] The present invention relates to a clinical decision support system and method for efficiently encoding, processing, and delivering machine-executable medical decision logic for use in medical software applications.).
It would have been obvious to a person skilled in the art before the effective filing date of the claimed invention to combine the modified AHMED with the program of KAWAMOTO. Doing so would allow efficient encoding, processing, and delivery of medical decision logic for use in medical software applications.
Response to Arguments
Applicant's arguments filed 2-17-2026 have been fully considered.
Regarding the 101, the capability of treating a patient based on the knowledge model is still considered abstract in that creating a treatment can be performed mentally. Applicant further argues that even if there is an abstract idea, it is integrated into a practical application and recites significantly more. Examiner respectfully disagrees. Applicant recites that an execution system processes patient medical device data, to create, validate, secure and execute medical logic for therapy. Applicant argues that a human cannot practically perform these operations with pen and paper. However it is believed that the features of processing medical data can be mentally observed (notated), the data can then be confirmed/validated through secondary observation, then execution of a medical diagnosis can be distributed to a patient. In example a flowchart on a piece of paper can be referenced or a medical professionals’ personal knowledge and evaluation would reasonably perform a similar method. The inclusion of the additional features such as the medical devices and interfaces are not considered significantly more, they are instead seen as generic computer components.
Regarding the amendments, it is believed that the cited areas in the rejection along with a passage from the reference captures the limitations.
Applicant also argues that there is no teaching or suggestion of validating a consistency of a medical knowledge model by checking for circular dependencies and/or incomplete pathways.
Applicant further argues that the noisy and missing link prediction module does not teach to validate a consistency of medical knowledge. Examiner respectfully disagrees. Applicants’ application states in paragraph 25 To validate the consistency, the medical knowledge model may be checked for, among other things, circular dependencies or incomplete pathways. Therefore according to applicants’ disclosure when Ghosh discloses that it is checking for entities with a missing edge or link (Paragraph 21), a form a validation is performed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure:
20150234992 A1 ABSTRACT
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Applicant is required under 37 C.F.R. § 1.111(c) to consider these references fully when responding to this action.
It is noted that any citation to specific pages, columns, lines, or figures in the prior art references and any interpretation of the references should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. In re Heck, 699 F.2d 1331, 1332-33, 216 U.S.P.Q. 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 U.S.P.Q. 275, 277 (C.C.P.A. 1968)).
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/SHERROD L KEATON/Primary Examiner, Art Unit 2148
5-29-2026
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