Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In the amendment dated 7/17/2025, the following has occurred: Claims 1 – 16 have been amended; Claims 17 – 20 have been added.
Claims 1 – 20 are pending.
This is the Examiner’s first review of the instant invention.
Priority
The priority claim to European Patent Application 22/176,059 filed on 05/30/2022 has been acknowledged. The effective filing date for the present application is recognized as 05/30/2022.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. an abstract idea) without significantly more.
Step 2A analysis: Prong one:
The claims include the abstract idea of:
obtain health data relating to a patient, and
obtain a medical update;
store at least health data in association with the patient, the at least health data including one or more protocols,
store each protocol in association with one or more care procedures such that a change to the protocol is related to a change to an aspect of the one or more care procedures associated with the protocol; and
determine if the medical update is relevant for the patient, and
if the medical updated is determined relevant:
store the medical update associated with the patient, wherein the medical update includes the change to the protocol, and
change the aspect of the one or more care procedures associated with the protocol based on the medical update.
The above claim describes a system receiving patient data, receiving updates, storing data in association with a patient, determining if the data is relevant to the patient and then storing it, and are thus grouped as “organizing human activity” which is an abstract idea.
The claims related to a health database updating system may be interpreted as organizing human activity because acquiring data, analyzing data, and finding a conclusion based on the data can be interpreted as managing personal behavior or relationships or interactions between people (See 2106.04(a)(2)). The combination analysis of all of the abstract ideas still leads to the determination that the limitations as a whole are grouped as “certain methods of organizing human activity” grouping of abstract ideas because, the claims involve collecting data, analyzing data, comparing data to previously received data, and storing data. Accordingly, the claims recite an abstract idea.
Dependent Claims 2-14, and 17 - 20 are directed towards
a medical update that contains a care procedure and health data which can include clinical information such as a diagnosis, test results, medical images, assessments, genomic data, lab values, and vital signs as well as
Collecting data, analyzing data, and outputting the collection of the analysis by
receiving, updating, determining, matching, obtaining, storing, etc.., data about a determined patient as well as raising a warning as an output from the data and are thus grouped as “organizing human activity” which is an abstract idea. Dependent claims 2-14 and 17 – 20 incorporate all the limitations of their respective independent claim.
Accordingly, the claims recite “certain methods of organizing human activity”, which falls within the judicial exception of an abstract idea. (Step 2A – Prong one: Yes, the claim is abstract).
Step 2A analysis: Prong two:
Claims 1, 15 and 16 recite additional elements beyond the abstract idea. The judicial exception is not integrated into a practical application. Claim 1 recites: a data interface, a database storage, and a processor. Claim 15 recites: a database storage. Claim 16 recites: A non-transitory computer readable medium and a processor system.
These additional elements, are recited at a high level of generality (i.e., as a generic processor performing generic computer functions), such that it amounts to no more than mere instructions to apply the exceptions using a generic computer component.
The Applicant’s specification indicates “a data interface” as “a communication interface 150, e.g., a data interface” (page 5) and “The communication interface 150 may be used to send or receive digital data, e.g., health data, care procedure, medical update, health data update, care procedure update, and the like” (page 5). The specification lacks specificity and technical detail regarding how the interface sends and receives data.
The Applicant’s specification indicates “a database storage” stores “at least health data in association with a patient” (page 6). The specification lacks specificity and technical detail regarding how storage stores data.
The Applicant’s specification includes “a processor” that “may be configured to execute
a version matching function to determine if the new version identifier and the stored identifier match” (page 8) and that “may be configured to determine if the health data update is relevant for the care procedure” (page 8). The specification lacks specificity and technical detail regarding how the processor executes a function and determines relevancy of updates. The statement describes typical computing operations.
The Applicant’s specification includes “A transitory or non-transitory computer readable medium” that “may store data 1020 wherein the data may indicate instructions, which when executed by a processor system, cause a processor system to perform a health database method” (page 23, lines 26-28). This statement describes typical computing operations.
Data generating system (page 11, lines 9 – 12) A data generating systems may be a hospital, a laboratory, a private sensor, etc. A data 10 generating systems may be a source of information, e.g., a publication, a clinical trial, etc. A data generating systems may comprise the output generated by updated processing algorithms, e.g., an AI medical system.
network – page 23, lines 5 – 12 e.g., the internet
Accordingly, these additional elements when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, Claims 1, 15 and 16 are directed to an abstract idea without practical application. (Step 2A – Prong two: No, the additional elements are not integrated into a practical application).
Step 2B
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements: (1) do not improve the functioning of a computer or any other technology or technical field, and (2) use the additional elements for performing the abstract idea.
A. Improvements to the Functioning of a Computer or To Any Other Technology or Technical
Field. MPEP 2106.05(a)
The additional elements of independent claims 1, 15 and 16, and dependent claims 2-14 and 17 – 20 do not integrate the abstract idea into a practical application and only use those elements for performing the abstract idea and not more than the judicial exception itself. None of the claims recite an “inventive concept” because the additional elements fail to improve the functioning of a computer or any other technology or technical field (See MPEP 2106.05(a)).
The Applicant’s specification indicates “a data interface” as “a communication interface 150, e.g., a data interface” (page 4, lines 28-29) and “The communication interface 150 may be used to send or receive digital data, e.g., health data, care procedure, medical update, health data update, care procedure update, and the like” (page 5, lines 16-17).
The Applicant’s specification indicates “a database storage” stores “at least health data in association with a patient” (page 6, lines 7-8).
The Applicant’s specification includes “a processor” that “may be configured to execute
a version matching function to determine if the new version identifier and the stored identifier match” (page 8, lines 20-21) and that “may be configured to determine if the health data update is relevant for the care procedure” (page 9, lines 16-17).
The Applicant’s specification includes “A transitory or non-transitory computer readable medium” that “may store data 1020 wherein the data may indicate instructions, which when executed by a processor system, cause a processor system to perform a health database method” (page 23, lines 26-28).
The claimed additional elements are used in a conventional manner to receive data, retrieve data, process data, store data, update data, etc., and the specification does not disclose any specific technical improvement in how this function is performed.
The use of a computer or processor to merely automate or implement the abstract idea cannot provide significantly more than the abstract idea itself. There is no indication that the additional limitations alone or in combination improves the functioning of a computer or any other technology, improves another technology or technical field, or effects a transformation or reduction of a particular article to a different state or thing.
There is no indication in the claims or specification that the invention improves the performance, efficiency, security, or functionality of a computer system beyond using generic components to perform a judicial exception. The claims do not improve how computers store, retrieve, transmit, or process data, nor do they enhance any other technical field.
Thus, because the claims fail to recite an improvement to the functioning of a computer or any other technology or technical field, they do not amount to significantly more than the judicial exception itself.
And B. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
The additional elements of independent claims 1, 15 and 16, and dependent claims 2-14 and 17 – 20 do not integrate the abstract idea into a practical application and only use those elements for performing the abstract idea and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea (See MPEP 2106.05(f)).
The requirement to execute the claimed steps/functions using a data interface, a database storage, a processor, a transitory or non-transitory computer readable medium, etc., (Independent Claim(s) 1, 15 and 16, and dependent claims 2-14 and 17 – 20) are equivalent to adding the words “apply it” on a generic computer and/or mere instructions to implement the abstract idea on a generic computer.
Similarly, the limitations of using a data interface, a database storage, a processor, a transitory or non-transitory computer readable medium, etc., (Independent Claim(s) 1, 15 and 16, and dependent claims 2-14 and 17 – 20) are recited at a high level of generality and amount to no more than mere instructions to apply the exception using generic computer components. This/these limitation(s) do/does not impose any meaningful limits on practicing the abstract idea, and therefore do/does not integrate the abstract idea into a practical application (See MPEP 2106.05(f)). (Step 2B: No, the claims do not provide significantly more).
In conclusion, the claims are directed to the abstract idea for managing data and to receive data, retrieve data, process data, store data, update data, etc.. The claims do not provide an inventive concept, because the claims do not recite additional elements or a combination of elements that amount to significantly more than the judicial exception of the claims. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology or contains instructions to implement the judicial exception, and the collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an ordered combination, the claims are nonetheless rejected under 35 U.S.C. 101 as being directed to nonstatutory subject matter.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 7-8, 10-12, 15 and 16 are rejected under 35 U.S.C 103 as being unpatentable over US Publication No. 2016/0162643 (“Newbold”) (cited on IDS received 5/22/2023).
With respect to Claim 1,
Newbold teaches A health database system comprising - a data interface configured for - receiving health data relating to a patient from multiple data generating systems, and - receiving medical updates from the multiple data generating systems ("An apparatus, system and method may provide for maintaining and updating a patient's medical records. A patient medical memory device may be assigned to a patient and used to store the patient's medical record, which may be accessible to a healthcare professional when visited by the patient. The medical record may be updated with new medical information derived from a visit with a healthcare professional by storing the new medical information in a memory of the memory device and/or in a remote computer database") (Newbold [Abstract]) and ("The current invention relates generally to apparatus, systems and methods for generating and updating medical records.") (Newbold [0002]) and ("These sets of medical information may include the typical vitals of the patient at a given time (e.g. the patient's temperature, blood pressure, heart rate, weight etc.) as well as current medications (being taken by the patient), medical conditions, chronic disease information, diabetic information, allergy information, past prior medical records, a diagnosis, a treatment, a treatment plan…") (Newbold [0045]) (Examiner note: medical information is maintained or updated; heart rate, blood pressure, temperature, etc., can be obtained from data generation systems; updates can include data from a diagnosis which can come from various data generation machines, i.e. ultrasound machine or MRI)
a database storage for storing at least health data in association with a patient, ("A patient medical memory device may be assigned to a patient and used to store the patient's medical record…The medical record may be updated with new medical information derived from a visit with a healthcare professional by storing the new medical information in a memory of the memory device and/or in a remote computer database") (Newbold [Abstract])
and - a processor configured to - determine if a received medical update is relevant for the patient, and, if so, store the medical update in the database storage associated with the determined patient ("At a given time, each medical record may include a set of medical information, to which may be added additional sets of medical information, wherein each set of medical information is related to a specific patient and each additional set is derived from a visit of that patient with a healthcare professional.") (Newbold [0046]) (Examiner note: for the update to be added to the record of a specific patient, the program must determine that the update is related and therefore relevant to that patient) and ("The method may also include receiving multiple additional sets of medical information—e.g., third, fourth, fifth, sixth, etc. sets of medical information—which are used to update a given medical record by storing these sets in the medical record file of the corresponding patient.") (Newbold [0052])
With respect to Claim 2,
Newbold teaches the limitations of Claim 1
Newbold teaches wherein the medical update comprises a care procedure from one or more of the multiple data generating systems, ("One method may involve the maintaining or storing of various sets of patient-specific information including sets of medical information of given patients in a computer database…") (Newbold [0045]) and ("These sets of medical information may include the typical vitals of the patient at a given time (e.g. the patient's temperature, blood pressure, heart rate, weight etc.) as well as current medications (being taken by the patient), medical conditions, chronic disease information, diabetic information, allergy information, past prior medical records, a diagnosis, a treatment, a treatment plan…") (Newbold [0045]) (Examiner note: a treatment plan is interpreted as a care procedure; medical information is maintained or updated; heart rate, blood pressure, temperature, etc., can be obtained from data generation systems; updates can include data from a diagnosis which can come from various data generation machines, i.e. ultrasound machine or MRI)
a care procedure relating to multiple patients ("The computer program is configured to access the computer database, in which are stored the medical records of a large number of people/patients in respective patient-specific medical record files.") (Newbold [0046])
(Examiner note: Newbold teaches an apparatus, system, and method that can be used for multiple patients, so a treatment plan can relate to multiple patients if for example two patients have the exact same diagnosis)
With respect to Claim 3,
Newbold teaches the limitations of Claim 2
Newbold teaches wherein receiving a care procedure comprises receiving a care procedure update ("In one aspect, the invention may provide a method comprising the steps of reading with a memory reader a memory of a first patient medical memory device of a patient to access a medical record of the patient comprising a first set of medical information; and storing in the memory with a memory writer a second set of medical information to update the medical record, wherein the second set of medical information is derived from a visit of the patient with a healthcare professional at a first medical facility where the memory reader is located.") (Newbold [0005]) (Examiner note: the medical update may contain a treatment plan, and a care procedure is being interpreted as a treatment plan)
the received care procedure comprising a new version identifier, determining if the received medical update is relevant for a patient comprises verifying that the database storage stores an association between the patient and a care procedure that has a stored version identifier matching the new version identifier, wherein the health database system processor is configured to execute a version matching function to determine if the new version identifier and the stored identifier match ("The method may also include receiving multiple additional sets of medical information—e.g., third, fourth, fifth, sixth, etc. sets of medical information—which are used to update a given medical record by storing these sets in the medical record file of the corresponding patient. ") (Newbold [0052]) and ("At a given time, each medical record may include a set of medical information, to which may be added additional sets of medical information, wherein each set of medical information is related to a specific patient and each additional set is derived from a visit of that patient with a healthcare professional.") (Newbold [0046])
With respect to Claim 4,
Newbold teaches the limitation of Claim 1,
Newbold teaches wherein the medical update comprises health data from one or more of the multiple data generating systems ("One method may involve the maintaining or storing of various sets of patient-specific information including sets of medical information of given patients in a computer database…") (Newbold [0045]) and ("These sets of medical information may include the typical vitals of the patient at a given time (e.g. the patient's temperature, blood pressure, heart rate, weight etc.) as well as current medications (being taken by the patient), medical conditions, chronic disease information, diabetic information, allergy information, past prior medical records, a diagnosis, a treatment, a treatment plan…") (Newbold [0045]) (Examiner note: medical information is maintained or updated; heart rate, blood pressure, temperature, etc., can be obtained from data generation systems; updates can include data from a diagnosis which can come from various data generation machines, i.e. ultrasound machine or MRI)
With respect to Claim 5,
Newbold teaches the limitations of Claim 4
Newbold teaches wherein receiving health data comprises receiving a health data update of a previous health data, determining if the received medical update is relevant for a patient comprises verifying that the database storage stores an association between the previous health data and a care procedure, wherein the health database system processor is configured to determine if the health data update is relevant for the care procedure ("At a given time, each medical record may include a set of medical information, to which may be added additional sets of medical information, wherein each set of medical information is related to a specific patient and each additional set is derived from a visit of that patient with a healthcare professional.") (Newbold [0046]) (Examiner note: An update may be added to the record of a specific patient, the program must determine that the update is related and therefore relevant to that patient. When updating a patient's medical record, the additional set of data is derived from a previous visit of a patient and healthcare professional, the data which can be derived from can include medical information such as a treatment plan which is interpreted as a care procedure) and ("The method may also include receiving multiple additional sets of medical information—e.g., third, fourth, fifth, sixth, etc. sets of medical information—which are used to update a given medical record by storing these sets in the medical record file of the corresponding patient.") (Newbold [0052]) (Examiner note: previous health data)
With respect to Claim 7,
Newbold teaches the limitations of Claim 1
Newbold teaches wherein the database storage comprises an electronic medical record (EMR), an electronic health record (EHR), and/or personal health record (PHR) ("A computer program is provided to achieve various steps of the method. The computer program is configured to access the computer database, in which are stored the medical records of a large number of people/patients in respective patient-specific medical record files. Each medical record typically has a substantial amount of medical information about the given person/patient, making up a complete medical history of that patient, or at least as complete as has been possible during the inputting of medical information into the database for a given patient.") (Newbold [0046])
With respect to Claim 8,
Newbold teaches the limitations of Claim 1
Newbold teaches wherein the health data stored in association with a patient comprises one or more of - clinical information, including, diagnosis, test results, medical images, assessments, genomic data, lab values, and vital signs ("A computer program is provided to achieve various steps of the method. The computer program is configured to access the computer database, in which are stored the medical records of a large number of people/patients in respective patient-specific medical record files. Each medical record typically has a substantial amount of medical information about the given person/patient, making up a complete medical history of that patient, or at least as complete as has been possible during the inputting of medical information into the database for a given patient.") (Newbold [0046]) and ("These sets of medical information may include the typical vitals of the patient at a given time (e.g. the patient's temperature, blood pressure, heart rate, weight etc.) as well as current medications (being taken by the patient), medical conditions, chronic disease information, diabetic information, allergy information, past prior medical records, a diagnosis, a treatment, a treatment plan, a prescription for a medication/drug to be taken by the patient and so forth. The sets of patient-specific information may also include the patient-specific information noted further above, such as name, address, date of birth and so forth.") (Newbold [0045])
With respect to Claim 10,
Newbold teaches the limitations of Claim 1
Newbold teaches wherein a care procedure is stored in association with a patient, as well as an application of the care procedure to said patient, obtained by applying the care procedure to the patient and specifying care procedure for the patient ("These sets of medical information may include… a diagnosis, a treatment, a treatment plan, a prescription for a medication/drug to be taken by the patient and so forth.") (Newbold [0045]) and ("After a patient receives a medical diagnosis, treatment and/or the like, the healthcare professional creates additional medical information (or a set of medical information) based on the diagnosis and/or treatment. That is, the medical diagnosis and/or treatment is recorded in writing such as on a computer.") (Newbold [0040])
With respect to Claim 11,
Newbold teaches the limitations of Claim 1
Newbold teaches wherein the health data stored in association with a patient, comprises particular treatment and/or test steps that have been taken for a patient as indicated by an application of a care procedure to a patient ("After a patient receives a medical diagnosis, treatment and/or the like, the healthcare professional creates additional medical information (or a set of medical information) based on the diagnosis and/or treatment. That is, the medical diagnosis and/or treatment is recorded in writing such as on a computer.") (Newbold [0040])
With respect to Claim 12,
Newbold teaches the limitations of Claim 1
Newbold teaches wherein the database storage comprises a distributed ledger, new tokens stored in said distributed ledger comprising health data and/or care procedures associated with a patient ("A patient medical memory device may be assigned to a patient and used to store the patient's medical record, which may be accessible to a healthcare professional when visited by the patient. The medical record may be updated with new medical information derived from a visit with a healthcare professional by storing the new medical information in a memory of the memory device and/or in a remote computer database") (Newbold [Abstract]) (Examiner Note: Applicant's specification says "The PHR is implemented here as a distributed ledger 270. The distributed ledger 270 may store medical information, e.g., associated with a patient…"; a PHR is a personal health record)
With respect to Claim 15,
Newbold teaches A health database method comprising - receiving health data relating to a patient from multiple data generating systems, - receiving medical updates from the multiple data generating systems ("An apparatus, system and method may provide for maintaining and updating a patient's medical records. A patient medical memory device may be assigned to a patient and used to store the patient's medical record, which may be accessible to a healthcare professional when visited by the patient. The medical record may be updated with new medical information derived from a visit with a healthcare professional by storing the new medical information in a memory of the memory device and/or in a remote computer database") (Newbold [Abstract]) and ("The current invention relates generally to apparatus, systems and methods for generating and updating medical records.") (Newbold [0002])and ("These sets of medical information may include the typical vitals of the patient at a given time (e.g. the patient's temperature, blood pressure, heart rate, weight etc.) as well as current medications (being taken by the patient), medical conditions, chronic disease information, diabetic information, allergy information, past prior medical records, a diagnosis, a treatment, a treatment plan…") (Newbold [0045]) (Examiner note: medical information is maintained or updated; heart rate, blood pressure, temperature, etc., can be obtained from data generation systems; updates can include data from a diagnosis which can come from various data generation machines, i.e. ultrasound machine or MRI)
storing at least health data in association with a patient ("A patient medical memory device may be assigned to a patient and used to store the patient's medical record…") (Newbold [Abstract])
determining if a received medical update is relevant for the patient, and, if so, store the medical update in the database storage associated with the determined patient ("At a given time, each medical record may include a set of medical information, to which may be added additional sets of medical information, wherein each set of medical information is related to a specific patient and each additional set is derived from a visit of that patient with a healthcare professional.") (Newbold [0046]) (Examiner note: for the update to be added to the record of a specific patient, the program must determine that the update is related and therefore relevant to that patient) and ("The method may also include receiving multiple additional sets of medical information—e.g., third, fourth, fifth, sixth, etc. sets of medical information—which are used to update a given medical record by storing these sets in the medical record file of the corresponding patient. ") (Newbold [0052])
With respect to Claim 16,
Newbold teaches the limitations of Claim 15
Newbold teaches A transitory or non-transitory computer readable medium comprising data representing instructions, which when executed by a processor system, cause the processor system to perform the method according to claim 15 ("A system comprising: a patient medical memory device having a memory in which is stored a first set of medical information of a patient to which the memory device is assigned; and a memory reader and writer capable of reading the memory to access the first set of medical information and writing to the memory to store a second set of medical information in the memory.") (Newbold [Claim 20])
Claims 6, 9, 13 and 14 are rejected under 35 U.S.C 103 as being unpatentable over US Publication No. 2016/0162643 (“Newbold”) (cited on IDS received 5/22/2023) in view of UK Publication GB 2598568 (“Hugh”) (cited on IDS received 5/22/2023)
With respect to Claim 6,
Newbold teaches the limitations of Claim 1
Newbold teaches comprising retrieving from the database a first diagnosis based on first medical data and a first protocol according to which the first diagnosis was made, obtaining a second protocol for making a second diagnosis ("In another aspect, the invention may provide a method comprising the steps of maintaining in a computer database a medical record of a patient comprising a first set of medical information of the patient; providing a first patient medical memory device having a memory in which is stored the first set of medical information; receiving a second set of medical information of the patient from the memory; and updating the medical record by storing the second set of medical information in the database.") (Newbold [0006]) and ("The method may also include receiving multiple additional sets of medical information—e.g., third, fourth, fifth, sixth, etc. sets of medical information—which are used to update a given medical record by storing these sets in the medical record file of the corresponding patient. ") (Newbold [0052]) and ("After a patient receives a medical diagnosis, treatment and/or the like, the healthcare professional creates additional medical information (or a set of medical information) based on the diagnosis and/or treatment. That is, the medical diagnosis and/or treatment is recorded in writing such as on a computer.") (Newbold [0040])
Newbold does not teach the specific limitation taught by Hugh
Hugh teaches determining differences between the first protocol and the second protocol, and assessing a likelihood that a second diagnosis based on the second protocol and the medical data is different from the first diagnosis ("The outputs of the sensors are used to determine the physical parameter and calculate a priority score which is displayed on a display 234.") (Hugh [Abstract]) and ("The health parameters being measured are not static and continuous change over time; therefore, neither do corresponding risk assessment rankings remain static.") (Hugh [page 11, lines 7-9]) (Examiner note: Updates about a patient can change as time passes. If the patient's priority score changes i.e., changes from a low priority to a very high priority, the patient's diagnosis and protocol may change as well)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system as taught by Newbold to determine the difference between first and second protocols and assess the likelihood that the second diagnosis is different from the first as taught by Hugh with the motivation of reducing healthcare service costs and improving the standard of care provided for patients (Hugh [Background]) and to optimize the use of available clinician resources (Hugh [page 11, lines 12-13]). In the combination of elements, it would have been obvious to one of ordinary skill in the art to add the determination between first and second protocols and asses the likelihood that the second diagnosis is different from the first diagnosis.
With respect to Claim 9,
Newbold teaches the limitations of Claim 1
Newbold does not teach the limitation taught by Hugh
Hugh teaches A health database system 1, wherein the health database system processor is configured to compute a risk score for the patient and to update said risk score if new health data and/or a new care procedure is received for said patient, the risk score indicating a risk that health data associated with the patient becoming unreliable as a result of the new care procedure, raise a warning if said risk score increases by more than a predetermined threshold ("For each patient monitored and triaged in this way, they are assigned priority score and their risk assessment level is continuously refreshed through the database being dynamically populated with updated real-time health data. Included in the device software is a patient "Early Warning Score" (EWS) calculation. The efficacy of the priority score and EWS is dependent on the composition and number of health parameters available for measurement: the continuous monitoring sensors give a provisional priority score, whereas as the continuous monitoring sensors, together with the manually inputted parameters give a complete triage priority score. Non-health parameter sensors on the wearable patient monitoring device may provide location tracking and accelerometer data as well as device systems diagnostic data. The device provides risk assessment information relating to physiological telemetry, alert thresholds and health monitoring software to recognize pattern variance in physiological parameters. Alerts are fed from the wearable patient monitoring device through cloud infrastructure to a network enabled clinician control dashboard for subjective risk assessment and intervention assessment decisions.") (Hugh [page 7, lines 18-33])
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system as taught by Newbold to compute a risk score for a patient and to update it in accordance to new patient health data, and to raise a warning if the risk score increases by more than a predetermined threshold as taught by Hugh with the motivation of reducing healthcare service costs and improving the standard of care provided for patients (Hugh [Background]) and to optimize the use of available clinician resources (Hugh [page 11, lines 12-13]). In the combination of elements, it would have been obvious to one of ordinary skill in the art to add the ability to compute a risk score for a patient and to update it in accordance to new patient health data, and to raise a warning if the risk score increases by more than a predetermined threshold.
With respect to Claim 13,
Newbold teaches the limitations of Claim 1
Newbold does not teach the limitations taught Hugh
Hugh teaches wherein the health database system processor is configured to - calculate a patient risk value, - determine an evaluation frequency of health data based on the calculated risk value - perform evaluation with the determined frequency ("A triage system may comprise the wearable patient monitoring device and a computer implemented method for patient prioritization, generating a risk assessment based on specified health parameters through one or more sensors on the device (e.g. heart rate risk due to low beat rate). Further definition may be added to the risk assessment via the inclusion of manual observation inputs via an input control panel on the device or a paired mobile user device application interface (e.g. Glasgow Coma Score assigning patient's alertness level). The health risk assessment system is derived from sensor data from the wearable patient monitoring device, manually inputted health parameters on the wearable patient monitoring device, manually inputted health parameters from a paired user mobile device; and/or manual inputted health parameters and information via a fixed user clinician dashboard on the system.") (Hugh [0005, page 2, lines 20-30]) and (The system management only requests or flags clinician interventions as and when required.) (Hugh [Page 2 lines 13-14]) (Examiner note: evaluation frequency can be raised if intervention from a clinician is required)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system as taught by Newbold to determine the evaluation frequency of health data based on calculated patient risk as taught by Hugh with the motivation of reducing healthcare service costs and improving the standard of care provided for patients (Hugh [Background]) and to optimize the use of available clinician resources (Hugh [page 11, lines 12-13]). In the combination of elements, it would have been obvious to one of ordinary skill in the art to add the ability to determine the evaluation frequency of health data based on calculated patient risk.
With respect to Claim 14,
Newbold teaches the limitations of Claim 1
Newbold teaches wherein the health database system is configured to receive from the multiple data generating systems medical information comprising at least health data and one or more care procedures ("After a patient receives a medical diagnosis, treatment and/or the like, the healthcare professional creates additional medical information (or a set of medical information) based on the diagnosis and/or treatment. That is, the medical diagnosis and/or treatment is recorded in writing such as on a computer. Typically, either the healthcare professional or one of his or her staff members records this information in writing or various symbols by inputting the new set of medical information into a computer file with one or more input devices, such as a keyboard, mouse and/or microphone, for example") (Newbold [40]) (Examiner note: a medical diagnosis can be made from data generation units) and ("One method may involve the maintaining or storing of various sets of patient-specific information including sets of medical information of given patients in a computer database…") (Newbold [0045]) and ("These sets of medical information may include the typical vitals of the patient at a given time (e.g. the patient's temperature, blood pressure, heart rate, weight etc.) as well as current medications (being taken by the patient), medical conditions, chronic disease information, diabetic information, allergy information, past prior medical records, a diagnosis, a treatment, a treatment plan…") (Newbold [0045]) (Examiner note: medical information is maintained or updated; heart rate, blood pressure, temperature, etc., can be obtained from data generation systems; updates can include data from a diagnosis which can come from various data generation machines, i.e. ultrasound machine or MRI)
one or more of the medical information stored in the database storage comprising a link to an earlier received medical information on which it is dependent ("The method may also include receiving multiple additional sets of medical information—e.g., third, fourth, fifth, sixth, etc. sets of medical information—which are used to update a given medical record by storing these sets in the medical record file of the corresponding patient.") (Newbold [0052])
Newbold does not teach the limitations taught by Hugh
Hugh teaches the processor being configured to determine for a received medical update for a first medical information if the database comprises a second medical information that is recorded as dependent upon the first medical information, and if the dependent second medical information is found to perform a resolution algorithm ("The third aspect of our approach based on the data sets compiled; is to improve our e-triage system through using machine learning to refine and update the priority care risk assessment system.") (Hugh [page 8, lines 13-15]) (Examiner note: The system of Hugh can use machine learning to update patient data. In order to change the risk priority of a patient the system must be able to compare the first medical information to the second medical information to see if there is an increase or decrease in a patient's risk)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system as taught by Newbold to perform a resolution algorithm using medical information as taught by Hugh with the motivation of reducing healthcare service costs and improving the standard of care provided for patients (Hugh [Background]) and to optimize the use of available clinician resources (Hugh [page 11, lines 12-13]). In the combination of elements, it would have been obvious to one of ordinary skill in the art to add the ability to perform a resolution algorithm using medical information.
Response to Arguments
Applicant’s arguments, see Claim Rejections under 35 U.S.C. §103, filed 7/17/2025, with respect to claims 1 – 16 have been fully considered and are persuasive. The 35 U.S.C. 103 rejection of claims 1 – 16 has been withdrawn.
Applicant's arguments filed 7/17/2025 have been fully considered but they are not persuasive.
Claim Rejections under 35 U.S.C. §101
The Applicant states, “Amended claim 1 does not recite a personal behavior or a relationship or interaction between people. Rather, amended claim 1 recites structuring of database storage to enable a medical update of a protocol to effectuate changes to one or more associated care procedures.” However, the Specification itself shows the relationship of the invention to patient medical treatment. The entire paragraphs (emphasis added)
[0002] Medical treatment is moving in a direction of increased specialization. For example, in fields such as oncology, diagnosis and treatment may be distributed-not just in hospitals, but across specialized centers for imaging, lab values, genomics, tissue and liquid biopsies.
[0003] This distribution may also involve multiple primary care professionals, such as the oncologist, pathologist, GP, nurses, etc. In such a distributed system, medical information is increasingly harder to access by the various parties that need such access.
[0095] For example, in an embodiment, the health database system may be configured to retrieve from the database a first diagnosis based on first medical data and a first protocol according to which the first diagnosis was made. A medical update may comprise a second protocol for making a second diagnosis. The second protocol may be an update of the first protocol, e.g., as indicated by a version control system, but this is not necessary. Differences between the first protocol and the second protocol may be determined, and a likelihood may be assessed, e.g., estimated, that a second diagnosis based on the second protocol and the medical data is different from the first diagnosis. For example, the first and second protocol may be protocols to diagnose the same medical condition.
[0096] Generally speaking, receiving a medical update may have a knock-on effect, e.g., as a result of protocol update, data update, or interpretation update. That is, receiving new health data or care procedure may have further implications, for example, they may require a reinterpretation of previous data. Note that there can be more than one protocol which may have been followed. Some protocols may be focused on data collection, while others on treatment, and others and diagnosis, and so on. In the health database, a medical information may be linked to a care procedure. Note that the links between medical information and care procedures need not be one to one. A medical information may be linked to multiple care procedures. Even, when a protocol remains the same, the patient data may have been updated. For instance new patient data may have been collected, or the interpretation of the data may have been changed.
[0097] If a medical update is determined to be relevant for a particular patient, then the health database system may be configured to inform health care personnel associated with the determined patient, and/or the patient him/herself, of the determined relevancy of the medical update.
The Applicant states, “The claimed invention improves the technical field of medical systems.” The Specification does not agree with the Applicant’s opinion. The Specification does not show that the invention is directed towards a technical improvement. Any further arguments toward technological improvements are considered moot.
The Applicant states, “This Example 42 is directed to subject matter that has similarities to the claims of the present application and should be used as guidance for evaluating the claims of the present application.” Example 42 relates to a technological improvement and therefore does not relate to the instant invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Felsher (US Publication No. 2002/0010679) describes an information record infrastructure, system and method.
Agassi (US Publication No. 2024/0331816) describes a code generator for accessing differing health record systems.
Fotheringham (US Publication No. 2013/0191140) describes caregiver processes and systems
Caffarel (US Publication No. 2016/0171177) describes a system to create and adjust a holistic care plan to integrate medical and social services
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Neal R Sereboff whose telephone number is (571)270-1373. The examiner can normally be reached M - T, M - F 8AM - 6PM.
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/NEAL SEREBOFF/
Primary Examiner
Art Unit 3626
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