DETAILED ACTION
Notice to Applicant
This communication is in response to the application submitted January 6, 2025. The present application is a Continuation in Part (CIP) of application 18/677,709 (now abandoned). Claims 1 – 20 are pending.
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 .
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., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step One
Claims 1 – 20 are drawn to a system, method, and non-transitory computer-readable medium, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claims 1, 12, and 20 recite receive first medical data associated with a first patient; parse based on the received first medical data; apply one or more pre-processing operations on the first medical data, wherein the application of the one or more pre-processing operations on the first medical data comprises appending a timestamp to the first medical data; generate second medical data based on the application of one or more pre- processing operations on the first medical data.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, where the present invention is directed to enabling the scheduling of medical treatments and provides tools for rescheduling feedback, contacting and receiving feedback from patients, physicians, and healthcare professionals. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because they address a need to improve the communication methods for scheduling and use of medical devices between healthcare providers (paragraph 39 of the published specification). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including:
Claim 1: “system”, “circuitry”, “one or more data sources”, “first proprietary data transmission protocol”, “convert the first proprietary data transmission protocol to a standard data transmission protocol based on the parsing of the first proprietary data transmission protocol”, “transmit the second medical data, using the standard data transmission protocol, to a medical data governance (MDG) system”, “receive a first set of commands from the MDG system based on the transmitted second medical data”, “control at least one data source to execute the first set of commands”
Claim 2: “system”, “circuitry”, “one or more data sources comprise at least one of: a set of medical devices, or a set of scanning devices, and wherein the set of medical devices comprises a set of diagnostic medical devices and a set of monitoring devices”
Claim 3: “system”
Claim 4: “system”, “databases”
Claim 5: “system”, “wherein the MDG system comprises one or more artificial intelligence (AI) models, and wherein the circuitry is further configured to: control the MDG system to apply the one or more AI models on the second medical data; control the MDG system to generate the first set of commands based on the application of the one or more AI models on the second medical data; and receive the first set of commands from the MDG system”
Claim 6: “system”, “circuitry”, “AI models”
Claim 7: “system”, “receive, from the one or more data sources, third medical data associated with the first patient, wherein the second medical data is received after the execution of the first set of command ….. and control at least one data source to execute at least one command of the second set of commands”
Claim 8: “system”, “circuitry”, “user devices”
Claim 9: “system”, “circuitry”, “metadata”
Claim 10: “system”, “circuitry”
Claim 11: “system”, “circuitry”, “validate the received first set of commands based on one or more criteria”, “control at least one data source to execute the first set of commands based on the validation”
Claim 12: “one or more data sources”, “first proprietary data transmission protocol”, “converting the first proprietary data transmission protocol to a standard data transmission protocol based on the parsing of the first proprietary data transmission protocol”, “transmitting the second medical data, using the standard data transmission protocol, to a medical data governance (MDG) system”, “receiving a first set of commands from the MDG system based on the transmitted second medical data”, “controlling at least one data source to execute the first set of commands”
Claim 13: “one or more data sources comprise at least one of: a set of medical devices, or a set of scanning devices, and wherein the set of medical devices comprises a set of diagnostic medical devices and a set of monitoring devices”
Claim 15: “databases”
Claim 16: “controlling the MDG system to apply the one or more AI models on the second medical data”, “control the MDG system to generate the first set of commands based on the application of the one or more AI models on the second medical data”, “receive the first set of commands from the MDG system”
Claim 17: “AI models”
Claim 18: “receiving, from the one or more data sources, third medical data associated with the first patient, wherein the second medical data is received after the execution of the first set of command ….. and controlling at least one data source to execute at least one command of the second set of commands”
Claim 20: “A non-transitory computer-readable medium including computer program instructions, which when executed by a system, cause the system to perform one or more operations”, “converting the first proprietary data transmission protocol to a standard data transmission protocol based on the parsing of the first proprietary data transmission protocol”, “transmitting the second medical data, using the standard data transmission protocol, to a medical data governance (MDG) system”, “receiving a first set of commands from the MDG system based on the transmitted second medical data”, “controlling at least one data source to execute the first set of commands”
These features are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The published specification supports this conclusion as follows:
[0055] The circuitry 202 may include suitable logic, circuitry, and interfaces that may be configured to execute program instructions associated with different operations to be executed by the system 102. For example, some of the operations may include, but are not limited to, receiving the first medical data, converting the first proprietary data transmission protocol to the standard data transmission protocol, and transmitting the first medical data. The circuitry 202 may include one or more specialized processing units, which may be implemented as an integrated processor or a cluster of processors that perform the functions of the one or more specialized processing units, collectively. The circuitry 202 may be implemented based on a number of processor technologies known in the art. Examples of implementations of the circuitry 202 may be an x86-based processor, a Graphics Processing Unit (GPU), a Reduced Instruction Set Computing (RISC) processor, an Application-Specific Integrated Circuit (ASIC) processor, a Complex Instruction Set Computing (CISC) processor, a microcontroller, a central processing unit (CPU), and/or other computing circuits.
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2 – 15 and 17 – 19 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
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.
Claim(s) 1 – 4, 9, 1 and 1 – 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biondi et al., herein after Biondi (U.S. Publication Number 2011/0087756 A1) in view of Padmani et al., herein after Padmani (U.S. Publication Number 2021/0304878 A1).
Claim 1. Biondi teaches a system, comprising:
a circuitry (paragraph 38 discloses the system can offload work to other devices (servers, processors, routers, hubs, etc.); claim 1 recites a processor based system) configured to:
receive, from one or more data sources, first medical data associated with a first patient (paragraph 7 discloses receiving data using a first protocol from the medical devices by a local authority; paragraph 24 discloses any device used to collect patient data, assist with patient safety or otherwise be used to facilitate medical treatment or diagnosis of one or more patients), wherein the first medical data is received using a first proprietary data transmission protocol (paragraph 3 discloses a local authority to receive data using a first protocol from the medical devices and convert the data to a second protocol; paragraph 4 discloses the first protocol is a native device protocol which is interpreted as a transmission protocol associated with the native device (medical device); paragraph 24 discloses various types of medical devices with their own native devices protocols can be used);
parse the first proprietary data transmission protocol based on the received first medical data (paragraph 51 discloses “medical device data exchange system in which a medical device A, exchanges data with a bridge using a native device language. In tum, the bridge 112 exchanges data with a local authority server 116 using a first protocol, protocol X. In another embodiment, a device network B, 118 also communicates with the local authority server 116 using a second protocol, protocol Y. This device network B may include a network having a plurality of medical devices such as a plurality of beds with a medical device associated with each patient in each of such beds. The local authority server 116 in this embodiment includes a plurality of parsers, such as parser X, 120 and parser Y, 122 as shown, configured to receive different protocols such as protocol X and protocol Y, respectively”);
convert the first proprietary data transmission protocol to a standard data transmission protocol based on the parsing of the first proprietary data transmission protocol (paragraph 3 discloses receiving data using a first protocol from the medical devices and convert the data to a second protocol, a central authority in communication with the local authority, and a user interface, in communication with the central authority; claim 3 discloses the local authority transforms the data from the plurality of heterogeneous medical devices from a first protocol (proprietary) to a second protocol (standard));
transmit the second medical data, using the standard data transmission protocol, to a medical data governance (MDG) system (paragraph 3 discloses “a system for providing for the display of data from a plurality of nonhomogeneous medical devices. In one embodiment the system includes a local authority to receive data using a first protocol from the medical devices and convert the data to a second protocol, a central authority in communication with the local authority, and a user interface, in communication with the central authority. The central authority routes data that has been converted to a second protocol for display by the user interface”; paragraph 26 discloses the serial output port of the medical device is connected to a network device which changes the serial output of the medical device to a protocol suitable for use over the network such as the internet transmission control protocol (TCP/IP), which is considered a standard data transmission protocol).
Biondi fails to explicitly teach the following limitations met by Padmani as cited:
apply one or more pre-processing operations on the first medical data based on the conversion, wherein the application of the one or more pre-processing operations on the first medical data comprises appending a timestamp to the first medical data (paragraph 22 discloses a time stamp from which the received medical data was generated by the medical device or received by the processor from the medical device; paragraph 50 discloses an identification of a therapy (medical) device type, identification of a therapy device serial number, a timestamp from which the treatment data was generated or received from the therapy device);
generate second medical data based on the application of one or more pre- processing operations on the first medical data (Figure 9 illustrates a first data subset and a second data subset; paragraph 14 discloses convert a second subset of the medical data to the second data format, and transmit the second subset of the medical data in the second data format for transmission via the same or a different output port as specified by the configuration file);
receive a first set of commands from the MDG system based on the transmitted second medical data (paragraph 48 discloses the “medical device data includes treatment programming information, which comprises one or more parameters that define how a medical device is to operate to administer a treatment to a patient. For a peritoneal dialysis therapy, the parameters may specify an amount ( or rate) of fresh dialysis fluid to be pumped into a peritoneal cavity of a patient, an amount of time the fluid is to remain in the patient's peritoneal cavity (i.e., a dwell time), and an amount ( or rate) of used dialysis fluid and ultrafiltration ("UF") that is to be pumped or drained from the patient after the dwell period expires”; paragraph 56 discloses the processor or therapy module of the medical device operates according to one or more instructions for performing a treatment on a patient, where the instructions may be acquired via the control interface); and
control at least one data source to execute the first set of commands (paragraph 55 discloses the medical device may include one or more control interfaces for displaying instructions and receiving control inputs from a user).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Biondi to further include digital communication module for transmission of data from a medical device as disclosed by Padmani.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of Biondi in this way to provide an improved system for conveying medical device data to medical device manufacturers. (Padmani: paragraph 34).
Claim 2. Biondi and Padmani teach the system according to claim 1. Biondi teaches a system wherein the one or more data sources comprise at least one of: a set of medical devices (paragraph 3 discloses a plurality of nonhomogeneous medical devices), or a set of scanning devices , and wherein the set of medical devices comprises a set of diagnostic medical devices and a set of monitoring devices (paragraph 24 discloses the medical devices and the system monitor patients to collect patient data which is transformed and processed such that improved medical treatment and patient safety results).
Method claim 13 repeats the subject matter of claim 2. As the underlying processes of claim 13 have been shown to be fully disclosed by the teachings of Biondi and Padmani in the above rejections of claim 2; as such, these limitations (claim 13) are rejected for the same reasons given above for claim 2 and incorporated herein.
Claim 3. Biondi and Padmani teach the system according to claim 2. Biondi teaches a system wherein the first medical data correspond to at least one of: a medical professional's prescription note, a pathology report, an X-radiation (X-RAY) report, a computed tomography (CT) report, a magnetic resonance imaging (MRI) report, an ultrasound report, a cardiac catheter report, or a cardiac stress report associated with the first patient (paragraph 49 discloses cardiac parameters may be displayed first in a cardiac ward).
Method claim 14 repeats the subject matter of claim 3. As the underlying processes of claim 14 have been shown to be fully disclosed by the teachings of Biondi and Padmani in the above rejections of claim 3; as such, these limitations (claim 14) are rejected for the same reasons given above for claim 3 and incorporated herein.
Claim 4. Biondi and Padmani teach the system according to claim 1. Biondi teaches a system wherein the MDG system comprises a set of medical record databases, and wherein a first medical record database of the set of medical record databases is associated with at least one of: the first patient, a first medical condition associated with the first patient, or a first medical facility associated with the first patient (paragraph 35 discloses data is written to the database by the configuration server using the ADO (active X data object), and the database is also written to by the administrative tool HL 7 ADT which in turn is written to by the configuration server where the administrative tool is used to update the patient information).
Method claim 15 repeats the subject matter of claim 4. As the underlying processes of claim 15 have been shown to be fully disclosed by the teachings of Biondi and Padmani in the above rejections of claim 4; as such, these limitations (claim 15) are rejected for the same reasons given above for claim 4 and incorporated herein.
Claim 9. Biondi and Padmani teach the system according to claim 1.
Biondi fails to explicitly teach the following limitations met by Padmani as cited:
wherein the circuitry is further configured to: generate medical metadata associated with the first patient based on the application of one or more pre-processing operations on the first medical data (paragraph 80 discloses the device data manager may be configured to include diagnostic data (identified by metadata, data field label, placement, etc.) in the first data stream or subset); and
render the generated medical metadata (paragraph 92 discloses the file and/or algorithm may identify JSON data by position, data label, field name, and/or metadata and specify how the data is to be converted, including conversion of data label names, metadata names, numeric format, positioning, etc. The internal agent then transmits the converted second data stream or subset and/or the log data to the internal interface).
The motivation to combine the teachings of Biondi and Padmani are discussed in the rejection of claim 1, and incorporated herein.
Claim 11. Biondi and Padmani teach the system according to claim 1.
Biondi fails to explicitly teach the following limitations met by Padmani as cited:
wherein the circuitry is further configured to:
validate the received first set of commands based on one or more criteria (paragraph 100 discloses validation information and/or the IP address of the DCM); and
control at least one data source to execute the first set of commands based on the validation (paragraph 101 discloses after validating, the server transmits the selected configuration file to the DCM via the external network and the medical network).
The motivation to combine the teachings of Biondi and Padmani are discussed in the rejection of claim 1, and incorporated herein.
Claim 12. Biondi teaches a method comprising:
receiving, from one or more data sources, first medical data associated with a first patient (paragraph 7 discloses receiving data using a first protocol from the medical devices by a local authority; paragraph 24 discloses any device used to collect patient data, assist with patient safety or otherwise be used to facilitate medical treatment or diagnosis of one or more patients), wherein the first medical data is received using a first proprietary data transmission protocol (paragraph 3 discloses a local authority to receive data using a first protocol from the medical devices and convert the data to a second protocol; paragraph 4 discloses the first protocol is a native device protocol which is interpreted as a transmission protocol associated with the native device (medical device); paragraph 24 discloses various types of medical devices with their own native devices protocols can be used);
parsing the first proprietary data transmission protocol based on the received first medical data (paragraph 51 discloses “medical device data exchange system in which a medical device A, exchanges data with a bridge using a native device language. In tum, the bridge 112 exchanges data with a local authority server 116 using a first protocol, protocol X. In another embodiment, a device network B, 118 also communicates with the local authority server 116 using a second protocol, protocol Y. This device network B may include a network having a plurality of medical devices such as a plurality of beds with a medical device associated with each patient in each of such beds. The local authority server 116 in this embodiment includes a plurality of parsers, such as parser X, 120 and parser Y, 122 as shown, configured to receive different protocols such as protocol X and protocol Y, respectively”);
converting the first proprietary data transmission protocol to a standard data transmission protocol based on the parsing of the first proprietary data transmission protocol (paragraph 3 discloses receiving data using a first protocol from the medical devices and convert the data to a second protocol, a central authority in communication with the local authority, and a user interface, in communication with the central authority; claim 3 discloses the local authority transforms the data from the plurality of heterogeneous medical devices from a first protocol (proprietary) to a second protocol (standard));
transmitting the second medical data, using the standard data transmission protocol to a medical data governance (MDG) system (paragraph 3 discloses “a system for providing for the display of data from a plurality of nonhomogeneous medical devices. In one embodiment the system includes a local authority to receive data using a first protocol from the medical devices and convert the data to a second protocol, a central authority in communication with the local authority, and a user interface, in communication with the central authority. The central authority routes data that has been converted to a second protocol for display by the user interface”; paragraph 26 discloses the serial output port of the medical device is connected to a network device which changes the serial output of the medical device to a protocol suitable for use over the network such as the internet transmission control protocol (TCP/IP), which is considered a standard data transmission protocol).
Biondi fails to explicitly teach the following limitations met by Padmani as cited:
applying one or more pre-processing operations on the first medical data based on the conversion, wherein the application of the one or more pre-processing operations on the first medical data comprises appending a timestamp to the first medical data (paragraph 22 discloses a time stamp from which the received medical data was generated by the medical device or received by the processor from the medical device; paragraph 50 discloses an identification of a therapy (medical) device type, identification of a therapy device serial number, a timestamp from which the treatment data was generated or received from the therapy device);
generating second medical data based on the application of one or more pre- processing operations on the first medical data (Figure 9 illustrates a first data subset and a second data subset; paragraph 14 discloses convert a second subset of the medical data to the second data format, and transmit the second subset of the medical data in the second data format for transmission via the same or a different output port as specified by the configuration file);
receiving a first set of commands from the MDG system based on the transmitted second medical data (paragraph 48 discloses the “medical device data includes treatment programming information, which comprises one or more parameters that define how a medical device is to operate to administer a treatment to a patient. For a peritoneal dialysis therapy, the parameters may specify an amount ( or rate) of fresh dialysis fluid to be pumped into a peritoneal cavity of a patient, an amount of time the fluid is to remain in the patient's peritoneal cavity (i.e., a dwell time), and an amount ( or rate) of used dialysis fluid and ultrafiltration ("UF") that is to be pumped or drained from the patient after the dwell period expires”; paragraph 56 discloses the processor or therapy module of the medical device operates according to one or more instructions for performing a treatment on a patient, where the instructions may be acquired via the control interface);
controlling at least one data source to execute the first set of commands (paragraph 55 discloses the medical device may include one or more control interfaces for displaying instructions and receiving control inputs from a user).
The motivation to combine the teachings of Biondi and Padmani are discussed in the rejection of claim 1, and incorporated herein.
Claim(s) 5 – 8, 10, and 16 – 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biondi et al., herein after Biondi (U.S. Publication Number 2011/0087756 A1) in view of Padmani et al., herein after Padmani (U.S. Publication Number 2021/0304878 A1) further in view of Amarasingham et al., herein after Amarasingham (U.S. Publication Number 2015/0213202 A1).
Claim 5. Biondi and Padmani teach the system according to claim 1.
Biondi fails to explicitly teach the following limitations met by Padmani as cited:
control the MDG system to apply the one or more AI models on the second medical data (paragraph 55 discloses the medical device may include one or more control interfaces for displaying instructions and receiving control inputs from a user);
control the MDG system to generate the first set of commands based on the application of the one or more AI models on the second medical data (paragraph 48 discloses the “medical device data includes treatment programming information, which comprises one or more parameters that define how a medical device is to operate to administer a treatment to a patient. For a peritoneal dialysis therapy, the parameters may specify an amount ( or rate) of fresh dialysis fluid to be pumped into a peritoneal cavity of a patient, an amount of time the fluid is to remain in the patient's peritoneal cavity (i.e., a dwell time), and an amount ( or rate) of used dialysis fluid and ultrafiltration ("UF") that is to be pumped or drained from the patient after the dwell period expires”; paragraph 56 discloses the processor or therapy module of the medical device operates according to one or more instructions for performing a treatment on a patient, where the instructions may be acquired via the control interface); and
receive the first set of commands from the MDG system (paragraph 56 discloses the processor or therapy module of the medical device operates according to one or more instructions for performing a treatment on a patient, where the instructions may be acquired via the control interface).
Biondi and Padmani fail to explicitly teach the following limitations met by Amarasingham as cited:
wherein the MDG system comprises one or more artificial intelligence (AI) models (claim 5 discloses an artificial intelligence logic module configured to detect, analyze, and verify trends indicated in the clinical and non-clinical data and modify the plurality of weighted risk variables and risk thresholds in response to detected and verified trends indicated in the clinical and nonclinical data).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Biondi and Padmani to further include a health information transformation system directed to methods, computer systems, and computer-readable media for use in transforming raw healthcare data and health care information from disparate sources into relevant healthcare data that may be utilized by a variety of healthcare applications as disclosed by Amarasingham.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of Biondi and Padmani in this way to provide timely identification of disease and appropriate engagement of patients and families required to offer patients appropriate care and treatment in order to avoid the progression of existing disease as well as the occurrence of a new adverse event, as well as to ensure that appropriate interventions and resources are available and deployed according to patients' needs (Amarasingham: paragraph 11).
Method claim 16 repeats the subject matter of claim 5. As the underlying processes of claim 16 have been shown to be fully disclosed by the teachings of Biondi, Padmani, and Amarasingham in the above rejections of claim 5; as such, these limitations (claim 16) are rejected for the same reasons given above for claim 5 and incorporated herein.
Claim 6. Biondi, Padmani, and Amarasingham teach the system according to claim 5.
Biondi and Padmani fail to explicitly teach the following limitations met by Amarasingham as cited:
wherein the circuitry is further configured to:
control the MDG system to determine an upcoming medical condition of the first patient based on the application of the one or more AI models on the second medical data (paragraph 36 discloses a clinical predictive and monitoring subsystem and method is adapted to accurately stratify risk for certain diseases and conditions such as 30-day readmission among congestive heart failure patients; claim 5 discloses an artificial intelligence logic module configured to detect, analyze, and verify trends indicated in the clinical and non-clinical data and modify the plurality of weighted risk variables and risk thresholds in response to detected and verified trends indicated in the clinical and nonclinical data);
receive the determined upcoming medical condition from the MDG system (paragraph 48 discloses the system includes a predictive model that provides treatment or therapy recommendations based on the patient's data (e.g. medical history, symptoms, current vital signs, lab results, and the clinician's notes, comments, and diagnosis), and forms the fundamental technology for identification of diseases, readmission risk, adverse events, and situation simulation); and
render the upcoming medical condition (paragraph 48 discloses identification of diseases).
The motivation to combine the teachings of Biondi, Padmani, and amarasingham is discussed in the rejection of claim 5, and incorporated herein.
Method claim 17 repeats the subject matter of claim 6. As the underlying processes of claim 17 have been shown to be fully disclosed by the teachings of Biondi, Padmani, and Amarasingham in the above rejections of claim 6; as such, these limitations (claim 17) are rejected for the same reasons given above for claim 6 and incorporated herein.
Claim 7. Biondi, Padmani, and Amarasingham teach the system according to claim 5. Biondi teaches a system wherein the circuitry(paragraph 38 discloses the system can offload work to other devices (servers, processors, routers, hubs, etc.); claim 1 recites a processor based system) is further configured to:
receive, from the one or more data sources, third medical data associated with the first patient, (paragraph 7 discloses a plurality of medical devices; paragraph 24 discloses any device used to collect patient data, assist with patient safety or otherwise be used to facilitate medical treatment or diagnosis of one or more patients), wherein the second medical data is received after the execution of the first set of commands;
transmit the third medical data, using the standard data transmission protocol, to the MDG system (paragraph 3 discloses “a system for providing for the display of data from a plurality of nonhomogeneous medical devices. In one embodiment the system includes a local authority to receive data using a first protocol from the medical devices and convert the data to a second protocol, a central authority in communication with the local authority, and a user interface, in communication with the central authority. The central authority routes data that has been converted to a second protocol for display by the user interface”; paragraph 26 discloses the serial output port of the medical device is connected to a network device which changes the serial output of the medical device to a protocol suitable for use over the network such as the internet transmission control protocol (TCP/IP), which is considered a standard data transmission protocol);
Biondi fails to explicitly teach the following limitations met by Padmani as cited:
control the MDG system to apply the one or more AI models on the second medical data, the third medical data, and the first set of commands (paragraph 55 discloses the medical device may include one or more control interfaces for displaying instructions and receiving control inputs from a user);
control the MDG system to generate a second set of commands based on the application of the one or more AI models on the second medical data, the third medical data, and the first set of commands (paragraph 48 discloses the “medical device data includes treatment programming information, which comprises one or more parameters that define how a medical device is to operate to administer a treatment to a patient. For a peritoneal dialysis therapy, the parameters may specify an amount ( or rate) of fresh dialysis fluid to be pumped into a peritoneal cavity of a patient, an amount of time the fluid is to remain in the patient's peritoneal cavity (i.e., a dwell time), and an amount ( or rate) of used dialysis fluid and ultrafiltration ("UF") that is to be pumped or drained from the patient after the dwell period expires”; paragraph 56 discloses the processor or therapy module of the medical device operates according to one or more instructions for performing a treatment on a patient, where the instructions may be acquired via the control interface);
receive the generated second set of commands based on the application of the one or more AI models on the first medical data, the one or more commands, and the second medical data (paragraph 56 discloses the processor or therapy module of the medical device operates according to one or more instructions for performing a treatment on a patient, where the instructions may be acquired via the control interface);
control at least one data source to execute at least one command of the second set of commands (paragraph 55 discloses the medical device may include one or more control interfaces for displaying instructions and receiving control inputs from a user; paragraph 56 discloses the processor or therapy module of the medical device operates according to one or more instructions for performing a treatment on a patient, where the instructions may be acquired via the control interface).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Biondi to further include digital communication module for transmission of data from a medical device as disclosed by Padmani.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of Biondi in this way to provide an improved system for conveying medical device data to medical device manufacturers. (Padmani: paragraph 34).
Biondi and Padmani fail to explicitly teach the following limitations met by Amarasingham as cited:
one or more artificial intelligence (AI) models (claim 5 discloses an artificial intelligence logic module configured to detect, analyze, and verify trends indicated in the clinical and non-clinical data and modify the plurality of weighted risk variables and risk thresholds in response to detected and verified trends indicated in the clinical and nonclinical data).
The motivation to combine the teachings of Biondi, Padmani, and amarasingham is discussed in the rejection of claim 5, and incorporated herein.
Method claim 18 repeats the subject matter of claim 7. As the underlying processes of claim 18 have been shown to be fully disclosed by the teachings of Biondi, Padmani, and Amarasingham in the above rejections of claim 7; as such, these limitations (claim 18) are rejected for the same reasons given above for claim 7 and incorporated herein.
Claim 8. Biondi, Padmani, and Amarasingham teach the system according to claim 7. Biondi teaches a system wherein the circuitry (paragraph 38 discloses the system can offload work to other devices (servers, processors, routers, hubs, etc.); claim 1 recites a processor based system)is further configured to:
compare the third medical data with pre-defined medical data (paragraph 51 discloses “medical device data exchange system in which a medical device A, exchanges data with a bridge using a native device language. In tum, the bridge 112 exchanges data with a local authority server 116 using a first protocol, protocol X. In another embodiment, a device network B, 118 also communicates with the local authority server 116 using a second protocol, protocol Y. This device network B may include a network having a plurality of medical devices such as a plurality of beds with a medical device associated with each patient in each of such beds”, indicating a plurality of medical devices); and
transmit an alert to a set of user devices based on the comparison (paragraph 37 discloses the smart alarm module reviews the data as it is received from the local authority; The data associated with the patient is compared to alarm settings for various parameters as stored in the database and when an alarm is triggered the alarm is displayed on multiple user screens through the user interface; paragraph 44 discloses a bed or room identifier is linked to a patient and a device, and one or more of the alerts).
Claim 10. Biondi and Padmani teach the system according to claim 1.
Biondi fails to explicitly teach the following limitations met by Padmani as cited:
wherein the circuitry is further configured to: generate audit trails based on the first medical data, the second medical data, and the first set of commands; and store the generated audit trails (paragraph 26 discloses the processor is configured to use event tracking to identify changes to the medical data between snapshots, and include only the changed medical data from a previous snapshot as at least one of the first subset of the medical data or the second subset of the medical data; claim 14).
The motivation to combine the teachings of Biondi, Padmani, and amarasingham is discussed in the rejection of claim 5, and incorporated herein.
Method claim 19 repeats the subject matter of claim 10. As the underlying processes of claim 19 have been shown to be fully disclosed by the teachings of Biondi, Padmani, and Amarasingham in the above rejections of claim 10; as such, these limitations (claim 19) are rejected for the same reasons given above for claim 10 and incorporated herein.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Padmani et al., herein after Padmani (U.S. Publication Number 2021/0304878 A1) in view of Biondi et al., herein after Biondi (U.S. Publication Number 2011/0087756 A1).
Claim 20. Padmani teaches a non-transitory computer-readable medium including computer program instructions, which when executed by a system, cause the system to perform one or more operations comprising:
applying one or more pre-processing operations on the first medical data based on the conversion, wherein the application of the one or more pre-processing operations on the first medical data comprises appending a timestamp to the first medical data (paragraph 22 discloses a time stamp from which the received medical data was generated by the medical device or received by the processor from the medical device; paragraph 50 discloses an identification of a therapy (medical) device type, identification of a therapy device serial number, a timestamp from which the treatment data was generated or received from the therapy device);
generating second medical data based on the application of one or more pre- processing operations on the first medical data (Figure 9 illustrates a first data subset and a second data subset; paragraph 14 discloses convert a second subset of the medical data to the second data format, and transmit the second subset of the medical data in the second data format for transmission via the same or a different output port as specified by the configuration file);
receiving a first set of commands from the MDG system based on the transmitted second medical data (paragraph 48 discloses the “medical device data includes treatment programming information, which comprises one or more parameters that define how a medical device is to operate to administer a treatment to a patient. For a peritoneal dialysis therapy, the parameters may specify an amount ( or rate) of fresh dialysis fluid to be pumped into a peritoneal cavity of a patient, an amount of time the fluid is to remain in the patient's peritoneal cavity (i.e., a dwell time), and an amount ( or rate) of used dialysis fluid and ultrafiltration ("UF") that is to be pumped or drained from the patient after the dwell period expires”; paragraph 56 discloses the processor or therapy module of the medical device operates according to one or more instructions for performing a treatment on a patient, where the instructions may be acquired via the control interface);
controlling at least one data source to execute the first set of commands (paragraph 55 discloses the medical device may include one or more control interfaces for displaying instructions and receiving control inputs from a user).
Biondi fails to explicitly teach the following limitations met by Padmani as cited:
receiving, from one or more data sources, first medical data associated with a first patient (paragraph 7 discloses receiving data using a first protocol from the medical devices by a local authority; paragraph 24 discloses any device used to collect patient data, assist with patient safety or otherwise be used to facilitate medical treatment or diagnosis of one or more patients), wherein the first medical data is received using a first proprietary data transmission protocol (paragraph 3 discloses a local authority to receive data using a first protocol from the medical devices and convert the data to a second protocol; paragraph 4 discloses the first protocol is a native device protocol which is interpreted as a transmission protocol associated with the native device (medical device); paragraph 24 discloses various types of medical devices with their own native devices protocols can be used);
parsing the first proprietary data transmission protocol based on the received first medical data (paragraph 51 discloses “medical device data exchange system in which a medical device A, exchanges data with a bridge using a native device language. In tum, the bridge 112 exchanges data with a local authority server 116 using a first protocol, protocol X. In another embodiment, a device network B, 118 also communicates with the local authority server 116 using a second protocol, protocol Y. This device network B may include a network having a plurality of medical devices such as a plurality of beds with a medical device associated with each patient in each of such beds. The local authority server 116 in this embodiment includes a plurality of parsers, such as parser X, 120 and parser Y, 122 as shown, configured to receive different protocols such as protocol X and protocol Y, respectively”);
converting the first proprietary data transmission protocol to a standard data transmission protocol based on the parsing of the first proprietary data transmission protocol (paragraph 3 discloses receiving data using a first protocol from the medical devices and convert the data to a second protocol, a central authority in communication with the local authority, and a user interface, in communication with the central authority; claim 3 discloses the local authority transforms the data from the plurality of heterogeneous medical devices from a first protocol (proprietary) to a second protocol (standard));
transmitting the second medical data, using the standard data transmission protocol, to a medical data governance (MDG) system (paragraph 3 discloses “a system for providing for the display of data from a plurality of nonhomogeneous medical devices. In one embodiment the system includes a local authority to receive data using a first protocol from the medical devices and convert the data to a second protocol, a central authority in communication with the local authority, and a user interface, in communication with the central authority. The central authority routes data that has been converted to a second protocol for display by the user interface”; paragraph 26 discloses the serial output port of the medical device is connected to a network device which changes the serial output of the medical device to a protocol suitable for use over the network such as the internet transmission control protocol (TCP/IP), which is considered a standard data transmission protocol).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Padmani to further include transforming and displaying patient data from medical devices in a central location as disclosed by Biondi.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of Padmani in this way to provide the medical devices and the system to monitor patients and to collect patient data which is transformed and processed such that improved medical treatment and patient safety results (Biondi: paragraph 24).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Doerr et al. (U.S. Patent Number 7,894,476 B2) discloses a system and method for managing a data transmission layer for a personal medical device.
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KRISTINE K. RAPILLO
Examiner
Art Unit 3682
/K.K.R/Examiner, Art Unit 3682
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