DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A preliminary amendment has been received on 05/22/2025, claims 2-20 have been newly added. Therefore, claims 1-20 remain pending in this application.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-14 are drawn to a system which is within the four statutory categories (i.e. machine). Claims 15-20 are drawn to a method which is within the four statutory categories (i.e. process).
Step 2A, Prong 1:
Claims 1, 10 and 15 recite:
“…receiving, from the device, the recorded data;
identifying biomarkers of the patient based on the received data;
generating biomarker information for the biomarkers of the patient based on processing the received data, wherein generating the biomarker information comprises:
assessing organ systems and physiologies associated with the breathing of the patient over the predetermined period of time,
assessing organ systems and physiologies associated with the eating of the patient over the predetermined period of time,
assessing organ systems and physiologies associated with the temperature of the patient over the predetermined period of time,
assessing organ systems and physiologies associated with the sleep of the patient over the predetermined period of time, and
assessing organ systems and physiologies associated with the growth of the patient over the predetermined period of time;
determining severity levels of the biomarkers;
determining a maturation level of the patient based on a combination of the severity levels of the biomarkers;…”
These limitations correspond to an abstract idea of “certain methods of organizing human activity”. This is a method of managing interactions between people, such as user following rules and instructions. The mere nominal recitation of a generic device (to record data about a patient) and generic computer system does not take the claim out of the methods of organizing human interactions grouping. Thus, the claims recite an abstract idea.
The computer system is described in the current specification as a generic computing device/combination of generic computing devices. The specification recites “The computer system 1100 may also be implemented as or incorporated into various devices, such as a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile device, a palmtop computer, a laptop computer, a desktop computer, a communications device, a wireless telephone, a land-line telephone, a control system, a camera, a scanner, a facsimile machine, a printer, a pager, a personal trusted device, a web appliance, a network router, switch or bridge, or any other machine capable of executing a set of instructions (sequential or otherwise) that specify actions to be taken by that machine.” in [0091].
Dependent claim also recites limitations that correspond to “certain methods of organizing human activities”, such as claim 4 recites “receiving patient data as user input from the computing device, wherein the patient data comprises at least one of weeks of gestation and weight at birth; and identifying the biomarkers of the patient further based on the patient data”, claims 5/14/20 recite “determining queries for each biomarker that are relevant to the maturation level of the patient; returning the queries for each biomarker for presentation in the GUI at the computing device; receiving user input from the computing device in response to presenting the queries; correlating the responses to the queries with the severity levels of the biomarkers; and returning information about the correlation for presentation in the GUI at the computing device”, claim 16 recites “determining the severity level of the biomarker comprises assessing, based on the recorded data, organ systems and physiologies of the patient that are associated with one or more characteristics of the patient from a group consisting of: breathing, eating, body temperature, sleep, and growth”, claim 17 recites “identifying a second biomarker of the patient based on the recorded data”, claim 18 recites “determining a severity level of the second biomarker; determining the maturation level of the patient based on a combination of the severity level of the biomarker and the severity level of the second biomarker;”. These limitations correspond to a method of managing interactions between people, such as user following rules and instructions.
After considering all claim elements, both individually and in combination and in ordered combination, it has been determined that the claims do not amount to significantly more than the abstract idea itself.
Claims 2-9, 11-14 and 16-20 are ultimately dependent from claims 1, 10, 15 and include all the limitations of claims 1, 10, 15. Therefore, 2-9, 11-14 and 16-20 recite the same abstract idea. Claims 2-9, 11-14 and 16-20 describe a further limitation regarding the basis for determining maturation level of the patient based on combination of biomarker information. These are all just further describing the abstract idea recited in claims 1, 10, 15, without adding significantly more.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claim recite the additional elements of that are shown in bolded style below:
Claim 1 recites a system for determining neonatal organ maturation, the system comprising:
a device configured to record data about a patient, the data corresponding to breathing, eating, temperature, sleep, and growth of the patient over a predetermined period of time; and
a computer system in communication with the device, wherein the computer system is configured to perform operations comprising:
receiving, from the device, the recorded data;
identifying biomarkers of the patient based on the received data;
generating biomarker information for the biomarkers of the patient based on processing the received data, wherein generating the biomarker information comprises:
assessing organ systems and physiologies associated with the breathing of the patient over the predetermined period of time,
assessing organ systems and physiologies associated with the eating of the patient over the predetermined period of time,
assessing organ systems and physiologies associated with the temperature of the patient over the predetermined period of time,
assessing organ systems and physiologies associated with the sleep of the patient over the predetermined period of time, and
assessing organ systems and physiologies associated with the growth of the patient over the predetermined period of time;
determining severity levels of the biomarkers;
determining a maturation level of the patient based on a combination of the severity levels of the biomarkers;
translating the maturation level and at least a portion of the biomarker information for the patient into graphic displays; and
returning instructions, that, when executed, cause a computing device to present, in a graphical user interface (GUI), the graphic displays.
Newly added claim 2 recites the system of claim 1, wherein translating the maturation level and at least the portion of the biomarker information comprises generating a graphical element for each biomarker of the biomarkers based on the respective biomarker's severity level.
Newly added claim 3 recites the system of claim 2, wherein the graphical element for each biomarker of the biomarkers is presented, in the GUI, using an indicia representing the respective biomarker's severity level, wherein the indicia comprises a color, wherein a first color corresponds to a severe severity level, a second color corresponds to a moderate severity level, a third color corresponds to a mild severity level, and a fourth color corresponds to a minimal severity level.
Newly added claim 4 recites the system of claim 1, wherein the operations further comprise: receiving patient data as user input from the computing device, wherein the patient data comprises at least one of weeks of gestation and weight at birth; and identifying the biomarkers of the patient further based on the patient data.
Newly added claim 5 recites the system of claim 1, wherein based on determining the severity levels of the biomarkers and the maturation level of the patient, the operations further comprise:
determining queries for each biomarker that are relevant to the maturation level of the patient;
returning the queries for each biomarker for presentation in the GUI at the computing device;
receiving user input from the computing device in response to presenting the queries;
correlating the responses to the queries with the severity levels of the biomarkers; and
returning information about the correlation for presentation in the GUI at the computing device.
Newly added claim 6 recites the system of claim 1, wherein the operations further comprise generating a display that shows the progress for a biomarker amongst the biomarkers over a period of time that includes the predetermined period of time.
Newly added claim 7 recites the system of claim 1, wherein the operations are performed, by the computer system, in real-time to track a real-time health of the patient.
Newly added claim 8 recites the system of claim 1, wherein the operations are performed, by the computer system, at predetermined time intervals to track changes in the patient's health.
Newly added claim 9 recites the system of claim 1, wherein the operations further comprise:
generating output including at least one of (i) therapeutic options that can be implemented and (ii) tests that can be ordered to address the maturation level of the patient or one or more of the severity levels of the biomarkers; and
returning the output for presentation in the GUI at the computing device.
Newly added claim 10 recites a system for determining neonatal organ maturation, the system comprising:
a device configured to record data about a patient over a period of time; and
a computer system in communication with the device, wherein the computer system is configured to perform operations comprising:
receiving, from the device, the recorded data;
identifying biomarkers of the patient based on the received data;
determining severity levels of the biomarkers for the period of time based on processing the received data;
determining a maturation level of the patient for the period of time based on a combination of the severity levels of the biomarkers;
translating the maturation level and at least a portion of the severity levels of the biomarkers into graphical elements; and
returning instructions, that, when executed, cause a computing device to present, in a graphical user interface (GUI), the graphical elements.
Newly added claim 11 recites the system of claim 10, wherein determining the severity levels of the biomarkers comprises assessing, based on the received data, organ systems and physiologies of the patient that are associated with one or more characteristics of the patient from a group consisting of: breathing, eating, body temperature, sleep, and growth.
Newly added claim 12 recites the system of claim 10, wherein the computer system is further configured to iteratively perform the operations at predetermined time intervals.
Newly added claim 13 recites the system of claim 10, wherein the period of time is real-time.
Newly added claim 14 recites the system of claim 10, wherein based on determining the severity levels of the biomarkers and the maturation level of the patient, the operations further comprise:
determining queries for each biomarker that are relevant to the maturation level of the patient;
returning the queries for each biomarker for presentation in the GUI at the computing device;
receiving user input from the computing device in response to presenting the queries;
correlating the responses to the queries with the severity levels of the biomarkers; and
returning information about the correlation for presentation in the GUI at the computing device.
Newly added claim 15 recites a method for determining neonatal organ maturation, the method comprising:
receiving recorded data about a patient over a predetermined period of time;
identifying a biomarker of the patient based on the recorded data;
determining a severity level of the biomarker based on processing the recorded data;
determining a maturation level of the patient based on the severity level of the biomarker;
translating the maturation level and the severity level of the biomarker into graphic displays; and
returning instructions that, when executed, cause a computing device to present, in a GUI, the graphic displays.
Newly added claim 16 recites the method of claim 15, wherein determining the severity level of the biomarker comprises assessing, based on the recorded data, organ systems and physiologies of the patient that are associated with one or more characteristics of the patient from a group consisting of: breathing, eating, body temperature, sleep, and growth.
Newly added claim 17 recites the method of claim 15, further comprising identifying a second biomarker of the patient based on the recorded data.
Newly added claim 18 recites the method of claim 17, further comprising:
determining a severity level of the second biomarker;
determining the maturation level of the patient based on a combination of the severity level of the biomarker and the severity level of the second biomarker; and
translating the severity level of the second biomarker into another graphic display for presentation in the GUI at the computing device.
Newly added claim 19 recites the method of claim 15, wherein the recorded data comprises user inputs provided at the computing device in response to queries that are associated with the patient's health over the predetermined period of time and presented in the GUI at the computing device.
Newly added claim 20 recites the method of claim 15, wherein based on determining the severity level of the biomarker and the maturation level of the patient, the method further comprises:
determining queries for the biomarker that are relevant to the maturation level of the patient;
returning the queries for the biomarker for presentation in the GUI at the computing device;
receiving user input from the computing device in response to presenting the queries;
correlating the responses to the queries with the severity level of the biomarker; and
returning information about the correlation for presentation in the GUI at the computing device.
These additional elements are hardware and software elements, these limitations are not enough to qualify as “practical application” being recited in the claims along with the abstract idea since these elements are merely invoked as a tool to apply instructions of the abstract idea in a particular technological environment, and mere instructions to apply/implement/automate an abstract idea in a particular technological environment and merely limiting the use of an abstract idea to a particular field or technological environment do not provide practical application for an abstract idea (MPEP 2106.05(f) & (h)).
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
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, the additional element of using a processor to perform both the identifying, generating, determining and correlating steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The claims are not patent eligible.
Conclusion
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/DILEK B COBANOGLU/ Primary Examiner, Art Unit 3687