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 .
This communication is in response to the amendment received on 12/10/2025. Claims 26-48 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 26-48 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 26-48 are drawn to a system which is within the four statutory categories (i.e. machine).
Step 2A, Prong 1:
Claim 26 has been amended and is provided below with markings separating abstract elements from the additional limitations, wherein the bolded style represents the additional limitations beyond abstract idea, and remaining limitations are directed to the abstract idea as discussed below.
“a memory storing data identifying
a first risk assessment process associated with a first clinical condition,
a first benchmark trajectory associated with the first clinical condition, the first benchmark trajectory established based on a first series of representative risk estimates over a first time period,
second risk assessment process associated with a second clinical condition, and
a second benchmark trajectory associated with the second clinical condition, the second benchmark trajectory established based on a second series of representative risk estimates over a second time period;
one or more physiologic sensors configured to couple externally to the patient and configured to acquire one or more physiologic signals; and
at least one processor configured to communicate with the memory and the one or more physiologic sensors, the at least one processor being configured to
generate electrocardiogram data and a plurality of physiologic parameters based on the one or more physiologic signals,
store the plurality of physiologic data in a first portion of a vector,
store the plurality of physiologic parameters in a second portion of the vector,
continuously update the first portion of the vector to add additional electrocardiogram data to the vector,
periodically update the second portion of the vector to add updated physiologic parameters to the vector,
record the observed clinical condition of the patient as the first clinical condition, wherein the observed clinical condition of the patient is a breathing disorder condition,
execute the first risk assessment process associated with the breathing disorder condition at a first frequency during a time interval based on the plurality of physiologic parameters stored in the vector, wherein executing the first risk assessment process includes comparing one or more of the plurality of physiologic parameters stored in the vector to one or more default parameters for the breathing disorder condition,
generate, based on executing the first risk assessment process, a plurality of risk estimates for the breathing disorder condition of the patient during the time interval, wherein the plurality of risk estimates for the breathing disorder condition define an established trajectory of the breathing disorder condition of the patient over the time interval,
evaluate a degree of similarity between the established trajectory and the second benchmark trajectory, wherein evaluating the degree of similarity includes comparing the second series of representative risk estimates over the second time period with the plurality of risk estimates for the breathing disorder condition during the time interval,
make a determination that the degree of similarity between the established trajectory and the second benchmark trajectory exceeds a similarity threshold,
after making the determination, record the observed clinical condition of the patient as the second clinical condition associated with the second benchmark trajectory,
execute the second risk assessment process associated with the second clinical condition based on comparing the electrocardiogram data stored in the vector to one or more default electrocardiogram metrics for the second clinical condition,
generate, based on executing the second risk assessment process, risk estimates for the second clinical condition, and
execute an action based on the risk estimates for the second clinical condition, wherein the action comprises one or more of setting a flag stored in the memory regarding the second clinical condition, or prompting a caregiver to provide information regarding the second clinical condition of the patient.”,
These limitations correspond to an abstract idea of certain methods of organizing human activities based on managing personal behavior and interactions between people regarding determining and generating risk assessment of the patient using various patient related data including electrocardiogram data, physiologic parameters of the patient and one or more default parameters. This is a method of managing interactions between people (such as, user following rules and instructions). The mere nominal recitation of a generic processor, generic memory and generic sensor devices does not take the claim out of the methods of organizing human interactions grouping. Thus, the claim recites an abstract idea.
Dependent claim limitations also correspond to certain methods of organizing human activities, such as claim 29 recites “after making the determination, transmit a notification to the caregiver indicating that the patient will be monitored using clinical criteria associated with the second clinical condition”, claim 30 recites “transmit a notification to the caregiver indicating that the patient will be monitored using clinical criteria associated with the breathing disorder”, claim 32 recites “the first risk assessment process is executed further based at least in part on the electrocardiogram data stored in the vector”, claim 33 recites “adjusting a frequency with which the at least one processor generates the risk estimates for the second clinical condition”, claim 36 recites “wherein executing the first risk assessment process includes identifying an association between the breathing disorder condition and at least one of the plurality of physiologic parameters”, claim 37 recites “wherein executing the first risk assessment process includes applying distinct weights to respective ones of the plurality of physiologic parameters”, claim 41 recites “wherein the at least one processor is further configured to generate the plurality of risk estimates for the breathing disorder condition using actual and predicted values of one or more of the plurality of physiologic parameters”, claim 43 recites “wherein: executing the second risk assessment process includes tracking an actual value for electrocardiogram metric stored in the vector, and generating a predicted value for the electrocardiogram metric”, claim 44 recites “determining, based on one or more of the plurality of physiologic parameters, that the first clinical condition of the patient is the breathing disorder condition”, claim 45 recites “receiving, from the caregiver, input that identifies the first clinical condition of the patient as the breathing disorder condition”.
These limitations are directed to user following rules and instructions in order the determine and generate risk assessment of the patient, using generic computing components. The “processor” is described in the current specification as a generic processor (in [0021]-[0024]).
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 27-48 are ultimately dependent from claim 26 and include all the limitations of claim 26. Therefore, claims 27-48 recite the same abstract idea. Claims 27-48 describe a further limitation regarding the basis for determining and generating risk assessments for the patient. These are all just further describing the abstract idea recited in claim 26, without adding significantly more.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claims recite the additional elements of “a memory storing data …; one or more physiologic sensors configured to couple externally to the patient and configured to acquire one or more physiologic signals; and at least one processor configured to communicate with the memory and the one or more physiologic sensors”, and using a processor to perform the steps of generating, storing, recording, executing the risk assessments, making a determination, establishing a trajectory, detecting a differentials, and executing an action… (claim 26), “using the processor to: receive at least one of medical history of the patient or demographic information of the patient; store, in a third portion of the vector, demographic information of the patient; and update the third portion of the vector in response to one or more of admission to a first healthcare facility, transfer between locations within the first healthcare facility, or transfer from a first location to a second location” (claim 31), “adjusting a frequency with which the at least one processor generates the plurality of risk estimates for the second clinical condition” (claim 33), “a user interface coupled to the at least one processor, wherein the action comprises prompting a user to input data to the user interface descriptive of at least one patient parameter” (claim 34), “the at least one processor is configured to execute the first risk assessment process at least in part by executing an enhanced Kalman filter” (claim 39), “a medical device with a housing including the memory and the at least one processor, wherein the medical device is ambulatory and wearable” (claim 42), “tracking an actual value for a electrocardiogram metric stored in the vector, and generating a predicted value for the electrocardiogram metric” (claim 43), “a medical device with a housing including the memory and the at least one processor, wherein the at least one processor is coupled with the one or more physiologic sensors” (claim 47), and “a server that includes the memory and the at least one processor, wherein the at least one processor is coupled with the one or more physiologic sensors via a network connection” (claim 48).
These additional elements correspond to 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)).
Claims also recite other additional limitations beyond abstract idea, including functions such as storing/recording data to a database and transmitting data are insignificant extra-solution activities (see MPEP 2106.05 (g)), which do not provide a practical application for the abstract idea.
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 executing, generating, evaluating, determining and establishing 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.
Response to Arguments
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed below in the order in which they appear.
Argument 1: Applicant argues that claim 26 recites “executing the first risk assessment process includes comparing one or more of the plurality of physiologic parameters stored in the vector to one or more default parameters for the breathing disorder condition” and “executing the second risk assessment process associated with the second clinical condition based on comparing the electrocardiogram data stored in the vector to one or more default electrocardiogram metrics for the second clinical condition” and these features are not directed to an abstract idea.
In response, Examiner submits that these limitations correspond to an abstract idea of certain methods of organizing human activities based on managing personal behavior and interactions between people regarding determining risk assessments of the patient using various patient related data including electrocardiogram data, physiologic parameters of the patient and one or more default parameters. This is a method of managing interactions between people (such as, user following rules and instructions). The mere nominal recitation of a generic processor, generic memory and generic sensor devices does not take the claim out of the methods of organizing human interactions grouping. The feature of “storing the patient data in portions of a vector” is not part of the abstract idea, and the feature of “the parameters stored in the vector” corresponds to stored and displayed data only.
Argument 2: Applicant argues that the claims recite “storing the plurality of physiologic parameters in a second portion of the vector” and “periodically [updating] the second portion of the vector…” uses less storage capacity and reduces system complexity.
In response, Examiner submits that the MPEP recites “a claimed process covering embodiments that can be performed on a computer, as well as embodiments that can be practiced verbally or with a telephone, cannot improve computer technology” in § 2106.05(a). The feature of “periodically updating the portion of the vector” correspond to 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)).
Therefore, Applicant’s arguments are not persuasive and claims are rejected under 35 U.S.C. §101 as being directed to non-statutory subject matter.
Conclusion
THIS ACTION IS MADE FINAL. 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 DILEK B COBANOGLU whose telephone number is (571)272-8295. The examiner can normally be reached 8:30-5:00 ET.
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/DILEK B COBANOGLU/Primary Examiner, Art Unit 3687