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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/15/2026 has been entered.
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 values for 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 values for 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 values for at least some of the 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, wherein executing the first risk assessment process includes
identifying an argument set for the breathing disorder condition, the argument set including (a) one or more of the plurality of physiologic parameters, (b) a weight for each of the one or more of the plurality of physiologic parameters, and (c) scoring criteria for each of the one or more of the plurality of physiologic parameters,
identifying, in the vector, a particular value for a particular physiologic parameter that is included in the argument set, the particular value corresponding to a particular time in the time interval,
determining a score for the particular value by comparing the particular value to the scoring criteria for the particular physiologic parameter,
determining a weighted score by weighing the score based on the weight for the particular physiologic parameter, and
generating a total weighted score for the argument set, wherein the total weighted score includes the weighted score, the total weighted score representing a particular risk estimate for the breathing disorder condition at the particular time in the time interval,
generate, based on executing the first risk assessment process multiple times, a plurality of risk estimates for the breathing disorder condition of the patient during the time interval, the plurality of risk estimates including the particular risk estimate, 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 (which are not shown in bolded style above) 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.
The limitations of “determining a score for the particular value by comparing the particular value to the scoring criteria for the particular physiologic parameter, determining a weighted score by weighing the score based on the weight for the particular physiologic parameter, and generating a total weighted score for the argument set, wherein the total weighted score includes the weighted score, the total weighted score representing a particular risk estimate for the breathing disorder condition at the particular time in the time interval, generate, based on executing the first risk assessment process multiple times, a plurality of risk estimates for the breathing disorder condition of the patient during the time interval, the plurality of risk estimates including the particular risk estimate, 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” also correspond to mathematical calculations, which falls within the “mathematical concept” grouping of abstract ideas.
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 second risk assessment process includes identifying an association between the second clinical condition and at least one of the plurality of physiologic parameters”, claim 37 recites “wherein executing the second risk assessment process includes weighting the at least one 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 second clinical condition using the actual and predicted values of the at least one of the plurality of physiologic parameters”, claim 43 recites “wherein: executing the second risk assessment process includes tracking an actual value for an electrocardiogram metric stored in the vector, and generating a predicted value for the electrocardiogram metric”, claim 44 recites “determining, based on at least one 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 that are shown above in bolded style (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 second 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 an 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 06/15/2026 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 claims are not directed to an abstract idea of certain methods of organizing human activity, since they are not directed to control or management over a person, the amendments to claim 26 define the functionality included in the first risk assessment process involve neither control nor management of either the caregiver or any patient.
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 MPEP recites “…the sub-groupings encompass both activity of a single person…and an activity involves multiple people…and thus, certain activity between a person and a computer…may fall within the “certain methods of organizing human activity” grouping” (MPEP 2106.04(a)(2) II).
Argument 2: Applicant argues that claims recite features that integrate the abstract idea into a practical application, since 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…,” which results in using less storage capacity and reducing system complexity.
In response, Examiner submits that according to the guidelines and in particular, June 25, 2014 memorandum, limitations references in Alice Corp. that may be enough to qualify as "significantly more" when recited in a claim with an abstract idea include, as non-limiting or exclusive examples: Improvements to another technology or technical field; Improvements to the functioning of the computer itself; Meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. By storing parameters data in a second portion of the vector” and “periodically (updating) the second portion of the vector” the current claims do not provide an improvement to the functioning of the computer.
Therefore, the arguments are not persuasive and claims are rejected under 35 U.S.C. §101 as being directed to non-statutory subject matter.
Conclusion
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/DILEK B COBANOGLU/Primary Examiner, Art Unit 3687
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