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 .
DETAILED ACTION
Response to Amendment
In the Amendment dated 07 October 2025, the following occurred:
Claims 1, 4, 5, 8, 9, 13-15, 18, and 19 were amended.
Claims 2, 3, 7, 11, 12, 16, 17, and 20 were canceled.
Claims 1, 4-6, 8-10, 13-15, 18, and 19 are pending.
Claim Objections
Claims 1, 8, and 18 are objected to because of the following informalities:
In claim 1, line 15, “the selecting machine learning model,” should read “the selected machine learning model.”
In claim 8, line 13, “the selecting machine learning model,” should read “the selected machine learning model.”
In claim 8, line 28, “of CRS event,” should read “of the CRS event.”
In claim 18, line 4, “a user input device,” should read “a UI device.”
Appropriate correction is required.
Subject Matter Free of Art
Claims 1, 4-6, 8-10, 13-15, 18, and 19 include subject matter that is free of prior art. The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within independent claims 1, 8, and 15. In particular, the cited prior art fails to expressly teach or suggest the combination of:
a set of sensor devices generating physiological data associated with a monitored patient;
a computer-readable medium storing instructions that are operative upon execution by a processor to:
receive the physiological data and user-provided health data associated with the monitored patient;
pre-define a window in which to predict a probability of CRS onset;
select a machine learning model from a plurality of pre-trained machine learning models based on a comparison of the physiological data and user-provided health data of the monitored patient to demographic information associated with each of the plurality of pre-trained machine learning models, wherein each of the plurality of machine learning models is associated with a patient demographic of a plurality of patient demographics that form training data sets used to train each respective machine learning model;
apply the selecting machine learning model to the physiological data and the user-provided health data associated with the monitored patient to generate a probability of a CRS event onsetting within the pre-defined window of time;
assign a severity grade to the predicted CRS event based on the physiological data, the user-provided health data, and the probability of the CRS event onsetting;
forecast near-term trajectory after onset of the CRS event indicating whether the monitored patient is likely to improve, remain stable, or deteriorate within the pre-defined window of time based on the severity grade; and
provide a notification including the probability of the CRS event onsetting within the pre-defined window.
The closest prior art DeMazumder (US 2021/0272696) teaches a set of sensor devices generating physiological data associated with a monitored patient; and a computer-readable storage medium storing instructions that are operative upon execution by a processor to: receive the physiological data and user-provided health data associated with the monitored patient; and provide a notification. However, DeMazumder fails to teach a CRS event.
The prior art Hong et al. (JP 2019/511057) teaches determining the probability of developing a systemic inflammatory response syndrome (SIRS) within a given time window, selecting and applying a machine learning model, and assigning a severity grade to the probability of the CRS event onsetting. However, Hong fails to teach assigning a severity grade to the predicted CRS event based on the physiological data, the user-provided health data, and the probability of the CRS event onsetting.
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, 4-6, 8-10, 13-15, 18, and 19 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.
Claims 1, 8, and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite a system, method, and one or more devices for cytokine release syndrome (CRS) event prediction, and therefore meet step 1.
Step 2A1
The limitations of (Claim 8 being representative) receiving […] physiological data and user-provided health data associated with a monitored patient; pre-defining […] a window in which to predict a probability of CRS onset; selecting […] a machine learning model from a plurality of pre-trained machine learning models based on a comparison of the physiological data and user-provided health data of the monitored patient to demographic information…; applying […] the select[ed] machine learning model to the physiological data and the user-provided health data associated with the monitored patient to generate a probability of a CRS event onsetting within the pre-defined window of time; assigning […] a severity grade to the predicted CRS event based on the physiological data, the user-provided health data, and the probability of the CRS event onsetting; forecasting […] near-term trajectory after onset of the CRS event indicating whether the monitored patient is likely to improve, remain stable, or deteriorate within the pre-defined window of time based on the severity grade; and providing […] a notification including the probability of CRS event onsetting within the pre-defined window, as drafted, is a process that, under the broadest reasonable interpretation, falls in the grouping of certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions).
That is, other than reciting a system and device implemented by a processor and a computer-readable medium, the claimed invention amounts to managing personal behavior or interaction between people. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The Examiner notes that the machine learning models are described in the Specification at Para. 00150 as any machine learning model (which necessarily includes linear regression and logistic regression). The Specification at Para. 00151 thereafter describes the training as being performed by decision trees. Each of the training of the ML and the ML itself are considered to be part of the abstract idea because they fall under data manipulations that humans perform and thus are part of rules or instructions.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of a computer-readable medium (claim 1) or one or more storage devices (Claim 15), i.e., computing system, that implement the identified abstract idea. The computing elements are not exclusively described by the applicant and are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the exception using generic computer components. See MPEP 2106.05(f). Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The claims recite the additional element of a set of sensor devices. The set of sensor devices represents a location from which data is received and merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
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 computer-readable medium (claim 1) or one or more storage devices (Claim 15) to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component cannot provide an inventive concept (“significantly more”).
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of a set of sensor devices was determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Accordingly, even in combination, these additional elements do not provide significantly more. As such, the claim is not patent eligible.
Claims 4-6, 9, 10, 13, 14, 18, and 19 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claims 4, 14, and 18 merely describe generating and presenting a visualization. Claim 13 merely describes the notification. Claims 4, 13, 14, and 18 further recite the additional element of a user interface (UI) device, which is considered to “generally link” under both the practical application and significantly more analysis.
Claims 5 and 19 merely describe aggregating and analyzing user-provided health data. Claims 6 and 10 merely describe generating risk scores or classes. Claim 9 merely describes receiving patient-related health data.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1, 4-6, 8-10, 13-15, 18, and 19, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons. Applicant argues:
There is simply no broad interpretation of these claims that can reasonably be construed as falling under the managing personal behavior including following rules of interactions subgrouping or the larger certain methods of organizing human activity grouping.
Regarding (a), the Examiner respectfully disagrees. MPEP 2106. 04(a)(2)(II) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The Examiner submits that the identified claim elements represent a series of rules or instructions that a person or persons, with or without the aid of a computer, would follow to predict an onset of a CRS event within a predefined window of time, assigning that CRS event a grade, and using the grade of the CRS event to forecast how the monitored patient may or may not recover following the CRS event. Furthermore, the Examiner submits that healthcare itself inherently represents the organization of human activity. Applicant has not pointed to anything in the claims that fall outside of this characterization. The Examiner notes that the machine learning models are described in the Specification at Para. 00150 as any machine learning model (which necessarily includes linear regression and logistic regression). The Specification at Para. 00151 thereafter describes the training as being performed by decision trees. Each of the training of the ML and the ML itself are considered to be part of the abstract idea because they fall under data manipulations that humans perform and thus are part of rules or instructions. Because the claim elements fall under a series of rules or instructions that a person or persons would follow to predict an onset of a CRS event within a predefined window of time, assigning that CRS event a grade, and using the grade of the CRS event to forecast how the monitored patient may or may not recover following the CRS event, the claimed invention is directed to an abstract idea.
Rejection under 35 U.S.C. § 103
Regarding the prior art rejection of Claims 1, 4-6, 8-10, 13-15, 18, and 19, the Examiner has considered Applicant’s arguments in light of the present amendments and withdraws the prior art rejection.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Syed et al. (U.S. 12080428) which discloses systems and methods for generating a medical recommendation.
Myers et al. (U.S. 2020/0352998) which discloses a method for assessing the reliability of clinical risk prediction.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAMRYN B LEWIS whose telephone number is (703)756-1807. The examiner can normally be reached Monday - Friday, 11:00 am - 8:00 pm EST.
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/CAMRYN B LEWIS/
Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683