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 17 April 2026, the following occurred:
Claims 1, 8, 15, and 18 were amended.
Claims 1, 4-6, 8-10, 13-15, 18, and 19 are pending.
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 […] raw sensor data associated with a monitored patient, the raw sensor data comprising one or more of PPG signals or ECG signals; receiving […] user-provided health data associated with the 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 user-provided health data of the monitored patient to demographic information…; analyzing and transforming […] the raw sensor 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 the 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 comprising at least one of a photoplethysmogram (PPG) sensor or an electrocardiogram (ECG) sensor. 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, which further defines the abstract idea. Claim 13 merely describes the notification, which further defines the abstract idea.
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, which further defines the abstract idea.
Claims 6 and 10 merely describe generating risk scores or classes, which further defines the abstract idea.
Claim 9 merely describes receiving patient-related health data, which further defines the abstract idea.
Response to Arguments
Claim Objections
Regarding the objection to Claims 1, 8, and 18, the Applicant has amended the claim such that the prior objection is no longer required. The prior objection has been withdrawn.
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:
The specification describes a specific technical problem: "symptoms associated with CRS, such as malaise, fever, hypoxia, and hypotension are common to many conditions, complicating early detection and diagnosis by human clinicians." …The specification further explains the technical solution: the system "operates in an unconventional manner by predicting onset and event grading of CRS in patients during a predetermined time-period ... using passively and or actively input patient-related health data," which "allows faster and more efficient CRS diagnosis and treatment for improved patient outcomes."
Regarding (a), the Examiner respectfully disagrees. MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicates that a practical application may be present where the claimed invention provides a technical solution to a technical problem. See, e.g., DDR Holdings, LLC. v. Hotels.com, L.P., 773 F.3d 1245, 1259 (Fed. Cir. 2014) (finding that claiming a website that retained the “look and feel” of a host webpage provided a technological solution to the problem of retention of website visitors by utilizing a website descriptor that emulated the “look and feel” of the host webpage, where the problem arose out of the internet and was thus a technical problem). Here, the Applicant’s argued problem is not a technological problem caused by the technological environment to which the claims are confined. The problem of overlapping symptoms leading to complications in early detection and diagnosis was not a problem caused by the computer, it is a problem that existed and/or exists regardless of whether a computer is involved in the process. At best, Applicant’s identified problem is a healthcare problem. Because no technological problem is present, the claims do not provide a practical application.
Further, there is nothing about the computer and the sensor that indicate they are operating in an unconventional manner. The computer is processing data, which is what computers are designed to do. The sensors are sensing data and outputting the data. There is nothing unconventional about that. The abstraction may be unconventional; however, that is immaterial with respect to whether a practical application or significantly more are present.
This is a transformation of a particular article (raw PPG/ECG waveform data) to a different state or thing (clinically actionable CRS predictions).
Regarding (b), the Examiner respectfully disagrees. MPEP 2106.04(d)(2) indicates that a practical application may be present where the claimed invention effects a transformation or reduction of a particular article to a different state or thing. MPEP 2106.05(c) thereafter describes that a transformation is present where a physical object or substance is transformed to a different state or thing. Notably, the mere manipulation of data has been deemed not to be a transformation within the meaning of the term “transformation.” See MPEP 2106.05(c): “mere manipulation of basic mathematical constructs i.e., the paradigmatic abstract idea, has not been deemed a transformation” (internal quotations omitted). Because no transformation is present in Applicant’s claimed invention, a practical application is not present.
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:
Gruenewald et al. (U.S. 2025/0035629) which discloses a method for assessing a subject with suspected infection.
Newberry et al. (U.S. 2020/0253562) which discloses a system and method for screening and prediction of severity of infection.
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
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