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
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 .
Status of Claims
The amendments and remarks filed on 07MAY2026 have been entered and considered.
Claims 1-2, 5-9, 11, & 22-25 are currently pending.
No claims have been amended.
Claims 1-2, 5-9, 11 & 22-25 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 20FEB2026 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant's arguments filed 07MAY2026 regarding the rejections under 35 USC 101 have been fully considered and have been found to be not-persuasive. Parts deemed not persuasive discussed below:
Regarding Step 2A Prong one, Applicant states (see Pages 12-13 of the Remarks):
The Office Action's Step 2A Prong One analysis rests on the assertion that the claimed invention can be performed by a human using pen and paper. Specifically, the Office Action states that "determining a probability value of mTBI encompasses nothing more than a user plotting ECG RR interval data and blood pressure on a piece of paper or other biometric data sets, and comparing to one another for abnormalities derived from baroreflex standards." This characterization contains a material factual error: the pending claims do not recite blood pressure data anywhere. Independent claim 1 recites receiving first ECG RR interval data and receiving first accelerometer data - not blood pressure data. Neither blood pressure collection nor blood pressure comparison appears in any pending claim. The Office Action appears to conflate the claimed invention with subject matter not present in the pending claims. Because the pen-and-paper analogy is grounded in a misreading of the claim language, it cannot support the Prong One finding. A rejection that rests on an inaccurate characterization of the claim language does not satisfy the examiner's initial burden to establish a prima facie case of ineligibility. See MPEP 2106.07(a). Paragraph 0041 of the specification expressly teaches that the system does not require a blood pressure cuff or blood pressure data, confirming that the Office Action's characterization relies on unclaimed features. As properly construed, the claims require real-time acquisition of beat-to-beat ECG RR interval data and accelerometer data, synchronized to defined postural transitions, and application of an algorithm derived from a trained logistic regression-based predictive model. This sequence of sensor-driven operations cannot practically be performed by a human and is not a mental process
However, the argument is not persuasive. The specification at paragraph 41 states “The system 100 does not require the use of a blood pressure cuff to collect blood pressure data from the subject 104.”. This is stating blood pressure readings does not require a cuff to collect and not fully excluding blood pressure readings based on the language. Further, regardless of the example including blood pressure, the claims amount to patent ineligible subject matter. The claims recite applying an algorithm to a trained predictive model which is a mathematical concept. The remaining limitations fall under mental processes for amounting to no more than process automation. A claim recites a mental process or mathematical concept even if it is limited to execution on a computer or automation of a system/process. Therefore, the 101 rejection is being maintained.
Regarding Step 2A Prong 2 Applicant states (see Pages 13-15 of the Remarks):
Even setting aside the blood pressure mischaracterization, the mental process characterization fails on its merits under current USPTO guidance. The August 4, 2025 Deputy Commissioner Memorandum explicitly states that the mental process grouping should not be expanded, and that claims involving technological processes - including steps that could theoretically be performed mentally in a trivial case - should not be rejected as mental processes if the claims as a whole are clearly technological. The memorandum specifically provides that claims involving machine-based analysis of large datasets to detect unusual patterns do not fall within the mental process grouping because such analysis cannot practically be performed in the human mind given the volume of data and the complexity of the pattern detection. The claims here present an even stronger case.
Claim 1 requires: (1) receiving real-time beat-to-beat RR interval data from a non-invasive ECG sensor positioned on a subject; (2) receiving accelerometer data from an accelerometer positioned on the same subject; (3) determining from the accelerometer data and a time interval that the subject's transition is configured to trigger a first baroreflex response within the subject; and (4) upon that determination, computing a probability value of mTBI by inputting the RR interval data to an algorithm derived from a logistic regression-based predictive model trained on two specific study populations. This sequence of simultaneous real-time data acquisition, accelerometer-based transition detection, baroreflex trigger timing, and logistic regression computation cannot practically be performed by a human with pen and paper. No human can monitor continuous beat-to-beat cardiac intervals in real time, simultaneously process accelerometer data to detect a postural transition with sub-second precision, determine baroreflex trigger timing, and apply a logistic regression model - all within the narrow window of a field-based postural change occurring within one hour of a head injury. Moreover, the beat-to-beat RR interval variability recited in the claims is measured with millisecond-level precision, and the diagnostically meaningful variability occurs on the order of milliseconds. Such precise, real-time measurement and analysis is not something a human could manually perform, further underscoring that the claimed steps cannot reasonably be characterized as a mental process. The written description makes clear that the claimed analysis is time-locked to an objectively detected transition event. Specifically, the specification explains that "[t]ransition timing was determined from accelerometer data," and that the "exact time of the transition was determined from" filtered accelerometer data (e.g., sagittal axis acceleration), with the transition time identified by a computed maximum of the filtered signal. The RR-interval stream is then segmented into defined pre-transition, transition, and post-transition periods relative to that accelerometer-derived transition time. This event-gated, sensor-driven timing architecture is not something a human can practically replicate with pen and paper. This analysis is directly supported by CardioNet, LLC V. InfoBionic, Inc., 955 F.3d 1358 (Fed. Cir. 2020). In CardioNet, the Federal Circuit reversed a finding that claims directed to beat- to-beat cardiac RR interval analysis were abstract, specifically rejecting the argument that the claims merely computerized what doctors had long done. The court stated that it was "difficult to fathom how doctors mentally or manually used 'logic to identify the relevance of the variability [in the beat-to-beat timing] using a non-linear function of a beat-to-beat interval." The same reasoning applies here with equal force. It is difficult to fathom how a clinician or non-clinician could mentally perform logistic regression analysis on accelerometer-gated, beat-to-beat RR interval data in a non-clinical field setting within one hour of injury. Moreover, paragraphs 0045- 0050, and especially 0045 and 0048, clearly explain how beat-to-beat (RR) extraction and automated filtering yield specific signal-processing improvement, not an abstract diagnostic correlation.
However. The arguments are unpersuasive because the claim fails to integrate the mathematical model into a practical application .The applicant states the August 4th 2025 memorandum with their real time “sensor driven timing architecture with millisecond precision” as support for the practical application. These features reflect the high speed capabilities of standard computing hardware. The ECG sensor and accelerometer are generic tools used for their standard purpose of data gathering for inputs into a logistic regression model This amounts to only the automation of data processing without reflecting the novelty in the processing steps, system components, or model architecture. CardioNet physically improves a cardiac devices noise filtering hardware where the instant application does not improve the physical structure or operation of the sensing itself nor does it provide a novel application of the sensing and data processing. Since the claim is using generic technology to perform data processing the claim is patent ineligible.
Regarding Step 2B Applicant states (see Pages 15-18 of the Remarks):
The Office Action dismisses the additional claim elements as "pre-solution activity of obtaining user data." This characterization is contrary to the August 4, 2025 Deputy Commissioner Memorandum, which instructs that the Prong Two analysis must consider the claim as a whole. Additional elements must not be evaluated in isolation from the recited judicial exception. The Office Action does precisely what the memorandum prohibits: it strips out the alleged abstract idea and then evaluates each remaining element independently, characterizing each as generic. More fundamentally, the technical integration of the claim elements is not pre-solution activity (i.e. it is the solution itself). The claimed architecture corresponds to a concrete, field-deployable signal-processing pipeline in which the accelerometer identifies the transition time and the system analyzes RR-interval behavior in defined time windows relative to that event; for example, the specification defines pre-transition, transition, and post-transition segments relative to the accelerometer-derived transition time and teaches a 30-second post-transition delay to exclude the large transient change in RR intervals associated with the transition. Further, the accelerometer does not merely gather data for later analysis. It performs a specific technical function in real time by identifying the precise moment that the subject's postural transition is configured to trigger a baroreflex response within the subject. Only upon that accelerometer- derived determination does the claimed system apply the logistic regression model to the concurrently captured ECG RR interval data. This triggering relationship (where the accelerometer-derived transition detection gates the application of the diagnostic algorithm to the simultaneously acquired ECG data) is a specific technical architecture that defines how the device achieves its diagnostic function. It is not generic data gathering. It is the mechanism by which field-deployable mTBI diagnosis becomes possible. The specification confirms these technical advantages. Paragraph 0058 of the specification states that biomarker extraction and mTBI prediction can be fully automated in a fieldable diagnostic tool. The clinical study documented 90% sensitivity. These specification-supported technical improvements are precisely the type of practical application that the August 2025 memorandum identifies as integrating a judicial exception into a concrete technological result. The Office Action's comparison of the claimed device to a "diagnostic smart watch" performing routine cardiology monitoring also fails. A generic cardiac smartwatch monitors resting heart rate or detects arrhythmias. It does not combine accelerometer-based postural transition detection with a logistic regression model specifically trained on baroreflex-inducing transitions from two differentiated study cohorts, deployed in a non-clinical setting within one hour of a head injury. No evidence of record, no prior art reference, no expert declaration, no statement by the examiner with technical support establishes that this specific combination is well- understood, routine, or conventional in the art. In the event the Office believes additional clarification would be helpful, Applicant notes that the specification expressly discloses that the transition time is determined from accelerometer data and that RR-interval analysis is performed in defined segments relative to that detected transition time (including a post-transition delay to exclude the transient interval). Applicant believes the pending claims already recite the operative sensor-gated architecture but would be willing to consider a clarifying amendment consistent with the written description if the Office identifies a specific § 101 concern that such clarification would resolve.
However, the applicants’ arguments are not persuasive. The claims as a whole lack an inventive concept under step 2B. Even when looking at its entirety such as is required by the memorandum the signal processing steps including specific time windows and a 30 second delay relies on standard sensors performing routine data processing. Further, the high clinical accuracy and the specific logistic regression model trained on two groups of subjects within one hour of injury does not provide an inventive concept. A mathematical algorithm’s statistical accuracy or training parameters cannot transform a generic data processing algorithm into patent eligible subject matter. Despite the applicants claims that the record lacks evidence of conventionality using an accelerometer and ECG is no more than using standard sensing systems for their intended function and does not add significantly more to the inventive concept.
Step 2B - The Claims Include Significantly More Than Any Alleged Judicial Exception For the reasons set forth above with respect to Prong Two, the additional elements of the claims (individually and as an ordered combination) amount to significantly more than any alleged judicial exception. The specification describes a concrete implementation that includes automated extraction of beat-to-beat RR intervals from raw ECG data, filtering to generate trend and variability components, accelerometer-based detection of transition timing, and computation of multiple transition features (e.g., slopes, valley/"trough" area, suppression intervals), with biomarker extraction and prediction described as fully automatable in a fieldable tool. The specific combination of a chest-positioned non-invasive ECG sensor, an accelerometer for real-time transition detection, a logistic regression model derived from two differentiated study populations undergoing defined baroreflex-inducing transitions, a threshold structure based on true positive and false positive rates from those populations, and a display providing a notification to a non- clinical user in the field goes well beyond what is routine or conventional in physiological signal analysis. The 35 U.S.C. 103 rejections in this application were withdrawn following the December 2025 amendments. As emphasized in Ex parte Desjardins, Sections 102, 103, and 112 are the traditional and appropriate tools to limit patent protection to its proper scope. The withdrawal of the prior art rejections is affirmative evidence that the claims define something beyond any alleged abstract idea. If the specific implementation were truly conventional and routine, the prior art rejections would have been maintained. The examiner's own withdrawal of those rejections is consistent with a finding that the specific combination provides an inventive concept sufficient for 35 U.S.C. 101 purposes.
However, the arguments are not persuasive because withdrawing the prior art rejections does not automatically mean the claims are patent eligible under Step 2B. A claim can be novel but still fail to be patent eligible if its novelty relies on an ineligible mathematical model. As stated previously the claims fail to present limitations that are significantly more than an abstract idea applied to mathematical models using components that are novel or processing that improves the technology or hardware of the device.
Applicant states (see Pages 18-19 of the Remarks):
The Claims Are Analogous to the Patent-Eligible Claims in CardioNet In CardioNet, LLC v. InfoBionic, Inc., 955 F.3d 1358 (Fed. Cir. 2020), the Federal Circuit held that claims directed to a cardiac monitoring device using beat-to-beat RR interval timing, ventricular beat identification, and specialized relevance-determination logic were directed to patent-eligible subject matter. The court held at Alice Step 1 that the claims focused on "a specific means or method that improves the relevant technology" rather than being "directed to a result or effect that itself is the abstract idea and merely invoke[ing] generic processes and machinery," citing McRO, Inc. V. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314 (Fed. Cir. 2016). The court also specifically rejected the argument that the claims merely computerized what doctors had long done, noting there was "no suggestion in the patent's written description that doctors were 'previously employing' the techniques performed on the claimed device." The parallel to the pending claims is direct. Like the CardioNet claims, the pending claims are directed to a specific physiological signal processing architecture using ECG-derived beat-to- beat RR interval data and specialized algorithmic logic to produce a clinically meaningful diagnostic output. Like CardioNet, the written description of the present application documents the technical advantages of the specific implementation, including 90% sensitivity confirmed by study data. And like CardioNet, nothing in the record establishes that the claimed combination was a pre-existing technique. The prior art rejections were withdrawn, and no evidence before the Office demonstrates that the specific integration of accelerometer-triggered baroreflex window detection with a logistic regression model trained on two study cohorts was previously employed in any clinical or non-clinical setting.
However, the arguments are not persuasive because in CardioNet the claims are eligible because they physically improved a devices operation by filtering noise. In contrast the instant application’s claims use standard preexisting sensors to collect data and feed it into a statistical calculation model. McRO establishes that using generic hardware or sensors to automate a mathematical model is not providing an inventive concept. Further, the high clinical accuracy and the specific logistic regression model trained on two groups of subjects within one hour of injury does not provide an inventive concept. A mathematical algorithm’s statistical accuracy or training parameters cannot transform a generic data processing algorithm into patent eligible subject matter. Despite the applicants claims that the record lacks evidence of conventionality using an accelerometer and ECG is no more than using standard sensing systems for their intended function and does not add significantly more to the inventive concept.
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 1-2, 5-9, 11, & 22-25 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:
Claim 1 is to a method.
Claim 24 is to a system.
Claim 25 is to a non-transitory computer-readable storage medium.
Therefore, claims 1-2, 5-9, 11, & 22-25 are directed to a statutory category of invention.
Step 2A, Prong One
Regarding claims 1, 24, & 25 the limitations of “detecting within an hour a mild traumatic brain injury (mTBI) on a subject having suffered a head injury”, “determining a probability value of the mTBI within the subject derived from inputting the first ECG RR interval data to an algorithm derived from a logistic regression-based predictive model” are mental processes. The limitations as drafted, covers performance of the limitations that can be performed by a human using a pen and paper under the broadest reasonable interpretation standard. For example, determining a probability value of mTBI encompasses nothing more than a user plotting ECG RR interval data and blood pressure on a piece of paper or other biometric data sets, and comparing to one another for abnormalities derived from baroreflex standards. If claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in human mind or by a human using a pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. See MPEP 2106.04(a)(2)(III). The limitation “determining a probability value of the mTBI within the subject derived from inputting the first ECG RR interval data to an algorithm derived from a logistic regression-based predictive model” additionally falls under the mathematical process category. A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the "mathematical concepts" grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word "calculating" in order to be considered a mathematical calculation. See MPEP 2106.04(a)(2)(I).
Step 2A, Prong Two
This judicial exception is not integrated into a practical application. In particular, the claims recite additional elements of “processor”, “memory”, “a non-invasive electrocardiogram (ECG) sensor communicatively coupled with the processor”, “non-transitory computer- readable storage medium storing instructions to be implemented within a field based chest positioned diagnostic medical device”, “accelerometer communicatively coupled with the processor “, “a logistic regression-based predictive model” and “display” are recited at high levels of generality (i.e. The commands themselves do not have any supporting structures to perform such commands, or are common in the field). This pre-solution activity of obtaining user data comprising electrocardiogram (ECG) data and blood pressure data using biosensors is well-understood, routine, and conventional in the field of cardiology as shown in references such as Torres and Zhang and all uses of the recited judicial exception require the pre-solution activity of data gathering. 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 claim is directed to an abstract idea.
Step 2B
The independent claims 1, 24, & 25 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The limitations of “logistic regression based predictive model wherein: the logistic regression based predictive model is derived from a first plurality of study participants having not been diagnosed with a brain injury and a second plurality of study participants having been diagnosed with an mTBI”, “receiving first RR interval electrocardiogram (ECG) data from the RR interval signal provided by a non-invasive ECG sensor positioned on the subject in a non-clinical setting, wherein the first RR interval ECG data is collected duringthreshold of a true positive rate derived from the second plurality of study participants having been diagnosed with an mTBI and a second threshold of a false positive rate derived from the first plurality of study participants having not been diagnosed with a brain injury within the logistic regression-based predictive model” further limits the claim as to its functionality, but does not provide any further support to the novel physical apparatus. Additionally, these limitations amount to no more than mere generic processes and parts, which are seen commonly in any electronic data processing system used for cardiology patient monitoring, such as with a diagnostic smart watch. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements as claimed amounts to no more than mere pre-solution activity of data gathering with a specified data target and generic equipment, which does not amount of an inventive concept. Therefore, the claims are not patent eligible.
Regarding dependent claims 1-2, 5-9, 11, & 22-23 the limitations of “determining the probability value associated with the first transition”, “receiving first accelerometer data from an accelerometer positioned on the subject”, “non-invasive ECG sensor”, “accelerometer”, “field based chest positioned diagnostic medical device”, and ecg/ accelerometer data sets used in the predictive model derived from the biometric data gathered further limits the claim as to its functionality, but does not provide any further support to the novel physical apparatus. Additionally, these limitations amount to no more than mere generic processes and parts, which are seen commonly in any electronic data processing system used for cardiology patient monitoring, such as with a diagnostic smart watch. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements as claimed amounts to no more than mere pre-solution activity of data gathering with a specified data target and generic equipment, which does not amount of an inventive concept. Therefore, the claims are not patent eligible.
Therefore, claims 1-2, 5-9, 11, & 22-25 are directed to an abstract idea without significantly more.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 extension fee 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 date of this final action.
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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