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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Status of Claims
The amendments and remarks filed on 29DEC2025 have been entered and considered.
Claims 1-2, 5-9, 11, & 22-25 are currently pending.
Claims 1, 5-9, 11, & 24-25 have been amended.
No claims have been added, canceled, or withdrawn.
No new matter has been added.
Claims 1-2, 5-9, 11 & 22-25 are under examination.
Response to Arguments
Applicant's amendments filed 29DEC2025 regarding the rejection under 35 U.S.C 112(a) have been fully considered and are found to obviate the rejections. Therefore, the 112(a) rejections have been withdrawn.
Applicant's arguments filed 29DEC2025 regarding the rejection under 35 U.S.C 101 have been fully considered but are not persuasive. Parts deemed not persuasive discussed below:
Applicant argues (Pages 15-17 of the Remarks):
“The pending claims are directed to a technological improvement in the field of physiological signal analysis and field deployable traumatic brain injury diagnostics. The Examiner asserts that the claims are directed to an abstract idea. However, consistent with the Federal Circuit's holding in McRO, Inc. V. Bandai Namco Games America Inc., 837 F.3d 1299 (Fed. Cir. 2016), the claims integrate specific, rule based improvements in processing ECG and accelerometer data to produce a new and useful diagnostic result that could not previously be obtained using conventional techniques. Like the claims in McRO, which recited a specific set of rules improving the automatic generation of animated lip synchronization, the present claims recite a specific, structured set of rules and data processing steps that use: motion specific accelerometer inputs to identify a baroreflex triggering transition, ECG data captured during that precise transition, and a logistic regression based predictive model trained on two distinct study populations undergoing defined transitions that induce baroreflex responses. These claim elements work together to produce a probability value of mTBI that allows accurate field based diagnosis in under an hour. Prior art approaches relied on general clinical observation or non specialized vital sign measurements, which lack the claimed rule based coupling of (i) a particular type of subject transition, (ii) baroreflex specific physiological timing, and (iii) a model trained on transition induced baroreflex responses from two differentiated study cohorts. The claims therefore do not merely apply a mental process or generic mathematical analysis to physiological data. They recite a specific technological process that constrains how the data are collected, how the transition is detected, when the ECG signal is evaluated, and how the model is applied. Consistent with McRO, these rules are not conventional or generic. They represent a specific improvement in computer implemented physiological signal analysis, enabling a device positioned on a subject's chest in a non clinical setting to achieve diagnostic functionality previously unavailable outside medical supervision. The claimed improvement is rooted in the technology of sensor based physiological assessment, changes how the underlying sensors and processor operate during the diagnostic workflow, and yields a novel diagnostic capability that is neither routine nor conventional. Because the claims recite a concrete technological solution using specific rules for detecting and interpreting baroreflex linked physiological responses, they are directed to patent eligible subject matter and should be found to be patentable under § 101.”
The examiner disagrees with this as the claimed invention states a generic process that can be produced similarly by a human with pen and paper, and the supporting structures currently claimed are also generic to the field and provide no novel solutions to the issue at hand. The application of generic processes and determinations into a machine learning model does not create a practical application, especially when combined with generic structures. The claims have not shown a process which amounts to more than the automation of tasks with intended results. The steps, data analysis algorithms, or model structures used to achieve these results has not been adequately shown in the claimed invention. Therefore, the rejection is being maintained.
Applicant's amendments/arguments filed 29DEC2025 regarding the rejection under 35 U.S.C 103 have been fully considered and obviate the rejections. Therefore, the current rejections have been withdrawn.
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 duringmedical professional”, “and the plurality of transitions includes seated-to-standing transitions and laying- to-standing transitions; and providing, to a display, a notification of the probability value of the mTBI”, “a plurality of transitions configured to induce baroreflex responses”, and “the probability value is further derived from a first threshold 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN FEDORKY whose telephone number is (571)272-2117. The examiner can normally be reached M-F 9:30-4:30.
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/MEGAN T FEDORKY/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796