IP Verse

Methods Of Determining A Treatment Protocol For And/Or A Prognosis Of A Patient'S Recovery From A Brain Injury

Patent No. US11275092 (titled "Methods Of Determining A Treatment Protocol For And/Or A Prognosis Of A Patient'S Recovery From A Brain Injury") was filed by Quanterix Corp on Jul 25, 2019.

What is this patent about?

’092 is related to the field of diagnostics for brain injuries , specifically focusing on methods for determining a treatment protocol or prognosis for a patient's recovery. The background acknowledges that brain injuries, particularly those resulting from hypoxic events, lead to neuronal damage and the release of biomarkers like tau protein. However, conventional immunoassays often lack the sensitivity to reliably measure these biomarkers in blood samples due to their low concentrations.

The underlying idea behind ’092 is to utilize a highly sensitive assay to measure tau protein levels in blood samples and correlate these levels with the severity of brain injury and potential for recovery. The key insight is that by accurately quantifying even trace amounts of tau protein, clinicians can gain valuable information for determining appropriate treatment strategies and predicting patient outcomes.

The claims of ’092 focus on a method of producing a bodily fluid sample containing an analytically quantified amount of endogenous tau protein. This involves obtaining a blood sample (or plasma/serum), diluting it, and then using a highly sensitive protein concentration assay to quantify the tau protein concentration. Crucially, the quantified tau protein concentration must be less than 5 pg/mL, and the assay must have a limit of quantification (LOQ) below 0.2 pg/mL .

In practice, the invention relies on a digital immunoassay that can detect extremely low concentrations of tau protein in diluted blood samples. This assay typically involves capturing tau protein on antibody-coated beads, isolating individual beads in femtoliter-sized reaction wells, and then using a fluorescent substrate to detect the presence of tau protein. The intensity of the fluorescence signal is then correlated with the tau protein concentration.

This approach differs significantly from prior methods that rely on less sensitive immunoassays. By achieving a much lower LOQ, the invention enables the detection of subtle changes in tau protein levels that would otherwise be undetectable. This allows for a more accurate assessment of brain injury severity and a more informed approach to treatment planning and prognosis, potentially leading to improved patient outcomes through early and targeted interventions .

How does this patent fit in bigger picture?

Technical landscape at the time

In the early 2010s when ’092 was filed, at a time when biomarker detection was typically implemented using ELISA or other immunoassay techniques, achieving high sensitivity and low limits of detection for biomarkers present in low concentrations in bodily fluids was non-trivial. Systems commonly relied on traditional laboratory techniques rather than automated, high-throughput methods for analyzing patient samples.

Novelty and Inventive Step

Claims were rejected as obvious over prior art. The examiner cited references teaching similar assay methods and biomarker detection techniques. The examiner also issued a provisional rejection for nonstatutory double patenting. The prosecution record does NOT describe the technical reasoning or specific claim changes that led to allowance.

Claims

This patent contains 21 claims, with claim 1 being the only independent claim. Independent claim 1 focuses on a method for producing a bodily fluid sample with a quantified amount of tau protein for patients suspected of having a neurological condition. The dependent claims generally elaborate on the specifics of the method, such as the type of assay used, the nature of the tau protein, the type of bodily fluid, and the neurological condition.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Analytically quantified amount
(Claim 1)		“In some embodiments, methods are provided for determining a measure of the concentration of tau protein in a patient sample containing or suspected of containing tau protein. The subject matter of the present invention involves, in some cases, interrelated products, alternative solutions to a particular problem, and/or a plurality of different uses of one or more systems and/or articles.”The quantity of tau protein in the bodily fluid sample, determined using an analytical protein concentration measurement assay.
Analytical protein concentration measurement assay
(Claim 1)		“Accordingly, assay methods which have very low limits of quantification (LOQ) and/or limits of detection (LOD) are generally necessary to determine a measure of the concentration of a biomarker in the patient's blood to provide statistically significant and/or meaningful results. In some embodiments, the methods of the present invention make use of methods having very low LODs and/or LOQs (e.g., in the low pg/mL range) to determine a measure of the concentration of a biomarker in a sample(s) obtained from a patient following a hypoxic event.”An assay used to quantify the concentration of tau protein in the bodily fluid.
Endogenous tau protein
(Claim 1)		“Tau proteins, with a molecular mass of 48 to 67 kd depending on isoform, are associated with microtubules and localized in the axonal compartment of neurons. Tau proteins plays a structural role in the assembly of tubulin monomers into axonal microtubule bundles, which are important for maintaining the cytoskeleton and axonal transport. Tau protein is generally elevated in the cerebrospinal fluid (CSF) of patients with neurodegenerative disease and severe head injuries, making it a candidate for peripheral measurement as a biomarker of acquired or traumatic brain injury (ABI, TBI).”Tau protein that is naturally present in the patient's bodily fluid.
Limit of quantification
(Claim 1)		“The LOD refers to the lowest concentration above background noise and at which detection is feasible. The LOD as used herein is defined as three standard deviations (SD) above background noise. The LOQ refers to the lowest concentration at which the analyte can not only be reliably detected but at which some predefined goals for bias and imprecision are met. Generally, as is used herein, the LOQ refers to the lowest concentration above the LOD wherein the coefficient of variation (CV) of the measured concentrations less than about 20%.”The lowest concentration of tau protein that can be reliably detected and quantified by the analytical protein concentration measurement assay.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
1:25-cv-00659May 28, 2025Fujirebio Diagnostics, Inc. V. Quanterix Corporation

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US11275092

QUANTERIX CORP
Application Number
US16522237
Filing Date
Jul 25, 2019
Status
Granted
Expiry Date
Jun 17, 2032
External Links
Slate, USPTO, Google Patents