PATENT CLAIM ANALYSIS

Application Number: 15934541
Application Type: Utility
Filing Date: 2018-03
Publication Date: 2018-11
Patent Classification: ["435", "007400"]

Abstract:
Disclosed herein are methods that aid in the diagnosis and evaluation of a human subject that has sustained or may have sustained an injury to the head, such as mild or moderate to severe traumatic brain injury (TBI), using an early biomarker, ubiquitin carboxy-terminal hydrolase L1 (UCH-L1). Also disclosed here are methods that aid in determining whether a human subject that has sustained an injury or may have sustained to the head would benefit from and thus receive a head computerized tomography (CT) scan based on the levels of UCH-L1. These methods involve detecting levels and changes in levels of UCH-L1 in one or more samples taken from a human subject at time points within 24 hours after the subject has sustained or may have sustained an injury to the head.

Claim (Index 1):
A method of aiding in the diagnosis and evaluation of a human subject that has sustained or may have sustained a head injury, the method comprising:\n c) performing an assay on a sample taken from the subject within 24 hours after a suspected head injury to measure or detect a level of ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) in the sample; and d) determining whether the subject has sustained mild or moderate to severe traumatic brain injury (TBI), wherein the subject is determined as having moderate to severe traumatic brain injury when:\n (i) the level of UCH-L1 in the sample is higher than a reference level of UCH-L1 and the subject is determined as having mild traumatic brain injury when the level of UCH-L1 in the sample is lower than a reference level of UCH-L1; \n (ii) there is a statistically significant increase or decrease from the level of UCH-L1 in a sample taken at a first time point to the level of UCH-L1 in a sample taken at a second time point and the subject is determined as having mild traumatic brain injury when there is no statistically significant increase or decrease from the level of UCH-L1 in a sample taken at a first time point to the level of UCH-L1 in a sample taken at a second time point; \n (iii) the level of UCH-L1 decreases or increases by at least an absolute amount from the first sample to the second sample or is determined as having mild traumatic brain injury when there is no decrease or increase by at least an absolute amount in the level of UCH-L1 from the first sample to the second sample; \n (iv) the level of UCH-L1 decreases or increases by at least a first absolute amount from the first sample to the second sample or is determined as having mild traumatic brain injury when the level of UCH-L1 decreases or increases by at least a second absolute amount from the first sample to the second sample; or \n (v) the level of UCH-L1 in the sample is higher than a reference level of UCH-L1 or when there is a significant increase or decrease of an amount X from the level of UCH-L1 in a sample taken at a first time point to the level of UCH-L1 in a sample taken at a second time point and the subject is determined as having mild traumatic brain injury when the level of UCH-L1 in the sample is lower than a reference level of UCH-L1 or when there is no significant increase or decrease greater than amount X from the level of UCH-L1 in a sample taken at a first time point to the level of UCH-L1 in a sample taken at a second time point.

Metadata:
- Claim Count in Document: 56.0
- Percentile: 90.0
- Lexical Diversity: 1.88158
- Patent Class: 435.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['12822560', '11107248', '15802489', '12950142', '14449093']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.5831904735898298
- 35 USC 102 Novelty (BERT): 0.5271903912440825
- Combined Prediction Score: 0.577590465355255
- Mean Citation Score: 317.504772
- Max Citation Score: 339.23605
- Similarity Product: 251.76832410092047

Labels:
- Claim Label 101: 0
- Claim Label 102: 1
- Claim Label 103: 1
- Claim Label 112: 0
- Combined Label: 0
- Label 101 Adjusted: 0

Dataset: test