Granted Patent
B2
US 12,601,749 · App. 18/637,770 · Granted Apr 14, 2026
Biomarker detection process and assay of neurological condition
Inventors:
Kevin Ka-Wang Wang (Gainesville, FL); Ronald L. Hayes (Alachua, FL); Uwe R. Mueller (Alachua, FL); Zhiqun Zhang (Auburndale, MA)
Assignee:
BANYAN BIOMARKERS, INC.
View Patent ↗
Loading inventors, assignments & file history…
Abstract
A robust, quantitative, and reproducible process and assay for diagnosis of a neurological condition in a subject. The method includes measurement of two or more biomarkers in a biological fluid such as CSF or serum resulting in a synergistic mechanism for determining the extent of neurological damage in a subject with an abnormal neurological condition and for discerning subtypes thereof or tissue types subjected to damage.
Claims (25)
1 . A process for determining the neurological condition of a subject, wherein the subject is known to have or is suspected of having a mild to moderate traumatic brain injury (TBI), wherein mild TBI is characterized as the subject having a Glasgow Coma Score (GCS) of 13-15 and moderate TBI is characterized as the subject having a GCS of 9-12, the process comprising:
measuring a sample obtained from the subject at a first time for a quantity of glial fibrillary acidic protein (GFAP) and a quantity of ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1), wherein the first time is within 12 hours of the TBI or the suspected TBI;
comparing the measured quantities of GFAP and UCH-L1 to normal levels of GFAP and UCH-L1, or to predetermined cutoff values of GFAP and UCH-L1; and
performing a head CT on the subject when the measured quantity of GFAP and/or the measured quantity of UCH-L1 exceed the predetermined cutoff values of GFAP and UCH-L1, or declining a head CT on the subject when the measured quantities of GFAP and UCH-L1 do not exceed the predetermined cutoff values of GFAP and UCH-L1.
2 . The process of claim 1 , wherein the subject has a GCS of 13-15.
3 . The process of claim 1 , wherein the sample is plasma.
4 . The process of claim 1 , wherein the sample is bloom serum.
5 . A method of assaying a biomarker combination after a traumatic brain injury (TBI), comprising:
obtaining a blood sample collected from a subject having the TBI within 12 hours after occurrence of the TBI; and
measuring levels of ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) by assaying the blood sample.
6 . The method of claim 5 , wherein the blood sample is collected from the subject having a GCS of 13-15.
7 . The method of claim 5 , wherein the blood sample is plasma.
8 . The method of claim 5 , wherein the blood sample is blood serum.
9 . A method of performing a head CT scan, comprising:
measuring levels of UCH-L1 and GFAP by performing the method of claim 5 ; and
performing the head CT scan on the subject when the levels of UCH-L1 and GFAP exceed predetermined cutoff values.
10 . A method of refraining from performing a head CT scan on a subject having a TBI, comprising:
measuring the levels of UCH-L1 and GFAP by performing the method of claim 5 ; and
refraining from performing the head CT scan on the subject when the levels of UCH-L1 and GFAP do not exceed predetermined cutoff values.
11 . A method of assessing a subject having a mild TBI or a suspected mild TBI, to determine whether to perform a CT scan, the method comprising:
measuring levels of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal esterase L1 (UCH-L1) by assaying a blood sample collected from the subject within 12 hours of the TBI or the suspected TBI,
determining whether to perform a head CT scan on the subject when the level of GFAP and/or the level of UCH-L1 exceed(s) predetermined cutoff values of GFAP and UCH-L1, or declining a head CT scan when the level of GFAP and the level UCH-L1 do not exceed the predetermined cutoff values of GFAP and UCH-L1.
12 . The method of claim 11 , wherein the blood sample is collected from the subject having a GCS of 13-15.
13 . The method of claim 11 , wherein the blood sample is plasma.
14 . The method of claim 11 , wherein the blood sample is blood serum.
Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 13, 2026
From: BANYAN BIOMARKERS, INC.
To: BIOMERIEUX, INC.
Reel/Frame 074323/0554 →
CHANGE OF ADDRESS OF ASSIGNEE
Recorded Nov 12, 2024
From: BANYAN BIOMARKERS, INC.
To: BANYAN BIOMARKERS, INC.
Reel/Frame 069340/0120 →
Continuity (8)
Continuation
13058748
Provisional Application
61271135
· Jul 18, 2009
Provisional Application
61218727
· Jun 19, 2009
Provisional Application
61097622
· Sep 17, 2008
Provisional Application
61188554
· Aug 11, 2008
References Cited (400)
US 4366241A
· Tom et al.
· 1982
[cited by applicant]
US 4376110A
· David et al.
· 1983
[cited by applicant]
US 4517288A
· Giegel et al.
· 1985
[cited by applicant]
US 4702909A
· Villarejos et al.
· 1987
[cited by applicant]
US 4837168A
· de Jaeger et al.
· 1989
[cited by applicant]
US 5045694A
· Beavis et al.
· 1991
[cited by applicant]
US 5118606A
· Lynch et al.
· 1992
[cited by applicant]
US 5118937A
· Hillenkamp et al.
· 1992
[cited by applicant]
US 5231000A
· Majocha et al.
· 1993
[cited by applicant]
US 5234814A
· Card et al.
· 1993
[cited by applicant]
US 5252463A
· Nelson et al.
· 1993
[cited by applicant]
US 5270163A
· Gold et al.
· 1993
[cited by applicant]
US 5475096A
· Gold et al.
· 1995
[cited by applicant]
US 5492812A
· Vooheis
· 1996
[cited by applicant]
US 5536639A
· Siman et al.
· 1996
[cited by applicant]
US 5567588A
· Gold et al.
· 1996
[cited by applicant]
US 5595877A
· Gold et al.
· 1997
[cited by applicant]
US 5614649A
· Iqbal et al.
· 1997
[cited by applicant]
US 5637459A
· Burke et al.
· 1997
[cited by applicant]
US 5660985A
· Pieken et al.
· 1997
[cited by applicant]
US 5670637A
· Gold et al.
· 1997
[cited by applicant]
US 5683867A
· Biesecker et al.
· 1997
[cited by applicant]
US 5696249A
· Gold et al.
· 1997
[cited by applicant]
US 5707796A
· Gold et al.
· 1998
[cited by applicant]
US 5710132A
· Moller et al.
· 1998
[cited by applicant]
US 5719060A
· Hutchens et al.
· 1998
[cited by applicant]
US 5777194A
· Scott et al.
· 1998
[cited by applicant]
US 5792664A
· Chait et al.
· 1998
[cited by applicant]
US 5830870A
· Iqbal et al.
· 1998
[cited by applicant]
US 5869336A
· Meyer et al.
· 1999
[cited by applicant]
US 5871712A
· Siman
· 1999
[cited by applicant]
US 5990083A
· Iqbal et al.
· 1999
[cited by applicant]
US 6011020A
· Gold et al.
· 2000
[cited by applicant]
US 6048703A
· Siman et al.
· 2000
[cited by applicant]
US 6057143A
· Meyer et al.
· 2000
[cited by applicant]
US 6183977B1
· Doyle et al.
· 2001
[cited by applicant]
US 6225047B1
· Hutchens et al.
· 2001
[cited by applicant]
US 6589746B1
· Zemlan
· 2003
[cited by applicant]
US 7144708B2
· Janigro et al.
· 2006
[cited by applicant]
US 7256252B1
· Siman et al.
· 2007
[cited by applicant]
US 7291710B2
· Hayes et al.
· 2007
[cited by applicant]
US 7396654B2
· Hayes et al.
· 2008
[cited by applicant]
US 7456027B2
· Wang et al.
· 2008
[cited by applicant]
US 7645584B2
· Svetlov et al.
· 2010
[cited by applicant]
US 8048638B2
· Svetlov et al.
· 2011
[cited by applicant]
US 8298835B2
· Wang et al.
· 2012
[cited by applicant]
US 8492107B2
· Wang et al.
· 2013
[cited by applicant]
US 8557526B2
· Ottens et al.
· 2013
[cited by applicant]
US 8642558B2
· Anagli et al.
· 2014
[cited by applicant]
US 9074019B2
· Anagli et al.
· 2015
[cited by applicant]
US 9664694B2
· Wang et al.
· 2017
[cited by applicant]
US 9810698B2
· Wang et al.
· 2017
[cited by applicant]
US 20010001285A1
· Moh
· 2001
[cited by applicant]
US 20020147998A1
· McConlogue et al.
· 2002
[cited by applicant]
US 20030040660A1
· Jackowski et al.
· 2003
[cited by applicant]
US 20030129134A1
· Chenard et al.
· 2003
[cited by applicant]
US 20030199000A1
· Valkirs et al.
· 2003
[cited by applicant]
US 20040203083A1
· Buechler et al.
· 2004
[cited by applicant]
US 20040253637A1
· Buechler et al.
· 2004
[cited by applicant]
US 20050063942A1
· Clark et al.
· 2005
[cited by applicant]
US 20050112585A1
· Zichi et al.
· 2005
[cited by applicant]
US 20050130226A1
· Ahn et al.
· 2005
[cited by applicant]
US 20050136489A1
· Tseng et al.
· 2005
[cited by applicant]
US 20060094064A1
· Ray et al.
· 2006
[cited by applicant]
US 20060240480A1
· Curdt et al.
· 2006
[cited by applicant]
US 20060292558A1
· O'Neill
· 2006
[cited by applicant]
US 20070027634A1
· Mendrick et al.
· 2007
[cited by applicant]
US 20070074972A1
· Nassef et al.
· 2007
[cited by applicant]
US 20070255113A1
· Grimes
· 2007
[cited by applicant]
US 20090087868A1
· Wang et al.
· 2009
[cited by applicant]
US 20090130658A1
· Barlag et al.
· 2009
[cited by applicant]
US 20110082203A1
· Wang et al.
· 2011
[cited by applicant]
US 20110097392A1
· Wang et al.
· 2011
[cited by applicant]
US 20110143375A1
· Wang et al.
· 2011
[cited by applicant]
US 20120196307A1
· Ottens et al.
· 2012
[cited by applicant]
US 20120202231A1
· Wang et al.
· 2012
[cited by applicant]
US 20130022982A1
· Wang et al.
· 2013
[cited by applicant]
US 20130029362A1
· Jeromin et al.
· 2013
[cited by applicant]
US 20130029859A1
· Svetlov et al.
· 2013
[cited by applicant]
US 20140018299A1
· Mondello et al.
· 2014
[cited by applicant]
US 20140024053A1
· Kobeissy et al.
· 2014
[cited by applicant]
US 20140275294A1
· Svetlov et al.
· 2014
[cited by applicant]
US 20140303041A1
· Hayes et al.
· 2014
[cited by applicant]
US 20140342381A1
· Hayes
· 2014
[cited by applicant]
US 20150141528A1
· Larner
· 2015
[cited by applicant]
US 20150259740A1
· Pollard et al.
· 2015
[cited by applicant]
US 20150268252A1
· Svetlov et al.
· 2015
[cited by applicant]
US 20170176460A1
· Larner
· 2017
[cited by applicant]
US 20170242036A1
· Pollard et al.
· 2017
[cited by applicant]
US 20170307640A1
· Kobaissy et al.
· 2017
[cited by applicant]
US 20180031577A1
· Wang et al.
· 2018
[cited by applicant]
US 20190064187A1
· Svetlov et al.
· 2019
[cited by applicant]
US 20190064188A1
· Wang et al.
· 2019
[cited by applicant]
US 20220113321A1
· Wang et al.
· 2022
[cited by applicant]
EP 0474765A1
· 1992
[cited by applicant]
EP 0518955A1
· 1992
[cited by applicant]
EP 0732399A2
· 1996
[cited by applicant]
EP 0752103A1
· 1997
[cited by applicant]
EP 0773991A1
· 1997
[cited by applicant]
EP 0789578A1
· 1997
[cited by applicant]
EP 0975971A1
· 2000
[cited by applicant]
EP 1037626A1
· 2000
[cited by applicant]
EP 1310797A2
· 2003
[cited by applicant]
EP 1519194A1
· 2005
[cited by applicant]
EP 2143735A1
· 2010
[cited by applicant]
EP 2245466A2
· 2010
[cited by applicant]
JP 2000505544A
· 2000
[cited by applicant]
JP 2003070498A
· 2003
[cited by applicant]
JP 2005538380A
· 2005
[cited by applicant]
WO 199015331A1
· 1990
[cited by applicant]
WO 1991013904A1
· 1991
[cited by applicant]
WO 199200374A1
· 1992
[cited by applicant]
WO 199324834A1
· 1993
[cited by applicant]
WO 1995026506A1
· 1995
[cited by applicant]
WO 199602634A1
· 1996
[cited by applicant]
WO 199614857A1
· 1996
[cited by applicant]
WO 199634097A1
· 1996
[cited by applicant]
WO 199821590A1
· 1998
[cited by applicant]
WO 199930707A1
· 1999
[cited by applicant]
WO 199951773A1
· 1999
[cited by applicant]
WO 200004389A2
· 2000
[cited by applicant]
WO 2000014546A1
· 2000
[cited by applicant]
WO 200056934A1
· 2000
[cited by applicant]
WO 2000078807A1
· 2000
[cited by applicant]
WO 2002093174A2
· 2002
[cited by applicant]
WO 2003016910A1
· 2003
[cited by applicant]
WO 2003019181A2
· 2003
[cited by applicant]
WO 2003032894A2
· 2003
[cited by applicant]
WO 2003062824A1
· 2003
[cited by applicant]
WO 2003085083A2
· 2003
[cited by applicant]
WO 2004025298A1
· 2004
[cited by applicant]
WO 2004059293A2
· 2004
[cited by applicant]
WO 2004078204A1
· 2004
[cited by applicant]
WO 2005004794A2
· 2005
[cited by applicant]
WO 2005029087A1
· 2005
[cited by applicant]
WO 2005029088A2
· 2005
[cited by applicant]
WO 2005106038A2
· 2005
[cited by applicant]
WO 2005113798A2
· 2005
[cited by applicant]
WO 2007007129A2
· 2007
[cited by applicant]
WO 2007046811A2
· 2007
[cited by applicant]
WO 2007094395A1
· 2007
[cited by applicant]
WO 2007140188A2
· 2007
[cited by applicant]
WO 2008008819A2
· 2008
[cited by applicant]
WO 2008063369A2
· 2008
[cited by applicant]
WO 2008095136A2
· 2008
[cited by applicant]
WO 2008097618A1
· 2008
[cited by applicant]
WO 2009100131A2
· 2009
[cited by applicant]
WO 2009129476A2
· 2009
[cited by applicant]
WO 2010019553A2
· 2010
[cited by applicant]
WO 2010033912A2
· 2010
[cited by applicant]
WO 2010059242A2
· 2010
[cited by applicant]
WO 2010148391A2
· 2010
[cited by applicant]
WO 2011011334A2
· 2011
[cited by applicant]
WO 2011032155A2
· 2011
[cited by applicant]
WO 2011123844A2
· 2011
[cited by applicant]
WO 2011160096A2
· 2011
[cited by applicant]
WO 2012051519A2
· 2012
[cited by applicant]
WO 2012141674A2
· 2012
[cited by applicant]
WO 2013040502A2
· 2013
[cited by applicant]
WO 2014194329A1
· 2014
[cited by applicant]
WO 2015157300A1
· 2015
[cited by applicant]
WO 2015157390A9
· 2016
[cited by applicant]
WO 2018081649A1
· 2018
[cited by applicant]
Rainer et al., “Effects of Filtration on Glyceraldehyde-3-Phosphate; Dehydrogenase mRNA in the Plasma of Trauma Patients and Healthy; Individuals,” Clinical Chemistry (2004) 50(1):206-208.
[cited by applicant]
Rainer et al., “Prognostic Use of Circulating Plasma Nucleic Acid; Concentrations in Patients with Acute Stroke,” Clinical Chemistry (2003); 49(4):562-569.
[cited by applicant]
Rao et al., “Marked calpastatin (CAST) depletion in Alzheimer's disease; accelerates cytoskeleton disruption and neurodegeneration: neuroprotection by; CAST overexpression,” J Neurosci (2008) 28(47):12241-12254.
[cited by applicant]
Response to Appeal, for Opposition for EP 09807153.3, dated Apr. 19, 2022, 89; pages.
[cited by applicant]
Rissman et al., “Caspase-cleavage of tau is an early event in Alzheimer; disease tangle pathology,” J Clin Invest (2004) 114:121-130.
[cited by applicant]
Roche, Instruction Manual for “DIG Detection ELISA (ABTS)” and “DIG; Detection ELISA (TMB)”, Version 2, Nov. 1999, retrieved from; http://jenobiotech.com/techsupport/protocol/ELISA 1-17.pdf on Apr. 25, 2014, 18 pages.
[cited by applicant]
Rohn et al., “Caspase-9 Activation and Caspase Cleavage of tau in the; Alzheimer's Disease Brain,” Neurobiol Dis (2002) 11 (2):341-354.
[cited by applicant]
Rudehill et al., “Autoreactive antibodies against neurons and basal lamina; found in serum following experimental brain contusion in rats,” Acta; Neurochirurgica (2006) 148(2): 199-205.
[cited by applicant]
Saatman et al., “Behavioral efficacy of posttraumatic calpain inhibition is not; accompanied by reduced spectrin proteolysis, cortical lesion, or apoptosis,” J; Cereb Blood Flow Metab (2000) 20(1):66-73.
[cited by applicant]
Saatman et al., “Calpain inhibitor AK295 attenuates motor and cognitive; deficits following experimental brain injury in the rat,” Proc Natl Acad Sci (1996); 93(8) :3428-3433.
[cited by applicant]
Shimohama et al., “Changes in caspase expression in Alzheimer's disease:; comparison with development and aging,” Biochem Biophys Res Commun; (1999) 256(2):381-384.
[cited by applicant]
Silber et al., “Patients with progressive multiple sclerosis have elevated; antibodies to neurofilament subunit,” Neurology (2002); 58:1372-1381.
[cited by applicant]
Silva et. al., “Presence of Tumor DNA in Plasma of Breast Cancer Patients:; Clinicopathological Correlations,” Cancer Research (1999) 59:3251-3256.
[cited by applicant]
Siman et al., “Proteins released from degenerating neurons are surrogate; markers for acute brain damage,” Neurobiol Dis (2004) 16(2):311-320.
[cited by applicant]
Singh et al., “Detection of brain autoantibodies in the serum of patients with; Alzheimer's disease but not Down's syndrome,” Immunol Lett (1986) 12(5-; 6):277-280.
[cited by applicant]
Sinjoanu et al., “The novel calpain inhibitor A-705253 potently inhibits; oligomeric beta-amyloid-induced dyanmin 1 and tau cleavage in hippocampal; neurons,” Neurochem Int (2008) 53(3-4):79-88.
[cited by applicant]
Smith et al., “Functional subsets of human helper-inducer cells defined by a; new monoclonal antibody, UCHL 1,” Immunology. (1986) 58(1): 63-70.
[cited by applicant]
Sorokina et al., “Autoantibodies to glutamate receptors and metabolic; products of nitric oxide in blood serum of children in the acute period of brain; trauma,” Zh Nevrol Psikhiatr Im S S Korsakova (2008) 108(3):67-72.
[cited by applicant]
Stagg et al., “Autoantibodies to glutamic acid decarboxylase in patients with; epilepsy are associated with low cortical GABA levels,” Epilepsia (2010); 51 (9):1989-1901.
[cited by applicant]
Svetlov et al., “Biomarkers of Blast-induced neurotrauma: profiling molecular and; cellular mechanisms of Blast brain injury,” Journal of Neurotrauma (2009); 26:913-921.
[cited by applicant]
Svetlov et al., “TITLE: Pathological Fingerprints, Systems Biology and; Biomarkers of Blast Brain Injury”, 2010, Retrieved from the Internet: URL:http:jjwww.dtic.mil/dticjtr/fulltextju2/a548699.pdf, p. 4-6.
[cited by applicant]
Taback et al., “Circulating Nucleic Acids and Proteomics of Plasma/Serum; Clinical Utility,” Annals of the New York Academy of Sciences (2004) 1022:1-8.
[cited by applicant]
Tanriverdi et al., “Antipituitary antibodies after traumatic brain injury: is head; trauma-induced pituitary dysfunction associated with autoimmunity?” Eur J of; Endocrinol (2008) 159(1):7-13.
[cited by applicant]
Terryberry et al., “Clinical Utility of Autoantibodies in Guillain-Barre; Syndrome and Its Variants,” Clinical Reviews in Allergy and Immunology (1998); 16:265-273.
[cited by applicant]
The SAFE Study Investigators, “Saline or Albumin for Fluid Resuscitation in; Patients with Traumatic Brain Injury,” N Engl J Med (2007) 357:874-884.
[cited by applicant]
Turner et al., “Expression of COX2, HO1, and GFAP following collagenaseinduced; intracerebral hemorrhage,” Neurology (2000) 54:A299.
[cited by applicant]
Van Geel et al., :An enzyme immunoassay to quantify neurofilament light chain; in cerebrospinal fluid, J. Immunol. Methods (2005) 296:179-185.
[cited by applicant]
Verbeek et al., “Accumulation of intercellular adhesion loecule-1 in senile; plaques in brain tissue of patients with Alzheimer's disease,” American Journal; of Pathology (1994) 144(1):104-116.
[cited by applicant]
Vissers et al., “Rapid immunoassay for the determination of glial fibrillary; acidic protein (GFAP) in serum,” Clin Chim Acta (2006) 366(1-2):336-340.
[cited by applicant]
Walker et al., “DNA-based molecular diagnostic techniques: research needs; for standardization and validation of the detection of aquatic animal pathogen; and diseases,” Report and proceedings of the joint; FAO/NACA/CSI…
[cited by applicant]
Wang et al., “Calpain and caspase: can you tell the difference?” Trends; Neurosci (2000) 23(1):20-26.
[cited by applicant]
Wang et al., “Simultaneous Degradation of all and 1311-Spectrin by Caspase 3; (CPP32) in Apoptotic Cells,” J Biol Chem (1998) 273(35):22490-22497.
[cited by applicant]
Wang, et al., “Proteomic identification of biomarkers of traumatic brain injury,”; Expert Rev Proteomics (2005) 2(4):603-614.
[cited by applicant]
Warren et al., “Calpain-and caspase-mediated all-spectrin and tau proteolysis; in rat cerebrocortical neuronal cultures after ecstasy or methamphetamine; exposure,” Intl J Neuro-Psychopharmacology, (2007) 10(4):479-489.
[cited by applicant]
Warren et al., “Concurrent calpain and caspase-3 mediated proteolysis of; alphall-spectrin and tau in rat brain after methamphetamine exposure: A similar; profile to traumatic brain injury,” Life Sciences (2005) 78(3):3…
[cited by applicant]
Wilhelm et al., “Immune reactivity towards insulin, its amyloid and protein; S1 00B in blood sera of Parkinson's disease patients,” Eur J Neural (2007); 14(3):327-334.
[cited by applicant]
Yang et al., “Calpain-Induced Proteolysis of Normal Human Tau and Tau; Associated with Paired Helical Filaments,” Eur J Biochem (1995) 223(1):9-17.
[cited by applicant]
Yen et al., “FTDP-17 tau mutations decrease the susceptibility of tau to calpain I; digestion,” FEBS Lett (1999) 461(1):91-95.
[cited by applicant]
Yokota et al., “Three distinct phases offodrin proteolysis induced in; postischemic hippocampus—involvement of calpain and unidentified protease,”; Stroke (1995) 26(10):1901-1907.
[cited by applicant]
Yoshiyama et al., “Enhanced neurofibrillary tangle formation, cerebral atrophy,; and cognitive deficits induced by repetitive mild brain injury in a transgenic; tauopathy mouse model” J Neurotrama (2005) 22(10):1134-114…
[cited by applicant]
Zemlan et al., “C-tau biomarker of neuronal damage in severe brain injured; patients: association with elevated intracranial pressure and clinical outcome,”; Brain Res (2002) 947(1):131-139.
[cited by applicant]
Zemlan et al., “Quantification and localization of kainic acid-induced; neurotoxicity employing a new biomarker of cell death: cleaved microtubule; associated protein-tau (C-tau),” Neuroscience (2003) 121 (2):399-409.
[cited by applicant]
Zhang et al., “Inhibition of autophagy causes tau proteolysis by activating; calpain in rat brain,” J Alzheimers Dis (2009) 16(1):39-47.
[cited by applicant]
Zhang et al., “Multiple alphall-spectrin breakdown products distinguish calpain; and caspase dominated necrotic and apoptotic cell death pathways,” Apoptosis; (2009) 14(11):1289-1298.
[cited by applicant]
Zhang et al., “Roles of autoantibodies in central nervous system injury,” Discov; Med (2011) 11 (60):395-402.
[cited by applicant]
Zhang et al., “Expression of glial fibrillary acidic protein in peri-cerebral; hemorrhage foci,” Journal of the Fourth Military Medical University (Di-si Junyi; Daxue Xuebao) (2003) 24(17):1586-1588.
[cited by applicant]
Zhao et al., “Maitotoxin Induces Calpain But Not Caspase-3 Activation and; Necrotic Cell Death in Primary Septo-Hippocampal Cultures,” Neurochem Res; (1999) 24(3):371-382.
[cited by applicant]
Zhu et al., “Non-invasive imaging of GFAP expression after neuronal damage in; mice,” Neurosci Letters (2004) 367(2):210-212.
[cited by applicant]
Zhang et al., J of Forensic Medicine, 22(2):88-92, Apr. 2006 (certified translation) (Year: 2006).
[cited by applicant]
“Anti-PGP9.5 antibody [13C4/13C4]ab 8189 11,” Abcam online catalogue, Jan. 1, 1988, Retrieved from the Internet: URL:http://www.abcam.com/PGP95-antibody-13C4-13C4-ab8189.pdf, retrieved on Jan. 4, 2018, 6 pages.
[cited by applicant]
“Cerebral contusion” published by Wikipedia online on Sep. 13, 2006. Retrieved from http://en.wikipedia.org/wik/Cerebral_contusion. Retrieved on Mar. 20, 2017 1 :54:09 PM.
[cited by applicant]
André et al., “NMDA Receptor Alterations in Neurons from Pediatric Cortical Dysplasia Tissue,” Cereb Cortex (2004) 14(6):634-646.
[cited by applicant]
Araki et al., “Developmentally regulated expression of Neuro-p24 and its possible function in neurite extension,” Neurosci Res (2002) 44(4):379-389.
[cited by applicant]
Aurell et al., “Determination of S-100 and glial fibrillary acidic protein concentrations in cerebrospinal fluid after brain infarction,” Stroke (1991) 22(10):1254-1258.
[cited by applicant]
Authoritative Dictionary of IEEE Standard Terms. Seventh Edition. 2000. Excerpt of definitions of “parallel” and “serial”.
[cited by applicant]
Baldwin et al., “Intermediate filament change in astrocytes following mild cortical contusion,” Glia (1996) 16(3):266-275.
[cited by applicant]
Belay et al., “Creutzfeldt-Jakob Disease in Unusually Young Patients Who Consumed Venison,” Arch. Neural (2001) 58(10):1673-1678.
[cited by applicant]
Berger et al., “Serum Concentrations of Ubiquitin C-Terminal Hydrolase-L 1 and all-Spectrin Breakdown Product 145 kDa Correlate with Outcome after Pediatric TBI,” J Neurotrauma (2012) 29(1): 162-167.
[cited by applicant]
Blennow “Cerebrospinal Fluid Protein Biomarkers for Alzheimer's Disease,” NeuroRx (2004) 1 (2):213-225.
[cited by applicant]
Brief Communication granting Extension of Time for EP 09807153.3, dated Mar. 18, 2019. 4 pages.
[cited by applicant]
Brief Communication Postponing Oral Proceedings for EP 09807153.3, dated Jun. 8, 2020. 2 pages.
[cited by applicant]
Brief Communication re Letter from Proprietor for EP 09807153.3, dated Jan. 9, 2020; 57 pages.
[cited by applicant]
Brief Communication Notification (Proprietor and Opponent) concerning the date of oral proceedings for EP 09807153.3, dated Jun. 8, 2020; 3 pages.
[cited by applicant]
Brief Communication Notifications (Proprietor and Opponent) concerning the date of oral proceedings for EP 09807153.3, dated Aug. 19, 2020; 2 pages.
[cited by applicant]
Brief Communication Notify Proprietor re Written Submissions for EP 09807153.3, dated Apr. 22, 2021; 1 O pages.
[cited by applicant]
Brief Communication Notifications (Proprietor and Opponent) concerning the date of oral proceedings for EP 09807153.3, dated Feb. 24, 2021; 6 pages.
[cited by applicant]
Brophy et al., “Alphall-Spectrin breakdown product cerebrospinal fluid exposure metrics suggest differences in cellular injury mechanisms after severe traumatic brain injury,” J Neurotrauma (2009) 26:471-479.
[cited by applicant]
Brophy et al., “Biokinetic Analysis of Ubiquitin C-Terminal Hydrolase-L 1 (UCHL 1) in Severe Traumatic Brain Injury Patient Biofluids,” J Neurotrauma (2011) 28(6):861-870.
[cited by applicant]
Cao et al., “Cleavage of Bax to p18 Bax accelerates stress-induced apoptosis, and a cathespin-like protease may rapidly degrade p18 Bax,” Blood (2003) 102(7):2605-2614.
[cited by applicant]
Gasset et al., “A peptide mimetic of an anti-CD4 monoclonal antibody by rational design,” Biochem Biophys Res Commun. (2003) 307(1): 198-205.
[cited by applicant]
CDC, Glasgow Coma Scale, published Apr. 19, 2004 [online] Retrieved from https://www.cdc.gov/masstrauma/resources/gcs.pdf; Retrieved on Feb. 7, 2020. (Year: 2004).
[cited by applicant]
Communication of Amended Entries Representative EP 09807153.3, dated Feb. 4, 2019. 1 page.
[cited by applicant]
Communication of Notice of Opposition for EP 09807153.3, dated Nov. 7, 2018, 116 pages.
[cited by applicant]
Communication of Notice of Opposition Request for Observations for EP 09807153.3, dated Nov. 16, 2018, 1 page.
[cited by applicant]
Communication Notifications (Proprietor and Opponent) concerning reference File Number for Notice of Appeal proceedings for EP 09807153.3, dated Oct. 12, 2021; 4 pages.
[cited by applicant]
Cookson, “Parkin's substrates and the pathways leading to neuronal damage,” Neuromolecular Med (2003) 3(1):1-13.
[cited by applicant]
Cox et al., “Dicyclomine, an M1 Muscarinic Antagonist, Reduces Biomarker Levels, But Not Neuronal Degeneration, in Fluid Percussion Brain Injury,” J Neurotrauma (2008) 25(11 ):1355-1365.
[cited by applicant]
Cutler et al., “Review of the Next Generation of Alzheimer's Disease Therapeutics: Challenges for Drug Development,” Prog Neuropsychopharmacol Biol Psychiatry (2001) 25(1):27-57.
[cited by applicant]
Dambinova et al., “Blood Test Detecting Autoantibodies to N-Methyl-Daspartate Neuroreceptors for Evaluation of Patients with Transient Ischemic Attack and Stroke,” Clin Chem (2003) 49(10):1752-1762.
[cited by applicant]
Dambinova et al., “The presence of autoantibodies to N-terminus domain of GluR1 subunit of AMPA receptor in the blood serum of patients with epilepsy,” J Neural Sci (1997) 152(1 ):93-97.
[cited by applicant]
Dash et al., “Biomarkers for the Diagnosis, Prognosis, and Evaluation of Treatment Efficacy for Traumatic Brain Injury,” Neurotherapeutics (2010) 7(1):100-114.
[cited by applicant]
Decision in Opposition Proceeding (Opponent) for EP 09807153.3, dated Jul. 15, 2021; 94 pages.
[cited by applicant]
Decision in Opposition Proceeding (Proprietor) for EP 09807153.3, dated Jul. 15, 2021; 94 pages.
[cited by applicant]
Dekosky et al., “Looking Backward to Move Forward: Early Detection of; Neurodegenerative Disorders,” Science (2003) 302(5646):830-834.
[cited by applicant]
Del Prete et al., “Migration of dendritic cells across blood and lymphatic; endothelial barriers,” Thromb Haemost (2006) 95(1):22-28.
[cited by applicant]
Denning et al., “Protein Kinase Cdelta Is Activated by Capase-dependent; Proteolysis during Ultraviolet Radiation-induced Apoptosis of Human; Keratinocytes,” J Biol Chem (1998) 273(45):29995-30002.
[cited by applicant]
Esselman et al., “Review of subject: Classification of the spectrum of mild; traumatic brain injury,” Brain Injury (1995) 9(4):417-424.
[cited by applicant]
Estrov et al., “Caspase 2 and Caspase 3 Protein Levels as Predictors of; Survival in Acute Myelogenous Leukemia,” Blood (1998) 92(9):3090-3097.
[cited by applicant]
Everbroeck et al., “A Prospective Study of CSF Markers in 250 Patients with; Possible Creutzfeldt-Jakob Disease,” J Neural Neurosurg Psychiatry (2003); 74:1210-1214.
[cited by applicant]
Frijns et al., “Inflammatory Cell Adhesion Molecules in Ischemic; Cerebrovascular Disease,” Stroke (2002) 33(8):2115-2122.
[cited by applicant]
Hajimohammadreza et al., “A Specific Inhibitor of Calcium/Calmodulin-; Dependent Protein Kinase-II Provides Neuroprotection Against NMDA- and; Hypoxia/Hypoglycemia-; Induced Cell Death,” J Neurosci (1995) 15(5):4093-410…
[cited by applicant]
Hajimohammadreza et al., “Neuronal Nitric Oxide Synthase and; Calmodulin-Dependent Protein Kinase II alpha Undergo Neurotoxin-Induced; Proteolysis,” J Neurochem (1997) 69(3):1006-1013.
[cited by applicant]
Hansen et al., “Frontal cortical synaptophysin in Lewy body diseases: relation; to Alzheimer's disease and dementia” J Neural Neurosurg Psychiatry (1998); 64(5) :653-656.
[cited by applicant]
Hinkle et al., “GFAP and S10013 Expression in the Cortex and Hippocampus in; Response to Mild Cortical Contusion,” J Neurotrama (1997) 14(10):729-738.
[cited by applicant]
Holm et al,, “Functional mapping and single chain construction of the anticytokeratin; 8 monoclonal antibody TS1 ,” Mol Immunol. (2007) 44(6): 1075-1084.
[cited by applicant]
Inden et al., “Proteasome Inhibitors Protect Against Degeneration of Nigral; Dopaminergic Neurons in Hemiparkinsonian Rats,” J Pharmacol Sci (2005); 97:203-211.
[cited by applicant]
Information Results from Oral proceedings for EP 09807153.3, dated Jun. 18, 2021; 22 pages.
[cited by applicant]
Jakowec et al., “The native form of alpha-synuclein is not found in the; cerebrospinal fluid of patients with Parkinson's disease or normal controls,”; Neurosci Lett (1998) 253(1):13-16.
[cited by applicant]
Kim et al., “Comparison of Proteome Between Hepatitis B Virus-and Hepatitis C; VirusAssociated Hepatocellular Carcinoma,” Clin Cancer Res (2003); 9(15):5493-5500.
[cited by applicant]
Kobeissy et al. “Degradation of 13II-Spectrin Protein by Calpain-2 and; Caspase-3 Under Neurotoxic and Traumatic Brain Injury Conditions,” Mol; Neurobiol (2015) 52:696-709.
[cited by applicant]
Higuchi et al., “Tau and axonopathy in neurodegenerative disorders,” Neuromolecular Med (2002) 2(2):131-150.
[cited by applicant]
Honda et al., “Serum glial fibrillary acidic protein is a highly specific biomarker; for traumatic brain injury in humans compared with S-1 00B and neuron-specific; enolase,” J. Trauma (2010) 69:104-109.
[cited by applicant]
Ingebrigsten et al., “Biochemical serum markers for brain damage: A short; review with emphasis on clinical utility in mild head injury,” Restorative; Neurology and Neuroscience (2003) 21 (3):171-176.
[cited by applicant]
Johnson et al., “Proteolysis of Tau by Calpain,” Biochem Biophys Res; Commun (1989) 163(3):1505-1511.
[cited by applicant]
Kadota et al., “A Newly Identified Membrane Protein Localized Exclusively in; Intracellular Organelles of Neurons,” Mol Brain Res (1997) 46(1-2):265-273.
[cited by applicant]
Kampfl et al., “Mechanisms of Cal pain Proteolysis Following Traumatic Brain; Injury: Implications for Pathology and Therapy: A Review and Update,” J; Neurotrauma (1997) 14(3):121-134.
[cited by applicant]
Kiraly et al., “Traumatic Brain Injury and Delayed Sequelae: A Review—; Traumatic Brain Injury and Mild Traumatic Brain Injury (Concussion) are; Precursors to Later-Onset Brain Disorders, Including Early-Onset Dementia,…
[cited by applicant]
Knoblach et al., “Multiple Caspases Are Activated after Traumatic Brain; Injury: Evidence for Involvement in Functional Outcome,” J Neurotrama (2002); 19(10):1155-1170.
[cited by applicant]
Kosik et al., “MAP2 and Tau Segregate into Dendritic and Axonal Domains; After the Elaboration of Morphologically Distinct Neu rites: An Immunocytochemical Study of Cultured Rat Cerebrum,” J Neurosci (1987); 7(10):3142-…
[cited by applicant]
Kovesdi et al., “Update on protein biomarkers in traumatic brain injury with; emphasis on clinical use in adults and pediatrics”, Acta Neurochirurgica (2010); 152(1):1-17.
[cited by applicant]
Krishnamurthy et al., “Molecular and biologic markers of premalignant; lesions of human breast,” Adv Anat Pathol (2002) 9(3):185-197.
[cited by applicant]
Lamers et al., “Protein S-100b, Neuron-Specific Enolase (NSE), Myelin Basic; Protein (MBP) and Glial Fibrillary Acidic Protein (GFAP) in Cerebrospinal Fluid; (CSF) and Blood of Neurological Patients,” Brain Res Bull (20…
[cited by applicant]
Le Prince et al., “Alterations of glial fibrillary acidic protein mRNA level in the; aging brain and in senile dementia of the Alzheimer type,” Neurosci Lett (1993); 151(1):71-73.
[cited by applicant]
Leon et al., “Free DNA in the Serum of Cancer Patients and the Effect of; Therapy,” Patients Cancer Research (1977) 37:646-650.
[cited by applicant]
Li et al., “Peptide alpha-Keto Ester, alpha-Keto Amide, and alpha-Keto Acid; Inhibitors of Calpains and Other Cysteine Proteases,” J Med Chem (1993); 36(22):3472-3480.
[cited by applicant]
Litersky et al., “Phophorylation, calpain proteolysis and tubulin binding of; recombinant human tau isoforms,” Brain Res (1993) 604:32-40.
[cited by applicant]
Lo et al., “Pediatric brain trauma outcome prediction using paired serum levels of; inflammatory mediators and brain-specific proteins,” Journal of Neurotrauma; (2009) 26:1479-1487.
[cited by applicant]
Lo et. al., “Presence of fetal DNA in maternal plasma and serum,” The Lancet; (1997) 350:485-487.
[cited by applicant]
Lumpkins et al., “Glial Fibrillary Acidic Protein is Highly Correlated With Brain; Injury,” J Trauma (2008) 65(4):778-782.
[cited by applicant]
Mao et al., “Electrochemiluminescence assay for basic carboxypeptidases:; inhibition of basic carboxypeptidases and activation of thrombin-activatable; fibrinolysis inhibitor,” Anal Biochem (2003) 319(1 ):159-170.
[cited by applicant]
McComb et al., “Alkaline Phosphatase,” 1979, Plenum Press, New York, D; Bibliography pages only.
[cited by applicant]
McCraken et al., “Calpain activation and cytoskeletal protein breakdown in the; corpus callosum of head-injured patients,” J Neurotrauma (1999) 16(9):749-761.
[cited by applicant]
McGinnis et al., “Alterations of Extracellular Calcium Elicit Selective Modes of; Cell Death and Protease Activation in SH-SY5Y Human Neuroblastoma Cells,” J; Neurochem (1999) 72(5):1853-1863.
[cited by applicant]
McKee et al., “Chronic traumatic encephalopathy in athletes: progressive; tauopathy following repetitive head injury,” J Neuropathol Exp Neural (2009); 68(7):709-735.
[cited by applicant]
McKnight et al., “Serum antibodies in epilepsy and seizure-associated; disorders,” Neurology (2005) 65(11):1730-1736.
[cited by applicant]
McLendon et al., “Immunohistochemistry of the glial fibrillary acidic protein:; basic and applied considerations,” Brain Pathol (1994) 4(3):221-228.
[cited by applicant]
Medana et al., “Axonal damage: a key predictor of outcome in human CNS; diseases,” Brain (2003) 126(3):515-530.
[cited by applicant]
Menke et al., “Improved Conditions for Isolation and Quantification of RNA in; Urine Specimens,” Annals of the New York Academy of Sciences (2004); 1022:185-189.
[cited by applicant]
Miller et al., “Utilizing clinical factors to reduce head CT scan ordering for; minor head trauma patients,” J. Emerg. Med. (1997) 15(4):453-457.
[cited by applicant]
Mohideen, “Brain natriuretic peptide is more than a marker,” Ceylon Medical; Journal, Sep. 2002 47(3):81-82.
[cited by applicant]
Moniem et al., “Autoantibodies to neurofilaments (NF), glial fibrillary acidic; protein (GFAP) and myelin basic protein (MBP) in workers exposed to lead,” J.; Egyptian Public Health Assoc (1999) 74 (1-2): 121-138.
[cited by applicant]
Morozov et al., “Autoantibodies against nerve tissue proteins long after; cranio-cerebral injury,” Vopr Med Khim (1996) 42(2):14 7-152.
[cited by applicant]
Mouser et al., “Caspase-Mediated Cleavage of Glial Fibrillary Acidic Protein; within Degenerating Astrocytes of the Alzheimer's Disease Brain,” Am J Pathol; (2003 168(3):936-946.
[cited by applicant]
Muller et al., “Methylated DNA as a possible screening marker for neoplastic; disease in several body fluids,” Expert Review of Molecular Diagnostics (2003); 3(4):443-458.
[cited by applicant]
Nakanishi et al., “Molecular Characterization of a Transport Vesicle Protein; Neurensin-2, a homologue of Neurensin-1, expressed in neural cells,” Brain Res; (2006) 1081 (1):1-8.
[cited by applicant]
Nath et al., “Activation of apoptosis-linked caspase(s) in NMDA-injured brains; in neonatal rats,” Neurochem Int (2000) 36(2):119-126.
[cited by applicant]
Nath et al., “Development and characterization of antibodies specific to; caspase-3-produced alpha II-spectrin 120 kDa breakdown product: marker for; neuronal apoptosis,” Neurochem Int (2000) 37(4):351-361.
[cited by applicant]
Nath et al., “Effects of ICE-like protease and calpain inhibitors on neuronal; apoptosis,” Neuroreport (1996) 8(1):249-255.
[cited by applicant]
Nath et al., “Evidence for Activation of Caspase-3-Like Protease in Excitotoxinand; Hypoxia/Hypoglycemia-Injured Neurons,” J Neurochem (1998) 71 :186-195.
[cited by applicant]
Newcomb et al., “Immunohistochemical study of calpain-mediated breakdown; products to alpha-spectrin following controlled cortical impact injury in the rat,” J; Neurotrauma (1997) 14(6):369-383.
[cited by applicant]
Ng et. al., “The pathological spectrum of diffuse axonal injury in blunt head; trauma: assessment with axon and myelin stains,” Clin Neural Neurosurg (1994); 96:24-31.
[cited by applicant]
Niebroj-Dobosz et al., “Immunochemical analysis of some proteins in; cerebrospinal fluid and serum of patients with ischemic strokes,” Folia; Neuropathol (1994) 32(3):129-137.
[cited by applicant]
Notice of Appeal, for Opposition for EP 09807153.3, dated Sep. 24, 2021, 5 pages.
[cited by applicant]
Okazaki et al., “Pathogenic roles of cardiac autoantibodies in dilated; cardiomyopathy,” TRENDS in Molecular Medicine (2005) 11 (7):322-326.
[cited by applicant]
Park et al., “The generation of a 17 kDa neurotoxic fragment: an alternative; mechanism by which tau mediates beta-amyloid-induced neurodegeneration,” J; Neurosci (2005) 25(22):5365-5375.
[cited by applicant]
Pettigrew et al., “Microtubular Proteolysis in Focal Cerebral Ischema,” J; Cereb Blood Flow Metab (1996) 16(6):1189-1201.
[cited by applicant]
Pettus et al., “Traumatically induced altered membrane permeability: its; relationship to traumatically induced reactive axonal change,” J Neurotrauma; (1994) 11 (5):507-522.
[cited by applicant]
Pike et al., “Accumulation of Cal pain and Caspase-3 Proteolytic Fragments of; Brain-Derived alpha-II-Spectrin in Cerebral Spinal Fluid After Middle Cerebral; Artery Occlusion in Rats,” J Cereb Blood Flow Metab (2004) 2…
[cited by applicant]
Pike et al., “Regional calpain and caspase-3 proteolysis of alpha-spectrin after; traumatic brain injury,” NeuroReport (1998) 9(11):2437-2442.
[cited by applicant]
Quintana et al., “Antigen microarrays identify CNS-produced autoantibodies in; RRMS,” Neurology (2012) 78(8):532-539.
[cited by applicant]
Yu et al., “Accumulation of immunoreactivity to ubiquitin carboxyl-terminal; hydrolase PGP 9.5 in axons of human cases with spinal cord lesions,” APMIS; (1998) 106(11):1081-1087.
[cited by applicant]
Zaffaroni “Biological Indicators of the Neurodegenerative Phase of Multiple; Sclerosis”, Neural Sci (2003) 24:S279-S282.
[cited by applicant]
Zemlan et al., “Quantification of axonal damage in traumatic brain injury:; affinity purification and characterization of cerebrospinal fluid tau proteins,” J; Neurochem (1999) 72(2):741-750.
[cited by applicant]
Zhang et al., “Phenotypes of T Cells Infiltrating the Eyes in Autoimmune; Anterior Uveitis Associated with EAE,” Invest Ophthalmol Vis Sci (2002); 43(5):1499-150818.
[cited by applicant]
Feb. 7, 2024 U.S. Notice of Allowance issued in U.S. Appl. No. 16/890,943.
[cited by applicant]
Huh et al., J Neurotrauma (Oct. 2003) 20(10): 975-984 (Year: 2003).
[cited by applicant]
Meric et al., Journal of Emergency Medicine vol. 38, No. 3, pp. 297-301, Epub May 22, 2008 (Year: 2008).
[cited by applicant]
Romner etal., J. Neurotrauma 17 (2000), pp. 641-647 (Year: 2000).
[cited by applicant]
Zee and Go, CT of head trauma, Neuroimaging Clin N Am., Aug; 8(3): 525-39 (1998); abstract only (Year: 1998).
[cited by applicant]
Pelinka et al., J Trauma, 57: 1006-1012 (2004) (Year: 2004).
[cited by applicant]
“Recommendations of the German Society for Clinical Chemistry,” Z. klin. Chem.; u. klin. Biochem., 1972, pp. 182-192.
[cited by applicant]
Adams et al., “The neuropathology of the vegetative state after an acute brain; insult,” Brain (2000) 123:1327-1338.
[cited by applicant]
Ankeny et al., “Mechanisms and implications of adaptive immune responses; after traumatic spinal cord injury,” Neuroscience (2009) 158:1112-1121; Epub; Jul. 4, 2008.
[cited by applicant]
Arnaud et al., “Proteasome-caspase-cathepsin sequence leading to tau; pathology induced by prostaglandin J2 in neuronal cells,” J Neurochem (2009); 110(1):328-342.
[cited by applicant]
Bartus et al., “Time-related neuronal changes following middle cerebral artery; occlusion: implications for therapeutic intervention and the role of calpain,” J; Cereb Blood Flow Metab (1995) 15(6):969-979.
[cited by applicant]
Bauman et al., “An introductory characterization of a combat-casualty-care; relevant swine model of closed head injury resulting from exposure to explosive; blast*,” Journal of Neurotrauma (2009) 26:841-860.
[cited by applicant]
Beer et al., “Temporal Profile and Cell Subtype Distribution of Activated; Caspase-3 Following Experimental Traumatic Brain Injury,” J Neurochem (2000); 75:1264-1273.
[cited by applicant]
Binder et al., “The Distribution of Tau in the Mammalian Central Nervous; System,” J Cell Biol (1985)101:1371-1378.
[cited by applicant]
Bitsch et al., “Serum Tau Protein Level as a Marker of Axonal Damage in; Acute Ischemic Stroke,” Eur Neural (2002) 47(1):45-51.
[cited by applicant]
Borghi et al., “Full length alpha-synuclein is present in cerebrospinal fluid from; Parkinson's disease and normal subjects,” Neurosci Lett (2000) 287(1):65-67.
[cited by applicant]
Bornstein et al., “Antibodies to brain antigens following stroke,” Neurology; (2001) 56(4):529-530.
[cited by applicant]
Bramlett et al., “Quantitative structural changes in white and gray matter 1; year following traumatic brain injury in rats,” Acta Neuropathologica (2002); 103:607-614.
[cited by applicant]
Buki et al., “Cytochrome c Release and Caspase Activation in Traumatic Axonal; Injury,” J Neurosci (2000) 20(8):2825-2834.
[cited by applicant]
Canu et al., “Tau Cleavage and Dephosphorylation in Cerebellar Granule; Neurons Undergoing Apoptosis,” J Neurosci (1998) 18(18):7061-7074.
[cited by applicant]
Chekhonin et al., “Enzyme immunoassay of antibodies to neurospecific; proteins in examination of blood-brain barrier function,” Immunologiya (1996); 0(2):67-69.
[cited by applicant]
Chung et al., “Proapoptotic Effects of Tau Cleavage Product Generated by; Caspase-3,” Neurobiol Dis (2001) 8(1):162-172.
[cited by applicant]
Clark et al., “Caspase-3 Mediated Neuronal Death After Traumatic Brain Injury; in Rats,” J Neurochem (2000) 74(2):740-753.
[cited by applicant]
Cotman et al., “The Role of Caspase Cleavage of Tau in Alzheimer Disease; Neuropathology,” J Neuropathol Exp Neural (2005) 64(2): 104-112.
[cited by applicant]
De Kruijk et al., “S-1 00B and neuron-specific enolase in serum of mild traumatic; brain injury patients,” Acta Neural. Scand.; (2001) 103:175-179.
[cited by applicant]
Delobel et al., “Proteasome inhibition and Tau proteolysis: an unexpected; regulation,” FEBS Lett (2005) 579(1):1-5.
[cited by applicant]
Dixon et al., “A controlled cortical impact model of traumatic brain injury in the rat,” J Neurosci Methods (1991) 39(3):253-262.
[cited by applicant]
Drubin et al., “Tau Protein Function in Living Cells,” J Cell Biol (1986); 103(6):2739-2746.
[cited by applicant]
Dvorak et al., “Characterisation of the diagnostic window of serum glial; fibrillary acidic protein for the differentiation of intra cerebral haemorrhage and; ischaemic stroke,” Cerebrovasc Dis (2009) 27:37-41.
[cited by applicant]
ECG Guidelines, “Part 7: The Era of Reperfusion, Section 2: Acute Stroke”,; Circulation 2000; 102(suppl 1):1-204-1-216, https://doi.org/10.1161/01.CIR.102.suppl_ 1.1-204 (Year: 2000).
[cited by applicant]
Eikelenboom et al., “Multiple sclerosis, Neurofilament light chain antibodies; are correlated to cerebral atrophy,” Neurology (2003) 60(2):219-223.
[cited by applicant]
El-Fawal et al., “Autoantibodies to neurotypic and gliotypic proteins as; biomarkers of neurotoxicity: assessment of trimethyltin (TMT),” Neurotoxicology; (2008) 29(1):109-115.
[cited by applicant]
Finfer et al., “A comparison of albumin and saline for fluid resuscitation in the; intensive care unit,” N Engl J Med (2004) 350(22):2247-2256.
[cited by applicant]
Foerch et al., “Serum glial fibrillary acidic protein as a biomarker for; intracerebral hemorrhage in patients with acute stroke,” J Neural Neurosurg; Psychiatry (2006) 77: 181-1 84.
[cited by applicant]
Franz et al., “Amyloid beta 1-42 and tau in cerebrospinal fluid after severe; traumatic brain injury,” Neurology (2003) 60(9):1457-1461.
[cited by applicant]
Gabbita et al., “Cleaved-Tau: A Biomarker of Neuronal Damage after; Traumatic Brain Injury,” J Neurotrauma (2005) 22(1):83-94.
[cited by applicant]
Gamblin et al., “Caspase cleavage of tau: Linking amyloid and neurofibrillary; tangles in Alzheimer's disease,” Proc Natl Acad Sci USA (2003) 100(17):10032-10037.
[cited by applicant]
Garcia et al., “Going new places using an old MAP: tau, microtubules and; human neurodegenerative disease” Curr Opin Cell Biol (2001) 13(1):41-48.
[cited by applicant]
Garcia-Sierra et al., “Truncation of Tau Protein and its Pathological; Significance in Alzheimer's Disease,” J Alzheimers Dis (2008) 14(4):401-409.
[cited by applicant]
Gaskin et al., “Patients with clinically diagnosed senile dementia of the; Alzheimer type make autoantibodies that react with neurofibrillary tangles,”; Clinical Research (1986) 34(2): 669A.
[cited by applicant]
Goryunova et al., “Glutamate Receptor Autoantibody Concentrations in; Children with Chronic Post-Traumatic Headache,” Neuroscience and Behavioral; Physiology (2007) 37(8):761-764.
[cited by applicant]
Gruden et al., “Differential neuroimmune markers to the onset of Alzheimer's; disease neurodegeneration and dementia: autoantibodies to Abeta((25-35)); oligomers, S100b and neurotransmitters,” J Neuroimmunol (2007) 186(…
[cited by applicant]
Grus et al., “Analysis of complex autoantibody repertories by surface-enhanced; laser desorption/ionization-time of flight mass spectrometry,” Proteomics (2003); 3(6):957-961.
[cited by applicant]
Guillozet-Bongaarts et al., “Tau truncation during neurofibrillary tangle; evolution in Alzheimer's disease,” Neurobiol Aging (2005) 26(7):1015-1022.
[cited by applicant]
Hailer., “Immunosuppression after traumatic or ischemic CNS damage: It is; neuroprotective and illuminates the role of microglial cells,” Progres Neurobiol.; (2008) 84:211-233.
[cited by applicant]