IP Library › Granted Patent US 12,196,656
Granted Patent B2
US 12,196,656 · App. 17/371,025 · Granted Jan 14, 2025

Device and methods

Inventors: Heinrich Anhold (Sligo, IE); Ruth Candon (Sligo, IE); Di-Sien Chan (Sligo, IE)
Assignee: EPONA BIOTECH LTD
G01N1/38B01L3/0203B01L3/0241G01N33/543G01N33/54388G01N33/54389G01N33/6893B01L2200/025B01L2200/026B01L2200/0689B01L2300/0838B01L2300/161G01N2001/383G01N2333/75G01N2333/775G01N2333/91188G01N2333/9123G01N2800/40Y02A50/30
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Quick Facts
Patent No.
US 12,196,656
App. No.
17/371,025
Granted
Jan 14, 2025
Kind
B2
Abstract

There is provided a method and materials pertaining to assays, for example immunoassays, for biomarkers in body fluids e.g. blood. Diagnostic or screening methods for infections, and methods of differentiating between infectious and non-infectious conditions in mammals, particularly equines, for monitoring response to anti-infective/antibiotic therapy are provided. A test fluid collection system adapted to permit dilution and analysis of the collected test fluid and an assay and device for monitoring exertional rhabdomyolysis in equines is also provided.

Claims (13)

1. A method of monitoring a mammal's response to a treatment for an infectious disease or an inflammatory response comprising administration of an anti-infective to the mammal, the method comprising:

collecting, by an analytical device, a body fluid sample of said mammal after treatment has been administered, the analytical device including a sample well, viewing window, and a flow path through which the body fluid sample flows by capillary action, the flow path leading from the sample well to the viewing window;

determining, by the analytical device, a concentration of Serum Amyloid A in the body fluid sample of said mammal; and

producing, by the analytical device in the viewing window, a visual representation of the determined concentration of Serum Amyloid A, the visual representation indicating whether the determined concentration is above a specified level, wherein said specified level is 50 μg/ml, and wherein said body fluid is a blood sample.

2. The method of claim 1 , wherein the anti-infective is an antibiotic.

3. The method as claimed in claim 1 , wherein the analytical device is a portable lateral flow device,

wherein the presence of Serum Amyloid A produces a line in the viewing window which indicates a Serum Amyloid A concentration of at or above 50 μg/ml in the blood sample, and wherein the device measures a Serum Amyloid A concentration over at least the range of 7.5 to 3000 μg/ml, and wherein the assay result within the concentration range 7.5 to 1000 μg/ml can be visually interpreted with the naked eye based on an intensity of the line, optionally by comparison to a reference showing different line intensities.

4. The method as claimed in claim 3 , wherein the flow path has an analyte-detection zone comprising a conjugate release zone and a detection zone, and wherein the line reveals the amount of Serum Amyloid A in the blood sample.

5. The method as claimed in claim 3 , wherein the portable lateral flow device further comprises a control zone positioned upstream or downstream of the analyte-detecting zone, capable of indicating the assay has been successfully run.

6. A method of monitoring a mammal's response to a treatment for an infectious disease or an inflammatory response comprising administration of an anti-infective to the mammal, the method comprising:

collecting, by an analytical device, a body fluid sample of said mammal after treatment has been administered, the analytical device including a sample well, viewing window, and a flow path through which the body fluid sample flows by capillary action, the flow path leading from the sample well to the viewing window;

determining, by the analytical device, a concentration of Serum Amyloid A in the body fluid sample of said mammal; and

producing, by the analytical device in the viewing window, a visual representation of the determined concentration of Serum Amyloid A, the visual representation indicating whether the determined concentration is above a specified level, wherein said specified level is 50 μg/ml, wherein said body fluid is a blood sample, and wherein said treatment is administered if the determined concentration of Serum Amyloid A is above 50 μg/ml and wherein said treatment is stopped if the determined concentration of Serum Amyloid A is below 50 μg/ml.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 8, 2021
From: CANDON, RUTH; ANHOLD, HEINRICH; CHAN, DI-SIEN
To: EPONA BIOTECH LTD
Reel/Frame 056797/0560 →
Priority Claims (2)
GB 1301951.8 · Feb 4, 2013 · national
GB 1314232.8 · Aug 8, 2013 · national
Continuity (4)
Continuation 17214795 · Mar 26, 2021
Continuation 16372264 · Apr 1, 2019
Division 14765247
Related Publication 20210333179A1 · Oct 28, 2021
References Cited (71)
US 3640268A · Davis · 1972 [cited by applicant]
US 5096669A · Lauks et al. · 1992 [cited by applicant]
US 5122284A · Braynin et al. · 1992 [cited by applicant]
US 5234813A · McGeehan et al. · 1993 [cited by applicant]
US 5494646A · Seymour · 1996 [cited by applicant]
US 5935864A · Schramm et al. · 1999 [cited by applicant]
US 6194163B1 · Doyle et al. · 2001 [cited by applicant]
US 6253967B1 · Sperna Weiland · 2001 [cited by applicant]
US 10288537B2 · Candon et al. · 2019 [cited by applicant]
US 10989633B2 · Anhold et al. · 2021 [cited by applicant]
US 20020001852A1 · Mendel-Hartvig · 2002 [cited by examiner]
US 20020020713A1 · Kis · 2002 [cited by applicant]
US 20030054412A1 · Kleinfeld · 2003 [cited by examiner]
US 20030143652A1 · Simonson · 2003 [cited by applicant]
US 20060228258A1 · Samsoondar · 2006 [cited by applicant]
US 20080138842A1 · Boehringer · 2008 [cited by examiner]
US 20100279274A1 · Lloyd, Jr. et al. · 2010 [cited by applicant]
US 20110144535A1 · Guirguis · 2011 [cited by applicant]
US 20110146419A1 · Gonzalez et al. · 2011 [cited by applicant]
US 20130021411A1 · Feinn et al. · 2013 [cited by applicant]
US 20130072580A1 · Barasch · 2013 [cited by examiner]
US 20140017147A1 · Kim et al. · 2014 [cited by applicant]
US 20140322724A1 · Walshe · 2014 [cited by applicant]
US 20160153878A1 · Candon et al. · 2016 [cited by applicant]
US 20190376880A1 · Anhold et al. · 2019 [cited by applicant]
US 20210285854A1 · Anhold et al. · 2021 [cited by applicant]
WO 02085185A2 · 2002 [cited by applicant]
WO 03103835A1 · 2003 [cited by applicant]
WO 2005089082A2 · 2005 [cited by applicant]
WO 2006137785A1 · 2006 [cited by applicant]
WO 2013088429A1 · 2013 [cited by applicant]
WO 2014118764A2 · 2014 [cited by applicant]
Casl et al., Clinical relevance of serum amyloid A protein monitoring in urinary tract infections, Ann Clin Biochem 1993; 30; pp. 272-277. (Year: 1993). [cited by examiner]
International Preliminary Report on Patentability issued in International Application No. PCT/IB2014/058785, entitled “Device and Methods,” Date of Report: Aug. 4, 2015, 13 pages. [cited by applicant]
“Serum Amyloid A (SAA) Kit for HORSE”, Jun. 21, 2011 (Jun. 21, 2011), pp. 1-2, XP055125418, Retrieved from the Internet: URL: http://www.frontier-institute.com/wp/wp-content/uploads/catalog/saa-eng.pdf [retrieved on Jun… [cited by applicant]
Allen, B.V., et al., “Leucocyte counts in the heathy English Thoroughbred in Training”, [cited by applicant]
Christensen, M., et al., “Evaluation of an automated assay based on monoclonal anti-human serum amyloid A (SAA) antibodies for measurement of canine, feline and equine SAA”, [cited by applicant]
Christofferson, M., et al., “Evaluation of the systemic acute phase response and endometrial gene expression of serum amyloid A and pro- and anti-inflammatory cytokines in mares with experimentally induced endometritis”, [cited by applicant]
Cywinska, A., et al., “Serum amyloid A level as a potential indicator of the status of endurance horscs”, [cited by applicant]
Hobo, S., et al., “Evaluation of Serum Amyloid A and Surfactant Protein D in Sera for Identification of the Clinical Condition of Horses with Bacterial Pneumonia”, [cited by applicant]
Hultén, C., et al., “Serum amyloid A (SAA) as an aid in the management of infectious disease in the foal: Comparison with total leucocyte count, neutrophil count and fibrinogen”, [cited by applicant]
Hultén, C., et al., “Interleukin 6, serum amyloid a and haptoglobin as markers of treatment efficacy in pigs experimentally infected with [cited by applicant]
International Search Report issued in International Application No. PCT/IB2014/058785, entitled “Device and Methods”, Date of Search: Jun. 27, 2014. [cited by applicant]
Jacobsen, S., et al., “Evaluation of a commercially available human serum amyloid A (SAA) turbidometric immunoassay for determination of equine SAA concentrations”, [cited by applicant]
Jacobsen, S., et al., “Evaluation of a commercially available apparatus for measuring the acute phase protein serum amyloid A in horses”, [cited by applicant]
Patterson, S.D., et al., “Acute phase response in the horse: plasma protein changes associated with adjuvant induced inflammation”, [cited by applicant]
Pepys, M.B., et al., “Serum amyloid A protein (SAA) in horses: objective measurement of the acute phase response”, [cited by applicant]
Stoneham, S.J., et al., “Measurement of serum amyloid A in the neonatal foal using a latex agglutination immunoturbidimetric assay: determination of the normal range, variation with age and response to disease”, [cited by applicant]
Van Wuijckhuise-Sjouke, L.A., et al., “Plasma fibrinogen concentration as a parameter of the presence and severity of inflammatory disease in horses and cattle”, [cited by applicant]
Heegaard et al., “The Acute Phase Response of Haptoglobin and Serum Amyloid a (SAA) in Cattle Undergoing Experimental Infection with Bovine Respiratory Syncytial Virus,” Veterinary Immunology and Immunopathology, 77 (20… [cited by applicant]
Non-Final Office Action issued for U.S. Appl. No. 17/214,795, entitled “Devices and Methods,” Apr. 20, 2023. [cited by applicant]
Final Office Action received for U.S. Appl. No. 17/214,795, mailed on Sep. 7, 2023, 7 pages. [cited by applicant]
Non-Final Office Action received for U.S. Appl. No. 17/214,795, mailed on May 13, 2024, 6 pages. [cited by applicant]
Allen, et al., “Fibrinogen response to surgical tissue trauma in the horse,” Equine Vet J 1988; 20: 441-443. [cited by applicant]
Burrows, “Dose-Response of Ponies to Parenteral [cited by applicant]
Chafflin et al. (2013), “Evaluation of Hematologic Screening Methods for Predicting Subsequent Onset of Clinically Apparent Rhodococcus Equi Pneumonia in Foals”. AEP Proceedings. vol. 59. 2013. p 267. [cited by applicant]
Chafflin, et al., “Evaluation of Ultrasonographic Screening Parameters for Predicting Subsequent Onset of Clinically Apparent Rhodococcus Equi Pneumonia in Foals,” AAEP Proceedings. vol. 59. 2013. p 268. [cited by applicant]
Couetil LL, et al., “Inflammatory Airway Disease of Horses,” J Vet Intern 2007; 21 :356-361. [cited by applicant]
Crisman, et al., “Blood Proteins and Inflammation in the Horse,” Vet Clin Equine Practice 2008; 24:285-297. [cited by applicant]
Heidman, et al., “Rhodococcus equi Pneumonia: Clinical Findings, Diagnosis, Treatment and Prevention,” Clin Tech Eq Pract 2006; 5:203-210. [cited by applicant]
Hulten, et al., “The Acute Phase Protein Serum Amyloid A (SAA) as an Inflammatory Marker in Equine Influenza Virus Infection,” Acta Vet Scand 1999; 40:323-333. [cited by applicant]
Hulten, et al. “Dynamics in serum of the inflammatory markers serum amyloid A (SAA), haptoglobin, fibrinogen and α2-globulins during induced non-infectious arthritis in the horse,” Equine Vet J 2002; 34(7): 699-704. [cited by applicant]
Jacobsen, et al., “Acute Phase Response to Surgery of Varying Intensity in Horses: A Preliminary Study,” Vet Surg 2009; 38:762-769. [cited by applicant]
Jacobsen, et al., “Concentrations of serum amyloid A in serum and synovial fluid from healthy horses and horses with joint disease,” Am J Vet Research 2006; 67(10): 1738-1742. [cited by applicant]
Parry-Billings, et al., “Plasma amino acid concentrations in the overtraining syndrome: possible effects on the immune system,” Med Sci Sports Excer 1992; 24:1353-1358. [cited by applicant]
Pusterla, et al., “Diagnostic Approach to Infectious Respiratory Disorders,” Clin Tech Eq Pract 2006; 5:174-186. [cited by applicant]
Rickets, “Hematologic and Biochemical abnormalities in athletic horses,” In: Hinchcliff KW, Keneps AJ, Geor RJ, editors. Equine Sports Medicine and Surgery, Philadelphia: W.B Saundeffi; 2004, p. 952. [cited by applicant]
Satue, et al., “Factors Influencing Serum Amyloid Type A (Saa) Concentrations in Horses,” Open Journal of Veterinary Medicine 2013 3:58-66. [cited by applicant]
Takizawa, et al., “Usefulness of Plasma Fibrinogen Concentration Measurement in Diagnosis of Respiratory Disorders in Thoroughbred Racehorses,” Equine Sci 2006; 17(2):27-32. [cited by applicant]
Tape, et al., “Apolipoprotein A-I and apolipoprotein SAA half-lives during acute inflammation and amyloidogenesis,” Biochem Biophys Acta 1990; 1043:295-300. [cited by applicant]
Vandenplas, et al., “Concentrations of serum amyloid A and lipopolysaccharide-binding protein in horses with colic,” Am J Vet Res 2005; 66: 1509-1516. [cited by applicant]