Source: https://patents.google.com/patent/US9308224B2/en
Timestamp: 2019-06-17 19:00:31
Document Index: 179736816

Matched Legal Cases: ['Application No. 61', 'Application No. 61', 'Application No. 61', 'Application No. 09715775', 'Application No. 09715775', 'Application No. 09715775', 'Application No. 09715775', 'Art. 94', 'Art. 94', 'Art. 94', 'Art. 94']

US9308224B2 - Methods and compositions for delivering interleukin-1 receptor antagonist - Google Patents
US9308224B2
US9308224B2 US14/271,722 US201414271722A US9308224B2 US 9308224 B2 US9308224 B2 US 9308224B2 US 201414271722 A US201414271722 A US 201414271722A US 9308224 B2 US9308224 B2 US 9308224B2
US14/271,722
US20140242045A1 (en
2014-05-07 Priority to US14/271,722 priority patent/US9308224B2/en
2014-05-07 Application filed by Biomet Biologics LLC filed Critical Biomet Biologics LLC
2014-07-14 Assigned to BIOMET BIOLOGICS, LLC reassignment BIOMET BIOLOGICS, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HIGGINS, JOEL C., HOEPPNER, JACY, WOODELL-MAY, JENNIFER E.
2014-08-28 Publication of US20140242045A1 publication Critical patent/US20140242045A1/en
2016-04-12 Publication of US9308224B2 publication Critical patent/US9308224B2/en
This application is a division of U.S. patent application Ser. No. 12/549,015, filed on Aug. 27, 2009, which is a continuation-in-part of U.S. patent application Ser. No. 12/394,723 filed on Feb. 27, 2009 which claims the benefit of U.S. Provisional Application No. 61/031,803, filed on Feb. 27, 2008; U.S. Provisional Application No. 61/116,940, filed on Nov. 21, 2008; and U.S. Provisional Application No. 61/155,048, filed on Feb. 24, 2009. The entire disclosures of each of the above applications are incorporated herein by reference.
Adipose tissue (120 g) is collected and prepared using GPS® III disposables (Biomet Biologics LLC, Warsaw, Ind., USA). The isolated adipose tissue is loaded into modified plasma concentration devices (Plasmax®, Biomet Biologics LLC, Warsaw, Ind., USA) and processed. The output is divided into 4 groups; IL-1ra in concentrated plasma with and without thrombin activation (1000 U/ml in 1 M CaCl2), or cell-free IL-1ra with and without thrombin activation. IL-1ra is measured using ELISA (R&D Systems) over time.
1. A method of treating a site of inflammation in a patient comprising:
(a) contacting a liquid volume comprising isolated adipose tissue with polyacrylamide beads, wherein the polyacrylamide beads activate the isolated adipose tissue to produce interleukin-1 receptor antagonist to form a solution rich in interleukin-1 receptor antagonist;
(b) separating the solution rich in interleukin-1 receptor antagonist from the isolated adipocytes and the polyacrylamide beads; and
(c) administering the solution rich in interleukin-1 receptor antagonist to the site of inflammation in the patient.
2. The method of treating a site of inflammation in a patient according to claim 1, wherein the isolated adipose tissue is derived from the patient.
3. The method of treating a site of inflammation in a patient according to claim 1, wherein the inflammation is associated with osteoarthritis.
4. The method of treating a site of inflammation in a patient according to claim 1, wherein the administering further comprises administering fibrinogen, thrombin, and calcium to the site of inflammation.
5. The method of treating a site of inflammation in a patient according to claim 1, wherein the administering comprises co-administering (i) a first solution comprising the solution rich in interleukin1 receptor antagonist and fibrinogen, and (ii) a second solution comprising thrombin and calcium.
6. The method of treating a site of inflammation in a patient according to claim 4, wherein the thrombin is made by a process comprising:
7. The method of treating a site of inflammation in a patient according to claim 6, wherein the whole blood or plasma is obtained from the patient.
8. A method of treating an inflammatory disorder in a patient, the method comprising:
(b) loading the adipose tissue into a concentrator assembly including polyacrylamide beads and incubating the mixture of beads and adipose tissue to form a solution rich in interleukin-1 receptor antagonist;
(c) rotating the concentrator assembly at centrifugal speeds to separate the polyacrylamide beads from the solution rich in interleukin-1 receptor antagonist;
(e) loading the whole blood and a calcium solution into a blood isolation device; (f) heating the whole blood for at least about 20 minutes, at a temperature of at least about 20° C.; (g) centrifuging the heated whole blood and obtaining a clotting fraction; and
(h) administering the solution rich in interleukin-1 receptor antagonist and the clotting fraction to the site of the inflammation in the patient.
9. The method of treating an inflammatory disorder in a patient according to claim 8, wherein the loading of step (b) further comprises loading a liquid volume comprising white blood cells with the adipose tissue into the concentrator assembly including polyacrylamide beads and incubating the mixture of beads, adipose tissue, and white blood cells to form a solution rich in interleukin-1 receptor antagonist.
10. The method of treating an inflammatory disorder in a patient according to claim 9, wherein the liquid volume comprising white blood cells is whole blood, platelet rich plasma, or whole blood and platelet rich plasma.
11. The method of treating an inflammatory disorder in a patient according to claim 8, wherein the administering further comprises administering fibrinogen to a site of the inflammation in the patient.
12. The method of treating an inflammatory disorder in a patient according to claim 8, wherein the site of inflammation is due at least in part to osteoarthritis.
13. The method of treating a site of inflammation in a patient according to claim 1, wherein the liquid volume comprising isolated adipose tissue further comprises platelet rich plasma or whole blood.
14. The method of treating a site of inflammation in a patient according to claim 1, wherein the patient is a human.
15. The method of treating a site of inflammation in a patient according to claim 1, wherein the solution rich in interleukin-1 receptor antagonist comprises from about 30,000 pg/mL to about 110,000 pg/mL interleukin-1 receptor antagonist.
16. The method of treating a site of inflammation in a patient according to claim 1, wherein the step (b) comprises centrifuging the liquid volume of isolated adipose tissue and polyacrylamide beads to obtain a supernatant comprising the solution rich in interleukin-1 receptor antagonist.
17. A method of treating a site of inflammation in a patient comprising:
(a) obtaining a liquid volume comprising adipocytes and a liquid volume comprising white blood cells from the patient;
(b) contacting the liquid volume comprising adipocytes and a liquid volume comprising white blood cells with polyacrylamide beads;
(c) separating the liquid volume from the polyacrylamide beads, the adipocytes and the white blood cells to obtain a solution rich in interleukin-1 receptor antagonist; and
(d) administering the solution rich in interleukin-1 receptor antagonist to the site of inflammation in the patient.
18. The method of treating a site of inflammation in a patient according to claim 17, wherein the liquid volume comprising adipocytes is part of isolated adipose tissue.
19. The method of treating a site of inflammation in a patient according to claim 17, wherein the step (b) comprises incubating the liquid volume comprising adipocytes and the liquid volume comprising white blood cells with the polyacrylamide beads for a time of from about 30 seconds to about 24 hours.
20. The method of treating a site of inflammation in a patient according to claim 17, wherein the liquid volume comprising white blood cells is whole blood, platelet rich plasma, or whole blood and platelet rich plasma.
21. The method of treating a site of inflammation in a patient according to claim 17, wherein the separating step (c) comprises centrifuging the liquid volume of adipocytes and polyacrylamide beads to obtain a supernatant comprising the solution rich in interleukin-1 receptor antagonist.
22. The method of treating a site of inflammation in a patient according to claim 17, wherein the solution rich in interleukin-1 receptor antagonist comprises from about 30,000 pg/mL to about 110,000 pg/mL interleukin-1 receptor antagonist.
23. The method of treating a site of inflammation in a patient according to claim 17, wherein the patient is a human.
US14/271,722 2008-02-27 2014-05-07 Methods and compositions for delivering interleukin-1 receptor antagonist Active 2029-09-17 US9308224B2 (en)
US12/549,015 Division US8753690B2 (en) 2008-02-27 2009-08-27 Methods and compositions for delivering interleukin-1 receptor antagonist
US20140242045A1 US20140242045A1 (en) 2014-08-28
US9308224B2 true US9308224B2 (en) 2016-04-12
WO2000046249A1 (en) 1999-02-01 2000-08-10 Orthogen Gentechnologie Gmbh Method for producing il-1ra, a therapeutically active protein from body fluids
JP2001515088A (en) 1997-08-16 2001-09-18 オルソゲン ジェンテクノロジーゲーエムベーハー Method for inducing a protein having a therapeutic effect
JP2002540818A (en) 1999-02-01 2002-12-03 オルソゲン アーゲー Methods for producing interleukin-1 receptor antagonist is therapeutically effective proteins from body fluids
CN102596173A (en) 2009-08-27 2012-07-18 拜欧米特生物制剂有限责任公司 Methods and compositions for delivering interleukin-1 receptor antagonist
WO2011031524A3 (en) 2009-08-27 2011-09-15 Biomet Biologics, Llc Methods and compositions for delivering interleukin-1 receptor antagonist
"Australian Application Serial No. 2010292553, First Examiner Report mailed Feb. 7, 2014", 3 pgs.
"Bio-Gel P Polyacrylamide Gel", Instruction Manual, downloaded on Jun. 20, 2012 from [Online] retrieved from internet: , 1-14.
"Bio-Gel P Polyacrylamide Gel", Instruction Manual, downloaded on Jun. 20, 2012 from [Online] retrieved from internet: <www.bio-rad.com/webmaster/pdfs/9154-Bio-Gel P.pdf>, 1-14.
"Canadian Application Serial No. 2,772,067, Office Action mailed Jan. 8, 2015", 3 pgs.
"Chinese Application Serial No. 2010800428565, Non Final Office Action mailed Feb. 14, 2014", W/ English Translation, 5 pgs.
"Chinese Application Serial No. 2010800428565, Non Final Office Action mailed Jan. 22, 2013", W/ English Translation, 10 pgs.
"Chinese Application Serial No. 2010800428565, Non Final Office Action mailed Sep. 10, 2013", W/ English Translation, 10 pgs.
"Chinese Application Serial No. 2010800428565, Response filed Apr. 29, 2014 to Non Final Office Action mailed Feb. 14, 2014", W/ English Claims, 7 pgs.
"Chinese Application Serial No. 2010800428565, Response filed Aug. 6, 2013 to Non Final Office Action mailed Jan. 22, 2013", W/ English Claims, 9 pgs.
"Chinese Application Serial No. 2010800428565,Response filed Nov. 25, 2013 to Non Final Office Action mailed Sep. 10, 2013", W/ English Claims, 10 pgs.
"European Application No. 09715775.4, Non Final Office Action mailed Apr. 26, 2011", 5 pgs.
"European Application No. 09715775.4, Preliminary Amendment filed Sep. 22, 2010", 9 pgs.
"European Application No. 09715775.4,Response filed Oct. 12, 2011 to Non Final Office Action mailed Apr. 26, 2011", 20 pgs.
"European Application No. 09715775.4,Supplemental Preliminary Amendment filed Nov. 17, 2010", 12 pgs.
"European Application Serial No. 10754379.5, Examination Notification Art. 94(3) mailed Aug. 16, 2013", 5 pgs.
"European Application Serial No. 10754379.5, Examination Notification Art. 94(3) mailed Dec. 15, 2014", 4 pgs.
"European Application Serial No. 10754379.5, Office Action mailed Apr. 3, 2012", 2 pgs.
"European Application Serial No. 10754379.5, Response filed Apr. 13, 2015 to Examination Notifaction Art. 94(3) mailed Dec. 15, 2014", 8 pgs.
"European Application Serial No. 10754379.5, Response filed Feb. 17, 2014 to Examination Notification Art. 94(3) mailed Aug. 16, 2013", 13 pgs.
"European Application Serial No. 10754379.5, Response filed Sep. 28, 2012 to Office Action mailed Apr. 3, 2012", 11 pgs.
"European Application Serial No. 12195882.1, Extended European Search Report mailed Jan. 31, 2013", 5 pgs.
"European Application Serial No. 12195882.1, Non Final Office Action mailed Jun. 30, 2014", 4 pgs.
"European Application Serial No. 12195882.1, Response filed Oct. 29, 2014 to Non Final Office Action mailed Jun. 30, 2014", 18 pgs.
"European Application Serial No. 12195882.1, Response filed Sep. 11, 2013 to Extended European Search Report mailed Jan. 31, 2013", 16 pgs.
"European Application Serial No. 13165543.3, Extended European Search Report mailed Jul. 1, 2013", 6 pgs.
"European Application Serial No. 13165543.3, Non Final Office Action mailed Jun. 27, 2014", 5 pgs.
"European Application Serial No. 13165543.3, Response filed Jan. 14, 2014 to Extended European Search Report mailed Jul. 1, 2013", 11 pgs.
"GPS® II System, Gravitational Platelet Separation System", Cell Factor Technologies, Inc., [Online]. Retrieved from the Internet: , (Sep. 16, 2005), 13 pgs.
"GPS® II System, Gravitational Platelet Separation System", Cell Factor Technologies, Inc., [Online]. Retrieved from the Internet: <http://www.cellfactortech.com/global-products.cfm,>, (Sep. 16, 2005), 13 pgs.
"International Application Serial No. PCT/US2009/035541, International Preliminary Report on Patentability mailed Aug. 13, 2010", 8 pgs.
"International Application Serial No. PCT/US2009/035541, International Search Report mailed Jun. 16, 2009", 3 pgs.
"International Application Serial No. PCT/US2009/035541, Written Opinon mailed Jun. 16, 2009", 7 pgs.
"International Application Serial No. PCT/US2010/046821, International Preliminary Report on Patentability mailed Mar. 8, 2012", 6 pgs.
"International Application Serial No. PCT/US2010/046821, International Search Report mailed Jul. 22, 2011", 4 pgs.
"International Application Serial No. PCT/US2010/046821, Written Opinion mailed Jul. 22, 2011", 4 pgs.
"Isolation of Granulocytes From Human Peripheral Blood by Density Gradient Centrifugation", Miltenyi Biotec GmbH, (2008), 2 pgs.
"Japanese Application Serial No. 2012-526988, Office Action mailed Oct. 1, 2013", W/ English Translation, 4 pgs.
"Japanese Application Serial No. 2012-526988, Response filed Mar. 3, 2014 to Office Action mailed Oct. 1, 2013", W/ English Claims, 21 pgs.
"U.S. Appl. No. 12/394,723, Advisory Action mailed Dec. 19, 2014", 3 pgs.
"U.S. Appl. No. 12/394,723, Final Office Action mailed Jun. 26, 2012", 11 pgs.
"U.S. Appl. No. 12/394,723, Final Office Action mailed Sep. 9, 2014", 8 pgs.
"U.S. Appl. No. 12/394,723, Non Final Office Action mailed Feb. 7, 2014", 8 pgs.
"U.S. Appl. No. 12/394,723, Non Final Office Action mailed Oct. 31, 2011", 11 pgs.
"U.S. Appl. No. 12/394,723, Response filed Apr. 30, 2012 to Non Final Office Action mailed Oct. 31, 2011", 16 pgs.
"U.S. Appl. No. 12/394,723, Response filed Aug. 22, 2011 to Restriction Requirement mailed Jul. 20, 2011", 2 pgs.
"U.S. Appl. No. 12/394,723, Response filed Dec. 10, 2014 to Final Office Action mailed Sep. 8, 2014", 18 pgs.
"U.S. Appl. No. 12/394,723, Response filed Dec. 19, 2012 to Final Office Action mailed Jun. 26, 2012", 16 pgs.
"U.S. Appl. No. 12/394,723, Response filed Jul. 23, 2014 to Non Final Office Action mailed Feb. 7, 2014", 19 pgs.
"U.S. Appl. No. 12/394,723, Restriction Requirement mailed Jul. 20, 2011", 7 pgs.
"U.S. Appl. No. 12/549,015, Examiner Interview Summary mailed Dec. 3, 2012", 3 pgs.
"U.S. Appl. No. 12/549,015, Final Office Action mailed Aug. 16, 2012", 8 pgs.
"U.S. Appl. No. 12/549,015, Non Final Office Action mailed Mar. 9, 2012", 8 pgs.
"U.S. Appl. No. 12/549,015, Notice of Allowance mailed Feb. 3, 2014", 9 pgs.
"U.S. Appl. No. 12/549,015, Response filed Dec. 17, 2012 to Final Office Action mailed Aug. 16, 2012", 17 pgs.
"U.S. Appl. No. 12/549,015, Response filed Feb. 9, 2012 to Restriction Requirement mailed Jan. 9, 2012", 2 pgs.
"U.S. Appl. No. 12/549,015, Response filed Jul. 6, 2012 to Non Final Office Action mailed Mar. 9, 2012", 12 pgs.
"U.S. Appl. No. 12/549,015, Restriction Requirement mailed Jan. 9, 2012", 5 pgs.
Anitua, E. et al. "Autologous platelets as a source of proteins for healing and tissue regeneration" Thromb Haemost, vol. 91 (pp. 4-15) 2004.
Bendele, Alison M, et al., "Combination Benefit of Treatment With the Cytokine Inhibitors interleukin-1 Receptor Antagonist and Pegylated Soluble Tumor Necrosis Factor Receptor Type I in animal models of Rheumatoid Arthritis", Arthritis & Rheumatism, Wiley, US, vol. 43, No. 1, (Dec. 1, 2000), 2648-2659.
Bielecki, T. et al, "Antibacterial effect of autologous platelet gel enriched with growth factors and toher acive substances" J Bone Joint Surg, vol. 89-B, No. 3 (P417-420) Mar. 2007.
Burnout, T. "Blood-derived, tissue engineering biomaterials" Biomedical Engineering-Applications, Basis & Communications, vol. 16, No. 6, Dec. 2004 (pp. 294-304).
Dayer, Jean-Michel, et al. "Adipose tissue has anti-inflammatory properties: focus on IL-1 receptor antagonist (IL-1Ra)", Annals of the New York Academy of Sciences, vol. 1069, (Jun. 2006), 444-53.
Dinarello, C. A. Interleukin-1 in the pathogenesis and treatment of inflammatory diseases. Blood, 2011, vol. 117 (14), p. 3720-3732.
Fiotti, et al., "Atherosclerosis and Inftammation, Patterns of Cytokine Regulation in Patients with Peripheral Arterial Disease", Atherosclerosis. Elsevier Ireland Ltd. IE, vol. 145, No. 1, (Jul. 1, 1999), 51-60.
Juge-Aubry, C. et al., "Regulatory Effects of Interleukin (IL)-1, Interferon-beta. and IL-4 on the Production of IL-1 Receptor Antagonist by Human Adipose Tissue", The Journal of Clinical Endocrinology & Metabolism, vol. 89, No. 6, (Jun. 2004), 2652-2658.
Juge-Aubry, C. et al., "Regulatory Effects of Interleukin (IL)-1, Interferon-β. and IL-4 on the Production of IL-1 Receptor Antagonist by Human Adipose Tissue", The Journal of Clinical Endocrinology & Metabolism, vol. 89, No. 6, (Jun. 2004), 2652-2658.
Kaufman, A. et al. "Human macrophage response to UHMWPE, TiAIV, CoCr, and alumina particles: Analysis of multiple cytokines using protein arrays" Journal of Biomedical Materials Research Part A, published online in Wiley InterScience DOI: 10.1002/jbm.a.31467 (pp. 464-474) Jul. 2007.
Klingenberg, et al., "Treating inflammation in Atherosclerotic Cardiovascular Disease: Emerging Therapies", European Heart Journal., vol. 30, No. 23, (Dec. 2009), 2838-2844.
Meier, H. "The production of antiinflammatory cytokines in whole blood by physicochemical induction", Inflamm. Res., vol. 52, (Oct. 2003), 404-407.
Murphy, Michael P. et al., "Autologous Bone Marrow Mononuclear Cell Therapy Is Safe and Promotes Amputation-Free Survival in Patients With Critical Limb Ischemia", Journal of Vascular Surgery, C.V. Mosby Co., St. Louis, MO, US, vol. 53, No. 6, (Jan. 28, 2011), 1565-1574.
Rader, C. et al. "Cytokine Response of Human Macrophage-like Cells After Contact With Polyethylene and Pure Titanium Particles" The Journal of Arthroplasty, vol. 14, No. 7 pp. 840-848 (Oct. 1999).
Swift, M. et al. "Characterization of Growth Factors in Platelet Rich Plasma" Cell Factor Technologies, Inc. (2005) from www.cellfactortech.com/global-products.cfm.
Woodell-May, J. et al. Autologous protein solution inhibits MMP-13 production by IL-1beta and TNFalpha-stimulated human articular chondrocytes. J Orthop Res Sep. 15, 2011; 29:1320-6.
US5837233A (en) 1998-11-17 Method for treating tumors
JP2008504816A (en) 2008-02-21 Clinically safe adipose tissue-derived regenerative cells are isolated, a system and method for using
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:HIGGINS, JOEL C.;WOODELL-MAY, JENNIFER E.;HOEPPNER, JACY;REEL/FRAME:033306/0378