Reduced volume formulation of glatiramer acetate and methods...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai

Reexamination Certificate

Rate now

  [ 0.00 ] – not rated yet Voters 0   Comments 0

Details

Reexamination Certificate

active

07855176

ABSTRACT:
A method for reducing frequency of relapses in a human patient afflicted with relapsing-remitting multiple sclerosis (RRMS) comprising administering to the patient 0.5 ml of an aqueous pharmaceutical solution of 20 mg glatiramer acetate and 20 mg mannitol.

REFERENCES:
patent: 5137516 (1992-08-01), Rand et al.
patent: 5981589 (1999-11-01), Konfino et al.
patent: 6048898 (2000-04-01), Konfino et al.
patent: 6054430 (2000-04-01), Konfino et al.
patent: 6342476 (2002-01-01), Konfino et al.
patent: 6362161 (2002-03-01), Konfino et al.
patent: 6620847 (2003-09-01), Konfino et al.
patent: 6939539 (2005-09-01), Konfino et al.
patent: 7033582 (2006-04-01), Yong et al.
patent: 7199098 (2007-04-01), Konfino et al.
patent: 7442185 (2008-10-01), Amark et al.
patent: 7560100 (2009-07-01), Pinchasi et al.
patent: 7585843 (2009-09-01), Garren et al.
patent: 7655221 (2010-02-01), Rasmussen et al.
patent: 2002/0077278 (2002-06-01), Yong et al.
patent: 2004/0039336 (2004-02-01), Amark et al.
patent: 2004/0106554 (2004-06-01), Konfino et al.
patent: 2006/0154862 (2006-07-01), Ray et al.
patent: 2007/0161566 (2007-07-01), Pinchasi
patent: 2008/0118553 (2008-05-01), Frenkel et al.
patent: 2009/0048181 (2009-02-01), Schipper et al.
patent: 2009/0149541 (2009-06-01), Stark et al.
patent: 1349590 (2006-05-01), None
patent: WO 02/47746 (2002-06-01), None
patent: WO 2006/029036 (2006-03-01), None
patent: WO 2009/070298 (2009-06-01), None
Gibson M. “Selection of Injection Volume”. Pharmaceutical Preformulation and Formulation. Interpharm/CRC. 2004, p. 332.
U.S. Appl. No. 12/761,367, filed Apr. 15, 2010, Ayelet Altman et al.
Pre-Examination Search Report, Feb. 23, 2010 from Envision IP Inc.
Updated Pre-Examination Search Report, Apr. 9, 2010 from Envision IP Inc.
Cohen et al., Randomized, double-blind, dose-comparison study of glatiramer acetate in relapsing-remitting MS, Neuroloy, 2007 68:939-944.
Teva Press Release, Teva Provides Update on FORTE Trial, Jul. 7, 2008.
Disease-moifying agents in multiple sclerosis, P.K. Coyle, Ann. Indian Acad. Neurol. Oct.-Dec. 2009 12(4) 273-282.
U.S. Appl. No. 29/370,420, filed Jul. 14, 2010, Tomer El-Gad, et al.
U.S. Appl. No. 29/370,417, filed Jul. 14, 2010, Tomer El-Gad, et al.
U.S. Appl. No. 12/806,684, filed Aug. 19, 2010, Klinger.
U.S. Appl. No. 12/861,655, filed Aug. 23, 2010, Stark and Ladakani.
Jun. 20, 2008 Office Action issued in connection with U.S. Appl. No. 11/651,212, filed Jan. 9, 2007 (U.S. Patent App. Publication No. US 2007/0161566) (“Pinchasi”).
Apr. 2, 2009 Final Office Action issued in connection with U.S. Appl. No. 11/651,212, filed Jan. 9, 2007 (U.S. Patent App. Publication No. US 2007/0161566) (“Pinchasi”).
Jul. 20, 2009 Office Action issued in connection with U.S. Appl. No. 11/651,212, filed Jan. 9, 2007 (U.S. Patent App. Publication No. US 2007/0161566) (“Pinchasi”).
Dec. 22, 2008 Amendment In Response to Jun. 20, 2008 Office Action issued in connection with U.S. Appl. No. 11/651,212 (U.S. Patent App. No. US 2007/0161566) (“Pinchasi”).
Jul. 1, 2009 Response to Apr. 2, 2009 Final Office Action issued in connection with U.S. Appl. No. 11/651,212, (U.S. Patent App Publication No. US 2007/0161566) (“Pinchasi”).
Jul. 27, 2010 Office Action issued by the Canadian Intellectual Property Office in connection with Canadian Patent Application No. 2,697,570, filed Apr. 15, 2010.
Aug. 30, 2010 Response to Jul. 27, 2010 Office Action issued by the Canadian Patent Office in connection with Canadian Patent Application No. 2,697,570, filed Apr. 15, 2010.
Supplementary European Search Report issued on Jul. 29, 2010 in connection with European Application No. 10160099.7-1219.
Anderson, et al. (1992) “Revised estimate of the prevalence of multiple sclerosis in the United States”. Ann Neurol. 31:333-36.
Anderson, et al. “Injection pain decreases . . . ” The Consortium of Multiple Sclerosis Centers 2010 Annual Meeting, Jun. 2-5, 2010, San Antoinio, Texas (Abstract only).
Arnon and Aharoni (2007) “Neurogenesis and neuroprotection in the CAN-Fundamental elements in the effect of . . . ”. Mol Neurobiol. 36:245-53.
Bjartmar C, et al. (2002) “Pathological mechanisms and disease progression of multiple sclerosis: therapeutic implications”. Drugs of Today. 38:7-29.
Bornstein, et al. (1987) “A pilot trial of Cop 1 in exacerbating remitting multiple sclerosis”. New Eng J Med. 317:408-14.
Bornstein, et al. (1991) “A placebo-controlled, double-blind, randomized, two-center, pilot trial of Cop-1 in chronic progressive multiple sclerosis”. Neurology. 41:533-39.
Brazeau GA, et al. (1998) “Current perspectives on pain upon injection of drugs”. J Pharmaceutical Sci.(87)6:667-677.
Chantelau e, et al. (1991) “What make insulin injections painful?” BMJ. 303:26-27.
Comi, et al. (2008) “Results from a phase III, one-year, randomized, double-blind, parallel-group . . . ”. Mult Scler. 14(suppl 1):S299.
Comi G. “Treatment with glatiramer . . . ”. Program and abstracts of the American Academy of Neurology 60th Annual Meeting; Apr. 12-19, 2008; Chicago, Illinois. LBS.003.
Comi, et al. (2001) “European/Canadian multicenter, double-blind, randomized, placebo-controlled study . . . ”. Ann Neurol. 49:290-7.
Dhib-Jalbut S. (2003) “Glatiramer acetate (Copaxone) therapy for multiple sclerosis” Pharmacology & Therapeutics. 98:245-55.
Dhib-Jalbut S. (2002) “Mechanisms of action of interferons and glatiramer acetate in multiple sclerosis”. Neurology. 58(Suppl 4):S3-S9.
Frenken LA, et al. (1994) “Analysis of the efficacy of measures to reduce pain after subcutaneous administration of epoetin alfa”. Nephrol Dial Transplant. 9:1295-1298.
Johnson, et al. (1998) “Extended use of glatiramer acetate (Copaxone) is well tolerated . . . ”. Neurology. 50:701-8.
Jørgensen, et al. (1996) “Pain Assessment of Subcutaneous Injections” Ann Pharmacother. 30(7):729-732.
Kansara, et al. (2009) “Subcutaneous Delivery”. Drug Deliv Technol. Jun. 2009; 9(6):38-42.
Miller D, et al. (2005) “Clinically isolated syndromes suggestive of multiple sclerosis, part I: natural history . . . ”. Lancet Neurol. 4(5):281-288.
Miller D, et al. (2005) “Clinically isolated syndromes suggestive of multiple sclerosis, part II: non-conventional MRI . . . ”. Lancet Neurol. 4(6):341-348.
Neuhaus O, et al. (2003) “Immunomodulation in multiple sclerosis: from immunosuppression to neuroprotection”. Trends Pharmacol Sci. 24:131-138.
Noseworthy, et al. (2000) “Multiple sclerosis”. N Engl J Med. 343:938-52.
Polman, et al. (2005) “Diagnostic Criteria for Multiple Sclerosis: 2005 Revisions to the “McDonald” Criteria”. Ann Neurol. 58:840-846.
Ruggiere, et al. (2007) “Glatiramer acetate in multiple sclerosis: A review”. CNS Drug Reviews. 13(2):178-91.
Schrempf W, et al. (2007) “Glatiramer acetate: Mechanisms of action in multiple sclerosis”. Autoimmunity Reviews 2007. 6:469-475.
Shire, et al. (2004) “Challenges in the Development of High Protein Concentration Formulations”. J Pharm Sci. 93(6):1390-1402.
Thrower BW. (2007) “Clinically isolated syndromes. Predicting and delaying multiple sclerosis”. Neurology. 68 (Suppl 4):S12-S15.
Tselis, et al. (2007) “Glatiramer acetate in the treatment of multiple sclerosis”. Neuropsychiatric Dis Treat. 3(2):259-67.
Weber, et al. (2007) “Mechanism of action of glatiramer acetate in treatment of multiple sclerosis”. Neurotherapeutics. 4(4):647-53.
Wolinsky, et al. (2007) “Glatiramer acetate in primary progressive multiple sclerosis: Results of a multinational, multicenter, double-blind, placebo-controlled trial”. An.
Wolinsky, JS (2006) “The use of glatiramer acetate in the treatment of multiple sclerosis

LandOfFree

Say what you really think

Search LandOfFree.com for the USA inventors and patents. Rate them and share your experience with other people.

Rating

Reduced volume formulation of glatiramer acetate and methods... does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Reduced volume formulation of glatiramer acetate and methods..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Reduced volume formulation of glatiramer acetate and methods... will most certainly appreciate the feedback.

Rate now

     

Profile ID: LFUS-PAI-O-4228099

  Search
All data on this website is collected from public sources. Our data reflects the most accurate information available at the time of publication.