Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
2011-05-24
2011-05-24
Chong, Yong (Department: 1627)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
active
07947681
ABSTRACT:
The present invention is directed to treatment methods of administering tetrahydrobiopterin, including in oral dosage forms, in intravenous formulations, and with food. Also disclosed herein are biopterin assays for measuring the amount of biopterin and metabolites of biopterin in a sample.
REFERENCES:
patent: 4550109 (1985-10-01), Folkers et al.
patent: 4778794 (1988-10-01), Naruse et al.
patent: 5753656 (1998-05-01), Sakai et al.
patent: 6288067 (2001-09-01), Okamura et al.
patent: 6410535 (2002-06-01), Kashiwagi et al.
patent: 6544994 (2003-04-01), Rabelink et al.
patent: 6995158 (2006-02-01), Rabelink et al.
patent: 7566462 (2009-07-01), Jungles et al.
patent: 7566714 (2009-07-01), Oppenheimer et al.
patent: 7727987 (2010-06-01), Moser et al.
patent: 2006/0035900 (2006-02-01), Moser et al.
patent: 2006/0194808 (2006-08-01), Richardson et al.
patent: 2006/0211701 (2006-09-01), Muntau-Heger et al.
patent: 2008/0075666 (2008-03-01), Dudley et al.
patent: 2008/0146577 (2008-06-01), Matalon et al.
patent: 2008/0213239 (2008-09-01), Morris
patent: 1964566 (2005-12-01), None
patent: 1757293 (2007-02-01), None
patent: WO 2004/058268 (2004-07-01), None
patent: WO 2005/049000 (2005-06-01), None
Musson et al., “The bioavaillability of Kuvan™ (sapropterin dihydrochloride) from intact or dissolved tablets administered with or without food to healthy volunteers,” Abstract 70, published on p. 259 ofMolecular Genetics and Metabolism, vol. 93, pp. 221-268 (2008) (presented at The Society for Inherited Metabolic Disorders (SIMD) Annual Meeting, Mar. 25, 2008, Pacific Grove, California).
Schirck's Laboratories, “Summary of Product Characteristics—Tetrahydrobiopterin 10 mg/50 mg Tablets,” dated Jan. 7, 2004.
Schaub et al., Archives of Disease in Childhood, vol. 53, pp. 674-683 (1978).
USPTO, Office Action, U.S. Appl. No. 12/329,838, dated Feb. 25, 2009, pp. 1-12.
USPTO, final Office Action, U.S. Appl. No. 12,329,838, dated May 14, 2009, pp. 1-13.
Belanger-Quintana, et al., “Spanish BH4-responsive phenylalanine hydroxylase-deficient patients: Evolution of seven patients on long-term treatment with tetrahydrobiopterin,”Mol. Gen. Metab., 86:S61-S66 (2005).
Blau, et al., “Optimizing the use of sapropterin (BH4) in the management of phenylketonuria,” Mol. Gen. Metab,, (2009), doi:10.1016/j.ymgme.2009.01.002.
Calbet, et al., “Role of caloric content on gastric emptying in humans,” J Physiol., 498.2: 553-559 (1997).
Fiege, et al., “Plasma tetrahydrobiopterin and its pharmacokinetic following oral administration,”Mol. Gen. Metab., 81:45-51 (2004).
Fleisher et al., “Drug, Meal and Formulation Interactions Influencing Drug Absorption After Oral Administration,” Clin. Pharmacokinet., 37(3):233 (1999).
Gu et al., “Predicting Effect of Food on Extent of Drug Absorption Based on Physicochemical Properties,” Pharmaceutical Research, 24(6):1118 (2007).
Hennermann, et al., “Long-term treatment with tetrahydrobiopterin increases phenylalanine tolerance in children with severe phenotype of phenylketonuria,”Mol. Gen. Metab., 86:S86-S90 (2005).
Lehne et al., Pharmacology for Nursing Care, Edition 4, pp. 63.
Levy, et al., “Efficacy of sapropterin dihydrochloride (tetrahydrobiopterin, 6R-BH4) for reduction of phenylalanine concentration in patients with phenylketonuria: a phase III randomised placebo-controlled study,”The Lancet, 370:504-510 (2007).
Levy, et al., “Recommendations for evaluation of responsiveness to tetrahydrobiopterin (BH4) in phenylketonuria and its use in treatment,”Mol. Gen. Metab., 92:287-291 (2007).
O'Brien and Haddard, US Pharmacist, 22:6: 62 (1997).
Ponzone, et al., “Hyperphenylalaninemia and pterin metabolism in serum and erythrocytes,”Clinica Chim. Acta., 216:63-71 (1993).
Trefz, et al., “Efficacy of Sapropterin Dihydrochloride in Increasing Phenylalanine Tolerance in Children with Phenylketonuria: A Phase III, Randomized Double-Blind, Placebo-Controlled Study,” J. Pediatr, (2008), doi:10.1016/j,peds.2008.11.040).
Schmidt, et al., “Single dose oral tetrahydrobiopterin (BH4) leads to a prolonged increase in aortic BH4 levels in ApoE-KO mice,”Abstracts/Atherosclerosis, 193:S1-S5 (2007).
Shintaku, et al., “Long-Term Treatment and Diagnosis of Tetrahydrobiopterin-Responsive Hyperphenylalaninemia with a Mutant Phenylalanine Hydroxylase Gene,”Ped. Res., 55(3):425-430 (2004).
Shintaku, et al., “Plasma biopterin levels and tetrahydrobiopterin responsiveness,”Mol. Gen. Metab., 86:S104-S106 (2005).
Steinfeld, et al., “A hypothesis on the biochemical mechanism of BH4-responsiveness in phenylalanine hydroxylase deficiency,”Amino Acids, 25:63-68 (2003).
Zurfluh, et al., “Pharmacokinetics of orally administered tetrahydrobiopterin in patients with phenylalanine hydroxylase deficiency,”J. Inherit. Metab. Dis., 29:725-731 (2006).
International Search Report for PCT/US2008/060041.
Written Opinion for PCT/US2008/060041.
Castillo Sianna
Dorenbaum Alejandro
Foehr Erik
Kostel Paul J.
Okhamafe Augustus
Biomarin Pharmaceutical Inc.
Chong Yong
Marshall & Gerstein & Borun LLP
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