Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2005-10-18
2005-10-18
Kemmerer, Elizabeth (Department: 1647)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C530S350000, C530S395000, C530S399000, C424S085100
Reexamination Certificate
active
06956023
ABSTRACT:
The subject invention provides methods for reducing or preventing villous atrophy and feeding intolerance in infants, particularly low birth weight and/or preterm infants, by enterally administering granulocyte-colony stimulating factor (G-CSF), erythropoietin (Epo), or both G-CSF and Epo. The subject invention also provides compositions that comprise G-CSF and/or Epo that may be administered to infants in need thereof. In one embodiment, the composition of the subject invention comprises recombinant G-CSF, recombinant Epo, and one or more electrolyte additives. In a specific embodiment, the electrolyte additive is selected from the group consisting of sodium chloride, sodium acetate, and potassium chloride.
REFERENCES:
patent: 4377513 (1983-03-01), Sugimoto et al.
patent: 4703008 (1987-10-01), Lin
patent: 4810643 (1989-03-01), Souza
patent: 4835260 (1989-05-01), Shoemaker
patent: 5206219 (1993-04-01), Desai
patent: 5399551 (1995-03-01), Ise et al.
patent: 5540945 (1996-07-01), Ikushima
patent: 5574136 (1996-11-01), Nagata et al.
patent: 5580755 (1996-12-01), Souza
patent: 5597562 (1997-01-01), Nomura et al.
patent: 5621080 (1997-04-01), Lin
patent: 5681720 (1997-10-01), Kuga et al.
patent: 5955422 (1999-09-01), Lin
patent: 5965121 (1999-10-01), Leone-Bay et al.
patent: 6096728 (2000-08-01), Collins et al.
patent: 6376218 (2002-04-01), Hsu et al.
patent: 2 283 912 (1995-05-01), None
Todd et al. Temporary banding of the gastroesophageal juncture in a very small neonate with esophageal atresia and tracheoesophagea fistula. Abstract, Minnesota Medicine 73 (7) 30-2 (1990).
Ledbetter et al. Necrotizing enterocolitis and hematopoietic cytokines, Clinics in Perinatology vol. 27/3:697-716 (Sep. 2000).
Bernt, K.M. et al. “Human milk as a carrier of biochemical messages”Acta Paediatr Suppl., 1999, 430:27-41.
Carmichael, R.D. et al. “The Effects of Maternal Phlebotomy and Orally-Administered Erythropoietin (Ep) on Erythropoiesis in the Sucking Rat”Biol. Neonate, 1978, 33:119-131.
Koldovsky, O. “Search for role of Milk-Borne Biologically Active Peptides for the Suckling”J. Nutr.,1989, 119:1543-1551.
Rodriguez-Palmero, M. et al. “Nutritional and Biochemical Properties of Human Milk: II”Clinics in Perinatology, Jun. 1999, 26(2):355-359.
Ames, M., “Gastric acidity in the first ten days of life of the prematurely born baby”Am J. Dis. Child, 1966, 100:252-256.
Benzie, R.J. et al., “Composition of the amniotic fluid and maternal serum in pregnancy”Am J Obstet Gynecol, 1974, 119:798-810.
Berseth, C.L. et al., “Birth asphyxia alters neonatal intestinal motility in term neonates”Pediatrics, 1992, 90:669-673.
Bonsnes, R., “Composition of amniotic fluid”Clin Obstet Gynecol, 1966, 9:440-448.
Britton, J.R. et al., “Enteral administration of recombinant erythropoietin to preterm infants”J. Perinatol.,1995, 15(4):281-283.
Britton, J.R. and Koldovsky, O., “Development of luminal protein digestion: Implications for biologically active dietary polypeptides”J. Pediatr. Gastroenterol. Nutr.,1989, 9(2):144-162.
Buescher, U. et al., “Erythropoietin in amniotic fluid as a marker of chronic fetal hypoxia”Int J Gynaecol Obstet, 1998, 60:257-263.
Calhoun, D. et al., “Distribution of granulocyte colony-stimulating factor (G-CSF)-receptor mRNA and protein in the human fetus”Pediatr. Res.,1999, 43:333-338.
Calhoun, D. et al., “Concentrations of granulocyte colony-stimulating factor in human milk after in vitro simulations of digestion”Pediatr. Res.,, 1999, 46:767-771.
Calhoun, D. et al., “Stability of filgrastim and epoetin alfa in a system designed for enteral administration in neonates”The Annals of Pharmacotherapy, 2000, 34:1257-1261.
Calhoun, D. et al., “Granulocyte colony-stimulating factor is present in human milk and its receptor is present in human fetal intestine”Pediatrics, Jan. 2000, 105(1):E7.
Calhoun, D. et al., “Granulocyte colony-stimulating factor in preterm and term pregnancy, parturition, and intra-amniotic infection”Obstet Gynecol, 2001, 97:229-234.
Clapp, J. et al., “The effect of regular maternal exercise on erythropoietin in cord blood and amniotic fluid”Am. J. Obstet. Gynecol.,1995, 172(5):1445-1451.
Lind, T., et al., “Composition of amniotic fluid and maternal blood through pregnancy”J. Obstet Gynaecol, 1971, 78:505-512.
McCracken, S. et al., “Expression of granulocyte-colony stimulating factor and its receptor is regulated during the development of the human placenta”J. Endocrinol.,1996, 149:249-258.
Mulvihill, S., et al., “Trophic effect of amniotic fluid on fetal gastrointestinal development”J. Surg. Res.,1986, 40:291-296.
Ohls, R. and Christensen R., “Stability of human recombinant epoetin alfa in commonly used neonatal intravenous solutions”Ann. Pharmacother, 1996, 30:466-468.
Schanler, R. et al., “Feeding strategies for premature infants: Randomized trial of gastrointestinal priming and tube-feeding method”Pediatrics, 1999, 103(2):434-439.
Scholz, T. and McGuinness, G., “Localized intestinal perforation following intravenous indomethacin for patent ductus arteriosus”J. Pediatr. Gastroenterol Nutr.,1988, 7:773-775.
Sinha, J., “The volume and compostion of amniotic fluid in early pregnancy”Obstet. Gynaecol.,1970, 77:211-214.
Tada, M. et al., “Analysis of cytokine receptor messenger RNA expression in human glioblastoma cells and normal astrocytes by reverse-transcription”J. Neurosurg.,1994, 80:1063-1073.
Trahair, J. and Harding, R., “Restitution of swallowing in the fetal sheep restores intestinal growth after midgestation esophageal obstruction”,J. Pediatr. Gastroenterol. Nutr.,1995, 20:156-161.
Cothran, D. et al., “Alteration of normal gastric flora in neonates receiving ranitidine”J. Perinatol, 1997, 17(5):383-388.
Emery, A. et al., “Antenatal diagnosis and aminoacid composition of amniotic fluid”Lancet, 1970, 760:1307-1308.
Gersting, J. et al., “Evaluation of the enteral administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF) to mouse pups with an intact G-CSF-Receptor (G-CSF-R) gene (WT) and pups deficient for the G-CSF-R gene (KO)”Pediatr. Res.,2000, 47(4), p. 287A, abstract No. 1696.
Giacoia, G. et al., “Indomethacin and recurrent ileal perforations in a preterm infant”J. Perinatol, 1993, 13:297-299.
Gilmore, W. et al., “Human milk contains granulocyte colony stimulating factor”Eur. J. Clin. Nutr.,1994, 48:222-224.
Juul, S. et al., “Tissue distribution of erythropoietin and erythrpoietin receptor in the developing human fetus”Early Hum. Dev.,1998, 52:235-249.
Juul, S. et al., “Immunohistochmemical localization of erythropoietin and its receptor in the developing human brain”Pediatr. Dev. Pathol.,1999, 2:148-158.
Juul, S., et al., “Why is erythropoietin present in human milk? Studies of erythropoietin receptors on enterocytes of human and rat neonates”Pediatr. Res.,1999, 46(3):263-268.
Juul, S. et al., “The effects of enteral vs parenteral recombinant erythropoietin (rEpo) on bowel growth”Pediatr. Res.,2000, 47(4), p. 165A, abstract No. 971.
Juul, S. et al., “The origin, fate, and function of erythropoietin in human milk”Pediatr. Res.,2000, 47(4), p. 289A, abstract No. 1707.
Kelly, E. et al., “Gastric acid secretion in preterm infants”Early Hum. Dev.,1993, 35:215-220.
Kling, P. et al., “Human milk as a potential enteral source of erythropoietin”Pediatr. Res.,1998, 43,(2):216-221.
Ledbetter, D.J. et al., “Erythropoietin and the incidence of necrotizing enterocolitis in infants with vary low birth weight”J. Pediatr. Surg.,2000, 35(2):178-182.
Berseth, C. “Minimal enteral feedings”Clinics in Perinatology, Mar.
Calhoun Darlene V.
Christensen Robert D.
DeBerry Regina M.
Kemmerer Elizabeth
Saliwanchik Lloyd & Saliwanchik
University of Florida
LandOfFree
Materials and methods for providing nutrition to neonates does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Materials and methods for providing nutrition to neonates, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Materials and methods for providing nutrition to neonates will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3446196