Appeal No. 2004-2170 Page 2
Application No. 09/901,429
wherein treatment with said propranolol improves skeletal muscle protein kinetics in
said individual as compared to [an] individual without said treatment.
The reference relied on by the examiner is:
Herndon et al. (Herndon), “Lipolysis in Burned Patients is Stimulated by the $2-Receptor
for Catecholamines,” Arch. Surg., Vol. 129, pp. 1301-1305 (December 1994)
Claims 1-7 and 9-12 stand rejected under 35 U.S.C. § 102(b) as anticipated by
Herndon. We reverse.
BACKGROUND
The hypermetabolic response to severe burn is associated with increased
energy expenditure and substrate release from protein and fat stores.
After severe trauma, net protein catabolism is increased which leads to
loss of lean body mass and muscle wasting. Muscle proteolysis continues
for at least 9 months after severe burn which predisposes patients to
delays in rehabilitation, and increased morbidity and mortality.
Endogenous catecholamines are primary mediators of the hypermetabolic
response to trauma or burn. Shortly after severe trauma or burn, plasma
catecholamine levels increase as much as 10-fold. This systemic
response to injury is characterized by development of a hyperdynamic
circulation, elevated basal energy expenditure, and net skeletal muscle
protein catabolism.
Specification, page 2 (citations omitted).
The present invention demonstrates that blockade of $-adrenergic
stimulation with orally administered propranolol decreases resting energy
expenditure and net muscle catabolism. Twenty-five [ ] severely burned
. . . children were studied . . . Thirteen of the subjects received oral
propranolol for at least two weeks, and twelve served as non-treated
controls. Propranolol was titrated to decrease resting heart rate 20% from
the patient’s baseline. Resting energy expenditure [ ] and skeletal muscle
protein kinetics were measured before and after two weeks of $-blockade
. . .
During beta blockade, heart rates and resting energy expenditures of the
propranolol group were lower than baseline and lower than those of the
control group (p<0.05). Corresponding to the significant differences in
heart rate and resting energy expenditure, muscle protein net balance
improved 82% relative to pre-treated baseline in the subjects treated with
propranolol while it decreased 27% in the non-treated control subjects
(p<0.05) . . .
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