Appeal No. 2005-2593 21
Application No. 90/005,867
J. Rejection of claims 31 and 32 under 35 U.S.C. § 103
Claims 31 and 32 are rejected under 35 U.S.C. § 103 as being unpatentable over
the combined teachings of Fahy, Scow, Umbreit and Pierpaoli. Claim 31 reads as
follows:
31. The kit of claim 30, wherein the amount of human growth
hormone is provided in intravenous unit form in doses of less than 0.5 mg
per day.
Fahy discloses that human growth hormone is administered by subcutaneous
injection or other efficacious route every day, every other day or three times a week at
an HGH equivalent dose of 0.01 to 0.05 mg/kg of body weight. See Fahy at 5, lines 6-
10. According to the teachings in Fahy, a dose of less than 0.5 mg per day would be
administered to a patient weighing less than 50 kg and receiving 0.01 mg/kg of human
growth hormone.13 It would have been prima facie obvious to one of ordinary skill in the
art to provide that dose in intravenous unit form as recited in claim 31.14 See Kotzab,
217 F.3d at 1370, 55 USPQ2d at 1317 (suggestion to modify may come explicitly from
statements in the prior art, the knowledge of one of ordinary skill in the art or may be
implicit from the prior art as a whole). The appellant has
failed to present any evidence to the contrary. Therefore, the rejection of claim 31
under
35 U.S.C. § 103 is affirmed.
13 Claims 30 and 31 are not limited to human patients.
14 The appellant does not argue that intravenous application is patentably distinct from subcutaneous
injection. See Reply Brief at 26.
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