Appeal No. 2001-1218 Page 6
Application No. 08/727,798
3. Obviousness
Claims 19-20 and 22 stand rejected under 35 U.S.C. § 103(a) as being
obvious over the combination of Rivier with Folkers.
It is the position of the examiner that:
Rivier discloses a peptide intermediate for a GnRH antagonist of
the structure as shown at col. 4, lines 1-68 through col. 6, line 8.
The definitions for each of the amino acids in the peptide sequence
are provided in col. 3 and abstract. Rivier fails to disclose a
peptide intermediate with Lys or Orn at position 5 and e.g.,
isopropyl Lys (ILys) at position 8, as recited. However, Folkers
discloses that substitution of Arg at position 5 with Lys and Ilys at
position 8 result in gonadotropin releasing hormone (GnRH) having
superior antiovulatory and histamine release activities. See e.g.,
col. 10, lines 30-46 and Table I. Accordingly, to prepare an
intermediate with Lys in the peptide intermediate of Rivier, instead
of Arg at positions 5 and/or 8, would have been obvious to one
having ordinary skill in the art at the time the invention was made
for the advantage taught by Folkers, above.
Examiner’s Answer, page 5
Appellants argue that the combination again does not teach or suggest a
peptide intermediate wherein the 5- and 6-position residues contain side chains
having primary amino groups that are modified with a base-labile, a hydrazine-
labile or a thio-labile protecting group. And again, the examiner did not address
that limitation in the statement of the rejection.
The burden is on the examiner to make a prima facie case of
obviousness, and the examiner may meet this burden by demonstrating that the
prior art would lead the ordinary artisan to combine the relevant teachings of the
references to arrive at the claimed invention. See In re Fine, 837 F.2d 1071,
1074, 5 USPQ2d 1596, 1598-99 (Fed. Cir. 1988). The findings of fact underlying
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