Appeal 2007-1821
Application 11/040,964
Secondly, the question is whether there is evidence that Appellants have
solved the need.
We do not find adequate evidence in the Blye 1 Declaration that there
was a long-felt need for a parenterally long-acting androgen as asserted in
Appellants’ Brief. In paragraph 4 of his declaration, Dr. Blye refers to a
“long-felt need for an oral androgen,” but does not mention a long-felt need
for a long-acting androgen (Blye 1 Declaration 2: ¶ 4). Later in the
declaration, Dr. Blye states that the Population Council asked his group
(“we”) to “make an ester which might prove long-acting upon parenteral
administration” (Blye 1 Declaration 3: ¶ 7). However, Dr. Blye does not
assert or explain how the Population Council’s request is evidence of a long-
felt need.
Dr. Blye states that 7α,11β-dimethyl-19-nortestosterone enanthate
(CDB-1422) was synthesized by the Research Triangle Institute (RTI) (Blye
1 Declaration 3: ¶¶ 8-9). This compound differs from the claimed
compound in having the n-C6H13 group at the 17-position rather than n-
C10H21 as in the claimed compound. It is the same compound described in
Example 3 of Cook (Cook, col. 17, l. 34 to col. 18, l. 3). Dr. Blye states that
a duration test1 was performed for this compound, but does not describe the
results of this test (Blye 1 Declaration 3: ¶ 9)
Evidence of the activity of 7α,11β-dimethyl-19-nortestosterone
enanthate (CDB-1422) is, in fact, shown in Cook (Cook, cols. 19-20) and in
Dr. Blye’s second declaration (Blye 2 Declaration (Exhibit 3)). Cook’s
Table 2 (Cook, cols. 19-20) establishes that 7α,11β-dimethyl-19-
1 We presume that the “duration test” is a test for “long-acting” activity.
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