Appeal 2007-1821
Application 11/040,964
no evidence in the record that this statement would not apply equally to all
Cook’s compounds, including the 7α,11β-dimethyl nortestosterone
enanthate of Example 3. Secondly, Appellants acknowledge that orally
active androgens were known in the art, including androgens with long-
chain esters. In the declaration dated December 1, 2005 (Blye 1 Declaration
(Exhibit 1)), the declarant Dr. Blye states:
The first of these, CDB-4386 the bucyclic acid ester, was
submitted for testing on April 6, 1998. I, as the Project Officer
for the Biological Testing Facility contract, ordered assay for
androgenic activity by both the oral and parenteral
(subcutaneous) routes. The compound was found to be several
times more active than methyltestosterone standard when
administered orally. This observation was cause for some
rejoicing since the then prevailing knowledge was that long-
chain esters of androgenic steroids did not exhibit potent oral
activity.
(Blye 1 Declaration 4: ¶ 11.) Thus, the skilled worker – as the Examiner
contends (Answer 6) – would have had reason to test other synthetic
androgens for oral activity and an expectation that such androgens would be
orally-active. Success does not have to be guaranteed as long as the skilled
worker would have perceived a reasonable likelihood of success. Alza Corp.
v. Mylan Labs., Inc., 464 F.3d 1286, 1295, 80 USPQ2d 1001, 1007 (Fed.
Cir. 2006).
Finally, we note that Appellants admit that there was a need for oral
androgens (Br. 5; Reply Br. 7).
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this leads
to the anticipated success, it is likely the product not of
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