Appeal No. 2001-2157 Page 8
Application No. 08/918,741
products structurally similar to raloxifene. At most, applicants contend, it would have
been obvious to try preparing raloxifene in an amorphous form by spray-drying. But the
result of that experiment, according to applicants, was not reasonably foreseeable. It
was not reasonably foreseeable, e.g., that raloxifene has sufficient heat stability to
withstand spray-drying as described in applicants' specification, page 8, lines 31
through 33. As stated more broadly in Paper No. 12, page 5, first complete paragraph:
Appellants respectfully assert that although it may have been
considered obvious to perform the experiment (obvious to attempt to
prepare the amorphous material), the result of that experiment (its
success or failure) was not reasonably foreseeable.. . . The art as a whole
teaches that preparing an amorphous form of a pharmaceutical
compound is only a desired possibility. Appellants respectfully assert that
the formulation sciences are an unpredictable art form and the ordinary
artisan practicing in that art does not know and cannot predict, a priori,
whether the amorphous form is obtainable.
Couched in terms of the case law, applicants' argument is predicated on a
requirement that the prior art must lead a person having ordinary skill to the claimed
invention with a reasonable expectation of success. As stated in In re Vaeck, 947 F.2d
488, 493, 20 USPQ2d 1438, 1442 (Fed. Cir. 1991),
Where claimed subject matter has been rejected as obvious in view of a
combination of prior art references, a proper analysis under § 103
requires, inter alia, consideration of two factors: (1) whether the prior art
would have suggested to those of ordinary skill in the art that they should
make the claimed composition or device, or carry out the claimed process;
and (2) whether the prior art would also have revealed that in so making
or carrying out, those of ordinary skill would have a reasonable
expectation of success. Both the suggestion and the reasonable
expectation of success must be founded in the prior art, not in the
applicant's disclosure. [citations omitted]
Further, see In re Dow Chem. Co., 837 F.2d 469, 473, 5 USPQ2d 1529, 1531 (Fed. Cir.
1988)("The consistent criterion for determination of obviousness is whether the prior art
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