Appeal of rejection by USPTO Board of Appeals. The invention at issue related to an anit-guanidine polypeptide factor allegedly useful in the treatment of arthritis and related diseases. The patent application disclosure included 5 examples of successful clinical results, and the applicant also submitted further affidavit evidence regarding the successful treatment of hundreds of patients with the claimed invention and an article supporting the claimed utility. The examiner rejected these proofs, stating that they were without controls and requiring double blind tests with the protocol of the experiment set forth in order to prove utility. The board affirmed this rejection, noting that arthritis treatment depends on both subjective and objective symptoms and requiring that “‘evidence should have been presented which showed either objective improvement, such as, for example, decreased swelling of the hand or X-ray observation showing improvement in the bone structure, or alternatively, demonstrated subjective improvement, by means of properly controlled tests.’†Id. at 977.
The court reversed the § 101 rejection. First, the court stated that “controlled tests such as double blind tests†are not the only means of establishing § 101 utility. Id. at 977. The court further disagreed with the standard of proof required by the USPTO. The court concluded that “{t}here is apparently little doubt that a double blind control is more reliable than a historical control {as was used in the applicant’s proofs}. But, the evidence clearly indicates that both types of control are accepted. . . . Thus it would appear that tests of the type conducted by appellant are convincing to many skilled in the art. We feel that the 888 tests {performed by the applicant and} found to be statistically significant . . . establish that appellant's compound possesses anti-arthritic utility of a degree sufficient to satisfy the patent statute. . . . The burden the Patent Office would place on appellant would, in effect, require proof beyond a reasonable doubt . . . .†Id. at 978.
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Saturday 18 of October, 2008 21:10:49 GMT by Unknown
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Saturday 18 of October, 2008 21:10:49 GMT by Unknown