Appeal from rejection by USPTO Board of Appeals. The invention at issue related to therapeutic compositions containing isoflavone compounds, which allegedly were useful in the treatment of vascular disorders and vitamin deficiencies. The examiner rejected the claims for the “‘absence of clear, convincing, scientific evidence that the composition is safe and effective for the purposes intended.†Id. at 975. The examiner further criticized the examples supplied by the applicant in the specification because they did not “contain sufficient data based on controlled tests involving both animals and humans which would enable others of ordinary skill in the art to accept the allegations as obviously valid and correct.†Id. at 977. The examiner required “showing on record that all of the claimed compounds in all of the claimed amounts would be safe and effective for all of the conditions allegedly benefited.†Id. at 977.
The court reversed the § 101 rejection. First, the court noted that the amount of evidence required to show utility depends on the facts of each case. The court then proceeded to discuss the various standards of proof necessary in each of three types of cases. Then, finding the applicant’s “assertions of usefulness . . . to be believable on their face and straightforward,†Id. at 978, the court found that the Patent Office was requiring too much proof of utility.
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Saturday 18 of October, 2008 21:42:20 GMT by Unknown
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Saturday 18 of October, 2008 21:42:20 GMT by Unknown