Federal Circuit Changes Course, Finds Claims to Novel Gene Obvious

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For more than 13 years, biotechnology companies have been able to count on one thing: a claim to a novel gene was nonobvious where the gene's sequence was unknown in the prior art. Under In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995), even where one of skill in the art might have a reasonable expectation of success at cloning an unknown gene, the gene itself was still held to be nonobvious.

The Deuel inventors claimed isolated and purified DNA and cDNA sequences that encoded heparin-binding growth factors (“HBGFs”). Id. at 1556 n.5. The prior art contained references disclosing a group of similar heparin-binding proteins, including a partial amino acid sequence, and general techniques of isolating a gene using a gene probe. Id. at 1556. The Federal Circuit held that knowledge of general cloning techniques and partial knowledge of the protein?s amino acid sequence would not necessarily lead a person of ordinary skill in the art to prepare the specific sequence claimed: “the existence of a general method of isolating cDNA or DNA molecules is essentially irrelevant to the question whether the specific molecules themselves would have been obvious.... A general incentive does not make obvious a particular result.” Deuel, 51 F.3d at 1559. Although it may have been “obvious to try” to prepare the claimed sequences, the actual sequences themselves were not obvious. Id. Thus, Deuel followed in the footsteps of In re Bell, 991 F.2d 781 (Fed. Cir. 1993). There, the Federal Circuit rejected an argument by the Patent and Trademark Office that “a gene is rendered obvious once the amino acid sequence of its translated protein is known.” Id. at 785.

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