Reversible error if BPAI fails to consider rebuttal evidence of nonobviousness
August 29, 2007

The Federal Circuit today vacated a decision by the Board of Patent Appeals and Interferences affirming an examiner's obviousness rejection. The inventors submitted three declarations evidencing the nonobviousness of their invention (unexpected results and teaching away), but the Board did not consider the evidence, finding that it related only to an intended use of the invention, which was not relevant as the claims were composition claims.

The Federal Circuit vacated, finding that while discovery of a new use of a previously known compound does not make the compound patentable, here the claimed composition was not known, as the rejections were only on obviousness grounds. As a result, in order to make a proper obviousness determination, the Board (and the examiner) must consider the evidence of nonobviousness presented by the inventors. As a result, the Board's determination was vacated, and the case remanded.

The application at issue is directed toward antivenom compositions effective against snakes of genus Crotalus, which comprises rattlesnakes. Antivenoms are really antibodies to the venom, and are typically either whole antibodies or F(ab)2 antibody fragments, which are whole antibodies with the portions that do not bind to the venom absent. Fab fragments were typically not used because although the likelihood of an allergic reaction in the recipient was reduced, they have distinct properties that were believed to make them ineffective in antivenoms.

The inventors found that Fab fragments could be used effectively against Crotalus genus snakes, and sought patent protection for their antivenom. During prosecution, the inventors submitted three declarations relevant to the nonobviousness of the claims. The three declarations provided evidence that the prior art taught away from the claimed antivenom, and that it showed unexpected results.

The Board did not consider this evidence, instead finding that:

The remainder of appellants [sic] arguments on this record, in addition to the Declarations of record, relate to the use of the claimed composition as an antivenom. Since we have placed not [sic] weight on the intended use of appellants’ composition we do not address these arguments or the Declarations.

The inventors appealed to the Federal Circuit.

On appeal, the PTO contended that because the declarations were only relevant to the intended use of the claimed compositions, and that a new use of an old composition cannot render the composition patentable, the declarations were irrelevant. The court disagreed, as in this case the composition was not alleged (or conceded) to be old. On the contrary, there was no anticipation rejection, only a rejection based on obviousness. As a result, in such a situation, when presented with evidence of nonobviousness, the Board must consider such evidence when making its obviousness determination.

As stated by the court:

[T]he Board was mistaken to assert that the declarations only relate to the use of the claimed composition. The declarations do more than that; they purport to show an unexpected result from use of the claimed composition, how the prior art taught away from the composition, and how a long-felt need existed for a new antivenom composition. While a statement of intended use may not render a known composition patentable, the claimed composition was not known, and whether it would have been obvious depends upon consideration of the rebuttal evidence.

The court therefore vacated the Board's decision and remanded for further consideration.

As an amusing side note, the background section of the opinion appears to derive its description of antivenom from Wikipedia. Compare the following, first from the opinion:

An antivenom is created by injecting a small amount of the targeted venom into an animal such as a horse, sheep, goat, or rabbit. The animal will suffer an immune response to the venom, producing antibodies against the venom’s active molecule. Those antibodies can then be harvested from the animal’s blood and used to treat humans who have been injected with venom from a snake bite.

Now, from Wikipedia's entry on "antivenin":

[Antivenom] is created by injecting a small amount of the targeted venom into an animal such as a horse, sheep, goat, or rabbit; the subject animal will suffer an immune response to the venom, producing antibodies against the venom's active molecule which can then be harvested from the animal's blood and used to treat envenomation in others.

Interesting similarities.

To read the full decision in In re Sullivan, click here.

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