In In Re Sullivan et al., Civ. Case 2006-1507 (Fed. Cir. August 29, 2007), the applicants filed U.S. Patent Application No. 08/405,454 (the ‘454 application), which is drawn to an antivenom composition that comprises a portion of an antibody molecule, a Fab fragment. Fab fragments recognize and bind to specific antigens, such as the toxin in rattlesnake venom. The prior art taught using whole antibody molecules.
The examiner rejected the claims as being obvious over two references (Sullivan and Coulter). The examiner asserted that Sullivan teaches whole antibodies purified from horse serum for use against venom from rattlesnakes, but fails to teach the use of Fab fragments. The Examiner also found that Coulter discloses a method for producing Fab fragments in place of whole antibodies. The Examiner noted that Coulter further teaches using Fab fragments in enzyme immunoassays (“EIAs”) to detect textilotoxin, a kind of snake toxin from the venom of the Australian brown snake. Also, Coulter teaches that Fab fragments used in EIAs yielded results similar to those obtained with whole IgG.
Over the course of prosecution, Applicants submitted three declarations to rebut the prima face case of obviousness put forth by the examiner, and amended the rejected claim as follows:
An antivenom pharmaceutical composition for treating a snakebite victim, comprising Fab fragments which bind specifically to a venom of a snake of the Crotalus genus and which are essentially free from contaminating Fc as determined by immunoelectrophoresis using anti-Fc antibodies, and a pharmaceutically acceptable carrier, wherein said antivenom pharmaceutical composition neutralizes the lethality of the venom of a snake of the Crotalus genus.
The Board held that the amendments to the claim merely relate to the use of the claimed product and do not render the claim patentable, because a new use of an obvious composition is not patentable. In regards to the declarations, the Board stated in a footnote that the declarations of record relate only to the use of the claimed composition as an antivenom, and thus, the Board expressly declined to give any meaningful consideration to them. Thus, the Board affirmed the Examiner’s decision that the claims were obvious.
On appeal, the Federal Circuit reversed. In reversing the Board, the Federal Circuit held that a claimed composition cannot be held to have been obvious if competent evidence rebuts the prima facie case of obviousness. In reviewing the Board’s decision, the Federal Circuit held that, by failing to consider the submitted evidence, the Board committed an error since the Board must give the declarations meaningful consideration before arriving at its conclusion.
The Federal Circuit held that the Board was mistaken to assert that the declarations only relate to the use of the claimed composition. The declarations were put forth 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. The Board incorrectly focused on the intended use of the claimed composition. While a statement of intended use may not render a known composition patentable, the claimed composition was not known, and therefore, whether the subject matter of the claim possesses an unexpected property is relevant. Whether the compound would have been obvious depends upon consideration of the rebuttal evidence. Thus, the unexpected property is relevant, and the declarations describing it should have been considered by the Board prior to finding the invention to be obvious.
Significance for Patent Applicants
While KSR v. Teleflex, 127 S.Ct. 1727, 82 U.S.P.Q.2d 1385, (2007) may have signaled that the courts and the USPTO should be more flexible in their approach to obviousness, the requirement for evidence to support whichever approach is taken is still very much in force. Conclusory statements that are unsupported by evidence (or which are contradictory to evidence) will not be sufficient to support a prima facie obviousness rejection even after KSR. As is evident from In Re Sullivan et al. as well as the Takeda Chemical, Ex Parte Catan and Ex Parte Smith discussed below, applicants should stress the evidentiary requirement in contesting obviousness rejections, and should require the Examiner explain any contrary evidence conflicting with any evidence relied upon by the Examiner. However, where such evidence is lacking or where there is only evidence of market pressures to make a combination, applicants and patent owners must provide contrary evidence to explain how a combination would not have been obvious as opposed to merely stating that there is no explicit teaching in the prior art.