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August 29, 2007

Snakebit

The USPTO has become venomously anti-patent. John Sullivan and Findlay Russell discovered a rattlesnake antivenom. The patent office appeals board turned a deaf ear to declarations of novelty. On appeal in court, the CAFC struck back.

In Re John B. Sullivan and Findlay E. Russell (CAFC 2006-1507)

The subject matter of the appeal relates to an antivenom composition used to treat venomous bites from a snake of the Crotalus genus, i.e., a rattlesnake. 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.

A whole antibody molecule, commonly referred to as an immunoglobulin, can be thought of as a Y-shaped protein comprised of three fragments... An intact antibody, F(ab)2, and Fab fragments have separate properties and utilities. Since 1969, most commercially available antivenom products have consisted of a class of whole antibodies, known as immunoglobulin G (“IgG”), but there have also been antivenom products that comprised only F(ab)2 fragments. Although antivenom products consisting of either IgG or F(ab)2 fragments are effective at binding to venom toxins, they often invoke adverse immune reactions in humans. Researchers did not experiment with antivenoms containing only Fab fragments because it was believed that their unique properties would prevent them from decreasing the toxicity of snake venom. Sullivan discovered, however, that Fab fragments are effective at neutralizing the lethality of rattlesnake venom, while reducing the occurrence of adverse immune reactions in humans.

The patent Board of Appeals and Interferences (BPAI) agreed with examiner rejection of obviousness, and even created a new ground for rejection on appeal. After another round of obviousness rejection by the examiner, the application landed back before the appeals board, which studiously ignored the most significant evidence appellants offered.

[T]he Board again stated that a statement of a new use for an otherwise old or obvious composition cannot render a claim to the composition patentable. The Board noted that the phrase, “an antivenom pharmaceutical composition for treating a snakebite victim,” simply states the intended use for the invention. Sullivan, No. 2006-0220, slip op. at 11. The Board also noted that “all the elements of appellants’ claimed composition are accounted for in the prior art relied upon on this record.” Id. at 13. Thus, the Board held that the amended preamble did not render the claim patentable.

Most relevant to the resolution of the appeal, the Board then stated in a footnote: “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.” Id. at 13 n.7.

Before the CAFC, Sullivan and Russell argued that its three declarations arguing against obviousness should not have been ignored.

On appeal, applicant argues that the Board failed to establish that the claimed composition was prima facie obvious over Sullivan in view of Coulter. Applicant specifically argues that a person having ordinary skill in the art would not have been motivated to combine Sullivan and Coulter to achieve the result of “neutralizing the lethality of the rattlesnake venom.” Applicant argues that Coulter teaches using Fab fragments to detect, rather than treat, venom. Applicant further argues that, even if the Board had shown that the invention was prima facie obvious, the Board erred by ignoring extensive rebuttal evidence. According to applicant, the Board failed to consider three expert declarations on the ground that they only describe the intended use of the composition. Applicant contends that the declarations describe how the prior art taught away from using Fab fragments to neutralize rattlesnake venom, how a person having ordinary skill in the art would not have known how to use Fab fragments to neutralize rattlesnake venom, and how Fab fragment antivenom exhibits an unexpected property. Moreover, applicant contends that the rebuttal evidence relates to objective indicia of nonobviousness, and that the Board erred as a matter of law by failing to consider that evidence.

According to the Director, the amendments to claim 40 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. The Director also submits that the Board did consider the declarations and correctly gave them no weight because they only relate to the use of the claimed composition. The Director also contends that applicant’s argument as to secondary considerations such as unexpected results and commercial success is being raised for the first time on appeal and should be deemed waived.

The appeals panel slapped the BPAI awake, telling it to pay attention: you can't ignore evidence.

We agree with applicant that the Board improperly failed to consider the rebuttal evidence and we therefore vacate the Board’s decision and remand for the Board to consider the declarations. It is well settled that the PTO “bears the initial burden of presenting a prima facie case of unpatentability. . . . However, when a prima facie case is made, the burden shifts to the applicant to come forward with evidence and/or argument supporting patentability.” In re Glaug, 283 F.3d 1335, 1338 (Fed. Cir. 2002). Rebuttal evidence is “merely a showing of facts supporting the opposite conclusion.” In re Piasecki, 745 F.2d 1468, 1472 (Fed. Cir. 1984). Evidence rebutting a prima face case of obviousness can include: “evidence of unexpected results,” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1369 (Fed. Cir. 2007), evidence “that the prior art teaches away from the claimed invention in any material respect,” In re Peterson, 315 F.3d 1325, 1331 (Fed. Cir. 2003), and evidence of secondary considerations, such as commercial success and long-felt but unresolved needs, WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999). When a patent applicant puts forth rebuttal evidence, the Board must consider that evidence. See In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995) (stating that “all evidence of nonobviousness must be considered when assessing patentability”); In re Sernaker, 702 F.2d 989, 996 (Fed. Cir. 1983) (“If, however, a patent applicant presents evidence relating to these secondary considerations, the board must always consider such evidence in connection with the determination of obviousness.”).

The Board failed to consider each of these 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. Sullivan, No. 2006-0220, slip op. at 13 n.7. As stated above, when an applicant puts forth relevant rebuttal evidence, as it did here, the Board must consider such evidence. The claimed composition cannot be held to have been obvious if competent evidence rebuts the prima facie case of obviousness. By failing to consider the submitted evidence, the Board thus committed error. That is not to suggest that the Board’s finding of obviousness must be overturned in light of the evidence; rather, the Board must give the declarations meaningful consideration before arriving at its conclusion.

The patent board did not even focus on the right issue: citing intended use as not rendering patentability, when the applicant also argued an unexpected property of the claimed composition: minimal side effects.

Furthermore, the Board’s focus on the intended use of the claimed composition misses the mark. The Board cites In re Zierden, 411 F.2d 1325 (CCPA 1969), for the proposition that a statement of a new use for an otherwise old or obvious composition cannot render a claim to the composition patentable. In that case, applicant conceded that his composition was distinguished from the composition disclosed in a prior art patent only by the statement of intended use. Our predecessor court held that that intended use for the known composition could not render the claim patentable. In this case, applicant does not concede that the only distinguishing factor of its composition is the statement of intended use and, in fact, extensively argues that its claimed composition exhibits the unexpected property of neutralizing the lethality of rattlesnake venom while reducing the occurrence of adverse immune reactions in humans. Such a use and unexpected property cannot be ignored. See In re Papesch, 315 F.2d 381, 391 (CCPA 1963) (“From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing. . . . There is no basis in law for ignoring any property in making such a comparison.”). The issue here is not whether a claim recites a new use, but whether the subject matter of the claim possesses an unexpected use. That unexpected property is relevant, and thus the declarations describing it should have been considered by the Board.

Vacated and remanded back the patent board.

Posted by Patent Hawk at August 29, 2007 11:02 AM | Prosecution