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Hope of Success Is Insufficient to Establish Conception

99-1604
March 21, 2001

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Last Month at the Federal Circuit - April 2001

Judges: Michel (author), Linn, and Dyk

In Hitzeman v. Rutter, No. 99-1604 (Fed. Cir. Mar. 21, 2001), the Federal Circuit affirmed the Board’s decision awarding priority in two interferences to William Rutter and three other inventors (collectively “Rutter”) for inventions concerning a hepatitis B vaccine produced by a genetically altered yeast.

The first interference, No. 102,416, was between Ronald Hitzeman and coworkers’ (collectively “Hitzeman”) U.S. Patent No. 4,803,164 and Rutter’s patent application 07/209,504. The second interference was between Rutter’s U.S. Patent No. 4,769,238 and Hitzeman’s patent application 07/248,863. Because the issues raised on appeal were very similar in each interference, the Federal Circuit addressed them together.

Both parties had claimed a component of a vaccine for hepatitis B, specifically a protein called the S-protein or HBsAg. Both parties had produced HBsAg in yeast, which allows the protein to form a 22 nm particle that is able to confer immunity. Previously, when the protein was produced in bacteria, it did not assemble into a 22 nm particle and so was not useful as a vaccine. The counts in both interferences reflected the importance of this size and sedimentation rate by reciting a DNA expression vector which produces HBsAg “in particle form having a sedimentation rate which is virtually identical to that of the authentic 22 nm hepatitis surface antigen particles.”

Hitzeman, the junior party to the interference, claimed that he had a complete conception of the invention by February 3, 1981. He presented evidence that on that date he had the materials to produce HBsAg in yeast and a “hope” that immunogenic particles would be produced. Hitzeman actually produced 22 nm particles in yeast on July 20, 1981, after alleged due diligence from his asserted date of conception. Rutter was able to produce 22 nm HBsAg particles in yeast by June 30, 1981.

In awarding priority to Rutter, the Board had determined that the particle size and sedimentation rates were material limitations of the counts and that Hitzeman was required to show that he envisioned these limitations when he conceived of the invention. The Board found that Hitzeman’s “hope” of producing such particles in yeast, on February 3, 1981, was not corroborated and even if it had been, a hope is not conception, but only a research plan or a general goal. Therefore, the Board concluded that Hitzeman had failed to show earlier conception than Rutter.

Hitzeman argued on appeal that the Board should not have required him to show that he had conceived of the sedimentation rate and size of the particle, because these were properties inherent to production in yeast. He further asserted that because he possessed the materials to produce HBsAg particles in yeast, he had demonstrated conception of them. The Federal Circuit disagreed.

The Court described “rare and special occasions” when a limitation might be deemed inherent and therefore might not have to be demonstrated, even though it was recited in the count. For instance, if a count recited the molecular weight of a compound, a party who did not know the molecular weight, but did know other identifying characteristics, such as water content and infrared spectrograph, would have sufficiently demonstrated it was in possession of a compound. In that instance, the molecular weight would add nothing to the demonstration that the compound was in the party’s possession. The Court ruled that to invoke the inherent conception rule, the inventor needs to show that the allegedly inherent property adds nothing to the count beyond the other recited limitations and is redundant to the count. In the instant case, though, the Court found that the size and sedimentation rates were central to the patentability and utility of the claimed invention and provided the basis for distinguishing Hitzeman’s claims from the prior art. Therefore, Hitzeman needed to show that he knew the size and sedimentation rate in order to demonstrate conception.

Hitzeman also asserted that his “hope” that particles of the correct size would be produced demonstrated conception. Because it was well known that only 22 nm particles were effective as vaccines and that previous attempts to produce such particles in bacteria had failed, Hitzeman argued that his “hope” was the only sensible route to producing an immunogenic protein. In rejecting this argument, the Court reiterated that conception is a definite and permanent idea of the complete and operative invention that could be conveyed to another skilled in the art, not a general goal or research plan.

The Court found that Hitzeman’s hope and resulting research plan to produce the correct particles in yeast were not sufficient to be conception. Furthermore, the Court found that Hitzeman did not even have a reasonable expectation that yeast would produce the particles. The lack of a reasonable expectation of the limitations was evident in Hitzeman’s own publications, written after his alleged conception, in which he postulated that yeast may not, in fact, be able to produce 22 nm particles. Therefore, even after producing the particles, Hitzeman did not know of the mechanism by which they were made and so could not have predicted that they would be made