By Dennis Crouch
Novozymes A/S v. DuPont Nutrition Biosciences (Fed. Cir. 2013)
At trial, the jury sided with the patentee Novozymes on the issue of validity – finding that DuPont had failed to prove "by clear and convincing evidence that any one or more of the claims are invalid because the application filed on November 16, 2000 . . . does not contain an adequate written description." Following the verdict, however, the district court judge rejected the jury verdict and instead held that, as a matter of law, the claims lacked written description support. On appeal, the Federal Circuit now affirms – finding that no reasonable jury could find the patent valid.
The written description requirement of 35 U.S.C. § 112(a) mandates that a patent application's written description must 'clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.' Vas-Cath. The requirement questions whether the inventor was in possession of the claimed invention at the time the patent application was filed.
In this case, Claim 1 of the invention is directed to an alpha-amylase enzyme variant with a 90%+ sequence identity to BSG alpha-amylase, an amino acid substitution at serine 239, and increased thermostability at pH 4.5, 90°C, and 5 ppm calcium. The enzyme is used to make ethanol.
The original patent application describes each element of the claimed invention. However, the application does not particularly identify this particular combination of limitations. Rather, the application lists BSG along with six other types of alpha-amylase; lists the 239 position mutation along with 32 other potential mutation positions; and indicates broader ranges for thermostability of 4.5-5 pH and 85-95°C. U.S. Patent No. 7,713,723.
In considering whether the description was sufficient, the Federal Circuit considered the claimed invention "as a integrated whole" rather than merely element by element:
While the 2000 application provides formal textual support for each individual limitation recited in the claims of the '723 patent, it nowhere describes the actual functioning, thermostable alpha-amylase variants that those limitations together define. Taking each claim—as we must—as an integrated whole rather than as a collection of independent limitations, one searches the 2000 application in vain for the disclosure of even a single species that falls within the claims or for any "blaze marks" that would lead an ordinarily skilled investigator toward such a species among a slew of competing possibilities.
The court makes clear here that written description is not satisfied merely by ensuring that each individual claim limitation is disclosed in the original disclosure. Rather, the written description requires disclosure of the patented claim as a whole.
Although strongly worded, this case is one in a spectrum of written description cases and thus only incrementally moves the law.
The majority opinion was written by Judge Schall. Chief Judge Rader wrote in dissent – arguing that substantial evidence supported the jury verdict.