Opinion ID: 152228
Heading Depth: 1
Heading Rank: 3

Heading: Porcine Circovirus Type II

Text: The district court found that the claim term porcine circovirus type II was limited to the five sequences that were deposited with the PTO as part of the description of the invention. The district court was persuaded by Intervet's arguments that the patent specification defined the invention as being these five sequences, and contained no disclosure from which to infer that any other sequences were also part of the invention. It is clear enough to us, however, that the patent states that the five deposited strains and listed sequences are  representative of a  type of porcine circovirus, and thus do not constitute the entire scope of the invention. '601 patent col.1 ll.60-61 (emphases added). Sequences are representative of the scope of broader genus claims if they indicate that the patentee has invented species sufficient to constitute the genera. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 967 (Fed. Cir.2002); In re Smythe, 480 F.2d 1376, 1383 (C.C.P.A.1973). Here, the deposited strains are representative species of the larger type II genus, where the genus is identified and claimed as the invention. Claims properly directed to a genus may be adequately supported by the patent disclosure if a sufficient number of species is disclosed so as to properly identify the scope of the genus. Id. Here, the patentee has disclosed five species of PCV-2, provided the full sequences for four, and identified the potential coding portions of the sequences. The patentee also provided a counterexample, PCV-1, that by definition lies outside the scope of the claimed genus, as well as a representative species of the counterexample, its sequence, and potential coding portions for the representative. Neither the claim itself nor the specification provides a homology threshold above or below which a particular PCV strain is properly considered PCV-2 rather than PCV-1. It refers instead to strains of the invention having significant serological similarity and stringent, selective cross-hybridization to the deposited strains over PK/15. The only quantitative boundaries disclosed in the patent are the 96% homology among representative PCV-2 sequences, and the 76% homology between those sequences and the representative of PCV-1. The patent's stated conclusion that the disclosed PCV-2 sequences thus represent a new type of porcine circovirus is based on the pathogenicity of the isolated strains, as well as the observed homology patterns. See, e.g., '601 patent col.5 ll.59-61. This conclusion comports with the way that viruses are typically classified in the relevant art. Cf. Universal Virus Database of the International Committee on Taxonomy of Viruses available at http:// www.ictvdb.rothamsted.ac.uk/. The invention is then defined as being the type II porcine circovirus, which is in turn as defined above. '601 patent col.5 ll.64. Thus, the pathogenicity and homology patterns are the defining properties of the new type of virus. The claim construction of porcine circovirus type II is therefore properly limited to porcine circoviruses that have these two defining properties. We therefore construe the claim term porcine circovirus type II to be a pathogenic pig virus having a circular genome that is at about 96% or more homologous with the four sequences disclosed in the present specification, and about 76% or less homologous with the PK/15 sequence. Strains that fit this definition would be expected to have strong serological similarity and cross-hybridize to the deposited strains under high stringency conditions. As such, limiting the claim scope according to these properties is not inconsistent with the other descriptive language in the specification.