Opinion ID: 152228
Heading Depth: 1
Heading Rank: 4

Heading: ORFs 1-13

Text: The district court's claim construction of ORFs 1-13 defines the claim scope as consisting of the DNA sequence of the thirteen ORFs enumerated in Example 13 of the patent specification as those ORFs apply to SEQ ID 4. Merial argues that the term should instead read on any translatable length of DNA between a start and stop codon in the PCV-2 gene sequence. Although the district court is correct that the disclosed ORFs define the claim term, the court erred in confining the scope of the term to the precise limits of the representative ORFs listed in Example 13, and the exact DNA sequence of SEQ ID 4. The ORFs listed in Example 13 are identified as corresponding to one representative PCV-2 sequence, designated in the patent as SEQ ID 4. Although the patent explains that the listed ORFs are identical for some of the deposited strains of PCV-2, it also identifies some variation. The specification explains that the ORFs listed in the table are representative, and one of skill in the art would understand that slight natural variation is to be expected. Indeed, limiting the construction of the term to the exact ORF sequences of SEQ ID 4 would even exclude from the claimed ORFs two of the four sequenced strains of PCV-2, the ORF variations for which sequences are expressly disclosed following the table in Example 13. Thus, we hold that the district court's construction is improperly narrow in scope. We reject the dissent's position that the specification limits ORFs 1-13 to the ORFs of the four sequenced strains. The discussion in Example 13, which explains that the limits of ORFs 1 to 13 are identical for certain sequenced strains (and not for others), strongly implies that the term ORFs 1-13 does not refer to a specifically defined list of limits, but instead contemplates the potential for variation in any given strain of PCV-2. Furthermore, the specification describes the analysis set forth in Example 13 as representative of the other circovirus strains associated with the multi-systemic wasting syndrome. We have already construed that set of circovirus strains to be broader than just the four sequenced strains, so it would be incongruous to selectively impose the narrower construction here, as the dissent suggests. We note that because isolates of the same viral type will have essentially the same proteins, they will have the same number of ORFs. The ORFs will be approximately the same size and located in the same relative regions of the genome. By identifying the thirteen ORFs of representative sequence SEQ ID 4, the specification purports to disclose to one of skill in the art the expected ORFs of all PCV-2 isolates. Thus a broader claim construction that allows for some variation in the precise limits of the ORFs and of the underlying DNA sequence is consistent with the expectations of a skilled artisan reading the patent disclosure. Thus the term ORFs 1-13 is properly construed as lengths of translatable DNA between pairs of start and stop codons, corresponding to the 13 ORFs identified in the patent specification. ORFs of some PCV-2 strains may not have limits 100% identical to the thirteen illustrated in the patent, but one of skill in the art would readily recognize those ORFs as corresponding to ORFs identified in the patent. Indeed, ORFs 1-13 could correspond to ORFs in other circoviruses, or even other species, as indicated by the examiner's initial rejection of the claim. It is the of porcine circovirus type II limitation, rather than Example 13, that confines the claim scope to ORFs of PCV-2.