Opinion ID: 625949
Heading Depth: 4
Heading Rank: 2

Heading: The Upstream Region of the IE Gene

Text: In addition, Sanofi alleges error in the construction of the term “DNA from the upstream region of the major immediate early (IE) gene of human cytomegalovirus (HCMV),” which the district court interpreted to mean “DNA from the region that is upstream of the transcription start site of the major IE gene of HCMV.” Claim Construction Order, 2010 WL 2525118, at  (emphasis added). Sanofi contends that the term “DNA from the upstream region of the major immediate early (IE) gene of human cytomegalovirus (HCMV)” should be construed to mean “DNA from upstream of the translation start site of the major IE gene of HCMV.” According to Sanofi, the specification discloses the use of HCMV enhancers including portions of viral DNA extending beyond the transcription start site to the HCMV splice donor site at +120 or the downstream PstI site at approximately +930. See ’522 patent col.2 ll.6–10, 44–56. To include those features, Sanofi argues, the claimed “upstream region of the major 9 SANOFI-AVENTIS v. GENENTECH immediate early (IE) gene” must encompass the transcribed, but untranslated, region spanning the transcription and translation start sites of the HCMV IE gene at +1 and approximately +950, respectively. We disagree. A diagram of the HCMV IE gene, adapted from figure 1a of the ’522 patent and marked to emphasize relevant points of reference, is shown below: Claim 1 recites the method of using an isolated DNA enhancer that consists of “DNA from the upstream region of the [HCMV IE gene],” and the specification uses consistent language in describing the HCMV enhancer’s position as “located in the upstream region of the [HCMV IE gene].” Id. [57] (emphasis added); see also id. col.1 ll.14– 17. But the specification describes the location of the +120 splice donor site differently, with the key phrase “upstream region” notably absent. Rather, the specification describes the +120 splice donor sequence as the “splice donor consensus sequence of the IE gene.” Id. col.2 ll.8–9 (emphasis added). Thus, while the +120 splice donor site is indeed part of the IE gene, the specification reserves the “upstream region” label from its discussion of the splice donor site, indicating that the claim term “DNA from the upstream region of the [HCMV IE gene]” specifies a distinct portion of the broader IE gene that excludes SANOFI-AVENTIS v. GENENTECH 10 the splice donor site (+120), the downstream PstI site (+930), and the translation start site (+950). 3 We therefore reject Sanofi’s contention that the downstream end of the “upstream region” recited in claim 1 extends to the translation start site of the IE gene, and we affirm the construction adopted by the district court.