An Implicit Disclaimer Limits Claim Scope Even When Contrary To Ordinary Meaning

In SkinMedica, Inc. v. Histogen Inc., No. 12-1560 (Fed. Cir. Aug. 23, 2013), the Federal Circuit affirmed the district court's grant of SJ of noninfringement, upholding the claim construction at issue.

SkinMedica, Inc. ("SkinMedica") filed suit against Histogen, Inc., Histogen Aesthetics, and Gail Naughton (collectively "Histogen") alleging infringement of U.S. Patent Nos. 6,372,494 ("the '494 patent") and 7,118,746 ("the '746 patent"). The claims-at-issue in the '494 and '746 patents generally relate to methods for producing and using pharmaceutical compositions containing "novel conditioned cell culture medium compositions." Slip op. at 2. SkinMedica alleged that Histogen used infringing methods to produce dermatological products.

The district court granted SJ of noninfringement based on a construction of the phrase "culturing . . . cells in three dimensions" that excluded Histogen's production methods. Specifically, the district court construed the phrase, which was common to both the '494 and '746 patents, as "growing . . . cells in three-dimensions (excluding growing in monolayers or on microcarrier beads)." Id. at 8 (citation omitted). Histogen's cell growth process, which uses microcarrier beads, was therefore found to be noninfringing. SkinMedica appealed.

"[W]e find that the inventors clearly redefined the scope of 'culturing . . . cells in three-dimensions' by disclaiming the use of beads—which would otherwise be included in the ordinary meaning of that phrase." Slip op. at 15.

On appeal, the Federal Circuit upheld the district court's claim construction, which was the only issue before the Court. The Court held that the patentees had disclaimed the use of beads as a means for three-dimensional cell growth. The Court reached this conclusion even after accepting that "the ordinary meaning of 'culturing . . . cells in three-dimensions' would reach the use of beads." Id. at 13. The Court reasoned that the intrinsic record, which it found to associate beads with two-dimensional growth and distinguish beads from three-dimensional growth, outweighed the evidence that suggested that cell growth using beads could be three-dimensional.

The Court relied on the written description, which included such language as "[c]ell lines grown as a monolayer or on beads, as opposed to cells grown in three dimensions," and "beads (i.e., two-dimensions)," and statements made during the prosecution of the '494 and '746 patents to find that "the patentees...