United States: 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 plainly and repeatedly distinguished culturing with beads from culturing in three-dimensions," "expressly defined the use of beads as culturing in two dimensions," and "avoided anticipatory prior art during prosecution by asserting that the conditioned medium produced by two-dimensional cultures was inferior and chemically distinct from the conditioned medium produced by three-dimensional cultures."  Id. at 15.  Therefore, "although the inventors never explicitly redefined three-dimensional cultures to exclude the use of beads, their implicit disclaimer of culturing with beads here was even 'so clear that it equates to an explicit one.'"  Id. at 27 (quoting Thorner v. Sony Computer Entm't Am. LLC, 669 F.3d 1362, 1368 (Fed. Cir. 2012)).

The Court was not persuaded by the evidence presented by SkinMedica that there was no explicit or implicit disclaimer, even after agreeing that the ordinary meaning of "culturing . . . cells in three-dimensions" could include cell growth on beads.  Therefore, "[b]ecause none of the evidence [presented] by SkinMedica would reasonably lead to a different reading of the intrinsic evidence," the Court found 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."  Id. at 15.

In conclusion, the Court held that "[b]ased on the clear language of the specification and the statements made by the patentees during prosecution, . . . the inventors of the '494 and '796 patents disclaimed beads as a method to culture the cells . . . used in their claimed inventions."  Id. at 42-43.  Therefore, the Court affirmed the district court's grant of SJ of noninfringement for Histogen.

Chief Judge Rader dissented, finding that "the patentees did not disavow the ordinary meaning of 'culturing . . . cells in three-dimensions' to exclude the use of beads."  Rader Dissent at 1-2.  Chief Judge Rader considered the statements in the written description and prosecution history regarding beads to be ambiguous and gave more weight to the extrinsic evidence.  Because he did not believe that the evidence supported a claim construction that excluded the ordinary meaning, Chief Judge Rader would have reversed the district court's grant of SJ.

Judges: Rader (dissenting), Clevenger, Prost (author)

[Appealed from S.D. Cal., Judge Sammartino]

This article previously appeared in Last Month at the Federal Circuit, September 2013

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