Case: Skinmedica, Inc. v. Histogen Inc., No. 2012-1560 (Fed. Cir. Aug. 23, 2013) (precedential). On appeal from S.D. Cal. Before Rader, Clevenger, and Prost.
Procedural Posture: District court granted defendants’ motion for summary judgment of non-infringement after construing a claim element common to both patents. SkinMedica appealed, asserting that the district court’s construction of the element was erroneous for failure to include cell culture on “beads”. CAFC affirmed.
- Claim Construction: CAFC agreed with the district court’s finding that the inventors implicitly defined the claim element in the specification to exclude the use of beads (and therefore, defendants’ process) through the use of various phrases such as “as opposed to,” the disjunctive “or,” and “i.e.” CAFC noted that although beads could be used to culture cells in three dimensions, the specification expressly defines the use of beads as culturing in two-dimensions, as opposed to the claimed three-dimensions. In addition, the specification contrasts the claimed three-dimensional process with two-dimensional processes, which by definition include use of beads. CAFC also noted that the inventors avoided anticipatory prior art during prosecution by implicitly disclaiming two-dimensional cultures, including the bead process used by defendants. This evidence cannot be overcome by a general citation in the specification to an entire source that ambiguously supports the plaintiff’s proposed construction, or by conclusory expert testimony that is inconsistent with the intrinsic evidence. In addition, arguments based on references first raised on appeal, even though included on the face of the patent, are deemed waived. Accordingly, CAFC found that the inventors disclaimed the use of beads as a cell culture method, and affirmed both the district court’s claim construction and grant of summary judgment.
Claim Construction: The inventors did not clearly redefine the claim term or disclaim the ordinary meaning of the term to exclude the use of beads. A disclaimer or disavowal must be unmistakable and unambiguous, which is not the case with the term at issue. The expert testimony, which was not conclusory, is not inconsistent with the intrinsic evidence, but rather explains the ambiguous intrinsic evidence. Because the claim construction issued by the district court was erroneous, the grant of summary judgment of non-infringement should have been reversed.