SkinMedica, Inc. v. Histogen Inc.
727 F.3d 1187
Fed. Cir.2013Background
- SkinMedica owns the '494 and '746 patents directed to conditioned cell culture media for pharmaceutical use; Histogen was accused of infringing after claim construction narrowed “culturing … cells in three-dimensions.”
- The asserted claims require culturing cells in three-dimensions to form a conditioned medium with extracellular products; beads are associated with two-dimensional culture.
- During prosecution, inventors narrowed the scope to three-dimensional cultures to avoid Shipley; beads were characterized as two-dimensional in the specification.
- The intrinsic record repeatedly distinguishes bead culture from true three-dimensional culture and defines beads as two-dimensional; Doyle/Circuit references do not redefine the term.
- District court construed “culturing … cells in three-dimensions” as excluding beads; summary judgment of noninfringement for Histogen followed; SkinMedica appeals on construction only.
- Ninth Circuit reviews claim-construction de novo, giving priority to intrinsic evidence (specification/prosecution) over extrinsic evidence.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does bead culture fall within three-dimensional culturing under the patent terms? | SkinMedica asserts ordinary meaning includes beads; patentees did not redefine term. | Histogen argues patentees implicitly redefined beads as two-dimensional via intrinsic record. | Beads are excluded from three-dimensional culturing per intrinsic record. |
| Did the patentees disavow bead-based three-dimensional culturing in the specification? | Beads could be used in three dimensions; no explicit redefinition. | Inventors repeatedly defined beads as two-dimensional and contrasted with 3D culture. | There is a clear implicit disclaimer of beads as three-dimensional culturing. |
| Can extrinsic references (Doyle, Seldon, Salomon) override intrinsic disclaimer? | These references show beads used in 3D contexts. | Extrinsic references do not override clear intrinsic disavowal; some cited materials are not properly incorporated. | Intrinsic record controls; extrinsic evidence insufficient to overcome disclaimer. |
Key Cases Cited
- Thorner v. Sony Computer Entm’t Am. LLC, 669 F.3d 1362 (Fed. Cir. 2012) (claim terms read in light of the specification; lexicography governs when defendants redefine terms)
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claims read with intrinsic evidence first; specification highly persuasive)
- Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996) (ultimately source for claim construction methodology (intrinsic over extrinsic))
- Edwards Lifesciences LLC v. Cook Inc., 582 F.3d 1322 (Fed. Cir. 2009) (‘ie.’ signals definitional definition in specification)
- SafeTCare Mfg., Inc. v. Tele-Made, Inc., 497 F.3d 1262 (Fed. Cir. 2007) (disclaimer by repeated emphasis in written description)
- Bell Atl. Network Servs., Inc. v. Covad Commc’ns Grp., Inc., 262 F.3d 1258 (Fed. Cir. 2001) (implied redefinition through inconsistent use of terms)
- Dealertrack, Inc. v. Huber, 674 F.3d 1315 (Fed. Cir. 2012) (rejects broad reading when the patentee disavows embodiments)