Opinion ID: 1038335
Heading Depth: 4
Heading Rank: 4

Heading: Dr. Salomon’s Testimony

Text: The district court afforded Dr. Salomon’s testimony “no weight” after finding that it was “inconsistent with the intrinsic patent record.” J.A. 23 n.5. SkinMedica, however, believes that Dr. Salomon’s testimony is relevant because of two points to which he testified “without contradiction”: (1) “skilled practitioners understood that three-dimensional culturing could be performed using beads” and (2) “culturing using beads in three-dimensions produces the same benefits over two-dimensional culturing that the patents describe—i.e., ‘exhibit[ing] cell-to-cell and cell-matrix interaction characteristic of whole tissue in vivo.’” Appellant’s Br. 33 (quoting J.A. 101615); see also Reply Br. 31. We agree with the district court. The first point from Dr. Salomon’s testimony highlighted by SkinMedica—that culturing with beads in three-dimensions was known in the art—simply confirms an assumption we already made during our analysis of the intrinsic record. When we determined that the inventors disclaimed culturing with beads, we assumed that culturing with beads in three-dimensions was known in the art. Dr. Salomon’s validation of our assumption is irrelevant. Dr. Salomon’s discussion of the benefits of culturing with beads is equally unhelpful here because it is conclusory and incomplete. SkinMedica asserts that Dr. Salomon testified that three-dimensional bead cultures can produce the same benefits of three-dimensional culturing described by the patents. To support that assertion, it points us to a single passage from Dr. Salomon’s testimony. Appellant’s Br. 33–34 (arguing that Dr. Salomon’s testimony is extrinsic evidence to show that “ordinary meaning applies”); see also Reply Br. 31. 40 SKINMEDICA INC v. HISTOGEN INC Q. In your opinion, Dr. Salomon, do fibroblasts that are cultured in three-dimensions on micro- carriers or beads, do they exhibit cell-to-cell and cell-matrix interactions characteristic of whole tissue in vivo. A. Yes. Q. And have you seen that? ... A. Yes. Q. And is that—is your opinion about that func- tional definition applied to three-dimensional use of beads consistent with what we saw in the Doyle reference . . . ? A. Yes. J.A. 101614–15 (emphasis added). While it does appear from that passage that Dr. Sa- lomon agreed that bead cultures can provide benefits similar to three-dimensional cultures, Dr. Salomon’s testimony consists exclusively of three conclusory affirmations elicited by leading questions posed by SkinMedica’s counsel. His testimony lacks any convincing detail explaining why or how cells in bead cultures exhibit the characteristics of whole tissue in vivo he claims they possess. Indeed, the patentees explained at length how the three-dimensional cultures used in their inventions have specific and valuable characteristics of tissue in vivo. For example, they described how their three-dimensional cultures can provide for: sustained long-term proliferation of cells; stimulation of cell growth and proliferation; provision of a greater surface area for protein attachment; regulation of cell differentiation; adequate spatial distribution of cellular elements; establishment of localized microenvironments; and greater potential for movement of migratory cells. See ’494 patent col. 1 ll. 37–40; col. 11 SKINMEDICA INC v. HISTOGEN INC 41 ll. 20–53; col. 14 ll. 20–36; J.A. 101245. But Dr. Salomon does not explain how culturing with beads provides for any of those important characteristics. He even fails to explain how culturing with beads provides for the sustained long-term proliferation of cells, the key characteristic of three-dimensional cultures that the patentees identified as distinguishing their invention from prior art—in both the specification and prosecution history. See discussion supra, Section I(A). Dr. Salomon’s oneword confirmations of directed conclusions in leading questions simply lack any helpful or informative detail regarding the benefits of culturing with beads. Moreover, while SkinMedica believes Dr. Salomon’s statements are “perfectly consistent with the intrinsic record,” Appellant’s Br. 34, they are not. The patentees plainly stated in the written description that: “Cell lines grown as a monolayer or on beads, as opposed to cells grown in three-dimensions, lack the cell-cell and cellmatrix interactions characteristic of whole tissue in vivo.” ’494 patent col. 1 ll. 37–40 (emphases added). Dr. Salomon, though, testified that “fibroblasts culture[ed] in three-dimensions on microcarriers or beads, . . . exhibit cell-to-cell and cell-matrix interactions characteristic of whole tissue in vivo.” J.A. 101614–15 (emphasis added). As the district court found, Dr. Salomon’s testimony is “inconsistent with the intrinsic patent record.” J.A. 23 n.5. In whole, Dr. Salomon’s opinions are unhelpful to our analysis here. They are conclusory and incomplete; they lack any substantive explanation tied to the intrinsic record; and they appear to conflict with the plain language of the written description. Without a more detailed explanation of how Dr. Salomon formed his conclusions and why they conflict with the plain language of the specification, we must agree with the district court that 42 SKINMEDICA INC v. HISTOGEN INC Dr. Salomon’s testimony deserves no weight. 14 See Phillips, 415 F.3d at 1318 (discussing how expert testimony “can suffer from bias that is not present in intrinsic evidence,” is “not useful” if based on “conclusory, unsupported assertions,” and should be “discount[ed]” if “clearly at odds with . . . the written record of the patent”); see also Bell Atl. Network Servs., 262 F.3d at 1269 (“[Extrinsic evidence] may not be used to vary, contradict, expand, or limit the claim language from how it is defined, even by implication, in the specification or file history.”); Vitronics, 90 F.3d at 1584 (“[W]here the patent documents are unambiguous, expert testimony regarding the meaning of a claim is entitled to no weight.”).