Skinmedica, Inc. and, i.e., Disclaimer

I was reading through the decision handed down on August 13, 2013 in Appeal No. 2012-1560, Skinmedica, Inc. v. Histogen Inc., and barely staying awake. (A copy is available at the end of this post.) The panel interpreted the claims of Skinmedica’s patents (U.S. Pat. Nos. 6372494 and 7118746)  on methods for producing “novel conditioned cell culture medium  compositions” by culturing the cells in “three dimensions” to exclude culturing on beads – the infringer cultured cells on beads— even though culturing on beads would normally be considered to include culturing in three dimensions. However, Skinmedica had amended away from culturing cells in two dimensions and had repeatedly differentiated – if not explicitly defined – culturing on beads from a method of culturing in three dimensions. In effect, Skinmedica had been its own lexicographer, since otherwise the POSA would consider that culturing on beads could include three dimensional culturing.

The Fed. Cir. has been pretty hard on defendants alleging disclaimer of claim scope in recent decisions but that was not the case here. But what caught my attention is that Judge Prost spent four pages of his opinion on the effect of the abbreviation, “i.e..”(Slip op. at 22-26). Early in the detailed description, Skinmedica stated: “The cells are cultured in monolayer, beads (i.e., two-dimensions) or, preferably, in three dimensions.” After finding that this list includes the disjunctive (“or”) “as the coordinating conjunction that…plainly designates that a series describe alternatives,” Judge Prost agreed with the district court that the “phrase ‘beads (i.e., two-dimensions)’ explicitly define[s] beads in a two-dimensional culture method, despite that culturing cells in three-dimensions on beads was known to the art.” Judge Prost was just getting started:

In a specification, a patentees “use of ‘i.e. signals an intent to define the word to which it refers.” [citing Abbott Labs. v. Novopharm Ltd., 323 F.3d 1324. 1330 (Fed. Cir. 2003) as holding that a patentee “explicitly defined a term by using ‘i.e.’ followed by an explanatory phrase”). The inventors also used the phrase “i.e.” elsewhere in the specification…to introduce an explanation or definition of a word or phrase….Based on the plain meaning of the term ‘i.e.’ and the patentees’ consistent use of it throughout the specification, there is no reason to believe that the inventors did not intend for the abbreviation to signal an intent to define the word it followed when they stated “[t]he cells are cultured in … beads (i.e., two dimensions) or preferably in three dimensions.”

Judge Prost went on to distinguish decisions in which the Fed. Cir. did not give “i.e.” its plain meaning and import: “And in Teva Pharmaceuticals, USA, Inc., we refused to limit a disputed claim term to a narrow definition introduced by “i.e.” in a patent specification because the specification expressly included a broader definition of the term in a different section that the ‘patentee clearly intended…to address the meaning of the same term.’[429 F.2d 1363 (Fed. Cir. 2005). Here there is no other section of the specification in which the patentees have defined ‘beads’ as being broader than ‘two dimensions.’” Judge Rader dissented, and argued that the references to beads in the specification “do not amount to an unmistakable and unambiguous disavowal.” I don’t know which side of the question you would come down on, but I know that I  am never going to use the abbreviation “i.e.” again.

12-1560.Opinion.8-20-2013.1

3 Responses to “Skinmedica, Inc. and, i.e., Disclaimer”

  1. Harold Burstyn says:

    Since i.e. is exclusive, one is better off using e.g.

  2. Charles Gholz says:

    Judge Prost is a woman. One should not refer to –her opinion– as “his opinion”!

  3. Yimei Hammond says:

    Great analysis. I never used the abbreviation”i.e.” before; now I am not going to use it. I also wonder if the inventor added the term “bead” in that sentence right before the filing? I also wonder if this opinion applies to similar words such as “etc” or “for example.”

    Finally, I wonder if a broad or semi-broad disclaimer of such interpretation would work to prevent this issue.