Disclaimers of Claim Scope Viewed in Context of the Entire Prosecution History

federal-circuit-building-corner-335Massachusetts Institute of Technology, Children’s Medical Center Corporation v. Shire Pharmaceuticals, Inc., No. 2015-1881, 2016 U.S. App. LEXIS 18426 (Fed. Cir. Oct. 13, 2016) (Before O’Malley, Chen, and Stoll, J.) (Opinion for the court, Stoll, J.) (Concurring, O’Malley, J.)

Massachusetts Institute of Technology and Children’s Medical Center Corporation (collectively “MIT”) brought suit against Shire Pharmaceutical, for infringement of two patents directed to 3D synthetic and biodegradable scaffolding for growing cells in vitro, and to produce organ tissue of varying thickness in vivo. Following claim construction, the parties stipulated to a final judgment of validity and infringement. Shire appealed, and argued that the district court’s claim construction of “vascularized organ tissue” and “cells derived from a vascularized tissue” was erroneous, that a prosecution history disclaimer applied, and that “three-dimensional scaffold” was indefinite.

Shire argued that “vascularized organ tissue” was limited to non-skin cells, based on statements made by MIT during prosecution of the patents. Shire cited a 1988 interview with the examiner, statements made in a declaration submitted by the inventor, and a claim limitation that was added by MIT but rejected by the examiner. The Federal Circuit agreed with the district court that this evidence did not demonstrate a “clear and unmistakable” disclaimer in claim scope. The Court emphasized that disavowals must be evaluated in the context of the entire prosecution history. Thus, the term “cells derived from a vascularized tissue” included both parenchymal (organ) and non-parenchymal cells. The file history statements did not amount to an unmistakable disclaimer of non-parenchymal cells, in light of the full prosecution history and the claim language pending at the time of the alleged disavowal.

Shire also argued that the term “three-dimensional scaffold” was indefinite under § 112 and that the district court’s construction of the term (“a supporting structure that allows cells to attach along its width, length, and height”) was a reversible error. However, the Federal Circuit found no error in this construction, given expert testimony regarding the ordinary meaning of the term.

Judge O’Malley concurred in the Court’s decision regarding prosecution history disclaimer and indefiniteness but believed the Court should not have exercised jurisdiction over the case because the district court still had to determine damages and willfulness. In his opinion, such a judgment was not sufficiently “final” to qualify as an exception to the final judgment rule.

For prosecution history disclaimer to apply, disavowals of claim scope must be clear and unambiguous and must be viewed in the context of the entire prosecution history and claims that were pending at the time the disavowals were made.




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