MIT, et al. v. Shire Pharmaceuticals, Inc. et al.

Docket No. 2015-1881

October 13, 2016

Brief Summary: DC decision of infringement and no invalidity based on finding of no prosecution history estoppel or indefiniteness affirmed.

Summary: MIT appealed DC claim construction after the parties stipulated to a final judgment of validity and infringement by Shire’s Dermagraft® product of MIT’s US 5,770,193 and 5,759,830 “directed to three-dimensional scaffolding for growing cells in vitro to produce organ tissue in vivo.” Representative claim 1 of the ‘830 patent is directed to “[a] cell scaffold composition prepared in vitro” for producing “functional vascularized organ tissue in vivo” using “a fibrous three-dimensional scaffold” and “cells derived from a vascularized tissue”. One aspect of the dispute was “whether prosecution history disclaimer applied to the asserted claims.” The ‘193 patent is a CON of 06/933,018 which was abandoned. During prosecution of that application as well as those of the ‘193 and ‘830 patents, MIT amended the claims to encompass only “non-skin organ cells” which were rejected as new matter. MIT then withdrew those amendments. The claims also included thickness limitations in the applications of the ‘193 and ‘830 patents which were removed after being rejected under § 112, first paragraph (written description) and MIT’s unsuccessful arguments. MIT then “shifted its prosecution history” such that the scaffold would be used “to produce functional vascularized organ tissue in vivo” and the claims were allowed. Shire argued that “‘vascularized organ tissue’ should be construed to exclude skin” based on the prosecution history. The FC panel opinion explained that “for prosecution history to attach, the disavowel must be both clear and unmistakable” (3M, FC 2013) and where it is “ambiguous, or even ‘amenable to multiple reasonable interpretations,’ we have declined to find prosecution disclaimer” (Avid Tech., FC 2016). The FC panel agreed with the DC that there was no “clear and unmistakable” disclaimer (e.g., ordinary meaning includes “skin” and the specification supports “organ” including “skin”). It found that Shire relied on, e.g., a “selected sentence” relating to claims not including the disputed terms and “isolated statements plucked from Dr. Vacanti’s declaration”. And “MIT’s attempt to add the ‘non-skin’ limitation” was also found to reinforce the DC’s conclusion. The FC panel also agreed with the DC that “cells derived from a vascularized tissue” include “parenchymal and non-parenchymal (e.g., bone-forming) cells” because the claims do not distinguish between the two, “the respective specifications do not limit the term”, and there was no “clear and unmistakable” disclaimer (e.g., statements relied on were regarding “very different claim language”). Shire also argued the term “three-dimensional scaffold” was indefinite but the FC panel agreed with the DC (ordinary meaning using a dictionary) under the Nautilus “reasonable certainty” standard (US 2014). Thus, the DC decision was affirmed.

This entry was posted in Claim Construction, Indefiniteness, Prosecution History Estoppel. Bookmark the permalink.

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