Opinion ID: 1405856
Heading Depth: 1
Heading Rank: 10

Heading: EPO Representations

Text: The district court found that Abbott had made directly contradictory representations to the EPO concerning the teaching of the '382 patent in European Patent EP 0 078 636 (the '636 patent)a counterpart to the '382 patent with virtually identical specificationsand that Abbott had not disclosed those contradictory representations to the PTO. In 1993, the '636 patent was revoked as obvious. One of the references the EPO relied on was a German reference labeled D1. Abbott [8] argued to the EPO that the D1 reference was distinguishable. On January 12, 1994, Abbott's patent counsel submitted to the EPO a brief distinguishing the '636 patent from the D1 reference, stating: Contrary to the semipermeable membrane of D1, the protective membrane optionally utilized with the glucose sensor of the patent is [sic] suit is not controlling the permeability of the substrate (as set forth above under IV.2., in the membrane of D1 the permeability for the substrate must be kept on a low value to achieve a linear relationship between the measures [sic] currency and the substrate concentration in the test solution). Rather, in accordance with column 5, lines 30 to 33 of the patent in suit: Optionally, but preferably when being used on live blood, a protective membrane surrounds both the enzyme and the mediator layers, permeable to water and glucose molecules. See also claim 10 of the patent in suit as granted according to which the sensor electrode has an outermost protective membrane (11) permeable to water and glucose molecules. Finally, see Example 7 in column 10, lines 19 to 26 reporting that by using such a protective membrane the response time did not increase but from 24 to 60 sec. (without membrane) to 36-76 sec. (with membrane). Accordingly, the purpose of the protective membrane of the patent in suit, preferably to be used with in vivo measurements, is a safety measurement to prevent any course [sic] particles coming off during use but not a permeability control for the substrate. J.A. 6530-31 (emphases added). On May 23, 1995, Abbott's patent counsel submitted another brief to the EPO regarding the D1 reference and the '636 patent. It again discussed the [o]ptionally, but preferably language: Optionally, but preferably when being used on live blood, a protective membrane surrounds both the enzyme and the mediator layers, permeable to water and glucose molecules. It is submitted that this disclosure is unequivocally clear. The protective membrane is optional, however, it is preferred when used on live blood in order to prevent the larger constituents of the blood, in particular erythrocytes from interfering with the electrode sensor. Furthermore it is said, that said protective membrane should not prevent the glucose molecules from penetration, the membrane is permeable to glucose molecules. J.A. 6585 (emphases added). The district court found that the EPO statements contradicted the PTO representations in at least two significant ways. First, the district court found that by describing the [o]ptionally, but preferably language as unequivocally clear, Abbott's EPO representations contradicted Abbott's representations to the PTO that a person having ordinary skill in the art would have understood the phrase as mere patent phraseology that did not convey a clear meaning. See Trial Opinion, 565 F.Supp.2d at 1110. Second, the district court noted that the EPO documents clearly explained that membranes were merely preferred for live blood. Id. at 1109-10. The documents identified reasons specifically directed toward live blood explaining why a membrane was necessary, supporting the position that these problems did not exist for in vitro testing of whole blood and that a membrane was not necessary for testing whole blood in vitro. See id. at 1109. These findings are not clearly erroneous, and indeed are manifestly correct.