CAFC: Specification and Prosecution History Triggers Vitiation

Ortho-McNeil v. Caraco (06-1102) January 19, 2007

The CAFC considered a district court's SJ finding of non-infringment where a claim term of "about 1:5" was interpreted as meaning "approximately 1:5, encompassing a range of ratios no greater than 1:3:6 to 1:7.1."

In reaching this conclusion, the district court relied upon both intrinsic and extrinsic expert testimony. The district court also considered evidence related to Ortho’s reissue application to the same patent, which was pending while proceedings involving the original patent were ongoing in the district court.

The claims of the reissue application were written in a more narrow form than the original claims, using the phrase "comprising an active ingredient that consists essentially of," instead of the broader "comprising" language of the original patent. More importantly, the court found that the distinct claiming of modified ratios throughout the claims indicated that a narrow range was intended:

The intrinsic evidence points to a meaning for the term "about 1:5" that is narrow because the 1:5 weight ratio, along with the 1:1 weight ratio, is distinctly claimed and distinguished from other broader weight ratio ranges in the patent. There are fifteen claims in the ’691 patent, all of which use the term "about" to modify the weight ratio or weight ratio ranges of tramadol to acetaminophen . . . There are two claims, claim 4 and disputed claim 6, that claim a single weight ratio; the other claims distinctly point out ranges of weight ratios . . . This leads to a conclusion that one of ordinary skill in the art would understand the inventors intended a range when they claimed one and something more precise when they did not.

Finding that Caraco’s ratio of 1:8.67 was outside the upper range of the claims 1:7.1 ratio, the CAFC found no literal infringement. On the doctrine of equivalents, the court found that the prosecution history barred Ortho from expanding the range since the argued ranges would vitiate other ranges contained in the claims (note: estoppel was not addressed in the opinion):

Also relevant is the prosecution history of the ’691 patent and the ’221 reissue patent, described above. Ortho admitted that it claimed more than it was entitled to claim in the ’691 patent when, in its reissue application, it cancelled the broader "comprising" claims, except for claim 6. In sum, having so distinctly claimed the "about 1:5" ratio, Ortho cannot now argue that the parameter is broad enough to encompass, through the doctrine of equivalents, ratios outside of the confidence intervals expressly identified in the patent. We agree with the district court that to do so would eviscerate the limitation. The intrinsic evidence in this case points to the criticality of the "about 1:5" parameter, which necessitates a narrow claim construction and range of equivalents that does not encompass Caraco’s product.

AFFIRMED