It's About TIme

Ortho-McNeil Pharmaceutical, Inc. v. Caraco Pharmaceutical Laboratories, Ltd., [06-1102](January 19, 2007)[MCKINNEY, Schall, Gajarsa] The Federal Circuit affirmed the grant of Caraco’s motion for summary judgment of non-infringement.
SIGNIFICANCE: The Federal Circuit brought some claritiy to the construction of "about" in patent claims.
BRIEF: At issue was the meaning of “about 1:5” in the claim relative to Caraco’s formula which had an average ratio of 1: 8.67 and a minimum ration of 1:7.5. Caraco argued that the proper construction is approximately 1:5, subject to error of 5 or 10%. Ortho argued that about 1.5 meant approximately 1.5, encompassing a range of rations of at least 1:3.6 to 1:7.1. The Federal Circuit noted that the parties agreed that “about” means “approximately”, but disagreed on the numerical limits. The Federal Circuit instructed:
[T]he word “about does not have a universal meaning in patent claims, . . . the meaning depends upon the technological facts of the particular case.

The use of the word “about,” avoids a strict numerical boundary to the specified parameter. Its range must be interpreted in its technological and stylistic context. We thus consider how the term . . . was used in the patent specification, the prosecution history, and other claims. It is appropriate to consider the effects of varying that parameter, for the inventor’s intended meaning is relevant. Extrinsic evidence of meaning and usage in the art may be helpful in determining the criticality of the parameter . . .

The Federal Circuit said the extrinsic evidence pointed to a narrow interpretation of 1:5 because this ratio was distinctly claimed (as opposed to other broader ranges in the patent. Additional intrinsic evidence if the narrowness of 1.5 was the fact that other ratio close to 1.5, such as 1.1 were also specifically claimed, and a broad interpretation of 1.5 would render these specific limitations meaningless. The presence of a broad range of about 1:1 to about 1:1600 while at the same time specific ratios 1:1 and 1:5 suggests to a person of ordinary skill that the inventors intended a range when they claimed one, and something more precise when the did not. This conclusion what bolstered by the data points in the examples, 1:1, 1:3, 1:5, 1:5.7 and 1:15, yet only 1:1 and 1:5 were claimed, rather than a range. The Federal Circuit agreed with the district court’s adoption of Ortho’s claim construction that about 1.5 encompassed 1:3.6 to 1.7.1.
However on infringement the Federal Circuit agreed with the district court and Caraco that interpreting about 1:7.1 to extend to Caraco’s minimum ration of 1:7.5 would vitiate the claim limitation. The Federal Circuit said stretching the bounds of the 1:5 limitation beyond the 95% confidence levels specifically taught in the patent conflicts the the patents express claims to the 1:1 and 1:5 ratios. Under these circumstances, it makes no difference whether the response at other ratios was “statistically different” the intrinsic evidence points to the desirability, and thus the criticality, of the 1:5 ratio as opposed to other ratios. The Federal Circuit said “having so distinctly claimed the about 1:5 ratio, Ortho cannot argue through the doctrine of equivalents that the parameter is broad enough to cover ratios outside the confidence intervals expressly identified in the patent – to do so would eviscerate the limitation.