Specification and Prosecution History Narrow the Plain Meaning of “0.001%.”

The claim at issue included a concentration of 0.001% of PVP. The term’s plain meaning is 0.001% within one significant figure (i.e., 0.0005% to 0.10014%). The Federal Circuit held that the term had a narrower meaning in light of the specification and prosecution history—“precisely 0.001% w/w PVP with only minor variations’” (i.e., 0.00095% to 0.00104%). As a matter of general construction and scientific convention, the term, expressed with only one significant figure, would encompass the larger range. The meaning of a claim term, however, is the meaning understood by one of ordinary skill in the art “after reading the entire patent.” Here, because the written description and the prosecution history strongly emphasized the stability of the claimed formulations (with 0.001% w/w PVP) as compared to close variations, a narrower construction was warranted. The specification touted a formulation with 0.001% w/w PVP as the “most stable” and the formulation with 0.0005% was one of the least stable. Further, during prosecution, the claims were amended to delete a PVP range from “about 0.005% to about 0.05% w/w” to a claim with “0.001% w/w” of PVP without using the term “about”. The inventors argued that data in the specification demonstrated that the range, as amended, was “critical”.