Appeal 2008-4371
Application 10/461,839
Technology Center 1600
Decided: March 9, 2009
Claim at issue:
1. A stable pharmaceutical formulation comprising at least 45 mg/ml PEGsTNF-R1, at least one tonicity modifier that is not NaCl, a surfactant and a buffer, wherein said pharmaceutical formulation is between pH 4.0 and 5.5 and wherein the viscosity is less than 400 cP.
The claim used the term "PEGsTNF-R1". The Examiner acknowledges that Appellants’ Specification defines PEGsTNF-R1 but insists that “the acronym ‘PEGsTNF-R1’ as recited in the claims should be spelled out and/or defined the first time it is recited in the claims." The Examiner acknowledges on this record that a person of ordinary skill in the art would understand the bounds of the claimed invention when read in light of the Specification. The Examiner argued that looking to the specification to define PEGsTNF-R1 would be adding an extraneous limitation. The Examiner relied upon In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993), to find that “[a]lthough the claims are interpreted in light of the specification, limitations from the specification are not read into the claims” (Ans. 7). The Board disagreed holding that “[I]t is entirely proper to use the specification to interpret what the patentee meant by a word or phrase in the claim.” In re Paulsen, 30 F.3d at 1480." Therefore, the claim was definite.
The claims were found to be obvious for standard reasons such as overlapping ranges and optimization of dosages requiring nothing more than routine experimentation.
Case can be found here
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