Writing Strong Antibody Claims: Avoiding Or Addressing USPTO Rejections For Written Description And Enablement

Many patent applicants currently face difficulty in obtaining antibody claims because of written description and enablement rejections under 35 U.S.C. §112(a). The United States Patent & Trademark Office (USPTO) routinely rejects claims as too broad, arguing that such claims cover more antibodies than the specification discloses, or that undue experimentation would be needed to determine whether an antibody reads on the claims. These heightened disclosure requirements increase laboratory costs to generate sufficient data for a §112(a)-proof specification.

Written Description and Enablement Generally

The legal standards for written description and enablement are well-established. To meet the written description requirement, the specification must convey with reasonable clarity that as of the filing date the inventor was in possession of the claimed invention. See, Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560 (Fed. Cir. 1991); Ariad Pharm., Inc. v. Eli Lilly & C