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 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.