Appeal No. 2000-1783 Page 3 Application No. 08/817,719 mediation of cell adhesion, regulation of IgE and histamine release, rescue of B cells from apoptosis and regulation of myeloid cell growth.@ Specification, page 1. A[Its] functional activities are mediated through the binding to specific ligands of cell- associated CD23, or sCD23 [(soluble CD23)], the latter acting in a cytokine-like manner.@ Id. Ligands of CD23 include CD21 (CD23-CD21 interactions are believed to play a role in IgE production), and the β-integrins (cell adhesion molecules) CD11b and CD11c. Id., page 2. According to appellant, CD23 binding agents that block the interaction between CD23 and its ligands Awork in vivo in treatment or prophylaxis of . . . autoimmune diseases.@ Id., page 4. DISCUSSION Enablement In its broadest aspect, the present invention is directed to treating autoimmune disorders by administering an agent that binds CD23 and blocks its interaction with a ligand it normally binds in vivo (e.g., claim 14). The examiner notes two principal concerns in concluding that A[t]he specification does not enable any person skilled in the art . . . to make and use the invention commensurate in scope with [the] claims.@ Answer, page 4. First, the examiner argues that A[t]he specification discloses the treatment of rheumatoid arthritis in mice but does not disclose the treatment of any other autoimmune disease@ (Id.), thus A[a]ppellant has not established in vivo therapeutic efficacy . . . [for] the numerous autoimmune diseases encompassed by the claims@ (Id., page 5), even though A[t]he therapy of autoimmune diseases . . . is highly experimental and unpredictable@ (Id., page 4). Second, the examiner argues that Athe claims encompass an enormous number of potential CD23 binding agents,@ but A[t]he specification does not disclose the administration of a bindingPage: Previous 1 2 3 4 5 6 7 8 9 10 NextLast modified: November 3, 2007