Commissioner’s Decision 1307

The application related to human receptors for the platelet factor 4 superfamily antibodies. It was also the subject of a voluntary divisional. The final action raised issues of obviousness double patenting and lack of support for monoclonal antibodies.

The relevant claims at issue for the obviousness double patenting argument were a claim to an antibody capable of binding an isolated platelet factor 4 superfamily receptor and a claim to an isolated platelet factor 4 superfamily receptor polypeptide. The Board held that the subject matter in the claims does not reflect the same intended utility. Furthermore, the Court held that the claims were not obvious variations, modifications or combinations. Thus, the Board found no double patenting would exist.

The claims at issue in the rejection for lack of support related to antibodies and pharmaceutical compositions of antibodies as well as the use of antibodies as an anti-inflammatory agent. The Board considered the submissions of the parties and held that as of the laid open date of this application, the core steps for producing a monoclonal antibody were well known and reliable. Furthermore, the Board held that a person skilled in the art would not need to undertake considerable or protracted experimentation to make monoclonal antibodies capable of binding the particular polypeptides described in the figures. However, the Board did require limitation of the scope of the claims to an antibody capable of binding the particular polypeptides described.

Finally, the Board refused to allow the use claims. After conducting a sound prediction analysis, the Board held that the factual basis in the specification would not lead a skilled person to conclude that blinding and/or blocking any one of the PF4AR polypeptides with a specific antibody would, on its own, necessary result in inhibition of inflammation.