Appeal No. 2002-0869
Application No. 08/580,384
substituting protein C for heparin in the eye.
Appellants argue that because the ocular area is normally isolated from the blood
stream by the blood-aqueous barrier, a vascular phenomenon that may apply in other
tissues does not necessarily apply to the ocular environment. Brief, page 10. It is
argued that there are many reasons why a cascade reaction may be disrupted in a
tissue specific manner such as the presence of tissue specific inhibitors or the tissue
specific absence of a required cofactor. In particular, appellants argue, the
effectiveness of protein C in reducing inflammation in the eye has not been
demonstrated prior to the present invention. Brief, pages 10-11.
In copending application Serial No. 08/696,698 (Appeal No. 2001-1685)
appellants argued that a person of ordinary skill in the art would not have had a
reasonable expectation that protein C would have a pharmacological effect in the eye.
In support of this position appellants argued that “delivery of therapeutic pharma-
ceuticals to the eye is not a trivial matter. In many instances, systemically administered
drugs do not reach the eye in therapeutic levels; and ... [m]any drugs, if systemically
administered in large concentrations to achieve a desired result in the eye, would result
in serious systemic dysfunction, side effects and possibly death.”
Upon return of the application to the examiner, it is recommended that the
examiner take a step back and review the record in copending application Serial No.
08/696,698 (Appeal No. 2001-1685) with respect to the issue of expectation of success.
In addition, appellants should consider making of record in the present case the prior art
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