Appeal No. 2001-1685
Application No. 08/596,698
systemically administered in large concentrations to achieve a desired result in the eye,
would result in serious systemic dysfunction, side effects and possibly death.” Brief,
page 7.
The examiner “completely agrees” with appellants' statement that in many
instances systemically administered drugs do not reach the eye in therapeutic levels.
Answer, page 5. Evidence of record also appears to support appellants' arguments as
to the difficulties associated with systemic delivery of drugs to treat the eyes. In
particular, Synder and Howard, submitted by appellants in an information disclosure
statement filed October 11, 1994, indicate that upon evaluation of various fibrinolytic
agents including urokinase, streptokinase, fibrinolysin and tissue plasminogen activator
(tPA), that all of these substances, except tPA were associated with corneal toxicity and
a marked inflammatory response. Howard, page 272, column 1. Snyder indicates that
“ ... fibrin degradation products have been shown to be toxic to rabbit corneal
epithelium and chemotactic for leukocytes. Rapid fibrinolysis may cause clinically
significant corneal damage ....” Snyder, page 1280, column 2.
In spite of the examiner's agreement with appellants' arguments concerning the
lack of expectation of success when administering fibrinolytic agents to the eye, the
examiner continues to argue, “[o]ne would reasonably expect protein C which has a
wider therapeutic index than available anti-coagulants according to Bang, to be more
effective than heparin taught by Iverson upon similar intraocular administration.”
Answer, page 5.
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