Appeal No. 2005-2690
Application No. 09/935,442
warns of problems that may occur if fibrinogen and thrombin are separately
introduced for in situ polymerization from such a spray method. In this
connection Delmotte states that “the lower the amount of residual
fibrinogen, the better the non-adhesive properties of the fibrin film, since
fibrinogen in vivo may promote fibrin formation and thus adhesion
formation.” (Col. 7, lines 1-4)(emphasis added).
In view of the above, it would appear that Dinh suggests that it is critical that the
final fibrin product coating the stent must be in a form so as to avoid clotting at the fibrin
interface. Also understood from Delmotte, is that the acceptability for medical use of the
final fibrin form upon polymerization in situ is dependent upon the amount and form of
the fibrinogen and thrombin used. Added to these concerns, one of ordinary skill in the
art would have recognized at least some level of unpredictability associated with in situ
fibrin formation on a medical device, especially one implanted into the heart.
Furthermore, Delmotte describes the application of fibrin glues and films to
prevent adhesions associated particularly with surgical procedures in the abdominal
cavity. Column 1, lines 20-45. Delmotte does not suggest that the medical devices
adapted to deliver fibrin to treat abdominal adhesions address the same or similar
problems associated with the prevention of vascular restenosis.
In supplement to the above, while the examiner argues “Delmotte suggests
different types of fibrin glues can be prepared by altering the amount of thrombin used
and allowing formation of fibrin at the site of administration by separately providing
fibrinogen and thrombin” (Answer, page 5), Delmotte does not provide for “separate
release” of the precursor and activator compounds from an adapted medical device for
local delivery, as claimed. Instead, in the device of Delmotte, the precursor and activator
compounds begin in separate containers but are pressurized through a single spray unit,
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