Appeal No.1997-0466
Application 08/154,158
During prosecution appellants amended the claims of the application to recite a
therapeutically effective concentration of collagenase and hyaluronidase, the concentration
of collagenase and hyaluronidase being effective to cause the dissolution and regression
of obstructive, hypertrophied, living prostatic tissue and to limit the concentration of
hyaluronidase to about 1600 to about 160,000 U/ml.2
Pinnell describes the administration of 150 units of hyaluronidase in a total volume
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of 0.2/ml along with various amounts of collagenase for the purpose of dissolution of
mammalian cicatrices. Pinnell further suggests that suitable amounts of enzymes required
for dilution of mammalian cicatrices will be varied and can be determined based on the
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nature of the cicatrix being treated, etc.
What is missing from the examiner’s analysis is why one of ordinary skill in the art
would be led to a composition including concentrations of hyaluronidase of about 1600 to
about 160,000 U/ml. (about 10 to 1000 times higher than that disclosed in Pinnell)
combined with collagenase for any reason, upon knowledge of the disclosure of Pinnell.
We do not find that one of ordinary skill in the art reading the disclosure of Pinnell
regarding suitable amounts and concentrations of enzymes would be led to a composition
2Paper No. 18, November 17, 1994.
3Pinnell, columns 3-4, Examples II, III and V.
4Pinnell, column 4, lines 46-56.
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