Appeal No. 2003-0839 Page 3
Application No. 09/646,339
Page 4. Such items are disclosed to “effectively prevent surface colonisation by
bacteria for a relatively long period (2-4 weeks).” Id.
Discussion
Claim 1, the only independent claim on appeal, is directed to molded items
(e.g., medical articles) made from a thermoplastic ally process able polyurethane,
containing an antibiotic substance and having a peak-to-valley surface
roughness of less than 5 µm. The examiner rejected all the claims as obvious in
view of Solomon, either alone or in combination with Darouiche. (The examiner
cited Darouiche only for its disclosure of items containing the antibiotic
ciprofloxacin; since none of the claims are limited to ciprofloxacin-containing
items, we will say no more about Darouiche.)
The examiner cited Solomon for its disclosure of “an anti-infective medical
article having chlorhexidine distributed throughout a polyurethane base layer. . . .
The bulk distributed chlorhexidine, due to the hydrophobic nature of the polymer,
migrates slowly to the surface when the article is in contact with a body fluid and
produced anti-infective activity of long duration.” Examiner’s Answer, page 3.
The examiner acknowledged that “Solomon does not explicitly teach the medical
article . . . having a specific surface roughness.” Id. She concluded, however,
that
it would be obvious to one of ordinary skill in this art, at the time of
invention . . . , by routine experimentation, to determine a suitable
surface roughness to control the rate of release as desired by
Applicant[s]. . . . The cited reference teaches the same properties
(such as a polyurethane containing a homogeneous distribution of
an antibiotic substance) and the same effect (a long duration of
release . . .). Therefore, there is no criticality established in the
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