Appeal No. 1997-2795
Application No. 08/438,933
prior art as to render the instant products prima facie obvious to the worker of ordinary skill in the art
at the time the invention was made” (answer, page 7) and, therefore, “the burden is on the appellants to
show a novel or unobvious difference between the claimed products and the product of the prior art”
(answer, page 8). We disagree.4
While the heparin derivatives of the prior art do show a sulfur content, i.e., degree of sulfation,
equal to or higher than the starting heparin from which they were derived, they have molecular weights
lower than that of the starting heparin. In fact, both the anti-Xa activities and APTT/anti-Xa ratios of
the derivatives of Naggi ‘063, to the extent that they are disclosed, do not meet the limitations of the
heparin derivatives in the claimed invention. Moreover, Naggi ‘063 explicitly states that it is the anti-
Xa/APTT ratio which allows evaluation of “the anticoagulant component of the potential antithrombotic
activity of the depolymerized and supersulfated heparins of the present invention without associated
hemorragic risks” (col. 9, lines 20-24). Given the difference in anti-Xa/APTT (or APTT/anti-Xa) ratio
between the heparin derivatives of Naggi ‘063 and the claimed derivatives in combination with the
4As stated in In re Best, 562 F.2d 1252, 1255-56, 195 USPQ 430, 433-34 (CCPA 1977):
Where, as here, the claimed and prior art products are identical or substantially
identical, or are produced by identical or substantially identical processes, the
PTO can require an applicant to prove that the prior art products do not
necessarily or inherently possess the characteristics of his claimed product. ...
Whether the rejection is based on 'inherency' under 35 U.S.C. § 102, on 'prima
facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the burden of
proof is the same, and its fairness is evidenced by the PTO's inability to
manufacture products or to obtain and compare prior art products.
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