Appeal No. 1997-2795
Application No. 08/438,933
reliance of Naggi ‘063 on this ratio to evaluate hemorragic risk, it is unclear on what factual basis the
examiner concluded that the heparin derivatives of Naggi ‘063 would impliedly have a “ ‘reduced
prolongation of bleeding time’ as recited in appellants’ claims” (answer, page 5). Similarly, while the
examiner relies on the background discussion in Naggi ‘881 that low molecular weight sulfated
polysaccharides have been proposed as involving a weak hemorragic risk (see Naggi ‘881, col. 1, lines
26-31; answer, pages 5-6), the claimed heparin derivatives do not have a low molecular weight, but
rather a molecular weight equal to or larger than that of standard bovine/porcine heparin. Furthermore,
the examiner has not established a factual basis for concluding that the skilled artisan would have
reasonably expected the APTT results disclosed by Petitou to correspond to the claimed reduced
prolongation of bleeding time (answer, page 6). An APTT test measures the activity of the extrinsic
total coagulation system (see Naggi ‘063 at col. 9, lines 10-11), whereas a bleeding time measures the
activity of plasma factors, i.e., intrinsic as well as extrinsic coagulation factors, and platelet functions
(see Platt, pages 225-226). Thus, the examiner has not met her burden to establish that the heparin5
derivatives of the prior art reasonably appear to be identical or substantially identical to those of the
claimed invention. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Therefore,
the burden has not switched to appellants to prove that the prior art heparin derivatives do not
necessarily or inherently possess the characteristics of the heparin derivatives of the claimed invention.
5William R. Platt, “Laboratory Diagnosis of Coagulation Defects” in COLOR ATLAS and TEXTBOOK OF
HEMATOLOGY, pages 225-26 (J. B. Lippincott Company, Philadelphia, 1969) (copy attached).
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