Appeal No. 1997-2795
Application No. 08/438,933
product AH-68 4,500 2.8
starting heparin
Parke-Davis 19,200 2.27
product DS-16 8,600 3.33 10% of 60% of >3
starting starting
heparin heparin
Naggi ‘881 describes a depolymerization and sulfation process of polysaccharides, including
heparin (col. 3, lines 3-7; col. 4, lines 4-5) and shows a pattern of relative molecular weights and
degree of sulfation similar to that in Naggi ‘063. For example, starting heparin D212 has a molecular
weight of 13,500 and a 1.95 degree of sulfation while products AH-16, AH-104, AH-103, AH-105,
AH-106 and AH-107 have molecular weights of 6,000 and degree of sulfations (% elemental sulfur) of
3.0 (12.93%), 2.9 (14.54%), 2.8 (14.63%), 3.0 (14.48%), 2.8 (14.54%) and 3.0 (14.12%),
respectively.
Petitou describes a process of preparing highly sulfated or “sursulfated” heparin (col. 6, lines
40-49). According to the examiner, Petitou “does teach a product having molecular weight higher than
9000 daltons” (answer, page 10). However, Petitou also discloses that standard heparin has a
molecular weight of 15,000 (line 4 in the table bridging cols. 17-18).
According to the examiner, the heparin derivatives described by Naggi ‘063, Naggi ‘881 or
Petitou are “the same as or substantially the same as those of the instant claim[s]” (answer, page 7) or
“[t]he products of the instant claims are considered to be so close to being the same as those of the
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