Appeal No. 1997-2795
Application No. 08/438,933
Claims 14 and 17 are representative of the subject matter on appeal and read as follows:
14. Process for preparation of porcine heparin derivatives comprising
a) subjecting porcine heparin to a mild chemical sulfation,
b) oxidizing the product from step a) using periodate at pH 4-5 at
0-10E C in the dark,
c) partially depolymerizing the products from step b) using alkali,
d) reducing the product from step c) with sodium borohydrine [sic],
e) fractionating the obtained product by using gel permeation
chromatography, ultrafiltration, hydrophobic interaction
chromatography, affinity chromatography, ion exchange
chromatography or precipitation from an aqueous solution by addition
of an organic solvent,
f) collecting the product with a molecular weight not less than that of the
porcine heparin used as starting material.
17. Heparin derivatives from porcine heparin obtained by the process of claim
14 and characterized by:
- having a molecular weight equal to or larger than standard porcine
heparin,
- showing a sulfur content which is equal to or higher than that of said
porcine heparin or at least 13% w/w,
- having an anticoagulant activity in the anti-FXa assay of less than 10%
of said porcine heparin it was made from,
- showing a ratio of APTT activity over anti-FXa activity of 3-35,
- showing a reduced prolongation of bleeding time compared to said
porcine heparin it was made from as measured in the rat tail after i.v.
administration, and
- showing enhancement of the rate of development of coronary
collaterals in dogs equal to or better than clinically used heparin.
Parallel product-by-process claim 12 and process claim 13 are drawn to heparin derivatives obtained
from bovine heparin starting material essentially using the process of claim 14 except that the mild
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