Appeal No. 1997-2795
Application No. 08/438,933
“a mild chemical sulfation,” see e.g., page 7, lines 5-10, page 9, lines 25-33, and page 13, line 30 -
page 14, line 5. For the foregoing reasons the rejection of claims 14 and 16 under 35 U.S.C. § 112,
second paragraph, as indefinite is reversed.
II. Rejection of claims 12 and 17 under 35 U.S.C. § 102 as anticipated by or, in the alternative,
under 35 U.S.C. § 103 as being unpatentable over any of Naggi ‘063, Naggi ‘881 or Petitou
Naggi ‘063 describes reacting a heparin of natural origin with a sulfuric acid/chlorosulfonic acid
mixture to produce depolymerized and supersulfated heparin products having molecular weights
between 2000 and 9000, with good fibrinolytic and hypolipemic activity joined to a weak anticoagulant
activity (col. 4, line 67 - col. 5, line 2; col. 5, lines 41-45), and which are useful for prevention of
thrombolytic diseases and treatment of atherosclerosis (col. 10, lines 58-66). Naggi ‘063 explicitly
describes at least the relative molecular weights and degree of sulfation (a measure of sulfur content)
between various starting heparin materials and their resulting product(s) and, in some cases, %
elemental S (% S), results of activated partial thromboplastin time (APTT), activity towards blood
coagulation factor Xa (anti-Xa activity), and the ratio anti-Xa/APTT. A summary of this data follows,
with calculated APTT/anti-Xa ratios where data was available.
mol. weight degree of APTT anti-Xa anti-Xa/ (calc.) APTT/
sulfation (% S) activity APTT anti-Xa
starting heparin
D212 13,500 1.95 1.000 1.20 1.20 0.83
product AH-16 6,000 3.0 (12.93%) 0.06 0.18 3.0 0.33
product AH-19 6,000 3.0 0.05 0.22 4.4 0.23
- 6 -
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Next
Last modified: November 3, 2007