Appeal No. 1999-1236
Application 07/571,782
disease were included in this study. Exclusion criteria
included normal aminotransferases (or elevated less than
twice), biopsy features of chronic persistent hepatitis (CPH),
inactive cirrhosis or normal histology; serum albumin < 3
gm/dl, serum bilirubin > 4 mg/dl, serum creatinine > 1.5 mg/dl;
history of encephalopathy, ascites or bleeding esophageal
varices; HDV infection, male homosexuality; pregnant females
(or without adequate contraception); corticosteroid or antiviral
therapy within the preceding 12 months; inadequate blood
2
counts (hematocrit < 30%, leukocyte count < 3000/mm ;
2 2
granulocytes < 1500/mm ; platelets < 75000/mm ); and
symptomatic heart disease or ECG evidence of ischemic
heart disease. Their pretreatment characteristics are shown in
Table 1.
Again, the parameters used by Waked to define compensated/decompensated liver
disease differ in content and in the range of values from those parameters used by either
Nevens or Dimopoulou to define the same medical condition.
Finally, appellant’s own specification is unclear concerning what criteria to use for
defining a patient as having “decompensated” liver disease. In lines 20-34 on page 6 of
the specification, the patients included within the study for the treatment of viral hepatitis by
injection with an effective dosage of thymosin are described as follows:
Patients between the ages of 18 and 70 years with
chronic type B hepatitis were included based on the following
criteria: Presence of hepatitis B surface antigen (HBsAg) and
elevated serum alanine aminotransferase (ALT) levels for at
least 6 months; positive serum test for hepatitis B virus DNA
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