Appeal No. 1999-1236
Application 07/571,782
The parameters and values thereof used as a diagnosis of decompensated liver disease
in the patients studied are described in the second column on page S104 of Dimopoulou
as follows:
Patients were required to have decompensated liver disease
proved by biopsy examination (the criteria used to define
decompensated liver disease in this study included the
presence of ascitis, serum albumin values below 3g/dl, and
serum bilirubin values above 3 mg/dl)(positive for either
hepatitis B surface antigen (HBsAg) or antibodies to hepatitis
C virus (anti-HCV)), serum transaminases 2-5 times the upper
limit of normal for more than six months, and absence of
encephalopathy, active bleeding, renal failure, or detectable
hepatocellular carcinoma.
Note that the parameters used by Dimopoulou to define “hepatic decompensation” differ in
content and in the range of values from those parameters used by Nevens to define the
same medical condition.
Another research study conducted by Waked (made of record in Paper No. 15)
analyzes patients with compensated liver disease. However, in the first column on page
311 of Waked, criteria are defined which excludes certain patients from being included in
the study. These excluded patients having values for certain parameters that fall outside of
the range of “compensated” liver disease. The relevant portion of Waked is as follows:
Forty patients (31M, 9F) who were HBsAg and HBeAg
positive for more than 6 months, with elevated
aminotransferases, histologically active liver disease, normal
blood counts, normal renal functions, and compensated liver
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