Appeal No. 1999-1236
Application 07/571,782
(HBV DNA); histologic confirmation of CAH (Knodell, R.G., et
al., Hepatology, 1:431-435 (1981)) within the previous 3
months of randomization and evidence of compensated liver
disease (prolongation of prothrombin time less than 4 seconds
over control values, serum albumin $3 gm/dl, and serum total
bilirubin $ 4 mg/dl). Additional requirements included a
3
hemoglobin $ 10 gm, a platelet count $ 70,000/mm , a white
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cell count (WBC) $ 3000 , a polymorphonuclear count (PMN)
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$ 1500/mm and serum creatinine # 1.4 mg/dl.
All of the patients included in the study are stated to have compensated liver
disease. Therefore, one of ordinary skill in the art would presume that those patients
having decompensated liver disease would have values for the described parameters
outside of the given ranges. However, it is not clear which of the several parameters listed
are to be considered in making a diagnosis of “hepatic decompensation” since several
additional requirements are described such as hemoglobin, platelet count, white cell count,
serum creatinine, etc. It is not clear whether all of these parameters in addition to the
prothrombin time, serum albumin levels and serum bilirubin levels must be considered in
making a diagnosis of “hepatic decompensation,” or whether only certain ones of the
parameters listed are critical in distinguishing compensated versus decompensated liver
disease.
From all of the ambiguities concerning how to define “decompensated liver
disease” found in both the prior art and in appellant’s own specification, no clear meaning
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