Appeal No. 1998-2267
Application 08/339,084
In the present case, the examiner relies on Podda for establishing that
ursodeoxycholic acid (UDCA) is known to be useful in the treatment of chronic liver
disease. Answer, page 4. The examiner acknowledges that Podda does not disclose the
use of UDCA for the treatment of NASH.2
Shironaga is relied on for the disclosure of the use of UDCA for the treatment of
fatty liver. Shironaga describes the inducement of a fatty liver condition in SRF mice using
a “stone-inducing diet”, which is a normal diet containing 1% cholesterol and 0.5% cholic
acid. An increase in liver weight was confirmed by histological and biochemical testing.
Shironaga, English translation, page 6.
The examiner summarizes (Answer, page 5) that:
One of ordinary skill in the art would have been motivated to employ
UDCA in the treatment of NASH, a well known type of hepatitis
characterized by fat abnormalities in the hepatic tissue, since UDCA was
known for the treatment of various chronic liver diseases, and known for the
treatment of another disease involving fat abnormalities in the hepatic tissue.
Where the prior art, as here, gives reason or motivation to make the claimed
invention, the burden then falls on an appellant to rebut that prima facie case. Such rebuttal
or argument can consist of any other argument or presentation of evidence that is
pertinent. In re Dillon, 919 F.2d 688, 692-93, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990)
2Appellant, however, does admit that NASH is considered a chronic liver disorder.
Lindor Declaration of February 19, 1996, pages 2-3.
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