Appeal No. 1998-2267
Application 08/339,084
(en banc), cert. denied, 500 U.S. 904 (1991). Accordingly, we carefully evaluate the
objective evidence of nonobviousness supplied by the appellant.
Appellant submits two declarations of Dr. Keith Lindor as evidence of the non-
obviousness of the claimed invention. The Declaration of Lindor dated February 19, 1996,
suggests that Podda describes three distinct liver pathologies, primary biliary cirrhosis,
primary sclerosing cholangitis and chronic hepatitis which are unrelated to NASH.
Declaration, paragraphs 4-7. Dr. Lindor suggests that “fatty liver” as described in
Shironaga, can be caused by many organic diseases and external toxins and that there
would be no reason for one of skill in the art, in possession of Shironaga “to conclude that
the administration of UDCA to humans with NASH would be an efficacious treatment.”
Declaration, paragraph 9.
The second Declaration of Dr. Lindor, dated February 23, 1996, provides evidence,
Kaplowitz, indicating that “NASH differs from fatty liver in that parenchymal inflammatory
changes and the presence of Mallory's hyalin are noted. Additionally, NASH may progress
to fibrosis or cirrhosis in one-third of cases, an outcome not usually associated with fatty
liver.” Kaplowitz, page 445. The second Declaration of Lindor states that “those of skill in
the art do not consider NASH under the rubric of chronic hepatitis, nor do those of skill in
the art consider the two diseases to be equivalents.” Declaration, page 2. Further, the
second Lindor Declaration suggests that Shironaga does not establish a mouse model
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