Ex parte Lindor

Board of Patent Appeals and Interferences

Apr 30, 2001

08339084 (B.P.A.I. Apr. 30, 2001)

1
The opinion in support of the decision being entered today was not written
for publication and is not precedent of the Board.
Paper No. 22
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte KEITH D. LINDOR
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Appeal No. 1998-2267
Application 08/339,084
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HEARD: April 24, 2001
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Before ROBINSON, MILLS and GRIMES, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. §134 from the examiner's final
rejection of claims 1-8, which are all of the claims pending in this application.
We reverse.
Claim 1 is illustrative of the claims on appeal and reads as follows:
1. A therapeutic method for the treatment of nonalcoholic steatohepatitis
comprising administering to a human patient in need of such treatment an effective amount
Appeal No. 1998-2267
Application 08/339,084
The examiner relied on an abstract of the Japanese patent application from1
HCAPLUS (Abstract 224). Appellant provided an English translation of the entire
Japanese patent application with the Brief (Appendix IV), which we rely on for purposes of
this appeal.
2
of ursodeoxycholic acid, a pharmaceutically acceptable salt thereof or a pharmaceutically
acceptable ester thereof.
The prior art references relied upon by the examiner are:
Shironaga JP 61-158995 KOKAI July 18, 19861
Podda et al. (Podda), “Effect of Different Doses of Ursodeoxycholic Acid in Chronic Liver
Disease”, Digestive Diseases and Sciences, Vol. 34., No. 12, pp. 59S-69S (1989)
Reference relied on by appellant:
(Kaplowitz), Biliary Diseases, pp. 327-337, 383, 445-446 and index, (Neil Kaplowitz ed.,
Wilkins and Wilkins 1992)
Ground of Rejection
Claims 1-8 stand rejected under 35 U.S.C. § 103 over Podda in view of Shironaga.
DISCUSSION
In reaching our decision in this appeal, we have given consideration to the
appellant's specification and claims, to the applied prior art references, and to the
respective positions articulated by the appellant and the examiner.
Rather than reiterate the conflicting viewpoints advanced by the examiner and the
appellant regarding the noted rejection, we make reference to the examiner's Answer for
Appeal No. 1998-2267
Application 08/339,084
3
the examiner's reasoning in support of the rejection, and to the appellant's Brief for the
appellant's arguments thereagainst. As a consequence of our review, we make the
determinations which follow.
35 U.S.C. § 103
Claims 1-8 stand rejected under 35 U.S.C. § 103 over Podda in view of Shironaga.
In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of
presenting a prima facie case of obviousness. See In re Rijckaert, 9 F.3d 1531, 1532, 28
USPQ2d 1955, 1956 (Fed. Cir. 1993). A prima facie case of obviousness is established
when the teachings from the prior art itself would appear to have suggested the claimed
subject matter to a person of ordinary skill in the art. In re Bell, 991 F.2d 781, 783, 26
USPQ2d 1529, 1531 (Fed. Cir. 1993). An obviousness analysis requires that the prior art
both suggest the claimed subject matter and reveal a reasonable expectation of success
to one reasonably skilled in the art. In re Vaeck, 947 F.2d 488, 493, 20 USPQ2d 1438,
1442 (Fed. Cir. 1991). With this as background, we analyze the prior art applied by the
examiner in the rejection of the claims on appeal.
Nonalcoholic steatohepatitis (NASH) is a liver condition which involves the
development of histologic changes in the liver which are comparable to those induced by
excessive alcohol intake, but in the absence of alcohol. NASH is commonly associated
with hyperlipidemia, obesity, and type II diabetes mellitus. Specification, page 1.
Appeal No. 1998-2267
Application 08/339,084
Appellant, however, does admit that NASH is considered a chronic liver disorder. 2
Lindor Declaration of February 19, 1996, pages 2-3.
4
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)
Appeal No. 1998-2267
Application 08/339,084
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(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
Appeal No. 1998-2267
Application 08/339,084
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which can be correlated to any human liver disease, much less the treatment of NASH.
Declaration, page 3. In sum, appellant argues the examiner has failed to show that one of
ordinary skill in the art would consider the conditions of Podda and Shironaga to be
equivalents of NASH. Brief, pages 11-12.
In response to appellant’s arguments and evidence, the examiner indicates that the
rejection of the claims “is not based on any asserted