Appeal No. 2005-0102 Page 7
Application No. 09/840,787
instant invention was made would not have been able to use the information obtained
from an expression profile in a useful manner.” Examiner’s Answer, page 6.
The examiner noted that claims 13, 14, and 21 are directed to diagnostic
methods but noted that “[n]either the specification nor the art of record disclose any
specific disease or conditions that can be diagnosed using a DNA encoding SEQ ID
NO:19. There is no indication that increasing or decreasing the expression of HRM-19
would have any use in diagnosing any diseases. . . . There is no motivation to
specifically select lung tissue an[d] lung cancer as a tissue and disease from the non-
discriminatory list of cancers of various types an[d] tissues disclosed on page 47, lines
24-29 of the specification.” Examiner’s Answer, page 7.
We agree with the examiner that the specification fails to disclose a utility that
satisfies the requirements of 35 U.S.C. § 101. Appellants argue that the claimed
polynucleotides are useful because they can be used in expression profiling methods in
connection with “toxicology testing, drug discovery, and disease diagnosis.” See the
Appeal Brief, pages 7-15. According to Appellants, “all expressed genes have a utility
for toxicological screening,” and therefore so does SEQ ID NO:19. See id., page 14.
A utility that could be asserted for any expressed human gene is not a “specific”
utility that will satisfy § 101. See Fisher, 421 F.3d at 1370, 76 USPQ2d at 1230 (a
specific utility requires “that [the] claimed invention can be used to provide a well-defined
and particular benefit to the public”) and id. at 1374, 76 USPQ2d at 1232 (“Any EST
transcribed from any gene in the maize genome has the potential to perform any one of
the alleged uses. . . . Nothing about Fisher’s seven alleged uses set the five claimed
ESTs apart from the more than 32,000 ESTs disclosed in the ‘643 application or indeed
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