Appeal No. 2006-1035 Page 5
Application No. 09/925,140
microarrays to detect gene “variants, mutations and polymorphisms” (id.), or to carry out
expression profiling in connection with toxicology testing (id., pages 6-8).
We agree with the examiner that the specification does not provide adequate
guidance to enable those skilled in the art to make and use the claimed polynucleotides
that encode a naturally occurring amino acid sequence at least 90% identical to SEQ ID
NO:1. The examiner has provided evidence that even slight changes in the amino acid
sequence of a protein can have large effects on the activity of the protein. Appellants
have provided no evidence, or even sound reasoning, to show the contrary. Thus, a
preponderance of the evidence of record supports the examiner’s position that many of
the species encompassed by part (b) of claim 3 will lack the activity of SDHH. The
specification does not enable those skilled in the art to use polynucleotides encoding
inactive SDHH variants without undue experimentation.
The uses that can be relied on to meet the how-to-use provision of § 112 must
also satisfy the utility requirement of § 101. See In re Fisher, 421 F.3d 1365, 1378, 76
USPQ2d 1225, 1235 (Fed. Cir. 2005) (“It is well established that the enablement
requirement of § 112 incorporates the utility requirement of § 101.”). See also In re Kirk,
376 F.2d 936, 942, 153 USPQ 48, 53 (CCPA 1967) (“[S]urely Congress intended § 112
to pre-suppose full satisfaction of the requirements of § 101. Necessarily, compliance
with § 112 requires a description of how to use presently useful inventions, otherwise an
applicant would anomalously be required to teach how to use a useless invention.”).
The U.S. Court of Appeals for the Federal Circuit recently addressed the utility
requirement in the context of a claim to DNA. See In re Fisher, 421 F.3d 1365,
76 USPQ2d 1225 (Fed. Cir. 2005). The Fisher court interpreted Brenner v. Manson,
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