In Re Fisher

421 F.3d 1365 (2005)

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Nature of the Case

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Facts

The claimed invention involves five purified nucleic acid sequences that encode proteins and protein fragments in maize plants. They are called 'expressed sequence tags' or 'ESTs.' DNA contains one of four bases, adenine (A), guanine (G), cytosine (C), and thymine (T), that are linked by hydrogen bonds to form complementary base pairs (i.e., A-T and G-C). When a gene is expressed in a cell, the relevant double-stranded DNA sequence is transcribed into a single strand of messenger ribonucleic acid (mRNA). Messenger RNA contains three of the same bases as DNA (A, G, and C), but contains uracil (U) instead of thymine. mRNA is released from the nucleus of a cell and used by ribosomes found in the cytoplasm to produce proteins. Complementary DNA (cDNA) is produced synthetically by reverse transcribing mRNA. cDNA is composed of nucleotides containing the four nitrogenous bases, A, T, G, and C. Scientists compile cDNA into libraries to study the kinds of genes expressed in a certain tissue at a particular point in time. One of the goals of this research is to learn what genes and downstream proteins are expressed in a cell so as to regulate gene expression and control protein synthesis. An EST is a short nucleotide sequence that represents a fragment of a cDNA clone. It is typically generated by isolating a cDNA clone and sequencing a small number of nucleotides located at the end of one of the two cDNA strands. When an EST is introduced into a sample containing a mixture of DNA, the EST may hybridize with a portion of DNA. Such binding shows that the gene corresponding to the EST was being expressed at the time of mRNA extraction. The ESTs in this claim are obtained from cDNA library LIB3115, which was generated from pooled leaf tissue harvested from maize plants. When P filed the '643 application, he claimed ESTs corresponding to genes expressed from the maize pooled leaf tissue at the time of anthesis. P did not know the precise structure or function of either the genes or the proteins encoded for by those genes. The application claims that these ESTs may be used in a variety of ways, including: (1) serving as a molecular marker for mapping the entire maize genome; (2) measuring the level of mRNA in a tissue sample via microarray technology to provide information about gene expression; (3) providing a source for primers for use in the polymerase chain reaction (PCR) process to enable rapid and inexpensive duplication of specific genes; (4) identifying the presence or absence of a polymorphism; (5) isolating promoters via chromosome walking; (6) controlling protein expression; and (7) locating genetic molecules of other plants and organisms. The examiner rejected the claim for lack of utility under §101; the ESTs were not supported by a specific and substantial utility. She reasoned that the disclosed uses were not specific to the claimed ESTs, but instead were generally applicable to any EST. The examiner found that any EST may serve as a molecular tag to isolate genetic regions and there was no known use for the proteins produced as final products resulting from processes involving the claimed ESTs. Under §112, she reasoned that one skilled in the art would not know how to use the claimed ESTs because the '643 application did not disclose a specific and substantial utility for them. The Board reasoned that 'without knowing any further information in regard to the gene represented by an EST, detection of the presence or absence of a polymorphism provides the barest information in regard to genetic heritage.' The Board concluded that using the claimed ESTs to isolate nucleic acid molecules of other plants and organisms, which themselves had no known utility, is not a substantial utility. The Board affirmed the examiner's rejection for lack of utility under §101 and for lack of enablement under §112. P appealed.