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Archived updates for Wednesday, December 22, 2004

Gene "Comprising" Nucleotide Sequence Anticipated by Starting Material Plasmid

In In re Crish, No. 04-1075 (Fed Cir. December 21, 2004), the claimed invention related to purified DNA molecules having promoter activity
for the human involucrin gene (hINV):

A purified oligonucleotide comprising at least a portion of
the nucleotide sequence of SEQ ID NO:1, wherein said portion consists of the nucleotide sequence from 521 to 2473 of SEQ ID NO:1, and wherein said portion of the nucleotide sequence of SEQ ID NO:1 has promoter activity.
As the name indicates, hINV contains the DNA sequence that codes for involucrin, a protein that interacts with keratin and other intracellular proteins on the skin to strengthen the plasma membrane of the cells.

Although the promoter region of hINV used in a prior art Crish publication was not sequenced, that publication "disclosed the complete structure of hINV including the approximate size (2.5 kb) of the promoter region, and referenced an earlier publication disclosing how a plasmid was obtained for use in isolating hINV." Crish asserted that a person of ordinary skill in the art starting with the plasmid disclosed in the publication would not necessarily obtain "SEQ ID NO:1" because different DNA sequencing techniques (for example, using different restriction enzymes), may result in workers obtaining different DNA sequences.

Nonetheless, the court rejected Crish’s argument that the claims were not anticipated because the prior Crish publication did not sequence the promoter region of hINV.
While the PTO’s position that the discovery of new properties of a known material does not make claims reciting those properties novel is correct, and we agree with the PTO as to its conclusion, we differ with its characterization of the nucleotide sequence of the gene as a property of that gene. The sequence
is the identity of the structure of the gene, not merely one of its properties. The gene may have functional, biological properties, and it may have physical properties, but its structure is its identity, not merely one of its properties.

The only arguable contribution to the art that Crish’s application makes is the identification of the nucleotide sequence of the promoter region of hINV. However, just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art
material also does not make it novel.

Moreover, Crish’s characterization that the pending claims cover a novel DNA sequence having promoter activity, whereas the references disclose only the starting material plasmid, is unsound. The starting material plasmid necessarily contains the gene of interest, including the promoter region, and once we have affirmed the PTO’s construction of the claims as commprising" more than the recited numbered nucleotides, the claims necessarily encompass the gene incorporated in the starting material plasmid. Accordingly, Crish’s pending claims encompassing the gene plus other nucleotides are anticipated by the starting material plasmid, which consists of the gene plus other nucleotides.
Crish’s argument that the claims contain the closed ended transition term “consists,� and that that term narrows the entire claim, was unpersuasive.
The reasonable interpretation of the claims containing both of the terms “comprising� and “consists� is that the term “consists� limits the “said portion� language to the subsequently recited numbered nucleotides, but the earlier term “comprising� means that the claim can include that portion plus other nucleotides. Read in context, the claims thus do not preclude a DNA sequence having additional nucleotides.
The court also noted that Crish did not argue that the portions of the plasmid not consisting of the involucrin gene are not nucleotides, nor did he argue that the preamble term “purified� has any operative meaning in this appeal. Watch for these issues to be raised in the next appeal.
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