In In re Crish, No. 04-1075 (Fed Cir. December 21, 2004), Crish filed a patent application for purified DNA molecules having promoter activity for the human involucrin gene (hINV). The Federal Circuit held that the claims were anticipated by two other publications that disclosed the complete structure of hINV.
The claimed invention relates to purified DNA molecules having promoter activity for the human involucrin gene (hINV). The outermost layers of the skin and other stratifying squamous epithelia are composed of dead cells densely packed with a fibrous protein called keratin. Involucrin is a protein that interacts with keratin and other intracellular proteins to form a cross-linked envelope within the dead cells to strengthen the plasma membrane of the cells.
As the name indicates, the involucrin gene contains the DNA sequence that codes for involucrin. Crish?s application discloses that Crish has isolated and sequenced the promoter sequence of hINV from plasmid pSP64 ? I-3 H6B using standard molecular biology techniques. Crish determined that the hINV promoter sequence was approximately 2.5 kb (kilobases) in size. Crish?s application also identified and numbered each nucleotide in the hINV promoter sequence and designated it as SEQ ID NO:1.
During prosecution, the examiner rejected the claims as being anticipated by a Crish publication and a Welter publication. The Crish publication lists James Crish, coinventor on the ?509 application, as a coauthor. The Crish publication analyzed the phenotype (physical appearance) of mice pups that had hINV (including the promoter region) microinjected into them at the embryonic stage. The microinjected hINV was isolated from the same plasmid pSP64 ? I-3 H6B referenced in Crish?s patent application. The Crish publication also disclosed the complete structure of hINV (the promoter region of hINV used in the Crish publication, however, was not sequenced), including the approximate size (2.5 kb) of the promoter region, and referenced an earlier publication 4 disclosing how the plasmid pSP64 ? I-3 H6B was obtained.
The Welter publication, which also lists James Crish as a coauthor, identified five protein-binding sites on the promoter region of hINV. The publication also confirmed that protein binding on two of those sites was necessary for the cell to begin transcribing the DNA coding region. The hINV that was used for this study was from plasmid pSP64 ? I-3 H/Hc. Although plasmids pSP64 ? I-3 H6B and pSP64 ? I-3 H/Hc are not identical, the PTO contends that the promoter regions of hINV contained in both plasmids are identical.
Crish argued that the Crish and Welter publications cannot anticipate his claims because the prior art does not provide any information regarding nucleotide sequences. According to Crish, the fact that Crish?s application references a prior art plasmid is irrelevant; the pending claims cover a specified novel DNA sequence, not the starting materials. Secondly, Crish asserts that even if the Crish and Welter publications are relevant, a person of ordinary skill in the art starting with the plasmid disclosed in the Crish and Welter publications would not necessarily obtain SEQ ID NO:1. Crish explains that different DNA sequencing techniques, for example, using different restriction enzymes, may result in workers obtaining different DNA sequences.
However, since the promoter region of hINV was not new, the court found 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.
The court rejected Crish?s argument that the claims are not anticipated because the 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. A long line of cases confirms that one cannot establish novelty by claiming a known material by its properties. E.g., In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) 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 ?comprising? 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. .
The court found that it was irrelevant whether other workers used the same plasmid as Crish and obtained a different sequence for the promoter region of hINV:
Crish is claiming what Crish earlier disclosed, and we presume that Crish correctly sequenced the promoter region of the hINV gene from plasmid pSP64 ? I-3 H6B, as he has described in his application on appeal. Crish cannot rely upon the inability of another worker to correctly sequence the promoter region of the hINV gene from plasmid pSP64 ? I-3 H6B when he has sequenced it accurately himself. His own work, as recited in his application, is better evidence than Lopez-Bayghen?s work. Finally, we address Crish?s argument that the Board improperly assumed that the plasmid referenced in Crish?s application is the same plasmid used in the Crish publication. We have previously explained that when the prior art evidence reasonably allows the PTO to conclude that a claimed feature is present in the prior art, the evidence ?compels such a conclusion if the applicant produces no evidence or argument to rebut it.? Spada, 911 F.2d at 708 n.3. Here, the Board reasonably concluded that the plasmids used in Crish?s application and the Crish publication were the same. Several facts support the reasonableness of the Board?s assumption. First, Crish is both an inventor on the subject application and an author of the prior art publication. Secondly, both the application and the publication refer to the promoter region as approximately 2.5 kb in size. Third, both the application and the publication refer to the same source for plasmid pSP64 ? I-3 H6B, a publication by Eckert et al.
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. It will be interesting to see if these are argued in subsequent appeals.
