October 2010
Claimed Subject Matter That Can Be “Envisioned” from the Specification Fails to Meet the Written Description Requirement
| Judges: Newman (author), Lourie, Bryson |
| [Appealed from Board] |
In Goeddel v. Sugano, Nos. 09-1156, -1157 (Fed. Cir. Sept. 7, 2010), the Federal Circuit reversed the Board’s decisions that, as to the counts of two interferences, party Haruo Sugano, Masami Muramatsu, and Tadatsugu Taniguchi (collectively “Sugano”) had priority over party David V. Goeddel and Roberto Crea (collectively “Goeddel”). The Court determined that Sugano’s initial Japanese Application did not constitute a constructive reduction to practice of the subject matter of the counts and that Sugano was not entitled to the benefit of the filing date of that application. The Court therefore remanded the cases back to the Board for further proceedings.
The involved patents and patent applications disclosed and claimed a recombinant DNA process for directly producing mature human fibroblast interferon (“hFIF”). Mature hFIF is created when the first 21 amino acids are cleaved from the precursor protein expressed from the naturally occurring hFIF gene. The recombinant DNA process modifies the naturally occurring hFIF gene such that, when inserted into a bacterium, the bacterium produces the desired mature hFIF having 166 amino acids without the 21 amino acid presequence of the precursor hFIF. Both counts are directed to this 166 amino acid mature hFIF without the 21 amino acid presequence. The question of priority for both interferences turned on whether Sugano’s initial Japanese Application constituted a constructive reduction to practice of the counts’ subject matter, as only that application predated Goeddel’s priority date.
Before the Board were two interferences between the parties. The first interference, referred to as the “DNA Interference,” involved Goeddel’s U.S. Patent Application No. 07/374,311 and two Sugano patents, U.S. Patent Nos. 5,326,859 and 5,514,567. The second interference, referred to as the “Protein Interference,” involved Sugano’s U.S. Application No. 08/463,757 and Goeddel’s U.S. Patent No. 5,460,811. Sugano’s patents and application claim priority to the Japanese Application filed on March 19, 1980, which predates Goeddel’s earliest claim for priority by six months. The Board held that Sugano’s Japanese Application constituted constructive reduction to practice of the subject matter of both interferences and awarded priority to Sugano. Goeddel appealed.
“Section 112, in the context of interference priority, requires that the subject matter of the counts be described sufficiently to show that the applicant was in possession of the invention. That a modified gene encoding the 166 amino acid protein could have been ‘envisioned’ does not establish constructive reduction to practice of the modified gene.” Slip op. at 12-13.
Sugano’s Japanese Application described the invention as “a novel recombinant plasmid,” having a gene that encompassed at least the entire coding region of the hFIF messenger RNA. Slip op. at 7. The application stated that the entire coding region was the part specifying the whole amino acid sequence of the protein of the hFIF in the hFIF messenger RNA sequence. The Japanese Application provided Table 5, listing the entire 187 amino acid sequence—without indication of either the presequence or the mature hFIF sequence. The Japanese Application also identified a scientific article by Knight, which disclosed a partial sequence of the first 13 amino acids of mature hFIF. Addressing this Knight article, the experts for both parties agreed that a skilled person “could” identify the boundary between the presequence and the mature hFIF.
Based on these facts, the Board found that the gene described in the Japanese Application encoded the 187 amino acid precursor hFIF. The Board also found that the sequences of mature hFIF DNA or polypeptide were not explicitly disclosed. In awarding priority to Sugano, however, the Board found that mature hFIF would be “readily apparent” to a person skilled in this field, in view of the Japanese Application’s description of the precursor hFIF and the Knight article. Id. at 8. The Board held that Knight’s disclosure would allow a person skilled in the field of the invention to determine where in the 187 amino acid precursor the presequence ends and the mature sequence begins.
The Federal Circuit disagreed. While acknowledging that experts for both sides agreed that a skilled person “could” identify the boundary between the presequence and the mature hFIF based on the Knight article, the Court held that the Japanese Application did not describe the counts’ subject matter. That is, the Japanese Application did not describe mature hFIF and did not describe the DNA coding for mature hFIF unaccompanied by the presequence.
The Court reasoned that Sugano described its invention, in the initial Japanese Application, as the recombinant production of the 187 amino acid precursor, using a gene that encompasses “at least the entire coding region.” It noted that 35 U.S.C. § 112, in the context of interference priority, requires that the subject matter of the counts be described sufficiently to show that the applicant was in possession of the invention. And that a modified gene encoding the 166 amino acid protein could have been “envisioned” from the Japanese Application does not establish constructive reduction to practice of the modified gene. The Court stated, “The question is not whether one skilled in this field of science might have been able to produce mature hFIF by building upon the teachings of the Japanese Application, but rather whether that application ‘convey[ed] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.’” Id. at 13 (alteration in original) (quoting Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc)). Accordingly, the Court held that the Japanese Application did not describe a bacterial expression vector that directly produces the mature hFIF, nor did it suggest producing a modified gene to directly encode the 166 amino acid mature hFIF.
The Court also disagreed with Sugano’s argument that its precedent holds that priority is established if a person of skill in the art could “envision” the invention of the counts. Addressing Sugano’s argument, the Court explained that “[p]recedent in evolving science is attuned to the state of the science, but remains bound by the requirement of showing ‘that the inventor actually invented the invention claimed.’” Id. at 14 (quoting Bradford Co. v. Conteyor N. Am., Inc., 603 F.3d 1262, 1269 (Fed. Cir. 2010)).
Accordingly, the Federal Circuit concluded that the Board’s decision that the Japanese Application constitutes constructive reduction to practice of the subject matter of the interferences was not in accordance with law, for the Japanese Application did not meet the criteria of § 112, first paragraph, as to this subject matter. The Court thus reversed the award of priority to Sugano and remanded the cases for appropriate further proceedings.
