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Disclosure That Merely Allows One Skilled in Art to ‘Envision’ an Invention Fails the Written Description Test of 35 U.S.C. §112, ¶1

September 7, 2010

An award of priority by the Board of Patent Appeals and Interferences was improper because it was based on the finding that a Japanese patent application could satisfy the written description requirement of 35 U.S.C. §112, ¶1 by merely “envisoning” a recombinant DNA process for directly producing mature human fibroblast interferon used to fight tumors, the Federal Circuit ruled Sept. 7 (Goeddel v. Sugano, Fed. Cir., No. 2009-1156, 9/7/10).

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 instead 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,” the court said, quoting its recent en banc ruling in Ariad Pharm. Inc. v. Eli Lilly & Co.

Interferences Over Human Fibroblast Interferon.

This case involves two related patent interference priority contests between one party— Haruo Sugano, Masami Muramatsu, and Tadatsugu Taniguchi (collectively “Sugano”) —and another party—David V. Goeddel and Roberto Crea (collectively “Goeddel”). The interferences—the “DNA Interference” and the “Protein Interference”—are both focused on a recombinant DNA process for directly producing mature “Human Fibroblast Interferon” (hFIF), which combats tumors. The naturally occurring gene produces a precursor form of hFIF, consisting of 187 amino acids in a specific sequence. However, the active “mature” form of hFIF is a protein consisting of 166 amino acids, which is produced inside the human cell upon cleavage of the first 21 amino acids from the precursor sequence.

The DNA Interference is between Goeddel’s U.S. Patent Application No. 07/374,311, and two Sugano patents, U.S. Patent No. 5,326,859 and its continuation-in-part, U.S. Patent No. 5,514,567. Goeddel’s ’311 patent application claims priority from U.S. Application No. 06/190,799, filed on September 25, 1980. The sole count of that interference is DNA encoding a mature human fibroblast interferon having a certain sequence of 166 amino acids and unaccompanied by a human fibroblast interferon presequence.

The Protein Interference is between Sugano’s U.S. Application No. 08/463,757, filed June 5, 1995, and Goeddel’s U.S. Patent No. 5,460,811, which also claims priority from the ‘799 application. The sole count of that interference is a composition comprising water and a nonglycosylated mature human fibroblast interferon polypeptide having a certain sequence of 166 amino acids.

The Board of Patent Appeals and Interferences awarded Sugano priority of invention as to both interferences based on Sugano’s “Japanese Application,” which was filed on March 19, 1980. Goeddel appealed.

‘Envisioning’ an Invention Does Not Meet Written Description Test.

The Board found that the gene described in the Japanese Application encodes the 187 amino acid precursor hFIF, and that “[t]he sequences of mature hFIF DNA or polypeptide are not explicitly disclosed.” However, in awarding priority to Sugano, 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 a scientific article by Knight entitled “Human Fibroblast Interferon: Amino Acid Sequence Analysis and Amino Terminal Amino Acid Sequence,” which identifies the first 13 amino acids of mature hFIF. To the Board, the Japanese Application satisfies the requirements of constructive reduction to practice because Knight’s partial sequence of the first 13 amino acids of mature hFIF would allow a skilled artisan to determine where in the 187 amino acid precursor the presequence ends and the mature sequence begins.

Goeddel attacked the Board’s conclusion that a skilled artisan “should have been able to envision” the DNA molecule that would encode mature hFIF unaccompanied by its presequence, stressing that the Japanese Application describes only the expression of precursor hFIF.

Quoting case authority, Sugano insisted that patent applications are “written for a person of skill in the art, and such a person comes to the patent with the knowledge of what has come before,” and thus “it is unnecessary to spell out every detail of the invention in the specification.” Lizard Tech. Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336 (Fed. Cir. 2005). Thus, in referencing the Knight article, the Japanese Application “conveyed” mature hFIF with “reasonable clarity” to a person of skill in the art, Sugano argued, quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991).

The Federal Circuit disagreed with the Board and Sugano, holding that the Japanese Application failed to meet the Patent Act’s written description requirement at 35 U.S.C. §112, ¶1. This statute states:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same…

“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,” Judge Pauline Newman wrote. 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, she said, continuing:

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.” Ariad Pharm. Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc); see also Lockwood v. American Airlines Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (in claiming priority under §120, “[a] description which renders obvious the invention for which an earlier filing date is sought is not sufficient”); Bradford Co. v. Conteyor North Am., Inc., 603 F.3d 1262, 1269 (Fed. Cir. 2010) (same). The Japanese application does not describe a bacterial expression vector that directly produces the mature hFIF, nor does it suggest producing a modified gene to directly encode the 166 amino acid mature hFIF. The Board erred in ruling that that priority is established if a person of skill in the art could “envision” the invention of the counts.

Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002) and University of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004), fail to support the view that envisioning an invention not yet made is a constructive reduction to practice of that invention, Newman wrote. She said that Enzo confirmed that the deposit of an actual sample can meet the written description requirement when science is not capable of a complete written description. University of Rochester, she observed, held that the description of the COX-2 enzyme did not also serve to describe all unknown compounds capable of inhibiting the enzyme. Precedent 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,” Newman concluded, quoting Bradford and Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1993).

The opinion was joined by Judges Alan D. Lourie and William C. Bryson.

Goeddel were represented by Thomas E. Friebel of Jones Day, New York. Sugano was represented by Noah A. Levine of Wilmer Cutler Pickering Hale and Dorr, New York.

 


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