In Goeddel v. Sugano, the Court of Appeals for the Federal Circuit (CAFC) has provided more guidance as to what is necessary for a sufficient “written description” of an invention, this time for a true “biotech” invention, in the context of a motion for benefit of priority in an interference. This case involved two interferences; one directed to DNA encoding human fibroblast interferon (hFIF) unaccompanied by a hFIF presequence (mature hFIF) and one directed to a composition comprising non-glycosylated hFIF. Sugano filed a motion for benefit of its Japanese priority application (Sugano priority application) and was granted priority by the Board of Patent Appeals and Interferences (the Board) in both interferences. Goeddel appealed that decision on the grounds that the Sugano priority application did not constitute a constructive reduction to practice because it did not enable the Counts and did not provide a sufficient written description of the Counts. The Federal Circuit reversed on the ground that the Sugano priority application did not provide a sufficient written description of the Count because the inventors were not “in possession” of the invention.
The “facts” critical to the decision were for the most part not disputed by the parties and their experts and were correctly determined by the Board. These critical facts were (1) the Sugano priority application adequately described DNA encoding “immature” hFIF which included the combined sequence of mature hFIF and the corresponding presequence; (2) the Sugano priority application did not describe where, in the combined sequence, the presequence ended and the mature sequence began; and (3) the end of the presequence and the beginning of the mature hFIF sequence could be easily determined by one skilled in the art by referring to an article of Knight et al. that was referenced in the Sugano priority application.
The Board and CAFC Opinions
The Board held that the Sugano priority application constituted a constructive reduction to practice of the Counts because one skilled in the art could “envision” the invention of the Counts based on the Sugano priority application by referring to the article of Knight et al. The CAFC reversed on the ground that despite the fact that one skilled in the art could “envision” the invention of the Counts, the Sugano priority application did not demonstrate that the inventors “had possession of the claimed subject matter” [of the Counts] or “actually invented the invention claimed” [of the Counts].
Does This Case Change Anything?
In my opinion, this case is just one more illustration of the difficulties patent owners face in satisfying the case law requirement that the inventors be “in possession” of the invention in order to satisfy the “written description” requirement of 35 U.S.C. §112, first paragraph. In an unpredictable biotechnology field, such as involved in the present case, if the specification describes what appears to be an actual experiment showing that the inventors actually made the claimed invention (and presumably showed that it was useful), then the inventors are presumably “in possession” of the invention. Although prior case law holds that it is not necessary that the specification describe an actual “working example” of the invention, in my view, if the inventors do not describe an actual working example, then there must be at least a very clear description of an embodiment of the invention that leaves nothing to the imagination for one skilled in the art. As stated by the CAFC, “these cases [Enzo Biochem and Rochester] do not hold that “priority is established if a person skilled in the art could “envision” the invention of the counts.”
One question that remains unanswered is whether a very detailed and workable “paper example” can be sufficient to show that the inventor was “in possession” of an invention in view of the evolving line of cases which are making the “in possession” requirement a formidable hurdle to meet in unpredictable technologies.
So, from a patent drafting perspective, what do we learn from this case? If you think you (the patent attorney) might want to submit a claim in a patent application to an invention that has not yet been reduced to practice in an unpredictable technology, you would be well advised to include a clear and detailed description of that subject matter that leaves nothing to the imagination of one skilled in the art. A paper Example clearly describing such an invention may be the best way to accomplish this. If the specification falls short of a clear description of the invention to be claimed and merely allows one skilled in the art to “envision” the invention, such a description may well not support a claim to that invention.