In re Kubin

Court of Appeals for the Federal Circuit

decided on 2009-04-03 00:00:00

panel: Rader, Friedman, Linn,

Overview

In In re Kubin (08-1184), the Court of Appeals for the Federal Circuit affirmed a decision of the Board of Patent Appeals and Interferences holding a claim to an isolated DNA oligonucleotide obvious in light of prior art disclosing the protein encoded by the DNA, a monoclonal antibody that specifically binds the protein, and techniques for cloning the DNA using the monoclonal antibody. With a straightforward opinion that reveals a palpable weight that clearly bore on its author, Judge Rader, the court officially transferred one category of classic biotechnology "inventions" - cloned DNA sequences that encode known polypeptides - into the realm of KSR-based obviousness under the labels of predictability and expected success. A peripheral "obvious to try" analysis runs through the court's reasoning, but ultimately yields to an analysis focused on the teachings of the prior art, a skilled artisan's motivation to seek the invention, and the existence of a reasonable expectation of success in finding it in light of the "well-known and reliable nature of the cloning and sequencing techniques in the prior art...." Noticeably absent from the court's analysis is a technical discussion of those techniques and any factors that might cut against their predictability. Also noteworthy, the court did not address a sequence identity limitation of the claim ("at least 80% identical") and, due to its obviousness determination, declined to reach an associated written description issue for broad genus claims based on DNA sequence identity.

Keywords

obviousness - The Board of Patent Appeals and Interferences had no obligation to predicate its obviousness finding on factual findings directed to a wherein clause that described an inherent, but heretofore unknown, binding characteristic of a protein encoded by a claimed DNA sequence.

obviousness - Acknowledging the Supreme Court's repudiation of In re Deuel and the Federal Circuit's prohibition against "obvious to try"-based obviousness analyses, the court characterized a claim for a DNA oligonucleotide encoding a protein as "obvious to try," and, indeed, obvious in light of prior art that taught protein, a monoclonal antibody that specifically binds the protein, and suitable cloning techniques for isolating the DNA sequence.

obviousness - Prior art teaching a protein, a monoclonal antibody with specificity for the protein, and techniques for cloning the corresponding gene using the antibody, in combination with a motivation to isolate the gene, renders a claim to the isolated gene obvious as "the product not of innovation but of ordinary skill and common sense."

obviousness - Ringing the KSR death bell for at least one category of classic biotech "inventions," the court explicitly declined to "cabin KSR to the predictable arts" (presumably referring to the mechanical and electrical arts, etc.) and characterized claimed biotechnology "results" (an isolated DNA oligonucleotide) as "profoundly predictable."

obviousness - Disclosing a polypeptide or corresponding polynucleotide sequence for a previously known protein represents a "minor advance in the art" that is not worthy of patent protection.

teaching away - A reference disclosing a murine protein cannot fairly be seen as dissuading one of ordinary skill in the art from combining its teachings with a reference teaching conventional techniques to isolate the corresponding human gene; rather, it "would have aroused a skilled artisan's curioisity to isolate the gene coding for the [human protein]."

Detailed review

No detailed review written.