Obviousness of DNA fragments in the post-Kubin era

James Monroe and Lawrence Ilag of Finnegan, Henderson, Farabow, Garrett & Dunner LLP analyse the impact of the US Court of Appeals for the Federal Circuit’s decision In re Kubin.

Four years ago, the Federal Circuit held in In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) that the claimed polynucleotide (DNA) sequences in that case were obvious, although the prior art did not disclose or suggest what the claimed sequences would look like. In effect, the Federal Circuit found the sequences obvious because the prior art disclosed sufficient information to make isolating and characterising the claimed DNA sequences a rather straightforward project.

We explore in this report how the Kubin decision has informed the United States Patent and Trademark Office’s (USPTO) standard in determining obviousness of DNA fragments. In particular, we describe and analyse here the USPTO’s Patent Trial and Appeal Board’s (PTAB) recent adjudications in appeals arising from obviousness rejections of polynucleotide claims. We then reflect on how DNA patent applications may be made more robust given this legal landscape.

In Ex parte Levinson, 2013 Pat. App. LEXIS 923 (PTAB Mar. 1, 2013), the invention related to compositions generating an immune response that did not target IgE sitting on mast cells and therefore avoided potentially deleterious mast cell release reactions.