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Kubin decided: Federal Circuit provides guidance for application of KSR in biotechnology
April 03, 2009

Today the Federal Circuit decided the appeal in In re Kubin, a case dealing with how the Supreme Court's KSR decision will apply in the field of biotechnology. The decision is available here. We previously blogged about the BPAI decision here and the Federal Circuit's oral arguments here. Those posts have detailed descriptions of the facts in the case.

The Federal Circuit affirmed the Board's finding that the claims were obvious. As to the applicability of KSR, and specifically the "obvious to try" rational that KSR permits in some cases, the court noted the Supreme Court did not limit KSR to only "predictable arts." Thus, a claim in biotechnology can sometimes be obvious if it would be "obvious to try," noting that language to the contrary in the Deuel case is no longer good law.

Instead, the Federal Circuit quoted its 1988 decision in In re O'Farrell, stating:

It is true that this court and its predecessors have repeatedly emphasized that "obvious to try" is not the standard under § 103. However, the meaning of this maxim is sometimes lost. Any invention that would in fact have been obvious under § 103 would also have been, in a sense, obvious to try. The question is: when is an invention that was obvious to try nevertheless nonobvious?

On this point, the court observed there are at least two such situations. The first is the inverse of the situation contemplated in KSR where a finite number of identified, predictable solutions exist. Such a case exists when "what would have been 'obvious to try' would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful." Another situation where an invention would be obvious to try but nonobvious is when "what was 'obvious to try' was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it."

Click below for more detail of the Federal Circuit's analysis of Kubin's claims.

Kubin's claims fell into neither of these situations. As described by the court:

The record shows that the prior art teaches a protein of interest, a motivation to isolate the gene coding for that protein, and illustrative instructions to use a monoclonal antibody specific to the protein for cloning this gene. Therefore, the claimed invention is "the product not of innovation but of ordinary skill and common sense." Or stated in the familiar terms of this court’s longstanding case law, the record shows that a skilled artisan would have had a resoundingly "reasonable expectation of success" in deriving the claimed invention in light of the teachings of the prior art.

Going further, the court also stated:

The record in this case shows that Valiante did not explicitly supply an amino acid sequence for NAIL or a polynucleotide sequence for the NAIL gene. In that sense, Kubin and Goodwin’s disclosure represents some minor advance in the art. But "[g]ranting patent protection to advances that would occur in the ordinary course without real innovation retards progress.” KSR, 550 U.S. at 419. “Were it otherwise patents might stifle, rather than promote, the progress of useful arts." Id. at 427. In light of the concrete, specific teachings of Sambrook and Valiante, artisans in this field, as found by the Board in its expertise, had every motivation to seek and every reasonable expectation of success in achieving the sequence of the claimed invention. In that sense, the claimed invention was reasonably expected in light of the prior art and "obvious to try."

Accordingly, the Federal Circuit affirmed the Board's finding of obviousness.

To read the full decision in In re Kubin, click here.

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