Brief Fact Summary. Kubin and Goodwin claimed a patent on the isolation and sequencing of DNA molecules encoding a protein known as the Natural Killer Cell Activation Inducing Ligand (NAIL). The Board of Patent Appeals and Interferences (the Board) rejected their claim as obvious, finding that the claim was the product of ordinary skill and commonsense, and not of innovation. Therefore, NAIL cDNA was not patentable because it would have been obvious to isolate it.
Synopsis of Rule of Law. A patent claim will be denied for obviousness where the prior art would lead a person skilled in the art to seek the claimed invention, with every reasonable expectation that using conventional methodologies will lead to success, thereby rendering the claim â€œobvious to try.â€
If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.View Full Point of Law
Issue. Will a patent claim be denied for obviousness where the prior art would lead a person skilled in the art to seek the claimed invention, with every reasonable expectation that using conventional methodologies will lead to success, thereby rendering the claim â€œobvious to tryâ€?
(Rader, J.) Yes. A patent claim will be denied for obviousness where the prior art would lead a person skilled in the art to seek the claimed invention, with every reasonable expectation that using conventional methodologies will lead to success, thereby rendering the claim â€œobvious to try.â€ First, there was sufficient evidence that Kubin and Goodwin used conventional techniques, as taught in Valiante and Sambrook, to isolate the NAIL gene sequence. Their arguments to the contrary are contradicted by their own disclosure to the extent that they disclose that the gene sequence can be derived and isolated by â€œstandard biochemical methods.â€ Their argument that other prior art, found in Mathew, teaches away from Valiante, also was properly rejected by the Board, since Mathew’s disclosure, in light of Valiante’s teachings regarding the p38 protein and its role in NK cell activation, would have aroused a skilled artisan’s curiosity to isolate the gene coding for p38. In fact, Mathew â€œexemplifies how the cDNA encoding 2B4, the mouse version of Valiante’s p38, can be isolated and sequenced.â€ Although this court previously held in In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995) that â€œknowledge of a protein does not give one a conception of a particular DNA encoding it,â€ and that â€œobvious to tryâ€ is an inappropriate test for obviousness, these aspects of Deuel were overturned by the United States Supreme Court in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007). The Court repudiated as â€œerrorâ€ the Deuel restriction on the ability of a skilled artisan to combine elements within the scope of the prior art, ruling that when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the options known within his or her technical grasp, and that if this leads to the anticipated success, the fact that a combination was obvious to try might show that it was obvious under Â§ 103. However, this ruling gives rise to two exceptions to the â€œobvious to tryâ€ test. The first is that, where a claimant simply throws metaphorical darts at a board filled with combinatorial prior art possibilities, courts should not succumb to hindsight claims of obviousness. The second is where what was â€œobvious to tryâ€ 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 regarding the particular form of the claimed invention or how to achieve it. In this case, the claimed invention does not come within either of these exceptions. 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 â€œthe product not of innovation but of ordinary skill and common sense.â€ In other words, the record shows that a person skilled in the art would have had a resoundingly â€œreasonable expectation of successâ€ in deriving the claimed invention in light of the teachings of the prior art. In addition, KSR applies not only to the predictable arts, but also to the unpredictable arts, such as biotechnology, which is the art at issue here. One of skill in the advanced art of biotechnology would find Kubin and Goodwin’s claimed â€œresultsâ€ profoundly â€œpredictableâ€ given the well-known and reliable nature of the cloning and sequencing techniques in the prior art, as well as the readily knowable and obtainable structure of an identified protein. The ease and predictability of cloning the gene that codes for that protein cannot be ignored as irrelevant to the question of obviousness. â€œThis court cannot, in the face of KSR, cling to formalistic rules for obviousness, customize its legal tests for specific scientific fields in ways that deem entire classes or prior art teachings irrelevant, or discount the significant abilities of artisans of ordinary skill in an advanced area of art.â€ Although Valiante did not explicitly supply an amino acid sequence for NAIL or a polynucleotide sequence for the NAIL gene, Kubin and Goodwin’s disclosure, which therefore represents a minor advance in the art, cannot be given patent protection because it is an advance without innovation. To give their minor advance such protection would stifle, instead of promote, progress in the useful arts. Their claimed invention was reasonably expected in light of the prior art and â€œobvious to try.â€ Affirmed.
Discussion. This important decision for the biotechnology field makes clear that the level of enablement of the prior art is very important to any conclusion of obviousness, and revives the â€œobvious to tryâ€ test. However, it does not hold that an invention that was â€œobvious to tryâ€ is necessarily obvious under Section 103(a). Going forward, as the court itself observes, the question relating to obvious to try situations will be, â€œwhen is an invention that was obvious to try nevertheless nonobvious?â€ (quoting In re O’Farrell, 853 F.2d 894 (Fed. Cir. 1988)). Kubin does not mean that any patent claiming a cDNA is necessarily obvious if the encoded protein was known in the prior art. It simply means that one can no longer presume that the cDNA is never rendered obvious under those circumstances. Rather, the inquiry becomes whether there was any kind of suggestion or motivation to clone the cDNA, and if there was, whether there was a reasonable expectation of success.