Ex parte Kubin

When the prior art supplies a known problem (isolating a particular cDNA), a limited number of conventional methodologies for solving it, and a reasonable expectation that at least one will succeed, the Board may treat the claimed product as obvious under § 103 because it was obvious to try, and a prior Federal Circuit rejection of an "obvious to try" test (Deuel) does not control. Separately, a specification that enables the full scope of a genus claim through routine experimentation can still fail written description under § 112, ¶ 1 if it lacks a representative number of species or a structure-function correlation; enablement and written description are independent requirements. The Board states that, after KSR, "obvious to try" may be an appropriate test in more situations than it previously contemplated, and that Deuel's viability is in doubt to the extent it rejected that test. For an examiner, a reference that discloses a protein and a conventional method for isolating its cDNA can support a § 103 rejection of the corresponding nucleic acid claim. A single obvious species can render a claimed genus unpatentable, and Deuel does not bar the rejection when the level of skill has advanced. For an applicant, a high level of skill and known cloning methods now cut against patentability of the isolated gene. Routine-experimentation enablement does not save a genus claim from a written description rejection if the specification does not show a representative number of species or a structure-function correlation. The Board relied on KSR Int'l Co. v. Teleflex Inc., In re Wallach, In re Crish, and, for § 112, University of California v. Eli Lilly, University of Rochester v. G.D. Searle, and In re Wands. LEGAL TEST OR STANDARD: Obvious to try under KSR: when there is motivation 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 known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. Here the Board asked whether the claimed nucleotide sequence would have been obvious based on Valiante's disclosure of p38 and its express teachings on isolating the cDNA by conventional techniques. For enablement, it applied the Wands factors to ask whether undue experimentation would have been required to practice the full scope of the claim. TRIGGERING FACTS: Valiante disclosed the p38 protein (the same as the claimed NAIL) and a detailed prophetic method of isolating its cDNA using mAb C1.7 and conventional techniques such as Sambrook. Appellants' own specification used those same methods. The level of skill was high and the state of the art had advanced significantly in the ten years between the Deuel filing (1990) and this application (2000). There were a limited number of methodologies for isolating NAIL cDNA, with a reasonable expectation of success. The claim was a genus (polynucleotides encoding a polypeptide at least 80% identical to amino acids 22-221 of SEQ ID NO:2 that binds CD48), and the specification disclosed no variants of that region. KEY QUOTE: "A single, obvious species within a claimed genus renders the claimed genus unpatentable under § 103." (Appeal 2007-0819, p. 7) PRIOR PRECEDENT AFFECTED: No prior Board precedential or informative decision is directly affected. The Board distinguishes In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995), as not controlling given the increased level of skill in the art and factual differences, citing In re Wallach, 378 F.3d 1330 (Fed. Cir. 2004). It notes that KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727 (2007), cast doubt on Deuel to the extent Deuel rejected an obvious to try test. PRACTICE TIP: Do not rely on Deuel to rebut a § 103 rejection of a gene or nucleic acid claim where the art discloses the protein and conventional isolation methods. Instead, show a lack of motivation, a lack of reasonable expectation of success, or an unpredictable or non-finite set of approaches. For genus claims, include a representative number of species or a structure-function correlation in the specification, because showing enablement through routine experimentation will not satisfy written description.