Ex parte Porro

Informative decision only: persuasive authority, not binding precedent. When a claim recites a genus of proteins defined by both a percentage sequence identity to a reference sequence (here at least 90% identity to SEQ ID NO: 11) and a function (LGDH enzymatic activity), the Board treats the functional subgenus as the genus requiring written description under § 112, first paragraph, and disclosure of a single functional embodiment (the reference sequence itself) within a genus of about 3.4 x 10^ variants does not adequately describe it. The specification must show possession by describing a representative number of functional variants or structural features common to functional variants that distinguish them from the rest of the genus, or some other way showing possession; the ability to make and screen variant libraries does not cure the deficiency. No prior Board precedential or informative decision is named in the text; the Board applied Federal Circuit written-description case law to a species-genus situation involving a functional subgenus defined by sequence identity. For the examiner, the decision supports a written description rejection for such claims where the specification discloses one functional sequence and gives no guidance on which structural features or amino acid changes preserve activity, and no enablement rejection is needed. For the applicant, reciting a percent-identity limitation does not avoid the problem, and arguments that the genus is too large to list, that screening is routine, or that the skilled artisan would expect operability do not answer a possession question. The Board relied on University of California v. Eli Lilly and Co., 119 F.3d 1559 (Fed. Cir. 1997), University of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004), and Enzo Biochem v. Gen-Probe, 323 F.3d 956 (Fed. Cir. 2002), while acknowledging Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005), and Falkner v. Inglis, 448 F.3d 1357 (Fed. Cir. 2006), which hold that there is no per se rule requiring recitation of every sequence. LEGAL TEST OR STANDARD: Under 35 U.S.C. 112, first paragraph, the specification must show possession of the claimed genus at filing. To describe the subgenus of functional variants within the genus of variants, the specification can describe a representative number of functional variants, or structural features common to functional variants that distinguish them from the rest of the genus (i.e., structural features that correlate with enzymatic activity regardless of other variations from SEQ ID NO: 11). The Board added that maybe a functional subgenus can be described in other ways as well, since the case law is a little hazy in this area, but disclosure of a single functional embodiment is not enough. Appellants bear the burden of showing description in one of the Eli Lilly ways or in some other way. TRIGGERING FACTS: Claim 13 recites a method using recombinant yeast transformed with a coding region encoding LGDH enzyme having at least about 90% identity with SEQ ID NO: 11. The specification discloses a single LGDH sequence from Arabidopsis thaliana. Appellants calculated the identity genus at 3.4 x 10^ proteins. The specification gave no guidance on which structural features are responsible for activity or which amino acid changes can be made without affecting activity. No enablement rejection was made, and the Board assumed that SEQ ID NO: 11 adequately describes the 90% identity genus. KEY QUOTE: "But, in our view, the case law makes clear that a functional subgenus is not adequately described by disclosure of a single functional embodiment - SEQ ID NO: 11 itself - within a genus of 3.4 x 10" variants of SEQ ID NO: 11." (p. 8) PRIOR PRECEDENT AFFECTED: No prior precedential or informative decision of the Board is directly affected. The Board followed University of California v. Eli Lilly and Co., 119 F.3d 1559 (Fed. Cir. 1997), and University of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004), and distinguished Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005), and Falkner v. Inglis, 448 F.3d 1357 (Fed. Cir. 2006). PRACTICE TIP: When claiming proteins by percent identity to a reference sequence plus a recited function, do not rely on the single reference sequence, the sequence-identity limitation or the ability to screen libraries. Instead, make sure the specification discloses a representative number of functional variants or structural features that correlate with activity, and argue possession on that record in the appeal brief.