Ex parte Chuang

Informative decision only: persuasive authority, not binding precedent. When a prior art reference discloses an amino acid sequence 100% identical to a claimed isolated protein, the Board may find anticipation under § 102(b) even though the reference never physically made the protein, because anticipation requires only an enabling disclosure, and the reference is presumed enabled. The burden is on the appellant to show non-enablement, and there is no generic rule that a cDNA or sequence disclosure cannot anticipate a protein. No prior precedent directly addressed this issue in the text; the Board distinguishes the interference decision Wen-Hwa Lee v. Thaddeus P. Dryja, 79 USPQ2d 1614 (BPAI 2005), as turning on non-enablement (stop codons) and a different standard, not on a rule that cDNAs cannot anticipate proteins. For the examiner, a showing that a reference teaches a 100% identical sequence is enough to make a prima facie case, since the reference is presumed enabled and actual production of the protein need not be shown. For the applicant, arguing that a cDNA or sequence at most renders the protein obvious will fail unless the applicant produces evidence that the prior art is not enabling for expressing the protein. The Board relied on In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985), Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1379 (Fed. Cir. 2001), Impax Labs. v. Aventis Pharms., 468 F.3d 1366, 1383 (Fed. Cir. 2006), and Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1380 (Fed. Cir. 2003). LEGAL TEST OR STANDARD: The Board framed the issue as whether the teaching of the amino acid sequence of SEQ ID NO: 1 by Kawai, without a teaching of the expressed protein product, anticipates an isolated protein comprising SEQ ID NO: 1. It applied the rule that anticipation requires only an enabling disclosure, not actual creation or reduction to practice. A reference is presumed enabled, and the burden rests with the appellant to establish that the prior art is not enabling. TRIGGERING FACTS: The examiner relied on references (Kawai and Okazaki) teaching polypeptide sequences with 100% identity to SEQ ID NO: 1, including a database entry with a May 18, 2001 date stamp, and the appellants did not dispute these facts. The prior art did not physically create the claimed protein, and appellants acknowledged that one of the myriad cDNAs encodes an amino acid sequence identical to SEQ ID NO: 1. Appellants offered no evidence rebutting the teachings and did not dispute that Kawai, with the skilled artisan's knowledge, was enabling for expression of the protein. KEY QUOTE: "A reference is presumed to be enabled for the purpose of an anticipation rejection." (p. 5) PRIOR PRECEDENT AFFECTED: No prior Board precedential or informative decision is directly affected. The Board distinguishes Wen-Hwa Lee v. Thaddeus P. Dryja, 79 USPQ2d 1614 (BPAI 2005), as an interference about possession of an enabled embodiment, where the disclosed cDNAs had a stop codon and could not express the protein. It follows In re Donohue, 766 F.2d 531 (Fed. Cir. 1985). PRACTICE TIP: Do not argue that a sequence or cDNA disclosure can never anticipate a protein; instead, come forward with evidence that the reference is not enabling for making the claimed protein, such as an inability to express it, since the burden is on the applicant.