To Claim An Antibody By Its Binding Affinity To An Antigen, The Antigen Must By Fully Characterized By Disclosure Or Deposition

Noelle v. Lederman, ___ F.3d ___, ___ USPQ2d ____ (Fed. Cir. Jan. 20, 2004) (Clevenger, Bryson, GAJARSA) (BPAI)
KEY WORDS: PRIORITY, WRITTEN DESCRIPTION, INTERFERENCE-IN-FACT, TWO-WAY TEST
Fed Cir affirms Board finding of no interference-in-fact and rejection of claims. Lederman’s issued patent describes and claims the human form of an antibody. Noelle’s application, a second continuation, is directed to mouse, human, and genus forms of the same antibody. Noelle admitted that if he could not claim priority to his original application, his claims would be rendered invalid by prior art, and the Board correctly found that Noelle could not claim priority. Priority: “An earlier application that describes later-claimed genetic mateiral only by a statement of function or result may be insufficient to meet the written description requirement.” Based on precedent established by Regents v. Lilly and Enzo Biochem, “as long as an applicant has disclosed a ‘fully characterized antigen,’ either by its structure, formula, chemical name, or physical properties, or by depositing the protein in a public depository, the applicant can then claim an antibody by its binding affinity to that described antigen.” And as the Fed Cir held in Utter and later cases, “a patentee of a biotechnological invention cannot necessarilty claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.” Here, Noelle did not describe the human antigen in his original application, but instead described only the mouse antigen, then claimed the mouse, human, and genus forms by citing to the ATCC number of the hybridoma secreting the mouse antibody. Because Noelle did not describe the human antigen, he basically claimed an unknown defined by its binding affinity to another unknown--and thus failed to satisfy the written description requirement.
Interference-In-Fact: Under Fed Cir precedent, a two-way patentability test is not required, rather: “In order for an interference-in-fact to exist, invention A must anticipate or make obvious invention B, and invention B must anticipate or make obvious invention A, thereby meeting both prongs of the ‘two-way’ test.” Under this test, the Board correctly found that a POSITA would not have a reasonably likelihood of success in isolating a human antibody from a mouse and vice versa. “A reasonable likelihood of success does not necessarily mean an absolute predictability, but rather a reasonable expectation of success.” Noelle cannot use the methods of isolating the human antigen disclosed in his original specification because that method was never claimed, so it is neither part of either parties’ inventions nor is it prior art (“A patentee’s invention is only found in a patentee’s claims, unless the patentee uses sufficient means-plus-function language to invoke [35 USC 112/6].”), and the PTO requires both parties to an interference to claim the same invention. Additionally, two of the three screening methods Noelle disclosed in his written description that would isolate the human antibodies require the use of a fusion protein, and the inventor of the fusion protein testified that it would have been unpredictable and unreasonable for a POSITA to be able to make the fusion protein at the time of Noelle’s first application. The inventor of the third screening method stated during prosecution that use of his expression cloning could not have led to successful isolation of the human antigen.
Decision
[This summary was authored by Dina Grinshpun]