This decision is nothing new. Broad claims must either be supported by multiple embodiments or some general principles describing how the single embodiment is applicable to other configurations. Failing that, a broad claim may fail the enablement prong. As seen here, even when enabled, a broad claim without sufficient support will be invalid under the written description requirement.
In re Alonso (Fed. Cir. 2008)
The PTO Board of Appeals (BPAI) rejected claim 92 of Kenneth Alonso's for failing the written description requirement of Section 112. "To satisfy this requirement, the specification must describe the invention in sufficient detail so that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought." (quoting case). In an opinion written by Judge Stearns (D.M.A.) sitting by designation, the Federal Circuit affirmed.
Claim 92 of the Alonso patent application claims a "method of treating neurofibrosarcoma in a human by administering an effective amount" of an idiotypic monoclonal antibody (mAb) secreted in a human-human cell hybridoma.
In his application, Alonso only described the preparation of a single mAb, but claimed essentially all Mab's that bind to neurofibrosarcoma, and the PTO found that a "skilled artisan would reasonably conclude that applicant was clearly not in possession of the claimed genus of compounds. Applicant should direct the claim language toward the only described embodiment (e.g., a mAb produced by hybridoma HB983)."
Standard of Review: The PTO's factual determinations are reviewed for "substantial evidence." Thus, the Federal Circuit will affirm when "a reasonable mind might accept [the evidence] as adequate to support a conclusion." Even if the Federal Circuit might ultimately have seen the facts differently, it will affirm if the PTO's position is reasonable.
Predictability: The Federal Circuit acknowledged that disclosure of a single embodiment can be sufficient for a broader genus claim. However, more disclosure is necessary when the composition and effectiveness of members of the genus is heterogeneous or unpredictable.
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We have previously held in a similar context that "a patentee of a biotechnological invention cannot necessarily 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." Noelle v. Lederman, 355 F.3d 1343, 1350 (Fed. Cir. 2004). |
Alonso argued that his single embodiment should be given more weight because he had actually reduced it to practice (unlike the Rochester COX-2 case). The Federal Circuit rejected that argument because Alonso had not provided the necessary predictive information – "nothing about the structure, epitope characterization, binding affinity, specificity, or pharmacological properties common to the large family of antibodies implicated by the method."
Notes:
- The court gives the following justification for the written description requirement: "The requirement 'serves a teaching function, as a quid pro quo in which the public is given meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.'" quoting Univ. of Rochester, 358 F.3d 916 (Fed. Cir. 2004) (in turn quoting Enzo Biochem, 323 F.3d 956 (Fed. Cir. 2002)).
- In his 2005 book on Electronic and Software Patents, Steve Lundberg, et al. include the understatement: "The purpose of the written description requirement has been in flux recently."
