Opinion ID: 477880
Heading Depth: 2
Heading Rank: 4

Heading: Enablement, Best Mode, and Definiteness Under Sec. 112

Text: 103 The section 112 defense appears to have been an afterthought of both Monoclonal, who briefly but unsuccessfully attempts to defend this utterly baseless determination, and of the district court which adopted the defense from Monoclonal's pretrial papers apparently without knowledge of the applicable law, to highlight, as it stated at trial, that it was part of its job to see that whoever wins wins all the way or whoever loses loses all the way. Taken as a whole, the court's comments on Sec. 112--split into two parts, one from Monoclonal's pretrial brief and the other from the adopted pretrial findings and conclusions--are internally inconsistent. The opinion states that the patent fails to disclose how (1) to make monoclonal antibodies; (2) to screen for proper monoclonal antibodies; and (3) to measure monoclonal antibody affinity and therefore the specification is nonenabling and does not satisfy the best mode requirement, and the claims are indefinite. We discuss each of these in turn.
104 Enablement is a legal determination of whether a patent enables one skilled in the art to make and use the claimed invention, Raytheon Co. v. Roper Corp., 724 F.2d 951, 960, 220 USPQ 592, 599 (Fed.Cir.1983), is not precluded even if some experimentation is necessary, although the amount of experimentation needed must not be unduly extensive, Atlas Powder Co. v. E.I. Du Pont De Nemours & Co., 750 F.2d 1569, 1576, 224 USPQ 409, 413 (Fed.Cir.1984), and is determined as of the filing date of the patent application, which was August 4, 1980. See W.L. Gore and Associates v. Garlock, Inc., 721 F.2d 1540, 1556, 220 USPQ 303, 315 (Fed.Cir.1983). Furthermore, a patent need not teach, and preferably omits, what is well known in the art. Lindemann, 730 F.2d at 1463, 221 USPQ at 489. 105 The record fully supports the '110 patent's statement that 106 The monoclonal antibodies used for the present invention are obtained by the [hybridoma] process discussed by Milstein and Kohler.... The details of this process are well known and not repeated here. 107 The district court itself stated that the method for producing monoclonal antibodies in vitro was well known prior to the alleged invention of the '110 patent, and used the sudden availability of monoclonal antibodies produced by the Kohler and Milstein discovery to support, albeit erroneously, its finding of a lack of nexus between the merits of the claimed invention and its commercial success. The court then about-faced and held the '110 patent deficient because it fails to teach how to make monoclonal antibodies. 108 With respect to screening, the only permissible view of the evidence is that screening methods used to identify the necessary characteristics, including affinity, of the monoclonal antibodies used in the invention were known in the art and that the '110 patent contemplated one of those. At trial, Monoclonal's counsel stated it is a procedure that was known in '78. In similar fashion, the district court held that the claimed subject matter would have been obvious in part because the existence of monoclonal antibodies having the affinity constants claimed in the patent was well known prior to the alleged invention.... [Emphasis ours.] Furthermore, there was not a shred of evidence that undue experimentation was required by those skilled in the art to practice the invention. We hold as a matter of law that the '110 patent disclosure is enabling.
109 The specification ... shall set forth the best mode contemplated by the inventor of carrying out his invention. 35 U.S.C. Sec. 112. Because not complying with the best mode requirement amounts to concealing the preferred mode contemplated by the applicant at the time of filing, in order to find that the best mode requirement is not satisfied, it must be shown that the applicant knew of and concealed a better mode than he disclosed. DeGeorge v. Bernier, 768 F.2d 1318, 1324, 226 USPQ 758, 763 (Fed.Cir.1985) (quoting with approval In re Sherwood, 613 F.2d 809, 204 USPQ 537 (CCPA 1980)). The only evidence even colorably relating to concealment is testimony by various Hybritech employees that sophisticated, competent people perform the screening and that the screening process is labor-intensive and time-consuming. It is not plausible that this evidence amounts to proof of concealment of a best mode for screening or producing monoclonal antibodies for use in the claimed '110 process, and therefore we are of the firm conviction that the district court's finding that the best mode requirement was not satisfied is clearly erroneous.
110 The basis of the district court's holding that the claims are indefinite is that they do not disclose how infringement may be avoided because antibody affinity cannot be estimated with any consistency. (Conclusion 6.) Even if the district court's finding in support of this holding--that there is no standard set of experimental conditions which are used to estimate affinities--is accurate, under the law pertaining to indefiniteness--if the claims, read in light of the specification, reasonably apprise those skilled in the art both of the utilization and scope of the invention, and if the language is as precise as the subject matter permits, the courts can demand no more, Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 624, 225 USPQ 634, 641 (Fed.Cir.1985)--the claims clearly are definite. The evidence of record indisputably shows that calculating affinity was known in the art at the time of filing, and notwithstanding the fact that those calculations are not precise, or standard, the claims, read in light of the specification, reasonably apprise those skilled in the art and are as precise as the subject matter permits. As a matter of law, no court can demand more.