contemplated by the inventor of carrying out his invention. [Emphasis
added.]
The parameters of a best mode inquiry are set by the claims. Zygo Corp. v. Wyko Corp., 79 F.3d
1563, 1567, 38 USPQ2d 1281, 1284 (Fed. Cir. 1996); Engel Indus., Inc. v. Lockformer Co. , 946
F.2d 1528, 1531, 20 USPQ2d 1300, 1302 (Fed. Cir. 1991) ("The best mode inquiry is directed to
what the applicant regards as his invention, which in turn is measured by the claims."); Chemcast
Corp. v. Arco Indus. Corp., 913 F.2d 923, 927, 16 USPQ2d 1033, 1036 (Fed. Cir. 1990) ("The other
objective limitation on the extent of the disclosure required to comply with the best mode requirement
is, of course, the scope of the claimed invention."). Unclaimed subject matter is not subject to the
disclosure requirements of § 112. Engel, 946 F.2d at 1531, 20 USPQ2d at 1302. See also
Randomex, Inc. v. Scopus Corp., 849 F.2d 585, 588, 7 USPQ2d 1050, 1053 (Fed. Cir. 1988) ("It
is concealment of the best mode of practicing the claimed invention that section 112 ¶ 1 is designed
to prohibit") (emphasis in original).
David’s claimed invention is a method for detecting and quantitating antigen in a sample using
monoclonal antibodies which have a certain characteristic, the affinity constant for the antigen must
be at least about 10 liters per mole. A screening assay is not a required step of David’s method8
claims. David’s semi-automatic screening assay is not necessary to practice the claimed invention.
The antibodies identified by David’s semi-automatic screening assay have not been shown to make
the claimed method work any better. Indeed, Engvall has not directed us to any evidence which
shows that the particular screening assay has any impact at all on the operation of David’s claimed
method. The fact that the semi-automated assay may give David an advantage over competitors is
simply of no relevance to David’s claimed invention. David’s semi-automatic screening assay is
simply not a mode or embodiment of the claimed invention and it was not necessary for the semi-
automatic screening assay to be disclosed in David’s specification.
Engvall argues that the disclosure of the best mode may require disclosure of features which
are not claimed. Engvall relies (Engvall Brief, p. 122; Engvall Reply Brief, p. 55) on the following
portion of Chemcast (913 F.2d at 928, 16 USPQ2d at 1037):
A patent applicant must disclose the best mode of carrying out his
claimed invention, not merely a mode of making and using what is
claimed. A specification can be enabling yet fail to disclose an
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