enablement requirement and written description requirement

Enablement

Section 112 requires that the patent specification enable "those skilled in the art to make and use the full scope of the claimed invention without 'undue experimentation'" in order to extract meaningful disclosure of the invention and, by this disclosure, advance the technical arts.16 Koito Mfg., 381 F.3d at 1155 (quoting Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (citation omitted)). Because such a disclosure simultaneously puts those skilled in the art on notice of the enforceable boundary of the commercial patent right, the law further makes the enabling disclosure operational as a limitation on claim validity. "The scope of [patent] claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation." Nat'l Recovery, 166 F.3d at 1196; see also In re Goodman, 11 F.3d 1046, 1050 (Fed. Cir. 1993) ("[T]he specification must teach those of skill in the art 'how to make and how to use the invention as broadly as it is claimed'."); In re Fisher, 427 F.2d 833, 839 (CCPA 1970) ("[T]he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art.").

Although Clontech's validity argument might have force had Invitrogen limited its claims to modified RT by reference to point mutation, Clontech overlooks the fact that the claims are not limited by the method of achieving the mutation. As the district court noted, "[t]he enablement requirement is met if the description enables any mode of making and using the invention." Johns Hopkins Univ. v. Cellpro, Inc., 152 F.3d 1342, 1361 (Fed. Cir. 1998); accord Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1335 (Fed. Cir. 2003); Engel Indus., Inc. v. Lockformer Co., 946 F.2d 1528, 1533 (Fed. Cir. 1991). In this case Invitrogen's teaching regarding deletion mutation is sufficient to satisfy its part of the patent bargain, as it fully teaches a mode of making the claimed invention.

Enablement does not require the inventor to foresee every means of implementing an invention at pains of losing his patent franchise. Were it otherwise, claimed inventions would not include improved modes of practicing those inventions. Such narrow patent rights would rapidly become worthless as new modes of practicing the invention developed, and the inventor would lose the benefit of the patent bargain.

The court therefore affirms the district court's judgment that the claims at bar are not invalid for lack of an enabling disclosure on point mutation.

Written Description

Clontech filed for summary judgment, arguing that this fashion of claiming the modified RT fails the § 112 written description requirement and renders the claims-in-suit invalid.Invitrogen opposed and filed a cross-motion that the claims were not invalid on this ground.

The district court tested the common written description of the patents-in-suit against the PTO guidelines. The guidelines state that the written description requirement of 35 U.S.C. § 112, ¶ 1, can be met by

show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics . . . i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.

Guidelines for Examination of Patent Applications under 35 U.S.C. § 112, first paragraph, "Written Description" Requirement, 66 Fed. Reg. 1099, 1106 (Jan. 5, 2001).19 The court adopted this standard in Enzo Biochem Inc. v. Gen-Probe, Inc., 323 F.3d at 964.

Unlike conception and enablement, compliance with the written description requirement is a question of fact. Enzo Biochem, 323 F.3d at 962-63; Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). Like the facts underlying conception and enablement, invalidating a claim requires a showing by clear and convincing evidence that the written description requirement has not been satisfied. Enzo Biochem, 323 F.3d at 962. In response to Invitrogen's partial summary judgment motion, the law required Clontech to come forward with evidence raising at least a genuine issue of fact regarding whether the patents failed the written description requirement. Novartis Corp. v. Ben Venue Labs., Inc., 271 F.3d 1043, 1046 (Fed. Cir. 2001).

In short, Clonetech misfired on all its written description arguments.

The court concluded that the undisputed evidence was entirely one sided in favor of Invitrogen, and granted partial summary judgment, ruling that the claims at issue were not invalid for lack of written description.