Opinion ID: 774976
Heading Depth: 2
Heading Rank: 1

Heading: Invalidity under 35 U.S.C. 112, Paragraph 1

Text: 42 After the district court's claim construction in March 1999, Medtronic moved for leave to supplement its response chart and amend its answer and counterclaim. Denial of Motion to Amend, slip op. at 5. The district court observed that at claim construction it was clear what prior art Medtronic was relying on for its 102 and 103 defenses, but Medtronic had not provided sufficient notice for any 112, paragraph 1 defense. Id. at 13-14. Accordingly, the district court granted Medtronic leave to amend with respect to the 102 and 103 defenses, but not with respect to the 112, paragraph 1 defense. Id. at 15. 43 We are faced with the question of which law to apply to our review of the district court's refusal to permit amendment of the pleadings. On this question, we apply the law of the regional circuit to which the district court appeal normally lies unless the issue pertains to or is unique to patent law, in which case we will apply our own law to both substantive and procedural issues intimately involved in the substance of enforcement of the patent right. Flex-Foot, Inc. v. CRP, Inc., 238 F.3d 1362, 1365, 57 USPQ2d 1635, 1637 (Fed. Cir. 2001) (citing Amana Refrigeration, Inc. v. Quadlux, Inc., 172 F.3d 852, 855-56, 50 USPQ2d 1304, 1307 (Fed. Cir. 1999) (citations omitted)). Determining the sufficiency of notice regarding defenses asserted under specific statutory provisions of the patent laws clearly implicates the jurisprudential responsibilities of this court within its exclusive jurisdiction. Accordingly, we review the district court's refusal to allow Medtronic's amendment to the pleadings under Federal Circuit law. Decisions concerning the amendment of pleadings are reviewed by this court under the abuse of discretion standard. E.W. Bliss Co. v. United States, 77 F.3d 445, 450 (Fed. Cir. 1996). 44 By the time the district court construed the claims, approximately three and one-half years after ACS's complaint had been filed, Medtronic had provided only the barest allegation of invalidity under 112, paragraph 1. Medtronic's position consisted essentially of a conclusory statement that if the claims of the '233 patent were not construed to include a coaxial limitation, then they would be invalid because nothing broader was disclosed. Clearly ACS would have been hard pressed to respond meaningfully to such a bare allegation. Accordingly, we cannot say that the district court abused its discretion in concluding that sufficient notice of Medtronic's 112, paragraph 1 defense had not been provided to ACS, or in deciding to deny Medtronic leave to amend.