Judges: Bryson (author), Gajarsa, Prost

[Appealed from N.D. Ohio, Judge O’Malley]

In Baran v. Medical Device Technologies, Inc., No. 10-1058 (Fed. Cir. Aug. 12, 2010), the Federal Circuit affirmed the district court’s holding that U.S. Patent No. 5,025,797 (“the ’797 patent”) and its CIP, U.S. Patent No. 5,400,798 (“the ’798 patent”) (collectively “the patents-in-suit”) were not infringed.

The patents-in-suit disclose single-use and reusable automated biopsy instruments in which the biopsy needle is formed from a stationary stylet and a retractable cannula. To collect a biopsy sample, the instrument is first charged by retracting the cannula and attached external guide, and locking the guide into the charged position with a lever. The stylet is then inserted into a subject and the lever is released, thus pushing the cannula over the stylet to collect the biopsy sample. Finally, the biopsy needle is removed from the subject and the biopsy sample is extracted. The accused device, the BioPince Full Core Biopsy Instrument (“BioPince”), is a single-use automated biopsy instrument that is charged for sample collection by means of a slider-crank mechanism and locking tab.

Dr. Gregory W. Baran sued defendants Medical Device Technologies, Inc., AMT Sverige, AB, Ascendia AB, Gedon AB, and Anders H. Weilandt (collectively “MDTech”), asserting that MDTech’s BioPince device infringed claim 2 of the ’798 patent and claim 7 of the ’797 patent. Following the district court’s claim construction order, Dr. Baran stipulated that he could not prove infringement of the ’798 patent, reserving the right to appeal the claim construction. The district court then granted SJ of noninfringement, finding that two limitations of claim 7 of the ’797 patent were not present in the BioPince device. Dr. Baran appealed.

Dr. Baran contested the district court’s construction of the terms “releasably” and “detachable” to require separation “without loss or damage,” thereby excluding the single-use BioPince apparatus from the claim scope. The Federal Circuit first noted that Dr. Baran’s argument that the ’798 patent did not disclose a stylet joined to a cannula in fact supported the district court’s construction, as the specification described the stylet and cannula as readily separable without loss or damage. The Court also found significant the different language used by the patentee to distinguish the single-use and reusable embodiments. The specification described the stylet and cannula as glued permanently into the support rod and the spring guide in the former, and detachably engaged in the latter. The Court noted that incorporating the “without loss or damage” limitation into the claim construction also comported with the plain meaning of “detachable.” Further, the Federal Circuit agreed with the district court that the terms “releasably” and “detachable” had the same meaning because they were used interchangeably in the ’798 patent, overcoming the implication that different terms have different meanings. Moreover, the Court rejected Dr. Baran’s argument that the district court’s claim construction excluded a preferred embodiment, explaining that each claim need not read on every embodiment, and noting that other claims covered the single-use embodiment. Finally, the Court rejected Dr. Baran’s argument that the district court’s claim construction improperly ignored the Summary of the Invention, noting that the Summary merely repeated claim language verbatim, and stating that claim terms used in the Summary need not be construed to encompass all embodiments of the invention. The Court upheld the district court’s construction of the remaining claim terms, and thus concluded that Dr. Baran’s stipulation of noninfringement remained effective.

Turning to the ’797 patent, the Federal Circuit concluded that no reasonable juror could find that the BioPince device satisfied the first means-plus-function limitation of a “release means for retaining the guide in the charged position.” Slip op. at 12. The Federal Circuit agreed with the district court that the claim recited both a release function and a retention function. The Court rejected Dr. Baran’s argument that the term “release” preceding the “means for” clause was a characteristic and not a functional limitation. The Court noted that the relevant inquiry was whether the term at issue was purely functional. The Court then concluded that the term “release” was a vital function of the means-plus-function limitation, as the contemplated function of the biopsy instrument requires the release of the biopsy needle on demand.

Moreover, the Court rejected Dr. Baran’s alternative argument that whether the accused device satisfied the retention/release limitation was a disputed issue of material fact that should not have been resolved on SJ. The district court concluded that the accused structure was substantially different from the disclosed structure because the BioPince device required the locking tab to flex in a yielding manner for the release to occur, while the patented invention relied on a lever that must be rigid to pivot on its fulcrum. Dr. Baran asserted that the lever disclosed in the ’797 patent specification was equivalent to the crank arm and locking tab in the accused BioPince device because the former, like the latter, flexed to release the guide. The Federal Circuit disagreed, finding that the lever only functioned to release the guide when rigid, in direct contrast to the locking tab mechanism, which flexed to release the guide. The Court explained that the specification’s references to “flexibility” referred to the lever’s ability to pivot flexibly rather than to flexibility of the lever material. Therefore, because the accused structure differed substantially from the disclosed structure, the Court found that the ’797 patent was not infringed.

Finally, the Federal Circuit rejected Dr. Baran’s contention that the district court erred in striking portions of his declaration in opposition to MDTech’s motion for SJ, because it provided expert testimony and Dr. Baran had not identified himself as an expert under Fed. R. Civ. P. 26(a)(2). The Court also rejected Dr. Baran’s argument that his declaration was timely because he was not obligated by Rule 26(a)(2)(B) to provide an expert report as he had not been “retained or specially employed to provide expert testimony.” Slip op. at 15. Instead, the Court explained that because Dr. Baran had elected to submit a written report, he was obligated to submit that report by the deadline in the district court’s case management plan, which applied to both mandatory and optional expert reports.