CAFC Affirms JMOL of Non-Infringement in Blood Sequestration Device Patent Dispute

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“Where a claim lists limitations separately, the clear implication of the claim language is that those elements are distinct components in the patented invention.” – CAFC

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The U.S. Court of Appeals for the Federal Circuit (CAFC) today issued a precedential decision in Magnolia Medical Technologies, Inc. v. Kurin, Inc., affirming a district court’s judgment as a matter of law of no infringement. The court determined that the plain and ordinary meaning of a claim with separately listed limitations requires separate corresponding structures, and because the accused product utilized a single structure for both limitations, it did not infringe as a matter of law.

The dispute centers on patents held by Magnolia Medical Technologies, Inc., covering blood sequestration devices that improve the accuracy of blood tests. Magnolia filed a lawsuit asserting that Kurin, Inc. infringed U.S. Patent Nos. 10,039,483 and 9,855,001 with its Kurin Lock product. The patented devices aim to reduce false-positive microbial test results by separating and excluding the initial portion of blood collected from a patient. The Kurin Lock achieves this separation through a U-shaped side channel containing a porous plug.

During claim construction in the U.S. District Court for the District of Delaware, the parties disputed whether the term “diverter” in the ‘001 patent should be construed as a means-plus-function term invoking 35 U.S.C. § 112(f). The district court concluded that the term should be construed as such, limiting the recited diverter to cover only the corresponding structures disclosed in the specification. Since the Kurin Lock undisputedly did not meet the diverter limitation under this construction, the parties stipulated to non-infringement as to the ‘001 patent. The parties did not seek construction of the “vent” and “seal” limitations of the ‘483 patent.

Following the verdict, Kurin moved for judgment as a matter of law, arguing that the Kurin Lock did not infringe because it did not contain two separate structures corresponding to the vent and seal limitations in claim 1. The district court granted the motion, concluding that because the vent and seal limitations are listed separately in the claim, the patented invention requires two separate corresponding structures. The evidence presented at trial was undisputed that the vent and seal limitations were met by the same structure in the Kurin Lock, the porous plug. The district court entered final judgment in favor of Kurin, prompting Magnolia to appeal.

Writing for the CAFC, Judge Lourie stated that the district court did not impermissibly adopt an untimely claim construction by concluding that the vent and seal limitations required two separate structures. Magnolia argued that the district court announced this construction for the first time in its post-trial decision, which was prejudicial because Magnolia never had an opportunity to argue infringement under a different construction to the jury. The Federal Circuit disagreed, explaining that it is permissible for a district court to elaborate on its construction post-verdict when it only clarifies what was inherent in the construction.

Relying on the court’s prior decisions in Becton, Dickinson & Co. v. Tyco Healthcare Group, LPand Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.the Federal Circuit explained that “where a claim lists limitations separately, the clear implication of the claim language is that those elements are distinct components in the patented invention.” By adhering to the plain and ordinary meaning of claim 1, the district court merely clarified what was inherent in the construction. The court noted that it was always incumbent upon Magnolia to provide a theory of infringement in accord with the plain and ordinary meaning of the claim.

Furthermore, the Federal Circuit agreed that the district court correctly determined the vent and seal limitations required separate corresponding structures. The court pointed out that claim 1 uses the transitional phrase “comprising,” and both limitations are preceded by the word “a,” meaning that one or more of each structure is required. Additionally, the two limitations are connected by the word “and,” suggesting that the vent structure is separate from the seal structure. The court found nothing in the text of claim 1 or the specification to suggest that the two separately listed limitations could be the same structure.

Magnolia also argued against the separate-structure construction under the doctrine of claim differentiation, citing dependent claim 6, which explicitly recites the vent and seal as separate structures. Magnolia contended that claim 1 cannot require the vent and seal to be separate components, or else claim 6 would lack independent meaning. The Federal Circuit rejected this argument, stating that a dependent claim may focus on one limitation of a broader claim and is not forced to be broader than the claim from which it depends in all respects.

In regard to the ‘001 patent, the Federal Circuit affirmed the district court’s determination that “diverter” is a means-plus-function term because the claim limitation does not use the word “means,” there is a rebuttable presumption that Section 112(f) does not apply. However, the court found that Kurin overcame this presumption by showing that the claim did not recite sufficient structure to perform the directing function. It also reasoned that the recited inlet and outlets operate passively, receiving and facilitating the flow of bodily fluid rather than directing it down one of two paths. The court highlighted testimony from Magnolia’s own expert, who stated that a diverter includes at least one inlet and two outlet branches, which the court viewed as an admission that the term diverter would not be understood by a person of ordinary skill to have a sufficiently definite structural meaning.

Ultimately, the CAFC affirmed the district court’s grant of judgment as a matter of law of no infringement as to the ‘483 patent and affirmed the district court’s construction of the ‘001 patent.

Rose Esfandiari image

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