Federal Circuit Affirms PTAB Rejection of Magnolia Medical Blood Collection Patent Claim as Anticipated

The U.S. Court of Appeals for the Federal Circuit (CAFC) issued a decision today in In re Magnolia Medical Technologies, Inc., affirming a Patent Trial and Appeal Board (PTAB) decision from an ex parte reexamination that found claim 1 of U.S. Patent 10,039,483 anticipated and therefore unpatentable.

The ‘483 patent covers a blood sequestration device intended to limit contamination that can occur when microbes near the surface of the skin enter a blood sample during collection. The device is designed to keep the earliest blood drawn separate from the portion of blood later used for testing. The only claim at issue on appeal, Claim 1, requires a housing with a fluid reservoir configured to receive an initial volume of blood withdrawn from the patient. The claim also requires a pathway that allows a later volume of blood to bypass the reservoir and flow directly to the sample collection outlet.

A third party requested ex parte reexamination of the ‘483 patent based on U.S. Patent 6,013,037, referred to in the opinion as Brannon, which describes a syringe designed to collect multiple blood samples while reducing contamination and hemolysis, the destruction of red blood cells. An examiner rejected claim 1 as anticipated by Brannon, and Magnolia Medical Technologies appealed to the Board, which affirmed the rejection.

On appeal to the CAFC, Magnolia challenged the Board’s findings regarding two disputed limitations of claim 1, the fluid reservoir limitation and the bypass limitation. Claim anticipation under Section 102 of the Patent Act requires every claim limitation to appear either expressly or inherently in a single prior art reference. The CAFC reviews the Board’s anticipation findings for substantial evidence. Under that standard, the court considered whether Brannon disclosed both limitations, as the Board had found.

Magnolia argued that the fluid reservoir limitation should be read to require that an initial volume of blood be present at the moment of venipuncture, when the needle is inserted into the vein. Magnolia further argued that Brannon’s fluid chamber needed to remain free of blood at that exact moment to avoid the risk of introducing an air embolism into the patient, meaning it could not simultaneously satisfy the claim requirement. The CAFC rejected this reasoning, finding nothing in the language of claim 1 that ties the fluid reservoir limitation to the specific moment of venipuncture. The court also noted that the Board had reasonably found Magnolia’s safety concerns unsupported, since an embodiment of the ‘483 patent itself operates in a materially similar manner.

Magnolia separately argued that Brannon does not meet the bypass limitation because Brannon discloses an initial flash of blood that flows into the sample ultimately tested, meaning the complete initial volume was not sequestered in the fluid chamber. The CAFC disagreed, explaining that the bypass limitation requires only that “an initial volume of blood” be sequestered, but not the full amount initially drawn from the patient. As the CAFC stated in rejecting Magnolia’s position, “it is therefore immaterial that some of the initial portion of blood in Brannon ultimately ends up in the sample collected and tested.”

Since the Federal Circuit found the Board’s findings on both limitations supported by substantial evidence and Magnolia’s remaining arguments unpersuasive, it affirmed the rejection of claim 1 in full. The decision leaves in place the Board’s determination that claim 1 of the ‘483 patent is anticipated by Brannon and therefore invalid.