By Kevin E. Noonan –

In a nonprecedential opinion, the Federal Circuit affirmed a decision by the Patent Trial and Appeal Board that the claim challenged in an ex parte reexamination was invalid for anticipation in In re Magnolia Medical Technologies, Inc.

The appeal involved the ex parte reexamination of U.S. Patent No. 10,039,483, wherein a third party requestor asserted that claim 1 was anticipated by U.S. Patent No. 6,013,037 disclosing a syringe that minimizes contamination or hemolysis in the collection of multiple blood samples.  The challenged claim was directed to a blood sequestration device and a specific configuration thereof; independent claim 1 was set forth in the opinion:

1.  A blood sequestration device, comprising:

a housing having an inlet port configured to be fluidically coupled to a patient and an outlet port configured to be fluidically coupled to a sample reservoir;

a fluid reservoir disposed in the housing and at least partially defined by a seal member, the fluid reservoir configured to receive an initial volume of blood withdrawn from the patient (this limitation was referenced in the opinion as the “fluid reservoir limitation”);  and

a vent disposed in the housing and configured to allow air to exit the housing as blood enters the fluid reservoir,

the blood sequestration device configured to allow the initial volume of blood to flow from the inlet port to the fluid reservoir,

the blood sequestration device further configured to allow a subsequent volume of blood to flow from the inlet port toward the outlet port via a sampling flow path, thereby bypassing the fluid reservoir and the initial volume of blood sequestered therein (this limitation was referenced in the opinion as the “bypass”).

(wherein italicized claim language was relevant to the issues before the Court on appeal).  The advantage of this device was that it reduced contamination from dermally residing microbes in externally administered blood sources.  The Board affirmed on appeal the Examiner’s rejection that the ‘483 patent claim 1 was anticipated.  In so doing, the Board found that the ‘037 patent disclosed “a . . . first [blood] sample is contained within the fluid chamber 30” which tracked the fluid reservoir limitation recited in claim 1 of the ‘483 patent.  Further, the Board found that the ‘037 patent discloses that the “fluid chamber 30 may be substantially separated from the second and any subsequent samples drawn,” which the Board considered to track the bypass limitation in the ‘483 patent claim.  This appeal to the Federal Circuit followed.

In a per curiam opinion by a panel of Circuit Judges Lourie and Prost and Judge Arun Subramanian, District Judge for the Southern District of New York sitting by designation, the PTAB decision was affirmed.  The panel’s decision was straightforward, the per curiam opinion asserted that Magnolia’s arguments on appeal were unpersuasive.

Regarding the fluid reservoir limitation, the panel considered Magnolia’s argument to be “built upon multiple premises,” explaining that:

[T]he phrase “initial volume of blood” as used in the fluid reservoir limitation should be construed to mean “the first volume of blood after venipuncture,” i.e., the insertion of a needle into the vein.  . . .  Magnolia then contends that Brannon’s fluid chamber 30 must be configured to be devoid of any air at the time of venipuncture to avoid the safety risk of introducing an air embolism into the patient [(based on an expert declaration)].  Accordingly, Magnolia asserts that the required configuration of fluid chamber 30 cannot meet the “an initial volume of blood from the patient” requirement of the reservoir limitation because it does not contain blood at the time of venipuncture.

However, the panel found nothing in the text of claim 1 of the ‘483 patent that required the limitation relating to a fluid reservoir be met at the time of venipuncture and that whether or not the limitation is met at the time of venipuncture does not affect its analysis regarding anticipation, citing Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370 (Fed. Cir. 2008).  In addition, the panel did not find persuasive Magnolia’s arguments regarding “purported” safety concerns because one embodiment of the invention claimed in claim 1 of the’438 patent operates “in a materially similar manner” to the supposed unsafe operation of the device disclosed in the ‘037 patent.  In the Court’s opinion “[m]ultiple premises upon which Magnolia’s argument are unsound, and thus the argument fails.”

Magnolia also argued that the ‘037 patent did not meet the bypass limitation because that patent disclosed the operation of the claimed syringe device having an “initial flash” of blood.  This was contrary to the ‘483 patent claims requirement that the initial volume of blood was “sequestered” in the fluid reservoir for which there was no disclosure in the ‘037 patent.  In the Court’s opinion, the ‘483 patent claim does not require that the “full amount” of the blood collected initially be sequestered, only “an initial volume” thereof (emphases in opinion).  This distinction rendered immaterial that the ‘037 patent required the initial portion ends up in the collected blood sample and the panel did not recognize any temporal differences sufficient to provide a distinction between the claimed blood sequestration device and the prior art.

The readiness with which the Board and the Federal Circuit found that that challenged claims of the ‘483 patent were anticipated by the ‘037 patent is perhaps partially explained by recognizing that upon review of the ‘463 patent it can be seen that the ‘037 patent was not cited by the patent Examiner nor disclosed in an information disclosure statement by the applicants.  Thus, the Office did not have a chance to consider the teachings of the ‘037 patent prior to the ex parte review that brought the patent to the Office’s attention for the first time, resulting in invalidation on anticipation grounds.

In re Magnolia Medical Technologies, Inc. (Fed. Cir. 2026)
Nonprecedential disposition
Panel: Circuit Judges Lourie and Prost and District Judge Subramanian
Per curiam opinion