United States: Where Patentee Failed To Rebut Presumption Of Prosecution History Estoppel, The Patentee Is Barred From Asserting That The Accused Device Infringes Under The DOE

In EMD Millipore Corp. v. AllPure Technologies, Inc., No. 14-1140 (Fed. Cir. Sept. 29, 2014), the Federal Circuit affirmed the district court's finding of SJ that the accused device did not literally infringe and further found that prosecution history estoppel prevented assertion of the DOE.

EMD Millipore Corporation, formerly known as Millipore Corporation; Merck Chemicals and Life Science AB, formerly known as Millipore AB; and Millipore SAS (collectively "Millipore") own the rights to U.S. Patent No. 6,032,543 ("the '543 patent").  The '543 patent discloses a device for introducing or withdrawing a sample from a container holding a fluid medium without contamination by using individual transfer members to maintain a closed system.  The accused TAKEONE device manufactured by AllPure Technologies, Inc., now known as AllPure Technologies LLC ("AllPure"), is an aseptic sampling system that may be attached to the outside of a container holding a fluid medium and has cannulas that can be inserted into the container to withdraw a sample.  The accused TAKEONE device is delivered fully assembled and sterilized, and it is intended to be disposable.  AllPure filed a motion for SJ of noninfringement.  The district court found that AllPure's TAKEONE device neither literally contained the claimed "removable, replaceable transfer member" nor did it provide an infringing equivalent, and the district court rejected Millipore's argument that a disassembled TAKEONE device satisfied the claim limitation in the '543 patent.  Slip op. at 5 (citation omitted).  The district court further found that the accused TAKEONE device did not provide an infringing equivalent of the limitation.  Millipore appealed.

"The district court should have proceeded under the presumption that prosecution history estoppel applies.  Millipore then had the burden to rebut the presumption through one of the three enumerated exceptions, but Millipore chose not to present any argument on this issue to the district court."  Slip op. at 12.

On appeal, Millipore argued that SJ was inappropriate because there remained a genuine issue of material fact relating to whether disassembly of the transfer member could qualify as the claimed removal of the transfer member.  The Federal Circuit, considering the district court's construction of "at least one removable, replaceable transfer member" as "at least one transfer member that can be removed from the magazine part of the device and replaced with at least one removable, replaceable transfer member," did not find Millipore's argument persuasive and instead agreed with AllPure and the district court.  Id. at 7 (citation omitted).  The Court explained, "If a transfer member does not exist when the device is disassembled, as even Millipore's counsel admitted, then there is no genuine issue of material fact over whether the TAKEONE device contains a 'removable, replaceable transfer member' as is literally required by claim 1 of the '543 patent."  Id. at 8-9.  The Federal Circuit, relying on language from the district court's decision, stated that "[t]he problem with Millipore's characterization of 'removal' of a transfer member . . . is the absence of necessary component parts of the transfer member once it is removed . . . .  [T]he part of the device removable from the magazine part must have all of the component parts—a holder, needle, and seal."  Id. at 9 (alterations in original) (citation omitted).  Accordingly, the Federal Circuit determined that the accused TAKEONE device, when disassembled, lacked a seal and thus lacks the claimed "removable, replaceable transfer member." 

The Federal Circuit then turned to the district court's grant of SJ, finding noninfringement under the DOE.  The Court, disagreeing with Millipore, concluded that the district court did not need to perform an analysis under the DOE because prosecution history estoppel barred Millipore's arguments.  The Court explained that because certain amendments made during prosecution were narrowing and those amendments were added to overcome a rejection, "[t]he district court should have proceeded under the presumption that prosecution history estoppel applies."  Id. at 12.  At that point, the Court explained, Millipore had the burden to rebut the presumption, which it failed to do.  Instead, Millipore argued that the amendment was not narrowing.  Since Millipore failed to rebut the presumption, the Federal Circuit concluded that the district court should have barred Millipore from making arguments that the accused TAKEONE device infringed under the DOE.  The Federal Circuit further explained that because the district court granted SJ of noninfringement under the DOE, this error did not change the outcome of the case.

Accordingly, the Federal Circuit affirmed the district court's entry of SJ because there was no genuine issue of material fact as to whether the accused TAKEONE device contained, either literally or under the DOE, a "removable, replaceable transfer member."

Judges:  Prost (author), O'Malley, Hughes

[Appealed from D. Mass., Judge Woodlock]

This article previously appeared in Last Month at the Federal Circuit, October 2014

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