United States Court of Appeals
for the Federal Circuit
______________________
EMD MILLIPORE CORPORATION
(formerly known as Millipore Corporation),
MERCK CHEMICALS AND LIFE SCIENCE AB
(formerly known as Millipore AB),
AND MILLIPORE SAS,
Plaintiffs-Appellants,
v.
ALLPURE TECHNOLOGIES, INC.
(now known as AllPure Technologies LLC),
Defendant-Appellee.
______________________
2014-1140
______________________
Appeal from the United States District Court for the
District of Massachusetts in No. 1:11-CV-10221, Judge
Douglas P. Woodlock.
______________________
Decided: September 29, 2014
______________________
SUSAN G. L. GLOVSKY, Hamilton, Brook, Smith &
Reynolds, P.C., of Boston, Massachusetts, argued for
plaintiffs-appellants. With her on the brief was
LAWRENCE P. COGSWELL, III.
2 EMD MILLIPORE CORPORATION v. ALLPURE TECHNOLOGIES,
INC.
CRAIG R. SMITH, Lando & Anastasi, LLP, of Cam-
bridge, Massachusetts, argued for defendant-appellee. Of
counsel was ERIC P. CARNEVALE.
______________________
Before PROST, Chief Judge, O’MALLEY and HUGHES,
Circuit Judges.
PROST, Chief Judge.
Plaintiffs-Appellants EMD Millipore Corporation,
formerly known as Millipore Corporation; Merck Chemi-
cals and Life Science AB, formerly known as Millipore
AB; and Millipore SAS (collectively, “Millipore”) appeal
the grant of summary judgment that Defendant-Appellee
AllPure Technologies, Inc., now known as AllPure Tech-
nologies LLC, (“AllPure”) does not infringe the asserted
claims of U.S. Patent No. 6,032,543 (“’543 patent”). See
EMD Millipore Corp. v. AllPure Techs., Inc., No. 11-
10221, 2013 WL 5299372 (D. Mass. Sept. 17, 2013)
(“Summary Judgment Order”). The district court found
that AllPure’s TAKEONE device neither literally contains
the claimed “removable, replaceable transfer member,”
nor does it provide an infringing equivalent. Id. at *9.
We agree with the district court that the TAKEONE
device does not literally infringe. We also conclude that
prosecution history estoppel prevents Millipore from
asserting the doctrine of equivalents as to this claim
limitation. On these grounds, we affirm the district
court’s grant of summary judgment.
I. BACKGROUND
Millipore owns the rights to the ’543 patent, which
discloses a device for introducing or withdrawing a sam-
ple from a container holding a fluid without contaminat-
ing the fluid. See ’543 patent abstract, col. 2 ll. 20-24. As
Figure 5 depicts, the claimed device is attached to the side
of a container holding a fluid medium. Id. at col. 1 ll. 54-
56.
EMD MILLIPORE CORPORATION v. ALLPURE TECHNOLOGIES, 3
INC.
’543 patent, Fig. 5
To avoid contamination problems, the ’543 patent uses
individual transfer members to maintain a closed system.
’543 patent col. 5 ll. 20-23, col. 5 ll. 35-39, col. 6 ll. 23-26.
Each transfer member has a needle embedded in a plastic
holder and a seal surrounding the needle which attaches
to the holder. ’543 patent col. 3 ll. 11-35.
The ’543 patent contains 14 claims, including 1 inde-
pendent claim. Independent claim 1 is reproduced below:
1. A device for one of introduction and with-
drawal of a medium into a container having an
aperture formed therein for receiving said device,
said device comprising:
at least one removable, replaceable transfer
member for transferring a medium into and
out of the container, said transfer member
comprising a holder, a seal for sealing said
aperture, a hypodermic needle having a tip,
said needle supported within said holder in a
longitudinal direction thereof, wherein the seal
has a first end comprised of a bellows-shaped
4 EMD MILLIPORE CORPORATION v. ALLPURE TECHNOLOGIES,
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part sealingly attached to said holder, and a
second end comprising a self-sealing mem-
brane portion interiorly formed at an end of
said bellows part, said membrane portion for
sealing said aperture of said container, where-
in said bellows-shaped part surrounds said
needle and is deformable in a longitudinal di-
rection, said membrane portion pierceable by
the tip of the needle to form a sealable chan-
nel;
a fastening device for sealingly securing the
transfer member via the seal with the aper-
ture of the container, thereby forming a closed
system, said fastening device comprising a
flanged part sealingly secured in the aperture
and formed with at least one hole
therethrough in communication with an inte-
rior of said container, a magazine part for re-
movable securement of said at least one
transfer member, and a fastening and center-
ing means for removable locking of the maga-
zine part to a flanged part in a position
wherein the membrane portion sealingly
abuts against the hole of the flanged part so
as to accept the hypodermic needle for intro-
duction into and withdrawal from the contain-
er through the membrane portion and the
hole.
’543 patent, claim 1 (emphases added).
AllPure’s accused TAKEONE device 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 device is delivered fully assembled and sterilized, and
it is intended to be disposed of following use. The
TAKEONE device, in a disassembled state, is shown
EMD MILLIPORE CORPORATION v. ALLPURE TECHNOLOGIES, 5
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below. Summary Judgment Order at *7. The TAKEONE
device’s transfer member (130) is composed of a holder
(150), a seal (comprising a bellows-shaped part (165) and
a membrane (166)), and needles (170). Id. When disas-
sembled, all components of the TAKEONE device’s trans-
fer member can be removed from the magazine part (135).
Id.
The district court granted AllPure’s motion for sum-
mary judgment of no infringement of the ’543 patent,
finding that “the TAKEONE device lacks a ‘removable,
replaceable transfer member’ as claimed in the ’543
patent.” Summary Judgment Order at *7-8. The district
court rejected Millipore’s argument that a disassembled
TAKEONE device satisfies this claim limitation. Id. at
*8. The district court also found that the TAKEONE
device does not provide an infringing equivalent of the
limitation. Id. 1 We have jurisdiction pursuant to 28
U.S.C. § 1295(a)(1).
1 In addition, the district court found that the
TAKEONE device did not literally possess a seal with a
“self-sealing membrane portion interiorly formed at an
end of a bellows-shaped part,” but it declined to grant
6 EMD MILLIPORE CORPORATION v. ALLPURE TECHNOLOGIES,
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III. STANDARDS OF REVIEW
Summary judgment is appropriate when there is “no
genuine dispute as to any material fact and the movant is
entitled to judgment as a matter of law.” Fed. R. Civ. P.
56(a). While we review summary judgment decisions de
novo, Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363,
1378 (Fed. Cir. 2008), “[i]nfringement, whether literal or
under the doctrine of equivalents, is a question of fact.”
Bai v. L & L Wings, Inc., 160 F.3d 1350, 1353 (Fed. Cir.
1998). However, “a court may determine infringement on
summary judgment ‘when no reasonable jury could find
that every limitation recited in the properly construed
claim either is or is not found in the accused device.’”
Innovention Toys, LLC v. MGA Entmn’t, Inc., 637 F.3d
1314, 1319 (Fed. Cir. 2011) (quoting Bai, 160 F.3d at
1353).
Whether prosecution history estoppel applies to a par-
ticular argument, and thus whether the doctrine of equiv-
alents is available for a particular claim limitation, is a
question of law reviewed de novo. Intervet Inc. v. Merial
Ltd., 617 F.3d 1282, 1290-91 (Fed. Cir. 2010).
IV. DISCUSSION
This appeal concerns Millipore’s challenges to the dis-
trict court’s grant of summary judgment of no infringe-
ment. The district court found that AllPure’s TAKEONE
summary judgment of no infringement on this limitation
under the doctrine of equivalents. Summary Judgment
Order at *5-6. The district court also declined to grant
summary judgment based on AllPure’s argument that
Millipore is judicially estopped from taking the position
that the TAKEONE device infringes the ’543 patent due
to statements it made during prosecution of another
patent. Id. at *3-4. However, we need not address these
findings to resolve this appeal.
EMD MILLIPORE CORPORATION v. ALLPURE TECHNOLOGIES, 7
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device lacked the claimed “at least one removable, re-
placeable transfer member” both literally and under the
doctrine of equivalents. For the reasons discussed herein,
we conclude that there is no genuine issue of material fact
relating to whether the TAKEONE device literally con-
tains “at least one removable, replaceable transfer mem-
ber.” We also conclude that the district court should have
barred Millipore from asserting that the TAKEONE
device contains an equivalent transfer member due to
prosecution history estoppel.
A. No Literal Infringement
The district court construed the claim limitation “at
least one removable, replaceable transfer member” to
mean “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.” See
EMD Millipore Corp. v. AllPure Techs., Inc., No. 11-
10221, 2012 WL 4862772, at *5 (D. Mass. Oct. 11, 2012)
(“Claim Construction Order”). Neither party has chal-
lenged this construction. However, the parties disagree
over the meaning of the term “removed,” as contained in
the district court’s construction. The district court ex-
plained that “remove” means “to move . . . by taking away
or off” or to “put aside, apart, or elsewhere.” Summary
Judgment Order at *7 (citing Webster’s New International
Dictionary 1921 (3d. ed 1986)). The district court also
noted that “[t]ake off” and “put apart” are significantly
different from “take apart” or disassemble; “the former
implies movement or separation of something as a whole,
whereas the latter implies deconstruction.” Id.
In examining the TAKEONE device, the district court
found that the transfer member lacked the necessary seal
once it is removed. Id. at *8. “Upon separating the holder
[150] from the various other elements, there ceases to be a
seal, . . . with two ends comprising a bellows and a mem-
brane, respectively. What Millipore characterizes as
8 EMD MILLIPORE CORPORATION v. ALLPURE TECHNOLOGIES,
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removal of a transfer member from the magazine part is,
in fact, disassembly of a transfer member as defined in
the ’543 patent.” Id.
On appeal, Millipore challenges the district court’s in-
terpretation of its own claim construction. It argues that
summary judgment was inappropriate because there
remains a genuine issue of material fact relating to
whether disassembly of the transfer member could qualify
as the claimed removal of the transfer member. Millipore
claims that when the TAKEONE device is disassembled,
all components of the transfer member are still removed
from the magazine part (135), even if the components of
the seal (i.e., the bellows-shaped part (165) and the mem-
brane (166)) are no longer physically connected.
AllPure responds by arguing that there is no triable
issue of fact—the TAKEONE device lacks a removable
and replaceable transfer member. Claim 1 requires that
at least one transfer member have a seal and be “remova-
ble, replaceable.” But in order for it to be removable and
replaceable, the TAKEONE device must be disassembled.
When it is disassembled, no seal exists because the re-
quired components are no longer connected. One part of
the seal, the bellows-shaped part (165), remains attached
to the holder (150), while the second part, the membrane
(166), is separated from the rest of the transfer member.
AllPure notes that Millipore’s counsel even admitted this
fact, choosing instead to argue that a transfer member
“does not have to still be a transfer member once re-
moved.” J.A. 2519. However, according to AllPure, if the
transfer member does not exist when it is removed, then
the TAKEONE device does not have the claimed “at least
one removable, replaceable transfer member,” so it cannot
infringe.
We agree with AllPure and the district court. If a
transfer member does not exist when the device is disas-
sembled, as even Millipore’s counsel admitted, then there
EMD MILLIPORE CORPORATION v. ALLPURE TECHNOLOGIES, 9
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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. As the district court properly noted,
“[t]he problem with Millipore’s characterization of ‘remov-
al’ of a transfer member . . . is the absence of necessary
component parts of the transfer member once it is re-
moved . . . . [T]he part of the device removable from the
magazine part must have all of the component parts—a
holder, needle, and seal.” Summary Judgment Order at
*7. Since the TAKEONE device lacks a seal when it is
disassembled, it necessarily lacks the claimed “removable,
replaceable transfer member.”
B. Prosecution History Estoppel Bars Millipore’s Doctrine
of Equivalents Arguments
We next examine whether the district court erred in
granting summary judgment of no infringement under the
doctrine of equivalents. Even without literal infringe-
ment of a certain claim limitation, a patentee may estab-
lish infringement under the doctrine of equivalents if an
element of the accused device “performs substantially the
same function in substantially the same way to obtain the
same result as the claim limitation.” AquaTex Indus., Inc.
v. Techniche Solutions, 419 F.3d 1374, 1382 (Fed. Cir.
2005) (citation omitted) (quotation marks omitted). The
district court concluded that it was not “possible for
Millipore to maintain a claim for infringement under the
doctrine of equivalents because the purportedly remova-
ble transfer member(s) of the TAKEONE device do not
serve the same function or function in the same way as
those in the ’543 patent.” 2 Summary Judgment Order at
*8.
2 As previously stated, the proper inquiry is actual-
ly whether the accused device performs substantially the
10 EMD MILLIPORE CORPORATION v. ALLPURE TECHNOLOGIES,
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As a preliminary matter, AllPure argues that the dis-
trict court should not have considered whether Millipore
could maintain a claim for infringement under the doc-
trine of equivalents because prosecution history estoppel
bars such a claim. Prosecution history estoppel applies
when an applicant during patent prosecution narrows a
claim “to avoid the prior art, or otherwise to address a
specific concern . . . that arguably would have rendered
the claimed subject matter unpatentable.” Warner-
Jenkinson Co. v Hilton Davis Chem. Co., 520 U.S. 17, 30-
31 (1997). Estoppel then bars the applicant from later
invoking the doctrine of equivalents to recapture the
surrendered ground. Festo Corp. v. Shoketsu Kinzoku
Kogyo Kabushiki Co., 535 U.S. 722, 734 (2002).
There is a presumption that prosecution history es-
toppel applies when a patentee has filed an amendment
seeking to narrow the scope of a claim, and “the reason for
that amendment was a substantial one relating to pa-
tentability.” Festo Corp. v. Shoketsu Kinzoku Kogyo
Kabushiki Co., 344 F.3d 1359, 1366 (Fed. Cir. 2003) (en
banc). The patentee bears the burden of rebutting the
application of prosecution history estoppel by establishing
one of three exceptions: (1) the equivalent was unforesee-
able at the time of the application; (2) the rationale under-
lying the amendment bears no more than a tangential
relation to the equivalent in question; or (3) there is some
other reason suggesting that the patentee could not
same function in substantially the same way to obtain the
same result. Aqua Tex Indus., 419 F.3d at 1382. Milli-
pore argues that the district court used the wrong stand-
ard, but for the reasons discussed herein, we conclude it
was unnecessary for the district court to even undertake a
doctrine of equivalents analysis. Therefore, this issue is
moot.
EMD MILLIPORE CORPORATION v. ALLPURE TECHNOLOGIES, 11
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reasonably be expected to have described the equivalent.
Festo Corp., 535 U.S. at 740-41.
During prosecution of the ’543 patent, the applicant
amended claim 1’s language, adding, inter alia, the re-
quirement that the transfer member’s seal have “a first
end comprised of a bellows-shaped part sealingly attached
to said holder, and a second end comprising a self-sealing
membrane portion interiorly formed at an end of said
bellows part.” J.A. 2143. The applicant stated that the
purpose of the amendment was to make claim 1 “allowa-
ble and distinguishable over the cited references.” J.A.
2148. The district court found that although claim 1 “was
narrowed to allow the device to be patented over prior art,
it was not narrowed so as to disclaim all multi-part seals.”
Summary Judgment Order at *5. The district court then
considered Millipore’s doctrine of equivalents arguments
on the merits. 3 Id. at *8.
Millipore argues that the claim language was actually
broadened. Prior to amendment, claim 1 required “at
least one transfer member . . . whereas the transfer
member . . . is removable for replacement thereof after
use.” J.A. 341 (emphasis added). Because the amended
claim 1 no longer contains the “after use” language,
Millipore suggests that the claim is broader and, there-
fore, prosecution history estoppel cannot apply. See J.A.
440-41.
3 The district court discussed prosecution history
estoppel in a separate portion of its summary judgment
order. See Summary Judgment Order at *5. However,
since there is only one seal in claim 1, the district court’s
statements about prosecution history estoppel and a
multi-part seal pertain equally to the “at least one re-
movable, replaceable transfer member” that is at issue.
12 EMD MILLIPORE CORPORATION v. ALLPURE TECHNOLOGIES,
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We disagree with Millipore and conclude that it was
unnecessary for the district court to perform a doctrine of
equivalents analysis because prosecution history estoppel
bars Millipore’s arguments. Although the applicant
eliminated the “after use” language, the applicant none-
theless added the requirement that the seal have a first
and second end with distinct elements. This narrows the
seal limitation, which in turn narrows the transfer mem-
ber limitation. And the applicant even stated in its
reasons for amendment that “none of the references show
or disclose a seal formed like the present one.” J.A. 2148
(emphasis added). Thus, these amendments were added
to overcome a previous rejection. And to the extent this
statement is ambiguous, we note that the Supreme Court
has stated “[w]here no explanation is established . . . the
court should presume that the patent applicant had a
substantial reason related to patentability for including
the limiting element added by amendment.” Warner-
Jenkinson, 520 U.S. at 33.
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. See Oral Arg. 24:06-24:20, available
at http://www.cafc.uscourts.gov/oral-argument-recordings/
14-1140/all (“Q: You never argued in the alternative that
if in fact there was a conclusion by the trial court that the
amendment was narrowing or limiting, that you could
rebut the presumption that would arise under Festo? A:
That is correct, your honor . . . .”). Instead it argued that
the amendment was not narrowing. See J.A. 2208-09.
Since Millipore failed to rebut the presumption, the
district court should have concluded that Millipore was
barred from arguing that the TAKEONE device infringes
the transfer member limitation under the doctrine of
equivalents. This error, however, does not change the
EMD MILLIPORE CORPORATION v. ALLPURE TECHNOLOGIES, 13
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outcome of this case, as the district court still proceeded to
grant summary judgment of no infringement under the
doctrine of equivalents on the merits. See Summary
Judgment Order at *8-9.
V. CONCLUSION
Since there is no genuine dispute of material fact re-
garding whether the TAKEONE device contains a “re-
movable, replaceable transfer member,” either literally or
under the doctrine of equivalents, we affirm the district
court’s grant of summary judgment of no infringement.
AFFIRMED