Be Mindful that the Potential Reach of Claimed Components under the Doctrine of Equivalents Can Be Affected by Amendments to Claimed Sub-Components.

| October 9, 2014

EMD Millipore Corporation v. Allpure Technologies, Inc. (Precedential Opinion).

September 29, 2014

Panel:  Prost, O’Malley and Hughes.  Opinion by Prost.


EMD Millipore Corporation (Millipore) appeals the District of Massachusetts decision that the accused infringer, Allpure Technologies, Inc. (Allpure) does not infringe its U.S. Patent No. 6,032,543 entitled a Device for Introduction and/or Withdrawal of a Medium into/from a Container, either literally or under the doctrine of equivalents.   The Federal Circuit affirmed that there was no literal infringement because the claims required a removable transfer member having a two part seal connected after removal, while the Allpure device had two parts of a seal separated after disassembly.   In addition, the Federal Circuit held that Allpure did not infringe under the doctrine of equivalents due to prosecution history estoppel  based on narrowing amendments limiting the transfer member to such a two part seal, along with a lack of any argument that the reasons for such amendments was not a substantial one related to patentability.


Factual Background:

Patentee, EMD Millipore Corporation (Millipore), appeals the District of Massachusetts decision that the accused infringer, Allpure Technologies, Inc. (Allpure) does not infringe its U.S. Patent No. 6,032,543 entitled a Device for Introduction and/or Withdrawal of a Medium into/from a Container, either literally or under the doctrine of equivalents.

In summary, the ‘543 patent pertains to a device used “within for instance the pharmaceutical and biotechnology fields” (see col. 1, lines 12+ of the ‘543 patent) for “sampling of media” within a sealed container in such a manner to maintain “low contamination.”  Specifically, in order to “avoid contamination problems, the ‘543 patent uses individual transfer members,” wherein “[e]ach transfer member has a needle embedded in a plastic holder and a seal surrounding the needle which attaches to the holder.”  See Order at page 3.

For reference, Fig. 5 of the patent, reproduced below, shows a container 36 with a medium 39 therein.  As further shown in Figs. 1 and 3 of the patent, the device includes a fastening member 3 with a plurality of transfer members 1, each transfer member 1 including a) needle embedded in a plastic holder and b) a seal surrounding the needle.  Moreover, as explained in the patent at, e.g., col. 3, lines 23+ (reproduced below), the seal 2 includes a bellows part 7 and a end membrane part 9.

1 Adobe Figs 1, 3,5 v4

The seal 2 is formed with an upper bellows-shaped part 7. At its upper end the bellows-shaped part 7 is formed with a bead 8 which is inserted in the groove 6, thus sealingly interconnecting the seal 2 and the holder 4. The bellows-shaped part 7 encloses the hypodermic needle 5 in the longitudinal direction thereof and it may be compressed in the lengthwise direction of the needle 5 between the positions illustrated in FIGS. 3 and 4, respectively. At its lower end the seal 2 is formed with a membrane portion 9 the upper end of which is sealingly attached to the bellows-shaped part 7. The membrane portion 9 is self-sealing and is pierceable by the tip 10 of the hypodermic needle.

See ‘543 Patent, col. 3, lines 23+.

The ‘543 patent contains one independent claim, which recites:

1.  A device for one of introduction and withdrawal 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 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, said membrane portion for sealing said aperture of said container, wherein said bellows-shaped part surrounds said needle and is deformable in a longitudinal direction, said membrane portion pierceable by the tip of the needle to form a sealable channel;

a fastening device for sealingly securing the transfer member via the seal with the aperture 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 interior of said container, a magazine part for removable securement of said at least one transfer member, and a fastening and centering means for removable locking of the magazine 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 introduction into and withdrawal from the container through the membrane portion and the hole.

On the other hand, Allpure’s accused infringing product is a sampling system shown below that “may be attached to the outside of a container holding a fluid medium and has cannulas [e.g., needles] that can be inserted into the container to withdraw a sample, and is intended to be disposed of following use.”  See Order at page 4 (emphasis added).   Allpure’s device is shown below, wherein the corresponding seal of Allpure includes a separated bellows part 165 and a membrane part 166.

Transfer member pic

Court’s Decision:

Standard of Review

The Federal Circuit reviewed the District Court’s holding of summary judgment of non-infringement, which is a question of fact for which the Federal Circuit determines if “no reasonable jury could find that every limitation recited in the properly constructed claim either is or is not found in the accused device.”  The court also noted that whether prosecution history estoppels applies is a question of law that is reviewed de novo.


The Federal Circuit upheld the District Court’s summary judgment of non-infringement that the Allpure accused product lacked the claimed “at least one removable, replaceable transfer member” both literally and under the doctrine of equivalents.


  1. Literal Infringement

First, the parties both agreed that the language “at least one removable, replaceable transfer member” means “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.”  However, the parties disagreed as to the meaning of “removed” in this context.

Second, the District Court had determined and the Federal Circuit agreed that “the transfer member lacked the necessary seal once it is removed,” in that “[u]pon separating the holder … there ceases to be a seal … with two ends comprising a bellows and a membrane.”   The C.A.F.C. explained that when it is disassembled, no seal exists because the required components of the claimed seal are no longer connected.  “One part of the seal, the bellows-shaped part … remains attached to the holder (150), while the … membrane … is separated from the rest of the transfer member.”

Third, thus, due to the lack of a seal, the Federal Circuit affirmed no literal infringement.

2.  Doctrine of Equivalents

First, in the absence of literal infringement, infringement can still be found where for some claim limitations an element of the accused device “performs substantially the same function, in substantially the same way, to obtain substantially the same result.”  See Order at page 9.

Second, a claim under the doctrine of equivalents can, however, in some instances be barred due to “prosecution history estoppel” wherein “during patent prosecution a patentee 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.”  In short, one cannot later seek to recapture such surrendered subject matter.

Third, the court explained that there is a presumption that prosecution history applies when an amendment is filed that narrows the scope of a claim and the reason for that amendment was a substantial one related to patentability.   The Federal Circuit emphasized that a patentee “bears the burden of rebutting this presumption” by establishing one of three exceptions:

(1)  The equivalent was unforeseeable at the time of the application;

(2)  The rationale under 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 have reasonably been expected to have described the equivalent.

Fourth, in this case, during prosecution, claim 1 was amended to add, inter alia, 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.”  Moreover, the patentee argued that the amendment was to make claim 1 allowable over the cited references and stated that “none of the references show or disclose a seal formed like the present case.”

Fifth, The C.A.F.C. also noted that the Supreme Court in Festo had indicated that if no explanation is provided, the court should presume that the reason for amendment was a substantial one related to patentability.  Here, rather than offering arguments under the three exceptions, Millipore argued at trial that the amendments were not narrowing.  Accordingly, the court held that Millipore’s failure to rebut the presumption should have barred Millipore from arguing infringement under the doctrine of equivalents.

Sixth, while Millipore had amended the language related to the seal so as to require both the bellows-shaped part and the sealing membrane portion, Millipore argued that the amendment was not narrowing because the language “after use” was removed.  Specifically, the language had been broadened in some respects from the originally recited language that the “transfer member … is removable for replacement thereof after use.”  However, the court dispelled that argument stating that because the seal limitation was part of the transfer member limitation, narrowing of the seal limitation necessarily narrowed the transfer member limitation despite the elimination of the language “after use.”

Take Away

  1. Reasons for Amendments

When filing amendments, consider filing remarks setting forth that the reason for amendment is not a substantial one related to patentability, as such remarks may potentially help avoid that application of prosecution history estoppel.

2.  Parts with Sub-Components

When claimed components include claimed sub-components, be mindful that limitations narrowing the sub-components – in turn – narrow the claimed components.   Among other things, as in this case, such amendments can impact the ability to rely on the doctrine of equivalents for such components due to prosecution history estoppels.

3.  Removable & Replaceable

When claiming elements as removable & replaceable, consider that such removed elements may be interpreted – as in this case – to need to continue to “exist” after removal with all of the components of the element “connected” together and not “disassembled.”  See Order at page 8.  Where this type of interpretation may be desirable, citation to this decision may be helpful.  On the other hand, where this type of interpretation is not desirable, it may be helpful to clarify the record that removed elements may not need to remain in a particular state after removal.

Full Opinion

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