10/01/14

EMD Millipore v. AllPure Tech.: Prosecution History Estoppel Applies After Term Deletion Alongside Addition of New Terminology

Category: Infringement 
 
 
 
 By: Jesus Hernandez, Blog Editor/Contributor  
 
TitleEMD Millipore Corp. v. AllPure Tech., Inc., No. 2014-1140 (Fed. Cir. Sept. 29, 2014).
Issues
[A. No Literal Infringement] 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 [...] are no longer physically connected. […]
EMD Millipore Corp. at *7.
[B. Prosecution History Estoppel Bars Millipore’s Doctrine of Equivalents Arguments] AllPure argues that the district court should not have considered whether Millipore could maintain a claim for infringement under the doctrine of equivalents because prosecution history estoppel bars such a claim.
Id. at *10.
Holdings
[A. No Literal Infringement] [W]e conclude that there is no genuine issue of material fact relating to whether the TAKEONE device literally contains “at least one removable, replaceable transfer member[,]” [because the TAKEONE device lacks a seal when it is disassembled, it necessarily lacks the claimed “removable, replaceable transfer member.”]
Id. at *7 (text added).
[B. Prosecution History Estoppel Bars Millipore’s Doctrine of Equivalents Arguments] The district court should have proceeded under the presumption that prosecution history estoppel applies [because, at the time of prosecution, the patentee amended claims to alter the scope in response to an Office Action. The amendment including both deletions and additions to the claim scope.].
Id. at *12 (text added).
 
 
 
 
 
Procedural HistoryPlaintiffs-Appellants EMD Millipore Corporation, formerly known as Millipore Corporation; Merck Chemicals 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 Technologies LLC, (“AllPure”) does not infringe the asserted claims of U.S. Patent No. 6,032,543 (“’543 patent”). […] 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. […]
EMD Millipore Corp., at *2 (internal citations omitted).
 
 
Legal Reasoning (PROST, O’Malley, Hughes)
Background
Claim 11. 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 center- ing 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.

EMD Millipore Corp. at *3-4.
Infringing deviceAllPure’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.
Id. at *4.
A. No Literal Infringement
If a transfer member does not exist when the device is disassembled, as even Millipore’s counsel admitted, then there s 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 ‘removal’ 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.”
EMD Millipore Corp., at *9.
B. Prosecution History Estoppel Bars Millipore’s Doctrine of Equivalents Arguments
Legal Standard: Prosecution History Estoppel
GenerallyProsecution 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).
EMD Millipore Corp., at *10.
Rebutting PresumptionsThere is a presumption that prosecution history estoppel 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 patentability.” 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 underlying 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 reasonably be expected to have described the equivalent. Festo Corp., 535 U.S. at 740-41.
Id. at *10-11.
AmendmentDuring prosecution of the ’543 patent, the applicant amended claim 1’s language, adding, inter alia, the requirement 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 “allowable and distinguishable over the cited references.” J.A. 2148.
Id. at *11.
Prosecution History AppliesWe 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 nonetheless 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 member 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.
Id. at *12.
No Presumption RebuttalThe 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. […] 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.
Id. at *12.
Conclusion
Since there is no genuine dispute of material fact regarding whether the TAKEONE device contains a “removable, replaceable transfer member,” either literally or under the doctrine of equivalents, we affirm the district court’s grant of summary judgment of no infringement.
EMD Millipore Corp., at *13.
 
 
 Image Attribution Statement: FIG. 5 of U.S. Patent No. 6,032,543.
 
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