Overview

EMD Millipore –The Circuit affirms summary judgment of no literal infringement, and holds that the district court should not even have reached the doctrine of equivalents because of prosecution history estoppel.

EMD Millipore Corporation et al. v. Allpure Technologies, LLC, Fed. Cir. Case 2014-1140 (September 29, 2014)

Millipore's patent ‎discloses a device for introducing or withdrawing a sample from a container holding a fluid without contaminating the fluid. The claimed device is attached to the side ‎of a container holding a fluid medium.

To avoid contamination problems, the invention uses ‎individual transfer members to maintain a closed system. Each transfer member has a needle embedded in a plastic ‎holder and a seal surrounding the needle which attaches to the holder.

Claim 1 is representative and recites in pertinent part:‎

‎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….‎

‎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's transfer member is composed of a holder, a seal (comprising a bellows-shaped part and a ‎membrane), and needles. When disassembled, all components of the TAKEONE device's transfer member can be removed from the magazine part.

The district court granted AllPure's motion for summary judgment of no infringement, either literally or under the doctrine of equivalents, ‎finding that the TAKEONE device lacks a "removable, ‎replaceable transfer member."

Standard 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 the Circuit reviews summary judgment decisions de ‎novo, infringement, whether literal or under the doctrine of equivalents, is a question of fact.‎ 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. Whether prosecution history estoppel applies to a particular argument, and thus whether the doctrine of equivalents is available for a particular claim limitation, is a ‎question of law reviewed de novo.

There is 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." The district court explained that "remove" means "to move . . . by taking away ‎or off" or to "put aside, apart, or elsewhere." 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."

Millipore challenges the district court's interpretation 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, even if the components of the seal ‎‎(i.e., the bellows-shaped part and the membrane 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 "remova‎ble, 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 required components are no longer connected. One part of ‎the seal, the bellows-shaped part, remains attached to ‎the holder, while the second part, the membrane, 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 re‎moved." 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.‎

The panel agrees with AllPure and the district court. 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 the claims.

Prosecution History Estoppel Bars Millipore's Doctrine ‎of Equivalents Arguments

The panel then turns to examine whether the court erred in ‎granting summary judgment of no infringement under the ‎doctrine of equivalents. 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. There 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." The patentee bears the burden of rebutting the ‎application of prosecution history estoppel by establishing ‎one of three exceptions: (1) the equivalent was unforeseeable 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.‎ See Warner-Jenkinson Co. v Hilton Davis Chem. Co., 520 U.S. 17, 30-‎‎31 (1997) and Festo Corp. v. Shoketsu Kinzoku ‎Kogyo Kabushiki Co., 535 U.S. 722, 734 (2002).‎

During prosecution of the '543 patent, the applicant ‎amended claim 1's language, adding 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." The applicant stated that the ‎purpose of the amendment was to make claim 1 "allowable ‎and distinguishable over the cited references."

The panel concludes 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." 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.