In this case, the Plaintiffs EMD Millipore Corporation appeals the district courts grant of Summary judgment that the Defendant, AllPure technologies does not infringe the asserted claims of US Patent Number 6,032,543.

The ‘543 patent claims are directed towards a device for introducing or withdrawing a sample from a container holding a fluid without contaminating the fluid. The claims in the ‘543 require a “removable, replaceable transfer member… said transfer member comprising a holder, a seal for sealing said aperture”, wherein the transfer member would be a device such as a needle to avoid contamination problems.

AllPure’s accused device is a sampling system that may be attached to the outside of a container holding a fluid, and has cannulas that can be inserted into the container to withdraw a sample. The device is delivered fully assembled and is intended to be disposed of following use. Allpure’s device includes a transfer member with a holder, seal, membrane, and needles. When disassembled, all of the components can be removed and pieced individually.

The district court granted AllPure’s motion of summary judgment of no infringement because the device lacks a “removable, replaceable transfer member.” On appeal, the plaintiffs argued that disassembly of the transfer member could qualify as the claimed removable of the transfer member. Thus, once all the parts of disassembled they can be removed.

AllPure argued that the claims ‘543 required that at least on transfer member have a seal and be removable and replaceable. However, for the transfer member to be removable, it must be dissembled. When the device is dissembled there is no seal because the required components are no longer connected.

The court of appeals agreed with AllPure that the device lacks a seal when it is disassembled, thus the device lacks the claimed “removable, replaceable transfer member” with a seal.

The court also held the prosecution history estoppel bars Millpore’s doctrine of equivalents arguments. Specifically, the court of appeals held that there is a presumption that persecution 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 substantial one relating to patentability.

Patent Attorney Take-a-Ways

  1. This is an interesting case that shows it is helpful to have a pending application at most times in front of the USPTO. After the fact (with hindsight) Millpore could have amended their claims to directly cover the infringing protect.
  2. I am not sure why the two words “removable” AND “replaceable” were included in the claim limitation. It seems like one of them could have been used, not sure if the outcome would have been different.
  3. When writing claims, try to avoid the language of the device includes “X”, and “X” includes “A”, “B”, “C”, wherein X is 1,2,3. When writing claims like that each limitation of 1,2, and 3 will be applied to each of A, B, and C, which might not be the case. Therefore, even though it might make for a longer claim try to only include adjectives to the least amount of elements in the claim.
  4. Something very interesting to me was the courts further holding that if an amendment was made without further clarification, then prosecution history estoppel may be brought, and the burden is on the patente to overcome the presumptions. I typically write a generic statement, such as “To expedite patent prosecution without conceding to the Examiner’s positions, Applicant has amended the independent claims to recite…”  However, under the interpretation of this case, this is a horrible way to go about things. That is because this generic statement would shift all burdens onto the patentee. It seems like it would be a better course of action to clarify the specific incident of why you are amending the claim, and thus limit the doctrine of equivalents arguments that could be brought against you.