ICU Medical v. Alaris Medical System (Fed. Cir. 2009)
This is the second post on the ICU case. Part I discusses the $4.6 million award of attorney fees to the accused infringer based on the patentee's litigation misconduct.
The district court found several of ICU's claims invalid for lack of written description under 35 U.S.C. § 112, ¶ 1. On appeal, the Federal Circuit affirmed. (Judges Michel (CJ), Prost, and Moore; Opinion by Moore). Although similar to enablement, the written description requirement pushes an applicant to "convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention." Most often, written description arises in cases where new matter is added to the claims during prosecution. That is also the case here - during prosecution ICU amended its claims to include "spikeless" claims -- directed to a valve mechanism for adding drugs to an IV without using needles.
To be clear - the original claims included the "spike." That element was removed during prosecution - seemingly broadening the claims. As the court stated "we refer to these claims as spikeless not because they exclude the preferred embodiment of a valve with a spike but rather because these claims do not include a spike limitation—i.e., they do not require a spike." It is that failure to include any discussion of a spike in the claim that lead to the claim being held invalid for lack of written description.
The Federal Circuit does not cite Gentry Gallery or the infamous "omitted element" or "essential element" theories. However, the court does rely heavily on LizardTech. In that case, the court did not point to any claim limitation that was not sufficiently described. Rather, the court found the claim invalid because an embodiment arguably covered by the claim was not sufficiently disclosed.
We addressed a similar issue in LizardTech . . . We explained that "the specification provides only one method for creating a seamless DWT, which is to 'maintain updated sums' of DWT coefficients. That is the procedure recited by claim 1. Yet claim 21 is broader than claim 1 because it lacks the 'maintain updated sums' limitation." We determined, however, that "[a]fter reading the patent, a person of skill in the art would not understand how to make a seamless DWT generically and would not understand LizardTech to have invented a method for making a seamless DWT, except by 'maintaining updat[ed] sums of DWT coefficients.'" We therefore concluded that claim 21 was invalid under the written description requirement of § 112, ¶ 1.
In LizardTech, the court explicitly rejected the argument that the written description requirement "requires only that each individual step in a claimed process be described adequately."
In this case, ICU's original disclosure focused on spiked embodiments, but the more generic claims are not so limited.
ICU's asserted spikeless claims are broader than its asserted spike claims because they do not include a spike limitation; these spikeless claims thus refer to medical valves generically—covering those valves that operate with a spike and those that operate without a spike. But the specification describes only medical valves with spikes.
Since all the embodiments included the "spike," the court concluded that "Based on this disclosure, a person of skill in the art would not understand the inventor ... to have invented a spikeless medical valve."
- This case also includes an important discussion of claim differentiation that will be dissected in a later post.
- Of course, this case suggests the best patent drafting practice of providing multiple embodiments of each claim element, and considering whether each and every limitation in the broadest original claims are necessary.
- ICU broadened its claim by dropping a limitation -- did ICU introduce new matter?
- In a powerful rhetorical approach, Judge Moore chose to refer to the broad claims as "spikeless claims." As mentioned, those claims do not include a "spikeless" limitation. Rather, they simply omit a "spike" element. As it turns out more than 99.9% all patent claims issued in 2008 are silent about "spikes," and under the traditional interpretation of the "comprising" transition - all those claims would literally cover embodiments without spikes. The holding here cannot be that all those claims are invalid. I believe that the holding here is largely a result of the fact that the accused device was in-fact spikeless. Unfortunately, this decision does not provide helpful guidance as to when it will apply. Rather, it appears to simply be an additional vague tool available to defense attorneys.
- The court did not mention enablement - since it was easy to remove the needle from a syringe and the disclosure includes a preslit seal that could arguably work with a spikeless syringe. That modification would have been enabled based on the original disclosure.