On February 23, 2016, a judge in the Northern District of Ohio
found three patents invalid for ineligible subject matter on a Rule 12(b)(6)
motion to dismiss (see opinion and order). The patents, U.S. Patents
Numbers 7,223,552, 7,459,286, and 8,349,581, are generally directed towards
Myeloperoxidase (“MPO”) testing, which analyzes inflammation of the blood
vessels to assess a patient’s risk for cardiovascular disease. MPO is an enzyme released by white blood
cells when inflammation occurs in the body, and thus MPO is an early symptom of
many types of cardiovascular disease.
The claims recite limitations such as “comparing levels of [MPO]
in a bodily sample from the test subject with levels of [MPO] in comparable
bodily samples from control subjects diagnoses not having the disease” and “determining
levels of [MPO] activity… in a bodily sample of the test subject.” They also contain “wherein” clauses, e.g., “wherein
elevated levels of [MPO] in the bodily sample from the test subject relative to
the levels of [MPO] in the comparable bodily sample from control subjects is
indicated of the extent of the test subject’s risk of having atherosclerotic
cardiovascular disease.”
For those familiar with patent eligibility case law, it
should come as no surprise that the District Court found these claims to be patent
ineligible under the Mayo/Alice test for patent eligibility (named after the Alice and Mayo Supreme Court decisions].
The court found that the relationship between MPO levels in the
bloodstream and the risk of having or developing cardiovascular disease is a
natural phenomenon (first prong of the Alice
test) and that the “determining” and “comparing” steps are insufficiently
inventive (second prong of the Alice
test). The court found that at the time
of invention a “myriad of methods well-known in the arts existed” for “determining”
MPO levels, and that a “comparing” step involves a mental process, “which does
not add an inventive step.”
The patent owner might have been able to help itself by
arguing for a narrower interpretation of claim terms such as “comparing levels”
and “determining levels.” Unfortunately,
in connection with its motion for temporary restraining order and preliminary
injunction, plaintiff argued to the Court that “[e]xcept for “MPO Activity and “MPO
Mass,” all of the claim terms should simply be afforded their plain and ordinary
meaning.” Later, in its brief opposing the Rule 12(b)(6) motion to dismiss, the plaintiff indicated “that it is now
apparent that additional terms new construction,” including “immunological
technique,” “comparing levels,” and “determining levels,” and argued that the Court could not address the
issue of patent eligibility prior to claim construction.
The judge rejected this argument,
noting that the defendant had stipulated to plaintiff’s proposed claim
construction, and that the plaintiff had failed to offer its own proposed
construction for these terms.
The court stated that “Plaintiff’s failure [offer its
proposed construction of the claim terms] will not serve to block the Court
from considering defendant’s motion.
Otherwise, a plaintiff could prevent dismissal before claim construction
simply by noting without explanation that claim construction is ‘necessary.’ The Court rejects any such rule.”
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