Patent eligibility is a balancing act; the Supreme Court
explained in Mayo that "too broad an interpretation
of this exclusionary principle could eviscerate patent law. For all
inventions at some level embody, use, reflect, rest upon, or apply
laws of nature, natural phenomena, or abstract ides." In an
era of subject matter eligibility uncertainty, the on-going
question is: How do you deal with 101 rejections and, in
particular, for diagnostic inventions in the life sciences space?
In a series of posts, we will explore different strategies to
answer that question.
Before starting, it's useful to keep up with the latest
court decisions. The USPTO keeps a summary of patent eligibility
cases, a link to which can be found here. The link is to the USPTO's
"Subject Matter Eligibility" page, which includes useful
examination guidance, examples, materials, and events.
One strategy, a common prosecution tool, is to keep a
continuation application pending. With the continually-developing
case law on subject matter eligibility, it may be helpful to keep a
continuation application on file while Congress and/or the courts
continue to address the question of what is patentable subject
matter. While this strategy does not solve the problem of obtaining
allowable claims, it provides applicants with the ability to obtain
claim coverage now based on current standards, while preserving the
opportunity to obtain broader coverage once the state of the law
has further developed.
While the Supreme Court and Federal Circuit decisions on patent
eligibility for diagnostic life sciences claims seem rather dim,
applicants can find hope in the instances in which life sciences
claims are held to contain eligible subject matter. As former Chief
Judge Giles Rich proclaimed, "The name of the game is the
claim." Stay tuned for Part II in which we will look at
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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