The guidelines outline a three-step inquiry for examining claims
that may fall under Prometheus:
1. Is the claimed invention directed
to a process, defined as an act, or a series of acts or steps? If
no, this analysis is not applicable. For product claims, see the
Interim Examination Instructions for Evaluating Subject Matter
Eligibility Under 35 U.S.C. § 101 issued August 24, 2009. If
yes, proceed to Inquiry 2.
2. Does the claim focus on use of a
law of nature, a natural phenomenon, or naturally occurring
relation or correlation (collectively referred to as a natural
principle herein)? (Is the natural principle a limiting feature of
the claim?) If no, this analysis is complete, and the claim should
be analyzed to determine if an abstract idea is claimed (see the
2010 Interim
Bilski
Guidance).
If yes, proceed to Inquiry 3.
3. Does the claim include additional
elements/steps or a combination of elements/steps that integrate
the natural principle into the claimed invention such that the
natural principle is practically applied, and are sufficient to
ensure that the claim amounts to significantly more than the
natural principle itself? (Is it more than a law of nature + the
general instruction to simply "apply it"?) If no, the
claim is not patent-eligible and should be rejected. If yes, the
claim is patent-eligible, and the analysis is complete.
The guidelines include a discussion of this framework and a list
of factors that may be helpful in answering Inquiry 3. The
guidelines emphasize consideration of the claim as whole, but
indicate that "there must be at least one additional element
or step that applies, relies on or uses the natural principle so
that the claim amounts to significantly more than the natural
principle itself."
The guidelines warn that the additional step must not be an
"insignificant extra-solution activity,"
"data-gathering," or "well-understood, routine, [or]
conventional." At the same time, the guidelines make clear
that the step need not be novel and non-obvious to
carry the claim across the patent-eligibility threshold.
The guidelines indicate that the following subject matter does
not require such close scrutiny:
Claims that do not include a natural
principle as a limitation do not raise issues of subject matter
eligibility under the law of nature exception. For example, a claim
directed to simply administering a man-made drug that does not
recite other steps or elements directed to use of a natural
principle, such as a naturally occurring correlation, would be
directed to eligible subject matter. Further, a claim that recites
a novel drug or a new use of an existing drug, in combination with
a natural principle, would be sufficiently specific to be eligible
because the claim would amount to significantly more than the
natural principle itself.
The Examples
The guidelines include one general example of a claim that is
not patent-eligible under this framework, and two specific examples
of claim sets with some claims that are patent-eligible and some
that are not. These examples should be helpful to practitioners,
whether they are drafting, prosecuting, evaluating or challenging
claims in view of Prometheus. While most claims will not fall
directly under one of these examples, the examples should at least
serve as a useful frame of reference for a Prometheus
analysis.
The Importance Of The State Of The Art
It is telling that the guidelines set up each example by
providing a summary of the state of the art. Indeed, such an
approach is consistent with the Supreme Court's analysis in
Prometheus--how else can you decide that the method recites more
than "well-known, routine or conventional" steps? On the
other hand, it is interesting that the guidelines emphasize that
the requirement for a step that is not conventional does
not require any single step to be novel and
non-obvious.
Patenting After Prometheus
In view of these guidelines, Applicants seeking to patent
methods that relate to "natural principles" may want to
consider whether their methods can be described in terms of the use
of a new drug or in terms of a new use of an existing drug (in
conjunction with the natural principle). Moving forward, applicants
may be able to set the stage in their patent applications to
support patent-eligibility by highlighting any and all
non-conventional steps that apply the natural
principle in order to satisfy § 101, while also demonstrating
the novelty and non-obviousness of their methods as a whole in
order to satisfy § 102 and § 103. Patent holders who have
concerns about the validity of granted method claims may want to
consider whether pursuing a reissue application is appropriate or
whether they might want to avail themselves of the new
Supplemental Examination proceedings that will become available
September 16, 2012.
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.
Specific Questions relating to this article should be addressed directly to the author.
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