The USPTO has issued new patent subject matter eligibility guidelines to aid examiners in applying the principles of Myriad and Prometheus to any claim "reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products." The guidelines include a general framework for analyzing such claims for patent subject matter eligibility and examples applying the framework to sample claims. The guidelines do not apply to claims that raise "abstract idea" issues, but are similar to the guidelines prepared for such claims under Bilski in that they include lists of factors that weigh towards and against patent eligibility. All practitioners and interested stakeholders should study the guidelines. Here I start with an overview of key points of the guidelines.
Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products
The memorandum to the Patent Examining Corps notes that the guidelines "implement[] a new procedure to address changes in the law relating to subject matter eligibility under 35 USC § 101 in view of recent court decisions including ... Myriad and Mayo [Prometheus]." The memorandum emphasizes that the guidelines apply to "all claims (i.e., machine, composition, manufacture and process claims) reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products," but do not apply to "claims reciting an abstract idea, which should continue to be analyzed for subject matter eligibility using the existing guidance in MPEP § 2106(II)." The memorandum does not prioritize the statutory requirements for a patent (e.g., § 101, § 102, § 103, and § 112), but states that "[u]nder principles of compact prosecution, Office personnel should state all non-cumulative reasons and bases for rejecting claims in the first Office action."
Overall Process for Determining Patent Subject Matter Eligibility Under 35 USC § 101
The first section of the guidelines outlines the "overall process" for making a subject matter eligibility determination, and includes this three-question flowchart.
The three questions are summarized below:
Question 1: Is the claimed invention
directed to one of the four statutory patent-eligible subject
matter categories: process, machine, manufacture, or composition of
matter?
If no, the claim is not eligible for patent protection and should
be rejected under § 101.
If yes, proceed to Question 2.
Question 2: Does the claim recite or involve one or more
judicial exceptions?
If no, the claim is patent-eligible, and the analysis is
complete.
If yes, or if it is unclear whether the claim recites or involves
a judicial exception, proceed to Question 3.
Question 3: Does the claim as a whole recite something
significantly different than the judicial
exception(s)?
[Unless the claim recites an abstract idea], answer this Question
using the factor-based analysis of "significantly
different" that is discussed below in Part II.
If the answer is no ... the claim is not patent-eligible and
should be rejected under § 101.
The "Significantly Different" Test for Patent Subject Matter Eligibility
The guidelines mandate a multi-factored analysis for assessing whether a claim recites something "significantly different" from non-eligible subject matter. The guidelines emphasize consideration of the claimed subject matter as a whole, in view of "every relevant factor and related evidence," similar to a Wands factor-based analysis used to evaluate" enablement. The guidelines emphasize that not every factor will apply to every claim, and that the analysis may change because "developing case law may generate additional factors over time."
The identified factors are listed below:
Factors that weigh toward eligibility (significantly
different):
a) Claim is a product claim reciting something that initially
appears to be a natural product, but after analysis is determined
to be non-naturally occurring and markedly different in structure
from naturally occurring products.
b) Claim recites elements/steps in addition to the judicial
exception(s) that impose meaningful limits on claim scope, i.e.,
the elements/steps narrow the scope of the claim so that others are
not substantially foreclosed from using the judicial
exception(s).
c) Claim recites elements/steps in addition to the judicial
exception(s) that relate to the judicial exception in a significant
way, i.e., the elements/steps are more than nominally,
insignificantly, or tangentially related to the judicial
exception(s).
d) Claim recites elements/steps in addition to the judicial
exception(s) that do more than describe the judicial exception(s)
with general instructions to apply or use the judicial
exception(s).
e) Claim recites elements/steps in addition to the judicial
exception(s) that include a particular machine or transformation of
a particular article, where the particular machine/transformation
implements one or more judicial exception(s) or integrates the
judicial exception(s) into a particular practical application. (See
MPEP 2106(II)(B)(1) for an explanation of the machine or
transformation factors).
f) Claim recites one or more elements/steps in addition to the
judicial exception(s) that add a feature that is more than
well-understood, purely conventional or routine in the relevant
field.
Factors that weigh against eligibility (not
significantly different):
g) Claim is a product claim reciting something that appears to be
a natural product that is not markedly different in structure from
naturally occurring products.
h) Claim recites elements/steps in addition to the judicial
exception(s) at a high level of generality such that substantially
all practical applications of the judicial exception(s) are
covered.
i) Claim recites elements/steps in addition to the judicial
exception(s) that must be used/taken by others to apply the
judicial exception(s).
j) Claim recites elements/steps in addition to the judicial
exception(s) that are well-understood, purely conventional or
routine in the relevant field.
k) Claim recites elements/steps in addition to the judicial
exception(s) that are insignificant extra-solution activity, e.g.,
are merely appended to the judicial exception(s).
l) Claim recites elements/steps in addition to the judicial
exception(s) that amount to nothing more than a mere field of
use.
The Broad Reach of the New USPTO Patent Subject Matter Eligibility Guidelines
Although the Supreme Court Myriad decision was limited to human DNA sequences and the USPTO's initial guidance in the wake of Myriad was limited to "naturally occurring nucleic acids or fragments thereof," the new guidelines have an expansive reach and include claims reciting:
The potential impact of the guidelines is underscored by the examples, which I will review in a future post.
Figuring Out Patent Subject Matter Eligibility Under The New USPTO Guidelines
As set forth in the memorandum to the Patent Examining Corps, these guidelines reflect a significant new procedure for examining a broad range of claims for subject matter eligibility.You can join me in figuring out the new guidelines during the IPO Chat Channel webinar, Myriad and Mayo: New USPTO Examination Guidelines, scheduled for Thursday, March 20, 2014, at 2:00 PM ET. I am honored to be speaking on a panel with Raul Tamayo of the USPTO, and Duane Marks of Roche Diagnostics Operations, Inc. (You can register for the webinar here.)
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.