New guidance from the USPTO on subject matter eligibility
The USPTO has issued updated interim examination guidance for determining subject matter
eligibility under 35 U.S.C §101, together with a set of explanatory examples relating to naturebased products. The new guidance appears to have incorporated some positive changes, in
particular in relation to determining the eligibility of nature-based products.
When determining if a nature-based product is markedly different from its counterpart
natural product (and therefore patent eligible) the product’s structure, function, and/or other
properties are considered. This means that a purified or isolated product will be patent eligible
if purification or isolation results in a change in characteristics sufficient to show a marked
difference from the product’s naturally-occurring counterpart. When determining whether
there is a ‘marked difference’, characteristics such as biological/pharmacological functions or
activities; chemical and physical properties; phenotype; and chemical, genetic and physical
structure and form will be considered. For example, a claim to a naturally-occurring antibiotic
is ineligible, whereas a claim to the same antibiotic in a purified form is patent eligible, if the
purified form is structurally different (e.g. forms a different crystal structure or comprises amino
acid substitutions that are not known to occur naturally).
In an important change from the previous USPTO guidance, when assessing claims directed
to a single nature-based product, once a markedly different characteristic has been shown it
is no longer necessary to determine whether the claim amounts to ‘significantly more’ than a
product of nature. The claim can be found to be patent eligible based solely on the identification
of a markedly different characteristic.
The examples accompanying the guidance clarify that isolated nature-based products, which
are not per se patent eligible because the isolated product is not markedly different from its
counterpart natural product, can still be the subject of a patent eligible claim directed to a
process of practically applying the product, for example in a method of treating a particular
disease.
In relation to cellular products, the examples accompanying the guidance clarify that
synthetic cells that are identical to naturally-occurring cells do not have markedly different
characteristics, and are therefore not patent eligible. However, changes in phenotype caused
by manipulating synthetic cells, e.g. such that the resultant cell expresses a marker not
expressed by the naturally-occurring cell, can result in the different characteristics required for
eligibility.
In order for a claim directed to a ‘product of nature’ (i.e. a nature-based product that is not
markedly different to its natural counterpart) to be patent eligible, the claim as a whole must
amount to significantly more than the product that falls within the exception. The guidance
clarifies that merely stating that a product of nature (e.g. a man-made cell indistinguishable
from the corresponding natural cell) is in a container is not sufficient to overcome the threshold
of ‘significantly more’. This is because a container recited at such a high level of generality is
not only well-understood, routine and conventional but is also required for growing and using
cells.
Gill Jennings & Every LLP
The Broadgate Tower 20 Primrose Street London EC2A 2ES
Tel: +44 20 7655 8500 Email: gje@gje.com www.gje.com
New guidance from the USPTO on subject matter eligibility
In contrast, a claim to the same cells in a biocompatible three dimensional scaffold is patent
eligible, because such a scaffold is not routinely required for growing or using cells, and is
not recited at a high level of generality. Furthermore, the addition of the cells to the scaffold
confines the claim to a particular useful application of the scaffold. These factors ensure that
the claim amounts to significantly more than the exception of the cells per se.
Claims directed to antibodies can be patent eligible if the antibody is created by human
manipulation of natural processes, or if the structure of the antibody is changed compared
with the naturally-occurring counterpart, resulting in markedly different characteristics. For
example, antibodies having different CDRs to naturally-occurring antibodies, and chimeric
or humanized antibodies formed by fusing together parts of different antibodies, will have
different structural and functional characteristics to naturally-occurring molecules. Therefore
they do not fall under the ‘product of nature’ exception.
USPTO Interim Guidance published 16 December 2014:
https://www.federalregister.gov/articles/2014/12/16/2014-29414/2014-interim-guidance-onpatent-subject-matter-eligibility
Gill Jennings & Every LLP
The Broadgate Tower 20 Primrose Street London EC2A 2ES
Tel: +44 20 7655 8500 Email: gje@gje.com www.gje.com