Nature-Based Products
product, i.e., a combination of cells, the nature-based product (the population) is analyzed to determine
whether it has markedly different characteristics from any naturally occurring counterpart(s) in their
natural state. As discussed above with respect to claims 1 and 2, the cells expressing marker Z have
markedly different characteristics than naturally occurring cardiac pacemaker cells because of their
phenotypic differences, but the cells expressing marker P do not have markedly different characteristics
because they are identical to naturally occurring pacemaker cells. However, as described in the
specification, when these cells are mixed together in the claimed ratio to form the claimed population, the
cells interact with each other to affect their growth rates, e.g., the cells expressing marker P grow faster in
the mixed population than when they are by themselves. Naturally occurring pacemaker cells do not grow
at this rate in their natural state. This difference in biological properties (rate of cell growth) between the
claimed cell population and naturally occurring human pacemaker cells rises to the level of a marked
difference, and accordingly the claimed population is not a “product of nature” exception. Thus, the claim
is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.
Claim 4: Ineligible. Because the claim recites a nature-based product, i.e., the population of cells, the
nature-based product is analyzed to determine whether it has markedly different characteristics from any
naturally occurring counterpart(s) in their natural state. As explained with respect to claim 1, isolated
man-made pacemaker cells do not have markedly different characteristics due to their isolation or human
manufacture. There is no indication in the specification that placing the cells in a generic container results
in the cells having any characteristics (structural, functional, or otherwise) that are different from the
naturally occurring cells in their natural state. Thus, the claimed population of cells does not have
markedly different characteristics from what occurs in nature, and is a “product of nature” exception.
Accordingly, the claim is directed to an exception (Step 2A: YES). Next, the claim as a whole is analyzed
to determine whether any element, or combination of elements, is sufficient to ensure that the claim
amounts to significantly more than the exception. Although the claim recites a container, use of a
container to hold cells is not only well-understood, routine and conventional activity already engaged in
by the scientific community, it is also required for growing and using the cells. Additionally, the claim
recites the container at such a high level of generality that it merely tells a scientist to use whatever
container she wishes to use. Therefore, the claim as a whole adds nothing significantly more to the
“product of nature” itself. Thus, the claim does not amount to significantly more than the judicial
exception itself (Step 2B: NO). The claim does not qualify as eligible subject matter, and should be
rejected under 35 U.S.C. § 101.
Claim 5: Eligible. Because the claim is a nature-based product, i.e., a combination of cells and a scaffold,
the nature-based product (the combination) is analyzed to determine whether it has markedly different
characteristics from any naturally occurring counterpart(s) in their natural state. As explained with respect
to claim 1, isolated man-made pacemaker cells do not have markedly different characteristics due to their
isolation or human manufacture. There is also no indication in the specification that placing the cells into
a biocompatible three-dimensional scaffold results in the cells or the scaffold having any characteristics
(structural, functional, or otherwise) that are different from the naturally occurring cells or scaffold in
their natural state. Thus, the claimed population of cells, and the claimed scaffold, do not have markedly
different characteristics from what occurs in nature, and are “product of nature” exceptions. Accordingly,
the claim is directed to an exception (Step 2A: YES). Next, the claim as a whole is analyzed to determine
whether any element, or combination of elements, is sufficient to ensure that the claim amounts to
significantly more than the exception. The recitation of the biocompatible three-dimensional scaffold in
combination with the pacemaker cells is not required for growing or using the cells, because the cells can
be grown or used in other containers, and is not recited at a high level of generality. The addition of the
pacemaker cells to the scaffold confines the claim to a particular useful application of the scaffold (repair
of cardiac tissue), because the pacemaker cells are not routinely required for all practical uses of the
scaffold. Further, the combination of these elements does more than generally link these two judicial
exceptions together; as described in the specification, this combination improves the technology of
regenerative medicine, by facilitating faster tissue regeneration than when pacemaker cells are implanted
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