Title: In re Fisher - Sullano

Facts:
Plaintiff submitted a patent application (the "643
application) that related to five purified nucleic
acid sequences (genes), also known as
expressed sequence tags (ESTs), that encoded
proteins and protein fragments in maize plants.
When Plaintiff filed the "643 application, he did
not know the precise structure or function of
either the genes or the proteins encoded for by
those genes. The "643 application disclosed
that the five claimed ESTs could be used in a
variety of ways.
These included: (1) serving as a molecular
marker for mapping the entire maize genome,
which consists of ten chromosomes that
together include about 50,000 genes; (2)
measuring the level of mRNA in a tissue sample
by way of microarray technology to provide
information
about
gene
expression;
(3)
providing a source for primers for use in the
polymerase chain reaction (PCR) process to
enable rapid and inexpensive duplication of
specific genes; (4) identifying the presence or
absence of a polymorphism; (5) isolating
promoters by way of chromosome walking; (6)
controlling protein expression; and (7) locating
genetic molecules of other plants and
organisms.
The patent examiner found that none of the
stated uses for the ESTs satisfied the
"substantial utility" standard and "enablement"
standard required for patentability. The board of
appeals and interferences affirmed, and the
court of appeals granted review.

Issue:
Does a patent application that reveals general generic
uses of a claimed invention, which simply assists
research, lack utility and lack enablement?
Held:
Yes. A patent application that reveals general
generic uses of a claimed invention, which are
simply assist research, lacks utility and lacks
enablement.
Plaintiffs argument that the claimed ESTs
provide seven specific and substantial uses,
regardless of whether the functions of the genes
corresponding to the claimed ESTs are known is
not convincing.
Basically, the claimed ESTs do no more than
assist in research that may help scientists to
isolate the particular underlying proteinencoding
genes
and
conduct
further
experimentation on those genes. The overall
goal of such experimentation is presumed to
understand the maize genome.
Therefore, the claimed ESTs are only "objects of
use-testing," meaning scientific research could
be performed on the objects with no assurance
that anything useful will be discovered in the
end. Plaintiffs comparison of the ESTs to a
patentable microscope is also not convincing. A
microscope can immediately reveal an objects
structure, but the claimed ESTs can only be used
to detect the presence of genetic material which
has the same structure as the EST itself. It is
not able to provide any information about the
overall structure let alone the function of the
underlying gene. So while a microscope can
give an immediate, real-world benefit in a

variety of applications, the claimed ESTs

cannot.
The claimed ESTs themselves are not an end of
Plaintiffs research effort, but only tools to be
used along the way while searching for a
practical utility. Plaintiffs claimed ESTs may add
a noteworthy contribution to biotechnology
research, but their utility is not sufficient to be
eligible for patent because Plaintiff does not
identify the function for the underlying proteinencoding
genes.
Without
sufficient
identification, the claimed ESTs do not deserve a
patent as they have not been researched and
understood to the point of providing an
immediate, well-defined, real world benefit to
the public. Plaintiffs claimed uses are not
sufficient to meet the standard for a
"substantial" utility under 101. The claimed
inventions also lack enablement under 112.
In the dissent of Justice Rader, he said that the
invention here, ESTs, has a utility as a research
tool to isolate and study other molecules. While
the ESTs are only useful in a research context,

they are still useful and patentable. The Court

determines the utility would not produce enough
valuable information, but the existence of any
information shows a utility. The ESTs are similar
to a microscope as they are a tool to enable a
researcher to move one step closer to a
discovery. The Patent Office is in a difficult
position because they have to distinguish
between an incremental tool appropriate for
patent protection and a tool that fails to provide
enough
advancement
to
justify
patent
protection. The Patent Office must do this
without the benefit of an obviousness
requirement for genomic inventions.
The
current law, however, includes research tools
that provide a recognizable benefit and the ESTs
have "utility" under 101.
Even though a research tool may not provide
immediate benefit to the public at large, Judge
Radar points out, and other scholars agree, that
the incremental benefit offered to researchers
should count as utility that deserves patent
protection. As it stands, the utility benefit is
narrowly applied.