The US Court of Appeals for the Federal Circuit issued a decision regarding the utility requirement for patents of expressed sequence tags (ESTs). The court affirmed the Patent and Trademark Office's rejection of a patent application for ESTs from corn plants. The majority found that the ESTs lacked a specific, substantial utility as required, as the application disclosed no information about the corresponding genes' structure or function. The court determined the disclosed potential uses for the ESTs, such as gene markers, were too generic and did not demonstrate real-world utility for the particular claimed ESTs. The decision confirmed that the utility standard under US patent law requires disclosure of a specific, practical benefit to satisfy the usefulness requirement.

1. By Lawrence T. Kass
and Michael N. Nitabach
SPECIAL TO THE NATIONAL LAW JOURNAL
IN A WIDELY followed appeal with extensive
amici briefing, the U.S. Court of Appeals
for the Federal Circuit recently issued In re
Fisher, 2005 WL 2139421 (Fed. Cir. Sept.
7, 2005), a decision of importance to
patent law and biotechnology. A panel
majority of the Federal Circuit concluded
that the “utility” standard, which requires
a patented invention to be useful, presents
a higher hurdle than many had supposed,
and that certain expressed sequence tags
(ESTs)—genetic fragments commonly
used as probes—do not meet that standard.
The case arises from a patent
application for ESTs filed by Dane K.
Fisher and others and owned by
Monsanto Co. The U.S. Patent and
Trademark Office (PTO) rejected the
patent claims for lack of utility, and
Fisher appealed. The Federal Circuit
affirmed on Sept. 7, holding that the
rejection was supported by substantial
evidence. In doing so, the panel
majority resolved issues that have been
percolating for years.
The utility requirement is embodied in 35 U.S.C.
101, which provides: “Whoever invents...any new
and useful...composition of matter...may obtain a
patent therefor.” In 1817, Justice Joseph Story
suggested that the requirement was
met so long as the claimed subject
matter was not “frivolous, or injurious
to the well-being, good policy, or good morals of
society.” Lowell v. Lewis, 15 F. Cas. 1018 (C.C. Mass.
1817). But in 1966, the U.S. Supreme Court
in Brenner v. Manson suggested another, higher
standard, requiring a “substantial utility...where
specific benefit exists in currently available form.”
383 U.S. 519, 534-35 (1966).
Following Brenner, the Federal Circuit required
a substantial or practical utility to
be disclosed if not readily apparent.
In re Ziegler, 992 F.2d 1197 (Fed.
Cir. 1993). But the court still did not characterize
utility as a significant hurdle, suggesting it would be
overcome unless the claimed matter were “totally
incapable of achieving a useful result.” Brooktree
Corp. v. Advanced Micro Devices Inc., 977 F.2d
1555, 1571 (Fed. Cir. 1992). Various entities relied
on a minimalist view to support attempts to patent
genetic data, particularly when genetic sequencing
became practical in the 1990s. For example, the
National Institutes of Health (NIH) and
others filed applications for uncharacterized
ESTs. NIH later abandoned its EST
applications and ultimately argued against
EST patentability, but other entities
continued to seek patents.
The relevant technology involves the
study of genes and related cellular processes.
Genes are segments of chromosomal
deoxyribonucleic acid (DNA) which are
typically “expressed” by “transcription” of
DNA into messenger ribonucleic acid
(mRNA), and “translation” of mRNA into
proteins. The diverse mRNAs in cells can
be purified and reverse-transcribed into
complementary DNA (cDNA) molecules
that correspond to genes expressed at the
time of sampling. The cDNAs in turn can
be partially sequenced to provide ESTs.
Accordingly, each EST represents a cDNA
fragment sequence. Scientists can synthesize
DNA molecules that have the EST
sequence and thus bind to corresponding
mRNAs. When labeled, these molecules
serve as tools for detecting the mRNAs and
the expression of corresponding genes.
An EST itself often provides insight into
the nature and function of the corresponding
gene and/or protein. Sometimes, however, the EST
is uninformative beyond indicating that some
gene is expressed. Fisher raised the question of
whether a patent application claiming an EST
satisfies the utility requirement in the absence of
any information about the nature or function of
the corresponding gene or protein.
Partially in response to public debate about
such applications, the PTO issued guidelines to
assess the utility and “written description”
patentability requirements. 66 Fed. Reg. 1092 (Jan.
5, 2001) (utility); 66 Fed. Reg. 1099 (Jan. 5, 2001)
(written description). The PTO also issued training
materials with biotechnology-specific examples.
According to the guidelines, an examiner should
not reject an invention if it has a well-established
utility or if the application discloses a specific and
Lawrence T. Kass is an associate and patent
attorney at Milbank, Tweed, Hadley & McCloy
in New York. Michael N. Nitabach is assistant
professor of molecular physiology at Yale Universi-
ty and a patent attorney.
Federal Circuit rules that some expressed sequence tags are not patentable.
Utility must be specific, practical
INTELLECTUAL PROPERTY
IN FOCUS monday, october 17, 2005
PAULFISCH
PATENT

2. substantial utility. The PTO suggested in Example
9 of its training materials that cDNA fragments in
isolation do not meet this standard.
Adoption of PTO guidelines
The following year, the Federal Circuit adopted
the PTO’s written-description guidelines after
having initially rejected them. Enzo Biochem v.
Gen-Probe, 296 F.3d 1316 (Fed. Cir. 2002). The
court’s deference to these guidelines was considered
significant. See Lawrence T. Kass and Michael N.
Nitabach, “Federal Circuit reconsiders ruling in
‘Enzo Biochem,’ ” NLJ, Oct. 14, 2002, at C13. But
it was not until Fisher that the court had occasion
to assess the utility guidelines.
In his patent application, Fisher claimed five
ESTs derived from corn leaf
cells during anthesis, i.e., pollen
shedding. He disclosed nothing
about the structure or function
of the corresponding genes, what
proteins they encoded or even
whether they served some function
specific to anthesis. He disclosed
only six generic uses for the ESTs,
e.g., as markers for gene expression
or to measure mRNA levels in a sample.
The examiner found that the disclosed uses were
not specific to the claimed ESTs, but rather were
generally applicable to any EST. The examiner also
considered the uses insubstantial, reasoning that if
a scientist found one of the claimed sequences
in a sample, he would not know how to use the
information. The examiner therefore rejected
the claimed ESTs for lack of utility under
§ 101. Fisher appealed to the PTO Board of Patent
Appeals and Interferences, which affirmed the
examiner’s rejections. Fisher then appealed
the board’s decision to the Federal Circuit.
Represented by former Solicitor General Seth
Waxman and others, Fisher emphasized Story’s
minimalist view of the utility requirement. Fisher
contended that, even after Brenner, the utility
threshold is not high and is met unless the invention
is totally incapable of achieving a useful result, as
the Federal Circuit observed in Brooktree. Fisher
argued that the claimed ESTs have specific benefits
because they can be used, for example, as markers for
specific, functional genes or to measure the level of
specific mRNAs in a sample. These benefits are
substantial because gene markers assist scientists to
navigate through complex genetic maps and mRNA
measurements provide information pertinent to
detecting changes in gene expression. Fisher also
asserted that commercial success with ESTs further
demonstrates their usefulness.
The government agreed that the utility
threshold is not high, but urged that an applicant
must disclose at least one specific and substantial
utility pursuant to Brenner, as articulated in the
PTO’s guidelines. The government further noted
that Fisher’s evidence of commercial success
involved only EST databases, clone sets and
microarrays, not the five individually claimed ESTs.
Specific, substantial utility
Citing case law, the PTO utility guidelines and
Example 9 of the training materials, a panel majority
of the Federal Circuit affirmed the board’s decision.
The majority observed that Brenner apparently
rejected Story’s de minimis view of utility and
imposed a more rigorous test, requiring a substantial,
specific benefit. The majority explained that
courts have since used the term “substantial”
interchangeably with “practical”
and “real world” to mean a claimed
discovery must provide some signif-
icant, current benefit to the public,
not one that may later prove useful
after further research. It further
stated that a “specific” utility is
not so vague as to be meaningless,
but rather is a well-defined and
particular benefit to the public.
The utility guidelines require a specific utility
that is particular to the claimed subject matter, the
majority observed, and a substantial utility that
defines a real-world use. The guidelines caution
against focusing on whether an invention is a
research tool, and instead focus on whether the
invention has a specifically identified substantial
utility that does not require further research to
identify or confirm. The majority concluded that
the guidelines comport with its own interpretation
of the utility requirement. It further noted that
Example 9 of the training materials applies to
the facts in Fisher.
The majority was not persuaded by Fisher’s
argument that the ESTs could be used as gene
markers or to measure the mRNA level in a sample.
Those uses are nonspecific, the majority found,
because Fisher disclosed nothing to distinguish
the five claimed ESTs from the more than 32,000
disclosed in the application. The majority found the
uses insubstantial because they represent mere
hypothetical possibilities that any EST might achieve,
but which the claimed ESTs have not achieved in
the real world. The majority distinguished the claimed
ESTs from research tools like microscopes that provide
immediate, real-world benefits of revealing structure.
The majority also dismissed Fisher’s reliance on
the general commercial success of EST databases
because there was no evidence of commercial
interest in the five claimed ESTs.
The majority analogized the facts to those in
Brenner, where a process for preparing compounds
of unknown use was found to lack utility. The
majority considered the facts even more analogous to
those of In re Kirk, 376 F.2d 936, 941 (C.C.P.A.
1967), where a nebulous assertion that claimed
compounds had “biological activity” and “biological
properties” was deemed nonspecific. The majority
found that here the claimed ESTs similarly lack
utility because they can only be used as research
intermediates in probing genes of unknown function.
Quoting the Supreme Court’s admonishment
in Brenner that a patent is not a “hunting
license,” and emphasizing that these standards
apply with equal force in any scientific discipline,
the majority affirmed the board’s rulings.
Judge Randall Rader dissented, asserting that the
claimed ESTs have utility, at least as research tools
in isolating and studying other molecules. Unlike
the compounds in Brenner and Kirk, Rader reasoned,
the claimed ESTs benefit society. For example, they
help scientists to isolate genes or confirm they are
being expressed at a particular time. Rader found
ESTs analogous to microscopes, which can help
identify cancer even though scientists still do not
fully understand why cancer grows. Although
further research is required, microscopes still have
utility because they take scientists one step closer
to answering such questions.
Fisher will likely seal the fate of many
now-pending EST patent applications and raise
questions about the patentability of other discoveries
that arguably lack specific, substantial utility.
Combined with Rader’s concerns, this may portend
some controversy. But while Fisher may have raised
the bar on utility and is therefore significant, the
decision should not jeopardize the patentability
of many research tools. Even a single EST may
be found to have utility as a probe if coupled with
disclosure of information about the corresponding
gene or protein. Similarly, a library of ESTs
may be found to have utility for determining
the genes expressed in a cell at a particular
time. The outcome of any particular case, of course,
will be fact-dependent.
Fisher has potentially broad implications
because the majority emphasized that the standards
for utility are not limited to biotechnology. Fisher is
also significant for its deference to the PTO utility
guidelines, which likely will now carry even greater
weight. Practitioners should carefully consider
Fisher and the guidelines in proceedings before the
PTO and courts.
THE NATIONAL LAW JOURNAL MONDAY, OCTOBER 17, 2005
Invention must
offer significant,
current benefit
to the public.
NLJ
This article is reprinted with permission from the
October 17, 2005 edition of THE NATIONAL LAW
JOURNAL. © 2005 ALM Properties, Inc. All rights
reserved. Further duplication without permission is
prohibited. For information, contact ALM Reprint
Department at 800-888-8300 x6111. #005-10-05-0018