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March 23, 2001
TRENDSPOTTER: What the PTO Means by
"Utility"
Written By: Rochelle K. Seide with Michelle LeCointe
COMPARED TO most sections of the Patent Act, Section 101 seems simple:
“Whoever invents or discovers any new and useful process, machine,
manufacture, or composition of matter, or any new and useful
improvement thereof, may obtain a patent therefore, subject to the
conditions and requirements of this title.” But its simplicity belies
some of the most controversial issues in patent law today,
particularly in regard to patenting polynucleotide and
polypeptide/protein inventions.
Section 101 has been cited as a bar to the patentability of such
diverse inventions as computer programs and transgenic bacteria. More
recently, its applicability to the field of genomics has come into the
spotlight. Modern research capabilities have forced the Patent Office
to re-examine
the law as set forth by Congress and applied by the courts to
determine what constitutes a “useful” invention. Its conclusions form
the Utility Examination Guidelines issued by the PTO on January 5,
2001 (http://www.uspto.gov/web/offices/com/sol/notices/utilexmguide.pdf
).
The utility guidelines impose three requirements: a “useful” invention
must have a specific, substantial and credible utility. The PTO has
derived these requirements from cases such as Brenner v. Manson and In
re Ziegler . But the guidelines are based upon a restrictive reading
of
these cases and seem to conflict with the spirit of other cases, such
as Juicy Whip v. Orange Bang, which generally hold that to violate the
utility requirement, an invention must be “totally incapable of
achieving a useful result.” Thus, the fate of these guidelines if they
are challenged in court is
uncertain. Regardless of the legal standing of the utility guidelines,
however, genomics researchers should consider them when filing a
patent application or prosecuting pending applications.
To satisfy the specificity requirement, the invention must have a
utility specific for the claimed invention. A general utility for
inventions of that class, such as generic use “as a probe” will not
suffice. Recitation of such a specific utility may also be necessary
to fulfill the “how to use
requirement.”
An invention must also have a substantial use, i.e. , one that is
feasible in the real world. This requirement excludes utilities such
as the use of a transgenic mouse as snake food. Precisely what
constitutes a substantial utility is unclear, but arguments may be
presented in support of any use
that is not infeasible or irrational.
Finally, an invention must have a credible use. This means that one of
skill in the art would accept that the invention is currently
available for that use. Satisfaction of this requirement may be shown
through information not contained in the application, such as test
data and publications, and such materials will often be required for a
convincing argument.
These requirements have various implications for different types of
genomics inventions. For expressed sequence tags (ESTs) and other
partial sequences, patentability is severely hampered or may even be
precluded. The Patent Office comments published along with the
guidelines and the guidelines themselves make clear that such partial
sequences will fail the utility requirement unless a rather detailed
utility is alleged. For instance, generic use as a probe will not
constitute an
adequate utility. However, their use as a probe for a specific
disease, chromosomal location, or for a specific and narrowly defined
type of gene or protein will likely be sufficient.
Inventions comprising entire open reading frames (ORFs) fare better. A
use for ORFs that encode for proteins of known function can almost
always be established based upon the function of the protein. An ORF
encoding a protein of an unknown function may satisfy the utility
requirements if it has sufficient sequence homology to known proteins
for a particular function to be likely. The Patent Office specifically
approved of comparisons through sequence homology in its comments on
the
guidelines. However, unique ORFs with too little homology to establish
a likely protein function may fail the utility requirement. As in the
case of ESTs, use as a probe for a protein or gene of unknown function
is not a sufficient utility.
The utility guidelines are not favorable to many early-stage genomics
inventions, but several steps can be taken to prevent or overcome
rejections under the guidelines. First, each DNA molecule
claimed should be tied to some function. Homology searches will often
turn up a hypothetical protein function or a type of protein or gene
for which the sequence may be used as a probe. The function does not
have to be the most useful function for the DNA molecule or even one
that
eventually works in practice. It need only be a function specific for
the molecule that would be deemed plausible by one skilled in the art
and that might have some real world value.
Second, if a specific, substantial and credible utility may not be
apparent to the patent examiner, spell one out in the application. Be
certain to point out that other utilities may exist, but include at
least one utility. This will help prevent the hassle of trying to
establish the utility later after receiving a rejection from the
examiner.
Third, keep in mind that the examiner must provide a well-reasoned
explanation for any rejection based upon lack of utility. This
explanation is preferably also supported by evidence. If such an
explanation is not provided with a rejection for lack of utility,
remind the examiner of the
requirement. If the explanation is scientifically or logically flawed,
explain the errors and include documentation if possible.
Though the utility guidelines may make it more difficult to obtain
patents for some genomics inventions, the guidelines do not prevent
patentability of all such inventions. In some cases, the guidelines
may even serve as a tool to prevent examiners from raising the utility
bar too high or
failing to provide adequate explanations for their rejections.
Rochelle K. Seide is a partner at the law firm of Baker Botts, where
she specializes in biotechnology, intellectual property, and patent
issues. She also has a PhD in human genetics. Michelle LeCointe is an
associate at Baker Botts and a registered patent agent. They can be
reached at rochelle.seide@bakerbotts.com and michelle.lecointe@bakerbotts.com
.
TrendSpotter is a weekly column that focuses on how trends in
politics, patent law, and the US and European markets will affect the
genomics industry. The column appears every Friday. Next week Ira
Leiderman, managing director of the Palladin Group, will write about
current market trends.
To access previous columns just enter the word "Trendspotter" in the
archive search window on the homepage.
Copyright © 2001 GenomeWeb LLC. All Rights Reserved.
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