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Have you ever sequenced a gene
and wondered what legal rights you can claim? In December of 1999, the
U.S. Patent and Trademark Office issued revised guidelines for examination
of the utility and written description requirements under the U.S. Patent
Law. The new guidelines are designed to apply to all technologies, although
the utility guidelines were revised primarily to address the patentability
of expressed sequence tags (ESTs). The revised guidelines are used by
patent examiners in the examination of patent applications for compliance
with the utility and written description requirements.
This is the first part of a series
covering the legal background and development of the Utility Requirements
under 35 U.S.C. §101 and the Written Description Requirements under the
first paragraph of 35 U.S.C. §112.
Editor's Note: Readers with little or no experience with the patent process
and language may want to consult the following websites for a more information
on the subject:
General Primers:
US
Patent and Trademark Office Introduction to Patents
General historical
and legislative context
Go to the Source:
Official documents and publications you might want to reference
More Biotech Law Content:
A resource for a wide range of links and articles on biotech law and patenting
This first installment
of this series describes the process by which a patent examiner determines
compliance with the Written Description Requirements for a patent
covering nucleic acid sequences in light of the revised guidelines.
We close with how these guidelines apply to biological material.
In Brief:
I.
How patents are examined. The three step process:
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Step 1
What is the scope of the claim?
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Step 2
What is the correspondence between what the applicant
has shown, or is in possession of, and what is claimed?
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Step 3
Is there sufficient detail in the description to indicate that the
applicant was in possession of the claimed invention?
i.
Defining a species.
ii.
Defining a genus.
iii.
A representative number.
II.
Consideration of biological materials.
I. How Patents
are Examined
The Written Description Guidelines
set out a methodology for patent examiners to determine the adequacy of
the written description. The role of the patent examiner is both constructive
and adversarial. Their goal is to present evidence or reasons why a person
skilled in the art would not recognize that the written description of
the invention provides support for the claims. There is a strong presumption
that an adequate written description of the claimed subject matter is
present in the specification as filed. During the examination process,
claims may be newly added or amended. However with respect to newly added
or amended claims, the applicant should show support in the original disclosure
of the additional claims.
Fulfillment of the written description
guidelines has come to be known as the "possession test". An
applicant proves "possession" by describing the claimed invention
in such detail as to enable one skilled in the art to practice the invention.
There is a specific process described in the Written Description Guidelines
for evaluating these claims. Of course, whether the description requirement
is met is a question of fact that must be determined on a case-by-case
basis. The methodology required by the Written Description Guidelines
includes the following steps:
Step 1 For
each claim, determine what the claim as a whole covers.
Step 2 Review the entire application
to understand what applicant has described as the essential features of
the invention.
Step 3 Determine whether there
is sufficient written description to inform a skilled artisan that applicant
was in possession of the claimed invention as a whole at the time the
application was filed.
Step 1
The Written Description Guidelines
instruct the examiner to analyze each claim separately and give the
claims their broadest reasonable construction consistent with the written
description. The claims as a whole, including limitations found in the
preamble, transition phrase and the body of the claim, must be sufficiently
described in the specification. The examiner must ensure that the claim
recites sufficient structure, acts or functions to make clear the scope
and meaning of the claim. Well-established terms, details or procedures
need not be included in the specification to satisfy the written description
requirement. Limitations may not be read into the claims from the specification,
however. The scope of the claims will determine the level of detail
in the written description required to support them (see genuses and
species in Step 3).
Step 2
The Written Description Guidelines
require that the examiner first must review the entire specification,
including drawings and sequence listings, to understand what applicant
has identified as the essential distinguishing characteristics of the
invention. The analysis requires that the examiner determine the correspondence
between what the applicant has described as the essential identifying
characteristics features of the invention, i.e., what the applicant
has demonstrated possession of, and what is claimed.
The Written Description Guidelines
state that there is an inverse correlation between the level of skill
and knowledge in the art and the specificity of the disclosure necessary
to satisfy the written description requirement. This issue becomes important
when a claim to a nucleic acid defines a composition by function rather
than structure. There must be a well-established correlation between
the structure and the function in the art or in the specification, thereby
permitting one skilled in the art to reasonably predict the structure
based on its function. In cases where such predictability exists, the
description of a nucleic acid sequence may be satisfied by disclosure
of its function alone. In the absence of a correlation between predicted
structure and function, however, the written description requirement
will only be satisfied by disclosing the actual structure., i.e., the
sequence.
Step 3
This step requires the critical
analysis of whether the applicant has possession of the claimed invention.
It is essential for there to be correspondence between the language
of the claims and the specification. The correspondence does not have
to be literal, but must be commensurate in scope. For example, if a
claim covers a genus of biological materials, then the specification
must describe a sufficient number of species within the genus to convey
with reasonable clarity to those skilled in the art that the inventor
was in possession of the entire genus at the time the patent application
was filed, or must provide guidance to permit those skilled in t he
art to understand what is covered by the claims.
The Written Description Guidelines
set forth a series of inquiries, the answers to which form the basis
for the analysis as to whether the claims comply with the written description
requirement. The Written Description Guidelines require application
of different sets of inquiries to claims which define a species or a
specific embodiment and those which define a genus. There is no numerical
value or hard and fast rule to determine the level of specificity that
will suffice.
3i. Defining a species
For each species claim, the examiner applies the following analysis:
(a) determine whether the application describes
an actual reduction to practice of the claimed invention.
(b) if the application does not describes
an actual reduction to practice, determine whether the invention
is complete as evidenced by a reduction to drawings (including sequence
listings).
(c) if the application does not describe
an actual reduction to practice or reduction to drawings, determine
whether the invention has been described in a written description
in terms of distinguishing identifying characteristics that are
sufficiently detailed to prove that applicant was in possession
of the claimed invention.
The analysis under (a) and
(b) is fairly straightforward. The Written Description Guidelines
set out detailed instructions for the analysis under (c). These include
analyzing whether the application as filed describes the complete
structure (or steps of a process) as a whole in such clear, concise
and exact terms so as to show possession of the claimed invention.
If a complete structure is disclosed, the written description is satisfied.
If the application does not disclose the complete structure (e.g.,
a nucleotide sequence is claimed but the sequence itself is not disclosed),
then the examiner must determine whether the specification discloses
other relevant characteristics (such as physical or chemical characteristics)
sufficient to show possession.
The Written Description Guidelines
emphasize that for emerging and unpredictable technologies (such as
biotechnology) a higher degree of evidence is required to show possession.
The example provided in the Written Description Guidelines is that
for unpredictable technologies, a method of making the invention and
its function (for example, a method of isolating a gene and its function)
is not sufficient to support a product claim other than a product-by-process
claim. Furthermore, disclosure of a partial structure without additional
characterization of the product may not be sufficient to show possession.
3ii. Defining a genus
For genus claims, the written description requirement may be satisfied
through a sufficient description of a representative number of species
by:
(a) actual reduction to practice
(b) reduction to drawings, or
(c) disclosure of relevant identifying
characteristics, e.g., structure or other physical/chemical properties,
by functional characteristics coupled with a known or disclosed
correlation between function and structure, or by a combination
of these sufficient to show possession of the claimed genus.
3iii. "A representative number..."
The Written Description Guidelines define a "representative
number of species" as sufficient species to be representative
of the entire genus. Thus, where there is substantial variation within
a genus, a sufficient variety of the species must be described so
as to reflect the variation within the genus. A "representative
number" depends on whether one skilled in the art would recognize
that the applicant was in possession of the necessary common attributes
or features of the elements possessed by the genus in view of the
species disclosed. In unpredictable arts, disclosure of a single species
will not provide sufficient support for a claim to the genus. There
is no magic number for a "representative number" of species.
The Written Description Guidelines state that what constitutes a "representative
number" is an inverse function of the predictability of the art.
The number must be sufficient to reasonably identify the other (non-disclosed)
members of the genus.
The Written Description Guidelines
attempt to clarify what level of support is required to show possession
of a claimed invention. The Federal Circuit has not yet enunciated a clear
test to determine when an applicant is in possession of an invention.
The Written Description Guidelines were formulated based on the Federal
Circuit court’s decisions in the cases which have specifically addressed
written description, some of which were discussed above.
II. Applicability to
biological patents
For biotechnology inventions, especially
those based on nucleic acid sequences, actual reduction to practice (i.e.,
the disclosure of the sequence) clearly complies with the written description
requirement for a claim to that sequence. Actual reduction to practice
of a biological material also may be supported by a biological deposit,
although a deposit is not a substitute for written description of the
claimed invention. However, there is no per se requirement that
the invention be actually reduced to practice. Identifying characteristics
can be used to show possession of a biological invention. Such characteristics
include amino acid or nucleic acid sequences, structure, binding affinity,
binding specificity, molecular weight and length, detailed restriction
maps, unique cleavage patterns by specific enzymes, isoelectric points
of fragments, a comparison of enzymatic activities, or antibody cross-reactivity.
It is unlikely that a biological sequence described only by a functional
characteristic without any known correlation between the function and
structure would meet the written description requirement.
Genes vs. ESTs vs. regulatory elements
The Written Description Guidelines
maintain the view that use of the word "gene" in the preamble
of an open-ended claim that covers only a coding sequence or an EST may
require elements that are not supported by the specification, e.g., promoters,
regulatory elements or untranslated regions. Such a claim probably will
not pass muster under the Written Description Guidelines unless the specification
contains specific support for the entire gene, including these elements.
However, a claim which recites a "DNA sequence" rather than
a "gene" would meet the written description requirements where
only the partial sequence or EST is disclosed in the specification. Although
such a claim may be permissible under the Written Description Guidelines,
it may not comply with the enablement requirements under 35 U.S.C. §112
¶1, which are not discussed herein, or the utility requirements under
35 U.S.C. §101, which are discussed in the third installment.
Back To Top
The next installment will cover
the biotech legal case history that lead to the establishment of the revised
1999 guidelines. The last installment will provide an overview of utility
requirements in the context of biotechnology patents.
General Comments or Questions about
the Industry Focus should be sent to: kim@thebiotechclub.org
Copyright 2000 Paula Campbell Evans. All Rights
Reserved. |
