Transcript Breaking Unity

Unity of Invention:
Biotech Examples
U.S. Patent and Trademark Office
Technology Center 1600
Michael P. Woodward
[email protected]
PATENT COOPERATION TREATY (PCT) INTERNATIONAL SEARCH AND
PRELIMINARY EXAMINATION GUIDELINES
Guidelines for the Processing by International Searching and Preliminary
Examining Authorities of International Applications Under the Patent Cooperation
Treaty as in force as from March 25, 2004.
Applies to all international applications filed on or after Jan. 1, 2004.
Available at http://www.wipo.int/pct/en/texts/pdf/ispe.pdf
PCT Rule 13.2 (10.01)*
With respect to a group of inventions claimed in an international
application, unity of invention exists only when there is a
technical relationship among the claimed inventions involving one
or more of the same or corresponding special technical features.
The expression “special technical features” is defined in PCT Rule
13.2 as meaning those technical features that define a contribution
which each of the inventions, considered as a whole, makes over
the prior art.
* (10.01) refers to chapter 10, paragraph 1 of the ISPE Guidelines
PCT Rule 13.2 requires that the
(1) group shares a technical feature and
(2) the technical feature makes a contribution over
the prior art.
Lack of unity may be evident
• a priori, before consideration of prior art,
because the groups do not share a same or
corresponding technical feature
• a posteriori, after a search of the prior art,
because the shared technical feature fails to
make a contribution over the prior art
Additional Considerations
• Contribution over the prior art is considered with
respect to novelty and inventive step (10.02)
• Unity of invention is considered in relation to the
independent claims (10.06)
Three Particular Situations
• Different categories of inventions (10.12)
• So-called “Markush Practice” (10.17)
• Intermediate and final products (10.18)
Markush Practice
All alternatives are of similar nature when they
(A) have a common property or activity and
(B1) have a common structure, that is, a significant
structural element or
(B2) belong to a recognized class of chemical
compounds.
Common structure is defined as one which
Occupies a large portion of the structure
or
Occupies a small portion which makes a
contribution over the prior art
Recognized class of chemical compounds
• Expectation from the knowledge in the art that
members of the class will behave in the same way,
that is, each member could be substituted one for
another with the expectation that the same result
would be achieved.
• Note that PCT Rule 13.2 also requires that the
shared feature must make a contribution over the
prior art.
Example 32: Multiple Structurally and Functionally
Unrelated Polynucleotides (10.52)
Claim 1. An isolated polynucleotide selected from the group
consisting of nucleotide sequences SEQ ID Nos: 1-10.
• SEQ ID Nos 1-10 are 500 bp cDNAs obtained from
human liver. The sequences are not homologous to each
other. They can be used as probes to obtain full-length
DNAs, although there is no description of the function or
biological activity of the corresponding proteins.
There is no prior art available. A human liver cDNA library
had not been established before.
Example 32, continued, analysis
The polynucleotides would have unity of invention if they had a common
property or activity and shared a significant structural element.
• The polynucleotides fail to share a common property or activity. A
probe of SEQ ID NO 1 could not be used to isolate SEQ ID Nos 2-10.
• The polynucleotides fail to share a significant structural element. The
sugar phosphate backbone of a nucleic acid chain is not considered to
be a significant structural element since it is shared by all nucleic acid
molecules. No other regions of homology are described.
• Isolation of the polynucleotides from a single source (human liver) is
not sufficient to meet criteria for unity of invention.
Inventions could be grouped as:
Inventions 1-10: Polynucleotides having SEQ ID Nos 1-10, respectively.
Example 33: Multiple Structurally and Functionally
Related Polynucleotides (10.53)
Claim 1. An isolated polynucleotide selected from the
group consisting of nucleotide sequences SEQ ID
Nos: 1-10.
Example 33: Multiple Structurally and Functionally
Related Polynucleotides (10.53)
• SEQ ID Nos: 1-10 share a significant structural
element and their corresponding mRNAs are
expressed only in hepatocytes of patients with
disease Y.
Example 33: Multiple Structurally and Functionally
Related Polynucleotides (10.53)
There is no prior art available. The shared structural
element had not been identified before, nor had any link
been established between genes expressing mRNA
containing that structural element and patients afflicted
with disease Y.
Example 33, continued, analysis
The polynucleotides would have unity of invention if they
shared
(1) a common property or activity,
(2) a significant structural element and
(3) a technical feature which made a contribution over the
prior art.
.
Example 33, continued, analysis
•
•
•
SEQ ID Nos 1-10 share a common property:
expression of an mRNA present only in patients
afflicted with disease Y.
SEQ ID Nos 1-10 share a significant structural
element which may be used as the probe to detect
mRNA of patients afflicted with disease Y.
There is no prior art found on the shared structural
element.
Example 33, continued, analysis
Therefore, SEQ ID Nos 1-10 meet the
requirement for unity of invention.
Example 36: Multiple nucleic acid molecules which
share a common structure and encode proteins with
common property (10.56)
Claim 1. An isolated nucleic acid selected
from SEQ ID No 1, 2 or 3.
• The three nucleic acids encode
dehydrogenases that include a conserved
sequence motif defining the catalytic site
and the dehydrogenase function of these
proteins.
Example 36: Multiple nucleic acid molecules which
share a common structure and encode proteins with
common property (10.56)
The three nucleic acids, isolated from
mouse, rat and human, are homologous
based upon their overall sequence
similarity (85-95%) at both the
nucleotide and amino acid sequence
levels.
Example 36: Multiple nucleic acid molecules which
share a common structure and encode proteins with
common property (10.56)
The prior art describes a nucleic acid
from monkeys which is 90% similar
and includes the catalytic site defined
by the conserved motif.
Example 36, continued, analysis
The nucleic acid molecules would have unity of
invention if they shared a common property or
activity and shared a significant structural
element.
Rule 13.2 requires that the technical feature
shared among the inventions defines a
contribution over the prior art.
Example 36, continued, analysis
• SEQ ID Nos 1-3 share a common
property of encoding
dehydrogenases.
• SEQ ID Nos 1-3 share a
significant structural element, the
conserved motif.
Example 36, continued, analysis
.
If no prior art were found, unity of
invention would have been accepted.
Example 38. Method of screening and compounds
identified by the method. (10.58)
Claim 1. A method to identify compounds that are
antagonists of receptor R, comprising the steps of…
Claim 2. Compound X, having formula 1.
Claim 3. Compound Y, having formula 2.
Claim 4. Compound Z, having formula 3.
Example 38. Method of screening and compounds
identified by the method. (10.58)
• Compounds X, Y and Z all act as receptor
R antagonists.
• Compounds X, Y and Z fail to share any
significant structural element.
Example 38. Method of screening and compounds
identified by the method. (10.58)
The method steps of Claim 1 involve observing
any change in the binding of R’s natural ligand
in the presence of a candidate molecule.
Receptor R, its biological function and its natural
ligand are known in the prior art. No compounds
which function as antagonists of receptor R are
known.
Example 38, continued, analysis
A product can have unity of invention with a method of
making or method of using the product. See Categories
of Invention, 10.12
• A screening method is not a method of making or using
the product.
• There is no single general concept that links the method
to the claimed compounds.
Example 38, continued, analysis
The antagonists would have unity of invention
with each other, a priori, if they shared a
common property or activity and shared a
significant structural element.
Although the antagonists share a common
property, they fail to share a common structure.
Example 38, continued, analysis
For these two reasons, unity is lacking
between method and products and among
the products.
Example 38, continued, possible
groupings
Group 1, claim 1, method to identify
compounds.
Group 2, claim 2, compound X.
Group 3, claim 3, compound Y.
Group 4, claim 4, compound Z.
Three other examples of interest
• Example 34: Functionally unrelated single
nucleotide polymorphisms (SNPs) (10.54)
• Example 35: Molecules which share a common
function not linked to a common structure (10.55)
• Example 37: DNA encoding Receptors with
partial structural identity and asserted common
property (10.57)
Summary
Unity of Invention is accepted when
• the group shares a technical feature- this
may be determined a priori, before
consideration of prior art
and, if a shared technical feature exists,
• the technical feature makes a contribution
over the prior art- this may be determined a
posteriori, after a search of the prior art.