Download Unity of Invention: Biotech Examples

Unity of Invention:
Biotech Examples
TC1600 Special Program Examiner
Julie Burke
(571)272-0512
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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
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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
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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.
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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
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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)
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Three Particular Situations
• Different categories of inventions (10.12)
• So-called “Markush Practice” (10.17)
• Intermediate and final products (10.18)
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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.
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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
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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.
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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.
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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.
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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.
• SEQ ID Nos: 1-10 share a significant structural element and
their corresponding mRNAs are expressed only in
hepatocytes of patients with disease Y.
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.
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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.
•
•
•
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.
Therefore, SEQ ID Nos 1-10 meet the requirement for unity of invention.
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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.
• 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.
The prior art describes a nucleic acid from monkeys which is 90% similar
and includes the catalytic site defined by the conserved motif.
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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.
• 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.
However, a nucleic acid molecule which encodes a dehydrogenase with this
conserved motif has already been isolated. Unity of invention is
lacking, a posteriori.
If no prior art were found, unity of invention would have been accepted.
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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.
• Compounds X, Y and Z all act as receptor R antagonists.
• Compounds X, Y and Z fail to share any significant structural element.
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.
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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.
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.
For these two reasons, unity is lacking between method and
products and among the products.
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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.
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Example 39: Protein and its Encoding DNA (10.59)
Claim 1. Isolated protein X having SEQ ID No: 1.
Claim 2. Isolated DNA molecule encoding protein X of claim
1.
• Protein X is defined by a specific structure, SEQ ID No 1.
• The disclosure sets forth a DNA molecule having SEQ ID
No 2 which encodes SEQ ID No 1.
There is no prior art.
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Example 39, continued, analysis
Rule 13.2 requires that the inventions share a same or corresponding
technical feature and that the technical feature shared between the
inventions defines a contribution over the prior art.
• Because the DNA molecule encodes the protein X, the DNA and
protein shared a corresponding technical feature and have unity, a
priori.
• Because there is not prior art on the protein or the DNA, the DNA and
protein share a special technical feature.
If prior art existed teaching either the protein X or DNA encoding protein
X, the corresponding technical feature would not make a contribution
over the prior art and unity would be lacking, a posteriori.
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Example 39, continued, analysis
If alternative DNA claims were presented that encompassed a DNA
molecule that did not encode protein X, the claims would not share the
same or corresponding technical feature. Examples of such claims
follow:
• Isolated DNA molecule encoding protein X or a DNA fragment
thereof.
• Isolated DNA molecule having SEQ ID No 2, or a DNA molecule
which hybridizes to SEQ ID No 2 under stringent conditions.
DNA inventions including these types of claims would lack unity with the
protein group because they would not share a same or corresponding
technical feature.
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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)
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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.
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