Unity of Invention: Biotech Examples

1
Unity of Invention Biotech Examples

• TC1600 Special Program Examiner
• Julie Burke
• [phone]

2
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

3
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

4

• PCT Rule 13.2 requires that the
• group shares a technical feature and
• (2) the technical feature makes a contribution
  over the prior art.

5
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

6
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)

7
Three Particular Situations

• Different categories of inventions (10.12)
• So-called Markush Practice (10.17)
• Intermediate and final products (10.18)

8
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.

9
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

10
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.

11
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.

12
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.

13
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.

14
Example 33, continued, analysis

• The polynucleotides would have unity of invention
  if they shared
• a common property or activity,
• a significant structural element and
• 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.

15
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.

16
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.

17
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 Rs 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.

18
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.

19
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.

20
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.

21
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.

22
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.

23
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)

24
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.