Download BACKGROUND OF THE INVENTION

Examination Guidelines for Inventions
in Specific Fields
5
<Biotechnology>
10
15
Korean Intellectual Property Office
1
Prologue
Biotechnological
patents
means
patents
including
inventions relating to biological materials which are directly
5
or indirectly self reproducible, in other words, ‘organisms
*1’ having self reproducibility, ‘genetic information’ and
‘reproduction’.
[Note 1] Here, the term ‘organisms’ means microorganisms,
10
animals and plants, including reproducible animal or plant
cells.
Recently, the number of patent applications in this field
has rapidly increased along with the rapid development of
15
biotechnology
diversified
and
the
into,
range
for
transformed animals, etc.
of
types
example,
of
inventions
monoclonal
has
antibodies,
The existing examination guidelines
for inventions in biotechnology have diverged into ‘inventions
relating
20
to
genetic
microorganisms’,
‘asexually
engineering’,
‘applied
reproducing
‘inventions
microbiological
plant
variants’
in
industries’
the
Guidelines for Inventions in Specific Fields.
thereof
overlap
and
do
technological development.
not
follow
relating
recent
to
and
Examination
The contents
trends
in
Therefore, in order to examine
2
patent applications in this field effectively, the systematic
and consistent ‘Examination Guidelines for Biotechnological
Inventions’ has been established by reinforcing the content of
the examination guidelines for ‘inventions relating to genetic
5
engineering’,
incorporating
‘applied
microbiological
industries’ into ‘inventions relating to microorganisms’ and
newly adding ‘inventions relating to animals’.
Since the biotechnological field deals directly and/or
indirectly
10
with
the
use
of
organisms,
a
third
party
has
difficulty repeatedly carrying out inventions of methods for
producing
or
using
organisms
with
generally described specification.
reference
only
to
the
This is the reason why a
specific ‘Requirements for the Specification Description’ has
been introduced and a separate standard for ‘Deposition and
15
Allocation of Microorganisms, etc.’ has been made in order to
supplement the specification description requirements.
Further, a standard for judging ‘Unpatentable Inventions’
with respect to issues specific to the examination of patent
applications relating to organisms, and a judging standard of
20
requirements for patentability, such as ‘Constitutionality of
Inventions’, ‘Novelty’ and ‘Inventive Step’ are concretely
explained.
However, to understand the patentability of the
inventions in this field applied to medicine, agriculture,
environmental technology, etc., reference should be made to
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‘Inventions
of
Use
of
Mono
3
Compounds’,
‘Inventions
of
Composition’, ‘Medical Technology’, ‘Pesticide’ etc.
Important international patent classes applied in this
examination guideline are as follows:
5
A01H, A01N 63/00-65/00, 67/00,
A01K 67/00 - 67/04
A61K 35/00 - 35/84, 38/00 - 48/00, 51/00
C02F 3/00 - 3/34
10
C07H 21/02 - 21/04,
C07K 2/00 - 16/46, 19/00
C12N, C12P, C12Q
G01N 33/50 - 33/98
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This
examination
‘Inventions
Relating
guideline
to
Genetic
is
categorized
Engineering,’
into
‘Inventions
Relating to Microorganisms’, ‘Inventions Relating to Plants’,
‘Inventions Relating to Animals’ and ‘Appendix’.
The
20
relating
to
relating
to
examination
Genetic
a
gene,
Guideline
Engineering’
a
vector,
applies
a
on
to
recombinant
‘Inventions
inventions
vector,
a
transformant, a fused cell, a monoclonal antibody, a protein
and a recombinant protein.
25
Matters of a monoclonal antibody,
a protein and a recombinant protein, which are omitted from
4
the existing Examination Guideline, are added.
How to write
the scope of the claims and the description requirements is
clarified,
and
the
standard
for
judging
novelty
and
the
presence of an inventive step is introduced according to the
5
type of invention.
Examination
guidelines
for
‘Inventions
relating
to
Microorganisms’, applied to the invention of microorganisms
*2
per se, and inventions relating to the use of microorganisms,
introduces a standard for judging the patentability of new
10
microorganisms, and inventions using existing microorganisms.
[note 2] Here, the term ‘microorganisms’ means viruses,
bacteria,
Actinomyces,
protozoa,
yeasts,
molds,
mushroom,
microalgae, undifferentiated animal or plant cells and animal
or plant tissue cultures, and is distinguishable from the
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meaning of microorganisms to be deposited in the process of
filing a patent application (‘microorganisms to be deposited’
means biological substances cable of being deposited.
‘Appedix
2.
Deposition
and
Allocation
of
See
Microorganisms,
etc.’).
20
The
Plants’
examination
applies
reproducible
guideline
to
plants
as
on
inventions
a
variant
‘Inventions
relating
plant,
in
relating
to
to
asexually
other
words,
inventions of variant plants per se, inventions relating to
parts of variant plants, inventions of methods of breeding
25
variant plants and inventions of methods for the
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asexual
reproduction of variant plants.
Unclear and overlapping areas
in the existing examination guideline ‘Asexually Reproduced
Variant Plants’ are thus organized.
The
5
Animals’
examination
applies
to
guideline
the
on
‘Inventions
invention
of
relating
animals
per
to
se,
inventions relating to parts of animals, inventive methods of
creating animals and inventions using animals.
The scope of
patent applications in this field has recently diversified
with
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the
advent
of
technology
for
animal
reproduction,
technology for animal transformation, and inventions relating
to animals producing useful materials using such technology.
Accordingly, a consistent examination guideline is set forth.
[note
3]
Here,
‘animals’
means
multicellular
animals
other than human beings.
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Appendix
1
introduces
the
guide
on
how
to
write
specification with a standarized sequence for precise and
prompt examination of applications with respect to inventions
disclosing
sequences
of
nucleic
acids
or
amino
acids.
Appendix 2 introduces the guide on deposition and furnishing
20
with respect to inventions disclosing biological substances
such as microorganisms.
Appendix 3 introduces the way to
document the taxonomic classification of microorganisms.
In conclusion, the examination guidelines for inventions
in the biotechnological field were in effect from March 1,
25
1998, and the ‘Inventions relating to Genetic Engineering’,
6
‘Inventions
relating
to
Microorganism
Industries’
and
Microorganisms’,
‘Novel
Asexually
‘Applied
Reproducing
Plants’ are repealed and removed from the existing examination
guidelines.
5
This dated 3rd day of February, 1998
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Contents
1. Inventions relating to Genetic Engineering
5
1.1 Requirements for the Description of the Specification
1.1.1 Scope of Claims
1.1.2 Detailed Description 7
1.1.3 Sequence Listing
10
1.2 Unpatentable Inventions
1.3 Requirements for Patentability
1.3.1 Constitutionality of Invention
15
1.3.2 Industrial Applicability
1.3.3 Novelty
1.3.4 Inventive Step
1.4 Unity of Application
20
1.5 Amendment of Specification
2. Inventions relating to Microorganisms
2.1 Requirements for the Description of the Specification
8
2.1.1 Designation of Microorganisms
2.1.1 Scope of Claims
2.1.3 Detailed Description
5
2.2 Unpatentable Inventions
2.3 Requirements for Patentability
2.3.1 Constitutionality of Invention
2.3.2 Industrial Applicability
10
2.3.3 Novelty
2.3.4 Inventive Step
2.4 Amendment of Specification
15
3. Inventions relating to Plants
3.1 Requirements for the Description of the Specification
3.1.1 Designation of Plants
3.1.1 Scope of Claims
20
3.1.3 Detailed Description
3.1.4 Drawings
3.2 Unpatentable Inventions
25
3.3 Requirements for Patentability
9
3.3.1 Constitutionality of Invention
3.3.2 Industrial Applicability
3.3.3 Inventive Step
3.4 Amendment of Specification
5
4. Inventions relating to Animals
4.1 Requirements for the Description of the Specification
4.1.1 Designation of Animals
10
4.1.2 Scope of Claims
4.1.3 Detailed Description
4.1.4 Drawings
4.2 Unpatentable Inventions
15
4.3 Requirements for Patentability
4.3.1 Constitutionality of Invention
4.3.2 Industrial Applicability
4.3.3 Inventive Step
20
4.4 Amendment of Specification
10
1. Inventions relating to Genetic Engineering
This examination guideline applies to inventions relating
to a gene, a DNA fragment, a vector, a recombinant vector, a
5
transformant,
a
fused
cell,
a
monoclonal
antibody,
a
recombinant protein, etc.
This examination guideline is also applied to inventions
relating to microorganisms, plants, animals, etc. when the
inventions use genetic engineering technology.
10
1.1 Requirements for the Description of the Specification
1.1.1. Scope of Claims
The scope of the claims is to clearly and simply describe
15
matter essential to the structure of an invention, and the
matter supported by the detailed description of the invention
is to be clearly understood from each claim.
Therefore,
claims which do not meet the following requirements are in
violation of the Article 42(4) of the Patent Law.
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(1)
Genes and DNA Fragments
① A gene and a DNA fragment should be described by
specifying the sequence thereof.
�1. TGTGAT … OOO gene expressed as AAGGAA sequence.
11
�2. An oligonucleotide defined in SEQ ID NO. 1.
�3. A polynucleotide comprising the DNA sequence of
SEQ ID NO. 2.
�4.
5
In
a
polynucleotide
consisting
of
the
DNA
sequence of SEQ ID NO. 3, a polynucleotide comprising a
DNA sequence of continuous 20-100 bases including G at
position 50.
[note] In this case, the DNA sequence is SNP which has G
at base position 50 while it is known that the base 50 is C in
10
the DNA sequence (500bp) of SEQ ID NO. 3.
② A gene may be described by specifying the amino acid
sequence of a protein encoded by said gene.
�1. A gene encoding a protein P comprising an amino
15
acid sequence expressed as Met Ala Val … Ser Leu.
�2. A OOO gene encoding an amino acid sequence
defined in SEQ ID NO. 2.
③ A genetic mutant: When the expressions ‘deletion’,
20
substitution,’ or ‘addition’ are used along with the
disclosure of a sequence, the position and the content
thereof should be specifically disclosed.
If an example of a mutant is given in the detailed
25
description, it is possible to describe
12
the invention by
limiting the function of the gene and the scope of the mutant.
In
this
case,
the
scope
of
the
genetic
mutant
is
not
considered to be sufficiently specified merely by disclosing
the actual hybridizing conditions.
5
�1. A gene wherein A at position 220 of the gene of
SEQ ID NO. 1 is substituted by G.
�2. A OOO gene encoding a protein wherein amino
acids at positions 25, 30, 89 or 251 to 254 of the amino
acid sequence of SEQ ID NO. 2 are substituted
10
with
hydrophobic amino acid residues.
[note] In this case, the substitution is for hydrophobic
amino acids, and the substitution of all hydrophobic acids
should be sufficiently supported by the detailed description.
�3. The following (a) gene or (b) gene:
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(a) DNA expressed as SEQ ID NO. 1;
(b) DNA encoding a protein having over 95% homology
with the sequence of SEQ ID NO. 1, and the activity of
enzyme X.
[note] The DNA of SEQ ID NO. 1 is a gene encoding a
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protein having the activity of enzyme X.
In the case of (b),
the expression ‘over 95% homology’ should be supported by the
detailed description, which should provide a concrete example
of a mutant having 95% homology.
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(2) Vectors
13
A vector should be described by specifying the base
sequence of its DNA, a cleavage map for the DNA, the molecular
weight, the number of base pairs, the source of the vector,
the
5
method
for
producing
the
vector,
the
functions
or
characteristics of the vector, etc.
[note] A cleavage map is a map which shows the relative
location and distance of
the cleavage sites when
various
restriction enzymes are used.
�
Pseudomonas
fluorescence
A
vector
having
a
cleavage map which is a plasmid pSF1, separated from ATCC
10
OOOO, shown in Fig. 1.
(3) Recombinant vectors
A recombinant vector should be described by specifying
15
the inserted gene and the vector.
the
requirements
for
If the inserted gene meets
patentability
and
does
not
need
a
specific vector to express the gene, it is possible to specify
the vector only with the inserted gene.
�1. Corynebacterium glutamicum A expressive vector
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pDHDP 812 including dap A gene
�2. A recombinant vector including the gene of SEQ
ID NO. 1.
(4) Transformant
25
A transformant should be specified by the host, defined
14
by the species name or the generic name followed by the
species name, in accordance with microbiological, plant or
animal nomenclature, and the introduced recombinant vector (or
gene).
5
A comprehensive description, which is not limited to a
particular
genus,
may
be
recognized
if
the
sufficiently supported by the detailed description.
claim
is
In other
word, a claim disclosing ‘a transformant microorganism’ or ‘a
transformant host cell,’ which are not limited to a particular
10
genus, should be accompanied by examples of transformation
using various host cells, such as bacteria, enzymes, molds,
animal
cells
or
plant
cells,
etc.
or
the
application
of
various host cells from a specific example described in the
detailed description of the invention or known technology
15
should be obvious to a person skilled in the art.
�1. Corynebacterium glutamicum
A colon bacillus (E.
coli) KCTC OOOOP transformed to an expressive vector
pDHDP 5812 including a dap A gene
�2. A bacillus transformed to a recombinant vector
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including a gene of SEQ ID NO. 1
�3. A host cell transformed to a recombinant vector
including a gene of SEQ ID NO. 1
[note] This case is recognized only when the description
is sufficiently supported by the detailed description of the
25
invention.
15
(5) Fused cells
A fused cell should be described by specifying parent
cells, the function and characteristics of the fused cell, the
5
method for producing the fused cell, etc.
(6) Proteins and recombinant proteins
①
A
protein
and
a
recombinant
protein
should
be
described by specifying the amino acid sequence or the base
10
sequence of
the
structural gene encoding said amino acid
sequence.
�1. OOO protein having amino sequence of SEQ ID NO.
2
�2. OOO protein encoded by a gene sequence of SEQ ID
15
NO. 1
②
Protein
Mutant:
When
the
expressions
‘deletion’,
‘substitution’, or ‘addition’ are used, the position and the
content should be clearly explained.
20
mutant
is
described
in
the
detailed
If an example of a
description,
it
is
possible to describe the invention by limiting the function of
said protein and the scope of the mutant.
�1. OOO protein wherein Ala at the 90th position of
25
the amino acid sequence of SEQ ID NO. 2 is substituted with
16
His.
�2. OOO protein, wherein the amino acid of the
position 25, 30, 89 or 251 to 254 is substituted with a
hydrophobic amino acid.
5
[note] In this case, the substitution is a hydrophobic
amino acid and the substitution of all hydrophobic acids
should be sufficiently supported by the detailed description.
�3. A protein X of (a) or (b) as follows:
10
(a)
A amino sequence of SEQ ID NO. 1;
(b)
A mutant having over 95% homology with the sequence
of SEQ ID NO. 1, and the activity of enzyme E.
[note] Protein X has the activity of enzyme E.
15
In the
case of (b), the expression ‘over 95% homology’ should be
supported
by
the
detailed
description,
which
provides
a
concrete example with respect to a mutant having 95% homology.
③ When a protein could not be specified in sequence, a
20
protein may be described by specifying all of functions,
physiochemical
of
the
protein, and the method for producing the said protein.
The
physiochemical
measuring
25
the
properties,
properties
molecular
the
should
origin
or
describe
weight,
the
source
the
best
method
activating
conditions, the isoelectric point, safety measures, etc.
17
of
In
this case, a protein not specified by sequence is acceptable.
� Bacillus subtilis Refined protease obtained by
culture of KCTC OOOOP and having the following characteristics
(a) to (e)
(a) the optimum temperature between 40 ℃ and 50℃;
5
(b) the optimum pH from 8.0 to 10.0;
(c) stable for over 72 hours at 50℃ and pH9.0
(d) the isoelectric point pI from 5.0 to 5.5;
(e) the molecular weight from 20 to 23 kDa measured by
10
sodium
dodecyl
sulfate
polyacrylamide
gel
electrophoresis
(SDS-PAGE)
(7) Monoclonal antibodies
A monoclonal antibody should be defined, in principle, by
15
specifying the amino acid sequence of the variable region or a
gene
sequence
encoding
it,
or
by
specifying
an
antigen
recognized by the monoclonal antibody or a hybridoma which
produces the monoclonal antibody, and could be defined with
reference
20
to
cross-reactivity
as
an
additional
defining
method.
However, if an antigen is novel and has an inventive
step, specifying the antigen can be recognized as specifying a
monoclonal antibody.
�1. A monoclonal antibody to antigen A, produced by
25
a hybridoma having KCTC Deposit No. OOOOP
18
�2. A monoclonal antibody to antigen A.
[note]
Antigen A should be described by specifying it
as a substance.
�3. A monoclonal antibody comprising an amino acid
5
sequence of SEQ ID NO. 1 as a variable region.
�4. A monoclonal antibody comprising an amino acid
sequence encoded by the gene sequence of SEQ ID NO. 2 as
a variable region
10
(8) Antisense
An antisense should be defined by specifying a base
sequence and the function thereof.
�
An
antisense
Nucleotide
of
SEQ
ID
NO.
1
prohibiting production of protein P.
15
1.1.2 Detailed description
In the detailed description of the invention, the object,
structure
and
effect
should
be
described
in
a
manner
sufficiently clear for the invention to be carried out by a
20
person having ordinary knowledge in the art to which the
invention pertains.
A detailed description of the invention
that does not meet the following requirements violates the
provisions of Article 42(3) of the Patent Law.
The meaning of ‘being able to carry out the invention’,
25
for an invention of a product, is to make and use the product,
19
for an invention of a method, to use the method, and for an
invention of a method for producing a product, to produce the
product.
The extent of ‘easily carry out’ means that a person
5
having ordinary skill in the art can clearly understand and
carry out the invention without a large amount of trial and
error or complicated experimentation.
(1)
10
manner
The detailed description should be described in a
that
is
sufficiently
clear
and
complete
for
the
invention to be carried out by a person skilled in the art.
With respect to biotechnological inventions, the detailed
description
should
be
clearly
stated
as
to
methods
for
producing and/or using genes, DNA fragments, an antisense,
15
vectors, recombinant vectors, proteins, recombinant proteins,
or transformants.
Accordingly, with respect to biotechnological inventions,
in the original specification it should be stated that the
starting substances can be easily obtainable or have been
20
deposited
with
a
depository
institution
according
to
the
provisions of Article 2 of the Enforcement Decree of the
Patent Law.
concretely
The detailed description and the drawings should
describe
the
method
of
obtaining
the
starting
substances and the means to easily carry out the invention.
25
However,
as
to
inventions
20
relating
to
genetic
engineering, in the case where description only on paper may
make it difficult to sufficiently describe the invention such
that it can be easily carried out with reference to the
described matter necessitates a large amount of trial and
5
error, the carrying out of the invention may be supported by
depositing
the
microorganisms,
institution
vectors,
fused
(See
recombinant
cells,
Appendix
etc.
2
vectors,
with
‘Deposit
transformed
a
depository
and
Furnishing
Microorganism, etc.’).
In addition, the functions or the utility of the claimed
10
inventions
relating
to
genetic
engineering
should
be
concretely described.
(2) Genes, DNA fragments, vectors and recombinant vectors
Inventions
15
of
genes,
DNA
fragments,
vectors
and
recombinant vectors should be described with reference to
respective specific requisites (sequence, cDNA, RNA, etc.),
concrete examples of the basis of the specification, origin or
source, means for obtaining a vector to be used, an enzyme to
20
be
used,
treatment
conditions,
steps
for
collecting
and
refining it, or means for identification, functions, etc.
(3) Transformants
A
25
transformant
should
be
concretely
described
with
reference to specific requisites therefor, examples of the
21
basis
thereof,
a
gene
or
a
recombinant
vector
to
be
introduced, the name thereof according to host nomenclature,
host origin, a method for introducing the gene, a method for
producing the transformant, such as a method for introducing
5
recombinant vector as well as a method for selecting and
collecting
the
transformant,
means
for
identification,
properties, generated product, functions and properties of the
transformant, etc.
(4) Fused cells
10
The fused cells should be concretely described by
stating the parent cells to be used, pretreatment of the
parent cells, fusion conditions, etc., along with the method
of
15
selecting
and
collecting
the
fused
cell,
means
for
identification, functions and properties of the fused cell,
etc.
(5) Proteins
Inventions relating to proteins should be described by
stating
20
the
gene
encoding
the
protein,
the
amino
acid
sequence, origin, process for collecting and refining the
protein, , means for identification, physiochemical properties
(molecular
weight,
the
optimum
activating
conditions,
isoelectric point, safety, etc.), glycosylation, degree of
purity, functions, biological properties and properties within
25
a test tube.
22
(6) Recombinant proteins
Inventions of a recombinant protein should be described
by stating the gene encoding the recombinant protein, the
vector
5
to
be
used
for
expression,
the
host
according
to
nomenclature, means for introducing the host, etc., a method
for producing a transformed microorganism, such as the method
for
introducing
the
gene
into
the
host,
a
process
for
collecting and refining the recombinant protein, means for
identification,
10
functions
and
properties,
etc.
of
the
recombinant protein.
(7) Monoclonal antibodies
Inventions of a monoclonal antibody should be described
by stating the method for producing antibody producing cells
15
(hybridoma), such as means for obtaining or producing
an
immunogen, means for producing them, a method of immunization,
a
method
for
selecting
identification
(reaction
confirmation
20
of
epitope,
and
or
collecting
non-reaction
extent
of
them,
to
an
activity,
means
for
antigen),
functions,
properties, etc.
However, when an antigen is patentable and the antigen is
described in such a manner that it can be easily devised and a
person skilled in the art could easily create and use the
antigen from the description of the specification, a concrete
25
example need not be described.
23
(8) Antisense
Inventions of antisense should be described by specifying
the specific requisites of antisense (sequence, activation of
5
prohibiting production of specific protein), concrete example
of
basis
of
specification,
production
method,
means
for
identification, etc.
1.1.3
SEQUENCE LISTING
10
(1)
When a nucleotide sequence consisting of 10 or more
nucleotides, or an amino acid sequence of a protein or peptide
consisting of 4 or more L-amino acids is described in a
specification, a Sequence Listing of the sequence prepared in
15
accordance
with
‘Guidelines
for
Preparation
of
Filing
of
Patent Applications including nucleotide and/or amino acid
sequence,’ published in the Public Notice 2004-1 of KIPO,
should be provided at the end of the detailed description of
the invention as a part thereof. (See Appendix 1)
20
(2) When a nucleotide sequence or an amino acid sequence
is to be set forth in the Scope of the Claims, the sequence
described in the ‘Sequence Listing’ prepared in accordance
with (1) may be cited.
25
24
1.2
Unpatentable Inventions
Inventions
relating
to
genetic
engineering
likely
to
contravene public order or morality or to harm public health
5
as follows shall not be patentable according to the provision
of Article 32 of the Patent Law.
approved
by
the
provisions
of
the
However, research works
‘Korean
Bioethics
and
Biosafety Law’ are excluded.
10
(1) An invention liable to destroy an ecosystem
(2) An invention liable to cause environmental pollution
(3)An invention liable to harm a human being or damage
human dignity
�1. A human cell obtained through an artificial
method that harms a human being
15
�2. A process for reproducing human beings, and a
process for transferring the genetic identity of the
human reproductive cell system and products thereof
[note 1]
20
Human cells, not obtained directly from human
beings but from already discharged tissues (blood, urine,
placenta, hair, skin, etc) or obtained through an artificial
method that does not harm human beings, are excluded.
[note 2]
claim
25
without
A host cell and an animal cell set forth in a
explicitly
excluding
regarded like a human cell.
25
human
cells
will
be
(4) An invention relating to a transformant not excluding a
human being
(5) An invention relating to a behavior or a research work
prohibited by ‘Korean Bioethics and Biosafety Act’
5
1.3
Requirements for Patentability
1.3.1 Constitutionality of Invention
10
The following inventions do not meet the requirements
provided in the provisions of Article 29(1) of the Patent Law.
(1) A mere discovery which is not a creation.
� A microorganism or protein existing in nature
15
which is merely discovered.
However,
when
specific
difficulty
is
recognized
in
isolating or selecting them, this could be recognized as an
invention as set forth in the provision of Article 29(1) of
the Patent Law.
20
(2) As to inventions of genes, DNA fragments, SNP, antisense,
vectors,
recombinant
vectors,
transformants,
fused
cells,
monoclonal antibodies, proteins and recombinant proteins, a
method for introducing them and means for producing them are
25
not concretely describe in the detailed description.
26
1.3.2
(1)
Industrial applicability
Utility should be described
As to an invention of genes, DNA fragments, antisense,
5
vectors,
recombinant
vectors,
transformants,
fused
cells,
proteins, recombinant proteins, monoclonal antibodies, etc.,
if
the
specific,
virtual
and
reliable
utility
is
not
described, or the utility thereof cannot be inferred, the
10
invention is not recognized as an industrially applicable
invention as set forth in the provisions of Article 29(1) of
the Patent Law.
①
15
As
to
an
invention
of
a
DNA
fragment,
the
description of the DNA fragment as only a probe to be used to
obtain full-length DNA is not regarded as having utility.
However, when the invention has a concrete description, such
as use as a probe to diagnose a specific disease or encode a
specific protein, the invention is regarded as having utility.
20
② As to an invention of SNP (Single Nucleotide
Polymorphism), mere description of the SNP to be used in
forensic medicine is not a basis for considering the invention
to
25
have
utility.
However,
when
the
invention
is
experimentally shown to be useful as a diagnostic medicine,
27
etc., the invention is considered to have utility.
③ As to an invention of full-length cDNA, when a
gene
5
of
specific
protein
is
deduced
by
the
result
of
a
homology search through a known D/B, the invention is not
regarded as having utility.
However, when the deduction can
be objectively recognized as a gene of a specific protein (in
the case where homology with the specific protein is high and
homology with the protein having second similarity is low),
10
the invention is regarded as having utility.
For example, in
the case where homology with a specific protein is over 90%
and homology with a second protein also having similarity is
lower than 50%, the invention is considered to have utility.
④
15
As
to
an
invention
of
a
protein,
when
the
invention describes only the sequence without the physical,
chemical
or
biological
properties
of
the
protein,
the
invention is not considered to have utility.
20
(2)
A method for treating and diagnosing the human body is
not recognized to be an industrially applicable invention
under the provisions of Article 29(1).
A method invention, such as a gene treatment method
targeting the human body, falls under the medical act, and
25
accordingly,
is
not
recognized
28
as
being
industrially
applicable.
However, when the substance used for treatment
and diagnosis is described as claims of medicine specifying
medical effect, the invention is recognized as having utility.
� ADA deficit treatment agent having an MDR1-ADA
5
fused gene described in SEQ ID NO. 1 as active content
1.3.3 Novelty
According to the provisions of Article 29(1) of the
10
Patent Law, the novelty of inventions relating to genetic
engineering is judged as follows:
(1)
Genes, DNA fragments, antisense and (recombinant) vectors
①
15
Novelty
of
genes,
DNA
fragments,
antisense,
vectors and recombinant vectors is judged, in principle, on
the ground of the structure (base sequence).
② When genes, DNA fragments, antisense, vectors and
recombinant vectors are known at a separated and refined
20
state,
are
specified
by
other
specifying
means
and
are
distinguishable substances compared with known substances, the
invention is considered to be novel.
(2) Fused cells
25
The novelty of fused cells is judged on the ground of the
29
parent cells that are used or monoclonal antibodies to be
generated.
(3) Proteins and recombinant proteins
① The novelty of proteins and recombinant proteins
5
is judged, in principle, on the ground of structure (amino
acid sequence).
② When proteins and recombinant proteins are known
in a separated and refined state, and are specified by other
10
specifying
means
and
are
thus
distinguishable
substances
compared with known substances, the invention is considered to
be novel.
③ When the biological activation of a protein is
known but the protein is not isolated, and an invention of the
15
protein is specified by isolating, refining and sequencing,
etc., the invention is considered to be novel.
④
When
a
recombinant
protein
specified
by
a
production method is different from a known protein in sugar
chain, etc. in the host that is used, the recombinant protein
20
is considered to be novel even though the recombinant is not
distinguishable from the known protein in amino acid sequence.
(4) Monoclonal antibodies
The Novelty of Monoclonal antibodies is judged on the
25
grounds of the antigen and an epitope thereof.
30
�1. When a specific antigen is novel, the monoclonal
antibody to the antigen is considered to be novel.
�2. When a monoclonal antibody to a specific epitope
of a specific antigen is known, a monoclonal antibody to
5
another epitope of the antigen is considered to be novel.
�3.
identical
to
When
or
an
antibody
similar
with
to
a
an
known
antigen
antigen,
which
is
and
has
identical epitope, has a different sequence from that of the
known antibody, or is specified by a technical means (for
10
example,
‘deposited
hybridoma’
or
‘cross-reactivity’)
distinguishable from conventional technology, the antibody is
considered to be novel.
(5) Known substances limited by production method
15
A known substance limited by a method of producing it is
not considered novel.
� 【Claim 1】 A method of refining albumin
� 【Claim 2】 A refined albumin produced by the
20
method of claim 1
[note] Conventional albumin has a purity degree of about
90%, however, albumin of 99.9% purity can be obtained through
the refining method of claim 1.
Heightened purity or density
means that the substance is not changed but is identical to
25
the existing substance and only the physical state of the
31
substance is changed.
Therefore, there is no novelty (Refer
to decision of the Patent Court dated July 15, 1999 on case
no. 98 HUR 10611)
1.3.4 Inventive Step
5
According to the provisions of Article 29(2) of the
Patent Law, an inventive step of an invention relating to
genetic engineering is judged as follows:
10
(1) Genes
① An invention of a gene encoding a protein has an
inventive step, if the protein has novelty and an inventive
step.
15
② When an amino acid sequence of a protein is publicly
known, an invention of a gene encoding the protein does not
have an inventive step.
However, when it is considered that
the gene is specified by a specific base sequence and has
advantageous effects in comparison with other genes encoding
20
the protein, the invention of said gene has an inventive step.
③ Where a protein is publicly known but its amino acid
sequence
is
not
publicly
known,
an
invention
of
a
gene
encoding the protein does not have an inventive step, provided
that a person skilled in the art could determine the amino
25
acid sequence easily at the time of filing.
32
However, when it
is considered that the gene is specified by a specific base
sequence and has advantageous effects in comparison with other
genes encoding the protein, the invention of said gene has an
inventive step.
5
④ When a structural gene is publicly known, an invention
relating to a structural gene of naturally obtainable mutant
having
10
the
same
properties
and
functions
as
the
said
structural gene does not have an inventive step.
However, if
the
effects
in
gene,
or
isolating
or
claimed
structural
comparison
with
difficulty
is
said
gene
has
publicly
recognized
in
advantageous
known
the
structural
method
of
selecting it, the claimed invention relating to the structural
gene has an inventive step.
15
⑤ As to an invention relating to full-length cDNA, when
a gene of a specific protein is elucidated as a result of a
homology search through a known D/B, the invention is not
considered to have an inventive step.
20
However, when special
circumstances, such as difficulty in the process of obtaining
the cDNA, are acknowledged, the invention is considered to
have an inventive step.
(2) DNA fragment
25
An inventive step of DNA fragment should be judged on the
33
ground
of
the
effect
of
the
use
or
utility.
When
a
relationship between a specific gene and a specific disease is
known, a DNA fragment which comprises parts of the gene for
diagnosing or treating the specific disease is not considered
5
to have an inventive step.
However, when the DNA fragment has
advantageous effects of diagnosing or treating the specific
disease even if the relationship between the specific gene and
the specific disease is known, the DNA fragment is considered
to have an inventive step.
10
(3)
Recombinant vectors
An
invention
of
a
recombinant
vector
produced
by
introducing a known gene to a known vector is not considered
to have an inventive step.
15
However, when the recombinant
vector produced by a specific combination thereof has
an
advantageous effect, the recombinant vector is considered to
have an inventive step.
(4) Transformants
An
20
invention
relating
to
a
transformant
produced
by
introducing a known gene into a known host is not considered
to have an inventive step.
However, when the transformant
produced by a specific combination of them has advantageous
effects, the transformant is considered to have an inventive
25
step.
34
(5) Proteins
① An invention relating to a protein has an inventive
step if the gene encoding the protein has an inventive step.
5
② As to a protein, the biological activation of which is
known, but which has not been isolated, specifying only by
isolating and refining, etc. is not considered inventive.
However, when a difficulty in a process of isolating and
10
refining it is recognized, and the protein has advantageous
effects in degree of purity, function, etc., the protein is
considered to have an inventive step.
③
15
An
invention
relating
to
a
protein
that
has
an
identical function to a known protein even though part of the
amino acid of known protein is deleted, added or substituted
is not considered to have an inventive step.
the
protein
has
advantageous
effects
in
However, when
activation,
side
effects, absorption, safety etc., the protein is considered to
20
have an inventive step.
④
When
a
protein
relating to a protein
is
publicly
from a
known,
an
invention
naturally obtainable mutant
having the same properties and functions as the known protein
25
does not have an inventive step.
35
However, if the claimed
protein
has
advantageous
effects
in
comparison
with
said
publicly known protein, or a difficulty is recognized in the
method of isolating or selecting it, the invention claiming
the protein has an inventive step.
5
(6) Fused cells
An invention relating to a fused cell obtained by fusing
two known parent cells is not considered to have an inventive
step.
10
However, when the fused cell has advantageous effects,
the invention is considered to have an inventive step.
(7) Fused proteins
A fused protein of two or more proteins is not considered
to have an inventive step.
15
However, when the fused protein
has advantageous effects, the fused protein is considered to
have an inventive step.
(8) Monoclonal antibodies
①
20
A
monoclonal
antibody
inventive step, in principle.
to
a
novel
antigen
has
an
When a monoclonal antibody to a
known antigen is specified by other technical characteristics
or
has
advantageous
effects,
the
monoclonal
antibody
is
considered to have an inventive step.
25
② An invention having no special difference except that
36
a known polyclonal antibody is substituted with a monoclonal
antibody is not considered to have an inventive step.
(9) Antisense
An antisense to a known gene is not considered to have an
5
inventive step, in principle.
However, when an antisense has
advantageous effects that a person skilled in the art could
not foresee, the antisense is considered to have an inventive
step.
10
1.4
Unity of Application
Whether an invention is ‘a group of inventions that form
a single general inventive concept’ (hereinafter referred to
15
as ‘unity’), stipulated by Article 45(1) of the Patent Law, is
dependent on the existence of “a technical relationship of
one,
two
or
more
identical
or
corresponding
to
‘special
technical characteristics’” among the inventions disclosed in
each claim.
20
The expression ‘special technical characteristic’
means that in each invention, ‘improved parts are discerned
from the prior arts as a whole’. (Examination Guidelines and a
Decision of the Patent Court dated January 14, 1999 on case
No. 98 HUR 5145)
Accordingly, whether an invention meets the requirements
25
for a single application varies according to the degree of
37
disclosure of the prior arts.
Concrete example of unity of a
biotechnological application is as follows:
�1.
【1】A structural gene having DNA SEQ ID NO. 1
【2】 A recombinant vector including the structural gene
5
of claim 1.
【3】 A microorganism of bacillus transformed using the
recombinant vector of claim 2.
【4】 A method for producing a specific protein using the
10
transformed microorganism of claim 3.
[Explanation] When a structural gene is novel and has an
inventive
step,
the
special
technical
characteristics
in
claims 1-4 meet the requirement for unity of an application
because they relate to the structural gene or the specific
15
protein thereof.
�2.
【1】Microorganism A
【2】A method for producing a protein E by culturing
microorganism A
20
【3】 DNA encoding protein E
【4】 A recombinant vector including the DNA of claim 3
【5】 A bacillus transformed by the vector of claim 4.
【6】 A method for producing protein E by culturing a
host cell of claim 5.
25
[Explanation]
When
protein
38
E
is
novel
and
has
an
inventive step, the special technical characteristics meet the
requirement
for
unity
of
application
of
the
protein
E.
However, when the protein E is publicly known, the protein E
is not regarded as having special technical characteristics.
5
Therefore, claims 1 and 2 are not considered to be unified
with claims 5 and 6.
�3.
【1】
A
gene
G
encoding
an
enzyme
A
drawn
from
Pseudomonas.
【2】 A recombinant vector including the gene of claim 1.
10
【3】 A transformed bacteria including the recombinant
vector of claim 2.
【4】
A
method
for
producing
an
enzyme
A
using
the
bacteria of claim 3.
【5】A
15
gene
G
encoding
an
enzyme
A
drawn
from
Agrobacterium.
【6】 A recombinant vector including the gene in claim 5.
【7】 A transformed bacteria including the recombinant
vector of claim 6.
【8】
20
A
method
for
producing
an
enzyme
A
using
the
bacteria of claim 7.
[Explanation] When the enzyme A is publicly known, claim
1 to 4 are not considered to be unified with claim 5 to 8
because no special technical characteristics is shared between
25
them.
39
�4.
【1】 A polypeptide fragment A of a virus C antigen
protein
【2】A
5
polypeptide
fragment
B
of
a
virus
C
antigen
protein
[Explanation] When a polypeptide X of virus C antigen
protein is known, the application is not considered unified
because
there
are
no
special
technical
characteristics.
However, when the virus C antigen protein is novel and has an
10
inventive step, it meets the requirement for unity of an
application because the special technical characteristic is a
virus C antigen protein.
�5.
【1】Specific DNA sequence A
【2】 Some other DNA sequence B, having the same function
15
as sequence A but having a different origin.
[Explanation] When the function is known, there is no
unity
because
characteristic.
20
there
is
no
distinctive
technical
However, when the function per se is novel
and has an inventive step, the function meets the requirement
for unity of an application because the function per se is a
special technological characteristics.
�6.
25
【1】 DNA sequence A
【2】 DNA sequence B having a different function but
40
having the same origin.
[Explanation]
Because a shared origin is not a special
technical characteristics, there is no unity.
Examples 4 to 6 are claimed in separate claims, however,
5
even if the disclosures are made in one claim, the judgment on
the unity of application is not changed.
�7.
【1】 An antigen protein
【2】 A monoclonal antibody to the antigen protein of
10
claim 1.
[Explanation] When an antigen protein is novel and has an
inventive step, the special technical characteristic is the
antigen, and therefore, there is unity.
15
�8.
【1】 A monoclonal antibody mAb-1 to an antigen A
【2】A monoclonal antibody mAb-2 to an antigen A.
[Explanation] When an antigen A is novel and has an
inventive
20
step,
the
antigen
A
has
special
technological
characteristics,
and
therefore,
the
antigen
A
meets
the
requirements for unity.
�9.
【1】 A polynucleotide consisting of the nucleic acid
sequence of SEQ ID NO:1.
25
【2】 A polynucleotide consisting of the nucleic acid
41
sequence of SEQ ID NO:2.
[Explanation]
[case
1]
According
to
the
detailed
description,
the
polynucleotide is derived from the cDNA library constructed
5
from human liver and is a 500bp cDNA.
be
used
as
a
probe
to
diagnose
The polynucleotides can
disease
Y
because
the
corresponding mRNA is expressed only in the liver cell of a
patient with disease Y.
homology.
10
The polynucleotides do not have high
According to the search of the prior arts, there is
no DNA only in a patient having the disease Y, and there is no
polynucleotide having a sequence similar to SEQ ID NO. 1 and
NO.
2.
In
this
case,
because
the
special
technological
characteristics is the use as a diagnostic probe, the unity of
invention can be acknowledged.
15
[CASE
2]
According
to
the
detailed
description,
the
polynucleotides are derived from a cDNA library constructed
from human liver, and are 500bp Cdna.
The polynucleotides are
parts of a structural gene and can be used as probes to obtain
full-length
20
homology.
DNA.
The
polynucleotides
do
not
high
According to the search of the prior arts, a
polynucleotide derived from human liver is known.
case,
have
because
there
is
no
special
In this
technological
characteristic, the unity of the invention cannot be admitted.
25
42
1.5
Amendment of Specification
The
following
amendments
do
not
comply
with
the
requirements stipulated by Article 47 of the Patent Law, and
5
are not within the scope of the specification or drawings as
filed (Hereinafter, regarded as the addition of new matter).
(1) When the structure of genes, DNA fragments, antisense,
vectors,
10
recombinant
vectors,
the
structure
of
proteins,
transformants, fused cells and monoclonal antibodies is not
clear in the specification as filed, so that a person skilled
in
the
art
description
could
to
not
clarify
easily
the
work
the
structure
invention,
by
a
new
amendment
is
considered the addition of new matter.
15
(2) When a starting substance is not sufficiently described to
be easily obtained, or a final product is not sufficiently
described to be easily produced from the starting substance in
the specification as filed, adding the starting substance,
20
means of obtaining (deposit number, etc.) the final product or
production means by amendment is considered the addition of
new matter.
However, when the fact that the microorganism has
been deposited is stated, or the deposit number is given, in
the specification as filed and the certificate of deposit is
25
filed late, that is not considered the addition of new matter.
43
(3) When the specification as filed has no description of the
utility
of
genes,
DNA
fragments,
antisense,
vectors,
recombinant vectors, proteins, transformants, fused cells or
5
monoclonal antibodies, adding new utility in an amendment is
considered the addition of new matter.
[note]
This
‘amendment
of
specification’
applies
to
applications filed after July 1, 2001, and existing guidelines
for judging change of gist apply to applications filed before
10
June 30, 2001.
44
2. Inventions relating to Microorganisms
This
guideline
deals
with
inventions
related
to
microorganisms per se, the use of new microorganisms and the
5
use of known microorganisms.
production
method
’Use of microorganisms’ means a
using
microorganisms,
a
method
for
processing substances using microorganisms, etc.
[note] The term ‘microorganisms’ means viruses, bacteria,
protozoa,
10
yeasts,
actinomycetes,
etc.
molds,
and
mushrooms,
further
unicellular
includes
algae,
undifferentiated
animal or plant cells as well as animal or plant tissue
cultures.
Matters relating to genetic engineering are covered in
‘1. Genetic Engineering’ even if they are inventions relating
15
to microorganisms.
2.1 Requirements
for
the
Description
of
the
Specification
20
2.1.1
Designation of Microorganisms
Microorganisms should be specified by scientific names in
accordance
with
designating
a
microbiological
strain
of
a
nomenclature.
microorganism,
45
it
When
should
be
specified by the strain name following the species name (in
accordance with microbiological nomenclature).
The scientific
names in Italic in parenthesis follow the Korean expression.
� Aspergillus niger KCTC OOOOBP.
5
2.1.2
Claims
10
Scope of Claims (See to 1.1.1)
are
to
be
clearly
and
simply
described
with
matters essential to the structure of the invention, and the
matters supported by the detailed description of the invention
are to be clearly understood from the claims.
Therefore,
claims which do not meet the following requirements are in
violation of the Article 42(4) of the Patent Law.
15
(1) Inventions of microorganisms per se
① A microorganism should be described by specifying
as follows:
20
A
microorganism
microorganism
name
should
and
be
deposit
described
number,
by
or
specifying
a
mycological
properties characterized by the microorganism can be added.
�1. Bacillus subtilis KCTC OOOOP.
�2. Aspergillus fumigates producing substance P
25
[note] In this case, the substance P should be novel, or
46
the yield of substance P in this microorganism, etc. should
have advantageous effects in comparison with when produced by
other microorganisms.
�3. Saccharomyces cerevisiae KCTC OOOOP, of which the cell
5
wall is hydrophobic as galactose nonfermenters.
② Undifferentiated animal or plant cells should be
specified by scientific names in accordance with zoological or
botanical
10
nomenclature,
and
the
deposit
institution
and
deposit number can be added.
(2) Inventions using microorganisms
① An invention using a novel strain, mutant strain
15
or a known strain should be described by the strain name.
� A method for producing an antibiotic A9828 from a culture by
culturing A9828 strain belonging to Streptomyces griseus.
② An invention using a novel species, a mutant
20
species or a known species should set forth the species name.
�
A
method
for
producing
streptomycin
from
a
culture
by
culturing Streptomyces griseus.
③ A microorganism should be described by the genus,
25
species or strans name thereof depending o the extent of
47
disclosure of prior art
�1. A method for producing yeast E using a Bacillus sp.
[note] When there is no prior art with respect to a
method for producing enzyme E using a microorganism belonging
5
to Bacillus, the invention need only specify the genus name.
�2. A method for producing yeast E using Bacillus subtilis.
[note] When there is no prior art with respect to a
method for producing yeast E but there is a prior art of a
10
method
for
producing
yeast
E,
the
invention
should
be
described by specifying the species.
�3. A method for producing yeast E using Bacillus subtilis
KCTC OOOOP.
[note] When there is a prior art with respect to a
15
method for producing yeast E using microorganisms in Bacillus
subtilis, the invention should be specified by deposit number,
etc.
20
④
When
‘microorganism
an
preamble
culture
of
a
medium’,
claim
the
is
stated
as
microorganism
a
is
patentable, and the patentability is acknowledged only when
the invention is limited by the name of the microorganism and
the deposit number.
25
[note]
A
microorganism
culture
48
should
consist
of
a
microorganism, and a culture medium having no microorganisms
is excluded.
� A pure culture medium of Rhodococcus rhodochrous KCTC OOOOP.
5
2.1.3
Detailed Description of the invention
In the detailed description of the invention, the object,
structure and effect shall be stated in a manner sufficiently
clear for the invention to be carried out by a person having
10
ordinary knowledge in the art to which the invention pertains.
A detailed description of an invention that does not meet the
following
requirements
violates
the
provisions
of
Article
42(3) of the Patent Law.
15
(1) The detailed description shall be stated in a manner
sufficiently
clear
and
complete
for
the
invention
to
be
carried out by a person skilled in the art.
With respect to inventions relating to microorganisms,
the detailed description shall clearly set forth the method
20
for obtaining and/or using a microorganism.
Accordingly, with respect to an invention disclosing a
microorganism, the original specification should state that
the starting substances could be easily obtained or deposited
25
with a depository institution according to the provisions of
49
Article 2 of the Enforcement Decree of the Patent Law.
The
detailed description and the drawings should concretely state
the method for obtaining the starting substance and the means
for easily carrying out the invention.
5
However, as to inventions relating to microorganisms, in
the
case
difficulty
where
in
a
description
sufficiently
only
describing
on
or
paper
may
easily
entail
executing
invention with reference to the described matter, or may
10
entail a large amount of trial and error, the invention may be
supported by depositing the microorganism with a depository
institution
(See
Appendix
2
‘Deposit
and
Furnishing
Microorganism, etc.’).
In addition, the functions or the utility of an invention
15
relating to a microorganism should be concretely described.
(2) As to a new microorganism, the microorganism should be
specified by the species name or the strain name following the
species name in accordance with microbiological nomenclature,
20
and furthermore, the microbiological characteristics should be
described.
As microbiological characteristics, it is desirable that
taxonomic characteristics generally used in the field (See
25
Appendix
3
‘How
to
write
50
classifying
property
of
microorganism’) be described, however, other microbiological
characteristics (e.g., selective productivity of metabolites)
may be described.
A microorganism which cannot be specified by the species
5
name should be specified by the strain name along with the
genus name, after clarifying the reason why the species name
cannot be given.
As to the microbiological characteristics,
New strain: the characteristics of the strain, as well as
10
the difference in the microbiological characteristics of the
strain from known strains within the species to which the new
strain belongs, should be clearly described.
New species: The taxonomic characteristics of the species
should
15
be
described
microorganism
clarified.
is
in
judged
detail,
to
be
and
a
the
new
reason
species
why
should
the
be
That is, the difference between the species and
existing similar species should be expressly described, and
the relevant literature used as the basis for the judgment
should be indicated.
20
(3) As to an invention relating to a microorganism per se or
relating
to
the
use
of
a
novel
microorganism,
means
for
creating the microorganism, such as means for separating,
refining, screening, mutagenesis, gene recombination, etc.,
25
should be described, so that a person skilled in the art can
51
create the said microorganism.
2.2
5
Unpatentable inventions
Inventions
relating
to
microorganisms
liable
to
contravene public order or morality or to harm public health
as follows shall not be patentable according to the provision
of Article 32 of the Patent Law.
10
(1) An invention relating to a microorganism liable to destroy
an ecosystem
(2) An invention relating to a microorganism liable to cause
environmental pollution
15
(3) An invention relating to a microorganism liable to harm
human beings
2.3
Requirements for Patentability
20
2.3.1 Constitutionality of Invention
The following inventions do not meet the requirement
provided in the provisions of Article 29(1) of the Patent Law.
25
52
(1) mere discovery, which is not a creation.
�
A
microorganism
existing
in
nature
which
is
merely
discovered.
However, when specific difficulty is recognized in the
5
method for isolating or selecting the microorganism and the
microorganism
has
specific
microbiological
characteristics,
the invention is determined to have creativity.
(2)
10
When
the
microbiological
characteristics
are
not
sufficiently described and thus, the microorganism that is
used is not clear, even if the microorganism that is used is
novel.
(3)
15
When
materials
to
identify
a
substance
are
not
sufficiently described even though the generated substance
used a microorganism is new.
2.3.2
When
20
an
Industrial Application
invention
relates
to
a
microorganism
whose
utility is not stated or cannot be inferred, the invention is
not recognized as an invention ‘capable of being industrially
applied’ under the provisions of Article 29(1) of the Patent
Law.
25
53
2.3.3 Novelty
According to the provisions of Article 29(1) of the
Patent
5
Law,
the
novelty
of
inventions
relating
to
microorganisms is judged as follows:
(1) Invention of microorganism per se
① Strains
When a known strain and an invented strain have the same
10
microbiological characteristics, the invention is not novel.
[note] Here, a strain means a specific strain having
certain mycological property.
② Species
When a known species and an invented species have the
15
same microbiological characteristics, the invention is not
novel.
③ Strains and species
An invention relating to a known species and an invention
of a strain falling into the species are not novel.
20
However,
if a claimed strain has advantageous effects over the known
species, the invention is novel.
(2) Inventions relating to use of microorganisms
When the object substance is the same, the novelty of the
25
invention is judged by the novelty of the microorganism that
54
is used (See (1) Invention of microorganism per se)
2.3.4
5
An
Inventive step
inventive
step
of
an
invention
relating
to
a
microorganism is examined by the provisions of Article 29(2)
of the Patent Law, as follows:
(1) Invention of microorganism per se
10
An inventive step of an invention of microorganism per se
should
be
characteristics
examined
or
based
other
on
the
characteristics,
microbiological
or
the
effects
produced by the use of the microorganism.
① New species
15
An
invention
of
a
new
species
whose
microbiological
characteristics are remarkably different from those of a known
species has an inventive step.
② When a new species has advantageous effects in the use
20
thereof, the invention of the new species has an inventive
step even if the microbiological characteristics of the new
species are not remarkably different from those of a known
species.
� A microorganism obtained by mutating a known species
25
has remarkably high metabolic productivity.
55
(2) When the microorganism that is used has an inventive step
and when the microorganism that is used is known
① When the microorganism that is used is new
5
When
the
microbiological
characteristics
of
the
microorganism that is used are remarkably different from those
of a known species, the invention of the new microorganism has
an inventive step even if the object substances are same.
[note] Even if the object substances are the same and the
10
microorganisms that are used fall into the same genus, the
invention of the new species has an inventive step in view of
the fact that the invention invents a new species and provides
a new industrial use.
15
② When the microorganism that is used is a taxonomically
known species and falls into the same genus as another known
microorganism
that
produces
the
object
substance,
the
invention of the new species does not have an inventive step.
However, when using the former microorganism has advantageous
20
effects
over
the
use
of
the
latter
microorganism,
the
invention of the new species has an inventive step.
2.4 Amendment of Specification
25
The following amendments do not meet the provisions of
56
Article 47 of the Patent Law and thus, are regarded as the
addition of new matter.
(1) An amendment listing new microbiological characteristics
5
of a microorganism is regarded as the addition of a new matter
when the microbiological characteristics of the microorganism
are not described or are insufficiently described in the
specification as filed.
10
(2) An amendment adding a means of obtaining the starting
microorganism or the product (Deposit number, etc.) or
a
producing means is regarded as the addition of new matter when
the means of easily obtaining the starting microorganism or
the means of easily producing the product from the starting
15
substance is not described in the specification as filed.
However, the late submission of a deposit certificate is not
regarded as the addition of new matter when the deposition of
the microorganism and the deposit number are described in the
specification as filed.
20
(3) An amendment listing a new use for a microorganism is
regarded as the addition of new matter when the utility of the
microorganism is not described in the specification as filed.
[note]
25
This
‘amendment
of
specification’
applies
to
applications filed after July 1, 2001; existing guidelines for
57
judging change of gist apply to applications filed before June
30, 2001.
58
3. Inventions relating to plants
This
guideline
deals
with
the
following
inventions
relating to ‘asexually reproducible variant plants’ defined by
5
the provisions of Article 31 of the Patent Law.
【note
1]
Asexual
reproduction,
or
vegetative
propagation, the opposite of sexual reproduction, produces
next generation plants from vegetative parts without breeding.
Asexual reproduction can reproduce variant plants regardless
10
of the existence or non-existence of breeding variant plants.
【note 2] Inventions relating to variant plants mean
inventions to plants of which one or more characteristics
among genetically expressed characteristics are expressed, and
which are stably and distinguishably reproducible.
15
① Inventions of variant plants per se or parts of
variant plants
② Inventions of method for breeding variant plants
③ Inventions
20
of
method
for
asexually
reproducing
variant plant
However, as to undifferentiated plant cells and plant
tissue cultures, reference should be made to the relevant
parts of ‘2. Inventions relating to microorganisms’.
59
3.1
Requirements
for
the
Description
of
the
Specification
3.1.1
Plants
5
Designation of plants
should
be
specified
by
accordance with botanical nomenclature.
scientific
names
in
The Italic scientific
names in parenthesis follow the Korean names.
3.1.2 Scope of Claims
Claims
10
are
to
be
clearly
and
simply
described
with
matters essential to the structure of the invention, and the
matters supported by the detailed description of the invention
are to be clearly understood from the claims.
Therefore,
claims which do not meet the following requirements are in
15
violation of Article 42(4) of the Patent Law.
(1)
Invention of variant plants per se or parts of variant
plants
As to an invention relating to a variant plant per se or
20
parts of variant plants, the following should be described to
clarify the structure of the invention.
① Name of plant
② Characteristics of the plant or a gene having the
25
characteristics
60
③ Method of asexual reproduction
�1. A variant rose having the characteristics A, B, C
····· and being asexually reproduced by stem cutting
�2. A plant falling into OO rose, the plant having the
5
distinctive
characteristics
of
XX…
and
being
asexually
reproduced by stem cutting.
However, a breeding method can be added.
(2)
10
Inventions of breeding variant plants
As to an invention of a method for breeding variant
plants, the following should be described to clarify the
structure of the invention.
① Steps of the breeding process
② Concrete conditions for the breeding method, such as
15
environment
③
Characteristics
of
basis
for
selection
(objective
index)
� A method for breeding a variant rose asexually
reproduced
20
by
stem
cutting,
wherein
OO
㎖
of
O
colchicines is sprayed OO times for O hours a day on OO
part of OO rose species and the rose species has OO
disease resistance.
[note] However, the detailed description should provide
experimental data, etc., to substantiate the description of
25
the breeding means.
61
(3) Inventions of method for asexual reproduction of variant
plants
As to an invention relating to a method for asexual
5
reproduction
of
variant
plants,
the
following
should
be
described to clarify the structure of the invention.
① Characteristics
of
the
plant
or
a
gene
of
the
characteristics
② Method of asexual reproduction
�
10
A
method
for
asexually
reproducing
a
variant
begonia with leaf cutting, wherein the variant begonia has the
characteristics of A, B, C ··· over A begonia.
3.1.3
Detailed description of invention
15
In the detailed description of the invention, the object,
structure
and
effect
shall
be
stated
in
such
a
manner
sufficiently clear for the invention to be carried out by a
person having ordinary knowledge in the art to which the
20
invention pertains.
A detailed description of the invention
which does not meet the following requirements violates the
provisions of Article 42(3) of the Patent Law.
(1) The detailed description shall be stated in a manner
25
sufficiently
clear
and
complete
62
for
the
invention
to
be
carried out by a person in the art.
As
to
an
invention
of
a
variant
plant
per
se,
a
reproduction of an invention can be demonstrated in the case
where the same result is reproduced when repeating the same
5
breeding process using the same genetic resource.
Accordingly, as to an invention of a variant plant per
se, the detailed description should state the characteristic
gene, the features thereof,
selection
10
process
in
the breeding process and the
detail.
When
a
third
party
has
difficulty in producing the final plant from the description,
the statement that the cell producing the variant plant is
deposited
with
a
depository
institution
according
to
the
provisions of Article 2 of the Enforcement Decree of the
Patent Law must be found in the specification as filed.
15
(See
2. ‘Deposition and Allocation of Microorganisms, etc.’)
The function or utility of the claimed invention of a
plant should be described.
(2) The technical problem to be solved is described as follows
20
① Characteristics of known plant to be improved
② Concrete method of improving specific characteristics
③ Concrete method to asexually reproduce a variant plant
25
(3) The means for solving the technical problem, i.e., names
63
of the variant plant (scientific name according to botanical
nomenclature),
characteristics,
breeding
method,
asexual
reproduction method, breeding condition, use, etc., should be
concretely described.
5
① Description of Characteristics
The
characteristics
specify
a
plant,
therefore,
all
characteristics of parts should be described in detail in
comparison with those of known plants.
In addition, the
description should specifically state numeric values actually
10
obtained through measurements, or the official standard, etc.
� Characteristics as a fruit tree: description of
figure,
vitality,
disease
tolerance,
yield
amount
(total
number of fruits produced per stock), branch parts, leaf
parts, etc.
15
Flower: size, type, color, pollen amount, etc.
Fruit: age of maturity, weight of one fruit, flavor
of juice, type of flesh, color of flesh, etc.
Root: Shape, type, etc. of a root
20
② Description of breeding method for variant plant
To describe the method of breeding a variant plant,
species
selected
crossbreeding,
25
the
for
crossbreeding,
standard
for
the
selecting
individual, etc. should be described in detail.
64
process
a
of
variant
However, if
the parent is novel, the means of obtaining it should be
described in detail.
③ Description of method for asexual reproduction of
5
variant plants
To describe a method for the asexual reproduction of a
variant plant, the part used for reproduction, the method for
asexual
reproduction,
other
environmental
conditions,
etc.
should be described in detail.
10
④ Description of breeding conditions of variant plants
As for the breeding conditions of a variant plant, the
required
items
among
temperature
(atmosphere
temperature,
earth temperature), humidity, light, sunshine duration, soil
15
properties,
environmental
conditions,
seeding,
fertilizer
application, watering, etc. should be described.
⑤ Description of use of variant plants
As to the use of a variant plant, the use of a plant,
20
such as food, processed food (canned food, juice, ..), etc. in
plants for food, herb medicine, processed medicine, etc., in
medicinal plants, and flower arrangement, dwarfed tree, ,
flower bed, etc. in ornamental plant, should be described.
25
(4) Effect of invention should be described as follows:
65
The effect of an invention of a variant plant per se and
an invention of a method for breeding a variant plant is the
characteristic of the effect per se or what can be obviously
drawn from the characteristics.
5
The effect of an invention of
a method for asexually breeding a variant plant, that is, the
maintenance, proliferation, etc. should be described.
[note] In this case, because the effect of an invention
is
obviously
drawn
from
the
characteristics,
the
characteristics could be both a structure of an invention and
10
the effect of the invention.
3.1.4 Drawings
As to an invention relating to a variant plant, drawings
or photographs of whole plants or individual parts of the
15
plant could be added to aid in understanding the technical
matters with respect to the structure.
3.2
Unpatentable inventions
Inventions relating to plants liable to contravene public
20
order or morality or to harm public health as follows shall
not be patentable according to the provision of Article 32 of
the Patent Law.
(1) An invention relating to a plant liable to destroy an
25
ecosystem
66
(2)
An
invention
relating
to
a
plant
liable
to
cause
environmental pollution
(3) An invention relating to a plant liable to harm human
beings
5
(4) An invention likely to cause an unpleasant feeling
3.3
Requirements for Patentability
3.3.1 Constitutionality of invention
10
A mere discovery of a variant plant does not meet the
requirement provided in the provisions of Article 29(1) of the
Patent Law.
15
� A mere discovery of a mutant plant, without an
artificial production process (breeding means)
3.3.2 Industrial application
20
When an invention relating to plants does not include a
description
of
the
utility,
and
the
utility
cannot
be
inferred, the invention is not recognized as an industrially
applicable invention under the provisions of Article 29(1) of
the Patent Law.
25
67
3.3.3 Inventive step
According to the provisions of Article 29(2) of the
Patent Law, the
5
inventive step of inventions relating to
plants is examined as follows:
(1) As to bred variant plants per se, the inventive step
should be examined on the basis of characteristics.
① Plants for food: Characteristics such as quantity and
numbers of contained nutrients, etc.
10
② Medicinal
plants:
Characteristics
such
as
content,
quantity, etc. of medicinally effective ingredient.
③ Dwarf
plants:
characteristics
such
as
color,
type,
numbers, etc.
15
3.4
Amendment of Specification
The following amendments do not meet the provisions of
Article 47 of the Patent Law and thus, are regarded as the
addition of new matter.
20
(1) When the characteristics, breeding method and asexual
reproduction method are not sufficiently described, so that a
person
skilled
in
the
art
cannot
easily
carry
out
the
invention, an amendment adding them is considered the addition
25
of new matter.
68
(2) As to an invention which requires the deposition of cells,
etc. capable of producing variant plants, an amendment adding
the deposit number which is not described in the specification
as filed is regarded as the addition of new matter.
5
However,
the late submission of a deposit certificate is not regarded
as the addition of new matter when the deposition of the
microorganism and the deposit number are described in the
specification as filed.
10
(3) An amendment adding a use of a variant plant is regarded
as the addition of new matter when the use of the variant
plant is not described in the specification as filed.
[note]
This
‘amendment
of
specification’
applies
to
applications filed after July 1, 2001; existing guidelines for
15
determining a
change of gist apply to applications filed
before June 30, 2001.
69
4. Inventions relating to animals
This section deals with inventions of animals per se,
those relating to parts of animals, those of a process for
5
creating animals, and those relating to the use of animals
(Hereinafter ‘Invention relating to animals’).
[note]
Here,
‘animals’
means
multicellular
animals
excluding humans.
With
10
regard
to
inventions
relating
to
genetic
engineering, reference should be made to the relevant parts of
‘1. Inventions relating to Genetic Engineering’.
4.1
Requirements
for
the
Description
of
the
Specification
15
4.1.1
Animals
accordance
Designation of Animals
should
with
be
specified
zoological
by
scientific
nomenclature.
names
The
in
Italic
scientific names in parentheses follow the Korean names.
20
4.1.2
Scope of Claims
The claims are to be clearly and simply described with
matters essential to the structure of the invention, and the
matters supported by the detailed description of the invention
70
are to be clearly understood from the claims.
Therefore,
claims which do not meet the following requirements are in
violation of Article 42(4) of the Patent Law.
(1) In the case of an invention of an animal, the animal
5
should be specified by the animal name, the unique gene for
the animal, the characteristics of the animal and the process
for creating the animals.
An deposit institution for the
animal (fertilized eggs) and the deposit number may be added
thereto.
10
[note] The name of animals can be specified by the
scientific name according to the zoological nomenclature or
standard Korean names.
�1. A diabetes mellitus-generating gene transgenic
mouse, the reproductive cells and somatic cells of which
15
carry a recombinant DNA comprising a 2.3kb BamHI-HindII
fragment of a human heat shock protein 70 linked to a
1.8kb HindIII-EcoRI fragment of a human insulin promoter
gene, said DNA being introduced into an embryonic stage
of the gene transgenic mouse.
20
�2. A transgenic mouse, prepared by microinjecting a
recombinant vector Pbgl2 (kctc 8756p) into a C57BL X CBA
lineage fertilized mouse egg and nidating the egg in a
fertile female mouse.
�3. A transgenic mouse (Mus musculus), prepared by
25
introducing a human beta interferon gene into a fertilized egg
71
therefor, the human beta interferon gene-induced fertilized
egg has a deposit number of ATCC OOOO, in which the human beta
interferon gene is carried by somatic cells and reproductive
cells thereof and is expressed at a level sufficient to show
5
anti-viral activity
(2) As to an invention of a process for creating an animal,
the process for creating the animal should be described step
by step.
The characteristics for the basis of the selection
of production conditions, such as the environment, should be
10
described, if necessary.
4.1.3
Detailed description
In the detailed description of the invention, the object,
structure and effect shall be stated in a manner sufficiently
15
clear for the invention to be carried out by a person having
ordinary knowledge in the art to which the invention pertains.
A detailed description of the invention that does not meet the
following
requirements
violates
the
provisions
of
Article
42(3) of the Patent Law.
20
(1) The detailed description shall be stated in such a manner
sufficiently
clear
and
complete
for
the
invention
to
be
carried out by a person skilled in the art.
With
respect
to
inventions
of
animals,
the
detailed
description should be clearly stated as to the method for
25
creating and/or using the animal.
72
As
to
inventions
relating
to
animals,
the
original
specification should state that the starting substances could
be easily obtained or deposited with a depository institution
according to the provisions of Article 2 of the Enforcement
5
Decree of the Patent Law.
The detailed description and the
drawings should concretely state the method of obtaining the
starting substances and the means of easily carrying out the
invention.
However, as to the invention of an animal, in the case
10
where a description only on paper may make it difficult to
sufficiently describe or easily execute the invention with
reference to the described matter, or where a large amount of
trial and error is entailed, the carrying out of the invention
may
15
be
supported
by
depositing
fertilized
eggs
with
a
depository institution (See Appendix 2 ‘Deposit and Furnishing
microorganism, etc.’).
The function or usefulness of the claimed invention of an
animal should be described.
(2)
The name of the created animal should be described.
The name of the created animal should be stated in the
20
form of a scientific name according to zoological nomenclature
and standard Korean names.
(3)
The
characteristics
of
a
created
animal
should
be
described.
25
All characteristics of an animal should be described,
73
specifically stating numeric values actually obtained through
measurements, and giving a detailed comparison with those of
known animals.
(4)
5
Specific
breeding
conditions
should
be
concretely
described according to need.
When
a
specific
characteristic
is
expressed
under
a
specific environment or a specific breeding condition, the
environment and the condition should be concretely described.
10
(5)
Industrial application should be concretely described.
4.1.4 Drawings
As to an invention relating to animals, drawings or
15
photographs of an animal could be added to make the technical
matter understandable with respect to the structure.
4.2
20
Unpatentable Inventions
Inventions
relating
to
animals
liable
to
contravene
public order or morality or to harm public health as follows
shall not be patentable according to the provision of Article
32 of the Patent Law.
However, research works approved under
the provisions of ‘Law relating to Life Morals and Safety’ are
25
excluded.
74
(1)
An invention relating to an animal liable to destroy an
ecosystem
(2)
An
invention
relating
to
an
animal
liable
to
cause
environmental pollution
5
(3)
An invention relating to an animal liable to harm human
beings
(4)
An
invention
relating
to
an
relating
to
an
animal
liable
to
cause
unpleasant feeling.
(5)
10
An
invention
negligible
beneficial
effect
animal
compared
liable
to
the
level
with
give
of
cruelty to the animal.
(6)
An invention relating to an animal not excluding human
beings
(7)
15
A process for reproducing a human being, a process for
transferring a genetic identity of a human reproductive cell
system, and products thereof
(8)
A
behavior
or
research
work
prohibited
by
‘Korean
Bioethics and Biosafety Law
20
4.3 Requirements for Patentability
4.3.1 Constitutionality of Invention
The
mere
discovery
of
an
animal
does
not
meet
the
requirement provided in the provisions of Article 29(1) of the
25
Patent Law.
75
� A mutant animal that is merely discovered without
artificial producing means thereof.
4.3.2
Industrial Application
When an invention relating to an animal does not include
5
a
description
of
the
utility,
or
the
utility
cannot
be
inferred, the invention is not recognized as an industrially
applicable invention under the provisions of Article 29(1) of
the Patent Law.
10
4.3.3
Inventive Step
According to the provisions of Article 29(2) of the
Patent
Law,
an
inventive
step
of
inventions
relating
to
animals is examined as follows:
15
(1)
Invention of animals per se
An inventive step of an invention relating to an animal
per se should be examined based on the characteristics of the
animal in comparison with those of known animals, and the
20
effects produced by the use of the animal.
① When the characteristics of a created animal
could not be easily foreseen from a known animal falling
under
the
same
species,
the
created
animal
has
an
inventive step.
25
② When a created animal has advantageous effects,
76
the animal has an inventive step.
(2)
Inventions of method for creating animals
An
5
inventive
step
of
an
invention
of
a
method
for
creating an animal should be examined on the basis of the
difficulty in means, condition, etc. of each step of a method
for creating the new animal and the inventive step of the
created animal.
4.4 Amendment of specification
10
The following amendments do not meet the provisions of
Article 47 of the Patent Law and thus, are regarded as the
addition of new matter.
15
(1)
When the characteristics and creation method of an animal
are not sufficiently described in the specification as filed,
an amendment adding them is regarded as the addition of new
matter.
20
(2)
As to an invention which requires the deposition of a
cell, etc. capable of creating an animal, an amendment adding
the
deposition
number
which
was
not
described
in
the
specification as filed is regarded as the addition of a new
25
matter.
However, the late submission of a deposit certificate
77
is
not
regarded
as
the
addition
of
new
matter
when
the
deposition of the microorganism and the deposit number are set
forth in the specification as filed.
5
(3)
An amendment adding the utility of an animal is regarded
as the addition of new matter when the utility of the plant is
not described in the specification as filed.
[note]
This
‘amendment
of
specification’
applies
to
applications filed after July 1, 2001; existing guidelines for
10
judging change of gist apply to applications filed before June
30, 2001.
78