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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 25 ‘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 15 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 15 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 5 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 10 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. 15 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 7 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. 20 (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: 15 (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 20 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. 25 (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 20 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 20 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