@@  PROVISIONAL TRANSLATION


When any ambiguity of interpretation is found in this translation        
the Japanese text shall prevail.


Implementing Guidelines for Inventions in Specific Fields

Chapter 2  Biological Inventions

     In this chapter, matters requiring special judgement and handling in examining patent applications 
relating to biological inventions are mainly explained. 
     Here, the term "organisms" means microorganisms, animals as well as plants, including reproducible 
animal or plant cells.
     In this chapter, "Implementing Guidelines" means "Section 1. Implementing Guidelines for 1994-
Revised Section 36 of the Patent Law" in "Practices in Examination and Appeals under 1994-Revised 
Patent Law (May 1995, the Japanese Patent Office)."

1. Genetic Engineering

     This section deals with inventions relating to genetic engineering in biological inventions. The term 
"genetic engineering" here means the technology which manipulates genes artificially by gene 
recombination, cell fusion, etc.
     Inventions relating to genetic engineering include those of a gene, a vector, a recombinant vector, a 
transformant, a fused cell, a protein which are obtained by transformation (hereinafter, referred to as "a 
recombinant protein"), a monoclonal antibody, etc.
     Inventions relating to microorganisms, plants and animals, and which are obtained using genetic 
engineering are treated here in this section, in principle.

1.1  Description Requirements for the Specification

1.1.1  Scope of Claim (See Implementing Guidelines, Chapter 1-2.2.2.)

@@ According to Section 36(6)(ii) of the Patent Law, the invention for which a patent is sought shall be 
clear, therefore, scope of claim shall be described that an invention shall be clearly identified on the basis of 
statements of each claim.
     In a claim, a gene, a vector, a recombinant vector, a transformant, a fused cell, a recombinant protein 
and a monoclonal antibody should be described as indicated below.

(1) Genes

1)  A gene may be described by specifying its base sequence.

2)  A structural gene may be described by specifying an amino acid sequence of the protein encoded by 
the said gene.

Example: 
     A gene encoding a protein consisting of an amino acid sequence represented by Met-Asp-₯₯₯₯₯₯-
Lys-Glu.

3)  A gene may be described by a combination of the terms "substitution, deletion or addition" or 
"hybridize" and functions of the gene, and if necessary, origin or source of the gene in a generic form as 
follows (provided that the claimed invention is clear and the enablement requirement is met (See 1.1.2.1 
below)).

Example 1:
     A gene encoding a protein of (a) or (b) as follows:
     (a) a protein whose amino acid sequence is represented by Met-Tyr-₯₯₯₯₯₯-Cys-Leu
     (b) a protein derived from the protein of (a) by substitution, deletion or addition of one or several 
amino acids in the amino acid sequence defined in (a) and having the activity of enzyme A.
[Note]
      The protein (a) has the activity of enzyme A.
      The gene encoding the protein (b) is described in the detailed description of the invention in such a 
manner that a person skilled in the art can make the said gene without large amount of trials and errors or 
complicated experimentations beyond the reasonable extent that can be expected from a person skilled in 
the art who is supposed to have ordinary skill.

Example 2:
     A gene selected from the group consisting of:
     (a) a DNA whose nucleotide sequence is represented by ATGTATCGG₯₯₯TGCCT
     (b) a DNA which hybridizes under stringent conditions to the DNA defined in (a) and encodes the 
human protein having the activity of enzyme B.
[Note]
     A protein encoded by the DNA (a) has the activity of enzyme B.
     "Stringent conditions" are described in the detailed description of the invention.

4)  A gene may be described by specifying functions, physiochemical properties, origin or source of the 
said gene, a process for producing the said gene, etc. (provided that the claimed invention is clear and the 
enablement requirement is met (See 1.1.2.1 below)).

(2) Vector

     A vector should be described by specifying a base sequence of its DNA, a cleavage map of DNA, 
molecular weight, number of base pairs, source of the vector, process for producing the vector, function or 
characteristics of the vector, etc.
[Note]
     A cleavage map is a map which shows the relative location and distance of the cleavage sites by 
various restriction enzymes.

(3) Recombinant vector

     A recombinant vector may be described by specifying at least one of the gene and the vector.

Example:
     A recombinant vector containing a DNA whose base sequence is represented by ACAGCA₯₯₯₯₯₯
AGTCAC.

(4) Transformant

     A transformant may be described by specifying at least one of 1) its host and 2) the gene which is 
introduced (or the recombinant vector) (provided the that the claimed invention is clear and enablement 
requirement is met (See 1.1.2.1 below)).

Example 1:
     A transformant comprising a recombinant vector containing a gene encoding a protein whose      
amino acid sequence is represented by Met-Asp-₯₯₯₯₯₯Lys-Glu.

Example 2:
     A plant wherein a toxin gene having a base sequence of ATGACT₯₯₯₯₯₯ is inserted and the said 
gene is expressed.

Example 3:
     A transgenic non-human mammal, having a recombinant DNA obtained by linking a           
structural gene encoding any protein to the regulatory region of a gene involved in the         
production of milk protein, and secreting the said protein into milk.
 
(5) Fused cell

     A fused cell may be described by specifying parent cells, function and characteristics of the fused 
cell, or a process for producing the fused cell, etc.

(6) Recombinant protein 

    1) A recombinant protein may be described by specifying an amino acid sequence or a base sequence 
of structural gene encoding the said amino acid sequence.

Example:
     A recombinant protein consisting of an amino acid sequence represented by Met-Tyr-₯₯₯₯₯₯-Cys-
Leu.

    2) A recombinant protein may be described by a combination of the terms "substitution, deletion or 
addition" and functions of the recombinant protein, and if necessary, origin or source of the recombinant 
protein in a generic form as follows (provided that the claimed invention is clear and the enablement 
requirement is met (See 1.1.2.1 below)).

Example:
     A recombinant protein of (a) or (b) as follows:
     (a) a protein whose amino acid sequence is represented by Met-Tyr-cc-Cys-Leu
     (b) a protein derived from the protein of (a) by substitution, deletion or addition of one or several 
amino acids in the amino acid sequence in(a) and having the activity of enzyme A.

[Note]
      A protein (a) has the activity of enzyme A.
      The protein (b) is described in the detailed description of the invention in such a manner that a 
person skilled in the art can make the said protein without a large amount of trials and errors or complicated 
experimentations beyond the reasonable extent that can be expected from a person skilled in the art who is 
supposed to have ordinary skill. 

    3) A recombinant protein may be described by specifying functions, physiochemical, origin or source 
of the said recombinant protein, a process for producing the said recombinant protein, etc. (provided that 
the claimed invention is clear and the enablement requirement is met (See 1.1.2.1 below)).

(7) Monoclonal antibody

     A claim directed a monoclonal antibody may be defined by specifying any of antigen recognized by it, 
hybridoma which produces it, or cross-reactivity, etc.

Example 1:
     A monoclonal antibody to antigen A.
     [Note] Antigen A is necessary to be defined by specifying as a substance.

Example 2:
     A monoclonal antibody to antigen A, produced by a hybridoma having ATCC Deposit No. HB-xxxx.
     [Note] Antigen A is necessary to be defined by specifying as a substance.

Example 3:
     A monoclonal antibody which binds not to antigen B but to antigen A.
     [Note] Antigen A and antigen B are necessary to be defined by specifying as substances.

1.1.2  The Detailed Description of the Invention  (See Implementing Guidelines, Chapter 1-3.)

     The detailed description of the invention shall be stated in such a manner sufficiently clear and 
complete for the invention to be carried out by a person having ordinary skill in the art to which the 
invention pertains (the enablement requirement), and shall be stated that the problem to be solved by the 
invention and its solution, or other matters necessary for a person having ordinary skill in the art to 
understand the technical significance of the invention (the Ministerial Ordinance Requirement).
     The detailed description of the invention which does not meet the above requirements violates 
Section 36(4) of the Patent Law.

1.1.2.1  Enablement Requirement (See Implementing Guidelines, Chapter 1-3.2.)

     Section 36(4) of the Patent Law states that  "the detailed description of the invention shall be 
stated .... in such a manner sufficiently clear and complete for the invention to be carried out by a person 
having ordinary skill in the art to which the invention pertains."
     This means that "the detailed description of the invention shall be described in such a manner that a 
person who has ability to use ordinary technical means for research and development (including 
comprehension of document, experimentation, analysis and manufacture) and to exercise ordinary 
creativity in the art to which the invention pertains can carry out the claimed invention on the basis of 
matters described in the specification (excluding claims) and drawings taking into consideration the 
common general knowledge as of the filing."
   @Therefore, if "a person skilled in the art" who is supposed to have ordinary skill cannot understand 
how to carry out the invention on the basis of teachings in the specification (excluding claims) and 
drawings taking into consideration the common general knowledge as of the filing, then, such a description 
of the invention should be deemed insufficient for enabling such a person to carry out the invention. For 
example, if a large amount of trials and errors or complicated experimentations are needed to find a way of 
carrying out the invention beyond the reasonable extent that can be expected from a person skilled in the art 
who is supposed to have ordinary skill, the detailed description of the invention is not described in such a 
manner that enables a person skilled in the art to carry out the invention.

1.1.2.1.1  An Invention of a Product (See Implementing Guidelines, Chapter 1-3.2.1(2).)

     For an invention of a product, the definition of carrying out the invention is to make and use the 
product. That a product can be used is interpreted as meaning that a product can be used in an industrially 
applicable way. Also, the said invention of a product should be explained clearly in the detailed description 
of the invention.
     Therefore, an invention of a gene, a vector, a recombinant vector, a transformant, a fused cell, a 
recombinant protein, a monoclonal antibody, etc. should be described as follows.

(1) "An invention of a product" being explained clearly

     If an invention of a product can be identified by a person skilled in the art based on the statements of 
a claim and can be understood from the statements and implications in the detailed description of the 
invention, then, the invention will be deemed as being explained clearly.

(2) "Can be made"

     For an invention of a gene, a vector, a recombinant vector, a transformant, a fused cell, a recombinant 
protein or a monoclonal antibody, the way of making the product shall be described in the detailed 
description of the invention except where the product could be made by a person skilled in the art without 
such description when taking into account the overall descriptions of the specification (excluding claims), 
drawings and common general knowledge as of the filing.

1) Gene, vector or recombinant vector

     A process for producing a gene, a vector or a recombinant vector should be described by respective 
origin or source, means for obtaining a vector to be used, an enzyme to be used, treatment conditions, steps 
for collecting and purifying it, or means for identification, etc.

     If genes are claimed in a generic form (See 1.1.1(1)3)) and a large amount of trials and errors or 
complicated experimentations are needed to produce those genes beyond the reasonable extent that can be 
expected from a person skilled in the art, the detailed description of the invention is not described in such a 
manner that enables a person skilled in the art to make the product.
     For example, in case that a claimed invention includes the gene actually obtained and many of genes 
whose identity is extremely low to the said gene obtained and is specified by their function and that as a 
result, many of genes which do not have the same function as the said gene obtained are included in the 
genes whose identity is extremely low, a large amount of trials and errors or complicated experimentations 
are generally needed to select the genes with the same function as the said gene obtained among the genes 
whose identity is extremely low beyond the reasonable extent that can be expected from a person skilled in 
the art, and therefore, the detailed description of the invention is not described in such a manner that 
enables a person skilled in the art to make the product.

[Example]
    A gene selected from the group consisting of:
    (a) a DNA whose nucleotide sequence is represented by ATGTATCGGcTGCCT
    (b) a DNA whose nucleotide sequence has more than X% identity to that of (a) and which encodes the 
protein having the activity of enzyme B.
[Note]
    A protein encoded by the DNA (a) has the activity of enzyme B.
    X% represents extremely low identity.

[Explanation]
@@Genes whose identity is extremely low to the gene actually obtained are included in the (b), although 
(b) is specified by its function. In case that " A DNA whose nucleotide sequence has more than X % identity 
to that of (a)" includes many of genes which do not have the activity of enzyme B, a large amount of trials 
and errors or complicated experimentations are generally needed to select the genes with the activity of 
enzyme B beyond the reasonable extent that can be expected from a person skilled in the art. Therefore, the 
detailed description of the invention is not described in such a manner that enables a person skilled in the 
art to make the product.

2) Transformant

     A process for producing a transformant should be described by a gene or a recombinant vector 
introduced, a host (a microorganism, a plant or an animal), a method of introducing gene or the 
recombinant vector into the host, a method of selectively collecting the transformant, or means for 
identification, etc.
     If the transformant is the one described by a generic taxonomical unit (e.g., a transformed plant, a 
transformed non-human vertebrate, a transformant (including microorganisms, plants and animals)), and if 
a large amount of trials and errors or complicated experimentations are needed to produce those 
transformants beyond the reasonable extent that can be expected from a person skilled in the art,  the 
detailed description of the invention is not described in such a manner that enables a person skilled in the 
art to make the product.

3) Fused cell

     A process for producing a fused cell should be described by stating pretreatment of the parent cells, 
fusion condition, a method of selectively collecting the fused cell, or means for identification, etc.

4) Recombinant protein

     A process for producing a recombinant protein should be described by stating means for obtaining a 
gene encoding the recombinant protein means for obtaining, an expression vector used, means for 
obtaining a host, a method for introducing the gene into the host, steps for collecting and purifying the 
recombinant protein from the transformant into which the gene has been introduced, or means for 
identification of the obtained recombinant protein, etc.
(See "1)  Gene, vector or recombinant vector" for the treatment of enablement requirement in case that 
recombinant proteins are claimed in a generic form.)
 
5) Monoclonal antibody

     A process for producing a monoclonal antibody should be described by stating means for obtaining 
or producing immunogen, a method for immunization, a process for selectively obtaining antibody 
producing cells, or means for identification of the monoclonal antibody, etc.

6) Deposit of microorganisms, etc. (For the detail of deposit and furnishing of microorganisms etc., see 
2.1.3.1.1 (2) 1) Deposit and Furnishing of Microorganisms.)

(a)   For an invention of a gene, a vector, a recombinant vector, a transformant, a fused cell, a 
recombinant protein, a monoclonal antibody, etc. produced by the use of a microorganism, etc. ( "a 
microorganism, etc." here includes a microorganism, a plant and an animal), a process for producing the 
said product should be described in the specification as filed so that a person skilled in the art can make it. 
Further, the microorganism used in the process should be deposited and its accession number should be 
described in the specification as filed unless the microorganisms readily available to a person skilled in the 
art (See 2.1.3.1.1(2) 1)(ii)).
 
(b)   For an invention of a gene, a vector, a recombinant vector, a transformant, a fused cell, a 
recombinant protein, a monoclonal antibody, etc., when it is not possible to describe a process for 
producing the said product in the specification in such a manner that a person skilled in the art can make it, 
the obtained transformant (including a transformant which produces a recombinant protein) or the fused 
cell (including a hybridoma which produces a monoclonal antibody) into which the gene, the vector, the 
recombinant vector has been introduced, should be deposited and its accession number should be described 
in the specification as filed.

(c)   Generally, the obtainment of a hybridoma producing a monoclonal antibody which satisfies 
limitative conditions, (e.g., a monoclonal antibody whose affinity to the antigen A is specified by the 
limitative coupling constant,) is not reproducible. Therefore, in case that the claimed invention is related to 
a monoclonal antibody which satisfies limitative conditions or a hybridoma producing the said monoclonal 
antibody, the said hybridoma should be deposited and its accession number should be described in the 
specification as filed, except where the hybridoma can be created by a person skilled in the art on the basis 
of the description in the specification.

(3) "Can be used"

     For an invention of a gene, a vector, a recombinant vector, a transformant, a fused cell, a recombinant 
protein, a monoclonal antibody, etc., in order to show the industrial applicability of the product, the way of 
industrial application of it shall be described in the detailed description of the invention except where it 
could be understood by a person skilled in the art without such description when taking into account the 
overall descriptions of the specification (excluding claims), drawings and common general knowledge as of 
the filing.
     For instance, in order to show the industrial applicability of the invention of a gene, it should be 
described in the detailed description of the invention that the gene has the specific function (in case of a 
structural gene, the protein encoded by the said gene has the specific function).
     In case that genes are claimed in a generic form and the function is not specified in the claim (genes 
specified only by "substituted, deleted or added," "hybridized" or "having more than X% identity," etc.), the 
genes claimed in a generic form contain the ones which do not have the said function and the part of the 
said genes cannot be used, and therefore, the detailed description of the invention is not described in such a 
manner that enables a person skilled in the art to use the product.

1.1.2.1.2  An Invention of a Process (See Implementing Guidelines, Chapter 1-3.2.1(3).)

     For an invention of a process, the definition of carrying out the invention is to use the process and 
that a process can be used is interpreted as meaning that a process can be used in an industrially applicable 
way. Further, the said invention of a process should be explained clearly in the detailed description of the 
invention. In order to describe the invention of the process in such a manner that the process can be used in 
an industrially applicable way, the enablement requirement in "1.1.2.1.1 An Invention of a Product" should 
be referred to, if necessary. For instance, "1.1.2.1.1(2) 6) Deposit of microorganisms, etc." should be 
referred to if deposit of microorganisms, etc. is necessary.

1.1.2.1.3  An Invention of a Process for Manufacturing a Product@(See Implementing Guidelines, Chapter 
1-3.2.1(4).)

     Where an invention of a process is directed to "a process for manufacturing a product," the definition 
of "the process can be used" means that the product can be manufactured by the process and either the 
process or the product shall be industrially applicable to meet industrial application. Further, the said 
invention of a process for manufacturing a product should be explained clearly.
     Therefore, for an invention of a process for producing a gene, a vector, a recombinant vector, a 
transformant, a fused cell, a recombinant protein, a monoclonal antibody, etc., the said process should be 
explained clearly and the description shall be stated so as to enable a person skilled in the art to produce the 
product by using the said process. In order to be stated so as to enable a person skilled in the art to produce 
the product by using the said process, the enablement requirement in "1.1.2.1.1 An Invention of a Product" 
should be referred to, if necessary. For instance, "1.1.2.1.1(2) 6) Deposit of microorganisms, etc." should be 
referred to if deposit of microorganisms, etc. is necessary.
     Further, it is necessary to describe the industrial applicability of the said process or at least one use of 
the said product.

1.1.2.1.4  How Specifically the Detailed Description of the Invention Must Be Described?@(See 
Implementing Guidelines, Chapter 1-3.2.1(5).)

     It is necessary for the applicant to describe at least one mode for showing how to carry out the 
claimed invention in the detailed description of the invention. When embodiments or working examples are 
necessary in order to explain the invention in such a way that a person skilled in the art can carry out the 
invention, "the mode for carrying out the invention" should be described in terms of embodiments or 
working examples. Embodiments or working examples are those which specifically show the mode for 
carrying out the invention (in case of an invention of a product, for instance, those which specifically show 
how to make the product, what structure it has, or how to use it, etc.) 
     In the case of inventions in technical fields where it is generally difficult to infer how to make and use 
a product on the basis of its structure, normally one or more representative embodiments or working 
examples are necessary which enable a person skilled in the art to carry out the invention.
     Since this technical field (i.e., genetic engineering) is the one where it is difficult to infer how to 
make and use a product on the basis of its structure, normally one or more representative embodiments or 
working examples are necessary.

1.1.2.1.5  Balance of the Claim and the Detailed Description of the Invention (See Implementing 
Guidelines, Chapter 1-3.2.1(6) and 3.2.3.)

     In the detailed description of the invention, at least one mode for carrying out the invention needs to 
be described in terms of "claimed invention." For not all embodiments nor all alternatives within the extent 
(or the metes and bounds) of the claimed invention, the mode for carrying out the invention needs to be 
described.
     However, when the examiner can show well-founded reasons that a person skilled in the art would 
be unable to extend the particular mode for carrying out the invention in the detailed description of the 
invention to the whole of the field within the extent (or the metes and bounds) of the claimed invention, the 
examiner should determine that the claimed invention is not described in such a manner sufficiently clear 
and complete to be carried out by a person skilled in the art. In such a case, the examiner should 
specifically point out a concrete reason and preferably the reason above should be supported by reference 
documents.

1.1.2.2  Ministerial Ordinance Requirement (See Implementing Guidelines, Chapter 1-3.3.)

     Matters required under the Ministerial Ordinance are (1) technical field to which an invention 
pertains and (2) problem to be solved by the invention and its solution.

(1) Technical field to which an invention pertains

     As "technical field to which an invention pertains," at least one technical field to which a claimed 
invention pertains shall be stated in a specification, in principle.
     In the inventions of genetic engineering, "technical field to which an invention pertains" should be 
described such as pharmaceuticals, analytical agents, production of plants, for example.

(2) Problem to be solved by the invention and its solution

     As "problem to be solved by the invention," an application shall state at least one technical problem 
to be solved by a claimed invention, in principle. As "its solution," an application shall explain how the 
technical problem has been solved by the claimed invention.
     For example, in the case of the invention of the process for the production of a plant resistant to 
disease A by using a vector into which disease A-resistant gene B has been inserted, the problem to be 
solved by the invention should be described as "to produce a plant resistant to disease A" and the means for 
solving the problem should be described as "cloning disease-resistant gene B from the chromosomal DNA 
of another plant resistant to disease A, obtaining a recombinant vector inserted by the said gene, and 
regenerating the plant body from the plant cell transformed by the said vector." 

1.1.2.3  Prior Art and Advantageous Effects@(See Implementing Guidelines, Chapter 1-3.3.2(3).)

(1) Prior art

     An applicant should describe background prior art, as far as he knows, which is deemed to contribute 
to understanding the technical significance of the claimed invention and examination of patentability of the 
invention, because such descriptions of prior art could teach the problem to be solved and could substitute 
the descriptions of the problems.
     Also, documents related to prior art are one of the important means for evaluating the patentability of 
the claimed invention. Therefore, when there exist any documents relevant to the claimed invention, it is 
strongly recommended to cite such documents.

(2) Advantageous effects over prior art

     It is an applicant's advantage to describe an advantageous effect of a claimed invention over the 
relevant prior art because such advantageous effect, if any, is taken into consideration as a fact to support to 
affirmatively infer the existence of an inventive step. Therefore, an applicant should describe an 
advantageous effect of a claimed invention over the relevant prior art, if any, as far as he knows.

1.1.3  Sequence Listing

(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 accordance with  "Guidelines for the preparation of specifications 
which contain nucleotide and/or amino acid sequence" published by the Public Notice of Japanese Patent 
Office should be described at the end of the detailed description of the invention as a part of it (See Note 
15e of Form 29, Section 24 of Regulations under the Patent Law, and Note 12e of Form 14, Section 11 of 
Regulations under the Law concerning the Special Provisions to the Procedure, etc. relating to the 
Industrial Property Right). The "Sequence Listing" should be submitted in coding data.
 

(2)   When a nucleotide sequence or an amino acid sequence is described in the scope of claim, the 
sequence described in the "Sequence Listing" prepared in accordance with "Guidelines for the preparation 
of specification which contain nucleotide and/or amino acid sequence" may be cited.

1.2  Unity of Invention
     -applicable to applications filed on or after January 1, 1988-
(See Implementing Guidelines, Chapter 3-2.)

     A single application may be filed for a set of claims describing inventions shown in the following 
examples.

[Example 1]
    1) An invention of a chemical substance produced with the use of a transformant (referred to as the 
"specified invention")
    2) An invention of a structural gene
    3) An invention of a recombinant vector containing the structural gene; and
    4) An invention of a transformant containing the structural gene
 
[Explanation]
     A structural gene has an inherent function of determining the amino acid sequence of a specific 
chemical substance.  Therefore, in providing the specific chemical substance, inventions of a structural 
gene, a recombinant vector containing the structural gene and a transformant containing the structural gene 
have a very close relationship with the chemical substance.  Thus, since it may be considered that the 
inventions of the structural gene, the recombinant vector and the transformant provide means to obtain the 
specific chemical substance, these inventions and the invention of the chemical substance produced with 
the use of the transformant are considered to solve the same problem. Accordingly, the specified invention 
and inventions 2 to 4 above meet the relationship under Section 37(i) of the Patent Law.
     In such a case, a claim directed to a process for producing the structural gene, the recombinant vector, 
or the transformant having the relationship provided in Section 37(iii) of the Patent Law with the 
inventions 2 to 4, for instance, may be included in a single application in accordance with the provision of 
Section 37(v) of the Patent Law.

[Example 2]
     1) An invention of a parent cell (specified invention); and
     2) An invention of a fused cell prepared from the parent cell

[Explanation]
     Since a fused cell contains, in general, the characters of its parent cell as a part of its characters, the 
substantial part of the matters being to be stated in the claim of both inventions is considered to be the same. 
Accordingly, the specified invention and the invention 2 above meet the relationship under Section 37(ii) of 
the Patent Law.

[Example 3]
     1) An invention of a transformant (specified invention)
     2) An invention of a process for manufacturing a chemical substance using the transformant

[Explanation]
     An invention of a process for producing a chemical substance using a transformant falls within the 
"invention directed to a process using the product" provided in Section 37(iii) of the Patent Law, because it 
utilizes functions and characteristics of the transformant.

[Example 4]
     1) An invention of a gene (specified invention),
     2) An invention of a process for producing a recombinant vector using the said gene; and
     3) An invention of a process for producing a transformant using the said gene

[Explanation]
     The invention 2 and invention 3 above fall within the "invention of a process using the 
product" under Section 37(iii) of the Patent Law, because it utilizes functions and characteristics of 
the gene.

[Example 5]
     1) An invention of an antigenic protein (specified invention); and
     2) An invention of a monoclonal antibody against the antigenic protein

[Explanation]
     It is obvious that the above-mentioned protein is antigenic and an antigen is associated with a 
monoclonal antibody.  An invention of the antigenic protein has a very close relationship with the 
monoclonal antibody in providing the monoclonal antibody against the antigenic protein. Since the 
invention of the antigenic protein is considered to aim at providing the monoclonal antibody against the 
antigenic protein, both inventions have the same problem to be solved.  Accordingly, the specific 
invention and the invention 2 above fall within the relationship under Section 37(i) of the Patent Law.

     However, the patent application does not meet the requirements of Section 37 of the Patent Law in 
the following case.
 
[Example 6]
     1) An invention of a transformant (specified invention); and
     2) An invention of a process using a chemical substance produced with the use of the transformant

[Explanation]
     The specified invention and the invention 2 above do not fall within any of the relationships 
provided in Items of Section 37 of the Patent Law.
     However, when a claim directed to the chemical substance produced with the use of the transformant 
is added, the invention 2 above has the relationship provided in Section 37(iii) of the Patent Law with the 
invention described in the added claim having the relationship provided in Section 37(i) of the Patent Law 
with the specified invention, and these inventions may be included in a single application in accordance 
with the provision of Section 37(v) of the Patent Law.

1.3  Requirements for Patentability

1.3.1  Invention Not Falling within "Industrially Applicable Invention"

     Inventions of a gene, a vector, a recombinant vector, a transformant, a fused cell, a recombinant 
protein and a monoclonal antibody whose utility is not described in a specification or cannot be inferred, do 
not meet the requirements set forth in the first sentence in Section 29(1) of the Patent Law.

1.3.2  Novelty (See Implementing Guidelines, Chapter 2-1.)

(1) Recombinant protein

1)   Where a protein X as an isolated and purified single substance is publicly known, a claimed 
invention concerning a recombinant protein X specified by a process of production, the said recombinant 
protein being identical as a chemical substance with the publicly known protein X, is not novel.

2)   In case where a recombinant process inevitably leads to a different product, for example in its sugar 
chain or the like, due to the difference of the host cells, even though the recombinant protein has the same 
amino acid sequence as the publicly known one, a claimed invention concerning the recombinant protein 
specified by a process of production is novel.

(2) Monoclonal antibody

1)   If antigen A is novel, a monoclonal antibody to the antigen A is generally considered novel. However, 
if a monoclonal antibody to publicly known antigen A' is publicly known and if the antigen A has the same 
epitope as that of A' because the antigen A is partially modified from publicly known antigen A' or the like, 
a monoclonal antibody to antigen A' also binds to antigen A. Therefore, in such a case, the claimed 
invention of "a monoclonal antibody to antigen A" is not novel.

2)   The claimed invention of a monoclonal antibody specified by a cross-reactivity, such as "a 
monoclonal antibody which binds not to antigen B but to antigen A" is not novel, if a monoclonal antibody 
to antigen A is publicly known and if there is no particular technical significance to specify the monoclonal 
antibody described by such a cross-reactivity (e.g., when it is clear that the publicly known monoclonal 
antibody to antigen A does not bind to antigen B either, because antigen B has no similarities to antigen A 
in the function, structure, etc.). 

1.3.3  Inventive Step (See Implementing Guidelines, Chapter 2-2.)

(1) Gene

1)   An invention of a gene encoding Protein A has an inventive step, if Protein A has novelty and an 
inventive step.

2)   Where Protein A is publicly known but its amino acid sequence is not publicly known, an invention 
of a gene encoding Protein A does not have an inventive step, provided that a person skilled in the art could 
determine the amino acid sequence easily at the time of filing. However, when it is considered that the gene 
is specified by a specific base sequence and has advantageous effects that a person skilled in the art cannot 
foresee in comparison with other genes having a different base sequence encoding the Protein A, the 
invention of the said gene has an inventive step.

3)   When an amino acid sequence of Protein A is publicly known, an invention of a gene encoding the 
Protein A 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 that a person skilled in the art cannot foresee in 
comparison with other genes having a different base sequence encoding the Protein A, the invention of the 
said gene has an inventive step. 

4)   When a structural gene is publicly known, an invention relating to a structural gene of naturally 
obtainable mutant (allelic mutant, etc.) of the said publicly known structural gene and which is derived 
from the same species as the said structural gene and has the same properties and functions as the said 
structural gene does not have an inventive step.  However, if the claimed structural gene has advantageous 
effects that a person skilled in the art cannot foreseen in comparison with the said publicly known structural 
gene, the claimed invention of the structural gene has an inventive step.  

(2) Recombinant vector

     In case where both a vector and a gene to be introduced are publicly known, a claimed invention 
concerning a recombinant vector obtained by a combination of them does not have an inventive step.
     However, even if both a vector and a gene to be introduced are publicly known, a claimed invention 
concerning a recombinant vector with a specific combination of them, which leads to an  advantageous 
effect that a person skilled in the art cannot foresee, has an inventive step.

(3) Transformant

     If both a host and a gene to be introduced are publicly known, a claimed invention concerning the 
transformant obtained by a combination of them does not have an inventive step.
     However, even if both of a host and a gene to be introduced are publicly known, a claimed invention 
concerning a transformant with a specific combination of them, which leads to an  advantageous effect 
that a person skilled in the art cannot foresee, has an inventive step.

(4) Fused cell

     If both of parent cells are publicly known, a claimed invention concerning a fused cell produced by 
fusing both of the parent cells does not have an inventive step. However, if the fused cell has advantageous 
effects that a person skilled in the art cannot foresee, the claimed invention of the fused cell has an 
inventive step.

(5) Monoclonal antibody

     If antigen A is publicly known and it is clear that the antigen A has immunogenicity (for example, 
antigen A clearly has immunogenicity because a polyclonal antibody to the antigen A is publicly known or 
because the antigen A is a polypeptide with a large molecular weight, etc.), the claimed invention of "a 
monoclonal antibody to the antigen A " does not have an inventive step. However, if the claimed invention 
is further specified by other features, etc. which leads to an advantageous effect that a person skilled in the 
art cannot foresee, the claimed invention has an inventive step.  

1.4  Amendment of Specification 

     Amendment of the specification relating to the deposit of microorganisms, etc. is handled as 
described in "2.3 Amendment of Specification" below

2. Microorganisms

     This section deals with inventions related to microorganisms per se as well as those related to the use 
of microorganisms, etc. Inventions relating to the use of microorganisms include not only those using a 
novel microorganism but also those based on finding of a method for using a publicly known 
microorganism (e.g., an invention of a process for producing a publicly known substance using a publicly 
known microorganism, an invention of a process for treating a material (e.g., water treatment, soil 
improvement) using a publicly known microorganism, an invention of use for a publicly known 
microorganism as a treating agent (e.g., water treating agent, soil improving agent).
     The term "microorganisms" means yeasts, molds, mushrooms, bacteria, actinomyces, unicellular 
algae, virus, protozoa, etc. and further includes undifferentiated animal or plant cells as well as animal or 
plant tissue cultures.
     Matters relating to genetic engineering are referred to "1. Genetic Engineering" even if they are 
inventions relating to microorganisms.

2.1  Description Requirements for the Specification

2.1.1  Designation of Microorganisms

     In principle, microorganisms should be specified by scientific names in accordance with 
microbiological nomenclature.  In case of designating a strain of a microorganism, it should be specified 
by the strain name following the species name (in accordance with microbiological nomenclature).  When 
a microorganism cannot be specified by the species name, it may be specified by the strain name along with 
the genus name.
     In case that a strain of a microorganism has been deposited, the said strain may be specified by the 
description of the accession number in addition to the species name or the strain name following the 
species name.

Example: 
     Bacillus subtilis FERM P-xxxxx strain

     Undifferentiated animal or plant cells should be specified, in principle, by scientific names in 
accordance with zoological or botanical nomenclature or standard Japanese names, respectively.

2.1.2  Scope of Claim (See 1.1.1 above.)

@@ According to Section 36(6)(ii) of the Patent Law, the invention for which a patent is sought shall be 
clear, therefore, scope of claim shall be described that an invention shall be clearly identified on the basis of 
statements of each claim.

2.1.3  The Detailed Description of the Invention (See 1.1.2 above.)

2.1.3.1  Enablement Requirement (See 1.1.2.1 above.)

2.1.3.1.1  An Invention of a Product (See 1.1.2.1.1 above.)

     As to an invention of a product, a microorganism to be created or a microorganism to be used should 
be described as follows.

(1)  A microorganism being explained clearly

     In order to explain a microorganism clearly, the microorganism should be described as indicated 
below.

     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, and also the 
microbiological characteristics should be described.  As microbiological characteristics, it is desirable that 
taxonomic characteristics generally used in the field (Appendix 1) are described, however, other 
microbiological characteristics (e.g., selective productivity of metabolites) may be described.  
     A microorganism which cannot be specified by the species name should be specified by the strain 
name along with the genus name, after clarifying the reason why the species name cannot be specified.
     Microbiological characteristics of a microorganism should be described as follows, depending on 
whether it is a new strain or a new species.

1)  New strain
     It should be clearly described that the characteristics of the strain as well as the difference in the 
microbiological characteristics of the strain from the publicly known strains within the same species to 
which the new strain belongs.

2)  New species
     The taxonomic characteristics of the species should be described in detail, and the reason why the 
microorganism is judged to be a new species should be clarified.  That is, the difference of the species 
from the existing similar species should be expressly described, and the relevant literature used on the basis 
of the judgement should be indicated. 

(2) "Can be made"

     As to an invention relating to a microorganism per se or relating to the use of a novel microorganism, 
means for creating the microorganism should be described so that a person skilled in the art can create the 
said microorganism.
     Means for creating microorganisms includes means for screening, means for mutagenesis, means for 
gene recombination, etc.
     If the means for creating the microorganism cannot be described in the detailed description of the 
invention so that a person skilled in the art can create the said microorganism, it is necessary to deposit the 
microorganism in accordance with Section 27 ‚‚‚‰‚“ of Regulations under the Patent Law (the detail is as 
follows).

1) Deposit and Furnishing of Microorganisms

Section 27‚‚‚‰‚“@of Regulations under the Patent Law (Deposition of microorganismsj
1    A person desiring to file a patent application for an invention involving or using a 
microorganism shall attach to the request a copy of the latest receipt referred to in Rule 7 of the 
Regulations under the Budapest Treaty on the International Recognition of the Deposit of 
Microorganisms for the purpose of Patent Procedure (hereinafter referred to as "Treaty") for the 
deposit of the microorganism issued by the international depositary authority defined in Article 
2(viii) of the Treaty, or a document certifying the fact that the microorganism has been deposited 
with an institution designated by the Commissioner of the Patent Office, except where the 
microorganism is readily available to a person skilled in the art to which the invention pertains.
2    Where an accession number is newly given after the filing of a patent application to the deposit 
of a microorganism under the preceding paragraph, the applicant for a patent or the patentee shall 
notify the Commissioner of the Patent Office without delay.
3    The notification under the preceding paragraph shall be made in accordance with Form 32 
with respect to a patent application, or Form 33 with respect to an International Patent Application.

Section 27‚”‚…‚’@of Regulations under the Patent Law (Furnishing of microbiological samples)
1    A person who intends to work for the purpose of tests or experiments an invention involving or 
using a microorganism deposited in accordance with the preceding section may be furnished with a 
sample of the microorganism provided that:
     (i)  registration for the establishment of a patent right to the invention involving or using the 
microorganism has been made;   
    (ii)  the person received a warning given in the form of a document describing the contents of 
the invention involving or using the microorganism in accordance with Section 65(1) of the Patent 
Law; or
   (iii)  such is necessary in order to prepare a written argument referred to in Section 50 of the 
Patent Law (including its application under Section 159(2) (including its application under Section 
174(2)) and Section 163(2)).
2    A person who has been furnished with a sample of the microorganism in accordance with the 
preceding paragraph shall not permit a third party to utilize the sample of the microorganism.

(i)  A person desiring to file a patent application for an invention involving or using a microorganism, 
shall deposit the microorganism with a depositary institution designated by the Commissioner of the Patent 
Office or international depositary authorities (hereinafter, the both are referred to as "depositary institution 
for the purposes of patent procedure"), unless a person skilled in the art can easily obtain the 
microorganism, shall state the accession number in the specification as filed, and shall attach to the request 
a document certifying the fact that the microorganism has been deposited.
     When a new accession number is given to the microorganism after filing, for the reason that, e.g., 
re-deposit was made, samples of the microorganism were transferred to another international depositary 
authority, or the deposit was converted from the deposit under the national law to that under the Budapest 
Treaty, the applicant or the patentee shall give a notice to that effect to the Commissioner of the Patent 
Office without delay.
     Where a microorganism which was deposited with a depositary institution designated by the 
Commissioner of the Patent Office and was confirmed to be viable is found to be no longer viable, the 
depositor, upon receipt of the "Notice that the microorganism cannot be furnished" (Official Gazette of 
MITI No.178 Section 15) from the depositary institution, should deposit immediately the same 
microorganism as that originally deposited.  Where the microorganism is related to a patent application or 
a patent, the applicant or the patentee should give a notice to that effect to the Commissioner of the Patent 
Office without delay. In such a case, the newly deposited microorganism is treated as having been 
deposited without intermission since the original deposit was made.
     The deposited microorganism can be furnished simultaneously with the registration for 
establishment of a patent right. Even prior to the registration for establishment of a patent right, though, in 
the case where Section 27‚”‚…‚’ (1)(ii) or (iii) of Regulations under the Patent Law is applied, the 
microorganism can be furnished.  
     The deposit of a microorganism should be maintained at least during the term of the patent for the 
invention related to the microorganism so that the microorganism can be furnished.

     For reference, a list of International Depositary Authorities and kinds of microorganisms accepted by 
the IDAs is shown in Appendix 2.

(ii)  Microorganisms excluded from obligation to be deposited

(a)  Microorganisms which cannot be stored or maintained by the depositary institution for the purpose of 
patent procedure for technical reasons or the like

     In such a case, however, furnishing of the microorganisms provided in Section 27‚”‚…‚’ of 
Regulations under the Patent Law should be guaranteed by the applicant. (Such microorganisms should be 
preferably deposited with a reliable cultural collection.)


(b)  Microorganisms readily available to the persons skilled in the art stated in "Section 27‚‚‚‰‚“@of 
Regulations under the Patent Law"
     More specifically, the following microorganisms are included for example:
(b-1) Commercially available microorganisms, such as baker's yeast, koji (Aspergillus oryzae), Bacillus 
natto, etc.
(b-2) A stored microorganism in the case where it has been confirmed, prior to filing, that the 
microorganism has been stored at a reliable cultural collection and is freely accessible from a catalog or the 
like issued by the said cultural collection
     In this case, the storage number of the microorganism should be described in the specification as 
filed.
(b-3) Microorganisms which can be created by a person skilled in the art on the basis of the description in 
the specification

(iii) Where a claimed invention in an application claiming priority relates to a microorganism which is not 
readily available to a person skilled in the art, the application can enjoy advantages of the priority provided 
that the microorganism has been deposited with a depositary institution for the purpose of patent procedure 
or a reliable public cultural collection and that the accession number or storage number of the 
microorganism is stated in the specification contained in the first application which has served as a basis for 
claiming a right of priority or in the specification contained in the earlier application which has served as a 
basis for claiming a right of internal priority.

(3) "Can be used"

     For the invention of a microorganism per se or of the use of a microorganism, in order to show the 
industrial applicability of it, the way of industrial application of the product shall be described in the 
detailed description of the invention except where it could be understood by a person skilled in the art 
without such description when taking into account the overall descriptions of the specification (excluding 
claims), drawings and common general knowledge as of the filing.

2.1.3.1.2  An Invention of a Process (See Implementing Guidelines, Chapter 1-3.2.1 (3).)

@@ Of those inventions related to the use of a microorganism, an invention of a process for the use of a 
microorganism (e.g. an invention of a process for treating a material with a microorganism) should be 
described as follows.
      For an invention of a process, the definition of carrying out the invention is to use the process and 
that a process can be used is interpreted as meaning that a process can be used in an industrially applicable 
way.  Further, "the said invention of a process" should be explained clearly in the detailed description of 
the invention.
      Accordingly, for the invention of a process for the use of microorganism, in order to show the 
industrial applicability of it, the way of industrial application of the process shall be described in the 
detailed description of the invention except where it could be understood by a person skilled in the art 
without such description when taking into account the overall descriptions of the specification (excluding 
claims), drawings and common general knowledge as of the filing. In order to describe the industrial 
applications, the enablement requirement described in "2.1.3.1.1 An Invention of a Product" should be 
referred to, if necessary. For instance, "2.1.3.1.1 An Invention of a Product (2) Deposit and furnishing of 
microorganisms" should be referred to, if the deposit of microorganisms is necessary.

2.1.3.1.3  An Invention of a Process for Manufacturing a Product@(See Implementing Guidelines, Chapter 
1-3.2.1(4).)

@@ Of those inventions related to the use of a microorganism, an invention of a process for producing a 
substance using a microorganism should be described as follows.
     Where an invention of a process is directed to "a process for manufacturing a product," the definition 
of "the process can be used" means that the product can be manufactured by the process and either the 
process or the product shall be industrially applicable to meet industrial application. Further, the said 
invention of a process for manufacturing a product should be explained clearly in the detailed description 
of the invention.
     Accordingly, for the invention of a process for producing a substance by using a microorganism, a 
process for producing the said substance shall be described in the detailed description of the invention so 
that a person skilled in the art can produce the said substance taking into account the overall descriptions of 
the specification (excluding claims), drawings and common general knowledge as of the filing. In order to 
describe the process in such a manner that a person skilled in the art can produce the said substance by the 
process, the enablement requirement described in "2.1.3.1.1 An Invention of a Product" should be referred 
to, if necessary. For instance, "2.1.3.1.1 An Invention of a Product (2) Deposit and furnishing of 
microorganisms" should be referred to, if the deposit of microorganisms is necessary.
     Further, it is necessary to describe the industrial applicability of the said process or at least one use of 
the said substance.

     As to "How Specifically the Detailed Description of the Invention Must Be Described?" and 
"Balance of the Claim and the Detailed Description of the Invention," see the relevant portions (1.1.2.1.4 
and 1.1.2.1.5) in "1. Genetic Engineering." 

2.1.3.2  Ministerial Ordinance Requirement (See 1.1.2.2 above.)

     Matters required under the Ministerial Ordinance are (1) technical field to which an invention 
pertains and (2) problem to be solved by the invention and its solution.

(1) Technical field to which an invention pertains

     As "technical field to which an invention pertains," at least one technical field to which a claimed 
invention pertains shall be stated in a specification, in principle.
     In the inventions related to a microorganism, "technical field to which an invention pertains" should 
be described such as pharmaceuticals, feed, food, water treatment, for example.

(2) Problem to be solved by the invention and its solution

     As "problem to be solved by the invention," an application shall state at least one technical problem 
to be solved by a claimed invention, in principle. As "its solution," an application shall explain how the 
technical problem has been solved by the claimed invention.

     As to "Prior Art and Advantageous Effects," see 1.1.2.3 in "1. Genetic Engineering."

2.2  Requirements for Patentability

2.2.1  Invention Not Falling within "Industrially Applicable Invention"
    The following inventions do not meet the requirement provided in the first sentence in Section 29(1) 
of the Patent Law.
 
(1) A mere discovery which is not a creation 
     Example: A merely discovered microorganism existing in nature.
     However, an invention of a microorganism which is isolated from nature artificially involves 
creativity.

(2) Inventions incapable of industrial application

     An invention of a microorganism per se whose utility is not described or cannot be inferred.

2.2.2  Inventive Step (See Implementing Guidelines, Chapter 2-2.)

(1) Invention of a microorganism per se

     An inventive step of an invention of a microorganism per se should be examined based on taxonomic 
characteristics of the microorganism as well as effects produced by the use of the microorganism.

1)   An invention of a microorganism whose taxonomic characteristics are remarkably different from 
those of publicly known species (i.e., a new species) has an inventive step.

2)   An invention involving a microorganism producing advantageous effects that a person skilled in the 
art cannot foresee, though the taxonomic characteristics of the microorganism are not substantially 
different from those of publicly known species, has an inventive step.
Example:
     A microorganism which was obtained by mutating a publicly known species and which has 
remarkably high productivity of metabolite.

(2) Invention relating to the use of a microorganism

1)   An invention relating to the use of a microorganism (e.g., an invention of a process for producing a 
substance) does not have an inventive step, if the microorganism used in the invention is a taxonomically 
known species and belongs to the same genus as another microorganism for which the same mode of use 
(e.g., producing the aimed substance) is known. However, if it is found that the invention using the former 
microorganism has advantageous effects that a person skilled in the art cannot foresee in comparison with 
the invention using the latter microorganism, the invention using the former microorganism has an 
inventive step.

(Explanation)
     Between publicly known species in the same genus, it is usually easy for a person skilled in the art to 
culture each microorganism and confirm its utility (e.g., substance productivity) and its effects.

2)  An invention relating to the use of a microorganism (e.g., an invention of a process for producing a 
substance) has an inventive step, if the microorganism used in the invention is remarkably different from 
publicly known species in taxonomic characteristics (i.e., a new species), even if the mode of use (e.g., the 
aimed substance) is the same.

(Explanation)
     Since the used microorganism per se has an inventive step as described (1) 1) above, a process using 
the microorganism has also an inventive step. 

2.3  Amendment of Specification
     - applicable to applications filed on or after January 1, 1994 -
(See "Implementing Guidelines for Amendment of Specification and Drawings" (Nov. 1993, the Japanese 
Patent Office) Chapter 1-1.)

(1)  An amendment of an accession number of a microorganism is not regarded as addition of a new 
matter, where microbiological characteristics of the microorganism are described to the extent that the 
microorganism can be specified in the specification as filed and deposit of the microorganism can be 
specified based on the name of the depositary institution, etc.
     In such a case, the applicant should make an amendment of the accession number without delay.

(2)  An amendment converting a storage number of a microorganism to an accession number based on the 
deposit of the microorganism with a depositary institution for the purpose of patent procedure is not 
regarded as addition of a new matter, where the microorganism used is stored at a reliable public cultural 
collection and the storage number of the microorganism is explicitly stated in the specification as filed and 
that it is clear that the identity of the microorganism is not lost.
     In such a case, the applicant should make an amendment of the accession number without delay.

(3)  An amendment adding microbiological characteristics of a microorganism is regarded as addition of a 
new matter unless a person skilled in the art can directly and unambiguously derive those characteristics 
from what is described in the specification and drawings as filed, even if the accession number of the 
microorganism stated in the specification as filed is not changed and microbiological characteristics of the 
microorganism are described in the specification as filed to the extent that the taxonomic species of the 
microorganism can be specified.

3. Plants

     This section deals with inventions of plants per se, those relating to parts of plants (e.g., a fruit), those 
of a process for creating plants, those relating to use of plants, etc.  The term "plants" means the plants 
under the classification where organisms are classified into three groups, namely microorganisms, plants 
and animals.
     As to undifferentiated plant cells as well as plant tissue cultures, which are treated as 
microorganisms, reference should be made to relevant parts in "2. Microorganisms."
     Matters relating to genetic engineering are referred to "1. Genetic Engineering" even if they are 
inventions relating to plants.

3.1  Description Requirements for the Specification

3.1.1  Designation of Plants

     In principle, plants should be specified by scientific names in accordance with the botanical 
nomenclature or standard Japanese names.

3.1.2  Scope of Claim  (See 1.1.1 above.)

     As to an invention relating to a plant, a claim should be described as follows.

     In the case of an invention of a plant per se, the plant should be specified by, for example, a 
combination of any of the species, the distinctive gene of the plant, characteristics of the plant, etc. and may 
be further specified by the process for creating the plants.

Example 1:
     A plant belonging to Castanea crenata (Japanese chestnut) having the ATCC Accession No. 
xxxx whose bark contains catechol tannin and pyrogallol tannin in the ratio of X‚P-X‚Q:  Y‚P-Y‚Q and 
has a catechol tannin content of z‚P-z‚Q ppm (weight ratio), or its mutatnt having the said 
characteristics.

Example 2:
     A watermelon obtained by crossing a diploid watermelon with a tetraploid watermelon          
obtained by polyploidizing a diploid watermelon, whose somatic cell has 33 chromosomes.

     As to an invention of a process for creating a plant, the process for creating the plant should be 
described in the claim step by step. In the case where selection is performed as one step of creation based 
on characteristics or the like, the characteristics or the like necessary for the selection should be additionally 
described.  Where conditions such as environment are necessary for creating the plant, such conditions 
should be also described.

Example:
     A process for creating a cabbage characterized by crossing a cabbage strain having the
ATCC Accession No.xxxx as a seed parent with another cabbage as a pollen parent by having 
resistance for the herbicide X.

3.1.3  The Detailed Description of the Invention  (See 1.1.2 above.)

    As to an invention of a plant per se or that of a process for creating a plant, the detailed description of 
the invention should be described as follows.

3.1.3.1  Enablement Requirement (See 1.1.2.1 above.)

3.1.3.1.1  An Invention of a Product (See 1.1.2.1.1 above.)

     An invention of a plant per se should be described as follows.

(1)  A plant being explained clearly

     In order to explain a plant clearly, for example, 1) matters regarding species of the plant created and 
2) matters relating to characteristic properties of the created plant should be described.

1) Species of the plant created

    In principle, the created plant should be specified by the scientific name in accordance with the 
botanical nomenclature or standard Japanese name.

2) Characteristic properties of the plant created

    In the case that properties of the created plant are characteristic, they should be described specifically 
stating by numeric values actually obtained by measuring or the like and it is desirable that they are 
described in comparison with those of publicly known plants, if necessary.
     For instance, it should be described not by a mere statement that the plant is high-yielding, but 
concrete numeric values commonly used in conventional yield surveys, such as total number of fruits 
produced per stock, total weight of fruits produced per stock, gross yield per are, etc., and they should be 
described in comparison with those of publicly known plants, if necessary.
     Colors, such as leaf color, fruit color, and flower color should be expressed in accordance with 
official standards, such as the color atlas JIS Z8721 which is a specification of colours according to their 
three attributes, JIS Z8102 concerning color names and the R.H.S. color chart.
     Where characteristic properties of the created plant cannot be expressed by a conventional 
cultivation method which a person skilled in the art usually conducts, or where characteristic properties of 
the created plant are expressed only in specific environments and under specific cultivation method though 
the method is conventional, such specific cultivation conditions should be specifically described.

(2) "Can be made"

     As to an invention of a plant per se, a process for creating the plant should be described step by step 
including species of parent plant(s), a step of selecting the plant to be aimed at based on objective 
indicators or the like.

(a)  Where a person skilled in the art cannot carry out the invention because of unavailability of the parent 
plant(s) even if the process for creating the plant is described in the specification step by step, its parent 
plant(s) (seeds, cells, etc.) should be deposited with a depositary institution prior to filing and its accession 
number should be described in a specification as filed similarly to the deposit under Section 27‚‚‚‰‚“ of 
Regulations under the Patent Law.

(b)  Where it is not possible to describe a process for creating the plant in the specification in such a 
manner that enables a person skilled in the art to create the plant, the created plant which is reproducible 
(seeds, cells, etc.) should be deposited with a depositary institution prior to filing and its accession number 
should be described in a specification as filed similarly to the deposit under Section 27‚‚‚‰‚“ of Regulations 
under the Patent Law.

     However, where the above-mentioned plant cannot be deposited with the depositary institute for the 
purpose of patent procedure due to some technical reasons or the like, means for obtaining the above should 
be described in the specification and the applicant should guarantee the furnishing of the samples similarly 
to the furnishing of samples under Section 27‚”‚…‚’ of Regulations under the Patent Law. (Such a plant 
should be preferably deposited with a reliable cultural collection.)

     For the details of the deposit and furnishing of microorganisms, etc., see "2.1.3.1.1 (2)  Deposit and 
Furnishing of Microorganisms in 2. Microorganisms" 

(3) "Can be used"

     For an invention of a plant per se, in order to show the industrial applicability of it, the way of 
industrial application of the product shall be described in the detailed description of the invention except 
where it could be understood by a person skilled in the art without such description when taking into 
account the overall descriptions of the specification (excluding claims), drawings and common general 
knowledge as of the filing.

3.1.3.1.2  An Invention of a Process for Manufacturing a Product@(See 1.1.2.1.3 above.)

@@ An invention of a process for creating a plant should be described as follows.
     An invention of a process for creating a plant should be described in such a manner that enables a 
person skilled in the art to create the plant by the said process.

     In order to describe the process in such a manner that a person skilled in the art can produce the said 
plant by the process, the enablement requirement described in "3.1.3.1.1 An Invention of a Product" should 
be referred to, if necessary. For example, in case that deposit of a plant is necessary, "3.1.3.1.1 (2) Can be 
made" should be referred to.

     Further, in an invention of a process for creating a plant, how the process or the plant created by the 
process is industrially applicable should be described in the detailed description of the invention, except 
where it could be understood by a person skilled in the art without such description when taking into 
account the overall descriptions of the specification (excluding claims), drawings and common general 
knowledge as of the filing.

     As to "How Specifically the Detailed Description of the Invention Must Be Described?", "Balance of 
the Claim and the Detailed Description of the Invention," " Ministerial Ordinance Requirement" and "Prior 
Art and Advantageous Effects," see the relevant portions (1.1.2.1.4, 1.1.2.1.5, 1.1.2.2 and 1.1.2.3) in "1. 
Genetic Engineering."

3.1.4  Drawings

     When photographs are attached as drawings, black-and-white photographs should be used. Color 
photographs may be submitted as reference materials.

3.2  Requirements for Patentability

3.2.1  Invention Not Falling within "Industrially Applicable Invention"

    The following inventions do not meet the requirement provided in the first sentence in Section 29(1) 
of the Patent Law.

(1) Mere discovery which is not a creation

     Mere recognition of a plant existing in nature as it is does not involve creativity and is nothing but a 
discovery.
     Example: A newly discovered plant per se.

     In order to show that an invention involves creativity, how the invention has been created should be 
described in the detailed description of the invention.

(2) Inventions incapable of industrial application

     Inventions whose utility is not described or cannot be inferred.

3.2.2  Inventive Step

(1)  An invention of a plant per se does not have an inventive step, where characteristics of the plant 
created can be easily predicted from the characteristics of publicly known plants within the species to 
which the plant belongs and where the invention does not have advantageous effects that a person skilled in 
the art cannot foresee. 

Example 1:
     A plant whose shape or color is similar to that of publicly known plants within the species to which 
the plant belongs.
Example 2:
     Mere combination of the characteristics of publicly known plants within the species to which the 
plant belongs.
     (Plants obtained by mere crossing: for instance, suppose that it is publicly known that Pisum sativum 
A (pea A) has a single-locus-controlling characteristics that the legume is yellow when premature and 
Pisum sativum B has a single-locus-controlling characteristics that it bears blossoms at each knot through 
the full length.  In such a case, a new Pisum sativum, obtained by merely crossing Pisum sativum A and 
Pisum sativum B and fixing their characteristics, having characteristics that the legume is yellow when 
premature and it bears blossoms at each knot, does not have an inventive step.)

(2)  An invention of a process for creating a plant does not have an inventive step, where the selection of 
parent plants, means, conditions or the like is not considered to be difficult and where the created plant 
does not have advantageous effects that a person skilled in the art cannot foresee.

3.3  Amendment of Specification

     Amendment of the specification relating to the deposit of plants is handled as described in "2.3 
Amendment of Specification" above.

4. Animals

     This section deals with inventions of animals per se, those relating to parts of animals, those of a 
process for creating animals, those relating to use of animals, etc.  The term "animals" means the animals 
(excluding humans) under the classification where organisms are classified into three groups, namely 
microorganisms, plants and animals.
     As to undifferentiated animal cells as well as animal tissue cultures, which are treated as 
microorganisms, reference should be made to relevant parts in "2. Microorganisms."
     Matters relating to genetic engineering are referred to "1. Genetic Engineering" even if they are 
inventions relating to animals.

4.1  Description Requirements for the Specification

4.1.1  Designation of Animals

     In principle, animals should be specified by scientific names in accordance with the zoological 
nomenclature or standard Japanese names.

4.1.2  Scope of Claim  (See 1.1.1 above.)

     As to an invention relating to an animal, a claim should be described as follows.

     In the case of an invention of an animal per se, the animal should be specified by, for example, a 
combination of any of the species, the distinctive gene of the animal, characteristics of the animal, etc. and 
may be further specified by the process for creating the animals.

Example:
     A mouse having DSM Accession No.xxxxx characterized by the occurrence of degeneration and 
swelling of anterior lens cortical fibers at 8 weeks of age, appearance of opacity of the lens at 5 or 6 months 
of age and rapid completion of cataract immediately after that, or its mutant having the said characteristics.

      As to an invention of a process for creating an animal, the process for creating the animal should be 
described in the claim step by step.  In the case where selection is performed as one step of creation based 
on characteristics or the like, the characteristics or the like necessary for the selection should be additionally 
described.  Where conditions such as environment are necessary for creating the animal, such conditions 
should be described.

4.1.3  The Detailed Description of the Invention  (See 1.1.2 above.)

      As to an invention of an animal per se or that of a process for creating animals, the detailed 
description of the invention should be described as follows.

4.1.3.1  Enablement Requirement (See 1.1.2.1 above.)

4.1.3.1.1  An Invention of a Product (See 1.1.2.1.1 above.)

      An invention of an animal per se should be described as follows.

(1)  An animal being explained clearly

      In order to explain an animal clearly, for example, 1) matters regarding species of the animal 
created and 2) matters relating to characteristic properties of the created animal should be described.

1) Species of the animal created

      In principle, the created animal should be specified by the scientific name in accordance with the 
zoological nomenclature or standard Japanese name.

2) Characteristic properties of the animal created

     In the case that properties of the created animal are characteristic, they should be described 
specifically stating by numeric values actually obtained by measuring or the like and it is desirable that they 
are described in comparison with those of publicly known animals, if necessary.
     Where characteristic properties of the created animal cannot be expressed by a conventional breeding 
method which a person skilled in the art usually conducts and they are expressed only in specific 
environments or only under specific breeding method, such specific conditions should be specifically 
described.

(2) "Can be made"

     As to an invention of an animal per se, the process for creating the animal should be described step 
by step including species of parent animal(s), a step of selecting an animal to be aimed at based on 
objective indicators or the like.

(a)  Where a person skilled in the art cannot carry out the invention because of unavailability of the parent 
animal(s) even if the process of creating the animal is described in the specification step by step, its parent 
animal(s) (fertilized ovum, etc.) should be deposited with a depositary institution prior to filing and its 
accession number should be described in a specification as filed similarly to the deposit under Section 27‚‚
‚‰‚“ of Regulations under the Patent Law.

(b)  Where it is not possible to describe the process for creating the animal in the specification in such a 
manner that enables a person skilled in the art to create the animal, the created animal which is reproducible 
(fertilized ovum, etc.) should be deposited with a depositary institution prior to filing and its accession 
number should be described in a specification as filed similarly to the deposit under Section 27‚‚‚‰‚“ of 
Regulations under the Patent Law.

     However, where the above-mentioned animal cannot be deposited with the depositary institute for 
the purpose of patent procedure  due to some technical reasons or the like, means for obtaining the above 
should be described in the specification and the applicant should guarantee the furnishing of the samples 
similarly to the furnishing of samples under Section 27‚”‚…‚’ of Regulations under the Patent Law. (Such an 
animal should be preferably deposited with a reliable cultural collection.)

     For the details of the deposit and furnishing of microorganisms etc., see "2.1.3.1.1 (2) Deposit and 
Furnishing of Microorganisms in 2. Microorganisms"

(3) "Can be used"

     For an invention of an animal per se, in order to show the industrial applicability of it, the way of 
industrial application of the product shall be described in the detailed description of the invention except 
where it could be understood by a person skilled in the art without such description when taking into 
account the overall descriptions of the specification (excluding claims), drawings and common general 
knowledge as of the filing.

4.1.3.1.2  An invention of a Process for Manufacturing a Product@(See 1.1.2.1.3 above.)

@@ An invention of a process for creating an animal should be described as follows.
     An invention of a process for creating an animal should be described in such a manner that enables a 
person skilled in the art to create the animal by the said process.

@@ In order to describe the process in such a manner that a person skilled in the art can produce the said 
animal by the process, the enablement requirement described in "4.1.3.1.1 An Invention of a Product" 
should be referred to, if necessary. For example, in case that deposit of an animal is necessary, "4.1.3.1.1 (2) 
Can be made " should be referred to.

     Further, in an invention of a process for creating an animal, how the process or the animal created by 
the process is industrially applicable should be described in the detailed description of the invention, except 
where it could be understood by a person skilled in the art without such description when taking into 
account the overall descriptions of the specification (excluding claims), drawings and common general 
knowledge as of the filing.

     As to "How Specifically the Detailed Description of the Invention Must Be Described?", "Balance of 
the Claim and the Detailed Description of the Invention," " Ministerial Ordinance Requirement" and "Prior 
Art and Advantageous Effects," see the relevant portions (1.1.2.1.4, 1.1.2.1.5, 1.1.2.2 and 1.1.2.3) in "1. 
Genetic Engineering."

4.1.4  Drawings

     When photographs are attached as drawings, black-and-white photographs should be used. Color 
photographs may be submitted as reference materials.

4.2  Requirements for Patentability

4.2.1  Invention Not Falling within "Industrially Applicable Invention"

    The following inventions do not meet the requirement provided in the first sentence in Section 29(1) 
of the Patent Law.

(1) Mere discovery which is not a creation

     Mere recognition of an animal existing in nature as it is does not involve creativity and is nothing but 
a discovery.
     Example: A newly discovered bird per se.

     In order to show that an invention involves creativity, how the invention has been created should be 
described in the detailed description of the invention.

(2) Inventions incapable of industrial application

     Inventions whose utility is not described or cannot be inferred.

4.2.2  Invention Contravening Public Order, Morality or Public Health

     When working of an invention inevitably contravenes public order, morality or public health, the 
invention falls under the invention as provided in Section 32 of the Patent Law.

4.2.3  Inventive Step  (See Implementing Guidelines, Chapter 2-2.)

(1)  An invention of an animal per se does not have an inventive step, where characteristics of the animal 
created can be easily predicted from the characteristics of publicly known animals within the species to 
which the animal belongs and where the invention does not have advantageous effects that a person skilled 
in the art cannot foresee.

(2)  An invention of a process for creating an animal does not have an inventive step, where the selection 
of parent animal(s), means, conditions or the like is not considered to be difficult and where the created 
animal does not have advantageous effects that a person skilled in the art cannot foresee.

4.3  Amendment of Specification

     Amendment of the specification relating to the deposit of animals is handled as described in "2.3 
Amendment of Specification" above.


Appendix 1:
     The Guidelines for Describing Taxonomic Characters

Appendix 2:
     The List of International Depositary Authorities and Kinds of Microorganisms Accepted by the IDAs


[Reference]

     The application of these guidelines should be as follows.

1. Genetic Engineering

  (i) New practices under the 1994-Revised Japanese Patent Law to be applicable to @@@
applications filed on and after July 1, 1995.

    1.1 Description Requirements for Specification
      1.1.1 Scope of Claim
      1.1.2 The Detailed Description of the Invention (1.1.2.2 Ministerial Ordinance               
Requirement)

  (ii) Clarification of the ambiguity of some current practices to be applicable to all 
pending applications.

    1.1 Description Requirements for Specification
      1.1.2 Description of the Invention (1.1.2.1 Enablement Requirement)
      1.1.3 Sequence Listing
    1.2 Unity of Invention
    1.3 Requirements for Patentability

2. Microorganisms
			Ditto

3.  Plants
 Ditto

4.  Animals
 Ditto