An English version of the current Examination Guidelines for Patent and Utility Model is available on the website of the Japan Patent Office (JPO).
The document specifies the requirements for patent applications, giving detailed examples on issues such as “clarity” or “unity of application” according to the Japanese law. These guidelines carry a lot of weight in patent examining before the JPO.
The Examination Guidelines also cover the patent applications relating to specific technical fields, e.g. computer-software, biological and medicinal inventions. Below, we set out some of the guidelines from the Biotechnology section:
Scope of Claim
Genes
A gene may be described by specifying its nucleotide sequence.
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.
A gene may be described by a combination of the terms “substitution, deletion or addition” or “hybridize” with 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)).
Example1: 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.
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, whose nucleotide sequence is complementary to that of the DNA defined in (a) and encodes the human protein having the activity of enzyme B.
Note: “Stringent conditions” are described in the detailed description of the invention.
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.
Transformants
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.
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 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.
Enablement Requirement
Genes, vectors or recombinant vectors
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 and a large amount of trials and errors or complicated experimentation 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 cases where 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 experimentation 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…TGCCT
(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 experimentation 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.
Unity of Application
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
(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 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.
See more details at the Japan Patent Office.
