Trilateral Project 24.1-Biotechnology 053

It is necessary for the applicant to describe in the detailed description of the invention at least one mode, which (s)he contemplates is the best, for showing how to carry out the claimed invention.

In this respect, the definition of "carry out the claimed invention" is that 1) the product can be made and used in the case of invention of a product, 2) the process can be used in the case of invention of a process, and 3) the product can be made by the process in the case of invention of a process for manufacturing a product.

Further explanation of each case is provided below. (Implementing Guidelines I-1-3.2.1)

1) Invention of a Product

The description shall be stated so as to enable to make the product for an invention of a product. To meet this, the way of making the product shall be explicitly described in the detailed description of the invention except where the product could be made by a person skilled in the art without such explicit description when taking into account the overall descriptions of the specification (excluding claims), drawings and common general knowledge as of the filing.

Furthermore, the description shall be also stated so as to enable to use the product. To meet this, the way of using the product shall be explicitly described in the detailed description of the invention except where the product could be used by a person skilled in the art without such explicit description when taking into account the overall descriptions of the specification (excluding claims), drawings and common general knowledge as of the filing.

2) Invention of a Process

In order to describe to use invention of a process, the description shall be stated so as to enable a person skilled in the art to use the process by taking into account the overall descriptions of the specification (excluding claims), drawings and common general knowledge as of the filing.

3) Invention of a Process for Manufacturing a Product

For an invention of a process for manufacturing a product, the description shall be stated so as to enable a person skilled in the art to manufacture the product by using the process. Considering this, three factors, namely i) materials, ii) process steps and iii) final product, shall in principle be described in such a manner that a person skilled in the art can manufacture the product when taking into account the overall description of the specification (excluding claims), drawings and common general knowledge as of the filing. When final product can be understood from description of materials and process steps, however, description on the final product may be omitted.

Furthermore, for an invention to be patentable, it must be industrially applicable. "A product (or a process) can be used" is interpreted as meaning that such a product (or a process) can be used in an industrially applicable way. Therefore, the way of industrial application shall be explicitly described except where it could be understood by a person skilled in the art without such explicit description when taking into account the overall descriptions of the specification (excluding claims), drawings and common general knowledge as of the filing.

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.