Trilateral Project 24.1-Biotechnology 032

(1)

It is a violation of Section 36(6)(ii) of 1994-Revised Patent Law that if a claimed invention cannot be clearly identified by a person skilled in the art. Particularly, it is a violation of Section 36(6)(ii) if the extent of the claimed invention is unclear to a skilled person even taking into account the specification (excluding claims), drawings and common general knowledge as of the filing. Specifically, the extent of a claimed invention should be deemed unclear if a skilled person in the art would not be able to understand whether or not the invention encompasses a specific product (provided that the specific product is the one that a skilled person can clearly understand as of the filing) (Implementing Guidelines I-1-2.2.2.2(1)).

Concerning enablement requirement, see 1.2.1.1(8), 1.2.1.2(7) (Implementing Guidelines I-1-3.2 (Note 2)).

According to the practice that 1987-Revised Patent Law, it is violating the requirement for claims that features defined in claims are composed of a single technical means and the technical means is expressed functionally or operationally (Examination Guidelines I-1-3.3.1(5))

(2)

It is clear if definition of "identity" (homology) is provided in the detailed description of the invention.
(Enablement requirement should be examined because the claimed protein having identity (homology) with the specific protein may be unlikely to have similar activity as the specific protein; see 1.2.1.2(6).)

(3)

A hybridization claim can be defined by a description containing all the elements listed below as 1) - 3).

• 1) One or more nucleotide sequences defined in, for example, working example
  
• 2)the phrase of "under stringent conditions" in the claim
  (The concrete definition of "stringent" conditions be provided in the detailed description of the invention.)
  
• 3) Property or function of encoded protein
  (Such a claim limitation needs to be the one which distinguishes the encoded protein from other proteins. The property or function may be specifically defined not in the claim but in the detailed description of the invention.)

However, in case that artificial DNAs are included in a claimed invention, because huge number of DNAs which are made artificially can hybridize to the invented DNA, DNAs which encode proteins having the same function as the invented protein cannot be selected form those DNAs without undue experimentation by a person skilled in the art in some cases. In those cases, the enablement requirement cannot be satisfied. (see 1.2.1.2 (3).)

(4)

An addition/deletion/substitution type claim can be defined with elements 1) - 3) listed below.

• 1) One or more nucleotide sequences or amino acid sequences defined in, for example, working example
  
• 2) A clear definition of the term "addition, deletion, substitution," that "the sequences added, deleted or substituted" have a high degree of identity (homology) with the sequences of 1)
  (The definition may be provided in the detailed description of the invention.)
  
• 3) Property or function of encoded protein
  (Such a claim limitation needs to be the one which distinguishes the encoded protein from other proteins. The property or function may be specifically defined not in the claim but in the detailed description of the invention.)

There is no difference in judging the clarity of the claim, even if the length of amino acid sequence of claimed invention is short, however, the enablement requirement is not satisfied if undue experimentation is required to carry out the claimed invention.

(5)

It depends on the definition of the terms in the patent specification whether or not the claim containing the above-mentioned terms is clear. To be judged clear, it is necessary to provide a clear description that the differences between the amino acid sequences of allele or derivative and the standard sequence shown in Fig. 1 are within a certain range.

In addition, in cases where undue experimentation is required to carry out the claimed invention, (i.e., to make and use the allele or derivative) enablement requirement is not satisfied.