OA:

Claim 1 relates to a differentiated cell population in an in vitro culture obtained by differentiating …… stem cells. However, there is a lack of “essential technical features”, such as culture media and culture conditions for the cell culture in vitro. Embryonic stem cells (ES cells) belong to undifferentiated pluripotent stem cells. It is general knowledge that ES cells participate in the generation of tissues and organs of the donee embryo, and that ES cells have the ability to differentiate into germ cells. Namely, the cell population of claim 1 includes germ cells. According to Chapter 10 of Part 2 of Guidelines for Examinations, an embryonic stem cell of an animal, an animal at the various stages of its formation and development, such as a germ cell, an oosperm, an embryo and so on, belong to the category of the “animal variety" in Section 4.4 of Chapter 1 of Part 2, and are unpatentable in accordance with the provisions of Article 25.1(4) of the Patent Law. So, claim 1 relates to a subject matter that is excluded from patent protection according to Article 25.1(4) of the Patent Law.

Response:

Claim 1 relates to a differentiated cell population obtained by differentiating …… stem cells, in which at least 60% of the differentiated cells are *** neurons, but not to the germ cell that Examiner referred to in the first OA. The differentiated cell population is distinguished from other cell populations by the distinct technical feature that at least 60% of the differentiated cells are *** neurons, which are unrelated with germ cells. Namely, claim 1 does not relate to the germ cell as mentioned in Chapter 10 of Part 2 of Guidelines for Examinations, so, claim 1 does not relate to a subject matter that is excluded from patent protection according to Article 25.1(4) of the Patent Law. It is inapposite to consider claim 1 to be related to animal variety just based on the possibility that the differentiated cell population of claim 1 comprises germ cells.

The object of the present invention is to provide a differentiated cell population. There is more than one substitutable culture medium and culture condition for the cell culture in vitro. The person skilled in the art has the ability to make a selection. So, these technical features are not essential technical features, and should not be written in claim 1. It would make a loss in the value for patent right protection to add these technical features into claim 1.

OA:

Claim 2 relates to a method of generating a differentiated neural cell population from mammalian pluripotent stem cells. Since the mammalian pluripotent stem cells include human ES cells, claim 2 relates to the use of human embryo for industrial or commercial purposes, which belongs to a subject matter that is excluded from patent protection according to article 5 of the Patent Law.

Furthermore, there still exist other defects in claim 2 even if the mammalian pluripotent stem cells are not human ES cells, such as: (a) -(d)lack of “essential technical features”, such as culture media and culture conditions for the cell culture in vitro. Based on the above reasons, the claim 2 is not sufficiently clear, which does not comply with the requirement of Rule 20, Paragraph 1 of Implementing Regulations of the Patent Law.

Response:

Claim 2 relates to a method of generating a differentiated neural cell population from mammalian pluripotent stem cells, but not to the use of mammalian pluripotent stem cells for industrial or commercial purposes. In other words, claim 2 relates to the use of the mammalian pluripotent stem cells instead of human embryo. So, claim 2 does not relate to the subject matters prohibited by Article 5 of the Patent Law.

The object of the present invention is to provide a method of generating a differentiated neural cell population from mammalian pluripotent stem cells. There is more than one substitutable culture medium and culture condition for the cell culture in vitro. The person skilled in the art has the ability to make a selection from them. So, these technical features are not essential technical features, and should not be written in claim 2. It would make a loss in the value for patent right protection to add these technical features into claim 2.