4. The Written Description

Patents / Biotechnology / US Biotechnology Practice

The second major hurdle encountered in patenting many pharmaceutical and biotechnology inventions is the need to comply with the requirements of the first and second paragraphs of 35 USC § 112.

The first paragraph addresses the requirements of the specification. The second paragraph addresses the requirements of the claims.

The requirement set out in the first paragraph of 35 USC § 112 is that a patent specification contains a written description of:

1) the invention;
2) the manner and process of making and using the invention "in such full, clear, concise and exact terms as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and use" the invention, and that the specification; and
3) describes the best mode "contemplated" by the inventor for carrying out the invention.

In cases where priority is claimed under 35 USC § 119 from an application filed abroad, that foreign application must comply with the requirements of the first paragraph of 35 USC § 112 for the priority claim to be effective. [31]

The USPTO Rules [32] require that:

(a) The specification must include a written description of the invention or discovery and of the manner and process of making and using the same, and is required to be in such full, clear, concise and exact terms as to enable any person skilled in the art or science to which the invention or discovery to which it pertains or with which it is most nearly connected, to make and use the same.

(b) The specification must set forth the precise invention for which a patent is solicited, in such manner as to distinguish it from other inventions and from what is old. It must describe completely a specific embodiment of the process, machine, manufacture, composition of matter or improvement invented and must explain the mode of operation or principle whenever applicable. The best mode contemplated by the inventor of carrying out his invention must be set forth.

The rules go on to require that where the invention relates to an improvement, the specification must "particularly point out "the parts of the invention to which the improvement relates".

[31] Yasuko Kawai et al v. Metlesics, 480 F.2d 880, 178 USPQ 158 (CCPA 1973). In Yamada v. Aggarwal, 57 USPQ2d 2002 (Bd of Apps 2000), it was made clear that one could not combine subject matter from different priority documents to meet this requirement but that there had to be a single priority document containing a written description capable of meeting the requirements of 35 USC § 112.

[32] 37 CFR 1.71.

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