The Requirements of Enablement and Written Description

Inventiveness has to be shown by the applicant or the patentee, if a lack of inventiveness is claimed by the patent examiner during the prosecution or the public in an opposition procedure. An indication of inventiveness is, for example, an unexpected result proven by comparative examples or improved properties of anew substance. Thus, if it can be shown that a new peptide or protein shows improved properties over the wild-type protein, inventiveness can usually be acknowledged. When aiming to achieve patent protection for evolutionarily designed molecules with predefined properties and functions, an inventor should keep this in mind. 

Patent systems typically require that the claimed invention must have utility (as set forth in 35 U.S. C. 101) or must be susceptible to industrial application (as set forth in Art. 57 EPC). With regard to genetic patenting, the European Patent Convention explicitly states that the industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application (see Rule 23e(3) EPC)). The requirement to associate the sequence with a function can also be found in U.S. law. 

Apart from the essentials of novelty, unobviousness, and utility discussed above, further challenges require special attention when seeking patent protection. The invention should be described in such a manner as to comply with both the written-description and the enablement requirement. These requirements are contained in 35 U.S.C. 112, which states that the specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same. .. . Similar regulations exist in other patent laws, as exemplified by Articles 83 and 84 EPC. 

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