The specification must also provide an adequate description of how to make and use the invention. The description must be sufficient enough so that one of ordinary skill in the art or science to which the invention pertains, could, after reading the specification, make and use the invention without undue experimentation.
For inventions relating to new chemicals, the specification must disclose how to make the new compound. For inventions relating to using new drugs for therapy purposes, the specification must explain how to make the compound, its specific formulation, or at least where the compound can be obtained (e.g., said compound can be obtained under model name or trademark "ABC" from the XYZ Company, Anywhere USA), and how the compound is used therapeutically. Generally information concerning administration and dosage is usually sufficient if one of ordinary skill in the art can determine the optimal prophylactic or therapeutic regimen without undue experimentation.
New Biological Material
Difficulty with the written description requirement often comes into play in applications involving "biological material." Biological material is defined by the PTO as material that is capable of self-replication either directly or indirectly; examples include: bacteria, fungi, including yeast, algae, protozoa, eukaryotic cells, cell lines, hybridomas, plasmids, viruses, plant tissue cells, lichens, seeds. If the biological material is known and readily available from a particular source, no problem is presented. All that is required is that the name and address of the company from which the material is available is listed in the specification.
However, in some instances, the biological material is not known and not readily available, and words alone are not sufficient to describe how to make and use the invention in a reproducible manner. In these instances, additional steps must be taken to comply with the written description requirement. These steps involve making a deposit of the biological material to an International Depository Authority (IDA) established under the Budapest Treaty on the International Recognition of protection. An example of a suitable IDA is the American Type Culture Collection in Rockville, Maryland.