Enablement

The specification must also include a written description that is sufficient to enable any person skilled in the art to make and use the invention. Although this enablement need only be addressed to those skilled in the art in explaining the technical aspects of the invention, it is desirable that it not be written in such a manner as to be understandable only by persons so skilled. This consideration may be ultimately important because the validity of a patent, if challenged, will initially be determined by a judge in a federal court who may have had little or no patent background and little or no technical background.

One way in the specification to teach persons skilled in the art how to make and use the invention is to include a number of representative examples. This represents only one way of teaching, however, and it is not the only means by which the requirements of the enablement portion of the statute can be satisfied. The specification need not convince those skilled in the art that its assertions are correct. There are instances, however, such as in certain chemical inventions where very broad claims are being advanced, that additional support may be requested to establish that the invention works as claimed.

A particular problem area involves inventions concerning biological materials such as microorganisms. Unless the biological material in question is known and available or can be readily produced by a known procedure without undue experimentation, it is usually not possible to explain how to obtain it merely by a written discussion. This problem of disclosure can be taken care of by depositing the material in an approved depository under conditions that will make it accessible once the patent issues. Making it accessible, however, does not give anyone the right to infringe the patent. In such a case, it is desirable for the biological material to be on deposit at the time the application is filed and for the application to refer to the access number given the microorganism by the approved depository. The description should also include any taxonomic information. Depositories in the United States include the following:

1. American Type Culture Collection, 12301 Parklawn Drive, Rockville, Md. 20852. Phone: 301-881-2600. Telex: 908-768.

2. National Research Culture Collection, U.S. Department of Agriculture, 1815 North University Street, Peoria, 111. 61604. Phone: 309-685-4011. Fax: 309671-7814.

A deposit in either of the foregoing depositories can also be used for satisfying deposit requirements for certain other countries, such as those observing the Budapest Treaty.

For applications involving a computer program, the disclosure should include the program itself or at least a flow diagram that sets forth the sequence of operations the program is to perform. Even with a flow chart, the disclosure might be questioned by the examiner, particularly if the operations stated are very general or very complex.

A specification must also teach how to use the invention it describes. In drug cases, the office refuses to accept general statements of utility as satisfying this teaching requirements. General statements that have been considered unacceptable include those purporting pharmacological or therapeutical purposes or biological activities. To satisfy the teaching requirements in such cases, it is necessary to present more specific uses, such as the treatment of a particular ailment or disease. It is also desirable to disclose precise dosages and treatment methods.

Besides requiring a statement of utility, the office may also require proof depending on the type of utility asserted. For instance, the highest degree of proof of utility is usually required for those inventions stated to cure or treat diseases, such as cancers, that are generally considered, at the present time, as being difficult to treat. On the other hand, compositions whose properties are usually predictable from a knowledge of their constituents, such as laxatives, antacids, and certain topical preparations, require little or no clinical proof.

Constipation Prescription

Constipation Prescription

Did you ever think feeling angry and irritable could be a symptom of constipation? A horrible fullness and pressing sharp pains against the bladders can’t help but affect your mood. Sometimes you just want everyone to leave you alone and sleep to escape the pain. It is virtually impossible to be constipated and keep a sunny disposition. Follow the steps in this guide to alleviate constipation and lead a happier healthy life.

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