CRITERIA FOR PATENT ISSUANCE

For an invention to be patentable, it must be useful, novel, and non-obvious. Each of these criteria has a strict legal definition. Furthermore, there is an enablement requirement that the patent must actually teach the reader how to make or use the invention properly. If a reasonably trained professional cannot follow the instructions in the patent and get it to work, the patent may not hold up in court if challenged. It is estimated that over 50% of patents can be invalidated on the basis of prior art or other technicalities. It is no trivial matter to obtain a defensible patent.

USEFUL

The usefulness of an invention is demonstrated by describing its applications. However, one cannot just claim that the invention could be used as cattle feed, as some unsuccessful gene patent applications supposedly have in the absence of function data.

NOVEL

Novelty is established relative to prior art, information pertaining to your invention that has been publicly disclosed prior to the filing date of your patent. Novelty is established by searching all patents and publications for evidence that the claimed invention was not described previously. Public disclosure also includes presentations at conferences and non-confidential distribution of business plans. If there has previously been public disclosure of a similar idea, your invention may not be considered novel. Even if a patent is allowed on the claimed invention, your competitors may be able to invalidate the patent if they can demonstrate that prior art existed and was not taken into account during examination of the application.

NON-OBVIOUS

Even if technically novel, your invention must not be an obvious extension of another technology. However, just because something may seem obvious does not mean it is by the legal definition of obvious. If an old patent claims that a drug should have anti-cancer activity yet studies fail to show this, you may be able to patent your own subtle derivation of the drug by showing that it actually does have anti-cancer activity. The logic is that if it were obvious, people who tried before you would have been successful by following the instructions in the old patent.

ENABLEMENT

Enabling an invention is not the same as proving that it works; enablement is actually a much lower hurdle. For example, showing that a molecule has activity in an in vitro inflammation assay may be adequate for a composition of matter patent that may block others from commercializing that compound. To secure a Use patent claiming the use of an anti-depressant to treat irritable bowel syndrome (IBS), you would only need to show that the drug improved the IBS symptoms of a single patient. Unlike the FDA, the US Patent and Trademark Office (USPTO) does not require double-blinded controlled clinical trials.