Statutory Requirements

In the United States, there are several major hurdles that an inventor must overcome before patent protection can be obtained. Specifically, an inventor must be able to demonstrate that the invention is new, useful, and nonobvious. A patent cannot be obtained unless the invention is new. In addition, the invention must not have been known or used by others in the United States, or patented or described in a publication in the United States or any foreign country, before the applicant made the invention. Moreover, if the invention was patented or described in a publication anywhere in the world or in public use or sale in the United States more than one year prior to the date the application is filed, a patent will be denied.

In connection with this last point, it is critical that a patent application be filed with the U.S. Patent Office prior to the one-year anniversary of the public disclosure, use, or sale of the invention. However, unlike the United States, most countries do not allow this one-year grace period. "Absolute novelty" is typically the requirement. Thus, any public disclosure, use, or sale of the invention will foreclose the right of the applicant to pursue patent protection in these countries. Public disclosure includes presentations, printed and online publications, public meetings, offers for sale, and discussions with someone not under a confidentiality agreement. Accordingly, because nanotechnologyrelated inventions have far-reaching benefits beyond the borders of the United States, it is imperative that an application be filed prior to any public disclosure, use, or sale.

To determine whether an invention is novel (i.e., new), an application is examined by a patent examiner skilled in the technology of the invention and is compared against the available prior art. The examiner makes a thorough study of the application and all the available public information pertaining to its claims. Currently, much of this examination is conducted electronically, and the examiner has access to databases of the USPTO, European Patent Office, and Japanese Patent Office. The examiner also has access to other non-patent literature; however, in practice this is more limited.

Given the interdisciplinary nature of nanotechnology-related inventions, as well as the potential for these inventions to have application in multiple industries, examiners may have a difficult time performing adequate searches. For example, an invention directed to the manufacture of nanoparticles might involve materials science, chemistry, and physics. Furthermore, if the invention involves the use of the nanoparticles for drug delivery or imaging purposes, additional consideration must be given to the fields of molecular biology and optoelectronics.

Moreover, there is no specific examination group within the U.S. Patent Office dedicated to nanotechnology. Consequently, the search process currently falls to other existing art units, many of which are overburdened with the number of applications to be examined. As a result, it is important that the application be provided with an adequate and thorough search of the prior art to ensure that the invention at issue is novel.

The invention must also be nonobvious. It is common for the U.S. Patent Office to reject a patent application as being obvious. In certain instances, it may well be that the invention is something that has never before existed. However, if the Patent Office determines that a hypothetical person having access to the available information concerning that particular field of technology would have "known" how to make the invention (or modify a previous invention to make it), it may reject the patent as being obvious.

The claimed invention must also be useful. This utility requirement is seldom a hurdle encountered by the established disciplines. However, it can be an issue for nanotechnology-related inventions. By way of example, as a nanotechnology start-up tries to fortify the landscape around its core technology, it may file additional patents that recite multiple commercial uses for the invention in a variety of industries without clearly knowing whether such uses may work. In doing so, the company may encounter a risk that the invention lacks utility and the patent application may be denied.

Inventions also must be fully described in an enabling manner. The requirements for an enabling disclosure can provide a unique challenge and must be carefully addressed. The nanotechnology-related invention being disclosed might involve not yet clearly understood phenomena or might be addressed by technology that is being disclosed for the first time in the application. Accordingly, for nanotechnology-related patent applications it is imperative

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