What is a Patentable Invention?

What is a Patentable Invention?
Obtaining Patents in the United States
                 Patent Applications
                 Inventorship
                 Patent Prosecution
What is the Relevance of a Publication to the Filing of a Patent Application?
Patent Protection in the United States
Patent Protection in Foreign Countries

I. WHAT IS A PATENTABLE INVENTION?

A. A person is entitled to obtain a patent on an invention provided:
i. he or she is the first person to make the invention;
ii. the invention is new and useful; and
iii. the invention would not have been obvious to a person having ordinary skill in the art to which the invention pertains at the time when the invention was made.

B. The Invention Must Be Useful
Generally, most uses will suffice. Therefore, this is a practical inquiry: whether a patent on the invention would generate a desirable level of royalties vis a vis the cost of patenting. It should be noted, however, that the United States Patent and Trademark Office still questions whether applications claiming subject matter which is useful for "research only" meet this requirement. In describing such use, the patentee's description of the invention must be "enabling" (i.e., it must allow one of skill in the relevant art to be able to duplicate the invention simply by reading the patent and using techniques or materials which were publicly available as of the time the application is filed) and must describe the "best mode" of the invention (i.e., the best way known as of the filing date for obtaining, making or using the invention).

C. The Invention Must Be Novel
There must be no public use, sale, written publication or other public disclosure more than one year before a patent application is filed in the United States. For many countries outside the United States, there must be no public use, sale, written publication or other public disclosure any time before a patent application is filed.

D. The Invention Must Be Non obvious
The invention must be more than the "next" obvious step in development in the field. Even if the invention is "obvious to try," it may be non obvious if the results are unexpected, or if the method of getting the results is unexpected or involves more than the application of known technical skill to get an expected result. An invention may be considered non-obvious if prior teachings (e.g. publications or other patents) in the art teach one to expect the opposite result.

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II. OBTAINING PATENTS IN THE UNITED STATES

A. Patent Applications

i. A patent application is a legal document which must comply with United States (and sometimes foreign) regulations. For this reason, its organization and contents are different from those of a scientific paper. In working with a patent attorney in the preparation of an application, a scientist acts as "one of skill in the art," providing the attorney with the scientific information necessary to comply with the disclosure requirements of the patent regulations. In addition to providing the disclosure of the invention, this may include providing some background literature, examples of how to make and use the invention, and information relating to potential modifications or improvements of the invention.

ii. The outside patent attorney then drafts the application, which is subsequently reviewed by the Inventor for scientific accuracy.

iii. Normally, a patent application follows a defined format set out by United States patent regulations, and for this reason, it will have some deliberate degree of repetition. The application should be written to support broad claims and provide enough description to prevent someone from "designing around" the invention in an obvious way.

iv. The application must teach those skilled in the art the best way to practice the invention and must be detailed enough that the invention can be practiced by the public without too much additional experimentation and without access to nonpublic material or information. This requirement is termed enablement and may require that a microorganism, cell line, antibody, or virus be deposit with an agent of the United States Patent Office, or the complete disclosure of nucleotide or amino acid sequences. The purpose of the claims is to provide a written definition of the scope of the invention so that others can know what the patent prevents them from doing.

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B. Inventorship

i. To comply with the host of United States regulations, and to ensure a valid patent, inventorship of the claimed subject matter must be accurately identified. (In the United States, incorrect identification of inventorship can be the basis for invalidating an otherwise valid issued United States patent.)

ii. Inventorship is a legal determination based upon the facts surrounding conception and reduction to practice of the novel and non obvious aspect of the invention.

iii. Considerations which are not relevant to inventorship include contractual obligations, collaborative agreements, and a desire to acknowledge another scientist's assistance. In other words, the attorney must receive the facts from the investigators regarding how the invention was developed, and from those facts the attorney must make a legal conclusion, based on United States case law, regarding who contributed to the invention in an inventive manner. For this reason, inventorship of claims will often differ from authorship of a paper, which acknowledges the collaborative efforts of the scientists involved and/or their contributions.

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C. Patent Prosecution

i. A United States patent is obtained by applying to the United States Patent and Trademark Office. An application is customarily examined after having been on file for about one year. The Patent Office Examiner checks it for conformity with the formal requirements of the law and for patentability of the invention. At this time, the Patent Office may require a restriction if more than one invention has been claimed. The examiner conducts a search of technical literature to find out if the claimed invention is novel and has not been described in, or predicted by, prior publications.

ii. If the applicant's response (which may include claim amendments, arguments and a declaration supplying additional evidence or data) results in allowance of the application, an issue fee is paid and the application is printed and issued as a patent, usually about three to six months later.

iii. If, however (as is more common in biological and chemical cases, due to their complexity), the response does not convince the Examiner to allow the application, he may issue a final rejection. At any point after the first Official Action, the applicant and his attorney may have a personal conference with the Examiner. However, after a final rejection, the applicant's range of options are generally limited. It is possible to appeal most Examiner's Actions to a three member Board of Appeals and thereafter to the Court of Appeals for the Federal Circuit or to the United States District Court for the District of Columbia.

iv. Note that because in the United States, an inventor is entitled to refile his application to present additional arguments to the examiner or to insert additional information into the application, this process is likely to take a number of years (and significant fees), depending on the breadth of the claims sought and the amount of evidence that can be presented to the examiner to support the claims, i.e., unexpected results, superior results, comparative results, etc.

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III. WHAT IS THE RELEVANCE OF A PUBLICATION TO THE FILING OF A PATENT APPLICATION?

A. United States applications

Under United States patent laws, an inventor has ONE YEAR from a public use, sale or publication to file an application. If a publication occurs more than one year before an application is on file and the publication substantially describes the invention, you cannot obtain a United States patent on that invention.

B. Foreign countries

i. Most foreign countries REQUIRE that there be NO public disclosure of the invention prior to the filing of the patent application. Any publication or public disclosure which substantially describes the invention will prevent the filing of a foreign patent application if the publication occurs even one day prior to the application filing. HOWEVER, if you file a United States patent application and then publish the invention, you have one year from the filing date of the United States patent application to file corresponding foreign applications which relate back to the pre publication United States filing date.

ii. These rules underlie the importance of informing your administration that you (or someone working for or with you) are intending to publish even an abstract describing the invention. When in doubt about the extent of disclosure that would destroy patent rights in an otherwise patentable invention, please consult the Office of Business Development.

iii. Also note that oral publications (conferences, talks, discussions, etc.) are at present a gray area in United States patent law. At present an oral publication only to persons requested to keep the information confidential is not a publication. An oral publication to persons not required to keep the information confidential may be a publication capable of barring patent protection.

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IV. PATENT PROTECTION IN THE UNITED STATES

At present, the statutory life of a United States patent is 20 years from the date it is filed. A patent entitles its holder to exclude others from making, using or selling the claimed subject matter. Note, however, that if a person's use of the patented composition or method is for research purposes only (i.e., there must be absolutely no commercial intent, either present or future), that person has a right to use under the very narrowly applied experimental use defense to patent infringement.

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V. PATENT PROTECTION IN FOREIGN COUNTRIES

A. Patents are territorial in extent. In other words, protection does not normally extend beyond the borders of the country in which the patent is granted. Each country has its own national law which must be observed, except to the extent that such law may be modified by treaty with other nations.

B. One such treaty is the so called "Paris Convention" to which most major industrial nations are signatory. Under this treaty, if an application were filed in the United States and a corresponding application were filed in a signatory country within one year of the date of the United States filing (six months in the case of design patent applications) the foreign application would be entitled to the United States filing date for purposes of establishing priority of invention in that country.

C. A decision as to whether or not to file a foreign application should be based on the commercial importance of the invention in the particular foreign country in which patent protection is desired. For instance, most foreign countries require the payment of annual maintenance taxes to maintain patents in force, in addition to the legal and translating costs that are needed to secure patent protection in each country.

D. Most major foreign countries are now so-called "strict novelty" countries. Under the laws of such countries, public use or disclosure of the invention anywhere in the world prior to filing in the country, except as may be modified by treaty, would be a bar to obtaining a valid patent. Therefore, it is very important that you notify the Office of Business Development of a new invention at least one month before you make any public disclosure so that we will have sufficient time to file a patent application and protect the patent rights in foreign countries.

E. If foreign patent protection is to be obtained for a new product or process, an application should be filed in the United States before the product is marketed or otherwise publicly disclosed or used. Thereafter, if within one year corresponding foreign applications are filed, the benefit of the United States filing date can be claimed under the Paris Convention and the application of the "strict novelty" bars can be avoided.

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