George Washington University Technology Transfer Guide

I.  Bayh-Dole Act

II.  Subject Matter

III.  Patent Process

IV.  Trademarks

V.  Copyrights

VI.  Trade Secrets

Attachment A – Invention disclosure

Attachment B – Statutory rules

ABOUT US

The Office of Health Research, Compliance and Technology Transfer (“OHRCTT”) is the technology transfer office at George Washington University. We are dedicated to assisting faculty, staff and students who feel they have something new and useful, that is potentially patentable or copyrightable.

Some of the duties of the OHRCTT include:

·  Managing George Washington University’s invention disclosures

·  Patenting and licensing activities

·  Reporting of inventions to federal government agencies

·  Oversight of material transfer agreements and confidentiality agreements

Information on forms and downloadable forms such as invention disclosures, Risk Assessment forms for completion of the MTAs and additional information can be found at the OHRCTT’s website: http://www.gwumc.edu/research.

Further information may also be found with a companion manual which can be picked up in Ross Hall, Suite 712.

Contact information:

Astra Bain-Dowell,

Assistant Vice President for Health Research, Compliance & Technology Transfer

Phone: (202)994-2995

Fax: (202)994-0465

Email:

Dorice Wang,

Technology Transfer Executive Associate

Phone: (202)994-2470

Fax: (202)994-0465

Email:

I.  Bayh-Dole Act: Under the Bayh-Dole Act, any invention, innovation, or discovery that is financed by the U.S. government requires the University to disclose the subject of that invention to U.S. government within two months of the date it was disclosed to the University. If the inventor fails to notify the U.S. government of his or her invention, there can be severe repercussions. When the Federal agency is properly notified, the University may elect to retain title to any such invention and has one year after electing title to file the initial patent application. (See Attachment A for Invention Disclosure)

II.  Subject matter: “Inventions,” “discoveries,” “technologies,” and “innovations” are the type of subject matter that may be patentable. Such results include, for example, computer programs, circuit designs of all types, data bases, technical and design drawings, biogenic materials, and other creations.

III.  Patent Process

While patent prosecution formally begins with the filing of an application at the United States Patent and Trademark Office, the patent process begins much earlier. Because the patent process is initiated as soon as a research project is planned, it is important to establish a record program to memorialize activities if there is any possibility that the inventor may seek protection of the intellectual property associated with any invention that might be developed from the work.

A.  Patentability: Novelty is the hallmark of patentability, whether prior art exists and if it does, how can this new discovery modify the discovery?

B.  Commercialability: Because a patent is an asset, a patent can be used to generate capital. A marketing analysis can help to sketch all of the competitors in the segment and whether to go forward with patenting an invention.

C.  Preparing and Filing Applications:

1. Specification: Written description of the invention or discovery and the manner in which the invention is to be made and used.

2. Claims: The most important part of the application that identifies the bounds of the invention. The claims define the boundary which delimits the subject matter that the inventor has discovered. Claims must at least define the invention with certainty and fit within the statutory classes of patentable subject matter.

3. Drawings: Illustrates features that are necessary to practice the invention and can show each feature that is recited in the claims.

4. Declaration: Specification must be accompanied by an executed oath or declaration that specifies that the inventor has reviewed and understand the content of the application and that the inventor believes he or she is the original and first inventor of the subject matter claimed.

D. Examination Process: The application is examined by a PTO examiner who has expertise in the field to which the subject manner belongs. The examiner will address matters of both form and substance according to states promulgated by the PTO, legal precedent and technical considerations. One of the primary roles of the examiner is to determine whether the claims and the specification meet the statutory rules, specifically 35 U.S.C. §112, first and second paragraphs, 35 U.S.C. §102 and 35 U.S.C. §103. (See Attachment B)

E. Options after Final: After final rejection, the applicant may appeal to the Board of Patent Appeals and Interferences. This is not the preferred route since it can be a long one and should be used as a last resort if the applicant can reach accord with the patent examiner. One of the more typical options used to maintain prosecution is the use of continuation applications. There are typically four options: (1) Divisional application; (2) Continuation-In-Part (CIP); (3)continuation application; (4) Request for Continued Examination (RCE).

F. Allowance: A Notice of Allowance will be mailed to the applicant notifying him or her of the amount and time period of the fees. A few weeks before the patent is issued, the applicant will be notified of the date of issue. The Letters Patent (ribbon copy) is to be preserved in the same way as a deed to any piece of property. Patents will have a term of 20 years from the earliest filing date and in addition to the issues fees, once the patent has been issues, the patent owner must pay maintenance fees to keep the document in force.

G. Rights and Obligations of the Inventor/Patentee:

1. Rights: Patents give the inventor the power to negotiate and create licensing opportunities. There are two types of infringement, direct and indirect, which the inventor has to identify.

2. Obligations: Patent owners are obliged to provide a “warning” to the public to enforce their intellectual property rights. This procedure involves the use of patent marking. Other obligations to consider revolve around patent validity.

H. Filing Strategy Considerations:

1. Provisional application: Does not mature itself into a patent but establishes a filing date for the subject matter disclosed in the application. Acts as a “place-holder” and has a one year life span.

2. Non-provisional application: Could mature itself into a patent. Will be examined and reviewed by the Patent Office.

3. Patent Cooperative Treaty (PCT) application: One year after filing provisional or non-provisional applications, the University will have to decide whether to obtain rights to the invention in foreign countries. If desired, then a PCT application is filed. A PCT application allows the inventor and the University to file a single application reserving the right to file individual applications in all of the varying PCT countries that you designate at a future time. The PCT application is yet another possible filing strategy because the U.S. is a PCT country.

4. Public disclosure of the application: Because non-provisional applications and PCT applications will be published 18 months after the earliest filing date, it will enter the public domain. Any competitors will have access to your application and may see fit to practice the invention or seek improvements to your invention. Thus, the race to commercialization no longer will be exclusive to you or to your exclusive licensee 18 months from your earliest filing date.

IV.  Trademarks

A trademark is a word, phrase, symbol or design or a combination of words, phrases, symbols or designs, that identifies and distinguishes the source of the goods of one party from those of another. Trademarks function to prevent consumer confusion as to the source of products or services. Unlike patents which have a term of 20 years from filing, trademark protection lasts as long as the trade dress or trademark is in use. Trademarks come in two basic forms, common law trademarks which exist in areas where the mark is being used or is known, and federal registrations, which exist nationwide.

Proposed marks can be divided into three categories:

(1)  those that can function as marks as soon as they are used – arbitrary and fanciful

(2)  those that can function as marks only after continuous and exclusive use – acquired distinctiveness

(3)  those that can never function as marks – generic marks

A. Trademark Procedure: An application begins with a conflict check/search by a competent practitioner. Once it is determined that there is no conflict with existing trademarks, an application is prepared and filed with the USPTO. In approximately 6-9 months, the USPTO will issue either an office action or a notice of publication. If an office action is issued, an amendment or response is usually prepared. If no opposition is filed or if the opposition fails, a Certificate of Registration will issue for applications based on use or a Notice of Allowance will issue for intent-to-use application in about 12 weeks.

B. Infringement: Trademark infringement occurs when another uses a confusingly similar trademark. To determine whether a likelihood of confusion exists, courts consider factors such as strength of the mark, similarity between the marks, proximity of the goods in the marketplace.

C. Obligations: The applicant must periodically file affidavits of continued use or excusable non-use under 15 U.S.C. §1508 and applications for renewal under 15 U.S.C. §1509. However, stopping use of the trademark, allowing the trademark to become generic, failing to prosecute infringements, improper licensing of the rights, and/or too significant of a change in quality or character of the goods or services may result in abandonment of the mark and loss of rights.

V.  Copyrights

A copyright protects the original authorship of a mode of expression of an idea in tangible form. The authorship may consist of text, artwork, music, audiovisual material, sound recordings, literary works, including dramatic, artistic and certain other intellectual works. A copyright enables its owner to do and to authorize others to reproduce the work in copies or phonorecords, prepare derivative works based on the work, and distribute the work publicly and in the case of sound recordings, to perform the work publicly by means of digital audio transmission.

A copyright comes into existence from the time the work is created in fixed form, whereupon it becomes the property of the creator immediately. Like patents, infringement occurs when a copyright owner can demonstrate that another has used the work in an unauthorized manner. But unlike patents, there are quite a few exceptions to this rule. One of the most important exceptions is the doctrine of “fair use” that states that it is not an act of infringement of a copyright to use copyrighted work for purpose such as criticism, comment, news reporting, teaching or research.

A. Copyright registration: Registration is intended to notify the public of facts related to a particular copyright. Some of the advantages of registration are:

(1) establishment of a public record

(2) registration is required before an infringement suit may be filed

(3) establishing a prima facie evident in court of the validity of the copyright

(4) allows the owner to record the registration with the U.S. Customs Service for protection against importation of infringing works

Registration is quite simple and all that is necessary is a completed application form, a fee and a non-returnable deposit of the work to be registered. However, for certain types of works such as a motion picture, computer programs, there are special deposit requirements.

B.  Websites: Websites generally fall under databases, computer programs, and more specifically to online works. For works transmitted online, the work may consist of text, artwork, music, and audiovisual material, sound recordings, etc. Copyright does not protect procedures, systems, or methods of operation which can be protected by other types of intellectual property such as patents.

VI.  Trade Secrets

The law of trade secrets protects proprietary business information against unauthorized use or disclosure by those who obtain it improperly through a confidentiality relationship. Typically trade secrets are protected by state law, however the Economic Espionage Act (EEA, 1996) has allowed the federal government to play a role.

Trade secrets come in many forms such as a formula, pattern, device, compilation, process and a list of customers. The tying principal is that a secret is used in one’s business to obtain an advantage over competitors who do not know or use it.

7