TUC Sponsored Programs

Intellectual Property

California State University - Chancellor's Office Executive Order (EO) 644 'Intellectual Property - Campus Policies' (September 7, 1995)

Discoveries and Inventions

Disclosure of Discovery or Invention Form

Public Disclosure Warning!

Faculty is often called upon to give talks on campus, at other institutions, at meetings, and at companies. Topics typically contain information about ongoing research or early stage concepts, for which research has not begun.

When improperly disclosed, such information is considered to have entered the public domain and therefore may not be patentable. If you make a presentation on work that is, or could be, the subject of a patent and may be a potentially commercializable invention, we strongly urge you to consult with TUC beforehand. We can advise you on how to best protect your work, which may ultimately be a source of revenue for you and your college.

Remember the following points:

  • Public disclosure prior to filing a patent can bar the work from being patented in the U.S. or abroad.
  • Submittal of papers to refereed journals is not public disclosure and will not affect the ability to patent an invention, as long as it is not published or circulated outside of the journal reviewers.
  • Once a patent application is filed, you are free to discuss the work, but limit such discussions to the areas covered by the patent application.
  • The use of a Confidential Disclosure Agreement is widely accepted and protects you from loss of intellectual property rights.

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Confidential Disclosure Agreements (CDA)

Before disclosing confidential information to others, you should carefully consider the consequences. Confidential Disclosure Agreements are used to protect the rights of the university, The University Corporation (TUC), and the researcher whenever confidential information is provided to or received from an outside source.

Confidential information should be protected for a number of reasons. One of the most important reasons is to maintain control over your information thereby preventing others from using your ideas. This can protect the novelty of the invention prior to patenting. Novelty is a key standard used to assess the patentability of an invention (i.e. whether the invention is new, or has entered the public domain). Often, the reason a patent application is not patentable is non-confidential disclosure of information. A CDA can therefore be critical protection when disclosing your information prior to filing a patent application. Information is no longer considered confidential after public disclosure unless that disclosure was protected under a CDA.

Faculty are often called upon to give talks on campus, at other institutions, at meetings, and at companies. Topics typically contain information about ongoing research or early stage concepts, for which research has not begun. When improperly disclosed, such information is considered to have entered the public domain and therefore may not be patentable. If you make a presentation on work that is, or could be, the subject of a patent and may be a potentially commercializable invention, we strongly urge you to consult with us beforehand. We can advise you on how to best protect your work, which may ultimately be a source of revenue for you and your laboratory. Remember the following points:

  • Public disclosure prior to filing a patent can bar the work from being patented in the U.S. or abroad.
  • Submittal of papers to refereed journals is not public disclosure and will not affect the ability to patent an invention, as long as it is not published or circulated outside of the journal reviewers.
  • Once a patent application is filed, you are free to discuss the work, but limit such discussions to the areas covered by the patent application.
  • The use of a Confidential Disclosure Agreement is widely accepted and protects you from loss of intellectual property rights.

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Material Transfer Agreements (MTA)

Materials Transfer Agreements must be used whenever the university / TUC provides tangible materials to, or receives tangible materials from an outside source.

A Materials Transfer Agreement is a legal contract that governs the transfer of materials to and from the University for research purposes. Materials may include cultures, cell lines, proteins, bacteria, transgenic animals, nucleotides, pharmaceuticals and other chemicals.

MTAs are needed whenever transferring or receiving materials. Most universities and organizations require that an MTA be in place between the supplier and the recipient prior to releasing or receiving any materials.Some of the important issues to be negotiated are intellectual property rights, indemnity clauses and publication rights. When the university/TUC is the supplier of materials, the MTA provides the following information:

  • Defines what material is being provided to the recipient;
  • Defines how the material will be used and disposed of by the recipient;
  • Defines ownership of the material provided to the recipient;
  • Assigns intellectual property rights jointly to the University and the recipient on modified materials;
  • Assigns intellectual property rights to the recipient for new substances and uses;
  • Grants the recipient first option to obtain an exclusive worldwide license from the University on modified materials, substances, or developments;
  • Protects the university, TUC and the researcher from litigation arising from the use, storage or disposal of the materials.

An MTA is important when you are supplying materials to an outside researcher because the MTA protects the supplier of materials by restricting use of the materials to academic research. It can also prevent commercial exploitation of your material, control release of the materials to a third party, and ensure you are appropriately acknowledged in publications. When the university / TUC is the recipient of materials, the MTA provides the following information:

  • Defines what material is being received
  • Defines how the material will be used and disposed of
  • Defines ownership of the material received
  • Grants the supplier first option to obtain an exclusive worldwide license from the University on modified materials, substances, or developments
  • Protects the supplier from litigation arising from the use, storage or disposal of the materials

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Recommendations For Keeping Laboratory Records

Do's and Don'ts for Keeping Lab Notebooks

By J. Peter Fasse Fish & Richardson, P.C.
@copy; Copyright 2000 Fish & Richardson P.C.
All rights reserved.

A laboratory notebook is a vital record of events leading to a patentable invention. The recorded information can establish dates of conception and reduction to practice of a technology as well as the inventorship of a patent claiming the technology. Below are fourteen rules you should follow when keeping lab notebooks.

#1 Do use bound books Inventors should use permanently bound notebooks, e.g., notebooks with spiral or glue bindings. If loose-leaf sheets are used, they should be consecutively numbered and each page should be dated, signed, and witnessed.

#2 Do sign and date Each notebook should be signed and dated on the inside front cover to indicate the first day the recipient started using the notebook. Each entry should be signed and dated. An independent witness, i.e., someone who understands the technology but will not be named as a co-inventor of the invention, should sign and date each entry after the statement: "Read and understood by ________". (The witness should preferably sign the entries on a contemporaneous or fairly contemporaneous basis, but entries can also be reviewed, signed, and dated on a periodic, e.g., weekly or monthly, basis.)

#3 Do use ink Notebook entries should be made in ink and in chronological order. Entries should not be erased or "whited out." If an entry contains an error, a line should be drawn through the error and new text should continue in the next available space.

#4 Don't leave blank spaces Blank gaps between entries should be avoided. If a blank space is left on a page, a line or cross should be drawn through the blank space, and the page dated to prevent subsequent entries.

#5 Don't modify Prior entries should not be modified at a later date. If data were omitted, the new data can be entered under a new date and cross-referenced to the previous entry. Record experiments when they are performed.

#6 Do use past tense Use the past tense (e.g., "was heated") to describe the experiments that were actually performed.

#7 Do explain abbreviations and special terms Explain all abbreviations and terms that are nonstandard. Explain in context, in a table of abbreviations, or in a glossary.

#8 Do staple attachments Attachments such as graphs or computer printouts should be permanently affixed in the notebook (e.g., by stapling), and both the attachment and the notebook page signed and dated. If the attachment cannot be stapled, it should be placed in an envelope and the envelope stapled to the notebook page. The envelope and page should then be signed and witnessed making reference to the attachment being placed in the envelope.

#9 Don't remove originals No original pages should be removed from the notebook.

#10 Do outline new experiments When a new project or experiment is started, the objective and rationale should be briefly outlined (e.g., in a short paragraph or by providing a flowchart).

#11 Do record lab meeting discussions Relevant discussions from lab meetings should be recorded as should ideas or suggestions made by others. The names of the people making the ideas and suggestions should be carefully documented. This information may be important in establishing inventorship.

#12 Do provide detail Record test descriptions, including preferred operating conditions, control conditions, operable and preferred ranges of conditions, and alternate specific materials; test results and an explanation of the results; and photos or sketches of the results or the test device. Any conclusions should be short and supported by the factual data. Opinions or speculation about the invention should be avoided.

#13 Do track notebooks Ideally, each lab should maintain a catalogue of notebooks in which each notebook is assigned a number, and the name of the author of each notebook is recorded. Further, the date the author received the notebook as well as the date the notebook was completed and turned in should be recorded. Upon leaving the lab, the author should return all notebooks checked out by or to him.

#14 Do save completed notebooks All completed notebooks should be indexed (e.g., by number, by author, by subject area) and safely kept in a central repository, together with corresponding patent applications or patents. Lab notebooks that relate to inventions on which patents have been granted should be kept for the life of the patent plus six years. © Copyright 2000 Fish & Richardson P.C. All rights reserved.


Do's and Don'ts for Keeping E-Lab Notebooks

By Diane L. Gardner Fish & Richardson, P.C.

Laboratory notebooks provide important legal information as well as scientific or engineering data. Lab notebooks may contain evidence related to priority of patent claims, as well as verification of compliance with FDA guidelines for good laboratory practices (GLPs) and good manufacturing procedures (GMPs). Electronic lab notebooks are not always acceptable in legal proceedings as a substitute for original, permanently-bound, handwritten records, particularly with respect to proving dates of invention in patent cases. Until electronic lab notebooks are fully approved by the courts, a hard copy of all data should be maintained. Following are guidelines to consider if you maintain electronic versions of laboratory notebooks.

#1 - Do adopt a written policy for electronic record-keeping Establish a written policy that is furnished to each employee and adopt the policy as part of your normal business routine. Review compliance periodically with employees.

#2 - Do retain permanent back-up copies Back-up all electronic data to a clearly labeled "write once" media. Store the back-up copy in a safe place free from magnetic fields or other corruptive conditions. Print computer generated data to paper and label, sign (with a witness), and date the hard copy and permanently attach the hard copy to the handwritten notebook. Reference all electronic data in the handwritten notebook. Store the hard and soft copies with a record custodian who can vouch for their integrity. Maintain all records/data for the duration of your established document retention period.

#3 - Do maintain computer system integrity Computer systems should be regularly validated to ensure reliability, accuracy, and consistent performance. Precautions should be taken against the importation of viruses.

#4 - Don't allow electronic records to be modified Hardware and/or software should be developed or used which prevents the ability of editing original research descriptions, i.e., WORM - Write Once, Read Many times. Additionally, all electronic records should be time-stamped by a separate server having highly restricted access.

#5 - Don't allow unauthorized computer access Prevent unauthorized access to your computer system. Use key and screen locks, as well as removable storage devices that can be locked away when not in use. Electronic/digital signature or encryption hardware and/or software will enhance the credibility of the electronic records. Limit access to the computer system to authorized personnel who have a genuine need for access. Limit distribution and use of information stored in the system. Frequently change individual user codes and passwords used to log on to the system and delete user codes when employees leave. Require periodic reports on who has accessed the system, and review the reports for any unauthorized persons.


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The External Patent Process (U.S. Patent and Trademark Office - USPTO or PTOs)

If it has been determined that a patent application should be filed on an invention disclosure, The University Corporation (TUC) will most often begin by filing a provisional patent application with the U.S. Patent and Trademark Office (USPTO or PTO). Provisional applications have only been available since 1995 and they allow the University to obtain an initial filing position quickly (e.g. if there is an upcoming publication) and often at a lower initial cost than a non-provisional application. A provisional application also gives The University Corporation a year from the date of filing to market the invention and evaluate the commercial interest in the technology. This assists TUC in determining whether the resources should be expended to file a utility (or non-provisional) patent application. During the drafting of the provisional application, the attorney will request the assistance of the inventors. Once a decision has been made that a utility application will be filed the typical process is as follows:

1) The Patent Application: The process begins when the invention disclosure is sent to outside counsel for the preparation of the patent application for filing. The preparation of the application can take from several weeks to several months from the beginning to the actual filing with the USPTO. During the drafting of the patent application, the attorney will be in contact with the inventors and request information and scientific details to be incorporated into the application. The patent contains two main parts, a specification and the claims. The specification is a description of the invention which may include drawings, that describes in detail how to make and use the invention. Following the specification are the claims which define the scope of the rights granted by the patent.

The two types of claims include independent claims, which cover the main points of the invention and stand alone, and dependent claims which refer to and incorporate earlier claims. Once a draft of the application has been approved by all parties, the attorney will file the patent application with the USPTO. Simultaneously or shortly thereafter, the attorney will request that inventors execute an Assignment and Declaration that will be filed with the PTO.

2) Information Disclosure Statement: Within 6 months from the filing of the non-provisional patent application an information disclosure statement (IDS) is filed with the PTO. The IDS would include copies of all known information (i.e. prior art) that shows or describes features of the claimed invention in the patent application.

3) Initial Office Action: The USPTO sends an Office Action to the attorney's office usually between 9 and 24 months from the date the application was filed. The Office Action is prepared and issued by an examiner from the USPTO. It is the examiner's job to make sure the specification sets forth what is claimed, that there is no prior art, and that the invention is useful and not obvious. The Office Action sets forth the examiner's objections including prior art concerns and reasons for believing the claims to the invention are anticipated or obvious. Within 3 months from the date of the Office Action, a response must be submitted to the examiner's objections. The attorney will usually contact the inventors in order to prepare a response to the Office Action.

4) Second Office Action: In general, there is a second and final Office Action from the USPTO examiner within 3 to 6 months following the filing of the response to the initial Office Action. As in the initial Office Action, the examiner presents additional rejections to the claims and a response to the Office Action is filed with the USPTO. Again, the attorney will usually contact the inventors to assist in the drafting of the response. At this point, once negotiations have concluded with the examiner, the examiner will indicate which claims have been allowed.

5) Notice of Allowance: Hopefully, the responses to the Office Actions will be satisfactory to the examiner and the USPTO will send out a notice of allowance. At this point, formal patent drawings must be submitted to the PTO along with the payment of an issue fee. The patent will usually issue between 2 to 6 months from the date the issue fee was paid. Please note that it can take anywhere from 2 to 4 years or longer for a patent application to become an issued patent. Biotech applications often take longer. Future maintenance fees for an issued U.S. patent will be due 3.5, 7.5, and 11.5 years after issuance. These fees range from $880 to $3,100. A patent is good for 20 years from the earliest effective filing date of the application.

6) Divisional Applications: If there was a restriction requirement to one or more claims in the initial office action, a Divisional application addressing the restriction can be filed prior to the patent issuing.

7) Continuation-In-Part Applications: This type of application is usually used to claim an improvement to the original patent application and can be filed while the application is still pending.


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Components of a Business Plan for the Commercialization of an Invention

1.1 Cover Page
(Identify the inventor(s), the invention, and date the plan)

1.2 Table of Contents

1.3 Executive Summary
(The most important single part of your document. It provides a high level overview of the entire plan and emphasizes the factors that will lead to success)

1.4 Background
(Provide specific information about the project, describing the inventors, the invention, history of the invention, potential products and services, benefits and risks)

1.4.1 Product & Service Description
List of Individual Product Features and Associated Benefits

1.4.2 Facility Asssement
Required Facilities
Available Facilities

1.4.3 People
Inventors Key People for Commercialization

1.5 Marketing Plan
(Present an analysis of the market conditions that the invention faces, set forth a marketing strategy that will be used to enter and operate on the market and provide a schedule of marketing activities to support sales)

1.5.1 Market Analysis
(External market factors, totality of the business environment, competitors, characteristics of your target customers, market size, distribution costs, industry trends)

1.5.2 Marketing Strategy
Identify your target customers
Identify your market segment
What is unique about the product
Pricing Philosophy
Plans for further market research
Future product & service development plans

1.5.3 Marketing & Sales Plan
How to effectively reach customers and market the product to customers. In essence the marketing plan takes the marketing strategy to a practical, action-oriented level. It sets forth specific steps requried to sell the product and provides a timetable for those actions

1.6 Action Plan
(Explain how to operate and manage the commercialization in areas not covered by the Marketing Plan. Show how operational and management issues will be resolved, including contingency planning)

1.7 Financial Projections
(Project costs and revenues for the commercialization of your invention; include historic data if available; demonstrate how the commercialization can be expected to do financially if the business plan's assumptions are sound)

1.8 Appendix
(Present supporting documents, statistical analysis, product marketing materials, resumes of collaborators in the commercialization)

Should you have any questions or need assistance in preparing the plan, please contact Georg Jahn at (818) 677-2698 or e-mail him at gjahn@csun.edu.