Villanova University Invention Disclosure Form (Updated 6/2015) VILLANOVA UNIVERSITY INVENTION DISCLOSURE PROCEDURE GUIDE I. INTRODUCTION: Villanova University protects both patentable and unpatentable technology developed by its personnel, and assists such technology to the marketplace. Upon joining the University, all faculty or staff members, fellows, students, or unpaid volunteers, become subject to the University's Patent Policies requiring the assignment to the University of intellectual property which emerges from any research, development or other activity sponsored by the University or developed with the use of University funds, equipment, facilities or other personnel of the University. It is impossible to give a precise definition of what constitutes a patentable invention, since the answer depends upon many factors and, in the last analysis, is a unique decision made by the U.S. Patent and Trademark Office. In general, there are three criteria for a patentable invention: novelty, utility, being non-obvious to one skilled in the art. However, one of the functions of the patent attorneys engaged by the University is to determine whether or not a disclosure appears to embody patentable subject matter. The University encourages employees to contact ORA to disclose their ideas for any new device or instrument, diagnostic assay or marker, therapeutic composition of matter such as a lead compound or a set of compounds, biological research material. ORA and University Counsel will work with the inventor candidate group to evaluate the invention, consider the feasibility of patent protection, and determine the appropriate commercialization path for the intellectual property. On occasion, the University also engages industry experts as consultants to provide commercial feedback. II. EVIDENCE OF CONCEPTION "Conception" of an idea relates to the time of an invention's formulation and must be provable by legally sufficient evidence. "Legally sufficient evidence" requires objective proof of the date of conception and its subsequent development. Carefully maintained laboratory notebooks and a timely and well written invention disclosure are, therefore, very important. “Reduction to practice” relates to the enablement of an invention after conducting experiments and obtaining supporting data to show the invention works. Such information is very important for marketing the invention to potential commercial licensees and attracting investment interest. An appropriate Invention Disclosure form is attached as Appendix A and instructions for preparing such a disclosure follow. III. HOW TO PREPARE AN INVENTION DISCLOSURE It is important in preparing an Invention Disclosure, to document the earliest date of the original concept of the invention. This may be as simple as a single, dated entry in a notebook. The inventor candidate should not wait for the final or ideal form of the idea to be developed, but should document the concept as soon as he/she has the first hazy outline of his/her invention. The inventor should not hesitate to contact ORA and submit an Invention Disclosure form. Addenda can be added as Page 1 of 10 Villanova University Invention Disclosure Form (Updated 6/2015) details are worked out. To secure the fullest protection possible for new ideas, laboratory records concerning such developments should be dated and signed, and kept in an orderly manner. An Invention Disclosure Form is attached as Appendix A. The instructions for completing the form follow: A. The Invention Disclosure should be written as soon as possible after you believe that you have made an invention. B. The Invention Disclosure should be as complete as it can be at the time when it is written. Remember - it can be updated - and probably will be as your research progresses. C. The first sketches or drawings and the first written description of each part of the invention, no matter how crude, are important legal records, particularly when they are signed, dated and witnessed at the time when they are made. D. If the subject matter of the invention has or will be publicly disclosed or commercialized, the date of first public disclosure, use, or sale must be mentioned in the Invention Disclosure so that the patent attorney will be on notice to be mindful of any deadlines for seeking patent rights. At the time of a public disclosure, the ability to seek patent rights in most European countries is lost. A few countries have a grace period—in Japan, six months from the public disclosure date, in the US and Canada, one year from the public disclosure date—to file a patent application. It is important to keep the ORA continually apprised of any pending public disclosure, such as the upcoming publication of a meeting abstract, journal article, or a to-be-funded grant. It is very important to notify ORA about any information provided by the editors regarding online publication, because this may occur before the print journal issues. While the review of a submitted abstract or manuscript is considered confidential, once they are accepted, they could be published at anytime. Some journals even publish the galley proofs before they have been reviewed by the authors. The review of grant applications is considered confidential, although applicants should mark “Confidential” on the confidential parts of the proposal. Once the grant has been approved for funding, the abstract will publish when the grant is awarded. Any proprietary information in the abstract will be considered a public disclosure. Therefore, we request that copies of manuscripts, abstracts, grant application abstracts and proposals, etc. related to previously disclosed or soon to be disclosed inventions be provided to ORA prior to submission to the funding agency, journal or conference, if possible. Your cooperation in this respect is greatly appreciated! IV. TRANSMITTAL: The completed Invention Disclosure should be transmitted directly to ORA, with a copy to your Department Chair, Dean and/or Supervisor. Page 2 of 10 Villanova University Invention Disclosure Form (Updated 6/2015) V. ACKNOWLEDGEMENT: ORA will acknowledge receipt of your Invention Disclosure in writing.. If you have any questions, do not hesitate to contact: Page 3 of 10 Villanova University Invention Disclosure Form (Updated 6/2015) ALL QUESTIONS MUST BE COMPLETED IN ORDER TO BE PROCESSED INVENTION DISCLOSURE FORM Appendix A DATE: ___________________ 1. Long Title of Invention: (A clear, plain language title describing what your idea is or does is essential). Short Title of Invention: (Please also provide a brief title that does not reveal the invention. This short title should be nonconfidential, as it may be made public for marketing purposes). 2. Inventor Candidate Information. Inventorship will be determined according to United States patent laws. (Please provide the full names, home and work mailing addresses, email address, position, telephone numbers and citizenship for each inventor candidate.) A. Lead Inventor Candidate Name: Home Address: City, State, ZIP: Telephone: Work Address: City, State, ZIP: Telephone: Email Address: Position/Title (e.g., Professor, post-doc, instructor, student, technician…) Citizenship: Official start date at Villanova (include Institution name if not Villanova employee): If currently at institution for less than 3 years, please list the name of ALL previous employers and the official start date during the past 3 years. Page 4 of 10 Villanova University Invention Disclosure Form (Updated 6/2015) B. Inventor Candidate Name: Home Address: City, State, ZIP: Telephone: Work Address: City, State, ZIP: Telephone: Email Address: Position/Title (e.g., Professor, post-doc, instructor, student, technician…) Citizenship: Official start date at Villanova (include Institution name if not Villanova employee): If currently at institution for less than 3 years, please list the name of ALL previous employers and the official start date during the past 3 years. (Use additional sheets as required.) 3. Please list the most relevant research area and potential application of the invention. If more than one category applies, please rank by relevance (1=most applicable). Research Areas/Fields Potential Application AND Page 5 of 10 ___Device ___Diagnostic ___Drug Discovery ___Research Tool (reagents, animal models, biological materials) ___Therapeutic ___Other Villanova University Invention Disclosure Form (Updated 6/2015) 4. Concise description of the invention. Please provide a clear description which explains what your idea is or how it works, without the excessive use of jargon. This description is an "Abstract" of the invention. A more complete discussion of your idea can be attached to the Disclosure if you think it would be helpful in explaining your invention. 5. From the above description, expand on the invention’s novel and unusual features: a. What makes the invention superior to the gold standard technology already in the marketplace? b. What problem does the invention address and solve – i.e., what is the need? 6. What are possible uses for the invention? Primary Applications: Secondary Applications: 7. Please indicate how you envision the invention will be utilized by potential commercial partners. a. Please provide a brief description of the “product in the box” b. Please provide a sense of the size of the market affected by the unmet need. Also, please provide an estimate of the number of patients who would be in need of the invention. How is that patient population segmented? Page 6 of 10 Villanova University Invention Disclosure Form (Updated 6/2015) c. How will the invention satisfy the current unmet need? 8. Please address present disadvantages or limitations of the invention? overcome? How can they be 9. Please provide the date, place and circumstances of any actual or anticipated public disclosure of this invention, e.g. awarded grant abstract, oral presentation, poster session, meeting abstract or journal publication, conversation (e.g., have you had conversations with anyone regarding your invention at meetings, informal get-togethers, meals or other social encounters?). Please provide ORA with electronic copies of these pending disclosures. 10. Please provide any supporting data and analysis as an attachment to the Report of Invention and also provide the dates and locations of the supporting reports and lab records. 11. Please attach any photographs or diagrams or prototypes to the Report of Invention. If a prototype is available, indicate when and where it was made and who contributed to the manufacture and/or design, and any contracts/invoices for the work. 12. Please indicate the further research and funding that will be necessary for commercialization of the invention. Generally, what are the future research plans to further develop and test invention? What other “enabling” technology would be necessary for the invention to work? 13. Are there any known related patents, inventions or publications, either by any of the inventors or any other person? If so, please indicate here the names of these scientists or any patent Page 7 of 10 Villanova University Invention Disclosure Form (Updated 6/2015) application number, issued patent number or journal article information and attach any available information or copies. 14. Please list ALL funding you have used to generate data for this invention (please indicate each grant that provided funding for the invention even if the grant aims were not specifically related to the invention). Such information should include any funding from federal organizations, state organizations, foundation, non-profit organizations, commercial entities, Villanova start-up package, Villanova departmental account, or gift from individuals or organizations. If you did not use any funding to generate the invention, please explain why. If you have data, the funding source(s) must be listed. (I) a. Name of the funding source b. Title of grant c. Grant/Contract No. if applicable d. Principal Investigator(s) e. Duration of the funding f. Amount of the funding (Use additional sheets as required.) No external funding was used ________________________________ to generate this invention because: A grant application to obtain supporting data for the invention was/will be submitted on __________________. A decision is expected around ________________. 15. Please list ALL materials you have received from any third party(ies) with or without Material Transfer Agreements (MTA) that were used to generate data for this invention. Please provide the Villanova MTA signature date if the materials are covered under an MTA. Include any research reagents, chemicals, sequence information, or other proprietary information which was provided to you with a “Limited Label License” for research purposes only and used in the course of the invention or which are necessary to “make the invention work.” If you did not use any third party materials to generate the invention, please indicate “None”. (I) a. Name of the providing Page 8 of 10 Villanova University Invention Disclosure Form (Updated 6/2015) institution/company b. Name of the providing scientist if applicable c. Name of materials d. Villanova MTA signature date e. Date materials received (Use additional sheets as required.) 16. Please list ALL types of human samples that were used to generate data for this invention. Please provide the respective IRB control number, IRB approval letter and patient’s informed consent for each type of human samples. If you did not use any human samples to generate the invention, please indicate “None”. (I) a. b. c. d. e. f. g. Type of human samples IRB Control number Study title Sponsor Sponsor reference number Duration of the Approval PI’s Name (Use additional sheets as required.) 17. a. What or who is a source of information on existing technology (e.g. reference books, colleagues, contacts in companies) to help us evaluate the advantages of the invention? b. Has any commercial interest been expressed in the invention? For instance, at meetings, have any companies viewed your poster(s) or enquired after a presentation(s) c. Please provide any “key words” in order for us to conduct market research. d. Do you know of any companies that might be interested in supporting research in this field or which might be interested in commercialization of this technology? If so, please provide the name of the company and any specific contact person(s) that you may know. e. Do you have any financial interest in any of these companies? Page 9 of 10 Villanova University Invention Disclosure Form (Updated 6/2015) 18. Signature(s) of inventor candidate(s) and date: Signature: ________________________________ Date: _________________________ Name: ___________________________________ Department/Division: _______________________ Institution : __________________________________ Signature: ________________________________ Date: _________________________ Name: ___________________________________ Department/Division: _______________________ Institution: __________________________________ Signature: ________________________________ Date: _________________________ Name: ___________________________________ Department/Division: _______________________ Institution: __________________________________ Signature: ________________________________ Date: _________________________ Name: ___________________________________ Department/Division: _______________________ Institution: __________________________________ Page 10 of 10