As a stand alone technology transfer office, the Office of Technology Transfer and Innovation Access (OTTIA) provides a complete array of services, supporting the National Institute of Dental and Craniofacial Research (NIDCR)'s technology development activities. To ensure that these activities comport with Federal statutes, regulations and the policies of the National Institutes of Health, a large part of OTTIA's responsibilities includes the day-to-day negotiations of transactional agreements between the NIDCR and outside parties, including universities, pharmaceutical and biotechnology companies. Concurrently, OTTIA broadens the impact of NIDCR intramural research by fostering scientific exchange, promoting NIDCR research, and obtaining material and financial resources. Agreements facilitate: *exchanges of research materials under the Material Transfer Agreements (MTAs); *collaborative research conducted under cooperative research and development agreements (CRADAs); *clinical studies to determine the safety and efficacy of new agents and devices under clinical CRADAs; *exchanges of confidential information or data under confidential disclosure and data sharing agreements (CDAs, DSAs); and *licensing of technologies for commercial evaluation, product development, internal private-sector research use, and support of external non-profit technology transfer efforts. OTTIA reviews employee invention reports, assesses patentability, evaluates commercial potential, and makes decisions concerning filing of domestic and foreign patent applications. We monitor the patent prosecution, and fulfillment of associated legal contracts, for NIDCR-owned inventions. We conduct marketing activities to license those inventions and develop and/or assess development strategies to bring technologies to fruition. OTTIA integrates the agreement and invention work to develop strategies for partnerships, thus complementing and extending NIDCR's capabilities to better meet our mission goals. Our staff participates in meetings, discussions and conferences, as appropriate, to stay apprised of and monitor scientists' needs, and to both contribute and learn from the NIH and broader Technology Transfer communities. NIDCR/OTTIA issued 57 task orders for patent prosecutions. NIDCR/OTTIA communicated effectively with NIH contract law firms and approved work order estimates and invoices in a timely manner. NIDCR/OTTIA picked up extra responsibilities including generating license application numbers, attaching and updating documents to TechTracS. NIDCR/OTTIA completed all training required by NIH. NIDCR/OTTIA continued taking technology transfer-related classes at FAES. NIDCR/OTTIA have obtained 15 credits, which are sufficient for a certificate in the Advanced Studies in Technology Transfer program. NIDCR/OTTIA filed 16 patent applications (table 1). NIDCR/OTTIA explained US patent regulations to investigators and helped them prepare significantly improved patent applications. NIDCR/OTTIA obtained 12 patents, including allowed patent applications (table 2). NIDCR/OTTIA reviewed more than 20 Office actions (patent examination reports) from the USPTO and foreign patent offices for our patent applications. NIDCR/OTTIA hosted more than 20 conference calls with attorneys and investigators to develop strategies to overcome rejections from patent offices. NIDCR/OTTIA managed patent maintenance and annuity. NIDCR/OTTIA timely abandoned patents or patent applications that have low commercial potential or have rejections that we dont have supportive data to overcome. NIDCR/OTTIA evaluated two technologies. One is from Dr. Ashok Kulkarni, entitled TFP5, a Cdk5 inhibitory peptide, attenuates inflammation and may serve as an analgesic, and the other is from Dr. Wanjun Chen, entitled TGF-b receptor NIDCR/OTTIA as a biomarker on T cells in cancer immunotherapy by checkpoint blockade. NIDCR/OTTIA decided not to file patent applications for these two technologies because these technologies have already been disclosed in prior arts. It is highly likely we would receive obviousness rejections if we were to file applications. NIDCR/OTTIA prepared six license agreements and already executed three of them (table 3). NIDCR/OTTIA negotiated a Letter of Agreement for Transfer of Material. This agreement is for Dr. John ChiorinNIDCR/OTTIA to receive serum and saliva samples from well characterized cohorts of mice from DoD. NIDCR/OTTIA prepared and negotiated three Confidential Disclosure Agreements. NIDCR/OTTIA hosted more than ten conference calls with potential licensees to commercialize NIDCR technologies. NIDCR/OTTIA have been representing NIDCR to attend the weekly NIH Patent Contracts Working Group meetings since May 2017. The purpose of this working group is to facilitate preparation, solicitation, evaluation, and award of new patent services contracts. NIDCR/OTTIA analyzed the NIH patent prosecution cost for the past eight years for the committee to use as a basis for our budget estimation for the next ten years. NIDCR/OTTIA also drafted survey questions for evaluation of the service quality of NIH contract law firms. NIDCR/OTTIA represented NIDCR to participate NIH OTT Enterprise Technology Transfer project to provide suggestions and advice on patent and licensing.

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10
Fiscal Year
2018
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Dental & Craniofacial Research
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Wei, Zheng; Angerer, Lynne M; Angerer, Robert C (2016) Neurogenic gene regulatory pathways in the sea urchin embryo. Development 143:298-305