Patents in USDA Agricultural Research Service Gail Poulos Supervisory Patent Advisor

USDA-ARS Office of Technology Transfer Coordinates Tech Transfer activities in ARS Has authority to develop and sign Cooperative Research And Development Agreements (CRADAs) Has sole authority for licensing any inventions developed within any of the USDA agencies (including Forest Service, FSIS, APHIS)

Office of Technology Transfer Centralized in policy and approvals, licensing, marketing; decentralized in negotiation and implementation of CRADAs Patenting 8 registered patent agents Located in Beltsville, MD; Peoria, IL; Albany, CA Marketing Targeted marketing Web subscribe Tech Alerts Partnering opportunities Licensing 4 senior licensing specialists HQ based Tech Transfer Coordinators 7 specialists with life science / ag background Distributed across geographic Areas of ARS Our office is structured such that we are centralized in policy and approvals, licensing, and marketing, but decentralized in negotiation and implementation of Cooperative Research and Development Agreements. Our patenting section consists of 8 registered patent agents distributed at 3 sites. The marketing section conducts targeted marketing, manages a web-based self-subscribe feature called Tech Alerts whereby companies are notified of new available technologies by categories, and assists in finding research partners by developing 1-pagers for the web or mailings. The licensing section consists of 4 senior licensing specialists, And 7 forward-deployed Technology Transfer Coordinators – all GS 15s with strong research and science backgrounds. They are located in the Area Offices of ARS, but report to headquarters --- providing service to scientists and the Area Director, but maintaining a national rather than regional perspective.

Office of Technology Transfer Byron Stover –ERRC 301-504-4783 Byron.Stover@ars.usda.gov Evelyn Rabin -- NAA 301 504-4781 Evelyn.Rabin@ars.usda.gov Patent Advisors Byron Stover - BA 301-504-4783 Byron.Stover@ars.usda.gov Albert Tsui – MWA & NPA 309-681-6512 Albert.Tsui@ars.usda.gov Gail Poulos – SAA 301-504-5302 Gail.Poulos@ars.usda.gov Evelyn Rabin - MSA 301 504-4781 Evelyn.Rabin@ars.usda.gov Beth Sampson / Howard Owens – PWA 510-559-6067 / 5731 Esampson@pw.ars.usda.gov Howens@pw.ars.usda.gov Albert Tsui – NPA 309-681-6512 Albert.Tsui@ars.usda.gov Randy Deck – MWA & SPA 309-681-6515 Randy.Deck@ars.usda.gov

OTT as Representative and Liaison University Interests ARS Mission U.S. Company Interests

Professional Services of ARS OTT – Patent Section Create, manage & convene Patent Review Committees (e.g., Invention Disclosure) Prepare, file, and prosecute U.S. patent applications, Coordinate cooperator-filed U.S. patent applications Facilitate and direct foreign filings with contractor Training of All ARS scientists We’ve also changed some of the policies in ARS to some degree. We have done so because of the changing world of intellectual property and our need to continue fostering the research partnerships. With the passage of the Technology Transfer and Commercialization Act of 2000, we can now license “protectable” technologies. And we do so, primarily with hybridomas used in developing monoclonal antibodies. Secondly, we have developed a new process to determine whether we need to protect IP of new plant materials. This is increasingly important in dealing with our university partners. And we anticipate the future need to protect animal intellectual property as we develop improved breeds of animals for food that are resistant to disease, faster growing, or otherwise modified to enhance international competitiveness.

Professional Services of ARS OTT – Patent Section Assist scientist in preparing electronic Invention Disclosure Determine whether invention under a CRADA is a “subject invention” Determine need to present CRADA invention to Patent Committee Perform inventorship determination We’ve also changed some of the policies in ARS to some degree. We have done so because of the changing world of intellectual property and our need to continue fostering the research partnerships. With the passage of the Technology Transfer and Commercialization Act of 2000, we can now license “protectable” technologies. And we do so, primarily with hybridomas used in developing monoclonal antibodies. Secondly, we have developed a new process to determine whether we need to protect IP of new plant materials. This is increasingly important in dealing with our university partners. And we anticipate the future need to protect animal intellectual property as we develop improved breeds of animals for food that are resistant to disease, faster growing, or otherwise modified to enhance international competitiveness.

Three “Subject Matter” Committees National Patent Committees Three “Subject Matter” Committees Life Sciences Chemical Mechanical and Measurement Each cover all geographic Areas of ARS

Advantages To The ARS Uniform committee recommendations across the Agency Committee recommendation within three months of filing an Invention Disclosure Scientists and management notified of annual schedule at the beginning of each fiscal year

Patent Committee Criteria Invention Disclosure Patent Advisor Committee Review “The Five Questions”

Patent Committee Criteria Invention Disclosure Patent Advisor Committee Review Q1: Is there current commercial interest in the invention or a high probability of commercialization in the future?

Patent Committee Criteria Invention Disclosure Patent Advisor Committee Review Q2: Is the magnitude of the market relative to the cost of commercialization sufficiently large to warrant a patent?

Patent Committee Criteria Invention Disclosure Patent Advisor Committee Review Q3: Would the patent likely play a significant role in transferring the technology to the user?

Patent Committee Criteria Invention Disclosure Patent Advisor Committee Review Q4: Would a patent be enforceable, i.e., is the invention drawn to, or does it employ a unique and readily identifiable material or device which could be bought or sold?

Patent Committee Criteria Invention Disclosure Patent Advisor Committee Review Q5: Is the invention of sufficient scope to justify patenting?

NEW USPTO RULES Strategies Implications

Strategies Review Entire Pending Docket Prior to Effective Date of Rule Change To: a. Determine number applications that have continuation potential b. Determine which applications should be filed prior to effective date of the rule c. Set up standard operating procedures for applications that will be filed after the effective date of rule change. d. Determine which applications do not comply with the 5/25 rule and correct.

Strategies File Provisional Applications for Technologies that will not meet the 5/25 Rule-Use the one year period to determine claims that should be protected by consulting with inventors. National committees will facilitate determining if other Areas in ARS have inventions that could be considered under 37 CFR 1.78 (f) (3) as having at least one patentably indistinct claim –the Patent Advisors will determine if the inventions can be combined in one application.

Strategies for Jointly-owned Inventions Will need to work more closely with a partner. May be an issue in that partner may have to disclose information about applications and claims that are not published. If partner does not fully disclose, may lose U.S. Government rights if application is abandoned by USPTO. Establish that the government is exercising due diligence in complying with rules. Protect govt. interest by written record of request for solely-owned (cooperator) patent applications having overlapping claims. Note: Filing an explanation that claims are patently distinct creates potential liability for joint owners and office preparing and prosecuting application

Implications to Operations Increase in the number of provisional and new applications filed will increase costs: Note provisional fee: $210.00 patent application filing: about $1500-$5,000 Increase in number of applications going to appeal will increase pendency & costs: Note: notice of appeal fee $510.00; appeal brief fee $510.00 Potential for the need to write more focused claims: Note: will result in narrow claims Need to increase number of provisionals filed File separate cases for distinct inventions to avoid restriction practice

Implications to Operations Potential for ARS preparing and prosecuting more patent applications for small business partners and university partners. Future partnering with large business may be more difficult if development of patentable technologies occurs. Presumption is that large business will opt for trade secret rather than patent protection Thorough review of all CRADAs to determine if there are overlapping technologies with different partners and different research units in the agency. i.e., CRADAs for biofuel research using same starting materials Need to increase number of provisionals filed File separate cases for distinct inventions to avoid restriction practice

Office of Technology Transfer 5601 Sunnyside Ave Beltsville, MD 20705 (301) 504-6905 HTTP://OTT.ARS.USDA.GOV