Patents in USDA Agricultural Research Service

1. Patents in USDA Agricultural Research Service Gail Poulos Supervisory Patent Advisor

2. 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)

3. Patenting Marketing Licensing Tech Transfer Coordinators • 8 registered patent agents • Located in Beltsville, MD; Peoria, IL; Albany, CA • Targeted marketing • Web subscribe Tech Alerts • Partnering opportunities • 4 senior licensing specialists • HQ based • 7 specialists with life science / ag background • Distributed across geographic Areas of ARS Office of Technology Transfer Centralized in policy and approvals, licensing, marketing; decentralized in negotiation and implementation of CRADAs

4. 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 309-681-6512Albert.Tsui@ars.usda.gov Randy Deck – MWA & SPA 309-681-6515 Randy.Deck@ars.usda.gov

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

6. 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

7. 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

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

9. 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

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

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

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

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

14. Invention Disclosure Patent Advisor Committee Review Patent Committee Criteria 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?

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

16. NEW USPTO RULES • Strategies • Implications

17. 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.

18. 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.

19. 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

20. 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 Implications to Operations

21. 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 Implications to Operations

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