1. TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

2. 2 Contact Information John Doll Commissioner for Patents e-mail:john.doll@uspto.govjohn.doll@uspto.gov Phone: 571 272 8800

3. Application Filings and and Examiner Production Examiner Production

4. 4 UPR Applications Filed FY 05 plan 375,080 (7% above FY 04) 383,000 as of 10/30/05 (preliminary) Current projection 1.7% over plan

5. 5 FY 04 FY 05 Target FY 05 UPR 1 FAOM 2 288,315297,614297,287 UPR Disposals 3 287,188295,456279,345 UPR Production Units 4 287,752296,535288,316 PCT Production Units 5 16,88222,91615,147 Production 1 UPR = Utility, Plant, and Reissue Applications. 2 FAOM = First Action on the Merits – first action count by an examiner after the filing of an application (does not include restrictions or other miscellaneous actions). 3 Disposal = An examiner allowance, abandonment, or disposals following a board decision. 4 Production Unit = First action count plus disposal count divided by 2. 5 PCT = Patent Cooperation Treaty. PCT applications are processed differently and tracked separately from US National stage applications. For FY 05, 15,147 PUs is 35,389 processed applications.

6. ... vs the Backlog PENDENCY

7. 7 FY 05 Patent Pendency (as of 10/1/2005) FY 05 Patent Pendency (as of 10/1/2005) Technology Center Average 1 st Action Pendency (months) 1 Average Total Pendency (months) 2 1600 - Biotechnology and Organic Chemistry23.0 32.3 1700 - Chemical and Materials Engineering 19.7 29.7 2100 - Computer Architecture Software and Information Security 32.7 43.5 2600 – Communications30.542.3 2800 - Semiconductor, Electrical, Optical Systems14.524.9 3600 - Transportation, Construction, Electronic Commerce18.4 26.9 3700 - Mechanical Engineering, Manufacturing and Products18.326.3 UPR Total (as of 10/1/2005) 21.129.1 FY 05 Target 20.7*31.0 1 Average 1 st action pendency is the average age from filing to first action for a newly filed application, completed during July-September FY 2005. 2 Average total pendency is the average age from filing to issue or abandonment of a newly filed application, completed during July-September FY 2005. * Assuming current input and output estimates, the agency should achieve first action pendency of 21.3 months by the end of FY 2005 and total pendency of 30.2 months.

8. 8 First Action Pendency by Art Areas High Pendency Art Areas Pendency 1 (months) Low Pendency Art Areas Pendency 1 (months) 1640 – Immunology, Receptor/ Ligands, Cytokines, Recombinant Hormones, and Molecular Biology 27.4 1620 – Heterocyclic Compounds and Uses 16.1 1764 – Distillation, Mineral Oil and Hydrocarbons 28.71752 – Radiation Imagery11.6 2123 – Simulation and Modeling, Emulation of Computer Components 41.6 2125 – Manufacturing Control Systems and Chemical/ Mechanical/Electrical Control 21.4 2617 – Interactive Video Distribution45.3 2636 – General Electrical Communication 18.2 2836 – Control Circuits25.62833 – Electrical Connectors8.0 3628 – Finance & Banking, Accounting48.43643 – Animal and Plant Husbandry11.8 3762 – Body Treatment, Kinestherapy, and Exercising 27.53742 – Thermal Combustion Technology10.6 1 Average 1 st action pendency is the average age from filing to first action for a newly filed application, completed during July-September FY 2005.

9. 9 Inventory by Art Examples High Inventory Art Areas Months of Inventory* Low Inventory Art Areas Months of Inventory* 1614, 1615, and 1617 – Drugs, Bio-affecting and Body Treatment 57-651620 – Organic Chemistry18 1753 – Radiation Imagery39 1734 – Adhesive Bonding and Coating Apparatus 13 2127 – Computer Task Management54 2125 – Manufacturing Control Systems and Chemical/ Mechanical/Electrical Control 13 2611 – Interactive Video Distribution88 2651, 2653 – Information Storage and Retrieval 14 2836 – Control Circuits422831 – Electrical Conductors8 3620 – Business Methods27 – 1063651 – Conveying11 3731 and 3737 – Medical Instruments, Diagnostic Equipment 44-51 3742 – Thermal and Combustion Technology 8 * The number of months it would take to reach a first action on the merits (e.g., an action addressing patentability issues) on a new application filed as of Jan 2005 at todays production rate. Todays production rate means that there are no changes in production due to hiring, attrition, changes to examination processing or examination efficiencies, and that applications are taken up in the order of filing in the given art unit/area. Of course, USPTO is taking aggressive steps to ensure changes that will significantly lower the inventory rates in high-inventory art areas.

10. 10 1600170021002600280036003700Total*Design New Applications 1 9/30/2004 55,40263,92371,77897,38077,65156,73865,005508,87818,451 New Applications 1 9/30/2005 62,64472,69776,529115,58594,42570,35483,225586,58024,056 Overall Pending Applications 2 9/30/2004 95,006105,447102,440138,822137,458101,097108,039809,32327,599 Overall Pending Applications 2 9/30/2005 107,647120,767117,728167,721159,687117,045130,168932,30037,607 TC Application Inventory 1 New Application inventory is the number of new applications designated or assigned to a technology center awaiting a first action. 2 Overall Pending Application inventory is the total number of applications designated or assigned to a technology center in an active status. Includes new applications; rejected awaiting response; amended; under appeal or interference; suspended; reexams and allowed applications awaiting grant publication. *Total inventory includes applications not assigned to a particular TC, awaiting processing either pre- or post-examination.

11. 11 Pendency Achieved Target 30.2 Months Target 21.3 Months

12. Patent Quality (Shared Responsibility)

13. 13 Quality of Products – FY 05 Fiscal Year 2005 FY 041600170021002600280036003700 Desig n FY 05 FY 05 Target Patent In-Process Examination Compliance Rate 1* 82.0%81.7%82.9%88.1%84.7%90.9%84.4%86.6%94.3%86.2%84.0% Patent Allowance Error Rate 2* 5.32%4.88%6.46%3.56%2.25%4.43%4.94%6.43%1.6%4.55%4.0% *Compliance and error rates as measured by OPQA. 1 Compliance is the percent of office actions reviewed and found to be free of any in-process examination deficiency (an error that has significant adverse impact on patent prosecution). 2 Patent allowance error rate is the percent of allowed applications reviewed having at least one claim which is considered unpatentable on a basis for which a court would hold a patent invalid. Allowance occurs before a patent is issued, so these errors are caught before any patent is actually granted.

14. 14 Percent of Allowed Applications with Material Defect Target 4%

15. Re-Work

16. 16 Technology Centers Rework* Statistics * Rework first actions are those actions that are in a Continuing (CONs and CIPs), RCE, CPA or 129(a) applications (excludes Divisionals).

17. Hiring and Retention

18. 18 Hires and Attritions 1600170021002600280036003700CorpsDesign FY 04 Hires753511511631264544315 FY 04 Attritions302658825843393364 FY 05 BOY Examiner Staff 417440563658742422439368172 FY 05 Hiring (10/1/05)101582251691849113195919 FY 05 Attrits (10/1/05)4239939254555042510 FY 05 Hiring Goal100352001501609012586020 New Hires as a Percent of Examiner Staffing in the TC 24%13%40%26%25%22%30%26%

19. 19 FY 05 Attrition of Average Staff

20. Pendency Projections

21. HistoricWithout Strategic Plan

22. HistoricWithout Strategic Plan 1,000 Hires & Low Attrits

23. HistoricWithout Strategic Plan 1,000 Hires & Low AttritsPlus Claims & Continuation Limits

24. HistoricWithout Strategic Plan1,000 Hires & Low AttritsPlus Claims & Continuation LimitsPlus Patentability Report

26. Production

27. 27

28. Stats and Stuff

29. 29 Continuation* Applications Filed *Straight Continuations 37 CFR §1.53 (b)(1) – No Divisionals or CIPs – as of 10/23/05

30. 30 RCE/CPA Filing Rates as of 10/23/05

31. 31 Total Continuation Filing Rates *Straight Continuations 37 CFR §1.53 (b)(1) – No Divisionals or CIPs – as of 10/23/05

32. 32 Total Continuation* Filing Rates *Continuation = Straight Continuations 37 CFR §1.53 (b)(1) + RCE + CPA – Not Divisionals or CIPs as of 10/23/05

33. 33 Continuation Filing Rates

34. 34 As of 10/24/2005

35. 35 Distribution of Independent Claims at Filing

36. 36 TC 1600 Distribution of Independent Claims at Filing

37. 37 Distribution of Total Claims at Filing

38. 38 TC 1600 Distribution of Total Claims at Filing

39. 39 Total Claims at Filing and Issue

40. 40 Distribution of the Number of References Cited in Applications

41. Markush Practice

42. 42 1.A cell adhesion protein of formula (1), A-(B)-(C)-(D) n -E or a pharmaceutically acceptable derivative thereof, wherein...

43. Accelerated Examination Would You Like Your Patent In 12 Months ?!?

44. 44 Accelerated Examination Features of the proposed revision: Features of the proposed revision: Move to the head of the line Move to the head of the line Final Disposition within 12 months Final Disposition within 12 months Program for expedited Issuance of Patents Program for expedited Issuance of Patents e-file application and all follow on papers e-file application and all follow on papers Single Invention Single Invention Limited Number of Claims Limited Number of Claims Patentability Report Patentability Report Possible Interview before 1 st Action Possible Interview before 1 st Action Shortened Statutory Period Shortened Statutory Period Enforcement of special status in the Corps Enforcement of special status in the Corps

45. 45 Contact Information John Doll Commissioner for Patents e-mail:john.doll@uspto.govjohn.doll@uspto.gov Phone: 571 272 8800