1. 1 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Biotech/ChemPharm Customer Partnership Meeting February 3, 2003 Jasemine C. Chambers Director, Technology Center 1600 United States Patent and Trademark Office Jasemine.Chambers@USPTO.GOV

2. 2 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Overview  Background  Benefits  Revision Process  General Features  Objectives  Organization of Content  Individual Chapters – claims, unity of invention, prior art, inventive step, industrial applicability, international search, common quality framework

3. 3 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Background In September 2002, the PCT Assembly adopted proposals by the PCT Reform Committee to introduce an enhanced international search and preliminary examination (EISPE) system.

4. 4 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Background – cont. EISPE system  Convergence of Chapter I and II procedures  In Chapter I, ISA establishes both ISR and WO  WO of the ISA will have the same scope and content as today’s WO of the IPEA  WO of the ISA is sent to applicant along with the ISR  ISR will be published with application, but WO of the ISA will not be  Applicant may informally submit comments to the IB

5. 5 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Background – cont. EISPE system – cont.  If no demand is filed by applicant, a Chapter I IPRP is issued, which is a repackaged WO of the ISA  If a demand is filed, then in Chapter II:  WO of the ISA is considered the first WO of the IPEA  A new WO of the IPEA is issued only in rare circumstances

6. 6 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Background – cont. The introduction of the EISPE system necessitated a significant revision of the PCT international search and preliminary examination guidelines to reflect new rules and procedures, and a single, combined set of guidelines for both search and examination.

7. 7 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Benefits  Opportunity to create an international standard for processes and methodologies to be used by each International Authority.  Will assist in the work sharing efforts.  Will assist in standardizing practices around the globe.

8. 8 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Revision Process  October 2002 Trilateral Meeting - USPTO agreed to take the lead in the drafting of the revised guidelines.  November 2002 Trilateral Conference – USPTO presented an action plan, which was adopted by the trilateral offices.  Three meetings of the IAs took place in February, May, and July 2003.  December 2003 – Final text of the revised guidelines established by the International Bureau after consultation with the IAs.

9. 9 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines General Features of the Revised Guidelines  Serve as common rules.  Do not have binding authority of a legal text.  Effective for applications filed on or after January 1, 2004.  Incorporated changes resulting from amendments to the Regulations under the PCT adopted by the Assembly in September 2002 as well as subsequent amendments.  Combined previously separate search and examination guidelines into a single text.

10. 10 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines General Features of the Revised Guidelines - cont.  Necessary because of convergence of the traditional Chapter I and Chapter II procedures under the EISPE system.  Will enhance consistency between the searching and examining authorities.  Detail the establishment (under the EISPE system) of the written opinion of the searching authority and the rules and guidelines governing such.  Detail the new search and examination timeline under the EISPE system.

11. 11 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Objectives of the Revised Guidelines  To provide more practical guidance to examiners.  To work toward a common approach wherever possible; however,  Where there were divergent practices in the national offices, the divergent practices were set forth in the appendices to the individual chapters.

12. 12 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Objectives of the Revised Guidelines – cont.  To reflect current search and examination practices, especially in:  Use of automated search tools.  Application of utility criteria.  Assessment of inventive step.  Analytical framework for assessing a holding of lack of unity.  USPTO examiners will have on-line access to the revised guidelines.

13. 13 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Organization of Content of the Revised Guidelines  Part I – Introduction and Overview  Chapter 1 –Introduction  Chapter 2 – Overview of the International Search Stage  Chapter 3 – Overview of the International Preliminary Examination Stage  Part II – The International Application  Chapter 4 – Content of the International Application (Other than the Claims)  Chapter 5 – Claims  Chapter 6 – Priority  Chapter 7 – Classification of International Applications  Chapter 8 – Rule 91 – Obvious Errors in Documents

14. 14 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Organization of Content of the Revised Guidelines – cont.  Part III – Examiner Considerations Common to Both the International Searching Authority and the International Preliminary Examining Authority  Chapter 9 – Exclusions From, and Limitations of, International Search and International Preliminary Examination  Chapter 10 – Unity of Invention  Chapter 11 – Prior Art  Chapter 12 – Novelty  Chapter 13 – Inventive Step  Chapter 14 – Industrial Applicability  Part IV – The International Search  Chapter 15 – The International Search  Chapter 16 - International Search Report

15. 15 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Organization of Content of the Revised Guidelines – cont.  Part V – Written Opinions/International Preliminary Examination Report  Chapter 17 – Content of Written Opinions and the International Preliminary Examination Report  Part VI – The International Preliminary Examination Stage (Other than the International Preliminary Report)  Chapter 18 – Preliminary Procedure on receipt of the Demand  Chapter 19 – Examination Procedure Before the International Preliminary Examining Authority  Chapter 20 – Amendments  Part VII– Quality  Chapter 21 – A Common Quality Framework for International Search and Preliminary Examination  Part VIII– Clerical and Administrative Procedures  Chapter 22 – Clerical and Administrative Procedures

16. 16 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Chapter 5 - Claims  Provides additional guidance to examiners with respect to:  Claim construction.  Conciseness.  Enablement.  Relationship of claims to the disclosure.  Includes an appendix that sets forth divergent practices on:  Multiple dependent claims.  Use claims.  Product by process claims.  Conciseness.

17. 17 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Chapter 10 – Unity of Invention  Provides an analytical framework for assessing a holding of lack of unity.  Includes new biotechnology examples.  Fully incorporated Annex B of PCT Administrative Instructions.

18. 18 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Chapter 11 – Prior Art  Includes guidance to examiners on how to address disclosure on the Internet.

19. 19 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Chapter 13 – Inventive Step  Sets forth the assessment of inventive step.  Includes an appendix that sets forth:  Problem-solution approach.  Examples in which a single document calls into question the inventive step.

20. 20 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Chapter 14 – Industrial Applicability  Includes an appendix that sets forth the application of the utility criteria.

21. 21 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Chapter 15 – The International Search  Revised to allow a more complete documentation of international search to assist examiners at the national stage.  Revised to reflect the use of automated search tools.

22. 22 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines Chapter 21 – A Common Quality Framework for International Search and Preliminary Examination  New chapter

23. 23 United States Patent and Trademark Office Revised PCT International Search and Preliminary Examination Guidelines THANK YOU Jasemine C. Chambers Director, Technology Center 1600 United States Patent and Trademark Office Jasemine.Chambers@USPTO.GOV