Legal Issues in Product Development

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United States Patent and Trademark Office
Revised PCT International Search andPreliminary
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_at_USPTO.GOV
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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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.

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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 todays 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

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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.

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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.

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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.

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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.

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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.

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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.

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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.

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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.

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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.

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• Chapter 11 Prior Art
• Includes guidance to examiners on how to address
  disclosure on the Internet.

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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.

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• Chapter 14 Industrial Applicability
• Includes an appendix that sets forth the
  application of the utility criteria.

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• 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.

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Revised PCT International Search andPreliminary
Examination Guidelines
United States Patent and Trademark Office

• Chapter 21 A Common Quality Framework for
  International Search and Preliminary Examination
• New chapter

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