Skip to main content Skip to footer
HomeHome
 
  • Homepage
  • Searching for patents

    Patent knowledge

    Access our patent databases and search tools.

    Go to overview 

    • Overview
    • Technical information
      • Overview
      • Espacenet - patent search
      • European Publication Server
      • Searching Asian documents: patent search and monitoring services
      • EP full-text search
      • Bibliographic coverage in Espacenet and OPS
      • Full-text coverage in Espacenet and OPS
    • Legal information
      • Overview
      • European Patent Register
      • European Patent Bulletin
      • European Case Law Identifier sitemap
      • Searching Asian documents
      • Third-party observations
    • Business information
      • Overview
      • PATSTAT
      • IPscore
      • Patent insight reports
    • Data
      • Overview
      • Linked open EP data
      • Bulk data sets
      • Web services
      • Coverage, codes and statistics
    • Helpful resources
      • Overview
      • First time here?
      • Asian patent information
      • Patent information centres
      • Patent Translate
      • Patent Knowledge News
      • Business and statistics
      • Unitary Patent information in patent knowledge

    UP search

    Learn about the Unitary Patent in patent knowledge products and services

  • Applying for a patent

    Applying for a patent

    Practical information on filing and grant procedures.

    Go to overview 

    • Overview
    • European route
      • Overview
      • European Patent Guide
      • Oppositions
      • Oral proceedings
      • Appeals
      • Unitary Patent & Unified Patent Court
      • National validation
      • Request for extension/validation
    • International route (PCT)
      • Overview
      • Euro-PCT Guide – PCT procedure at the EPO
      • EPO decisions and notices
      • PCT provisions and resources
      • Extension/validation request
      • Reinforced partnership programme
      • Accelerating your PCT application
      • Patent Prosecution Highway (PPH)
      • Training and events
    • National route
    • MyEPO services
      • Overview
      • Understand our services
      • Get access
      • Find a professional representative
      • File with us
      • Interact on your files
      • Online Filing & fee payment outages
      • Tutorials
    • Forms
      • Overview
      • Request for examination
    • Fees
      • Overview
      • European fees (EPC)
      • International fees (PCT)
      • Unitary Patent fees (UP)
      • Fee payment and refunds
      • Warning

    UP

    Unitary Patent

  • Law & practice

    Law & practice

    European patent law, the Official Journal and other legal texts.

    Go to overview 

    • Overview
    • Legal texts
      • Overview
      • European Patent Convention
      • Official Journal
      • EPC Guidelines
      • PCT-EPO Guidelines
      • Guidelines revision cycle
      • Extension / validation system
      • London Agreement
      • National law relating to the EPC
      • Unitary patent system
      • National law relating to the UP
    • Court practices
      • Overview
      • European Patent Judges' Symposium
    • User consultations
      • Overview
      • Ongoing consultations
      • Completed consultations
    • Substantive patent law harmonisation
      • Overview
      • The Tegernsee process
      • Group B+
    • Convergence of practice
    • Options for professional representatives

    legal text

    Legal texts

  • News & events

    News & events

    Our latest news, podcasts and events, including the European Inventor Award.

    Go to overview 

     

    • Overview
    • News
    • Events
    • European Inventor Award
      • Overview
      • About the award
      • Categories and prizes
      • Meet the finalists
      • Nominations
      • Watch the 2022 ceremony
    • Press centre
      • Overview
      • Patent Index and statistics
      • Search in press centre
      • Background information
      • Copyright
      • Press contacts
      • Call back form
      • Email alert service
    • Innovation and patenting in focus
      • Overview
      • Firefighting technologies
      • Green tech in focus
      • CodeFest on Green Plastics
      • Clean energy technologies
      • IP and youth
      • Research institutes
      • Women inventors
      • Fighting coronavirus
      • Lifestyle
      • Space and satellites
      • The future of medicine
      • Materials science
      • Mobile communications
      • Biotechnology
      • Patent classification
      • Digital technologies
      • The future of manufacturing
      • Books by EPO experts
    • "Talk innovation" podcast

    Podcast

    Listen to our podcast

  • Learning

    Learning

    The e-Academy – the point of access to your learning

    Go to overview 

    • Overview
    • European Patent Academy
      • Overview
      • Learning activities
      • Learning paths
    • Professional hub
      • Overview
      • EQE - European qualifying examination
      • EPAC - European patent administration certification
    • Learning resources by area of interest
      • Overview
      • Patent granting
      • Technology transfer and dissemination
      • Patent enforcement and litigation
    • Learning resources by area by profile
      • Overview
      • Business and IP managers
      • EQE candidates
      • Judges, lawyers and prosecutors
      • National offices and IP authorities
      • Patent attorneys and paralegals
      • Universities, research centres and technology transfer centres (TTOs)

    European Patent Academy

    Boost your IP knowledge with (e-)training from the European Patent Academy

  • About us

    About us

    Find out more about our work, values, history and vision

    Go to overview 

    • Overview
    • The EPO at a glance
    • 50 years of the EPC
      • Overview
      • A glimpse of the planned activities
      • Kids’ collaborative art competition
      • 50 Leading Tech Voices
    • Legal foundations and member states
      • Overview
      • Legal foundations
      • Member states of the European Patent Organisation
      • Extension states
      • Validation states
    • Governance
      • Overview
      • Communiqués
      • Calendar
      • Select Committee documents
      • Administrative Council
    • Principles & strategy
      • Overview
      • Our mission, vision, values and corporate policy
      • Public consultation on the EPO's Strategic Plan 2028
      • Towards a New Normal
    • Leadership & management
      • Overview
      • President António Campinos
      • Management Advisory Committee
    • Social responsibility
      • Overview
      • Environment and sustainability
      • Art collection
    • Services & activities
      • Overview
      • Our services & structure
      • Consulting our users
      • European and international co-operation
      • European Patent Academy
      • Chief Economist
      • Ombuds Office
      • Reporting wrongdoing
    • Procurement
      • Overview
      • Procurement forecast
      • Doing business with the EPO
      • Procurement procedures
      • About eTendering and electronic signatures
      • Procurement portal
      • Invoicing
      • General conditions
      • Archived tenders
    • Transparency portal
      • Overview
      • General
      • Human
      • Environmental
      • Organisational
      • Social and relational
      • Economic
      • Governance
    • Statistics and trends
      • Overview
      • Statistics & Trends Centre
      • EPO Data Hub
      • Clarification on data sources
    • History
      • Overview
      • 1970s
      • 1980s
      • 1990s
      • 2000s
      • 2010s
      • 2020s

    about us

    Patent Index 2022

 
en de fr
  • Language selection
  • English
  • Deutsch
  • Français
Main navigation
  • Homepage
  • New to patents
    • Go back
    • Overview
    • What's your big idea?
    • Are you ready?
    • What to expect
    • How to apply for a patent
    • Your business and patents
    • Is it patentable?
    • Are you first?
    • Why do we have patents?
    • Patent quiz
    • Unitary patent video
  • Searching for patents
    • Go back
    • Overview
    • Technical information
      • Go back
      • Overview
      • Espacenet - patent search
        • Go back
        • Overview
        • National patent office databases
        • Global Patent Index (GPI)
        • Release notes
      • European Publication Server
        • Go back
        • Overview
        • Cross-reference index for Euro-PCT applications
        • EP authority file
        • Help
      • Searching Asian documents
      • EP full-text search
      • Bibliographic coverage in Espacenet and OPS
      • Full-text coverage in Espacenet
    • Legal information
      • Go back
      • Overview
      • European Patent Register
        • Go back
        • Overview
        • Release notes archive
        • Register documentation
          • Go back
          • Overview
          • Deep link data coverage
          • Federated Register
            • Go back
            • Overview
            • BG - Federated Register Service
            • GB - Federated Register Service
            • NL - Federated Register Service
            • MK - Federated Register Service
            • ES - Federated Register Service
            • GR - Federated Register Service
            • SK - Federated Register Service
            • FR - Federated Register Service
            • MT - Federated Register Service
          • Register events
      • European Patent Bulletin
        • Go back
        • Overview
        • Download Bulletin
        • EP Bulletin search
        • Help
      • European Case Law Identifier sitemap
      • Searching Asian documents
      • Third-party observations
    • Business information
      • Go back
      • Overview
      • PATSTAT
      • IPscore
        • Go back
        • Release notes
      • Patent insight reports
    • Data
      • Go back
      • Overview
      • Linked open EP data
      • Bulk data sets
        • Go back
        • Overview
        • Manuals
        • Sequence listings
        • National full-text data
        • European Patent Register data
        • EPO worldwide bibliographic data (DOCDB)
        • EP full-text data
        • EPO worldwide legal event data (INPADOC)
        • EP bibliographic data (EBD)
          • Go back
          • EBD files (weekly download) - free of charge
            • Go back
            • Secure EBD ST.36 files (weekly download) - for national patent offices only
        • Boards of Appeal decisions
        • EP full-text data for text analytics
      • Web services
        • Go back
        • Overview
        • Open Patent Services (OPS)
        • European Publication Server
      • Coverage, codes and statistics
        • Go back
        • Weekly updates
        • Updated regularly
    • Helpful resources
      • Go back
      • Overview
      • First time here? Patent information explained.
        • Go back
        • Overview
        • Basic definitions
        • Patent classification
          • Go back
          • Overview
          • Cooperative Patent Classification (CPC)
        • Patent families
          • Go back
          • Overview
          • DOCDB simple patent family
          • INPADOC extended patent family
        • Legal event data
          • Go back
          • Overview
          • INPADOC classification scheme
      • Asian patent information
        • Go back
        • Overview
        • China (CN)
          • Go back
          • Overview
          • Facts and figures
          • Grant procedure
          • Numbering system
          • Useful terms
          • Searching in databases
        • Chinese Taipei (TW)
          • Go back
          • Overview
          • Grant procedure
          • Numbering system
          • Useful terms
          • Searching in databases
        • India (IN)
          • Go back
          • Overview
          • Facts and figures
          • Grant procedure
          • Numbering system
        • Japan (JP)
          • Go back
          • Overview
          • Facts and figures
          • Grant procedure
          • Numbering system
          • Useful terms
          • Searching in databases
        • Korea (KR)
          • Go back
          • Overview
          • Facts and figures
          • Grant procedure
          • Numbering system
          • Useful terms
          • Searching in databases
        • Russian Federation (RU)
          • Go back
          • Overview
          • Facts and figures
          • Numbering system
          • Searching in databases
        • Useful links
      • Patent information centres (PATLIB)
      • Patent Translate
      • Patent Knowledge News
      • Business and statistics
      • Unitary Patent information in patent knowledge
  • Applying for a patent
    • Go back
    • Overview
    • European route
      • Go back
      • Overview
      • European Patent Guide
      • Oppositions
      • Oral proceedings
        • Go back
        • Oral proceedings calendar
          • Go back
          • Calendar
          • Public access to appeal proceedings
          • Public access to opposition proceedings
          • Technical guidelines
      • Appeals
      • Unitary Patent & Unified Patent Court
        • Go back
        • Overview
        • Unitary Patent
          • Go back
          • Overview
          • Legal framework
          • Unitary Patent Guide
          • Main features
          • Applying for a Unitary Patent
          • Cost of a Unitary Patent
          • Translation and compensation
          • Start date
        • Unified Patent Court
      • National validation
      • Extension/validation request
    • International route
      • Go back
      • Overview
      • Euro-PCT Guide
      • Entry into the European phase
      • Decisions and notices
      • PCT provisions and resources
      • Extension/validation request
      • Reinforced partnership programme
      • Accelerating your PCT application
      • Patent Prosecution Highway (PPH)
        • Go back
        • Patent Prosecution Highway (PPH) programme outline
      • Training and events
    • National route
    • MyEPO services
      • Go back
      • Overview
      • Understand our services
        • Go back
        • Overview
        • Online Filing 2.0 pilot
        • MyEPO Portfolio - pilot phase
        • Online Filing 2.0 pilot continuation
        • Exchange data with us using an API
      • Get access
        • Go back
        • Overview
        • Installation and activation
      • Find a professional representative
      • File with us
        • Go back
        • Overview
        • What if our online filing services are down?
        • Release notes
      • Interact on your files
      • Online Filing & fee payment outages
      • Tutorials
    • Fees
      • Go back
      • Overview
      • European fees (EPC)
        • Go back
        • Overview
        • Decisions and notices
      • International fees (PCT)
        • Go back
        • Reduction in fees
        • Fees for international applications
        • Decisions and notices
        • Overview
      • Unitary Patent fees (UP)
        • Go back
        • Overview
        • Decisions and notices
      • Fee payment and refunds
        • Go back
        • Overview
        • Payment methods
        • Getting started
        • FAQs and other documentation
        • Technical information for batch payments
        • Decisions and notices
        • Release notes
      • Warning
    • Forms
      • Go back
      • Request for examination
  • Law & practice
    • Go back
    • Overview
    • Legal texts
      • Go back
      • Overview
      • European Patent Convention
        • Go back
        • Overview
        • Archive
          • Go back
          • Overview
          • Documentation on the EPC revision 2000
            • Go back
            • Overview
            • Diplomatic Conference for the revision of the EPC
            • Travaux préparatoires
            • New text
            • Transitional provisions
            • Implementing regulations to the EPC 2000
            • Rules relating to Fees
            • Ratifications and accessions
          • Travaux Préparatoires EPC 1973
      • Official Journal
      • EPC Guidelines
        • Go back
        • Overview
        • Archive
      • PCT-EPO Guidelines
        • Go back
        • Overview
        • Archive
      • Guidelines revision cycle
      • Extension / validation system
      • London Agreement
      • National law relating to the EPC
        • Go back
        • Overview
        • Archive
      • Unitary Patent system
      • National measures relating to the Unitary Patent 
    • Court practices
      • Go back
      • Overview
      • European Patent Judges' Symposium
    • User consultations
      • Go back
      • Overview
      • Ongoing consultations
      • Completed consultations
    • Substantive patent law harmonisation
      • Go back
      • Overview
      • The Tegernsee process
      • Group B+
    • Convergence of practice
    • Options for professional representatives
  • News & events
    • Go back
    • Overview
    • News
    • Events
    • European Inventor Award
      • Go back
      • Overview
      • About the award
      • Categories and prizes
      • Meet the finalists
      • Nominations
      • Watch the 2023 ceremony
      • European Inventor Network
        • Go back
        • Activities granted in 2023
    • Press centre
      • Go back
      • Overview
      • Patent Index and statistics
      • Search in press centre
      • Background information
        • Go back
        • Overview
        • European Patent Office
        • Q&A on patents related to coronavirus
        • Q&A on plant patents
      • Copyright
      • Press contacts
      • Call back form
      • Email alert service
    • In focus
      • Go back
      • Overview
      • Firefighting technologies
        • Go back
        • Overview
        • Detection and prevention of fires
        • Fire extinguishing
        • Protective equipment
        • Post-fire restoration
      • Green tech in focus
        • Go back
        • Overview
        • About green tech
        • Renewable energies
        • Energy transition technologies
        • Building a greener future
      • CodeFest on Green Plastics
      • Clean energy technologies
        • Go back
        • Overview
        • Renewable energy
        • Carbon-intensive industries
        • Energy storage and other enabling technologies
      • IP and youth
      • Research institutes
      • Women inventors
      • Fighting coronavirus
        • Go back
        • Overview
        • Vaccines and therapeutics
          • Go back
          • Overview
          • Vaccines
          • Overview of candidate therapies for COVID-19
          • Candidate antiviral and symptomatic therapeutics
          • Nucleic acids and antibodies to fight coronavirus
        • Diagnostics and analytics
          • Go back
          • Overview
          • Protein and nucleic acid assays
          • Analytical protocols
        • Informatics
          • Go back
          • Overview
          • Bioinformatics
          • Healthcare informatics
        • Technologies for the new normal
          • Go back
          • Overview
          • Devices, materials and equipment
          • Procedures, actions and activities
          • Digital technologies
        • Inventors against coronavirus
      • Lifestyle
      • Space and satellites
        • Go back
        • Overview
        • Patents and space technologies
      • Healthcare
        • Go back
        • Overview
        • Medical technologies and cancer
        • Personalised medicine
      • Materials science
        • Go back
        • Overview
        • Nanotechnology
      • Mobile communications
      • Biotechnology
        • Go back
        • Overview
        • Red, white or green
        • The role of the EPO
        • What is patentable?
        • Biotech inventors
      • Classification
        • Go back
        • Overview
        • Nanotechnology
        • Climate change mitigation technologies
          • Go back
          • Overview
          • External partners
          • Updates on Y02 and Y04S
      • Digital technologies
        • Go back
        • Overview
        • About ICT
        • Hardware and software
        • Patents and standards
        • Artificial intelligence
        • Fourth Industrial Revolution
      • Additive manufacturing
        • Go back
        • Overview
        • About AM
        • AM innovation
      • Books by EPO experts
    • Podcast
  • Learning
    • Go back
    • Overview
    • European Patent Academy
      • Go back
      • Overview
      • Learning activities
      • Learning Paths
    • Professional hub
      • Go back
      • Overview
      • EPAC - European patent administration certification
      • EQE - European Qualifying Examination
        • Go back
        • Overview
        • Archive
        • Candidates successful in the European qualifying examination
        • Compendium
          • Go back
          • Overview
          • Pre-examination
          • Paper A
          • Paper B
          • Paper C
          • Paper D
    • Learning resources by area of interest
      • Go back
      • Overview
      • Patent granting
      • Technology transfer and dissemination
      • Patent enforcement and litigation
        • Go back
        • Overview
        • Patent enforcement in Europe
        • Patent litigation in Europe
    • Learning resources by profile
      • Go back
      • Overview
      • Business and IP managers
        • Go back
        • Overview
        • Innovation case studies
          • Go back
          • Overview
          • SME case studies
          • Technology transfer case studies
          • High-growth technology case studies
        • Inventors' handbook
          • Go back
          • Overview
          • Introduction
          • Disclosure and confidentiality
          • Novelty and prior art
            • Go back
            • Overview
            • Is the idea ‘obvious’?
            • Prior art searching
            • Professional patent searching
            • Simple Espacenet searching
            • What is prior art?
            • Why is novelty important?
          • Competition and market potential
            • Go back
            • Overview
            • Research guidelines
          • Assessing the risk ahead
            • Go back
            • Overview
            • Exploitation routes
            • Significant commercial potential
            • Significant novelty
            • What about you?
            • What if your idea is not novel but does have commercial potential?
          • Proving the invention
            • Go back
            • Overview
            • Help with design or redesign
            • Prototype strategy
          • Protecting your idea
            • Go back
            • Overview
            • Forms of IPR
            • Patenting strategy
            • The patenting process
          • Building a team and seeking funding
            • Go back
            • Overview
            • Building a team
            • Sources of funding
            • Sources of help for invention
          • Business planning
            • Go back
            • Overview
            • Constructing a business plan
            • Keep it short!
          • Finding and approaching companies
            • Go back
            • Overview
            • First contact
            • Meetings
          • Dealing with companies
            • Go back
            • Overview
            • Advance or guaranteed payment
            • Companies and your prototype
            • Full agreement – and beyond
            • Negotiating a licensing agreement
            • Reaching agreement
            • Royalties
        • Best of search matters
          • Go back
          • Overview
          • Tools and databases
          • EPO procedures and initiatives
          • Search strategies
          • Challenges and specific topics
        • Support for high-growth technology businesses
          • Go back
          • Overview
          • For IP professionals
          • For business decision-makers
          • For stakeholders of the innovation ecosystem
        • IP clinics
      • EQE Candidates
        • Go back
        • Overview
        • Coffee-break questions
        • Daily D questions
        • European qualifying examination - Guide for preparation
      • Judges, lawyers and prosecutors
        • Go back
        • Overview
        • Compulsory licensing in Europe
        • The jurisdiction of European courts in patent disputes
      • National offices and IP authorities
        • Go back
        • Overview
        • Learning material for examiners of national officers
        • Learning material for formalities officers and paralegals
      • Patent attorneys and paralegals
      • Universities, research centres and TTOs
        • Go back
        • Overview
        • Academic Research Programme
          • Go back
          • Overview
          • Completed research projects
          • Current research projects
        • Pan-European Seal Young Professionals Programme
          • Go back
          • Overview
          • For students
          • For universities
            • Go back
            • Overview
            • IP education resources
            • University memberships
          • Our young professionals
          • Professional development plan
        • IP Teaching Kit
          • Go back
          • Overview
          • Download modules
        • Intellectual property course design manual
  • About us
    • Go back
    • Overview
    • The EPO at a glance
    • 50 years of the EPC
      • Go back
      • Overview
      • 50 Leading Tech Voices
      • Kids’ collaborative art competition
    • Legal foundations and member states
      • Go back
      • Overview
      • Legal foundations
      • Member states
        • Go back
        • Overview
        • Member states by date of accession
      • Extension states
      • Validation states
    • Governance
      • Go back
      • Overview
      • Communiqués
        • Go back
        • Overview
        • 2022
        • 2021
        • 2020
        • 2019
        • 2018
        • 2017
        • 2016
        • 2015
        • 2014
        • 2013
      • Calendar
      • Documents and publications
        • Go back
        • Overview
        • Select Committee documents
      • Administrative Council
        • Go back
        • Overview
        • Composition
        • Representatives
        • Rules of Procedure
        • Board of Auditors
        • Secretariat
        • Council bodies
    • Principles & strategy
      • Go back
      • Overview
      • Mission, vision, values & corporate policy
      • Strategic Plan 2028
      • Towards a New Normal
      • Data protection & privacy notice
    • Leadership & management
      • Go back
      • Overview
      • About the President
      • Management Advisory Committee
    • Procurement
      • Go back
      • Overview
      • Procurement forecast
      • Doing business with the EPO
      • Procurement procedures
      • About eTendering
      • Procurement portal
        • Go back
        • Overview
        • e-Signing contracts
      • Invoicing
      • General conditions
      • Archived tenders
    • Services & activities
      • Go back
      • Overview
      • Our services & structure
      • Quality
        • Go back
        • Overview
        • Foundations
          • Go back
          • Overview
          • European Patent Convention
          • Guidelines for examination
          • Our staff
        • Enabling quality
          • Go back
          • Overview
          • Prior art
          • Classification
          • Tools
          • Processes
        • Products & services
          • Go back
          • Overview
          • Search
          • Examination
          • Opposition
          • Continuous improvement
        • Quality through networking
          • Go back
          • Overview
          • User engagement
          • Co-operation
          • User satisfaction survey
          • Stakeholder Quality Assurance Panels
        • Patent Quality Charter
        • Statistics
          • Go back
          • Overview
          • Search
          • Examination
          • Opposition
      • Consulting our users
        • Go back
        • Overview
        • Standing Advisory Committee before the EPO (SACEPO)
          • Go back
          • Overview
          • Objectives
          • SACEPO and its working parties
          • Meetings
          • Single Access Portal – SACEPO Area
      • Our user service charter
      • European and international co-operation
        • Go back
        • Overview
        • Co-operation with member states
          • Go back
          • Overview
        • Bilateral co-operation with non-member states
          • Go back
          • Overview
          • Validation system
          • Reinforced Partnership programme
        • Multilateral international co-operation with IP offices and organisations
        • Co-operation with international organisations outside the IP system
      • European Patent Academy
        • Go back
        • Overview
        • Partners
      • Chief Economist
        • Go back
        • Overview
        • Economic studies
      • Ombuds Office
      • Reporting wrongdoing
    • Statistics and trends
      • Go back
      • Overview
      • Statistics & Trends Centre
      • EPO Data Hub
      • Clarification on data sources
    • Social responsibility
      • Go back
      • Overview
      • Environment
      • Art collection
        • Go back
        • Overview
        • The collection
        • Let's talk about art
        • Artists
        • Media library
        • What's on
        • Publications
        • Contact
    • History
      • Go back
      • Overview
      • 1970s
      • 1980s
      • 1990s
      • 2000s
      • 2010s
      • 2020s
    • Transparency portal
      • Go back
      • Overview
      • General
        • Go back
        • Overview
        • Annual Review 2022
          • Go back
          • Overview
          • Foreword
          • Executive summary
          • Goal 1: Engaged and empowered
          • Goal 2: Digital transformation
          • Goal 3: Master quality
          • Goal 4: Partner for positive impact
          • Goal 5: Secure sustainability
      • Human
      • Environmental
      • Organisational
      • Social and relational
      • Economic
      • Governance
  • Boards of Appeal
    • Go back
    • Overview
    • Decisions of the Boards of Appeal
      • Go back
      • Overview
      • Recent decisions
      • Selected decisions
    • Procedure
    • Annual reports
      • Go back
      • Overview
    • Organisation
      • Go back
      • Overview
      • President of the Boards of Appeal
      • Enlarged Board of Appeal
        • Go back
        • Overview
        • Pending referrals (Art. 112 EPC)
        • Decisions sorted by number (Art. 112 EPC)
        • Pending petitions for review (Art. 112a EPC)
        • Decisions on petitions for review (Art. 112a EPC)
      • Technical Boards of Appeal
      • Legal Board of Appeal
      • Disciplinary Board of Appeal
      • Presidium
        • Go back
        • Overview
        • Composition of the Presidium
          • Go back
          • Overview
          • Archive
    • Code of Conduct
    • Business distribution scheme
      • Go back
      • Overview
      • Technical boards of appeal by IPC in 2023
      • Archive
    • Annual list of cases
    • Communications
    • Publications
    • Case Law of the Boards of Appeal
      • Go back
      • Overview
      • Archive
    • Case Law from the Contracting States to the EPC
    • Oral proceedings
  • Service & support
    • Go back
    • Overview
    • Website updates
    • Availability of online services
      • Go back
      • Overview
    • FAQ
      • Go back
      • Overview
    • Publications
    • Ordering
      • Go back
      • Overview
      • Terms and conditions
        • Go back
        • Overview
        • Patent information products
        • Bulk data sets
        • Open Patent Services (OPS)
        • Fair use charter
    • Procedural communications
    • Useful links
      • Go back
      • Overview
      • Patent offices of member states
      • Other patent offices
      • Legal resources
      • Directories of patent attorneys
      • Patent databases, registers and gazettes
      • Disclaimer
    • Contact us
      • Go back
      • Overview
      • Filing options
      • Locations
      • Specific contact
      • Surveys
        • Go back
        • Overview
        • Search services
        • Examination services, final actions and publication
        • Opposition services
        • Patent filings
          • Go back
          • Overview
          • Detailed methodology
          • Archive
        • Online Services
        • Patent information
          • Go back
          • Overview
          • Innovation process survey
        • Customer services
        • Filing services
        • Website
        • Survey on electronic invoicing
        • Companies innovating in clean and sustainable technologies
    • Subscription centre
      • Go back
      • Overview
      • Subscribe
      • Change preferences
      • Unsubscribe
    • Official holidays
    • Forums
    • Glossary
Board of Appeals
Decisions

Recent decisions

Overview
  • 2023 decisions
  • 2022 decisions
  • 2021 decisions
https://www.epo.org/en/node/t990310eu1
  1. Home
  2. T 0310/99 (Down Syndrome/MACRI) 01-04-2003
Facebook Twitter Linkedin Email

T 0310/99 (Down Syndrome/MACRI) 01-04-2003

European Case Law Identifier
ECLI:EP:BA:2003:T031099.20030401
Date of decision
01 April 2003
Case number
T 0310/99
Petition for review of
-
Application number
90903086.8
IPC class
G01N 33/76
Language of proceedings
EN
Distribution
DISTRIBUTED TO BOARD CHAIRMEN (C)

Download and more information:

Decision in EN 45.26 KB
Documentation of the appeal procedure can be found in the European Patent Register
Bibliographic information is available in:
EN
Versions
Unpublished
Application title

Down Syndrome Screening Method

Applicant name
MACRI, James N.
Opponent name
CIS Bio International
Board
3.3.08
Headnote
-
Relevant legal provisions
European Patent Convention Art 52(1) 1973
European Patent Convention Art 52(4) 1973
European Patent Convention Art 54 1973
European Patent Convention Art 56 1973
European Patent Convention Art 83 1973
European Patent Convention Art 123(2) 1973
Keywords

Main request: allowability of an amendment (no)

First auxiliary request: invention technical in character (yes)

Excluded diagnostic method (no)

Sufficiency of disclosure (yes)

Novelty (yes)

Inventive step (yes)

Catchword
-
Cited decisions
T 0385/86
T 0775/92
T 0931/95
T 0964/99
Citing decisions
G 0001/04
G 0001/04
G 0001/04
G 0001/04

I. The patent proprietor (appellant I) and the opponent (appellant II) both lodged appeals against the interlocutory decision of the opposition division posted on 22 January 1999, whereby the European patent No. 0 409 956 was maintained on the basis of the second auxiliary request as filed at the oral proceedings on 23. November 1998.

II. The patent had been opposed under Article 100(a) EPC, on the grounds that (i) the invention was not a patentable invention (Article 52(1) and (2) EPC), (ii) it related to diagnostic methods practised on the human body (Article 52(4) EPC), (iii) it lacked novelty (Article 56 EPC) and (iv) it did not involve an inventive step (Article 56 EPC) as well as under Article 100(b) EPC on the ground that the invention was not sufficiently disclosed (Article 83 EPC).

The opposition division decided that, while the main and first auxiliary requests on file lacked novelty in view of product claim 10, the second auxiliary request, wherein claim 10 was formulated as a use claim, met all the requirements of the EPC.

III. Both appellants filed a statement of grounds of appeal requesting that the decision of the opposition division be set aside, appellant I requesting the maintenance of the patent on the basis of a new main request.

IV. Each appellant filed additional observations in reply to the statement of grounds of appeal of the other appellant.

V. On 27 December 2002, the board issued a communication pursuant to Article 11(2) of the Rules of Procedure of the Boards of Appeal indicating its preliminary views.

VI. In reply thereto, appellant I filed with a letter dated 28. February 2003 a new main and two auxiliary requests.

The main request consisted of 17 claims, of which independent claims 1, 4, 9, 10, 11, 13, 14 and 17 read as follows:

"1. An in vitro screening method for determining if a pregnant woman is carrying a fetus with Down syndrome comprising: assaying a pregnant woman's blood for free beta human chorionic gonadotropin (hCG), the results of the assay being indicative of increased risk of fetal Down syndrome."

"4. An in vitro screening method for determining a pregnant woman's risk of carrying a fetus with Down syndrome comprising: measuring said pregnant woman's maternal blood for the free beta (hCG) level during a time period selected from the group consisting of: the first trimester of pregnancy, the second trimester of pregnancy and the third trimester of pregnancy, and comparing said level of free beta (hCG) to reference values of the level for free beta (hCG) during the time period in: (1) pregnant women carrying Down syndrome fetuses and (2) pregnant women carrying normal fetuses, said comparison being indicative of said pregnant woman's risk of carrying a fetus with Down syndrome, wherein a higher level of free beta (hCG) is indicative of a higher probability of carrying a fetus with Down syndrome."

"9. An in vitro method for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome comprising: measuring the pregnant woman's maternal blood level of an analyte selected from the group consisting of free beta (hCG), a variant (variants) of free beta (hCG), or an aberrant form (aberrant forms) of the free beta (hCG) and comparing the data of measurement of the analyte to a set of reference data to determine the pregnant woman's risk of carrying a fetus with Down syndrome."

"10. An assay kit adapted to carry out a method as claimed in claims 1, 2, 4 or 5 for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome, comprising means for assaying a pregnant woman's blood for free beta hCG and means for comparing the measured level of the free beta hCG to a set of reference data."

"11. Use of an apparatus for the method of any of claims 1 to 9, said apparatus comprising: means adapted for receiving the data of measurement of a pregnant woman's maternal blood level of free beta (hCG) and computer means for comparing the data of measurement of the level of the free beta (hCG) to a set of reference data to determine fetal chromosomal trisomies."

"13. Use of an apparatus for the method of any of claims 1 to 9, said apparatus comprising: means adapted for receiving the data of measurement of the pregnant woman's maternal blood level of free beta (hCG), means adapted for receiving the data of measurement of the pregnant woman's maternal blood level of alpha fetoprotein, and computer means for calculating a set of normative data from a set of reference data containing reference values of the level of free beta (hCG) and the level of alpha fetoprotein at various gestational ages in: (1) pregnant women carrying Down syndrome fetuses and (2) pregnant women carrying normal fetuses, and for incorporating said data of measurements of said levels of said free beta (hCG) and alpha fetoprotein, and said pregnant woman's gestational age into a probability density function, thereby comparing said levels and said pregnant woman's gestational age to the set of normative data to determine said pregnant woman's risk of carrying a fetus with Down syndrome."

"14. Use of an apparatus for the method of any of claims 1 to 9, said apparatus comprising: means adapted for receiving the data of measurement of a pregnant woman's maternal blood level of free beta (hCG), and computer means for calculating a set of reference data and for incorporating said data of measurement of said levels of free beta (hCG) and said pregnant woman's gestational age into a probability density function, thereby comparing said pregnant woman's level of free beta (hCG) and said pregnant woman's gestational age to the set of normative data to determine said pregnant woman's risk of carrying a fetus with Down syndrome."

"17. Use of an apparatus for the method of any of claims 1 to 9, said apparatus comprising: means adapted for receiving the data of measurement of a pregnant woman's maternal blood level of an analyte selected from the group consisting of free beta (hCG), a variant (variants) of free beta (hCG), or an aberrant form (aberrant forms) of the free beta (hCG) and computer means for calculating a set of reference data and for incorporating said data of measurement of said level of the analyte and said pregnant woman's gestational age into a probability density function, thereby comparing said pregnant woman's level of said analyte and said pregnant woman's gestational age to the set of normative data to determine said pregnant woman's risk of carrying a fetus with Down syndrome."

Claims 2, 3, 5 to 8, 12, 15 and 16 of the main request were dependent claims.

Auxiliary request 1 differed from the main request only in that claim 10 read:

10. "Use of an assay kit for carrying out the method claimed in claims 1, 2, 4 or 5 for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome comprising: means for assaying a pregnant woman's blood for free beta hCG."

Each of the main and the first auxiliary requests differed from the claims as granted in that in claims 4 and 9 the terms "in vitro" had been added and claim 10 was formulated differently.

Claim 10 as granted read:

"10. An assay kit for carrying out the method claimed in claims 1, 2, 4 or 5 for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome comprising: means for assaying a pregnant woman's blood for free beta (hCG)."

The first auxiliary request differed from the claims on the basis of which the patent was maintained (see section I, supra) only in that the terms "in vitro" had been added in each of claims 4 and 9.

VII. Oral proceedings took place on 1 April 2003. They were attended only by appellant I, appellant II having informed the board of its intention not to attend.

VIII. The submissions of appellant I as made in writing and at the oral proceedings, insofar as they are relevant to the decision, may be summarized as follows:

The claimed method consisted of two steps which were both technical in character, the first one because it involved an in vitro assay of a pregnant woman's blood (for free beta human chorionic gonadotrophin (hCG) and possibly alpha fetoprotein (AFP)), and the second one because it involved a biochemical analysis of reference maternal blood samples. The second step created a new technical effect in combination with the technical features represented by the first step. The invention did not solely reside in a mathematical method for the analysis of data obtained by a known assay. Therefore, the claimed method was patentable within the meaning of Article 52(1) EPC.

Each of claims 1, 4 and 9 of the main request was directed to an in vitro diagnostic method, as now emphasized by the presence of the term "in vitro" in the claims.

The disclosure was enabling. The required technical means such as antibodies specifically recognising free beta hCG were available in the prior art. A patient's specific risk parameters to be taken into consideration when determining the probability of Down syndrome were disclosed in the patent in such a way that all the embodiments of the claimed invention were reproducible, more particularly whatever the gestational age. In this last respect document D36 (see section X, infra) was cited.

The subject-matter of claims 1 to 9 was new over document D8 (see section X, infra). Also the subject-matter of claim 10, which associated means for assaying for free beta hCG and means for comparing the measured level of the free beta hCG to a set of reference data, was new over the state of the art.

Document D1 (see section X, infra) being taken as the closest prior art, the technical problem underlying the invention was the provision of improved means and methods for determining the risk of a pregnant woman carrying a fetus with Down syndrome. The solution to this problem relied primarily on the determination in the maternal serum of the free beta hCG level. None of the cited prior art documents would have prompted the person skilled in the art to attempt this solution.

The same observations applied to the first auxiliary request. In particular the subject-matter of the amended claim 10 was sufficiently disclosed, was new and involved an inventive step.

IX. The written submissions of appellant II were in respect of claims 1 to 17 as maintained by the opposition division. No submissions were made in respect of the requests at issue. The submissions on file are summarised here, insofar as they are relevant to the decision:

The method of claim 1 contained both a technical feature, namely the step of determining the level of free beta hCG, and a non-technical feature, namely the indication of an increased risk for the pregnant woman of carrying a fetus with Down syndrome. The technical feature was known, in particular in view of document D3 (see section X, infra). The non-technical feature was part of the exclusions of Article 52(2) EPC, because it related to a mathematical method which employed a computer program and a presentation of information. The technical problem solved by claims 1 and 2 was the analysis and treatment of the free beta hCG level measured with the view of reformulating it in the form of a value indicative of a risk of Down syndrome. Said problem was not of a technical nature. Nor was its result. Therefore, the subject-matter of claims 1 and 2 was not patentable within the meaning of Article 52(1) EPC (cf decision T 775/92 of 7 April 1993).

The screening method of claims 1 to 9 required that a physician be involved and resulted in the taking of a medical decision. Therefore, it was an excluded diagnostic method as referred to in Article 52(4) EPC (cf decision T 385/86 OJ 1988, 308).

The disclosure of the claimed invention as a whole was insufficient in that it failed to indicate which essential maternal factors were to be taken into consideration. Also the gestational age was not duly relied on with the exception of 14 to 16 weeks. Accordingly, the person skilled in the art was not in a position to perform the screening process of the invention during the first and third trimesters of gestation. In this last respect, in particular, document D31 (see section X, infra) was cited.

The subject-matter of claims 1 to 4, 9 and 10 was not new in view of document D8 (see section X, infra). Document D15 (see section X, infra) was an irrelevant letter dated 2 April 1991 and relating not to a "Beta-hCG method" but to an "hCG method" as explicitly mentioned therein without the indication of the particular question the letter was supposed to answer. At the publication date of document D8 (see section X, infra), the expression "BetahCG" was used to mean not "intact hCG plus free BetahCG" but "free beta hCG".

Document D1 (see section X, infra) represented the closest prior art. The problem solved was the provision of a screening method permitting improved detection of Down syndrome. The person skilled in the art would have regarded it as obvious to measure free beta hCG instead of intact hCG in view of a combination of documents D1 and D7 or D1 and D28 (see section X, infra). Therefore, the subject-matter of claims 1 to 9 did not involve an inventive step. In view of documents D2, D3 and D4 (see section X, infra), again the subject-matter of claim 10 was not inventive. As the use of a computer did not require inventive skill, the subject-matter of claims 11 to 17 was not inventive in view of documents D7 and D9 (see section X, infra).

X. The following documents are referred to in the present decision:

(D1) Mark H. Bogart et al., Prenat. Diagn., Vol. 7, 1987, Pages 623 to 630

(D2) English translation of the Japanese patent application with publication number 54-126723 published on 2 October 1979

(D3) Mehmet Ozturk et al., Endocrinol., Vol. 120, No. 2, 1987, Pages 549 to 558

(D4) Copy of a commercial brochure presenting the "Beta HCG-RIA-100" kit manufactured by IRE with a letter attached thereto from the "Commissariat à l'énergie atomique" to the "Ministère de la santé et de la famille" dated 31 December 1980

(D7) R. Bharathur et al., Am. J. Hum. Gen., Vol. 43, No. 3, Suppl., September 1988, Page A226, Abstr. 0901

(D8) H. Arab et al., Am. J. Hum. Gen., Vol. 43, No. 3, Suppl., September 1988, Page A225, Abstr. 0896

(D9) Nicholas J. Wald et al., BMJ, Vol. 297, 8. October 1988, Pages 883 to 887

(D10) B. B. Butler et al., Am. J. Hum. Gen., Vol. 41, No. 3, Suppl., September 1987, Page A268, Abstr. 798

(D15) Letter of Prof. P.Y. Wong to Dr. James N. Macri dated 2 April 1991 together with a copy of the cover page of a commercial brochure relating to the "hCG MAIA Clone" kit of Serono Diagnostics

(D28) U. Gaspard et al., Ann. Endocrinol. (Paris), Vol. 45, 1984, Pages 269 to 280

(D29) Ulf-Hakan Stenman et al., Scand. J. Clin. Lab. Invest., 1993, Vol. 53, Suppl. 216, Pages 42 to 78

(D31) Document reproducing information presented in the internet site of NTD Laboratories Inc. dated 3 to 5 May 1999 with 14 pages hand-numbered as page 1 to page 14

(D36) Copy of a commercial brochure of CIS bio international entitled "Free Beta Screen / A strategy for prenatal screening of trisomy 21", with a cover page and pages 1 to 28, undated but containing citations dated 1992

XI. Appellant I requested that the decision under appeal be set aside and the patent be maintained on the basis of the main request or one of the two auxiliary requests all filed on 28 February 2003.

XII. Appellant II requested that the decision under appeal be set aside and the patent be revoked.

Main request

Article 123(2) EPC

1. In order to overcome the novelty objection against claim 10 which led to the refusal of the main and auxiliary requests by the opposition division, claim 10 has been amended in the new main request at issue. The question thus arises whether the application as filed disclosed an assay kit which contains, in addition to means for assaying a pregnant woman's blood for free beta hCG, not only the means referred to in claim 10 as granted but also means for comparing the measured level of the free beta hCG to a set of reference data.

2. An assay kit as commonly used in the field of medical diagnosis may be regarded as a set of reagents selected and pre-conditioned in such a way that they represent means appropriate for the determination of a particular analyte.

3. Whereas the description as filed contains an implicit disclosure of a kit containing reagents for assaying a pregnant woman's blood for free beta hCG (indeed, examples of such reagents are described in detail on pages 26 and 27, the reagents being (i) an antibody specific to the free beta hCG, (ii) a wash buffer, and (iii) a blocking solution), there is by contrast no disclosure (implicit or explicit) of a kit additionally including reagent means for comparing the measured level of the free beta hCG to a set of reference data.

4. Therefore, the board concludes that claim 10 as granted has been amended in such a way that claim 10 of the main request does not comply with the requirements of Article 123(2) EPC, and, consequently, the main request as a whole is not allowable.

First auxiliary request

Article 123(3) EPC

5. The board notes that the scope of claims 4, 9 and 10, the only amended claims (compared to the claims as granted) of this request is narrower than that of the corresponding granted claims. Indeed, claims 4 and 9 have been amended by specifying that the claimed method is an "in vitro" method and claim 10 is directed not to an assay kit as previously claimed but to the use of the same. Therefore, the requirements of Article 123(3) EPC are met.

Article 123(2) EPC

6. The added term "in vitro" in claims 4 and 9 only confirms the nature of the screening methods of the invention, which, because they are practised on a blood sample, are in vitro diagnostic methods (see points 12 to 17, infra). Since there is no doubt that a kit as defined in claim 10 was disclosed in the application as filed (see point 3 supra), support exists therein for the use of such a kit. Therefore, the said claims comply with the requirements of Article 123(2) EPC.

Article 84 EPC

7. The amendments contained in claims 4, 9 and 10 have not introduced any unclarity and are supported by the description. Therefore, those claims comply with the requirements of Article 84 EPC.

Article 52(1) EPC

8. Claim 1 is directed to an in vitro screening method which primarily relies on an activity of assaying a pregnant woman's blood for free beta hCG, ie a concrete activity requiring a skilled practitioner to accomplish material (as opposed to mental) acts using technical means generally available in a laboratory. Based on this activity the invention provides free beta hCG as an independent marker for determining if a pregnant woman is carrying a fetus with Down syndrome and thereby solves a technical problem. Therefore, claim 1 is technical in character.

9. Adding to that activity of assaying an activity of comparing, which as defined in dependent claim 2 comprises not only material acts associated with the use of technical means such as computer means but also mental acts, does not alter the nature of the invention which still solves the same technical problem. Therefore, claim 2 is also technical in character.

10. In support of these submissions appellant II referred to decision T 775/92 of 7 April 1993. In that decision, it was said that when examining whether the three step method of an independent claim may be considered to be an invention within the meaning of Article 52(1) EPC, it has to be assessed whether non-technical steps (b) and (c) involve a contribution to the field not excluded from patentability. Therefore, that decision applies the so-called contribution approach for which it has been recognised in the later decision T 931/95 (OJ 2001, 441; see point 6 of the reasons) that there is no basis in the EPC. For that reason the present board considers that decision T 775/92 (supra) is not relevant in the present case.

11. Therefore, the subject-matter of claims 1 and 2 is patentable under Article 52(1) EPC.

Article 52(4) EPC

12. Article 52(4) EPC is meant to exclude from patent protection all methods practised on the human or animal body which relate to diagnosis or which are of value for the purposes of diagnosis (see T 964/99, OJ EPO 2002, 4, point 4.4. of the reasons).

13. The methods according to claims 1 to 9 are not practised on the body of the pregnant woman but on a sample of her blood. Furthermore, none of the claims contain a sampling step. Moreover, each of the claims contains the explicit mention that it relates to an in vitro method.

14. The activities, as referred to in the claims, of assaying a blood sample for free beta hCG or alpha fetoprotein and of using computer means for comparing the measured levels to a set of reference data taking into account the gestational age of the woman can undoubtedly be carried out by a laboratory assistant without requiring the actual intervention of a physician.

15. Furthermore, whereas it is accepted that a preliminary interview may be carried out by a physician and that it is the duty of also a physician to counsel a patient on the basis of the results provided by any screening method of the invention and, if necessary, a further diagnostic test to confirm the presence of Down syndrome, these activities of the physician take place respectively before and after the claimed method is performed and should not be restrained by patent rights.

16. Decision T 385/86 (OJ 1988, 308) which was referred to by appellant I relates to a different factual framework, the claims examined relating to a medical diagnosis in which not a sample of a body fluid but a whole, intact, living animal or human body is examined (using magnetic resonance). Consequently, decision T 385/86 (supra) is not applicable to the present case.

17. Therefore, claims 1 to 9 meet the requirements of Article 52(4) EPC.

Article 83 EPC

18. Appellant II objected that no antibodies were disclosed in the patent which were appropriate for the determination of free beta hCG.

19. Indeed, no particular such antibodies are disclosed in the description which, however, states that "[t]he maternal blood level of free beta-hCG is then measured by conventional analytical methods such as immunological methods known to the art" (see page 4, lines 32 to 34 of the patent specification). As a matter of fact, document D3 discloses such a method which relies on the use of monoclonal antibody FBT11, an antibody which recognises antigenic determinants present only on free beta hCG (see left-hand column of page 551). Therefore, at the priority date means for the determination of free beta hCG were available to the person skilled in the art.

20. The board is also satisfied that the other technical means required for the performance of the various aspects of the invention, such as means for the determination of alpha fetoprotein and appropriate computer software, were similarly available.

21. Appellant II mainly based its objection of insufficiency of disclosure on the allegation that the patent failed to disclose sufficiently the patient's specific risk parameters to be taken into consideration when determining the probability of Down syndrome.

22. Risk parameters such as maternal age, gestational age, levels of intact hCG and/or alpha fetoprotein and/or unconjugated estriol, and the manner of incorporating them in a set of reference data are referred to in many places in the patent (see, in the patent specification, the passage in the description from line 45 of page 3 to line 1 of page 4 and the "Detailed description of the invention" on pages 4 to 7). The person skilled in the art is thereby advised that, depending on the degree of detection efficiency that is sought, one or more of those parameters can be incorporated into the set of reference data to refine the screening process.

23. Appellant II also argued that the screening method of the invention could not be performed at a gestational age other than the second trimester of pregnancy. In support of their submission, they referred to document D31 (see page 4) which contains the indication that AFP is not an efficient marker during the first trimester. The board notes, that whereas this observation may have an impact on the cost-efficiency of a Down syndrome screening using both AFP and free beta hCG as markers performed during the first trimester, it has no impact on the reproducibility of such screening because, as AFP and free beta hCG are separately measured, free beta hCG will in any case permit the achievement of an accurate screening.

24. The board notes that the description contains no disincentive to the person skilled in the art from performing the invention not only during the well-documented second trimester of gestation but also during the first and third trimesters.

25. The board also notes that document D31 (see page 4) which was cited by appellant II also readily illustrates that free beta hCG may be used as an efficient marker for the screening of Down syndrome whatever the gestational age, including the first trimester. Similarly document D36 (see page 26) contains the observation that free beta hCG levels are also high in the first trimester of pregnancies complicated by trisomy 21 (Down syndrome). Appellant II itself (as the editor of document D36) admits that this observation offers the real prospect of screening for trisomy 21 in the first trimester.

26. The board concludes that at the priority date the person skilled in the art was in a position to reproduce the basic core of the invention, ie the determination of free beta hCG in the maternal serum, and additionally to take into consideration one or more risks parameters to reproduce each and every aspects of the claimed invention.

27. Therefore, the requirements of Article 83 EPC are met.

Article 54 EPC

28. An essential technical feature of the invention as defined in independent claims 1 to 4 and 9 is the step of assaying a pregnant woman's blood for free beta human chorionic gonadotropin. As pointed out in the patent specification (see in particular, page 9, lines 53 to 58) free beta hCG and intact hCG are regarded in the patent as distinct markers which are determined independently. Therefore, there can be no doubt that the gist of the invention is the use of means which recognize specifically the free beta hCG subunits and do not recognize the intact hCG, thereby measuring the concentration of such subunits in the maternal serum.

29. Document D8, which is the only document cited by appellant II as being novelty-destroying, is an abstract which briefly reports that the determination of maternal serum beta hCG combined with maternal serum alpha-fetoprotein (AFP) is superior for prenatal screening for Down syndrome to either test alone. The maternal serum beta human chorionic gonadotropin assays were performed using a commercially available monoclonal antibody immunoradiometric assay kit.

30. It is important to note the fact that there is no indication in the document that the beta hCG assayed for was in its unbound form.

31. Appellant II expressed the view that, despite the fact that document D8 did not refer explicitly to the "free" beta hCG, one could not exclude that the unbound form of beta hCG was actually assayed for in the experiments reported therein.

32. This submission is no more than mere speculation. What is not questionable is that as early as 1984 and still in 1993, ie years after the priority date, there was uncertainty as to the precise meaning of the commonly used expressions "beta hCG assay" (or alternative expressions such "BetahCG assay" and hCGBeta assay"), such an assay concerning either the determination of the intact HCG plus the free beta hCG subunits or the determination of only the free beta subunits (see document D28, page 270, right-hand column and in document D29, the sentence bridging pages 50 and 51).

33. At the priority date, the person skilled in the art would not have been in a position to identify which kit was meant in document D8 by the term "a commercially available monoclonal antibody immunoradiometric assay kit". Moreover, against the unsupported hypothesis made by appellant II that a kit permitting determination of the free Beta hCG was used in the experiments of document D8, one can set the attestation made in document D15 by an author of document D8 that in "the 1988 study" a "hCG MAIAclone kit" from Serono was used, which according to document D29 (see Table 3 on page 65) allows the determination of the intact hCG.

34. In view of these remarks, the board considers that appellant II has not proved that a kit which allows the determination of free beta hCG was used in the experiments of document D8.

35. Therefore, the subject-matter of claims 1 to 4, 9 and 10 is new.

Article 56 EPC

Claims 1, 4 and 9

36. Both parties agreed that document D1 represented the closest prior art. This was also the opinion of the opposition division.

37. The purpose of the study presented in document D1 was to evaluate the possibility of using serum hCG levels as a screening test for potential chromosomally abnormal pregnancies. Serum samples were collected from 25. women carrying a fetus with a chromosome abnormality. In 17 cases this abnormality was trisomy 21, ie Down syndrome. A prior art radioimmunoassay was used which employed an antibody recognizing intact hCG and free beta hCG but the results are expressed only in terms of hCG levels expressed in IU/ml. Two other radioimmunoassays were used for the determination of alpha fetoprotein (AFP) and of alpha-hCG. It was concluded that determination of hCG and alpha-hCG levels was a superior screening procedure to AFP determination for detecting chromosomally abnormal fetuses. Nevertheless, the authors noted that association of both high and low concentrations of [intact] hCG with fetal abnormalities was enigmatic (see document D1, page 629, third full paragraph).

38. It can be derived from document D1 that, as the same antibody was capable of recognizing both the intact hCG and the free beta hCG, that antibody recognized an antigenic site available thereto whether the beta-subunit was bound to the alpha-subunit or not and, therefore, was not capable of specifically detecting only free beta hCG.

39. In view of document D1, the technical problem solved by the invention as defined in claims 1, 4 and 9 may be regarded as the provision of an improved screening assay for Down syndrome. The solution to this problem is a screening assay which focuses on the use of free beta hCG as a distinct marker, the beta hCG subunits being measured independently from the intact hCG.

40. Only two other prior art documents, namely documents D8 and D9, deal with the screening of Down syndrome based on the determination of intact hCG or the subunits thereof in maternal serum. The content of document D8 has been already discussed (see point 29, supra). Document D9 reports on a study aiming at improving the effectiveness of antenatal screening for Down syndrome by measuring hCG concentrations in maternal serum. The samples were assayed for hCG, with the Serono MAIA-clone kit which as already noted (see point 33 supra) allows the determination of intact hCG. Document D9 also recites a mathematical method of estimating the risk of a Down syndrome term pregnancy.

41. None of documents D1, D8 and D9 suggests that a correlation may exist between the level of free beta-hCG and the suspicion of a fetus with Down syndrome. The finding of such a correlation being hindered in the prior art by the fact that, free beta hCG being a minor component compared to the intact hCG during normal and abnormal pregnancy (see document D3, pages 553 to 555), the studies of the prior art concerned with the screening of Down syndrome have focused on the evaluation of the intact hCG.

42. Free beta hCG was first recognized as a valuable independent marker for Down syndrome screening by the inventor without any incentive from the prior art.

43. Appellant II put a particular emphasis on documents D7 and D28 and attempted to combine each of them with document D1.

Document D7 is an abstract which briefly reports that amniotic fluid beta hCG levels were, on an average, higher in Down syndrome than in unaffected pregnancies. The information therein lacks any statement that this was based on the evaluation of free beta hCG. Moreover, the study was carried out not on maternal serum but on amniotic fluid.

Document D28 reports on a study in which each of intact hCG and free beta hCG was independently evaluated as a marker for several pregnancy disorders. Nevertheless, those disorders do not include Down syndrome. Moreover, free beta hCG is not recognized as a powerful diagnostic aid therefor.

Therefore, neither of documents D7 or D28 would have suggested to a person skilled in the art that the markers of document D1 might be replaced by free beta hCG.

44. Therefore, the subject-matter of independent claims 1, 4. and 9 involves an inventive step.

Claim 10

45. In addition to document D3 (see point 19, supra) appellant II referred to documents D2 and D4.

Document D2 describes the preparation of antibodies with specificity for free beta hCG. Said antibodies are susceptible of application in areas such as diagnosis of abnormal pregnancies, no preference for any of them being mentioned.

Document D4 relates to a commercial kit for the determination of free beta hCG in particular in maternal serum as an indicator for the survey of pregnancies. Abnormal pregnancies with a risk of carrying a fetus with Down syndrome are not referred to.

46. Although means for assaying a pregnant woman's blood for free beta hCG were known in the art (see documents D2, D3 and D4), their use in a method for Down syndrome screening was in no way suggested, and thus the subject-matter of claim 10 also involves an inventive step.

Claims 11 to 17

47. In addition to document D9 (see point 40, supra) document D10 was cited by appellant II. Document D10 is an abstract which reports on a personal computer program for a maternal serum AFP screening program including, as a program function, calculation of parameters with interpretation of risk for Down syndrome.

48. As neither of documents D9 and D10 suggests the use of free beta hCG as an independent marker for screening of fetal chromosomal trisomies such as Down syndrome, at the priority date the person skilled in the art would have found no incentive to combine the means referred to in any of independent claims 11, 13, 14 and 17 in an apparatus and use said apparatus for the method of any of claims 1 to 9.

49. Therefore, the subject-matter of claims 11, 13, 14 and 17 involves an inventive step.

Order

ORDER

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The case is remitted to the first instance with the order to maintain the patent on the basis of the first auxiliary request and the description and drawings as granted.

Footer - Service & support
  • Service & support
    • FAQ
    • Contact us
    • Subscription centre
    • Official holidays
    • Publications
    • Procedural communications
    • Ordering
    • Glossary
Footer - More links
  • Jobs & careers
  • Press centre
  • Single Access Portal
  • Procurement
  • Boards of Appeal
SoMe facebook 0
European Patent Office
EPO Jobs
SoMe instagram
EuropeanPatentOffice
SoMe linkedIn
European Patent Office
EPO Jobs
EPO Procurement
SoMe twitter
EPOorg
EPOjobs
SoMe youtube
TheEPO
Footer
  • Legal notice
  • Terms of use
  • Data protection and privacy
  • Accessibility