Print

5. Exclusions and exceptions for biotechnological inventions

Overview

General Part
1. Preliminary remarks
1.1 Relationship between the PCT and the EPC
2. Explanatory notes
2.1 Overview
2.2 Applicability of the PCT‑EPO Guidelines
2.3 Relationship between the PCT‑EPO Guidelines and the ISPE Guidelines
2.4 Further sources of information
2.5 Abbreviations
2.6 Forms used by the RO, ISA, SISA and IPEA
2.7 Publications
3. Annexes
3.1 Annex I: EPC-PCT concordance table
3.2 Annex II: Criteria chosen by the EPO as ISA/IPEA on specific points in the ISPE Guidelines
PCT Part A – Guidelines for Formalities Examination
Chapter I – Introduction
1. Overview
2. Purpose of Part A
3. Other parts relating to formalities
Chapter II – Filing of international applications and examination on filing
1. Where and how international applications may be filed
1.1 Filing with the EPO as receiving Office
1.2 Methods of filing with the EPO as receiving Office
1.2.1 Filing of applications electronically
1.2.2 Filing of applications by delivery by hand or by post
1.2.3 Filing of applications by other means
1.3 Filing of documents subsequent to the application
1.4 Debit orders for deposit accounts held with the EPO
1.5 Application numbering system
2. Competence of the EPO to act as receiving Office
3. Procedure on filing
3.1 Acknowledgement of receipt
3.2 Filing via a competent national authority
4. Examination on filing
4.1 Minimum requirements for according an international filing date
4.1.1 Transmittal of the international application to the ISA and IB
4.2 Defects
5. Incorporation by reference of missing elements or parts
6. Correction of erroneously filed elements or parts
6.1 Correct element or part not furnished for the purpose of incorporation by reference
6.1.1 International filing date has not yet been accorded
6.1.2 International filing date has already been accorded
6.2 Correct element or part furnished for the purpose of incorporation by reference
Chapter III – Fees
1. General
2. Amounts of fees
3. Methods of payment
4. Fees to be paid to the EPO as receiving Office
4.1 Transmittal fee
4.2 International filing fee
4.3 International search fee
4.4 Fee for a certified copy of the priority document
4.4.1 Fee for establishment and transmittal of a certified copy of the priority document to the IB
4.4.2 Fee for a certified copy of the priority document for the applicant
4.5 Late payment fee
4.6 Fee for requesting restoration of priority right
5. Fees to be paid to the ISA/EP
5.1 Additional search fee
5.2 Protest fee
5.3 Fee for the late furnishing of sequence listings
6. Fees to be paid if a SIS request is submitted
6.1 Supplementary search handling fee
6.2 Supplementary search fee
6.3 Review fee
7. Fees to be paid to the IPEA/EP
7.1 Handling fee
7.2 Preliminary examination fee
7.2.1 Additional preliminary examination fee
7.3 Protest fee
7.4 Fee for the late furnishing of sequence listings
7.5 Late payment fee
8. Reduction of fees
8.1 Reduction of the international filing fee
8.1.1 Reduction for applications filed in electronic form
8.1.1.1 Reduction for filing in PDF
8.1.1.2 Reduction for filing the request in XML
8.1.1.3 Reduction for filing request and specification in XML
8.1.2 Reductions for applicants from certain states
8.2 Reduction of the (supplementary) international search fee
8.2.1 Reduction of the additional search fee
8.3 Reduction of the (supplementary search) handling fee
8.4 Reduction of the preliminary examination fee
8.4.1 Reduction of the additional preliminary examination fee
9. Refund of fees
9.1 Refund of the international filing fee
9.2 Refund of the (additional) international search fee
9.2.1 Examples of refunds
9.2.1.1 Full refund
9.2.1.2 Partial refund
9.2.1.3 No refund
9.3 Refund of additional search fees and, where applicable, the protest fee
9.4 Refund of the supplementary search fee
9.5 Refund of the review fee
9.6 Refund of the handling fee
9.7 Refund of the preliminary examination fee
9.8 Refund of additional examination fees and, where applicable, the protest fee
Chapter IV – Special provisions
1. PCT Direct service (see also B‑IV, 1.2)
1.1 General remarks
1.2 Form of submissions
1.3 Processing by the EPO as RO
1.4 Processing by the EPO as ISA
2. Withdrawals
2.1 General remarks
2.2 Withdrawal of the international application
2.2.1 Conditional withdrawal
2.3 Withdrawal of designations
2.4 Withdrawal of priority claims
2.5 Withdrawal of the supplementary search request
2.6 Withdrawal of the demand or of elections
3. Applications disclosing nucleotide and/or amino acid sequences
Chapter V – Drawings
1. Graphic forms of presentation considered to be drawings
1.1 Technical drawings
1.2 Photographs or coloured drawings
2. Presentation of drawings
2.1 Grouping of drawings
2.2 Reproducibility of drawings
2.3 Figure accompanying the abstract
3. Requirements regarding the paper used
4. Presentation of the sheets of drawings
4.1 Usable surface area of sheets
4.2 Numbering of sheets of drawings
5. General layout of drawings
5.1 Page-setting
5.2 Numbering of figures
5.3 Whole figure
6. Prohibited matter
7. Execution of drawings
7.1 Drawings of lines and strokes
7.2 Shading
7.3 Cross‑sections
7.3.1 Sectional figures
7.3.2 Hatching
7.4 Scale of drawings
7.5 Numbers, letters and reference signs
7.5.1 Leading lines
7.5.2 Arrows
7.5.3 Height of the numbers and letters in the drawings
7.5.4 Consistent use of reference signs in the description, claims and drawings
7.5.5 Consistent use of reference signs in the drawings
7.6 Variations in proportions
8. Text matter in drawings
9. Conventional symbols
10. Amendments to drawings
11. Graphic forms of presentation not considered to be drawings
11.1 Chemical and mathematical formulae
11.2 Tables
11.2.1 Tables in the description
11.2.2 Tables in the claims
Chapter VI – Examination of formal requirements
1. Claim to priority
1.1 Formal requirements under Rule 4.10
1.2 Priority period
1.3 Inconsistency in the priority claim
1.4 Defects in the priority claim
1.4.1 Correction of the priority claim upon invitation
1.4.2 Failure to correct
1.5 Restoration of the right of priority
1.6 Applicant's entitlement to claim priority
1.7 Provision of the priority document
1.8 Certified copies of international applications
2. Designation of states
2.1 Non-designation for reasons of national law
3. Extension and validation states
3.1 Extension states
3.2 Validation states
4. Designation of inventor
Chapter VII – Languages
1. Admissible languages on filing
1.1 General
1.2 International application filed in multiple languages
1.2.1 Abstract and text matter of the drawings
1.2.2 Request
1.2.3 Description and claims
1.2.3.1 Sentences or short fragments of the description and/or claims in a language other than the language of the proceedings
1.2.3.2 Technical or non-technical terms used in the description and/or the claims in a language other than the language of the proceedings
1.2.4 Sequence listing
2. Language of the proceedings
2.1 Language for the purpose of the international search
2.2 Language for the purpose of the supplementary international search
2.3 Language for the purpose of the international preliminary examination
2.3.1 Language of the international application
2.3.2 Language of the amendments
2.3.3 Language of the demand
3. Derogations from the language of the proceedings in written proceedings
3.1 Written submissions
3.2 International applications filed in Dutch
3.3 Priority documents
3.4 Third-party observations
4. Correction of the translation
5. Authentic text of the international application
Chapter VIII – Common provisions
1. Representation
1.1 General principles
1.2 Representation by an agent
1.3 Representation by a common agent, common representative or "deemed common representative"
1.4 Representation by an employee
1.5 Manner of appointment of an agent, common agent or common representative
1.6 Address for correspondence
1.7 Representation before the EPO as International Searching Authority
1.8 Representation before the EPO as Supplementary International Searching Authority
1.9 Representation before the EPO as International Preliminary Examining Authority
1.10 Representation before the EPO as designated or elected Office
1.11 Power of attorney
1.12 General power of attorney
1.13 Waivers – exceptions to applicability
2. Form of documents
2.1 Documents making up the international application
2.2 Later documents
2.3 Number of copies
2.4 Filing of subsequent documents
3. Signature of documents
3.1 Documents filed after filing the international application
3.2 Signature of the PCT request and a power of attorney
3.3 Form of signature
3.4 Joint applicants
PCT Part B – Guidelines for Search
Chapter I – Introduction
1. Purpose of Part B
2. The examiner
2.1 Consultation with other examiners
2.2 Search Division consisting of more than one examiner
Chapter II – General
1. International search and written opinion under Chapter I
1.1 Competence of the EPO as ISA
2. Objective of the search
3. Search documentation
4. Search report
5. Time limit
6. Representation before the EPO as ISA or SISA
Chapter III – Characteristics of the search
1. Scope of the search
1.1 Completeness of the search
1.2 Effectiveness and efficiency of the search
1.3 Search in analogous fields
1.4 Search on the internet
2. The subject of the search
2.1 Basis for the search
2.2 Interpretation of claims
2.2.1 Claims with explicit references to the description or drawings
2.3 Obvious mistakes and missing or correct parts/elements
2.3.1 General considerations
2.3.2 Request for rectification of obvious mistakes (Rule 91)
2.3.3 Incorporating missing parts or elements, or correct parts or elements, completely contained in the priority document
2.3.4 Correct elements or parts notified after the start of the search and additional fee
2.4 Anticipation of amendments to claims
2.5 Broad claims
2.6 Independent and dependent claims
2.7 Search on dependent claims
2.8 Combination of elements in a claim
2.9 Different categories
2.10 Subject-matter excluded from search
2.11 Nucleotide and amino acid sequences
2.12 Lack of unity
2.13 Technological background
Chapter IV – Search procedure and strategy
1. Analysis of the application prior to searching
1.1 Taking into account results of an earlier search and classification
1.2 PCT Direct applications
1.2.1 Requests for PCT Direct
1.2.2 Processing of PCT Direct letters
1.3 Third-party observations
1.4 Documents cited in the application
2. Search strategy
2.1 Subject of the search; restrictions
2.2 Formulating a search strategy
2.3 Carrying out the search; types of documents
2.4 Reformulation of the subject of the search
2.5 Closest prior art and its effects on the search
2.6 End of search
3. Procedure after searching
3.1 Preparation of the search report
3.2 Amended international search report
Chapter V – Preclassification and IPC classification of international patent applications
1. Definitions
2. Preclassification (for file routing and distribution)
2.1 Incorrect preclassification
3. IPC classification of the application
3.1 Amended classification of late‑published search reports
3.2 IPC classification when the scope of the invention is not clear
3.3 IPC classification in cases of a lack of unity of invention
3.4 Verification of the IPC classification
Chapter VI – The state of the art at the search stage
1. General
2. State of the art – oral disclosure, etc.
3. Priority
4. Conflicting applications
4.1 Potentially conflicting European and international applications
4.2 National prior rights
5. Date of reference for documents cited in the search report; filing and priority date
5.1 Verification of claimed priority date(s)
5.2 Intermediate documents
5.3 Doubts as to the validity of the priority claim; extension of the search
5.4 Documents published after the filing date
5.5 Non‑prejudicial disclosures
5.6 Matters of doubt in the state of the art
6. Contents of prior‑art disclosures
6.1 General remark
6.2 Citation of documents corresponding to documents not available or not published in one of the official EPO languages
6.3 Conflict between abstract and source document
6.4 Insufficient prior-art disclosures
6.5 Incorrect compound records in online databases
7. Internet disclosures – technical journals
Chapter VII – Unity of invention
1. General remarks
2. Lack of unity at the search stage
3. No request for payment of additional search fees
4. Cascading non-unity
5. Documents relevant only to other inventions
6. Reply from the applicant to the invitation to pay additional search fees
6.1 No payment of additional search fees
6.2 Payment of additional search fees without protest
6.3 Payment of additional search fees under protest
7. Protest procedure
7.1 Admissibility of the protest as checked by the formalities officer
7.2 The work of the Review Panel
8. Lack of unity and incomplete search
Chapter VIII – Subject-matter to be excluded from the search
1. General remarks
2. Subject-matter which the ISA is not required to search and examine
2.1 Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body
2.2 Subject-matter according to Rules 39.1(i), (iii), (v) and (vi)
2.2.1 Computer ‑implemented business methods
3. No meaningful search possible
3.1 Examples of impossibility to perform a meaningful search over the whole of the claimed scope
3.2 Nucleotide and amino acid sequences
3.3 Informal clarification
3.3.1 Informal clarification by telephone
3.3.2 Informal clarification by written request
3.4 Reply to the invitation for informal clarification
3.4.1 Failure to reply in time or no reply
3.4.2 Reply in time
3.5 The content of the WO‑ISA after an invitation for informal clarification and/or in case of a restriction of the search
3.6 Combination of an incomplete search and lack of unity
4. Multiple independent claims per category
Chapter IX – Search documentation
1. General
1.1 Organisation and composition of the documentation available to the Search Divisions
1.2 Systematic access systems
2. Patent documents arranged for systematic access
2.1 PCT minimum documentation
2.2 Unpublished patent applications
2.3 Search reports
2.4 Patent family system
3. Non‑patent literature arranged for systematic access
3.1 Periodicals, records, reports, books, etc.
4. Non‑patent literature arranged for library‑type access
Chapter X – Search report
1. General
2. Different types of search reports drawn up by the EPO as ISA
3. Form and language of the search report
3.1 Form
3.2 Language
3.3 Account of the search
3.4 Record of search strategy
4. Identification of the patent application and type of search report
5. Classification of the patent application
6. Areas of technology searched
7. Title, abstract and figure(s) to be published with the abstract (as indicated on supplemental sheet A)
8. Restriction of the subject of the search
9. Documents noted in the search
9.1 Identification of documents in the search report
9.1.1 Bibliographic elements
9.1.2 "Corresponding documents"
9.1.3 Languages of the documents cited
9.2 Categories of documents (X, Y, P, A, D, etc.)
9.2.1 Particularly relevant documents
9.2.2 Documents defining the state of the art and not prejudicing novelty or inventive step
9.2.3 Documents which refer to a non‑written disclosure
9.2.4 Use of "P" documents in the search report
9.2.5 Documents relating to the theory or principle underlying the invention
9.2.6 Potentially conflicting patent documents
9.2.7 Documents cited in the application
9.2.8 Documents cited for other reasons
9.3 Relationship between documents and claims
9.4 Identification of relevant passages in prior-art documents
10. Authentication and dates
11. Copies to be attached to the search report
11.1 General remarks
11.2 Electronic version of document cited
11.3 Patent family members; the "&" sign
11.4 Reviews or books
11.5 Summaries, extracts or abstracts
11.6 Citation of video and/or audio media fragments available on the internet
12. Transmittal of the search report and written opinion
Chapter XI – The written opinion
1. The written opinion
2. Basis of the written opinion (WO‑ISA)
2.1 Applications containing missing parts or elements, or correct parts or elements, incorporated by reference
2.2 Applications filed in Dutch
3. Analysis of the application and content of the written opinion
3.1 The search division's dossier
3.2 Reasoned objections
3.2.1 Opinion on novelty, inventive step and industrial applicability
3.2.2 Multiple independent claims
3.2.3 Dependent claims – WO‑ISA
3.2.4 Clarity, conciseness, support and formal defects – WO‑ISA
3.3 Making suggestions
3.4 Positive or negative WO‑ISA
4. Priority claim and the WO‑ISA
4.1 Restoration of priority
4.2 Use of "P" documents in the written opinion
4.3 Use of "E" documents in the written opinion
5. Unity in relation to the written opinion
6. The written opinion in cases of a restriction of the search
7. Sequence listings
8. Options open to the applicant following receipt of the ISR and WO‑ISA
Chapter XII – Supplementary international search (SIS)
1. General
2. Time limits
3. Basis for the search
4. Scope of the search
5. Limitation of the search for reasons other than non-unity
6. Filling out the search report
7. Explanations under Rule 45bis.7(e)
8. Validity of priority and E/P documents
9. Copies of documents cited in the SISR
10. Non-unity
10.1 General procedure
10.2 Deciding what is to be considered the main invention
10.3 The main ISA found that unity of invention is lacking
10.4 Review procedure
11. Combination of SIS and Chapter II
PCT Part C – Guidelines for Procedural Aspects in Chapter II
Chapter I – Introduction
1. General remark
2. Work of an examiner
3. Purpose of international preliminary examination
Chapter II – Formal requirements to be met before the start of the international preliminary examination
1. Filing of the demand
1.1 Time limit for filing the demand
1.1.1 Time limit for filing a demand to delay national phase entry
2. The EPO as competent IPEA
3. Identification of the international application in the demand
4. Applicant's entitlement to file a demand
5. Representation
6. Election of states
7. Signature
8. Basis for international preliminary examination
9. IPEA file
10. Correction of deficiencies
11. Payment and refund of fees
12. Transmission of demand to the International Bureau
13. Language requirements
Chapter III – Documents forming the basis of the international preliminary examination
1. Substitute sheets and rectified sheets
2. Sheets filed under Rule 20.6 containing missing parts or elements or correct parts or elements
3. Amended sheets
4. Added subject-matter
Chapter IV – Examination of the WO‑ISA and replies
1. General procedure
1.1 Subject-matter which the IPEA is not required to examine
2. Despatch of a further written opinion (Form 408)
2.1 Procedure when the EPO was not the ISA
2.2 Procedure when the EPO was the ISA
2.3 Supplementary international search (SIS) by another office
2.4 Files arriving late
2.5 Request for a further written opinion
3. Late-filed reply after a first or further WO-IPEA (408) has been sent
4. Consequences of a restriction of the search
4.1 Submissions prompted by a restriction of the search or a declaration that no search is possible
4.2 Consequences of a declaration of no search or an incomplete search in subsequent European procedure
5. Top-up searches in PCT Chapter II
5.1 Timing, basis and forms
5.2 Exemptions from top-up search
5.3 Documents newly found in the top-up search, when further objections are present
5.4 Intended positive IPER and top-up search
Chapter V – Unity of invention
1. Unity of invention under Chapter II
2. No payment of additional search fees
3. Searched claims did not comply with unity of invention
3.1 Payment of additional search fees without protest
3.2 Payment of additional search fees under protest
3.3 No request for payment of additional search fees
4. Applicant's reply to the invitation to pay additional fees (Form 405)
4.1 No payment of additional examination fees or failure to reply
4.2 Payment of additional examination fees without protest
4.3 Payment of additional examination fees under protest
5. Protest procedure
5.1 Admissibility of the protest as checked by the formalities officer
5.2 The work of the Review Panel
Chapter VI – Time limits
1. Start of the international preliminary examination
2. Time limit for international preliminary examination
3. Extension of the time limit
Chapter VII – Other procedures in examination
1. Request for an interview or telephone consultation
2. Confidentiality
3. Examination of observations by third parties
Chapter VIII – The IPER
1. Opinion given in the IPER (Form 409)
2. Completing the IPER
2.1 Sequence listings
3. Positive or negative IPER
4. Rectification of the IPER
Chapter IX – Special requests
1. Withdrawal of demand under Chapter II
2. Request for examination of a different set of claims
3. Request for examination of certain claims only
4. Complaint against the findings at the search stage
PCT Part E – Guidelines on General Procedural Matters
Chapter I – Introduction
Chapter II – Observations by third parties
Chapter III – Patent Prosecution Highway (PPH)
1. General
2. PPH based on a WO‑ISA established by the EPO as ISA
3. PPH based on an IPER established by the EPO as IPEA
Chapter IV – Time limits in the international phase
1. Computation of time limits in the international phase
2. Excuse of delays in meeting time limits and extension of time limits in the international phase
Chapter V – External complaints
Chapter VI – Notification
PCT Part F – The International Application
Chapter I – Introduction
Chapter II – Content of an international application (other than claims)
1. General
2. Abstract
2.1 Purpose of the abstract
2.2 Definitive content
2.3 Content of the abstract
2.4 Figure accompanying the abstract
2.5 Checklist
2.6 Transmittal of the abstract to the applicant
2.7 Comments on the abstract by the applicant
3. The title
4. Description (formal requirements)
4.1 General remarks
4.2 Technical field
4.3 Background art
4.3.1 Format of background art citations
4.3.1.1 Examples of quotation for non-patent literature
4.3.1.2 Examples of quotation for patent literature
4.4 Irrelevant matter
4.5 Technical problem and its solution
4.6 Reference in the description to drawings
4.7 Reference signs
4.8 Industrial applicability
4.9 Manner and order of presentation
4.10 Terminology
4.11 Computer programs
4.12 Physical values, units
4.13 Registered trademarks
5. Drawings
5.1 Form and content of the drawings
5.2 Photographs
6. Nucleotide and amino acid sequence listings
6.1 Reference to sequences disclosed in a database
7. Expressions, etc., not to be used
7.1 Categories
7.2 Expressions or drawings contrary to morality or public order
7.3 Disparaging statements
7.4 Irrelevant matter
7.5 Omission of matter from publication
Annex 1 – Checklist for considering the abstract (see F‑II, 2.5)
Annex 2 – Units recognised in international practice (see F‑II, 4.12)
Chapter III – Sufficiency of disclosure
1. Sufficiency of disclosure
2. Sufficiency vs. additional subject-matter
3. Insufficient disclosure
4. Burden of proof as regards the possibility of performing and repeating the invention
5. Cases of partially insufficient disclosure
5.1 Only variants of the invention are incapable of being performed
5.2 Absence of well-known details
5.3 Difficulties in performing the invention
6. Inventions relating to biological material
6.1 Biological material
6.2 Public availability of biological material
6.3 Deposit and availability of biological material
6.4 Priority claim
7. Proper names, trademarks and trade names
8. Reference documents
9. "Reach-through" claims
10. Sufficiency of disclosure and Rule 20.5(e) or Rule 20.5bis(e)
11. Sufficiency of disclosure and clarity
Chapter IV – Claims (Art. 6 and formal requirements)
1. General
2. Form and content of claims
2.1 Technical features
2.2 Two-part form
2.3 Two-part form unsuitable
2.3.1 Two-part form "wherever appropriate"
2.4 Formulae and tables
3. Kinds of claim
3.1 Categories
3.2 Number of independent claims
3.3 Independent and dependent claims
3.4 Arrangement of claims
3.5 Subject-matter of a dependent claim
3.6 Alternatives in a claim
3.7 Independent claims containing a reference to another claim or to features from a claim of another category
3.8 Claims directed to computer-implemented inventions
3.8.1 Cases where all method steps can be fully implemented by generic data processing means
3.8.2 Cases where method steps require specific data processing means and/or require additional technical devices as essential features
3.8.3 Cases where the invention is realised in a distributed computing environment
4. Clarity and interpretation of claims
4.1 Clarity
4.2 Interpretation
4.3 Inconsistencies
4.4 General statements, "spirit" of invention
4.5 Essential features
4.5.1 Objections arising from missing essential features
4.5.2 Definition of essential features
4.5.3 Generalisation of essential features
4.5.4 Implicit features
4.5.5 Examples
4.6 Relative terms
4.7 Terms like "about", "approximately" and "substantially"
4.8 Trademarks
4.9 Optional features
4.10 Result to be achieved
4.11 Parameters
4.12 Product-by-process claim
4.12.1 Product claim with process features
4.13 Interpretation of expressions stating a purpose
4.14 Definition by reference to use or another entity
4.15 The expression "in"
4.16 Use claims
4.17 References to the description or drawings
4.18 Reference signs
4.19 Negative limitations (e.g. disclaimers)
4.20 "Comprising" vs. "consisting"
4.21 Functional definition of a pathological condition
4.22 Broad claims
4.23 Order of claims
5. Conciseness, number of claims
6. Support in description
6.1 General remarks
6.2 Extent of generalisation
6.3 Objection of lack of support
6.4 Lack of support vs. insufficient disclosure
6.5 Definition in terms of function
6.6 Support for dependent claims
Annex – Examples concerning essential features
Chapter V – Unity of invention
1. Assessment of and reasoning for unity of invention
2. Lack of unity during search
3. Lack of unity during the PCT Chapter II procedure
Chapter VI – Priority
1. The right to priority
1.1 Filing date as effective date
1.2 Priority date as effective date
1.3 Validly claiming priority
1.4 Subsequent application considered as first application
1.5 Multiple priorities
2. Determining priority dates
2.1 Examining the validity of a right to priority
2.2 The same invention
2.3 Priority claim not valid
3. Claiming priority
3.1 General remarks
3.2 Declaration of priority
3.3 Certified copy of the previous application (priority document)
3.4 Translation of the previous application
3.5 Withdrawal of priority claims
3.6 Correction or addition of priority claim
3.7 Re‑establishment of rights in respect of the priority period
PCT Part G – Substantive requirements of the application
Chapter I – Patentability
1. General disclaimer
2. General remarks
Chapter II – Inventions
1. General remarks
2. Examination practice
3. List of exclusions
3.1 Discoveries
3.2 Scientific theories
3.3 Mathematical theories
3.4 Aesthetic creations
3.5 Schemes, rules and methods of doing business, performing purely mental acts or playing games
3.6 Programs for computers
3.7 Presentations of information
4. Exceptions to patentability
4.1 Matter contrary to public order or morality
4.2 Surgery, therapy and diagnostic methods
5. Exclusions and exceptions for biotechnological inventions
5.1 General remarks and definitions
5.2 Biotechnological inventions
5.3 Exceptions
5.4 Plant and animal varieties, essentially biological processes for the production of plants or animals
5.5 Microbiological processes
Chapter III – Industrial application
1. General remarks
2. Methodology
3. Industrial applicability
Chapter IV – Prior art
1. General remarks and definition
2. Enabling disclosures
3. Date of filing or priority date as effective date
4. Documents in a non‑official language of the (S)ISA or IPEA
4.1 Machine translations
5. Conflict with other applications
5.1 Prior art pursuant to Rules 33.1(c) and 64.3
5.2 Co-pending applications
6. Prior art made available to the public anywhere in the world by non-written disclosure
6.1 Types of non-written disclosure, in particular use, and instances of prior art made available in any other way
6.2 Matters to be determined as regards use
6.2.1 General principles
6.2.2 Agreement on secrecy
6.2.3 Use on non-public property
6.2.4 Example of the accessibility of objects used
6.2.5 Example of the inaccessibility of a process
6.3 Prior art made available by means of oral description
6.4 Internet disclosures
6.5 Standards and standard preparatory documents
7. Cross-references between prior-art documents
8. Errors in prior-art documents
Chapter V – Non-prejudicial disclosures
1. General
Chapter VI – Novelty
1. Prior art pursuant to Art. 33(2)
2. Implicit features or well-known equivalents
3. Relevant date of a prior document
4. Enabling disclosure of a prior document
5. Generic disclosure and specific examples
6. Implicit disclosure and parameters
7. Examination of novelty
7.1 Second or further medical use of known pharmaceutical products
7.2 Second non‑medical use
8. Selection inventions
9. Novelty of "reach-through" claims
Chapter VII – Inventive step
1. General
2. Prior art; date of filing, date of priority
3. Person skilled in the art
3.1 Common general knowledge of the skilled person
4. Obviousness
5. Problem‑solution approach
5.1 Determination of the closest prior art
5.2 Formulation of the objective technical problem
5.3 Could-would approach
5.4 Claims comprising technical and non‑technical features
5.4.1 Formulation of the objective technical problem for claims comprising technical and non-technical features
5.4.2 Examples of applying the steps listed in EPC Guidelines G‑VII, 5.4
6. Combining pieces of prior art
7. Combination vs. juxtaposition or aggregation
8. Ex post facto analysis
9. Origin of an invention
10. Secondary indicators
10.1 Predictable disadvantage; non-functional modification; arbitrary choice
10.2 Unexpected technical effect; bonus effect
10.3 Long felt need; commercial success
11. Arguments and evidence submitted by the applicant
12. Selection inventions
13. Dependent claims; claims in different categories
14. Examples
PCT Part H – Amendments and Corrections
Chapter I – The right to amend
1. Introduction
2. Amendments before receipt of the search report
3. Amendments prior to the start of international preliminary examination
4. Further opportunity to submit amendments
5. Amended sheets
6. Indication of amendments and their basis
Chapter II – Allowability of amendments
1. Introduction
2. Allowability of amendments
2.1 Basic principle
2.2 Content of the application as "originally" filed – general rules
2.2.1 Features described in a document cross-referenced in the description
2.2.2 Incorporating missing or correct parts or elements completely contained in the priority document
2.2.2.1 Test for "completely contained"
2.2.2.2 Review by the examiner
2.2.3 Sequence listings filed after the filing date
2.2.4 Priority documents
2.2.5 Citation of prior art in the description after the filing date
2.2.6 Clarification of inconsistencies
2.2.7 Trade marks
Chapter III – Allowability of amendments – examples
1. Introduction
2. Amendments in the description
2.1 Clarification of a technical effect
2.2 Introduction of further examples and new effects
2.3 Revision of stated technical problem
2.4 Reference document
2.5 Alteration, excision or addition of text in the description
3. Amendments in claims
3.1 Replacement or removal of a feature from a claim
3.2 Inclusion of additional features
3.2.1 Intermediate generalisations
3.3 Deletion of part of the claimed subject-matter
3.4 Further cases of broadening of claims
3.5 Disclaimer disclosed in the application as originally filed
4. Disclaimers not disclosed in the application as originally filed
4.1 The subject-matter to be excluded is not disclosed in the application as originally filed (so-called undisclosed disclaimers)
4.2 The subject-matter to be excluded is disclosed in the application as originally filed
5. Amendments to drawings
6. Amendments derived from drawings
7. Amendments to the title
Chapter IV – Correction of defects and errors
1. Substitute sheets (Rule 26)
2. Request for rectification of obvious mistakes in the application documents (Rule 91)
2.1 Introduction
2.2 Authorisation or refusal of the request for rectification of obvious mistakes in the application documents
2.3 Allowability of rectifications
2.4 Examples
Alphabetical Keyword Index
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
Z
&
List of sections amended in 2025 revision

5.5 Microbiological processes 

See ISPE Guidelines 9.06. GL/EPO EPC Guidelines G‑II, 5.5, applies mutatis mutandis.

Rule 39.1(ii),
Rule 67.1(ii)
OJ EPO 2017, A115
OJ EPO 2018, A24

Previous
Next