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6.3.8.4 Box III Non-Establishment of Opinion with Regard to Novelty, Inventive Step & Industrial Applicability

Date Published

Key Legislation:

Patent Cooperation Treaty (PCT):

  • Article 17 Procedure Before the International Searching Authority 
  • Article 33 The International Preliminary Examination 
  • Article 34 Procedure Before the International Preliminary Examining Authority 

Administrative Instructions under the PCT:

  • Annex C INSTRUCTIONS RELATING TO THE PRESENTATION OF NUCLEOTIDE AND AMINO ACID SEQUENCE LISTINGS IN INTERNATIONAL PATENT APPLICATIONS UNDER THE PCT

Regulations under the PCT:

  • Rule 66.2 Written Opinion of the International Preliminary Examining Authority
  • Rule 67.1 Definition

PCT ISPE Guidelines

  • para 9.39 Sequence Listings
  • para 16.28-16.29 Restriction of the Subject of the International Search
  • para 17.09 Overview of Content
  • para 17.32-17.37 Box No. III: Non-Establishment of Opinion with Regard to Novelty, Inventive Step and Industrial Applicability
  • para 17.60 Excluded Subject Matter
  • para 18.13 Documents, Etc., for the International Preliminary Examining Authority
  • para 18.18 Nucleotide and/or Amino Acid Sequence Listings
  • para 19.22 Cases Where No Written Opinion May Be Issued
  • para 19.25 Claims for Which No International Search Report Has Been Established

Rule 67.1 establishes that no International Authority shall be required to examine the subject matter of a PCT application to the extent that it is any of items i – vi below. The agreement between WIPO and Australia further qualifies this by excepting from exclusion any subject matter which is examined under national grant procedures. [Art 17(2)(a)(i) Rule 67 PCT/GL/ISPE/12 para 17.32]

For Rule 67.1 subject matter that is not excluded under Australian law (e.g. methods of treatment of humans), examiners should disregard Box III ("Non-establishment of opinion...") of PCT/ISA/237, PCT/IPEA/408 or PCT/ISA/409 and establish the written opinion or IPRPII with regard to novelty, inventive step and industrial applicability in the usual way.

The subject matter specified in Rule 67.1 is:

i. scientific and mathematical theories

ii. plant or animal varieties or essentially biological processes for the production of plants and animals, other than microbiological processes and the products of such processes

iii. schemes, rules or methods of doing business performing purely mental acts or playing games

iv. methods for treatment of the human or animal body by surgery or therapy, as well as diagnostic methods

v. mere presentations of information

vi. computer programs

Where excluded subject matter under Australian law has not been claimed, go to 6.3.8.5 Box IV Unity of Invention

Where some or all claims define excluded subject matter, this observation must be included in Box III checkbox 3 of an ISO (form PCT/ISA/237) and Box III checkbox 3 of an IPEO and IPRPII (forms PCT/IPEA/408 and PCT/IPEA/409, respectively). Additionally, checkbox 6 in Box III of the above forms will need to be checked to record the fact that no international search has been established for the specified claims.

Where the description, the claims, or the drawings are so unclear, or the claims are so inadequately supported by the description that no meaningful opinion can be formed on the questions of novelty, inventive step, or industrial applicability of the claimed invention, then the ISO and IPEO may be restricted to those claims that are sufficiently clear and supported by the description to enable an opinion to be prepared (4th and 5th checkboxes). [Rule 66.2(a) PCT/GL/ISPE/12 para 18.13, 18.18, 19.22(vi), 17.09, 17.32, 17.34, 17.60]

Applicants must be given at least one opportunity to consider these observations (the ISO counts as at least one opportunity) before an IPRPII is established see 6.3.5.1 First IPE Action.

The issues of clarity and descriptive support of claims may be raised separately to considerations of novelty, inventive step and industrial applicability at Box VIII of the written opinion or IPRPII.  See Box VIII Certain Observations.

Where the ISA has not established an ISR (for all or some of the claims) and instead issued a declaration under Art 17 (relating to excluded subject matter, clarity or full support), the questions of novelty, inventive step and industrial applicability cannot be addressed since there are no documents to consider under Art 33(6), and such reasoning is added to the 'non-establishment' Box of the ISO, IPEO and IPRPII form (Note that this applies even where Art 34 amendments may have overcome consideration under Art 34(4)(a)(ii)). [Art 33(6) PCT/GL/ISPE/12 at para 19.25]

For those claims of the nature described above, the questions of novelty, inventive step and industrial applicability will not be addressed. [PCT/GL/ISPE/12 at para 17.60]

Note: Box III of the ISO, IPEO and IPRP should NOT be filled out when no international search report has been established due to lack of unity of invention.  Instead, item 3 of Box IV of the ISO, IPEO and IPRP is to be filled out in these circumstances – see 6.3.8.5 Box IV Unity of Invention.

A failure to supply nucleotide and/or amino acid sequence listing information, or have it complying with the Administrative Instructions standards, will preclude any meaningful search or international preliminary examination being carried out (see Box III checkbox 7 of the ISO,  IPEO and IPRPII form). Additionally, checkbox 6 in Box III of the above forms will need to be checked to record the fact that no international search has been established for the specified claims. In the case of a PCT search, checkbox 2 in Box II of the ISR should also be checked. [Ad. Inst. Annex C, PCT/GL/ISPE/12 at para 9.39, 16.28-16.29, 17.37].

For instructions on completing Box III in respect of Omnibus claims see 6.3.8.8 Box VII Certain Defects and see Annex O for example.

Amended Reasons

Amended Reason Date Amended

Published for testing

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