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2.1.9.3.5 Other Considerations Independent of FER Validity

Date Published

Additional matters that need to be considered under Australian law regardless of the quality of the FER include:

  • Contrary to law, sec 50(1)(a)
  • Mere mixture/admixture, sec 50(1)(b)
  • Multiple applications, sec 64
  • Manner of manufacture – in particular kit claims, claims to nucleic acid sequences and where peptides etc are not claimed in isolated/recombinant etc form.
  • Notice of Entitlement
  • Budapest Treaty issues
  • Reach through claims (however there is generally comment on these types of claims in the FER).
  • "For Use” limitation – EP, US and JP may construe this as limiting.
  • Interpretation of “contains”, “consists” and “comprises”.
  • Section 18(2) (human beings) and sec 18(3)
  • Omnibus claims
  • “Whole of Contents” issues
  • Where the search report lists E or P, X citations, and there is no discussion of these in the FER, examiners should be aware that these documents may be relevant to examination if there are AU family equivalents (including WO documents that designate AU).  Where the FER discusses E or P, X citations, and there are AU family equivalents, examiners should refer to the FER discussion in their report if appropriate, following the guidelines in 2.1.9.4 FERs and Report Formulation.
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