The Australian Patent Office's decision in The
Background
The claimed invention related to antibodies exhibiting selectivity for the 'eta' isoform of the 14-3-3 protein over other isoforms of that protein. The ability of the antibodies to discriminate between the isoforms has utility in the diagnosis of inflammatory conditions such as arthritis. The claims, as proposed to be amended, were directed to methods of determining the presence of the eta isoform of the 14-3-3 protein in a sample using the antibodies, and kits containing an immobilised antibody.
The applicant (The
Issues and findings
The Delegate (Dr
a) Section 40(2)(a) - enablement
b) Section 40(3) - support
c) Section 40(2)(aa) - best method
In relation to the first issue, enablement, the Delegate cited the approach taken in the earlier Patent Office decision
"EP andUK decisions have provided some general guidance on factors that come into consideration, including: uncertainty and a lack of predictability, incomplete experimental details and a lack of guidance in the specification including instructions on how to proceed in case of failure."
Turning to the question of "plausibility" the Delegate further cited
"the scope of the monopoly, as defined in the claims, must correspond to the technical contribution the patentee has made to the art. If the assertions made in the specification are not plausible then it cannot be reasonably said that the patentee has made a contribution to the art."
and at [44]:
"an invention that is plausible may still fail on sufficiency if the specification essentially sets out a research programme and there is an undue burden of experimentation required to put it into practice. If an invention is implausible then it would inherently require an undue burden of experimentation to put it into practice (if at all)."
Applying the approach from
As to the second issue, support, the Commissioner cited
"An important question will often be whether the technical contribution to the art is a general principle or the specific examples in the specification."
The Delegate found that both the specification and information provided by
For the final issue, best method, which is not a major consideration in jurisdictions outside of
"it is necessary to determine what method is disclosed in the specification, and then to ask whether there is any evidence that the applicant was aware of a better method of performing the invention."
The Delegate explained at [21] that the specification identified four immunogens and their use in preparing hybridomas for producing the antibodies of interest, and that there was no evidence that the applicant was aware of a better method.
The objections raised under section 40 were therefore all overruled by the Delegate. However, the application will now undergo examination for novelty and inventive step. The deadline for acceptance is 3 months post the date of the hearing and may be extended upon request by the applicant at the discretion of the Commissioner.
Implications
This recent decision highlights some of the leading Patent Office decisions in
When drafting specifications in the areas of biotechnology and pharmaceuticals intended for prosecution in
The decision is also a good reminder that a declaration from the inventor (in some cases more preferably from an independent expert) can assist in showing that a skilled person can perform the claimed invention on the basis of the disclosure in the specification. Further, the ability to request a hearing is worth considering to address an Examiner's maintenance of objections in
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