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In a much anticipated decision for the applicant, the patent office issued its decision on The University of British Columbia [2020] APO 15 matter on 20 March 2020. The invention relates to antibodies produced using select epitopes disclosed in the specification.

The decision centres on a hearing requested by the applicant due to an impasse with the examiner regarding enablement, support and best method under subsections 40(2)(a), 40(3) and 40(2)(aa), respectively, of the Patents Act 1990.

Enablement

The primary examiner took the view that there would be an undue burden in preparing antibodies to the various epitopes defined by their amino acid sequences and assaying them to determine whether they selectively bind to the protein from which the epitopes were derived. At [6] to [8], the Deputy Commissioner of Patents summarised the factors for consideration of enablement, which included:

  • the nature of the invention
  • the scope of the claims
  • the art in which the invention is made, including uncertainty and lack of predictability in the art
  • incomplete experimental details or lack of guidance in the specification, including instructions on how to proceed in case of failure
  • plausibility, for example if an invention is implausible then it would inherently require an undue burden of experimentation
Support

The primary examiner asserted that the specification does not support the claims because the specification does not enable the invention over the full scope of the claims, i.e. the enablement and support objections went hand-in-hand.

At [14] with respect to support, the Deputy Commissioner explained that it is important to consider whether the technical contribution to the art is a general principle or limited to the specific examples in the specification.

Best method

In a requirement somewhat peculiar to Australia, the primary examiner also held that the specification does not disclose the best method known to the applicant of performing the invention as claimed, because the antibodies exemplified in the specification were described only by internal designation, but not by CDRs or by making available hybridomas expressing the antibodies. In considering best method, the Deputy Commissioner reaffirmed [18] that:

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.

Decision 

In coming to his decision, the Deputy Commissioner paid close regard to a declaration by an inventor filed during prosecution.

The Deputy Commissioner decided that the specification does enable the invention as claimed. At [12], the Deputy Commissioner explained that the inventor had provided sound basis to consider that the specification provides a general method of producing hybridomas, explains how to distinguish hybridomas that produce the desired antibodies, and that such testing is routine in the art.

At [16], the Deputy Commissioner determined that both the specification and the inventor’s evidence indicated that the technical contribution to the art is the use of select epitopes to produce antibodies that bind selectively to a protein. This was held to be a principle of general application, and therefore deserving of claims broader than the specific examples disclosed in the specification.

At [21], the Deputy Commissioner explained that the best method lay in the identification of four specific immunogens and their use in preparing hybridomas that express antibodies selectively binding the target protein, and that there is no evidence that the applicant was aware of a better method of performing the invention.

Consequently, the Deputy Commissioner overruled the objections and the application was remitted to examination for consideration of novelty and inventive step.

Deadline

Although the deadline for acceptance of the application had passed, the Deputy Commissioner set the deadline for acceptance 3 months from the date of his decision. However, the Deputy Commissioner left the door ajar for a request for further time if needed, to be granted upon application and at the discretion of the Commissioner of Patents.

What can we learn?

Despite being a relatively short decision of only 24 paragraphs, this recent matter does provide some useful reminders for applicants in relation to the following issues:

  • during examination, when responding to difficult enablement, support and/or best method objections, it is worth walking the examiner through and responding to each of the issues the case law has highlighted as important, e.g. Evolva SA [2017] APO 57, CSR Building Products Limited v United States Gypsum Company [2015] APO 72, and Kineta, Inc [2017] APO 45
  • declaratory evidence, including by an inventor, can be persuasive in overcoming enablement and support objections, and can be filed during examination or with written submissions in respect of a hearing
  • if an impasse is reached with an examiner regarding any type of objection, requesting a hearing can be a useful way to progress an application. Not only does the hearing effectively ‘stop the clock’, (which is important given Australia’s non-extendible 12 month period to have an application accepted), but perhaps more importantly, a hearing moves the matter to a hearing officer who may consider the issues from a different perspective.

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