In the Practice Notice, CIPO has adopted a problem and solution
approach to analyzing claims to diagnostic methods, summarized
Based on the description and the examiner's understanding of
the common general knowledge in the art, the examiner should first
identify the problem(s) the inventors set out to solve. The
Practice Notice discusses two types of problems – a
"data acquisition problem" and a "data analysis
problem" – and provides non-exhaustive factors that may
indicate their existence.
A data acquisition problem may be indicated, for example, by
disclosure relating to an analyte that is not common general
knowledge, or by significant detail or emphasis relating to how to
identify or quantify a particular analyte.
A data analysis problem may be indicated, for example, by
emphasis on the discovery of a new correlation between a condition
and an analyte that is common general knowledge, with relative
absence of technical details on how to acquire data about the
analyte, or by indication that it is common general knowledge to
apply means contemplated by the application to acquire data about a
A solution to a data acquisition problem is provided by those
elements that provide a means to acquire data about an analyte,
such as steps of detecting or measuring the concentration of X.
A solution to a data analysis problem is provided by those
elements that relate to the analysis of the acquired data for the
purpose of providing diagnostic meaning, such as "comparing
the expression levels of genes A, B and C to a control standard,
wherein a decrease in the levels as compared to the control is
indicative of disease Y".
The next step is purposive claim construction, including
determining whether elements in the claims are essential (provide
the solution to the problem) or non-essential.
Where a data acquisition problem exists, the essential
element(s) is the means to acquire data about an analyte.
Where a data analysis problem is identified, "the essential
elements will include steps relating to the mental analysis and/or
intellectual significance of the data and will likely not include
any steps to acquire the data since the way the data is acquired
does not change the nature of the solution".
Determining whether the claim defines statutory
CIPO makes a distinction between "physical", versus
"disembodied", essential elements in considering whether
or not a diagnostic method claim is directed to patentable
subject-matter, i.e. within the meaning of "invention" in
the Canadian Patent Act.
Where a physical step of data acquisition is identified as an
essential element of a claim, the claimed subject-matter will
likely be statutory.
In contrast, where the claim "consist[s] solely of
essential elements that are disembodied (e.g., mental process,
lacking physicality, no practical application, etc.)" –
generally, where the solution is only provided by an element(s)
associated with the analysis or significance of the acquired data
(e.g. a correlation) – the claimed subject-matter will be
identified as non-statutory.
The preceding is intended as a timely update on Canadian
intellectual property and technology law. The content is
informational only and does not constitute legal or professional
advice. To obtain such advice, please communicate with our offices
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A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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