The European problem & solution approach [PSA]
Obviousness: European problem and solution approach ). One notes that there is a divergence
between Europe and the United Kingdom on PSA (e.g., Obviousness Approaches of the EPO and The English Courts ), discussing Actavis v Novartis  EWCA Civ 82, 17th February 2010 . Canada follows the United Kingdom approach, rather than
that of the EPO PSA ( eg, Inventive step and non-obviousness )
Note comments at IPKat on Actavis v Novartis : It also probably doesn't help when the crucial step of identifying what the technical effect of the difference between the claimed invention and the closest prior art is somewhat skated over, if not missed out altogether.
***Of support for the "problem" in the specification, from Ru Li on PSA :
the problem has to be formulated on the basis of the information given in the patent application (properties, effects). It must be known or capable of being deduced by the skilled man from the data given in the application. In other words, the problem must be sufficiently concrete and has technical content that is meaningful to the skilled person to look for a solution.
[cross-reference: http://www.bepress.com/ndsip/papers/art17/ ]
***Note mention of PSA within 2009 Wis. L. Rev. 1435 :
The Kubin standard closely mirrors the European standard for assessing "inventive step," which is the general European patentability requirement analogous to nonobviousness. The European approach to [p. 1453] assessing inventive step is called the "problem-solution" approach. n123
Footnote 123 states: Another appropriate way to think of the approach may be to consider the task at hand and how it was successfully accomplished. Fordham Symposium, Panel I Remarks, supra note 11, at 882 (remarks of John Richards).
***As to the problem, see http://www2.ari.net/foley/leonard.html which notes:
2. Formulation of the Technical Problem
The closest prior art having been determined, the second step is to
establish in an objective manner the technical problem which the invention
sets out to solve. The technical problem in this sense is the aim and task
of modifying or adapting the closest prior art to provide the technical
effects which the invention provides over the closest prior art. The problem
can thus be seen as the task the inventor has set himself, viewed in the
light of the closest prior art.
The technical problem may be to improve in some way an effect already known
from the prior art. Alternatively it may be to make available a totally new
effect. Examples of the former can be to find new compounds having a higher
activity than structurally close known compounds or to modify known
compositions in such a way as to avoid unwanted side effects.
The establishment of the technical problem must be based on ob jectively
established facts derived from the available prior art. This prior art may
not have been available to the Applicant at the time of filing of the patent
application and the objectively established technical problem may thus be
different from the problem as seen by him. It is necessary to ensure that
any problem considered does not contain any elements of the solution, since,
if it does, its formulation may result from post facto considerations.
Furthermore it must actually be solved by the invention. The latter can
often be settled on the basis of information available in the patent
application itself or on the basis of evidence filed by the Applicant after
the filing date of the application. Where more than one technical effect is
obtained, the invention may solve more than one problem. In this case each
of these problems will generally have to be considered separately.
In response to an objection that an invention is obvious an Applicant or
Patentee may submit evidence to show that the invention leads to effects
different from those originally considered, with the result that the
Technical Problem solved by the invention may have to be reformulated. The
extent to which the Technical Problem can be reformulated in this way will,
of course, depend on the disclosure of the Application or Patent and of the
closest available prior art and has to be assessed on the merits of the
particular case. Any effect provided by the invention may be used as a basis
on which the problem may be formulated, so long as that effect is derivable
from the application as originally filed or the patent as granted(8). The
person skilled in the art must be able to recognise this effect as implied
by or related to the technical problem initially suggested(9). An effect
however which is different in kind from or is not implied by or related to
the originally considered Technical Problem, and could not have been
foreseen in the light of the application as originally filed cannot be used
as a basis on which to reformulate the problem.
The reformulation of the problem may be illustrated by the following Example
taken from the Guidelines(10):
The invention as filed relates to a pharmaceutical composition
having a specific activity. At first sight, having regard to
the relevant prior art, it would appear that there is a lack of
inventive step. Subsequently, the Applicant submits new
evidence which shows that the claimed composition exhibits an
unexpected advantage in terms of low toxicity. In this case it
is allowable to reformulate the technical problem by including
the aspect of low toxicity, since pharmaceutical activity and
toxicity are related in the sense that the skilled person would
always contemplate the two aspects together.
(Re)formulation of the technical problem in the sense referred to here is
carried out essentially for the purpose of assessing whether or not the
invention is or is not obvious. It cannot normally give rise to any
amendment of the application or patent. Any such amendment is only
allowable, if it meets the requirements of Article 123, part 2, i.e. it does
not add subject matter which extends beyond the content of the application
as originally filed(11).