PAB Clarified Sound Prediction and Functional Claim Drafting

PAB Clarified Sound Prediction and Functional Claim Drafting

Re. Patent Application No. 592,567, CD

The subject application was rejected by the Examiner under section 2 of
the Patent Act for containing claims for which the utility could not be
soundly predicted and under subsection 34(2) of the Patent Act for
containing claims directed to a desired result.

The Commissioner of Patents agreed with the recommendations of the Board
that the application be allowed, provided a specified amendment is made.

The invention relates to multiphase metal oxide compositions which are
capable of superconductivity.

Claim 1 reads:

1. A material which is superconductive at a temperature of 77K or
higher, said material comprising

a multiphase oxide of nominal composition M*aA*bOy wherein M* is a
mixture of divalent alkaline earth metals selected from the group consisting of
Ba, Sr, and Ca wherein the ratio of the alkaline earth metal of larger atomic
radius to the alkaline earth metal of smaller atomic radius is from about 1:1
to about 3:1; A* is a mixture of Cu and a trivalent metal selected from the
group consisting of Bi and Tl wherein the molar ratio of Cu to said trivalent
metal is from about 1:1 to about 3:1; "a" is 1 to 2; "b" is
1; and "y" is 2 to 4.

Claim 11 reads:

11. A crystalline phase composition comprising cations of Bi, Ca, Sr,
and Cu approximating the ratio of 2:1:2:2 for Bi:Ca:Sr:Cu and which exhibits
zero electrical resistance at a temperature of 77K or higher.


Sound Prediction

The Board found the utility of the claimed subject matter to have been
soundly predicted.

The issue to determine is whether the compositions defined in these
claims could be soundly predicted to have the promised utility; viz. to be
superconductive at a temperature of 77 K or higher. This determination is based
on the disclosure, the state of the art and the common general knowledge
available to a person skilled in the art.

The Board agreed with the Applicant's argument that there is no
requirement for testing and proving the invention in all its claimed
applications. There are, however, the requirements of the Wellcome test
that must be met for the prediction to be considered sound.

Applicability of the Doctrine of
Sound Prediction to New Compounds

It is settled law that the doctrine does in fact also apply to new
compounds. For example, see Pfizer Canada Inc. v. Apotex Inc., 2007 FC
26, 59 C.P.R. (4th) 183 (Pfizer) at paragraph 36.

Therefore, the doctrine of sound prediction is appropriately applied to
the utility of new compounds as well as old and, as for the suggestion that the
bar is set higher for new uses of old compounds, this argument of the
Applicant's was not substantiated by any jurisprudence, nor could the Board
find any to support such a double standard. In contrast, the jurisprudence
intimates that the same standard applies to new and old compounds equally.

Evidence of Inutility or that the
Prediction is not Sound

What 'evidence' is required to be presented by the Examiner in rejecting
predictions as being unsound?

Depending on the nature of the defect the only realistic option for an
Examiner making a lack of sound prediction objection may be to identify
omissions in the factual basis and sound line of reasoning in some detail. In
the objection, the Examiner should endeavour to clearly show where the gaps are
between the factual basis, the sound line of reasoning, and the prediction made
in the claim.

The onus is then on the Applicant to address these highlighted gaps, and
thus defend the soundness of the prediction, or amend to restrict the
prediction to overcome the objection.

That said, a balance must be struck during examination, with the
Examiner clearly noting why it is perceived that the prediction is not sound,
by way of the criteria (i.e. the test) set forth in Wellcome, such that
the Applicant can appreciate the case to be met.

The Board noted that simply stating the utility is insufficient on its
own to lead to a finding that the prediction is sound. Instead, that determination
must be made via the tripartite Wellcome test, as in the analysis that

Analysis of Sound Prediction

There are insufficient grounds for concluding that there can be no sound
prediction of utility for compositions falling within the scope of the claims.

Factual Basis

The Board found there was a sufficient factual basis.

Sound Line of Reasoning

On considering the balance of probabilities, the Board did not find
there to be sufficient grounds to fault the sound line of reasoning supporting
a prediction of utility.

Without any reason to suggest otherwise, it makes a certain intuitive
sense that if two extremes of a range are shown to work, then values within the
range would be expected to also work.

In addition, the fact that the range of 'a' in the compositions that
fulfils the promised utility is relatively broad, there is an order of
magnitude between the lowest and highest values, suggests that there is less
reliance on a specific value for 'a', but some compositional flexibility is
permitted. A line of reasoning can be drawn from this fact; viz., that a
certain degree of variation is not detrimental to the utility of the
compositions as superconductors.

Proper Disclosure

In the present case, all the compositions forming the factual basis were
taught, as was the information used to establish a sound line of reasoning. For
this reason, the Board concluded that the proper disclosure criterion was

The Second Objection: Desired Result

The Board rejected the Examiner's assessment that claims 1-13 and 15-21
do not comply with subsection 34(2) of the Patent Act.

The Board viewed the suggestion that, absent any further structural or
process limitations (or other "conditions"), the claims are
"merely restating the research objectives" as inaccurate. The claims
include a limitation on which atoms are present in the material and their
proportions by way of the nominal formulae.

Although there may be many compounds that satisfy them, the nominal
formulae nevertheless substantially restrict the scope of the claims in a
meaningful manner.

The Board therefore did not agree that the claim is simply directed to a
desired result, or that it is merely repeating the research objective, without
further consideration of the facts of the case.

Having a desired result appended to a claim is not automatically grounds
for rejection; the result serves as a functional limitation on the claim that
may in fact be appropriate and acceptable.

Therefore, contrary to the Examiner's position, the Board took the view
that the desired result may be an important feature to have in the claims

There can therefore be little doubt that not all compositions that
satisfy a given nominal formula in the claims will have the desired
result/promised utility. While on its face this may seem problematic, the
reality is that in fields such as ceramics/materials, where the exact structure
of a product may defy full elucidation, it may be reasonable to claim the
product by the nominal formula coupled with a functional limitation in the form
of a desired result. Whether it is appropriate will depend, inter alia, on
whether there is sufficient teaching to enable a person skilled in the art to
achieve the desired results for the range of compositions the formulae

In the case at hand, the Board was not satisfied that a person skilled
in the art would have had to resort to inventive ingenuity in order to practice
the full breadth of the claims, based on the extent of the disclosure and the
degree of enablement it affords.

There are insufficient grounds upon which to conclude that the notional
skilled person could not succeed without any undue amount of experimentation or
recourse to inventive ingenuity. Therefore, based on the detail in the
disclosure, the Board did not see grounds for finding that a person skilled in
the art would not be able to make the compositions of the given formulae that
where high-temperature superconductors, or would need to exercise inventive
effort to do so.


In this Commissioner’s Decision, the PAB has adopted the “promise
doctrine” established by the Federal Courts. According to established law, if a
promise cannot be construed from the specification, then only a "scintilla
of utility" is required to meet the statutory utility requirement.
However, according to the promise doctrine if a “promise” is construed from the
specification then utility is measured against that promise, where such utility
must be either demonstrated or soundly predicted as of the filing date of the
patent application.

Numerous patents have been invalidated on the ground that the patent
specification did not adequately disclose the factual basis for a sound line of
reasoning to establish sound prediction of utility (See Eli Lilly v. Apotex
, 2009 FCA 97 [raloxifene]; Novopharm Ltd. v. Eli Lilly & Co.,
2010 FC 915; aff'd Eli Lilly & Co. v. Teve Canada Ltd., 2011 FCA 220
[atomoxetine – Strattera]; Apotex Inc. v. Sanofi-Aventis, 2011 FC 1486
[clopidogrel]). In this decision, the PAB had adopted the approach taken by the
Courts of turning to the specification for disclosure of the factual basis
necessary for the conclusion that the invention has the promised utility.

In spite of the recent controversy surrounding the “promise doctrine”,
including the recent NAFTA challenge filed by Eli Lilly, we believe that the
statutory requirement of utility clearly forms part of the consideration for
grant of letters patent, and where utility has not been demonstrated or proven
but is predicted in advance of any actual tests or experiments being performed,
the bargain that lies at the heart of patent law requires “a heightened
obligation to disclose the underlying facts and the line of reasoning for
inventions that comprise the prediction” (Eli Lilly Canada Inc. v. Apotex
, [2009] F.C.J. No. 404 at para 14, 2009 FCA 97 (F.C.A.), leave to
appeal refused [2009] S.C.C.A. No. 219 (S.C.C.)).

In selection patent cases, the bargain is fulfilled by showing and
explaining in the specification which one of many known compounds is to be
selected, and why. Accordingly, in a selection patent case the recitation of a
promise and fulfilment of the promise is at the core of the bargain, otherwise
novelty cannot be established; see for example Sanofi-Aventis Canada Inc. v.
Ratiopharm Inc.
, 2010 FC 230 at paras 68-69. One should not, however, lose
sight of the fact that selection patent inventions are the minority of
specifications but have also been litigated more frequently, at least of late.
Caution is therefore urged against unintentionally extending the necessity of a
promise unreasonably beyond the selection patent scenario.