COMMISSIONER'S DECISION
Breadth of claims; lack of support - A class of "Amino-substituted tetracyclic
compound's is claimed. Examiner objected to the number of compounds covered.
Applicant amended to find support - accepted. Proposed claims were considered
not to go beyond sound prediction of utility for the class claimed; claims are
allowable in principle - Objection reversed in part.
This decision deals with a request for a review by the Commissioner of Patents
of an examiner's Final Action under Rule 47 of the Patent Rules, dated July 24,
1980 on application serial number 318,927 (class 260-200.1). The application
which is a divisional application of application 199,996 (since issued to Canadian
Patent 1,051,877) has an effective filing date of May 15, 1974 and is entitled
"AMINO-SUBSTITUTED TETRACYCLIC COMPOUNDS".
The application under review relates to processes and compounds which are
intermediates to the processes and products claimed in the parent case. The
intermediate compounds are, themselves, described as being pharmacologically active
and the final products are medicinal compounds.
In the Final Action the examiner made three objections to the claims in the
divisional, as follows:
(1) claims 1 to 5, 28 and 29 are too broad in view of the disclosure
(2) claim 1 includes inoperative subject matter
(3) claims 9 to 20, 25 to 27, 32 to 37, 40 and 41 lack support in the disclosure
In response to the Final Action, Applicant suggested an amendment which would over-
come objections (2) and (3) above and would at the same time substitute proposed
claims 1 to 5, 13 and 14 for claims 1 to 5, 28 and 29 at present in the case. (An
obvious typographical error in proposed claim 1 was corrected by a telephone call
to Applicant's agent.) The Board recommends that the part of the amendment that
overcomes the examiner's (2) and (3) be accepted and we will not consider these
objections further. This leaves for consideration proposed claims 1 to 5, 13 and
14 which, according to the examiner, are not allowable because of the number of
compounds they cover.
The examiner has required that the broad process and product claims be restricted
to cover only compounds that he considers have been adequately disclosed and
exemplified. Applicant disagree with the examiner and has asked the Commissioner
of Patents to review the Final Action and to find that claims of the breadth he
has proposed are, in principle, allowable to him.
The position taken by the examiner in his Final Action is shown in the
following passage:
...
The examiner contends however that applicant is not
necessarily entitled to claims for the
intermediates of the general formula (XII) of
equivalent scope as those obtained for the final
product (I) of the parent patent. The parent
patent discloses and claims several methods of
preparing the final products of general formula (I)
many of which do not involve intermediates of
formula (XII) at all. In fact claim 1 of the
patent defines seven alternative methods of
preparing the final products of general formula (I)
each starting with a different starting material.
Of these seven processes only one involves
intermediates of general formula (XII), that is,
process (g) wherein compounds of general formula
(XII) may be used as intermediates in the
preparation of starting material (VIII). Even in
this process it is not essential that compounds of
general formula (XII) be used. Reference to page
7, lines 2 to 4 of the patent is made which
indicates that in the preparation of the primary
amide of formula VIII the preparation of the
corresponding carboxyl compound (compound of
general formula XII) may be completely bypassed.
It is clear from reviewing the parent patent that a
large proportion of the processes disclosed and
exemplified for preparing the compounds of general
formula (I) do not utilize the intermediates of
general formula (XII) claimed in this application.
The fact that applicant was able to obtain broad
claims to the compound of general formula (I) which
are based on processes through routes other than
those utilizing compounds of general formula (XII)
does not in itself entitle applicant to claims to
compounds of general formula (XII) of equivalent
scope.
Applicant is entitled to claims to compounds of
general formula (XII) which are adequately
disclosed and exemplified by the disclosure. The
only such compounds are those of general formula
(XII) wherein rings A and B are unsubstituted and X
is oxygen or -CH2-. Claims 1 to 5, 28 and 29 must
be restricted accordingly.
The general formula (XII) is
(see formula I)
and in the proposed claims X represents oxygen, sulphur, the group
= NR7 or the group - CH2-; rings A and B may have as substituents a
halogen, an alkoxy group of 1 to 4 carbon atoms, an alkyl group of 1 to
4 carbon atoms and a hydroxy group; ring B may also have a
trifluoromethyl group; R7 represents hydrogen or methyl and n is 1 or
2. The restrictions required by the examiner are shown in the second
paragraph quoted above from his Final Action.
In the above passage the examiner was responding to Applicant's
argument that the divisional application should be allowed with claims
of "equivalent" scope to those allowed and issued to patent in the
parent case. The examiner thus made it plain that his objection is
based on the relationship between the claims and disclosure of this
divisional application, and not on a relationship between the claims of
this application and the specification of the parent case.
The Board would like to point out that Section 38(3) says, in part:
Such divisional applications shall be deemed to be
separate and distinct applications under this Act,
to which the provisions thereof apply as fully as
may be...
Since the provisions of the Act apply to this divisional "as fully as
may be" the Board considers that this specification must meet the
provisions of the Act independently, without relying on the parent case
for information contained in the parent but not present in the
divisional application. The Board is therefore of the opinion that
Applicant's argument based on what has been allowed in the parent case
and what is an "equivalent" claim in this case has no bearing on the
question of what should be allowed in this divisional application.
During the prosecution, Applicant argued that a sound prediction can be
made that a person skilled in the art would be able to convert all the
intermediates into the final products claimed in the parent case. The
examiner has not disputed the soundness of this prediction. He has,
however, maintained that useful pharmacological activity, on which
invention is predicated, either for the compounds in their own right as
medicinals or as intermediates for other medicinal compounds, cannot be
predicted for the number of compounds claimed from the few that have
been disclosed. To meet this objection, Applicant has argued for what
he calls the "dual utility" of these intermediates. On one hand they
are medicinal compounds but on the other hand they are simply chemical
entities prepared on the route to the final products, and as such their
predictability is greater than it would be in the difficult-to-predict
medicinal arts.
The Board has no doubt after reading pages 1, 2 and 3 of this
disclosure that the substances defined by general formula (XII) are
prepared by chemical processes and that the ultimate utility of the new
intermediate compounds is clearly, directly or indirectly, dependent on
medicinal properties. We do not agree, therefore, with Applicant's
argument for a "dual utility" that should cause these compounds to be
viewed as medicinal subject matter in one light but as mere chemical
entities in another. We think that these intermediates are firmly in
the area of compounds intended for medicine as envisaged by the Patent
Act.
In Monsanto Company v. The Commissioner of Patents (1979) S.C.R. at
1121, the Supreme Court said:
In my opinion the Commissioner cannot refuse a
patent because the inventor has not fully tested
and proved it in all its claimed applications.
This has since been elaborated by the recent decision in Ciba-Geigy v.
Commissioner of Patents, Federal Court, Hay 28, 1982. With these cases
in mind, the Board is of the opinion that the examiner's requirement
that the claims be restricted to what Applicant has exemplified goes
too far and should not be upheld by the Commissioner. The examiner
would also restrict the claims to what he considers to be adequately
disclosed, in fact the examiner has linked the objections of inadequate
disclosure and exemplification together. The Board notes that the
compounds are defined in exactly the same terms, or in the case of X in
narrower terms, in the claims as in the disclosure and, consequently,
we think the claimed subject matter has in fact been disclosed. Since
the general formula (XII) and its associated definitions are sufficient
to identify the subject matter claimed and disclosed, the Board
considers that what is being claimed has also been "adequately"
disclosed or, in patent jargon, the claims are supported by the
disclosure. We recommend therefore that the requirements made by the
examiner based on inadequacy of disclosure and exemplification should
not be upheld.
The question of how broadly claims may be drawn in terms of chemical
classes, where actual preparation and testing is necessarily limited,
by practical considerations, to certain members of the classes and
consequently physical data are not available for all the compounds
covered by the claims is a difficult one to resolve. It has been
examined many times by the courts. See for example Hoechst v. Gilbert,
(1966) S.C.R. 189, where the Supreme Court adopted the view that no one
may obtain a valid patent for an unproved and untested hypothesis in an
uncharted field; or B.V.D. v. Canadian Celanese, (1936) Ex. C.R. 139,
and 1937 S.C.R. 221 where the courts spoke about claims going beyond
the invention. In Boehringer Sohn v. Bell Craig, (1962) Ex. C.R. 339,
it was said that an inventor cannot patent more than he has invented
and in Rh“ne Poulenc v. Gilbert, claims were held invalid because
substances claimed had never been made or tested. It is thus clear
that there are limits to what may be claimed as the invention in any
particular case. Even in Monsanto, which Applicant has cited, where
the Commissioner was directed to allow an application to issue to
patent for a group of compounds, not all of which had been prepared or
tested, the Supreme Court would not go beyond a "reasonably sound"
prediction into the area of speculation.
Notwithstanding the Monsanto case where it was said:
...what is meant by a "sound prediction". It
cannot mean a certainty since it does not exclude
all risk that some of the area covered may prove
devoid of utility.
and also:
...the Board, in spite of a complete absence of any
evidence of unsoundness of the prediction, deny the
claims and would in the end limit them to the area
of proven utility instead of allowing them to the
extent of predicted utility. In my view this is
contrary to S. 42 of the Patent Act.
the courts have, on several occasions, cautioned against overclaiming.
See, for example, Gilbert v. Sandoz, 64 C.P.R. 37,
Indeed one may even be disposed to wonder why such
blatant assertions of the usefulness of large
classes of substances, most of which obviously have
never been made, should appear in patent
specifications or why applications for patents
based on such wild assertions are not rejected out
of hand as being palpably false.
and also Farbwerhe Hoechst v. The Commissioner of Patents, (1966) Ex.
C.R.
Applicants...deliberately set out to monopolize
what was for the most part an unexplored field of
organic chemistry so as to prevent others during
the life of the patent from exercising their right
to search in that field for... new substances.
Neither of these cautionary statements appears to be a fair comment on
this application. The Board takes the view that the definitions of the
substituents on rings A and B in formula (XII) are acceptable. They appear
to us to cover the usual, simple substituents commonly included in patent
specifications to cautiously embrace closely related compounds and, since
we cannot say they are obviously false, we regard them as unobjectionable.
We have some doubt about the definitions of X to include nitrogen and
sulphur as hetero atoms even though such compounds are disclosed. These
definitions may cover more than a single class of compounds and may be thought
to cover several classes but, in the absence of any evidence that nitrogen
and sulphur heterocycles lack utility, we are prepared to give the benefit
of the doubt to Applicant.
Accordingly, the Board recommends that the Commissioner finds proposed
claims 1 to 5, 13 and 14 allowable in principle.
G. A. Asher A. McDonough
Chairman Member
Patent Appeal Board, Canada
I have reviewed the prosecution of this application and concur with the
reasoning and findings of the Board. Accordingly, I direct that prosecution
should be resumed on the basis of the amended specification.
J.H.A. Gariepy
Commissioner of Patents
Dated at Hull, Quebec
this 12th. day of November, 1982
Agent for Applicant
Fetherstonhaugh & Co.
Box 299, Station D
Ottawa, Ont.
K1P 5Y6