COMMISSIONER'S DECISION
Support for broad claim in disclosure - Sec. 36
The broad claims, which relate to pharmacologically active compounds, were
refused because no single compound corresponding to the eight radicals
under rejection is fully described and characterized in the disclosure.
Narrower claims would be supported, and allowable.
Final Action - Affirmed
*****************
This decision deals with a request for review by the Commissioner of
Patents of the Examiner's Final Action dated December 1, 1975, on
application 177,408 (Class 260-2391.4). The application was filed on
July 26, 1973, an the name of Graham Durant et al, and is entitled
"Cyanoguanidines." The Patent Appeal Board conducted a Hearing on
June 24, 1977, at which Mr. W. Mace represented the applicant.
Also in attendance was the British Patent Agent, Dr. R.A.A. Hurst.
The application relates to pharmacologically active compounds, in
particular to pharmacologically active cyanoguanidines, to pharma-
ceutical compositions comprising these compounds and to processes
for their preparation.
In the Final Action claims 1 and 14 were rejected in their present form.
The reason for such rejection is the presence in the definition of "Het"
of eight radicals which define eight classes of compounds of which
no representative individual is described in the disclosure. In that
action the examiner also stated (in part) as follows:
...
The radicals are oxazole, isoxazole, pyrazole, triazole,
thiadiazole, pyrimidine, pyrazine and pyridazine.
The standards of description of synthesis of organic
chemical compounds have been established for more than one
hundred years. As a result, organic chemistry is one
of fields, where the norms governing the conditions of
full disclosure ream red by the Patent System, are the best
known, the clearest and the simplest.
The text to which applicants refer in order to include the
eight rejected classes of compound. in claims 1 and 14 does
not describe claimable subject matter, in the light of the
relevant Canadian jurisprudence, a sample of which is
provided in the Manual of Patent Office Practice, chapter 9.
The compounds covered by the radicals under rejection are
not fully characterized and their utility may merely be
suggested on the basis of their structural relationship
with the compounds actually described. This does not meet,
even closely, the stringent tests defined in the pertinent
jurisprudence, especially in the unpredictable field of
therapeutic activity.
And the Vidal dilemma, adopted in Canada, for instance in
the Rhone-Poulenc case, is fully pertinent: if applicants
know more about the 8 classes of compounds than they disclose,
they have not complied with the statute regarding full
description: on the other hand if applicants know no more
than the disclosure teaches, they are claiming an invention
which was not made.
In response to the Final Action the applicant had this to say (in part)
as follows:
...
Applicant respectfully submits that there is no statutory
requirement that all compounds set forth in the specifica-
tion must include full physical characteristics nor is
there any statutory requirement that each and every compound
disclosed be fully tested. In applicant's opinion the
specification and particularly the radicals objected to
by the Examiner meet fully the requirements of Section 36(1)
of the Patent Act which provides that the specification
shall correctly and fully describe the invention and
its operation or use "as contemplated by the inventor" -
it is respectfully pointed out that Section 36(1) does not
require the inventor to specifically disclose what was
actually done by the inventor. It is respectfully sub-
mitted that if the inventor "contemplated" the various
radicals within the scope or his invention, he then has
a positive duty to disclose such radicals in view that
he contemplated their use. If for example, the inventor
contemplated the radical imidazole but did not specify such
in his disclosure would he have complied with the require-
ments of the Patent Act if later testing showed such
radical to be the "best mode"? It is thus a requirement
on the part of the applicant to disclose all which is
contemplated and based on such disclosure applicant should
be entitled to frame claims of a similar nature.
Applicant respectfully submits that all of the require-
ments of the Patent Act have been met, both in the present
disclosure and with respect to claims 1 and 14 on file
rejected by the Examiner. It is submitted that Section
36(1) of the Patent Act has been met in that applicant
has, in the specification, described the invention as
contemplated by the inventor and with the presence of the
various examples in the disclosure including example 16
has set forth clearly the sequential steps of the process
for making various compounds. It is further submitted
that the requirements of Section 36(2) of the Patent Act
have been fully met with respect to claims 1 and 14 in that
both claim 1 and claim 14 do state distinctly and in ex-
plicit terms the things or combinations which the applicant
regards as new. It is further submitted that applicant
has complied with the requirements of Section 2 with
respect to the definition of "invention" in disclosing
new and useful compositions of matter. In addition all of
the requirements of Section 28 of the Patent Act have been
met as applicant believes that the inventor specified is
the first inventor of the subject matter under consider-
ation, the subject matter including the subject of claims
l and 14. The jurisprudence indicated by the Examiner has
been reviewed however such is not deemed to be either
pertinent or applicable to the present circumstances. It is
applicant's firm belief that if the teachings of the
instant application are followed such will result in com-
pounds all of which have the same utility. If by some remote
chance unknown to the applicant some compounds are later
fond not to have the required utility the validity of
claims covering such compounds may be in doubt. As previously
discussed applicant is willing to accept this consequence
and as applicant has previously stated all of the compounds
disclosed and defined by claims 1 and 14 are believed to
possess the disclosed utility.
The issue to be considered is whether or not claims 1 and 14 are support-
ed by the disclosure. We have carefully studied the prosecution of this
application and the remark made at the Hearing by Mr. Mace and Dr. Hurst.
Claim 1 reads as follows:
A process for the production of a compound of the formula
(see formula I)
wherein R1 is hydrogen or lower alkyl; and R2 is a grouping of
the structure
Het - (CH2)m Z(CH2)n -
wherein Het is a nitrogen containing 5 or 6 membered hetero-
cyclic ring selected from imidazole, pyridine, thiazole,
isothiazole, oxazole, isoxazole, pyrazole, triazole, thiadiazole,
pyrimident, pyrazine and pyridazine which ring may optionally
he substituted by lower alkyl, trifluoromethyl, hydroxyl,
halogen or amino; Z is sulphur, oxygen, N.H. or a methylene
group; and m and n are integers from o to 4 such that their sum
is from 2 to 4; in which an amine of the formula
R2NH2
wherein R2 has the above significance is reacted with a
compound of the formula
(R3-Y)2C=N-CN
wherein R2 has the above significance is reacted with a com-
pound of the formula
(R3-Y)2C-N-CN
wherein R3 is alkyl, aryl or aralkyl and Y is sulphur or
oxygen to give an intermediate compound of the formula
(see formula I)
wherein R2, R3 and Y have the above significance which inter-
mediate compound is then reacted with an amine of the formula
R1NH2
wherein R1 has the above significance.
We have no quarrel with the jurisprudence (which was discussed at the
Hearing) with reference to the requirement of a disclosure as outlined
by Thorson P. in Noranda Mines v Mineral Separation C.P.R. 99 - volume 12;
nor with the statements, re utility, taken from Boehringer Sohn v
Bell Craig (1963) S.C.R. 410.
To the jurisprudence relied upon by the applicant we add the recent find-
ings of the Supreme Court of Canada in Burton Parsons Chemicals v. Hewlett-
Packard, which has been reported in 17 C.P.R. (2d) Part 2, April 1975,
97 ff. In considering whether the claims of Burton Parsons were broader
than the invention, Mr. Justice Pigeon stressed that:
While the construction of a patent is for the Court, like
that of any other legal document, it is however to be done
on the basis that the addressee is a man skilled in the art,
and the knowledge such a man is expected to possess is to
be taken into consideration (p. 104).
and further
The evidence makes it clear that this was obvious to any
person skilled in the art because the characteristics of
suitable emulsions and of suitable salts were well known.
From this it is clear that due consideration must be given to what persons
skilled in the art would take from a disclosure.
The objection that a claim is too broad in view of the disclosure because
it covers unknown and uncharted areas where the applicability of the
invention is unpredictable arises most frequently in the chemical arts.
Since claims are defective if they are speculative, there are important
limitations upon an inventor's right to claim a generalization from his
disclosure. Such claims, if allowed, may create needless litigation with
useless expense and impede the true progress of the arts. We are more con-
corned by what was done by the inventor rather than statements of what
may be done with the invention. We now turn to the jurisprudence which
examines such issues.
In Hoechst v. Gilbert, (1966) S.C.R. 189, a chemical case where certain
drugs were claimed, the Supreme Court of Canada has come out (at p. 194)
against overclaiming in these terms:
In challenging the validity of the patents in question,
counsel for the respondents put his case upon the footing
that no one could obtain a valid patent for an improved and
untested hypothesis in an unchartered field. That is what
the appellant has tried to do in claim 1 of each of the patents.
It has sought to cover, in the words of Thurlow J., "every
mathematically conceivable sulphonyl area of the class" and
has consequently overclaimed, and, in so doing, invalidated
claim 1 in each patent.
The point has also been considered in Rhone-Poulenc v Gilbert (1968)
S.C.R. 950 at 953.
In Steel Co. of Canada v. Sivaco Wire and Nail, 11 C.P.R. (2d) 153 at 195,
we find the term "mere paper suggestions" applied to patents for inventions
which have not been developed.
In B.V.D. v Canadian Celanese (1936) Ex. C.R. 139 at 148 it was stated that
before a prior patent may be relied upon to anticipate a later patent. "It
must be shown that the public have been so presented with the invention
that it is out of the power of any subsequent person to claim the invention
as his own. And an improvement, claimed to be invention, must not be
dismissed as unpatentable merely because of some vague adumbration of it
in the prior art." It seems to us that a corollary of that, which should
be equally valid, is that a prior patentee should not be entitled to claim
an invention which he may have outlined or foreshadowed without bringing it
into being. The Supreme Court (1936 S.C.R. 221 at 237) found the B.V.D.
patent invalid because: "The claims in fact go far beyond the invention."
In Boehringer Sohn v Bell Craig, 1962 Ex. C.R. 201 we find:
.., a patent purporting to give an exclusive property in more
than the inventor has invented is also contrary to what the
statute authorizes....(p.239)
and
...a patent which includes in its specification a claim which
claims more than the inventor has invented purports to grant
an exclusive property in more than the inventor has invented and
at least in so far as that claim is concerned the patent, in my
opinion, is not granted under the authority of the statute and
is therefore not lawfully obtained. ...a claim which is invalid
because it claims more than the inventor invented is an outlaw
and its existence as defining the grant of a property right is
not to be recognized as having any validity or effect (p.241).
Mr. Justice Thurlow found the claim in suit to be too broad because it
covered a large number of substances of which only a limited number had
been prepared. The Supreme Court (1963 S.C.R. 410 at 412) supported his
findings. The Boehringer Sohn case did involve, of course, pharmacological
substances whose properties may be even less predictable than other
chemical substances, and the group of compounds claimed was extremely large.
Similar conclusions in comparable circumstances were reached in Hoechst
v. Gilbert (1965) vol. 1, Ex. C.R. 710 and 1966 S.C.R. 189 and in
Re May and Baker (1948) 65 R.P.C. 255, (1949) 66 RPC 8 and (1950) 67 R.P.C. 23
The Supreme Court, in the Hoechst decision, adopted the view that
"no one could obtain a valid patent for an unproved and untested hypothesis
in an unchartered field." The dangers of overclaiming were also explored
an Socic‚t‚ Rh“ne-Poulenc v Ciba (1967) 35 F.P.C. 174, at 201-205 and
1968 S.C.R. 950 in which a broad claim was found invalid because the
majority of the substances of the class had never been made or tested. by
anyone.
Objections of this nature are not, however, limited to pharmaceutical inven-
tions, or even to chemical inventions. In the Matter of Abraham Esau et al
(1936) 49 R.P.C. 85, it was said of an electrical apparatus that:
I think that it is most desirable that patentees in such
circumstances should realize that it is not the practice
of the Patent Office to allow broad and indeterminate
claims of a speculative character, and that if they put such
claims into their complete specification, they must expect
to find them disallowed unless they are able to give a
sufficiently detailed and full description to support. them.
See also Rohm & Haas v. Commissioner of Patents, (1959) Ex. C.R. 153 where
claims were refused for being too broad and going beyond the invention made,
Vidal Dyes v. Levenstein (1912) 29 R.P.C. 245, and Eastman Kodak's Application
(1970) R.P.C. 548 at 561-563.
The problem before us is not peculiar to Canadian or British jurisprudence.
It has been considered, for example, in In re Stokal et al, 113 USPQ 283(1957).
We will now consider claim 1. It is clear that each variation or radical of
Het represents a class and there are twelve such representations. We find
however, that no single compound corresponding to the eight radicals under
rejection is fully described and characterized in the disclosure (eight of the
twelve radicals in claim 1 were refused). On this point at the Hearing, Mr. Mace
pointed out that the present disclosure "provides a teaching as represent-
ed by Example 16 to which one skilled in the art can readily carry out [the
invention]." Example 16 lists 13 compounds, introducing 8 different hetero-
cyclics which are then added to the claims as valves for Het. Mr. Mace
went on to say that "It is thus submitted that there is sufficient
teaching in Example 16 to meet the standards of description of synthesis
of organic chemical compounds and that the compounds outlines by Example 16
may be readily prepared." The specific question which must be answered
is whether or not the text designated as Example 16 is sufficient to satisfy
the requirements of Section 36(1) of the Patent Act.
Before reaching our conclusions we think it also appropriate to refer to
a recent British decision, Olin Matheson v. Biorex (1970) RPC 157, and in
particular to two passages, the first of which is taken from the arguments
for the patentee, at p. 169:
Inevitably in a case of this kind broad claims will be open
to attack, but the question is whether the inventor ought
to be limited to the actual substances which he has tested, and
if he be entitled to venture a little further, how much
further? If he were restricted to substances actually
tested the value of the patent would be nil because the
patentee would be making a present to those who would wish to
avail themselves of the start made by him and thereby develop
improvements upon his tested materials with impunity.
Additionally, if the patentee was not entitled to claim more
than what he had tested and verified as being useful, there
would be no basis for selection patents. The other
important point is that there is a world of difference
between making a very broad claim in an unexplored field, and
making one, as is the case here, where although the claim may
cover millions of compounds, the field has been so well
explored by others that one may rely upon their work in making
a reasonable prediction as to the usefulness of all the com-
pounds within the claim. [It should be noted that the invention
involved the insertion of the CF3 radical into the 2-position
of a well known and 'well-worked' group of pre-existing compounds.]
The second is taken from the judgement itself, at page 193:
Where, then, is the line to be drawn between a claim which goes
beyond the consideration and one which equiparates with it?
In my judgement this line was drawn properly by Sir Lionel when he
very helpfully stated in the words quoted above that it
depended upon whether it was possible to make a sound
prediction. If it is possible for the patentee to make
a sound prediction and to frame a claim which does not
go beyond the limits within which the prediction remains
sound, then he is entitled to do so [emphasis added],
This last paragraph puts succinctly what we have been able to distil from
the jurisprudence discussed above. An applicant, in our view, should be
able to put forward a claim in generic terms to a group of like substances,
all of which need not have been prepared or tested, where it would be
reasonably able and sound to make a prediction about the area covered.
A recent Canadian case is also very much to the point - Monsanto v
Commissioner of Patents in the Federal Court (June 24, 1977) were Heald J.
had this to say on a case which was concerned with broad claims where there
was lack of support in the disclosure.
We are all of the opinion that the Commissioner of Patents
did not err in affirming the refusal of a patent in respect
of Claims 9 and 16 in the appellant's application. The
refusal is justified on the ground alone that the dis-
closure in the appellant's application is not sufficient
to support the claim to such a broad range of new compounds.
We would refer to the reasoning of Jackett, C.J. in the case
of Leithiser v. Pengo Hydra-Pull of Canada Ltd. 17 C.P,R. (2d)
110 to the effect that full and explicit compliance with
section 36(1) of the Patent Act requires a specification that
tells all the world what the invention is and how to make use of
it and also describes how to produce the product for which
an invention is claimed. Claim 9 covers a vast number of
compounds. Claim 16 claims, as the product of Claim 9, some
126 different specific compounds. The specifications provide details
in respect of only three of these specific compounds. A
perusal of these details makes it clear that detailed and
specific instructions (different in a number of particulars in
each case) are necessary in order for a skilled chemist to be
able to make use of the invention. Such detailed and specific
instructions are not contained in the specifications except for the three
specific compounds referred to above.
Further, the Commissioner was entitled to weigh the expert
opinion as to whether there could be a sound or reasonable pre-
diction that all the compounds would possess utility and to
arrive at a contrary judgment or opinion on the basis of the
finding and recommendation of his own advisors acting as the
Patent Appeal Board.
In applying the above principle to the application before us it is abundant-
ly clear, as mentioned, that no single compound corresponding to the
eight radicals, under rejection in claim 1, is fully described and charact-
erized in the disclosure. Example 16, lists 13 compounds, introducing eight
different heterocyclics which are then added to the claims as values for
Het. In other words the claim is extremely broad, and covers eight c~
of compounds in which no representative individual is described in the
disclosure. We think it goes beyond the area of rea~ab~ prediction ~
have no hesitation in recommending the refusal of claim 1. Claim 14 is a
product claim which is of the same scope as claim 1 and should also be
refused. The arguments used in refusing claim 1 apply equally to it.
In the Final Action the applicant stated: "If by some remote chance unknown
to the applicant some compounds are later found not to have the required
utility the validity of claims covering such compounds may be in doubt.
As previously discussed applicant is willing to accept this consequence...."
We are not overly impressed with this act of coverage, especially while
drafting narrow independent claims which are possibly immune to invalidity.
This we perceive is further evidence that the claims are speculative. An
applicant must not set out to monopolize "an unexplored field in organic
chemistry so as to prevent others during the life of the patent from
exercising their right to search in the field for new substances which might
turn out to be useful or even more useful" (see Farbwerke Hoechst v Commissioner
of Patents (1966) Ex. C.R. at page 91).
In summary, we are satisfied that claims 1 and 14 are not properly supported
by the disclosure because no single compound corresponding to the eight radicals
under rejection is fully described and characterized therein. We recommend
that the decision in the Final Action to refuse claims 1 and 14 be affirmed.
Claims 1 and 14 would however, in our view, be allowable if all the radicals
from "OXAZOLE" to "PYRIDAZINE" inclusive were deleted from the claims.
J.F. Hughes
Assistant Chairman
Patent Appeal Board, Canada
I have studied the prosecution of this application and have carefully
reviewed the recommendation of the Patent Appeal Board. In the circum-
stances I have decided to refuse claims 1 and 14 in their present form.
I will however, accept claims when amended as suggested by the Board.
The applicant has six months within which to appeal my decision under
the provision of Section 44 of the Patent Act.
J.H.A. Gariepy
Commissioner of Patents
Dated at Hull, Quebec
this 22nd day of August, 1977
Agent for Applicant
Cowling & Henderson
Box 466, Terminal A
Ottawa, Ont.
K1N 8S3