COMMISSIONER'S DECISION
UTILITY - Non support in disclosure.
The application was refused under Section 36 for insufficient disclosure of
utility. An amendment to overcome that objection, with an amplified
utility, was refused under Rule 52. The amendment was entered as not contra-
vening Rule 52.
Final Action - Reversed
***************
This decision deals with a request for review by the Commissioner of
Patents of the Examiner's Final Action dated February 24, 1976, on
application 139,256 (Class 260-238.60). The application was filed on
April 7, 1972, in the name of Minoru Shindo et al, and is entitled
"1,4,5 - Benzotriazocine Derivatives And Process For The Production
Thereof." The Patent Appeal Board conducted a Hearing on November 17,
1976, at which Mr. K.P. Murphy represented the applicant.
The present invention is directed to novel 1,4,5 benzotriazocine derivat-
ives and their preparation which compounds possess an action upon the
central nervous system and are consequently of use in the medicinal
field.
In the Final Action the examiner refused the application because the spe-
cification does not meet the requirements of Section 36(1) with respect
to the "description of utility." The examiner also refused to enter a
proposed amendment under Rule 52 of the Patent Rules because he considered
it to be new matter. No objection was made to the claims.
In that action the examiner stated (in part):
The rejection of this application is maintained as the
specification does not meet the requirements of Section
36(1) of the Patent Act with respect to the description
of the utility.
In order to meet the criteria of Section 2(d) of the Patent
Act the description of the invention and its operation must
satisfy the requirements of Section 36(1) of the same Act.
"The description of the invention must also be full; this means
that its ambit must be defined, for nothing that has not been
described may be validly claimed. The description must give
all information that is necessary for successful operation or
use of the invention, without leaving such result to the chance
of successful experiment". (See: Minerals Separation vs.
Noranda Mines, 1947 Ex. C.R. at 316-317).
The disclosure of this application fails to satisfy the requirements
of a disclosure as set forth above in regard to the utility of
the compounds claimed. It does not give all information that is
necessary for successful use of these compounds without leaving
such result to the chance of further and successful experiment.
There are no measurable and quantitative data about utilizable
properties in terms which constitute useful and most needed
information for a man skilled in the art in order to avoid such
experiments as this applicant carried out.
The applicant's arguments have been considered. However, they
cannot be accepted for the following reasons.
At first, for the patentability of organic-chemical compounds
both the structure and the utility must be considered as
inseparable.
Secondly, there are not two compounds, no matter how closely
structurally related they may be, which have the same specific
utilizable properties (especially bio-properties).
Therefore, the description of the structure and the processes,
without the description of the utility, is not adequate to
render the application in conformity with Section 36(1) of
the Patent Act. It is even less adequate if the compounds of the
same basic structure are already known in the art. Therefore,
the applicant's arguments on page 2 of the letter of May 6, 1975
are not acceptable.
The above statements are based on the well accepted fact that
the utilizable properties render the compound patentable, and
the fact that bio-properties (especially specific properties) are not
predictable. Consequently, the utility, as the only unpredictable
feature may give the new compound the attributes of "unobvious"
and "patentable". The preparation of similar compounds (similar
to the already known) does not represent more than imitation.
The processes (generally and without the indication to the contrary)
are known or are considered as the exercise of a professional skill.
Neither imitation nor performance of a professional skill could
be considered as patentable invention.
The applicant in his response to the Final Action argued that the original
statement of utility is quite adequate to meet the requirements of Section
36(1) of the Patent Act since it quite clearly indicates to those in the
art, to whom the specification is directed, the field in which the novel
compounds of the invention are active. Furthermore, it is his position
that in any event the disclosure can be amended to amplify the description
of the utility to include data in support of the utility which was known
to him prior to the filing date of the present application. He further
explained his position with respect to the following:
1) The decision of the Exchequer Court of Canada in Jules R.
Gilbert Ltd. v Sandoz Patent Ltd. reported in 64 CPR 14; and
2) the provisions of Rule 52 and Section 50(1).
On the above points he stated (in part):
The disclosure [in Sandoz] refers to an invention in a class
of new phenothiazine derivatives, although all the claims in
the patent are in fact restricted to a single compound which
is known as thiorizadine and its salts.
In the specification of the Sandoz patent as originally filed
the only support of the utility of the phenothiazine derivatives are
the statements which appear in the sentence at page 4, lines 13
to 16, and page 4a, line 10 to page 5, line 12, of the granted
patent. The latter description relates to a fungicidal action
of the compounds.
In the decision of the Exchequer Court invention in the novel
compound thiorizadine was upheld on the basis of its therapeutical
utility as a neuroleptic drug accompanied by extremely weak extra-
pyramidal effects. Compounds similar to thiorizadine were known
to have neuroleptic properties and in particular the compound
chloropromazine was in use as a neuroleptic drug. The significant
advantage of thiorizadine over chloropromazine was that thiorizadine had
much reduced extra-pyramidal effects which effects were a problem
in using chloropromazine.
In the decision of the Court it was recognized that it was this
superior utility of thiorizadine which made it inventive over the
known structurally related and neuroleptically active compound
chloropromazine. In this respect reference is made to page 39 of the
decision wherein Thurlow J. commented ".... that is to say, its
extremely low extra-pyramidal effects which is what gives the discovery
of the utility of the substance a character of a patentable
invention". And further at page 40 of the decision "....and that fact
in itself, in the circumstances as described in evidence, not only
distinguishes thiorizadine from other members of the class but
gives the discovery the character of a separate invention and, secondly,
because the invention of thiorizadine having been a valuable
contribution to the art and having been in fact disclosed by the
specification and claimed, a construction of the specification which
will give effect to the patent, should, I think, be preferred to
one the result of which would be to destroy it."
...
The portion of the disclosure of Canadian patent 779,890 which
more fully describes the medicinal utility of thiorizadine and
which identifies the extremely weak extra-pyramidal activity
of thiorizadine was in fact introduced into the disclosure of the
Sandoz application some ten years after the filing date of the
Sandoz application. For convenience the all important description
of utility which was introduced into the Sandoz specification
ten years after filing has been encircled in red ink.
It is to be emphasized that this statement of utility introduced
into the Sandoz specification is vital to the validity of the
Sandoz patent since it establishes the particular significance
and utility of thiorizadine in comparison with the larger class
of compounds and previously known neuroleptic agents.
Furthermore it is to be noted that the Court specifically approved
the introduction of the statement of utility into the Sandoz
specification and considered that it was not contrary to Rule 52
of the Patent Rules. In this respect reference is made to page 40
of the decision wherein Thurlow J. stated -
"Nor do I think the scope of a Rule invoked
by the Applicant to amend the specification before
the grant of the patent so as to insert the sentence
above referred to and other sentences relating to
the utility of the substances of the class can be
invoked to give the specification as amended a differ-
ent interpretation from that which considered as a whole
it bears."
The reference here to "a Rule" is a reference to Rule 52 of the
Patent Rules.
Clearly the Court considered that the introduction of the specific
statement of utility into the pending application did not contravene
Rule 52 of the Patent Rules and the validity of the claims to the
thiorizadine based on this utility was upheld.
...
Reference is made to Section 50(1) of the Patent Act which
provides for re-issue of any patent which is deemed to be de-
fective or inoperative by reason of insufficient description
or specification where the error arose from some inadvertence,
accident or mistake without any fraudulent or deceptive
intention. Thus, the Statute provides authority for correction
of an alleged defect of draftsmanship in an issued patent. It
would seem that if the patent on the present application was
issued (without the amplified description of the utility) that
Applicant would be permitted to re-issue the patent to more fully
describe the utility if this was considered necessary in order
to render the patent effective. It would seem that an amendment
permitted by the Statute to correct a possible defect after
issue of a patent should equally be permissible during the
pendency of the application and that any other conclusion would
be illogical.
The disclosure of the application describes the novel compounds and their
preparation in some detail and in particular by reference to thirty-five
detailed major examples and some fifty-two subsidiary examples. In all of
these examples the novel compounds of the invention are fully characterized
by reference to their physical properties.
The original disclosure included the following statement (at page 6):
The compounds represented by general formula (I) are
invariably novel compounds which, by virtue of their
action upon the central nervous system, are of use as
medicines.
It is the object of this invention to provide compounds
which, as aforesaid, are new and useful as medicines.
The 1, 4, 5 benzotriazocine derivatives are represented by formula (1)
as follows:
<IMG>
wherein X is hydrogen, halogen or lower alkyl; R1 is hydrogen
or lower alkyl; R" is hydrogen, -COCH2Y or -COCH2A, where Y is
halogen, and A is a nitrogen atom to which two or three of R1,
R2 and R3 are attached and which, when R1, R2 and R3 are attached,
carries an anion; R1, R2 and R3 are the same or different and
each is selected from hydrogen, lower alkyl, lower alkenyl, phenyl,
phenyl-amino and phenyl-lower alkyl; said phenyl and phenyl-lower
alkyl being unsubstituted or substituted by one or two substituents
selected from lower alkyl, lower alkoxy and halogen, or 2 or 3
of R1, R2 and R3 being taken together, represent a polymethylene
group of 4 to 6 carbon atoms which may have one to four hetero-
atoms selected from oxygen and nitrogen therebetween.
After the application was refused for failing to meet the requirements of
Section 36(1) with respect to the description of utility, the applicant
proposed the following amendment to the disclosure:
The derivatives of formula (I) are novel compounds which possess
activities for depression of the central nervous system, more
particularly an action for prolonging sleeping time, analgesic
activity and sedative activity and are of use in the medicinal
field. It is thus an object of this invention to provide
derivatives of formula (I) which, as aforesaid, are new and
useful in the field of medicine.
The proposed amendment was then refused by the examiner under Rule 52 of
the Patent Rules, because it is considered in his view to be "new matter."
We have considered with care the prosecution of this application and the
arguments ably presented at the Hearing by Mr. Murphy.
The broad issue to be reviewed is whether the specification meets the
requirements of Section 36(1) with respect to the description of utility.
The more specific and initial question which we will consider however, is
whether the proposed amendment, with an amplified description of utility,
would be considered as contravening Rule 52 of the Patent Rules. The
reason for looking at the proposed amendment first is we feel that, if accep-
ted, it would give more effective information on how the results of the
invention are accomplished which would be beneficial to the public (see
Section 36 - operation or use). Further, if the amendment is acceptable the
broad issue, referred to above, will not have to be considered.
Rule 52 of the Patent Rules reads as follows:
No amendment to the disclosure shall be permitted
that describes matter not shown in the drawings or
reasonably to be inferred from the specification as
originally filed, and no amendment to the drawings
shall be permitted that adds thereto matter not
described in the disclosure.
Rule 52 must necessarily take into consideration the import and content of
Rules 53 to 57 as a whole. For example, Rule 53 relates to "subject matter"
warranting a new filing date as capable of supporting new claims which are
not fairly based on the original disclosure alone. We think the key words
in Rule 52 are "reasonably to be inferred." Webster (second edition) gives
the meaning of infer: "To derive by reasoning or implication; to conclude
from facts or premises...."
Rule 52 does not "countenance" admission of subject matter to complete an
invention (except as it qualifies under Rules 52 and 53). This however must
be distinguished from the expansion of ancillary description and technical
matters relating to "operation or use," which is reasonably to be inferred.
Amendments may be made to a disclosure before an application is issued to
patent, or in the case of a reissue patent Section 50(1) an applicant may
"amend the description and specification" within four years if a "patent is
deemed defective or inoperative by reason of insufficient description or
specification". It is trite laic that the insufficient description referred
to can be made accountable to imperfections of draftmanship. We must also
keep in mind that in Minerals Separation v Noranda, (1947) Ex. C.R. 306 at
316 a distinction was made between imperfection of draftmanship and non-
compliance of statutory requirements.
The specific question then is whether the amplified utility, in the proposed
amendment can reasonably be inferred (derived by reasoning or implication)
from the specification as filed.
It is of interest to note that the examiner is satisfied that the reference
to "the amplified utility in the proposed amendment is in the expected area
of such original utility." It is the applicant's position that "the man
skilled in the art to whom the specification is directed would appreciate
the nature of the utility of the derivatives described in view of the
statements in the disclosure indicating that the derivatives were of use as
medicines by virtue of their acticn upon the central nervous system."
Of pertinence to this decision is the rationale of the court in Gilbert v.
Sandoz, supra. In that case, an amendment was introduced after the filing of
the application which related to an amplified utility. On this point Thurlow
J. (at page 40) stated:
... the invention of thioridazine having been a valuable
contribution to the art and having been in fact disclosed
by the specification and claimed, a construction of the
specification which will give effect to the patent should,
I think, be preferred to one the result of which would be
to destroy it. (Vide: Kellock, J., in Wandscheer et al
v. Sicard Ltd., (1948) S.C.R. 1 at p. 17.)
Nor do I think the scope of a rule [Rule 52] invoked by the
applicants to amend the specification before the grant of
the patent so as to insert the sentence respecting the
extremely low extra-pyromedal effects of thiaxidazine above
referred to and other sentences relating to the utility of
the substance of the class can be invoked to give to the
specification as amended a different interpretation from
that which considered as a whole it bears. (emphasis added]
For convenience we will repeat the utility as presented in the application
as filed:
The compounds represented by general formula (1) are inva-
riably novel compounds which, by virtue of their action upon
the central nervous system, are of use as medicines.
It is the object of this invention to provide compounds
which, as aforesaid, are new and useful as medicines.
The proposed amendment to amplify the utility reads as follows:
The derivatives of formula (1) are novel compounds which
possess activities for depression of the central nervous
system, more particularly an action for prolonging sleeping
time, analgesic activity and sedative activity and are of
use in the medicinal field. It is thus an object of this
invention to provide derivatives of formula (1) which, as
aforesaid, are new and useful in the field of medicine.
In the first examiner's action it was indicated that there should have been
disclosed (at least) the nature of the CNS action (e. g. anaesthetics, anticon-
vulsants, analgesics....) and the field of treatment (e.g. psychoses, anxiety...")
This was considered by the examiner as minimum necessary for the disclosure
of utility since it was known that structurally similar compounds (benzo-
diazepines, benzotriazocines) were known to possess CNS activity properties,
i.e. the basic structure as a potential carrier of the basic (CNS) properties
were known.
The amplified utility more fully describes the medicinal use of the novel
compounds. We are satisfied, and the examiner agrees, that the proposed
amendment would satisfy the nature of the CNS action and gives a more
specific field of treatment as indicated in the first examiner's action.
Of interest it is clear, from the record, that the amplified utility, as
stated in the proposed amendment, was clearly known to the applicant prior
to the filing date of the present application. This was covered by affidavit
and the fact that a similar amplified disclosure was present in the United
States application which was filed almost of even date with the present
application. The point of this of course is to merely indicate that there
is no consideration of the proposed amendment relating to matter which was
discovered after the filing date of this application.
In considering this case we have been influenced by two factors. First, the
examiner is satisfied that the reference to "the amplified utility in the pro-
posed amendment is in the expected area of such original utility;" and
secondly, that "it was known that structurally similar compounds (benzodiazepines,
benzotriazocines) were known to possess CNS activity properties." Having
that in mind we have come to the conclusion that the utility of the novel
compounds are, in the present circumstances, reasonable to be inferred from
the original disclosure, and that the application could proceed on that disclosure.
The disclosure however, would be improved by the amplified utility in the proposed
amemdment.
In view of the above consideration we are constrained to conclude that the
applicant should be permitted to amend the disclosure to introduce the additional
data in order to more fully comply with the requirement that, "when the period
of monopoly has expired the public will be able, having only the specification,
to make the same successful use of the invention as the inventor could at the
time of his application." (vide, Mineral Separation v Noranda, supra) It is
our opinion that it falls under the heading of imperfection of draftmanship
rather than non-compliance of statutory requirements.
In summary, we are satisfied that the scope of the rule used by the appli-
cants in an attempt to amend the disclosure relating to the amplified utility
of the substance, as indicated, can not be invoked to give to the specification
as amended a different interpretation from that which considered as a whole
it bears (see Gilbert v Sandoz, supra).
We recommend that the decision in the Final Action to refuse the application
be withdrawn and that the proposed amendment be accepted.
J.F. Hughes
Acting Chairman
Patent Appeal Board, Canada
I have studied the prosecution of this application and have carefully reviewed
the recommendations of the Patent Appeal Board. In the circumstances I with-
draw the Final Action and will accept the amendment to the disclosure. The
application is returned to the examiner for resumption of prosecution.
J.H.A. Gariepy
Commissioner of Patents
Dated at Hull, Quebec
this 20th. day of June, 1977
Agent for Applicant
Alan Swabey & Co.
625 President Kennedy Ave.
Montreal 111, Quebec