COMMISSIONER'S DECISION
NON SUPPORT IN DISCLOSURE: The application (claims 15 to 17) describes
certain polyhydroxyl-phenyl chromones, known as Silymarin I, II, III, IV.
Claims 15 to 17 were refused because no invention was described commen-
surate with the scope of claims 15 to 17. The proposed amendment
under Rule 52 was also refused because it related to new "subject
matter".
Final Action: Affirmed.
This decision deals with a request for review by the Commissioner of
Patents of the Examiner's Final Action dated March 20, 1975, on applica-
tion 053,025 (Class 260-373.3). The application was filed on May 29,
1969, in the name of Rolf Madaus, and is entitled "Method For Recovering
Polyhydroxyphenyl." The Patent Appeal Board conducted a Hearing on
November 17, 1976 at which Mr. K.P. Murphy represented the applicant.
The application described certain polyhydroxy-phenyl chromones, known as
Silymarin, which exhibit valuable pharmacological properties relating
to stabilizing of cell structure and regulation of the cell metabolism.
The claims are directed to:
a) a process for recovering polyhydroxyphenyl chromones
(claims 1 to 9);
b) polyhydroxyphenyl chromones whenever produced by the
process of claim 1 (claim 10);
c) the process of claims 1 to 7 followed by separating Silymarin II
and III from the polyhydroxyphenyl chromones (claims 11 and 12);
d) Silymarin II and III whenever produced by the process of
claims 11 and 12 respectively (claims 13 and 14); and
e) a therapeutic composition comprising a mixture of Silymarin
I, II, III and IV in association with a pharmaceutically
acceptable carrier (claims 15 to 17).
It is to be noted that Silymarin I and IV were known prior to the present
application and that Silymarin II and III are novel compounds (see applicant's
letter of April 29, 1974, page 2, lines 7 to 10). Claims 1 to 14 were found
to be allowable.
Claims 15 to 17 were rejected, and the reason for rejection is
that "the therapeutic composition claimed in claims 15 to 17, which allegedly
relates to a synergistic mixture of Silymarin I, II, III and IV in association
with a pharmaceutically acceptable carrier, is not supported by the disclosure."
In that action the examiner discussed a number of court cases which deal
with the requirements of Section 36(1) of the Patent Act. He also stated
(in part):
...
....The disclosure does not teach that the concentrate comprising
Silymarin I, II, III and IV (Silymarin I and Silymarin IV were
known prior to the present alleged invention) shows greater
activity than would be expected from the summation of the properties
of the individual Silymarins alone. There is no indication in the
disclosure of any unexpected synergism, or any details about the
operation, use of effect of the invention. Clearly Section 36(1)
is not satisfied.
...
As for evidence now presented (a copy of Applicant's accepted
German application 1,923,082, which has a different number than the two
Convention Priority applications of the present application) that
invention is in fact present, we would refer to the statement of
the President of the Exchequer Court in Riddell v Patrick Harrison
195b-60 Ex. C.R. 213 at 225:
...what has to be considered in a patent case is the
invention as described in the specification and defined
in the claims rather than that described in the evidence".
Applicant has submitted that "what is an invention in West Germany
is equally an invention in Canada". We do appreciate it, but would
like to emphasize that the requirements of an inventive step and
proper disclosure of the invention in Canada are governed by the
Canadian laws.
In his response to the Final Action the applicant argued along the following
lines:
a) the compositions defined in claims 15 to 17 are certainly
supported by the disclosure. Page 11, at lines 12 to 14,
of the disclosure discloses tablets, sugar-coated tablets
or capsules for oral therapy containing Silymarin embedded
in a carrier;
b) it would seem that the claims have been rejected for lack of
support in view of the absence of the specific term "synergism";
c) the synergism is merely the scientific explanation as to how
the advantageous pharmacological effect is achieved and is of
a scientific character;
d) there is no requirement in Section 36(1) that the applicant
provide a scientific explanation as to why his invention works
in the way it does;
e) it is believed that the language employed in the disclosure re-
ferring to surprising activity and considerably higher activity
is essentially equivalent to "synergism";
f) it is requested that the disclosure be amended to insert at page 3,
after line 27, a paragraph reading:
According to a further aspect of the invention, there is
provided a therapeutic composition comprising a mixture
of Silymarin I, II, III and IV in association with a
pharmaceutically acceptable carrier. The composition of
the invention may be conveniently formulated in the form of
a tablet or capsule for oral administration with each tablet
or capsule suitably containing a total of 35 mg of Silymarin
I, II, III and IV.
And further that the disclosure be amended at page 6b, after
line 10, to introduce the following paragraph:
The therapeutic composition of the invention comprising the
mixture of Silymarin I, II, III and IV is found to have a
greater activity than would be expected from the summation of
the properties of the individual Silymarins alone, for example,
when the pharmacological properties of the four components
of the Silymarin mixture and the mixture were investigated
on animals (mice) complete protection was obtained utilizing
150 mg/kg of Silymarin I; 250 mg/kg of Silymarin II;
150 mg/kg of Silymarin III as compared with 30 mg/kg of the
mixture of Silymarin I, II, III and IV;
g) the applicant could also introduce the table appearing in columns
5 and 6 of the applicant's corresponding West German patent
1,923,082 from which the present application claims priority under
International Convention;
h) it is believed that the introduction of this matter is permissible
under the relevant provisions of the Act and Rules as interpreted
by the Courts in Canada; and
i) in support of this view the applicant refers to Canadian Patent
779,890 to Sandoz Patents Ltd. (Jules R. Gilbert Ltd. v. Sandoz
Patents Ltd.(1970) C.P.R. Vol. 64, page 14).
We have studied with care the able and interesting arguments presented
at the Hearing by Mr. Murphy.
The question to be considered is whether or not an invention of the scope
covered by claims 15 to 17 is supported by the disclosure.. Claim 15 reads
as follows:
A therapeutic composition comprising a mixture of Silymarin
I, II, III and IV in association with a pharmaceutically
acceptable carrier.
There was considerable discussion about the term "synergism." The applicant
indicated that the application was being rejected because he had not said
the mixture was synergistic. We think, however, that the question whether
the term "synergism" was used is academic. The real issue is whether the
applicant demonstrated in his disclosure that there was a synergistic
effect in mixing the compounds.
We are satisfied that the applicant has described the utility of the mixture.
The applicant, however, argues that "the therapeutic composition of the
invention comprising the mixture of Silymarin I, II, III, and IV is found
to have a greater activity than would be expected from the summation of
the properties of the individual Silymarins alone...." At first blush we
could probably say that, if properly disclosed, the applicant has obtained
a new and unexpected result which is unobvious and inventive over the
single compounds.
The specific question is whether claims (15 to 17) to this alleged invention
are properly supported by the disclosure, and if not are the proposed amend-
ments, noted above, acceptable.
At the Hearing the question was asked by the Board "Is there a clear indication
in the disclosure that the mixture of the Silymarins is different and better
than the individual Silymarins [mixture] .... [answer by Mr. Murphy]
I am not sure if I would go that far - most of the description of the utility
is discussing the mixture itself and it says there is surprising activity -
it is not saying it is surprising as compared to one of the compounds."
And later on in the Hearing [the Board]...having read the disclosure [of
the instant application]we would not assume that there would be any advan-
tage in using the mixture over the individual compound - [answer]. "That
is a fair comment .... My disclosure - the Canadian disclosure - does not
say that the mixture of the 4 Silymarinsis more useful than any of the
individual ones in the same sort of amount." He also stated, "He does
not make a distinction in his original disclosure between the surprising
results that he gets when he used the mixture - he doesn't suggest that
it is better than using one of the compounds alone."
In our view therefore, it is abundantly clear from the above and the
responses to the examiner's actions that the alleged invention defined in
claims 15 to 17 is not supported by the disclosure. There is no invention
described commensurate with the scope of claims 15 to 17 over the results
of using one of the compounds. It is trite law that the applicant must
fully describe the invention and its operation and use. This is also
codified by Section 36 of the Patent Act.
The next consideration is whether the disclosure may be amended, as proposed
above, to support claims 15 to 17.
The proposed amendment relates to "a further aspect of the invention ...
comprising a mixture of Silymarin I, II, III, and IV in association with a
pharmaceutically acceptable carrier .., the mixture is found to have a greater
activity than would be expected from the summation of the properties of the
individual Silymarins alone. The applicant maintains that such an amendment
is permissible under the relevant provisions of the Act and Rules and refers
to Jules R. Gilbert Ltd. v Sandoz Patents Ltd. (1970) C.P.R. Vol. 64, p.14.
In the Sandoz case an amendment was introduced after the filing of the
application which related to an amplified utility. On this point Thurlow J.
stated "Nor do I think the scope of a rule 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 thiaridazine] 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." In our view
this is totally different from the instant application where no invention
is described commensurate with the scope of claims 15 to 17.
In our view the proposed amendment relates to new and separate subject matter
which cannot be entered under Rule 52. It describes an alleged invention
separate from the compounds when used alone. We agree with the applicant
when he states that "he does not have to know the composition works in the
way that it does." He must however, state what and where the invention is.
How is one to make use of the invention when there is no disclosure that there
is in fact an invention of. the scope as covered by claims 15 to 17.
The applicant argues that the proposed amendments should be accepted in mew
of the fact that some amendments were accepted by the West German patent office.
We must remember however, that the requirements of a proper disclosure in
Canada are governed by the Canadian Patent laws, which may well differ from
the patent laws of West Germany. In our view the amendments should not be
accepted.
We think the wording of the Court in Riddell v Patrick Harrison (1956-60)
Ex. C.R. 213 at 225 is pertinent to this case. It states, "...what has to
be considered in a patent case is the invention as described in the specification
and defined in the claims rather than that described in the evidence...."
It appears there might also be some other reasons to object to claim 15.
It covers substantially the same ground as claim 10. Whether that raises
such objections as redundancy, an improper avoidance of the requirements
of Section 41, or a contravention of the date expressed in Gilbert v Sandoz
1974 S.C.R. 13-36 against composition-with-carrier claims, have not been
considered, and we see no need to go into those issues here.
We are satisfied that the claims are not supported by the disclosure, and
that the proposed amendments cannot be accepted because they relate to an
alleged invention not previously described in the disclosure. We recommend
that the decision in the Final Action to refuse claims 15 to 17 be affirmed.
J.F. Hughes
Assistant Chairman
Patent Appeal Board
I have studied the prosecution of this application and have reviewed the
recommendation of the Patent Appeal Board. In the circumstances I have
decided not to accept the amendment to the disclosure and to refuse claims
15 to 17. The applicant has six months within which to remove claims 15
to 17, or to appeal this decision under the provision of Section 44 of the
Patent Act.
J.H.A. Gari‚py
Commissioner of Patents
Dated at Hull, Quebec Agent for Applicant
this 31st day of January, 1977
Alan Swabey & Co.
625 President Kennedy Ave
Montreal, Quebec
H3A 1K4