COMMISSIONER'S DECISION
1) LACK OF NOVELTY: Animal peed
2) UNSTATUTORY, UNSUPPORTED:
The invention resides in the discovery that a specific concentration of
a known antibiotic is effective against coccidiosis in animals. Claim 11
is rejected as not patentable over the composition claims since it does
not specify the amount of antibiotic. Claims 12 to 17 related to the
curative and preventative treatment of a disease as well as lacking proper
disclosure support.
FINAL ACTION: Affirmed.
This decision deals with a request for review by the Commissioner of
Patents of the Examiner's Final Action elated November 13, 1973, on
application 030,226 (Class 167-180). The application was filed on
September 18, 1968, in the name of Julius Berger and is entitled
"Animal Feed". The Patent Appeal Board conducted a Hearing on July
16, 1975, at which Mr. R. Gould represented the applicant.
This application relates to an anti-parasitic composition which is
effective in the treatment and control of coccidiosis. Coccidiosis is
a disease caused by a protozon parasite and is a major problem in the
poultry industry.
In the prosecution terminated by the Final Action the examiner refused
claims 11 to 17. Pre-mix claim 11 is rejected as not patentable over
the composition claims and claims 12 to 17 are refused as being
directed to a judicially declared unpatentable process.
The examiner in the Final Action stated (in part):
The rejection of claim 11 is maintained and the reasons
for such rejection is that, applicant discloses definite
amounts of the active ingredient is useful in the
treatment of coccidiosis and he supports this statement
with toxicity tests and results showing the cure obtained.
A concentrate or a premix to be diluted to the right
proportions so as to provide the proper levels for
effective cure or prevention of coccidiosis is a conve-
nient packing foam only, and therefore is not patentable
over the composition claims.
The rejection of claims 12 to 17 is maintained and the
reason for such rejection is that claims 12 to 17 are
relating to a method of medical treatment which is not
within the field of inventions as defined in Section 2 of
the Patent Act and therefore a non patentable process.
In the recent decision of the Supreme Court handed down in
December 1972 of "Tennessee Eastman Co. v. The Commissioner
of Patents" Mr. Justice Pigeon gave his reasons for holding
methods of treatment unpatentable, when he said:
"In my view this necessarily implies that with
respect to such substances, the therapeutic use
cannot be claimed by a process claim apart from
the substance itself. Otherwise, it would mean
that while the substance could not be claimed
except when prepared by the patented process, its
use however prepared could be claimed as a method
of treatment".
Further, his conclusion that methods of medical treatment are
not processes within the meaning of "invention" in Section 2
of the Patent Act, can be seen in his following words:
"Having come to the conclusion that methods of
medical treatment are not contemplated in the
definition of "invention" as a kind of "pro-
cess ......"
Claims 12 to 17 are refused as being directed to a judicially
declared unpatentable process.
The applicant in his response to the Final Action dated February 13,
1974 and February 10, 1975 stated (in part):
Claim 11 is directed to a pre-mix which can be used for
preparing coccidiostatic compositions as defined in claim
1, this pre-mix comprising an active ingredient in
association with an inert orally ingestible carries. It
seems to applicants that it is very clear that this
claim is very different in scope from claim 1. Furthermore,
its purpose and intent are different. Whereas claim 1 is
directed to the coccidiostatic composition that would be
suitable for feeding directly to animals affected by
coccidiosis, claim 11 is drawn to a concentrate for produ-
cing such a coccidiostatic composition. As discussed on
page 10 of the disclosure, when using the compounds of the
invention, that is the antibiotic X-537 A or a pharmaceuti-
cally acceptable salt thereof, for treating or preventing
coccidiosis, the coccidiostat (that is, the active ingredient)
can be first compounded or blended with a feed ingredient or
carrier to become a feed additive pre-mix, a feed concentrate,
or a feed additive supplement. A feed additive, concentrate
or pre-mix is an article intended to be diluted to produce a
complete feed, i.e. an article intended to be administered
as sole ration. Feed additive supplements, concentrates and
pre-mixes contain a relatively large percentage of coccidiostats,
i.e. the active ingredient, and are conveniently prepared by
adding the active ingredient to a suitable carrier and mixing
in a manner to give substantially uniform dispersion of the
coccidiostat in the carrier.
In the normal course of events, the producer of the anti-
biotic which is the active ingredient of the compositions of
his invention, would at most dilute the active ingredient
with an inert orally ingestible carrier in order to produce
such a pre-mix. It would then be left to other dealers, in
particular, animal feed suppliers, to further dilute the
pre-mix to produce a final coccidiostatic composition which
would be sold to farmers for administration to animals.
Relatively feu manufacturers could be expected to produce
the antibiotic and the pre-mixes. On the other hand, the
dilution of the pre-mix in order to produce the final
coccidiostatic composition suitable for feeding to the
animals could be carried out by any number of feed suppliers,
or even by the farmers themselves. Thus, it can be seen that
claim 11 is a claim likely to be infringed only by the
relatively few people who would be manufacturers and
distributors of the active ingredient in the form of a pre-
mix, In general, it is undesirable to sue the ultimate user
of a composition for patent infringement, particularly where
such an ultimate user might be the farmer. Accordingly, it
can be seen that claim 11 is very necessary for the adequate
protection of applicant's invention. It is a claim directed
to one form of the composition aspect of applicants' invention,
and it is not seen that it is proper to reject this claim as
not patentable over the composition claims. A rejection of
lack of patentability presupposes some piece of prior art
which anticipates or renders obvious the claim rejected.
It is clearly not the case in the Examiner's rejection of
the claim 11. In the absence of a citation of relevant
prior art, applicants believe they are entitled to the
claim to the pre-mix as defined in claim 11.
Former claims 12-17 have been replaced by three new claims
directed to the method of improving the efficiency of
conversion of feed to weight gains in poultry. These three
new claims are thus no longer directed to a method of
medical treatment, but are rather directed to a method
which it is believed the Office considers to be inherently
patentable under the provisions of Section 2. Support for
these revised method claims exists in the disclosure, ...
This application is based on the discovery that a specified concentration
of the known antibiotic X537A and its pharmaceutically acceptable salts
are effective against coccidiosis in animals. The effective amount is
from .001% to .0125% of the active ingredient by weight of daily feed
consumption.
Preparation of the antibiotic X537A is disclosed in the Journal of the
American Chemical Society, Vol. 73, pages 5295-5298 (1951). On page
5295 the journal states that the antibiotic "is active in vitro against
certain gram-positive bacteria and mycrobacteria," and that "tolerated
dose levels showed no significant activity in vivo against a variety of
bacterial and protozoan infections."
The applicant has, however, discovered that a composition of X537A com-
prising .001 to .0125 parts by weight of daily feed does combat
coccidiosis. As Lord Simons stated in Raleigh Cycle Co. Ltd. v.
H. Miller & Co. Ltd., (1948) 65 APC 141 at 148: "The discovery was
the inventive step which gave to the invention the necessary merit."
In situations of this kind the Board is satisfied that the applicant
may obtain novel composition claims which represent the inventive
step in the discovery. The applicant may also be entitled to
method of use claims provided such claims do not relate to medical
treatment in the strict sense (curing or preventing disease).
In response to the Final Action the applicant has submitted amended
claims 11 to 14 which replace refused claims 11 to 17. Amended
claim 1l reads:
A pre-mix useful for preparing by dilution a coccidiostatic
composition comprising a compound selected from the group
consisting of antibiotic X537A and pharmaceutically
acceptable salts thereof in association with an inert
orally ingestible carrier which is a solid carrier or a
liquid carrier containing a surface active agent.
At the Hearing the applicant argued that a claim to the pre-mix should
be allowed because that is the form in which a manufacturer of an
antibiotic would merchandise it. He emphasized that it is a claim to
one form of the composition aspect of the invention.
As previously mentioned the Board is satisfied that the applicant may
obtain novel composition claims which will represent the inventive
step in the discovery as set forth by the applicant. The discovery
that a specified amount of the known antibiotic X537A, effective in
combating coccidiosis in animals, is the inventive step which gives
to the invention the necessary merit (Vide: Raleigh Cycle v Miller,
supra), for it was originally thought that the antibiotic was not
suitable for this purpose.
It is clear from amended claim 11 that no specific amount of the
antibiotic is mentioned. This claim then does not represent a
novel and practical application of the new discovery. The merit of
the invention is completely lacking from the claim.
In supporting his position the applicant relied on Commissioner of
Patents v Farbwerke Hoechst 1964 S.C.R. 49 at 53 wherein the court
stated:
A person is entitled to a patent for a new, useful and
inventive medicinal substance but to dilute that new sub-
stance once its medical uses are established does not
result in further invention. The diluted and undiluted
substance are but two aspects of exactly the same
invention. In this case, the addition of an inert
carrier, which is a common expedient to increase bulk,
and so facilitate measurement and administration, is
nothing more than dilution and does not result in a
further invention over and above that of the medicinal
itself. If a patent subsists for the new medicinal
substance, a separate patent cannot subsist for that
substance merely diluted.
It is observed that the court refers to a new substance and not to a
known substance. Furthermore, that situation related to a patent and
to a pending application.
We are satisfied that claim 11 does not represent a novel and
practical application of the new discovery and should be refused. It
is observed that claims 1 to 10 satisfied this requirement and have
not been refused.
Former claims 12 to 17 which relate to a method of curing and preventing
disease have been replaced by amended claims 12 to 14. Amended claim
12 reads:
The method of improving the efficiency of conversion of
feed to weight gains in poultry due to coccidiosis which
comprises orally administering to said poultry an
effective amount of a compound selected from the group
consisting of antibiotic X537A and pharmaceutically
acceptable salts thereof, in admixture with a physiolo-
gically acceptable carrier for oral administration.
At the Hearing the applicant stated that disclosure support for these
claims was found on pages 4, 9 and the table on page 21. Claim 12
specifies "the method of improving the efficiency of conversion of
feed to weight gains in poultry." This of course would include
treating uninfected chickens as well as treating infected chickens.
The statement of invention is given on page 4 of the application and
reads:
The present invention, therefore, is directed to a method
of treating coccidiosis in animals, advantageously poultry,
especially turkeys and chickens, by introducing into the
gastro-intestinal tract of the animal infected with a
causative pathogenic agent of the disease, a therapeutic
amount of an antibiotic designated in the laboratory as
X537A or its pharmaceutically acceptable salts, e.g.,
sodium, potassium, barium, and the like. The antibiotic
is preferably employed in the crystalline form. Further-
more, the present invention is directed to a method for
avoiding the development of coccidiosis in animals,
especially poultry, which involves introducing compositions
containing antibiotic X537A, preferably crystalline anti-
biotic X537A, or its pharmaceutically acceptable salts into
the gastrointestinal tract of the animal prior to infection.
Finally, this invention relates to coccidiostat compositions
containing said antibiotic X537A.
There is little doubt but that the applicant regards his invention as
relating or as being directed to methods and compositions relating to
the treatment (curing or preventing) of coccidiosis.
A review of the disclosure reveals very minor references to improving
the efficiency of conversion of feed to weight gains. In his response
of February 10, 1975 the applicant states "the table on page 21
wherein the chickens treated with the antibiotic exhibited gains
of 105-108% compared with 100% for the untreated uninfected control
chickens." While it is true that the table on page 21 shows a
weight gain of 105-108% for infected chickens compared with 100%
for untreated uninfected control chickens, it is observed that the
table on page 19 discloses a weight gain of only 85%-92% for infected
chickens compared to 100% for untreated uninfected chickens. In
both the test results identical dosage of antibiotic was used. There
is no question that a chicken which has been successfully treated for
coccidiois will regain its health and improve its weight as compared
to an infected chicken. This inherent characteristic is to be expected
in nature.
We are satisfied, therefore, that amended claim 12 lacks proper
support in the disclosure, and is merely a new label for the previously
refined claims 12 to 17, which claims related to curative or preventa-
five treatment of a disease.
Claims 13 and 14, which are directly or indirectly dependent on claim
12, specify the carrier and active ingredient used. These are not of
patentable significance and the remarks used to refuse claim 12 are
applicable to them.
The Board is therefore satisfied that claims 11 to 14 should be
refused for the reasons discussed.
J.F. HUGHES
Assistant Chairman,
Patent Appeal Board
I concur with the findings of the Patent Appeal Board and refuse
to grant a patent on claims 11 to 14. The applicant has six months
within which to delete these claims, or to appeal this decision
under the provisions of Section 44 of the Patent Act.
Decision accordingly.
A.M. Laidlaw,
Commissioner of Patents
Dated at Hull, Quebec
this 27th day of August, 1975
Agent for Applicant
Fetherstonhaugh & Co.,
Box 2999, Station D,
Ottawa, Ontario.
K1P 5Y6