Section 2, Inhibition of Undesired Effects of Platinum (II) Compounds
Additional claims submitted at and after the Hearing were found not to have
full support in the application. The rejected claims were considered to be
directed to a medical treatment, not merely to a chemical reaction.
Rejection affirmed
This decision deals with Applicant's request for review by the Commissioner
of Patents of the Final Action on application 383,442 (Class 167-256) filed
August 7, 1981. It is assigned to Regents of the University of Minnesota.
The inventor is Richard. F. Borch. The Examiner in charge issued a Final
Action on April 11, 1985 refusing to allow the application. A Hearing was
held on May 11, 1988, and arguments were made by his Patent Agent,
Mr. R.H. Barrigar, assisted by Messrs. D.M. McGruder and R. Scott.
Subsequent to the Hearing, the Applicant submitted further comments by
letter dated July 6, 1988.
The application relates to a method for inhibiting platinum (II) toxicity
in multicellular organisms, e.g. a live mammal being treated by a
physiologically active platinum (II) (Pt(II)) compound. Within 0.5 to 6
hours after administering the toxic Pt(II) compound, a platinum-binding
dithiocarbamic (DTC) compound suitable for non-oral administration is
introduced into the multicellular organism or mammal. The platinum-binding
compound reacts to inhibit certain undesired effects of the platinum such
as bonding irreversibly to useful substrates, and nausea in a mammal, but
permits the platinum to continue to inhibit tumor growth.
In taking his Final Action, the Examiner said, in part, as follows:
...
The applicant argues that the process claims are not directed
to a method of medical treatment because the claims in the
present application set out no steps of medical treatment.
This argument however cannot overcome the objection because
as stated in the last Office Action, the purpose of the
process of this application is to administer platinum-binding
dithiocarbamic compound to a human who is undergoing cancer
chemotherapy treatment with platinum compounds in order to
reduce the undesired side effects caused by the platinum
compounds. This purpose is clearly taught in the disclosure
(see page 16, lines 23 to 27 for example).
The applicant's argument that the claims are directed to a
method of forming a stable, square planar Pt(II) complex from
the components comprising a Pt(II) compound and a
dithiocarbamic compound and therefore they are not directed
to a method of medical treatment is unacceptable. According
to the disclosure, all the reaction takes place within a body
of a human who is undergoing chemotherapy treatment and
therefore in order for the reaction to proceed, both Pt(II)
and a thiocarbamic compound must be administered to a body of
a human who is suffering from a cancer. It is clear from the
disclosure that when a dithiocarbamic compound is
administered to a cancer patient who is undergoing Pt(II)
chemotherapy. the said dithiocarbamic compound acts as a drug
in reducing or removing the side effects caused by Pt(II)
compounds. Furthermore the disclosure teaches no reaction,
other than the reaction of dithiocarbamic compound within a
body of a human cancer patient. It is clear from the
disclosure that the displacing of the platinum complexing
ligand from the complex by means of a dithiocarbamate can
only proceed when the dithiocarbamate is administered to a
patient who is undergoing Pt(II) chemotherapy.
In order for an alleged invention to be patentable, the Act
requires that the said alleged invention has an utility. The
utility taught in the disclosure is for reducing or removing
side effects caused by Pt(II) compound. It is therefore
clear to this examiner that the process claims, even though
the applicant argues that they fail to mention medical
treatment steps and therefore not a method of medical
treatment, are directed to a method of medical treatment
because of the teaching of the disclosure and the lack of any
evidence that the present process is useful in any other
situation.
...
In his response, the Applicant argues, in part, as follows:
...
It is respectfully submitted that the reactions to which
reference is lade in the claims, insofar as they are in vivo
reactions, do not necessarily occur in human beings. In vivo
reactions may occur in animals as well as humans and even in
test tubes or petri dishes.
Furthermore, the applicant submits that a method of medical
treatment using drugs involves preliminary diagnosis by the
physician, the administration of the appropriate medicine and
evaluation of its effects on the patient. The medicine may
bring about a chemical reaction in the body of the patient,
but the mere occurrence of a chemical reaction does not
amount too a method of medical treatment. The claims in the
present application set out no steps of medical treatment.
...
What may be unpatentable is a series of steps which, taken as
a whole, constitute a method of medical treatment. But that
does not necessarily place any particular individual step or
subcombination of steps outside the realm of statutory
subject matter. To understand this, let us take a different
example. Suppose that a method of medical treatment
comprises the steps of
(a) defining a cutting line forming a closed loop
on the skin;
(b) burning an area of skin on either side of the
cutting line to carbonize the skin;
(c) cutting along the cutting line through the
carbonized area;
(d) removing the area of skin defined by the closed
loop; and
(e) performing surgical incisions in the flesh in
the area from which the skin has been removed.
Now suppose that the subcombination of steps (a), (b), (c) is
novel and unobvious as applied to any layered organic
material, including skin. An applicant could then claim as
follows:
-- A method of cutting and removing layered organic
material, comprising:
(a) defining a cutting line forming a closed loop
on the outer surface of the layered organic
material;
(b) burning an area of the layered organic material
on either side of the cutting line to carbonize the
material along the cutting line; and
(c) cutting along the cutting line through the
carbonized material. --
Now the foregoing claim does not exclude skin, and does not
exclude the possibility that the subcombination of the
claimed steps is part of a method of medical treatment. Yet
the claim is clearly statutory, involving as it does the
everyday physical steps of burning and cutting.
Equally the claims of the present application are statutory.
They say nothing whatever of a method of medical treatment.
We are talking here of chemical reactions. If there was ever
a type of process clearly within the realm of statutory
subject matter, it is a chemical reaction. The plant and
animal world is filled with wonderful organisms which can
perform a whole hose (sic: host) of organic chemical
reactions - conversion of starches to sugars, generation of
acids, oxidation reactions of many types. But that does not
mean that every time an applicant applies to patent a
chemical reaction invention, one must then go on to enquire
whether the reaction could be an in vivo reaction. Nor does
one need to enquire whether it could be conceivably part of a
method of medical treatment. So what if it could be? It
remains a chemical reaction. A chemical reaction is not,
repeat not, a method of medical treatment any more than the
physical steps of cutting and burning are per se methods of
medical treatment. To have a method of medical treatment, we
must go on to enquire: Does the claim call expressly or by
necessary implication for a human patient? Does it call for
some diagnostic procedure, or some administration of
specified doses of defined medicines to the patient? If these
last two questions are answered affirmatively, then the claim
may define a method of medical treatment.
But that is not the case here. The claims refer to formation
of certain platinum (II) complexes. The steps are defined in
terms of chemical reactions in a defined physical-chemical
environment, Nothing is said about a patient. Nothing is
said about medicines or dosages or administering same to a
patient. Nor are any of these last-mentioned concepts
present by necessary implication. Claim 17 admittedly calls
for "administering" a certain defined chemical substance "to
the dithiocarbamate-degrading system", but such system need
not be within a human patient, or even within an animal.
Other verbs than "administering" could have been used equally
well - "introducing" or "adding", for example.
When we reach claim 22, we find that the environment includes
certain agents "encountered in a living biological system".
But the system need not be human. and again there is no
notion of a patient nor the administration of medicines or
dosages to a patient. If any physician were asked "would you
regard claim 22 as an adequate definition or even any
definition of a medical treatment or procedure?", the
physician would clearly respond "no - it defines a
biochemical reaction that might be of some value in a medical
treatment or procedure, but it certainly does not define any
such treatment or procedure".
In fact, the inventor has actually conducted experiments in
vitro with DNA, platinum compounds, and a dithiocarbamic
"rescue' agent of this invention, more specifically DDTC. He
has also conducted experiments with enzymes blocked or
inactivated by platinum and has successfully used DDTC to
re-activate these enzymes. Although the claimed method can
be carried out in vivo, it can also be carried out in vitro,
with the necessary agents, including those "encountered in a
living biological system", being introduced into the in vitro
environment. There is nothing in the language of the claims
except claims 13 and 34, restricting the method to an in vivo
environment.
In the experiments with DNA/Pt complexes, it was found that
the DDTC did not remove any platinum. In short, the present
inventor is believed to be the first to discover that DDTC is
a platinum-complexing agent which is just strong enough to
reverse the blocking of enzymes or the like by platinum, but
not so strong as to remove platinum from DNA. Accordingly,
our existing claim 1 includes ordinary test-tube chemistry.
...
It is, of course, acknowledged by the applicant that the
processes claimed are applicable in connection with the
treatment of living animals, but it is respectfully submitted
that this by itself is not a bar to the patentability of the
claims. In this connection, the Commissioner's attention is
respectfully directed to the case of Re Application
No. 880,719 (Patent No. 994,693), (1973), 18 C.P.R. (2d) 114
(PAB), at page 119, where the following is stated:
"Since the subject-matter of the present process is
in the "means", as distinct from the "end", it
should be entitled to a patent within the meaning
of a manual or productive art as stated in Lawson
v. Commissioner, supra. The fact that the
relevance of the end result of the present process
may be applied in connection with the treatment of
living animals is incidental to the subject-matter
of the present invention, it is a fact that the
present process does not apply any pharmaceutical
properties of a substance to effect a curative or
preventive treatment of an ailment. That
patentability should be denied merely because
treatment of a living animal is a prerequisite of
the usefulness of the end product is untenable
since it would be wide enough to exclude medicines
as well as their processes of manufacture intended
to be governed by s.41(1), new and obvious tests
for quality assurance of industrially produced
pharmaceuticals, and such other inventions intended
to have medical and surgical application. The
foregoing conforms to the S.C.C.'s decision in
Tennessee Eastman v. Commissioner of Patents (on
appeal from the Exchequer Court's decision on the
same case, supra) when it stated that the process
then under consideration of applying an adhesive
substance to body tissues" ... is clearly in the
field of practical application" as opposed to a
mere scientific principle or abstract theorem
excluded by s.23(3) (sic: s.28(3)) of the Patent
Act. ...
In any event the present claims distinguish
factually from the claims then under consideration
in that no step of medical or surgical treatment is
set out in the claims.".
...
It is further submitted that the treatment of cancer patients
is not the only utility contemplated by the inventor. The
applicant admits that this is one utility of the invention.
However, the inventor considers that his invention, when
practised in an in vitro environment, or in vivo in
microorganisms, has significant utility as a research tool.
Although this use is not explicitly discussed in the
specification, it is clear that the application contemplates
the practice of the invention in an environment which is not
limited to humans or animals....
...
The issue before the Board is whether or not the subject matter of claims 1
to 37 of the application is patentable under Section 2 of the Act. Claim 1
reads:
A method for forming a stable, square planar Pt(II) complex
from the components comprising (a) a Pt(II) compound, and (b)
a dithiocarbamic compound, wherein said method is carried out
in the presence of
agents Which can inactivate dithiocarbamic compounds
through degradation or conjugation, and
platinum-complexing ligands which occur in complex
multi-cellular organisms;
at least some of the Pt(II) compound reacting to form a
complex with a said platinum-complexing ligand, said Pt(II)
canpound having the formula:
(See figure I)
wherein X1 and X2 are the same or different and represent
anionically ionizable leaving groups, or, taken together, X1
and X2 can constitute a cyclic difunctional leaving group,
and L3 and L~ are the same or different and represent the
residues of ammine or amine ligands, or, or (sic) in
combination, L3 and L~3 together represent the residue of
aliphatic or cycloaliphatic diamine ligand;
said method comprising displacing the
platinum-complexing ligand from said complex by means of a
dithiocarbamate in the form of an anionic species formed from
the dithiocarbamic compound
R1R2NCSM
wherein R1 and R2 are the same or different and represent
electro-donating lower aliphatic or lower cycloaliphatic
radicals, and M is (1) hydrogen, (2) an electropositive,
ionically bonded metal, in which case the remainder of the
dithiocarbamic compound is negatively charged, or (3) the
radical -S-CNR3R4, R3 and R4 being defined in the same manner
as R1 and R2; thereby forming said stable square Pt(II)
complex, in which the functional group R1R2N-C-S- is
coordinately bonded to the platinum in place of the enzyme or
ligand.
We comment briefly on the example of the method claim with step (a) to
(c) for cutting and removing a layered organic material which the Applicant
presents and discusses in his response to the Final Action. Steps (a) to
(c) relate to, defining a cutting line, burning an area on either side of
it, and cutting along the line. The Applicant says this kind of claim is
statutory due to the steps of burning and cutting. In view of the decision
in Tennesee Eastman v The Commissioner of Patents (1974) S.C.R. 112, we
believe such a claim would not be permissible where the invention is for
surgical or medical treatment of a living mammal. The purpose of an
invention must be looked at in determining whether the invention meets the
requirements of Section 2 which reads:
"invention" means any new and useful art, process,
machine, manufacture or composition of matter, or
any new and useful improvement in any art, process,
machine, manufacture or composition of matter.
Moreover, we note the three steps in the example do not deal with removing
material such as set out in that claim's preamble. We think the example is
not persuasive that thin application is acceptable under Section 2.
In dealing with the kind of method in this application, we learn from the
description that it comprises two major steps. The first is for
administering a Pt(II) complex to attack cancerous cells, and the second ie
for administering a DTC compound within a certain time period thereafter to
prevent nausea that results due to the first step. The first step itself
is a method of treating cancer and is a medical treatment. Combining with
that the second step, namely, a method of alleviating nausea arising from
the first step does not make the method any less a medical treatment.
Following the response to the Final Action and prior to the Hearing, an
affidavit by Mr. Borch, the inventor, was filed as a supplement. It sets
out that the methods in the application may be carried out in an in vitro
environment or an in vivo environment in microorganisms and cell cultures.
It describes exposing an enzyme preparation to a platinum drug, monitoring
enzyme activity, washing the enzyme preparation free of the platinum drug,
and exposing the preparation to diethlydithiocarbamate (DDTC, a DTC
compound) for removing platinum from the site, and measuring restoration of
enzyme activity. It refers to the chemistry of DDTC and complexes of
platinum coordinated to biological macromolecules, noting that platinum
bound to adenine is removed by DDTC whereas platinum bound to guanine is
unreactive.
As we understand the affidavit, it does not provide for the effect that a
living mammal imparts to the DTC after it is administered, nor for the
timing of the DTC treatment for preventing irreversible damage.
The application describes the efficacy of using DTC compounds in inhibiting
the irreversible bonding of Pt(II) compounds to useful substrates without
eliminating the desirable effects of Pt(II). The purpose of the DTC
compounds is for inhibiting the toxicity of Pt(II) in order to reduce the
severity of nausea. In noting that timing is of great importance in
administering the DTC, four beneficial timing periods are set down as
being, from 0.5 to 6 hours after the Pt(II), after a certain minimum and
maximum of half lives of the Pt(II), prior to 6 hours after the initiation
of physiological effects of the Pt(II), after the Pt(II) begins complexing
but before it irreversibly damages renal tubules. The utility of the
invention is said to be obtained when a Pt(II) complex is introduced into a
complex multicellular organism having kidneys and a digestive tract. The
results of tests on animal models are described, including reductions in
blood urea nitrogen, weight lose, and tumor site. In describing the
procedure for the treatment, the Pt(II) complex is administered in a
conventional manner, either intravenously or intraperitoneally, and the DTC
compounds are administered in a manner taking into account their rapid
metabolism, degradation, or inactivation in acidic media, living biological
systems, and others.
On closer comparison of the affidavit to the application, we note the
affidavit does not include any information concerning the timing periods
for administering a DTC compound. Nor does it refer to reducing the
severity of nausea. In our view, it relates to biochemical research and
chemical experiments studying desoxyribonucleic acid (DNA) cells grown in
culture.
On page 9 of the application, it is said experiments with DNA, platinum,
and DTC, show that DTC dislodges platinum from DNA/PT(II) complexes formed
in vitro, and that from the experiments it would appear that DTC would be
poor for inhibiting PT(II) toxicity since it might be expected the
chemotherapeutic effect of the platinum would be reversed. On page 10, it
is said such reversal in vitro does not happen in living multicellular
systems. One reason given is that DTC compounds are present in vivo as
anionic species which have difficulty in penetrating cell membranes. A
second noteworthy reason says that the DTC compounds penetrating the cell
walls are degraded or conjugated to form non-chelating products before they
can access the DNA/Pt(II) complexes within the cell. Reference is made
that the biological half life is long enough to provide reversal of the
Pt(II) aide effects. It is said that acidic media may be stomach acid.
In view of Mr. Borch's affidavit and the application, we see that two
methods are under discussion for using Pt(II) complexes and DTC compounds.
The first relates for example to in vitro experiments and is referred to in
the affidavit. The second involves the two step treatment of living
mammals and is set forth in the application with particular reference to
prescribed times for administration for the purpose of achieving a
chemotherapeutic effect by the Pt(II) complex, and alleviation of nausea by
the DTC compounds due to the assistance of the mammal's system. From the
affidavit we see the purpose of the first method is to determine enzyme
inhibition and to obtain useful information from the testing procedure.
From the application, the purpose of the second method in our opinion is
for treatment of a mammal. It may be that the application would support
subject matter related to the first method, but such is not present. The
method we find now in the application as it relates to treatment of a
mammal, in our opinion, is the kind that has been determined not to be
acceptable by the decision in the Tennessee Eastman case.
We saw look at the groups of claims that are under consideration. Group A
comprises claims 1 to 37 rejected by the Examiner. Group B is claim X
introduced at the Hearing. Group C, as a result of the letter of
July 6, 1988, consists of a suggestion for an amendment to claim X, and
although there is no amended claim X on file, we include the suggestion for
discussion purposes.
In group A there are three independent claims, 1, 17 and 22. Claim 1
includes the term agents and their function of inactivating DTC compounds.
According to the application, the agents include mammals. In our opinion
therefore, the presence of a mammal forms part of the claim. Claim 1
refers to platinum complexing ligands occuring in complex multicellular
organisms. In the application, a multicellular organism includes kidneys
and a digestive tract, and in our view encompasses living mammals to
provide the necessary complexing action with the platinum. We think claim
1 relates to a medical treatment. We note claim 1 does not recite the time
delay in applying the DTC component to act with the platinum. From the
application, we learn this feature provides the effectiveness of the
treatment. We think claim 1 lacks definition of the treatment disclosed.
We believe however, that since claim 1 pertains to a medical treatment the
inclusion of the time delay in the method would not remove claim 1 from the
category of a medical treatment.
Claim 17 calls for a DTC degrading system. From the application, such a
system includes a living mammal which provides for a certain action on the
DTC compound. We find claim 17 is directed to a medical treatment.
Claim 22 is similar to claim 1 in that it calls for agents, and locates
them in a living biological system as yell as in the complex multicellular
organisms in such a system. We find claim 22 sets forth a medical
treatment.
None of the claims in group A present other than a medical treatment, and
none of them is allowable.
Group B has only claim X. The Applicant argues that it does not contain
any terms that might be construed as limiting the method to a living
mammal. To this end claim X omits the references to the agents. After the
Hearing, in reviewing claim X and Mr. Borch's affidavit, the Board felt
that insofar as claim X might relate to a non medical method, it was sot
sufficient with respect to carrying out the method in vitro or in vivo with
microorganisms such as described in the affidavit. Is so informing the
Agent, the Board suggested considering the addition to claim X of the
phrase relating to in vitro and in vivo activities as found in the
inventor's affidavit. Hence, group C a suggestion for possibly deriving an
amendment to claim X.
In the letter of July 6, 1988, the Applicant suggests the possibility of an
amendment to claim X that would introduce reference to in vitro and in vivo
activities in microorganisms or cell structures, but no claim containing
such amendment was submitted. The Applicant, however, in retaining the
claims of groups A and B, requests that the suggestions for the claim in
group C be considered by the Board as one of the claims under review. Our
comments hereinafter are made with respect to all the groups.
Mr. Barrigar stresses that all the claims under review should be assessed
as representing only chemical reactions. He considers chemical reactions
are statutory, patentable subject matter. He argues that regardless of
where the chemical reaction occurs, such reactions remain the same whether
they be performed either inside or outside the body of a living mammal. In
the letter of July 6, 1988, the Agent summarizes his oral presentation at
the Hearing, as follows:
a) Chemical reactions are inherently statutory; chemical
processes have long been acknowledged to be statutory subject
matter.
b) The utility to which any invention is put is not
determinative of whether the invention is statutory. The only
practical utility of a particular pharmaceutical composition
or of a particular surgical implement may be utility for
medical treatment, but that does not render the surgical
implement or the pharmaceutical composition unstatutory -
either may be properly claimed as an invention.
c) While methods of medical treatment involving clinical
steps have been rejected as unstatutory, the basis for such
rejection in Canada, at least where such methods involved the
use of chemical compositions, appears to rest upon the
Tennessee Eastman case decided by the Supreme Court of Canada
which in turn rests upon the proposition that Section 41(1) of
the Patent Act as then in force, prohibited the claiming of
pharmaceutical compositions per se. Now that that statutory
provision has been repealed, the underpinning for the
Tennessee Eastman case has disappeared, and there ie no longer
any basis for rejection of claims directed to the use of a
pharmaceutical composition. A fortiori, there can be no
objection to a claim to a chemical process involving the use
of a particular chemical composition.
With respect to point (a) where there is merely a chemical reaction, we are
in agreement. Concerning points (b) and (c), we do not share the Agent's
views. He suggests the Tennessee Eastman case rests upon the proposition
that Section 41(1), as it was then in force, prohibits the claiming of
pharmaceutical compositions per se. He notes Section 41(1) does not now
contain the previous requirement, and therefore there is no basis in
existence for the decision taken in the Tennessee Eastman case. In the
recent case Imperial Chemical Industries Ltd v The Commissioner of Patents
(1986) 9 C.P.R. (3d) 289, (ICI), the Federal Court looked to the Tennessee
Eastman case, and in particular to the significance of the then Section
41(1) which Heald J. dealt with, as follows:
Coming now to the decision of the Supreme Court of
Canada, Mr. Justice Pigeon delivered the Court's
decision. He commences his reasons by setting out
the agreed statement of facts and issues. At page
204 of the report, he reproduces, with approval,
that portion of the reasons of Kerr J. set out
supra. It is true that he does discuss the impact
of Section 41, presumably since that case was a
subsection 41(1) case. However, after that
discussion, at page 207 of the report, he states:
Having come to the conclusion that
methods of medical treatment are not
contemplated in the definition of
"invention" ae a kind of "process",
the same must, on the same basis, be
true of a method of surgical
treatment.
In my opinion, this is a clear and unequivocal
statement that "...methods of medical treatment are
not contemplated in the definition of "invention" as
a kind of process...". That was the sole issue
before the Court and it is here answered in
unmistakeable and unambiguous language.
Accordingly, in my view, the force of that
pronouncement cannot be restricted merely to factual
situations where subsection 41(1) of the Act
applies. It follows, therefore, that the
Commissioner did not err in considering himself
bound by the ratio of Tennessee Eastman. (our
emphasis)
In our opinion, Heald J. says that Section 2 is determinative with respect
to methods for treating a living mammal, particularly in view of his
inclusion of Mr. Justice Pigeon's comments on page 207. Further, from
Tennessee Eastman, we note that following his remarks, Pigeon J. then dealt
with the relevance of the British case, Swift's Application (1962) R.P.C.
37 and found it not relevant to the situation before him. Pigeon J. drew
attention to another British case, Schering A.G.'s Application (1971)
R.P.C. 337. He derives direction therefrom by quoting a passage and
providing emphasis to a certain portion that was not so emphasized by the
British Court in its report, shown as follows:
Although, however, on a full consideration of the
matter it seems that patents for medical treatment
in the strict sense must be excluded under the
present Act, the claims the subject of the
application do not appear to fall within this
prohibition and, on the law as it stands today, they
should, at least at this stage in our judgment, be
allowed to proceed. As Swift's Application (1962)
R.P.C. 37 in the Divisional Court of the Queen's
Bench Division clearly established, the Office and
the Patents Appeal Tribunal are at this stage not
deciding the question of "actual patentability", as
the phrase was used in that case, and unless there
is no reasonable doubt that a manner of manufacture
is not being claimed or the application is plainly
without justification, it is their duty to allow
the claim. The applicants Will then have the
opportunity in due course, if the matter arises, of
having "actual patentability" decided in the High
Court. (Emphasis added).
We believe it is helpful in reviewing the Applicant's subject matter to
look at Kerr J.'s reasons given in the Lower Court, that were included by
Mr. Justice Pigeon in his decision on the Tennessee Eastman case, as
follows:
...The method lies essentially in the professional
field of surgery and medical treatment of the human
body, even although it may be applied at times by
persons not in that field. Consequently, it is my
conclusion that in the present state of the patent
law of Canada and the scope of subject-matter for
patent, as indicated by authoritative judgments that
I have cited, the method is not an art or process or
an improvement of an art or process within the
meaning of s. 2(d) of the Patent Act.
In comparing the opinion of Kerr J., to that expressed by Pigeon, J. after
his consideration of Section 41(1), we see no differences in their
viewpoints. The findings by both Courts in Tennessee Eastman, and as
followed by the Federal Court in ICI, state that medical and surgical
treatments do not merit patent protection under Section 2 of the Act.
We think that the basis of the Tennessee Eastman decision is Section 2, not
Section 41(1), and that Section 2 governs the determination of the issue
before us. Moreover, we do not share the Applicant's viewpoint that only a
chemical reaction is occuring within the mammal's body. We believe that
more than that occurs when the purpose of the method is to administer to a
mammal's body particular substances for treating the body. There is no
doubt a particular component such as a DTC compound may under proper
circumstances be patentable itself. However, where the consideration is
with respect to a method of treating a mammal, we think the decision in the
Tennessee Eastman case directs that such a method is not patentable. We
are persuaded that the method described by the Applicant does not propose
nor relate to a mere chemical reaction. We are satisfied the application
identifies the utility of the method is achieved when a mammal is treated
by administering the PT(II) compounds, followed by the DTC compounds in
timed relation thereto.
In our view, the affidavit is concerned with a chemical reaction as it is
carried out in vitro or in vivo with microorganisms and cell cultures. We
cannot make a recommendation that the description in the application deals
with the affidavit subject matter since that matter has not been clearly
identified in the application at any stage of the prosecution including at
and after the Hearing.
In summary, we find the claims in group A are directed to a medical
treatment. The scope of the subject matter discussed in groups B and C may
be in accord with the inventor's affidavit, but after a careful
consideration of all the matter submitted, we are persuaded that scope
presently finds no full support in the application.
We recommend that the refusal of claims 1 to 37 of the application be
maintained for presenting no more than a medical treatment, and that the
scope of claiming for the subject matter discussed in groups B and C not be
accepted.
M.G. Brown S.D. Kot
Acting Chairman Member
Patent Appeal Board
I have reviewed the prosecution of this application. I concur with the
findings and the recommmendation of the Patent Appeal Board. Accordingly,
I refuse to grant a patent containing the claims of this application, and I
refuse to accept the additional scope of claiming for the subject matter
presented at and after the Hearing. The Applicant has six months within
which to appeal my decision under the authority of Section 44 of the Patent
Act.
J.H.A. Gari‚py
Commissioner of Patents
dated at Hull, Quebec
this 22 day of November 1988.
Barrigar & Oyen
Suite 700
The National Building
130 Slater street
Ottawa, Ontario
K1P 6E2