COMMISSIONER'S DECISION
STATUTORY - Section 2: Pathological Test Process
Method for determination of antigens in an aqueous fluid of a living
animal (including humans), not possible by conventional methods, is
not a treatment applying medicine to such a living animal; and satisfies
the criteria of a "useful" process or art within the definition of Section
2(d) in that it belongs to the manual or productive arts, it is controllable,
and it has utility in practical affairs; and a patent therefore is not
contrary to the public interest.
FINAL ACTION: Overruled.
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This decision deals with a request for review by the Commissioner of
Patents of the Examiner's Final Action dated May 10, 1972 on
application 003,389, This application was filed in the name of
Antonius H.W.M, Schuurs and refers to "Immunochemical Determinations
Of Antigens And Antibadies".
In the prosecution terminated by the Final Action the examiner rejected
claims 1 to 8 as covering non patentable subject matter under Section
2(d) of the Patent Act.
Claim 1 reads:
Method for the immunochemical determination, by means of an
agglutination reaction, of antigens or antibodies in an aqueous
solution in which they are present in a concentration too low to
be reliably determined by conventional agglutination reaction
procedure without prior fractionation or concentration or are
attended with factors disturbing to conventional agglutination
reactions arising from contaminants present in the aqueous
solution to be tested, comprising
(a) adsorbing one of the immunochemical reaction components
selected from the group, consisting of antigens and
antibodies on carrier particles suitable for antigens
and antibodies;
(b) reacting said component by joining it with the aqueous
solution to be tested containing the other reaction
component to be deterniined;
(c) separating the carrier particles, after the reaction
has taken place, from the reaction mixture:
(d) resuspending the particles in a small volume of a suitable
aqueous medium; and
(e) visually determining the reaction pattern of the carrier
particles.
In the Final Action the examiner stated in part:
Applicant's arguments imply that the meaning "Any new and useful
art, process, ...." must be given the broadest possibly interpre-
tation and any subject matter encompassed by this definition is
patentable, unless the Patent Act specitically forbids it, This
is not the case, however, as the Patent Office has consistently,
over many years held the view that everything that is new and use-
ful is not necessarily patentable and it is well established that
there are arts and processes which are definitely excluded from
patent protection, some by statute (as in Section 28(3) of the
Patent Act) and others by court decisions; for example, methods
dependent on professional skill (See Lawson vs. Commissioner of
Patents or Tennessee Eastman Co, vs. Commissioner of Patents). In
the area of processes the Patent Act is designed to protect those
which have novelty, utility, inventive ingenuity and are also
susceptible of industrial application
Although the present method for the immunochemical determination
of antigens or antibodies may be new, useful and unobvious, it is
however not susceptible of industrial application. The method
here, which is performed on a non-industrial product, viz., human
body fluids, is rather conceived as being essentially non-economic
as it does not produce a result in any way associated with trade,
commerce or industry in the sense that those expressions have been
used in the above particular patent case judgements and is also
contrary to the spirit of the expression "working on a commercial
scale" referred to in the Patent Act. Therefore, it is deemed
not being in the public interest to grant patents for such methods
of pathological diagnosis.
In the response of November 10, 1972 the applicant stated in part:
Now applicants will admit that the provisions of Section 2(d)
require some qualification which, as the Examiner has correctly
put, arise either from the provisions of Section 28(3) of the
Patent Act or from court decisions. However, in applicants' view,
neither Section 28(3) nor the pertinent decisions of the courts
require Section 2(d) to be qualified in such a manner that a
patentable process must be "susceptible of industrial application".
Rather, applicants would urge that the relevant criteria are more
accurately identified by Dickson C.J. lit National Research
Development Corporation's application (Australia) (1961) RPC
135 where, at page 145, the following statement is made in the
judgement:
"The point is that a process, to fall within the limits of
patentability which the context of the Statute of Monopolies
has supplied, must be one that offers some advantage which is
material, in the sense that the process belongs to a useful
art as distinct from a fine art (see Virginia-Carolina
Chemical Corporation's Application (1958) R.P.C. 35 at p.
36) that its value to the country is in the field of
economic endeavour. (The exclusion of methods of surgery
and other processes for treating the human body may well
lie outside the concept of invention because the whole
subject is conceived as essentially non-economic:, see
Maeder v. Busch (1938), 59 C. L. R. 684 at p. 706.)"
This passage was referred to in the judgment of Cattanach J. in
the decision of the Exchequer Court in Lawson v. Commissioner of
Patents. In summary, it appears to be necessary that a patentable
process belongs to a useful art as distinct from a fine art and
is not essentially non-economic. These criteria appear to have
been accepted by the Office in recent decisions of the Patent
Appeal Board.
In applicants' submission, the subject matter of claims 1 to 8
does belong to a useful art as distinct from a fine art or, in
the words of the Patent Appeal Board in the decision referred to
above, does relate to a manual or productive art as distinct
from a fine art. The method steps of the claims comprise those
which are set out clearly in claim 1 as steps (a) to (c) inclusive.
It is submitted that these steps clearly do not belong to a "fine
art" involving the use of professional skills having judgmental
content, and are not for instance comparable to methods of
surgery and other processes of treating the human body. Moreover,
such methods appear most frequently today to be carried out by
commercial testing laboratories (clinical laboratories) who bill
the customer directly for their services even though in some cases
such matters may be covered by medical insurance, Thus, even if
the method is not susceptible of industrial application, it
certainly is of commercial application and yields a result that
is essentially of an economic nature in that such a test
procedure is ordered and paid for in the ordinary way of business.
Furthernnore it is beside the point that the method is performed
on a non-industrial product; it is submitted that the relevant
criterion is whether the method is susceptible of commercial
application.
At the outset the Board observes that the Final Action at the time
conformed with Patent Office guidelines relating to the patentability of
inventions involving methods of testing of human body fluids, as distinct
from such other testing processes as those applied to other natural
products, or to industrial products, or to materials used in the manufac-
ture of such products, even though the end result of the test process is not
necessarily a physical product in that it may be tangible information only.
The basic issue is whether the subject matter of the process claims 1 to 8
constitutes a "useful art or process" within the meaning of Section 2(d)
of the Patent Act defining patentable subject matter, and more particularly
whether the subject matter satisfies the principles and criteria applied by
jurisprudence dealing with the question. In cases of claims involving
methods of testing the established criteria of utility is usually the
critical area in determining whether such subject matter is a patentable
invention within the meaning of Section 2(d) of the Patent Act. In the
present case the prerequisites of novelty and unobviousness are assumed
since no objection has been made on such grounds.
Section 2(d) of the Patent Act reeds:
"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.
Recently there has been two Exchequer Court caves of particular interest
in the interpretation of Section 2(d) of the Patent Act. They are
J. Wyburn Lawson v The Commissioner of Patents (1970) 62 C.P.R. 101,
which concerns claims to a plot of land subdivided in a certain manner,
and Tennessee Eastman v The Commissioner of Patents (1970) 62 C.P.R. 117,
which concerns claims directed to a method of surgical bonding of body
tissues of human beings.
The question of whether a subject matter is an "art" or a "process"
was considered In Re Lawson v Commissioner. In that case "art", "process" and
"method" were viewed as one and the same thing, and in any event it was
settled that "art" may include a method or process citing Refrigerating
Equipment Limited v Waltham Systems Incorporated (1930) Ex. C.R. 154 at
166, wherein Cattanach J. then stated at page 109:
"An art" or operation is an act or series of acts performed
by some physical agent upon some physical object and producing
in such object some change either of character or of condition.
It is abstract in that it is capable of contemplation of the
mind. It is concrete in that it consists in the application of
physical agents to physical objects and is ithen apparent to the
senses in connection with some tangible object or instrument.
And at page 110 he also stated:
It is now accepted that if the invention is the means and
not the end, the inventor is entitled to a patent on the means.
That the process under consideration falls within that meaning of an
"art" is a matter of fact in that the process consists in the appli-
cation of physical chemical agents to a physical solution, the result-
of which is then apparent in the treated solution, for if there is no
physical or chemical change in the character or condition of the solution
as a result of applying the process, it would not be possible to determine
the reaction pattern of the carrier particles in the solution after, as
well as before, the physical or chemical agents performed upon it. On the
other hand, In Re Lawson v Commissioner, supra, it was held that as a
result of the process then under consideration, neither the character
nor the conditian of a material object ytas in any way physically changed,
nor was the user's ability to deal with it in anyway increased or decreased.
The other factor to be decided is whether the "art" in terms of the present
process satisfies the prerequisites of being a "useful" art or process
within the meaning of Section 2(d), which may be conveniently stated,
inter alia as to: whether the subject matter is useful in a "manual or
productive art" (as distinct from a fine art such as that in which novelty
is solely the exercise of professional skills, or that having intellectual
meaning or aesthetic appeal alone), whether the subject matter is con-
troliable and reproducible by the means disclosed so that the desired
result inevitably follows whenever it is worked, and whether the subject
matter has utility in practical affairs (as that in relation to trade,
commerce or industry) which is beneficial to the public.
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 Re Lawson v Commissioner,
supra. The fact that the relevance of the end result of the present process
eay 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 affect or employ the physiological processes of a living
animal. That patentability should be denied merely because treatment
of a living animal is a prerequisite of the usefulness of the end produced
is untenable since it would be wide enough to exclude medicines as well
as their processes of manufacture intended to be governed by Section 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 Rc Tennessee Castman v Commissioner of Patents, of December 19, 1972
(unreported), (on appeal from the Exchequer Court's decision on the same
case, supra) when it stated that the process then under consideration of
applying a medicine to a human being "...is clearly in the field of practical
application" as opposed to a mere scientific principle or abstract theorem
excluded by Section 28(3) of the Patent Act.
In the S.C.C.'s decision Tennessee Eastman v Commissioner, supra, it was
held that patents for medical treatment per se must be excluded under
the Patent Act in that the use of a medical substance cannot be claimed
by a process apart from the process of producing it. In any event the
present claims distinguish factually from the claims then under consid-
eration in that no step of medical or surgical treatment is set out in the
claims. It is also noted that in this decision the Supreme Court seemed
to equate its decision with the latest reported case brought to its
attention, In Re Schering A.G.'s Application (1971) RPC 337 , a case
dealing with a method of contraception, citing the conclusion of the
Patent Appeal Tribunal at page 345 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 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 judgement, be allowed to proceed. As swift's Application (1962)
RPC 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 appli-
cation 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 by the Court)
It is also of interest to note that the material advantage and the economic
issues were indicated by the citation of the National Research Development
Corporation's Application (1961) RPC 135 in both the Lawson v Commissioner
and Tennessee v Commissioner (Exchequer Court), supra, wherein it is stated:
The point is that a process, to fall within the limits of
patentability which the context of the Statute of Monopolies
has supplied, must be one that offers some advantage which is
material in the sense that the process belongs to a usefut art
as distinct from a fine art (sec Virginia-Carolina Chemical
Corporations's Application (1958) RPC 35 at p. 36) -- that its
value to the country is in the field of economic endeavour.
(the exclusion of methods of surgery end other processes for
treating the human body may well lie outside the concept of
invention because the whole subject is conccived as essentially
non economic: see Maeder v Busch (1938) 59 C. I..R 684 at p. 706).
(Emphasis added)
The Board is therefore satisfied that the present state of the law
provides no basis on which to exclude the present subject matter from
patent protection. The subject matter lies in the field of a "useful art"
as opposed to a "fine art", "abstract theorem" or "scientific principle".
It is an invention which is inherently beneficial to the public, and one
which is reproducible and controllable to produce the desired result when-
ever it is worked or used. Furthermore, it has utility in practical affairs,
has commercial application and is not contrary to the public interest.
In the circumstances, therefore, the Board is satisfied that the Commissioner
ought not to refuse claims 1 to 8 on the grounds that the subject matter
falls outside the statutory requirements of Section 2(d) of the Patent
Act, and recommends that the Final Action refusing claims 1 to 8 be
withdrawn.
J.F. Hughes
Acting Chairman
Patent Appeal Board.
I concur with the findings of the Patent Appeal Board and withdraw the
Final Action and seturn the application to the examiner for resumption
of prosecution.
Decision accordingly,
J.A. Brown
Acting Commissioner of Patents.
Dated at Ottawa, Ontario
this 23rd day of Mach, 1973
Agent for Applicant
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