COMMISSIONER'S DECISION
STATUTORY - Section 2(d): Chemical Test Using New Fluorescent Dye
The process of applying a fluorescent dye to the teeth and gums so as to reveal
to the naked eye diseased tissue when subjected to light in the specified
Angstrom range is a matter of fact within the meaning of "art" which produces
a physical change or result; the making and use of which satisfies the pre-
requisites of a "useful'' invention as have been applied by jurisprudence.
FINAL ACTION: Reversed
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This decision deals with a request for review by the Commissioner of
Patents of the Examiner's Final Action detect May 16, 1972 on application
880,719. This application was filed in the name of Herbert Brilliant
and refers to "Use Of Fluorescent Dyes to Matters In Oral Cavity".
In the prosecution terminated by the Final Action the examiner refused
claims 1 to 6 as not patentable under Section 2(d) of the Patent Act,
and claims 7 to 9 as not patentable over the prior art:
Canadian Patent:
500,625 Mar. 16, 1954 Alderman et al
In the Final Action the examiner stated in part:
The rejection of claims 1 to 6 is maintained and the reason for
such rejection is that not all processes are patentable. The
methods of clinical testing in claims 1 to 6 belong to the realm
of practising medicine in general and more specific in the pro-
fessional field of dentistry and surgery and therefore are not
patentabie under Section 2(d) of the Patent Act.
The rejection of claims 7 to 9 is maintained and the reasons for
such rejection is that the subject matter of claims 7 to 9 is not
patentably different from the compositions taught by Alderman et
al in Canadian Patent 500,625 which teaches an oral cleanser or
dentrifice containing a fluorescent substance which fluoresces
when exposed to light containing some U.V. radiation e.,g. 2920
to 4000 ~ units in an aqueous carrier. The amount of the fluor-
escent dye claimed in claims 7 to 9 is in the range 0,00005% to
5.00% and therefore still incorporates the range of 0.001% to
0.1% claimed in the above mentioned patent. Also the range of
wavelength claimed of 3000 to 5000 .ANG. units still incorporates
part of the wavelength of the above mentioned patent eg. 2920
to 4000 ~ units.
In the response of August 12, 1972 the applicant stated in part:
The Examiner has cited Canadian patent 500,625 against claims 7 to
9. These claims have been amended to remove the abjectionable
subject matter, and in particular, claim 9 (old claim 7) has been
amended to restrict the lower limit of fluorescent dye and the re-
maining claims also contain such restrictions as well as an amended
lower limit of wave length frequency in the case of claim 11. It
is submitted that the amended claims define patentable subject matter
over patent 500,625. This reference is directed to the use of
alkaline aqueous carrier which is not the case in the present
invention. The range of fluorescent dye in the cited reference
as stated by the fixaminer at the top of page 2 of the official
action of May 16th is 0.001% to 0.1%. The new composition claims
contain restrictions as to the amount of fluorescent dye and
frequency of light wave exposure, all being outside the range
referred to in the Alderman cited patent.
Corresponding amendments have been made to method claim 1 and new
method claims 2 and 3 have been added containing revised ranges.
Reconsideration of the Examiner's rejection of claims 1 to 6 is
also respectfully requested. The reason given in the official
action for the rejection is "that not all processes are patentable".
This may well be the case, but applicant submits that method claims
1 to 8 are patentable in the present situation.
The Examiner has also suggested that inventions in the "realm of
practising medicine in general and more specific in the professional
field of dentistry and surgery" are not patentable. Applicant knows
of no Canadian law prohibiting such inventions, and in any event,
as is clear from the enclosed brochure the method of new claims 1
to 8 is not in the "professional" field of dentistry since it is
intended to be carried out by the non-professional user.
It is submitted that the invention defined in the method claims 1
to 8 is distinguishable from the Exchequer Court case of Tennessee
Eastman v. The Commissioner of Patents 62 C.P.R.117. That case was
directed to clams primarily for a method treatment of human
bodies, namely the surgical bonding of tissues. In the present
case the applicant's invention is not "treating" human bodies as
discussed above.
This invention relates to means for making visible to the naked eye
pathological conditions on topical areas of the human body. More
particularly, it has reference to means for making readily visible tumors,
epithelial aberrations and the like which exist in or near the external
body tissues, as well as plaques, microcosms, tartar, leaky dental
fillings and dental decay. The composition of the solution used is
also claimed. Claim 1 and claim 9 which are representive of the invention
read:
Claim 1:
A method of making visible to the naked eye the presence of
disease-causing foreign matter in the oral cavity of a living
human being, comprising, applying a composition consisting
essentially of water is which is dissolved from about 0.00005% to
about 5.0% of a non-toxic, pharmaceutically acceptable fluorescent
dye, to the areas suspected of having disease-causing foreign
matter and to the areas adjacent thereto having relatively no
such foreign matter, and bathing both areas in light whose wave
length has a frequency within the range of between about 3000
and 5200 Angstrom units, whereby the two areas are sharply
delineated as the one of said areas which contains the foreign
matter is caused to glow with the color of the florescent dye
while the other remains substantially un-illuminated.
Claim 9:
A composition which may readily be applied to the various areas
of the oral cavity of a living human being in order to make
visible to the naked eye the presence of disease-causing foreign
matter therein, said composition consisting of water in which is
dissolved from about 0.2% to about 5.00% of a non-toxic, pharmaceut-
ically acceptable fluorescent dye which, when it comes into contact
with areas having disease-causing foreign matter and areas adjacent
thereto having relatively no such foreign matter, and both areas
are bathed in light whose wave length has a frequency within the
range of between 3000 and 5200 Angstrom units, causes the two
areas to be sharply delineated as the one of said areas which
contains the foreign matter is caused to glow with the color
of the fluorescent dye while the other remains substantially
un-illuminated.
At the outset the Board observes that the Final Action at the time
conformed with Patent Office guidelines routing to the patentability
of inventions involving methods of testing involving the human body, 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 amended process claims
1 to 8 constitutes a "useful art or process" within the meaning of Section 2
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 of the Patent Act. In the
present case there is no need to consider novelty and unobviousness of tire
process claims since no objection has been wade on such grounds.
Section 2 of the Patent Act reads in part:
"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,
manufacure or composition of matter.
Recently these has been two ~~~~~~~~ Court case of particular interest
in the interpretation of Section 2 of the Patent Act. They are
J. W Lawsen v The Commissioner of Patents (1970) 62 C.P.R. 101
which concerns claims directed to a method of ~~~gical bonding of body
tissues.
The question of whether a subject matter is an "art" or "process"
was considered In Re Lawson v Commission. 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. And later at page 109 Cattanach J. stated:
"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 ins abstract in that it is capable of contemplation of the
wind. It is concrete in that it consists in the application of
physical agents to physical objects and is then apparent to the
senses in connection with some tangible object or instrument.
And at page 110 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 the meaning of an
"art" is a matter of fact, for the process consists of the application
of a fluorescent dye to the teeth and gums which produces a physical
change in character of the result to be achieved when subjected to
light in the specified frequency range.
The other factor to be decided is whether the"art "in the terms of the present
process satisfies the prerequisites of being a "useful " art or process
within the meaning of Section 2, 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-
trollable and reproducible by 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
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 ~ffect a curative or preventive treatment of an aliment.
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 Re Tennessee Eastman v Commissioner of Patents, of December 19,1972
(unreported), ton 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 Section 28(3) of the Patent Act.
In the S.C.C.s decision Tennessee Eastman v. Commissioner, supra, it was
concluded 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 referred
to in latest reported case brought to its attention, In Re Schering
A.G's Application (1971) RPC 337, a case dealing with a method of contracep-
tion, 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 the subject o 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.... (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 RCP 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 useful art
as distinct from a fine art (see 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 ....
(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";
it is an invention which is inherently beneficial to the public; one
which is reproducible and controllable to produce the desired result when-
ever it is worked or used, and it has utility in practical affairs.
In the circumstances, therefore, the Board is satisfied that the Commissioner
ought not to refuse amended claims 1 to 8 on the grounds that the subject
matter fails outside the statutory requirements of Section 2 of the Patent
Act, and recommends that the refusal on this ground be withdrawn.
The second ground of rejection that claims 7 to 9 are too broad in scope
is well taken,however, the applicant has presented amended claims 9 to 13
in an attempt to overcome the cited art.
The cited patent (500,625) relates to an oral cleansing agent in the
form of a dentifrice containing a fluorescent substance in a slightly
alkaline, aqueous carrier. The disclosed operable concentration of the
fluorescent substance was 0.001 to 0.1%, furthermore,the purpose and
function of the fluorescent substance was to create and optical illusion
of greater whiteness to the teeth.
In contrast, the composition of the current application consists solely
of an aqueous solution of a fluorescent dye in the concentration range
of 0.2 to 5.0%. The purpose of the fluorescent dye is to differentiate
between healthy and unhealthy tissues or teeth when exposed to the
appropriate activatable light rays for the dye. There is , however,
no teaching in the reference that the alkaline, aqueous solution of the
fluorescent dye could be used for the purpose intended by the applicant.
The Board is therefore satisfied that amended claims 9 to 13 avoid the
cited prior art, however ,some consideration should be given to amended
claims 1 to 8 in view of the cited prior art.
I concur with the findings of the Patent Appeal Board and withdraw the
ground of rejection under Section 2 of the Patent Act, and accept claim
9 -13 as avoiding the cited prior art. The application is returned to
the examiner for resumption of prosecution.
Decision accordingly,
A.M.Laidlaw
Commissioner of Patents.
Dated at Ottawa, Ontario
this 16th day of April, 1973
Agent for Applicant:
Smart & Biggar,
Ottawa, Ontario