COMMISSIONER'S DECISION
Patentability of Kits, Aggregation - Radio isotopic Scanning Agents
Applicant discovered that phospholipids are particularly suitable carriers
for technetium radio isotopes used in radio analysis of liver organs.
Because of the short half life of the mixture, it must be prepared
immediately before use, and cannot be sold premixed. Consequently applicant
wished claims to a package of the separate ingredients, said ingredients
to be mixed when used. It was held that under the circumstances existing
the claims should not be rejected as aggregative, or because they are
directed to a package or kit of ingredients. However the application was
remanded to the examiner to consider the application of Section 41, since
the ingredients were claimed in per se form.
*************
Application 241,628 (Class 167-48) was filed on December 12, 1975 for
an invention entitled "Labelled Phospholipid Spheres for Organ Visual-
ization". The inventors are Abram Petkau and Stanley D. Pleskach. On
May 8, 1979 the examiner, in a Final Action, refused some of the claims.
A hearing was requested originally, but applicant subsequently withdrew
that request.
The subject matter involves the use of a phospholipid carrier for radio-
isotopic scanning agents. Phospholipids have proven to be particularly.
suitable carriers for radioisotopes to be administered to patients to
permit radioanalysis of various organs, such as the liver. Nineteen
claims directed to a process for mixing the radioisotopes with phospholipids,
and to the resulting admixture were considered by the examiner to be allow-
able. However he refused the last eight claims 20 to 27, in which the
applicant claimed a package or kit of the separate ingredients used to
carry out the process and prepare the phospholipid-radioisotope composition.
He considered that the latter claims were directed to a mere aggregation of
ingredients which do not inter-react until taken from their separate con-
tainers and used in the process.
Claims 20 to 27 are limited to a particular radioisotope of the element
technetium. Because of its short half life there is a particular need
to prepare it just before use. Claim 20 covers a kit of the various
ingredients used to prepare the injectable material when it is needed.
The injectable material itself cannot be readily sold as such since it
would deteriorate seriously before it reached the user. Claim 20 reads
as follows:
20. A combination yielding medical scanning agents labelled
with short-lived radioisotope 99mTc, comprising:
(1) a 99Mo radioisotope generator yielding pertechnetate anion
99mTcO-4 in solution,
(2) a concentrated reducing agent for obtaining from 99mTcO-4,
99mTc in multivalent cationic form, said multivalent
cation form of 99mTc forming a firmly-bound complex
when contacted with phospholipid of (4)
(3) a buffering reagent for the solution of 99mTc in multi-
valent cationic form,
(4) an aqueous colloidal dispersion of phoshholipid material
having a predetermined particle size so as to localize
at preselected organs after injection, and
(5) kit means to separately contain until use predetermined
amounts of at least (2), (3) and (4).
(Tc is the radioactive element technetium).
The examiner rejected the refused claims on the grounds that that they were
directed to a mere juxtaposition of parts, and as such amounted to an agg-
regation rather than an active combination.
Trough the years the definitions of "combination" and
"aggregation" as used in the patent field have been
many and varied. A few are represented here as examples.
Combination - a collection of inter-communicating parts
so as to arrive at a single and not complex
result (British United Shoe V.A. Fussell a
Sons (1908) 25 R.P.C. 631)
- where the old integers when placed together
have some working inter-relation producing a
new or improved result then there is patent-
able subject matter in the idea of the working
inter-relation brought about by the collocation
of the integers (British Celanese v. Courtaulds
(1935) 52 R.P.C. 171 at 193)
Aggregation - it is accepted as sound law that a mere placing
side by side of old integers so that each per-
forms its own proper function independently of
any of the others is not a patentable combina-
tion (British Celanese decision supra)
- each functions independently...no common re-
sult (Lester v. Commissioner of Patents (1946)
C.P.R. 6 at 3)
- mere juxtaposition of parts is insufficient for
patentability. The elements must combine for
a unitary result. If any clement in the arrange-
ment gives its own result, without any result
flowing from the combination, then there is no
invention (Domtar Ltd. V. MacMillan Bloedel
Packaging Ltd. (1977) C.P.R. 33 182 at 189)
As examples of aggregation may be cited the well known toy pistol-
whistle (Lester decision supra) and the more recent non-cooperating
elements of the rectangular container for beer bottles (Domtar
decision supra).
In any event, the indispensable prerequisites of utility, novelty,
and inventiveness required of patentable inventions must be met.
Using the above as a basis we must turn to the subject matter of
claims 20 to 27 in order to determine whether the kit falls into
the broad category of combination or that of aggregation.
The claims broadly- describe a three (or more) component system with
each component being separated from the others until use, when they
are mixed. This could conceivably be accomplished by placing
individual components in separate stoppered test tubes or bottles
one of which serves as mixing vessel when the agent is prepared;
another possibility would be a multi-compartmented vessel where the
components are kept separate until mixed by transfer from one
compartment to another or by breaking barriers between compartments.
The previous is conjecture; however, any such contrivance would
serve the purpose of the claim.
The applicant does not disclose a new apparatus for keeping components
separated until use. It is clear that such a contrivance has not been
invented in this application.
Further, it is clear that each component of the kit is known separately
and not one of these components is claimed separately.
The method of preparing the radioactively labelled phospholipid particles
and the product thereof appear to be allowable and the use of such for
medical treatment appears to be inventive albeit non-patentable.
It is held that the association of components as defined in claims 20
to 27 (three or more separate entities associated in the spaced rela-
tionship of a kit) is not allowable in view of the above.
There is no inter-communication or working inter-relation between the
components. The components are merely placed side by side, each main
taining its individual character, remaining independent, not influencing
or being influenced by the others. The relationship of the components
is not that of a result or product but rather that of starting materials.
Certainly the product of end use of the kit could be a patentable com-
bination because the labelled phospholipid product is a unitary result
which is not the mere sum of the components but rather the result of
their interaction. The kit claimed herein could well be compared wit
a kit to a new apparatus, i.e. an assemblage of parts or components
with instructions as to how the parts fit together; surely this is
not patentable.
In his response to the Final Action, applicant said:
In the Final Action, the Examiner has provided some quotations from
jurisprudence relating to patentable combinations and to aggregations.
It is submitted that the quotations presented by the Examiner
relating to combinations are applicable to the present claims.
For example, one of the quotations is from "British United
Shoe v. A. Fussell & Sons" (1980) 25 R.P.C. 631 which reads
"--- a collocation of inter-communicating parts so as to arrive
at a single and not complex result ---". The combination
presently being claimed has a "collocation" of components
adapted to "inter-communicate" and when it is put into a
"single result" is obtained and the whole definition fulfilled.
The combination is used to produce one end result, not several
unconnected results as, for example, the aggregation of a
pencil and its eraser.
It is further submitted that the quotations relating to an
aggregation do not apply to the present claims, as is rev-
ealed on examination of them. One of the quotations, for
example, is from the decision British Celanese v. Courtaulds
(1935) 52 R.P.C. 171 wherein it was stated that "It is
accepted as sound law that a mere placing side by side of
old integers so that each performs its own proper function
independently of any of the others is not a patentable com-
bination". It is quite evident from the present specifica-
tion as a whole that the combination of components which is
being claimed is not a mere placing side by side of old
integers so that when put into use performs its own proper
function independently of any of the others. The components
of course do not "perform" any function until put into use
by the user but when used the function is that of a combination
which yields a novel and inventive result.
Another quotation made by the Examiner relating to an aggrega-
tion is "Domtar Ltd. v. McMillan Bloedell Packaging Ltd".
(1977) C.P.R. 33, 182 at 189 wherein it was stated that "Mere
juxtaposition of parts is insufficient for patentability. The
elements must combine for a unitary result. If any element in
the arrangement gives its own result, without any result flowing
from the combination, then there is no invention". Again, this
quotation does not describe the present invention as claimed in
proposed claims 20 to 27 in that when the components are used,
the elements do combine to produce a unitary result. Again,
we can refer to a typical example of an aggregation as being a
pencil and its eraser.
His contentions that the claims to the "kit" represent a patentable combination
are as follows:
The claims to the combination describe components adapted
to produce a patentable result when used. Thus, it seems
to us that a true combination is involved by virtue of
the intended use. This is the commercial embodiment of
the invention and the purchaser is not going: to buy it
unless it is going to be used for its intended use. The
combination as such has no other utility. Granted, each
component taken separately has its own utility which may
be for a number of other purposes but no one is going to
purchase the combination to use those components separately
for other reasons. In this respect, of course, the Examiner
states that each component is known and none are claimed
separately: It is quite true that the components are not
being claimed separately but this is the whole point. There
is an interrelationship between the components when they are
put into use, which is the only conceivable use of the com-
bination. The parts or components are not being sold separately
nor are they being claimed separately. It is the combination
that must be considered.
In fact, we do not know of any jurisprudence which precludes
the claiming of a set or combination such as is the subject
matter of the claims in dispute. To our knowledge, the
specific point has not been ruled upon. However, we can
refer to some Commissioner's decisions for consideration.
As far as the proposed revised claims are concerned, it is to
be emphasized that there is a sequential relationship of the
components which is very significant. The components, as they
are listed, are for sequential use in preparing scanning agents
according to the invention. There is the radioactive pertech-
netate anion in solution, which is then reduced by means of a
concentrated reducing agent in order to obtain radioactive
technetium in multivalent cationic form, a buffering agent is
then used and finally the radioactive material is added to an
aqueous colloidal dispersion of phospholipid material. Dep-
endent claims list other components which fit into this sequence.
This sequence of preparation of the scanning agents is quite
clear from the disclosure and reference can be made for example
to pages 11 and 12 wherein the preparation of a scanning agent
is exemplified.
Applicant then went on to discuss two recent Commissioner's Decision, which
he alleged were definitive with regard to Office Policy on aggregation, His
arguments on that point, are reproduced here:
As the components in combination interact in sequence to yield
a novel and inventive result, it is contended that the Examiner's
position is contrary to Office Policy as set forth in the
Commissioner's decision regarding the application that is now
Canadian Patent No. 984,296, the decision being reported in the
Canadian Patent Office Record, 13 July 1976, page xiii. In
that decision, claims to a package of contraceptive pills so
arranged as to be adapted to the use of which they were to be
put were held to be patentable. The significance of the claims
to the package was that by special construction of the package
and/or indication to ensure that the pills were taken in the
right order, the proper ratio of two types of pills would be
taken and in the proper sequence. It was held that this
constituted a novel application of the discovery made by the
Applicant with the pills so arranged as to take advantage of
that discovery. Thus, it was considered that the Applicant
had discovered a new method and that the method of applying
that discovery was what was patentable even though the applica-
tion of the discovery might be quite simple once the discovery
had been made. Thus, by this decision, claims directed to a
package containing individual pills or capsules containing the
two types of steroids were obtained, the components having an
interrelationship taken effect when the package was utilized
by the purchaser.
It is believed that this decision is analogous to the present
situation. In the present case, there is also a novel and
practical application of a new discovery, the new discovery
being the particular scanning agents and the method of making
them. However, because a short-lived radioisotope is used
for labelling the scanning agents, these agents are not suit-
ably prepared until just prior to use. Thus, the components
for preparing the scanning agents are sold in combination and
this is the novel and practical application of the discovery
of the products and the method of making them. Thus, to
repeat, it is believed that if the proposed revised claims
arc not accepted, then this is counter to Patent Office policy
expressed in the aforementioned decision.
We can also refer to another Commissioner's decision which
related to an application which is now Canadian Patent No.
1,051,713 and was reported in the Canadian Patent Office
Record on 15 May 1979, p. iv. The application in question
related to a process and apparatus for the manufacture of
coffee extracts. The claims to the process were not at
issue in the appeal as it was agreed that those claims
defined patentable subject matter. The claims, in question,
related to apparatus, which the examiner had rejected as
being a mere mechanical juxtaposition of conventional units
of apparatus to implement a given process, even though the
process was considered patentable. The Applicant stated
that a unitary result was achieved which was the ability of
the apparatus system to carry out the inventive process and
argued that apparatus and process were different aspects of
the same invention. It was held that the claims to the
apparatus were to a combination in that a unitary result
could be produced, the unitary result being the coffee
extract produced in a more expeditious manner than previously.
It was held that all the elements of the apparatus contributed
their part to produce the unitary result.
As the individual parts of the apparatus in the aforementioned
application were apparently conventional, surely the unitary
result emphasized in the decision could only be achieved when
the apparatus was used to carry out the method. It is believed
that this is analogous to the present situation where the
combination comes into complete effect when the components
are used to prepare the scanning agents just prior to use. The
components are, however, by their nature specially adapted to
provide the end result.
It is believed that these two Commissioners' decisions substantiate
the position taken by the present Applicant that the claims as
proposed define patentable subject matter and ought to be allowed
in accordance with Patent Office policy as expressed in those
decisions.
Applicant submitted additional arguments about the patentability of the kit
claims as follows:
There are other reasons for submitting that the proposed claims
ought to be allowable. A patentee is entitled to claim all
aspects of his invention and a commercial form of that invention
is surely one aspect which is believed to be suitable for patent
claiming. As pointed out previously, the commercial aspect of
the present invention is the combination of components ready for
use in preparing medical scanning agents.
Although claims to the preparation of the scanning agents and to
the products so produced have been indicated as allowable, these
claims are in practice virtually impossible to police as the
method would be carried out by the user only prior to scanning
tests and thus manufacturers are not going to be making and
selling the scanning agents. The claims to the method of prepara-
tion of the scanning agents and the products so produced would
only be infringed by health practitioners, who are individuals
against whom one would not normally claim patent infringement
damages. Thus, the claims presently under consideration are
the only real protection afforded the Applicant by way of
protection for the commercial embodiment of the invention. The
Examiner agrees that an invention and an advance in the art have
been made by his indication that the process and product-by-process
claims are allowable. As the claims now in dispute are vital to
the Applicant, we believe they ought to be allowed in the absence
of relevant prior art.
Finally, applicant discussed the inconsistent nature of the present practice
in the Patent Office with regard to kit or package claims, particularly in
the chemical arts. We present his view of this practice below:
In our view, there is no precedent in jurisprudence for rejecting
claims of the present type and we are not aware of any established
precedent for rejecting claims of this type in the Patent Office
practice. It is understood that in the mechanical arts, claims
to kits of cooperating integers are frequently granted. Obviously,
the present situation is analogous.
Also, we direct attention to Canadian latent No. 1,012,449 of Cohen
issued 21 June 1977. That patent contains claims to a kit for use
in determining nitrogenase activity in soil. There is also Cana-
dian Patent No. 1,056,729 of Clarke et al issued 19 June 1979. This
patent contains claims to a two-pack container or syringe, one part
containing dry amoxycillin trihydrate or sodium amoxycillin and the
second part containing a sterile mixture of water and a water-misciele
pharmaceutically acceptable alcohol. The pact is to be used to
prepare a solution of the amoxycillin suitable for injection just
prior to use Even though the particular end solution is disclosed
as having enhanced utility, it is still most practical to avoid
problems by preparing the solution just prior to use. There are
also claims in the patent directed to the end solution and the
process of making it, It is our view that the claims in this patent
are analogous to the present situation and it must be pointed out
that the prosecution of the application which became Canadian Patent
No. 1,056,729 was handled by the Examiner who is in charge of the
present application. Thus, if the present claims are refused, every-
thing else aside, there is not consistency of examination before
the Patent Office.
Applicant summarized hie arguments as follows:
In summary, therefore, we believe that there is no precedent
in jurisprudence or in Patent Office practice for rejecting
claims of the type order discussion here. Furthermore, it
is believed that any contention that the claims in question
are directed to an aggregation is untenable in view of the
reasons presented including recent Commissioner's decisions.
We do not think too much weight should be given to what is or is not the
alleged practice of the Patent Office, or upon what patents may have been
issued or refused. In our view we must look at the application itself and
see if it complies with the patent law as stated in legislation, and as
interpreted in jurisprudence by the courts.
The case before us raises the interesting question of whether an applicant
is entitled to claim ingredients used to prepare a new and patentable
composition where those ingredients are assembled together in a unitary
package, and when the ingredients are separately old and known in the prior
art. The same question would arise in a mechanical case where an inventor
claims a box of selected standard and known parts which if assembled according
to his instructions would produce a new and patentable machine. In both cases
we must ask ourselves whether the parts properly define the invention as
required by Section 36 when the invention is something made from those parts.
We must also determine in the present case whether the requirements of
Section 41 are being circumvented.When it was pointed out to applicant
during the prosecution of this application that Section 41(1) governed the
new composition being claimed, he made those composition claims dependent
on the process for preparing them. See present claim 17, for example. We
do not know whether there are other ways of preparing the desired product
from the same ingredients than that covered by applicants process claims,
but by claiming the ingredients used independently of any process claims,
applicant effectively blocks all possible routes to the scanning agent
using those ingredients, and there may indeed go beyond what is permitted
by Section 41(1). He has not particularly described what those other
processes may be, and his protection would be broader than a product made
by the process of claim 1.
This is, we believe, comparable to the situation which arose in Commissioner
of Patents v. Farbwerke Hoechst,1964 S.C.R. 47, where the applicant attempted
to claim per se a new medicine in a carrier. Mr. Justice Judson remarked,
at p. 53
If a legal impediment exists against a patent claim for the
new medicinal substance, namely S. 41(1) of the Patent Act,
that legal impediment is equally applicable to the diluted
substance.
and at page 54:
The decision under appeal is of extreme practical significance.
It gives effect to form rather than substance. The claim to a
pharmaceutical composition with which the present application
is concerned is free from the limitations imposed by S. 41(1)
and a person who obtained a patent in this way could assert
such claims against anyone using the pharmaceutically active
ingredient constituting the substance of the invention regard-
less of the process by which it was produced. Furthermore,
it might affect compulsory licensing applications under S.
41 (3) .
In a later case, Tennessee Eastman v. Commissioner of Patents, 1974 S.C.R.
111 to 118, Mr. Justice Pigeon said:
Section 41 was enacted for the purpose of restricting the
scope of patents "relating to substances prepared or
produced by chemical processes and intended for food or
medicine. The same principle proclaimed is that in the
case of such inventions, "the specification shall not
include claims for the substance itself, except when
prepared or produced by the methods or processes of
manufacture particularly described in the claim or by
their obvious equivalents". 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. In
other words, if a method of treatment consisting in the
application of a new drug could be claimed as a process
apart from the drug itself, then the inventor, by
making such a process claim, would have an easy way out
of the restriction in S. 41(1).
It is thus clear that the courts are concerned about the effective circum-
vention of Section 41 by use of per se product claims for something
one step removed from the crux of the invention. In the two cases just
cited the crux of the invention was the chemical compound, and the
applicants wished to project patentability forward to something coming;
later, in the one case a process for using the compounds, in the other
to mixtures containing the compounds. however the court recognized
that this would effectively avoid Section 41, and held the claims to be
unpatentable. In the present case applicant is projecting from the
composition backward to the ingredients used to make the compounds, and
claiming those ingredients without any process limitation. Claim 20
furthermore, would protect those ingredients no matter what use they may
be put to.
In a similar case, In re Dow Corning, 1974 R.P.C. 235 the Patent Appeal
Tribunal was also considering claims to packs containing known substances,
and submitted that the claims were in fact a disguised form of claim to a
process for the medical treatment of human beings, and could not be allowed.
In the present case, it can equally be said that the claims are a disguised
form of claiming a medicinal substance.
We are not satisfied, however, that claims to "packs" or "kits" are always
objectionable, or aggreative in nature. In the matter of Organon Laboratories
Ltd.'s Application (1970 R.P.C. 574) it was concluded that there might be
invention on placing pills (where the ingredients were old) upon a card in a
particular order, which new order was suitable for a newly discovered method
of treatment, even though it was already known to arrange other packs or cards
to make it easier for the public taking treatment to select the appropriate
pill at the appropriate time. The rationale for allowance was that a particular
order was necessary to permit the pills to be used for a newly discovered
method of treatment. As explained in the Dow Conning case, supra the effect
of the Organon decision would not secure to the patentee a monopoly for
their discovery of medical treatment, since others would be free to take the
pills in the prescribed order provided they did not use the cards to select
their pills.
In the matter of L'Oreals' Application, 1970 R.P.C. 565 the applicant sought
to patent a pack containing two components for use in a process of treating
hair, it being essential to keep the components apart until just before
treatment of the hair. The claims were wide enough to cover the case where
the ingredients to be made were placed in separate bottles in the same box,
subject to the limitation that each container should be of a size sufficient
for one treatment of hair. The claims were rejected by the Tribunal, it
being found that
(1) the composition to be prepared by mixing together the
contents of the two containers in the pack was well
known (though for a different purpose)
(2) It was well known that the composition could be prepared
from the ingredients
(3) It was well known to make two component pack when
circumstances demand it, e.g. when the components
should be kept apart until they are used.
Under those circumstances, the court made some interesting observations:
From L'Oreals' Application 1970 R.P.C.
By their present application the applicants seek to secure
claims to a, so-called, "two-component pack". In such a
pack the ingredients for the hair treatment process are
sold to the public in separate containers. The reaction
components are thus kept separate but ready for admixture
by the user immediately prior to the application to the
hair .
The desirability of such a claim from the applicants'
point of view is self-evident. Treatments of the kind
envisaged will be carried out by hairdressers or by
members of the public at home. If the only claims which
can be alleged to be infringed are process claims, as
already secured, the applicants are likely to be put
in the possibly difficult and certainly undesirable
position of having to sue potential customers. If
other manufacturers do no more than sell competing
"two-component packs", it is, to say the least,
uncertain on the law as it at present stands, whether
an action against them on the process patent would
succeed.
It is accepted by the applicants that, if their claim is
allowed, they would be able to stop anyone carrying away
from a chemist shop two small bottles containing the
ingredients and done up in one parcel for whatever
purpose he required them. The applicants say however that
in practice no proceedings would ever be taken on such a
case as we have just postulated, which they describe as
unreal, and they further say that in any event they ought
to be entitled to sue such a man. Why it is said that
they should be entitled to sue such a man is not entirely
clear to use. The case cannot be described as wholly unreal.
A man might well want to use materials suitable for the hair
treatment process, and in similar quantities, for other
purposes for which they had already been proposed or might
be found useful. In general it mould appear to us to be
wrong to prevent the public buying or processing known
ingredients for making a known compound in any quantities
they like. If anyone uses the compound made from the
known ingredients for treating hair they may well of
course infringe the applicants' process patent.
What then are the proper considerations to be taken into
account when deciding whether the application should be
refused because the invention claimed is quite plainly
obvious and there is no possibility that it involves any
inventive step so as to add something to human knowledge?
The first and fundamental matter is of course to establish
the proper construction and scope of the claim, and it
should be noted that the applicants wish this case to be
approached on the basis that their claim is not further
limited than we have indicated above. It is thus clearly
seen to be so broad that the invention includes the mere
wrapping together in a paper bag of two small bottles of
the previously known ingredients which will make a known
compound irrespective of the purpose for which it is used.
Is such an invention so obvious and so clearly lacking in
inventive step that it should be refused and what consi-
derations are involved in deciding the question? Obviousness
is a question of fact which must be decided objectively. It
has been said to be a sort of jury question and was always
so treated specifically when patent cases were tried by a
judge and jury. Being a jury question, it is right that the
jury should, in deciding it, take into account all the
relevant circumstances. That, however, does not mean that
the question can be decided by taking into consideration
matters which, as a matter of law are not relevant and which
should not therefore be given any weight in deciding the
question.
Here it is clear that, if the jury in considering whether the
combined pack is an invention are entitled to take into con-
sideration and give weight to the fact that the applicants
allege that they have discovered a new method of treatment,
which on the material before the Comptroller is not shown
or admitted to be obvious, or if for some other reason it seems
it may not have been obvious to associate the benefit of the
doubt and allow them to have a claim to the combined pack.
The reason is that it can then be justifiably said that no one
would have thought of the combined pack unless they had already
conceived the idea of the treatment in question, and the
applicants are entitled to full protection for their discovery.
It thus seems to us that the vital question here is this:
is one entitled to take into account the fact that the treatment
for which the pack is ancillary is now and not obvious, or is
there present some other reasons why it may not be obvious to
associate the ingredients in one pack? If it is proper to take
the first of these matters into account or if there is some
other reason for non-obviousness present, then the claim should
be allowed, but if not the claim should be refused.
The correct conclusion thus may well depend, and in our judgement
in this case does depend, on the form and scope of the claim under
consideration construed in the light of the relevant surrounding
circumstance. In this case the Claim is so wide that it covers
the mere association of two bottles of the known basic ingredients,
known as useful when mixed together for purposes other than the
treatment of human hair, in one pack. The article covered by
the claim must, in our view, be tested without reference to the
discovery that the compound resulting from the combination of
the basic ingredients is very suitable for the treatment of
human hair. It is not suggested that there is any reason why
an ordinary member of the public wishing to use the product of
the known ingredients when combined,such product also being
known to be useful for other purposes, should not buy two
bottles of the ingredients and wrap them up together. Whether
the claim could have been limited in such a way as to cover a
pack or product which would be, from its construction or
otherwise, for practical purposes only suitable for the treat-
ment of the human hair is another matter. It is not so limited
and, in our judgment, refusal in such circumstances is the
inevitable consequence.
The applicants claim a pack consisting of two known ingredients
suitable for producing a known compound. The ingredients and
their product being known, the applicants have added nothing
whatever to human knowledge and have not given the consideration
necessary to support a grant of letters patent in the form which
they seek. The proposed claim covers no more than another
example of a form of combined package in itself well known. It
would be an unwarranted restriction upon the freedom of the
public to grant a monopoly which would prevent them buying or
producing such a package. In our view, the mere putting up
of two ingredients in separate containers in one pack, the
ingredients being intended to be mixed together before use to
produce a known compound, cannot prima facie amount to a manner
of new manufacture. It can only do so if some ground for
non-obviousness of the proposal, which it is permissible to take
into account, is apparent or may well exist. On the facts
admitted here, no such ground is present and the person making
the proposal for the pack in question has contributed nothing
to the stock of human knowledge and to grant such a person a
monopoly would be both hurtful to trade and generally incon-
venient.
The present case is, of course, distinguishable from that in L'Oreal because
the composition to be prepared was not known previously, since it contains
phospholipid materials added by the applicant for a specific purpose.
In another case, Ciba-Geigy, 1977 R.P.C. 83, Applicant wished to claim a
known substance in a container with instructions for a new use for that
substance as a weed killer. The application was refused on the basis
that there is nothing inventive in parcelling a known material in a
convenient package or container having written thereon the information
that it can be used for a new purpose. We quote from pp 88 and 89:
It is known that by crop-spraying with particular compounds
dicotyledinous weeds can be destroyed without damage to
monocotyledinous crops. The appellants have by research
and experiment discovered that if you spray the locus of
certain crops with a known compound it is possible also to
destroy monocotyledinous weeds (for example grasses) without
damage to the monocotyledinous crops. This discovery
qualifies as an invention on the basis of N.R.D.C. case (1961)
R.P.C. 134. This confers upon the appellants the monopoly
of the use of this compound for this purpose in respect of
such crops. However, since the compound is a known compound,
the monopoly may be of little value, and the appellants'
research and experiment little rewarded, because of the
difficulty of "policing" the unlicensed exercise of the
discovered method of selective weed eradication. Apart
from the manifest difficulties of policing, It is commercially
invidious to sue potential purchasers from the appellants
(or their licensees) such as farmers and crop-spraying firms.
They want to be able to prevent or discourage rival manufacturers
of the known compound from selling it with instructions that
it is suitable for application according to the appellants'
discovery. It is on authority questionable whether they can
do this as a matter of general principle. However, materials
such as this will in the ordinary course be sold with instruc-
tions for their use on the sack or other container.
For this reason, the appellants seek to claim in their complete
specification as follows, to take one of the two instances
under review: "12. A compound of the formula defined in claim 1
in a container which bears instructions for use in selectively
combating weeds at a locus comprising wheat, barley, rye, oats,
rice, maize, cotton or soya".
The examiner concluded that it is customary, in presenting a
substance for sale, to place the substance in a container with
a written indication of the use to which it is intended the
substance be put, and that the claim was not confined to an
invention, was clearly lacking in subject-matter and devoid
of any invention or manner of new manufacture, The patents
Appeal Tribunal (Graham, J.) considered that it was impossible
to say of claim 12 that the appellants were thereby doing
more than claiming the contents in any package of any size or
shape, and not one modified or qualified in shape or construc-
tion so as to be particularly suitable for the purpose for
which the contents were intended to be used: and upheld the
decision. From this the appellants appeal, with leave.
At the outset of the argument we were startled by the proposition
that it can be an invention to state in writing that which has
been discovered; that is to say, that the known material can be
used to combat selectively weeds in the loci described. It is
however clear that if the claim can be sustained so that rival
manufacturers of the substance cannot without infringement or
licence sell in containers hearing the information in question,
it will contribute greatly to the solution of the policing
problem. Graham, J. after discussing the cases of L'Oreal (1970)
R.P.C. 565 and Organon (1970) R.P.C. 574 and Dow Corning (1974)
R.P.C. 235 and after referring to a passage from the opinion of
Lord Roche in the Mullard case (1936) R.P.C. 323 with a comment
thereon with which we agree, summarized his decision as follows:
"Applying the principles of those cases ... it seems quite
impossible to say that by the claim (claim 12) ... the
applicants here are doing any more than claiming any
package of any shape or size which will not in any way be
modified by any instructions also included, that pack
containing only a well known and admittedly old material ...
they have not by the words used in any way modified their
pack or qualified it so that it has a particular shape or
construction or is particularly suitable for the purpose
for which the material is intended to be used. It is
really in effect only claiming the old material as such".
We find ourselves entirely in agreement with the decision of the
Patents Appeal Tribunal. We cannot see that it can sensibly be
said that there is any invention involved in claim 12, any manner
of new manufacture. The invention is the discovery that this
known substance may be used without harm to the stated crops for
the purpose of selectively combating weeds. There seems to us to
be nothing inventive about parcelling up the known material in any
and every convenient package or container having written thereon
the information that it can be used fox the stated puy ose in the
stated loci. There is no interaction between the container with
its contents and the writing thereon. The mere writing cannot
make the contents in the container a manner of new manufacture.
There is nothing novel in the mere presentation of information
by ordinary writing or printing on a container.
The United States Court of Customs and Patent Appeals has also shed some
light upon this question in its decision In re Venzici 189 U.S.P.Q. 149
(1976). In it the applicant wished to claim a kit of interrelated parts
to be used to splice cables. The normal way in which the invention would
be marketted was as kits, the parts to be assembled in the field when
cables were to be joined. The U.S. Patent Office had rejected the claims
on the ground that they did not properly define the invention, which it
considered to be the splice itself. The court held that the claims were
not indefinite, and said:
We do not believe the words in question (manufactures)
are to be so narrowly construed. To hold that the words
"any manufacture" exclude from their meaning groups or
"kites " of interrelated parts would have the practical
effect of not only excluding from patent protection
those "kit" inventions which are capable of being claimed
as a final assembly (e. g. a splice connector), but also
many inventions such as building blocks, construction
sets, games, etc., which are incapable of being claimed
as a final assembly. We do not believe Congress intended
to exclude any invention from patent protection merely
because it is a group or "kit" of interrelated parts.
We therefore hold that a group or "kit" of interrelated
parts is a "manufacture" as that term is used in section
101.
We are consequently persuaded that it is both legally and judicially sound
to permit claims to disassembled inventions or "kits" in certain cases.
It would be permissible, for example, where there is inventive novelty in
the manner in which the kit is constructed (as in the Organon case). It
would also be permissible when the invention would normally be marketted in
the disassembled form or indeed that is the only way in which it could
be marketted and the contents of the kit had not been assembled before
(for other purposes). There must of necessity be both ingenuity and
novelty in what has been done. It would not be permissible to cover
the mere placing together of ingredients previously known to be useful
for other purposes (cf L'Oreals). Nor to claim an old material packaged
with instructions for a new use for the old material. Nor to circumvent
other provisions of the Patent Act. It must comply with Section 36, for
example, by being directed to what really is the invention.
In the present case, there appears to be present both an element of novelty
and one of ingenuity in the claims rejected, and we do not believe the
rejection should proceed on the grounds relied upon in the final action.
We are satisfied from the cases cited that kits are not necessarily aggre-
gations nor can it be said applicants claims are directed to an aggreation.
We do believe however that the requirements of Section 41 should be con-
sidered.
G.A. Asher
Chairman
Patent Appeal Board, Canada
Having reviewed the recommendation of the Patent Appeal Board, I reverse
the rejection on the grounds relied upon, and remand the application to
the Examiner to consider whether Section 41 should be applied, or other
objections made.
J.H.A. Gariepy
Commissioner of Patents
Dated at Hull, Quebec
this 13th. day of January, 1981
Agent for Applicant
Scott & Aylen
170 Laurier Awe. W.
Ottawa, Ont.
K1P 5V5