COMMISSIONER'S DECISION
S2 Medical Treatment: Intravenous Therapy and Hyperalimentation
The steps of inserting a catheter into a body and determining its
placement in a living body i.e. in the domain of the professional
skills of a medical practioner performing a medical or surgical
method. Rejection of claims to non patentable subject matter
affirmed.
This decision deals with Applicant's request for review by the Commissioner
of Patents of the Final Action on application 394,006 (Class 128-91) filed
January 12, 1982, assigned to Catheter Technology Corporation entitled
Methods and Apparatus for Intravenous Therapy and Hyperalimentation. The
inventors are Leroy E. Groshong and Ronald J. Brawn (Deceased). The
Examiner in charge issued a Final Action on September 17, 1984, refusing to
allow the application. A Hearing was held on October 2, 1985, at which
Applicant was represented by his Patent Agent, Mr. Michael D. Manson.
The application relates to methods and apparatus for short term and long
term intravenous, IV, therapy including hyper-alimentation. Figures 1A and
2B reproduced below, show the catheter used for feeding the IV fluid.
<IMG>
In the illustrations reproduced below, the manner of inserting the catheter
into a patient for short term therapy is shown by figures 5A and 5C, and
the manner of subcutaneously positioning the distal end of the catheter
for long term therapy is depicted by figures 6D and 6F.
(see formula I, II, III, IV)
The proximal end 14 of catheter 10 (figure 1A) has a one way valve 12
adjacent to it and has a radio-opaque substance 15 therein. In use the
one way valve permits fluid to flow only from the inside of catheter 10
to the outside due to pressure of the IV fluid. The removable stiffener
18 is used to position the catheter inside the vein, and the substance 15
permits detection by x-ray during positioning. The flow reducer 21
regulates the IV fluid.
To position the catheter (fig. 5A) a syringe 28 with a needle 30 is used,
having a shield 34 placed over the needle. After penetrating the vein
the syringe is used to withdraw a quantity of blood sufficient to ensure
proper entry. The sleeve is moved forwardly, held, and the needle and
syringe removed. The catheter, filled with IV solution to eliminate air
from its interior, is inserted through the sleeve into the vein, and its
proximal end moved by the stiffener to its limit as determined by means
of the radio-opaque material and x-ray (figure 5C). The sleeve is then remov-
ed over the distal end projecting from the patient and the catheter secured
at the incision. Flow reducing adapter 20 (figure 2B) with restrictor 21
is then positioned on the distal end.
For long term IV therapy (fig. 6D), the shoulder area and catheter exit
area e.g. the chest, are prepared for surgical incision, including local
anaesthetic. The passer 36 is inserted to provide for passage of the
catheter to the exit point, followed by securing the catheter, removing the
passer, closing the incisions, and coupling an IV source to the distal end.
In his Final Action, the Examiner refuses all the method claims, 1 to 28,
for being directed to non-statutory subject matter and therefore "...outside
the definition of invention given in Section 2 of the Patent Act." He
indicates claims 29 to 32 are allowable. His rejection of the method claims
reads:
Claims 1 to 25 and 27-28 are directed to a method of
treating humans by means of therapy and claim 26 is
directed to a surgical method. These claims also in-
clude steps usually performed by a medical practitioner
in the normal practice of his profession.
The Applicant however, believes the Examiner is not applying
Tennessee Eastman v The Commissioner of Patents (1974) SCR 111 against the
factual situation of this application. The applicant argues, as follows,
in part:
...there is nothing in Section 2 in respect of the
definition of "invention" which provides grounds for
rejecting an application for patent of a method for such
therapy. The definition of "invention" in Section 2
includes any new and useful process. The claimed method
is clearly a new and useful process. The utility of such
a process is clearly disclosed in the application. The
applicant submits that the subject matter claimed in
claims 1 to 28 of this application is patentable subject
matter within the definition of invention as given in
Section 2 of the Patent Act.
The Applicant comments that he is entitled to the grant of a patent unless
the Commissioner can determine by law that no patent should be granted, and
he draws attention to Monsanto v The Commissioner of Patents (1979) 42 C.P.R.
(2d) 161 at 178 and the words of Mr. Justice Martland as follows:
Whenever the Commissioner is satisfied that the applicant
is not by law entitled to be granted a patent he shall
refuse the application and, by registered letter addressed
to the applicant or his registered agent, notify the
applicant of such refusal and of the ground or reason
therefore.
I have emphasized by law to stress that this is not a
matter of discretion: The Commissioner has to justify any
refusal. As Duff, C.J., said in Vanity Fair Silk Mills
v The Commissioner of Patents, (1938) 4 D.L.R. 657, (1939)
S.C.R. 245 at page 246:
'No doubt the Commissioner of Patents ought
not to refuse an application for a patent un-
less it is clearly without substantial foundation'.
The issue before the Board is whether or not the subject matter of claims
1 to 28 is patentable under Section 2 of the Patent Act. Claim 1 reads:
A method of performing intravenous therapy including
hyperalimentation comprising the steps: inserting the
proximal end of a flexible catheter having a one way
valve adjacent its proximal end through the skin of a
patient and into a vein having a suitably large flow
of blood therethrough; coupling the distal end of the
catheter to an interchangeable static flow reducing
means capable of restricting flow of fluid, from a
source positioned to provide a predetermined fluid head,
into said catheter at a rate no greater than a predeter-
mined clinically described flow rate, coupling a source
of intravenous solution to said flow reducing means,
positioning said source at an elevation to provide said
fluid head, and allowing said solution to flow by gravity
through said flow reducing means into said catheter and
thence into said vein.
At the Hearing, the importance of the words 'by law" found in Monsanto
supra, was stressed by Mr. Manson in making the following observations:
Section 2 does not preclude a method of medical treatment but refers to
"any new and useful art", there is nothing in the jurisprudence to limit
the kinds of method that the Applicant claims, and part 12.03.01(b) of the
Manual of Patent Office Procedures has no foundation in law or statutorily
and provides no basis for the Patent Office to limit the scope of Section
2. He reasons therefore, Applicant's method with its specialised
instructions of insertion of a catheter to provide food to an animal body
should be allowed. In Mr. Manson's view, the method claims contain only
mechanical steps to provide nutrition and the step of inserting the
catheter is an incidental step. He argues the steps represent the "means"
to attain an "end", and are not claiming the "end". He further reasons
that even if the Board is inclined to find the scope of Section 2 can be
limited, noting that the Applicant does not agree with such a view, the
methods of the Applicant's claims relate to performing intravenous (IV)
therapy which include alimentation or total parenteral nutrition to an
animal body including humans. Mr. Manson asserts they are not directed to
medical treatment. He contends the steps are for insertion, with
specialized instruction, of a catheter into a large vein in the body to
provide nutrition. He points out the,Applicant's claimed methods are not
related to diagnosis, prevention, or curing of an ailment. He says the
Applicant is willing to limit the scope of the claims by deleting from the
first lines of claims 1, 2 and 15 the words "...performing intravenous
therapy including...", leaving only a method of hyperalimentation i.e.
total parenteral nutrition, that in his opinion would clearly be outside
the scope of a medical treatment. He argues the fact of inserting a
needle, a catheter, or a device into a human body is only incidental.
Mr. Manson discusses a passage from Tennessee Eastman supra p.118, arguing it
is directed to the use of a substance that would affect the organic workings
of a human body; the passage reads:
"It is clear that a new substance that
is useful in the medical or surgical treat-
ment of humans or of animals is an 'invention'.
It is equally clear that a process for making
such a substance also is an 'invention'. In
fact, the substance can b a claimed as an
invention only when prepared or produced by'
such a process. But what of the method of
medical or surgical treatment using the new
substance? Can it too be claimed as an
invention? In order to establish the
utility of the substance this has to be
defined to a certain extent. In the case
of a drug, the desirable effects must be
ascertained as well as the undesirable side
effects. The proper doses have to be found
as well as methods of administration and
any counter-indications. May these thera-
peutic data be claimed in themselves as a
separate invention consisting in a method
of treatment embodying the use of the new
drug? I do not think so, and it appears
to me that s.41 definitely indicates that
it is not so.
Section 41 was enacted for the purpose
of restricting the scope of patents "relating
to substances prepared or produced by chemi-
cal processes and intended for food or
medicine'. The first 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
a art from the substance itself. Otherwise,
it would mean that while the substance could
not b a claimed except when prepared by the
patented process, the 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 b a claimed as a process apart from
the drug itself, then the inventor, by mak-
ing such a process claim, would have an easy
way out of the restriction in s.41(1)."
(emphasis mine)
Mr. Manson regards this statement as an expression of Mr. Justice Pigeon's
concern over the attempt, by trying to patent a method of medical treat-
went in relation to a substance, to skirt around Section 41, and of the
concern that, by claiming a method of medical treatment and by not having
process or product by process claims, it would be possible to avoid the
import of Section 41. Mr. Manson believes the statement is restricted to
the fact situation there, and has no relevance to Applicant's apparatus
and method claims.
Mr. Manson points to page 120 in Tennessee Eastman supra, where Mr. Justice
Pigeon commented that cases in Britain, Australia and New Zealand dealing
with the patentability of medical treatment should not be given the weight
that certain authors feel they should be accorded. Mr. Manson emphasizes
the Applicant's method is to the use of an apparatus and is directed to
any medical practitioner including nurses concerned with IV feeding. He
believes the findings by the Patent Appeal Board in re Application 880,719
(Patent No. 944,693) 18 C.P.R. (2d) 114 support his contention, noting
the Board there found the "means" distinct from the "end". The subject
matter relates to the use of fluorescent dyes for a dental application. The
Board considered the process used therein did not apply any pharmaceutical
properties to affect a curative or preventive treatment, and that there was
no step of medical or surgical treatment in the claims. The Board also
referred therein to a passage quoted by Mr. Justice Pigeon in Tennessee
Eastman page 121 from in Re Schering A.G.'s Application (1971) R.P.C. 337,
at 345, and we note here the emphasized portion as follows:
...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,...
In commenting on the description of the short term and long term therapy
Mr. Manson considers there is nothing in the steps of Applicant's claims
to suggest surgical or medical treatment, emphasizing there are only
mechanical steps of inserting the catheter and making connections for IV
feeding. He acknowledges a certain threshold level of skill by a person
skilled in the art to place the catheter in the vein, but stresses that
Applicant's method is not the equivalent of a medical operation in the
true sense that it is trying to correct an ailment or prevent something
from spreading or to remove some part of the body.
Concerning Mr. Justice Pigeon's reference with respect to the emphasized
portion from in Re Schering, Mr. Manson believes Mr. Pigeon regarded that
phrase in the same way he expressed himself on page 119 of Tennessee Eastman,
supra, "...having come to the conclusion that methods of medical treatment
are not contemplated...the same must...be true of a surgical treatment...".
Mr. Manson links these comments to the concern by Mr. Justice Pigeon in
preventing an applicant from skirting Section 41. After noting the
reference in Schering was obiter dicta, Mr. Manson returned to Applicant's
proposal to limit the wording of claims 1, 2 and 15, saying the claims then
would be restricted to the feeding aspect of the application.
Mr. Manson's attention was directed to claim 15 and the various steps of;
incising a patient's skin, dissecting tissue to reveal a vein and incising
the vein, feeding the catheter to the desired position, threading a passer tube
subcutaneously to an incised exit area and passing the catheter therethrough,
and closing the incisions. Observing there is a higher level of skill here,
Mr. Manson however feels these are only mechanical steps performed by the
person in the art, i.e. the medical art.
Responding to an observation that Applicant's claims could be considered
as teaching the medical profession how to do its tasks, Mr. Manson argues
the steps are directed to technicians in the art area and relate only to
mechanical procedures which incidentally are in the medical field.
Responding to questions on the method set forth in claim 26, Mr. Manson
indicates a willingness to delete the claim, but not the other claims
wherein the steps are performed the same way each time. Mr. Manson
differentiates the others from the subject matter in Lawson vs. The
Commissioner of Patents (1970) 62 C.P.R. p. 109. In Lawson, he feels the
design could not be reproduced the same way each time, and that the skills
of the designer control the process.
Concerning the operation involving the incision in a patient to insert a
catheter, Mr. Manson dealt with the term "operation" as having different
degrees of interpretation, saying, in terms of medical or surgical
treatment, it is done within the context of removing, curing, or treating,
to achieve an end result by medically treating the body. He believes that
Applicant's operation of inserting the catheter through the skin into a
vein has nothing to do with the end result of treatment, saying it is
merely a mechanical way in which the apparatus is placed to apply nutrition
through the device into a body: in his view not a medical treatment.
We deal first with Lawson supra. We regard the direction given by the
decision differently from Mr. Manson. In our opinion the Court considered
it settled that all new and useful arts and manufactures do not reside
within the definition of invention. In Lawson, Cattenach J. pointed to a
passage from Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius &
Bruning vs. The Commissioner of Patents (1962) 39 C.P.R. 105 at 124 in
which Thorson P. said if an art or manufacture were:
...new and useful it is an invention within the
meaning of the definition and, therefore, patent-
able under the Act...
Cattenach J. then referred to the appeal from Thorson's decision as
follows:
On appeal the view of Thorson, P., as above
expressed was repudiated by the Supreme Court of
Canada...
and concluded:
It is, therefore, clear that words of limitation must
be read into s. 2(d).
In Cattenach's opinion, the procedure of dividing land did not reside in
a patentable art area in Canada, notwithstanding that in the United States
Patent Office the Board of Appeal found certain claims acceptable.
In determining the kind of subject matter presented by Applicant, we find
direction in The Commissioner of Patents vs Farbwerke Hoescht Aktiengesell-
schaft Vormals Meister Lucius & Bruning (1964) S.C.R. at 55 where Judson, J.
said:
Following statements made in R. v Patents Appeal Tribunal,
Ex p. Swift & Co., the Exchequer Court said that the
Commissioner should not refuse to allow an application to
proceed to the grant of a patent unless he is quite satis-
fied that the subject-matter of the application could not
conceivably b a patented within the meaning of the Patent Act.
The Commissioner was well within even this definition of
the scope of his duties but I think that the obiter of
the Exchequer Court expresses the duties of the Commiss-
ioner too restrictively and fails to recognize the distinction
between the United Kingdom and the Canadian Patent Acts.
Under ss 6, 7 and 8 of the United Kingdom Patents Act 1949,
the Examiner may examine only for anticipation. He may not
and does not as a matter of practice examine as to invent-
iveness. This is left to the Court. Further, as pointed
out in Re Levy & West's Application, no appeal lies from
the Patent Appeal Tribunal, whereas in a subsequent action
the validity of the patent may be impeached in the highest
court in the land.
In contrast, in Canada the Patent Office, supervised by the
Court, does examine as to inventiveness, and an applicant
may appeal to the highest court. Moreover, in the particul-
ar class of case with which we are here concerned dealing
with drugs and medicines, there is considerable public
interest at stake, and the Commissioner should most carefully
scrutinize the application to see if it merits the grant of
monopoly privileges and to determine the scope of the monopoly
available.
In the above passage, Judson J. points out that applications are examined
to determine the presence of inventiveness, and he stresses that it is
the Commissioner's duty to determine the patentability of subject matter,
particularly where there is a perceived public interest in the application.
We look now to the significance of the whole passage from re Schering
page 345, which Pigeon, J. referred to just prior to dismissing the appeal
in Tennessee Eastman:
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 prohibit-
ion 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) 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)
Mr. Manson viewed the emphasized portion in Schering as being an obiter
comment by Mr. Justice Pigeon rather than a statement relating to the facts.
We do not fully share that view. We consider the emphasis placed on the
statement is in accord with Mr. Justice Pigeon's conclusion on page 119
that methods of medical treatment are not contemplated under Section 2.
Moreover there are other points in Schering which we believe relate to the
issue before us. One is that the Appeal tribunal considered that patents
under the Patents Act in Great Britain "...for medical treatment in the
strict sense must be excluded...". Another is that neither the Appeal Tri-
bunal nor the United Kingdom Patent Office were deciding "actual patentability";
it is said the High Court decides such matters. Comparing these comments
in Schering to the direction laid down by Mr. Justice Judson ((1964) S.C.R.),
we find one of the Commissioner's duties is to scrutinize an application and
determine if it merits a patent grant. When the subject matter relates to
medical treatment, we believe Mr. Justice Pigeon, by emphasizing the portion
from re Schering, provides direction that medical treatment is not patentable.
Moreover, we are persuaded Mr. Pigeon's reference to the emphasized portion
is more than obiter dicta, particularly since it was not emphasized on page
345 in the manner given to it by Mr. Justice Pigeon.
We see nowhere in the remarks made by Pigeon, J. in Tennessee Eastman supra,
that the findings by the Exchequer Court, 8 C.P.R. (2d) 202, when the case
was before it, should be disregarded, and we refer to the reasoning provided
by Kerr, J. in the follow ing passage:
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 patents, as indic-
ated by authoritative judgements 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.
(our emphasis)
Even assuming that Applicant's method could be administered by someone other
than a physician, it is our opinion that from the direction given by Kerr, J.,
a method which lies in the professional field of medical treatment is not
patentable under Section 2.
In Schlumberger Canada Ltd. v The Commissioner of Patents (1981) 56 C.P.R.
204, Section 2 of the Act was reviewed in dealing with a computer program,
and Pratte J. said:
As to mental operations and processes it is clear in my
view that they are not the kind of processes that are re-
ferred to in the definition of invention in s. 2.
The preceding cases before the Canadian Courts have directed that the wording
in Section 2 must be given restrictive meanings. They also provide authoritat-
ive judgements, and in view of them, we believe sufficient reasons, by law,
are provided to meet the requirements of Monsanto, supra, which Mr. Manson
relies on.
In each of the rejected claims the first step involves insertion of an in-
strument through the skin and into and within a selected vein. In the
description of the kinds of IV therapy, our attention is directed to the
role of the physician who in each type of therapy selects the vein e.g.
cephalic, subclavian, internal jugular, external jugular, basilic, or
median cubital. Local anaesthetic is injected around the area of insert-
ion and the area surgically prepared. Our attention is drawn in the first
example to the importance of the syringe and needle to ensure no air is
entrapped in the fluid flow, and to the sleeve surrounding the needle to
provide a passage for the catheter to the vein. Again in the second
example, the syringe is highly significant as it is used to aspirate air
to prevent an air embolism when a catheter is placed in a vein without
filling the catheter with the IV fluid. In our view the description of
these procedures alone represents steps carried out in a medical treatment.
Moreover, the skill in determining the progress of the catheter travel
inside a vein to a desired location, for example in the superior versa cava,
using the radio opaque material and the x-ray equipment, readily persuade us
that a level of professional skill is involved equivalent to that used in
medical and surgical treatments. We are further persuaded to this view
when consideration is given to the many different individuals presenting
different health and physical conditions that have to be assessed before
and during the catheter placement.
To accept Applicant's view that only mechanical steps are involved, we would
have to consider for example, in achieving fluid flow from one point to
another, that passing a catheter by means of a stiffener through a vein
is equivalent to passing a hose through a conduit under a street; a compari-
son that is untenable in our view. We are informed too that a passer tube
must be threaded sub cutaneously through the body of a person, and the incisions
finally closed. We find the levels of skill involved in Applicant's
methods lie in the domain of the professional skills of a medical
practitioner performing medical or surgical steps in the treatment of a
human body. It may well be that certain of the steps in some of the
rejected claims may per se be considered mechanical steps, particularly to
medical practitioners, however, on consideration of the overall subject
matter we are satisfied that the requisite level of skill to perform
Applicant's kind of IV therapy relies on expertise found in the field of
medical treatment. We find claims 1 to 28 not to be patentable. The
claims do contain steps of medical treatment concerning the incision of a
body, insertion of a catheter, and clinical treatment of a body including
alimentation, whereas in re Application 880,719 no step of medical
treatment was found.
The decisions in the cases we have considered in reviewing Applicant's
subject matter demonstrate significant developments in the definition of a
patentable invention according to the Canadian Patent Act, and identify the
determinations the Commissioner must make based on the interpretations
given by Canadian Courts. Our review has shown differences in Canada in
the practical application of the definition of a patentable invention from
the way that patentability is determined in the United Kingdom.
In summary we find that Applicant's method claims recite subject matter
that lies in the professional field of surgery and medical treatment, and
involves the professional skills of a medical practitioner in treating a
human body. We find direction in the jurisprudence discussed herein. We
are satisfied the subject matter of method claims 1 to 28 of this
application is not patentable within the definition of Section 2 of the
Patent Act in view of the jurisprudence.
We recommend that claims 1 to 28 be refused for falling outside the defin-
ition of invention in Section 2.
M.G. Brown S.D. Kot
Acting Chairman Member
Patent Appeal Board
I concur with the findings and recommendations of the Patent Appeal Board.
Accordingly, I refuse to grant a patent on this application containing claims
1 to 28. 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 13th day of August 1986
Smart & Biggar
Box 2999, Station D
Ottawa, Ontario
K1P 5Y6