COMMISSIONER'S DECISION
Non-Statutory S.2: The method involves the skills of a medical practioner in
inserting into a living body a proper amount of material compatible with the
body's anatomy. Rejection affirmed.
This decision deals with Applicant's request for review by the Commissioner of
Patents of the Final Action on application 329,163 (Class 128-52) filed June 6,
1979. It is assigned to RSP Company and is entitled METHOD AND APPARATUS FOR
THE HYSTEROSCOPIC NON-SURGICAL STERILIZATION OF FEMALES. The inventor is
Robert A. Erb. The Examiner is charge issued a Final Action on October 29,
1982 refusing to allow method claims 18 to 26 of the application. The
remaining claims, directed to the apparatus, were indicated to be allowable. A
Hearing was held on June 25, 1986, at which Applicant was represented by his
Patent Agent Mr. R. Smart.
This application relates to a method and apparatus for the non-surgical,
reversible sterilizaton of females. Figures 4A to 4E, shown below, depict the
procedures. Telescoping flexible plastic tube portions 30, 31, of the
by steroscope are used in locating the oviduct and positioning the instrument
there in sealing contact. Curing elastomer is introduced to fill the oviduct
fully and is allowed to set. The plastic tubes are released and moved
relatively to one another to disconnect from the cured materiel and the
by steroscope removed.
(see formula I, II, III, IV, V)
In rejecting claims 18 to 26, the Examiner said in his Final Action, in part,
as follows:
...
The applicant in his letter argues that the method claimed
in claims 18 to 26 is patentable because the method in
question is directed to a non-surgical method and that a
method of birth control is not amongst the examples of
non-statutory subject matter set forth in Section
12.03.01(b) of the Manual of Patent Office Practice, i.e.,
methods of treating humans by surgery or therapy, nor to the
diagnosis, prevention or curing of an ailment.
This argument, however, cannot overcome the objection
because contraception is a method used to control and
prevent discomfort, possible injuries associated with
conception or hereditary diseases and therefore it is a
method of medical treatment excluded from the definition of
patentable invention in Section 2 of the Patent Act.
The applicant also states in his letter that the words "work
on a commercial scale" should not be used to test the
patentability of a claim and that his method claim 18 is
capable of being worked on a commercial scale. Section
67(3) of the Patent Act states that patents should be worked
on a commercial scale, and Section 2 of the Patent Act
defines "work of a commercial. scale" as meaning the carrying
on of a process in or by means of a definite and substantial
establishment. Also it is an obvious truth to say that a
process must result in a vendible product without which the
process is not useful.
With regard to applicant's method, it cannot be worked on a
commercial scale, such as in factory or similar substantial
establishment. Also the method does not result in a
vendible product. In fact, the use of the device will be
provided as a service for a fee. In the case of applicant's
method, there is no starting material which is to be
modified by the method to produce a vendible product. The
modification which results is a modification of the normal
processes of a female human body.
In view of the above points of argument, applicant's method
cannot be considered to be a process in the sense intended
by the Patent Act and the method is therefore unpatentable.
Claims 18 to 26 are required to be deleted.
...
The Applicant argues that his method claims are directed to a method of
manufacturing an article in-situ, and as such are permissible under Section 2
of the Act. He points to the sequence of steps which obtain the construction
of an elastomer material fitted to the particular anatomy of a user. He
distinguishes his method claims from those found not to be patentable in
Tennessee Eastman v. The Commissioner of Patents (1974) S.C.R. 111.
The Applicant stresses his invention does not relate to a substance intended
for medicine, and says:
If, as suggested by the examiner, the purpose for which the
device made by the claimed process is used, namely to effect
birth control by oviduct blockage, is a method of medical
treatment, that conclusion does not affect the patentability
of the claimed method by which the device is made. At most,
it would render the claimed method subject to a compulsory
license pursuant to s. 41(4).
To further support his views that the method claims are allowable, the
Applicant reasons, in part, as follows:
There is no requirement in the Canadian Patent Act that
requires that a patentable method produce a vendible
product. The only requirements are that the method is new
and useful, and that it not be obvious.
There is likewise no requirement that a patentable method be
capable of working on a commercial scale such as in a
factory or similar substantial establishment.
The method of the invention is certainly capable of being
worked on a commercial scale in substantial establishments.
There is no reason to believe that it could not be worked in
birth control clinics, some of which are of substantial
size. In some instances, these have been actually referred
to as "factories". No one would doubt that their activities
are "commercial".
The starting materials for the claimed process are the
polymeric material, the catalyst, and in some cases the
obturating tip. The claimed method modifies these to make
of them the fitted device which is the "vendible" product.
It is this product - the device and not the claimed method -
which functions to perform the birth control method. That
this is so is clear from the fact that the device is non-
surgically removable, and that the birth control method
cannot be carried out unless the device is left in place in
both oviducts throughout at least one menstrual cycle.
None of these assertions of the examiner ae to the claimed
process have any basis in law as a requirement for a
patentable method. None are mentioned as such in the Patent
Act. Some of them appear to be lifted from British cases
dealing with compliance with the requirements of the British
Patents Act, which Act differs markedly from the Canadian
Act, as pointed out by Pigeon J. in the Tennessee Eastman
case at p. 120.
In sum, it is submitted that the rejection of claims 18-26
by the examiner is not based upon grounds upon which the
Commissioner could be satisfied under s. 42 that the
applicant is not by law entitled to a patent. (See Monsanto
Co. v. Commissioner of Patents (1979), 42 C.P.R. (2d) 161).
The issue before the Board is whether or not claims 18 to 26 are directed to
patentable subject matter in view of Section 2 of the Patent Act. Claim 18
reads:
The method for non-surgically forming in situ a plug to
occlude an oviduct comprising the steps of hysteroscopically
locating the uterine end of an oviduct; inserting a pair of
inner and outer co-extensive telescoping flexible plastic
tubes, releasably maintained in fixed relative position one
to the other, through the operating channel of the
hysteroscope and positioning said tubes about the oviduct
opening in sealing relationship thereto, the releasing means
remaining external of said hysteroscope; dispensing a
predetermined amount of curable elastomer-precursor into
said oviduct through the inner of said tubes, permitting
said elastomer-precursor to cure in situ; releasing said
inner and outer tubes one from the other and moving one
relative to the other to thereby break the cured elastomer;
and withdrawing said hysteroscope tubes.
Mr. Smart argues that Applicant's method is directed to no more than the steps
of mechanically blocking an oviduct. He points to page 6 the disclosure of the
application where it states that, due to its properties, the elastomeric
material will adhere only to other silicone rubbers and not to the body tissues
except by flowing into voids to cause mechanical interlocking. He notes the
topically external nature of the oviduct, stressing that the elastomer does not
cross tissue lines. He describes the flow of the elastomer takes it to both
sides of the isthmus neck of the fallopian tube where a mechanical lock forms
on curing.
Mr. Smart stresses the non-surgical nature of Applicant's in-situ formation of
an elastomer tube to fit the anatomy of the wearer. He notes there is no birth
control method recited by the steps. He refers to the retrieving means that is
provided on the elastomer plug. He comments that the practice of birth control
would occur only if each oviduct had a plug in place for one complete menstrual
cycle of the wearer, and that the user would decide this issue, just as the
user has the choice of other birth control devices and measures. He reasons
that the act of installing the elastomer according to Applicant's method
represents a mechanical procedure, and not a birth control procedure, per se.
Mr. Smart looks to the decision in The Commissioner of Patents v. Farbwerke
Hoescht Aktiengesellschaft Vormals Meister Lucius & Bruning [1964] S.C.R. 49 at
57, a case dealing with Section 41(1) of the Act, as follows:
The section was held to be restrictive of the rights that an
inventor would have except for the prohibitions of the
section. Consequently, the Court should not find that a
particular application came within its prohibitions unless
the conditions for its application are clearly present. I
can see no justification for this interpretation. There is
no inherent common law right to a patent. An inventor gets
his patent according to the terms of the Patent Act, no more
and no less. If the patent for which he is applying comes
within the provisions of s. 41(1) of the Act, then he must
comply with that section.
his view, this case settled that Canadian patents are creatures of the
Patent act, and that applications should be scrutinized in view thereof.
In referring to Tennessee Eastman v. The Commissioner of Patents [1974] S.C.R.
p. 111, Mr. Smart discusses a passage given by Kerr, J. in the Exchequer Court
decision in this case, and reproduced in Mr. Justice Pigeon's decision at page
114 as follows:
In my view the method here does not lay in the field of
manual or productive arts nor, when applied to the human
body, does it produce a result in relation to trade,
commerce or industry or a result that is essentially
economic. The adhesive itself may enter into commerce, and
the patent for the process, if granted, may also be sold and
its use licensed for financial considerations, but it does
not follow that the method and its result are related to
commerce or are essentially economic in the sense that those
expressions have been used in patent case judgments. The
method lies essentially in the professional field of surgery
and medical treatment of the human body, even although it
may be applied at times by persons not in that field.
Consequently, it is my conclusion that in the present state
of the patent law of Canada and the scope of subject matter
for patent, as indicated by authoritative judgments that I
have cited, the method is not an art or process or an
improvement of an art or process within the meaning of
subsection (d) of section 2 of the Patent Act.
Mr. Smart indicates that Mr. Justice Pigeon makes no comment on this passage.
He then refers to certain questions that Mr. Pigeon posed, and observations
made in dealing with the matter before him as follows:
on page 117
...
The sole question is therefore whether a new use for
surgical purposes of a known substance can be claimed as an
invention.
on page 118
...
Here, we have to deal with a substance that was known and
also with its previously known essential properties, that is
to form an adhesive by polymerization on application.
Therefore, the only element of novelty ie in its application
to surgical use and the discovery is limited to the
unobvious adaptability to such use. This is why the claims,
as previously pointed out, are only for a surgical method of
joining tissues by means of such an adhesive rather than
with thread or clips. Is such a method an "art" or
"process" within the meaning of the definition of
"invention"?
It is clear that a new substance that is useful in the
medical or surgical treatment 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 be 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 therapeutic 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.
on page 119
...
In my view, this necessarily implies that, with respect t
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).
Mr. Smart points to the implication given by Pigeon J. that a method of using a
medicinal substance is excluded as claimable subject matter. In Mr. Smarts
view, Pigeon J. means by a method of medical treatment, simply the application
of a medicinal substance. He believes Pigeon J. means the same thing when
referring to a surgical treatment. Mr. Smart derives his belief from Mr.
Justice Pigeon's conclusion in the passage on page 119, mid-page:
Having come to the conclusion that methods of medical
treatment are not contemplated in the definition of
"invention" as a kind of "process", the same must, on the
same basis, be true of a method of surgical treatment.
He reasons that Pigeon J. looked on the term medicine as being something that
is to be given a wide interpretation on the basis of some earlier cases. Mr.
Smart notes that the basis could have been on the fact that surgery is a part
of medicine when medicine is being used in its broad sense.
Mr. Smart refers to another passage from Tennessee Eastman, page 121,
concerning surgical or medical processes which are excluded, per se. He
interprets it as referring to the kind of methods of surgical or medical
processes that are related to the application of a medicament to a person, for
example, the process of curing a disease by taking a pill, or using an adhesive
to adhere pieces of flesh together based on the discovered properties of the
adhesive. That passage reads:
While those decisions may be of some interest in dealing
with the patentability of inventions related to slaughtering
or agricultural processes, I fail to see anything that would
tend to overbear the implication of s. 41(1) with respect to
the exclusion of a surgical or medical method per ase from
the area of patentable process.
In view of the Tennessee Eastman case, Mr. Smart submits that not all methods
that produce their effect upon or in conjunction with a human body are methods
of surgical or medical treatment in the sense used by Pigeon J.
Mr. Smart discussed the unreported Federal Court of Appeal decision rendered
April 21, 1986, Imperial Chemical Industries v. The Commissioner of Patents.
There, he reasons, the method claims of applying the substance to the teeth
were refused for being a medical process of reducing caries. Mr. Smart refers
to the penultimate paragraph of the decision, noting it records that the
Commissioner did not err in the basis for refusing the claims, viz, that it was
a medical process involving the application of a substance to a human, and that
the Federal Court felt itself bound by Tennessee Eastman.
In view of these cases, he believes the implication, based on her. Justice
Pigeon's ratio, does not extend beyond medical or surgical treatment relying on
the use of substances, per ase, to effect a treatment due to their properties.
Mr. Smart reasons there does not exist an implication, concerning medical
processes involving medical or surgical devices, that such processes are
unpatentable. He indicates the Act does not contain such an implication.
Mr. Smart submits six Canadian patents 946,084, 968,108, 1,003,167, 1,071,820,
1,150,464, and 1,166,810 having methods of forming caste related to the human
body. He says they have a lot in common with the method in the present case,
for example, the product being made conforms to the anatomy of the wearer. He
suggests in many of these a samples, the wearing of the article could be
considered a surgical or medical method. He comments however, these methods
are not the kind of method which Pigeon J. was addressing in Tennessee Eastman
because they are not methods which consist only of the application of a
medication or a substance that has physiological properties. Be reasons his
client's method is worthy of patent protection.
concerning the Examiner's reference to Section 67(3), Mr. Smart considers that
subsection (3) is only for determining abuse of exclusive rights in connection
with subsection (2) concerning compulsory licence applications. As such he
argues Section 67(3) has no relevance to what is patentable or not.
In summation Mr. Smart relates that claims 18 to 26 are directed to manufacture
of a device, and are not directed to a method of surgical or medical treatment,
per se. He restates there is nothing in the act to preclude their
patentability. Finally, he refers to Monsanto Co. v. The Commissioner of
Patents [1979] 42 C.P.B. (2d) 161 at 178, in which the significance of the
term, by law, in Section 42 is emphasized. He indicates that reasons found in
the Patent Act or in jurisprudence must be presented why his client is not by
law entitled to a patent.
As the issue before us relates to the subject matter contained in this
application, we make no comments on the claims in the Canadian patents referred
to by the Patent Agent. Accordingly, we look to Applicant's subject matter in
view of the Patent Act and related jurisprudence.
From the disclosure we see certain methodology is presented in carrying out the
method found in claims 18 to 26. On page 11 preparing a patient for
hysteroscopic examination is described using standard medical procedures and
local anesthesia. A description is given of the type of hysteroscopy fluid
that replaces the air in the hysteroscope sheath prior to insertion of the
device into the cervical canal. After insertion the hysteroscopy fluid is
pressurized to inflate the uterus for a subsequent procedure. This fluid aids
in providing visualization of the uterus. An account of identifying the
sometimes hard to find tubal ostium is given, including the use of a dye in
saline solution. Mention ie made of positioning the obturating tip With s
force to achieve moderate sealing. Details are given for miring the
ingredients forming the elastomer material to provide the necessary
consistency. Proper force to seat the hysteroscope end to propel the elastomer
to fill the oviduct and both sides of the isthmus of the fallopian tube, is
said to be obtained by simultaneously observing the flow of material during
dispensing. After gelling, a retrieval portion is provided by actuating the
reciprocating plungers of the hysteroscope to separate the plug from the
oparatus. After the technique is completed for the other tubal ostium,
confirmation of plugs of suitable length is determined by a flat x-ray plate.
We lock on Applicant's method as essentially involving steps requiring the
skills of a medical practioner attending on a patient. We are not persuaded by
the arguments advanced by the Patent Agent that the method should be considered
as a mechanical procedure it the field of manual or productive arts. It may be
that the elastomer is a commercial item and may be patentable, and if so,
licenced for financial considerations. We believe however, that the remarks of
Kerr J. reproduced in Tennessee Eastman, supra, p. 114, and discussed
previously by Mr. Smart appropriately relate to the kind of method in claims 18
to 26 in this application:
... but it does not follow that the method and its result
are related to commerce or are essentially economic in the
sense that those expressions have been used in patent case
judgments. 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 mater for patent, as indicated by authoritative
judgments that I have cited, the method is not an art or
process or an improvement of an art or process within the
meaning of subsection (d) of section 2 of the Patent Act.
We note that claim 18 is directed to s method pertaining to a living animal
body involving, an operating hysteroscope, its insertion and use to pressurize
the uterine cavity, its location at the oviduct in sealing relation thereto,
dispensing a curable elastomer via an inner portion of the hysteroscope to at
least the isthmus of fallopia, permitting curing, and withdrawal of the
apparatus to break the cured elastomer near the end of the inner portion. We
see this as more than a routine method of forming a product, such as suggested
by the Applicant. Mr. Smart acknowledges that probably the operation is
performed by an obstetrician. He submits that apart from what Mr. Justice
Pigeon found in Section 41(1) there is nothing in the Patent Act saying that
processes carried out by doctors or surgeons are any different from a process
carried out by anybody else, so far as a patent is concerned. It is true that
the Act does not per se, refer to such processes. It is equally true in our
view, that the jurisprudence developed by Tennessee Eastman, supra, does deal
with medical methods or processes, as is evident from the passage by Kerr J. in
interpreting Section 2. Moreover, Mr. Justice Pigeon after inserting the
remarks by Kerr J., and after reviewing Section 41(1), concludes on page 119,
as previously noted by Mr. Smart, "... that methods of medical treatment are
not contemplated in the definition of "invention" as a kind of "process", the
same must, on the same basis, be true of a method of surgical treatment." We
are of the opinion that Mr. Pigeon's remarks cover medical treatment in a broad
sense, and not simply the application of a medicinal substance.
At the Hearing, the Board referred to a passage quoted by Mr. Justice Pigeon on
page 121 in Tennessee Eastman from in Re Schering A.G.'s Application (1971)
R.P.C. 337, at 345, and in particular to 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,...
Mr. Smart suggests it points out the reason the case was allowed in Great
Britain. There, he says, they were not examining for patentability, and that
by allowing the application any question of patentability could be brought
before the Courts. We believe ii indicates more. We see the emphasis given by
Pigeon J. to the Schering passage is in line with his conclusion on page 119
that methods of medical treatment are not contemplated under Section 2.
We find direction from the Farbwerke Hoescht case discussed by Mr. Smart, in
the following remarks made on page 55 by Judson J.:
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
satisfied that the subject-matter of the application could
not conceivably be patented within the meaning of the Ptent
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 Commissioner too
restrictively and fails to recognize the distinction between
the United Kingdom and the Canadian Patent Acts. Under as
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
inventiveness. 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 art applicant
may appeal to the highest court. Moreover, in the
particular class 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 our view, Farbwerke Hoescht points out that the Commissioner' duty is to
determine the patentably of subject matter and if be finds it is not patentable
that he may refuse to allow an application provided be is satisfied by
sufficient reasons.
We see the remarks by Pigeon J. in Tennessee Eastman, as included on page 119
in the Supreme Court decision do not disregard the findings by Kerr J. in the
Exchequer Court. We are guided by the conclusion reached on page 121 by Pigeon
J. We read in the remarks by Heald J. in Imperial Chemical Industries that the
ratio of Tennessee Eastman is an acceptable basis for refusing a method of
medical treatment.
Mr. Smart points to Cibs vs. The Commissioner [1959] S.C.R. saying that the
method applied to certain materials may be patentable in producing a new
material. The issue was whether making a sew and useful product by
conventional chemistry was patentable, and in that case was found to be
acceptable. We do not equate Applicant's method to a process of conventional
chemistry.
Applicant's method is our view, involves the skills of a medical practioner in
achieving a satisfactory insertion into a living body of a proper amount of
material compatible with the anatomy of the body. We believe the steps clearly
point to the performance of a method that resides within the domain of a
medical practioner.
In summary, we find that method claims 18 to 26, even though they are couched
in terms of being non-surgical, are nevertheless directed to a method of
medical treatment, and may not be considered as falling within the ambit of
Section 2.
We recommend the rejection of claims 18 to 26 be affirmed for not being
directed to patentable subject matter.
M.G. Brown S.D. Kot
Acting Chairman Member
Patent Appeal Board
I concur with the findings and the recommendation of the Patent Appeal Board.
Accordingly, I refuse to grant a patent containing claims 18 to 26. The
Applicant has six months within which to appeal this decision under the
provisions of Section 44 of the Patent Act.
J.H.A. Gari‚py
Commissioner of Patents
Dated at Hull, Quebec
this 15th day of August 1986.