IN THE CANADIAN PATENT OFFICE
DECISION OF THE COMMISSIONER OF PATENTS
Patent application 502,082 having been rejected under Rule 47(2)
of the Patent Regulations, the Applicant asked that the Final
Action of the Examiner be reviewed. The rejection has
consequently been considered by the Patent Appeal Board and by
the Commissioner of Patents. The findings of the Board and the
ruling of the Commissioner are as follows:
Agent for Applicant
Swabey Ogilvy Renault
Suite 800
1001 boul. de Maisonneuve ouest
Montreal, Quebec
H3A 3C8
COMMISSIONER'S DECISION SUMMARY
C.D. 1172... App'n 502,082 (B00),(J00)
Indefiniteness of Claims and Lack of Industrial Value
Although the claims include " a heart straining maneuver",
the apparatus claimed is not dependent upon this maneuver and the
mention of the maneuver in the claims does not render them
indefinite. Furthermore, the assessment of diagnostic methods
should be that the methods, and their results, have value to the
community to which they are addressed, be reproducible by anyone
skilled in the art, and be capable of allowing a practitioner to
derive some economic benefit, rather than the utilization of pure
commercial value. Rejection withdrawn.
This decision deals with the applicant's request for review by
the Commissioner of Patents of the final action on application
No. 502,082, entitled "Evaluating Heart Mechanical Performance",
Class 326-13.5, filed February 18, 1986. The inventor is Kevin
M. McIntyre. The examiner issued a final action on May 11, 1990
refusing to allow the application. An oral hearing was held on
January 6, 1992, and arguments were presented by the applicant's
patent agent, Mr. R. Mitchell.
The application is directed to an apparatus and method for
evaluating a patient's heart function by monitoring the change in
arterial pulsations while the patient performs a heart straining
maneuver.
In his final action, the examiner rejected all of the claims in
the application as being indefinite, and lacking in industrial
and commercial value. The following are excerpts from the
examiner's action and the applicant's response.
As to his first grounds of rejection, for indefiniteness, the
examiner said:
In detail, claim 1 is objectionable because the clause
"means for detecting the change..." relies upon the
implied method step of making "a heart straining
maneuver" which of course cannot be written as a piece
of apparatus because it must be either the making of a
voluntary effort on the part of the patient or else
some action on the part of the operator of the method,
...
Similar objections apply to the process claims; the
indefiniteness takes another form in that claims 4 and
5 are directed to "evaluating the mechanical condition
of a heart" by "detecting (a) pulse signal" i.e.
without even "a heart straining maneuver"... Formally
stated, the promise of the preamble is not met by the
scope of the claimed steps. Indeed, the steps
specifically claimed are little more than those of
taking a reading of blood pressure.
In his written response, Mr. Mitchell argued against the
rejection on indefiniteness as follows:
... the Examiner states that claim 1 is objectionable
because it relies on an implied method step of making
"a heart straining maneuver". The applicant
strenuously rebuffs this objection. The claims define
a structure which is clearly set out without relying on
the method of making a heart straining maneuver. The
fact that this apparatus can be used for detecting
different pulse signals coming from a patient at
different stages of activity does not make the
apparatus dependent on the heart straining maneuver. The
apparatus must be taken for itself, and the elements recited
in a claim must be considered on their face value. Claim 1,
particularly as submitted in the new set of claims, is
clearly definite in reciting the combination of structural
elements, and the fact that it may refer to elements extra
the apparatus is merely to clarify the function of the
apparatus.
... the Examiner objects to claim 4 as being directed
to an evaluation of the mechanical condition of a heart
and that it is only in claim 7 that a heart straining
maneuver is introduced. In fact, claim 4 describes the
steps of providing a pulse signal by placing pressure
sensitive transducing means for providing an electrical
signal representative of pressure in contact with the
skin of a patient while applying a further step of
applying pressure at least in part through the pressure
sensitive means to adjacent skin at controlled pressure
within the range of at least just above the diastolic
pressure of said patient and a pressure of
substantially half of said diastolic pressure and then
detecting the pulse signal. Surely this claim fulfills
the promise of the preamble of the claim, that is, to
evaluate the mechanical condition of a heart. What is
claimed in claim 4 of the present set of claims is not
merely the taking of a reading of blood pressure as
suggested by the Examiner, but the taking of the
arterial pulsation and applying pressure at a
controlled pressure within a particular range which is
at least just above the diastolic pressure of the
patient and a pressure substantially half the diastolic
pressure.
The examiner's second rejection was for a lack of industrial or
commercial value:
The basic objection to the process claims is that
because they must essentially be practised upon an
individual body, they therefore cannot define an
industrial process. The result, an individual whose
heart performance is evaluated, is not a marketable
product.
Further even a non-invasive "heart straining maneuver"
process step requires some degree of skill and
judgement on the part of the operator, whether he be a
physician or a trained technician. The inventor
himself will be aware that the Valsalva manoeuvre
specified in claim 8 is contraindicated for patients
suffering from infection of the upper air passages such
as rhinitis, sinusitis and the like.
Flowing from these considerations of claimed process
details any economic result (or any money changing
hands) will be in the nature of a fee for an individual
personal service rendered and the process, in total,
cannot be called "work on a commercial scale" without
gross distortion of language.
From these somewhat semantic considerations flows a
commonplace objection, in that the claimed process or
method cannot yield the 100% reproducibility required
of a patentable process. The starting material, being
physiological, is not of the same uniform quality of,
say, feedstock for a pulp mill. Thus the step of
"subjecting the patient to a heart straining maneuver"
deemed essential for "evaluating the mechanical
condition of a heart" will require judgement in choice
and time and will be entirely unsuitable for some
patients.
In response, Mr. Mitchell countered, in part, by saying:
... the Official Action states that the method claims
lack industrial value... This question of the method
or process lacking industrial value or having any
economic result for working on a commercial scale is
not understood. The claims must have utility, in an
economic sense, and they do. It has been accepted and
the Office has been directed by the Courts to the
effect that diagnostic methods are patentable under
Section 2 of the Canadian Patent Act. As recently as
in Re Application for Patent Goldenberg, the
Commissioner of Patents rendered a decision on May 13,
1988 reversing the Examiner's objection to what was
essentially a diagnostic method for detecting cancerous
tumors in the body by injecting a certain type of
antibody substances.
The operating of the diagnostic method will require
some skill, but this is no more than skill of the
"person skilled in the art" to which the specification
is addressed. Any timing or other requirements as
taught in the,specification are clearly 100%
reproducible, and the results of the diagnostic tests
will, of course, vary depending on the physiological
condition of the patient being tested.
... the Examiner refers to comparing the starting
material of a process with the uniform quality of
feedstock for a pulp mill. Surely the Examiner does
not seriously think that feedstock for a pulp mill has
uniform quality. Tests must be made constantly to
determine the relative quality of the feedstock to then
adjust the process and the equipment. However, a
diagnostic or testing method within a pulp mill will be
constant; only the results will differ. Likewise, the
diagnostic method as applied to a human patient will be
constant and reproducible, but the results will vary.
The task before the Board is to decide if the claims to the
apparatus and method are framed in a definite manner as defined
in Section 34(2) of the Patent Act, R.S.C 1985, c. P-4; and if
the claimed method has industrial value.
The Board must then look to the claims for a better understanding
of the applicant's invention. Claims 1 and 9 of the newly
submitted set of claims read, respectively:
Apparatus for evaluating the mechanical condition of a
heart of a patient having skin, comprising,
pressure sensitive transducing means adapted to be
responsive to arterial pulsation for providing a pulse
signal,
pressure applying means for applying controlled
pressure through means including said pressure
sensitive transducing means to the patient skin and
maintaining said controlled pressure within the range
of substantially just above the diastolic pressure of
said patient and a pressure substantially half of said
diastolic pressure,
and means for detecting the change in said pulse signal
during and after a heart straining maneuver relative to
said pulse signal dust before said heart straining
maneuver.
A method of evaluating the mechanical condition of a
heart, which method includes the steps of:
non-invasively providing a pulse signal representative
of arterial pulsation by placing pressure sensitive
transducing means for providing an electrical signal
representative of pressure, in contact with the skin of
a patient while applying pressure at least in part
through the pressure sensitive transducing means to
adjacent skin at a controlled pressure within the range
of substantially dust above the diastolic pressure of
said patient and a pressure of substantially half of
said diastolic pressure,
subjecting said patient whose blood pressure is
characterized by said pulse signal to a heart straining
maneuver,
and detecting the change in said pulse signal after
said maneuver relative to said pulse signal during a
base period before said maneuver.
The Re Application for Patent of Goldenberg, 22 C.P.R. (3d) 159
decision, referred to by Mr. Mitchell in both his written and
oral arguments, clearly finds that diagnostic techniques are
patentable. In their decision, the Patent Appeal Board said, in
part:
... patents for medical treatment in the strict sense
must be excluded under the Patent Act.
In determining whether or not the applicant's method is
a diagnostic method and therefore patentable, we are
unable to find, in reviewing the claims as they pertain
to a non-medical treatment, using pharmacologically
inert substances within the context of the application,
that they are directed to more than a diagnostic
treatment.
The Webster's Third New International Dictionary defines
"diagnostic" as meaning adapted to or used in diagnosis, and
"diagnosis" as the art or act of identifying a disease from its
signs and symptoms. The invention, as disclosed in the
application, is a method and an apparatus for detecting abnormal
heart function by recording the change in the amplitude and rate
of arterial pulsations after the patient performs a heart
straining maneuver, such as expiring forcibly into a confined
space for a predetermined interval. The data thus collected
flows a skilled practitioner to evaluate the patient's heart
function and detect an abnormal heart condition. It is the view
of the Board that this application discloses an invention that is
purely diagnostic and in deciding on the two objections raised by
the examiner we have kept in mind the diagnostic nature of the
claimed subject matter.
Diagnostic devices and methods, by their very nature, require the
presence of a human subject. Claims are patentable which define
the structure of the apparatus and the method of diagnosis,
provided that such use does not constitute medical treatment.
The heart straining manuever referred to by the examiner may
constitute a voluntary effort on the part of the patient being
diagnosed, but there is no therapeutic benefit derived from this
maneuver, nor does the act of expiring require any special skill
or training. We find that the apparatus is not dependent on this
maneuver, and that the means for detecting the change in the
arterial pulsations is through the pressure sensitive transducing
means claimed in Claim 1. The apparatus and method will produce
the claimed results when used by a normally skilled practitioner
in the assessment of various patients, provided that the patients
are capable of breathing. Thus, we feel that the mention of the
heart straining maneuver in the claims does not render them
indefinite.
Similarly, we also reverse the rejection on lack of commercial
~lue. If diagnostic methods are to be patentable then commercial
value can not be assessed as if they are processes for producing
milled feedstock. The test must be that the method, and its
result, has value to the community to which it is addressed; that
the method be reproducible by anyone skilled in the art; and that
some economic benefit can be realised by those who practice the
method. We see no reason to doubt that the method claimed in
this application will not be useful to the medical community.
Likewise, we believe that the diagnosis would be reproducible for
any given patient and would not be dependent on the operator's
judgement, but on the condition of the patient's heart. The
method can be worked on a commercial scale that is adequate and
reasonable under the circumstances, and which will certainly
result in some form of economic benefit for the practitioner.
In summary, we believe that the rejected claims clearly define
the invention of the applicant in accordance with Section 34(2)
of the Patent Act, and that the method claimed has a commercial
value as expected for a diagnostic procedure. Therefore, we
recommend that the refusal of the claims be withdrawn.
F.H. Adams M. Howarth A. Kinsman
Chair Member Member
Patent Appeal Board Patent Appeal Board Patent Appeal Board
I concur with the findings and the recommendation of the Board.
Accordingly I remand the application to the examiner for
prosecution consistent with the findings of the Board.
J.H.A. Gari‚py
Commissioner of Patents
Dated at Hull, Quebec
this 7th day of February 1992
Swabey Ogilvy Renault
Suite 800
1001 boul. de Maisonneuve ouest
Montreal, Quebec
H3A 3C8