Commissioner's Decision
Section 2 Method to accelerate natural cell renewal
The method for improving the capacity of the human body to increase the
renewal of skin cells is found to be a method for treating living portions
of the body. Rejection affirmed.
This decision deals with Applicant's request for review by the Commissioner
of Patents of the Final Action on application 374,547 (Class 167-310) filed
April 2, 1981. It is assigned to Lilly (Eli) and Company and is entitled
"SKIN CELL RENEWAL REGIME". The inventors are J.A. Cella, M.G. Flom,
A.M. Herrold, J.O. Martin, O. Vargas. The Examiner in charge issued a
Final Action on February 17, 1983 refusing to allow the application. A
Hearing was held on June 17, 1987, at which Applicant was represented by
hia Patent Agents, Mr. G.E Fisk and Mr. F. Pole.
The application relates to a method to accelerate natural cell renewal by
applying to the skin four components: a cleanser, a cream, a lotion, and a
tonic.
The Examiner bases his rejection on Section 2 of the Patent Act, and says,
in part, as follows:
. . .
The refusal of all claims is maintained because they
are directed to a method of medical treatment which is
outside the definition of invention as given in Section
2 of the Patent Act and judicially declared unpatent-
able by Tennessee Eastman v. Commissioner of Patents
(1974) S.C.R. 111.
Applicant's argument is a rejection of the pertinence
of the Tennessee Eastman decision on the ground that
the instant method claimed is a cosmetic method. See
amendment letter of December 8, 1982 on pages 7, 36 and
37.
Applicant's argument is rejected because the instant
method claimed has for its objective an increase of
skin cell turnover (see preamble of claim 1). As such
this method modifies the physical condition of the
human body and affects its metabolism. It treats an
integral part of the human body, the skin, and is
equivalent to a method of medical treatment which may
be applied by persons not in the field of medicine.
In the Court decision of Tennessee Eastman Co. v. The
Commissioner of Patents (62 C.P.R.) at page 154, the
judge gave his reasons for holding methods of treatment
unpatentable when he said:
"In my view the method here does not lay in
the field of the 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 (sic) 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 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 judgements that I have cited,
the method is not an art or process or the
improvement of an art or process within the
meaning of s. 2(d) of the Patent Act."
...
Following the initial response to the Final Action, the Applicant submitted
several submissions discussing numerous Canadian Court decisions, as well
as foreign jurisprudence dealing with the patentability of medical and
non-medical methods of treatment. Amongst several Canadian cases felt by
the Applicant to be supportive of the acceptability of the claimed method
are Tennessee Eastman Co. v. The Commissioner of Patents (1973) 8 C.P.R.
(2d) 202, hereinafter Tennessee Eastman, Burton Parsons Chemical Co. v.
Hewlett Packard (Canada) Ltd. 17 C.P.R. (2 d) (1975) 97, 7 C.P.R. (2d)
(1973) 198 hereinafter Burton Parsons, Imperial Chemical Industries Limited
v. The Commissioner of Patents 1 Ex. C.R. (1967) 57, 51 C.P.R. (1967) 102,
hereinafter ICI 1967, and Imperial Chemical Industries Limited v. The
Commissioner of Patents (1986) 9 C.P.R. (3d) 289, hereinafter ICI.
Included with the submissions are an affidavit by Warren E. Epinette, a
doctor of medicine from Stanford Medical School and for many years a
part-time dermatology consultant with Elizabeth Arden Inc., and an
affidavit by Marguerite Russell-Pavier, a Training Director for facial
treatments in the employ of the Red Door Salons of Elizabeth Arden, Inc..
In the Applicant's written submissions, the following statements are made
concerning the above Canadian cases:
re Tennessee Eastman -
...(the) decision of the Supreme Court of Canada, upon
which the Examiner has heavily relied as support for
his position, is not considered as especially detrimen-
tal to applicants' position, because the Court in the
Tennessee Eastman decision was concerned only with
patentability of methods of medical or surgical treat-
ment in the strict sense of the term; and there is
nothing from that decision which would indicate that
the Court intended its ruling to apply to all methods
or processes whatsoever in which the human or animal
body is, or might be, in some way involved. The pres-
ent invention is directed to patentable subject
matter.
...
...In applicants' method there is nothing comparable
involved: there is no surgical procedure; no profes-
sional skills are required; and no deformity, mal-
function, or defect of the human body is being
corrected thereby,...
re Burton Parsons -
Thus it will be seen that a compound which is used in a
medical context, to carry out a test for the informa-
tion of physicians, and which is applied to the skin,
was not held to be "intended for medicine", because it
was not necessarily or mainly used in connection with
the treatment of diseases. The present method is not
used in connection with the treatment of disease at
all, so it is considered that the Burton Parsons case
clearly supports applicant's position that it (appli-
cant's method) is patentable.
re ICI 1967 -
...In each and every definition, it is inherent and
specifically stated that the medicine must have a cura-
tive or preventative action, or must in its widest
meaning, be part of a therapeutic regimen. None of the
definitions give any interpretation of the word
"medicine" as broad as that given by the Patent Appeal
Board in some of its recent decisions. It is manifest-
ly clear therefore, that Mr. Justice Gibson in deciding
that Halothane was a medicine did not broaden the defi-
nition of "medicine" in the manner suggested by the
Patent Appeal Board, but broadened it only to include
any substance which forms part of the therapeutic regi-
men. Thus, it is submitted that Mr. Justice Gibson in
referring to biological agents and to hormones as
"medicine" clearly envisages such compounds as taking
part in the therapeutic regimen, such as surgical bond-
ing agents as were considered in the Tennessee-Eastman
decision.
re ICI -
...there was evidence that one main function of the
I.C.I. method which was the subject of appeal was the
treatment of periodontal disease by removal of dental
plaque and/or the prevention of caries, both of which
could (at least in a broad sense) be considered as the
treatment of a disease condition in a part of the human
body, viz., the teeth. In contrast, in the present
case, there is no evidence that applicants' method has
any medical function; in fact the evidence points the
other way - that the present method is solely cosmetic
in effect. Moreover the Federal Court in the above-
discussed I.C.I. Ltd. v. Commissioner decision (at
least impliedly) made a clear distinction between a
cosmetic function or purpose and a medical function or
purpose. It is submitted, then, that the above-
discussed Federal Court of Appeal decision in I.C.I.
Ltd. v. The Commissioner of Patents is not controlling
with respect to the present appeal.
The issue before the Patent Appeal Board is whether or not Applicant's
claims for applying various formulations to the skin are directed to a
method that is acceptable under Section 2 of the Patent Act.
Section 2 specifies:
"invention" means any new and useful art, process,
machine, manufacture or composition of matter, or any
new and useful improvement in any art, process,
machine, manufacture or composition of matter;
Claim 1 reads:
A cosmetic method, whereby the rate of skin cell turn-
over is increased without causing skin irritation,
which method comprises applying to the skin in a
regime;
a) a cleanser formulation which comprises, in percent
by weight:
Ingredients Percent
deionized water 39.73
propylene glycol 6.00
magnesium aluminum silicate 1.10
sodium carboxymethyl cellulose 0.10
methyl p-hydroxybenzoate 0.20
imidazolidinyl urea 0.30
ethylenediaminetetraacetic acid 0.02
sodium N-lauryl-.beta.-iminodipropionate 4.00
titanium dioxide 0.75
sodium isostearoyl-2-lactylate 2.00
Soya sterols 1.00
polyoxyethylene (10) soya sterols 2.50
polyoxyethylene (3) myristyl ether myristate 8.00
polyoxypropylene (15) stearyl ether 8.00
heavy mineral oil 8.00
propylene glycol dicaprylate/dicarprate
(80/20 to 50/50) 7.00
cetyl alcohol (1-hexadecanol) 4.00
stearyl alcohol (1-octadecanol) 2.00
propyl p-hydroxybenzoate 0.10
glyceryl monostearate and polyethylene
glycol (100) monostearate 2.00
triple pressed stearic acid 2.50
lactic acid 0.10
fragrance 0.60
b) a cream formulation which comprises,in percent by
weight:
Ingredients Percent
light mineral oil 4.45
polyethylene homopolymer (1500 MW,
density 0.91 g/cc) 2.50
undecanoic triglyceride 2.00
squalane 5.00
distilled lanolin alcohol 0.55
white beeswax 1.00
polydimethyl cyclosiloxane 9.00
triglyceryl diisostearate 4.00
isopropyl myristate 5.00
propyl p-hydroxybenzoate 0.10
quaternary bentonite 0.40
deionized water 59.00
methyl p-hydroxybenzoate 0.20
70% sorbitol solution 5.00
imidazolidinyl urea 0.30
urea 0.50
glyoxyldiureide 0.20
DL-pantothenyl alcohol 0.50
cis-1-(3-chloroallyl)-3,5,7-triaza-1
azoniaadamantane chloride 0.10
fragrance 0.20
c) a lotion formulation which comprises, in percent
by weight:
Ingredients Percent
deionized water 69.35
xanthan gum 0.15
propylene glycol 5.00
polyoxyethylene (30) stearate 1.70
methyl p-hydroxybenzoate 0.20
imidazolidinyl urea 0.30
polyphenylmethylsiloxane 3.00
polyethylene homopolymer (1500 MW,
density 0.91 g/cc) 1.00
glyceryl monostearate, neutral
non-emulsifying 2.00
propyl p-hydroxybenzoate 0.20
sorbitan monostearate 2.00
ethylene glycol monostearate 1.00
lanolin oil 2.50
isopropyl myristate 3.00
squalane 8.50
fragrance 0.10
and
d) a tonic formulation which comprises, in percent by
weight:
Ingredients Percent
deionized water 80.12
polyethylene and polypropylene glycol 2.00
glyoxyldiureide 0.20
polyethylene glycol (300) 9.00
imidazolidinyl urea 0.40
denatured alcohol 7.00
methyl p-hydroxybenzoate 0.10
propyl p-hydroxybenzoate 0.05
polyoxyethylene (60) sorbitan fatty acid
ester 0.30
polyoxyethylene (10) oleyl ether 0.50
menthol 0.03
fragrance 0.30
Mr. Fisk argues that nowhere in the application is there any description of
a medical treatment. He draws attention to pages 1 and 14 thereof, saying
the Applicant's invention is a skin cell renewal cosmetic regime to
increase the rate of skin cell turnover without skin irritation.
Mr. Fisk points to Dr. Epinette's affidavit in which it says the method is
not to treat any disease. Mr. Fisk notes that Ms. Russell-Pavier's affi-
davit identifies the method is practiced as the Elizabeth Arden Millenium
Method Face Treatment by beauty specialists for a fee. It relates the com-
mercial success of the treatment by Elizabeth Arden, and Mr. Fisk reasons
the Applicant's method is a commercial method.
Of concern to the Board is the meaning of the term "rate of skin cell turn-
over without causing skin irritation" as used in the application in order
to have new cells in the outer skin layer. Mr. Fisk comments that dead
cells are continually being released from the skin during the natural
renewal cycle. He suspects that by removing the outer layer of dead cells
more quickly the body reacts and encourages the growth of new skin tissue.
In this way, he suggests the body Works harder to replace the dead cells.
In our view, the application does not provide a description of the reaction
that occurs. For example, there is no information given that describes how
the components provide the cell renewal process and prevent skin
irritation. We recall, however, from pages 1 and 14 of the application,
that the invention is aimed at acceleration of natural cell renewal in
order to speed up the replacement of new cells to increase the rate of cell
turnover. On neither of these pages, nor elsewhere, do we find a
disclosure of what occurs when the components are applied to the skin. The
purpose of applying the various products set out in the Applicant's method
is to increase or accelerate natural cell renewal. This indicates to us
that the Applicant intends that the method actually does accelerate new
skin cell growth. Indeed, the Applicant submits a table of tests made and
relies on the results shown therein as proof that the rate of new cell
growth has, in fact, been accelerated. Such proof, in our opinion, points
not to a cosmetic method, but to a treatment of living portions of the
human body.
We refer to Tennessee Eastman page 204, and to the passage by Kerr J. which
the ICI case considered was reproduced with approval, 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 essen-
tially 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 essen-
tially 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 authori-
tative judgments that I have cited, the method is not
an art or process or an improvement of an art or pro-
cess within the meaning of s. 2(d) of the Patent Act.
In Tennessee Eastman the subject matter related to the use of a substance
to adhere living tissue together during a surgical treatment. Here, the
Applicant teaches the use of several substances for application to the skin
to accelerate the rate of natural cell renewal.
We look now to the Australian Case discussed at the Hearing, Joos v. The
Commissioner of Patents (1973) R.P.C. No. 3, p. 65. In Joos, the subject
matter involves the treatment of keratinous material, such as hair and
nails, of a human, such material being inanimate matter, not living matter,
as the Court observed on page 63:
Those who apply chemical preparations to the skin to
prevent sunburn in climates which enjoy sunshine and
moderate air temperatures can scarcely be regarded
either as, in a relevant sense, treating their bodies
or as undergoing treatment. On the other hand, the
application to the skin of an ointment designed and
effective to remove keratoses from the skin would be an
instance of medical treatment. To be treatment, in the
relevant sense, it seems to me that the purpose of the
application to the body whether a substance or a pro-
cess must be the arrest or cure of a disease or dis-
eased condition or the correction of some malfunction
or the amelioration of some incapacity or disability.
and on page 66:
In my opinion, if it be accepted that process claims
for medical treatment of human disease, malfunction,
disability or incapacity of the human body or of any
part of it cannot satisfy the requirements of an inven-
tion under the Act, the class of such claims should be
narrowly defined. I can find no warrant in public
policy or in the decided cases for including in that
class processes and methods for improving, or at any
rate for changing, the appearance of the human body or
of parts of it. Such cosmetic processes and methods
are, in my opinion, not of a like kind with medical
prophylactic or therapeutic processes or methods.
There may, of course, be many borderline instances of
processes for use upon the human body or parts of it in
respect of which a decision as to whether the process
constitutes medical treatment or not may prove diffi-
cult. But I do not have here such a borderline case.
The process with which I am presently concerned with is
clearly not a method of treatment of a disease, mal-
function, disability or incapacity of the human body or
of any part of it. In fact, it does not purport to
deal with living tissue of the body; the hair to which
the solution is to be applied being dead, though its
attachment to the body is by or through the follicles
which may be regarded as part of the living tissue.
The process here is clearly cosmetic, in high contra-
distinction to a prophylactic or therapeutic medical
process. In my opinion, it does not fall within the
class of medical treatment which, for the purposes of
this case, may be taken to be an inappropriate subject
to the grant of letters patent. As I have mentioned
earlier, I am not concerned in this case to discover
and express a basis for excepting such a class of pro-
cess claims. If I had to do so, as at present advised,
I would place the exception, if it is to be maintained,
on public policy as being, in the language of the
Statute of Monopolies, "generally inconvenient", not
limiting what may fall within those words to things of
a like kind to those described by the preceding words.
Thus, after due consideration, I have reached the con-
clusion that it cannot properly be said that the appel-
lant's application cannot be granted simply because its
claims are for a process for application to the human
body. They are not, in my opinion, claims for a manner
or method of medical treatment of the human body within
the narrow exception to patentability to which I have
referred.
We note that keratinous material may contain keratin, a principal constitu-
ent of epidermis, hair, and nails.
In Joos, the treatment of dead parts of the body, namely the hair, was held
to be a cosmetic treatment, after considering whether it resided in the
category of a method of treatment of disease, malfunction, disability or
incapacity of the human body. Here, we feel that an objection made on the
ground that the process is to be applied to the human body, is not support-
able solely for that reason. Is this case, however, we are instructed by
the application and the submissions both written and oral that the desired
result is to accelerate the rate of new cell renewal. This invention is
different from that in Joos where the invention was to improve the appear-
ance of inanimate portions of the body, for example the hair. The Appli-
cant here proposes to accelerate the new growth of cells. It is explained
that the old cells will be displaced more quickly when there is an acceler-
ated rate of growth of new cells. Nowhere do we find, however, that the
Applicant has described any treatment to be performed on the dead cells
that may be compared in any way to treating the human hair to obtain a dif-
ference in its texture. Applicant's method is to increase the rate of
natural cell renewal without irritating the skin or causing damage thereto.
We are persuaded that the Applicant's method is for improving the capacity
of the body to renew skin cells at an increased rate so that they may
surface sooner. We are informed by the information in the application that
all the new products identified therein are intended to improve the rate of
renewal of new cells. In our opinion, the Applicant's method purports to
deal with living tissue and is designed to improve the capacity of the body
by treating it to produce new cells at an improved rate. We believe the
method is directed to more than performing a cosmetic treatment such as
waving hair. We find nowhere that the dead cells are massaged or acted on
to change their appearance. They are merely pushed off.
We are unable to find any patentable invention in view of Section 2 of the
Act. We obtain direction from Mr. Justice Kerr's passage above in
Tennessee-Eastman which we believe was not discredited by the Supreme
Court. In our opinion, this passage indicates that a method of treatment
that may be likened to a medical treatment of living tissues, as we so find
the Applicant's method, may be applied at times by persons that may or may
not be in the medical field. We consider the Applicant's method is not
merely an application of a substance to the human body, such as was
determined in the case of applying a dye to a tooth solely for
identification purposes. We regard the Applicant's method to be in the
same category of subject matter as that in the ICI case, in that there is
an intent for the method to improve the function or health of a particular
living part of the body, not merely to add cosmetic improvement even though
that condition may be present. From the ICI case therefore, we learn that
if a medical treatment and a cosmetic treatment occur together as a result
of the substance used, no patent may issue for either treatment.
Subsequent to the Hearing the Applicant submitted an affidavit from
Patricia Warrick, accompanied by Exhibits A, C and D. Ms. Warrick was
responsible for testing to determine the mechanism by which the skin cell
renewal regime acts to increase epidermal cell turnover. She states " ...
it was determined that the mechanism by which the regime operates is to
enhance epidermal cell turnover by removal of the outer layer of the
stratum corneum ... by detaching dead cells from the outer surface of the
skin and removing them. The body then functions in its normal way to
rebuild the stratum corneum by generating more cells which die and form a
layer of the stratum corneum." In support of her conclusions, Ms.
Warrick's affidavit refers to Exhibit A in which John A. Cells, Vice
President of Elizabeth Arden Inc, describes skin cell renewal. Mr. Cella
states that
"The above studies demonstrate that Millenium causes
the skin's cell renewal rate to accelerate and, in so
doing, causes it to function younger since the
renewal rate of younger skin is faster."
Further, he states that "this study clearly demonstrates that the skin
cells produced during the use of the millenium regime are of better quality
and appearance".
We note that, Exhibit A, by stating that the skin cell renewal is
accelerated, does not support Ms. Warrick's views' that the method relates
to separation of dead tissue from the body. We are unable therefore to
attribute any weight to the Warrick affidavit, since Mr. Cella's statements
describe cell renewal rate which in our view deals with living tissue
function.
In summary, we find that the Applicant's claims, although phrased in terms
of a cosmetic method, are directed to a method for treating living portions
of the human body to obtain skin cell renewal.
We recommend that the refusal of the claims be affirmed for being directed
to unpatentable subject matter.
M.G. Brown S.D. Kot
Acting Chairman Member
Patent Appeal Board
I concur with the findings and recommendation of the Patent Appeal Board.
I am satisfied this application is not directed to statutory subject
matter. Accordingly, I refuse to grant a patent under Section 42 of the
Act. The Applicant has six months within which to appeal my decision,
under Section 44 of the Act.
J.H.A. Gari‚py
Commissioner of Patents
dated at Hull, Quebec
this 20 day of April 1988
Gowling & Henderson
Box 466, Terminal A
Ottawa, Ontario
K1N 8S3