COMMISSIONER'S DECISION
UTILITY OF KNOWN COMPOUND: STERILIZATION PROCESS
Applicant claims a known composition (B.C.G.) for use in sterilization of
mammalian species. The rejected claims fail to define the relationship of
any limited form of BCG in terms of its make-up or constitution together
with the other necessary components that formulate a composition.
Final Action: Affirmed *******************
This decision deals with Applicant's request for review by the Commissioner
of Patents of the Final Action of application 322,706 (Class 167-135),
entitled "Sterilization Process for Mammals." The inventor is G.P. Talwar.
The Examiner wrote a Final Action on July 8, 1982 refusing claims 1 to 4
of the application to proceed to patent.
The invention relates to a method of sterilization of mammalian species.
Bacillus of Calmette and Guerin (hereinafter referred to as BCG) is a known
vaccine for protection against tuberculosis. Applicant has discovered
a new, unexpected use for BCG having regard to its known utility and properties.
He discloses that sterilization in mammalian species occurs when BCG is
intro-testicularly injected at a dose of at least 1.5 x 10 7 organisms.
In the Final Action the Examiner said in rejecting claims 1 to 4 (in part):
Claims 1 to 4 are directed to known products in terms
of a novel utility. BCG per se is old and known as acknowledged
in the disclosure on page 7 and remains old and known no matter
what purpose it is used for. Only novel adaptations thereof are
patentable. The BCG per se defined in teams of utility as in
claims 1 to 4 does not define patentable subject matter.
In response to the Final Action the Applicant stated (in part):
It is submitted that the definition of the novel form of BCG
in claims 1 to 4 is as equally allowable as the definition
of the novel form of BCG in claims 5 and 6. Claims 1 to 4
define a novel composition of matter in the same way that
claims 5 and 6 define a novel composition of matter. Both
groups of claims define novel adaptations of BCG.
It is submitted that there is nothing in The Patent Act
which prevents the patenting of claims 1 to 4. While limit-
ing a product claim by reciting the use to which it is to be
put may be an unusual form of limitation, nevertheless, it
is submitted that such recitation is a limitation. It is
noted that the Examiner has chosen to cite no case law or
other authority which would support his position.
Claims 1 to 4 are infringed only if BCG is used in the manner
recited therein, and, therefore, these claims extend only to
such use. The claims are not directed to BCG per se, but
rather to the restricted form of BCG recited therein.
The utility is novel and unobvious and worthy of patent pro-
tection. The applicants, in claims 1 to 4, have chosen to
define the invention in terms of a composition of amtter
limited to use in the novel and unobvious manner. It is sub-
mitted that such limitation results in a claim which is
novel and unobvious and hence patentable.
...
On page 4 of the response it is argued (in part):
Claims 1 to 4 do not claim BCG per se. BCG is a known substance
and hence cannot be claimed. What is claimed is that compound
limited by the end use to which it is put. It is submitted that
the recitation of the use in the claims is a proper limitation
and one which distinguishes the claims from the prior art.
...
The issue before the Board is whether or not claims 1 to 4 define patentable
subject matter. Claims 1 to 4 read as follows:
1. The Bacillus of Calmette and Guerin when used in the
sterilization of mammalian species.
2. The invention of claim 1, wherein the mammalian species
is selected from the group consisting of rams, non-human
primates, rats, guinea pigs or rabbits.
3. The invention of claim 1, wherein the mammalian species
is dogs.
4. The Bacillus or Calmette and Guerin when used for intra-
testicular injection in an amount of at least 1.5 x 10 7
organisms per testicle.
We see from the prosecution both the Applicant and the Examiner agree that
BCG is known and old. Applicant argues that claims 1 to 4 represent a
limited form of BCG in terms of a composition of matter. He points to the
term "when used" in claims 1 and 4 to illustrate that these claims are
directed to a composition, but we are not persuaded that these words impart
any patentably limiting chemical or physical feature to BCG. They merely
indicate an intention without including a material diference over the known
BCG. Also in claim 4 we note an amount is given. In our opinion, merely
referring to BCG in terms of an amount, does not lend to claim 4 any
characteristics or properties which may be said to be properly definitive
of a new composition. We note further that claim 4 is not directed to a
composition. We are persuaded claim 4 recites no more than the same BCG used in
treating tuberculosis. In summary, we find claims 1 to 4 fail to define the
relationship of any limited form of BCG in terms of its make-up or constitut-
ion together with the other necessary components that formulate a composition.
We are satisfied therefore that claims 1 to 4 do not define patentable subject
matter.
We recommend that the rejection of claims 1 to 4 be maintained.
A. McDonough M.G. Brown S.D. Kot
Chairman Assistant Chairman Member
Patent Appeal Board
I concur with the findings and recommendation of the Patent Appeal Board.
Accordingly, I refuse to grant a patent containing claims 1 to 4 of the
application. The Applicant has 6 months within which to appeal my decision
under the provisions of Section 44 of the Patent Act.
J.H.A. Gari‚py
Commissioner of Patents
Dated at Hull, Quebec
this 9th. day of August, 1984
Agent for Applicant
Sim & McBurney,
330 University Ave.
Toronto, Ont.
M5G 1R7