IN THE CANADIAN PATENT OFFICE
DECISION OF THE COMMISSIONER OF PATENTS
Patent application 471,056 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
McFadden, Fincham, Marcus & Anissimoff
Suite 606
225 Metcalfe Street
Ottawa, Ontario
K2P 1P9
COMMISSIONER'S DECISION SUMMARY
C.D. 1171... App'n 471,056 (B20), (F00)
Excessive Width of Claims and Lacking Novelty
The amended claim serves to differentiate the microorganism
claimed from the microorganism as it exists in nature. Also the
evidence submitted, particularly the fact that two other bacteria
of the genus Alteromonas were found using the methods disclosed
in the application, was persuasive that the three criteria used
by the Supreme Court in Monsanto Co. v. Commissioner of Patents,
42 C.P.R. (2d) 161 in determining whether the description of a
few members of a group entitled claims to the whole group.
Rejection modified.
This decision deals with the Applicant's request for review by
the Commissioner of Patents of the Final Action on application
serial number 471,056 (Class 195-34.7), assigned to Research
Corporation. The application is entitled "INDUCTION OF
SETTLEMENT AND METAMORPHOSIS IN CRASSOSTREA VIRGINICA BY MELANIN-
SYNTHESIZING BACTERIA AND OTHER DERIVATIVE METABOLIC PRODUCTS",
and the inventors are R.M. Weiner, R.R. Colwell, D.B. Bonar and
S.L. Coon. The Examiner issued a Final Action on January 24,
1990 refusing claims 1, 5, 11, 16, 24, 30 and 35 for being broad
in view of the teachings of the disclosure and claim 1 for
failing to distinguish the microorganism claimed from that as it
exists in nature. The applicant further requested an oral
hearing for the purposes of presenting verbally applicant's
position.
Claims 1, 5 and 11 read:
1. A melanin-synthesizing marine bacterium of the
genus Altermonas and mutants of said bacterium capable of
inducing the settlement and metamorphosis of Crassostrea
virginica larvae.
5. A method for inducing the settlement and
metamorphosis of Crassostrea virginica larvae comprising
exposing said larvae in an aqueous medium to melanin-
synthesizing marine bacteria or to metabolic products of
said bacteria.
11. In a method for producing DOPA by bacteria, the
improvement comprising culturing melanin-synthesizing marine
bacteria of the genus Altermonas in a growth medium to
produce said DOPA as a metabolic product of said bacterium.
The other rejected claims are of the same format as claim 11 but
relate to the production of acid polysaccharide exopolymer,
melanin, tyrosine and tyrosinose respectively.
In response to the Final Action and to further communication with
the Patent Office the applicant presented arguments and modified
claims.
Modified claims 1 and 5 now read:
1. A biologically pure culture of a melanin-
synthesizing marine bacterium of the genus Alteromonas and
mutants of said bacterium capable of inducing the settlement
and metamorphosis of Crassostrea virginica larvae.
5. A method for inducing the settlement and
metamorphosis of Crassostrea virginica larvae comprising
exposing said larvae in an aqueous medium to melanin-
synthesizing marine bacteria of the genus Alteromonas, or to
mutants thereof, or to metabolic products of said bacteria.
The remaining claims remain as prior to the Final Action.
The issue before the Board is whether a) the arguments and/or b)
the amendments satisfy the objection raised by the Examiner in
her Final Action.
In her Final Action the Examiner stated (in part):
...
Moreover, in claim 1, applicant is required to further
define the marine bacterium of the genus Altermonas as being
a "biologically pure culture" to distinguish the
microorganism claimed from the microorganism as it exists in
nature.
Claims 1, 5, 11, 16, 24, 30 and 35 are rejected as being
broad in view of the teachings of the disclosure. Amendment
is required under Rule 25 of the Patent Rules in order to
specify that the melanin-synthesizing marine bacteria is
Altermonas colweilliensis, ATCC numbers 33887, 33888 and
39565.
Applicant's alleged invention relates to a melanin-
synthesizing marine bacterium, Altermonas colweilliensis and
variants and mutants thereof. The bacterium is alleged to
elaborate certain metabolic products (for example,
dihydroxyphenylalanine, (DOPA), melanin, tyrosine,
tyrosinose and a polysaccharide exopolymer) which function
as oyster larvae attractants. As such, the bacterium via
the metabolic products is useful in inducing the settlement
and metamorphosis of the oyster, Grassostrea virginica
larvae.
Applicant's discovery of one species of Altermonas said to
be capable of inducing settlement and metamorphosis of C.
virginica, does not entitle applicant to all species of this
genus, known or unknown. Had applicant taught several
species of Altermonas, he would be entitled to a broad claim
to that genus.
The disclosure lacks support for species of Altermonas other
than A. colweilliensis, ATCC numbers 33887, 33888 and 39565.
In his amendment of July 11, 1989, applicant made reference
to Monsanto vs. the Commissioner of Patents (Supreme Court)
42 C.P.R. 161. It is submitted that this decision is not
applicable to the present case.
The Monsanto decision related to a class of chemical
compounds wherein it was held that a sound prediction could
be made for a group of di-imido chemical compounds whose
physical data was not provided in the disclosure. Claims to
these compounds was based on three specific compounds that
were fully characterized and supported by the disclosure,
and differed from the former in the substituents on a given
moiety. The Monsanto case was for a pioneer invention in an
unexplored field of chemical compounds useful as inhibitors
of premature vulcanization of rubber.
...
In response to the Final Action the applicant states (in part):
... at page 2 thereof
In the action, the Examiner has also requested
amendment to claim 1 to specify that the bacterium of the
genus Alteromonas is a "biologically pure culture";
applicant would agree with this requested amendment and for
the purposes of this appeal, it is respectfully requested
that amended claim 1 be entered. To this end, a new page of
claims (in duplicate) containing claim 1 is submitted
herewith.
... at page 10
The applicant would like to point out that claim 1, and
the others involved, is in fact a specific type of claim
directed only to certain specific features commensurate with
the scope of the invention. An analysis of the claim (that
is claim 1) will show that this claim has the following
features:
(a) that it is only for a melanin-synthesizing marine
bacterium which is a biologically pure culture;
(b) that the claim is only directed to such bacterium
which are of the genus Alteromonas (and mutants thereof);
and
(c) that the only claim is to bacterium of the genus
Alteromonas (and mutants thereof) which are capable of
inducing the settlement of and metamorphosis of C. virginica
larvae.
...
From the above analysis of claim 1, it will be seen
that this claim is quite specific in that only bacterium of
one single genus are being claimed and amongst those
bacterium only those which have the characteristic of being
capable of inducing the settlement of the defined larvae are
included in the scope of the claim. The claim does not
extend to other genuses nor does it extend to even those
members of the genus Alteromonas which do not have the
feature of the present invention.
Claim 1 and the other claims under rejection, are
clearly supported by the disclosure. Page 4, lines 20 et.
seq. specifically teach that the disclosure relates to the
class of bacteria which are species of Alteromonas; page 5,
lines 1 to 4 clearly state that the invention relates to a
melanin-synthesizing marine bacterium which is capable of
performing certain functions; etc.
The disclosure clearly exemplifies various examples of
the genus Alteromonas (as discussed hereinafter in greater
detail; the three examples which are shown are clearly
taught as being only preferred embodiments of the invention.
These examples show that three different bacterium, which
are abbreviated as LST, DIP and HYP, are specifically taught
and can be employed in a process for inducing the settlement
and metamorphosis of Crassostrea virginica larvae.
... at page 12 thereof
The Appeal Board's attention is directed to the
decision held in the Supreme Court of Canada case of
Monsanto Co. v. Commissioner of Patents, 42 C.P.R. (2d) 161
at 171 et. seq. wherein it is indicated that where
disclosure in the specification is insufficient for a
layman, i.e. one lacking skill in the art, it may very well
be sufficient for one skilled in the art.
Attached to this submission is an Affidavit by Dr. R.
Weiner and it is respectfully requested that it be entered
as part of this submission. With respect to the sworn
statements of this affiant, attention is respectfully
directed to Dr. Weiner's profession, namely, that of a
Professor of Microbiology; thus Dr. Weiner is qualified as
"a person skilled in the art to which this invention
pertains".
As will be noted from Dr. Weiner's affidavit, he has
stated that "I have discovered that several members of the
genus Alteromonas have the characteristics contemplated by
the present invention. In particular, this includes the
production of metabolic products ... associated with
metabolism and exopolymer synthesis. These organisms are
Alteromonas, and like A. colwelliana exhibit the ability to
induce the settlement and metamorphosis of Crassostrea
virginica larvae. Using methods disclosed in the
Specification for identification of A. colwelliana (see
Specification, Page 26, Table 1), I have found that two
other melanin-synthesizing bacteria of the genus
Alteromonas, A. hanedai (ATCC No. 33224) and A. nigrifaciens
(ATCC No. 233-27) each synthesize PAVE, which also plays an
important role in inducing settlement and metamorphosis of
C. virainica".
... at page 15 thereof
The leading case of authority in this area is that of
Monsanto v. Commissioner of Patents, supra, pages 161 et.
seq.; it is a Supreme Court decision dealing specifically
with the identical issues raised by the Examiner in this
application.
The decision involving the Monsanto application under
Rule 25 dealt with a di-imido compound in which there were a
large number of substituents attached to the basic moiety;
the question addressed by the Supreme Court was whether,
having regard to the preparation of three compounds taught
in the disclosure, the product claims including broad claim
9 (encompassing a generic class of compounds) and a
subgeneric claim 16 (listing one hundred and twenty-six
species) was adequately supported and whether the invention
which was taught could be said to be fairly described m the
disclosure having regard to the scope of the claims.
Another specific issue in the Monsanto case was whether
the product species, which is not specifically described and
exemplified in the specification, could be claimed.
... at page 17
Turning now to the specifics of the Monsanto decision
in the Supreme Court, the majority decision of the Court
dealt with issues relating to (i) "conclusions as to
prediction"; (ii) whether a person skilled in the art could
prepare the compounds claimed based on the teachings of the
patent application; and (iii) evidence of lack of utility.
... at page 18
Clearly, this Supreme Court decision in Monsanto has
found that it is essential that before a patent is to be
considered invalid, it is a matter of fact and law that some
or all of the claims containing compounds would not have
utility.
In the present instance, there is not one piece of
evidence put forth by the Examiner, nor is there any
evidence in the file, that there is any bacterium, which has
no utility, within the scope of the present invention and
claims and conversely, there is no evidence of inutility for
the corresponding process and method of use claims rejected
by the Examiner.
As noted in the Supreme Court decision, page 173 of
C.P.R., the Supreme Court held that it appeared to the Court
that the lower Court had completely overlooked "... the rule
that a patent specification is addressed to a person
'skilled in the art'". In the Monsanto decision, an
affidavit was put before the Patent Office and in that
affidavit, a person skilled in the art attested to the fact
that by following the teachings of the specification, one
could prepare all of the described compounds even though
specific directions were given for three or less compounds.
... at page 20
Clearly, there is a complete and proper teaching of tie
invention to one skilled in the art, which is fully
supported throughout the disclosure and not only is fully
supported, but also is fully exemplified by sufficient
examples to enable such person skilled in the art to which
the present invention appertains to fully practice the
invention in its broadest scope.
In addition, the Affidavit Dr. Ronald Weiner, a person
skilled in the art, has further emphasized and confirmed
that the teachings of the present disclosure enable one
skilled in the art to fully practice the present invention.
As Dr. Weiner has attested to, the present invention is
applicable to those bacterium of an of the species of
Alteromonas which are capable of inducing the settlement and
metamorphosis of Crassostrea virainica larvae.
... at page 23
Applicant respectfully requests the Board to consider
what evidence there is on record relative to the Examiner's
statement. On one hand, there are the teachings of the
application which, as noted above, clearly say that those
bacterium and only those bacterium of the genus Alteromonas
which are melanin-synthesizing marine bacterium are those
which are claimed in accordance with the invention to have
the utility described in the disclosure and that it has been
"surprisingly discovered" that those bacterium have such
utility. There is also the evidence of the Affidavit of
record by Dr. Ronald Weiner. Conversely, there is
absolutely no evidence to the contrary; the Examiner has
only made a flat statement not supported by any prior art
nor any other type of evidence which would go towards
establishing a case of non-utility as required by the
Supreme Court in the Monsanto decision.
... at page 36
The decision of Rouleau, J. of the Federal Court, is
extremely similar on the points in issue here to the
decision in Monsanto v. Commissioner of Patents. Once
again, the facts addressed are evidence for the lack of
utility and "sound and reasonable" predictions thereof,
which in both cases were held to be insufficient grounds to
deny an applicant a patent. As previously stated herein,
the Examiner has not provided any evidence for inutility of
any bacterium within the scope of the invention and
secondly, the case is devoid of such evidence to corroborate
the rejected process and method claims, and the Affidavit
submitted herewith clearly establishes the soundness of
prediction and utility.
... at page 37
It must further be pointed out in this respect that if
the Examiner's statements were correct, then not only in
biological cases such as the present one, but also in every
mechanical case where an applicant disclosed one embodiment
or a broader "means" could not claim anything but the
specific-one embodiment described and exemplified in the
specification.
...
Moreover, the Examiner further appears to be
misconstruing Rule 25 as applied to the specific embodiments
of an application. There is absolutely no requirement
whatsoever, in Section 34, that each and ever embodiment
embraced within the broader invention must be exemplified
before it can be claimed. The examples of an application
are only that - they are examples of certain preferred
compounds or preferred mechanical means within the broader
context of the invention. There is not one decision, or one
section in the Act or Rules, which contemplates that an
applicant has to set out a whole genus as an example - if
so, this would mean that even mechanical patents would run
to hundreds of pages of disclosure as would chemical
patents, by the time that every mechanical component or
every bacterium or compound form ing part of the invention
was exemplified.
The rejection of claim 1 for failing to distinguish from the
microorganism as it exists in nature no longer holds as the
applicant has introduced the qualifier "biologically pure
culture" to said claim; this point needs no more consideration
here.
The rejection of claims 1, 5, 11, 16, 24, 30 and 35 needs further
consideration in view of the affidavit submitted by the co-
inventor Dr. Weiner and in view of the jurisprudence dealing with
Rule 25 of the Patent Rules and Section 34 of the Patent Act.
In his affidavit Dr. Weiner submits that using methods disclosed
in the specification for identification of A. colwelliana he
found two other bacteria of the genus Alteromonas meeting the
characteristics of the organisms that are the subject of the
rejected claims.
The Board accepts applicant's view of the applicability of
Monsanto Co. v. Commissioner of Patents, 42 C.P.R. (2d) 161 to
the present case. The Supreme Court considered three criteria in
determining whether in fact the description of a few members of a
group entitled claims to the whole group: (i) conclusions as to
prediction; (ii) whether a person skilled in the art could
prepare the compounds claimed based on the teachings of the
patent application; and (iii) evidence of lack of utility.
Regarding criterion (i) the Board is satisfied that no evidence
or arguments have been submitted to support a rejection on lack
of predictability. Although it is true that biological systems
are highly variable and not as predictable as say mechanical
systems it does not follow that all biological systems are
totally unpredictable and follow no particular rhyme or reason.
The fact is that biological systems are complex and are acted
upon by their environment in a complex fashion. However the
patent field is replete with examples of how biological systems
have predictably been used in industrial processes. The
production of a variety of products by a variety of organisms
leads one to conclude that it is not wholly unpredictable that
families of organisms exist or can be made to exist to carry out
a particular function or produce a particular product.
The second criterion is certainly met by the submission of Dr.
Weiner's affidavit. There is no question that Dr. Weiner is
skilled in the art and he was able to find organisms comparable
to those of the rejected claims using the teachings of the
disclosure.
The third criterion is met by the formulation or language of the
claims. Each claim in fact incorporates a statement of utility
and thus useless embodiments are clearly excluded. Each organism
covered by the claims must a) be a member of the genus
Alteromonas, b) be a melanin-synthesizer, and c) either induce
the settlement and metamorphosis of Crassostrea virginica oyster
or product a specified metabolic product.
We recommend the acceptance of the claims as amended as a result
of the Final Action and of further discussion with the Board.
F.H. Adams Dr. M. Howarth A. Legris
Chairman 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
McFadden, Fincham, Marcus & Anissimoff
Suite 606
225 Metcalfe Street
Ottawa, Ontario
K2F 1P9