COMMISSIONER'S DECISION
Patentable Subject Matter - Phenotypic Concentration of Spermatozoa
Claims to a concentrate of mammalian spermatozoa were rejected on
prior art and as being directed to unpatentable subject matter.
It was held the claims failed to distinguish over subject matter
disclosed in a prior French patent, but that modifications would
clear that reference. It was also concluded that in the present
circumstances there was present allowable subject matter.
Rejection: Affirmed and Modified.
********************
Patent application 079973 (Class 209-69), was filed on April 13,
1970, for an invention entitled "Method And Means For Controlling
The Sex Of Mammalian Offspring And Product Therefor." The inven-
tor is Wallace Shrimpton. The examiner in charge of the
application took a Final Action on June 21, 1976 refusing to allow
it to proceed to patent. In reviewing the a rejection, the Patent
Appeal Board held a Hearing on August 9, 1978, and at which the
applicant was represented by Mr. D.G. Finlayson. The inventor,
Mr. Shrimpton, was also present.
The invention for which the applicant seeks protection is a means
for controlling the sex of mammalian offspring. It involves
separating the spermatozoa of the male into two fractions, one of
which contains the male-producing sperm and the other the female-
producing sperm. The female ovum is then fertilized with the male-
producing sperm or with the female-producing sperm, according to
the sex wanted in the offspring. The procedure is particularly
useful in breeding cattle. If the ultimate object is milk herds,
for example, one would wish to reproduce only females.
The general method is known, but the applicant has developed a new
way to separate the two types of sperm utilizing differences in
density between them. The sperm, which contains both the male-
producing sperm (referred to as Y-sperm) and female-producing
sperm (referred to as X-sperm), is introduced into the middle of
a column of a liquid separation medium having a uniform density
gradient from the lightest density at the top to the heaviest
density at the bottom. The lighter Y-sperm rise more quickly,
and a concentrate rich in Y-sperm is skimmed off the top. Milk
fractions have proven to be effective separation media, ones which do
not harm the sperm, though other media, such as tomato juice, may also
be used. ~Temperature and other conditions must be suitably controlled,
but these do not form part of the question before us.
Claims 1, 15, 17 and 45 are representative of the invention claimed.
1. A method for separating X-sperm and Y-sperm according
to phenotypic differences to make possible the control
of the sex of mammalian offspring, the steps of mixing
fresh sperm with a nutrient medium, cooling the mixture
of sperm and medium to a temperature in the range of
-5.degree.C. to 2.degree.C. to immobilize the sperm, introducing
the cooled mixture of sperm and medium to a separation
medium in the form of a separate body of nutrient
medium to a separation medium in the form of a separate
body of nutrient medium and maintaining the said
temperature range in the separation medium, said
separation medium having a uniform density gradient
extending from a lightest density at the top to a
heaviest density at the bottom, at least part of said
separation medium being substantially equivalent in
density to the density of said mixture, applying buoyant
forces to the sperm introduced to said separation medium
tending to separate the sperm at levels of suspension
within the separation medium of known density containing a
sperm density, and then separating a portion of the
separation medium of known density containing a
suspended sperm fraction of equivalent density and
desired predetermined sex characteristics.
15. A method as in Claim 1 wherein said sperm is a member
of the group consisting of primates, cattles, pigs, sheep,
rabbit, buffalo, goat and horse sperm.
17. A method as in Claim 15 wherein said sperm is human
sperm.
45. A composition of matter comprising deep frozen mammalian
sperm in a nutrient medium wherein at least 90% of said
sperm has chromosomes of one sex, said nutrient medium
at O.degree.C. having a viscosity below about 1.0 poise, a
density within the range from about 1.010 to about 1.044
grams per cc, a pH between about 6.0 and 8.0.
The examiner was ready to accept the process claims as being directed
to a novel way to separate sperm, but rejected the product claims
45-50 (of which claim 45 quoted above is representative). The same
claims had been refused in 1974 and "withdrawn without prejudice"
on July 29, 1974. The application was subsequently allowed, forfeited,
restored and the product claims reinserted on December 22, 1975.
The examiner's continued objections to them is that the product claims
do not distinguish inventively from those taught in French Patent
1472775, issued to the SWB Corporation on January 30, 1967, and that since
the sperm is living matter it is not patentable under Section 2 of
the Patent Act. He said:
The reference teaches the separation of a sperm population
into predominently Y-chromosome or X-chromosome containing
sperm fractions. Such fractions are used in insemination
to increase the chances of obtaining offsprings of one sex
over the other. The reference broadly teaches the use of
various media including milk and glycerol as the separation
media and more specifically egg yolk amp glycine as the
preferred medium. Further, the desired properties of the media
taught in the reference are essentially the same as those
claimed by the applicant. The "deep frozen" limitation
recently added to instant claim 45 does not define further
invention as applicant points out in his letter of April 28,
deep freezing "is a common and accepted manner of storing
and shipping products of this type".
Further, the product defined by claims 45 to 50 does not
fall within the scope of section 2 of the Patent Act.
Living or viable matter is not patentable. Mixing or
diluting such matter with a nutrient medium and freezing
said mixture does not confer patentability to said matter.
The applicant contends that his product distinguishes from that disclosed
in the French patent because it is much more successful in producing
the desired sex in offspring, and is viable when deep frozen. Further
he says the product has commercial use in "the modern industry of
providing animal protein for human consumption", is reproducible, and
as such is patentable subject matter. An affidavit taken by the inventor
was submitted as evidence of the differences between his product and
that disclosed in the citation.
The applicant has also argued that the Patent Office allowed similar
product claims in Canadian Patent 891017, which is the counterpart of
the French citation, and that consequently he himself should be allowed
similar claims so that "any subsequent determination of the correct
patentee can be settled in the Canadian courts. We cannot, however,
accept that particular argument. The other Canadian application is not
in suit, and it would be improper for us to assess its patentability.
What we do have before us is application 079973, and we must determine
whether we think the claims in it are patentable, divorced from any
question of validity of claims in other patents.
In discussing the Canadian patent 891617, applicant says (p. 4, response
of December 21, 1976):
As an application that patent was copending with the present
application for twenty-one months and indeed the first
Examiner attempted to apply that Canadian patent against the
present application. The Canadian patent includes a number
of product claims for the same viable commercial product and
the limitations of that composition are not identical to
the composition and qualities and characteristics of the
composition in Claims 45, et seq. The applicant contends
that a conflict should have been declared in the normal
prosecution of these two applications and that while the
present rejection is not on the basis of that Canadian
patent, the Examiner has rejected Claims 45-50 as containing
no patentable subject matter and yet the Patent Office
issued a patent with claims for a similar type and parallel sub-
ject matter at a time when the present application had
already been on file for more than a year and a half.
[underlining added]
We see these statements as an admission that the product claims in the
Canadian patent [and also in the French patent] are the same as what
applicant claims. Otherwise we do not see how applicant can contend conflict
should have been declared. If the products are different (as applicant
argues elsewhere) there would be no conflict.
For our part, we have been persuaded by the affidavits and evidence
presented at the Hearing that applicant's product must indeed differ
from that claimed in Bhattacharya's Canadian and French patents.
Otherwise the results obtained using Shrimpton's product would not
differ so greatly from that using Bhattacharya's product. Its higher
pregnancy rate and viability demonstrated in applicant's arguments,
affidavit, and the article in Nature August 20, 1966 indicate it is a
significantly different product. Such a difference is more than a
question of degree.
The difficulty, one recognized by Mr. Finlayson at the Hearing, is that
the claims as now defined do not clearly distinguish from Bhattacharya,
and in our view were consequently properly refused by the examiner
because of his citation. Mr. Finlayson suggested that he should perhaps
add a process limitation to the claims to avoid this difficulty. We agree
that this is indeed a proper case to include a process limitation as the
only apparent way to properly define over the prior art. To overcome the
rejection of anticipation we would consequently call up on the appl~cant
to make such an amendment. We also think it would be proper to remove
the term "deep frozen" from claim 45 as requested by Mr. Finlayson, since
the product of claim 1 would not be deep frozen, and indeed would not
be viable when deep frozen unless other additives are included. We
further see no objection to amending the reference to 90% sperm of one
sex to 70%, since on page 26 of the disclosure it is shown that at least
70-80% of the sperm should be of one sex for commercial purposes, and it
is only "essential" to have 90% of one sex to obtain best results.
These amendments would, we are satisfied, clear the objections based upon
anticipation in the French patent. We are still left, however, with the
more thorny question whether the product is objectionable as not being
directed to statutory subject matter.
At the Hearing Mr. Finlayson recognized the general prohibition against
patenting living matter per se. It is a prohibition which also applies
to animal breeding. We have, on earlier occasions, concluded that both
are directed to non-statutory subject matter, not encompassed within
the meaning of the word invention as used in Section 2 of the Patent Act.
Most of the earlier decisions of the Commissioner unfortunately are
unpublished, but we can refer to the Patent Office Record for Jan. 4, 1977
xiii (The Human Liver Cell Line Case), to Dec. 20, 1977 at p. xiv (the
Wehrmeister decision; and to May 23, 1978 at xiv (the Miyairi case).
In reaching such conclusions we have had recourse to Tennessee Eastman v
Commissioner of Patents 1973 C.P,R. 8, (2d) 202; N.V. Philips Application
(1954) 71 R.P.C. 192; Lawson v Commissioner of Patents (1970) 62 C.P.R. 109;
Commissioner of Patents v Farbwerke Hocchst (1964) S.C.R. 49; In re Rau G.m.b H
(1935) 52 R.P.C. 362; R.H.F.'s Application (1944) 61 R.P.C.; Leonard's
Application (1954) 71 R.P.C. 190; N.V. Philips' Gloe~~ampenfabriel~n's
Application (1954) 71 R.P.C. 192; In re A.D. Goldhaft et al 1957 R.P.C. 276;
In re American Chemical Paint 1958 R.P.C. 47; Swift and Company's Application
1962 R.P.C. 37; In re Canterbury Agricultural College's Application
1958 R.P.C. 85; National Research Development's Application 1961 R.P.C. 131;
the British Patent Act of 1977, Ch. 37, Part 3(b); the Convention for the Grant
of European Patents, Article 53(b); J.R. Short Milling v George Weston et al
1941 Ex. C.R. 69 and 1942 S.C.R. 187; American Cyanamid v Frosst (1965)
2 Ex. C.R. 355; In re Virginia-Carolina Chemical 1958 R.P.C. 351; In re
Hamilton-Adams (1918) 35 R,P.C. 90; and Standard Oil Development's
Application (1951) 68 R.P.C. 114. 1n the United States a very recent ruling
of the United States Supreme Court effectively denied patentability to
new forms of microorganisms, In re Bergey, June 26, 1978, as reported in BNA's
Patent, Trademark & Copyright Journal No. 385 June 29, 1978, page A,
reversing the U.S. Court of Customs and Patent Appeals as reported in No. 349,
Oct. 13, 1977 at p. D-1. Earlier United States decisions had held that
living organisms and matter were not patentable. Sec for example
Guaranty Trust v Union Solvents 54 F. 2d 400,410; In re Arzberger 1940 C.D. 65,
& 46 U.S.P.O. 32; In re Nancy 499 F. 2d 12 89, 1294; and American Fruit
Growers v Brogdex, U.S. Supreme Court, 1931 C.D. 77, which while now an
old case was relied upon in the dissenting opinions In re Bergey, supra,
and In re Chakrabarty P.T.C.J. 3-9-78-p. D-l, which dissents were subsequent-
ly endorsed by the Supreme Court (supra).
In the present case applicant's claims stop short of the breeding steps,
covering only materials to be used in breeding. The controversy will con-
sequently turn upon whether the rejected claims should be refused for being
"living matter," a "product of nature," or a "living organism."
There is no doubt that spermatozoa possesses certain attributes of life,
including mobility and the ability to generate life when coupled with
ova. On the other hand they cannot reproduce themselves, at least not
directly, and really are only part of a living organism, much as a leaf or
seed is part of a plant, or a heart is part of a human organism. In
his dissenting opinion (subsequently tacitly endorsed by the U.S.Supreme Court)
in the Bergy case (supra), Mr. Justice Miller said:
The nature of organisms, whether microorganisms, plants, or
other living things, is fundamentally different from that of
inanimate chemical compositions [which are patentable]. For
example, both the microorganisms claimed herein and honeybees
are alive, reproduce, and act upon other materials to form
technologically useful product (lincomycm and honey, respectively).
This cannot be said of chemical compositions. I agree with
the board [of appeals] ... that living organisms (e.g.
plants and biologically pure cultures of microorganisms were
not intended by Congress to be within the scope of 35 U.S.C.101
(which like the Section 2 of the Canadian Patent Act defines
what is an invention].
While there are obvious similarities between the applicant's subject
matter and that in Bergy, there are also differences. The sperm do not
reproduce sperm, nor do they themselves produce a "technologically"
useful product.
In the Goldhaft decision, supra, we find:
Mr. Watson urged, however, that the Applicant's method was
truly a "manner of manufacture", or, expressed in another
way, that what 1 may perhaps call the sex-controlled egg
was in fact a vendible product within the meaning to be
given to that phrase when applying the G.E.C. rules. After
careful consideration, I find I cannot agree with this
contention. The fertilisation of the ovum, the production of
the egg, its incubation and the hatching of the chick are
steps in a process of nature, in a natural phenomenon. The
Applicants' invention as claimed consists merely in the
act of intervening, by the introduction into the egg of an
appropriate chemical compound, in this natural process to
alter the sex of the chick ultimately to be hatched, and
to be hatched whether or not the applicants do so intervene.
In my judgement, such an act is not. a "manner of manufacture"
within the meaning of the statute. Alternately stated a
"sex-controlled" egg must, like fruit and growing crops,
be excluded from the ambit of the phrase "vendible product"
as used in the G.E.C. rules.
Again, in some respects the subject matter of the decision and that of
the application are similar, but there are differences. The applicant's
process is not a natural phenomenon, and there is no creation either of
living matter or of a living organism. The separation carried out
in the invention is completely artificial.
The last case to which we would refer is In re Rau, supra, quoting
from p. 363:
In my opinion, the production by selective cultivation of seeds
having the desired compositions set forth in Claims 1 to 4
cannot be held to be a manner of manufacture within the meaning
of Section 93 of the Acts. Selective breeding of animals
and cultivation of plants for the obtainment of improved stocks
by the rigorous selection of and breeding from the few
individuals which are nearest the ideal has, as is well known,
been practised from the earliest times as a part of agricultural
or horticultural development, as for example in the production
of improved flowers or fruit with desired characteristics in
the progeny, and the exercise of art or skill in these
directions has not been regarded as coming within the term
'manufacture'. I think that the subject of the present applica-
tions is clearly distinguishable from the invention considered
in the case of Commercial Solvents Corporation v. Synthetic
Products Co., Ltd. ((1926) 43 R.P.C. 185) referred to by Counsel,
it seems to me that the process in the latter case is analogous
to a chemical manufacturing process or operation, the cultured
bacteria playing a part in the conversion of starchy bodies
into acetone and alcohols similar to that of chemical reagents
or catalysts.
As regards Claims 5 and 6, these claims simply refer to the
ordinary known methods of extracting the oils or fats from oil-
bearing seeds in general and to the usual use of the residues,
and Claims 7-9 are the usual appendant product claims; there is
no suggestion in the Specification that the seeds according
to Claims 1 to 4 are to be treated in any but the ordinary manner
of treating seeds to obtain oils, fats and fodder residues.
The present case differs from Rau's invention in that the vital steps present
in cultivation are absent.
Jasper Utermann, in his article Reflections on Patent Protection of Products
of Nature IIC Vol. 9 No. 5 1978, p. 409, has analysed objections
based upon the view that products which occur naturally or are found in
nature are unpatentable. The basis for such an objection is that products
which occur naturally should remain freely available to the general
public. That, of course, is not a factor in this case, since the synthetic-
ally separated sperm would not occur as such in nature.
While the present case is fraught with some uncertainty, we have reached
the conclusion that the product of claim 45 (when properly amended) is
not open to the usual objections based on living matter, lining
organisms, and products of nature, and that this is not one where the
Commissioner could say with any certainty that the applicant is not by law
entitled to be granted a patent, as referred to in Section 42 of the Patent
Act. We would consequently recommend that the present objection against
such claims when amended, be withdrawn.
We note that the present title of the application does not clearly express
what the new claims would protect. Something such as "Phenotypic Separation
of Spermatozoa" would, we think, be more appropriate.
Another matter was also discussed at the Hearing. The claims are broad
enough to cover human sperm, and the disclosure specifically mentions
that aspect of the invention. This raises some doubts as to whether in
their broadest term the process and product claims are only commercial
and industrial, but rather extend to the socio-medico sphere, encompassing
methods for controlling human populations. Mr. Shrimpton also indicated
at the Hearing that his work had really been limited to livestock, and
there is some uncertainty as to its practicality (and therefore utility)
with humans. To avoid these objections the applicant offered at the
Hearing to exclude the human species from his claims, so there would he
no need for the Board to consider such issues. First it was proposed the
claims should be limited to "animals," but Mr. Finlayson argued that
humans are often classified as an animal species. To avoid that problem
it was agreed that all the claims would be limited to non-human
mammals.
With that and the other amendments agreed upon, the Board recommends that
the present objections be withdrawn.
Mr. Finlayson would also like to add certain claims dependent upon claim 45
to include glycerol. and other additives which render frozen sperm more
viable. We see no objection to that, but believe it is a question which can
be more properly worked out with the Examiner when prosecution is resumed.
Gordon Asher
Chairman
Patent Appeal Board, Canada
Having reviewed the prosecution, I adopt the reasons, conclusions and
recommendations of the Board. The rejection of present claims 45-50 is
affirmed. The applicant should now proceed to make the amendments agreed
upon at the Hearing within six months of the date of this decision, or to
appeal under Section 44. The application is to be returned to the Examiner
to resume prosecution.
J.H.A. Gariepy
Commissioner of Patents
Dated at Hull, Quebec
this 7th. day of March, 1979
Agent for Applicant
Meredith & Finlayson
77 Metcalfe Street
Ottawa, Ontario