Section 2; Isolation and Modification of a Togavirus strain
Amended claims to the characteristics of the altered state of an
isolated virus from body fluids and modified to a useful togavirus
strain free of primate proteins and useful in making vaccines,
were held allowable under Section 2. Rejection modified.
This decision deals with Applicant's request for review by the Commissioner
of Patents of the Final Action on application 400,069 (Class 167-41) filed
March 31, 1982. Entitled NON-A, NON-B HEPATITIS ASSAY AND VACCINE, it is
assigned to Connaught Laboratories Ltd. The inventors are P.L. Coursaget,
P. Maupas (deceased). The Examiner in charge issued a Final Action on
June 22, 1984, refusing to allow the application. A Hearing was held on
May 18, 1988, at which the Patent Agent, Mr. M.I. Stewart, represented the
Applicant. On May 26, 1988, Mr. Stewart submitted a set of amended claims.
The application relates to a togavirus strain particle that has been
discovered in body fluids of Non-A, Non-B (NANB) hepatitis patients, and
that has been rendered noninfective for tissue culture by exposure to ether
or upon heating at about 25·C in aqueous suspension. The particle may be
replicated in vitro by culturing, recovered by decanting, and purified.
In rejecting claims 1 to 6, and 10 to 15, the Examiner said, in part, as
follows:
. . .
The refusal of claims 1 to 6 and 10 to 15 is maintain-
ed. Claims 7 to 9 and 16 to 23 are allowable. The
rejected claims define subject matter that is outside
the definition of invention as given in Section 2 of
the Patent Act and outside the criteria set out in the
decision of Abitibi published on July 6, 1982. Appli-
cant's product has been isolated from nature. There-
fore it is not new and inventive.
In applicant's last response and in the disclosure, it
is mentioned that the product claimed has been isolated
and purified from "body fluids", for example "urine"
and "serum". See letter of May 3, 1984, first para-
graph and in the disclosure on pages 3/4 lines 10-18.
Therefore the product does not comply with the criteria
of Abitibi and Section 2 of the Patent Act. "The
organisms, to be claimed, should not of course have
existed previously in nature, for in that event the
"inventor" did not create it, and his "invention" is
old. And it must be sufficiently different from known
species that it can be said that its creation involved
the necessary element of inventive ingenuity".
(Abitibi last paragraph).
. . .
The Applicant contended that the rejected claims were allowable, arguing in
part, as follows:
Non-A non-B (NANB) hepatitis is defined as clinical
hepatitis which cannot be attributed to infection by
cytomegalovirus, Epstein-Barr virus or hepatitis A or
B. NANB hepatitis represents up to 907 of the post-
transfusion hepatitis cases and the risk of contracting
NANB hepatitis is very high. NANB hepatitis has been
found to be associated with a variety of virus-like
particles. What the inventors have found is a particu-
lar previously-unknown and previously-unidentified
virus particle which is an etiological agent for NANB
hepatitis. By isolating and purifying the particle,
there is obtained an agent useful for making vaccines
against NANB hepatitis and conducting immunoassays for
detecting NANB hepatitis.
The applicant does not deny that the invention defined
in the rejected claims is based on materials found in
the body fluids of humans but such materials are not
claimed. Claim 1 defines a togavirus strain which is
isolated from the body fluids of a patient diagnosed to
have NANB hepatitis, and purified.
Claim 1 does not define a product found in nature but
rather an isolated and purified form of a viral par-
ticle, which, it is submitted, in this form is a new
substance. What the inventors had to do was to screen
samples of body fluids from patients apparently suffer-
ing from NANB hepatitis, identify an apparently causa-
tive virus, and only then isolate and purify the viral
particle for further analysis and characterization.
Others of the rejected claims also clearly do not
define a product as found in nature....
. . .
Contrary to (the Examiner's) position, it is submitted
that the Abitibi case actually supports the applicant's
position that the rejected claims define patentable
subject matter. It is clearly stated therein (see page
89 of the decision as it appears in 62 C.P.R. (2nd)
81):
"...this decision (i.e. a finding that
lifeforms are patentable] will extend to
all micro-organisms... viruses..."
(Emphasis added).
. . .
The applicant does not deny that the product has been
isolated from body fluids but does deny that this means
that the isolated and purified product defined in claim
1 and further modified and processed forms thereof
defined in claims 2 to 6 and 10 to 15 is not new and
inventive subject matter. The applicant is not claim-
ing the product as it appears in nature but rather a
processed form thereof. Further, whether or not the
material is "new and inventive" has nothing to do with
what constitutes subject matter outside the definition
of "invention" in Section 2 of the Patent Act. The
Abitibi case clearly states that viruses are per se
patentable subject matter, as nosed above, so that the
Examiner's rejection is without foundation.
. . .
As to whether or not the products defined in the re-
jected claims are new and inventive, it is submitted
that the products meet the legal requirements in this
regard. The hitherto-unknown viral particle defined in
claim 1 has been identified in the body fluids of NANB
hepatitis patients, the product has been isolated and
purified and the viral particle characterized. The
viral particle as defined in claim 1 does not exist in
nature, is a new and useful product and may be manufac-
tured in significant quantities by cultivation, as
described in the specification. It is submitted that
these characteristics meet all the criteria of the
quoted portion of the Abitibi decision.
The issue before the Board is whether or not claims 1 to 6, and 10 to 15
define subject matter that is patentable within Section 2 of the Patent
Act. Amended claim 1 reads:
A togavirus strain isolated from the body fluids of a
patient diagnosed to be suffering from non-A, non-B
hepatitis and purified, said purified strain being
substantially free of primate proteins and having
identifying characteristics of ATCC accession nos.
VR-2011, VR-2012, VR-2013 or VR-201, said togavirus
strain comprising a particle of diameter of about 50 to
60 nm.
Mr. Stewart opened the Hearing by proposing that the rejected claims be
considered in light of amendments be suggested be included to identify the
purified strain in claim 1 line 3 as "being substantially free of primate
proteins" and as having "identifying characteristics" of the accession
numbers stated on lines 5 and 6. These modifications are set forth in the
amended claim above he submitted on May 26, 1988, after the Hearing.
Mr. Stewart explains that the Applicant's invention involves the isolation
of a togavirus strain from body fluids, notably from urine, of NANB hepati-
tis patients. By this isolation, he states, the Applicant has succeeded in
obtaining the causative agent in hepatitis that was not previously known to
exist. He notes that a further modification, namely purification, was
needed to obtain a substance useful to make vaccines, or testing materials
for assays. He adds that such a modified particle is not found in the body
fluids, as was the causative agent. He points out that if the unpurified
togavirus were injected into a patient, most likely the patient would
become infected, whereas injection of a purified togavirus would not so
affect a patient. Due to the purification step, he says that the hand of
man was present to change the isolated virus into something useful.
The examiner contends that for a substance like the Applicant's virus to be
a patentable subject matter, it would have to be man made. He rules out
that the Applicant's transformation of a virus falls within a patentable
art area. He believes that neither isolating, nor merely purifying, a
virus alters it from the state in which it was found in the body fluids.
Mr. Stewart notes the discussion and determination relating to what is a
chemical reaction, as given in Laboratoire Pentagone Limit‚e v. Parke Davis
& Co. (1968) S.C.R. page 307. There, he points out, it was concluded that
the processes of extraction described in the patent should be regarded as
chemical processes in the usual sense of the term "chemical process".
Mr. Stewart regards the solvent extraction under review in Laboratoire
Pentagone as being by the hand of man, just as he regards the purification
process used by the Applicant is something attributable to the hand of
man. He stresses that it is the purified state of the togavirus particle
that makes it usable, whereas without purification the togavirus may not be
used in the manner described by the Applicant.
Mr. Stewart refers to Re Application of Abitibi Co. 62 C.P.R. (2d) 81, a
Commissioner's Decision dated March 18, 1982, saying it supports the
patentability of his client's claims. He argues the Decision extends to
"micro-organisms, yeasts, moulds, fungi, bacteria, actinomycetes, unicellu-
lar algae, cell lines, viruses or protozoa", such as may be produced en
masse, as chemical compounds are formed (page 89).
In summary, the Examiner suggests that the purified togavirus of the
amended claims is nothing more than the virus that exists in nature, and
which may be readily available from the body fluids. The Agent counters by
saying the application describes, and by pointing out in his arguments,
that the togavirus was not known to exist by itself in nature, but had to
be isolated, from the body fluids, and then purified to a certain limit to
meet the identifying characteristics of American Type Culture Collection
accession numbers.
We are persuaded that the togavirus defined in the amended claims did not
exist in nature. We think the Applicant has isolated a particle resembling
a togavirus strain from a body fluid containing many kinds of elements. He
says the particle was previously unknown, and after isolation, the particle
was altered by purification. From the Applicant's arguments, he says the
purified strain would not affect a patient, whereas the isolated only virus
would.
In the Abititi decision we find the following passage to be significant to
the issue before us:
The organism, to be claimed, should not of course have
existed previously in nature, for in that event the
"inventor" did not create it, and his "invention" is
old. It must also be useful, in the sense that it
carries out some useful known objective, such as
separating oil from sand, producing antibiotics or the
like. It cannot be a mere laboratory curiosity whose
only possible claim to utility is as a starting
material for further research. And it must be
sufficiently different from known species that it can
be said that its creation involved the necessary
element of inventive ingenuity.
In view of the above reasoning in Abitibi, and the nature of and utility
described for the purified togavirus particle, we are satisfied the
Applicant's amended claims meet the tests outlined by Abitibi.
We recommend that the amended claims be accepted.
M.G. Brown S.D. Kot
Acting Chairman Member
Patent Appeal Board
I have reviewed the findings and the recommendation of the Patent Appeal
Board. Accordingly, I accept the amended claims, and I remand the
application for examination consistent with the recommendation.
J.H.A. Gari‚py
Commissioner of Patents
Dated this 20th day of September 1988
Hull, Quebec
Sim & McBurney
Suite 701
330 University Avenue
Toronto, Ontario
M5G 1R7