Decisions of the Commissioner of Patents - Summary of decision number  1317

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This table provides a summary of decision number 1317

Decision Number 1317
Application Number 2264559
Date 2011-09-09
Patent Number 2264559
CPC:
IPC:
Topics A50: APPLICATION FOR PATENT - Final Action Practice
O00: OBVIOUSNESS

Decision Text

COMMISSIONER'S DECISION SUMMARY


C.D. 1317 App'n No. 2,264,559

The application relates to a dual balloon catheter which is used to isolate an organ or other area of
the body from blood flow. The catheter is insertable into a blood vessel, flow through which is then
blocked by inflation of the two spaced apart balloons. The Applicant's invention includes the
provision of a blood bypass through the occluded segment of the catheter, separate inflation of the
two balloons, and a lumen passing through the catheter with a plurality of ports opening into the
occluded segment for injection and/or evacuation of fluids therethrough.

Jurisdiction to Consider Post-Final Action Defects
The Applicant alleged that because the objections in the Final Action had been overcome by
amendment, the Commissioner has no jurisdiction to identify any defects which may arise as a result
of the Applicant's response to the Final Action in accordance with the decisions of the Federal Court
of Canada in Belzberg v Canada (Commissioner of Patents), 2009 FC 657, 75 CPR (4th) 283 and
Bartley v Canada (Commissioner of Patents), 2011 FC 873.

Held: The Commissioner has jurisdiction to raise issues which may arise as a result of the
amendments made by an applicant in response to a Final Action. Statements made in the Belzberg
and Bartley decisions concerning the examination process must be considered in light of the facts of
that case. Neither the Court nor the drafters of the examination provisions could have intended for
applications to be allowed regardless of what defects might be introduced in response to a Final
Action.

Obviousness
Claims 1, 2, 4, 9, 10, 12, and 13 in the application were rejected by the Examiner as being obvious
in view of a combination of references.

Held: Rejection on these grounds affirmed.

The rejection of claims 1, 2, 4, 9, 10, 12, and 13 of the application based on the combination of
references was justified. The Applicant is required under paragraph 31(c) of the Rules to amend
independent claims 1, 9 and 13 to incorporate the features of dependent claims 3, 11 and 14,
respectively, as the addition of these features would place the claims in allowable form. If the above
amendments are not made the Commissioner intends to refuse the application.








IN THE CANADIAN PATENT OFFICE


DECISION OF THE COMMISSIONER OF PATENTS







Patent application number 2,264,559 having been rejected under subsection 30(3) of the Patent
Rules, has consequently been reviewed in accordance with subsection 30(6) of the Patent Rules by
the Patent Appeal Board and the Commissioner of Patents. The findings of the Board and the ruling
of the Commissioner are as follows:










Agent for the Applicant

GOWLING LAFLEUR HENDERSON LLP
One Main Street, West
HAMILTON Ontario
L8P 4Z5

INTRODUCTION

[1] This recommendation deals with a review by the Commissioner of Patents of patent
application no. 2,264,559 entitled "BALLOON CATHETER WITH OCCLUDED
SEGMENT BYPASS." The Applicant is DELCATH SYSTEMS, INC. The inventor is
Morton G. Glickman.

[2] The invention relates to a catheter, particularly a dual balloon catheter which is used to isolate
an organ or other area of the body from blood flow in a blood vessel passing through that
area. Such a catheter is insertable into the blood vessel, a portion of which is then blocked
from blood flow by the inflation of two spaced apart balloons.

[3] As explained by the Applicant, a problem with the known dual balloon catheter is that not
only is blood flow through the occluded segment blocked, but blood flow through the blood
vessel passing through that area of the body is completely interrupted. Although the body
naturally increases blood flow through parallel blood vessels to compensate, this may be
undesirable depending on the stress on the affected parallel blood vessels.

[4] With reference to Figure 1 of the subject application shown below, the applicant proposes a
dual balloon (12, 14) catheter which provides for a shunt or bypass (20, 22, 25) through
which blood may flow during occlusion of the vessel. In this way alleviation of the necessary
increase in blood flow through parallel vessels is achieved. The Applicant also proposes an
improvement over the prior art through the provision of separate lumens to inflate/deflate
each of the two balloons, achieving advantages such as increased control over blood flow
to/from the isolated area of the body. As presently claimed, the Applicant's alleged invention
also provides a lumen connected to a plurality of ports opening into the occluded segment
through which fluid may be injected and/or evacuated.













PROSECUTION HISTORY

[5] This application was filed on July 28, 1997 and claims priority based on a US application filed
on August 30, 1996, this therefore being the applicable claim date under sections 28.2 and
28.3 of the Patent Act.

[6] In a Final Action dated December 2, 2008, the Examiner rejected the application on the basis
that then-pending claims 1, 2, 4, 9, 10, 12 and 13 lacked novelty in view of US Patent No.
5,135,484 to Wright. In a response dated June 1, 2009 the Applicant amended the
independent claims to include the following limitation (worded slightly differently in claim 1):

at least one lumen extending to the external end of the catheter and connected
to a plurality of ports in a wall portion of said catheter located between said
first expandable balloon and said second expandable balloon.

[7] This limitation, although supported by the description of the invention as originally filed, was
not present in any of the claims previously. In a Summary of Reasons to the Patent Appeal
Board, which was forwarded to the Applicant on April 21, 2010, the Examiner explained that
while the amendment to the claims overcame the anticipation issue, some claims were
defective because they would have been obvious. In particular, amended claims 1, 2, 4, 9, 10,
12, and 13 would have been obvious having regard to Wright, in view of Canadian Patent
Application No. 2,186,493 to Forman published October 26, 1995, US Patent No. 5,320,604
to Walker et al. ["Walker"] issued June 14, 1994 and US Patent No. 5,059,178 to Ya issued
October 22, 1991. The introduction of the above-noted limitation into the claims had
necessitated a further search of the prior art, since such a limitation was not previously
considered for patentability. Claims 3, 5, 6, 7, 8, 11 and 14 were indicated by the Examiner
to be allowable.

[8] The Applicant was given notice of the obviousness issue in the above-noted communication
of April 21, 2010. Further to a telephone enquiry by the Board as to the Applicant's desire
to make further submissions, the Applicant was given formal notice of its opportunity to be
heard on the obviousness issue in a letter dated February 23, 2011. In a response dated
March 17, 2011, the Applicant requested an oral hearing, which took place on May 30, 2011.
Written submissions were provided to the Board on May 26, 2011. At the hearing the
Applicant was represented by Alex Ross of GOWLING LAFLEUR HENDERSON LLP and
the Patent Branch was represented by Megan McTavish, the Examiner in charge of the
application, and her Section Head, Jennifer Stickley.

[9] At the hearing, and in the written submissions, the Applicant's arguments focussed not on the
obviousness of the claims, but on the propriety of the consideration of defects under
obviousness in response to the amendments made by the Applicant subsequent to the Final
Action. The Applicant contended that since all of the objections in the Final Action were
overcome by amendment, the Commissioner is required by law to allow the application to
proceed to grant, in view of the decision of the Federal Court of Canada in Belzberg v
Canada (Commissioner of Patents), 2009 FC 657, 75 CPR (4th) 283 ["Belzberg"].

[10] The Applicant made it clear at the hearing that no submissions would be made on the
obviousness issue either orally or in writing and that they did not intend to answer any
questions the Board might have in regard to the obviousness issue. The Applicant was given
notice at the hearing, and acknowledged, that if the Board could not recommend to the
Commissioner that the application be allowed in view of the Applicant's submissions in
relation to Belzberg, the Board would then proceed to assess the case for obviousness put
forward by the Examiner in the Summary of Reasons.

ISSUES

[11] In view of the Summary of Reasons and the Applicant's submissions prior to and during the
hearing, the issues to be resolved are the following:

(1) Is the Commissioner required by law to allow the present application because the
objections in the Final Action were overcome?
(2) If the answer to the first question is no, then would claims 1, 2, 4, 9, 10, 12, and 13 have
been obvious in view of Wright when viewed in light of the references to Forman, Walker and
Ya, and therefore non-compliant with section 28.3 of the Patent Act?

IS THE COMMISSIONER REQUIRED TO ALLOW THE APPLICATION?

Legislative Framework

[12] Subsection 4(2) of the Patent Act provides, in part, that the Commissioner:

... shall perform and do all acts and things requisite for the granting and
issuing of patents of invention...

[13] The Commissioner's authority to grant patents is outlined in subsection 27(1) of the Act
(emphasis added):

The Commissioner shall grant a patent for an invention to the inventor or the
inventor's legal representative if an application for the patent in Canada is
filed in accordance with this Act and all other requirements for the issuance
of a patent under this Act are met.

[14] Once a patent issues, there is a presumption that it is valid, per subsection 43(2) of the Act.

[15] In order to assess whether the requirements of the Act are met, the Act provides for patent
applications to be examined by examiners employed for that purpose, per subsection 35(1)
of the Act.

[16] In cases where the Commissioner is satisfied that an applicant is not entitled by law to be
granted a patent, the application, per section 40 of the Act, shall be refused. The path which
is to be followed during examination, particularly in cases where the result may be refusal
under section 40 of the Act, is set out in subsections 30(3) to 30(6) of the Rules. If, in the
course of examination, an impasse is reached between the examiner and applicant, a Final
Action may be issued, which, per subsection 30(4) of the Rules:

shall indicate the outstanding defects and shall requisition the applicant to
amend the application in order to comply with the Act and these Rules or to
provide arguments as to why the application does comply, within the
six-month period after the requisition is made or, except in respect of Part V,
within any shorter period established by the Commissioner in accordance
with paragraph 73(1)(a) of the Act.

[17] If, as a result of the response to the Final Action, the Examiner "has reasonable grounds to
believe that the application complies with the Act and these Rules", the Commissioner notifies
the applicant that the rejection is withdrawn, and that the application has been found
allowable, along with requisitioning payment of the final fee (see subsection 30(5) of the
Rules).

[18] If the rejection is not withdrawn, then as per subsection 30(6) of the Rules:

the rejection shall be reviewed by the Commissioner and the applicant shall
be given an opportunity to be heard.

[19] The present issue centres around the interpretation of subsections 30(4) to 30(6) of the Rules,
and the effect of the Belzberg decision on these provisions.

Analysis

[20] In the written submissions to the Board and at the hearing, the Applicant's arguments
focussed on two aspects of the application process:
(1) the Final Action, as per the Belzberg decision must be "comprehensive rather than a
mere
selectio
n"
(Belzbe
rg at
para.
43) and
therefor
e there
is no
provisio
n to
bring
forward
further
defects
in the
applicat
ion once
the
Final
Action
is
written
(i.e. the
PAB
and the
Commi
ssioner
are
without
jurisdict
ion to
consider
any post
Final
Action
issues)

(2) As a result of the objections in the Final Action being overcome, the Commissioner must
allow the application to proceed to grant since there is no authority to decide the fate of the
application on the basis of other issues, again per the Belzberg decision.

[21] We first point out that the facts of the Belzberg case are distinguishable from those of the
present case. In Belzberg a Commissioner's Decision was issued based on the outstanding
defects, subsequent to which prosecution continued. The continued prosecution was
characterized by the Court as "a problem which had arisen during earlier examinations but
which had not been raised in the Final Action report and not considered by the PAB"
(Belzberg at para. 26). Justice Simpson also refused to send the application back for further
examination since there was "no evidence that the PAB or any examiner recommended new
areas for investigation" (Belzberg at para. 46).

[22] In contrast, in the present case the issue of obviousness arose, not after a Commissioner's
decision, but because of amendments made by the Applicant in response to the Final Action.
As noted earlier, when the Examiner notified the Board of the issue, the Applicant was given
notice of it and was offered the opportunity to respond before the Board made a
recommendation to the Commissioner. This issue is not one which "had arisen during earlier
examinations" since the features added by amendment were not previously part of the claims.
The issue was clearly indicated by the Examiner and the Board as a "new area of
investigation" prior to the hearing before the Board.

[23] Per subsection 30(4) of the Rules, in response to a Final Action, an applicant is given six
months in which to "amend the application in order to comply with the Act and these Rules
or to provide arguments as to why the application does comply." The Patent Office however,
has no control over the content of the amendments submitted, other than to later raise any
issues that arise as a result of those amendments, as was done in the present case.

[24] The Applicant, in accordance with the first point outlined above, submits that because of the
Belzberg decision, "the outstanding defects" of subsection 30(4) of the Rules, to be included
in the Final Action, are exhaustive. According to this interpretation, once a Final Action is
written, the Patent Office has no jurisdiction to raise any further issues regardless of what has
been submitted in response to the Final Action.

[25] Admittedly, an argument might be made in support of such an interpretation when one looks
at the statements made by Justice Simpson, particularly at paras. 41-43 pointed to by the
Applicant in their written submissions and at the hearing. At para. 41 Justice Simpson states:

I do not find that a requirement that final actions detail "all" outstanding
defects is unduly onerous or contrary to the spirit and intent of the patent
regime. The Canadian patent application process can be quite lengthy and
uncertain, as evidenced by the present case. It seems sensible to me in that
context to give the word "final" its ordinary meaning. At the point when a
requisition is issued that potentially triggers a hearing, it is reasonable to
conclude that all outstanding issues would be before the PAB.

[26] Similarly, at para. 43 she states:

I view the word "outstanding" in the amended provision as indicating that the
defects identified in a final action are comprehensive rather than a mere
selection. This interpretation is not only harmonious with the object and
intention of the scheme, but also gives meaning to the amendment.

[27] The amended provision referred to above is the change from former subsection 47(2) of the
Rules to current subsection 30(4).

[28] In the Belzberg case, unlike the present one, there were no new issues created by the
amendments made in response to the Final Action, and so Justice Simpson had a very
different fact situation before her.

[29] Further, we do not understand Justice Simpson to have meant for her statements to be
absolute, nor do we believe that the Applicant's interpretation of these statements reflect what
was intended by the drafters in arriving at the examination provisions. To illustrate why, we
would point first to the present case as an example of the consequences of the Applicant's
view.

[30] The Examiner issued a Final Action based on the claims then on file, which were identical to
those pending when the previous office action was issued. Based on those claims, the only
outstanding defects were related to the novelty of claims 1, 2, 4, 9, 10, 12 and 13, as the
Examiner believed that these claims read on a single prior art reference. Examination in
relation to novelty and obviousness is focussed on the claims, and not on everything that may
have been described in the application. In response, the Applicant amended the claims to add
a feature disclosed by the application but not before recited in any claim. As it was not
previously claimed, the patentability of the claims in light of this feature had not been
assessed. The Examiner, faced with the amended claims, conducted a further search and
arrived at the conclusion that, despite being novel, the amended claims were nevertheless
obvious.
[31] To adopt the Applicant's interpretation of Belzberg, the Examiner, the Board, and the
Commissioner would be required, in light of the fact that the amended claims (presented to
the office for the first time) were novel, to allow the application to grant without ever having
fully considered the patentability of those claims. The allowance of claimed subject matter
which was not previously examined cannot have been what was intended by the drafters of
the Rules, nor do we believe this was what was intended by the Court in Belzberg. Such an
interpretation would conflict with section 27 of the Act, which requires "all other
requirements for the issuance of a patent" (which includes the requirements under section
28.3) to be met.

[32] Another example of the effect of the Applicant's interpretation would be a situation where,
in response to a Final Action, an applicant overcomes the defects set out therein, but adds
new matter not to be reasonably inferred from the specification or drawings, contrary to
section 38.2 of the Act. Using the Applicant's interpretation, such an application would have
to be allowed with the defect not being subject to scrutiny by the Examiner, the Board or the
Commissioner.

[33] Even if the filter for amendments in response to a Final Action was whether or not the
response was in good faith, per paragraph 73(1)(a) of the Act, as suggested by the Applicant
at the hearing, this would not prevent the situations noted above from occurring. The fact
that an examiner alleges new matter has been added would not by itself provide justification
to say that the response was in bad faith. However, it would give an examiner reason to say
there were no reasonable grounds to believe that the application complied with the Act and
Rules, as required by subsection 30(5) of the Rules in order to withdraw a rejection and
prevent review by the Commissioner under subsection 30(6) of the Rules.

[34] The Applicant noted that in Belzberg Justice Simpson points to Chapter 21 of the Manual of
Patent Office Practice ("MOPOP") to understand the scope of the Final Action process
(Belzberg at paras. 11, 24 and 25). The relevant passage from MOPOP reads as follows:

The final action report must be comprehensive and deal with every grounds
for which the application is considered to be defective. The appeal process
is restricted to the particular issues discussed in the final action and there is
no further opportunity for the examiner to make objections which may have
been missed in the final action. Similarly there is no opportunity for the
applicant to amend the application other then to make any revisions required
by a Commissioner's decision on the patentability of the case.

[35] It is, as quoted above, the general practice of the Patent Office to include all "outstanding
defects" in a Final Action report, as occurred in the present case in view of the then-pending
claims. The quotation speaks of the duties of an examiner in a Final Action when faced with
an established impasse. However, while this section guides an examiner not to raise
"objections which may have been missed in the final action" it does not purport to address a
situation where, in response to the Final Action, new defects are introduced by the
Applicant's amendments.

[36] At the hearing, the Applicant submitted that it should not have to address an identified defect
in the application for the first time before the Board, as its ability to amend the application is
limited to what the Commissioner might require under paragraph 31(c) of the Patent Rules
(The Applicant even suggested that such amendments were not possible in view of Belzberg,
a point we will address later). It is true that there is no right for the Applicant to, without
direction from the Commissioner, amend the application once a case has been forwarded for
review by the Commissioner. However, as stated by Justice Simpson in Belzberg at para. 25,
a Final Action is intended to lead to disposition of the case, and therefore the steps thereafter
cannot be equivalent to the normal prosecution of applications. A Final Action is written
when an impasse is reached, when the Applicant has already had a chance to address certain
defects, as in the present case, where the same defect had been raised on three occasions prior
to the Final Action.

[37] The second aspect of the Applicant's submissions relates to the consequences of the issuance
of a Final Action. To reiterate the Applicant`s position, since all of the defects in the Final
Action have been overcome (and this is not disputed by the Examiner or the Board), and since
these are the only defects which the Examiner, Board or the Commissioner may review, the
application must proceed to grant, in accordance with the Applicant`s view of Belzberg.

[38] Justice Simpson at para. 44 of Belzberg stated:

In my view, the MOPOP, the language of section 30, the scheme of the Act
and the amendment to the provision regarding "Final Actions", make it clear
that a final action is to dispose of a patent application. In other words,
following a PAB hearing the Commissioner is to make one of two decisions:
i) refuse the patent application under section 40 of
the Act if the PAB has found alleged defects to be
justified; or
ii) grant the patent application under section 27 of the
Act.

[39] The Applicant takes the above passage to mean that since all of the defects in the Final Action
have been overcome, then, as per part (ii), the Commissioner must grant the application under
section 27 of the Act. The passage, taken on its own, might suggest that the only options for
the Commissioner after a hearing are to refuse or to grant, but again, these statements must
be considered in light of the facts of the Belzberg case. In Belzberg, whether some of the
claims were allowable while others were not was not at issue, and so there was no reason for
the Commissioner to take any action other than to refuse or grant the application.

[40] According to paragraph 31(c) of the Rules, refusal or grant are not the only options following
a hearing. This paragraph provides for the possibility that the Commissioner, in a decision,
requires certain amendments in order to make the application compliant with the Act and
Rules. While this may eventually lead to refusal or grant, depending on the Applicant's
actions in response thereto, it is a third possible outcome following a hearing which leads to
a decision by the Commissioner. This third possibility is described in section 21.07 of
MOPOP, i.e. where the Commissioner is satisfied that:

[...]
(c) certain amendments are necessary for compliance with the Patent
Act or the Patent Rules, the applicant will be informed of the
required amendments and the reasons therefor and will be given a
three month period to effect the changes. Should the applicant not
amend the application accordingly it will be refused under section 40
of the Patent Act.

[41] At the hearing the Applicant suggested that the above-noted outcome was no longer a valid
option in light of Belzberg. In Belzberg, Justice Simpson at paras. 12 and 13 quoted from
MOPOP in which paragraph 31(b) of the Rules was mentioned. However, she did not
mention 31(c), and gave no indication that she considered this provision to be no longer
applicable. In light of these circumstances, we do not believe that it was her intent to
eliminate this possibility.

[42] The present case, unlike the situation in Belzberg, is not one where examination is being
restarted after a Final Action (Belzberg at para. 2). It is a case where the Examiner, per
subsection 30(6) of the Rules, could not withdraw the rejection in accordance with subsection
30(5) of the Rules, because she did not believe that the application was compliant with the
Act and Rules.

[43] The above considerations lead us to the conclusion that the statements pointed to by the
Applicant in the Belzberg case must be taken in the context of the facts of that case, and that
the Commissioner has jurisdiction to deal with the obviousness issue in the present case.
Further, the Commissioner of Patents has not only the right, but the obligation, to consider
the obviousness issue in this case, in view of his statutory duty under subsection 27(1) of the
Act.


Post-hearing submissions by Applicant

[44] In a letter dated July 14, 2011, the Applicant provided supplemental written submissions to
the Patent Appeal Board, enclosing a copy of the decision of the Federal Court of Canada in
Bartley v Canada (Commissioner of Patents), 2011 FC 873, dated July 12, 2011. In
particular, the Applicant drew the Board's attention to para. 80 of the decision, which recites
[emphasis added by Applicant]:

I find, as Justice Simpson did in Belzberg, supra that a Final Action is meant to be
just that, final. There is an obligation upon the Examiner to put everything on the
table that requires the applicants, and, if necessary, the Board and the Commissioner,
to deal with. There is no provision to reserve upon or keep certain matters
"outstanding".

[45] An answer to this has been provided previously [see in particular paras. 22, 30 and 35], where
the facts in the present circumstances were distinguished from those in Belzberg, and we see
no reason to expound any further on this subject.

[46] The answer to the first issue being no, we proceed to consider the issue of obviousness.

OBVIOUSNESS

The Claims at Issue

[47] For the sake of convenient reference, we set out the problematic claims below:

1. A catheter positionable in a blood vessel of a body having a blood flow
therethrough, said catheter comprising:
a first expandable balloon expandable beyond a wall of said
catheter;
a second expandable balloon expandable beyond a wall of said
catheter;
said first balloon and said second balloon spaced along said catheter
for generating an occluded segment of said blood vessel between
said first balloon and said second balloon when said first balloon
and said second balloon are expanded:
at least one fenestration lumen extending to the external end of the
catheter and connected to a plurality of ports in said catheter located
between said first expandable balloon and said second expandable
balloon;
a first port in said wall of said catheter, said first port positioned
upstream in the direction of said blood flow from said first balloon;
a second port in said wall of said catheter, said second port
positioned downstream, in the direction of said blood flow from said
second balloon; and,
a lumen within said catheter and having a first end and a second end,
said first end connected to said first port and said second end
connected to said second port for defining a bypass for blood in said
blood flow for shunting said occluded segment of said blood vessels
spaced and positioned for passing a portion of said blood from
upstream in the direction of blood flow from said occlusion to
downstream in the direction of blood from said occlusion.
2. A catheter according to claim 1 wherein said first balloon is located
upstream, in the direction of said blood flow from said second balloon.
4. A catheter according to claim 1 wherein said second port defines a tip of
said catheter.
9. A catheter positionable in a blood vessel of a body, said catheter,
comprising:
a first balloon and a second balloon spaced from each other;
means for expanding said first balloon and said second balloon to a
wall of said blood vessel for generating an occluded segment in said
blood vessel between said first balloon and said second balloon
when said first balloon and said second balloon are expanded;
a first lumen within said catheter coupled to and opening into an
interior of said first balloon for expanding and contracting said first
balloon therethrough and independent of said second balloon,
a second lumen within said catheter coupled to and opening into an
interior of said second balloon for expanding and contracting said
second balloon therethrough and independent of said first balloon,
and;
at least one lumen extending to the external end of the catheter and
connected to a plurality of ports in a wall portion of said catheter
located between said first expandable balloon and said second
expandable balloon; and
a bypass for bypassing at least a portion of blood from
upstream in the direction of blood flow of said occluded
segment to downstream in the direction of blood flow of
said occluded segment.
10. A catheter according to claim 9 further comprising:
a first port in a wall of said catheter upstream, in the direction of
blood flow through said blood vessel, from said first balloon;
a second port in said wall of said catheter downstream, in the
direction of said blood flow through said blood vessel, from said
second balloon; and
a third lumen within said wall of said catheter having a first end and a second
end and said first port defines said first end of said third lumen and said
second port defines said second end of said third lumen.
12. A catheter according to claim 10 wherein said second port defines an
anterior end of said catheter.
13. A catheter positionable in a blood vessel of a body having a blood flow
therethrough, said catheter comprising:
a first balloon and a second balloon, spaced from each other
longitudinally along said catheter and expandable beyond a wall of
said catheter to a wall of said blood vessel, said first balloon and
said second balloon for generating an occluded segment in said
blood vessel between said first balloon and said second balloon
when said first balloon and said second balloon are expanded;
at least one lumen extending to the external end of the catheter and
connected to a plurality of ports in a wall portion of said catheter
located between said first expandable balloon and said second
expandable balloon;
a first port in said catheter, said first port positioned adjacent said
first balloon and upstream, in the direction of said blood flow from
said first balloon;
a second port in said wall of said catheter, said second port
positioned adjacent said second balloon and downstream, in the
direction of said blood flow from said second balloon, and,
a lumen within said catheter and having a first end and a second end,
said first end connected to said first port and said second end
connected to said second port for defining a blood shunt in said
catheter for bypassing said occluded segment of said blood vessel
spaced and positioned for passing a portion of said blood from
upstream in the direction of blood flow from said occlusion to
downstream in the direction of blood from said occlusion.

Legal Principles

[48] Section 28.3 of the Patent Act sets out the conditions under which a claim may be found to
be obvious:

28.3 The subject-matter defined by a claim in an application for a patent in
Canada must be subject-matter that would not have been obvious on the
claim date to a person skilled in the art or science to which it pertains, having
regard to
(a) information disclosed more than one year before the filing date by the
applicant, or by a person who obtained knowledge, directly or indirectly,
from the applicant in such a manner that the information became available
to the public in Canada or elsewhere; and
(b) information disclosed before the claim date by a person not mentioned in
paragraph (a) in such a manner that the information became available to the
public in Canada or elsewhere.

[49] In Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61, [2008] 3 SCR 265 ["Sanofi"],
the Supreme Court set out the approach to be followed in the assessment of obviousness,
which now involves the following four steps, with the possibility of an "obvious to try" test
at step 4, which is not at issue in this case:

(1) (a) Identify the notional "person skilled in the art";
(b) Identify the relevant common general knowledge of that person;
(2) Identify the inventive concept of the claim in question or if that cannot readily
be done, construe it;
(3) Identify what, if any, differences exist between the matter cited as
forming part of the "state of the art" and the inventive concept of the claim
or the claim as construed;
(4) Viewed without any knowledge of the alleged invention as claimed, do
those differences constitute steps which would have been obvious to the
person skilled in the art or do they require any degree of invention?

[50] In Sanofi, Rothstein J., at para. 65, equates obvious with "very plain." This interpretation has
been noted by the Federal Court of Appeal in Pfizer Canada Inc v Apotex Inc, 2009 FCA 8
at para. 29, [2009] 4 FCR 223.

[51] In a case such as this where an argument is made that the invention would have been obvious
in view of a combination of references, the following guidance from Justice Snider in
Laboratoires Servier v Apotex Inc, 2008 FC 825 at para. 254, 67 CPR (4th) 241; aff'd, 2009
FCA 222, 75 CPR (4th) 443 ["Servier"] must be kept in mind:
As acknowledged by Servier, a mosaic of prior art may be assembled in
order to render a claim obvious. Even uninventive skilled technicians would
be presumed to read a number of professional journals, attend different
conferences and apply the learnings from one source to another setting or
even combine the sources. However, in doing so, the party claiming
obviousness must be able to demonstrate not only that the prior art exists but
how the person of ordinary skill in the art would have been led to combine
the relevant components from the mosaic of prior art.

Analysis under the Sanofi Four-step Approach

(1)(a) The person skilled in the art

[52] In the Summary of Reasons the Examiner identified the person skilled in the art as "a person
working in the field of balloon catheters ..." The Applicant did not comment on the
Examiner's identification of the person skilled in the art. While nothing in this case would
turn on the exact identification of the skilled person, we would state it less generally as a
physician with experience in the use of balloon catheters and the procedures associated with
them, since a physician would be the typical user of such a device.

(1)(b) The relevant common general knowledge

[53] In the Summary of Reasons submitted to the Board, the Examiner stated that the person
skilled in the art:

would know that the occluded section of a blood vessel can be treated in a
variety of ways, for example by the delivery of drugs or the removal of
plaque using a slurry.

[54] While the Examiner has shown that the above features were known (as evidenced by several
cited references, to be discussed later), she has not established that these features had become
part of the common general knowledge by the claim date. In a usual case, in which an
applicant addresses an obviousness objection on its merits, a failure to address an assertion
by an examiner may be taken by a reviewing body as an applicant's acceptance of an
examiner's statements. However, as previously noted, the Applicant in this case did not
address the obviousness issue on its merits, based on the belief that the defect should not have
been raised, and made it clear at the hearing that they were neither agreeing nor disagreeing
with the Examiner's assertions. This was also the first time this issue was raised, the present
case therefore lacking the normal back and forth between the Examiner and the Applicant.
In view of these facts and the fact that the basis for the Examiner's statements as to common
general knowledge is not established, the Board will look to the evidence at hand to determine
what may be taken to be common general knowledge.
[55] We start with the present application itself. What the Applicant portrays as common general
knowledge in their own discussion of the prior art is to be taken as a binding admission
(Merck & Co v Pharmascience Inc, 2010 FC 510 at para. 8, 85 CPR (4th) 179). At pages
1-2 the Applicant discusses prior art catheters in general. Such devices are known to be used
for controlling blood flow and/or isolating an area of the body or an organ in medical
procedures. Also well known is a design where body organs and/or body areas are isolated
by two spaced balloons on a catheter. The Applicant does not disclose the delivery of drugs
to, nor the removal of plaque from, the occluded area as being conventional.

[56] Looking to the prior art applied by the Examiner, Wright, in the background portion,
discusses balloon angioplasty in general, but makes no reference to dual balloon catheters nor
to the delivery of material to an occluded segment. The removal of plaque using a slurry is
part of the invention disclosed by Wright, and therefore we would have no basis to take it to
be part of the common general knowledge.

[57] Forman also discusses conventional balloon angioplasty, as well as the delivery of agents to
the affected area that may reduce restenosis, such as heparin to prevent clotting and
dexamethasone to prevent smooth muscle cell migration and proliferation. Forman reveals
that there are various methods known to deliver agents, such as "weeping" balloons which
are inflated to deliver an agent after an angioplastic procedure. Forman discloses that devices
are known which comprise a pair of occlusion balloons with a dilation balloon therebetween.
A drug delivery conduit is provided between the balloons as well. However, whether the
particular prior art designs pointed to in Forman were part of the common general knowledge
is not clear.

[58] In Walker, angioplasty is again discussed in general, including the use of dilation balloons in
such a procedure, whether to simply open the artery by dilation or to remove the blockage
by withdrawing the dilated balloon past the blockage. Walker discusses various known
balloon catheter designs including what are described as conventional dual balloon catheters.
These are catheters used subsequent to artery dilation, with the two balloons serving as
occlusion balloons, and they comprise an additional lumen communicating with the space
between the balloons to supply therapeutic fluids to a lesion. A further balloon may be
provided that, when inflated, drives the material into the lesion. This is similar to what was
described in the background of the Forman reference. However, in this case it is more clearly
portrayed as general background knowledge.

[59] In Ya, the prior art discussion discloses three generally known techniques for treating an
arterial blockage, one of which is Percutaneous Transluminal Coronary Recanalization
(PTCR) which involves injecting a thrombus (blockage) dissolving agent to the blockage
location. Ya does not discuss any conventionally known catheter designs.

[60] Based on the above, including the Applicant's own discussion of the prior art, we find that
it was common general knowledge at the claim date to use a dual balloon catheter in the
treatment of a blockage in a blood vessel. It would also seem that it was common general
knowledge to direct treatment agents to the area of the blockage, as stated by the Examiner,
both by using a single balloon through which the therapeutic agent flowed and by supplying
the agent to the space between two occlusion balloons through a lumen. However, we cannot
say that it was common general knowledge to use a slurry, in particular, to remove a plaque
deposit.

[61] Before addressing the inventive concepts of the claims, we should add a comment regarding
common general knowledge. We do not wish to be taken as concluding that because we were
unable to ascertain that certain features of the cited references form part of the common
general knowledge, these features cannot be used in an obviousness argument. Even in cases
where certain features are found not to form part of the common general knowledge, features
appearing in one reference may be combined with those of another reference if, as stated in
Servier, cited above, it can be demonstrated "how the person of ordinary skill in the art would
have been led to combine the relevant components from the mosaic of prior art."

(2) The Inventive Concept(s)

[62] Referring again to the Summary of Reasons, the Examiner identified the inventive concept
of the claims as:

a catheter with two or more inflatable balloons which are individually and
separately operated, a blood bypass for retaining blood flow through a vessel
while the blood flow to and from a predetermined part or area of the body is
shut-off or isolated by the balloons of the catheter, and a lumen, having a
plurality of ports, for delivering a substance to the occluded area between the
balloons.

[63] The Examiner's statement appears to be an inventive concept that is a combination of the
features of independent claims 1, 9 and 13. While the independent claims, especially claims
1 and 13, are very similar, there are differences. In particular, claim 9 includes first and
second lumens for separately expanding and contracting the first and second balloons, but
claims 1 and 13 do not include such a limitation. Likewise, claims 1 and 13 claim the bypass
in detail, while claim 9 generally claims a bypass. Different claims can, and generally will,
have different inventive concepts (see Eli Lilly & Co v Apotex Inc, 2009 FC 991 at footnote
190, 80 CPR (4th) 1; see also Pozzoli SpA v BDMO SA, [2007] EWCA