Ex Parte Mortensen et al

Board of Patent Appeals and Interferences

May 8, 2012

11211115 (B.P.A.I. May. 8, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/211,115 08/24/2005 J.D. Mortensen FKL-10803/38 5772
25006 7590 05/09/2012
GIFFORD, KRASS, SPRINKLE,ANDERSON & CITKOWSKI, P.C
PO BOX 7021
TROY, MI 48007-7021
EXAMINER
WIEST, PHILIP R
ART UNIT PAPER NUMBER
3761
MAIL DATE DELIVERY MODE
05/09/2012 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte J.D. MORTENSEN,
ROBERT N. SCHAAP, and BARRY BAGLEY
__________

Appeal 2010-012383
Application 11/211,115
Technology Center 3700
__________

Before TONI R. SCHEINER, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to blood gas
exchanger systems. The Examiner entered rejections for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

STATEMENT OF THE CASE
Claims 1-22 and 31 stand rejected and appealed (App. Br. 2).
1
Claim
1 is representative and reads as follows:

1
Appeal Brief entered January 7, 2010.
Appeal 2010-012383
Application 11/211,115

2

1. A blood gas exchanger system comprising:
a plurality of compliant blood gas exchangers, arranged
anatomically as an artificial respiratory prosthesis, for enabling
oxygen and carbon dioxide exchange in circulating venous blood, a
compliant blood gas exchanger of the plurality of exchangers
comprising:
a housing having a first end, a second end opposing the first
end, and an elastomeric sidewall extending there between, the
elastomeric sidewall bounding a chamber, the chamber being in
communication with a blood inlet subconduit and a blood outlet
subconduit;
a first support member disposed at least partially within the
housing at the first end of the housing, the first support member being
in communication with a gas inlet subconduit;
a second support member disposed at least partially within the
housing at the second end of the housing, the second support member
being in communication with a gas outlet subconduit;
the blood outlet subconduit having a sealed end and an open
end, the open end of the blood outlet subconduit extending beyond the
second support member;
a plurality of hollow fibers having a first fiber end secured by
the first support member and a second fiber end secured by the second
support member, the plurality of hollow fibers having a porous
surface through which the plurality of hollow fibers is capable of
gaseous exchange but not liquid exchange and surrounding the blood
outlet subconduit at said second fiber end;
a blood inlet conduit in fluid communication with the blood
inlet subconduit;
a blood outlet conduit in fluid communication with the blood
outlet subconduit;
a gas inlet conduit in fluid communication with the gas inlet
subconduit; and
a gas outlet conduit in fluid communication with the gas outlet
subconduit.

Appeal 2010-012383
Application 11/211,115

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The following rejections are before us for review:
(1) Claims 1-10, 13, 14, 21, and 22, under 35 U.S.C. § 103(a) as
obvious over Montoya,
2
von Segesser,
3
and Vaslef
4
(Ans. 3-7);
(2) Claims 3 and 20, under 35 U.S.C. § 103(a) as obvious over
Montoya, von Segesser, Vaslef, and Berry
5
(Ans. 8);
(3) Claims 11 and 12, under 35 U.S.C. § 103(a) as obvious over
Montoya, von Segesser, Vaslef, and Winters
6
(Ans. 8-9); and
(4) Claims 15-19 and 31, under 35 U.S.C. § 103(a) as obvious over
Montoya, von Segesser, Vaslef, and Chambers
7
(Ans. 9-10).

DISCUSSION
The Examiner found that Montoya described a gas exchanger
substantially as claimed, except for the elastomeric sidewall recited in claims
1 and 14, which the Examiner concluded would have been obvious in view
of von Segesser‟s use of that element in a similar device (Ans. 3-4). The
Examiner also concluded that it would have been obvious to anatomically
arrange a plurality of Montoya‟s devices as a single artificial respiratory
prosthesis, in view of Vaslef‟s disclosure of using a plurality of gas flow
passages in a single intravascular prosthetic respiratory device (id. at 5-6).
The Examiner further reasoned that “the mere duplication of parts does not
constitute grounds for patentability (see MPEP § 2144.04)” (id. at 6).

2
U.S. Patent No. 5,698,161 (issued December 16, 1997).
3
U.S. Patent App. Pub. No. 2002/0143397 A1 (filed April 1, 2002).
4
U.S. Patent No. 5,037,383 (issued August 6, 1991).
5
U.S. Patent No. 5,098,376 (issued March 24, 1992).
6
U.S. Patent No. 5,182,317 (issued January 26, 1993).
7
U.S. Patent No. 6,682,698 B2 (filed August 23, 2001).
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While the Examiner also conceded that Montoya‟s device was
configured differently than required by claims 1 and 14, the Examiner found
that Montoya‟s “blood gas exchanger . . . has substantially the same
functionality as the instantly claimed device. Therefore, the fact that the
fiber bundle does not surround the blood outlet subconduit between the first
side and the sealed end of the subconduit is inconsequential to the
functionality of the device” (id. at 4).
The Examiner thus reasoned:
Repositioning the outlet conduit to the outside of the bundle,
such that blood passes from the inside of the fiber bundle to the
outside of the bundle (rather from the outside to the inside, as
taught by applicant) would have been an obvious matter of
engineering choice to one of ordinary skill in the art at the time
of invention because doing so would provide substantially the
same functionality. See MPEP § 2144.04.

(Id.)
Appellants argue, among other things, that the Examiner failed to
adequately explain why an ordinary artisan would have been prompted to
modify Montoya‟s device such that it would be configured as required by
claims 1 and 14 (App. Br. 19). In particular, Appellants urge that the mere
fact that parts of a prior art device could be rearranged to arrive at the
claimed device does not demonstrate the device‟s obviousness, absent some
reason to make that rearrangement, without resort to hindsight:
The mere fact that a worker in the art could rearrange the parts
of the reference device to meet the terms of the claims on
appeal is not by itself sufficient to support a finding of
obviousness. The prior art must provide a motivation or reason
for the worker in the art, without the benefit of appellant‟s
specification, to make the necessary changes in the reference
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device.” Ex parte Chicago Rawhide Mfg. Co., 223 USPQ 351,
353 (Bd. Pat. App. & Inter. 1984). (Emphasis added.)

(App. Br. 20-21 (quoting MPEP 2144.04); see also id. at 25.)
We conclude that Appellants have the better position.
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted).
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), while the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question, it also reaffirmed that “rejections on obviousness
grounds cannot be sustained by mere conclusory statements; instead, there
must be some articulated reasoning with some rational underpinning to
support the legal conclusion of obviousness.” Id. at 418 (quoting In re
Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (emphasis added).
As our reviewing court has explained, therefore, to support a
conclusion of obviousness, “[w]hether the Board relies on an express or an
implicit showing, it must provide particular findings related thereto. Broad
conclusory statements standing alone are not „evidence.‟” In re Kotzab, 217
F.3d 1365, 1370 (Fed. Cir. 2000) (citation omitted).
Thus, “section 103 requires a fact-intensive comparison of the claimed
process with the prior art rather than the mechanical application of one or
another per se rule.” In re Ochiai, 71 F.3d 1565, 1571 (Fed. Cir. 1995); see
also id. at 1572 (“[R]eliance on per se rules of obviousness is legally
incorrect and must cease.”).
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In KSR, the Supreme Court also reaffirmed that, despite the
importance of a flexible and commonsense approach when evaluating
obviousness, fact finders “should be aware, of course, of the distortion
caused by hindsight bias and must be cautious of arguments reliant upon ex
post reasoning.” KSR, 550 U.S. at 421.
Accordingly, as our reviewing court has noted, even after KSR, fact
finders must “still be careful not to allow hindsight reconstruction of
references to reach the claimed invention without any explanation as to how
or why the references would be combined to produce the claimed invention.”
Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 n.3 (Fed. Cir. 2008)
(emphasis added).
As the court explained in In re Fritch, rather than relying on reasoning
grounded in hindsight, the Examiner must advance an evidence-based
explanation to support a conclusion that it would be obvious to modify an
apparatus in a particular manner. See In re Fritch, 972 F.2d 1260, 1266
(Fed. Cir. 1992) (“The mere fact that the prior art may be modified in the
manner suggested by the Examiner does not make the modification obvious
unless the prior art suggested the desirability of the modification.”). Thus,
“[i]t is impermissible to use the claimed invention as an instruction manual
or „template‟ to piece together the teachings of the prior art so that the
claimed invention is rendered obvious.” Id.
Applying these principles to the rejections before us, we conclude that
the Examiner has not made out a prima facie case of obviousness. In
particular, the rejection does not provide a specific reason or evidence-based
explanation as to why an ordinary artisan would have been guided from
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Montoya‟s device to a device configured as recited in claims 1 and 14,
despite the significant differences in the devices‟ configurations.
Instead, in contravention of the principles discussed above, the
rejection relies on a conclusory statement to the effect that, because the
differences between the configurations of the claimed and prior art devices
“are inconsequential to the functionality of the device[s,]” an ordinary
artisan would have considered reconfiguring Montoya‟s device in the
manner claimed to merely be “an obvious matter of engineering choice”
(Ans. 4 (citing MPEP § 2144.04)). We first note that, in advancing this line
of reasoning, the rejection does not point to any particular obviousness
rationale discussed in MPEP § 2144.04.
Moreover, as pointed out above, both the MPEP and In re Fritch
caution against concluding that a mere rearrangement of parts can render a
claim obvious where the prior art fails to provide a reason for making the
rearrangement. See MPEP 2144.04.VI.C; see also In re Fritch, 972 F.2d at
1266. Further, and perhaps more importantly, the rejection fails to point to
any specific teaching in any of the cited references, or any specific concept
within the general knowledge of an ordinary artisan, which would have
directed an ordinary artisan, without hindsight, from Montoya‟s device to a
device configured as claimed.
Specifically, claim 1 recites a blood gas exchanger system composed
of a plurality of compliant blood gas exchangers, arranged anatomically as
an artificial respiratory prosthesis. Each gas exchanger has a housing with
first and second opposing ends, with an elastomeric sidewall that defines a
chamber extending between the two ends, the chamber being in
communication with a blood inlet subconduit and a blood outlet subconduit.
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The exchanger has a first support member disposed at least partially
within the housing at the first end, the first support member being in
communication with a gas inlet subconduit. The device has a second
support member disposed at least partially within the housing at the second
end, the second support member being in communication with a gas outlet
subconduit.
Claim 1 requires the blood outlet subconduit to have a sealed end and
an open end, and also requires the open end of the subconduit to extend
beyond the second support member. Claim 1 also requires its device to have
a plurality of gas-exchanging hollow fibers secured at opposite ends of the
device by the first and second support members, with the plurality of fibers
surrounding the blood outlet subconduit at the second end of the device.
Thus, in essence, claim 1 requires the device to be configured such
that the blood outlet subconduit extends from inside the chamber to outside
the chamber, beyond the end from which the gas outlet subconduit exits, and
also requires the blood outlet subconduit to be surrounded by the gas-
carrying fibers, within the chamber at the second end of the device. Claim
14 requires a similar arrangement. Appellants‟ Figure 3 shows an example
of a device encompassed by the claims, with blood outlet 248 exiting the
right hand side of the device.
In contrast, in Montoya‟s device, as seen in Figure 6a, only fluid inlet
54 extends into the chamber and is surrounded by fiber mesh bundle 44.
Thus, rather than having a blood outlet subconduit contained within the
chamber and surrounded by the gas-carrying fibers, Montoya‟s fluid outlet
56 lies entirely outside the fiber bundle.
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Montoya‟s device functions by forcing blood from the centrally
located fluid inlet, which extends the entire length of the fiber-containing
chamber, in a radially outward direction through the fiber mesh bed, with the
fluid outlet positioned alongside an entire outside edge of the entire fiber
mesh bed. Thus, even assuming for argument‟s sake that, because both
devices allow gas exchange in a fluid, the claimed device has the same
functionality as Montoya‟s, this functionality is achieved in a significantly
different way.
Given the significant differences between the configuration of the
device recited in claims 1 and 14, as compared to the device described by
Montoya, and given the rejection‟s failure to point to any specific evidence
suggesting that the claimed configuration was a known prior art alternative
suitable for this type of device, or a similar device, we agree with Appellants
that the Examiner has not adequately explained why an ordinary artisan
would have been prompted to reconfigure Montoya‟s device to arrive at a
device having the features of claims 1 and 14, arranged as in those claims.
Thus, while the Examiner intimates an alternative rationale, that because
“the direction of blood flow has no bearing on the efficiency of the device,”
and it would therefore have been “an obvious design choice to change the
direction of blood flow such that blood flows from an inlet outside the
diameter of the fibers, across the fibers, and through an outlet within central
portion of the fibers” (Ans. 11-12), the Examiner has not provided an
evidentiary basis to support the obviousness of that conclusion or its
underlying finding.
Therefore, as we are not persuaded that the Examiner has provided an
adequate evidence-based explanation as to why an ordinary artisan would
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have been prompted to reconfigure Montoya‟s device so as to arrive at the
device recited in claims 1 and 14, we are compelled to reverse the
Examiner‟s rejection of those claims, and their dependents, over Montoya,
von Segesser, and Vaslef.
The Examiner also rejected claims 3 and 20, which depend from
claims 1 and 14, respectively, as obvious over Montoya, von Segesser,
Vaslef, and Berry (Ans. 8). The Examiner reasoned that the crimped fiber
shape recited in claims 3 and 20 would have been obvious in view of Berry‟s
disclosure that employing gas exchanging fibers in a wavy pattern caused an
advantageous turbulent flow of blood around the tubes (see id.). However,
as the Examiner points to no teaching in Berry that remedies the deficiencies
discussed above as to the rejection of claims 1 and 14, we are constrained to
reverse this rejection as well.
The Examiner also rejected claims 11 and 12, which both depend
ultimately from claim 1, as obvious over Montoya, von Segesser, Vaslef,
and Winters, reasoning that it would have been obvious in view of Winters
to use thromboresistant-coated (i.e. heparin coated) fibers in devices such as
described by Montoya, von Segesser, and Vaslef (Ans. 8-9). Again,
however, as the Examiner points to no teaching in Winters that remedies the
deficiencies discussed above as to the rejection of claim 1, we are compelled
to reverse this rejection as well.
The Examiner also rejected claims 15-19 and 31 as obvious over
Montoya, von Segesser, Vaslef, and Chambers (Ans. 9-10). As evidence
that an ordinary artisan would have considered it obvious to arrange adjacent
gas exchanging chambers with a shared elastomeric sidewall, as recited in
claim 15, the Examiner cited Chambers as disclosing an implantable blood
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oxygenating device in which a compliant chamber was surrounded by a rigid
chamber (id. at 9 (citing Chambers, col. 9, ll. 4-9)).
As claims 15-19 all depend directly or ultimately from claim 14, and
as the Examiner points to no teaching in Chambers that remedies the
deficiencies discussed above as to the rejection claim 14, we reverse the
Examiner‟s rejection of claims 15-19.
Independent claim 31 recites a blood gas exchanger system similar to
that recited in claims 1 and 14, with a plurality of compliant gas exchangers
“disposed in a pouch shaped to fit within a subject thoracic cavity” (App. Br.
35). The Examiner found that Chambers described “an apparatus for gas
exchange comprising an integral housing 12 that . . . encases the entire
device such that it is suitable for implantation into the thoracic cavity of a
mammal (Column 6, Lines 45-51)” (Ans. 10).
Therefore, the Examiner reasoned, “the housing of Chambers is
substantially the same as applicant‟s claimed pouch, in that it contains the
gas exchange element so that it may be implanted into the body” (id.).
Based on these teachings, the Examiner concluded that an ordinary artisan
would have considered it obvious to modify the blood gas exchanger of
Montoya, von Segesser, and Vaslef “with external housing that is designed
for implantation into the thoracic cavity because doing so would allow for
the blood-gas exchange to occur inside the body, thereby eliminating the
need for extracorporeal treatment. The use of blood gas exchangers placed
within the thoracic cavity is established in the art” (id.).
We will reverse this rejection as well.
While it is unclear how lines 45-51 of column 6 of Chambers describe
a pouch that contains a plurality of gas exchange chambers, we acknowledge
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Chambers‟ disclosure that the elliptical shape of its device‟s housing is
advantageous with respect to thoracic implantation (see Chambers, col. 3, l.
66, through col. 4, l. 3). Chamber nonetheless describes its housing as
“preferably comprised of a rigid material” (id. at col. 4, ll. 4-5; see also id. at
col. 9, ll. 4-9).
While it is well settled that the PTO must give claims their broadest
reasonable interpretation, it is well settled that that interpretation must
actually be reasonable. See In re Buszard, 504 F.3d 1364, 1367 (Fed. Cir.
2007).
As the Examiner has not pointed to any disclosure in Chambers
teaching or suggesting that its device should be contained within anything
resembling a pouch, and as we are not persuaded that a rigid housing can
reasonably be considered a pouch, we agree with Appellants that the
Examiner has not made out a prima facie case of obviousness as to claim 31.

SUMMARY
We reverse the Examiner‟s obviousness rejection of claims 1-10, 13,
14, 21, and 22 over Montoya, von Segesser, and Vaslef.
We also reverse the Examiner‟s obviousness rejection of claims 3 and
20 over Montoya, von Segesser, Vaslef, and Berry.
We also reverse the Examiner‟s obviousness rejection of claims 11
and 12 over Montoya, von Segesser, Vaslef, and Winters.
We also reverse the Examiner‟s obviousness rejection of claims 15-19
and 31 over Montoya, von Segesser, Vaslef, and Chambers.

REVERSED
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